AHLA's Speaking of Health Law
The American Health Law Association (AHLA) is the largest nonprofit, nonpartisan educational organization devoted to legal issues in the health care field. AHLA's Speaking of Health Law podcasts offer thoughtful analysis and insightful commentary on the legal and policy issues affecting the American health care system.
AHLA's Speaking of Health Law
The Current Landscape of Vaccine Law and Regulation
Brian Dean Abramson, Adjunct Professor of Vaccine Law, Florida International University College of Law and University of Houston Law Center, speaks with Vanessa Burrows, Partner, Simpson Thacher & Bartlett LLP, and Dr. René Najera, Director of Public Health, College of Physicians of Philadelphia, about the rapidly changing environment of vaccine law and regulation. They discuss current availability, recommendations, and funding of vaccines at the federal level; implications for companies involved in vaccine testing, development, distribution, and administration; the future of employer mandates; changes at the state level; and developments related to the National Vaccine Injury Compensation Program. Brian is the author of AHLA’s Vaccine, Vaccination, and Immunization Law, Third Edition.
Watch this episode: https://www.youtube.com/watch?v=PLaXvbvZ7cQ
Learn more about the book: https://store.lexisnexis.com/ahla/products/ahla-vaccine-vaccination-and-immunization-law-ahla-members-grpussku5628107m.html
Essential Legal Updates, Now in Audio
AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Premium members. Get all your health law news from the major media outlets on this podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast.
Stay At the Forefront of Health Legal Education
Learn more about AHLA and the educational resources available to the health law community at https://www.americanhealthlaw.org/.
For more information, visit AmericanHealthLaw.org.
SPEAKER_00:Hello, I am Brian Dean Abramson. I am the author of the American Health Law Association's Treatise Vaccine, Vaccination, and Minimization Law, which has just come out in its third edition earlier this year. And I also teach vaccine law at the Florida International University College of Law and the University of Houston Law Center. And as I came out with this third edition, I thought the state of vaccine law after the events of the last few years with the pandemic had somewhat stabilized and we weren't going to see big changes or disruptions. And as it turns out, we are in the midst of some tremendous upheaval in the field, which is why I am joined here today by Dr. Renee Nehera and Vanessa Burrows, who are going to join me in discussing some of these upheavals in vaccine law, also matters that we'll be discussing at the forthcoming National Vaccine Law Conference. Why don't I go to Vanessa and allow you to introduce yourself then?
SPEAKER_01:Hi, I'm Vanessa Burrows. I'm a partner in Simpson Thatcher's Washington, D.C. office. I handle health care regulatory and FDA regulatory matters, usually in the context of capital markets transactions, as well as for mergers and acquisitions. And I'll turn it to Rene.
SPEAKER_03:Hi, my name is Rene Nahed. I am the Director of Public Health at the College of Physicians of Philadelphia. I'm also the Director of the History of Vaccines Project here at the college, and I'm a fellow of the college as well. I also teach at Johns Hopkins University and at George Mason University on public health and epidemiology.
SPEAKER_00:Excellent. Well, thank you both for being here. And, you know, as I said, we are in a period of upheaval. And what we are seeing, what we've seen throughout the pandemic is changes to different areas of vaccine law sort of progressively increasing. Or things that have occurred that brought attention to those areas in terms of the approval of the covert vaccine in particular. Now, we are seeing some substantial changes in the regulatory structure of vaccines and really in who's making the decisions. in terms of whether vaccines are going to be approved. Would either of you wanna jump in and talk about what exactly we're seeing with that and how that's going to affect potentially the availability of vaccines and recommendations for vaccines?
