tinalexander.github.io / notes / 2025 / 05 /
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From January 1 to May 26, 2025, CDC received 62 reports of travelers who were infectious with measles while traveling on an airplane. CDC initiated airplane contact investigations for 50 of these travelers because they traveled into the United States or between U.S. states and territories while infectious with measles. There has been only one situation during this period in which measles appeared to have been transmitted during air travel (i.e., a confirmed case of measles identified in an airplane passenger who was seated near a traveler with infectious measles on an airplane).
Exposures at the airport itself are more difficult to track, and state, local, and territorial health departments lead these investigations.
“After a rigorous review, we concluded that continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable,” said HHS Communications Director Andrew Nixon. “This is not simply about efficacy—it’s about safety, integrity, and trust. The reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.”
On background: The U.S. Department of Health and Human Services (HHS) is terminating an award to Moderna by the Biomedical Advanced Research and Development Authority (BARDA). The funding was intended to support development of an mRNA-based H5N1 avian influenza vaccine. After a comprehensive internal review, HHS determined that the project does not meet the scientific standards or safety expectations required for continued federal investment.
While early-stage data showed limited promise, the decision reflects broader concerns about the use of mRNA platforms—particularly in light of mounting evidence of adverse events associated with COVID-19 mRNA vaccines, including myocarditis and other post-vaccination complications. A recent Senate investigation revealed that the prior administration withheld critical safety data and downplayed known risks tied to the mRNA COVID-19 products, raising serious questions about the reliability and transparency of the current evidence base.
The move signals a shift in federal vaccine funding priorities toward platforms with better-established safety profiles and transparent data practices. HHS remains committed to advancing pandemic preparedness through technologies that are evidence-based, ethically grounded, and publicly accountable.
QUESTION 04;34;01 PM
The practical effects of the CDC recommendation, does that mean it will not, most likely then be covered under insurance for someone trying to get a COVID shot not in those high risk cohorts?
MARTY MAKARY, FDA
So that is up to each individual insurance company and the fact that the CDC or the government is not recommending a vaccine with such absolutism in young healthy populations simply means it is between that individual and their doctor, along with every other medical decision they make together.
QUESTION
We talked about the risk calculation that young kids did not need it, they did not suffer from COVID, they did not need to run the risk of the shot, did that factor into your decision as well, that we are not appropriately measuring the risk of vaccine injury for someone who may not be getting the benefit designed because they were not at risk for COVID?
MARTY MAKARY, FDA
Well as you know Will, hundreds of thousands of Americans have claimed they have been injured by the COVID vaccine and so we have got to listen.
It takes a lot of time to do a proper analysis, that has not been done to date, and it has to go into– factored into the equation.
Now, the recommendation was really based on the voice of many doctors across the country who have said, look at the rest of the world, look at Europe, and look at where we are, we need science-based, evidence-based approach.
Robert F. Kennedy Jr. [00:24:28]
There’s a bad Supreme Court case recently that equated pharmaceutical advertising with freedom of speech and gave it, endowed it, with a limited First Amendment protection. There’s still things that we can do, and we’re working on that. So we think that we’re going to be able to do something, but I’m not going to talk more about that.
And the issue we hear that people understand, because a lot of the people who support us are for freedom of speech. They’re absolutely– but this is a very different issue because, first of all, the pharmaceutical companies are advertising products that are being paid for by the taxpayer. And they advertise all these drugs on television, a person who’s going to get the bill from that drug is my agency. And the taxpayer’s gonna end up paying for it.
If you selling cereal or Coke or something that might not be so good for you, at least, you know, the consumer’s paying for that themselves. Except if they’re getting it from this from the SNAP, and we’re going to end that.
Question [00:25:27]
Yeah. I heard 25 states now have–
Robert F. Kennedy Jr. [00:25:29]
Have legislation to get sodas off of SNAP. And some of them are looking at candy and you know, other stuff.
Question [00:25:36]
Yeah. 10 billion dollars, I heard, of the 120 billion roughly of the SNAP program, just for soda.
Robert F. Kennedy Jr. [00:25:41]
So it’s a huge recipe for these companies. And you know, I, listen, if you want to buy a Coke, you should be able to do it in America. You can do what you want.
The taxpayers should not be paying for this a nutrition program. And when 10% of the money is going for something that has no nutrients in it, it’s not a good outcome.
The other thing about pharmaceutical ads is the company gets a tax deduction on them, but we’re paying for the ads and we’re paying for the product …
…
Robert F. Kennedy Jr. [00:27:24]
… then we’re paying for all the diseases that that product is causing. And so it’s different than any other kind of product and it’s regulated differently. And those– those regulations–
A drug company does not have carte blanche from FDA to advertise any product it wants and have – there are conditions that we can place on it. And, those are some of the things that we’re looking at now.
…
Robert F. Kennedy Jr. [00:27:37]
A drug company does not have carte blanche from FDA to advertise any product it wants and have – there are conditions that we can place on it. And, those are some of the things that we’re looking at now.
…
Robert F. Kennedy Jr. [00:31:22]
What we’re gonna do is we’re gonna devote probably 20% of NIH’s budget to replication. Every study has to be replicated.
We’re going to publish the peer review for the first time.
We’re probably going to stop publishing in The Lancet, The New England Journal of Medicine, JAMA, and those other journals, because they’re all corrupt. And even the heads of those journals, like Marcia Angell, who for 20 years was the head of the New England Journal Medicine says that we no longer are a science journal. We are a vessel for pharmaceutical propaganda.
Because they control the journals, they buy the preprints, right, which is– and they– if you want to publish in a journal, you have to pay $10,000 to get the study published. So the pharmaceutical company concocts a study that shows the outcome that they want, that statins work, or that SSRIs work, and then they’ll publish that. They pay to get that published.
And they order reprints from the journal, the reprints, as you know, it’s a five or six page document that has the logo of the journal on it. They sell them for enormous profits. And then they give them to the pharmaceutical reps, to hot looking girls and hot looking guys who go to the doctor’s office, take ‘em out to lunch, give them the preprint and say, this product works. Why don’t you prescribe if, 500 times during the next month, and then I’ll be back here to see right with all these kind of implied promises of what what’s going to happen. And that’s how this system works.
And so what we’re going to do is change the system and say, you can’t– you know, Richard Horton, who was head of the Lancet who really disgraced himself during COVID with the– the Lancet letter and all this– he says the same thing he says, yeah, we’re not, we are no longer science journals. We are about promoting pharmaceutical products and that’s what we do.
So unless these journals change dramatically, we are going to stop NIH scientists from publishing there. And we’re going to create our own journals in health in each of the institutes.
Question [00:33:32]
They will become the preeminent journals because–
Robert F. Kennedy Jr. [00:33:34]
And they’re gonna become the preeminent journals, because if you get NIH funding, it is anointing you as a good legitimate scientist.
…
Robert F. Kennedy Jr. [00:36:04]
We’re going to end the war at FDA against alternative medicine, the war on stem cells, the war on chelating drugs, the war on peptides, the war on anything that you know is not going to make big pharma–
Question [00:36:17]
It’s music to my ears.
Robert F. Kennedy Jr. [00:36:18]
The war on vitamins.
Question [00:36:20]
Yeah, vitamins, minerals, amino acides, nutrients. Yeah. Peptides. I mean, these things that can heal humanity.
Robert F. Kennedy Jr. [00:36:25]
Our position is that FDA has a job, which is to do the science on these kind of issues, and then tell the public what they’ve learned from the science, but not tell people and not tell physicians what they can and cannot prescribe.
And that if you want to take an experimental drug that, you can do that, you ought to be able to do that. You shouldn’t have to go to – you shouldn’t have to go to Antigua to get stem cells, which I had to do for my throat. And they helped me enormously. Why did I have to go to Antigua for that?
We don’t want to have the wild west. We want to make sure that information is out there, but we also want to respect the intelligence of the American people, the capacity of people who explore the outcomes that are going to benefit them the most.
And of course, you’re going to get a lot of charlatans and you’re going to get people who get– who have bad results, but ultimately you can’t prevent that either way. And leaving the whole thing in the hands of pharma is not working for us.
You know, Peter Ghosh, who was one of the founders of the Cochrane Collaboration, one of the great scientists in the world, and he just did a study recently that showed that the third largest cause of death in this country after heart attacks and cancer are pharmaceutical drugs.
So for people to say, we have to be very careful about nutrients and vitamins? And that people may misuse them or stem cells or hyperbaric chambers? For people to– it’s not the government’s purview to tell people they cannot have access to those things, because what they’re giving us access in the narrow range of drugs that they want to– products that they want to restrict us to are not making us healthier.
You got to rely on democracy and the good sense of the American people and the drive that we all have to take care of ourselves. And God’s gift to us of a healthy body that has its own set of defenses that we need to respect.
In the paper, scientists looked at the relative frequency of test ordering and positivity by age and over time within one health system in Wisconsin. This study demonstrates that testing occurs more frequently among older age groups, and repeat testing among people who are already positive occurs. This generates positive laboratory results not related to a current illness. The time frame reflected, and the fact that this study is in one health system and not nationwide, limits the degree to which we can infer that these testing patterns explain data in 2022 and beyond. However, they provide evidence that testing practices differ by patient age, which could explain the disproportionate increase in Lyme disease incidence among older adults with the switch to laboratory-based reporting. Nevertheless, passive public health surveillance data does not represent everyone with Lyme disease in the United States. Early Lyme disease is diagnosed based on clinical symptoms and exposure history, not laboratory testing.
It’s estimated that nearly half a million people are diagnosed and treated for Lyme disease each year. Overall, vector-borne disease cases are increasing in frequency and present a growing public health threat in the United States, underscoring the need for proven and acceptable interventions. Effective and broadly acceptable prevention measures are needed to protect people from the growing threat of vector-borne diseases. Prevention measures can include use of an EPA-registered insect repellent, checking for ticks daily, and showering after spending time outdoors.
On the record, attributable to CDC Spokesperson
CDC is aware of reported cases of COVID-19 NB.1.8.1 in China and is in regular contact with international partners. There have been fewer than 20 sequences of NB.1.8.1 in the U.S. baseline surveillance data to date, so it has not met the threshold for inclusion in the COVID Data Tracker dashboard. We monitor all SARS-CoV-2 sequences, and if it increases in proportion, it will appear on the Data Tracker dashboard.
On background
More about the variant:
- NB.1.8.1 is a derivative of a recombinant lineage of several JN.1 lineages called XDV.
- XDV and its sublineages have been circulating for many months, most notably in China.
- During this same period, other countries including the United States experienced displacement of its original JN.1 lineages by another recombinant lineage called XEC.
- NB.1.8.1 is similar to XEC.
- It has two notable substitutions in the part of the spike protein that bind to the cell.
- One of those is present in multiple lineages, indicating it may give the virus an advantage, another is new and unique.
Vinay Prasad, FDA [08:34:53]
I’ve received so many, many emails on this topic. I’ve received so many supportive statements, statements from both in the United States and from abroad as we bring the U.S. policy in line with the rest of the rest of Western Europe and the world. And I’ve also received additional thoughts and questions and clarifications.
Ultimately, we still want to give people a little more time to digest the policy. We’re still interested in soliciting questions and feedbacks and thoughts.
