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Memorial Day weekend is around the corner, which means summer is finally here. Ahead of the holiday, we spoke to Scott Gottlieb, former FDA commissioner and self-appointed czar of the American grill, to discuss the proper temperature of a backyard burger, the future of the agency he used to run, and why the origins of SARS-CoV-2 are important for science.

This conversation has been lightly edited and condensed for clarity.

Scott, please tell us, what does a burger cooked to the volcanic temperature of one hundred and sixty degrees actually taste like?

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It tastes safe. A burger properly grilled tastes safe. The issue with your medium rare, rare burgers, is that, as you know, with meat, the key is to grill the outside of the meat because you can get fecal material on the outside of meat. But when you grind chopped meat, you can grind the components around the exterior of the meat into the interior of the chopped meat. And so you want to make sure that … a hamburger is properly cooked right through to the center. So its not like your steak; your steak could be could be rare because you’re cooking the outside of the steak. Although with needle tenderization, the things that we do tend to chop meat, you can also get translocation of the bacteria into the center of the steak. So it’s still important to cook it to a proper temperature. But you have more risk when you’re grinding it up.

So Taste Safe is not exactly the most appetizing marketing slogan for a burger. Where are you buying your chopped meat to make your burgers? I mean, look, I go to Whole Foods and buy grass fed. I’m assuming it’s a little bit of a cut above your regular supermarket burgers …

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But the risk is probably in the butchering process, not in how the the cattle is raised. Right? You look at the label and and you see that it’s grass fed and free range, but that doesn’t necessarily guarantee you that the butchering process was done well or that there wasn’t some kind of accidental contamination with meat. That’s why you want to make sure the meat is properly cooked.

Well, Scott can we expect some some food safety tweets this weekend from you?

There will be. I’m going to talk about the proper temperature to cook ground meat, which is 165 degrees Fahrenheit, poultry, [which is] 165 degrees. Fresh meat and chops, roasts should be about 145 degrees. You should use a temperature thermometer to check the temperature that you’re cooking it too. So I’m going to try to put out some safe grilling techniques.

And now we want to do some grilling of Dr. Gottlieb with some questions about what’s going on in the world. You had a little bit of a Twitter encounter with Brett Giroir this week. Tell us about that. 

So Janet Woodcock [the acting FDA commissioner] had tweeted out the agency’s latest enforcement action around kratom. And I commented on the fact that the FDA had tried to schedule kratom [as a controlled substance] and we had worked for years with DEA and NIH to try to schedule kratom, which is a substance that everyone agrees is a weakly acting opioid. … And we were about to schedule it and Giroir {assistant secretary of health during the Trump administration], he sort of admitted it on Twitter. He spoke to this. He intervened unilaterally to to block the scheduling of the product.

You know, when I had discussions with him about it at the time, he had said that he had spent a lot of time over the weekend reading the literature on kratom, and it caused him to change his mind about it. So it was blocked. Ultimately, the process was allowed to go forward. This ended up getting elevated. There was discussion about it at the White House. We were allowed to go forward, but then the government shutdown happened and the whole process just lost momentum. So kratom remains unscheduled. And I think if you’ll talk to a lot of addiction specialists, they do believe that kratom is contributing to the opioid crisis. Now, the counter argument is that there’s a belief that people who are currently addicted to opioids are using kratom to self-medicate and treat the addiction, and that it’s helping people break a cycle of addiction with opioids. But if that’s true, it should be properly studied and demonstrated and kratom should be properly formulated.

Speaking of the FDA, we are almost in June and there is no nominee to be a permanent commissioner of that agency. We’ve heard criticism of the administration for not prioritizing this to a greater degree, given the fact that we’re in a pandemic, and there are counterarguments to that as well. What do you think is going on at this point with that decision?

