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Valerie Jensen, FDA [00:05:20]
So I want to give you a little more information about these additional lots that are being released.
So, this was an issue where we had some product that Baxter identified that has a very small proportion of leaks.
And so this is a large volume of fluid. I can tell you it’s hundreds of thousands of bags, and so very small proportion of this known issue with leaks.
And so these lots were actually manufactured at the North Carolina facility before Hurricane Helene and Baxter has investigated this issue, and they found that the leak would most likely be presented as an obvious defect before handling.
And so it would present itself as an obvious defect, once the pressure is applied to the product.
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Francis Godwin, FDA [00:11:01]
The four lots that were announced, these lots were produced before the hurricane. They, Baxter, had them in their warehouse. They wereinvestigating and evaluating these before they were be to be released to the market. And then the hurricane hit.
And with these, you know, all IV bags tend to have leakers in general. This is just kind of the nature of millions of bags being shipped through trucks, being jostled around after they leave the plant.
And so when we’re discussing with Baxter, we looked at the scenario and there are small proportion of leakers in these lots that are slightly higher than what you normally see. But we already know that healthcare providers are on the lookout for leaking bags, just from the general wear and tear that exists in the supply chain.
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Francis Godwin, FDA [00:12:11]
When it comes to leaking bags, there can be various manufacturing issues that happen along the way.
The dear healthcare provider letters talk in general about, you know, there’s a couple different scenarios.
But in this case, the proportion of leaking bags that are found is typically in the tens or– it’s measured in defects per million. So it’s definitely a very low percent, but it’s still a little bit above what we would normally see.
That’s why we wanted to alert the public today.
The Foods Typically Purchased by Supplemental Nutrition Assistance Program (SNAP) Households report published in November 2016, is the latest (and only item-level report) available. Please note, the data in the report is not a nationally representative. Therefore, one can’t interpret the data as the total amount of SNAP benefits that were spent on a category of food. The report is best used to compare the purchases of SNAP and non-SNAP households, as the same caveats apply to both groups. For example: About 3.5% of food expenditures was spent on milk by SNAP households versus 3.8% for non-SNAP households.
You can view more about the caveats and limitations on page 3 of the report.
Has the suspected wild bird exposure been ruled out?
The investigation is ongoing.
Has exposure to contaminated dairy products been investigated?
There is no exposure to raw milk or raw milk products.
Have any additional symptomatic contacts been identified?
No additional cases have been identified.
Regarding this line:
“The cost per utilization was based on 2024 prescription drug event (PDE) data for the drugs in question. These costs were trended forward to each projection year and adjusted for estimated manufacturer rebates. To account for changes in the AOM drug development pipeline, the estimates assumed that there would be a gradual shift from older to newer products.”
Are you able to describe how much was the cost per utilization that was used in the modeling? Or is there another way that you can describe it, like per enrollee per month?
…
The estimate is based on 2024 Part D drug experience, which shows an average gross drug cost of approximately $1,000 per utilizing member per month. This amount was projected forward bearing in mind cost trends, new drugs entering the market, and other considerations.
[00;13;49] Chiquita Brooks Lasure, CMS
During my time at CMS administrator, I have heard from countless people about how this coverage exclusion is a barrier preventing people from treating obesity and living healthier lives.
People with obesity deserve to have affordable access to medical treatment and support including anti-obesity medications for this disease, just as a person with type 2 diabetes can access these medications to get healthy, for example.
That’s why we’re proposing to revise our interpretation of the law and provide coverage of anti-obesity medications for the treatment of obesity and give millions of people a just opportunity to get the care they need.
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[00:25:32] Dan Tsai, CMS
I think there’s a question on kids and Medicaid.
We would rely on what is indicated in the FDA label.
And currently, products are indicated for obesity and weight loss management for patients aged 12 and older.
So to the extent there are kids 12 and older that meet the clinical definition obesity as indicated in the FDA label, the proposed rule would require coverage of these medications for those kids, for those young– for those adolescents.
So that’s the answer to your first question.
The second piece for timing.
We actually invite comments specifically on timing of when states would be required to implement this provision.
We note in the rule that the rule reinterprets the Medicaid statute, which means this would govern all Medicaid programs, but we specifically invite comment on a range of implications and timing for states.
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[00:28:16] Meena Seshamani, CMS
As you noted, this rule is a proposed rule and it will go through notice and comment rulemaking.
And based on the comments, then the rule would be finalized in the next administration.
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[00:30:07] Dan Tsai, CMS
So we estimate that– so the answer is yes, the federal government will be substantially helping states with the cost of this.
We estimate that the cost of this over a 10-year period will– the federal government will pick up $11 billion. And states will pick up 3.8 billion.
And so the federal government will cover more than the majority of the cost.
As you note, states are also feeling substantial state budget pressure. And we are doing our part to make sure that patients, Medicaid enrollees all across the country can get access to life-saving and life-altering medications.
And we would urge drug manufacturers to do their part as well, make sure they’re thinking about offering fair, appropriate prices to the Medicaid program all across the country.
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[00:33:38] Meena Seshamani, CMS
And for the reasons that I mentioned, because of the protections in the Inflation Reduction Act, we do not expect any short-term impact on premiums from this proposal.
And in fact this proposal provides a significant savings for people who currently may be paying out of pocket for these medications, in addition to the overall savings that people will will have through the $2,000 out-of-pocket tap that goes into effect January 1st.
The 2025 Dietary Guidelines Advisory Committee, a federal advisory committee, is in the process of finalizing its Scientific Report to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). This Scientific Report will be published online later in the year. This Scientific Report will contain the Committee’s review of the current state of nutrition science and includes independent advice for HHS and USDA to consider as the departments develop the Dietary Guidelines for Americans, 2025-2030.
Once the Scientific Report is published online later in the year, HHS and USDA will open a public comment period, inviting the public to share feedback on the report with both departments.
Once the Scientific Report is published on DietaryGuidelines.gov, the activities of the Committee will be complete. The Committee’s Scientific Report – and comments on the Scientific Report from the public as well as input from federal agencies – will be key resources the departments will use as they develop the next edition of the Dietary Guidelines for Americans.
HHS and USDA continue to demonstrate their commitment to transparency, equity, and scientific integrity throughout the entire process of developing the Dietary Guidelines for Americans, 2025-2030. HHS and USDA plan to release the Dietary Guidelines for Americans by the end of 2025. To learn more please visit DietaryGuidelines.gov.
The viral characterization of the clade I sample from California returned results of clade Ib, which has been the predominate subclade associated with travel during the outbreaks in Central and Eastern Africa.
“The makers of America’s household brands deliver safe, affordable and convenient products that consumers want, need and trust, every day. Keeping consumers and their families safe is our number one priority. The federal regulatory agencies within HHS operate under a science and risk-based mandate and it is critical that framework remains under the new administration. As the largest domestic manufacturing employer, supporting more than 22 million American jobs, we are prepared to work with the confirmed appointee and qualified experts within HHS to support public health, build consumer trust and promote consumer choice.”
The Hawaiʻi State Department of Health is investigating human contacts to the flock infected with H5N1. No humans in Hawaiʻi have tested positive for avian influenza at this time. To date, 54 individuals have been investigated for potential exposure. Of those, 34 were offered testing because of either having a unprotected exposure, meaning without use of adequate personal protective equipment, to the infected birds within the past 10 days, or because they had developed respiratory symptoms within 10 days of contact with the birds. Twenty-nine consented to testing, including 13 who had at least one symptom of respiratory infection and 16 who had no symptoms. All of the individuals who would be considered to have very high-risk exposure to the infected birds, including prolonged direct contact with visibly sick, dying, or dead birds, consented to testing. Testing involved collection of swabs from the nasopharynx, nose, throat, and/or conjunctiva which were tested by polymerase chain reaction (PCR) at the State Laboratories Division. Results for all 29 of those tested, including those with very high-risk exposure and/or symptoms, have come back negative for avian influenza. Two symptomatic individuals tested positive for common cold viruses. Investigation into potential exposures to individuals who interacted with ducks or geese at the Mililani Pet Fair is ongoing. At least 4 individuals whose only exposure was at the Mililani Pet Fair have been tested for avian influenza with all negative results. Additional investigation results will be shared as they become available.
While initial human testing results are reassuring, DOH urges the public to continue to exercise caution. Avoid close contact with wild birds, and if you encounter birds that appear sick or have died, don’t approach them. Report sick or dead birds, especially if multiple or unusual, to the Department of Agriculture (808-483-7106 during Monday to Friday from 7:45AM to 4:30PM, or 808-837-8092 during non-business hours and holidays).
Hawaiʻi residents who recently visited or worked on a farm in another state with known or suspected H5N1 animal infections should contact the Hawaiʻi Department of Health’s Disease Reporting Line (808-586-4586) for a telephone risk assessment.
Ian Williams, CDC [00:06:24]
We’ve been very busy.
Right now, there are about 860 agency staff currently supporting one of several active CDC emergency responses, including Marburg, Lassa, Mpox, Dengue, Influenza H5N1, Polio, and the recovery mission from Hurricane Helene.
So lots of busy, lots of work going across CDC.
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Ian Williams, CDC [00:06:24]
We’ve been very busy.
Right now, there are about 860 agency staff currently supporting one of several active CDC emergency responses, including Marburg, Lassa, Mpox, Dengue, Influenza H5N1, Polio, and the recovery mission from Hurricane Helene.
So lots of busy, lots of work going across CDC.
…
Ian Williams, CDC [00:12:29]
Mpox clade I cases have appeared in neighboring countries of Burundi, Rwanda, Central African Republic, Republic of Chicago and Uganda.
Travel associated cases have now been reported in Germany, India, Kenya, Sweden, Thailand, and over the last weekend here in the United States.
At this time there is no data to suggest that sustained transmission has been occurring in these countries.
The two cases in Sweden, Thailand occurred in August, and the case of the United States has occurred here– in the United States– and they didn’t update the slide here, because it just happened over the weekend, but hopefully folks either saw the media, there was a health alert network posting that came out Monday night, I believe, or Tuesday morning, that gives sort of updates on that.
