The darkest aspect of corrupt clinical trials1 and the defective products that follow is the toll of injured people they leave behind.
Those who have not watched Dr David Graham’s brilliant Senate presentation2 on 18 November 2004—given while he was Associate Director in the FDA’s Office of Drug Safety—should do so3. It lays bare the Vioxx disaster.
Our public-health authorities dealt with the issues Dr Graham raised in predictable fashion: they strengthened the mediocracy to ensure that no principled, talented individual could rise high enough to cause trouble.
During the COVID-19 crisis, these same authorities professed deep concern for public welfare—but greeted the injured with gas-lighting and contempt, ignoring their insights and constructive suggestions. Perhaps they hoped the problem would die off with the patients themselves. Some did survive. Hardened by watching thousands censored and countless promises evaporate, they recorded their interactions with regulators.
React19.org has now released the audio of seven FDA meetings—redacting only a few names for safety—and paired it with an excellent timeline on therealpetermarks.com. The site documents the pandemic-era actions of Dr Peter Marks, one of the most corrupt public officials of modern times, who directed the Center for Biologics Evaluation and Research until March 2025, along with related disclosures that have since emerged.
In accordance with the administrative rule that the decision-makers must also rate their own decisions, Marks oversaw not only the approval but also the post-release safety analysis of the COVID-19 “vaccines.”
Readers may judge for themselves the diligence shown by these remarkable professionals.
It is impossible to convey, in full, seven hours of betrayed hopes, ignored suggestions, unmined data, and the prodigious incompetence of FDA officials and their VAERS subcontractors. Yet this short excerpt from Brianne Dressen’s plea at the 25 May 2022 meeting—one year in—offers a taste.
Transcripts generated with Whisper, curated for readability, appear below, each linked to the corresponding recording.
Please report in the comment any transcript error you may note.
FDA CEBR - REACT19 - 2021-04-10
[No sound up to 41 seconds]
00:00:41 -> 00:00:47
Peter Marks/FDA: ... and what you would like to see from FDA?
00:00:48 -> 00:04:19
Brianne Dressen: Well, as you can tell, we've got thousands of people that are having issues with the neurological side effects to the COVID vaccines. We are currently involved with research at the NIH, but the research at the NIH has been kind of mired and slowed in the last I want to say last couple of months. And in do that could be, you know, because of the surge of the Delta variant and everybody that, you know, across the country is spread thin. Unfortunately, because we are not able to get any kind of acknowledgement or communication to the medical community that this is happening, we've got a lot of people across the country that are sick and showing up in ERs and medical clinics without any kind of proper acknowledgement or provisions of any sort to help them. Unfortunately, now this is happening to teenagers and so even just last week I was on the call on a call in the middle of the night with a mom that was crying because she was in the ER with her daughter who couldn't lift her head up and her throat muscles were paralyzed and she was having all kinds of problems and her physicians there were just refusing to look into it at all. Unfortunately, you know, the NIH has told us, the very select few that have been there, that earlier intervention is something that definitely could help stop the neurological decline that happens after the vaccination reaction ensues, but because the medical community doesn't know that this exists, these people are not being afforded that essential medical care. So for me, it's very black and white, this is an issue. Obviously, neurological reactions have happened with previous vaccines, you know, in particular we have the HPV vaccine that has, you know, documented several cases with autonomic, dysautonomia, neuropathy, several things that are pretty similar to what we have going on. And so it's kind of naive for us to assume that the COVID vaccines would not be doing the same thing, but at this point, if you're okay with it, I'd like to turn that time over to Dr. [redacted] but just to kind of give you an introduction of who she is. She's a physician who's double board certified in both emergency medicine and critical care medicine and the former chief resident and chief fellow in each of her training programs, and she currently splits her time equally in both departments, and she is the director of the emergency critical care at her shop, and she is suffering from a similar neurological injury as I am, as well as thousands of others, and she has, you know, she's maintaining a scientific mindset about it and her experience in treating the sickest of the sick of COVID patients allows her to fully understand how important the vaccines are despite her own injury. So I want to turn that conversation over to her because I do think that her perspective from a, you know, frontline medical personnel is pretty relevant to this issue.
00:04:20 -> 00:08:54
Anonymous Dr: Thank you, Bri, for inviting me. I'm so grateful for this opportunity, and Dr. Marks, it's really wonderful to meet you. I know your time is very valuable, and I'm incredibly thankful to you for speaking with us. You asked what our goal was, and our goal is that we want the FDA to publicly recognize vaccine-induced neurological injuries. And as Bri was indicating, this recognition is a crucial piece of the puzzle to help those afflicted receive the proper diagnosis and treatment that they deserve. As you know, the physician community holds the FDA guidance regarding the safety of the COVID vaccines and incredibly high esteem. So when the FDA recognizes an adverse vaccine reaction, the resulting physician education from this dramatically improves diagnosis, and treatment outside reaction. And myocarditis is a great example of this. I saw this in my own shop when I was still able to work clinically. In the spring, we had a patient who, in hindsight, likely had myocarditis from the Moderna vaccine that we didn't recognize. But by the summer after the FDA communications about myocarditis came out, both the ER and cardiology teams were tuned to look for it. And together, we identified over 20 patients within a few short weeks, including a teenage child at one of our EP cardiologists. Our patient care dramatically improved all due to the FDA advisory. But the unfortunate downside of your reputation being so strong in regard to vaccine safety is that a shockingly overwhelming amount of physicians are only willing to talk about the FDA-recognized vaccine adverse events.They have become completely closed-minded to the possibility of any other adverse reaction existing. And it's resulted in a negative feedback loop. So the FDA is not naming additional adverse reactions to the vaccines because the passive surveillance systems aren't displaying it. But the passive surveillance systems aren't displaying it because physicians are blinded to the adverse reactions in their patients. And thus aren't reporting them. We need to figure out how to break this loop. And I believe that this loop is why we're having a hard time getting recognition from the FDA regarding our neurologic reaction. What we have found in the form of neurologic injuries in particular is that for us as individuals, it starts with a clear temporal relationship with getting the vaccine. For both Bri and I, it's glaringly obvious. It started within an hour of getting the vaccine. For both Bri and I, it's glaringly obvious.
It started within an hour of getting the vaccine. And we're both young, and we were totally healthy before getting the vaccine. We then interacted with others that this happened to. And it led us to identify the same pattern. The same neurologic injury pattern in thousands of others. And our data shows that it occurs predominantly in the young and previously healthy women. And these are less injuries. They're life-altering, severely disabling neurological injuries,
neurologic injuries to the point that people have committed suicide because of it. By us being injured and by us, you know, connecting with so many others,
it puts us in a unique position where we can see the pattern and the incidence
beyond what a single physician or a single researcher or health organization can see. But despite our unique position, we unfortunately see that on our end,
and especially on your end, that we're both drastically underestimating the true incidence of vaccine-induced neurologic injuries. And it's partly due to reactions. These neurologic reactions include rare disease entities such as small fiber neuropathy and dysautonomia. I know it was something that I had not heard about, nor my PCP, or even my general neurologist. And it took me eight months to get that diagnosis. And I can't imagine how long it takes somebody who's not medically savvy to obtain it if they ever do. But it's also partly due to poor physician insight on the possibility of vaccine injury to begin with. As I mentioned above, it's a terrible combination. It directly hurts patients. But despite the gross underestimation of neurologically injured,
we believe that enough data exists already to demonstrate the signal of its existence at minimum. Thus it was concerning for us to hear that from the FDA's perspective, that those safety signals haven't been identified, that we exist.
We want to try and figure out with you how this happened, where the breakdown might be, and how to correct it. So we're really hoping to have a conversation with you that has more specific details with how the FDA has looked into things such as small fiber neuropathy, dysautonomia, general neuropathy, in response to our previous communications and meetings with you.
00:08:55 -> 00:10:08
Peter Marks/FDA: Yeah, no, thank you. So we have looked into a variety of neurologic syndromes that are typically that have been seen with previous vaccination efforts
as part of both our passive surveillance in the VAIR system,
but also we're starting to look into it using our active surveillance systems,
both the vaccine safety data length from CDC, which the CDC works with,
but we have the best system. It might be helpful for me. I mean, just to get a better understanding, we are generally looked for certain conditions.
It's not like we can just cluster neurologic symptoms in general. So is the majority of folks with this, is it dysautonomia? What would you say are kind of the top three? Not to be just one, but what are the top couple of things that you think we should be looking for?
00:10:09 -> 00:10:10
Anonymous Dr: So they're all in the neuropathy family. Go ahead, Bri.
00:10:11 -> 00:14:29
Brianne Dressen: Yeah, so you definitely have neuropathy. Small fiber neuropathy sometimes is coming up. Dr. Safavi at the NIH would be someone that would actually be, and Dr. Wallet at the NIH would be really good to ask them about their theories on that because they believe that even if the small fiber neuropathy tests are not coming back positive, that there is some type of inflammation that's causing neuropathy to happen. I myself have non-linked dependent neuropathy, and so the neuropathy is presenting in a couple of different ways, and then also that's extending to the dysautonomia. The dysautonomia has actually been very, very common. Unfortunately, as you guys know, with dysautonomia, it's something that it's a broad myriad of symptoms, and it's hard to pin it down, especially if you're looking at a various report where it's symptom-by-system broken out into different, totally separate symptoms instead of clustering them together. The strange thing is that, especially with, there's a researcher in LA that's finding the spike protein in the non-classical monocytes of long haulers, so symptomatic, you know, people who are having symptoms, lingering symptoms after COVID infection. Their long haulers are coming back after they were having issues from the COVID vaccine. Of course, it's not all of them, as you guys know, some improve. Some most stay the same, and then there are some that get worse, but the group that got worse, they started coming back saying they had symptoms, so then they were curious, and they decided to ask the question, well, what about people that have never had COVID, that are also presenting with similar symptoms to long haulers? So they've tested our blood, they tested my blood. I have, and I'm 11 months out now, past vaccination. I have over 50% of my non-classical monocytes have some kind of spike protein particle in them. So this is something that they're seeing in what they're calling the post-vaccine syndrome group, as well as those that are long haulers. But the interesting part about this information that they're putting together is the asymptomatic post-vaccine group do not have spike in their non-classical monocytes. And so there is some kind of physiological connection there between the two groups, and maybe it is an immune dysfunction, an underlying immune dysfunction. But I do know that Dr. Spabian, Dr. Wallet and Math is overseeing what they're working on, and there's a couple of researchers at Mount Sinai, as well, that are vaccine experts that have looked into it as well. There's Dr. Poland at Mayo, and he's been trying to run the case series, but unfortunately, because of the polarized dynamic, he hasn't been able to get the case series published. I do think that the case series that he has done is very well done, and it does kind of describe the dysautonomia portion of this, and the neuropathy, as well. The third thing, which has been published by a team of physicians at Harvard already has to do with the imaging for neuroinflammation that's been coming up, and that's been coming up in a smaller subset. So, new lesions on the brain and the spine. With some of our cases, actually, the lesions on the brain have decreased as they've gone further away from the, you know, their initial vaccine reaction. The dysautonomia is a big one. Is there another one that you can think of that I'm missing? So, we've got neuropathy dysautonomia, but the dysautonomia seems like to be the big one. There's a smaller subset of people that have had autoimmune markers pop up, but the problem is it's not, it doesn't appear to be consistent with. Reflective of, you know, everybody seems like neuropathy, and the dysautonomia seems to be the top two.
00:14:30 -> 00:15:33
Anonymous Dr: From our perspective, I think the easiest place for the FDA to start would be the small fiber neuropathy. And the reason I think that is when you look at the published incidents of small fiber neuropathy, it's low to begin with. But the study that's out there, the Neurology Green Journal, talks about it being a male predominant disease of an average age of 56. And what we found in our own data of the injured is that we have a percentage of women, 85% women, is who are finding, and 80% of them are in an age range of 20 to 49.
My Gestalt, though, looking at all the cases that we see, is that the peripheral nervous system is under attack in different ways. Whether it be like a mono neuropathy, or a pneumonic neuropathy, or misdiagnosed as a routine like peripheral neuropathy, and really probably small fiber. But I do think small fiber is probably the easiest one to start with to show that there's a signal of a problem.
00:15:34 -> 00:15:41
Brianne Dressen: Right, and then unlike the pendant one, because that's the limit, a lot of us that have negative small fiber neuropathy, that one's been popping up for some reason.
00:15:42 -> 00:18:14
Peter Marks/FDA: That's really helpful to hear. So this is like the type of neuropathy that Dr. Waheed published back in April. Is that correct?
Anonymous Dr: I'm not familiar.
Peter Marks/FDA: It's kind of a post-COVID vaccine, small fiber neuropathy,
or a documented case of that. So that's okay. I'll hold up on it, because I got that. So just in terms of what I can say that we'll do here, I mean, I'm very happy to go back to our, and it seems for us to make some kind of a statement publicly, we have to have, we have to find the data in our database that says that in a group of vaccinated individuals, versus a group of unvaccinated individuals or comparing pre-vaccination, post-vaccination, as we sometimes do in intervals, that we have some type of signal. Now it sounds like if you say that there are thousands of people that have been injured in this way, we're able to, these are relatively uncommon diagnoses. And we were able to pick out, you know, we pick out, we routinely have picked out, you know, higher incidences of things like Guillain-Barré or a thrombotic thromocytopenia syndrome in the case of the Johnson vaccine. It doesn't have to necessarily be as common as myocarditis, so which is also still a relatively rare event. So we'd want to try to go back to our databases and see if we can, if we can tease these out using additional key terms and see where we get to, because that's how we generally, you know, that's how we generally work. We work based on data showing that even small safety signals here should be detectable. And you know, safety signals enroll these small numbers of people when they're relatively unusual things like small fiber neuropathy. And that's not a common diagnosis.
It should, as we go through our electronic databases, even if it's not thousands of people, even if it's hundreds of people, we should be able to pick that up.
00:18:15 -> 00:23:23
Brianne Dressen: So what about paresthesia? Paresthesia is a pretty good one.
And I've noticed in the various system that one's pretty significant. Actually, with the Canadian COVID Task Force on their tracking database, with their severe reactions, they have paresthesia is actually number two above headache, myalgia. And I have noticed that, at least with the paresthesia, that's definitely one of the, you know, I want to say top five symptoms that people are complaining about.
Peter Marks/FDA: And that's on an ongoing basis, or just shortly after getting the vaccine. It's a continuing months after.
Brianne Dressen: Yeah, I still have it. And it's severe enough that it keeps me from being able to function at a normal level. Like my body just feels like it's fighting itself all the time, because the paresthesia is that bad. There's internal tremors as well, but I think people are lumping that into the paresthesia as well. I sent a copy of our latest patient-led survey, because, you know, we want to be taken seriously. So we really do a very thorough job of vetting who we work with. And we also were sick and so our time and our energy is very limited. And so we do do a thorough job of vetting who we work with and who we include in surveys and such. And paresthesia is really high up on the list. I can't send it to you, because I sent it to Dr. Woodcock a while ago. But it illustrates, you know, that the reaction starts within 24 or 48 hours for the vast majority. And within the first week for another solid chunk. And just like we mentioned earlier, it's young people. And it's predominantly female. And the top symptoms are all things that are lasting. There are some people. It appears to be about 39 to 40 percent of us. The symptoms get better with time. The other portion, it appears to be split evenly between symptoms that evolve as time goes on. And there's another chunk of people that things get worse. So we have people that could walk at the beginning and now they can't even walk. And those are the ones that I'm really concerned about. You know, obviously, well, I mean, they're all concerning. But the fact that these people went from healthy functioning people to now they're.
Peter Marks/FDA: If they can't walk, that's paralysis. That should be, that should show up in databases as paralysis.
Brianne Dressen: So the problem is, is that they're being diagnosed inappropriately diagnosed, because nobody knows that this can happen. So if it is some kind of progressive neuropathy, you know, and all of a sudden their legs are stopping working. And I mean, there was a gal. She's a nutritionist, a dietitian. And, you know, all of a sudden she became incontinent and her legs stopped working. So, you know, it's like, okay, and the physicians don't know what's going on with her. So they're not sure, well, do we need to run imaging to see if she's got transverse myitis? That's popped up, you know, a few months after her initial onset or, you know, like there's just a bunch of messy question marks that are popping up for people and we're not able to get care. And it's really just because we don't have any doors that are opening to just even have, you know, the medical community would get it. And it's, you know, like my husband in my family, I mean, just not that people should have to prove that they're worthy of getting medical care, but, or, you know, to be taken seriously. But like we're still pro-vaccine. My husband's here in, he's in a pro-vaccine campaign here locally done by the county. His face is on the side of buses telling people to get vaccinated. I mean, so it's not a question of whether or not to vaccinate. It's a question of, okay, we have limited, you know, we have a rare portion of people that are being harmed. What do we do for those people? And then especially because now this is happening to youth, that's been incredibly disturbing for me to see those, you know, those parents come into these groups now and they're terrified for their little kids. And the crazy thing is, as we've had a couple of kids for quite a while, that their ability to get medical care has not progressed at all because the subset of specialty, as you know, for pediatrics is incredibly small when you start looking into neuropathy in kids and dysautonomia in kids. And so we need to make sure that there's some kind of plan or anything. I mean, even just people being willing to recognize it before this keeps happening to more kids. These kids definitely deserve to have some kind of protocols or even physicians that are willing to look at it before, you know, their lives get ruined.
00:23:24 -> 00:26:05
Peter Marks/FDA: So they're not getting pediatric neurology care. I mean, it would seem like if nothing else, they would need to be getting routine care, regardless of the vaccination or not.
Brianne Dressen: Yes, and that's what's been frustrating because they're by and large and this has been the issue with the adult population as well because this is not being discussed and because this is not being communicated with the medical community. Like even if it's closed communication with medical organizations, I think that would make a lot of head wave for people to be able to get appropriate care going. But because it's not recognized on any level, we have several kids that are being labeled with FND. And then they're not even afforded the opportunity at all to get much needed immunotherapy, which is immunomodulatory therapy, which is what the American Academy of Neurology has said. And I talked to Dr. Woodcock about that too, you know, about what the American Academy of Neurology had issued with their guidance. They said that these neurological issues could happen from the vaccines and they listed out several. And they said that because there is a recording bias, there is concern and that these reactions, you know, this issue must be acknowledged and possible immunotherapy being implemented. Somehow we need to get that communicated to the medical community because immunotherapy at a time where people actually need it, they're not being afforded that essential care. I know for myself, I'm 11 months in and I am just now starting the paperwork with my insurance to file for IVIG. 11 months into it. So at that point, if you think about someone that's got like a cyclical, you know, persistent neurological syndrome that could be of, you know, reversed or stopped from the issue of progressive neuropathy, it would only seem appropriate that, you know, that these people are afforded the interventions that are there and are available to try. And I'm actually very, very, very rare case of being able to get my physicians to even consider IVIG. As Dr. Mills, she's doing the same problem.
00:26:06 -> 00:27:24
Peter Marks/FDA: The do out that I have is I will go back with our epidemiologists and see exactly what search terms they've queried, where we've gone. And I think probably the other thing that I will do is I will try to get from Dr. Woodcock. It sounds like there was a survey that you sent to her. I'll try to get that from her and if I can't, I'll ask Lori to get in touch with you so we can get another copy just sent to us. So I cannot take a look at that because I'd like to take a look at that. I haven't seen that myself. We obviously want to try to, you know, we take, we take all adverse events very seriously and especially if they're really impairing people's lives. In order for us to make some broader statement, we need to try to understand them better and I think probably by going through our databases appropriately, that may be a helpful start. So I will go check with our statisticians and our epidemiologists to see whether we've actually looked through, because we may have looked at some broader search terms instead of the more specific ones that you've given to see if we can see anything in terms of a neurologic signal here.
00:27:25 -> 00:28:47
Anonymous Dr: The problem that I find with VAERS is that we are encouraged to report a reaction immediately. So when we report a reaction, it's not neuropathy that we're reporting. It's paresthesia because it's too soon. You have to have a continuing paresthesia over time to have a neuropathy. So as a result with the neuropathy diagnosis, we're not encouraged as a public to go back and update our VAERS report. And I know that when I tried to do that on the website, it says email this email address and will give you a code to update it, and it never happened. And it wasn't until my six-month V-save check-in that they told me to put in a separate VAERS report on which neuropathy still wasn't my diagnosis yet. So one of the things that should overcome that weakness is what's published on the CDC website. The contractor for VAERS is supposed to request health records for everybody that has a serious reaction, and it clarifies that a lasting disability is a serious reaction. But we pulled our people and other people who put in a VAERS report. 78% of them never had any follow-up. So I'm concerned that the reason why you're not seeing it is because VAERS is not set up to recognize this exact rare entity.
00:28:48 -> 00:29:49
Peter Marks/FDA: Well, we also have the best database which uses claim databases and electronic health records, which is in many ways more powerful for us to be able to detect signals so we can query that as well, and that may be helpful. I'm unfortunately going to have to go to another meeting, but we will circle back here. It may take a little time because we have to get our programmers to do the programming, and then potentially run these other search terms through our various systems, and they do these every other week in a way of running them through the databases. But I'm talking, has been concerned about this, and I share her concern that we take the seriously to look into it further.
00:29:50 -> 00:34:03
Anonymous Dr: There's 88 distinct search terms on VAERS, so I'm hoping that we can look at all of them to indicate neuropathy. 88 different ways that VAERS lists it when you curate to indicate neuropathy, so I'm hoping we can look at all of them.
Brianne Dressen: That would be a good list to send.
Peter Marks/FDA: Yes, please feel free to send that to us. That would be helpful. Okay, well, thank you so much for taking the time today, and we will follow up. So you'll send us that list, or you'll make sure we have what you sent, Dr. Woodcock, and I'll look over all of that. In the meantime, I hope that things get better for you both, and we'll continue to look into things. Thanks. Take care.
Lorrie McNeil/FDA: We appreciate you taking the time.
Brianne Dressen: Thanks, Laurie. Thank you.
Lorrie McNeil/FDA: And I'll be in touch if we don't have the survey. I'll shoot you an email to follow up on that.
Brianne Dressen: All right, sounds good. And actually, I'll send you an updated one anyway, because we have. We have a lot more data points, so I'll send you an updated one as well. I'll work on that today.
Lorrie McNeil/FDA: I'd be terrific. Whenever you get a chance to get to it, in the meantime, we'll look and see what we have there.
Brianne Dressen: All right, sounds good.
Lorrie McNeil/FDA: Thank you both. Take care. Thanks.
Anonymous Dr: Thank you for your time.FDA CEBR - REACT19 - 2021-08-23
00:00:00 -> 00:02:08
Lorrie McNeil/FDA: We are ready to proceed when you all are. Okay. Wonderful. Good morning, everyone. Thank you so much for joining us this morning to share your experiences following vaccination with COVID-19 vaccines. My name is Lauren McNeil and I'm the Director of the Office of Communication Outreach and Development in FDA's Center for Biologics, Evaluation and Research, or CBER for short. As you may know, CBER is a center within FDA that's responsible for regulating vaccines. Joining us today from FDA are Suzanne Frantz-Bohn, the Deputy Director of the Office of Communication, Diane Bartell, the Director of the Division of Communication and Consumer Affairs, and Paul Richards, the Chief of the Consumer Affairs Branch. Unfortunately, Dr. Marks, the Director of CBER is unable to join us today due to a conflict. We look forward to hearing from each of you during the meeting. I'd like to start off with a few housekeeping announcements. First of all, we understand that each of you would like to share your personal experiences and how the adverse events you've experienced have impacted your lives. Given our limited time today, we would ask that you limit your remarks to five to seven minutes each for this portion of the meeting. We'd also like to ask you if you're comfortable to turn your camera on when it's your turn to speak and provided you're comfortable again doing so. We'll also ask you when it's your turn to unmute your microphone. I think a box will come up in the screen asking you to do so. I'd also like to note that FDA will not be recording or transcribing today's meeting in any way due to the potential inclusion of personal health information in our discussion. Finally, if for any reason you're having any technical difficulties today, please raise your hand and we'll reach out to you. You'll find this option across the bar at the bottom of the screen under the reactions icon and you can just click on raise your hand. So with that, I would like to turn it over to Ms. Dressen for introductions.
00:02:09 -> 00:02:42
Brianne Dressen: Hi, thanks so much for having us. Yes, we were told that Peter Marks would be here. So we look forward to speaking with him at some other time, hopefully soon. I am Brian Dressen. I'm a preschool teacher here in Utah. Thank you for meeting with us and putting this together and taking the time to hear our voices. We are going to first start with Dr. [redacted] and then after [redacted] speaks we'll hear from Dr. [redacted] and then Denise Hertz, Dr. Denise Hertz.
00:02:43 -> 00:09:06
Anonymous Dr: Hi, can you guys hear me okay?
Lorrie McNeil/FDA: Yes, we can. Thank you.
Anonymous Dr: So thank you for having the meeting today. My name is redacted. I'm the current attending physician at redacted hospital in Pennsylvania. In terms of my medical background, I was chief resident in emergency medicine residency at redacted. Chief fellow at University of redacted medical center and critical care medicine fellowship. I currently split my time 50 50 between the ER and the ICU and I'm director of critical care. This pandemic has been awful. My hospital this past winter had an incredible surge of patients and I was responsible for an unsafe amount of patients in the ICU, especially overnight. At one point we ran out of ECMO leading me to make tough ethical decisions that still haunt me to this day. To say that I was excited about the vaccines when it first became available is an understatement. The risk benefit ratio was and still is clearly in favor of a vaccine. And I still believe in the vaccine strongly despite my own vaccine induced health issues and despite the health issues that I have seen in my patients. I'm here today because I'm concerned that there's a failure in your vaccine safety monitoring systems that is preventing you from recognizing and thus further investigating safety signals regarding adverse events caused by the vaccines. Your agency has stated that with rare outcomes you have to start using the vaccine to see them. Thus you need a robust safety monitoring system to find this. And I'm concerned that you don't currently have this. I believe this because I am an example of a rare outcome that the FDA is not recognizing or investigating. I have symptoms since this time that are still ongoing to this day, which is nearly eight months later. I am disabled from them and I'm currently on my third leave of absence from work due to them. Every single physician that I have seen cites the vaccine as a direct cause of my ongoing health issues. My main and most disabling health issue has been vertigo, which I've been diagnosed with vaccine induced neuritis. But I have other symptoms too. Without concrete diagnosis, they've been progressing and escalating over time. I have issues such as chest pains, ascending paresthesia, intermittent muscle weakness, brain fog, inappropriate tachycardia presyncopy. These symptoms when I list them and it's listing on VAERS makes them sound more benign and insignificant than what they actually are. When I tell you that I'm currently scheduled for testing over the next few weeks to rule out myopera carditis, small fiber neuropathy, pots and dysautonomia. The conversation suddenly changes and gives you a much better sense of the level of disability that I have. And the level of concern that other physicians have. My repeated work absences unfortunately negatively affect my community and my colleagues. And especially have affected the critically ill pediatric and adult patients who need ECMO as their last hope for survival. And I cannot currently accumulate them. I am especially concerned about the VAERS reporting system. This system is co-sponsored and monitored by the FDA as a passive surveillance system intended to help identify potential signals of harm. I have concrete data to demonstrate my concern. This year I have submitted 17 reports to VAERS. 18 including my own. 11 of these patients that I have that I submitted, they had their symptoms start within seven days of receiving the messenger RNA vaccine. 16 of them were hospitalized, 12 of them in the ICU, six of them died. VAERS asked for stat medical records for one of them. A patient whose medical records was not collected includes a 44-year-old gentleman with normal BMI, no medical problems, no family history. Who's asserting that the day after receiving a second dose of Moderna felt fatigued and felt this way every single day until day 12 when he had acute cardiac arrest? There is no justification for not investigating at minimum all deaths reports to VAERS, especially in the young and previously healthy. Of nine other patients that I had who were hospitalized, who did not die, VAERS asked for only two of their state medical records. A 29-year-old female was not included in these medical records requests, and for her only four days after receiving her second dose of Moderna, she was given TPA due to concerns for a stroke. Also included on this no further investigation list is somebody that I submitted that I was concerned was a marker of vaccine enhanced disease. On the VAERS website, there is a link between a 2015 article entitled, Safety Monitoring and a Vaccine Associated Event Reporting System. And I quote from this article for reports classified as serious. The VAERS contractor requests associated health records, including hospital discharge summaries, medical laboratory results, death certificates, and autopsy reports. Serious events include at least one of the following, deaths following vaccination, life-threatening health event or lasting disability. My own case in those patients I reported demonstrate that this follow-up is not occurring as published guidelines indicate that they should. And you have a process and system failure as a result. So in some, even though the risk-benefit ratio clearly favors the use of the vaccines, the FDA is responsible for identifying the minority harm from the vaccines so that they can take steps to mitigate this risk for this minority. And if they can't mitigate it, then at minimum, providing guidance to medical community, to aid in the identification and treatment of such adverse events. I, as well as my patients listed above, are proof that the current systems in place intended to allow the FDA to perform this duty have failed. This FDA failure is transmitting to a failure of the medical community to properly recognize, diagnose, and treat such patients. Thank you for this time and the opportunity to speak with you today.