SPEAKER_01:Sure, so even within the last day, right before we started this podcast, we've seen, I think a major change in terms of which vaccines will be recommended. which could potentially go to approvals at a later point in time. But the U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. had recommended or formally rescinded, actually, the federal recommendation for flu vaccines that have thimerosal. So this is apparently not going to reduce the vast amount of flu vaccines that are currently on the market, but that would prevent recommendations for the... vaccines that do still have a thimerosal component, which is, to my understanding, a small percentage of current vaccines. I don't know, Rene, if you want to also
SPEAKER_03:comment on that. Yeah, no, you know, thimerosal has been a boogeyman in the anti-vaccine circles for quite some time now. It's a solution that contains mercury. And so when you don't understand chemistry and you don't understand biology, you know, putting thimerosal into you through a vaccine seems like something very scary, but it's not. It's harmless. It's been around for over 100 years We know it's toxicity levels and the levels in the vaccines are nowhere near toxic. My worry with this, you know, yeah, thimerosal was removed from childhood vaccines for the most part at the beginning of the century, 25 years ago. And, you know, that's fine. That's fine for us. My worry is the rest of the world. In the rest of the world, people don't enjoy the infrastructure to keep their vaccines safe in terms of storage. And they rely on thimerosal primarily to keep the vaccines, the dead virus vaccines, without any kind of bacterial contamination. And so all these countries now, they're gonna be looking to the US and saying, well, the US removed thimerosal, why do we still get to have it? If it's so dangerous, according to people like RFK Jr., then why is it still in our vaccines? And that's where I think we're gonna see a further erosion worldwide of vaccine acquisition by people. That's my worry when it comes to these kind of regulatory actions and their impact on public health.
SPEAKER_00:Let me actually step things back a little bit and give a bit of a primer, because I think there are a lot of people who don't know the structure by which vaccines are approved and recommended. So there is a body in the Department of Health and Human Services called ACIP, the Advisory Committee on Immunization Practices. And there's a very longstanding practice rule, basically, that ACIP is composed of experts in the field, And they make recommendations. They say these vaccines should be administered to children or to pregnant women or to adults. They make recommendations for all the vaccines. And those recommendations have legal consequences. One of which is currently that under the Affordable Care Act, if ACIP recommends a vaccine, then it has to be covered by insurance companies. Another being that if ACIP recommends a vaccine for women to children or pregnant women, then that vaccine will fall under the National Vaccine Injury Compensation Program, which limits the liability both of manufacturers, and I think most pertinently to AHLA members, to administrators, the doctors, the hospitals they work for, their liability has certain limitations on it due to that structure. And historically, ACIP has been, I think, very well regarded for the depth of its inquiry into the safety and effectiveness of vaccines and their utility for people in different age groups and circumstances. But for those who are sort of not in the know, earlier this year, and this is something that was kind of widely reported in the news, it's sort of an unusual level of attention for a vaccine law issue, but Secretary Kennedy fired all 17 members of ACIP, alleging corruption based on the fact that some of them were scientists who had worked on vaccines for vaccine manufacturers. Some of them had been involved in conferences or projects or things of that sort that received funding from the manufacturers. And this was widely derided in the community of researchers because these are people who have real expertise in vaccinology and immunology and epidemiology. And he fired those 17 members and replaced them with eight people who generally don't have that expertise. But many of them have a history of publicly agreeing with certain anti-vaccine tropes, some of them kind of myths. And that body has since been much more reticent to be full-throated and endorsing vaccines. And even with the recommendations that body made, that body made some recommendations, which Kennedy then rejected, that$8 person group that he appointed made some recommendations for the vaccination schedule that Kennedy rejected. And those have legal consequences as well in terms of whether there's going to be funding for those, whether there's going to be availability for those. So that's kind of the background and the milieu of what we're working with. So what does the horizon sort of look like for the availability of vaccines in the United States and funding of vaccines in the United States? Rene, is there something you can speak to?
SPEAKER_03:Well, it's yet to be determined, obviously, with everything still being in flux. But I can tell you that a lot of the local health departments that provide vaccines, especially for children, especially coming up in August for the school year so that these kids meet the requirements for their school, they're preparing for no funding. They're preparing to be self-funded either through the local taxes, the local money. A lot of clinics have closed as well, something that we saw even before this decision with the firing of ACIP and the replacement, the federal money was withheld for clinics out in Texas where there's a massive measles epidemic going on. So a lot of the local health departments that actually do the work, they're preparing for not having the money available for vaccination. The vaccines are there. They're still being produced by the manufacturers. It's all the money to pay for those vaccines, which You know, at a small scale, they're not very expensive, but when then you start talking about hundreds and thousands of kids, then yes, it starts getting expensive, especially for low income health departments in low income counties in the United States that are going to be affected. So it's just a cascading effect that has now reached the local public health workers. The average person in the U.S. will probably still get to access vaccines. They'll probably still get to go to their physician and get it prescribed and then go get it because the vaccines have not been outlawed per se. But as far as the poor, low-income countries in the U.S., that's where there's going to be trouble. because the money is being rescinded or just withheld from them to be used for these programs. Number one, catch kids up, which we saw during the pandemic that a lot of kids didn't get their vaccinations. So now they're being caught up. And number two, get kids for entering the school system, which tens of thousands of children enter the school system every year. They also need their vaccines to be up to date as a requirement for education. And they're not going to be able to have them at a reduced or free rate.