Those of you on this committee, you know how to reach me and my team. I’m interested in your thoughts, you know how to reach me and let me know what you’re thinking. And we intend to respond to those with more videos, more discussion, and more policy statements. We want to engage with that thought process.
And we will try to make all our thinking open and transparent.
…
Jerry Weir, FDA [08:53:01]
Now, the goal of this process, in this meeting that we are here today, is to reassess the current vaccines and decide if improvement is needed and can offer any benefit.
Our current target for review is late spring, early summer, and this coincides with the availability of recent vaccine effectiveness data and serology study data from current vaccines.
But as we’ve said, many times, we’re flexible, and this may change depending on circumstances, particularly if there’s a concerning change in the virus landscape or the emergence of a more pathogenic escape virus in the context of a public health emergency.
…
Sara Meyer, CDC [08:56:05]
I did have a question on how the new regulatory framework put forward this week might affect aspects related to selecting the strain. For example, if a different strain was selected for this season, would that require additional clinical trials, et cetera?
Jerry Weir, FDA [08:56:25]
I think that’s a little off topic. Obviously, as Dr. Prasad said, he just released this earlier this week and we are still in discussions, within the agency and with manufacturers.
So I think for today, we focus mainly on what we think in this committee should be in the vaccine and then the rest of it will be– we will work on that later.
…
Natalie Thornburg, CDC [09:07:57]
I’m going to show you the dendogram, the relatedness of these lineages in the next slide, but I just want to tell you that all of these lineages are descended from JN.1. So unlike last year, we did not see a strain replacement this winter.
Next slide, please. All right.
So this is a dendogram that I’ve pulled off of our COVID data tracker. You can see kind of towards the bottom, the XBB.1.5 lineage. You can kind of see that BA.5 lineage, which was previously, and then the large circle is the JN.1 lineage. And then the smaller circles are the lineages, I just showed you in the previous slide, that have predominated over the past 12 months.
Now this large circle is a little bit deceptive because there’s a lot of lineages there. As you remember, what we’ve been observing in SARS CoV 2 evolution is emergence of a new lineage that’s quite different. And then we see a little bit of drift, but that little bit of drift is often convergent evolution, and we’ll see sort of independent evolution of lineages that have the identical spike.
So a lot of these independent lineages actually have identical spikes or very, very similar spikes. So we have observed since the emergence of JN.1 continued convergent evolution and not a strain replacement.
…
Natalie Thornburg, CDC [09:12:00]
The only lineage right now we have that’s increasing in proportion is a recombinant. That’s a recombinant of LP.8.1 and an LF.7 lineage, next slide, please.
And where that is on the dendogram? You can see it’s still within that JN.1 lineage, those two, the two sort of predominant lineages and the recombinants, that we’ve observed there. So it’s still the emerging virus andnothing is emerging really quickly, and hasn’t been over the past six to eight months.
They’re all within the JN.1 lineage.
…
Natalie Thornburg, CDC [09:22:37]
I can say throughout this winter, we didn’t see that strain replacement that we have in the past couple of years. But I’m not saying that the virus will not shift again in the immediate future. I just don’t– we don’t know.
…
Natalie Thornburg, CDC [09:30:45]
I think it is fair to say that we have definitely fallen into a pattern now of circulation, to say, five years is probably enough to say it circulates all year round. It doesn’t disappear in the United States.
It has a bimodal wave. I don’t think it’s, it’s been circulating long enough to say the summer wave will always be bigger than the winter wave. You know, I think maybe it’ll probably take a decade to get into some, and even once we do get into sort of a routine cadence, things are unpredictable.
You know, we saw the really unusual RSV circulation a couple of years ago, like right after the pandemic and we still see shifts in the season for influenza, so, what I have learned to expect of COVID 19 is stay on your toes and expect the unexpected.
…
Darin Edwards, Moderna [11:13:01]
The KP.2 vaccine has the highest titers against JN.1 and KP.2, both of which no longer circulate and reduce neutralization against currently circulating variants, including LP.8.1.
The LP.8.1 vaccine has the highest titers against LP.8.1, which is dominant in the U.S. and many other regions and cross neutralizes, other currently circulating variants, including NB.1.8.1, a dominant JN.1 subvariant in many Asian countries.
…
Jacqueline Miller, Moderna [11:17:33]
We are prepared to supply COVID 19 vaccine by mid-August based on the strain recommendations made by the FDA and in this committee.
As in prior years, we will conduct a clinical study post licensure of the vaccine composition selected for the fall. And we will continue to monitor vaccine safety and effectiveness.
…
Darin Edwards, Moderna [11:19:21]
As you can imagine, we are continuing to see evolution of the JN.1 lineage. You know, the names be damned, all of them, despite the fact that they are now listed with different letters come from the JN.1 lineage.
NB.1.8.1 is very similar to both KP.2 but also to more similar to LP.8.1, sharing some of the mutations present on LP.8.1, and others that are present on KP.2.
…
Kayvon Modjarrad, Pfizer [11:20:42]
We at Pfizer and BioNTech have reviewed the new framework that Dr. Prasad presented and published in the New England Journal of Medicine. We look forward to working with the agency in aligning on the data package to support the 2025 2026 COVID 19 variant vaccine indication.
…
Kayvon Modjarrad, Pfizer [11:35:45]
Overall, the LP.8.1 vaccine elicited neutralizing antibody responses that were three to fourfold higher than the KP.2 vaccine against LP.8.1 variants and a two and a half fold higher response against the LP.8.1 recombinant variant XFG. This range of improvement was similar to what has been observed for variant adapted vaccines in prior years.
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Kayvon Modjarrad, Pfizer [11:37:42]
Pfizer and BioNtech are prepared to initiate supply of a 2025 2026 vaccine formula per FDA guidance immediately upon approval.
As we move toward the upcoming and subsequent seasons, we look forward to working with the agency to ensure timely provision of appropriate data to support COVID 19 vaccine approval and access for those who need it most.
…
Robert Walker, Novavax [11:58:04]
So we’re prepared to manufacture in time for the 2025 2026 respiratory virus season. The data we’ve shown you supported JN.1 lineage level selection. This covers the benefit of both covering cur current and emerging strains and allowing us to provide vaccines to patients as soon as possible.
If the committee recommends LP.8.1, we anticipate that the timeline for product availability would be close. And just like to reemphasize that we are prepared to manufacture in time for the season.
…
Jerry Weir, FDA [12:12:39]
One of the fastest increasing variants in the U.S., XFC, which is increasing, is a recombinant is a recombinant between LF.7 and LP.8.1.
A couple of more points I want to make, that I think Dr. Thornburg and others have also mentioned earlier, is that there are changes that we’ve seen in the N terminal domain of the most recent JN.1 lineage viruses, have a new glycosylation site. It’s actually in two different ways in LP 8.1, it’s due to a deletion at S31 as whereas in LF.7 and also the variant that Dr. Monto mentioned, NB.1.8.1, has a new glycosylation site that is due to a substitution of T 22 N.
So once again, this shows an interesting convergence of even addition of glycosylation sites in certain part of the spike molecule.
…
UNCLEAR, FDA
Yes, thank you for that question. As was earlier mentioned, there are differences in terms of the vaccines that are being evaluated in these different studies, and in terms of the immune backgrounds.
But what I showed is that the LP.8.1 vaccine elicits improved responses anywhere from 2 to 4 fold against the LP.8.1. lineages and as well as a two and a half-fold improved response with respect to the XFG lineage, which is a recombinant of the LP.8.1, and a near two-fold improved response against NB.1.8.1, another emerging rising lineage that derives from both the XBB and JN.1 lineages.
…
JERRY WEIR, FDA
This was what I was trying to point out at the very end of my talk about about the models in general, about how, first of all, how heterogeneous they are. They’re not the same from manufacturer to manufacturer.
And I didn’t actually mention, but I think everybody knows, the assays used, of course, are different on top of the models themselves.
And then the models themselves have serious limitations about how accurately, if accurately, it’s not even not the right word, probably, they reflect any sort of human condition.
And I do think there’s a lot more basic studies that are needed to try to both harmonize these models, but also probably improve them and find out how closely they do mimic a human situation.
So I think there’s a lot of basic knowledge that’s still not known.
And that’s what makes comparing from manufacturer to man– even study with – within the same manufacturer, comparing two studies, is really difficult.
…
JERRY WEIR, FDA
There may be somebody better suited to answer it than me, but my understanding was that the decision being made today did not influence how we would implement a new path– new framework.
But I will pass it over to OVRR, more of CBER IOD, if they want to comment.
DAVID KASLOW, FDA
Yeah, no, I think Jerry’s got it right.
I think that the goal today is to figure out what the selection of the strain is, but we don’t anticipate– and our goal is not to impact the timely availability of vaccines.
But we’re really looking to all of you to give us your best judgment in terms of the optimal strain to bring forward.
…
NATALIE THORNBURG, CDC
We do have decreasing numbers of sequences, that we use for our situational awareness and growth rate analysis, both internally generated as well as coming from our partners in state and public health laboratories and the academic community.
It is a continued challenge for us to have the power that we need to support NowCast, and I do expect that we’ll – we already have lower detection limits than we did a year ago and two years ago.
It’s been sort consistently decreasing, detection thresholds. And we expect that to decrease even more in the next few months, to the point that we will likely have to change our dashboards and the way that we look at the genetic data.
We acknowledge that it’s incredibly important for situational awareness, for detection of new emerging variants, for growth rate analysis, it’s one of our top priorities to continue doing that and to provide that data to the public and to themedical community.
And so we do plan to keep doing the analysis and making it available in real time. We’re just having to consider, how do we need to tweak our methods and our communication of those methods and the frequency of the of the dashboard postings, so that we have the statistical power and continue to feel confident in the results that we’re posting.
So, I know that’s sort of a non-answer, just to say, yes, it is a continued– it becomes more and more challenging every single week to generate that surveillance data, but we’re committed, and it’s a top priority for us, and we’re committed to keep trying to do it as best we can.
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NATALIE THORNBURG, CDC
If people are not infected, which there are fewer specimens to sequence, and that is a wonderful problem to have, that is kind of whenever we see sometimes a lot of evolution, is during times of low circulation, so it is important for us to really push to get those specimens and get those sequences generated to make sure that we are still sequencing in times of low circulation, but that is a great problem to have when we don’t have a lot of sequences.
So even labs with really high levels and capacity for sequencing, if there’s no specimens, there’s no data. So that is always a problem.
You know, our state and public health laboratories don’t have as much access to staffing and resources to generate those sequences, and it’s everything, and testing practices have changed.
So it’s the whole picture that’s making data availability more and more difficult.
…
NATALIE THORNBURG, CDC
We do have a little bit of data, that I don’t have on some extra slide that I didn’t bring with me today.
We do have a seasonality analysis that’s – we’re working on, tying up– we absolutely are seeing consistent cadence, a 26-week cycle, 52-week cycle, and we have sort of combined those analyses with looking at genomic shifts, and we do often see, um, a shift or a change sort of right before a surge.
So, I do think after 5 years now, we are seeing very distinct patterns that is falling into a more predictable pattern, and I’m sorry I don’t have those slides at the tip of my fingers.
But yes, I can say that we are consistently seeing a wave in July, August, December, January, and it is falling at about a 26– 52-week sort of cycle.