00:09:07 -> 00:15:16
Brianne Dressen: Dr [redacted]
Anonymous Dr: Good morning. Can you hear me? All right. My name is Dr. Redacted. I'm an MD as well as MBA in health care administration. I came from Canada to live the American dream. I went to Emory University for my family medicine residency where I also served as chief resident. I'm a fellow of the American Academy of Physicians and also worked as a research coordinator for the highly regarded podiatry institute in Atlanta. My most recent job is as an outpatient primary care provider. I'm a 40-year-old, healthy former ballet dancer and up until I got my second Pfizer shot, I still danced and worked out six days per week, even while pregnant. The pandemic has hit us all hard, especially me. I was cut off from my family in Canada and still am today. I said goodbye to my dying grandfather over the phone. I worked in my clinic during COVID, while pregnant, and had to procure my own N95 masks due to the lack of PPE, within my hospital system. The only bright spot was when I welcomed my first baby, a daughter, one year ago, in August. Unfortunately, my Canadian family has still not met her to this day. When I returned to work after the baby, the vaccine was just available. My office staff was too scared to get it, so my partner and I decided to get it and show them it was safe and the science was strong. At four months postpartum, I got my first shot on December 26, 2020. I started having flushing tachycardia, elevated blood pressure, and dizziness 11 minutes afterwards. I was monitored for about an hour and it self-resolved. A nurse told me they had seen a few flushing reactions, but that it wasn't a big deal. The same thing happened after my second shot. On January 15, except this time, it started two minutes after. The episode lasted 20 minutes, and then I left. It then happened again, but worse, while I was driving home on the freeway, my face was on fire, and I felt like I was going to pass out. I barely made it off an exit, and into a parking lot. After that, I started having severe flushing tachycardia, and dizziness episodes more frequently, even at night. My whole body would tingle, even my tongue. I eventually collapsed at my practice on February 6, and was taken by ambulance to the ER. My D-dimer was extremely high, but my CT pulmonary embolism and everything else was negative. I was told that I likely had postpartum anxiety, and to get some more sleep. The ER doctor said that there was no known adverse vaccine events like this. Over the next few months, I underwent over $100,000 in workups, with doctors who had no idea what was going on. I was fortunate to be accepted into a study by the NIH, and was diagnosed by them, with immune-mediated dysautonomia, pots, and small fiber neuropathy, induced by the Pfizer COVID-19 vaccine. I progressively lost the ability to walk more than 100 feet at a time, and spent days in bed. I spent two weeks at the NIH, away from my baby, and was admitted for five days of IVIG. It was heartbreaking, because before I left for the NIH, my baby had just started saying, Mama, and when I returned, she didn't say it again for over a month. I was unable to work for 12 weeks. I was still very weak when I returned. However, my employer denied an ADA accommodation, and told me enough is enough, do you know how much money you cost us? They threatened to fire me if I didn't see my regular patient load. I was unable to do so, and they terminated me, without warning, or notifying my patients, on July 2. I made three VAERS reports since December 2020. I got a 60-day follow-up letter from them, in June, and then, they urgently requested my medical records, July 9. I have never heard back, after I uploaded three documents, which is the maximum allowed. I requested a key to upload more, and even called them about this. They said to wait a bit longer for the email, and that they really just wanted to see a copy of my vaccine card. I also responded to all VSA reports. I self-reported to CISA, but got turned down by the pediatrician, who was evaluating adult cases, because she felt I likely had a history of COVID causing my symptoms, and that I needed blood work to prove I never had it. I eventually got this blood work months later, at the NIH, and it was negative. I emailed Janet Woodcock about my issues in February, and she stated she couldn't help me. She admitted, in another email to someone else, that she has been in contact with Dr. Nath at the NIH, and is aware of them studying our vaccine reactions. This means the FDA knows what is happening to us. I am angry, because the FDA issued a warning about single-digit myocarditis cases, yet has completely ignored the immune-mediated neurological complications that they know about. Between my patients, my friends, and my husband's contacts, thousands of people know my story. The fact that the government keeps its secret breeds distrust in the vaccines. The NIH has studied at least 50 to 60 people, with the same type of reactions in person, and they do many more telemedicine evaluations. They told me they get hundreds of emails per day about these vaccine reactions. I was offered a national interview to discuss my experience, but turned it down out of fear of repercussions to my job and my license. I am still pro-vaccine, however, I feel like collateral damage. My life matters. My thousands of patients need me. My family needs me. I still can't dance. I wake up and feel like an arthritical woman. I want another baby, and I don't know if that can happen. If the FDA would be more open and honest about these reactions, it would improve treatments, and actually increase trust in vaccines. We know that you know, why aren't you saying anything? Why aren't you issuing a warning? I did my part when I lost my job and my health. I want you to do your part. Thank you.
00:15:17 -> 00:20:06
Brianne Dressen: Dr. Hertz?
Dr. Denise Hertz: Hi, thank you so much for having us here today. My name is Dr. Denise Hertz. I am a 64-year-old retired UCLA trained gastroenterologist. I was in private practice for 33 years and retired just a few months before the pandemic started. I received the Pfizer COVID vaccine on December 23rd of 2020. I was eager to take a step toward putting COVID behind us. I was told the vaccine was safe and effective and was given no warning about any potential side effects. Little did I know, my health would be robbed for me that day. I soon went to bed with agonizing burning pain and numbness in my face, scalp, tongue, eyes, and limbs. I felt internal vibrations, tremors, twitching, as well as a very tight band around my chest. My vision became blurred, my eyelids swollen, and I had loud ringing in my ears. I experienced rep-sided chest pain, shortness of breath, and tachycardia. I had profound fatigue, walking a few steps was a major effort. When the symptoms peaked, I felt like I was being electrocuted. I saw many doctors who did not recognize what was wrong with me and told me I was fine. I told them I was not fine. I said help from experts across the country, including the NIH. I was eventually diagnosed with mass cell activation syndrome and was put on many medications with minimal results. My case was presented at CDC brand rounds and they were agreeing with this diagnosis. The symptoms have gradually lessened but are still present every minute of every day and are still at times unbearable. I have worn out, been so ill and in pain for so long. I believe that there is some physiological process occurring in my body, post-vaccine, that we don't yet understand. I have cried out loudly to the heads of the FDA, CDC, NIH, and Pfizer to no avail. Instead of running to help us and look into these reactions, in fact, you have run away from us. My many reports to be safe, theirs, and Pfizer have gone unnoticed. I started writing comments after articles on the internet and people contacted me from all over the world with similar neurological reactions to the vaccines and similar inability in getting medical care. We formed a group of 150 people and are fighting for recognition and help. We have hit a brick wall with every effort. There are other vaccine injury groups with thousands more. There's reports many thousands with neurological insults from these vaccines. Why is nobody following up? Why won't anybody help us? The people in my group are believed in the vaccines. We are believed that every effort should be made to stop the pandemic. We are pro-vaccine and pro-science. We are Americans and humans deserving of medical care. We are being ignored by our government and the medical community. We are collateral damage from the pandemic. We have a new disease. We are calling it post-COVID-Bex-seen, wrong-haul reaction. We need doctors to be aware that these reactions are happening. We just need medical care. We need to have top-level research to study when it's caused these reactions and how to treat them. I am pleading with you, the FDA, as well as the CDC, NIH, and vaccine manufacturers to help us. We can continue our campaign to control the pandemic and help the vaccine injured at the same time. Ignoring us is not acceptable. Bearing the facts is just plain wrong. It is un-American. It is inhuman. Thank you so much.
00:20:07 -> 00:28:27
Brianne Dressen: Thank you, Dr. Hertz. I'm going to try to make my comments pretty quick. My name is Brianne Dressen. I'm going to try to make my comments pretty quick. My name is Briandressen. I am not a physician. I'm just a preschool teacher here in Saratoga Springs, Utah. I'm the parent of two small kids. I was previously healthy. I was so confident in this that I enrolled in the clinical trial here in the United States for AstraZeneca. Unfortunately, my reaction started within an hour. It started with tingling down my arm. I ended up with severe blurred vision and double vision by that night. And I had extreme sensitivity to sound by the time I went to bed. The following morning, after a typical vaccine response with fever, myalgia, overnight, that had resolved. And by the morning, I got up to get ready for work. And I had a slumped left leg. And so I was walking into the left side of doorways. Sensitivity to sound was still there, as well as the vision problems. I still went to work. And, of course, by the end of the day, things were so unbearable for all of the sensory input that I had to have. The lights turned off in the classroom. And I just remembered telling the little kids over and over, well, your voices are a little loud today. So I called the test clinic, unfortunately. I didn't hear back. Called them the next day. Things were worse. I was trapped in my room in darkness and silence by myself. And I didn't hear back. And so I heard back from them on the third day, I went in for a neurological evaluation. And they said, well, you probably have a mess. So that was off to the ER we went because no neurologist in town could see us for, you know, three months. Unfortunately, that was one of many hospital visits. And within two and a half weeks, my function had declined to the point where I could no longer walk. I was incontinent. I couldn't have a bowel movement. My heart rate was skyrocketed. I had extremely high blood pressure. And I began to have this extremely painful electrical sensation surging through my body that continues to this day. And when I was admitted to the hospital, obviously, it was during the clinical trial. So it was expected that nobody really knew what was going on. I wasn't blinded from the clinical trial. And then I was dropped. I am unsure what happened to my data. I do believe that if my case was reported to the DSMB. It would have showed anxiety because that's what my medical records showed. So my legs stopped working because of anxiety. And unfortunately, fast forward a little bit to now where there are thousands of us that have found each other. What has happened to me and my misdiagnoses and the lack of understanding is still happening today. It is just as relevant. The conversation has not changed from when I first went into the hospital. This conversation is the exact same conversation that the vast majority of us are experiencing and having with our physicians. That this is something in our heads that this is not happening here in Utah just two weeks ago. They released a PSA from the most major hospital system here in the state. They are the largest employer here in the state and they run over 80% of the hospitals. And in their PSA they said that vaccine reactions are not happening. And that this is misinformation and it is dangerous and it needs to stop. So you can imagine hearing that as someone and there are hundreds of us that I know of here in Utah that have had this very similar neurological reaction to hear that from the very top that's an approved message being sent out to the entire state. And that it is okay for that to be aired instead of there are some rare reactions. Let's talk about those. Instead it's nope, it's not happening. This is making a complete stop gap in people's ability to get medical care because this reaction is not being acknowledged. Unfortunately, I wake up every single day trying to convince myself that it's okay and I have to live this way for the rest of my life. Unable to work, burden on my family. With an incredibly painful electrical sensation searching through my body 24 seven. I went eight months without any appropriate diagnosis because nobody understood what was going on because it's not being talked about. I was one of the few fortunate to fly out to the NIH where I was finally able to receive appropriate diagnoses, non-lake dependent neuropathy, short-term memory loss, sensory neuropathy of my hands, severe pot, severe autoimmune dysautonomia. I was then given IVIG which fortunately made it so I didn't feel like I was dying all the time. So it dialed it down just a little bit. I subsequently came home with a stack of documents from the NIH and my physicians here because this still is not being acknowledged, dropped it. No interest in taking care of it, no interest in medical care for me, for follow-up. The stories that you heard today, there are thousands that each one of us have heard. This suffering that is upon us is profound. We are being silenced and that's not an exaggeration. There's a reason that these physicians came here today with the special request that this be confidential and it is because of the very real risk that there will be repercussions with their jobs. They have a very real illness and they should and absolutely deserve to be seen and heard and believed by their medical care teams. We absolutely believe that the vaccines do play a role in prevention of death and to mitigate the spread of the disease. Unfortunately we wrote a letter because nothing was happening to help us. So we unified and we wrote a letter in May and we sent it to the heads of the FDA and the CDC and as well as to the White House and it described the nature of the reaction which is a broad myriad of symptoms and our plight and our complete lack of to get medical care. Unfortunately every single word that we wrote in that letter is just as relevant now as it was then if not more so. We need help and we needed help months ago. We have been pleading and begging for months. The time is now and we definitely need acknowledgement and it needs to be communicated to the medical community. This is completely unfair to the patients but this is also not fair to the physicians and practitioners who are met with this reaction when we show up into the ERs. At the NIH they have repeatedly told me and others that this can be mitigated with early intervention and possible immunotherapy. It breaks my heart to know that there are people like me that did their job to protect those around them and getting this vaccine only to be met with a reaction and they go to the ER and the tools that should be there to help them are not available. I plead with you to please make a place at this table for us because as of right now there is not a seat at the table. There isn't even a crumb on the floor for us. Thank you.
00:28:28 -> 00:31:23
Lorrie McNeil/FDA: Thank you all for sharing your stories with us. It's a very powerful for us to hear and very important for us to hear. I do have a couple of questions if you will allow me. I'm stressing you mentioned the TV ad in Utah that's airing. I would be very interested in seeing it or it's online somewhere so that we can review it. Obviously there's some sharing of responsibility and regulating advertisements that appear on TV but for an FDA standpoint our role is to make sure that the information is truthful and not misleading. We also work with the Federal Trade Commission on advertising so from that standpoint it would be very interested in learning more about that because that obviously would be concerning if they are saying in their advertisements there are no adverse events because obviously that's not the case.
Brianne Dressen: I'm more than happy to provide the link.
Lorrie McNeil/FDA: If you are willing to do so, I would be interested if you could send me. I believe everyone said that they had submitted reports to VAERS. You also mentioned reports that you submitted on behalf of patients including a number of reports of fatalities. If you all would be willing to send the VAERS ID numbers to me, I can give you my email address before we end. What we can do is flag those for the folks that review adverse events here in FDA. I'm sure you are aware VAERS is co-managed by FDA and CDC and our folks interact very regularly with the staff at CDC who evaluate the reports. I think that the my understanding for the reports of death and this is specifically related to the reports that you mentioned that all of those reports should be followed up and records are requested. In particular, I would be interested in those so that we can make sure that we flag them for our folks. For everyone who has submitted something, I cannot make any promises as far as follow-up goes, but I would like to bring your reports to the attention of the medical officers here to make sure that they have seen them. If that's something that you'd be willing to do, I'd be more than happy to take those numbers and make sure they get to the right folks here.
00:31:24 -> 00:33:55
Lorrie McNeil/FDA: Yes, Dr. Hertz.
Dr. Denise Hertz: Thank you for your effort to help us as individuals. I think our message is not that as individuals, we want you to help us. So many thousands, we don't even know how many because as you know, only a small fraction of reports are being made to VAERS that are actually happening. I mean, there are many, many people that don't know about VAERS and it's a complicated system. The physician had to learn how to do it, you know, it wasn't that easy. We're speaking for the masses and we want the FDA to come out and say these reactions are happening, maybe at a very small rate when you look at the total number of people getting vaccinated, but it has to be said because we can't get medical care. I myself have seen at least 10 physicians and Los Angeles, I picked the best of the best. No one had still to this day, they don't know anything. When I have a follow up appointment, I asked them, have you learned anything? Do you have any other ideas? No, sorry. That's not acceptable. We need to educate the medical community so that they can take care of us as individuals and the many, many, many thousands out there that we don't even know about. So we appreciate your effort to help us as individuals. Yes, we can get you our numbers. So what we're here for, I mean, yes, we want help as individuals, but we feel it is the FDA's responsibility to our country to make a statement of some sort that these neurological reactions can occur. And this is what we recommend is treatment or what I don't know, I know you don't make treatment recommendations, but yes, they are real and that physicians need to be aware of them so that they can help their patients. That's what we're here for. So thank you for helping us.
00:33:56 -> 00:34:46
Lorrie McNeil/FDA: And thank you for that. I completely appreciate and agree with the purpose of today's meeting. And I think, you know, helping me put it into context for our folks with the individual reports, but also the context of our conversation without, you know, obviously, you know, as we said at the top, we respect your personal privacy. We will not share any information outside of the FDA, but I think it's important for me and the folks in my office to provide context of this discussion to the medical officers. So thank you for for that. Yes. Let's see, I do this right there.
00:34:47 -> 00:35:20
Anonymous Dr: I was going to add to that, yes, I would love for you all to review our specific cases. You know, my VAERS reports weren't acknowledged till six or seven months later. I would also encourage, I know you work in tandem with the NIH and they have had in person, at least 50 to 60 patients as well, whom you could derive data from. And they've also conducted hundreds of telemedicine interviews with people who have had these kind of reactions. So I do believe they have a lot of data that might be useful for you.
00:35:21 -> 00:40:33
Lorrie McNeil/FDA: Thank you, that's helpful. And if you could let me know, I'll give you my email address before we finish, if you could let me know who and NIH.
Anonymous Dr: Absolutely.
Lorrie McNeil/FDA: That would be terrific.
Anonymous Dr: Yes.
Brianne Dressen: Okay, so yes, we, the NIH, they have all of the information necessary. They also co-authored a article that I sent to, let's see, Peter Marx. I think Paul Richards was on there too, and Janet Woodcock. And they, actually in there on like page 11, it's in there, but they do describe, you know, several of the neurological side effects that can occur. So by the AAN, it has been communicated. Mayo also has communicated these reactions, so it's on their website under precautions. Unfortunately, you know, just to add another layer to what's happening with us. We've reached out to several research groups, instead of including, you know, like those organizations that are advocates for patients like Dysautonomia International and MECFS and Solve ME and even the Long Hall Alliance. Unfortunately, because of the stigma that's connected to this, they have been extremely hesitant to collaborate and bring us on and all of that, which is unfortunate because in my discussions with the NIH, I have, you know, hey, we're having a meeting with the Long COVID Alliance. Hey, we're having a meeting with these people and they've been extremely excited to see that we're trying to collaborate and build these relationships that will help these patients. But unfortunately, we can't get our foot in the door because there's at least one or two members in those organizations that's like, nope, we can't mess with the vaccine. We've been injured. People is too ugly to touch. It's going to damage our reputation. I can't tell you how many times I've heard that from these organizations. It will damage our reputation. It will, we will lose credibility. So this is just an added layer of the challenge that we are up against because we're trying to advocate for ourselves and for these patients, but we can't get anywhere with any of these research institutions. We also have several researchers that we've discussed this with. They don't have funding obviously because this isn't happening, so how can we even begin research? So we're several months behind on the research on this. Also, it's not being openly discussed between these researchers because they are concerned about the repercussions that will happen to them if they do publicly discuss this or openly discuss this at all. So there really is this heavy tone that is, so it's one thing to be sick. It's another thing to be sick with something that's brand new that nobody understands anything about. But then it's a whole other layer to have this. We're trying to function under this veil of quietness and delicateness with everybody that we talk to because we need anything we can get from people, from these researchers, from officials at the NIH or whatever. But I mean, you know what I'm saying? So there's this whole layer that's keeping all of this suppressed that's completely halting any progress and understanding in medical care for anybody. And Dr. Hertz and I, we wrote letters to all kinds of medical organizations asking people to see even just a small hand full of us because it's not a huge number like long haulers, but it still is happening. And we haven't received a single email back from any credible legitimate medical organization. But I will say that we have been working with the NIH since January. That's when I first reported my reaction to them and they took the information and they, you know, they got running. They have my CSF, my blood and all that stuff. We also are working with a couple of researchers at Mayo and there's a group in LA. They're a private company and they're researching this as well. Unfortunately, when I talk to every single one of them, they said we need funding and we need this to be, we need encouragement from people in an authoritative position. So those from a federal level that can help open the door. So this can be looked at. I do know that the Canadian COVID community immunity task force. They have something started and where they're looking at it and they also have a little bit of a website started where they're tracking the symptoms and they're disclosing some of the issues and kind of seems like that would be kind of a common sense thing to do. Unfortunately, we're so behind the ball at this point. We have people that are so desperate for care that they're running out to these illegal establishments that are infusing them with who knows what we have two people that got mono from these illegal things. So we are not getting help from our own medical teams and people are so desperate to get help. They're willing to do anything and so they are harming themselves even further.
00:40:38 -> 00:42:40
Lorrie McNeil/FDA: Thank you for that. Are any other comments before we close? Mrs Dressen?
Brianne Dressen: So I just have a question on behalf of everybody. So obviously our main goal is to be able to begin dialogue with you, which I really appreciate you being willing to do. But number two and probably more important is to somehow figure out how and when this can be communicated with the medical community. I know like here in my own state, I reached out to my state health department after I got home from the NIH and they said specifically they cannot help me until this is communicated from a federal level. I've been in dialogue with Janet Woodcock and a few others at your organization for a couple of months now. I've provided all of our researchers information well before now. We've been literally begging. So it's not like we haven't been trying and so I do think that we are long overdue for something to happen and we would like to know what kind of timeline we're looking at for some kind of communication to happen with the medical community in regards to this issue. And we understand that it's complex. It's not like blood clots where you just look and you can see them, you know, like on an MRI. Unfortunately, it is happening and more and more people are going to grow more and more desperate and sick and it's just not fair. You know, we've been doing this for months. This isn't new. The agencies know this is happening. They've known for a long time that this is happening. So there there probably is an effective way and I'm just a preschool teacher, but I mean, you know, I sit down with my preschool kids and like even they would say, okay, well, you're sick. So people should help you. It's like, yes. So we do need to be able to establish some kind of timeline on when this will happen. So I guess we're just asking when can we expect to see some kind of advocacy happen on our behalf from the federal level.
00:42:41 -> 00:44:25
Lorrie McNeil/FDA: It's a great question. I wish I hadn't answered for you today. I don't, but I can commit to you that I will go back and talk to Dr. Marks, who extends his apologies for missing today. And the folks in our office advise statistics and epidemiology, who are the ones I mentioned earlier, who evaluate the adverse events. And I hope that we can maintain an open dialogue. You know, if you don't hear from us, you know, email us, call us. I know you have all's email. Let me give you mine because I did promise to give everyone that. It's spelling of my name, which is on the screen. So it's Lori L-O-R-R-I-E dot McNeil MCN-E-I-L-L at F-D-A dot H-H-S as in Sam dot GOV. Okay, well, thank you all. Again, we really appreciate you taking the time and sharing this information with us. It was very important for us to hear. And as I said, we will look forward to seeing anything, any additional information you'd like to send in to me or or Paul, Mr. Sunder, you have his email too. And we would definitely be in touch. So thank you for meeting. Take care.FDA CEBR - REACT19 - 2022-03-03
[No sound up to 48 seconds]
00:00:50 -> 00:01:17
Brianne Dressen: So I'm Brian Dresden facts injured also the co-chair of React 19.org and we've been trying to advocate and do our best to help those that have been injured by the COVID vaccines. They're regaining their health and Dr. Dresden wants to introduce herself because I think Dr. Nair and Wollinsky and Susan you may know I'm not sure but go ahead.
00:01:18 -> 00:02:22
Anonymous Dr: Hi my name is Redacted I'm an ER and ICU physician. I am also unfortunately vaccine injured since January of last year.
Lorrie McNeil/FDA: Thank you. Peter do you want to start off or would you like us to go?
Peter Marks/FDA: You know I just want to say thank you for for meeting today I think we're very much interested in continuing to listen and dial live around how we can what we can do here how we can be of help and I think we can we can tell you around what progress we've had but would be very happy to just hear from you first you know I think it seems like you know everyone on our side but it's if you'd like if we can we can we can talk all the introductions and just dive in.
00:02:23 -> 00:02:40
Brianne Dressen: That sounds great. So as far as the updates that you have I would love to hear what updates you have for us and then we can just kind of fill in the blanks with some questions that we have.
00:02:41 -> 00:04:09
Peter Marks/FDA: You know I so I what I can say is that you know and I'll let Narayan I continue on with this we we continue to do the safety monitoring that we do on vaccines and you know we have not there there's not a clear signal for the specific kinds of neurologic events that that you have been reporting but that that's not saying it doesn't exist it just says that we don't have a signal we I know that we continue to look at individual cases and are trying to understand things I know that Dr. Woodcock and we've been in conversation with the neurologist NIH who has been working in this area I know that Dr. Woodcock has also been in conversations with other sister HHS agencies with the ultimate goal of seeing whether there could be some type of a specific study started to help better understand this the the hope is it has the long COVID studies get started up that something could be started up in this regard as well but aside from that those are the high-level updates that I have it I'll turn it over to Narayan to fill in anything I may have missed.
00:04:10 -> 00:05:38
Narayan Nair/FDA: Yeah yeah thanks Dr. Marks and thanks Dr. thanks again stressing for for joining us and providing us this information I didn't have a lot to add you know we're continuing you we have a team of doctors that monitor the reports coming in VAERS we're continuing to monitor these we're continuing to monitor the literature we reached out to international regulators to see what information they have to thank you for providing some names of some individuals Dr. Marks mentioned we spoke with Dr. Nath a couple of times and that was extremely helpful actually more than a couple of times I also reached Dr. Mahid and he was extremely generous with his time and describing his experience and very very fruitful conversation we have a neurologist colleague who joined us for that that call and we're going to continue to contact remain in contact with him I reached out to a couple of other actually several other folks and I haven't heard back and and one individual that's on my list actually that was delaying getting back to me but did get back and I actually have been remissing getting back to him we just the kind of playing phone tag is as Dr. Geretay I believe right it was very interesting to learn of their experience as well and we've exchanged a couple of emails so that's on my to-do list to again gather more information from some of these folks that are involved in this field.
00:05:39 -> 00:09:17
Brianne Dressen: Okay well I appreciate you I'm happy I'm very encouraged to hear that you guys have connected with Wahid we're working with him on one of his bigger studies that he's putting together and as far as we're concerned Stanford so those physicians at Stanford they are interested in discussing with you and we when we reached out to them they said that this was a conversation for their entire department with you so that is encouraging for me to hear as well just because we do have you know the entire team over there wants to talk to you guys as far as these other researchers the male physician so Dr. Poland see if he doesn't respond to you let me know and I'll get him to respond back to you the reason that he would be really relevant in this is because he himself is injured and he's also a vaccine researcher and Dr. Yogendra but their information is more you know physiologically what's going on and as far as questions so I know that Dr. [Redacted] and myself we've been kind of pushing the MIS a little bit and we saw that the CDC acknowledged that two weeks ago. I think we are happy to see that it's been acknowledged I am concerned with how it was acknowledged however we do have a couple of kids that even after it was acknowledged they took the communication from the CDC into their physicians and one of them is actually still in the ICU with a trait he's six years old and the physician still refused to evaluate this child appropriately for MIS so we do still have this breakdown with communication even with MIS being disclosed to the medical community so I guess our question at this point is is there something that could be done to kind of help clarify that to physicians I know the CDC has a fabulous form that they drafted for MIS and COVID but it doesn't have anything on there to note you know for a vaccine if a vaccine may or may not be related to the MIS case and so I'm wondering if we can get that either added to that form or if something can be generated because it seems like it's the same thing for the vaccines so that these patients are not suffering and being dragged into a chronic condition especially with these little kids and then the other question is with the neuropathy terms we're trying to figure out you know what what can we do or what can be done to kind of help identify the neuropathy in this in the system I know that Dr. [Redacted] and I and a few others we've evaluated the system ourselves and we've been able to find it especially with the 88 terms that we submitted previously and just the sheer fact that we have men you know men typically they have an onset about age 59 to have neuropathy happen but with us it appears to be women and they're much younger so about an age 34 age 35 is the average age so we're wondering if that has been teased out by age and gender and maybe that's when the signal would come up and also we're we're very curious about what communication has been you know submitted to the the medical community at large to actually you know start soliciting to get some of this information on a larger scale back to you so I guess that was like five questions.
00:09:28 -> 00:11:45
Narayan Nair/FDA: Euh, I wasn't sure.. Dr Marks, would you want to respond or ..?
Peter Marks/FDA: No I'm maybe you can start and I will I'm going to have to just run actually running to my computer inside right now so I'll back in a minute.
Narayan Nair/FDA: Sure you know those are all really good questions extremely good questions in terms of what we have in bears and I'm sure you're well aware you know being well versed in vaccine safety and your advocacy work is you know it's limited in certain ways and in several limitations that's why we rely on multiple different systems to monitor vaccine safety we do have reports of neuropathy sensory neuropathy there's no question there's reports and bears and we have reports of many other conditions what we're not seeing at this point and again it could just be the limitations of bears that we're not seeing it there's no way to tell at this point but but we're not seeing an excess in cases of unexplained neuropathy many of the neuropathy cases that we do get as we get medical records subsequent and because of privacy reasons that might not be visible in fact they more likely aren't visible on the public side of bears we find alternate ideologies that they're neurologist identified as you know there are alternate ideologies for neuropathy so on in some cases we find other causes that seem to be at least their providers feel the cause and they don't feel like the vaccine is the ideology agent so we're still looking we're still encouraging people to to report not just of you know neuropathic symptoms but any symptoms related to the vaccines is still a you know we want to make sure we capture as much as we can and we use this language irrespective of whether they think it's caused by the vaccine we want to capture as much as information as we can and so you know I'm hoping that that prompts people to you know respond to provide us the information that we need to assess this issue and I know you ask several questions I think that might have answered a couple of them are probably not all of them so you wouldn't mind if there's others that I didn't really respond to please let me know.
00:11:46 -> 00:14:05
Anonymous Dr: You mind if I just follow up on what you just said real quick are you looking into neuropathies as a bucket or are you looking at small fiber neuropathy as a separate entity?