SPEAKER_00:That is going to be a troubling development because that'll be a vector through which these diseases spread. I think we're seeing that with the current measles outbreak. That's sort of an illustration of what happens when you have reductions both in support for those programs and increases in hesitance driven by a lot of the rhetoric we're seeing. Vanessa, can you speak to how this is going to affect the public companies that are involved in vaccine testing, development, distribution, and administration?
SPEAKER_01:Sure. So we do advise public companies on risk factors and how to explain to the public through SEC filings, Securities and Exchange Commission filings, what the potential risks to their companies are. One thing, and also this happens in kind of the private context as well, just advising, acquirers on risks associated with particular products that might be either in development or already commercially marketed and what these changes could mean for them. I think generally speaking, it seems to have been a very stable area in the past. Since the Affordable Care Act was passed, there were recommendations for coverage for vaccines so that health plans would have to provide coverage for preventative services and people would know that their vaccines would be covered on an annual basis if it's a flu vaccine or otherwise. And then we also saw during the COVID-19 pandemic that Congress passed additional laws such as the CARES Act that provided coverage for COVID-19 vaccines specifically. So kind of the risk factors associated with development of new vaccines, those I think are still there, but the risk factors that companies are may need to consider adjusting are the ones that are associated with recent events in the Department of Health and Human Services and at ACIP. What the recommendations are, could the recommendations be revoked? With the decision recently, this is not to say that there's indications that other drug approvals or vaccine approvals will be revoked, but to the extent that there's going to be future actions to decrease recommendations for particular products or decrease the number of individuals who are eligible. Let's say no longer make recommendations for children or no longer make recommendations for pregnant women or limit the recommendations for the COVID vaccine to individuals of a certain age who are on the older side. All of that might lead to a decrease in vaccine uptake, maybe a decrease in manufacturing. There could be new safety or adverse event report requirements. I mean, currently vaccine manufacturers have to provide adverse event data and report that to FDA, as do healthcare providers who are administering the vaccines. But to the extent that there could be other requirements imposed, then that would be an additional obligation on a provider or a vaccine manufacturer that they might have to follow and address those recommendations as well. So just generally speaking, companies in this space, I think, are taking a new look at what their current risks are and what their future risks could be. And if this would have a material impact on any of their products or their revenue.
SPEAKER_00:So we are looking at something of a chilling effect on the development of new vaccines, just because there's sort of a fear that HHS with its current constituency or current leadership might impose some costly new, for example, as they did, I think they have done with some vaccines already. They've said, you know, we're not going to allow this for certain groups unless you conduct an entirely new clinical trial. And those are tremendously expensive. So I wanted to ask, and I think I'll direct this at Renee, if you have any thoughts on this. How is this going to affect the ability of employers to mandate vaccines or encourage or incentivize or otherwise increase vaccination rates for their employees, particularly in the healthcare sector where vaccination may be ubiquitous?