And the short answer, if you haven’t seen that is, this was very similar to the cases we saw in the UK and Sweden, which is a traveler who returned from a country where the mpox is endemic.
He basically presented to care with a rash illness and was subsequently picked up as having traveled to this part of the world.
All the right stuff happened, and big kudos to our colleagues in the state of California and San Mateo county who were basically picked it up.
They had that right testing at the right place in the right time and were able to go from a sort of a, a clinical diagnosis to basically get laboratory confirmation very quickly, over last weekend.
Where we are currently with that case is following up contacts both within the community, folks that he traveled with, who are in two additional states, and those states have been notified of those travelers, we’re following up on everyone who sat in surrounding him on the airplane, on the flights on the way back to the United States.
We’re following up members in the community, including all the healthcare workers. And just to give you a flavor of there’s around 60 or so healthcare workers that have been, are currently being followed up by our colleagues in the state of California.
Good news is it does not look like there’s any sort of high risk exposure there. But of course we’re following this very closely just to make sure that there is no ongoing transmission in the community.
Last thing I’ll mention is there’s also wastewater detection monitoring that’s happening within the community.
There have been no case recent cases of or no recent wastewater detections there in San Mateo or the surrounding counties.
So the good news is that the system that we’ve been working on for almost 10 months now worked sort of as it was supposed to, again, big kudos to our state local colleagues who basically made it run seamlessly.
So, we’re not out of the woods with this one yet, but we’re watching it very closely.
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Ian Williams, CDC [00:20:36]
We’ve also issued, CDC has also issued a updated level two travel health notice, per enhanced precautions for travelers to DRC or the neighboring countries. It advises travelers to be aware of mpox exposures, risks and symptoms, reiterates vaccine recommendation, reminds travelers to seek immediate medical attention if a new or unexplained tr skin rash develops after visiting a country with ongoing clade one transmission.
And just to emphasize that CDC and the WHO do not discourage travel to the DRC or elsewhere at this time due the risk of the mpox outbreak nor is CDC conducting entry screening at U.S. ports for entry for mpox. Nonetheless again, CDC is ready to respond to ill travelers at ports of entry 24 7 each day of the year.
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Fernando Torres, CDC [00:28:04]
So now into the outbreak, on September 30th, the WHO issued a disease outbreak news report on this outbreak. This is the first time that we see Marburg in Rwanda.
Most of the cases have been confined to two facilities in the capital Kigali, among healthcare workers and the presumptive index case has been suggested to be a miner, in a mine near Kigali.
At this point, the outbreak seems to be under control. The last case was confirmed on October 30th.
So WHO started to countdown for the, to declare the outbreak over. And that would be December 21st, if there’s no other cases.
It is important to know that historically this has been the Marburg outbreak with the highest number of survivors or recovered individuals, and that we partnered with WHO and other USG colleagues to use this opportunity for a phase one clinical trial of a Marburg vaccine and monoclonal antibiotics. Next slide.
To date, the risk to the U.S. remains slow. However, October 16, the Department of Homeland Security directed all travelers from Rwanda to just three airports in the United States.
That would be JFK, Chicago O’Hare and Dulles Washington, and we have CDC staff deployed in this airport conducting screening tests for all travelers.
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Lyle Petersen, CDC [00:41:13]
Now that we’re getting in towards the end of the year, cases are starting to decrease, as expected.
This large decrease down here is just largely due to reporting delay, but cases are starting to decrease.
So what’s happened here is we’ve had a pretty substantial outbreak. There’s been about 4,700 laboratory confirmed cases, about 2,700 hospitalizations.
But the important thing is there’s only been nine deaths despite having a huge number of hospitalizations, 2,700.
And this is due to the fact thatwe’ve really worked on training physicians in Puerto Rico to recognize dengue and to treat it properly so that, so I think this has been a huge public health success.
Now, the one thing that didn’t happen is a massive outbreak.
As I mentioned earlier, sometimes we’ve seen outbreaks of 10,000 cases or more in Puerto Rico. And right now we’re at nowhere near that number.
So this was a little unexpected, but again, this was still a huge outbreak.
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Lyle Petersen, CDC [00:44:22]
Now what’s happening in Southern California is really interesting.
So far we’ve found 15 locally acquired dengue cases, both in L.A. county, San Bernardino county and in San Diego.
And so dengue in California had never been reported locally transmitted dengue, I should say, had never been reported in California before last year.
Last year, there were two local transmission cases in Los Angeles county. This year we have 15.
And the reason for this and the reason it’s starting to occur in Southern California is simply due to the fact that the Aedes aegypti mosquito has invaded California as well as numerous cities throughout the southwestern United States. And it never used to be there.
And so Aedes aegypti is present in much of California at this point. And in other cities like Phoenix and Las Vegas and other basically all over the Southwest at this point.
Why Aedes aegypti is invading the Southwestern United States is not clear, but as illustrated on this slide, it certainly raises the possibility of local dengue transmission in places where it never occurred before.
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Chris Brown, CDC [01:03:49]
I know that in the news folks have probably been paying’s attention to recent cases, particularly in Canada with Canada’s first detection of a human case, pediatric case, as part of this particular outbreak, as well as the pediatric suspect case that California identified within the last number of days.
Testing around that last one is ongoing right now, and we’re still trying to work with partners on the ground, including at the healthcare system where the case was identified, to get more information about the case.
The epi investigation is underway, and we’re working through some issues around sampling and laboratory analysis of that sample to learn more about what’s going on there.
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Chris Brown, CDC [01:05:02]
Really what we’re seeing is the bulk of human cases resulting from occupational exposures, on the various types of farms that are affected. So that’s really where the focus I think of this response is gonna remain unless the trajectory of the outbreak changes with what we may, you know, still learn about the recent California and other cases.
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Chris Brown, CDC [01:06:40]
We’ve reached out and we’re trying to engage OSHA. This is a challenging landscape, I will say because of the way the OSHA programs are structured about half the states across the country are OSHA state plans. Meaning the state gets funding from the federal government to operate their own plan. They’re required to be minimally, at least as affected as the federal standards.
States have the purview to go further if they want, than the federal standards, but by and large, it’s a consistent program. But that means the jurisdiction is kind of a patchwork between whether it’s federal OSHA or state OSHA.
The other challenge here is that on the agriculture side, OSHA does not have many prescriptive standards in this space. There is one standard for general sanitation that is largely relevant and the other occupational protection standards that apply to agriculture deal with things like farm equipment rollover. So they’re not relevant to preventing exposure to an infection with infectious diseases.
We’re engaging OSHA on that. I mean, I think the regulatory climate that we will likely see going forward probably will not allow us to do too much more in that space, but we are working with them to try to leverage the partnerships that we can.
Our Manufactured Food Program registers and inspects Taylor Farms. The last routine inspection occurred on October 10, 2023. No significant violations were observed at the time of inspection. We are collaborating with the Food and Drug Administration on the E. coli investigation. Those inspection records are not available because the investigation is ongoing.
There are no licensed dairies in Alameda County. Also, there have been no detections of H5N1 in poultry flocks. We are seeing an increase in wild bird detections across California, but the last report in Alameda was in early 2024. Follow-up testing from the California Department of Fish and Wildlife since September 1 confirms no new detections in the county.
Please see below for a message from CDER Director Dr. Patrizia Cavazzoni to CDER Staff regarding Dr. Throckmorton:
Dear CDER Colleagues:
After 34 years of distinguished federal service, including 27 years at CDER, Doug Throckmorton, M.D., the deputy center director for regulatory programs, will retire in early January 2025.
It was bittersweet when Doug told me in September that he planned to retire around the new year. I am excited for him to begin this next phase of his life after dedicating so many years to CDER, but as a long-standing senior leader with extensive public health experience and institutional knowledge, he will be sorely missed.
Doug’s CDER career began in 1997 when he joined FDA as a medical officer in the Division of Cardiac and Renal Drug Products in the Office of New Drugs. He was soon promoted to deputy division director and then to division director in 2002. In this role, he helped shape the agency response to drug-induced QT prolongation to successfully avoid additional drug withdrawals.
In 2004, he became acting deputy center director, a role that became permanent in 2005 and which he has held ever since. During his service as deputy center director, Doug has overseen many critical and complex areas in the CDER portfolio, including the regulation of controlled substances, drug shortages, counterterrorism and emergency coordination, combination product regulation, and the impact of pharmaceuticals in the environment.
In addition, Doug has advised me and previous center directors on complex regulatory policy and programmatic matters. We have been fortunate to have his strategic guidance over the years, and I am grateful that he has been such a steadying presence and a sound advisor on a wide range of topics vital to CDER. Doug has had an immeasurable impact on public health.
Please join me in thanking Doug for his outstanding service and commitment to CDER. Let’s wish him all the best as he looks forward to a well-deserved retirement! He says he has no immediate plans beyond relaxing, but one never knows.
Calley Means [00:02:53]
My sister and I got into this from her experience being in the medical system, from me being a lobbyist, and our mom abruptly dying of cancer.
You know, one of the many Americans struck down by our chronic disease crisis.
And we started companies. We wrote a book, we started going on podcasts. You know, I’ve known you, as you said for years.
And just organically, this beautiful movement has sprung up. We got connected to RFK, got connected to the Trump campaign, just reached out, hey, this is kind of interesting. We wanna fold this into President Trump’s talking points. Members of Congress reached out and had an opportunity, I had a spiritual feeling after President Trump got shot.
I just felt the need to pick up the phone and call Bobby Kennedy, who I had been talking to a lot and say, maybe this is time to call President Trump and discuss unity and was able to make that connection that night, with the help of Tucker Carlson.
And have a little bit of a seat watching them connect. And I think what’s so powerful and what I think people are so scared about is there was a real meaningful connection on big ideas.
And I think that that almost spiritual level of connection came through in the campaign to where I was shocked, in the final weeks of the campaign, President Trump talking about our food toxins and childhood chronic disease and taking on corruption in the USDA and the FDA and the CDC.