Narayan Nair/FDA: We've looked at both neuropathies as a bucket and small fiber neuropathy and we're gonna continue to look and continue to try and find and assess these reports one thing we we've tried to reach out and we've had discussions with Dr. Nath a key point that we really need to to establish is the reports we're seeing in bears and again we have many reports and because we've encouraged providers to report to us for all different adverse events regardless of attribution to the vaccine you know we have a lot of different reports in there that clearly aren't related to the vaccine of different conditions what we're hoping to get and working on is some type of background rate for the small fiber neuropathy and all the neuropathic symptoms and we haven't just limited to that actually we've looked at terms related to brain fog we've looked at we've heard of some folks having difficulty speaking we've looked at those we've looked at short-term memory loss we've looked at sort of a whole bucket list individually and collectively to see what we have in bears and at this point we don't have evidence that we're seeing that increased over the background rate now there could be several reasons for that and you know that's it's still an open question and it's still something we're gonna look at so just to answer your question I was a long-winded answer but to respond we've looked at both and we're trying to find whether you know a good study that shows what the background rate pre-COVID of neuropathy is because that's the key point for our analysis if we see it in the passive surveillance it's increased over the background rate like we did with GBS or the ants and vaccine certainly did for TTF or our frombosis with fromboside opinion with with the ants and we certainly have for myocarditis with Moderna and Pfizer so that that's a key part of our analysis and we have found that for other safety signals and that's sort of a a key fork in the road for us...
00:14:06 -> 00:15:00
Anonymous Dr: There's been two different studies for small fiber neuropathy for an incidence for the background one in 2013 and another one in 2021 can you show us the data did you calculate an incidence for small fiber neuropathy that's been recorded that has been vaccine-induced
Narayan Nair/FDA: Yeah we I don't have that available right now we don't have incidence data we can't reporting data because it's passive surveillance you know we aren't able to figure out the incidence data but we are working on an analysis to figure out the incidence data and and certainly if we find anything we'll be happy to share that.
Anonymous Dr: So it sounds like you haven't done active surveillance for small fiber neuropathy?
Narayan Nair/FDA: My knowledge they've done active surveillance I work just on the passive surveillance with bears knowledge for active surveillance in terms of doing a large database study the neurologic issues they're looking at and and Dr. Marks can can chime in here are the ombre syndrome a trend for my lightest I believe those are the ones that that come to mind.
00:15:01 -> 00:16:38
Anonymous Dr: So since you work on the passive surveillance side with bears what causes you to ask for the medical records because we did an informal survey of the people that report small fiber neuropathy and other incidents of neurologic diseases to us and the overall vast majority have not had a medical records request from VAERS, and that includes myself...
Narayan Nair/FDA: Thanks thanks for pointing out I've heard that from others as well for medical records there's a regulatory definition for serious cases I mean all adverse events regardless are serious I don't like to use that term but there is a regulatory definition that we it's as serious and it's people that are hospitalized or people that have a chronic disability long-term birth effects and there's or something life threatening and so if someone meets that criteria they there really should be a request for records now there could be two reasons that people have that happened one is the request could have gone to the hospital or the or the treatment facility and patients might not be aware the other could be you know we've received a large volume and I I don't know what the backup is in terms of requesting these will prioritize any death report you know we prioritize getting the records for those extremely quickly and but then the others there should be a request we should get records from those so I will check in to see you know why that hasn't happened or why you haven't heard anything...
00:16:39 -> 00:17:38
Anonymous Dr: It's frustrating to hear because I've talked with the FDA on a meeting similar to this in August and I brought up that there was a medical records issue because I myself was hospitalized when I was able to work last year I had a patient for example that died within 14 days of getting his Moderna vaccine a young man in his 40s I've had other ICU patients and the majority of patients that I have submitted to the ER the medical records request has not been made so what I've seen from my personal health what I've seen from patients in my hospital system what I've seen with the people that we've connected with it continues to be a vast lack of medical records requests for serious adverse events as defined like you mentioned hospitalization prolonged disability and death so it's concerning that despite our conversations with you guys that you're not meeting your defined definition of follow-up on these VAERS reports and my report was back in January so there's no way you guys are over a year behind.
00:17:39 -> 00:18:31
Narayan Nair/FDA: Yeah if you and I don't want to add to your work I know you're very busy I used to actually practice in New York hospital so I know that's extremely busy but if if you have an opportunity to to send us the VAERS numbers...
Anonymous Dr: I've done that but I can send them to you...
Narayan Nair/FDA: Okay did you okay because I don't believe I see but...
Anonymous Dr: Yeah it sounds like there's a breakdown in your system if you haven't seen them it's unfortunate but I appreciate our conversation and that you're willing to see them now because I'm concerned that there's a signal on your end within bears that's failing which is causing the missing signal that we're seeing on our end for the small fiber neuropathy cases and the MIS cases and because you're not seeing a signal in your passive surveillance system then you're not willing to do the active surveillance system research.
00:18:32 -> 00:20:01
Narayan Nair/FDA: Yeah we will we'll take a look at the at the VAERS numbers and see what we have. We have had cases where you know actually the other day where you know I couldn't find a records for a case that met the serious and if they try multiple times and they don't get a response that sometimes that that is the reason but that that doesn't sound like the case here so so I'd be very interested to look at those VAERS numbers.
Anonymous Dr: Bree I didn't mean to hijack I know you have other questions..
Brianne Dressen: I thought that was fine thank you it's appreciated because it's all really crucial information that's actually one of my questions I was asking to see what have been done on the previous information that we had submitted which was last August and then I think in October we submitted the neuropathy terms to be reviewed through the VAERS system and you answered that question as well I am I you know every time we have a meeting you know it's exhausting for us just because we we see the faces of these people that are being impacted and can't get medical care because there is a question mark on what the root cause of their neuropathy is you know if MIS was at play initially in their disease and so you know...
00:20:02 -> 00:24:29
Peter Marks/FDA: Could you explain to me a little bit more why they can't get medical care I'm really trying to understand that because as somebody who's practiced a lot you always treat the patient in front of you so I don't understand why they're they're not I mean people should be getting treated for whatever is in front of them right is so what's what's happening there?
Brianne Dressen: So to put this you know very straightforward a couple of classic cases which this is this doesn't happen to just a few this is very very common people are going into ERs and they are being told that they have anxiety we had someone who very clearly had MIS and they didn't even run the labs to see if there was MIS in her and they told her it was anxiety so her husband took her scooped her up and took her to another ER across town and they ran the appropriate labs and they found out she had MIS post-vaccine the other issue that we're having is we really this is where I really really need to figure out who in an authoritative position can help us out with this because this is literally putting people six feet under there whatever the communication was from the medical boards that says if you talk about misinformation if you you know whatever with misinformation then we're gonna review your license we cannot get medical care if we can't so we have people that are like sneaking in to these clinics like my own doctors K so my own doctors after I've been to the NIH after I was you know diagnosed at the NIH all of that right all of that workup was done my own doctor's still at home they're afraid to say COVID vaccine injury or COVID vaccine reaction they say COVID related illness so if you guys are looking through insurance codes or if you're looking through various reports or whatever you're missing a ton of stuff because the doctors I know this sounds really weird but this is absolutely a problem because there is no clear definition for the doctors on what is and what is not misinformation and because you know we're not part of the conversation whatsoever as far as there may be a potential for an injury or you know any of that then we're running into that issue and it's it's just a full stop so if we can't even say this may be something that happened to me or this may be an issue that's related to you know my reaction then you know it's a full stop and care if we can't look at what's actually happened to the patient then we're not going to be able to get them better so until we can actually clear the air with these physicians that are on the front line and tell them it's okay to actually evaluate a patient if they suspect that they've had a vaccine reaction we're not going to get care it's almost like it's a dirty word it's really weird like for me myself I have one doctor that says COVID vaccine reaction and the only reason he says it is because the NIH put it on my record so it's it's very common and that's why people aren't getting the care that they need that's also why like doctor and myself and others like for some reason people keep calling us for advice on their medical care instead of their medical teams because their medical teams are afraid and I don't know how you guys fix that or if you guys know who would be able to help provide the appropriate guidance for that to happen but the medical community they it's a full stop which is why we keep coming back to these meetings because until someone says hey it's okay to say there might be something wrong with this patient because of their vaccine we're not going to get anywhere we get labeled with anxiety we have neuropathy that builds for months and months and months and then before you know it we have people that are you know their hearts are giving out because their neuropathy is progressed they you know they're in their beds they're in wheelchairs now I mean it's desperate it's really it's really bad just this week in four days we had two suicides two injured kids yesterday again and we just print out all the stuff for MIS and say hey take this to your doctor and they still like they're just afraid.
00:24:30 -> 00:26:29
Anonymous Dr: I can follow up with that from a physician's perspective and Bri is right the stigma is certainly there small fiber neuropathy is not just central neuropathy it's an autonomic neuropathy it's very disabling but more importantly I'm focusing on it because we see this a lot this is a rare disorder it is not taught to ER doctors critical care doctors family physicians even among neurologists it's very rare at my own shop my Cleveland clinic trained neurologist did not know small fiber neuropathy other than it existed he did not know how to diagnose it he did not know how to treat it and he is still fumbling along with me that's why I had to go to the NIH to because all of my local physicians failed so when you have adults who see their adult physicians and have a struggle getting appropriate treatment and diagnosis which then delays and it's after your VAERS report because VAERS only asks for the immediate signs of symptoms so you have a multiple month delay of getting proper diagnosis and only a handful of centers in the country can do the autonomic testing to diagnose you with small fiber neuropathy or skin biopsy with children it's even harder because this disease entity in children is rare usually the traditional patient is a diabetic small fiber neuropathy which is very different from what we have and only recently with the HPV vaccine that kind of came up with small fiber neuropathy but again difficult to diagnose so these people continue to get worse and worse and worse without appropriate treatment you delay effective treatment which is IVIG that we found the later you delay treatment the less likely of a positive effect this might have and we're also focusing on diseases with you like small fiber neuropathy and MIS as we're trying to do research base and we're trying to be narrow and we're hoping that by looking at concrete data together with you that we can help identify the safety signal that we're seeing on our side.
00:26:30 -> 00:27:20
Brianne Dressen: I don't know if that answered your question Dr. Marks I hope it did.
Peter Marks/FDA: Yeah well it does partially I mean I'm just surprised that the neurologists aren't treating what they're seeing in front of them but it sounds like the problem is that they're not getting to the right diagnosis in the first place and maybe that's what the problem is if I'm understanding correctly.
Anonymous Dr: You have a non-determinable pattern sensation of numbness that you can't reduce on exam so you have this in a woman in their 20s 30s 40s or a teenager if they don't know what small fiber neuropathy is you're going to say it's anxiety it's psych it's functional neurologic disorder especially when you add on that the dysfunction often presents as exercise intolerance which again just sounds vague it's very vague symptoms and requires a thorough physician who has more than 15 minutes to spend with you and has a background knowledge to diagnose it.
00:27:21 -> 00:28:36
Narayan Nair/FDA: Are these individuals in your experience the stories you're hearing are they getting the work up in terms of ruling out of the causes are they getting EMGs and skin biopsies like Dr. Waheed was mentioning that you know that's what his practice is to do that and that's the case series he's developing but it sounds like maybe there's a group that isn't...
Brianne Dressen: So yeah so the common the most common is the the workup that people get is an MRI they might get an EKG while they're in ER and a few you know basic like a basic CBC panel that look for D dimer and all of that but as far as like the the skin punch biopsy the autonomic testing and there's a there's a special autoimmune panel that we are running out of Germany it's actually one step above what we're seeing with out of the pot's panel done at Mayo and it's incredibly you know it's got it's it's held in high regard our colleagues in Germany are are running it as well and it's really showing some autoimmunity that's popping up for the vast majority of us and it's the same markers and all of us they shoot a short-term memory loss what was the question I'm so sorry I hate when this happens but it happens...
00:28:37 -> 00:30:10
Peter Marks/FDA: It's okay I think you answered you know it's it's mainly getting that they're just challenges but the reason why it sounds like it's not getting treated right is that it's not getting diagnosed in the first place because of issues so...
Brianne Dressen: Yes yes and really if that was if that happened that would open the gate and we I mean I'd be able to go back to being a mom and take care of my kids I mean this whole focus is these people just need medical care and there's just these stopgaps that are just making it not it just is not happening and so like when people come to us they've got these you know typical MRI or whatever and if they do have MS or some other thing then great they can get care but then the skim fiber you know the small fiber neuropathy test and you know the the EMG and the tilt table test and the QSAR test we have to actually tell the patients we're like K you need to find a doctor in your area that will do these tests and so and it usually takes like six nine months before they actually can get into the right neurologist to get that testing done and that evaluation done but I do know that there are long COVID clinics that are set up nationwide that do they're buried I know I understand that they're you know buried with sick people as well but they do have the right you know systems in place to kind of push through some of these patients so it does seem like that would be an easy place to put these people they just need to be you know these practitioners just need to get the signal or this you know appropriate communication from somewhere that it's okay to evaluate a vaccine injured patient.
00:30:11 -> 00:31:19
Peter Marks/FDA: Yeah well that's something we will discuss with the folks at NIH who are dealing with long COVID because that may be a good way of trying to get people clogged in I cannot make any promises because we don't run NIH but we'll certainly be happy to bring that up.
Brianne Dressen: That would be a that would be a big step for us because really I mean and doctor [Redacted] agrees so I mean really all we want is just for people to get medical care that's it.
Anonymous Dr: That's why we're looking to you because the physician community is looking at the FDA the FDA says the vaccine is safe and effective we hear the vaccine is safe and effective the only thing you guys have talked about is myocarditis it's the only thing in my physician community it's the only thing we're really talking about neurologists are trained for skin biopsies it's not a neurology thing and you have a handful of autonomic testing in the United States that usually require a referral your neurologist believes you before they would send you so on our end we've asked whether we know to go back and update the VAERS report to say if they have a core diagnosis of small fiber neuropathy we remind them to go back just trying to help you guys as much as we can.
00:31:20 -> 00:32:30
Brianne Dressen: But then again we're not you know in a place of authority we're just sick people helping other sick people so we're not really the appropriate avenue to be you know providing this kind of guidance needs to be coming from someone much more reputable...
Peter Marks/FDA: Well you know we will we will continue to work work through this and I think we also just you know we networked with quite a number of other foreign regulatory agencies I know that they have also been looking at a mentioned Germany they are looking at this I know in Germany and I know the Nordic countries are looking for signals as well I don't know that there's been to my knowledge Narayan and I don't know there's been any definitive signal in any one of those countries but we'll continue to we continue to work with them in many cases because particularly the Nordic countries their electronic medical record systems are integrated in a way that we simply don't have here so they may they often pick up not always but they often pick up signals even ahead of when we might because of that...
00:32:31 -> 00:33:26
Brianne Dressen: Are you guys in touch with all of the German researchers
by chance would that be a benefit to you guys?
Peter Marks/FDA: I mean I'm we're happy that we're happy we are in touch with the German regulator but if you have particular researchers that you'd like to let us know about we're happy to have those names and to try to make contact with them.
Brianne Dressen: I think that they'd probably be a really they'd plug in some pretty good pieces for you just because like here we've been really pushing the neuropathy and the MIS and in the same in the same you know thread they've been really pounding autoimmunity from this and so they've they've unearthed some really interesting pieces to the puzzle recently and I kind of think...
Sarah Walinsky/FDA: I'll have to go to another meeting so I'm gonna drop off but I want to thank you all for this this is helpful.
Brianne Dressen: Thank you.
00:33:27 -> 00:34:36
Peter Marks/FDA: So please do let us know there I mean happy happy to connect with them because we we do you know we do have international dialogue on this and happy to either they say we've been we've been dealing with the regulators Paul early institute but happy to happy to connect with the docs.
Brianne Dressen: Okay and I yeah I am encouraged to hear like if there was a way that we could somehow like you said no promises but if we could somehow figure out how to piggyback the the vaccine reactions with either long covid research or in some of those clinics that are across the country I think that would help and I know that Stanford on their own they're headed that direction um UCLA is headed that direction Yale is headed that direction and I think they probably just need a little bit more of a nudge to make that happen clear the air forum so they you know they feel more confident and being able to to move forward with what they want to look into an examine.
00:34:37 -> 00:35:28
Anonymous Dr: I'm assuming we can talk about the MIS cases I understand the limitations of small fiber why it's difficult for you guys to pick up a signal but that one we're confused about why the vaccine signal has not been picked up?
Peter Marks/FDA: Do you mean from why why why there's not this uh and they so so this was reported by I think the best I could say is it's been reported and it's been followed by CDC um and we've followed it I think Narayan I think it's the issue is that the number of cases have not risen uh to a number that that that leads to a clear differentiation uh that it's a signal but maybe you can explain that better?
00:35:29 -> 00:38:10
Anonymous Dr: With a novel disease that didn't exist before covid how many cases would you need?
Peter Marks/FDA: It well that's a symptom complex of things I think that's that's the question um um I mean I think obviously we need to figure out what's going on there uh so it's just I just I don't know what you what what we do further until we make a determination that it's it's clearly vaccine related um...
Brianne Dressen: I do find it kind of... sorry go ahead...
Peter Marks/FDA: I don't know that I I'm for sure I'm not I'm not the expert in making the causality determination...
Narayan Nair/FDA: Yeah yeah yeah yeah so so the the MIS is a reportable disease and so that's reportable the CDC so they have a separate MIS team um separate from their as I understand it from the vaccine safety team um but there was this concern and MIS has always been on our radar you know when we authorize these vaccines in in December 2020 before you know um we didn't have any evidence that they caused MIS but it was a theoretical concern and so we made that a mandatory reporting requirement for manufacturers and vaccine providers um and and those cases reported for MIS were tracked for any of them that that had received and this was MIS seed predominantly any of them that had received the vaccine um and so uh we looked at those cases and they were individually adjudicated so these were cases that had a diagnosis met the criteria for MIS um and and CDC did this work predominantly um but also had received the vaccine and they found nearly all the cases um they had uh tested positive for SARS-CoV-2 infection and the feeling was that that was sort of the culprit these were individuals that got infected and then as you know MIS can present several weeks later and that seemed to be the case with with the data we also looked in VAERS just in case there is any cases that weren't reported for MISC and and provided that to information to the CDC team for them to include in their analysis now there are a small handful of cases and and I don't know the precise numbers but relatives and the number vaccinated but they indeed they could not find in fact evidence of infection in those cases and they did publish that I'm sure you're aware that that that was recently published by CDC so um in that sense that there is those cases that are out there that that have been publicly disseminated that information in that paper that was uh I think it was in Lancet.
00:38:11 -> 00:39:04
Anonymous Dr: Hum so in that paper the CDC paper they have three cases that they acknowledge they did a giant workup and said the only thing it could be was the vaccine additionally in that same CDC paper that recently got published your MISC or MISA usually presents within six weeks it's really rare for you to present past that and in that paper they have patients who are 15 to 34 weeks out from their COVID infection who get their vaccine and then eight to 48 days later get MIS so even with the cases that are novel you have the CDC that's done three cases which to my understanding is a minimum scientific burden of proof but the only thing they can find that caused it is the vaccine so I'm curious how many cases would you need for the FDA on your end to add it to the safety labeling of the Pfizer vaccine?
00:39:05 -> 00:40:30
Peter Marks/FDA: It's a good it's a it's a it's a reasonable question to ask um and you know we generally we generally look at number of cases over the denominator of doses given strength of associations it's something I think we can go back and we can I'm happy to go back and discuss it with our team again um but um that's that that's basically the way we we we we would look we would look at it as the number of cases over the denominator of a vaccine doses given um and try to understand the strength of the association.
Anonymous Dr: The reason why I'm focused on it is because these kids can die you have a couple of kids that die your vaccine program is going to go up and smoke I don't want that to happen it's also a novel disease that requires steroids and IVIG which isn't a traditional treatment for shock and on top of that the fact that you found three cases is amazing because the CDC definition requires a mandatory COVID infection so you have doctors who thought outside the box outside the CDC definition to make a diagnosis which then makes me wonder how many doctors who follow the CDC definition are strictly misdiagnosis in children and Bri has already met people who have been misdiagnosed because of the CDC definition that doesn't include the vaccine.
00:40:31 -> 00:42:29
Brianne Dressen: Right the lack of diagnosis and the lack of reporting you know is going to compound that issue to you know make it extremely more rare and unusual than than what we're finding on our end um but that that's kind of consistent with all of it we've also um we've kind of theorized that the pathology of the myocarditis appears to be the similar to what's happening with the MIS um so it's kind of interesting I would love to see if there's any researchers on your end that are evaluating you know because if you have a vaccine that's um that may have some you know similarities between a the actual disease and if the vaccine you know has some syndromes that are identical then it kind of does kind of lead you back to you know what's actually happening because you've got COVID that you know does myocarditis and MIS and transfers myitis and GPS and for us it's no question you know that we have neuropathy due to the COVID vaccine and neuropathy you know Dr. Nath just released that neurology today that there's a huge uptick in neuropathy due to COVID and so if you do have the same syndromes in the COVID vaccines it would be kind of interesting to see if we could open that door a little bit examine it a bit further but yeah the the myocarditis and the MIS is actually published literature at this point that they are connected oh and the um so the year label label I know we talked about this with the parasitia it's been added to the label um in the European Union for Pfizer and I know it seems like that's a pretty benign thing to add to a label here in the US but I was wondering um if there is a definitive reason on why that hasn't been added to the package insert here in the US?
00:42:30 -> 00:43:48
Peter Marks/FDA: I think it has to do with the data that they presented and how it also is described by other words they're talking what they're talking about parasitias they're talking about tingling around the time of administration of the vaccine as opposed to parasitias as in long-term neurologic complications that one can have from B12 other small fiber neuropathies other demilinating diseases so I think it's it's a it they're they're actually we we're not that fond of that because when you when we scratched under the surface of what they were describing with parasitia they were basically using that word to describe tingling sensations around the injection site so we didn't we didn't label that because it's not with with parasitias because we don't agree with the way they it may be that they may be that in the European translations that that translates just fine to tingling around the site of injection but that's that's what the the cases were that they were reporting it wasn't it wasn't uh the those parasitias don't represent cases uh people four weeks or six weeks out for reporting you know tingling sensations um much as you might have and and you know in a postured column or some other uh or some other syndrome.
00:43:49 -> 00:46:50
Brianne Dressen: Right like in ours we have a lot of people that have lingering parasitias um like I myself it's still in my hands and in my feet and it actually was progressing up my legs uh with my neuropathy until I got IVIG and so I do think that IVIG was um critical and reversing my my whatever was going on in my body um so the NIH thanks to the federal government the NIH I'm pretty sure uh was crucial in helping save my life so so as far as next steps um is there like a time that we could do for a follow-up on some of these inquiries um...
Peter Marks/FDA: Yeah you know maybe maybe the best way for us to follow up here is you're you're you're gonna I think that to do that we have we have a couple to do as I have to talk to we have to talk through I I owe you guys an answer and what we would consider I think it is a fair question about you know how much MIS would we need to see before we put something on a label and how would we make that determination we can try to I think we can internally discuss that um because some of that is determined by our folks that work with Narayan and some of our office of vaccines um I think we can also very happy to hear more if you if you give us the information on who we do contact in Germany um that would be absolutely fine um very happy to contact them and learn more about these panels these these in inflammation panels actually if you help explain something as I received somebody sent me one of these and they are in tests that are normally run in the United States and I think they might have been run by this German now now I know where they are it's probably been run out of this uh German physician our physicians um so that might be helpful to know because then we could better understand those um and you know I it's it's it's probably going to happen the next couple weeks it this may be something where circling back I know I know you know it it always seems like it takes time but it does it's just the rate that things work here we are in discussions with our sister health agencies about you know trying to get studies started potentially as I say if you jump through with the studies for long COVID uh and so you know it it we're probably you know I I would say I'd love to say have another meeting in four weeks but it might not happen by then um so it it may be that we want to circle back uh as we as we come in uh to kind of mid spring and into the April May time frame does that does that sound reasonable? In the meantime we can be back and forth by email um uh and and and we're we're clear Narayan can I I think we'll we'll go back and try and um uh check into a few of these things as well...
00:46:51 -> 00:49:45
Narayan Nair/FDA: Yeah actually we were just talking about uh some uh a lab panel um and and we were kind of going back before and we discussed it with some immunologist and allergist and then we went to neurologist and rheumatologist and then none of them these were all US trained and they worked familiar with but they did ultimately say that it was something used in Germany so that that would be very very helpful for us to learn more about that and I I did want to go back to the VAERS issue and reports not follow up I do recall an inquiry and and we've not found so many and this was last year where we did have some individuals saying that they had received reporting it we did follow up on that but I don't know if that's the one that you would brought up so I um I apologize if it was and you didn't hear back but I'll you know I'll go back through my notes and see exactly because if if they're serious we should be really capturing those reports there might be a delay but it shouldn't be that long so I'm very interested to hear if you know what happened in its cases um...
Brianne Dressen: And I'm wondering if there's a way um to kind of work through follow up for those that are chronic that you know like originally they were not classified as serious but now they're trapped in their beds trying not to die um you know they go to the ER and the ER is like well we we don't know what this is so go home you know and...
Narayan Nair/FDA: It could be that could be the cases isn't we have that initial ER report and that's what's coveted and and if we don't get subsequent communication it might be coded as a non-serious that doesn't mean that if records are submitted and we'll see that but if if they don't the contract or won't go out and try and obtain records if it's a serious they should go out and they definitely prioritize uh death cases if it's a young death in particular uh they prioritize but they should get to all of them and we've been checking to make sure there there's not a backlog so I'm I'm interested to hear about uh you know why these these weren't the record to obtain so thanks for bringing that up...
Brianne Dressen: And I yeah thanks and I know that the reporting bias is pretty heavy on that one too so you're gonna get a bunch of people that are going in and they can't breathe and they can't move their arms and they're you know they're code say anxiety and so I don't know somehow we've got to figure out how to get you know eyes open a little bit more...
Narayan Nair/FDA: Yeah I will say one strength although it's you know I've mentioned a limitation one strength this is it's really rare that we get a report that's just one symptom like anxiety more often it'll be you know it'll be everything you know and today I reviewed a bunch of reports it was you know that were listed as diabetes and and they were all people had diabetes for years previous to their so that's coded whatever's mentioned is ends up in the code on our end and so if they have the shortness of breath from the other symptoms we should be able to and the neurologic symptoms we should be able to capture that even if you know exactly isn't there as well...
00:49:46 -> 00:51:54
Anonymous Dr: I'm curious how you deal with discrepant medical records so let's say they go to the ER and get diagnosed with some medical disorder and then they later go to a neurologist and get a new diagnosis who's reviewing these charts to decide which diagnosis is taken?
Narayan Nair/FDA: Yeah we don't assign a diagnosis and say oh it's this and not that so for that instance they both would be coded so so you know the initial report would say some out of I mean again the vast majority of the time you know in fact I would say almost all they they record all the symptoms so it wouldn't just say some out of form it would say shortness of breath anxiety heresthesia so it would have their their physical symptoms that have been recorded if they're record if they're not in the medical record we can't do that and then the subsequent report would would be sort of they basically group them together and then that would be an additional diagnosis so they wouldn't one wouldn't proceed the other I guess as well...
Anonymous Dr: I understand the coding aspect but when you're going back and reviewing the charts for small fiber neuropathies that we're talking about earlier and you're deciding whether it was related to the vaccine or not if you have discrepant medical records because you have somebody who's less qualified to evaluate your chart initially how do you guys go through that to decide if it's truly vaccine related or not if you have two different physicians saying different things?
Narayan Nair/FDA: Causality assessment is you know challenging when we do manual reviews oftentimes we do automated reviews and if we you know do automated reviews we sort of specify that but if we do manual reviews we try and have strict kind of criteria so it's not just arbitrary and there's not sort of into interoperability you know variability we want to you know make sure we're consistent and so oftentimes we'll use a case definition will establish a case definition and if they meet the case definition regardless of whatever the provider says I mean often you know we take that in consideration but really you know we'll have a case definition that we use and that if they meet that they're in and they're counted as that diagnosis if if they if information is missing we don't necessarily rule it out but we'll just say you notice these are missing you know keep these information...
00:51:55 -> 00:53:28
Anonymous Dr: Can you share with us your case definitions for small fiber neuropathy patients and especially for the vaccine induced?
Narayan Nair/FDA: Yeah so right now we're at the stage where we've done search terms and done the search terms we haven't done a manual review looking at these reports as of yet the neurologic reports and I should say when we did our review we looked at everything we didn't focus on small fiber neuropathy at that time we looked at sort of symptoms concerning for for long COVID we we really looked at the brain fog we looked at the fatigue we looked you know I have seen reports of people having difficulty with speech and so we looked at multiple different terms related to speech and I'm that took us a long time but I wanted to be broad I didn't want to use a bias and be narrow but but I'm thinking now is the time to really focus on the small fiber neuropathy and do a deep dive on that that's sort of my I'm glad I did that other approach or we did it I think that was suitable at that time but I think that'll be sort of our next step...
Anonymous Dr: I appreciate our discussion and that's why I've been focused on small fiber neuropathy since the last meeting because I appreciate how much you guys have gotten in data from VAERS how broad it is and how difficult it can be to narrow it down to the disease entity and with the current published data for especially the age and the gender for the small fiber neuropathy and the low incidents at baseline I do think that's where the money is at when you're looking at the neurologic injuries and I think it's probably the easiest one to go after.
00:53:29 -> 00:55:16
Narayan Nair/FDA: No you know thanks for sharing that insight...