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NATALIE THORNBURG, CDC
Well, I can tell you from just anecdotal evidence that they’re having a surge in Hong Kong.
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HAYLEY GANS, VRBPAC
We all decided 100% to be in the JN.1 lineage, but I do think that the data more highly supports the KP– or, I’m sorry, LP.8.1, and that strain appears, again, to have the best, for what the data we are seeing, we know the systems are different and everything associated with that, but it does appear to have the best relevant immunity.
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ERIC RUBIN, VRBPAC I feel the same way. I do think that the data are not suggest that there are not enormous differences right now, but we’re trying to pick an antigen for the future, and not the antigen for now, and if you at the directions right now, and we cannot predict the future very far out, but it does seem like LP.8 would be– is likely to provide us better coverage within JN.1
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ARCHANA CHATTERJEE, VRBPAC
I would also agree. Think back to a little less than a year ago when we were trying to make a very similar decision about JN.1, where there were other variants appearing at that time, and we decided to stay with that.
So I think also that, proceeding with the newest data that we have, even though we’ve heard from the CDC and some others that perhaps this may not be the variant that we end up with in the fall, but this is the closest to it that we can probably get, so the variant that they—European agencies have recommended is the one that I would as well.
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SARA MEYER, CDC
I think I have maybe just a little bit of a different perspective.
And just to start out by acknowledging, I think these discussions are very challenging because, as we’ve just said, it’s very hard to predict where things are going to go with strain evolution.
But I do think the goal remains selecting a vaccine antigen with broad protection.
So in terms of selecting the specific strain, I do think there are arguments on both sides of this.
I did find it very helpful to see that vaccination with the current JN.1 or KP.2 strains significantly increased neutralizing titers against all tested JN.1 lineage strains.
We did see data that suggests there may be an incremental benefit of an LP.8 vaccine over our current vaccines, but I did not find this evidence compelling enough to warrant a change in the strain for the next season.
Another consideration for me is that staying with a JN.1 or KP.2 vaccine for the next season is most straightforward from a programmatic and implementation perspective.
So I think where I’m landing on this is just based on the totality of the evidence and other considerations.
I more favor staying with our current JN.1 or KP.2 for this season. But I do think an LP.8 strain is a fine option, and I would support that as well.
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SAAD OMER, VRBPAC
So, our fallback on the overall public health imperative to provide the benefit, the net benefit, accounting for safety, of course, to the most, to the highest number of people.
Based on that consideration, and based on the consideration that we should step back from fall season-based thinking that we have all been conditioned to think in the context of the other major respiratory vaccine, i.e. the influenza vaccine, and considering that the benefit, while, overall demonstrable in some of the studies of LP.8 vaccines, but not to a magnitude, that would make it a slam-dunk case, I’m leaning towards, um… either continuing the current recommendation of JN.1 or KP viruses, in the vaccine or antigens.
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STANLEY PERLMAN, VRBPAC
I completely agree with that, with that recommendation, because I think that for the on the TAG CO VAC, we went back and forth between saying, okay, well, we should go recommend the LPA.8.1, or we should recommend the JN.1.
And we came out a certain way, but I think the feeling was that either one would work. And that the main goal is actually to get people vaccinated.
So if whatever approach, if we had two alternatives, and if it turns out, for example, Novavax can’t make a vaccine, in time, an LP.8.1, I think if they– and there are people who just want the Novavax vaccine.
I think that they’re getting the JN.1 vaccine would be much better than they’re not getting vaccinated at all. So I tend to also like to include both possibilities, and then how we weigh it is I don’t have a strong opinion about.
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HAYLEY GANS, VRBPAC
As I’ve already stated, we need to stay ahead of this virus as opposed to behind it. So therefore, allowing there to be replication even further than we’re already seeing, whether it’s breakthrough or not, allows it to actually then become a further variant.
So, I think what we need to do is to have the most effective vaccine, not one that predicts that it would be less effective down the line.
So I just wanted to make sure that people realize that, we are not withholding a current vaccine availability to individuals.
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ARNOLD MONTO, VRBPAC
And from what I’ve heard, and please, let me know if I didn’t summarize correctly there is– not a difference of opinion, but a feeling of somewhat unease in terms of going with what would normally be the ideal choice, based on where we are now, and that’s the LP.8.1 variant, in terms of where we’re going in the future.
And what this will do, in the situation where we have a lot of vaccine still available, which may be eligible, for vaccination, for use, and there’s not as much persuasive data for changing what the population is comfortable with and knows what it’s recommend—who– it’s recommended for right now.
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JERRY WEIR, FDA
Would it be possible to update at another time of the year? It’s possible, but I think manufacturing decisions will be made on what we decide VRPAC, because they have to have plans in place to go forward.
And just to clarify, even though there’s a lot of talk about the winter season at least some vaccines, the mRNA vaccines, do become available, usually by the late summer. I mean, that’s been the pattern for the last couple of years.
So it doesn’t take them 6 months. They’ve already made– They have already made prototype vaccines and are prepared to implement this, and so I think you could count on those happening within a couple of months, two or three months.
But again, back to my first answer to your question, I think if you don’t give them a firm recommendation of what to do and put it off, they won’t proceed with manufacturing something new at risk. That would not be the way most manufacturers work.
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HAYLEY GANS, VRBPAC
I don’t think anybody would think that we would ask the manufacturers to change more than once a year.
So I do think we are asking being asked, what is– and again, we can talk about when it needs to become available, because I think we get the sense that late summer is not consistent with what we’ve been seeing in the surges that we’ve seen, and that’s because we’re allowing children to all come together, and co-circulate strains that then become prominent strains.
So without staying ahead of that, that’s what’s going to happen, I think those two things are important in the conversation, and I just wanted to add them, because I don’t feel like they can– and I agree, it’s not fair to ask them to continually monitor and make any changes along the way.
I think we’re going to have a once-a-year immunization and we have to decide, and– my feeling is that we need to be having these conversations, whatever the time frame is to get something at the beginning of the summer, not the end of the summer, available for those who want it.
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JERRY WEIR, FDA
Although one can’t predict evolution, and you don’t know how this is going to keep spread diversifying, the overwhelming odds are that what does come and predominate in the next few months, the next 6 months, next year will come from something that’s circulating now. It won’t come from something that doesn’t exist any longer.
And so I did want to point that out. It will probably keep moving from what’s out there now. Now, will it come directly from LP 8.1 or LF.7, that I don’t know, but it’ll come from something that’s here now, not from something that was– existed 6 months ago.
Brooke Rollins, USDA [00:15:11]
Also Secretary Kennedy and I are so excited in our partnership on crafting the Dietary Guidelines for Americans, which are set to be released, I think, we thought maybe this fall, but I think it’s gonna be a lot sooner than that, but more more details coming.
But I think what you’re going to see is a whole new day on dietary guidelines where federal nutrition advice will be sound, it will be simple, and it will be clear. Those guidelines will prioritize whole, healthy, and nutritious foods such as dairy, like whole milk, fruits, vegetables, and meats, and suggest limitations of foods high in sugar and salt.
So again, for all the reporters on the phone, I just want to make sure that we’re thinking about this from the bigger approach, not just the report today, although certainly the report today is unprecedented.
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Brooke Rollins, USDA [00:16:16]
Chronic disease is a challenge in our country. We have all talked about that.
Most American children’s diets are dominated by ultra processed foods that are high in sugars and saturated fats, added sugars and saturated fats.
We know that the American food system is the safest in the world. It is the safest, most reliable, most robust in the world, but now we talk about how to make it even better and healthier.
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Lee Zeldin, EPA [00:23:06]
The U.S. government, especially at the Trump EPA, is committed to ensuring transparency in everything we do and building science throughout the agency to better understand the potential we have at our fingertips to address these issues.
We must better understand the full range of impacts of any harmful chemical exposure to our children and its impact on chronic disease.
This cannot happen through a European, mandate driven regulatory system that stifles growth.
It will happen through a renewed focus on improved science throughout the federal government, and our partners, and through unleashing private sector innovation to produce better solutions for our children.
This is not a binary choice. We can ensure the health of our children and protect the environment while powering the great American comeback.
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Robert F. Kennedy Jr., HHS [00:35:44]
There is no budget, we know that– and we don’t have, at this point, there’s no concrete policy that could be funded in a budget.
We’re going to work out the policy recommendations over the next hundred days.
We know that chronic disease is expensive for our country, that the costs are existential, we’re paying $4.5 trillion a year, most of it for healthcare, most of that goes to treating chronic disease.
And that’s an expense– when I was a kid, my uncle was president, we spent zero on chronic disease.
It’s devastating to our military preparedness. We have 74% of American kids who cannot qualify for military service.
And we will save lot by addressing this chronic disease epidemic head on.
We’re going to save a lot more money in the long run, and even in the short run, if we can reduce the numbers, which we intend to do during this administration.
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Robert F. Kennedy Jr., HHS [00:45:39]
The report is the product of a consensual process, and it represents, it was a collaborative effort of all the agencies and the White House. And it represents a consensus that is probably the strongest and most radical consensus by a government agency in history about the state of America’s health.
It is very strong, it is very frank, and it is a clarion call to do something with utmost urgency to end this crisis.
And that’s what we wanted.
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Robert F. Kennedy Jr., HHS [00:47:25]
The report is really a prescription, it’s a diagnosis.
The prescription comes in a hundred days, how we’re going to handle it, but we’re already doing a lot of the research.
We were not waiting for this report to come out to begin researching the crises, including the autism crises.
And we already have a, Jay Bhattacharya over at NIH already, has launched an initiative that is going to deploy ultimately about 15– 10 to 15 of the gold standard scientists, research teams all over the country to ask the right questions and determine what is the etiology of the autism crisis.
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Brooke Rollins, USDA [00:48:26]
This has been a really good process. There has been a lot of voices at the table. The teams I think have done a good job.
Do all of these, all of us agree on everything? Of course not, but the place that we have landed, which is, I think all of us agree is that this is not a binary choice between industry, agriculture and health.
In fact, it couldn’t be further from a binary choice. The two are just inextricably linked, moving forward and forever.
Corn Growers Deeply Troubled by MAHA Report Release
The Make America Healthy Again Commission today released its long-awaited report, which denigrates the safety of key pesticides used by corn growers and other farmers. In response, the National Corn Growers Association released the following statement:
“The Make America Healthy Again Report is filled with fear-based rather than science-based information about pesticides. We are deeply troubled that claims of this magnitude are being made without any scientific basis or regard for a long history of EPA expert evaluations of these products.
“Decades of extensive research and testing show that pesticides, including atrazine and glyphosate, can be applied safely for their intended uses. If the administration’s goal is to bring more efficiency to government, then why is the secretary of Health and Human Services duplicating efforts by raising questions about pesticides that have been answered repeatedly through research and reviews by federal regulatory bodies?
“We call on the administration to respect the existing body of science on pesticides and, moving forward, to include America’s farmers in discussion as this process evolves.”
Fred Hutch is closely monitoring federal policy changes that may impact our work. We remain committed to serving as the coordinating and communication center and the statistics and data center for the Cancer Screening Research Network (CSRN) and to helping evaluate the use of multi-cancer detection tests. At this time, federal funding for these centers has not been impacted.