It’s like these are bipartisan issues. These are anti-corruption issues. These are us versus the uni-party.
And, I think as you saw Liz, these issues connected with I think the base.
You heard really loud applauses. Trump was shocked. He said by the applauses, RFK and these issues were getting.
And I think it brought millions of new people into the coalition. When you look at the gender gap closing, independents, young people, Latinos. I mean, I think this really, really resonated.
And I got to say, from my standpoint behind the scenes, this was good vibes. Like I’ve never seen a partisan or kind of calculated word exchanged in the closed door sessions.
It’s all about how can we actually communicate this childhood chronic disease crisis.
So on this particular topic, and I think in a lot of topics, honestly, when Trump was working with Elon and talking about big ideas, it honestly was coming from everything, I’ve seen, a very good place.
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Calley Means [00:12:08]
We’re going to return to science.
I think what bad interests have realized is that there’s nothing higher level in society than an NIH study.
And I’ve actually, Liz had conversations in the past three days with the senior most members of the NIH who are defending the institution publicly, who are saying, this is an absolute and utter dumpster fire.
There’s huge DEI regulations and parameters around what can and can’t be said, a feeling of absolute assault on academic freedom, and from what I’m hearing, when you add it up, 80 to 90% of NIH grants and funding goes to pharmaceutical R&D, there has been an absolute freeze on foundational scientific research.
And we just need to call a spade a spade here, a huge institutional force from preventing embarrassment to previous guidelines, whether that’s on pharmaceutical interventions or on food.
What President Trump, in some bold statements and videos, the first day is we are going to get back to freedom of speech. We’re going to get back to truth. We’re going to get back to academic freedom. We’re going to get any type of ideology out of our scientific guidelines. He said that directly.
And I– that’s the key to everything. I mean, the key and a victory in the first year is returning the NIH to asking the question, why are we getting so sick?
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Calley Means [00:15:10]
There’s nothing conservative or liberal about the USDA recommending added sugar as part of a healthy two year old’s diet.
That then flows to hundreds of billions of dollars of various subsidies.
I think a huge problem. And I think Trump talked about this one with this first video, let’s get the DEI out of all the federal agencies.
DEI has actually infected science in a really problematic way where the dietary guidelines actually have to consider affordability. They have to consider equity.
And actually they recommend ultra processed food to kids because they say, well, we can’t possibly expect people to afford real whole food.
You should have zero thought about equity or affordability in scientific guidelines. The job of the USDA is to say the truth, which is then in the midst of a diabetes and obesity crisis among six year olds, that we should be steering kids away from ultra processed food, away from sugar, towards whole food made by American farmers.
And that’s the USDA’s job. That’s the executive branch’s job. And there’s actually no policy there.
But that recommendation should be from the science and then policy makers and money can flow where we see fit.
But the problem is that you actually have fear in these scientific agencies about saying the wrong thing and getting attacked for being classist. That’s got to end.
We need unbiased science about what food’s doing, what vaccines are doing, what fluoride’s doing, all these things. Why are we so afraid to ask these questions?
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Calley Means [00:19:56]
What we are preparing for President Trump’s consideration and consideration by the transition team.
Well, when you get into food regulations, you get into what’s called GRAS standards. So generally recognized as safe.
So there was a bill passed in the 1950s, basically saying that things are just, that are absolutely no-brainers like food additives that are just natural no-brainers that they can be, you know, okay, those are good to go.
And through various corrupt regulatory interpretations today, it’s full self-policing from the food industry, to where a food company can add any chemical whatsoever into our food system.
And then it can only be taken out if it’s demonstrably proven that it’s harmful after it’s been in our kids food.
And we have 10,000 chemicals in our food that are phased out of European countries, and we have full self policing.
Now that isn’t the free market, that’s been a totally rigged system.
And I would just say like, let’s take food colorings, artificial food colorings, that is literally crude oil.
One thing I’d like love the USDA and FDA to pursue is actually just more honest labeling of what food products are.
Natural flavors encompass thousands of harmful chemicals, you know, red 40 that’s crude oil. That’s literally what it is.
So we are coloring those neon colors in our kids’ food that have no nutritional need, that’s phased out of every other developed country.
And it’s absolutely demonstrably tied to ADHD and other neurological issues.
I mean, it’s astounding as you’ve seen Liz, if you actually a kid with some ADHD issues, if you take food coloring out of their diet, it’s actually astounding, studies are showing this. But instead we just give them Adderall.
So yeah, I think it’s not an attack on– and we got to just be, as you said, very specific.
I think the overall posture of the FDA should be actually a lot of deregulation. I think we should have a golden age of innovation and drug development. Nobody’s standing in the way of that.
But when it comes to food, when it comes to generally recognized as safe, complete self-policing from this industry, allowing them to put chemicals in our food that are banned in every other country and have hundreds of studies saying are harmful, yeah, there needs to be a review of GRAS standards. Absolutely.
Now that, I don’t think that’s punitive on the food system. And I want to make this really clear. And this is what we’re talking about.
This is a dual fault. The government and the food industry has created a regulatory regime and a sub system that’s led U.S. food to not be nutritious.
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Calley Means [00:23:32]
So what nutrition researchers who are paid by food companies do, is they look at these dynamics where 80% of the American people are obese or overweight. And we have disastrous health outcomes compared to every other developed country.
And they sit around in a circle endlessly and say, is it the glyphosate? Is it the food colorings? Is it the BHT preservatives? Is it the seed oils? And they have endless conferences.
And they sit in these five year cycles of the USDA nutrition guidelines and just fight about, and it’s a game, it’s a total game.
The issue is that we are relying too much on ultra processed food, which includes grains, which in the United States specifically are sprayed with many types of pesticides and herbicides that almost all come from China, that are phased out of the EU food supply.
Because, you know, Alex Jones actually was right on some of these things. I mean, some of these chemicals that are sprayed by the truckload on our food, actually are feminizing agents, are estrogen producing agents that do actually change the gender of frogs that swim in the water run off of our fields.
I mean, that is absolutely happening.
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Calley Means [00:24:43]
Debating whether it’s the glyphosate, whether it’s some other ingredient, it actually loses the point. And it’s kind of the spiritual strain that RFK hits, it’s what Good Energy, our book, is about.
We need to actually just reassert common sense. Like we shouldn’t be eating grains that are sprayed with pesticides that require the workers to wear a hazmat suit that kill everything in sight that are being phased out of every other country.
Like clearly that’s impacting our microbiome, which regulates many of our hormones in ways we don’t even fully understand.
Like we’re not going to have that science. Our body is this absolute awe inspiring interconnected machine. And it just totally misses the point to try to isolate.
If we literally, and I mean this literally, fired every single nutrition researcher in the United States government and cut all funding for nutrition research to zero and replace that with a standard that we should lower ultra processed food consumption for kids from 70% to 20%, we’d have a transformation of human capital in this country.
A mass increase in life expectancy and our economy would be on fire because what we’re doing by having 38% of kids is prediabetic is we’re ruining their futures and actually ruining their future of human capital.
So, that gets to the type of principles that we’re looking at. We got to return to simplicity.
I’m actually getting a lot of messages from various nutrition researchers saying that we have to have a 20 person panel to advise RFK on what specific ingredients, we need to have a mass panel of debating seed oils and all these other things.
No, we need to actually use this mandate to get back to simplicity, simplicity. That’s the key.
I think a lot of evil forces are hiding in the complexity of our dietary debate.
…
Calley Means [00:27:20]
Let me give the framework that I think Bobby’s talking about and that we’re certainly talking about and recommending for the new administration, which is that nothing is too important to subject to science.
I mean, we should not be afraid to conduct science on, particularly interventions that we’re giving and essentially mandating for every single child.
So the argument that vaccines are too important to study when demonstrably, there are terrible incentives of the vaccine schedule to where companies invest billions of dollars on new development, and then the second they’re able to lobby to get something on a schedule, it’s the only product in America that the governments pays for for every single American citizen, and then uses the regulatory agencies and the media, which the pharma industry funds, to call anyone who questions that schedule a war criminal.
We can be generally supportive of vaccines and admit that the incentives of getting new and more and more and more vaccines on the schedule are extremely problematic.
I would say anyone, anyone that’s actually stepping back and looking at the situation would probably say some vaccines, maybe have been good. There’s probably almost certainly issues with the schedule, that we probably have too many on the schedule, that we should analyze how our schedule’s different than other countries, that we should trust American parents to make the best decision for their kids.
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Calley Means [00:31:15]
We have the opportunity to have a golden age of innovation, including pharmaceutical innovation, but this idea that there’s no liability protection, this idea that you’re basically called a war criminal for questioning any vaccine and the fact that everyone’s grouped together, that we’re not even differentiating when they’re given.
I mean, there’s nuance in all of this. Like, obviously hepatitis B in the first day of birth makes no sense. It’s indefensible. I’ve yet to hear a defense of it. If the mom is tested for hepatitis B.
The literal answer from scientific authorities, when you press them on that, is that the American people are too stupid to remember. So we might as well just give to everyone.
It is an STD okay or intravenous needles. Never in American history has a child tripped on a needle that just had hepatitis B on it and got it– it’s ridiculous. Right?
So maybe that is a important intervention for many Americans, but the timing is like, but even to question the timing, you’re anti-vax.
Every reporter I talked to, to even insert nuance on 72 immune system changing interventions before a child reaches maturity is anti-vax.
That is the problem that I think the American people are pushing back on.
And you know, I think this movement is much wider than this issue, but I think it’s like why are we prevented from asking a question about that?
Why is the medical system mobilizing so much force to prevent any questions or any discussion of that issue?
But then when it comes to childhood obesity, childhood prediabetes, child diet, it’s hands off.
It’s way too expensive to possibly intervene. It’s $1,600 for Ozempic jabs, fine. Medicare approved that. Healthy food for kids not possible, right?