Peter Marks/FDA: That that is that I say this is some progress I think to an extent because the the ability to go after a specific entity like that is much is much easier than when it's helpful to have a specific target to look for that's what I'm just trying to say... yeah like I mentioned we went broad earlier and really looked at a plethora of different things because that's what we were hearing and but you know I think this insight is very very helpful.
Anonymous Dr: And there is a broad spectrum don't get me wrong but it's just difficult because with long COVID for example the data sharing there seems to be like a vasculitis phenomenon that's why it's so broad and different for so many people but from my understanding of how the FDA works the nearer you can be the better it's going to be to really see that safety signal.
Narayan Nair/FDA: Yeah yeah no definitely you know a diagnosis is helpful I think one of the initial communications that at least I saw at a number of different individuals with a you know a number of different symptoms and I didn't want to cherry pick and say oh we'll look at this one and not look at others so I really didn't think that was fair I wanted to do justice for all of them and we looked at all of them and the reporting rates were fairly low in the context of you know as you know hundreds of millions of people have been vaccine new you know there's numerous doses out there that have been administered but I think as you suggest um looking at this certain issue might be sort of a better yield for us I don't I don't know as I mentioned past the surveillance particularly if it's a latent phenomena we may not capture it um but as clay we're not you know I think it mirrors a good examination.
00:55:17 -> 00:56:36
Anonymous Dr: That is the big downfall of VAERS when you have a latent diagnosed phenomenon you are not going to capture it because of the VAERS propaganda you're given the card after you get the vaccine you're told to put in your symptoms or issues which are going to be parasithesia at that point some of which go away I mean the majority go away for most people and then it becomes really difficult because the public is not told and even as a medical community the importance of going back and putting in a new VAERS report with new information that leads back to that vaccine.
Brianne Dressen: And then also from a patient's perspective if you're going in to see someone nine months after your original vaccination um and their skeptical to begin with you're going to be running up against you know actually getting a report submitted to begin with even though he's claimed from as a from a patient you know while the tingling started within an hour of my vaccination and my legs gave out within the first two weeks you know all of that stuff um because it has been so much time as laps before you are able to get into an appropriate specialist um that's a lot of time lost and then you know you're up against a game of well you know the timeline just as muddy so the reporting bias you're running into a reporting bias again...
00:56:37 -> 00:59:30
Anonymous Dr: So Bri and I are hoping that we can understand the deficits of VAERS and we're hoping that we can we have a depth of patient information that you don't have so really that's why we keep trying to meet with you and having these emails and we're hoping to show you what we can bring to the table to help you see what we're seeing.
Peter Marks/FDA: Yeah understood and I appreciate that I think what we'll do is we will circle back I think we appreciate just like we appreciate getting in touch with the the the German physicians I think we'll I think Narayan we can circle back on the small flyer neuropathy issue I think we'd be attached by email and we'll circle back with our colleagues at our sister agencies and see where we can we can get to whether whether they whether they's whether it's searching further for small flyer neuropathy or whether it's trying to get some research protocol on for people with neurologic issues after vaccination I either and are probably both worthwhile pursuing for us so we will try.
Brianne Dressen: It's much appreciated thank you.
Peter Marks/FDA: So we'll fall I guess we'll be back in touch with you we'll we'll look forward to getting your emails we'll Narayan we'll be like I spoke we'll be back in touch as we as we learn more as we have questions and then we'll just circle back and and and and a bit of time does that that sound reasonable? yeah Lorrie anything else on your end?
Lorrie McNeil/FDA: No thank you Peter.
Peter Marks/FDA: Great okay thanks very much for meeting today and you know I you know just so you have you know our assurances we are taking this we take this very seriously you know Narayan and his his group they really do a great job trying to dog things down and I will continue to work to try to figure out what's going on here um we you know I think we really appreciate you're working with us on this.
Anonymous Dr: You don't have to meet with us and the fact that you do we know how busy you are and we really appreciate it I know we've asked you some hard questions and we appreciate you taking them seriously this is our community this is why I became a doctor I'm sure you did too we genuinely want to help our community and make sure that they're safe and that we can do everything we can to help them.
Peter Marks/FDA: I appreciate it thanks very much.
Suzanne Frantz-Bohn: Thank you.FDA CEBR - REACT19 - 2022-05-25
00:00:00 -> 00:02:54
Lorrie McNeil/FDA: We're just waiting for Dr Marks. I'm sure he is running from one meeting to the next, I'll give him a quick... Here he comes.
Peter Marks/FDA: Hey... Sorry... Just took a minute to move from meeting to meeting here. Sorry about that. Great. So... Hi. Nice to see everyone. Do we want to just go around with a round of introductions?
Lorrie McNeil/FDA: Lorrie McNeil, CBER, Office of Communications.
Brianne Dressen: Brianne Dressen, vaccine injured, co-chair of React19.org, patient advocacy organization for the COVID vaccines injured.
Anonymous Dr: Hi, my name is [Redacted], I'm a vaccine injured physician.
Peter Marks/FDA: Great. Ok... And I think...
Paul Richards/FDA: Hi, it's Paul Richards. I'm the chief of the Consumer Affairs Branch within the Center for Biologics Evaluation and Research.
Peter Marks/FDA: So... thanks... I'm looking forward to hearing... And I think Sarah Walinsky is joining... she is my chief of staff... just a second... I'll let her join and then we can start... Hum... let's see... she is almost there... Hum... But I was... What I was thinking... I'm happy to tell you... I have a modest number of updates... I'm happy to tell you... I have a modest number of updates... I'm happy to tell you, on our side... Sarah, do you want to introduce yourself?
Sarah Walinsky/FDA: Hi, this is Sarah Walinsky, I'm the Chief of Staff, Center of Biologics, Hi again. I'll put on my camera in a moment, okay.
00:02:55 -> 00:05:48
Peter Marks/FDA: Ok, thanks. Does that make sense? So... from the standpoint... first of all, I just want to send Narayan Nair's regrets, he had wanted to be there but he had an appointment of his own with the Doctor that he couldn't miss, so, apologies for that, but just to kind of give you the follow up of where things are at the moment... Um, uh, he, uh, they continue to, to query the various databases, the large databases, uh, for, uh, neurologic adverse events, still have not seen a signal. That's not to say we're not, no one's denying it. Not just to understand. That just means that on a gross level, um, for the various, uh, neurologic adverse events that they've been looking for, they have not, uh, seen one, either here in the United States, or, uh, we are members of, uh, a group of, uh, international regulators, um, um, it's roughly about 60, from about 60 countries, and they get together, uh, once every two weeks go over adverse events, um, and, uh, nothing has, uh, signaled, uh, at least in the, in the other countries that we're working with, either. Um, that said, I think, you know, as, as you may have heard, Dr, Dr, uh, Woodcock, when she was a commissioner, acting commissioner, um, was very much, uh, committed to, uh, trying to further investigate things in that regard. We've had conversations with NIH, and we continue to remain in a dialogue with them. As they set up the long COVID follow-up cohorts, uh, we are trying to see if there would be going to add a cohort, um, of people who are vaccine injured, uh, to this, uh, to, uh, see if, uh, if we can understand, uh, better what's going on. Uh, so we're, we're still, again, still working through that, um, uh, the idea is to hopefully get support, um, from the companies, and, uh, for doing so, as well as through NIH for doing so. Uh, so that's, that is, uh, pretty much the, the latest we, uh, that, that back and forth with NIH has, uh, been ongoing as, as recently as a week or two ago. Um, so that's where we stand right now from, uh, from our perspective. I mean, I think that would probably be getting an arm added to that study, would probably be a really good thing, um, uh, because it would help, help us, uh, better understand this. That, that's, that's my updates.
00:05:49 -> 00:07:58
Brianne Dressen: Is this the recover study?
Peter Marks/FDA: That's the recover study, correct.
Brianne Dressen: So there's, the injured, the only reason we know about this is because the injured actually, there's several that are enrolling right now, uh, under a few of the institutions in, in the US right now. Um, and they've been told that it's because this is already, um, going to be studied for, with the vaccine injured as being like a subset. I've asked all of them to document that very clearly, uh, as far as I'm concerned, I'm, I'm trying to figure out like how to ensure that this information obviously for both sides, you know, to make sure that the long hauler research is evaluated correctly and then also that the post-vaxxed research is evaluated correctly. Um, it does. I'm kind of curious...
Peter Marks/FDA: Yeah, I mean, to my, it's interesting because I didn't know they had actually opened the cohort. My understanding was they had not opened the cohort. I mean, they may be enrolling with the idea that they'll put them into this cohort eventually. I didn't know they'd actually opened the cohort yet, but, but I may be behind the times. So it was last time I spoke with them was about a week or two ago.
Brianne Dressen: Okay. Yeah, because I'm, I'm kind of curious. Maybe they're, maybe it's the institutions themselves that are trying to sneak these people in. But I'm going to make sure that we circle back. And I appreciate you following up with that, um, with the NIH specifically. Um, on Friday, I have a meeting with Dysautonomia International, which I'm sure you guys know that patient advocacy group. Um, and we're going to move forward with them and ME action, self-ME. So some of these other patient advocacy organizations that have been in this sphere for years and years, uh, to see how we can start bridging the gap between, uh, some of these syndromes and this new disease that we're experiencing now. So I do appreciate, um, the effort that you've put forth to kind of bridge that gap with the current research and the current funding that's available. Uh, if there's anything that we can do on our end, uh, through our other patient advocacy organizations that we're partnering with to help apply pressure in the right avenues. Just let us know we're happy to do so.
00:07:59 -> 00:09:45
Peter Marks/FDA: Now, I appreciate that because I think, uh, we, I, I may just refer them over to you potentially, uh, uh, to help, help them understand kind of the importance of, of getting this arm set up. Um, uh, I think they do understand that it's, it's, as, as usual, it's, it's just getting them over the activation energy. Um, so we'll try to get there.
Brianne Dressen: Right. Okay. Um, oh, as far as the international, uh, collaborative with looking into the side effects, what is everyone's relationship with Germany? Because I know in Germany, they've got quite a bit of research going. They also have disclosed a little bit of neuropathy, uh, with some of the mRNA technology. Um, and so I'm curious if anyone on your side has been able to connect with them in particular. Germany is represented in this group.
Peter Marks/FDA: Um, Paul Ehrlich institute is one that we work with also. Um, I, I, I don't know that I, I do know that they've had reports of neuropathy, but I, I guess there's, there's, and this is kind of the situation that we're in. No one, none of us are denying that there are these reports of neuropathy and that there are potentials, there's potential vaccine injury here. No one's denying that. But the issue is that that versus a safety signal that, you know, or that, or a potential safety signal, is that that's what we have to, that, that's what we're asking about. And so you cannot, it may just be that there's something that's there, but it's just not a strong enough signal to, to come up in the surveillance system. So that, that may be why it's not coming up with these meetings.
00:09:46 -> 00:10:30
Brianne Dressen: Okay. Maybe what I'll do is I'll send you, because it's actually on the government's website. So maybe I'll send you a link to it. Um, you can pass it on to Dr. Nair.
Peter Marks/FDA: Sure. Yeah.
Brianne Dressen: Um, but yes, I know that they're really pushing through on the, the getting the right, you know, information onto the labels. And, and I know you guys are as well, but, you know, obviously we're tracking everything globally, uh, with this information that's coming out. So I'll send you that along with, um, probably our contacts, but I think you probably already are connected with those researchers there. Um, is there been any progress with any of the researchers that we connected to with here in the United States, like Mayo or Stanford or?
00:10:31 -> 00:11:24
Peter Marks/FDA: So we've, the, the progress that we had, I think, was in talking, uh, with the folks at NIH. We've, we've made contact with the folks at Mayo. Um, I know that Narayan was, uh, still working with them, uh, to try to move things along. I'm not sure how things, how fast things have moved with them, because I haven't heard an update. So I, I think I probably would've heard if we had made some progress, but, um, Lorrie, did you, did you, did you hear anything from, uh, that, that's one where I did not have, I have not heard an update.
Lorrie McNeil/FDA: No, I, I have the same recollection you do, uh, Peter, that, you know, Narayan has been reaching out, um, but we haven't gotten any substantive updates recently. But we'll check in with him, uh, and, and let you know if there's anything to share.
Brianne Dressen: Okay. Um, Dr [Redacted], do you have any questions about?
00:11:25 -> 00:17:50
Anonymous Dr: Sure. In the last meeting, you and Dr. Nair committed to doing a manual review of VAERS, specifically looking for small fiber neuropathy. Has it happened yet?
Peter Marks/FDA: I do believe that that, that I do believe has been, um, I'll, I'll triple check with, with, with Narayan, but I believe they did look through, um, to try to query that search term as opposed to, um, as opposed to doing a, uh, essentially one of the, uh, the, the, the standard queries that we're doing, uh, in, in our best system, system, but I, well, we can, we can just make sure that we get back to, so he can answer definitively one way or the other. I thought we did, but, but I want to make sure I don't give you misinformation.
Anonymous Dr: Because if you did do a manual review, then you should have numbers about how many charts you found and be able to calculate an incidence of it and compare it to the general population. Look at the gender and the age.
Peter Marks/FDA: Yeah. I, I, I, I see. I, I want to say that they actually did this. Again, I, I, I just want to make sure that I don't give you misinformation. I, I think when they did this, they found no increase to observe, to expect it, but let me, let me make sure we get you the right information.
Anonymous Dr: Do you have an estimated timeline where we can have the hard numbers?
Peter Marks/FDA: I can't, I can't give you an, I can't tell you about the hard numbers, but I can, I can, I can get, I can certainly tell you that Lorrie can get back to in the next week with at least an answer of whether we did it or not. And if we did, um, we can have it to pass along what we found, and if we didn't, we can give you an idea of when we'll get it done by.
Anonymous Dr: Okay
Peter Marks/FDA: I, I do, I, I have to say I, I'm, I just, I just don't want to overstate stated. I, I'm, I, because we've, we've looked so many different adverse events over time that I, I, I, I just want to make sure I'm not confusing it with one of the other neurologic effects that besides small fiber that we've looked at, but I thought we did.
Anonymous Dr: And these are small numbers of patients, even in the studies that look at the finding and incidents and prevalence, so you know 100 charts could be significant. But I don't know until you pull the numbers.
Peter Marks/FDA: Well, I will, we'll just find out from, we'll find out from Narayan.
Anonymous Dr: I don't know. Bri, if you wanted to briefly bring up that the NIH did put out a preprint about small fiber neuropathy and the vaccine injured, which helped support our cause. And interestingly, there's also a preprint out for long haulers and small fiber neuropathy, and they actually have more patients in the vaccine injured study than they do in the long hauler study. Brianne Dressen: Did they send that on to you guys before they released it?
Peter Marks/FDA: Not to my knowledge.
Brianne Dressen: So it was pretty interesting. I mean, 50% of the people in the, in the study came back with neuropathy of some sort, which is, you know, pretty substantial. The other thing I thought that was interesting was none of the MRIs came back positive for anything so the MRIs looked fine, which that's kind of the hang up for the medical community right now is we go in there. We get a standard CBC and then we get an MRI and then we're told we're fine and good luck and we go home right. So we're trying to figure out one, how we can help support get this information out there to a broader audience, mostly so we can get researchers looking into this right and to open up the door for them to look into this. Because the findings are, you know, they didn't say that it's not connected, right, but they did say that further study is needed, which I think is absolutely what needs to happen at this stage. I do find that I'm a little, as you can imagine, we all connected with you a year ago as of yesterday. So, you know, please forgive my impatience on my part, but I am kind of, you know, discouraged by how slow the wheels are moving. I'm also discouraged that this document from the NIH was snuck onto a pre-print server instead of put out on a medical journal, which I know none of us here actually have control over that. But I do wish that this information was something that, you know, could actually be distributed amongst the medical communities for people to look at so they can help their, their patients. And I don't know if there's anything that can be done with the AMA or some of these other medical associations to help people see that it's actually there. The findings between the lung collar research and the post-vax research, there's quite a few parallels there, including the treatments obviously because we were both, you know, being funneled through the same parallels there at the NIH and the only reason I know that's because I was one of the participants in that trial or in the study, sorry, not the trial. But so I'm trying to figure out what we can do to help some of these patients get the help that they need. In a more timely manner, we have a large subset of people that are getting worse. The surveys, we've done a couple of them. The last one we did was on a cohort of over 1,000 patients and 11% of them are getting worse. A lot of them are having issues that are with their heart, new found, you know, problems where they're, they're going to die because their doctors are not helping them. And the reason their doctors aren't helping them is because they use the convenient excuse over and over and over that the FDA and the CDC do not say this is a thing. So we're not going to help you. And so as you can imagine dealing with that with thousands of people all day every day, it's, it's tragic to see. So I know that you guys are doing what you can. I just wish there was a way that we can move this along a little quicker before we have more people die.
00:17:51 -> 00:20:43
Peter Marks/FDA: The people, can you just tell me a little bit more, the people, the people are dying of what, what, they're dying of what? Because their doctors are less than to what, what is it, what are they dying of?
Brianne Dressen: Well, there's the, you know, of course, there's obviously the acute phase for people. And those are a classic example is there is a five year old here in Salt Lake City. And she died what we suspect is from MISV, the hospital is so afraid of attributing the fact that she was vaccinated five days before her death. They won't associated with it. So they actually told the parents that most likely it was SIDS. And the child's five years old. So we just have this really strong confirmation bias just from the start. I think that every single patient deserves to have some kind of evaluation, whether or not it's from the vaccine, you know, maybe they went played with ferrets and got the plague. I don't know. But the fact that we're not even allowed to discuss it is unfair to the patients, especially because if it's immune mediated, there are some interventions that can be implemented to save people's lives. With the people that are chronic. So those of us that are like a year out, you're in a half out. There's a lot of people that are having their hearts start to give out. And so they're, they're starting to have like pericarditis and myocarditis that are coming up later. We're having some increased incidents with Moderna with T cell lymphoma. And so in just the last two weeks, we've had seven people that have been positively diagnosed with T cell lymphoma. These are all people that also had moderate lymphatinopathy after the acute onset of their reaction to Moderna. But in specific with the neuropathy people, the people with neuropathy, they are having these issues with their heart come up that's so their hearts are giving out. And you know, there's a limited number of autonomic testing labs in the country. A lot of them are seeing us, they know, but a lot more are they're afraid because of the communication of misinformation. I can't tell you how many times like I've been called misinformation in the doctor's office. So I wish there was a way that we could figure out how to equalize this before we lose more patients and just kind of set, you know, some kind of precedent for the medical community. That hey, it's okay to talk to your patient if they've got neuropathy, right? Because at this point, I mean, we can't have people dying, but we stepped up to do the right thing. You know, we were, we were on, we were on the right side of history. We did our part and we also did our part with reporting to the government, reporting to the drug companies. We did all that. So...
00:20:44 -> 00:22:59
Peter Marks/FDA: I guess that I'm still the one piece I'm still not really confused about for these doctors is why aren't they treating what's in front of them, right? Because whether or not you would say that something is related to the vaccine or not, they should be treating what they're seeing in front of them, right?
Brianne Dressen: Yeah. They're not doing that. They're just saying. They're afraid. I mean, Dr [Redacted] can talk about this. She's a doctor. She's in that community. She knows the world. It's unprecedented. It's unlike anything that, you know, in the history of the United States, we haven't had this kind of pressure on, you know, on medicine to behave a certain way and say certain things a certain way and do things a certain way. I don't know. Dr [Redacted]... Do you want to talk about that?
Anonymous Dr: It's not that they're necessarily not treating what's in front of them, like the myocarditis patients are being treated appropriately. For example, I've been doing a research protocol that I got through the IRB at my own shop and I pulled a chart the other day. A patient presented four days after their second dose of Pfizer and they're a young male got diagnosed with paracarditis and nobody attributed to the vaccine. And it just wasn't even on their mind. So sometimes if you don't attribute to the vaccine, it changes how you treat the patient. An example was us with neuropathy. Traditional small fiber neuropathy isn't treated by IVIG. But certain types of immune mediated, like showgreens, for example, responds well or other viruses are known to do it. Influenza has done it in the past. Those respond to IVIG. So if you don't attribute the right cause, you're not going to give the right treatment. And that's also if you don't know that it's linked, you're going to have a delay in diagnosis. And as I mentioned in the last meeting with shock, it is so rare to have a shock that your treatment is IVIG and steroids. Steroids in the critical care setting is usually more for lung injury, but just shock chronic dysfunction. So if you don't think about the diagnosis, you don't treat it. And then the risk is that a child can die, which sounds like it might have happened, which is what we suspected in Utah, which nobody wants to happen.
00:23:00 -> 00:25:38
Peter Marks/FDA: Understood. Understood. We've kept pretty good track of any pediatric deaths. So I'll check into that one. I know we did a fair amount of investigating into a couple of other pediatric deaths. And happy to see if I'm sure we would have heard about it. They're under an obligation, by the way, to report. If the child received the vaccine, regardless of because of the emergency authorization provisions, they're obligated to report that whether or not they thought it was related or not.
Anonymous Dr: Just what are the consequences if they don't?
Peter Marks/FDA: Well, they're technically on the wrong side of the law if they don't, but that's your right. We don't have, when it's not like we can send out, it's not like we can send out a team. But the parents are, but even if the doctors are unwilling to report it, the parents, the reports to various can be essentially made by anyone. And so the parents, if you do double back, I don't know whether you're having contact with them, you should encourage the parents or anyone who is involved that they should feel free to report it.
Brianne Dressen: I will, and I appreciate that. So just on a basic sociology scale, so we have disinformation boards, right? And there's obvious consequences for physicians if they even so far as tiptoe that line. But there's no consequences that are obvious for people that don't report potential vaccine injury or suspected vaccine injury. So those connections are not going to be made. In the CDC with MIS, there's a fantastic form for MISC on the CDC website, right? Like I can find it, and I'm a preschool teacher, it's accessible. It's very clear to understand. So the reporting form is there. And of course, as you know, with the vaccine injuries, we've got fares, which is very complicated. But now that we also have MIS, and the CDC did acknowledge it kind of, you know, it would be nice if there was some kind of convenient, easy way to report MIS from the vaccine in a similar way that they have with COVID, especially just because the symptoms are, you know, it's identical.
00:25:39 -> 00:30:58
Lorrie McNeil/FDA: So we've been in contact with our counterparts, our communication counterparts at CDC, and they are currently undertaking a review of the bare sight and how to streamline it and make it more user friendly. Now, I don't know if part of that will include being able to, in the drop-downs, pull down MISB, for example. But I can certainly ask that question as they conduct their overview of the site.
Brianne Dressen: Okay, that would be appreciated. Dr [Redacted], did you have any other questions?
Anonymous Dr: Yeah, I want to go back to the MIS. Last time we had asked how many children or adults need to be diagnosed with that from the vaccine, before it would make it to the safety label, and you promised to get back to us about that. Do you have any updates with that?
Peter Marks/FDA: You know, the safety update, the way it works with the label is they look for changes, differences. What I'm not the expert here for pharmacovigilance, but what they do is they're looking for differences between observed and expected, and until they actually see something, or until they have kind of definitive evidence that something is related, it will not go on the label. Now, that doesn't mean that there are things that are constantly getting reviewed, and it may be that with one of the label updates, it will get put on that. This is one of those things that our folks review with CDC, and that also then they, the Narayan's group reviews, and we will update the label if we feel that it's appropriate if things belong on it.
Anonymous Dr: My understanding is MIS did not exist before COVID, so the incident is zero, to be expected, unless you had COVID. You had a CDC study published in the Lancet in February that clearly defines multiple cases, primarily in children, who at MIS, that they deemed they could find no cause, other than the vaccine.
Peter Marks/FDA: So, yeah, again, there's that case study. I think there's about 20 cases where there's some question about what's going on, and in the absence of having some better way to figure out what it is, there's not a definitive association that our folks feel more is putting on the label. I'm just telling you the consensus of CDC and the FDA experts. I think it's because they still don't have the perfect link there, but that's just what I'm told by them.
Anonymous Dr: What else do they need? The study, I'm looking at it right now, they have 21 cases. They use the CDC definition for incidents to describe MIS. They use the CDC definition. And what's interesting in this study is that they decided to go outside of the criterion, because the CDC for MIS in the general population uses a cutoff of four weeks from infection, and they chose not to use that cutoff in the study, which is odd. But when you go into the results, there are three children who had the vaccine, but didn't have blood work to confirm that they had anti spike in their body. So they were excluded, which I would argue is inappropriate if you knew they didn't have COVID, and you knew you got the vaccine from a physician. That seems odd. But even so, they had another six children that they said never had COVID. They don't have an anti-nucleocapsid antibody. They don't have a current COVID test, but they do have anti spike antibody. And these kids, you know, they're days from the vaccine, so it makes sense to be from the vaccine. So now you're up to nine kids who you don't have any explanation, other than the vaccine. And none of the kids who had COVID, for example, I don't know why they didn't use the four weeks. It seems suspicious because there was a kid who had COVID 34 weeks ago, and they decided that it wasn't from the vaccine, which was 48 days before. You know, why would you say that? That COVID 34 weeks ago was more correlation than a vaccine 48 days ago, days compared to weeks. There was another child who had COVID, I'm reading from the study right here, six weeks ago, and within 24 hours of the vaccine has MIS and doesn't have active COVID symptoms. So in nine patients who have no identifiable COVID or the ones that had COVID before, six of them, they could only find nucleocapsid antibodies. So they never had symptoms of COVID, got the vaccine, and a day later have MIS. And then five had COVID, but again, you're 34 weeks before. So all of a sudden, if you add up those numbers, that's 20 kids, which then makes an incidence of one in one million, which is the same incidence that you used to stop the Janssen rollout for thrombotic thrombosis thrombocytopenia. So it's a similar incident.
00:30:59 -> 00:32:43
Peter Marks/FDA: Let me do this. Let me, I think our folks have, because I don't want to misbeke here, because they, we are generally pretty liberal about putting stuff on the label in terms of making sure we include, whereas inclusive as we can, of adverse effects. And I know that this was talked about, but this is probably one where it's a shame that Narayan's not here, because I think he could probably better articulate this. Lorrie, we can, we can potentially get back with our response to you and writing about the, about that 21 case report, and why that's not, why that wasn't added to the label at this point. That's, I think that's probably better than me saying something that could be less than correct.
Anonymous Dr: Because even the conclusion in the study was that it occurs, but they're saying less than COVID. So the fact that the CDC says this occurs from the vaccine, and then Pfizer put in a VAERS report from all of the cases they were receiving, and they said they cannot exclude a possible causal association. So Pfizer is saying it. The CDC is saying it. It seems like the FDA is the only organization that's not willing to put it on a safety label. You have to understand why I'm upset about it. Why we're really pushing it, I should say, is you have a meeting coming up soon, right? You're going to potentially expand the age range for the vaccine, and you just had a third booster dose approved. And we are talking about having a child that were concerned as misdiagnosed and died from MIS. With this being a forefront in the vaccine fight against COVID, I had hoped that having genuine safety information and discussion would have been more forthcoming.
00:32:44 -> 00:34:38
Sarah Walinsky/FDA: Oh, sorry, I think I missed that. So did the 21 kids in the case were for they all die?
Anonymous Dr: No, they didn't, but does it matter? They were all in the ICU.
Sarah Walinsky/FDA: Okay, so they were just, they were, and they weren't long term.
Anonymous Dr: They didn't talk about long term.
Sarah Walinsky/FDA: Okay, thank you.
Peter Marks/FDA: And we'll, we'll, I'll ask Narayan to circle back on this one.
Anonymous Dr: It just seems unfair because these kids are easily identified to COVID to a fault. But for some reason, the standard is higher with the vaccine to the point that the standard for COVID in this paper of four weeks was intentionally disregarded in terms of timelines to make sure we can attribute more due to COVID.
Peter Marks/FDA: Yeah, you know, point, point, well, points well taken. Let me, let me just circle back with our folks on this one, but they have looked at this paper pretty closely. So I'll ask them to take a look. I think that the safety effects will be discussed again at these upcoming advisory committee meetings. Because we do care a lot about kids safety in these kids. And that's actually one of the reasons why it's taken so long to get to the place of having these for the youngest kids, vaccines for the youngest kids because the safety data sets are larger. And the benefit risk has to be pretty clear.
Anonymous Dr: My sense from these meetings is they look to you as their leader. You know, they want you to have this information as well. I feel like you look to them for your information and they look to you to give them information. And it's just going back and forth.
00:34:39 -> 00:36:23
Peter Marks/FDA: It's actually the way it works is we actually go based on the data that actually are submitted in these by the companies that we get from our surveillance systems. And that's what's presented to the folks. It seems like we have some do outs on our side, which is to get back to you. We'll get back to in writing about the 21 cases. Just remind me that's I'm just blanking. That's from the MMWR or is that from another? That was published by CDC and the MMWR or is that from a separate paper, I think. It was a separate paper. I'm actually going to try to find it on my.
Anonymous Dr: It was published in the Lancet.
Peter Marks/FDA: Lancet, yep.
Anonymous Dr: The online edition came out February 22nd, but they just published it in actual print this month.
Peter Marks/FDA: Yep, okay. We'll get you back. We'll get you back to you on an answer on that one. And we owe you also also need to get back to you on kind of the status of where things landed on the. I can just give you a status update on where the addition of the arm to the NIH folks that the NIH recovered trial is. And Lorrie, I think Amy Patterson is the one who is working on the larger on kind of the larger multi-arms of that trial.