I don’t have a lot of insight into it. If I had to guess, it’s that they have a very good acting commissioner who they’re happy with and in no rush to make a change. I think that it’s going to be hard to find someone who’s more competent than Janet Woodcock in filling that role, and that could be more effective in terms of getting things done right now in the setting of a crisis. And so why would you change that out? If you want to move quickly, you want to advance policy quickly, you have the perfect commissioner to do that. Any transition, frankly, is going to be disruptive to what the agency is able to accomplish. Based on what I’ve heard, there’s still a lot of people who’d like to see Janet permanently nominated for the role.

Are there consequences to not having an official FDA commissioner or somebody not confirmed into that role? Or can an acting FDA commissioner essentially do everything a confirmed FDA commissioner can do? 

I think that it depends on who the person is. There’s no legal reason why a confirmed commissioner would be more effective for the agency than an acting commissioner. I mean, there must be some aspects of how regulations get implemented or maybe some other sort of very tertiary aspects of the job that I’m not aware of.

I think that it’s more a question of does a person who’s in the acting role — are they able to act with the same authority? Are they able to interact with Capitol Hill with the same authority? Are they able to make commitments to other people where they have to win concessions? And I think Janet can do all those things. I mean, I think you have in Janet Woodcock an acting commissioner who knows the role really well, is trusted, is trusted to get things done, is very well regarded on Capitol Hill. So I don’t think you are losing anything by having her in an acting role versus having someone else in a confirmed role.

We were talking about aducanamab, the Alzheimer’s drug, and how the approval decision date is coming up June 7. It’s pretty much one of the most consequential drug approval decisions that the FDA is going to be making in recent years. And I’m just wondering, from your perspective, is that something that crosses the desk of the FDA commissioner? Or is it still handled at a lower level?

Yeah, it wouldn’t cross the FDA commissioner’s desk. It was very rare that I got briefed on a drug approval decision before the decision got made. The circumstances in which I did were typically where there was some really more profound policy issue, where there was a legal issue where we might be legally vulnerable, where there was a lot of interest from Capitol Hill in a particular approval. But it was really uncommon.

So another subplot of the entire pandemic has been the interest in and debate over the origins of the virus that causes Covid-19. That has really heated up in recent weeks, with a lot of attention on a theory that it could have leaked from a lab rather than the more common explanation that it had jumped from an animal. What do you think about the state of that debate, and what kind of information do you feel we need to see to have a definitive grasp on the answer to that question? 

I’m not sure we’re ever going to have a definitive grasp on the answer to that question unless we find the intermediate host where the virus originated from, the animal host, which we haven’t found after an exhaustive search. Unless we have something that definitively demonstrates that this came out of the lab, a whistleblower, access to information that somehow was made available, that hadn’t been made available previously. So barring those two things, I think that this is going to remain subject to speculation.

From my standpoint, this matters because a lot of the discussion around how to prevent the next pandemic is focused on zoonotic sources and trying to improve handling of foods and wet markets and trying to look at all the risk associated with humans encroaching on natural habitats. None of the discussion has been around how do we get better security and better practices around BSL [biosafety level] 3 and 4 labs? BSL 3 labs are springing up all over the world. We don’t really have good international governance of those labs. We don’t have good governance of their practices. We don’t have good governance of what kind of research is going on in those facilities. There’s no sort of Atomic Energy Commission where we go in and inspect or make sure labs are meeting certain international specifications in a really meaningful, robust way. And if you think that there’s a possibility this came out of a lab, I think part of the policy response ought to be getting better governance around high-risk research and high-risk laboratories. And that discussion is not happening.

And as far as the lab leak theory, I think there’s two narratives here and one is interfering with the other. One narrative is that this is the result of gain-of-function research that NIH paid for that the Wuhan Institute of Virology was doing, and so there is a direct connection between NIH and U.S. researchers and this strain, which was engineered deliberately by Chinese researchers, not necessarily to be a bioweapon, but engineered deliberately. I think that narrative is untrue. And I think that political narrative is conflicting with a more plausible narrative, which is that this was a strain that was found in nature, that was brought to the lab for further evaluation, and in the course of evaluating it, and maybe doing research on how to develop countermeasures against it that were well intentioned, it became more humanized, more human adapted and accidentally was  walked out of the lab, probably by people infecting themselves. I think that there is some plausibility to the second scenario.