It’s– you are a war criminal if you’re a single lower income mom to not give 72 shots on the exact day that they’re recommended, even if your child is immunocompromised, or is sick, they still – CDC recommends to give it the shot. Don’t miss anything, versus, hands off on what you’re feeding your kid and actually added sugar and Coca-Cola and food stamps and all this other stuff is fine.
And the American Academy of Pediatrics has nothing to say about that.
It is obviously wrong where the industry is focusing. And I– I think vaccines are an important part of public health. I think the message is they should absolutely be subjected to science. Parents should absolutely be able to ask questions.
Parents aren’t trying to hurt their kids.
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Calley Means [00:40:57]
The FDA and the USDA, I believe their job is to explain the American people, when we have toxic, demonstrably toxic chemicals in our food, and are recommending even those chemicals, that’s their job.
It’s Congress’s job. They’ll scream, bloody murder, the food industry of like, you know, this is going to raise food prices, et cetera, et cetera.
We have to understand that is we should be working constructively with the food industry and Congress, because this is not a free market right now.
And I do, obviously, as these changes happen, we’re going to have a deep conversation with all stakeholders to reform the incentive structure and the subsidy structure that is propagating our current system.
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Calley Means [00:44:43]
I think that’s why we should have optimism. I think President Trump, the promise of his presidency and his promise to voters, is he’s going to empower people like RFK, and he’s going to take the blowback from the special interests.
Why are we optimistic too, with the inevitable deep state reaction to this?
We’ve got the presidential microphone and pulpit. I think what I constantly hear from members of Congress is that they kind of want this stuff done as humans.
I mean, we all understand the FDA shouldn’t be funded by pharma 75%, and totally co-opted and research, but it, they always say, it’s not the national issue. It’s like the corruption kind of happens because there’s not a spotlight on it.
By having a spotlight from President Trump and hopefully Bobby Kennedy, I think it draws and these things are, I think that’s why people are waking up being radicalized. It’s unimpeachably bad.
Like the stuff we’re talking about just literally makes no sense. It just does not make sense for our children’s food to be covered in crude oil that the USDA says is healthy.
I mean, that just doesn’t make any sense. So, if we could just keep up the spotlight, have good lawyers have kind of an attitude that we’re going to just do it, that we’re going to stand up to the scrutiny. You bring these things light.
This is not a monolithic, all powerful, this is not an all powerful industry. They can be disrupted. So that’s what gives me hope.
The voters and President Trump’s microphone are on our side.
The U.S. food supply remains one of the safest in the world. The Economist regularly updates a report that measures the Global Food Security Index, which considers food affordability, availability, quality and safety, and sustainability and adaptation, across 113 countries. The U.S. has moved up 25 positions for the food safety indicator since 2012 and is ranked a joint first for the food safety indicator in 2022.
Most recalls in the U.S. are carried out voluntarily by the product manufacturer, importer, or distributor. A company may initiate a recall based on their own sampling or findings, after notification of a problem by the FDA or other regulatory agency, or as follow up to internal investigations regarding consumer complaints. The FDA’s role is to ensure that the recalling firm is taking appropriate steps to protect the public from violative goods. This includes, processing the recall, evaluating the health hazard posed by the product, verifying the effectiveness of the recall, and encouraging the recalling firm to alert the public, when appropriate.
Our ultimate goal is for industry to do their part to ensure that the foods they introduce into the market are not adulterated or misbranded. Recalls help get the food off the market quickly when something goes wrong. Outbreak advisories provide important food safety information to the public. The occurrence of recalls and outbreaks means that manufacturers, importers and distributors are monitoring for issues and taking action when they detect a problem. Consumers should know that recalls and outbreaks indicate that the problem has been identified and is being addressed.
When a company issues a public warning, typically via news release, to inform the public of a product recall, the FDA shares that release on our website and communicates the recall information through multiple social media platforms. In instances where firms refuse to issue a public warning, the FDA may issue a Public Health Alert.
New York City has experienced an increase in Mycoplasma pneumoniae among people under age 18. The NYC Health Department is closely monitoring the situation and regularly receives updates from providers, laboratories, and health care facilities. Mycoplasma pneumoniae is not a reportable disease; however, we work closely with the health care community to get the most complete picture as possible.
Regarding Boar’s Head, I can confirm that an inspection is being conducted by USDA OIG’s Office of Audit.
The objective of the inspection is to determine whether the Food Safety and Inspection Service and the Virginia Department of Agriculture and Consumer Services established an effective process to (1) ensure that corrective and enforcement actions for reported noncompliances at the Boar’s Head Establishment, Jarratt, Virginia were implemented; and (2) identify, elevate, and address recurring noncompliances reported at State-inspected establishments to reduce the risk of adulterated product entering the food supply.
Due to this being an active public health investigation and to protect the privacy of all parties involved, we are unable to answer your first question at this time. Regarding your question about if the county has identified other avian influenza cases in animals or workers so far this year, we have not.
CDC is aware that California has identified a presumptive positive influenza A (H5) case in a child. CDC is supporting the investigation by the California Department of Public Health and is awaiting the specimen to test at its lab for confirmation and will provide further updates promptly.
Yes, that is correct – the child and their family members tested positive for the same, more common respiratory viruses that are not bird flu.
Yes, that is correct – the child and their family members tested positive for the same, more common respiratory viruses that are not bird flu.
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Can you also clarify whether it is known if the child consumed dairy products?
At this time, we do not have any additional information to share beyond what was included in our news release.
August remains the peak for the percentage of pneumonia-associated emergency department visits with a Mycoplasma pneumoniae diagnosis. As shown in the figure on Mycoplasma pneumoniae Infection Surveillance and Trends M. pneumoniae CDC, these diagnoses dropped a little after August, but remained high through early November. Of note, diagnoses among 0–1-year-olds have steadily increased throughout the fall without any subsequent decrease.
Though we have seen an increase in every region, the highest levels are in HHS Regions 2, 6, and 7, while the lowest are in HHS regions 8, 9, and 10. It’s important to note that while the National Syndromic Surveillance Program collects data from the vast majority of emergency departments, it isn’t 100%, so there may be regions of the country with more or less reporting. CDC will continue to monitor the situation.
The genotype is confirmed as A3, indicative of a spillover from migratory birds and represents a different genotype than that found in the current outbreak among dairy cows in the U.S.
Is it known how H5N1 was introduced to the flock that was confirmed this month?
No, it is not known. However, wild bird introduction is possible.
For example, wondering if any links have been identified to imports or travel.
No, no link has been made to importation or travel. (FYI – Hawai‘i has strict importing regulations for birds and other animals, including cattle)
Also, are you able to say if multiple herds or flocks have been identified infected with H5N1 in Hawaii, or only one?
There is only one confirmed site and investigations are ongoing.
Robert Redfield [00:00:13]
I’m probably one of the biggest advocates for vaccine. You mentioned that I, when I was CDC director, I would say that I think vaccines are the greatest gift for science to modern medicine. And I still believe that.
Kennedy’s not, anti-vaccine. What Kennedy is about is transparency about vaccine, honest discussion about vaccines, asking for the data to show that these vaccines are safe and they are efficacious.
And the mere question of asking what’s the data for safety, many of his detractors say, okay, well, you’re, anti-vax.
No, just show me the safety data. Show me the efficacy data.
I have high confidence that Kennedy is going to be a strong supporter of, of transparency on vaccines and when the vaccine data shows that they’re efficacious and a benefit to the American public, he will promote them.
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[00:01:36] We need transformational change.
Right now, we’ve created over the last 20, 30 years, we’ve developed a disease system. We need to make a health system.
And when Kennedy says he wants to help make America healthy again, when I was CDC director, one of the challenges was we lost about 1.2 million people died of COVID.
Other countries like Taiwan lost less than 10,000 people. Why did we lose so many people?
We lost so many people is cuz we’re because (crosstalk) we’re a sick nation.
And Kennedy is really committed to making us healthy again.
And I do agree with you. We should all get behind him. Making a healthy America is not a partisan issue.
The routine contract tracing investigation continues, and the risk assessment – that there is no concern or evidence that mpox clade I is currently spreading among individuals in San Mateo County or elsewhere in the United States – remains unchanged.
CDC should have viral sequencing completed soon– we are currently awaiting the specimen, which is being handled according to select agent regulations.
It looks to me like the NORS figures totaling the number of foodborne illnesses linked to Escherichia only go through 2022.
Is there any more recent totals available? If not, are you able to share an estimate for when those are expected to be released?
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I checked with our experts, and it sounds like those are expected to be released by late winter 2025.
“There’s no question that we need a pro-life HHS secretary, and of course, we have concerns about Robert F. Kennedy Jr. I believe that no matter who is HHS secretary, baseline policies set by President Trump during his first term will be re-established.”
Sen. Susan Collins [7;55]
Well, you know, I am a member of the HELP committee, the Health Education, Labor and Pensions Committee, we have partial jurisdiction over the Secretary of Health and Human Services, so we will be holding a hearing on Mr. Kennedy’s nomination.
The committee that actually votes on it and will also hold a hearing is the Senate Finance Committee, so I anticipate having ample opportunity to question him and learn more about his views.
That department is a huge, very complex department with a lot of different programs, and I will be talking to him about that and his managerial experience, as well as about some of the views that he reportedly holds.
So I’m not worried about not having enough information or enough time, because in that case, I actually am on the committee that has partial jurisdiction.
Question [9;04]
Are you worried about some of the views he has?
Sen. Susan Collins [9;11]
You know, I want to hear directly from him, because I’ve never met him, so all I have are press reports.
So I want to hear directly from him.
John Mize, CEO of Americans United for Life:
“Like many newcomers to the conservative pro-life movement, Robert F. Kennedy Jr. needs further education on the reality of abortion and its harmful effects on children, women, public health, and our nation. We are optimistic about working with RFK Jr. to correct the wrongs of the Biden/Harris Administration. I find his statement at the Iowa State Fair in August to be encouraging. This man had thought through the issue and drew a line at 15 weeks, much further towards conception than any of his Democrat political colleagues ever would. I hope RFK Jr. shows a clear sign to the pro-life movement that he is aware of this devastating threat to American children to encourage support of his nomination. Showing his desire to re-instate REMS, basic safety measures on the abortion pill, would be a large signal to the movement.”