00:36:24 -> 00:41:15
Lorrie McNeil/FDA: I have one more action item for us, which was the small fiber neuropathy review and what the status of that was.
Peter Marks/FDA: Yep, exactly. Yep. Yes, thank you for getting that. I forgot to mention that.
Anonymous Dr: That's something I also brought up. I was concerned that the regulatory standard for follow-up on these VAERS reports wasn't being addressed and performed appropriately. Dr. Nair said he was going to make sure that the VAERS report number IDs I had provided months ago were pulled to make sure that medical records were obtained or at least requested. Did he ever follow up on that?
Peter Marks/FDA: You know, we can ask, we can ask him. In general, I think they've been pretty good about following up on these, but let's just add that to the list to ask him.
Lorrie McNeil/FDA: He did send us an update on that since he wasn't going to be here for the meeting. Because he did note that you're concerned that the VAERS was not retrieving the follow-up records. So he reviewed each of the VAERS ID numbers individually in the system that you had provided and found that for all of the reports categorized as serious, the VAERS contractor either obtained records or made several attempts to do so and closed out a report if they didn't get a response. So all of them were followed up on.
Anonymous Dr: I would be interested too. One of the numbers in there was mine. I would be interested to see who they tried to follow up with mine because I know I never got it.
Lorrie McNeil/FDA: Yeah, apologize for interrupting. What Dr. Nair said last time was that the individual reporter generally is not the entity that is reached out to. It's the institution where the medical records would be. But I can follow up with him on that and let you know.
Anonymous Dr: I would love to because I have gotten follow-up from VAERS for some of these patients that I did not include on the list, like a pregnant patient, for example. They were all over me about it. They wanted medical records. I got an email over and over and over again. And one of my own reports. They did ask for a 60 day follow-up, but they never asked for medical records. So there seems to be a discrepancy on what he's saying is performed and what I'm seeing in real life. And I also noticed I had talked to VAERS last year on one of their follow-ups. And I was telling him I had a hard time updating my file and he told me to put in another report to formally update it. So I actually tried to pull it today. I ended up having three VAERS numbers and two of them are wiped. They are not there anymore and they were small fiber ones in particular. So I was wondering how that happened because my first report wasn't updated with the information that I put in the second and third VAERS numbers.
Lorrie McNeil/FDA: Are you talking about the information that is available from the public-facing system?
Anonymous Dr: So the way the VAERS query works, at least from the public aspect, is you can put in when VAERS sends you a formal case ID. You can search for and an individual record pulls up. That's why I have the Pfizer data. I can see exactly what they put in for VAERS for MIS. I can search for a number of cases. I can read it. I can find my first VAERS number but the next two are gone and I'm wondering why. If they were deleted, what happened? Especially because again, it updates my small fiber neuropathy diagnosis. I'm wondering what's happening. We had a big call out and we asked many people, I think we have hundreds of people who updated their VAERS using the same method that I do by putting in a separate report. And I'm wondering if there's something in VAERS that deletes them.
Lorrie McNeil/FDA: I don't know that any of you are deleted so much as they are combined, if the reports are related, but we can follow up on that.
Anonymous Dr: Is it something where I can send you the VAERS numbers about it? I had collected last time to, based on our conversation, I had collected like VAERS numbers from other people, mostly small fiber patients who never had records followed up, to try and provide them. Especially because we're talking about small fiber, so much so that you could pull out those individual reports.
Lorrie McNeil/FDA: That's the list that the doctor near looked at.
Anonymous Dr: I gave you the list of like a cardiac arrest patient that had died, a woman who had an epidural hematoma after Pfizer, four days later who then died. Those were the cases. My own case was one of them. There were a lot of hospitalizations and deaths, but I was the only small fiber case in that one. But I have a separate list that I have reached out, and I was hoping to give you that as more small fiber link for the most part. Some outliers.
Lorrie McNeil/FDA: Yeah, feel free to send that to me. I'll make sure it gets to him and have him take a look.
Anonymous Dr: That would be great. Thank you.
Lorrie McNeil/FDA: Thank you.
00:41:16 -> 00:45:43
Peter Marks/FDA: Okay, so I think we have we have our to do is I should now thanks for I see I just I I saw I know this is I see what Narayan sent here, so that's really helpful. And the one thing I can confirm out from saying that from looking at what piece that I just said to confirm out if I my memory was correct. That they continue to look for a small fiber neuropathy cases coming into theirs to look to see if they can find some imbalance and they have not yet seen any imbalance of observed over expected. But again, they're pretty they're pretty, you know, since these are rare events, it's always hard to figure that out. So again, not I'm not judging one way or the other here.
Anonymous Dr: Just important for us to have numbers, you know, a manual review will result in chart numbers and incidents, population incidents, gender, age, just like with VAERS reports. If you reviewed them, you should know the cases that I'm talking about. They were not small fiber. So the details that you guys are providing are concerning for the follow up and it's also frustrating when we talk about the same talking points over and over again for months now. And you guys have given us verbal commitments, you know, and you come back and it's frustrating enough to have them. This is our health and it's been a year.
Peter Marks/FDA: We have continued to do our best here to try to understand things. We do continue to carefully monitor safety and I will tell you that there is nothing that I care about more than making sure that we have safe vaccines. We will continue to do that and we will continue to look very carefully at safety on these and we will continue to work with people to do that. No one's trying to stonewall you. No one's trying to do anything more than do what we can, which is to look at the data we have in front of us. And the fact that it's slower going than it might is because it's just challenging. And we don't have data, data, it's large amounts of data that people sift through and they're trying to do the best and not give you misinformation because we rush stuff. So that's what's going on here.
Brianne Dressen: In the meantime, our lives are misinformation. I think you have done it. I mean, I can't tell you. I mean, I'm 40 years old. I've spent my entire life going doctors visits. I know what a proper medical process is, even just as an adult. And what's happening now is not an appropriate, you know, pathway for medical care for these people. Because really, I mean, these people, they just want their lives back. They just want their health back. So, you know, I do appreciate, you know, I can tell on your voice that you do care for these people. From historically looking at your history, you can tell that you do care for your patients. And, you know, everybody there that we've talked to has given us respect. But thank you for acknowledging that, you know, that this is an extremely hard situation for us to be in because we do see it every day. We breathe it. We live it. And so as far as we're concerned, I mean, there's no better expert than those people that are living it every single day. You know, to be able to portray this new disease and to help those who are in power to understand that this is a real issue that, you know, it is life altering. And in some cases, it has been fatal.
Peter Marks/FDA: Appreciate that. Okay. I think Lorrie, anything else on your end? Thanks very much for sharing. We'll do our best to get as good answers as we can in writing to you. Lorrie, let's try to just commit to doing the next two weeks.
Lorrie McNeil/FDA: Of course.
Brianne Dressen: We appreciate it. Thank you very much.
Peter Marks/FDA: Okay. Thanks a lot.
Brianne Dressen: Bye-bye. Thanks.FDA CEBR - REACT19 - 2022-09-19
00:00:00 -> 00:01:13
Lorrie McNeil/FDA: There's on Suzanne Frantz-Bohn and Paul Richards are both on we're just waiting for Dr. Marks.
Brianne Dressen: Okay, great.Thank you.
Lorrie McNeil/FDA: Sure thing
00:01:14 -> 00:04:40
Lorrie McNeil/FDA: I think that everyone is on. I don't know. Brianne, do you want to go through introductions quickly? Or do you want to jump right in? It's up to you?
Brianne Dressen: I'm... doing introductions will be good. Do you want to start on your side first?
Lorrie McNeil/FDA: Certainly.
Peter Marks/FDA: Sure. I'm happy to start on Peter Marks director of the Center for Biological Evaluation, Research and I bring regrets from Narayan Nair who you've met before but he is not in today. And so he won't be joining but he did leave me with a bunch of information that he had gone through that I can potentially hopefully help with answering questions on. So look forward to the discussion today. Let me turn it over. I may pass along to Sarah.
Sarah Walinsky/FDA: Alright, Sarah Walinsky. Sarah Walinsky. I am Peter's chief of staff here in Seabird.
Lorrie McNeil/FDA: Hi. Good afternoon. I'm Lorrie McNeil. I'm the director of the Office of Communication Outreach and Development here in Seabird.
Suzanne Frantz-Bohn/FDA: Hi, I'm Susan Franspon. I'm a deputy director of Seabird's Office of Communication.
Lorrie McNeil/FDA: Paul Richards was on but he might be having connection issues so he rejoins. He is also here in the Office of Communication Outreach and Development. Brianne?
Brianne Dressen: Okay, great. Thank you. You guys know me, Brian Dressen with react19.org, advocating for the COVID vaccine injured. And of course we have Dr. [Redacted] who you guys know well as well. Here to my left we have Steve Wangari. He's a construction project manager who is injured by J&J. Next to him is Henrietta Simolas. Her son was injured and died from Pfizer. Susanna Newell, who is a corporate financial responsibility injured by Pfizer. Sean Barkivatch, research nurse practitioner injured by Pfizer. Jennifer Jones, her child was injured by Pfizer. Julia Marx, which you probably can't see her all the way down there. But she's a nurse injured by Moderna, Kyle Warner, professional mountain biker, injured by Pfizer. Alexa Quinter, injured by Pfizer. She's a clinical systems analyst. Christopher Drysback, who was in criminal law, injured by Pfizer. Joel Walskog, physician, injured by Moderna. Ernest Ramirez, his son, was killed by Pfizer. Stephanie Amatted, Gary, clinical trial participant with Pfizer, Mona Hosegawa, who works in banking, injured by Pfizer. So that's as quick as the introductions as we could make. And if you want, I can email you the long list.
Peter Marks/FDA: That actually might be great. That would be fantastic. And we really appreciate that.
Brianne Dressen: So we really do appreciate you guys taking the time to meet with all of us. Obviously we can't squeeze everybody in on one screen. But we we are here in DC this week, logging for basically the issues that we have compensation is is failing us as well as several issues that we've been discussing over the last year and a half. We are meeting with well over 30 politicians, senators and elected representatives. Looks like it's a very even split between Democrats and Republicans, which I am encouraged to see. I know that Dr. [Redacted] probably has a few questions for you. Do you want to start with the questions that you have?
00:04:49 -> 00:10:32
Anonymous Dr: I just want to verify. Can you all can you guys hear me OK?
Peter Marks/FDA: You were breaking up a little bit, but then you got clearer.
Anonymous Dr: Dr. Marks, did you get a chance to review that email that I sent about the MIS, the CDC data?
Peter Marks/FDA: I did and actually Dr. Nair also reviewed it. And you know, the issue that at least Dr. Nair was very familiar with the paper and it got through it pretty carefully felt that the data for that we have to date is really does not necessarily connect the vaccine. I mean to MISC, the information there that came from that was published in that in that paper essentially was not sufficiently robust from the work that's been done subsequently to make the connection of MISC with the vaccine. So although we understand MISC, you know, it comes, it is, it is something that obviously we know from COVID, the idea that the vaccine would cause it. And the, at least the feeling is that the association from that Lancet paper is not sufficiently robust to make it. This is just to understand, I'm not the, I've read it. I'm not the expert to make that definitive statement, but our statisticians, at least that's their impression of it.
Anonymous Dr: Even though the paper calculated a reporting rate for MISC after vaccination, it sounds like the FDA does not believe that any cases have been attributed to the vaccine by the CDC. Am I interpreting that correctly?
Peter Marks/FDA: I guess that the feeling is that at the end of the day, that the association of the vaccine causing the ideas that the issue of the vaccine causing MISC is felt to be a very, that the association is too weak to make them feel comfortable in saying that is an association of the vaccine, either an adult or in children.
Anonymous Dr: The paper had or went further in that the child having a record of vaccination wasn't enough. They had it as a poor relationship and then they also went further to check for that anti spike antibody. And then they made sure that these children met the CDC criteria for MISC with the only exception instead of it being COVID, it was the vaccine. What additional evidence are you guys looking for to be able to attribute? What is missing?
Peter Marks/FDA: Well, so what they've done, let me just go through what CDC and FDA have been working together. And so what they have done is using the integrated surveillance systems. CDC has been monitoring reports of MISC and people who previously received the COVID-19 vaccine and it had onset of MISC within at least well within 90 days of their last COVID-19 vaccine. So the way they do this is they pick some interval so that they can at least feel more comfortable with the association. So they pick 90 days as the interval. And they're in particular, they come down and looked at children age five to 11 and they had identified as of August, the end of August of this year. They had identified 58 children in the surveillance databases of the 58 children that had MISC who had been vaccinated 54 of them had laboratory evidence of past or recent SARS coronavirus to infection to did not. Number two, they were unable to determine the status. And so at the end of the day, given the 7.3 million children involved here that they in this age range, they felt that it was impossible to make a clear association. Again, these are the data that they've provided to me. And in children less than six years old, there have been no verified reports of MISC after the Pfizer BioNTech vaccine or the Moderna vaccine. So it's actually for Pfizer, it's less than four years, four years or less than for Moderna, it's less than five years or less. So those are those are what he had to bring to this in terms of that paper and what CDC's done since then and with FDA.
00:10:33 -> 00:12:41
Anonymous Dr: The paper from February looks at a different age range in 12 to 20 in that 12 to 20 age range. That's where they find the six patients that have an anti spike antibody for getting MIS within five days or 14 days from it who never had COVID and don't have an anti nucleocapsid antibody. Another three children also met criteria except that nobody sent an anti spike antibody, but they were vaccinated. That brings us up to nine and then you have other children who are much closer to the vaccine compared to the COVID infection. You know, there's this one child. I'll read from this table here on table three who is 111 days from their positive COVID test, but only three days from the vaccine or another child 284 days from COVID, 48 days from the vaccine. And usually with MIS the CDC has a definition they do have a time limit with how long like you were saying like 90 days the CDC definition in the paper is four weeks. So it goes back to my original question. You know what level of evidence what connection are we missing in this paper that you feel like you can't say that this is MIS in these children, which this paper says it has a reporting rate of vaccine and MIS. What is missing for the FDA to review it?
Peter Marks/FDA: The issue is that when you look at the rates of something that's on the level of one in a million, it's very hard to make definitive associations. And I think that's what Dr. Nair was pointing to here is that if you look at the rates that they're getting to, it's very hard to come up with definitive associations when things are this rare. It doesn't mean that nobody is saying that it's not real. It's just saying that making definitive associations is very challenging when rates are so low.
00:12:42 -> 00:15:25
Anonymous Dr: But the rate for the Johnson and Johnson vaccine with the TTS there was only six patients. The rate was 0.75 per million and the vaccine was stopped. And this is a similar rate of about one in one million. So it's actually a little higher rate.
Peter Marks/FDA: The strength of the association there, though, was very different. The strength of the association there was that nobody who didn't get the vaccine. There wasn't there wasn't any kind of an association potentially with with MISC. The problem is you have MISC in the background with COVID-19, right?
Anonymous Dr: Right. But it's not like that's the only way that it happens. Whereas it doesn't have to be COVID.
Peter Marks/FDA: Virtually the only people who get TTS are people that it is, it is a incredibly rare hemologic syndrome that's associated with adenoviral infection in some orthopedic procedures and incredibly rarely on the order of one in millions and millions. And then you have it show up in several participants who have received people who have received the Johnson vaccine. So there the association was very strong because you don't see it in COVID itself. And yet you saw it in all people in these people who had it with the Johnson vaccine. And by the way, we had a control population, which was the literally hundreds of millions of people who had received the Moderna and Pfizer vaccines where there was no such signal. It became very it became very clear very quickly because of having essentially a concurrent control and not having a background of something in other words, we didn't have the background to sort out. It's a little bit like the same reason why myocarditis was a little hard to sort out at first. There's clearly no one's denying that there's a myocarditis signal at all. There is definitely a myocarditis signal with both of the mRNA vaccines. It did take a while to sort out what the actual rate was because of the background rates of myocarditis from COVID-19. But I think we now have those numbers better, we better understand those numbers. So this is this is a little bit of the same thing here. We understood with TTS because we had there was a cleaner background to have.
00:15:26 -> 00:19:36
Anonymous Dr: It sounds like you'll for sure need to have MIS on the vaccine to make the rate stronger and easier to see compared to COVID, even though there have been multiple children that the CDC has defined that they could not find that COVID link. Just the vaccine, but you need a stronger signal connected.
Peter Marks/FDA: I think the idea is that so two children, so take it as this, there were four children out of 7.3 million that they looked at in the 5 to 11 age range, who had MSIC, who had received the vaccine, who did not appear to either, two of them, did not appear to be infected and two of them they couldn't test or they couldn't determine from the test. And so it's that with those low rates, it's very hard to know what you're really looking at.
Anonymous Dr: In those 54 children who had COVID in the past, how far into the past, was it anybody that ever had COVID ever, or did you put a limit on when they had COVID versus when they had the vaccine. And I asked that because the two to 12, sorry, the 12 to 20 paper in the Lancet, if they ever had COVID, they didn't link it to the vaccine, even those clearly or purposely much more related to the vaccine, days versus months.
Peter Marks/FDA: Yeah, let me go. I'm just going to look at notes here and see if I can, if they have any exactly how recently it was, because I don't recall seeing how recent the most recent COVID. Yeah, so I can't tell you right now, we have to go back and try to get those data for you. In some of them, it was recent, but not in all, it was in past in some of them.
Anonymous Dr: Well, if it's drastically passed, then why weren't these children considered to be apart from the vaccines, as it's more likely, significantly more likely to be from the vaccine. If you're only a couple of days from the vaccine, but months from COVID, that would then change your incident rate to a higher value.
Brianne Dressen: I do remember that we discussed this last time that we actually in back in March as well. And it was all but two cases in that report from Lancet, all of them had their vaccine within a week or two weeks of their MIS onset, and their COVID cases were months prior. So if we are looking at correlation or some kind of association, it would lead to me to suspect that, you know, maybe we do need to be looking at the vaccine. If we've got people that have and kids that had COVID months before, and then they get their vaccine and then two weeks later within two weeks, they have an issue. And so I do kind of wonder if what are we missing, you know, if we have 20 patients with a potential vaccine-induced MIS, and we're just ruling them out because they have COVID antibodies. If we actually look at the timeline, common sense says that they're very well could be something to the timeline with the vaccine. So I would strongly recommend that we, you know, actually look at the timing of the onset of these diseases, and not just if they ever had COVID in the past. Because really, if you end up with COVID, and we've seen this with youngsters all the time in our organization, they get COVID, and then they get vaccinated, and then just having the two together, there's an issue. So why I would suspect that maybe with the FDA and the CDC, they recommended that if you do have active infection that you don't go out right away and get vaccinated, because if you already have something going on in your body, you don't need to cause another inflammatory or immune response. So it makes sense to me that we do examine this by the timeline instead of just if they had COVID or if they didn't.
00:19:37 -> 00:23:21
Anonymous Dr: And that's why I agree with everything you said. The myocarditis is...
Peter Marks/FDA: So I think one of the things we do have to have a foundation here is that we have had safety signals that we have found. You talked about TTS. We have myocarditis. I think we're constantly learning more here and we're constantly accumulating more knowledge about this. And this is not to say that in the future, we won't understand that there is some association. The issue is that at this point, the strength of the association is too weak to make, at least for us to make definitive. That's not to say we won't continue to look because we continue to look for a variety of things, including things like small fiber neuropathy, various thromboembolic phenomena, we're continuing to look for all of those things to try to see if there's an association. And we will continue to do that because even small associations can be very, you know, can be important when you have a prophylactic vaccine. And nonetheless, that overall, when we do our benefit risk assessment in the pediatric age range, even if you include some of these side effects like a myocarditis, you end up still with a positive benefit risk assessment on getting children vaccinated.
Brianne Dressen: I suspect that this may be something that strikes a chord with several of the parents of children here, obviously, so please forgive a few of your things. But in our defense, obviously, we do understand that there's several countries in Europe that have ceased vaccination, recommended vaccinations for pediatrics. And so, you know, and that could be side effects or just effectiveness or whatever. But in addition to that, we're trying to figure out how we can cross the goalposts. I mean, with myocarditis, you and I, we talked about the myocarditis cases over a year ago, and you discussed how there were six cases of myocarditis, and the signal was very strong. Same thing with TTS, there were six cases. So here we are discussing 20 patients with MIS, right? So there's 20, and we're kind of letting the waters with timing or whatever, which obviously I have a strong opinion that probably you go back and look at that signal. And then also with neuropathy, you know, neuropathy, the very first time we met with you, it was August of last year, and there were six of us all with neuropathy. Then in addition to that last May, so May of 2021, we presented 18 cases to Janet Woodcock and yourself. And I do believe that Janet reviewed a few of those cases. Then in addition to that with neuropathy, we also have that we were flown into the NIH, and we were studied, and then the NIH actually published a study with 23 cases of neuropathy. So where is the, you know, where is the goalpost here for a getting some kind of public announcement for just for the medical community to be identifying this? Are we anywhere near with that? It sounds like MIS right now, is it a stalemate? Is neuropathy anywhere closer? Has anything been done with that since we met in May?
00:23:22 -> 00:26:32
Peter Marks/FDA: So Dr. Nath at NIH continues to work on neuropathy, and it's my understanding that he is potentially publishing soon on that again. So I think that will again be something that will hopefully keep providers aware of that. It's we're certainly continued to be aware of that because we continue to look through our databases, not just in the United States, but internationally to try to look for signals of small fiber neuropathy. And so I, I, there I would say the jury is still out as far as I'm concerned on that one. It's a rare event that we just don't know yet because we don't have a sufficient, we just don't have sufficient data to distinguish the rate of small fiber neuropathy. And they are, I actually talked just Steve Anderson who couldn't be on our lead statistician, you know, they, they recently query this and the problem was they could not distinguish small fiber neuropathy in those vaccinated from those who were not vaccinated. And so you couldn't really tell, not you just couldn't tell whether there was a signal or not, but that doesn't mean there isn't, we're just saying that doesn't mean there isn't one. It just means that it's just maybe too small for us to tell with our current state of things. Now, I will say one thing, when we first talked, there were only a few cases of myocarditis, but this dates back more than a year ago, I think, right, Lorrie, I think that's when we did. Now, obviously, we know that there are hundreds of cases, the difference here is now that there are hundreds of cases of myocarditis. And globally, I don't know how many, I mean, I'd have to, I'd have to look in our databases. But we're talking about many, many, many cases of myocarditis that we can distinguish in people who did not have COVID-19 preceding. So we know that wasn't COVID-19 induced myocarditis and we know when they were vaccinated and we know the temporal association that it happened between two, generally happened between two and seven days after receiving the vaccine more commonly with the second dose of vaccine. A little less commonly with the third dose of vaccine and least common after the first dose of vaccine. So there, we have actually, and there's, and there's biologic plausibility there. So everything, we kind of wraps up into a totality that makes us feel, yep, that's a pretty real association and it's clear. The problem and it wasn't as clear, you know, that's why Ms. Dressen, I think you're, you're, you're, you're right that when we only had six cases, it wasn't as clear, but now it's become very clear. So the fact that we don't see something doesn't mean that it won't, that we won't in the future, it means that at this point in time, using the best available tools we have, we just, we don't see anything right now.
00:26:33 -> 00:30:10
Brianne Dressen: Okay, so, so we're probably in agreement with saying that it's not like it's a certainty that there is not correlation. We're still trying to examine that. Is that what I understand?
Peter Marks/FDA: I think that's a fair, that is a fair statement. That is an absolutely fair statement.
Brianne Dressen: Okay, so in addition, so my other question with this is, so on our side, we have, we've sent you all of our data. Germany, right, Germany has made the association actually with long COVID and post-vax syndrome. I don't know if you've seen that, it's been released by their Ministry of Health, which is very useful for us. And obviously in the conversations that we have all had here for many months, and then of course the NIH, the research they were doing, we were running and congruent with their long COVID research, right. So I do think that most people do suspect that there is something with the spike protein that's coming in, you know, that it has to play. But I'm trying to figure out how we can, one, as we've discussed before, get research, piggybacked into long COVID so we can figure out, is this actually long COVID's like, is there something with the spike protein itself, or is this something different? And research is not happening, as you know, and it's definitely not having on the scale that it needs to happen, which is one of the reasons why we're here in DCs, we're trying to get appropriation for funds for this. But in addition to that, I would love to get you guys in touch with our international partners in Germany, because between what they're doing at Margaret University, and I have this study here, where they actually make the correlation between long COVID and post-vax syndrome.
Peter Marks/FDA: Is that a published study? Where is it published?
Brianne Dressen: It is. It's in frontiers, and so it's by our partners at Marburg University in Germany. They have a post-vax clinic there set up, and so they're actually taking care of the patients there. It's not great, but it's better than what we have here, right. But it does mirror what they found at the NIH when we were there. So I do wonder, so I remember back when the press releases started with myocarditis with the six cases, there was a press releases that, hey, heads up, we think that there's a signal we're looking into it, and it was just a, hey, we're looking into this. So I'm trying to figure out why, with all of the cases and all of the data, and how tightly correlated, even with the timeline, why we're not seeing the same press release or communication be released about a potential post-vax syndrome or potential post-COVID vaccine syndrome or potential post neuropathy after the vaccine. And then also, in addition to that, as you know, the European Union did put paresthesia on the package insert, which, actually, can you guys raise your hand if you still have paresthesia? Okay, so we're looking at at least 75% of the people at the table. So I think that even though it seems like it's a minor detail, just letting people know that paresthesia could happen is going to change them from anxiety or whatever psychosomatic misdiagnosis that we get to. Why do people have paresthesia? Why is this happening to them? It's very common, but Dr. [Redacted], do you have anything else before I move to just a few statements, if you guys are gracious enough, of your time?
00:30:32 -> 00:32:21
Anonymous Dr: [Unintelligible, poor cell service] ... And it makes sense. Perhaps that's why myocarditis is from COVID, an mRNA and AstraZeneca, and even case reports from Johnson and Johnson all show the spike. So Pfizer released documents. It says that they altered the spike that they used. They put in proline mutation, and they unintelligible, poor cell service.
Peter Marks/FDA: I'm sorry, I kind of got a little bit of that. I couldn't really hear. I heard about every other word.
Brianne Dressen: Yeah, we couldn't hear it on our end either.
Anonymous Dr: Can you hear me now? Is that better?
Peter Marks/FDA: Yeah, yeah.
Anonymous Dr: [Unintelligible, poor cell service]
Peter Marks/FDA: We will have to follow up with an email on that. I think we better try with an email. Because I think that we just, you're breaking up. I think you were saying something about their multiple cardiac biopsies, but I couldn't really hear much else other than that.
Anonymous Dr: I'm sorry about that. I'm sorry you guys can't hear me, but I'm happy to send an email.
Peter Marks/FDA: Maybe give it one last try. We were coming through just fine just then.
Anonymous Dr: Okay, I was wondering why with all these biopsies showing spike protein in the vaccine injured and Pfizer had altered the spike protein, but didn't do any research that was conducted to ensure the spike was being removed from the body. I was wondering why the FDA didn't request them to do that research.
00:32:22 -> 00:34:52
Peter Marks/FDA: In terms of understanding that the duration of spike protein in the body, that's what you're talking about. Because there were, there were animal studies done that looked at the duration, some of the duration issues, nonclinical studies that were done. But the assumption here was that these mRNA vaccines behave like previous mRNA vaccines, in which generally within days of the administration, the expression of the mRNA is gone. Now, I know that there have been reports of spike protein present later, and some of those are ones that we are following up on. I just, I don't have a final answer. I can give you on that because I, so I can't say yes or no of how long that could be present. But your point, your, I understand your point there is that the concern about, about spike proteins potentially being present for additional periods of time.
Brianne Dressen: The other interesting thing about that is, is we just got word last week that the NIH did study that with us, and the majority of those of us, and it's in their study that they already put in the preprint. We didn't have COVID before we got our vaccine, right? And for the clinical trial, I mean, they had to confirm that I had not had COVID. And so the question is, you know, why is there spike protein in our blood if we never had COVID, but we got vaccinated. Either we had a symptomatic COVID or, you know, our bodies are having an issue metabolizing the spike, which also is important to communicate to the research community in particular, because long haulers also have the same issue. So if it's something as simple as there's something physiologically going on where we just can't clear out the spike, and if we can figure out how that connects already with what we understand with long COVID, open up the door for researchers to examine the two groups together. I think that we're going to do a benefit for long COVID research as well as for post-vax research.
00:34:53 -> 00:36:50
Peter Marks/FDA: And can I just ask that the spike protein was, and who's, how are they confirming the spike protein here? What assay are they using? So I understand.
Brianne Dressen: It's actually flow cytometry mass spectra from what I've read, and there's an independent group that did it, but then also the NIH replicated it.
Peter Marks/FDA: Okay, I'll ask Dr. Nath. I bet Dr. Nath will know. I can check with Dr. Nath and see, because I'd be interested in that. That I didn't know about. So I'll have to look into that further.
Brianne Dressen: I think that would be really a really useful tool, and the reason why I want to make sure that we're focusing on, I understand that, you know, basically most of the US has had a COVID infection at this point, but Dr. Nath at the NIH has our samples from before we got COVID, right? They did the research so early on, it was before COVID had circulated everywhere. So I think that it's really important to use that data, analyze those samples, but then more importantly for those of us here at this table and everybody else, that that information is then provided to the public in a transparent manner. So then, because we just want to get better, but we can't get better until the research happens, and if the research hasn't even begun, we're stuck, you know. So if you guys are okay, can we start with a few testimonies? We have five people here that would like to share. We're going to do three minute testimonies, and we really do appreciate your time and willingness to hear these people. And obviously these are consumers of these products, so their information is relevant. So we're going to slide you down the table here.