SPEAKER_03:Yeah, I was thinking of the healthcare sector right off the bat, right? But what you have to understand is that in the healthcare sector, for the most part, you have people that are not vaccine adverse, you know, they're They're pro-vaccination. They understand the science. They understand the need to, even if the vaccine increases your risk of whatever, they're willing to take that risk because they're that kind of people. You know, we're talking physicians, physician assistant nurses, et cetera. That said, you know, what is a hospital going to do for infection prevention purposes? For example, with the flu vaccine, when somebody like HHS says, you know, the flu vaccine in a certain age group is not as effective or the COVID vaccine or hepatitis B is also a big deal in healthcare settings. And it's very infectious and you need to be protected against it because you come into contact with it almost daily if you're in direct patient contact in the United States. And so it's going to be tough for them to, on the one hand say, here's the science, here's the evidence, here's why you need to be vaccinated and also to protect us from liability of you getting hurt on the job by getting this infection and this disease. But on the other hand, the honchos at HHS, you know, in the most powerful nation in the world are saying, don't do it. So how do we marry the two? Hopefully for the most part, people will understand that the people in charge at HHS right now are, if not anti-vaccine, they're vaccine hesitant. And so, you know, they'll just kind of work with that. A lot of the medical organizations, societies, et cetera, are giving their own point of view on these things and they're stepping up to fill in the gaps that HHS, CDC, FDA might not be filling in. But it's going to be tough to kind of put together, marry those two situations. On the one hand, the science, and on the other one, the policy. And it's something that, it's a tension that has not been seen in a long time when it comes to vaccination. You see it more in discussion forums online, but now we're seeing it in the real world. And it's gonna be interesting to see how you know, it, it plays out with, with healthcare institutions. And of course, you know, then there are others that are other, um, other employers who might require certain vaccines based on the work that their employees do. I'm thinking of restaurants and I'm thinking of food handlers and some companies require the hepatitis A vaccine because you have hepatitis A and you're processing food, you might affect a lot of people and that's a big liability, right? How do you mandate that if for some reason down the line, HHS decides that the hepatitis A vaccine is not recommended or not to be used? and so on and so forth. So it's going to be a delicate balance between the science and the policy. And I do not wanna be in the position of the people that have to make that decision right now. That's how I see it affecting companies at this point.
SPEAKER_00:Well, so far we've only been talking really about HHS and the changes in the federal government. What are we seeing from the states in terms of their action towards vaccination mandates and employer mandates?
SPEAKER_03:Yeah, so some states are reverting. Mississippi and West Virginia, for example, were some of the handful of states, I think like three or four, that had no exceptions for vaccines other than medical exceptions. And now they're changing their tune. Now they're adding exceptions based on philosophical, religious points of view. And so that is opening the door for people to just say, I don't want my kid vaccinated. You know, I'll sign the form and that's it. where it used to be that you had to go to a physician and get a proper diagnosis, and then that's the only way you could get around getting vaccinated. California went the opposite way. California used to have philosophical and medical and non-medical extensions, and they went to just medical, increased the rate of vaccination, increased the acceptance of vaccines in the state. And so that really worked out. But now we have these two states And then you have other states that are looking again, you know, after this debate in the early 2000s with things like the HPV vaccine. We're taking another look at the HPV vaccine, and I'm thinking of Texas and other states in the South, you know, places where HPV disproportionately affects people of color. So they're looking at these vaccines as dangerous. You have states like, I forget if it's South Dakota or North Dakota, they were wanting to classify people. the mRNA vaccines as genetic therapy or as agents of biological warfare. And so this just shows a misunderstanding of what the mRNA vaccines are. So you're seeing these little bills that we try to keep on top of by tracking them online, but you see them, and sometimes they don't get past committees, and sometimes they do. And so when they do, it's a mobilization of pro-science people, particularly parents, to try to talk to their legislators and get them to not do what they're thinking of doing. But it all centers around the ability to be exempt from certain vaccines, which kind of, you know, it's kind of scary because where does it stop? Do you just then instead of exempting people, do you just make it an opt-in instead of an opt-out? And then what does that lead to? And we see some of that with measles. Pertussis is another one, another disease that is exploding in the U.S. You know, and with measles comes rubella. People should go and see what happened with rubella in the 1960s before the vaccine was available. It brought us Roe versus Wade because of everything that was going on to pregnant women at the time with rubella. So yeah. You know, that's what's percolating out there. It'll all depend on the tone that the politics takes. And right now we're super polarized. So, you know, we'll pay close attention to what happens, but that's what keeps me open by this. A big state with a big population all of a sudden saying, okay, vaccines are opted. It's up to the parents to opt into vaccines and we don't need to worry about them having them, you know? And so we're off to the races with big epidemics.