Another one who’s another great mind, and a great guy, and so popular, and I think he’s right, he wants to make people healthy. It’s driven him pretty wild over the last number of years.
And the Democrats didn’t treat him well. He was doing fantastically well, and I think they came out with some rule that you had to do this Mike, you had to get 70 or 75% of the vote to qualify to be in the primary. That was a pretty tough thing to get.
And he was doing incredibly well and he decided he can’t do it, went independent, now he’s with us all the way. And today I nominated him for, I guess, if you like health, and if you like people that live a long time, it’s the most important position: RFK Jr.
Bobby? Good.
And I just looked at the news reports. People like you Bobby. Don’t get too popular Bobby. You know, you’ve reached about the level. No.
We want you to come up with things and ideas and what you’ve been talking about for a long time. And I think you’re going to do some unbelievable thing.
Nobody is going to be able to do it like you, and boy does he feel it in his heart. So congratulations also, to your family.
This conversation took place a few weeks before RFK Jr. suspended his campaign and endorsed President Trump.
They were speaking generally about different positions, not specifically HHS secretary although that might have come up.
There have been no methodological changes from last year to this year. One thing to note is COVID-19 vaccine distribution for the 2024-25 season was earlier then last season for the updated 2023-24 COVID-19 vaccination. This earlier start could likely be the leading reason for the higher coverage in all age groups at this time compared to similar calendar time last season. We will continue to track vaccination data as we continue through the season.
Peter Marks, FDA [00:22:16]
If we end up having to spend a lot of time, re-litigating things that we know work, like prophylactic vaccines, it will take away from the time that we have to help push innovation of very novel products.
So I think that’s the– I think where we have to, or this has been a problem in the United States that’s been around for the past years, since– it was there before the COVID 19 pandemic. And it has only grown in place, this doubt about vaccine safety and effectiveness of vaccines.
And hopefully we’ll be able to clear up some of the misinformation over the next years.
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Peter Marks, FDA [00:32:57]
I think we’re going to continue to work– we are public health professionals. We’re here.
In some ways I think, I don’t mean to have a strange analogy, but much like the Department of Defense, we’re the Department of Defense against pathogens that are coming around, people– we are going to have to stand guard, and that doesn’t matter who’s in the White House because, I hate to tell you, the bird flu for those– is now in a lot of different species, including cows, which are big, it’s replicating. And it’s just a matter of time before we see more breakout and potentially something that could be either epidemic or pandemic potential, whether it’s this year, next year or the year after. So we have to be prepared for that.
We have to have, keep our heads about us, and I think we’ll get support, hopefully. And I think we found working, we managed to get by, by keeping our eye on public health, and drowning out a lot of the noise. So, that’s what we’ll have to do here.
It’s my one reason why I just hope we can keep vaccine confidence up, because it would be, if we do have another epidemic, it would be really nice not to lose lives unnecessarily like we did during COVID 19, from people who didn’t take vaccines, who, because they had false impressions of what they were about.
So I think our, our goal is focus on public health, get the work done, and I think we’ve, best analogy is if we can go through and be kind of stealth below the radar screen, get the public health mission done and only pop up above the radar, into the radar zone when we need to.
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Peter Marks, FDA [00:32:57]
I think we’re going to continue to work– we are public health professionals. We’re here.
In some ways I think, I don’t mean to have a strange analogy, but much like the Department of Defense, we’re the Department of Defense against pathogens that are coming around, people– we are going to have to stand guard, and that doesn’t matter who’s in the White House because, I hate to tell you, the bird flu for those– is now in a lot of different species, including cows, which are big, it’s replicating. And it’s just a matter of time before we see more breakout and potentially something that could be either epidemic or pandemic potential, whether it’s this year, next year or the year after. So we have to be prepared for that.
We have to have, keep our heads about us, and I think we’ll get support, hopefully. And I think we found working, we managed to get by, by keeping our eye on public health, and drowning out a lot of the noise. So, that’s what we’ll have to do here.
It’s my one reason why I just hope we can keep vaccine confidence up, because it would be, if we do have another epidemic, it would be really nice not to lose lives unnecessarily like we did during COVID 19, from people who didn’t take vaccines, who, because they had false impressions of what they were about.
So I think our, our goal is focus on public health, get the work done, and I think we’ve, best analogy is if we can go through and be kind of stealth below the radar screen, get the public health mission done and only pop up above the radar, into the radar zone when we need to.
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Question [00:36:44]
From where you sit. And when you talk about conspiracy theories and so forth, is there a positive spin on unleashing RFK on the FDA?
Peter Marks, FDA [00:36:56]
Positive spin?
So I guess it’s how you react to a challenge and we’d be very happy to have lots of public advisory committees, where there are experts who– that will speak. And hopefully that would be returned, at the return favor that we would ask, is that someone keep an open mind to the fact that vaccines might actually work and might not be dangerous.
So I think we are open minded. I think that could be– look we at FDA want, are trying to lean in as much as we can. We have a group of devoted public servants.
I think, we can be asked to respond to a lot of different incoming that are not our typical incoming.
The only thing I would ask from anyone is to just do it with respect, because just as I think at CMS, we have now up to 20,000 people in FDA, 1,500 in my center, 6,000 in the center for drugs, who are so devoted to what they do. And they do what they do to protect the American people. Not because they’re trying to, not for any kind of nefarious purpose.
So they, and during the COVID pandemic, people worked 14 hours a day to move those vaccines along. So there’s a lot of devotion there. So hopefully we can have a dialog that is a civil one.
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Peter Marks, FDA [01:01:46]
So I sat in the room with Mr. Kennedy before on the issues of vaccines multiple times now.
I think there’s this great opportunity if he focuses on chronic diseases and on health. I think his concept of doing things about our, what we do with foods, and what we do with things, you don’t need GLP one inhibitors, if you don’t actually have weight problems to start with, because you have good diet and exercise, perhaps. And if he takes an approach towards that perhaps, very supportive.
I think as we, as he comes towards FDA, I think we’ll be looking to have– we’ll engage– happy, we’ll have to engage with a dialog with him and see.
I just would ask– what I would ask of him is that he keep an open mind. We’re happy to try to show as much of the data as we can. And I think the data are essentially overwhelming, in certain areas, but we’ll just have to– we’ll just have to engage in the dialog.
And perhaps engaging in that dialog, especially if it’s in a public venue, it may help, it may help bring some of the rest of the country along because sometimes as somebody is convinced, perhaps, maybe some of the rest of the country will be convinced of the utility of vaccines.
Remember vaccines also help chronic conditions. If you look at people who get influenza vaccinated, and COVID vaccinated, they have a lower risk of heart attacks, et cetera.
So, basic public health measures, we’ll do what we can to interact with Mr. Kennedy to try to help make sure that those get delivered to patients.
It’s been good. You know, vaccines have been good since about, we’ve known that they’re worthwhile since about 17 something. So it’s probably a– and George Washington wanted to virulate his troops. So they’ve been around for a little while.
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Peter Marks, FDA [01:03:42]
If he wanted to engage I’m– we’re open, he knows where– he probably knows where to find me.
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Peter Marks, FDA [01:03:56]
In terms of the safety of the safety of vaccines. We’ve tried to do that pretty actively with our CDC colleagues, and people are free to go to our websites, but I’m happy to have anyone contact me. We’re happy to– we’re happy to try to provide as much information as we can, because there again, there’s no secret files.
I mean, if there’s secret, they’re– you know, I hold a security clearance. If they are secret from me then, so they must be at some other level of classification.
But as far as I know, all the data we have indicate that the vaccines that we have licensed in the United States are safe and effective.
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Peter Marks, FDA [01:04:53]
I think I would say something that I’ll say– I’m going to try to try to be very fair.
There are doctors with MDs and there are PhDs. Okay? I can tell you that PhDs are able to dive down to a level of understanding of science, perhaps that MDs, some MDs, can’t.
I think he has an understanding of science that perhaps does not– it’s not as deep as others might, but I think what, I would just ask him more than anything else, rather than, because I know a number of attorneys who know more than most PhDs and MDs about medicine. So it doesn’t, it’s not the degree.
It’s just a matter of keeping an open mind.
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Peter Marks, FDA [01:08:08]
Look, the people who I work with absolutely are committed to what we do in terms of protecting the health of Americans and– so yes, I do want to keep my job and I do want to make sure, because I think we have a team together that has been put together that can help protect.
We’ve been through– we have a team now that’s been through a pandemic. We managed to respond to the mpox epidemic remarkably rapidly. And it did not become greater than it was in part because we were able to respond so well because we had done it before.
Emergency use authorizations were issued in a matter of weeks instead of months because of how well people did it.
So I think you have a group of people that are there very committed to public health because they feel a commitment to the individual people in the country, not to politicians, but to what it means to mothers, fathers, sons, daughters, to have the best possible state of public health in this country.
The declines in estimated overdose deaths that we have continued to see in these recent data are unprecedented, robust, and appear to be reflecting real trends. These data give us hope that we may finally be making significant progress in reducing the devastating loss of life from the overdose crisis.
While these data are cause for optimism, we must not lose sight of the fact that nearly 100,000 people are still estimated to be dying annually from drug overdose in the U.S. Each death represents a tragic loss that could have been prevented. It’s also important to acknowledge that progress has not been equal for all groups. Unfortunately, for the most affected groups, namely Native Americans and Black American men, the death rates are not decreasing and are at the highest recorded levels.
Understanding the causes for the different trends in overdose mortality is needed to tailor implementation and support of evidence-based strategies to prevent and reduce deaths. We must continue to prioritize efforts to prevent drug use, treat addiction, provide access to lifesaving harm reduction services, and support people in recovery that are equitable and accessible to everyone who would benefit from them.