Peter Marks/FDA: Okay, no problem. Thanks for doing this, and thank you to all.
00:36:51 -> 00:39:30
Steve Wenger: My name is Steve Wenger. I was 55 years old at the time of the vaccine. May 18th of 2021, I got the Janssen vaccination. Within seven days, I started having issues walking. I started falling, started tripping, losing my balance. On the 14th of June, I was admitted to the hospital because I could no longer walk at that point. Through a lumbar puncture, I was diagnosed with GBS, Gillain-Barré Syndrome. I spent the next 98 days in the hospital. My diagnosis was ultimately upgraded to CIDP, chronic inflammatory, demyelinating pylon neuropathy. That diagnosis was reached through a biopsy of the Suril nerve out of my right ankle. Prior to getting the vaccine, I had never had any medical issues. I had no medical history. I had not had COVID. I was 100% healthy. I was an active hiker and active outdoor enthusiast. Today, I got out of the hospital. Today, I walk with a cane. I can no longer participate in the sports that I enjoyed just a little over a year ago. I can no longer hike with my wife. I get retuximab infusions on a six-month basis. I get IVIG infusions every 14 days. These IVIG infusions, my neurologists have told me I will be getting into the foreseeable future for years to come. The ending result I have is I have severe neuropathy, ringering neuropathy to my fingers, my legs, my lower limbs. I have lost my job, my income, the financial implications have been massive. I went from financially secure to, I will probably be declaring bankruptcy in the next two years. Medical debt is just crushing us. I understand the vaccines have saved many lives, and I don't dispute that, but they also have affected many lives in negative ways. We are just looking for assistance to get our lives back on track. I appreciate you listening to my story.
00:39:31 -> 00:40:32
Peter Marks/FDA: No, thank you. Just so you know. This is one of those issues. Guillain-Barré syndrome is something we realized later. This is something we haven't spoken about, Mrs Dressen. This is an association with the Jansen vaccine. It's one of the reasons why we took the labeling on the Jansen vaccine now is no longer as a first-line vaccine. It's now for people, and I'm so sorry for your troubles. I do sincerely hope that things get better for you.
Steve Wenger: CDC actually announced, CDC actually released that statement on the 12th of July 2021 that with that point, I believe they had stated they had 100 cases that they had linked back to the vaccine. At that point, that was prior to me getting my incident into various. Again, I appreciate your time.
Peter Marks/FDA: Thank you.
Steve Wenger: We'll slide you down to the next person.
00:40:33 -> 00:44:08
Henrietta Castile Samos: Thank you. My story is a little bit different than that of the ones you're going to be hearing today. My name is Henrietta Castile Samos. Prior to May 6, 2021, I was a retired Spanish teacher, a non-practicing attorney, and a mother to three wonderful children. I am now a mother that greaves daily for the one I lost. On April 20, 2021, my healthy 34-year-old son, Victor, who had never had COVID took his first dose of the Pfizer vaccine. Six days later, he had a massive headache, and on the morning of May 6, a complaint of chest pain and jaw numbness. He called 911. As the paramedics were checking his vitals, he collapsed and became unresponsive. The ER doctor suspected he died of a vaccine-induced pulmonary embolism, but in fact, the autopsy showed a thoracic aortic dissection. He died just two weeks after his first vaccine. We have ruled out genetic predisposition, and we have had his blood serum examined by a world renowned immunologist who concluded he had an exceedingly high number of inflammatory markers, and indeed had had a severe inflammatory response. Victor was the last of the family to get the vaccine and believed it to be safe. We reported his death to VAERS. The hospital did not. I was profoundly shocked when no one from the CDC or FDA reached out to me to investigate my son's death and possible safety problems with the vaccine. After frantic calls to the CDC, I received form condolence letters stating the vaccine was safe, and no indications of following up to analyze my son's adverse event. I felt dismissed. My life is now that of a bereaved mother. I grieve for the life I had envisioned among no longer have. I grieve for my other children that have lost a beloved brother and uncle to their future children, but mostly I grieve for the life Victor did not get to live. He was about to propose to the love of his life, had named his future children, and was working at his dream job as a level seven senior manager at Amazon in Seattle. More importantly, he looked forward to spending time with the family he loved and called several times a day. How can you help me? I will never again be able to hug and hold my son. To you, he may not be nothing more than a statistic, collateral damage, but to me he was my entire world. Please learn from the mistakes that have been made. Every life is too precious to be ignored. I call for an investigation into the adverse events and to the failures to act. I call for the agencies to stop ignoring adverse event data and those crying for help. I call for transparency and that we be informed of the adverse events associated with a vaccine so we can make informed decisions. It's too late for my son, but had the risks been properly disclosed and the clinical trial data publicly available, Victor would have made an informed decision and would be here for me to hold once again. Thank you.
00:44:09 -> 00:44:18
Peter Marks/FDA: Thanks so much for sharing that and I'm so sorry for your loss.
Henrietta Castile Samos: Thank you.
00:44:19 -> 00:47:15
Susanna Newell: Hello, my name is Susanna Newell. I live in St. Paul with my husband and two teenage kids. I worked in financial services for 25 years as a VP of Corporate Social Responsibility and sadly I'm on disability. I was previously very active doing 150 mile bike rides and completing triathlons yearly and was a caregiver for my sister. I had no underlying health conditions additionally confirmed by two nucleoclasspid tests have not had COVID to date. My last one was on August 10, 2022. I did have confirmation that I still have some of the vaccine antibodies in my blood as of August 10, 2022. On April 13, 2021, my whole life changed within 30 hours when I very willingly and with pride in doing the right thing for my community followed the recommendation of the CDC and took my second Pfizer shot. It started with a swollen lump of my neck, extreme fatigue, a brain fog and a rash on my forehead that exists today, bruising and joint pain. By May 26, 2021, things were exponentially worse and I could no longer walk unassisted anymore. It felt like my whole body was shutting down and I was going to die. My husband drove me to the Mayo Clinic ER with my will in hand. I was extremely dizzy, my vision was blurry, my right pupil was not dilating properly. I had weakness in my right arm and my right leg had extreme burning pain in addition to whole body vibrations. During my three days stay at the hospital, they ran many tests but I left the hospital with lots of new medications for symptoms and no diagnoses. Fast forward to today, 17 months later, I'm now a frequent flyer at the doctor. It's a game of hot potato between specialists. I see multiple neurologists, rheumatologist, cardiologist, vascular specialist and allergist among others all who agree the vaccine caused my reactions. I've been diagnosed with small fiber polynomrapathy, cryoglobulin, anemia vasculitis, SVTs, adrogenic and cardiophagal dysfunction. Even with diagnoses, it's very hard to get the recommendations for IVIG that both my neurologists asked for. They both been denied twice. I was able to get retoxamab because of the cryoglobulin anemia vasculitis but I'm still fighting with insurance on an $80,000 bill. I have many days where I can't perform simple tasks. I can't feel hot or cold. The way that I could before, it's extremely dangerous and my children have to push me in a wheelchair. I'm lucky I have a strong support system and a savings account that I'm burning through but many of us don't. How can we abandon them? I've always believed in the U.S. I believe that we had excellent health care and a government that cared about his people and I want to keep believing that. Can we count on you to be on the right side of history?
00:47:15 -> 00:47:53
Peter Marks/FDA: Thanks for sharing that. We do take all, you know, we do try to take and we do take every adverse event that we see seriously and try to do our best understanding what's going on here. I appreciate you're sharing that.
Susanna Newell: Yeah, I think I'm in a unique position because I still haven't had COVID yet confirmed by two nucleoclospid tasks so I'm officially vaccine injured but multiple things would be good to study.
00:47:54 -> 00:51:52
Sean Barcavige: Hi, Dr. Marks, thank you so much. Safe and effective, safe and effective as a New Yorker, that's all I heard on TV every 10 minutes but listening to this hearing today I realize how much we really don't know and that worries me for my own health and for the safety and health of the general population. I'm Sean Barcavige, I'm a research nurse practitioner. I worked for a very prestigious institution in New York. I worked research on clinical drug trials so I'm very familiar with the FDA and how things work. During the pandemic I transitioned to researching therapeutics to save people's lives including vaccines. 52 years old, I was healthy, completely healthy, no drugs, nothing, no comorbidities, no history of any chronic illness. I took my first dose of Pfizer, I stepped up to do the right thing that was asked of me by the government on December 29, 2020. Within 20 minutes I had Mormon cult sensations up my right arm, over days it progressed into my face and my eye, flushing in my ear. Numbness and tingling ensued, I saw a neurologist at my hospital, a very prestigious neurologist who deals with neuropathy. He advised me to get a second dose, unbelievable. Against my own better medical judgment, I proceeded to get a second dose on January 19, that set me on fire. I got my second dose in my left arm, all my neuropathies erupted again on my right side into my face and my eye. I went on a rampage to save my life. I consulted across the country, across the world. I found the most help in Germany, I found nothing but denials in my own country, from my own colleagues, and even my own hospital, who told me to take a vacation and try to hide me as they mandated the vaccine. I suffered with tenitis that was so severe, it left me on the bathroom floor, weeping and sobbing, and suicidal thinking I would never live with that condition. I had intractable insomnia, I couldn't sleep for months, I would have bolting awake during the night, disautonomia, pots, internal tremors, electrical zaps on my legs. This went on for months, could not get help. I am pro-science, I'm pro-vaccine. What I didn't know were the systemic failures in place, that there was no system during the pandemic for the rollout of an emergency-use authorized vaccine, in place to help people who may be injured by this product. I was left alone, afraid, no diagnosis and no prognosis. Every intervention I have received today, from plasmix changes, with two hospitalizations, IVIG trials, as a Theoprene, it was all from my own research, my own diligence, my own pressure of the medical community to help me, to help me. We all stepped up to do what was right and what was asked of us. We now need our government to step up and do what is right for us. We cannot be human collateral damage, we deserve better, Americans deserve safer medical products, we rely on the FDA for that. Our human lives are worth that, thank you.
00:51:53 -> 00:54:32
Peter Marks/FDA: Thanks for sharing that.
Jennifer Jones: Hi, my name is Jennifer Jones, I am Riley's mom, she's eight years old, and on January 6th Riley received her Pfizer vaccination, and six days later she caught COVID. The Pfizer vaccine is caused Riley to have extensive memory loss, cognitive decline, loss of sensation below her waist, inability to control her bladder, recurring pneumonia infections, blurry vision, blackouts, fainting, chronic pain from her neck to the bottom of her back. Gluten and other food intolerances, fatigue and swollen lymph nodes around her neck. Her reaction was not all in one day, these nightmare symptoms piled on week after week. Riley was in the first three weeks, she wouldn't allow anyone to touch her. I couldn't comfort her, I couldn't reassure her, I was completely helpless. She had pens and needles throughout her entire body, she's eight years old, and one day she just woke up a different person, she began to have daily blackouts and fainted after many of them. I will never forget when Riley cried out to me, where is my mommy, where is my mommy, where is my mommy, and I was right there beside her holding her hand, and she didn't acknowledge, she couldn't see that I was right there. I felt alone with Riley that time, and we were in a hospital, and there were other 10 other doctors and nurses in the room, and they couldn't help us. When this first began, we didn't know what was happening to her, her medical teams were perplexed as well because they didn't know. They put my daughter in a psych unit for three and a half weeks. To her father and I, this was torture. We were in complete agony as we were powerless to help our daughter, and we knew that the doctors had no idea what was happening to her. Because the government will not acknowledge or assist with the medical bills that we have incurred throughout this horrific ordeal, we've had to find help elsewhere. We've found the community of people, and if the FDA had made things known to us, we may not have had to go through what we've went through. Thank you.
00:54:33 -> 00:57:46
Brianne Dressen: It's an interesting thing about Jennifer's story with her child. When we first met her, her child was in a wheelchair and diapers. And we have other kids that were in the same situation. We were able to find Riley, and Riley was able to get medical intervention within months, within four months. So this goes back to had she not found us, if it were up to the government. This eight-year-old child would still be in a wheelchair and diapers. The only reason this child walked back into school three weeks ago is if nothing had ever happened to her. It's because her mother was just lucky enough to find us, random people on the internet, that had the secrets from the NIH on the treatment that her eight-year-old needed. The NIH, when I was there, and it's confirmed in emails, they know that early intervention is key. They have published it with the AAS and the AAN, sorry. But also, Janet Woodcock agreed with this, that early intervention is key. So this is the, as you understand, so if you can imagine all of these people here, right, multiply that by 20,000. We have well over 20,000 COVID vaccine injured here in the United States with a very similar constellation of symptoms. Of all of the data that we've collected, the vast majority of these issues have an onset of within the first 24 hours to the first five days. There is a very, very small number that start after that. But to me, that's a very strong correlation. The average onset, the average number of symptoms that people report is 23. That's a lot, right? So I want to make sure that we are being transparent, we are being honest, and we are being open, because we have not been honest, because the agencies have not done their job on our behalf. We have people that are permanently damaged when they don't have to be. They don't have to be, and it doesn't mean it's just like if we have somebody get hit by a car, right? And they're allowed to say they got hit by a car, they're allowed to, you know, have, they're allowed to say there's investigations. But do we say stop driving cars, there's a few people that got hit by a car? No, we still drive cars. So just because we say there's adverse events to a vaccine doesn't mean that the vaccines will stop. But if we mismanage the harms, right, then we have a problem. So transparency, I think, is key. We need to do right by the medical community, because the agencies have not disclosed these issues. Now it's become the medical community's problem. And so the financial issues are there. And also there's a bunch of the cases that still, they're not reported, right? So we've got a lot of education that needs to happen, but it starts with acknowledgement. Anyway, so I know we're out of time. Do you have any closing comments for everybody?
00:57:47 -> 01:01:19
Peter Marks/FDA: I just would, I would just say thank you so much for sharing. You know, our goal is always to try to understand the safety of these vaccines as best as we can. And we struggle, I know it may not seem that way perhaps to you, but we struggle very diligently. And to try to understand safety signals and to make use of them and in changing labels as quickly as we can. That's what we did with Janssen when we recognized what was going on with that vaccine. And we'll continue to look at data as it comes in. And so very happy to continue to get information from you. I really appreciate hearing what we heard today. And we'll continue to work towards trying to understand what is, you know, the safety profile of these vaccines is best as we can. And we don't have any secrets here. Our goal is to understand and to make the public aware of the benefits and rest of these vaccines. So I appreciate you're sharing with us today.
Sean Barcavige: Can I add something?
Brianne Dressen: Yeah.
Sean Barcavige: Yeah, I just wanted to add that, you know, to date, it's, I'm in my 21 months of hell. And my case has still not been reported to VAERS by any of my doctors. So how can you be so sure about your signal method if half of our cases are under reported? I have begged my doctors to report it, but they don't.
Brianne Dressen: Oh, there's also the issues with doctor [Redacted]. Through cases that have neuropathy specified, we submitted those reports in May supports in May. So her original report is still there in the public system and the other two are missing. And those are the two that have neuropathy.
Peter Marks/FDA: Anyone can report to VAERS. So if your doctor, if your doctor has not reported, you should report. It should be, it should definitely be reported. And so I don't understand that. I don't quite understand why a doctor would refuse to report to VAERS because. Reporting to VAERS doesn't imply anything other than somebody who got a vaccine.
Sean Barcavige: Because I can tell you. Because they work at Wild Cornel Medicine, right? So I see there's many of them have not reported cases. One, I think they think they have to make a judgment about it. My provider clearly knows what happened to me. He agrees it's the vaccine. I think it's just they're overwhelmed like most medical providers these days so they don't take the time to do it. So he said for me to do it. But I really think that medical doctors should do it. They're required to do it. And I've never had COVID. So my case is like as clear as can be as a researcher, there's not only temporal associations, but there's just a clear definitive association. So it's indisputable what has happened. And it's just unfortunate that the medical system is failing us. I have to say it's the biggest shock of my medical career. And in fact, I am unable to work today. I put myself through a nurse practitioner school and nursing school. It worked very hard to do that. And today I can barely function. I'm trying to get my medical career back.
01:01:19 -> 01:03:21
Brianne Dressen: We need your help to make that happen. So I know that we're over time and we all have our other meetings that we have to run to. We really do appreciate you taking the time to meet with us. If you don't mind, we'll send you a boatload of more information. And I'll send you everybody's contact info as well. So if you need to follow up with them, you can as well.
Peter Marks/FDA: That would be great. And thank you again for sharing really appreciated.
Unidentified React19 speaker: Hey Peter, is there a number that you're looking for when it comes to a signal, like a threshold that must be hit? Like with myocarditis?
Peter Marks/FDA: No, it's not there's not a single threshold. It's more of a, it has to do with the, it has to do not only with numbers, but the strengths of the association. And I probably, I'd be the wrong one to ask for exactly how they determine that. That's more something that, um, Dr. Narayan, or Dr. Anderson, but it's a combination of the numbers and the strength of the association and the background incidence of things. That's what I think the best way to explain it. But I'm happy to, you know, when you send me the information, I'm happy to get to see what I can, I can, if I can get it back, a better answer for you than that.
Unidentified React19 speaker: Yeah, we've also been curious what, if there's a definition, a medical definition for rare, and that's one thing that we get told a lot. I don't, I just don't know if the FDA has a medical definition for rare.
Peter Marks/FDA: We don't, we don't have one for rare because rare is such a, rare can be anything from one in a million to one in a thousand. It's a very, it's a very, it depends on what you're dealing with. So, but, but we, we also get it that rare if it's affecting you is common. So, um, we take, I take what you said today seriously, and we will continue to work through this. So, thank you.
Brianne Dressen: We appreciate your time.
Peter Marks/FDA: Take care.FDA CEBR - REACT19 - 2022-10-01
00:00:10 -> 00:00:21
Lorrie McNeil/FDA: Hi everybody, my apologies. I didn't realize I had this setup where I had to admit people from the waiting room and I didn't even notice that that was showing at the top of my apologies for the delay.
00:00:22 -> 00:00:35
Joel Wallskog: It's okay. Can you hear me?
Celia Witten/FDA: Yes. Hi, Joel.
Joel Wallskog: Brianne, how are you?
Brianne Dressen: Doing okay.
Jan Maisel: Good morning.
00:00:36 -> 00:01:05
Peter Marks/FDA: Good afternoon wherever you're located. Thanks. So I'm Peter Marks, Director of Center for Biologics, and Laurie McNeill was the first to set this up. And maybe what we can do on the FDA side is maybe we could first ask Dressen if you want to, everyone on, wants to just introduce themselves, it might be helpful and then we can introduce everyone from the FDA.
00:01:06 -> 00:01:27
Brianne Dressen: Okay, so my name is Brianne Dressen. I am a person that participated in the clinical trial for AstraZeneca here in the United States. I was injured by the COVID vaccine on November 4th and have been suffering persistent symptoms ever since. Let's have Dr. Maisel, do you want to go next?
00:01:28 -> 00:04:15
Jan Maisel: Okay, hi, I am Jan Maisel. I have a PhD in molecular biology. My thesis work was early work on what is now known as Retroviruses. Subsequently, I changed career directions and went to medical school. And I practiced primary care pediatrics for 35 years. A significant percent of my time was spent in promoting and administering vaccines to children, as you can well imagine. I never in those 35 years had a patient killed or disabled by a vaccine. And on a personal level, I got every vaccine I was able to get, including as I got older, the pneumococcal vaccine admission goes vaccine, et cetera. So I happily got a Moderna vaccine on December 29th of 2020, early on because my hospital had gotten supplied. Eight days later, I had at home an acute onset of something that felt like impending doom with absolutely blinding head and abdominal pain and a blood pressure of 230 over 115. I was taken to the ER by ambulance. And that was the beginning of numerous such episodes, as well as the onset of multiple additional symptoms over the next weeks. After a massive but unrevealing multi-system workup looking for a diagnosis over six months, I finally was seen in June by the head of the Stanford Autonomic Disorders Group. He diagnosed me with significant hyperadrenergic dysautonomia and a small fiber neuropathy, not link-dependent. He recently let me know that he is putting together a case report series of people who quote him, got what you got, unquote, after their COVID vaccine. One year later, I still have daily symptoms and this has ruined my career as I've been unable to work once this happened to me. And so my question after your introductions, my burning question is that I'm sure by now all of you had a chance to review numerous case reports and I suspect most of you know history around the withdrawal of the rotavirus vaccine and the switch of the polio virus vaccine in past years. Has there been ever in your knowledge been a vaccine associated with adverse events involving so many body systems and of such long duration? That's my question. Thank you.
00:04:16 -> 00:04:26
Brianne Dressen: Should we continue to the next one and then we will come back to Jen's question?
Peter Marks/FDA: That sounds perfect.
Brianne Dressen: Okay. Dr. Walskog.
00:04:27 -> 00:08:10
Joel Wallskog: First of all, my video isn't working, is that correct?
Brianne Dressen: Yes
Joel Wallskog: But you can hear me, okay?
Brianne Dressen: Yes
Joel Wallskog: Okay. Well, thank you all for allowing me to speak. My name is Joel Wallskog. I'm a 51-year-old orthopedic surgeon from Wisconsin. I'll briefly review my clinical history. I had a symptomatic COVID in September of 2020 diagnosed by positive antibody testing after being exposed like most of my clinicals staff with symptomatic COVID. On December 30th of 2020, I received my first winter shot uneventfully. On about January 7th of 2021, I began having paresthesia in my feet in a positive Lhermitte's sign. Within a few days, I began having weakness and balanced problems. I began to stumble and fall. I subsequently was diagnosed with transverse myelitis based on a demyelinated lesion of my thoracic spine spinal cord. I'm sorry, the T8 T9 level. I was treated with hyposteroids followed by IVIG with no improvement. Now, almost a year later, my sensory symptoms have decreased, but my motor symptoms are really unchanged. I reported my condition to VAERS, only to be told that my condition was listed as non-serious. You know, according to the vast CDC workgroup that I looked up by November 11th of this year, they reported that 7 percent of the 12,000 VAERS reports that they reviewed were categorized as serious. Certainly, I view this as very considering the well-recognized under-reporting rate of VAERS and considering my condition that has caused permanent disabilities, is categorized as non-serious. The FDA's state of purpose on their website is to protect the public from drugs and medical devices, and I do not feel protected. I like thousands of vaccine injured people feel far from protected. In fact, we feel abandoned. The vaccine injured people have been abandoned physically, financially, and psycho-socially. What are my personal asks? Publicly acknowledge that the vaccine injuries occur. This acknowledgement will allow communication and education to occur for health care workers that will see vaccine injuries. They won't see what they don't know. This education will then foster an opportunity for treatment of the vaccine injured. Hundreds of thousands of vaccine injured people are not getting appropriate medical care right now. Brianne Dressen, a preschool teacher, I as an orthopedic surgeon, are contacted daily by the vaccine injury. Vaccine injured were asking for a "consultation" from us on their condition. They're literally desperate for care. Just last night at 9 p.m., I responded to a yet another email to a daughter of a vaccine injured person from Hawaii. Her father couldn't work. I'm sorry, couldn't walk, was in severe pain. He had already been evaluated, had no diagnosis. Felt and told that he was, "crazy". At this point, all I can offer him is advocacy at React 19 organization, and get him into a support group to reassure him he is not alone. These people need help. Thank you.
Brianne Dressen: That's everybody from our camp.
00:08:11 -> 00:09:14
Peter Marks/FDA: Okay, thanks. And I'll just just, you know, who's on the line before we kind of just make some comments. Maybe I'm going to more questions or hear more. Let me just start with Celia.
Celia Witten/FDA: Celia Witten, I'm a deputy director.
Peter Marks/FDA: I'm just going to go right across my screen. Narayan?
Narayan Nair/FDA: Narayan Nair. I'm the director of division of technology under Dr. Mark's division.
Peter Marks/FDA: Sarah?
Sarah Walinsky/FDA: I'm acting chief of staff for the Center for Biologics.
Peter Marks/FDA: Paul?
Paul Richards/FDA: Good afternoon. I'm Paul Richards. I'm the chief of the Consumer Affairs Branch within the Center for Biologics Evaluation and Research.
Peter Marks/FDA: And you met Laurie, but you're ahead, Laurie.
Lorrie McNeil/FDA: Director of Office of Communications.
00:09:15 -> 00:12:34
Peter Marks/FDA: So, thanks. I think, let me just, from my perspective, obviously, you know, I think we're very much in listing mode. I think we very much hear the concerns you're raising. We have continued to evaluate the safety of vaccines and we continue to collect data. The group at FDA, there's a group at FDA and group at CDC, large groups that are very much involved in this and trying to understand what's going on. We continue to look for logic events and other events. But our, you know, I think our goal today is to hear from you to try to better understand your concerns and to be able to take back with us what we, you know, hence what we may further need to look for. We do look for major neurologic issues and Dr. Nair can probably say more about that, but we have continued to be on the lookout for various adverse events. And I think just to conclude what I'll say is that I think we, nobody on this call, I think, from the FDA side will deny that there's the possibility that vaccines can cause injury to people. That's why there actually is for vaccines in general, a vaccine's compensation fund for those who have had injuries that ultimately are felt to be due to vaccines. The question for us is understanding what is related to vaccines and what is not, because sometimes that's a very challenging thing to sort out. Although it seems like it should be so simple, it actually, it actually isn't. And with that, I just, any of my colleagues from FDA want to say anything, correct anything I might have gotten wrong here. Now, obviously we just, let me turn it over, over to you Ms. Dressen again, but just to say, we very much, you know, I think we hear this and what's going on. I think we very much want to understand and we do sympathize and empathize here. So just understand that our goal, obviously, is to try to understand what's going on here and then be able to best do the right thing by public health. So let me turn it back over to you because it seemed like perhaps others might have wanted to say more or had had, you know, I think other questions.
00:12:35 -> 00:13:36
Jan Maisel: So in order to get me up to speed, I reviewed six months of emails between Brianne and Dr. Woodcock and Brianne and you. And I was truly shocked, utterly shocked at the statements over and over and over starting last May of promises to look at this, assurances to look at this, action items from prior meetings, none of which has come to pass. So I think you know our stories. I think you reviewed many of these case histories and we're not here to tell you necessarily more stories. We're here to find out what you have done to get this, you know, to understand this. And I'm not hearing it. Nothing you said has told me what the process is and what what you were looking at in your system.
00:13:37 -> 00:15:16
Peter Marks/FDA: So the process, first of all, let's also just stop with something that's just I would ask you. Just as I will ask, I want to take what you say on face value, take this on face value, there is not huge under-reporting in VAERS during the time of COVID. If anything stimulated reporting in VAERS has occurred because we've encouraged it. So we go through VAERS and we try to understand what the signals there are. And that's.. that's why we have experts like Dr Narayan Nair around that do this. And they have looked for various signals like transverse myelitis. And they have looked for other neurologic conditions and they have not found a rate of ransverse myelitis, for instance, that is higher than would be expected in the population. Now that doesn't mean, I just want you to understand, that's not I'm not denying that, that doesn't, just so we're.. we step back. That doesn't mean that any given individual might not have had something related to the vaccine. I'm not denying anything here, but I'm just saying that we look on a population basis using our systems and and we do that relatively diligently to try to understand these things. That's how we.. we make inferences about these and you know Narayan do you want to say anything more about that? Because you might be able to explain the process that you just you've looked at enough different things there.
00:15:17 -> 00:18:01
Narayan Nair/FDA: Yeah sure I'd be happy to and I guess I would preface my remarks by again reiterating what you said. Thank you for reaching out and thank you for for sharing your stories and and thank you you know for for providing us this information it's it's it's very valuable and your voices are very important. Our our process it basically works in multiple layers you know starting even before these products are ever injected in a human you know there's a multiple evaluations to make sure that they're safe and then we have the clinical trial data and compare it to obviously what we see in placebo and then once it's it's out there and authorized and being given to the public we have two different sort of ways of looking at it one is the passive surveillance that's VAERS where we look at all the reports and we focus on reports of people that are hospitalized death reports that we receive after vaccine vaccination anyone that's hospitalized maybe had a prolongation of their hospitalization or any kind of serious disability and then we have so various adverse events that that we think are important to look at such as transverse myelitis and other neurologic issues and non neurologic issues and so we have a team of doctors many of them like myself came from clinical practice and and look at these these cases and just as Dr. Marks says we we look at it kind of the and we have received reports of transverse myelitis so we have received reports of Guillain Baray I can tell you with Guillain Baray syndrome we did see increased reports after the Janssen vaccine and we did add a warning to the label they were very rare but it was above what we saw what we would have expected for Moderna and Pfizer we have not seen that for transverse myelitis or other neurologic conditions we haven't seen any evidence that you're more likely to get those conditions after receiving the vaccination then if you haven't received the vaccination we haven't received that in our passive surveillance and we haven't had any information in our active surveillance where we do actually form from epidemiologic studies and looking at that to my knowledge the FDA databases and CDC databases we haven't seen it there either but again that's to a certain extent if you're an individual who experienced these adverse events that's not a very satisfactory answer I recognize that and and that's difficult but we're always continuing to look this is the ongoing process that we do every single day we look at these adverse events we're always reevaluating data the directive that I've received from Dr. Marks is to leave no stone unturned to continue to look at this very vigorously and and and do everything we can to understand all the safety related to this products and you're helping us by sharing your information so that that I hope to some extent answers your question.