Americans deserve radical transparency around the safety and efficacy of COVID vaccines and the FDA is delivering on their promise to do just that. Moderna and Pfizer should take steps to ensure that individuals are aware of COVID vaccine-related adverse events resulting in myocarditis and pericarditis.
We appreciate the FDA’s clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans.
We are evaluating the details shared today and discussions with the FDA are ongoing.
We stand by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19-associated hospitalizations and severe disease, including death. The Pfizer-BioNTech COVID-19 vaccines have been administered to over a billion individuals, including adults, adolescents and children, generating robust data demonstrating a favorable safety profile.
Yes, the City of Milwaukee Health Department Laboratory did request limited technical assistance from the CDC to help validate a new instrument used for environmental lead testing. However, this support was made separately from the Milwaukee Public Schools lead hazard crisis.
A single CDC staff member was on-site from May 5 to May 16 to assist with preparatory steps for the onboarding of our new Atomic Absorption Spectrometer. The work was focused solely on equipment validation and documentation to ensure regulatory compliance for long-term lab operations.
Again, this was an independent request that would have occurred regardless of the MPS crisis. To date, no federal epidemiological or analytical assistance has been provided to support our response to lead hazards in MPS schools. Our formal Epi Aid request was denied by the CDC.
MHD is proud of the team currently serving Milwaukee families, managing its regular caseload while also responding to the lead crisis in MPS schools. While we would have welcomed federal support, we continue to move forward without it.
On background to an HHS spox: At the request of the Milwaukee Health Department Laboratory (MHDL), CDC is assisting with validating new lab instrumentation used for environmental lead testing. Staff from MHDL are focused on the lead response and other routine testing while CDC will assist with testing validation, laboratory quality management, and regulatory requirement documentation to onboard the new laboratory instrument.
At this time, we have not received any information about funding changes to the Cancer Moonshot Scholar grant held by Chelsey and others at Huntsman Cancer Institute.
Chelsey and team utilize their Cancer Moonshot Scholar award to partner with community health centers across Utah, including many rural areas, to test prevention strategies that support weight management – this is an important area of cancer prevention study given that obesity is related to at least 13 types of cancers.
Vinay Prasad, FDA [13:01:59]
I think we have to admit to ourselves that America is deeply divided on the policy issue of repeat COVID 19 vaccine doses or boosters.
There are some Americans out there who are worried that the FDA has not fully documented and interrogated the safety harms of these products, and they are categorically opposed to these products.
There are also some Americans, we also have to recognize, who are desperate for additional protection and they demand these products.
But the truth is that most doctors and most of the public are entirely uncertain. And that is reflected in low vaccine uptake of these products.
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Vinay Prasad, FDA [13:05:14]
Especially as we enter this seventh, eighth, and ninth dose, all companies will be asked to conduct a randomized control trial, testing their product as follows against a saline placebo, we want to know the full safety profile of these products, in a randomized control trial, targeting people between the ages of 50 and up to 64, less than 65.
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Vinay Prasad, FDA [13:06:30]
We’re going to ask the manufacturers to give us more evidence for 50 to 64 year old people, run randomized control trials. And I’ll describe that more.
This is a huge group of Americans that could potentially enroll in such studies. 62 million Americans are out there. So I’m confident, very confident, these studies will accrue and be given to us as we suggest.
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Vinay Prasad, FDA [13:07:39]
In the course of preparing these remarks, people have asked me a few questions, which I hope to address here. What about very young kids?
And the answer to that is we encourage sponsors to conduct randomized control trials in that population.
And to show you some reason why we think there’s also equipoise here. This is cumulative COVID 19 hospitalization by age 50 to 64, it’s approximately 55 per 100,000 over the last season. And one to four is 20 per 100,000.
If you go down to zero to four, it’s 30 per 100,000 compared to 55 per 100,000. And this is much different than say for instance, 65 to 74, where it’s 150 per 100,000, a much higher risk of COVID 19 hospitalization.
And a final point I want to make is that these numbers include children who have risk factors for severe COVID 19. So the number these actual numbers in healthy children are likely lower, put another way.
In other words, we at FDA believe there is equipoise for 50 to 64 year olds, ergo, there must be equipoise for younger ages. And we encourage companies, if they see fit, to conduct such studies.
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Vinay Prasad, FDA [13:12:19]
I’ve heard people say, what’s the role of the FDA? And what’s the role of the CDC here, the Centers for Disease Control?
The Centers for Disease Control may issue recommendations on who should receive the FDA approved vaccines. And we look forward to that, but the FDA can only approve products if it concludes based on the available scientific evidence, the benefit to harm balance is favorable, and we simply need more data to have that confidence for younger individuals at low risk of severe disease.
We have to do our duty here too at the FDA.
The FDA is committed, and let me say this very clearly, we are committed to ensuring companies generate that evidence and we strongly suggest they complete any agreed upon post-marketing studies.
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Vinay Prasad, FDA [13:14:56]
So I think one thing worth discussing is, as you alluded to, the dogma. There was so many things that happened in the last five years that I think have bred a broader distrust in the American people from the scientific community.
Well, one thing we’re just taking for granted is the idea that COVID 19 vaccines will be changed every single year. And what we’ve seen over the course of the last 18 months or two years is that the COVID 19 virus is different than influenza. It’s mutating at a slower rate.
And we are actually still in JN.1 lineage. And in fact, the WHO just a week or two ago advised that JN.1 COVID 19 vaccine boosters are still appropriate in the current time.
So what’s my point?
My point is that instead of having a COVID 19 strategy that’s year to year where we change every single year, why don’t we let the science tell us when we should change? When there’s a major antigenic shift, when the virus really changes, then perhaps we should change our strategy.
So I don’t envision randomized trials every year, but I do think we have an obligation every few years or however long that may be to generate credible evidence for the American people to clarify that we know where we stand.
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Vinay Prasad, FDA [13:20:14]
I can speak personally if that, if you proved it to me, that there’s a benefit to someone like me, I will take it.
And most of the doctors I know are responsive to that evidence. If the companies conduct these studies and those studies are glowingly positive, I think that doctors will embrace it and be able to counsel the patients in a way they haven’t been able to honestly counsel.
How do you counsel a healthy, thin 50 year old in your office who has had COVID three times, had five shots. How do you counsel that person about– it’s almost impossible with the current evidence base.
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Vinay Prasad, FDA [13:21:56]
You make a fair point, which is, that there are so many vaccines we have approved and are going to approve in the future. And we don’t default to this yearly schedule, without good evidence that that yearly schedule is of a benefit.
In this particular case, I think we have a really good balance between the vulnerable people that people still at high risk will still have a rapid path to access, but people at average risk and low risk, they need evidence.
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Vinay Prasad, FDA [13:28:18]
I actually have never spoken to RFK and I’ve never met the man. You might be able to help me out with that. I don’t know the guy.
And so this was developed by me and you, the only authors on the paper, the only people who wrote the paper.
You know me for a long time, I’ve been critical of medical writers. So we wrote this paper ourselves.
Marty Makary, FDA [13:28:36]
Yeah. And, I would just add to that this is in line with his general instinct, that we need more clinical trial data in making decisions.
But I asked you, early on, to think about this issue and to present a framework for COVID annual booster regulation, and you presented this framework to me and then we discussed it.
And so I think, you’ve really hit a nice sweet spot in terms of evidence based approach and a practical approach, and also sticking to the general promise that we are not going to be removing vaccines from the market that are already approved.
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Vinay Prasad, FDA [13:32:01]
And there’s another lesson there, which is that change in medicine isn’t always easy.
You know, there are lots of advances in medicine that aren’t always easy. And I think there’s going to be some people out there who are concerned about various aspects of our framework, but ultimately I do think this is a step forward. And a lot of these questions will be answered by next calendar year when we start to get the interim results of some of these studies back, and we will have more information to tell the American people and the results of these studies could surprise everybody.
We don’t know what the– that’s the whole point of running a study. You don’t know what you’re going to get.
Sen Baldwin [10:34:03]
When might I expect a detailed operational plan? I’ve referenced in my opening statement, the fact that 530 programs or activities, when you provided that information had an asterisk in place of a dollar amount, when might I expect the detailed plan?
Secy Kennedy [10:34:24]
That, as I explained to you, those decisions are being made by OMB.
Sen Baldwin [10:34:34]
So you’re really not in charge of the spend plan?
Secy Kennedy [10:34:36]
For this is not– this is not a HHS issue, it’s a government wide issue.
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Sen Capito [10:39:55]
Has HHS or any sub agency assessed the impact of patient access to clinical trials through the reorganization effort?
Secy Kennedy [10:40:03]
We are not cutting any clinical trials. We are not cutting any clinical trials. We’re cutting– and we’re not cutting drug development. We’re cutting administrative costs.
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Secy Kennedy [10:51:50]
Senator, the best way to prevent the spread of measles is through vaccination. We urge people to get their MMR vaccines.
There are groups in this country that don’t want to be vaccinated for religious– many of them for religious reasons. I spent a lot of time with the Mennonites and the MMR vaccine has millions of fragments of human DNA in it from aborted fetal tissues. And that’s a religious objection to them that I have to respect.
We need to be able to treat people who do get sick, which the CDC does not give people advice, physicians advice on now, until I came in and we started a new program to treat people who actually get sick.
We’ve done a better job at controlling measles since I came into this agency than any other country in the world.
We today we’re at 1,035 cases, and we only added 27 cases last week. Canada, which is 8%, one eighth of our population has a outbreak double that size and they added 300 last week. Mexico, which has a population a third our size is almost the exact number of measles that we do. Europe has almost 7,000 cases. So seven times what we have and they’re growing and adding cases.
We’ve deployed the epidemic intelligence services to all the states that have requested our help. We have people on the ground in those states and they’re doing a great job at limiting the spread of the outbreak. And if Kansas, the governor of Kansas, wants to contact us, we will deploy a team to Kansas to make sure that that outbreak is curtailed there.
Sen Moran [10:53:47]
Do you have all the tools at HHS to be of help to Kansas and other states?
Secy Kennedy [10:53:51]
We do. We not only have tools like vaccination and the tracking and tracing and surveillance and analytics and lab support, we also now are for the first time, are able to provide physicians with at least some treatment protocols so that when children do come to a hospital with measles, there’s a protocol for treating.
And most children– firstly, no child should die of measles. We’ve only had four measles deaths in 20 years in this country.
And even before the introduction of the vaccine, the death rate for measles was about one in 10,000.
So children, healthy children should not die from measles. And there’s ways of treating them.
Most of the kids who are the kids who died either have comorbidities, but in addition to comorbidities, they have bacteriological infections that are associated oftentimes with measles.
And we need to give the physicians the tools to treat those bacteriological infections. And they have not had that.
CDC has never given them those protocols because it’s one solution only. And, it has not been a good system.
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10:57:49 KENNEDY: We are continuing to fund the program. And in Milwaukee, we have a team in Milwaukee, and we’re giving laboratory support to the– to the analytics in Milwaukee, and we’re working with the health department in Milwaukee.
SEN REED: Well, that’s Milwaukee. What about the rest of the country?
KENNEDY: Well I don’t– as I said, I have– I have a TRO now, a federal TRO, that does not allow me to talk about the reorg.