An individual has been hospitalized at British Columbia Children’s Hospital diagnosed with presumptive positive influenza A(H5). This is the only presumed influenza A(H5) illness among humans identified in Canada. CDC has been in touch with Canadian health authorities and expects to learn more as Canadian health authorities acquire additional information. Contact the Public Health Agency of Canada for the most up to date information on this potential case.
Influenza A(H5N1) has been detected recently in poultry, wild birds, and mammals in British Columbia. Ongoing outbreaks of influenza A(H5) have been detected globally in animals. Sporadic cases are not surprising; nevertheless, CDC continues to work vigilantly to monitor worldwide H5N1 activity.
The risk to the U.S. general public continues to be low. People with exposure to infected animals, including birds and dairy cows, are at higher risk.
Mandy Cohen, CDC [00:01:20]
What I’ve been sharing with my team is that an election happened, but our mission hasn’t changed one bit.
CDC exists to protect health and improve lives. We’re going to stay focused on that mission. And folks want fundamentally, I believe, want their families to be safe, want their families to be healthy.
And we need an entity like the CDC, as well as our larger public health ecosystem, to protect folks health every day. And we’ve been working hard to be a different CDC. We are.
Four years has been really important for the CDC to learn some very important lessons and we’ve taken action on those. And so I’ve told our team stay focused on the things that we have been prioritizing, making sure we are ready to respond to any health threat coming our way.
We prioritized improving mental health in reaction to exactly what we were seeing in those polls, and supporting young families and making sure we’re preventing, and not just reacting to those health threats.
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[00:05:41] Fundamentally folks want to make sure that we have an entity that is ready to respond to health threats. And that means we need data infrastructure to be able to identify those things, have the people who are talented to understand how to respond.
But I do think that there, Rob said it well, there is a difference between understanding the evidence and the data and policy choices. And I think particularly when we look at resources, I think that is where I’m most concerned, because this kind of work and that infrastructure takes resources and you need to maintain it.
Now we already knew we were going to hit a bit of a cliff in the next coming year to two years as COVID funding goes away. And so there was already going to be a choice, but I am concerned when I see proposed budgets out there that zero out our ability to work on overdoses and suicide.
What do you think is killing people under the age of 50, top reason? It is unintended injury, right? Which is a combination of suicide, overdoses, car accidents.
And for children, the number one thing that is killing our children is drowning, right? So if, if we are drowning, our young kids, right, two to five, right?
So if– we have to work on those issues, we need the data and the evidence and the investment in those areas. But the good news is in the last four years, we’ve been making progress on overdose.
And actually you’re going to see some new data from the CDC today, um, about overdoses and continued progress in that space.
We’ve had our first reductions in fatal overdoses that we have seen.
And we need to keep progress on that.
So we, we are concerned again about having those ongoing resources to do this important work, to highlight the problems and the challenges, and then bring the evidence to solve those challenges.
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[00:08:03] So it is a real trend and that’s great. Look, we are throwing a lot at this, and we are starting to really break through, I think with some important things.
One, we know connecting folks to care at a moment of a non-fatal overdose is really critical, right? Because folks have had a major life event happen. They’ve almost lost their lives. It is the important time to connect them to care. We’re using way more peer supports to do that.
We have– we are much more, talking much more about fentanyl, and making sure that folks understand that fentanyl could be in things that you don’t think fentanyl could be in.
And so using things like fentanyl test strips, that is a common, common language in our high schools, unfortunately we had to be there.
So those are the kinds of ways in which we are highlighting it. I mean, and this work has been going on for years.
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[00:10:13] As you were saying in the United States, at least those cases had been quite mild, reassuring, but as we were seeing around the world, when we see other cases of avian, it has been more severe.
And so this case in Canada that came over the weekend, we have some more work to do to understand the strain of the virus.
It is our presumption that it potentially is from one of wild birds. It may look more like some of the avian flu cases we see often in Southeast Asia, that tend to be more severe, but we don’t know that until we can do the genetic analysis.
But what we want to make sure again, how do we think about any of these potential pandemic threats is making sure we have the infrastructure ready to go, to be able to detect, to prevent and to respond, right? And so we have a very extensive network of flu surveillance across the country.
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Question [00:14:20]
We have heard a lot about Robert F. Kennedy Jr. potentially taking some kind of czar like role over health agencies. You know, he tweeted in March that he wants to clean up the cesspool of corruption at CDC and forced the public health agencies to come clean about COVID vaccines.
He’s also said that he wants to require there to be long term placebo controlled trials run on all childhood vaccines recommended by the CDC.
What is your message to people working in public health about how to respond to that kind of language?
Mandy Cohen, CDC [00:14:55]
You know, I think we have a very short memory of what it is like to hold a child who has been paralyzed with polio or to comfort a mom who has lost their kid from measles, and it’s not that many generations ago, but it is a far enough away that folks have forgotten.
And we need to remember that the reason we have these childhood vaccines is to make sure that we are the strongest, the healthiest, that we can be as a community.
And I don’t want to have to see us go backwards in order to remind ourselves that vaccines work. Like they work, they protect our kids, they are our best defense against these terrible illnesses that luckily we haven’t seen, but we are starting to see around the world, because vaccine rates post pandemic are lower.
We’re seeing more measles cases. Again, measles is one of the most contagious viruses out there. It’s the canary in the coal mine for vaccination rates. We’re seeing more measles cases here in the United States, but luckily more than 90% of our, of our communities are vaccinated that protects us.
But remember that vaccines are– only work well when we are all getting to that. We’ve heard those terms, herd immunity, when we’re all in this together, because we know that some of some folks whose immune systems don’t work as well as others, their vaccines are not going to protect them. So they don’t have the kinds of choices that some of us do have.
So we, I think the important part in this moment is to remember, to make sure that we’re focused as Dr. Califf said on the evidence, and that we stay focused on what works to protect the health of communities.
No one wants to see a child paralyzed, a child die from something that we can prevent.
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Question [00:16:52]
And how do you respond to sort of charges that there are these tropes of hidden data that the CDC has not released about vaccine safety?
Mandy Cohen, CDC [00:16:59]
You know, look, CDC has been incredibly transparent with information and data, and I’m really proud of that, of that transparency.
And so, we want to make sure folks feel reassured about vaccine effectiveness, about vaccine safety. And I think that’s what folks are going to continue, continue to see.
[00:00:57] This person was admitted to the BC children’s hospital late on Friday, and over the weekend, their condition had varied and sadly, they right now remain in critical condition.
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[00:05:51] That has been our priority, the contact tracing over the past few days to make sure that there are not other cases out there that we’re missing, to make sure that people who have been in contact with this young person during their infectious period are assessed, are tested. And, all of the people who’ve been in contact either at home or in the hospital are notified.
So we’ve been following up. We, and I say that the team at Fraser Health Public Health at the BC CDC, BC children’s hospital BCH, have been working together over these last few days to ensure that all family, friends and contacts have been identified in the community, that our public health teams are following up with healthcare workers as well, that have been in contact with this young person.
And we would have tested a number in the vicinity of three dozen people for influenza to make sure that there’s no hidden or asymptomatic or mild infections out there. And people have been offered prophylaxis with an antiviral medication called oseltamivir to, prevent them from developing symptoms, should they be infected.
And we’ll be following up the public health teams who will contact people daily for 10 days from their last exposure.
That is one of the reasons why I have confidence that we at at this point have not identified anybody else that is sick with this virus in British Columbia right now.
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[00:08:35] We’re very grateful again, to the family of this young person who at the same time they’re caring for and supporting their loved one have been very generous in sharing information with us as best they can, and being committed with us to finding out how this happened.
Having said that, I must caution that there is a very real possibility, we may not ever determine a source, but at this point we have a number of leads that we’re following, and we will be tracking down everyone.
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[00:14:46] As I mentioned in BC, we’re in our sixth wave of high pathogenic AI from H5N1, and it’s affecting now, as of this morning, 26 premises across British Columbia, primarily in the lower mainland Fraser valley area. And this is aligned with migratory waterfowl, so geese and ducks that migrate from the north and they fly south at this time of year and then back north again in the spring.
So back to our investigation, we are looking very, very carefully at all potential animal exposures, bird exposures. There were other pets in the house, and there was contacts with pets in other houses.
Right now, we have no specific source identified, but the testing is ongoing in partnerships with our veterinary colleagues and will be continuing that investigation very thoroughly.
I will also say there has been no link to any of the infected poultry premises here in British Columbia. So that’s not where we seem to have a source, related to this case, as I mentioned, an environmental source is also something that we need to investigate thoroughly, although it’s less likely.
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[00:22:54] Their initial symptoms started, not surprisingly with conjunctivitis, so infection in the eyes, fever and cough. And those are really the hallmarks.
It’s very difficult early on to determine if that is from influenza from COVID from other respiratory viruses.
So it really was the surveillance network that we have in place and the testing that was done that led us to identifying the H5 in this person.
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[00:26:48] So there were a variety of animals that had been in contact, in different settings, including dogs, cats, some reptiles, no birds that were aware of.
So those are the ongoing investigation that were, that the public health teams and the veterinary teams are doing together.
There was one one animal, a dog that was sick and advanced testing has been done on that animal. And so far, all of the tests that have been done on the animal so far have been negative.
So we’ve not yet identified a source, but that is absolutely an ongoing investigation.
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[00:36:59] This person does not live on a farm and there is no contact with any poultry farming or any other farming, in the– their area, or in the family.
So there’s no obvious quick connection to a farm or exposure to wild birds or to poultry that we can detect at this time.
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[00:41:47] As you can imagine, things have progressed and the clinical condition can change very rapidly. But, they’re experiencing acute respiratory distress syndrome.
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[00:42:52] So yes, we have a lot of people working back and forth across– moving back and forth across the borders.
In this case. However, there was no– this person did not have any contact with– did not cross the border. Did not have any contact with farms or ill animals in Washington state.