SPEAKER_00:One thing that keeps me up is something that's gone on in a big state with a small population, which is Montana, where the state banned employer vaccination mandates. So it's the law of the state now, and I think it only applies to COVID vaccination, but there are other states that have sort of legislators with similar mindsets and views on vaccination. And that was actually challenged in court and initially the United States District Court in Montana throughout that prohibition on various grounds and the grounds that you may have employees who are unable to be vaccinated and for their protection they need to be around employees who are vaccinated. And the United States Court of Appeals for the Ninth Circuit overturned that. So now it is the law of the land that a state can actually ban employer vaccination mandates or but sort of draconian limits on it. You know, Texas has put requirements in place that if an employee basically says they have a religious or philosophical or conscientious objection to vaccination, the employer has to grant them an exemption. So it's an exception that eats the rule. So that's something that we're seeing. And I think the states are being very divergent and it's a very different way path than we've had historically. At the outset of the COVID pandemic, we saw that there were a lot of states that didn't want to take measures to prevent the spread of COVID, didn't want to be kind of pro-vaccination when the vaccine was developed. And the federal government try to step up and fill in that gap with an OSHA requirement, which was ultimately struck down by the Supreme Court. So there are certainly limits that have been imposed on what employers can do, even in the healthcare field, even where it's most stringently required that people be vaccinated. And on top of that, We're seeing an increase in courts around the country and in the Supreme Court of a willingness to expand religious exemptions and say that even where you're allowed to have vaccination requirements, We're going to take federal laws that require that you not discriminate on the basis of religion and extend them into broader and broader abilities of people to object to vaccination or avoid vaccination. So that's certainly an area of concern where we're going to have people in those positions in America. positions where there are medical professionals who are dealing directly with patients and should be vaccinated and maybe in some sense being dissuaded from being vaccinated. I want to shift a little bit to the distinction between COVID vaccine and other vaccines and the vaccine entry compensation. Vanessa, is that something that you wanted to speak to? I
SPEAKER_01:think In general, there's the National Vaccine Injury Compensation Program, which provides compensation for certain types of vaccines. It's gotten a little bit of attention over the years and kind of in waves, but more recent attention from the Senate Homeland Security and Governmental Affairs Committee because they have been focusing on children who've been injured or individuals who've been injured by vaccines. But the program does cover if there's a vaccine that is mandated. Any individuals who are injured that have certain types of injuries, when the injuries appeared within a certain timeframe of the vaccination being administered to the individual and protects manufacturers and provides certain liability protections for manufacturers of those vaccines. But it does provide a way for individuals who are injured to receive compensation. Of course, to the extent that there would be a severe adverse event associated with the administration of a vaccine, arguably there's no compensation that could equate for that. you know, in general, this provides a congressionally mandated mechanism for individuals to seek recourse through the federal court system and through this program. So recently, as I mentioned, the Senate Homeland Security and Governmental Affairs Committee has had a few hearings about the individuals and this program generally. I don't think that they're is an appetite to push major legislation to make serious changes to the program at this point in time. But of course, having these hearings draws attention to the program and what it does. It has been amended over time to include additional types of vaccines. So for example, I think it was amended during the COVID-19 pandemic to provide additional types of to cover additional types of vaccines that were being administered during that time. But correct me if I'm wrong, Brian or Renee, on that.