So what I can tell you is that if you appropriate the money, that we are going to spend it.
SEN REED: We have appropriated the money, Mr. Secretary.
You indicated that you have a program in Milwaukee. What about the rest of the United States?
This is not a problem exclusive to Milwaukee.
KENNEDY: My understanding is that that program is continuing. I’m hoping to– I’m very, very happy to talk to you, senator, after this and find out exactly what the details are.
SEN. REED: Well, it should be a very simple answer. The program’s back up and running. We’ve hired the staff. Which I don’t think you have.
And that doesn’t indicate that you’re serious about getting the program running again.
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11:19:25 KENNEDY: Your information about the report is just simply wrong.
The drafts that I’ve seen, there is not a single word in them that should worry the American farmer.
SEN. HYDE-SMITH: And you can prove that beyond a shadow of a doubt?
KENNEDY: You’ll see the report, it’s going to be released on Thursday. Everybody will see the report.
And there’s nobody that has a greater commitment to the American farmer than we do, the MAHA movement collapses if we can’t– if we can’t partner with the American farmer in producing a a safe, robust, and abundant food supply. And we understand that.
I said during my campaign, when I was running for president, and I have said repeatedly throughout this process, that we cannot take any step that will put a single farmer in this country out of business.
There’s a million farmers who rely on glyphosate – there’s a million farmers who rely on glyphosate. 100% of corn in this country relies on glyphosate, and we all– we are not going to do anything it jeopardize that business model. We are–
SEN. HYDE-SMITH: But you’re saying my comments are totally inaccurate.
KENNEDY: Totally inaccurate.
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Secy Kennedy [11:37:58]
I’m very grateful to Russell Vought. I told him how important Head Start was to me. My uncle Sargent Shriver started the program. There’s 800,000, the poorest kids in this country, who are served by this – that program.
It not only teaches the kids preschool skills, reading, writing, and arithmetic before they get to prepare them, for schools. But it also teaches the parents and it teaches them how to be good parents and it’s, and we see that the children who are exposed to those programs has have less contact with law enforcement later in life. They’re more likely to graduate from high school and college. They’re more likely to hold down jobs.
There’s a lot of problems with Head Start. We’ve kept it fully funded, and I’m very grateful to Russell Vought for that and to the president, but there’s things we need to correct.
One is the food that they’re serving at Head Start is terrible. We need to change that. We’re poisoning kids from the poorest kids from their youngest years, and we’re going to change that. And then there’s other issues too, that need to be corrected, but we’re going to have a better and brighter Head Start by the end of this administration.
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Sen Schatz [12:00:55]
… a statement you made during last week’s HELP hearing questioning the recommended childhood vaccine schedule and implying that these vaccines should be tested in children against a placebo control, like a saline shot.
I just want you to know this is not a gotcha. I’m hoping that I misunderstand what you’re talking about.
You know, placebos exist, placebo controlled trials exist for– in the existing vaccine approval process.
Are you suggesting something different than that?
Secy Kennedy [12:01:26]
No, there are placebo controlled trials senator, and by the way, my uncle Ted Kennedy in 1975, held the hearings that ended the Tuskegee experiment. And so I’m very, very familiar and I’ve met some of the people who actually were suffered from that.
The– under the current vaccine schedule, none of the vaccines with the exception of COVID have ever experienced a safety trial pre licensure that that involves an inert placebo. None of them. COVID’s the only one.
And I don’t think that it’s ethical to go back and retest those vaccines against a placebo, if that’s what you’re suggesting that –
Sen Schatz [12:02:10]
That’s what I’m trying to clarify. And I–
Secy Kennedy [12:02:12]
Now– but you know what? The Cochrane Collaboration in 2016 published a study that showed that the predictive capacity of placebo controlled trials, which are the gold standard, is actually not any better than good observational trials and retrospective trials.
So we can do those kind of studies without subjecting people to an unethical experiment.
Sen Schatz [12:02:38]
That’s that’s all I wanted. I– this is not a gotcha. I wanted to just clarify that we’re not contemplating population wide studies of –
Secy Kennedy [12:02:50]
No.
And they do– just to clarify, they do have efficacy tests against placebos, but they don’t have the safety testing.
Calley Means [00:37:43]
The problem is is that we’re the sickest country in the world and, to the media and to everyone, and there’s a lot of cynicism, like this is real. And they talked about this for hours and hours and hours.
Today, just today, there’s going to be 3,201 kids that get prediabetes. We have 50% of kids overweight or obese. It’s about 3% in Japan. There’s 212 countries that measure cancer rates. And we have the highest cancer rates of any country in the world, and the highest rates of pediatric cancer.
As President Trump shows on the graph, he at Joe Rogan many times, we’re three to four times more on our healthcare spending per capita, three times more than any country in the world, and live 7, 8, 9, even 10 years, less than other countries. That’s a problem we need to assert because as Democrats say, oh, no, no, the only thing that’s standing between us and better health is more Medicaid spending. The only thing standing between us and better health is helping the system more, is putting more money, more bureaucrats into the system.
That’s just wrong. The problem is the system itself and why this is happening. And this is simple. This is nonpartisan. This should not be controversial. And this is the adult conversation that this administration is going to have.
Why is it happening? It’s happening because our beautiful children theirselves are being poisoned and they’re being poisoned through areas that there’s not even that much scientific disagreement on. And that are obvious.
We’ve gone from 0% of a child’s diet being ultra processed food to today, it’s 70%. That ultra processed food is comprised of three ingredients, primarily that did not exist 120 years ago. Refined grains, 120 years ago, did not exist. It’s a Franken food. You take the fiber off. It takes all out all the nutrients. It’s basically a sugar bomb. And that’s the chief source of children’s calories today.
Of course, you have added sugar, which has exploded, refined sugar, essentially didn’t exist generations ago, now it’s absolutely loaded. And it’s made of seed oils. And there’s a lot of debate about seed oils, we were called conspiracy theorists for talking about seed oils. Seed oils didn’t exist a hundred years ago. Now it’s the top source of American fat a hundred years ago, almost a hundred percent of our fat source was animal based, today, almost 80% of it is seed oils. Seed oils are heated up toxic sludge that’s put in rust remover, that’s put in bleach. It has eight other process steps to make it.
We don’t know, we don’t have full science on it, but it’s certainly an area of inquiry, an area that we should have thinking about, whether these processed ingredients, added sugar, refined grains, and seed oils, being the core part of our children’s diet in just one generation.
Obviously it’s because of sedentary behavior, because of our children’s sleep, we’re getting two hours less sleep for a kid than they did just two generations ago. Kids get less time outdoors in an average public school than a maximum security prison. We’re so sedentary that 77% of our military aged youth aren’t eligible during the military because of a chronic condition or a mental health condition.
Obviously it’s because of environmental toxins. We produce and ingest 25% of the world’s pesticides, the leading herbicides and pesticides that we use in the United States, many of them are phased out or banned in every other country in the world.
Now, I want to be clear, I want to be clear about how I’m seeing conversations on this. There is a difference between discussing obvious reality and policy.
What I think is so unique about the MAGA MAHA movement is we talk about these things and talk about the dramatic overprescriptions among kids, the fact that SSRI rates have gone up 600% among teenage girls in the past five years.
Talking, talking about the fact, is it a dynamic that we’ve gone from one injection in 1980 for a person in the first year of life to 30? Is it a dynamic that 18% of teenagers are on a stimulant? Is it a dynamic that 35% of teens are on a pharmaceutical product? Does these make people healthier?
What the administration’s doing, and what is so inspiring, and I think we all need to support President Trump and Bobby Kennedy on is they’re laying this baseline of truth. I think a lot of the next two years is winning this argument. If we can win this argument, we are on the precipice of a radical change. And, and then there’s a big difference between talking about these dynamics and then policy.
This report coming out on the 22nd is a scientific assessment. It’s a statement of what’s happening. It’s a statement of these unimpeachable facts. Then we get to policy.
And, you know, when it comes to things like regulatory action on pesticides, we don’t want a European nanny state system, the Republican party, the MAGA party, is the party of Elon Musk. Elon Musk saw a problem with environmentalism. He didn’t ask for a bunch of regulations. He innovated a company. He created a company in the free market to solve that issue.
And I do think we’re on the precipice now of being able to have an adult conversation about the facts. And it’s shocking. It’s shocking to me, how many lobbyists come in and they’re not lobbying for policy. They’re saying it’s going to scare the American people to get facts out. They’re putting so much pressure on President Trump, so much pressure on secretary Kennedy to not release facts, to not release facts about these foundational factors that are impacted on metabolic health.
The statement from the administration is we are going to have a discussion about facts. We are gonna stop infantilizing the American patient, the American people. We are going to get the facts on the table.
We are gonna get the NIH away from funding gain of function research that led to a pandemic that killed– that cost $25 trillion. We’re gonna get the NIH away from pharmaceutical R&D, they can do that themselves. We’re going to get the NIH studying these foundational issues. We’re going to get Americans the facts, and we’re going to figure out pro growth.
We’re going to figure out pro-innovation policies to solve this issue, because at the end of the day, this is about optimism. We are at an existential issue for children’s health and health in America.
Mehmet Oz, CMS [00:02:42]
Those countries in Europe, Asia have negotiated more effectively than the American government has been able to negotiate for the American people.
And so if you let the private sector do things, they’ll try to make money. You know, that’s what they’re hired to do. And sometimes they’ll make more money in one area than another, depending on how well folks are negotiating.
Right now, we have a crisis in America. Two thirds of Americans who are going into bankruptcy, go bankrupt because of healthcare issues, like the price of medications. In fact, the medications are so expensive for so many Americans that about a third of the time patients aren’t able to take their medications.
What is it like to be able to know you’ve got health at the tip of your fingertips? If you can just get it from the pharmacy, but you actually can’t afford to get the help?
The trade off we’re asking the American people to make is you want to be healthy or do you want to be bankrupt? It’s your choice. Right? And so that, unfortunately, that’s not a good option, especially when you’ve got members of your family who desperately need these meds.
So that creates a tremendous amount of pressure on the pharmaceutical sector. They don’t want to be vilified. They don’t want to be the bad guys.
So that the president said, he’s a great negotiator, I don’t know of a better one, is go out and talk to these guys.
We met, and we have already been approached, by a half a dozen of these companies, that they want to talk. They know this is not right.
The question is, how do we correct– what everyone is in agreement– can be done better. Can we come up with better solutions?
Again, we don’t want to hurt the industry or destroy the industry. Just want to do something that’s fair for the American people.
The jump in cases is not due to an outbreak, but rather normal classification processes, as most diseases are not classified in real-time.
MARK HARTMAN, FDA 00:44:48
We talked about GRAS, did a very nice job identifying the main issues that have been identified by stakeholders with the GRAS program, transparency, having a federal entity approve new substances before they enter the food supply, and also the question of what exactly is the nature of the universe of chemicals currently in the food supply that have been self-affirmed over time and how do we go about trying to answer those questions?
Secretary Kennedy in one of his first, I call it the first programmatic announcement he made, was actually directing FDA to explore rulemaking to address these issues and we are actively in the process of doing just that. And we’re making good progress in that regard.
As we continue to watch what’s happening on the Hill and happening in different state capitals, we’re focused on carrying out that part of our mission.