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[00:44:28] This was a healthy teenager, prior to this, so no underlying conditions, and it just reminds us that in young people, this is a virus that can progress, and cause quite severe illness.
And the deterioration, as I mentioned was quite rapid. So the person, I mentioned that this symptoms started on November 2nd. But they had not been in school.
There were definitely people that they were in contact with during the infectious period, but they were not in school during their infectious period for a variety of reasons.
And no there’s been no travel in any of the contacts, any of the family or friends, outside of the country– I shouldn’t say that– to Vietnam or other areas in Southeast Asia in the last little while.
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[00:49:09] And we know as I mentioned that young people in Vietnam and China and other places also are more likely to have severe illness with this virus. So that tells us that something about our immunity as we get older, seems to protect us from getting those deep lung infections that cause the more serious illness.
One of the hypotheses that I think there’s some evidence for is that as we get older, we have more exposure to the N1, particularly since 2009 where we’ve had an H1N1 circulating every year.
So whether we have exposure to that, N1, confers some protection either from vaccination or from previous infections that we accumulate some better protection for those more serious infections from that, from having that history of vaccination or infection that you just don’t have the time to accumulate, if you’re a young person.
So that’s a hypothesis. I think we don’t really know why mostly it’s a milder infection while mostly in older people, especially adults, and why it doesn’t transmit thankfully very easily between people.
Robert F. Kennedy Jr [00:02:20]
The stuff that he is really, like, bad.
It’s not– campaign food is always bad, but the food that goes on to that airplane is like just poison.
It’s all– you have a choice between– you don’t have the choice. You’re either given KFC or a Big Mac. That’s the big– that’s like when you’re lucky.
And then the rest of the stuff, is I consider kind of inedible, but I was eating it.
And then he eats Diet Coke, I saw it, I was with Dana White the other day, and who was really good, great for my campaign. He was a huge, huge supporter.
He’s very close to Trump. They’ve had a relationship for 20 years for, you know, through UFC.
He said during that time, sometimes he’ll sit through a fight with Trump, and he’s five hours in the fight, said he has never seen Trump drink a glass of water.
Question [00:03:34]
Yeah, exactly, just like sodas or Diet Coke or whatever?
Robert F. Kennedy Jr [00:03:39]
On diet coke.
But he has this extraordinary energy.
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Bobby Kennedy [00:22:11]
I’ve seen that now, again and again, with Trump, during the transition where we make all these suggestions about who should be at each post, he comes into the meeting, and he very quickly, we have– there’s eight giant screens and each person has a picture of themselves on the screen. They have a biography next to ‘em. You can press a button and you can see three different clips from that person.
So you can see how he talks and how he presents himself. He or she. And he goes through them very, very quickly.
And then he says, I want that guy. And– and he’s making the decisions. He listens to what people say, but he makes the decisions. And he has very, very firm ideas. And he decides very quickly, and the meetings are very quick when he comes in.
And it really– you know, Elon Musk is in the room. Amaryllis, my daughter-in-law is in the room, and a few other people, and they all have very strong ideas. These are all alpha people. And they’re, you know, they have very strong ideas about what should happen, but he makes those decisions. He makes it very quickly.
I’ve seen a level of decisiveness, a real vision. And the interesting thing about him is he doesn’t care what that person believes. The person, there’s a very big sympathy among all of his advisors that we should stay away from the neocons.
But if he puts a neocon up there, you shouldn’t worry about it because the decision ultimately is going to come from him.
And he said to me, at one point, he said he really hates John Bolton. John Bolton was his NSA advisor.
And he said, but it was good that I had him there because it scared the shit out of everybody in the world at, if I had John Bolton there, John Bolton wants to bomb at every country in the world.
And he said, they believe that I was gonna do it too. So it was good for me to have him there. And so that’s the way he thinks about things.
He doesn’t care what you believe. He doesn’t care what your ideology is. He’s going to make this decision himself.
And I’ve been so impressed with that. It’s completely changed my opinion of who he is, and really convinced me that this guy that I had such contempt for such disdain for is actually, you know, a really extraordinary leader that he could be one of the great presidents in history.
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Calley Means [00:37:19]
I think President Trump, with his team of Bobby Kennedy, Tulsi Gabbard, Elon Musk, you know, on down the list, have a mandate from everyone here, a mandate from voters to kick the special interest in the deep state, out of the office and really drive foundational change.
So I think what we can all do is just maintain that and continue to just speak out support President Trump and support him in what he wants to do and what he’s promised to do, which is true transformational change, not partisan change, but true foundational change.
When it comes to MAHA, and I’ll just be real quick here, and Bobby obviously will have much more to add, but we’ve talked about three things, cleaning up corruption.
What can we do? The FDA is 75% funded by pharma, the USDA nutrition guidelines, which set guidelines for our children, 19 out of the 20 advisors are funded by food or pharma companies. The NIH is an orgy of corruption where 88,000 grants in recent years have gone to conflicted researchers.
That ties to number two, the gold standard, just this isn’t about any agenda. It’s just understanding what’s happening.
We have AI, we have so many smart people. We should be open sourcing all the data. We should be fearlessly understanding why people are getting sick. We should let the data data guide us to where it goes. We should not be covering up for any previous guidance.
We basically need to say a lot of guidance on pharmaceutical products, on food, on what we’ve been giving our children might be wrong. We need to have fearless data. That’s all we’re asking for.
And you can do that very quickly.
And then just end the chronic disease epidemic and what Bobby’s talked about and what President Trump has talked about. In the Republican platform, it says, we believe in chronic disease reversal and benefit flexibility.
We are not telling anyone what drugs to take, what food to eat, what to do, but the $4.5 trillion of medical system right now is top down, it’s mandates.
When you are a child on Medicaid, who’s a little bit sad, you got a 15 minute appointment, you’re getting a pill, SSRI. If you have high cholesterol, 15 minute appointment, you’re getting a pill, statin on down the list. Now they’re pushing Ozempic on 12 year olds.
The mom, that mom on Medicaid should have flexibility to go to health coaching, to go to nutrition, to go to more functional methods.
Just giving patients the choice, if we can get the science, right, and then let patients make their own decisions, Americans aren’t trying to kill themselves.
They want their kids to be healthy. That’s the foundation of the policies we’re putting together.
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Bobby Kennedy [00:40:03]
There is a lot of science that suggests that mental health is deeply connected to the food intake.
There’s a very, very good study that shows that children who are insulin resistant at age nine are five times, four, five times more likely to have a psychotic episode before they’re 24. There’s another very, very strong study that shows that kids who become obese during puberty are four times more likely to suffer severe depression, by the time that they’re 22 years old.
And, there’s a dispute about whether the depression is come coming from the social demotion that you get from being obese and fat shaming or whatever, but it is really an irrelevant dispute. If you are overweight, you’re more likely to be depressed.
There’s a recent study of epidemiological study of 300,000 people that shows a very, very strong link between depression and– people who eat processed food every day are three times more likely just to experience clinical depression and people who don’t eat it every day, in other words, not people who are eating organic food all the time, but just people who don’t eat every day, less than every day.
And then there’s a series of pilot studies. And normally I wouldn’t quote because they’re not strong science, but they’re indicative, and they should be mentioned that diseases like anorexia actually disappear. You lose your diagnosises by treating them with diet with keto diets and other kind of diets.
And those are the studies that NIH should be doing.
NIH won’t do those studies because they don’t want to know the source or the cure or the treatment for chronic disease.
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Calley Means [00:48:21]
I can’t look at my phone without 20 messages from reporters, writing stories about how this man is gonna be dangerous to public health.
Public health, we are on the verge of collapse. Like we, we are destroying our children’s future right now.
And there are evil forces trying to protect that because it is the largest and most profitable industry and the fastest growing industry in the country is healthcare. And it profits from children being sick.
And success, one big level of success, and what we can all do in this room is we can stand up to these forces and change consciousness to where we all, a lot of people in this room see it, we can’t go back. We must change the incentives. We must change it to where we, we stop just poisoning and then drugging kids at scale and start asking what they’re eating. Start asking what they’re putting in their body. Start asking about environmental factors and start, people are saying, this is gonna be bad for farmers.
We want farmers to be at the center of healthcare. In the United States, we spend two times less per capita. We spend half the amount per capita on food as they do in Europe, but they spend three to four times less per capita on healthcare in Europe, they live 5, 6 years longer. Like they’re, they’ve got something going right there. They’re not poisoning their population and then cleaning up the mess.
Like, that’s the level we’re on. This can happen quickly if we all stay on that consciousness level and really help Bobby and help President Trump stay high level and not get lost in the weeds.
Like we just need to change our paradigm of how we think about these things.
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Calley Means [00:52:46]
It’s so simple, but if we have a obesity and diabetes crisis and among six year olds, maybe it’s not working to drug them.
Maybe doctors should be recommending dietary interventions. Maybe we should be incentivizing exercise. You can do that from the medical system.
If you get the standards of care, and frankly, a lot of this is bureaucratic. It’s not even statutory. You don’t even need Congress.
The– we have outsourced billing codes and Medicare, Medicaid to the AMA, which is a lobbying group for pharma. And they outsourced to medical groups like the American Diabetes Associaton, American Academy of Pediatrics, that are literally pharma front groups.
And there’s not a word in American Academy of Pediatrics guidance on childhood obesity about food. It actually says, do not wait for dietary interventions, drug your child right away. And they’re going down to six.
So the research which Bobby’s talking about, if we can get control of the research, that’s what the bad people have realized.
There’s nothing higher in society than a Harvard or NIH study. All culture, all policy flows from that gold star scientific research and because the research has been co-opted that has trillions of dollars of ramifications.
So if we in the next four years can get not with any ideology, but just get the conflicts out of the research that then impacts what doctors can do.
They’re stuck in this system from the top.
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Bobby Kennedy [00:54:45]
If I could wave a magic wand, I would put the same effort into this as we put into COVID: to declare a national emergency and to do things that are going to be really dramatic and bold that change very, very quickly.
President Trump wants to see, has told me, he wants to see concrete, measurable diminishment in chronic disease within two years.