SPEAKER_00:Well, I think there's been a very interesting history in the past decade or so of the VICP just because Shoulder injuries were added to it, and they were added at the tail end of the Obama administration, and they were removed by the Trump administration. They were put back by the Biden administration. And at the moment, it doesn't seem like there's any intent on the part of the second Trump administration to remove them again. But shoulder injuries from... basically from an incorrect administration technique where the needle doesn't go in quite right, aren't necessarily caused by anything to do with the vaccine themselves. They're entirely about administration. And since those were added to the program, they very quickly came to account for half of all vaccine injury claims with the VICP and a substantial increase. So that and vagabagal syncope, which is basically fainting, or vasobagal syncope, those were added, and those have added some strain to the program. There haven't been new vaccines added in some time. And I think the last vaccine was added, I want to say it was rotavirus, which was a while ago, maybe influenza in 2005. But one of the big bones of contention is that the COVID vaccine is itself not covered by the Vaccine Injury Compensation Program. And that's sort of an interesting topic of, you know, Kennedy thinks it should be. It's currently covered by a thing called the Countermeasures Injury Compensation Program, which is a separate program set up under the PREP Act. And that program is sort of notoriously stingy compared to the VICP. There have been far fewer determinations that an injury was caused by the vaccine, far smaller awards, with one kind of a substantial outlier where someone was awarded about$2.5 million for an asserted COVID vaccine injury. But outside of that, they've been in the tens of thousands, which is much lower than the VICP usually awards. But the thing is, a vaccine, as the law is currently structured, cannot be added to the vaccine injury compensation program unless it's recommended by ACIP for administration to children or pregnant women. And ACIP is not going to make that recommendation for the COVID-19 vaccine as ACIP is currently constituted. HHS under Kennedy has specifically contravened such a recommendation for those groups that would bring in under the VICP. So it's going to take an act of Congress to put COVID-19 vaccine under the VICP if they want to move it out from the CICP. So that's kind of an interesting direction where things are going with that. And there are competing kind of bills that have been brought in the House of Representatives going in very different directions. One bill that has garnered some support would, in fact, move... COVID to the CICB and increase the number of special masters who deal with these cases. There's a statutory limit of eight special masters to deal with all these vaccine injury cases, which made sense 40 years ago when there were a handful of them. Now, when there are thousands of them and the docket is bloated with the shoulder injury cases taking up half of it, if we add COVID cases to that, it'll basically double again. So that's structural change that would need to be made in order for these cases to be heard in any sort of reasonable amount of time. But there's also a bill pending in Congress that would just eliminate all of these cases manufacturer limitations and liability, administrator limitations and liability, and get rid of all of these provisions of the VICP. And that has some support as well. And I saw an analysis of that study. These sort of two competing directions are each garnering enough support to ensure that neither one of them is going to pass. So something is going to have to give at some point because the current situation is not sustainable forever. I
SPEAKER_03:want to make an important distinction here that just that something gets reported to the vaccine adverse events reporting system or that something reaches the vaccine court, as it's called, doesn't mean that it was an actual injury from the vaccine. As you mentioned, the shoulder injuries are because of the administration. So that's human error. which is fine to try to get some compensation, especially if the injury was severe enough. You also have some cases from the storage of the vaccines. And we go back to the issue of thimerosal. Thimerosal-free vaccines can spoil. And there have been instances where those vaccines have been administered to people and they have some sort of bacterial contamination and they cause some sort of injury. Again, you know, not the vaccine per se, but the administration, the handling of the vaccine. So I think it's important for those who are listening to this that just because the cases have jumped or the cases are happening doesn't mean that the vaccines are less safe. If anything, they've been getting safer with time. It's just that, you know, there's this thing that we use in epidemiology called surveillance bias. If you look for something long enough, you're going to find it. And so when you have millions upon millions upon millions of people getting the COVID vaccine, even if it causes a one in a million chance, you're going to have several hundreds of people who are going to be flaming or having legitimate claims of injury. And then you're going to have all the, you know, temporarily associated. So it happened after the vaccine, so I'm blaming it on the vaccine. vaccine, which we see all the time with the HPV vaccine. The HPV vaccine, you go into the Vaccine Adverse Events Reporting System, and many of the claims, many of the claims are for blood clots. And if you look at the cases with details, they are blood clots in women who had other comorbidities that increased their risk of blood clots altogether, smoking, overweight, obesity, and use of contraceptives. And so was it the vaccine or was it any of those things? Well, it's hard to tease apart without actually, you know, having a study with each one of these people. But it is what it is. And I think, you know, as you said, if we increase the number of vaccines and make it into the system, then it's going to increase the number of reports. And in the public space, point of view, it's going to increase the danger of the vaccine. Then they turn to their legislators or to the current administration. And it's like a self-fulfilling prophecy of a circle. Now we think vaccines are more dangerous, so we need to get rid of them, or you need to compensate me more if I take on the risk. And it's just one of those things that in public health, we kind of throw our hands in the air because it's one of those things that we cannot control. We just have to deal with it and continue to educate the public.