…
MARK HARTMAN, FDA 00:45:45
A couple of weeks ago, you may have seen a press conference where Secretary Kennedy and Dr. Makary also announced the approach we have for synthetic dyes, which I think were also mentioned on the last panel.
So we’re front and center in carrying out many of those items that were announced then, including initiating the process for revoking the authorizations for Orange B and Citrus Red 2, one of which was correctly said has not been certified for quite some time.
We still think it’s really important to go ahead and clean up those regulations as part of a kind of comprehensive approach to addressing these color additives.
At the same time, we are working with industry to encourage elimination and phasing out of the remaining synthetic color additives.
Almost every day there’s a new announcement from someone in the food industry getting on board with this approach. Tyson Foods, I think it’s the most recent one.
I think we’ll continue to see different companies stepping into that space and taking up the challenge to make that transition.
And during any time of change, it’s really important that we also focus some of our attention and resources on clearing the path for alternatives to those color additives in the marketplace.
Secretary Kennedy announced that we were going to be complete four of those reviews this summer. We already completed three of them that were announced last week. We’re well on the way of completing at least one more in the near future.
And we’re going to continue to look at ways to look at our process to make sure we’re as efficient as we can be in conducting those reviews. And prioritizing those reviews as we continue to work with folks to try to move out of the synthetic color additives.
…
MARK HARTMAN, FDA 00:48:14
Last but not least, in the post-market space, some of you will remember that we are, you know, back in the fall, we had a public meeting and issued a process paper that described what would be our systematic process for doing a postmarket review program.
We got 70,000 comments. Thank you very much. And I think we should, you know– we need to start talking to people about the late comments. I mean, the last second comments, you know, with 10,000 until the last day and then it’s 70,000. We got to go– People often tell us that we have to move faster. I’m here to tell you, I think the stakeholders need to move faster in their comments. But seriously.
So, I mean, again, looking for an approach to systematically look at the universe of substances in our food supply, prioritize which ones rise to the level of requiring additional review, risk assessment, and if necessary after that risk assessment, risk management approaches on an ongoing basis over time.
And while we’re standing up that program, we do have a number of chemical activities that are already in flight. We’ll continue to be working those chemicals that are already listed on our website as chemicals that we’ve been working on either because they are or we’re – we were petitioned to take some action or otherwise identified as priorities.
And there’s supposed to be breaking news today, so I’m going to announce it anyway, even though the press announcement hasn’t gone out. So I’m taking a risk here. No– not really. It’s already– but as soon as today and maybe tomorrow, we’ll be putting out an announcement on some of our progress on the post market review program to include, we talked about prioritization, we’ve developed a draft prioritization schema that we’re going to be releasing for public comment and peer review. We expect that to be happening in the coming weeks.
In addition to that, we are going to—we plan on updating that process paper I talked about and having to finalize that process based on comments that we received and have that ready later this year, as well as updating that list of chemicals that I talked about that we’re currently working on to include BHT, make sure I get them right, BHA and ADA will be added in addition to others.
Now, that won’t be happening today, but we’re in the process of getting ready to do an update to that list. So there’s a lot of activity in the post-market space.
…
MARK HARTMAN, FDA 00:55:38
Now, so, identifying a chemical to go through this process is step one.
Step two is actually going through the scientific review and assessment of the hazard and exposure associated with that chemical.
So, I mean, just because something shows up on a list of things that we’re focusing on does not necessarily mean there’s an outcome down the line. I mean, we don’t look at it that way.
And, do you work for General Mills? I was going to say, because one of my– I have three kids. My middle son has never– he’s always been an odd eater. And one of the things he will eat is Cheerios.
And he is very aware of when they are stale and he has—his version of stale is like they’ve been open for a day. So, you know, so I have personal stake in making sure that both that they’re safe and also that we assess them appropriately.
Martin Makary, FDA [00:33:41]
So on June 4th, as a part of a series of new round tables that we’re going to convene, we can do them quick. We can get the top experts from around the world. We don’t go through the bureaucracy of a FACA.
And we convene experts, and we’re going to do one on infant formula with the top infant formula experts around the country. It’s going to be public and available and media welcome to come. If there’s any media here, you’re welcome.
On June 4th, we’re doing one on menopause and hormone replacement therapy for too long. Women have not gotten the research and evidence that they deserve around some of these giant topics where there’s been a lot of misinformation.
Peanut allergies were rare two generations ago. It’s now extremely common. Why? What’s going on? The cumulative burden of all these molecules that don’t appear in nature that are going down the GI tract, it’s doing something, it’s creating some inflammation or immune response, and maybe it’s triggering autoimmune diseases. I don’t know.
But why are do one in five to one in six women have an autoimmune disease. And it was rare two generations ago? We can’t keep going down the path of drugging our population at scale.
The best way to lower drug prices are to stop taking drugs we don’t need.
…
Martin Makary, FDA [00:34:59]
And so that’s why we announced the removal– the plan to remove petroleum, all petroleum based food dyes from the U.S. food supply, ideally by the beginning of school year next year, we’d like to see that.
We’re meeting with companies. Danone just made a big announcement. Thank you, Danone. We’re meeting with many of these companies. A lot of them have been terrific. They’re saying, we just want a common national standard and timeframes. So our competitors don’t have an unfair advantage.
…
Martin Makary, FDA [00:39:19]
We want to be very transparent and we want to create a framework for vaccine makers, that they can use, so they have a predictable FDA where they don’t have to worry, how is this going to be received?
And so we are talking openly about this. We’re doing a lot of interviews. We’re doing a lot of fireside chats. And Dr. Vinay Prasad who’s the head of CBER is planning to sort of unleash a massive framework so that all the companies will know exactly what we’re thinking.
And probably in the coming days.
He just started and we have– he has been doing a lot of meetings and meetings with industry and also meetings with the staff at CBER.
He also believes in gold standard science and common sense, especially when it comes to rare diseases. We’ve had these conversations.
He is bringing the perspective of a hematologist, where some of these drugs that have been approved. We don’t know if it influences overall survival. That doesn’t mean they shouldn’t be available to patients. We both believe in both the letter and the spirit of right to try, but we should also be looking in post-approval monitoring about what’s actually going on. Is there a safety signal we didn’t see in the trial? And is there a benefit that we didn’t see in the trial?
We’ve never been able to do that before, but now with big data, we are assembling some of the biggest electronic health record databases. And, we will be able to query those databases in real time, as soon as we approve a drug. And that will also influence our decision as to when to green light something, because if we have eyes on it, the second it’s approved, we can feel more confident about understanding safety signals.
10:06:01 KENNEDY: Let me address your first issue first, because I want to correct you. We have about 1,100 measles cases in this country. The growth rate last year was 15 additional, so we have plateaued.
Mexico has roughly the same number with a third of our population, and they got 300 extra cases last week. Canada has more measles, 1,500, they have one eighth of our population.
Western Europe has about 6,000 which is 10 times the number that we have. So you are wrong about earlier.
…
10:10:26 KENNEDY: We have under the reorganization, and I’m going to talk very, very broadly, because as of four o’clock yesterday afternoon, we are under a court order not to do any further planning on the reorganization. And I’ve been advised by my attorneys not to talk about it.
But I will just say broadly, many of the programs that the Democrats are now saying were cut at CDC were not cut at all. Those programs were transferred to the Administration for a Healthy America.
But I’m not allowed– I’m not permitted to talk in any more detail because of a court order.
…
10:24:52 KENNEDY: They were made– I mean, ultimately we executed the decisions.
HOYER: I know you executed them, but my question is–
KENNEDY: Elon Musk gave us help in trying– in figuring out where there was waste, fraud, and abuse in the department. But it was up to me to make the decision. And there are many instances where I pushed back and said, we don’t want to– that would hurt us to eliminate that group.
HOYER: Let me ask you a question based upon that response. Was there an analysis of the consequences of these cuts, and the reduction in force and elimination of programs, was there an analysis that you can provide the committee that indicated those, as you concluded in your statement, would not harm people, would not undermine, frankly, the people not served, children not educated, research not accomplished, frankly, lives not saved. Is there an analysis that you can provide to this committee prior to us, determining the budget, that will show that in fact those cuts will not be harmful to those objectives?
KENNEDY: I mean, there were analysis. The simplest analysis was at the outset, the analysis that we’re spending 2 trillion dollars a year that we don’t have. Mr. Musk said he was going to cut the two trillion dollars more than you have. You have to make cuts.
The other analysis that was more detailed–
HOYER: Is that the children or the Indians that you’re so concerned about?
KENNEDY: We didn’t cut the Indians. We didn’t cut the Indian services–
HOYER: I understand you. I’m asking you–
KENNEDY: I made sure that those services were not cut. I made sure that Head Start was not cut.
And– but the cuts that were done were cuts that were to duplication, to redundancy, to streamlining.
…
10:34:40 KENNEDY: If you had a child today, would you vaccinate for measles?
For measles? Um– probably for measles. I– you know, what I would say is my opinions about vaccines are irrelevant.
I have directed Jay Bhattacharya–
POCAN: Like I said–
KENNEDY: So that everybody could make that decision. But I don’t want to seem like I’m being evasive.
I don’t think people should be taking advice, medical advice from me.
POCAN: Right, I got that. And I’m not asking you to give them medical advice, but would you vaccinate your child for measles?
KENNEDY: I think if I answer that question directly, that it will seem like I’m giving advice to other people and I don’t want to be doing that.
I want people to make up their own–
POCAN: But that’s kind of your jurisdiction, because CDC does give advice, right? I’m not trying to do it as a gotcha.
KENNEDY: I think what we’re going to try to do is to lay out the pros and cons, the risks and benefits, accurately as we understand them, with replicable studies.
POCAN: Can you talk about chickenpox? Would you vaccinate your child against chickenpox?
KENNEDY: I– again, I don’t want to give advice.
I can tell you in Europe, they don’t use the chickenpox vaccine specifically, because the preclinical trial shows that when you innoculate the population from chickenpox, you get shingles in older people, which is more dangerous.
POCAN: Just one last one, just a yes or now please, if we could, polio.
KENNEDY: Polio? Again, I don’t want to be giving advice.
…
10:52:06 KENNEDY: I reinstated 328 employees at NIOSH, about a little over a third of them were in Morgantown, and about a third in Cincinnati, and the World Trade Center group also reinstated.
MOORE: Well, thank you for that. The black lung screening program, and the coal workers health surveillance program, are particularly important to West Virginia. My understanding is that the coal workers health surveillance program at NIOSH will be fully reinstated. Is that correct?
KENNEDY: Yes, the program will continue to function with continuity.
…
11:07:21 KENNEDY: We are about to reissue the dietary guidelines and we’re going to do it very quickly. We have until January, but we’re going to do it.
I think we’ll have it done even before August.
And we took the Biden guidelines, which were 453 pages long and were clearly written by industry, that are incomprehensible, driven by the same industry capture and those kind of carnal impulses that put Froot Loops at the top of the food pyramid. And we are changing that.
So we’re going to have four page dietary guidelines that tell people essentially eat whole food, eat the food that’s good for you.
That’s going to drive changes in the school lunch programs. And we’re going to need your help to make sure we can get good school lunches to Head Start.
I’ve been touring these Head Start facilities. Everything they eat is in a package. And it is loaded with sugar and with chemicals.