As all of this investigation is going on into the origins of the virus, we’re, of course, entering a summer in the United States that many people are incredibly excited about. More than 50 percent of adults are vaccinated. Case numbers are now experiencing exponential decay, which is just the most wonderful term I’d never heard before the pandemic that I’m now understanding. What is your expectation for the summer [and] after the summer here in the U.S.? And, are you are you worried about what’s going on around the world?

Well, very worried about what’s going on globally, but I do think that in the U.S. we’re entering sort of a post-pandemic period and it’s not going to be a binary point in time. And we’re going to evolve out of the pandemic period into a more seasonal type of picture with the coronavirus. Barring something really unexpected happening with a new variant that changes the characteristics in such a profound way that we’re effectively dealing with a new virus. But this winter is going to be a winter of transition. We’re still getting immunity into the population. Next winter could be a pretty hard flu season because we missed a whole year of flu. Maybe the epidemiology of disease has changed a little bit because we’ve all become a little bit of germophobes in this country. So maybe all the Purell that we’re going to continue to do and the occasional mask-wearing and just being more conscious of the spread of respiratory pathogens generally, maybe all of those activities are going to help mitigate the spread of some of these things that might otherwise take off because we haven’t seen them in a while. So it’s hard to know which way that cuts.

Thanks a lot for joining us, and have a great Memorial Day weekend. What’s on the menu for the weekend?

Well, I’m going to cook your favorite burgers.

Listen to Gottlieb’s full interview on this week’s episode of The Readout LOUD.

 

  • Maybe, if the US wouldn’t have such low food standards, largely pushed by his fellow republicans for decades, food poisoning wouldn’t be such a way too common phenomenon as compared to other developed nations.

  • “…. which was engineered deliberately by Chinese researchers, not necessarily to be a bioweapon, but engineered deliberately. I think that narrative is untrue.”
    And yet, his favorite hosting “unbiased” newspaper, his former boss, and the vast majority of republican lawmakers and voters are all over it, and have already decided a long time ago that’s the only explanation they need and that makes them happy. Gottlieb is really mastering the double standard of reality.
    BTW, a very lame bioweapon as it kills almost exclusively elderly people.

  • Gottlieb IMO takes common-sense positions in respect to Janet Woodcock as successful FDA acting commissioner, the required proof in seeking the origin of Covid, and the over-hyping of the expectable upcoming flu bouts. The only control the general public has is on that last item: we all ought to be ready for certain smart flu-preventing personal measures by now, by not throwing caution about what we have learned in the past 15 months into the wind, thus by choosing to use our brains rather than low bravado.

  • Gottlieb has the responsibility to investigate kratom and submit an 8-factor analysis before reverting to the drug war solution and recommending to the DEA it be placed on Schedule 1, turning millions of Americans into criminals. Their investigation amounted to a sloppy database search of any decedent who had mitragynine, kratom’s main alkaloid, in their blood. This included people who were murdered, committed suicide, fell from ladders, and had deadly levels of other substances in their system. In the case of one suicide, the decedent swallowed acetominiphen and a family member told the doctor they might have taken kratom. It was clear that this team under Gottlieb wanted to reach a foregone conclusion on kratom and entirely inaccurate information was presented to the public to justify criminalizing millions of consumers. This is why the DEA rescinded their decision to Schedule 1 kratom in 2016, and it’s why HHS decided to overrule FDA in 2018. The motive is that kratom’s alkaloids do act on opioid receptors, but they are partial opioid agonists that don’t recruit the beta arrestin which has been shown to cause the harmful side effects of classical opioids, like respiratory depression, which is why opioid overdose is deadly. This is the golden ticket for pharmaceutical companies like Pfizer, where Gottlieb serves as a board member after passing through the revolving door from the FDA. If you don’t believe me look at this analysis by Dr. Jane Babin, a molecular biologist and attorney. The Gottlieb FDA’s kratom “investigation” wouldn’t receive a passing grade in a freshman pharmacy course. https://t.co/G76TVsWdLY?amp=1

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