SPEAKER_00:Right, and then I think it's worth adding to that couple points, one being that the vaccine injury compensation program itself is a no fault compensation program. You don't actually have to show that there was any fault on the part of anyone involved in the manufacturer or administration of the vaccine. And for certain kinds of injuries, you don't actually have to show the vaccine caused the injury. You just have to show a proximity in time between vaccination condition and. for compensation purposes, everything else is assumed. And also, I think it's important to note that in this entire framework of things, there are some people who are either outright bad actors and trying to stir the pot and score political points, or people who just genuinely believe bad things about vaccine that aren't supported by the science and the research. And we see... claims that are being filed, VAERS reports that are being filed that are kind of blatantly, no, that's not really connected, but filed by people who want to make that connection. We see that a lot with the autism cases. There was a study in about 25 years ago where someone claimed to have found the connection between vaccination and autism. That study was later found to be fraudulent. But that connection was made in sort of the public mind. Very good studies have been done since then showing that there is no correlation between vaccination and autism. And in fact, the signs of autism changes to the brain structure can now be found in children in the womb before any vaccines are administered. So that's sort of been disqualified as a component of the development of autism. And I've recently posted about the fact that exposure to fossil fuel fumes is strongly correlated with the development of autism in children. But we have this committee now on HHS that has been formed to, quote unquote, determine the causes of autism. And that is a group of people who have this sort of long-term history of asserting that there's a connection between vaccines and autism. So there may be, again, coming from our federal government, something of a foregone conclusion that they're sort of looking to cherry-pick evidence to support which again would be used to affect recommendations for vaccination, recommendations for compensation for vaccine injuries, what's going to end up on that table, what people are going to end up, what's going to end up coming out of the government's pocket for that. Vanessa, did you have any additional thoughts that you wanted to
SPEAKER_01:add? I mean, I think that's, yeah, there's going to be probably continuing developments over the course of the next, you know, three and a half years or so in this space and people should be prepared. I think people had a certain perspective as to what might happen based on, you know, initial confirmation hearings for Secretary Kennedy and that has, you know, continued to change. I think we'll continue to see additional changes and companies should just, and healthcare providers should just take the steps that they can to, address concerns from their patients, address concerns from other healthcare providers, address concerns from people in research and development to the best that they can. And then to the extent that the policies are to reduce recommendations for vaccines, answer questions about off-label usage potentially. I'm not encouraging off-label usage by any means, but let's say that certain vaccines are limited for certain patient populations. the federal government can make the recommendations as to what patient populations are appropriate for a drug that's FDA approved. But generally speaking, the US Food and Drug Administration does not regulate how physicians decide to administer the drug and for the individuals they decide to administer a drug for. So even if the recommendations change, if a physician determines it's appropriate for the particular patient, let's say the recommendation is for 62 and above, and the patient is 61, but has a bunch of comorbid conditions, and the physician determines that it's appropriate to administer the drug to someone who is age 61, the physician determines in most states has that ability within the scope of their practice of medicine to make that determination. You know, if let's say something did happen to that individual who's 61 and not 62, you know, the physician could be sued. You know, that's why they have malpractice insurance, but, but there is even, even if the recommendations change, you know, physicians still have the ability to make determinations as to what's appropriate for their own patients.
SPEAKER_00:Excellent. And I think that's, that's a, A very good summation. And I want to thank you both very much, Renee and Vanessa, for joining me for this podcast. And it's been very informative, I think, to me and to hopefully everybody who's watching. And thank you so much. And let's hope that everyone stays safe and healthy out there.
SPEAKER_01:Thanks, Brian.
SPEAKER_00:Thank you for having us.
SPEAKER_02:If you enjoyed this episode, be sure to subscribe to AHLA's Speaking of Health Law wherever you get your podcasts. For more information about AHLA and the educational resources available to the health law community, visit AmericanHealthLaw.org. And stay updated on breaking healthcare industry news from the major media outlets with AHLA's Health Law Daily Podcast, exclusively for AHLA Premium members. To subscribe and add this private podcast feed to your podcast app, go to AmericanHealthLaw.org daily podcast. you