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11:17:59 KENNEDY: What happened to many of those children is just horrific.
They were being– my predecessor was deliberately employing a policy of speed over safety. So they waived all of the identification requirements for sponsors. Sponsors were not required to show valid identification. They were never fingerprinted. So we didn’t know if they had criminal records. There was no DNA testing. So their claims that they were taking a family member were
CLYDE: Dubious at best?
KENNEDY: Yeah, they were dubious. In Cleveland, according to the grand jury testimony and the grand jury findings in Florida, there are so many episodes. One of them is a man in Cleveland who picked up a 16-year-old girl claiming to be her brother, raped her, impregnated her, put her in a home where she was being regularly raped of all men. And then got a 16-year-old boy who disappeared. And went back two other times for other children.
This was happening again and again. One agency placed 592 children with 120 sponsors. 400 children were shipped to a town, where there’s a meat packing plant in Kansas, 400 children who, you know, they had to come and claim that they – the sponsors had to claim that those children lived in that town.
And we’ve seen a fake ID where you have one guy who is photoshopped in with a whole bunch of different children and he’s showing up and picking up at these kids one at a time. The Biden administration knew about it. They saw the same pictures we did, and they did nothing.
There’s 160,000 help complaints that were never investigated. I’ve launched now a criminal task force. We’ve opened up 500 criminal investigations and already brought 80 to court. So we are going to try to do everything we can. We’re working with DHS to find these children.
But the federal government under the Biden administration became the biggest facilitator for child abuse probably in the history, certainly in the history, of our country.
CLYDE: Well, thank you. I was going to ask you, how are you going to hold these contractors and officials accountable, but I think you answered that question already.
KENNEDY: We’re already doing fingerprinting on every sponsor. We’re doing DNA testing on every sponsor. We’re doing income testing on every sponsor and we’re doing valid ID testing.
Nobody gets a kid without showing that they are a family member.
For too long, Americans have been subsidizing prescription drugs for other nations. That ends under President Trump and Secretary Kennedy’s leadership. Unlike the previous administration, this one is committed to keeping pharmaceutical manufacturers from charging Americans high drug prices while giving steep discounts to other wealthy nations. As noted in the executive order, HHS will be establishing a mechanism through which Americans can buy pharmaceuticals directly from manufacturers and, if manufacturers fail to offer most-favored-nation pricing, the Secretary will propose, through rule making, rules to impose most-favored-nation pricing along with other measures to ensure lower prices for Americans.
For your reporting purposes, I’d also like to direct you to the fact sheet which provides more details about this initiative.
Secretary Kennedy has been working hard to ensure that the critical functions under NIOSH remain intact. The Trump Administration is committed to supporting coal miners and firefighters, and under the Secretary’s leadership, NIOSH’s essential services will continue as HHS streamlines its operations. Ensuring the health and safety of our workforce remains a top priority for the Department.
HHS and the FDA are taking bold action to protect America’s children by initiating the removal of unapproved, ingestible fluoride prescription drug products from the market. These fluoride prescription drug products, given to infants and toddlers, have never been approved by the FDA and pose real risks to developing children — including harm to the gut microbiome, potential thyroid dysfunction, weight gain, and even reduced IQ. This is not just a public health issue — it’s a moral issue.
The American people deserve transparency and accountability. HHS and FDA are launching a full safety review, with public input, and aim to finalize action by October 31. The Department will issue new guidelines promoting safe, effective dental hygiene without compromising gut health.
This marks another step toward delivering on our Make America Healthy Again promise—by ending outdated practices and putting Gold Standard Science at the center of children’s health.
The FDA has not found sodium fluoride chewable tablets to be safe and effective, and the labeling for these products has not been approved by the FDA.
This means that while these tablets are available by prescription, they have not gone through the FDA’s rigorous approval process to ensure safety and efficacy.
The Institute for Agriculture and Trade Policy notes that no fluoride products designed for ingestion have been approved by the FDA, with the exception of topical products like toothpaste.
Sodium fluoride chewable tablets are considered “unapproved drugs”.
It’s important to note that even though these tablets are not FDA-approved, they are still available by prescription from a dentist or doctor, particularly for children at high risk of tooth decay in areas with low fluoride in the drinking water.
Question [00:02:20]
Do these drug price cuts apply to Medicare Part D? Can you answer the question?
Robert F. Kennedy Jr. [00:02:27]
Yeah, they absolutely will. They’ll apply to Medicare, and they’ll apply in the private market as well.
Mehmet Oz [00:00:25]
Well, the president wants equalization. That’s the word that he used and it’s mostly about fairness.
So over the next 30 days, we are approaching all the major pharmaceutical companies and saying this is what your drugs costs in other countries that are similar to ours.
We want most favored nation status, which means, very specifically, if you’re willing to sell, as President Trump’s anecdote about a portly friend of his was getting a GLP drug in London said, I can get it for $88 here. I’ve got to pay a thousand dollars in America. That doesn’t seem fair.
And so most pharmaceutical companies, I believe, and they’re gonna hear from us over the next few weeks are understand that this is not really right for America, that to generate 70% of their profits, and we’re only 4% of the world population.
So we believe there’s going to be a desire to come to an understanding. And you see from the stock prices on pharmaceutical companies that others may think this is also okay for that sector.
My belief is that if we can’t get this to the right place in 30 days, there are tactics we can use. They exist already within government. The president has some opportunities. Congress obviously has options.
But the best case scenario would be all– we all get along and say, ‘hey, listen, this is something that you, as an American, probably don’t think is right either. How do we get Europe to pay a little more? So America can pay a little less?’
And that is exactly what I think the pharmaceutical shareholders will be okay with, because they’re going to make the same amount of money, just not all of it from the U.S.
Robert F. Kennedy Jr. [00:04:04]
I think it will stick Rob. And the reason I think it’ll stick is because I think the pharmaceutical companies know that it’s time.
And we’ve been meeting with them and, you know, this was not a surprise to them.
I had meetings with most of the CEOs last week and I gave them at least a veiled warning that this was coming, but they knew it was coming.
And one of the things that they really want is to get rid of the middle men, to get rid of the pharmaceutical benefit managers, the PBMs who collect a lot of the money and don’t produce anything.
They’re supposed to bargain for better prices, but there’s all kinds of ways that they can make money on it.
And it’s been a thorn in the side or a stone in the shoe of the pharmaceutical companies for years.
And one of the things that we did with this, with this executive order, is to allow– is to eliminate the PBMs in these transactions.
So I think that’s something, that’s a carrot for the pharmaceutical companies. And then, there’s a stick too.
Which is we have ways of enforcing this if we can’t come to an agreement.
Robert F. Kennedy Jr. [00:05:05]
I’m very, very happy and grateful President Trump for nominating Casey as the surgeon general.
There – the industries that are threatened by her nomination are mobilizing and they’re actually paying a lot of bloggers, we’ve learned now, to attack her. They’re attacking her on mainly on the critique that she stopped practicing medicine.
Casey was at the top of her Stanford class. She was president of her Stanford class. As a resident, she won every award that you could get for the kind of surgery that she was doing. But she realized very early on that she was not healing patients. They were coming back again and again, because the surgeries were treating the symptoms and not the underlying causes.
And she decided to devote her life to figuring out what those underlying causes were. And to ending those exposures.
She wrote a bestselling book that really galvanized the MAHA movement, and Rachel, I’m very glad to, I’m very, very grateful to you, the leadership that you’ve shown in, in telling this story to the American public.
But, Casey is an incredible storyteller. She is a pregnant mom right now. So she has a touchstone with every mother in this country.
How do you take– how do we take care of our babies? How do we give them good milk? How do we make sure that their foods are not poisoning them?
And she can tell that story and there’s going to be– I don’t think there’s going to be a more effective surgeon general in our history because of the capacity and the talents and the experience that she has.
Question [00:06:54]
Is Donald Trump gonna stick by this nomination?
Robert F. Kennedy Jr. [00:07:01]
I’m very optimistic that he will. He had a great meeting with Casey and really liked her.
And, you know, I think he knows how important she is for our country.
“We should look at every avenue to get drug companies to lower list prices. Americans are getting ripped off paying the highest prescription drug prices of any nation, and that is why America’s PBMs have repeatedly called on big drug companies to lower their prices. PBMs are the only ones whose mission is to lower prescription drug costs and the only check against drug companies’ unlimited pricing power, negotiating lower costs where competition exists.
PCMA commends President Trump for rightfully recognizing the price is the problem. We encourage the Administration to work with us to harness the power of PBMs’ work lowering costs as we all push to lower prescription drug prices for the American people.”
We do not comment on potential CMMI demonstration projects under consideration. This Administration remains committed to lowering prescription drug prices for Americans in line with the President’s Executive Order.
This is nothing of a surprise. These probationary employees were previously told in February that their jobs were impacted. This is the final step of the process where they receive their final notice.
Robert F Kennedy Jr [00:09:09]
What happened with her withdrawal?
What– we talked to Dr. Nesheiwat, she is going to– we’re going to put her at a very good place here at HHS.
Casey Means we felt was the best person to really bring the vision of MAHA to the American public. She has this unique capacity to articulate it. She’s written a book that really mobilized, galvanized the movement. She is an extraordinary–she is excellence in everything that she’s ever endeavored.
Question [00:09:44]
Obviously she’s come under her own criticism about some of the things she’s advocated for. She never finished her residency and she doesn’t currently have an active medical license, but that’s not–
Robert F Kennedy Jr [00:09:54]
Yeah, she was the top of her– the very top of her medical class at Stanford. She’s in every– during her residency, she won every award that she could win.
She walked away from traditional medicine because she was not curing patients. She couldn’t get anybody within her profession to look at the nutrition contributions to illness.
And she said, if we’re really going to heal people, if we’re healers, we can’t just be making our life about billing new procedures.
We actually have to figure out new approaches to medicine. And that’s the kind of leadership that she’s gonna bring to our country.
Question [00:10:31]
And last thing on this, your former running mate weighed in today saying that she wasn’t happy about this and said that you’re somehow being controlled. Your decisions are being controlled. That’s what she posted.
Robert F Kennedy Jr [00:10:42]
Listen, you got sitting here four people who are all canceled during COVID.
Question [00:10:47]
Yeah, that’s right.
Robert F Kennedy Jr [00:10:48]
Of these people are all– you’ve got an– the entire leadership of this agency is renegades who are juggernauts against convention and who are trying to look for truth, no matter what the cost.
Question [00:11:02]
So nobody’s controlling–
Robert F Kennedy Jr [00:11:03]
Casey is among those.
On background to an HHS Spox: To be clear, NIH has been actively engaged in transition planning throughout the Department’s transformation. It is inaccurate to suggest there was no effort to ensure continuity of essential functions such as emergency management, maintenance, and lab safety. These are mission-critical responsibilities, and NIH leadership has taken deliberate steps to prevent any disruption. All decisions have been made with careful consideration of operational needs and ongoing obligations.
On background to an HHS spox: HHS granted the CDC an exemption to onboard and train newly selected EIS officers. EIS officers continue to investigate outbreaks, analyze public health data, respond to emergencies, and support health departments worldwide.
Most Oklahoma cases have reported domestic exposure, with only one reporting international exposure potential during their incubation period.