And, in order to do that, we need to operate very, very quickly. And we need to treat this with the same kind of urgency that we did, the COVID epidemic.
This is a thousand times worse than COVID in terms of what it is the cause that it’s imposing on our society and on our lives.
COVID was killing people mainly in the last year of their lives. 81, 82 was the average death from COVID.
But this is hurting people from the day that they’re born and it’s destroying lifespans of years. And the cost that it’s imposing on us is existential.
So we need to be able to respond very quickly and in order to do that we need to have a really good crack staff right now.
We have the people, we need to get them paid, we need to get them housing in Florida, so they can be right there while we walk into these transition meetings, day after day.
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Calley Means [00:58:45]
We are pushing so hard. We’ve got the mandate. Now we just need to operationalize what Bobby’s saying.
So this is so helpful, but we’re really trying to build out an incredible coalition, to both identify names to staff these 600 key positions and really just build, continue this movement.
I mean, on the “All In” podcast, they said, well, Bobby and Trump, it’s a realignment of American politics.
So if we can build this coalition, get the right names, get the organization, we’re going to get real change done. And I think really, really revolutionize American politics with this new coalition.
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Bobby Kennedy [01:00:01]
I see what’s happening now that we have to restore people’s mental health. We have to restore their physical health and create, right now start growing a new generation of kids that is super healthy, the way that Americans were when I was a kid.
But there’s also spiritual health in this country. And that I think is at the core of everything that we’re engaged now in spiritual warfare. And it’s spiritual warfare against this kind of elite technocracy that’s trying to take away our power and take away our rights and to commoditize our health, our children, our landscapes, everything that we value in this country.
And, there’s no other country in the world that has what we have in this country. I’m always skeptical of people who talk about America as an exemplary nation, because it’s been used to justify warfare and, military dominance of the globe.
But the truth is today, we are the last redoubt for personal freedom in the world. There’s no country in Europe that has a constitution like we do.
We have the constitution in the United States is unique on earth. And, we had this, we were part of this project to take all those freedoms away from us.
And, you know, thank God in some ways for COVID because it was progressing, without any kind of interference for many years.
And– and people weren’t noticing it. And I think so many people now have woken up and seen that this is the most existential threat to us.
And, and it’s a spiritual threat. It’s going to– but the United States now has an opportunity because of this election to reverse that trend here, and then to rescue the rest of the world.
And, so I’m very, very optimistic about the future under this president. I’m watching what’s happening and there is nothing that I’m seeing, on day to day at moral, that– my level of hope and optimism increases every day.
So, you know, I’m, I’m very happy and I think let’s go forward. Let’s be kind to the people.
We need to fight for them, all those people, your relatives who hate you, and won’t talk to you anymore. We need to be fighting for them until they can wake up and fight for themselves.
Robert Califf, FDA [00:10:47]
Personally I’m disappointed in the election, and it’s not about me because, I think it’s pretty well known, I had not planned on coming back to FDA until I got a call asking me to come back. I was having a pretty good life in Alphabet land. And, so I came back and I feel like from the FDA perspective, we are sort of got all engines on go right now, we’ve done a massive reorganization. We’ve got very significant plans. There’s a meeting going on today that I just left going over the hiring, we’re hiring pretty well and not having trouble getting very talented people.
And I think, we just don’t know what’s going to happen now. So it’s not correct of me to make any specific comments about exactly what will happen, but I do think it’s pretty clear that the gist of this administration from everything that’s been said is to change a lot of things and how it gets changed depends on who gets appointed into key positions and how the various policies play out.
And I also think how the broader, as FDA is concerned, how the broader regulated industries see things and play into this.
So, in times of changing chaos, there’s also opportunity. And, I will just comment, there are a lot of things that I’ll bet almost everyone in leadership positions in the health agencies would’ve liked to have changed, but couldn’t because of the sort of gridlock of various interests that made it difficult to change things.
So, I think this obviously I’m biased, but I feel like the FDA is sort of at peak performance right now. And, we’ll just see what happens as a new team comes in.
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Question [00:13:10]
I’m curious how you respond to the kinds of threats that have been made by people like RFK Jr. saying very specifically that he wants to clear out FDA groups that work in certain categories like nutrition and who knows what else?
Because from the outside, we see that and we’re like, oh my God, I can’t believe he just said that. But you at the agency, how do you guys take that kind of threat? How do you respond to something like that? Well, that’s out there, it’s going viral. It’s being– it’s all over the place.
Robert Califf, FDA [00:13:36]
In my role, it’s best not to respond to those kinds of things, because what– getting into a back and forth about hypotheticals is not productive for anyone.
I will say, I was, I’m not an expert on food. And my first term, Steve Ostroff had been the acting commissioner and he did have food expertise and he became the deputy commissioner when I came in and handled most of that.
So this time around though, it’s been, the majority of my time, for example, has been on food. And, I don’t think you have to be too smart to say, we have a chronic disease crisis going on in this country that starts in childhood with terrible diets that are not getting better. And, there is work that needs to be done.
But I still love Alastair Woods’s old article in the New England Journal, kick the FDA, America’s favorite sport.
The things that go on with the American diet, they’re the people who work in the nutrition of FDA– I’ve gotten to know them pretty well. They are really hard working people and they’re limited in what they can change by the laws that Congress passes.
And, so, I don’t want to get into a back and forth about it. I would just say, I want to stand by the people who work at FDA.
They’re good people, there’s hardworking, and they want what’s best for the American public. I have no question about that.
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Question [00:15:17]
Do you foresee any kind of mass exodus or change at the agency at the sort of the staff, the drug reviewer level, based on the what’s happened in the election?
Robert Califf, FDA [00:15:27]
I think people are waiting to see, and from things that have been said, the change could happen internally or for external decisions made by the administration.
So I just think we have to wait and see and have some faith that hardworking high quality people are going to still be in place and will have support, I hope from the external regulated community, which given the dynamics is likely to be the most important factor.
I don’t think that there’s a lot that people inside of FDA can say.
And you know, what I’ve seen already is that they’re putting their heads down and doing their work.
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Robert Califf, FDA [00:19:07]
First of all, it is very clear, that there is a hierarchy of– it’s an executive branch.
So you got a commissioner, and you’ve got an HHS secretary and you got a president. And the tradition in 99.95% of FDA decisions about individual products, is that those decisions are made by career civil servants.
The commissioner actually has no role in that, unless there’s an internal dissent and an appeal, or in some cases, an external appeal that makes it all the way up to the commissioner level, but it’s totally within the law for the president or the HHS secretary to overrule the entire FDA.
And, so that could happen. Did it happen to me? No. But I also want to say, I think the view that there’s a sharp line between political and scientific, we got to speak truthfully about this. It’s not a sharp line in many cases.
I feel like for individual product decisions where you have high quality evidence, where the criteria is based on survive, feel, or function, the sort of standard criteria for medical products, there is no role for politics there. If a drug enables people to live longer and the benefit risk equation is positive by law, the FDA should approve it.
But there’s so many other aspects of this that are integrated in various ways with politics. And there’s just no way around it.
I have a whole series of essays I’m going to write when I finish. I’m up to over 90, but three of them are on something called OIRA, which I’ve been asking as I go around to public health schools and other places I’ve been doing lately because of H5N1, no one knows what OIRA is.
But as I think, you know, if FDA wants to put out a rule, which is interpreting a law, basically that Congress has passed in a way that has a huge impact on what happens, it cannot get through without OIRA letting it through. And that’s a political arm of the White House.
So, to argue that there’s no integration of politics and science, I think is a mistake, and we’re going to need to talk bluntly about this, I predict, as we go through the next phase.
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Robert Califf, FDA [00:32:11]
Well, I think in the ideal– you know, I’m an observer of this, I’ve never been a center director. I’ve never been a staff. I was a deputy commissioner for a while, so I’m just an observer.
But this is part of what I mentioned with executive function. In the ideal world, as I said, that uncertainty is being reduced. I think the most underappreciated part of the FDA is all those meetings that occur before the final application goes in.
And during the course of those meetings, if there’s a controversy in the ideal circumstance, the staff and the leadership of the center would be in conversations to resolve those issues. So overruling would be unnecessary.
So in the ideal world, you should never have to overrule your staff, but we don’t live in an ideal world and we have personalities in the FDA and we also have a situation in a way it was sort of the good old days when I was on the cardiorenal panel, there was one FDA opinion.
Now it was opaque what all the different sub opinions were within that. Now, everyone can express their opinion in writing. And so that leads to a much more give and take between the center director and the staff.
So– but I think a goal of any center director would be to make it so that was, the goal should be sort of like ventilator acquired pneumonia, zero should be the goal, realizing in the real world, you can’t quite achieve that.
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Question [00:33:47]
Do you have two or three priorities that you you have set on or what are sort of the few things that you wanna get accomplished in the time you have left at the agency?
Robert Califf, FDA [00:33:56]
Well, I feel like the medical products are on the way and there’s some very significant, relatively technical things that need to get done.
The big deal for the public health is tobacco and food. And we have major things there that we’re hoping to get done.
It’s publicly known, the menthol rule has been an issue, and we also have a very good understanding of what the addictive level of nicotine is. So the nicotine standard would be the biggest deal.
We can’t enforce a nicotine standard, but we could possibly put out a proposed rule that would unveil to the public what’s at stake in terms of public health.
And then for food, it’s just simple stuff. Like, how can it be that you can’t get the label on the front of the package? That just sounds crazy to me, but it’s a ordeal.
Many in the industry are opposed to it, and we’re trying to update the term healthy so that when you put, let’s face it, most people are busy when they go shopping. They don’t study the label and take 10 minutes for every decision. They react to what’s in front of them.
So if we could just label things that are basically healthy as healthy, that would make a big difference. Those are the very, most important things.
I don’t wanna belittle the medical product side, but the changes there are technical and very important to the elements that are involved, but food and tobacco that’s what’s causing the chronic and serious crisis we’re having right now in our life expectancy.