00:18:02 -> 00:18:56
Jan Maisel: Well it seems to me to be honest that the VAERS system wasn't necessarily built to deal with the situation that we're in at this point because anybody can post anything and obviously if you're looking at somebody who reports a stroke or an MI and they're 85 years old and they got their vaccine a week ago that's going to be really hard to tease out as to whether the vaccine caused those things. But I do not understand why you are not thinking minimally outside the box and taking on the people that we know the our Facebook group, Brianne's Facebook group, hundreds of people and saying we're going to investigate each of these cases and get their records and figure out is there an explanation for these people aside from vaccine injury that is completely low hanging fruit for you guys.
00:18:57 -> 00:28:36
Brianne Dressen: So I do have a couple of questions Dr. Marks if that's okay with the follow-up from our last meeting I was talking to Dr. [redacted] last night about this because she... and she regrets not being here but you know like our follow-up appointments with our doctors we wait for months and that's like food for us at this point they're critical and so even you know her rescheduling that would sacrifice her health so she did need to you know do what was right for her but we were kind of discussing a couple of the action items that were left from the last meeting one we were discussing this specific issue where we have a myriad of symptoms that are coming through the VAERS system, right and so we hand it over like 88 terms or 80 terms for neuropathy, and so we were wondering what what had become of that and then of course you know obviously she did point out that she is concerned about if we are looking primarily at the VAERS and the best system these as you guys know these syndromes are not going to come through the system because they are a broad set of symptoms but that's why we've submitted you know like our symptom surveys to you guys and all that other stuff but with that said she did make a good point last night she was like what these guys really need to do is really drill down with specialists in this area. She is an emergency room physician and a critical care physician if you remember correctly and in all of her 10 years of, you know, being in practice she had not seen a single positive case of neuropathy come through where it been diagnosed through the ERs or the ICUs and so if you look at the VAERS reports the vast majority of VAERS reports are coming from those types of environments instead of where you would see these syndromes months later, which would be an autonomic labs, autonomic specialists, and so like what Jan was talking about with Stanford. So the Stanford autonomic lab just so you guys know there's a physician in that lab that told me a week and a half ago that he's now seeing more post-vax patients than he is actually long haulers and so it does appear that there's this trend the long haulers are kind of starting to taper off and the post-vax are finally figuring out where they need to go for care and so it's starting to ramp up a bit. We talked to Dr. Waheed which I believe you may or may not have talked to him before but he he's the one that discussed you know small fiber neuropathy post vaccine he's wrapping up a study right now with a hundred participants we're handing him over all of those participants right now we have about 56 and we're working on the remainder and we'll be able to get those in the next two days for him so he's going to have a pretty extensive report coming out I heard will be approved and the whole thing that's going to tie, you know, give us some stronger signals through the scientific literature to tie this, you know, the neuropathy back to the COVID vaccine specifically. These are all people that have negative nucleocapsid tests like me they kept going into the ERs and the ERs just kept thinking that it was actual COVID and so they also have been tested negative many many times for COVID I myself I tested negative for COVID over 12 times the first two and a half weeks so there is some correlation there. There's another interesting advance that's come through and it's going to hit the pre-print servers this week probably at the end of this week there's some researchers which you guys may or may not have heard of them but there's Dr. Patterson and Dr. Yogendran in California they had a a paper published through Immunology Today - maybe I have the journal wrong - but it's an immunology journal and in this journal they talk about how in lung haulers they have found spike protein in the non-classical monocytes of lung haulers and and so that what that did make peer review. So, they decided to start looking at us, because they have 300 to 400 post-vax patients with the same syndromes and they found the same spike protein in our non-classical monocytes - these are people that never had COVID - we all had to prove that we had negative nucleocapsids and negative COVID tests and the whole thing.. but not only just the S1 subunit but the S2 subunit as well and our amino acids are messed up as well. The reason I know this is because I am one of the participants of that study and when they asked me to participate I said you know what my information is probably not going to be very relevant because I'm way farther out than the vast majority of people that who have been vaccinated. Unfortunately I actually have more spike in my non-classical monocytes than any of their other patients. So there's been in that format of that paper for the post-vax group this week because of the political climate as you guys have seen they are extremely nervous to put it out there because they are pretty sure that they're going to get canceled but it is interesting science. If we're looking for a smoking gun I do think that some of these things are starting to emerge but like what Jan was mentioning I've been very I'm very discouraged at this point. I'm hopeful that you guys can shed a little bit of light and hope for the vaccine injured. Just like Joel was talking about we have 12,000 people just in our small group. No help. There's no help for these people they are trapped in their beds there are people like me who were trapped in their bed and they're getting better but we have an equal amount that they are kind of bad and now they're really really bad and they're just trying to hang on every single day for life we all did our part right we gladly signed up we enlisted in the fight against the pandemic and so between all of the lettered agencies at the US government and the horrific vitriol that's been cast on these people it's one thing to be injured and it's a whole other thing to feel like you're completely on your own in this so we've been having people in crisis people have tried to and their lives I've sent you guys some of those letters um we have kids now that are in wheelchairs still no help for them they're being labeled as FND when they have really really messed up labs like elevated CRP and D dimer and all kinds of things that their physicians just because they're so seeped in this narrative of the vaccines are safe period there's no further examination being given and afforded to these Americans that did their job and so at this point we really need some advocacy on your part we need this to kind of be streamlined to a point where these people know that you guys have our backs because right now all the doors are closing they've closed um we have people that are moving our researchers are moving in the shadows quietly because they're afraid of losing their jobs I mean this whole thing is so un-American to me um it's and and just another thing so we had one of our support groups that had over 12,000 people in it pulled down from Facebook for a post someone put up from the Australian government on their website that had a bunch of adverse events on there and so we went to when we said how can you pull all these people apart and they said well according to the CDC and the FDA you guys don't exist so this so I know that this is probably strange for you to understand but the lack of action on the federal government's part has caked into every single avenue for the vaccine injured to get any kind of care recognition help collaborate with each other collaborate with researchers um and so I really I need to figure out like if we can actually get some kind of something moving at this point I mean Dr. Hertz was sending you guys emails and I believe Peter Marx you were on their agenda what caught was on there the NIH was on there in March and April and her emails it's repeatedly promised to her that give us a couple more weeks and we're gonna figure this out and then we'll communicate this to the public like it's there in black and white right I went to the NIH and the NIH was like hey we're gonna help you we're gonna publish just hang on we're gonna publish we're gonna publish we're gonna publish nothing's happened and in the meantime we've got people that are like dropping like flies and like I know you guys probably celebrated Christmas fine but I know Joel and I both I spent my damn my day on my phone supporting those who had lost loved ones to the COVID vaccines and then also we raised a phone call from one of them who two days before Christmas FEMA called him his son had died from the COVID vaccine 16 year old boy from my myocarditis... FEMA called him and asked him to change his death certificate to say COVID was the reason that he died instead of the COVID vaccine... so there's definitely a check some balances it's way off and we need your help to bring it back to center.. badly.
00:28:36 -> 00:32:23
Jan Maisel: If your signal is not getting through then something is wrong with the whole system.. with with how you're approaching it and we we need a different approach. Canada has a task force... it seems to me that given that as far as work concern no progress has been made in this... that you need a task force. There was a press release from the Canadian task force in less summer saying that they were going to do a study of $800,000 allocated to look for the appropriate approach to track adverse events from vaccines now they're not putting anything out there so far but at least they're talking to talk a little bit and it seems to me if you look at at all these different syndromes that people are having I think what the the conclusion has to be that post vaccine injured people have a subset of long COVID symptoms and long COVID is getting attention it didn't in the beginning they were all told they were crazy in the beginning but now they're getting clinics and they're getting attention and they're getting publication we we I really believe we are a subset of them and if you accept that hypothesis as a starting point what that leads to is really clear and strong sign posts for the researchers because most of us myself included have never had COVID so if we have a subset of long haul COVID there are basically three main possibilities as to what's happened to us one is the effects of the spike protein itself manufactured from the messenger RNA in our protein synthesis factories on multiple organ systems two is effects of the antibody to the spike protein on those systems and the third is autoimmune phenomena that have accidentally been generated along with the immune response and those seem like very clear sign posts and very very relevant very able very accessible to get people working on and there are certainly some people working on this but I at this point it's really time for you guys to say yes you are we accept that you are a subset of this and I understand the politics I understand this is very difficult but people are committing suicide and people are are still in terrible shape and Dr. Marks I'm going to read something I know we're we're short on time I'm going to read a quote from an interview that you gave in 2019 when you compare working in clinical medicine to pharmaceuticals to government and you said "in government you are working on behalf of the entire population and do so in a variety of ways we are committed to serving public health from addressing the needs of individuals in need of access to investigational medicines to working to prevent global pandemics and everything in between" you said that in 2019 very prescient and I am so hopeful that in looking back later in your life you are not going to realize that you have totally trampled on your stated mission in addressing the needs of individual people.
00:32:24 -> 00:34:27
Peter Marks/FDA: Okay well you know we've we've come to a close of the time that we have together but I can say this and I think this would be helpful to me we we take what you're telling us very seriously and in fact we the amount of effort is being put into trying to understand adverse events is pretty significant here you can listen into the the ACIP meeting from CDC tomorrow to hear about the discussion of myocarditis different kind of adverse events but we understand that they can occur with vaccines and no one's denying that adverse events can occur with them we just need to understand them and I'm not denying that again I'm no one here is denying the symptoms and what you're what's going on here we need to just better understand it to the extent that the physician that's putting together the case series of the the the small fiber or other triopathies that he's put together even after he submits it or I don't want to know I don't want any anyone to think we're going to try to wave him off from we want him to publish that and we'd like to get in touch with him because I think we'd like to understand those case series so we would be very happy for you to put those physicians in touch with us because we'd like to be able to understand these case series the people are putting together we're trying to work with our colleagues at NIH because NIH is trying to put together I believe a case series as well so understanding that will help us and I wish we could get there faster I wish we could but it's not that we're trying to ignore things it's that we continue to look and I give you my commitment that we will continue to look I can't always promise that I'm going to have a result but I can't promise things that I don't that I that I don't have I don't have the the data to be able to make a make a connection yet but
00:34:28 -> 00:35:23
Brianne Dressen: So I have a question on that Dr. Marks that's okay the European Union the European version of the FDA they have added paresthesia to the package insert for Pfizer so I'm kind of curious what data has allowed them to make that progress in my mind it's progress where maybe that's something that the US could follow suit the other thing is I'm more than happy to hand over all the researchers information I'm I'm definitely happy to do that I have done that I sent two different batches of researchers information to Janet Woodcock over the summer unfortunately none of those researchers have been contacted from the FDA other than those researchers at the NIH and so if I do hand over this information I know that they would be more than happy to discuss with you I just would implore you to follow up with them in a timely manner.
00:35:24 -> 00:36:38
Peter Marks/FDA: I aside from the researchers at at NIH I was not aware of any of any so if you send them to maybe be very happy to contact them I believe the paresthesia that were added to the European label had to do with paresthesia immediately after vaccination that's tingling immediately after getting a vaccine I think what they were talking about there is something very different from the longer term neurologic effects that we're talking about but I can I can make sure that that's you know Narayan we can go back and double check that that's what what they added there but that was my understanding but that's neither here nor there I I would greatly appreciate it if if you'll pass along I'm sorry that I did not get connected with the names of of those putting together the case series because whether they be at Stanford or wherever be very helpful to connect because nobody nobody here is denying that you're and nobody here wants to have to deny what's going on and nor would we ever ask anyone to change anything on any kind of report to try to make vaccines look better that's not what we're about.
00:36:39 -> 00:37:41
Jan Maisel: I'm glad to hear that you're not denying but the people the doctors in the trenches are denying. Every single one of us has been told we need a therapist after multiple episodes of blood pressure over 200 my cardiologist told me I needed a therapist and just said this is just a side show to whatever it is that happened to you every one of us has been told that and as a doctor when I know when I'm asked a question by somebody by a patient I want to answer that question out of a fund of knowledge right we answer out of our funds of knowledge and so when people are showing up at the ER and their primary doctors and neurologists and there's asking questions and people have no fund of knowledge about this they have nothing to say and when we have nothing to say we often want to pretend it doesn't exist I have to say it's not the trenches you need to communicate with.
00:37:42 -> 00:43:00
Brianne Dressen: There's 80% of the people in our groups were misdiagnosed with anxiety just so you know Dr Marks like in my case I went in and my legs weren't working and I became incontinent and I was in the hospital for three or four days and the fourth day the doctor came in and said oh you had a mental breakdown so I was sent home with intensive physical and occupational therapy in home to recover my walking and to help me be able to sort through the dysfunction that was happening with the right and left brain and the extreme dizziness and to me you know and for me I was like ah you know I'm one of the first this is brand new nobody knows anything about it but what has been extremely concerning is to see the vast amount of people that are being gaslit to no end by their medical teams coming forward and to be honest I don't blame the physicians because they're not being provided any kind of guidance like you know at least with COVID we were you know communicating with the medical community at large saying look for syndromes and then as things were popping up even if they weren't confirmed to be directly correlated to the virus we still were saying hey looks like here's some issues with neurological breakdown that may be connected everybody look into it but that guidance hasn't been provided to the medical community within this case in this case instead it's been the vaccines are safe period myocarditis is mild period and so when physicians who are overrun right so they've been run down by the COVID pandemic they don't have time to go digging to see what actually could be going on with the vaccines they're overworked you know they're not going to be able to take the time to actually sit down and say oh maybe there is something going off these patients there are a series of physicians out there that are starting to identify this and they're trying to figure out what to do with this information but even in my own office visit I had with my rheumatologist two weeks ago okay so over a year into my problem he's afraid to say the word COVID vaccine he would not say it he cannot say it so he says COVID related illness so the tone needs to change your agency definitely has the capability to in your leadership positions to open the door for these physicians to feel more confident with being able to look for these syndromes identify these syndromes and start the conversation to get these people better there's not a single person that I've worked with in Jan's one and Joel's one Dr. Hertz they don't want to stop the vaccine program as we've stated many times that's not what this is about but just like he said all vaccines do cause side effects and unfortunately we drew the short straw but because we drew the short straw we do need to be very diligent to help these people and it's not about well there's more people that are suffering with these other syndromes this vaccine is being mandated right and so and it does have a far shorter span of research and understanding than any other vaccine that has been implemented here in the US so if we're doing that we definitely need to make sure that we're dedicating extra time extra resources and having a much more transparent conversation with the public on what can and cannot happen with the vaccines and to me I would feel far more confident with you know receiving a vaccine or a medication if I saw a list of side effects like Tylenol has a longer list of side effects in the COVID vaccines at this point so I don't know in my husband he got vaccinated after this happened to me so it's it's not about whether this is a good or bad product but these people have been abandoned and I don't know if this would be something that would be reasonable for anyone in your agency if there would be a way that you could communicate either to the medical community what's going on or even just to the vaccine injured themselves because at this point the vaccine injured themselves like we feel like we've had a knife stuck in our back and the knife just keeps getting twisted because we keep reaching out and then we still like there's no help coming and so we are getting guess lit we are being abused and it's not okay like these are good people and we deserve better we've repeatedly reached out for months and months and months right I know that like Peter Marks you and I like I sent our first vaccine injury meal back in May and we haven't moved the needle at all to get these people better and so we've got in the typical healthcare process you've got people with long COVID right and then you've got people that have been vaccinated smaller subset people that have been vaccinated or having issues long COVID people have clinics they have resources they have people that are saying hey look at these syndromes do the research let's figure this out so they are moving through the healthcare process to get the care that they need even though it is still complicated and muddy but we can't even get ourselves in the door so instead of a few vaccine injured now it's stacking and so there's a ton just built up against this barrier.
00:43:01 -> 00:43:41
Jan Maisel: And we need you to help with that we need to know yeah I was lucky here you're listening you're listening and reviewing and what we says is transpired is the case and I so far in this call haven't heard anything different I mean there's a three-prong thing that needs to happen one is is figuring out the clinical issues another is figuring out the molecular biology of it at the bench and the third is getting information to doctors and support to patients so that's I don't know if the FDA can do those three things.
00:43:42 -> 00:44:33
Peter Marks/FDA: So let me just let me just say that so this has been very useful today I think one thing I want to thank you all for for reiterating what you've told us today I do really appreciate it I know it's not moving at this pace you might like but I do think one action item that we can specifically come out of today is if you can get me the names of the various physicians copy Lori... Lori we'll keep you honest here we will contact those physicians with case series and make sure we understand what's going on there and we will continue to look into this because it is an issue and and just so you understand it's not that we ever stopped between the last time we've talked this is something we continue to do so...
00:44:34 -> 00:45:33
Brianne Dressen: I do remember you mentioned something about working with reprogramming something to see if we could identify a multi-symptom signal I was curious if that had happened or what the status of that was.
Peter Marks/FDA: I believe that what I think what has been done is people try to look at multiple terms in our in the in the adverse event system to see if there were any languages and I know that people gave out a try and I didn't and when I heard back I guess there was no no signal from there but again once we get these in additional information if if there we may learn that from the what we hear about in the case reports that you send me if we can better understand what we're looking for we can potentially better program to look through the various reports so it could be helpful and that's why I think it's really worthwhile for us to pursue understanding understanding these.
00:45:34 -> 00:47:36
Brianne Dressen: So my other question and I appreciate your time as usual doctor Marks I really do.
Peter Marks/FDA: I'm.. unfortunately going to have to leave in about a minute because I have another call that I have to get on.
Brianne Dressen: Is there some way that someone could like okay this is what happened with the vaccine injured we had a huge problem after the FOA release data release so obviously you guys know that you have a huge stack of documents that have been you know mandated or required that you guys have to release them and you guys are going through and you're requested 50 years so if you can imagine for the vaccine injured that was like a big kick in the pants for them to hear that the FDA who approved this vaccine after five months of review of the data is now requesting 50 years to release the data that very well could hold some of the keys to getting them better and then the other thing is...
Peter Marks/FDA: Let me just... I'm going to have to get off... but I want to assure you something I want that this I will assure you of that the having the biological license application for the Pfizer vaccine or the Moderna vaccine or any other vaccine that's not going to help here I can I can just say that with absolute certainty because that's not that's not what's at that that that has manufacturing information it has clinical trial information that will have to be redacted what what really is here is what we're seeing is and and it's what I believe is what we're seeing is what happens with vaccines in the real world and so we have to look at the data that we have now in front of us such as the case series that you'll hopefully connect us with and make sense out of that that's that's what we really need to do we're not trying to stonewall believe me if I could expedite that quickly I there's nothing to hide there it's just that I'm just telling you that that's a rock that you're looking under that I think that once even if we could produce it and I'd be happy if I could instantly I don't think that you'd actually find the answer to the problems that are going on.
00:47:37 -> 00:48:17
Brianne Dressen: They kind of did and that's kind of why I'm wondering if someone could dedicate some time to that one because in the post marketing report from Pfizer it covered the first two months of world data and so they don't understand it so what they're seeing is everyone is found they found their syndromes in there that they were told for months don't exist and then they found it there in black and white and for them it's been devastating to see their syndromes there in black and white in the Pfizer reports every one of them are in there and it's very detailed it's broken down and the strange thing is is the information that Pfizer published it's this it really mirrors the demographics and the syndromes.
00:48:18 -> 00:49:00
Peter Marks/FDA: I'm really sorry but I'm going to have to I think we have a path forward you're I'm sorry I do have to go but I don't I I'm not sure that I you know I think we're pretty confident and you know it it'll come out in the wash and you'll see I don't think there's anything being hidden here in the clinical trials that explain what's going on here so thanks thanks so much for the time today and I'm sorry I do have to go to another meeting now I'm late for it thank you all right thank you.
Brianne Dressen: Thank you.FDA CEBR - REACT19 - 2022-12-14
00:00:10 -> 00:03:32
Lorrie McNeil/FDA: Hi, good afternoon all. I think we're just waiting for Dr. Marks to join.
Brianne Dressen: I like your new background, Lorrie.
Lorrie McNeil/FDA: Sorry, I'm muted. You can't see all the mess behind me.
Paul Richards/FDA: Good afternoon, everyone.
Brianne Dressen: Hi, Paul. How are you?
Paul Richards/FDA: I'm good. How are you?
Brianne Dressen: I'm still alive.
00:03:33 -> 00:04:16
Brianne Dressen: I'm curious if any of you have seen the pots study that came out yet? It was published in Nature 3 days ago.
Lorrie McNeil/FDA: I have not seen it yet.
Paul Richards/FDA: I have not.
Brianne Dressen: I'll throw it in the chat here since we're waiting.
00:04:17 -> 00:05:02
Peter Marks/FDA: Hi. I apologize for being a few minutes late. I have minor connectivity issue. Sorry about that.
Lorrie McNeil/FDA: Thank you, Peter. I think we're all on. So we're ready to go.
Peter Marks/FDA: Great thanks. So I think, you know, I think that, Ms. Dressen, I think probably, you know, the people on our end here. I think, you know, Dr. Nair, Sarah Walinsky has been on previous calls, you know, Lorrie. I think we would really turn it over and you've met Suzanne, obviously, and Lorrie and Paul. I just really would turn this over to you for updates from your end. And then I think Narayan and I can provide the updates that we have on our end.
00:05:03 -> 00:06:52
Brianne Dressen: Okay. Thanks for meeting with us once again. We really do appreciate it. Dr. [Redacted] can't be here. She's super sick. She's going downhill pretty fast. So she apologizes. She gave me a few notes so hopefully I can relay her questions. But I did bring Dr. Wallskog, who is my co-chair at React 19. And Joel is, he's been injured as well. And he has transverse malitis. I guess I'm just kind of curious what kind of updates you guys may have. I know on our end, things just so you guys know. I mean, things were really, really, really bad when we started meeting with you guys. The illnesses and the, you know, the prognosis and the, you know, the health of these people they were bad to begin with. They still are not getting recognized for their injuries. It's gotten really bad. So we've had three suicides in the last three weeks. It's the beginning of winter. So it's going to get worse. So we're trying to give these people some hope. And something to hang on to. Something to hang on for. Obviously, they're suffering every single day. Their lives are ruined. They're permanently disabled. And the last thing we want is for these people to feel like they're completely on their own. So anyway, yeah. So do you guys have any updates for us?
00:06:53 -> 00:08:52
Peter Marks/FDA: So I can start with a couple just so that we, after our last meeting, we really appreciate your sending along the paper from the German group. And that was helpful because we were able to have a conversation with our European colleagues and the German regulators. I think that the paper from Dr. Schiefer, Dr. Schiefer and Schiefer. You know, we went through the paper. We spoke to our German colleagues about that. They have been looking for, they tell us that they have been looking for a signal for small fiber, some small fiber myopathy and other neurologic syndromes. But at least from what they told us they have not found it. We asked the larger group of European regulators, the International Council of Medical Medicine Regulatory Agencies, on one of their calls. They also don't have a safety signal. Now, that doesn't mean it doesn't exist. Okay, I'm not just telling you, though, that we're trying to do due diligence here. And I can turn it over to Narayan for updates on the U.S. send of things, but from the European standpoint, I don't think we haven't gained more insight into the safety signal, because potentially because they just haven't detected it yet. So I can't, again, I can't say that it's there or not. I'm not going to say, well, I'm just going to say that they don't report anything.
00:08:53 -> 00:10:10
Brianne Dressen: Did they give you any kind of enlightening information on why they chose to put the parasitias on there when we have them?
Peter Marks/FDA: Well, they did that. I asked them, and they did that, because for the same reason that we actually had parasitias on our label at one point, is that sometimes when people have been getting the vaccine within the day or two after they've had parasitias in the area or in the armware vaccinated, but it was not like long-term parasitias that they're talking about, but they put that there so that people would be aware of that.
Brianne Dressen: Okay, and the tinnitus, it was kind of the same thing.
Peter Marks/FDA: Yeah, tinnitus has been an interesting one. I'm going to leave that for Narayan to cover. I mean, it's been a question about whether that's been a signal or not, and again, it's my understanding that it hasn't come out as a signal, but Narayan, I'll turn that over to you. They did not have it. It's been something that's been reported, but not as something that is clearly a vaccine related. But let me turn it over to that, because we've looked for that in the U.S., so I'm going to turn that over to Narayan.
00:10:11 -> 00:13:22
Narayan Nair/FDA: Yeah, thanks, Dr. Marks, and thanks to both of you for speaking with us and sharing your information and your stories. I'll start off with tinnitus. We've looked at that several times and in the vaccine adverse event reporting system in VAERS. And we do have reports of tinnitus following vaccination, but when we've looked at what the background rate is, we haven't seen anything more than what we would expect with the background rate. Now, I would emphasize that doesn't mean that it's not a safety signal. It doesn't mean that it's not occurring after the vaccine. It just means that what we have in our data right now shows that it's not occurring more often than we would have expected with the background rate, but we're still continuing to follow it. We're aware of a number of individuals who have experienced this, and it's not a minor inconvenience. It definitely affects their lives. Tinnitus can be fairly significant and really debilitating, and it's sort of along the continuum. And we're aware of those cases that have occurred after vaccination, and it's of particular interest to delve into that issue and figure out. But right now, we don't have any information that that's occurring more frequent in the vaccinated population than the general population, but we're continuing to look. And it might be, if there's a number of reasons VAERS has a number of limitations as you're aware, that's why it's only one of many systems we use to monitor a vaccine safety. But that's sort of where we're at with VAERS. We've been continuing to monitor the small fiber neuropathy issue. We actually are working with the neurologist in evaluating cases that we're receiving to see if there's any particular pattern, any cluster of cases, anything related that we can find. We haven't found any associated with any particular lots or anything of that nature. That's another one where the number reports we have, certainly we have reports there of small fiber neuropathy, and we're aware that this is really significantly impacted individuals. But the reports, number reports, given the number of large number of people that have been vaccinated is still below what we would think with the background rate. But we are looking at some other possibilities to do. One of the limitations of the passive surveillance is we don't have a control group. And so we can compare to background rates, but it's not ideal. And so we're looking at different ways and feasibility of doing some type of evaluation where we do have a control group in one of our databases. We've looked in the past at different issues such as brain fog, the mental status changes, speech difficulties. Again, those are ones in VAERS when we've looked, we haven't found a large number of reports relative to the number of reports we get for other things. Those are conditions that are somewhat their symptoms really, and it's difficult for us to assess those because it's difficult to compare it to a background rate. But again, we have shared that data and looked over it with a number of physicians in our office and also had some external consultants look at it, neurologists, to see if there's any particular pattern or any further evaluation that's needed.
00:13:23 -> 00:14:38
Brianne Dressen: So the neuropathy, thanks for letting us know all that. That was really helpful.So one of the questions that we had was the neuropathy when you were looking into the cases. Has anyone looked into the age, if it's been broken down by age, if it's been broken down by gender, if it's been any kind of demographics? Because if you lump them all together, you may not find it, but I guarantee you, if you pull out females that are young, you're going to find it. But the other concern that we have is obviously, and we've talked about this a million times, is that the small fiber neuropathy test, people still can't get it because vaccine injuries aren't a thing. And so they go into their neurologists, their neurologists are like, oh well, you're tingling all over and it's in your head. And so they can't get their skin punched biopsies. But we are starting to get those. Every single one of those, we've encouraged them to update their reports and VAERS. But we've heard on the back end that they're not entirely sure if their information actually goes through the VAERS system. So that's something else that we have questions on. Has there been any demographic breakdown on there with the neuropathy stuff?
00:14:39 -> 00:17:46
Narayan Nair/FDA: Yeah, I think that's a great question. We did look at the, and I don't have the numbers, but it was predominantly female, where we had race information. It seemed predominantly Caucasian. And I will say it does seem to be in their 30s and 40s. Not a large, you know, not a huge spike or by any means, but that seemed to be the predominant reports that we received. And we've been following very closely, you know, the pediatrics for many different adverse events. This is one and we haven't seen it in that population, really.
Brianne Dressen: So that's interesting about the pediatrics. We've seen quite a bizarre run of problems with the pediatrics. There's a bunch of kids that are getting diagnosed with CADP and we actually have to get it like, okay, this is how bad it is. Okay, so through our advocacy organization, because this is a disease that is not established or talked about or allowed to be talked about. There's literally kids that are in wheelchairs and we have to fly them across the country in secret with, on our dime, by the way, government's not paying for any of this. Drug companies not paying for it. To get them medical care and appropriate diagnoses to get them EMGs, to get them small fiber neuropathy skin punched by MCs and get the proper neuro-workup. So they can actually figure out what the medical care needs to be that they need to get. So we do have kids with CADP. So I actually was trying to find a researcher to put together a case series on it because there are enough of them that there should be a case series put out on it. And of course, as you guys know, kids shouldn't have CADP. So that's something that, you know, it's not happening to old people, it's happening to youngsters, and that's where I'm really concerned.
Joel Wallskog: I have a question too. With regards to, have you all communicated with Dr. Nath? I mean, Dr. Nath studied in 2021 a series of people's small fiber neuropathy at the NIH. Are you communicated to him and the NIH about their findings and their recommendations?