Jay Bhattacharya [00:00:08]
It’s been an education in many ways. It would be normally difficult to lead an agency of 20,000 people and 50 billion, Rob.
But, the main thing for me is we will have to restore gold standard science, to this agency. We have to restore the focus on making America healthy. And we have to make sure that we don’t ever use this agency to conduct research that puts the American people in danger the way that the research on gain function, that the previous sort of leadership of the agency sponsored, we have to make sure that that never happens again.
And with this executive order by the president, that gives me the tools to do that for sure.
…
Jay Bhattacharya [00:04:04]
There’s no more beagles on campus, for experiments. There’s no more dog experiments on the NIH campus.
And we put in a place a new policy that strongly encourages alternatives to animal use, not just here on campus, but all across the country, in the grants we support.
Often what happens is you run an experiments on a mouse, and it’s misleading. We can cure Alzheimer’s in a mouse, but that doesn’t translate over to humans.
We’re going to change that so that we’re focused more on things that actually translate into human health.
Robert F Kennedy Jr [00:04:00]
That is an issue for us. It’s mainly a cost issue. These drugs are very expensive.
Ozempic is sold for about $1,300 a month. And in Europe, by the way, and England, you can get it for $88 or $88 a dose. We pay 1,300 a dose, a weekly dose.
And, if we made that so that Medicaid, Medicare paid for it, it would– and that private insurance companies had to pay for it, we would double the cause of health insurance to most employers in this country. And that would really be destructive.
So these are miracle drugs in many ways, as you point out, if you can reduce obesity, you’re also reducing diabetes and heart disease and a lot of other comorbidities. And it’s something that could be very beneficial to the Amer– to many people in the American population.
And right now the big impediment is really price. And we’re negotiating that with the drug companies and seeing if we can at least launch some pilot programs, or if we can get the price low enough, we can make it available at government cost to everybody.
…
Robert F Kennedy Jr [00:10:24]
And we’re going to have a very, very comprehensible– the dietary guidelines that we got from the Biden administration that we inherited were 453 pages long, and they were incomprehensible and they were really just a template for industry capture for promoting bad foods that people should not be eating.
We’re going to have a very simple– I’ve asked them for a four page guideline that can tell people to eat whole foods, eat meat, eat protein, eat vegetables and fruits, and try to eat locally, try to find local sources of your food.
And then we’re going to make that very comprehensible and that’s going to change the school lunch program. And I think it’s going to have a dramatic impact on public health in this country, particularly for our children.
Dear Colleagues,
I am pleased to inform you of the appointment of Vinayak “Vinay” Kashyap Prasad, M.D., M.P.H., as the new director of the Center for Biologics Evaluation and Research (CBER).
Dr. Prasad, whose specialty is hematology and oncology, has a long and distinguished history in medicine, having worked in a variety of public scientific, medical, and academic institutions at both the federal and state level. He comes to the FDA from The University of California at San Francisco, where he has served since 2020 as a professor in the Department of Epidemiology and Biostatistics. Before that, Dr. Prasad was a Professor of Medicine in the Division of Medical Oncology and the Department of Public Health and Preventive Medicine at Oregon Health & Science University.
Before entering academia, Dr. Prasad worked at the National Cancer Institute, where he completed a Fellowship in Cancer Prevention, and concurrently was a Fellow in Hematology and Oncology at the National Institutes of Health. Dr. Prasad has published more than 500 academic articles, done extensive research in the field of oncology and has presented at hundreds of scientific and medical conferences. He is also the author of the books, “Malignant: How Bad Policy and Bad Evidence Harm People with Cancer” and “Ending Medical Reversal: Improving Outcomes, Saving Lives.” He also hosted the oncology podcast Plenary Session and ran The Drug Development Letter.
Dr. Prasad graduated from Michigan State University with a B.S. in Physiology and Philosophy. He received his M.D. from the University of Chicago Division of Biological Sciences Pritzker School of Medicine, with an Internship and Residency in Internal Medicine at Northwestern University, and a Masters Degree in Public Health from the Johns Hopkins University Bloomberg School of Public Health.
He brings a great set of skills, energy, and competence to the FDA, and I know that he is eager to begin immersing himself in the important work of CBER and the agency as a whole.
I want to thank Scott Steele for serving as Acting Director of CBER. Scott will continue to work to ensure a smooth transition in leadership and will resume his previous position in CBER as Senior Advisor for Translational Science.
I hope you will join me in congratulating Dr. Prasad on his selection to this important post and thanking Dr. Steele for his excellent work as Acting Director.
Sincerely,
Marty
Martin A. Makary, M.D., M.P.H.
Commissioner of Food and Drugs
Robert F Kennedy Jr [19:29:07]
President Trump has not cut the 9/11 program.
We took that program and we took a lot of OSHA, and there was also a lot of complaints that we ended OSHA, but we’ve just consolidated that in a new sub agency called the Administration for Healthier America.
Those programs were not terminated, as the media has reported. But they’ve simply been consolidated into a place that makes more sense.
…
Robert F Kennedy Jr [19:31:23]
One of the problems that we’ve had at CDC and NIH and FDA has been a kind of data chaos, and particularly around the issue of autism where they don’t even– don’t not only– not only do they not understand and they can’t tell us the etiology, the origins of why are we having an epidemic, but they deny an epidemic exists.
And even though every year the numbers go up, we’ve gone one in 10,000 in 1970, to one in every 31 kids today. In California, which has the best database, it is one in every 20 children. One in every 12.5 boys.
This is an existential disease. Every other disease like this has a registry. So that – and it’s voluntary – so that public health officials can monitor the numbers.
It’s not private information. It’s not information that is going to go out to other agencies.
It’s a voluntary system where your privacy is protected. Just a system for keeping track of a disease that is now becoming debilitating to the American people.
President Trump [00:02:39]
We’re going to have a big announcement next week on some of this kind of thing, but more related to costs, the costs of medicines and drugs. Because we’re being ripped off as you know, very badly, being ripped off compared to the rest of the world.
…
Jay Bhattacharya [00:08:10]
This is a historic day, the conduct of this dangerous gain of function research, which aims at taking pathogens and making them more virulent, more transmissible in humans, many scientists believe is responsible for the COVID pandemic.
The conduct of this research does not protect us against pandemics. As some people might say. It doesn’t protect us against other other nations.
What it does is it– there’s always a danger that in doing this research, it might leak out just by accident even, and cause a pandemic.
Any nation that engages in this research endangers their own population, as well as the world, as we saw during the COVID pandemic.
This proclamation makes it so that most science is actually– has poses no threat to human populations. The vast majority of science will go on under this as normal.
But the fraction of this research that has the risk of causing a pandemic, harming every single person on the face of the earth, we’re going to put in – this proclamation, this executive order puts in place a framework to make sure that the public has a say that if such a risk is being taken, that only scientists alone, won’t be able to decide that that in fact, the public can say, no, don’t take this risk.
And I’m really, really proud to be here with President Trump, who has signed this order, ending this research for the first time, putting in place a real regulatory framework to make it go away forever.
…
Robert F Kennedy Jr [00:10:10]
There are, I think, three leaks from BSL-3 and BSL-4 labs, our highest rated laboratories almost every week.
There’s no laboratory that does this, right. There’s no laboratory that’s immune from leaks, and this is going to prevent those kind of inadvertent leaks from happening in the future and endangering humanity.
The COVID outbreak cost 20 million lives and cost the world at least 25 trillion dollars.
And this executive order is a precaution against us being involved in those, that kind of research, in the future.
…
Marty Makary [00:15:47]
We have had this crazy system in the United States where American pharma manufacturers in the United States are put through the ringer with inspections and the foreign sites get off easy with scheduled visits, while we have surprise visits in the United States. While a scheduled visit is no inspection.
So we are at the FDA delivering on this promise in the president’s executive order and switching from announced to surprise inspections overseas.
We’re also not going to have our inspectors hanging out for three or four weeks. They’re going to get in and out, and we’re going do more inspections with the same resources as a result.
The U.S. Department of Health and Human Services (HHS) remains fully committed to supporting American families and delivering critical services as part of its reorganization to better serve the nation’s health.
Guided by President Trump’s Executive Order, the Department’s restructuring is focused on cutting wasteful bureaucracy, eliminating duplicative administrative roles, and allowing HHS to redirect resources where they’re most needed—delivering better outcomes for the American people.
As part of the standard union negotiated process, HHS issued specific notice on Friday to approximately 700 employees, who were previously notified of a RIF. These notices provide important details to employees including their full information, giving them important information about their planned offboarding date set for July.
After careful review, less than 250 employees across HHS were notified that they are also impacted by the reduction in force announced in March 2025. […] The savings from these reductions will help redirect resources toward critical programs and strengthen our ability to serve the American people effectively. The goal is clear: reduce waste and maximize the impact of every taxpayer dollar.
The simple fact is that the important work of serving the American people will continue without disruption. Because of the reorganization, HHS will be better positioned to meet the needs of those who count on us most.
However, the same number of employees will be brought back in critical areas
We look at the trends over time and we’d want to see several weeks of decline. New cases sometimes get reported to public health up to a week after someone was tested, especially if the test was done at a commercial lab. We are also watching to see if travel over the long Easter holiday weekend results in an increase in new cases. Cases from travel that weekend would likely start to be reported in the next week or two.
On background to an HHS spox: The CDC continues to recommend measles vaccination as the most effective way to prevent the disease. At the same time, we recognize that some individuals and communities across the U.S. may choose not to vaccinate. Our commitment is to support all families—regardless of their vaccination status—in reducing the risk of hospitalization, serious complications, and death from measles.
Secretary Kennedy will be enlisting the entire agency to activate a scientific process to treat a host of diseases, including measles, with single or multiple existing drugs in combination with vitamins and other modalities. This effort will involve collaboration with universities nationwide to develop protocols, conduct testing, and pursue approval for new uses of safe and effective therapeutics that meet the highest scientific standards.
Generation Gold Standard marks a critical step in restoring strategic focus and radical transparency to America’s pandemic preparedness. Developed entirely by government scientists—free from industry influence—the BPL vaccine platform could provide broad, long-lasting protection against all influenza viral pathogens, including influenza and coronaviruses, with the added potential to block transmission and stop outbreaks at the source.
This initiative realigns BARDA with its core mission: preparing for all flu viral pathogens, not just COVID-19. It delivers a cost-effective, accountable alternative to the Biden administration’s wasteful Project NextGen, which spent $1.63 billion on COVID-19 vaccines and $1.19 billion on therapeutics, neglecting broader pandemic preparedness.
Secretary Kennedy’s HHS has pledged radical transparency to the American public. This means being honest and straightforward about what we know — and what we don’t know — about medical products, including vaccines. The CDC’s former practice of suppressing information about vaccine injuries has badly eroded trust in our public health agencies.
Under Secretary Kennedy’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices. Except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.
The CDC’s own research has shown that the post-licensure surveillance system, VAERS, captures fewer than 1% of vaccine injuries. It’s a system that was designed to fail. The Vaccine Safety Datalink (VSD) — intended as a backup to VAERS — is virtually unusable for serious research. Both systems have become templates of regulatory malpractice.
HHS is now building surveillance systems that will accurately measure vaccine risks as well as benefits — because real science demands both transparency and accountability.