Peter Marks/FDA: Indeed, we've had conversations with Dr. Nath. I think both Narayan and I have had conversations. I think he's trying to get... I mean, he continues to try to treat people who present with this. It's still very hard, though, to understand what is... You know, because so many people were vaccinated, it's hard to understand what was the baseline of what might have been there without COVID-19 vaccination. And what is from... You know, that could be associated with vaccination. I think that's... Again, it's not to say that there is or isn't an association. It's just to say that it's been... It's not been possible to tease out, but he continues to treat people. And it's had some success with immune-vogulant with people. And Narayan, is that... I mean, that was my last conversation with him was a couple of months ago, but maybe you've had a more recent one.
00:17:47 -> 00:20:46
Narayan Nair/FDA: Yeah, I think that was about the time frame I spoke with him as well. We've had several conversations and meetings with him, and he's been very generous in sharing his data with us. And so that's something we're continuing to follow as well.
Joel Wallskog: So, I guess part of the thing that troubles me is kind of the paradigm here. So, historically, you know, a new drug, a new medical device, and you have to prove it's safety and efficacy. Things are almost backwards right here. It's almost upside down where we're literally trying to prove the ineffectiveness or lack of safety, you know, with regards to the vaccine. So, the whole thing, just trying to, you know, troubles me. But I understand we're in a pandemic. We're under an emergency authorization. But I guess what Bri is trying to say, too, is for these people a lot of times, it would really help, even if you haven't seen a safety signal yet. Okay, we've had this conversation before about myocarditis. And I think early on, there wasn't exactly safety signals immediately. But again, they did come. But the providers in the street, I mean, I'm a orthopedic surgeon. So, people that are out practicing that are on the street seeing or in the clinic, seeing patients need to know what they might see. So, I guess my concern is, even though there may not be a safety signal as of yet for small fiber neuropathy, what is the harm in communicating from the federal agencies such as the CDC and FDA to health organizations and to the providers in the street that there may be an issue here, and here is the issue you may see, which then could help these people be recognized. The problem is, they're going in, they're going in with symptoms, they're not diagnosed. Literally, we are helping people by the thousands now get diagnoses by guiding their care. But I guess what's the harm in trying to communicate the possible safety signals that we could be seeing? And I'm using small fiber neuropathy as one, because there's just a ton of it out there. And I'm not, it's from the vax, it's from COVID. The practitioners on, you know, they're out there seeing these patients are completely unaware of what they may, what may show up in their clinic. And therefore, the patient gets gaslit, does not get diagnosed, and basically goes off and is untreated. And we know, especially, and again, I think Dr. Nath will attest, and I think he has a paper too, that time is of the essence, early treatment leads to better results. And that's the problem with this patient population, especially the small fiber neuropathy, is I think they're going to just be out there complaining of certain neuropathic symptoms, and undying knows it because their providers are completely unaware of that this could be. And I didn't say is a problem, but could be a, the vaccine could be a problem for causing, for a cause of small fiber neuropathy.
00:20:47 -> 00:22:38
Peter Marks/FDA: I guess one question I have is you're, you've now said that two things that are a bit of concerning to me. First of all, it sounds like thousands of cases, which we're just not aware of, right? But also the idea that some of these people have had to be treated in secret on what, why didn't providers, I mean, why was there any need for secrecy here, right? I mean, we don't, we're not looking to, I mean, we, we need to know about these things, so I'm just, I'm just wondering what's, what was that about?
Joel Wallskog: The secrecy is two issues. Well, first of all, I think there are thousands of cases of small fiber neuropathy...
Brianne Dressen: Well, we do have that. We, we have documented thousands of neuropathy cases.
Joel Wallskog: But with regards to the secrecy issue is first, if providers aren't aware that they may be seeing a higher than usual, small fiber neuropathy, you know, population in their clinic, their, their level or index of suspicion is not going to be high enough. And unfortunately, these people then are not, they don't get the correct diagnosis. They get a standard workup. We've already done a study that shows 40% of people on initial medical evaluation, all the tests are negative. And I can tell you the story, and every time you hear the story tests were negative, did you get a small fiber neuropathy, did you get a small fiber? I'm sorry, skin biopsy, and the answers no they get it, they get a diagnosis, but it takes a year and then I'm talking to us to recommend that. So that's kind of what I mean by secret. But I also think that the whole NIH experience that Brianne went through was somewhat secretive. I mean, that was the, you know, the NIH flying 23 people out to the NIH studying them and not telling them to communicate their experience to other injured people.
00:22:39 -> 00:25:23
Brianne Dressen: Which I'll go on record. I will tell you guys exactly what they told me face to face. They said, do not talk about the research when I was there. And it's not like they just said it once, they said it several times, and we were so afraid of what they were going to do to us, not to us, but to shut down the research or whatever you want to call it, that we literally went through the support groups that we knew of, and we deleted all commentary of the NIH research. And it was really a shame because that information that was gleaned from that early research from the NIH has still been a staple to being able to get people care, namely the early intervention that Nath talked about. And actually I talked about that with Janet Woodcock when she was the acting commissioner, and I sent her a copy of the paper. Oh yeah, American Academy in neurology, they published it in October of 2021, and he talked specifically about potential reporting bias. And so, you know, that could actually deter clinicians from actually validating what's going on with their patients. And then he discussed the need or potential need for early intervention and immunotherapy. But also on top of that, and I'm sure you guys know this, if you don't, you probably should. At that time, Dr. Nath was consulting with hundreds of patients one-on-one across the country and private and their physicians. And I know this because I sent him many myself. So my question is with this added context, just so you guys kind of, and the reason I'm bringing this up is just so you guys can kind of understand the perspective that we're coming to remember this. It's just kind of a, it's frustrating, right? Because we dedicated ourselves to the science. We trusted the science. We trusted the government. And then some fishy stuff, which whatever regulations or whatever the reason was, this information, the promises that were made to us were not kept, right? We were promised that if we stayed quiet, that this information would be publicized, and that the rest of the thousands of people that we now know would get help. But sadly, we have no credibility because we're just an injured group of people mashed together, right? This information does need to come from a position of authority, and it doesn't mean that we want, you know, people to look bad or whatever. But literally people are dying. They are dying. And we can't do anything about it. We're completely helpless. We know these people, we know their families, we know their names.
00:25:24 -> 00:30:13
Peter Marks/FDA: Well, you know, I mean, interesting. There, there, there, I do have to interrupt because if you know of people that are dying, we, we, we should, we should get a list of the first of all, you're, you're right. The privacy, once you die, when you're right to privacy, once you die is no longer there. It's actually a matter of public record. So it's not even a hippoconcern at that point. So it would be really great to understand if you, if you know people that are dying that you think that, that, that, that there is a relationship. I know that Dr. Nair has, we, we dog those cases down for autopsy data. We will, we, because we, we need to know. So there, if people are dying, and it sounds like you feel like there are a lot of bodies in the streets, so to speak. I'd love to, I really would welcome, you know, at names, dates of deaths. And we don't, you know, something, I don't, I don't want to, if you're worried that there's going to, we don't, we're, there's absolutely no, I can promise you, there's no possibility of retribution to any provider or anything, because we just want to understand what's going on here.
Brianne Dressen: So that's how we work. I mean, that's, that's, that's kind of the frustrating thing, because it's, you know, I mean, we've been doing this for, what, a year and a half. And it feels like we haven't gotten anywhere, right? Like I send you, I sent you guys a suicide letter, like three weeks ago, four weeks ago, and I didn't get a response back. The man he's gone, he flew to another country to end his suffering. And I know exactly what he was dealing with, because I deal with it every day. So yes, people are dying. Like I can't tell you how many people I have, I have a file on my computer of people's wills, because they're like, look, I'm going to be done. People's throats. This is a long standing issue that we're now seeing. People are having problems swallowing about a year and a half, two years into their vaccination now. So it, and it, I mean, it makes sense if you actually understand small fiber neuropathy, you know, that that's going to start happening. But the problem is, is that people are not getting treated and they can't get access to care. So doctor [Redacted], I don't know if you remember, you probably don't, but the first time we met with you, she, she talked in about the importance of identifying the potential of the signals, right? So she had seen what happened before myocarditis was acknowledged by the FDA, and she talked about all of these, they had solved one case, right, in their ER. And then after the communication about potential, you know, hey, look out for myocarditis, then they saw 36 within the next, you know, for the whole two, three weeks. And so that's kind of where we keep going back to. We've seen a success with myocarditis, right? Myocarditis is something that can be identified readily, and, you know, and, and you guys were able to identify it with six cases. PR, press release came out, communication, education came out to the medical community about it. And then the providers were actually able to watch for it, and then they were able to save more lives. But because, you know, and so I'm trying to figure out how come this isn't happening with this other syndrome that actually, from the analysis that we've done, it's, it's happening in a far higher rate than myocarditis. And that paper I put it in the chat is kind of an interesting nod to that. And it's, it's a POTS paper, and they say that POTS can be caused by long COVID into a lesser extent of vaccines, which we've 100% agree. We understand that we're the lesser extent to all of this stuff, right? We're not saying that the vaccines are killing all these people, blah, blah, blah. But we are saying that it is killing people, and that it is meaning others. But the question is how many does it need to name? How many cases do we need to come up with before there is communication to the medical community? Because it's, you know, in that paper is really interesting because they actually separated out by demographics. So there is the men, and there's the women, right? And so the men, the most prominent issue is cardiovascular is myocarditis, and then POTS is either two or number three. And then they separated out by women, and on the women chart, on the females, it's dysautonomia and POTS is number one. And that's totally what we're seeing. So there's this neurological issue that's happening with females that it's, it looks different than what's happening with males. And so that's why when we keep going back to this neuropathy thing, we also keep pointing back to, you know, whittling this down to what's actually happening with females. Because what's happening with females is different than what is happening in males.
00:30:14 -> 00:31:18
Peter Marks/FDA: Interesting.
Brianne Dressen: But I like that paper. And we, we're working with them. I was talking to another patient advocacy organization. They are going to start pushing to request that POTS is disclosed on the EUA paper work, I guess. I meant the EUA to have POTS on there. So that's what they're going to start pushing for as well. So we're going to team up with them and work through that as well. But it's hopeful, you know, to see little tiny clues come through in the scientific wit. But at the same time, I mean, that's not enough for these people to hang on. That's not like there's, there's got to be something, you know, because like my friend that died and I sent you his letter. I mean, I told him that you guys were working on it.
00:31:19 -> 00:32:58
Peter Marks/FDA: You know, I mean, it's so sorry. I mean, very sorry to hear, you know, you know, it's. We are, I think we're trying to do our best here to document safety signals. Look for them. I think if we believe people are, if people are, you know, are dying, we need to know about it. That, that I would say for sure. And it sounds like this, in this case, obviously a suicide. It's, it's, I guess the idea here is it's a suicide that's related to vaccine injury. Understood.
Brianne Dressen: And he's listed the reason why I sent it, you know, like a bunch of them when they send us their letters. They're like, goodbye, you know, don't let us die in vain. Which is tragic still. But his, he listed out specifically, you know, the tests he had had done, what the tests were that were positive. And so he, you know, it's one of those things where it's. That's why there's clues in there that he left. Which are, it's actually very classic staple, his positive labs, a very classic staple of what we've been seeing, you know, even with the people that are still alive. But those people that are still alive there, I mean, there's even people on our board that are injured that they're like, yeah, I'm going to be dead in the year because they're just declining. Because they can't get treatment because they didn't get the golden ticket to go to the NIH like I did.
00:32:59 -> 00:34:52
Peter Marks/FDA: Yeah, I'm not, I mean, it seems like this is, this is, I'm a little bit agaced at our medical care system here. Because in general, you know, our medical care system should be trying to provide for what they see in front of them. You know what I'm talking about, I mean.
Brianne Dressen: Yeah, I do, but if, I mean, if you're going to be realistic about it, I mean, the stigma is bad, right? I mean, like the media, I, I will tell you 100% the truth, the reporters have told us they cannot report on this. They can't. So there's that, right? And then number two, right? So you've got this stuff going on in California and misinformation. Nobody has actually gone back through all of this madness and insanity to make sure that the vaccines are, you know, have a secure place in society and blah, blah, blah. Nowhere in there does it say no one is communicated to the medical boards. Look, you're still going to have people that are injured by vaccines and you still need to take care of them. So what that has done is enabled the providers to essentially discount us and in some ways and many ways be abused, gas lit abandoned, but then also just so you guys know, big tech, they're using you guys as the excuse for censoring us and shutting us up. And I'm not saying that people are out there, you know, I know there's the tinfoil hadders and all that stuff going on, but I'm talking literally like someone says, hey, I got injured by my vaccine. This is what happened and I just want to give you a heads up and then get shut down. And then we appeal it. We appeal the decision, right? And they literally in the appeal letter back to us. Sorry, you guys don't exist. The CDC and FDA say you don't exist. So you guys just need to shut up.
00:34:53 -> 00:35:30
Peter Marks/FDA: But that's very, because we never say, I mean, I think we never say that you don't exist. We've never said that to any of these. That's, it's just very strange.
Brianne Dressen: Yeah. So that's why I keep telling that.
Peter Marks/FDA: We're in the business of collecting adverse events and understanding them.
Brianne Dressen: Right. So you guys know we exist. We know that you know that we exist, right? So, but the public doesn't think that you guys know that we exist. And we know this for a fact because we have it in legal documents from all of these prestigious whoever it is. Like they just don't acknowledge it because they point back to you guys every time. My own health department did it too.
00:35:31 -> 00:37:55
Joel Wallskog: Yeah, I mean, I'm glad to hear that you said you are a grass-root. You know, that kind of crude status out here because coming from a physician to practice 20 years at a very large practice. I'm frankly a grass-root too and I'm embarrassed about it. You know, again, I can just tell you my own experience, which is, you know, I've been hypertensive ever since the first week after for two years now. And now I have a normal renal function. And there are ample studies now with spike related, you know, problems with hypertension, kidney problems. And who is guiding my care? I am. Why? Because I go pull the literature. Okay, and I can show you, you know, I'm sure you probably know about some of that. Just an omia, you know, blood pressure, heart rate variability, some of the kidney problems that are coming out. That's unfortunate, you know, that's where it's left to is the patient. And all I'm asking, which is getting back to my question, is is, what is harmful about communicating, not to say safety signals, but concerns or trends to two health organizations and two providers so that when these patients present, they can have a little bit higher index of suspicion of what could be going on. And truly, all I'm trying to say is, is that if you don't communicate with the health organizations in this country, they're employed physicians. If they don't have their blinders off, they're not going to see a lot of these injuries. And I can speak for myself. Okay, I've been watching my doctors, ignoring my blood pressure for two years. And finally, now when my renal function, you know, my creatinine went to 1.5, I said, well, maybe I got to do something. But I don't think it should be patient driven. And I think we need to communicate better. And this isn't really to delay blame, this isn't. And it's really to try to improve patient care. But improve patient care requires improved signals. If you only wait, let's say, let's say, malacharitis, you know, let's say you didn't hit the safety signal and you waited long. Well, it does result in significant morbidity and mortality. I think the more communication, the better. And I think we could really improve patient care by communicating, not just, quote, safety signals, but concerns.
00:37:56 -> 00:39:57
Peter Marks/FDA: Well, I appreciate that. We can take this back and talk through it. Usually when we communicate a, and again, I'll ask Narayan to comment this. Usually when we communicate a potential, we had a method for doing this with CDC, which is that when something rises to a certain level, we put it out there as a potential concern. This has not, unfortunately, the strength of the evidence today has not gotten to a place where it's at a level where it's even, it's been strong enough to call it a potential safety signal concern based on the number of events above baseline. But we can continue to have that discussion. And I'm happy to, again, happy to go back with CDC colleagues and to talk about this since, you know, that's how we've worked in the past. Narayan, thoughts about that. I mean, that's my understanding of this, at least.
Narayan Nair/FDA: Yeah, no, I would agree with everything that you said, Dr. Marks. I think that's absolutely correct and sort of have a threshold and then, you know, launched into sort of communications outreach and so forth. And I'm also, you know, troubled as well. I'm an internal medicine physician and I'm very troubled to hear these stories of people not receiving treatment. I would have patients all the time that would come in and say, oh, I have this ailment and I think it's because of something. And I didn't necessarily, I would never refuse treating whatever their underlying condition. If you have high blood pressure, I would treat your blood pressure regardless of why you thought you had the high blood pressure. That's very surprising to me to hear that. I'm really disappointed that you need to hear these stories and you share those a number of times. And I did want to just convey that, you know, my empathy for that. That's really disappointing that people would decline to treat you based on what you think your symptoms are due to. That shouldn't play into it. They should treat you.
00:39:58 -> 00:41:45
Joel Wallskog: Well, that's the reality. I mean, this is a very highly, you know, we, we're a very non-platformization, et cetera. So this is just a very polarized environment. And that's just the truth. My gosh, you should know that if you're out in California, you're practicing. And somebody says that you said something against the vaccine. You lose your license. I mean, Bill, two or nine eight takes it to a whole another level. I mean, that is a censorship of the patient physician relationship. But that being said, 90 over 90% of us are gassed. That's just a fact. And then you'd have to talk to enough injured people who, you know, are gassed that. And unfortunately, some of the guests that I think is just because of the lack of knowledge of the conditions that they may see. And that's what I'm asking to help overcome this. How do we educate these providers about things that they could be seeing, whether or not it's who COVID or the vaccines? I mean, there's a lot of people out there that are miserable from long COVID. And again, and, you know, we have no, how many, you know, COVID vaccines, adverse event clinics are there in the United States? Zero. Zero here. I mean, there are COVID adverse event clinics in Germany. But we don't have anything. And that's part of, because we don't exist. And again, you'd have to be in this position that the vaccine injured are to understand how you're not just forgotten. You're actively censored. You're actively told you don't exist. I mean, it's just, it's a, it's a one word I would say. And I'm, again, I'm, I was in orthopedic practicing for 20 years at a very, very large practice. It's called being abandoned. And sometimes I say it's beyond even being actively censored. So... can I ask a couple of questions about the header trimmer?
00:41:46 -> 00:45:06
Brianne Dressen: Oh, I wanted to ask Joel. So Joel just got his CICP rejection. So the lack of communication also is affecting people's ability to get compensated.
Joel Wallskog: Yes. So right now, okay, I don't know if you guys know historically the HHS CICP program. 94% of their budget is for overhead. 6% goes out to patients. That's their historical budget. But now they're, what they're using is whatever you guys say is adverse as, as, as current science. So the only thing they're going to accept claims for now are myocarditis, anaphylaxis and blood clots. So that's unfortunately where now the injured are because that's the level of causation you need, which is you guys provide the science. Okay, because you are the only current science and knowledge. It's not, it's not a word. It's an executive decision by the HHS. So everyone's getting denied except I think as of October, I think there was three or four cases of myocarditis and maybe two anaphylaxis. And that's out of, they have, I think, over 10 or 15,000 applications. My was reviewed this transverse myelitis has not yet been. There's the current science and knowledge does not suggest that transverse myelitis is caused by COVID-19 vaccine. Now that could change, but my claim is denied.
Brianne Dressen: And once you're denied you're done.
Joel Wallskog: It's not a judicial process.
Brianne Dressen: The science is not going to catch up in time for people to get compensated. So everyone's going to get rejected.
Joel Wallskog: So what you guys do say is incredibly important, even when it comes down to the compensation issues. Because you then are becoming the, the science because there's not enough. There's not an alter. Can I add in a couple, I just want to... So there's a, I want to talk a little bit about heterotrimers. And it's in Moderna revealed at the summer, December, I'm sorry, September 1st, ACIP meeting. That the two mRNA vaccine or the, I'm sorry, that, that the bivalent vaccine are loaded into the same lipid nanoparticle. And that upon transfection, heterotrimers are formed. And this is a quote from them, this actually leads to more open confirmation and exposure of additional antigens. And we believe that it's exposure to those additional antigens that leading to the improved antibody persistence, not only against the variant of concern, but against the original strain and other variants as well. I would assume number one that you're all aware of the new novel, heterotrimers that are formed. And are you aware that this means that there's really not two, but four different kinds of spike proteins that could be produced?
00:45:07 -> 00:47:18
Peter Marks/FDA: In terms of combinations of the various, you know, within the, because of the, because of what comes out and what's synthesized there. Yes, because we are aware, because that's, it's, it's what is potentially possible. I guess through this, through associations, correct?
Joel Wallskog: Moderna, because of the way the way mRNA is expressed in a cell. So Moderna says that two of these heterotrimers represent improved immunology and therefore potentially improved pharmacology. Why doesn't this present potentially new toxicology?
Peter Marks/FDA: Because actually we've looked at, I think in part because we've looked into, you know, we have data to suggest that small changes in the molecule don't, you know, in the, in certain regions of the molecule, although they may affect antigenicity, they don't, they don't affect the basic toxicology of the molecule. That doesn't mean that it couldn't change certain profiles. And that's why we continue to do. That's why Dr. Nair is in business because whenever time we, we change over something in, we look for safety changes in humans, but we haven't seen differences. And we've looked pretty carefully. I mean, now that the, the bi-valent vaccines, both VA one bi-valent and VA four or five bi-valent have been given to tens of millions of people, we haven't seen a different safety profile with these vaccines than we have with the original vaccines. So, you know, that's the, that's the best, I can ask people who are more familiar with the basic science of it, but that's, at my level, that's my understanding of it.
00:47:19 -> 00:49:11
Joel Wallskog: So you definitely admit that, you know, the spike protein is certainly immunogenic and you're admitting that in the bi-valent vaccine, there's potentially four different spike proteins produced.
Peter Marks/FDA: Yeah, you know, I before I say what I'm admitting or not, I have to go back and make sure that our folks, my understanding is that you could have different combinations. I don't want to say whether it's four or two or three, it could be four. I want to make sure that our experts would give you an answer on that. So I can ask our experts.
Brianne Dressen: So we're finding bi-valent people, we're not finding them, they're finding us, but it's been kind of nice because we've been able to be like, hey, you're newly injured. Oh, here's some things to try right away. And so the severity of their disease is less. So we don't have the resources to put that to a clinical trial, obviously, but it just keeps going back to that paper that Nath co-authored last, last October, talking about really intervention and immunotherapy. Maybe these are some, sorry, Dr. Marks, you had something to say?
Peter Marks/FDA: No, no, I was going to say that what, what, you know, Narayan, maybe what we can do is maybe you could, if you don't mind doing me a favor, we can send Dr. Nath an email and try to get an update on where things stand. And maybe we can even get a quick call with him just to together to see to kind of get an update. So it will be useful for us. So that's one thing that may be helpful. We do need to kind of wrap up because I have a five o'clock that I need to be on right on time, but let's just continue on. I didn't need to interrupt. Go ahead.
00:49:12 -> 00:51:33
Brianne Dressen: So a final thing, VAERS, I'm hoping that maybe you can help me figure out or understand who we need to report our issues with VAERS to. I'm assuming it's not you guys, but we've found Dr. [Redacted] sent three of her reports, I think, to Dr. Nair, or maybe it was to Lori to send on to Nair, and it was in May, because her third report is missing. And the information from her third report actually has a small fiber neuropathy and everything else in it that's relevant, right? And it's gone. And it's not updated in the previous two reports. And so we didn't hear back from you guys. You guys probably got too busy and didn't look at it. So we decided to just ask people, we're like, hey, if you have a VAERS number, just let us know what it is. So we asked them for their VAERS number. And then we basically did an audit. So we did a little audit on 126 VAERS reports. We looked at every single report. We found that 11% of the reports were deleted. Some of them didn't make any sense. And then we found another, and this was the part that I can't quite figure out that's just as concerning for me is there's 22% of the reports that never made it through the system. So what we did, there's stuck in temporary mode, is what the VAERS call center was telling us. So we had every one of those injured people call the VAERS center and ask them what happened to their report, right? If it's why isn't it in the public system or whatever. And we got a litany of responses back, but they all were basically, we have your information. Thank you so much. We'll let you know if we need anything further. And then of course we told the injured were like, you should have a permanent ID. Ask them for the permanent ID. And some people could get one and some people couldn't. So transparency is lacking in that system. So we would like to file an appropriate complaint and ask for either an external audit or something to be done or someone to just explain to us what is going on with everybody's reports. And some of the reports that have been deleted are death reports. And those people are really, their family members are really sad and upset about that.
00:51:34 -> 00:54:32
Peter Marks/FDA: So. I'm not aware that anything ever gets deleted from VAERS in terms of death reports. And that, that seems, we're, Narayan, is that, is that ever the case?
Narayan Nair/FDA: No, they're, they're the only reports to my knowledge that are ever deleted are when it's purely fraudulent. And, you know, we've gotten a couple of hoax kind of, oh, this is a report by Mickey Mouse, those will be deleted. And that's a very, very small number. Sometimes what happens is there's a couple issues with, with VAERS. Sometimes if someone files a report and then someone else files a report, it's about patient one. And, for instance, if someone files a report, I have this adverse event. And later on, for what if they succumb to their injuries, they die. And someone else has a follow-up report. They will combine those, they'll merge those. So when we're looking at the system, we realize it's the same person. So those are called duplicate reports. They'll merge those. So my knowledge, they, they, they shouldn't delete any reports. So I'm not sure if that's what's happening. I know last time and please, you know, convey the doctor. I hope she, she feels better. She provided some, some VAERS numbers. I did go through those numbers. And I think the concern she raised at the time is, is whether the medical records were in the system. And, and there's two parts to VAERS, the front end system and the back end. They are in the back end. Medical records or anything derived from medical records by law, because VAERS is under something called the Privacy Act. We can't post that on the public facing system. And that's a good thing. And we, we want to be very sensitive to people's privacy. The problem that arises is oftentimes I'll, I'll have people call me and say, Hey, I filed a VAERS report. And I, I will, they call Lori and the message gets to me, rather. And I filed a VAERS report and, and I said it. I was vaccinating Wisconsin. Actually, I was vaccinated in Michigan. And I want to change that. And they submit a change. And I see that on the back end. But they never see it on the front end because we don't alter that initial report. And so oftentimes people will send in, follow up information. And the public facing side is, is not updated. They don't see it. And there's a concern. Well, I spent all this time submitting this and, and, and, you know, I'm being ignored. They're not, they're not seeing my information. And I've had several people reach out asking that question. It's a very valid question. But we do have, and I actually went through the, the, you know, numbers. And I go through when I'm asked by somebody and make sure that they're, their information. Occasionally, it's, it's, it's not, that hasn't happened too often. Almost every time I found that the records are there on the back end system. But again, they don't come in through the front end. And they have a very broad interpretation of medical records. So if someone comes in, and after their initial report, and, and does, provides additional medical information, that's considered on the privacy act by our attorneys. They say that, that, that we shouldn't post that on the public facing side. As you know, that public facing side, even though it's redacted, you know, it theoretically people could use insert information and triangulate, you know, who someone is. And so we're very sensitive to that. So on the back end, it, it looks very different than the front end. So sorry, that's a long-winded answer to your question.
00:54:32 -> 00:56:26
Brianne Dressen: Thank you.
Joel Wallskog: Thank you. Could you, could you take a look specifically at these cases that Brianne was referring to? Because it's not, you know, we did a study. What is it? A hundred in some cases? And it, but it's pretty alarming. What is it?
Brianne Dressen: There are real people. So I would let, here, I'll send, here, I'll put this in the link on the chat.
Joel Wallskog: How many people disappeared?
Brianne Dressen: 11%. So we have it here. I'll send you the link if you guys are willing to look at it. It's got the stats on on the front end. And maybe they didn't disappear. We're just not seeing them on the front end. They've called VAERS. I mean, these are real people. Their reports are disappearing. And whether it's a duplicate or whatever. But the problem is, is that on the public facing side, what we found is that the reports are not showing that, because you get, like, basically one chance, like your original report is there, and then your subsequent reports are going to have small fiber neuropathy, dysautonomia, you know, the appropriate diagnoses that we've been trying to fight through the medical system to get. And those, that information is not on the public facing side. And so my concern, obviously, as I'm sure you guys could understand, is this issue with transparency, data transparency. So there does need to be something to change there, for sure, to have that process be more transparent for the public to be able to access that information as it's updated in people's charts. But I would like to send you this, because we're requesting an external audit be done, because I think an external audit would obviously show some of these shortcomings that, you know, the various system may have. And then, obviously, an audit would bring recommendations from a professional on what we can do to improve it.
00:56:27 -> 00:57:34
Peter Marks/FDA: Okay. So we appreciate it. Send, please do send those along. I think we need to close. So I think we'll circle back with Dr. Nath. Do send Dr. [Redacted] or regards, I hope she feels better. I think we can continue to try to work, you know, on our end, we will continue to look for safety signals as they come up for our procedures. I think we can try to work through with Dr. Nath and getting updates there. We always welcome data that you want to provide us, and as I said, this information on there is very much appreciated, because we don't want, we, records should not go missing.
Brianne Dressen: Right. Because that's humans. I mean, it's hiding people and that's how they're feeling right now. So we need to help them feel validated so they'll hang on.
Peter Marks/FDA: I understood. Thank you all for your time.
Joel Wallskog: Okay. Thanks very much.
Brianne Dressen: Thank you. Bye.
Vinay Prasad just replaced him. Thank God.
Peter Marks is a charlatan who was allowed to dupe the public for far too long. The best indication of his character is the hostile and arrogant way in which he responded to RFK Jr's appointment. He should be prosecuted and put in jail, at the very least, for maiming and killing, let alone lying, so many people during his tenure.