11.2 Consequential Chemicals: Makena, COVID vaccine, and TinFoil Hats

[00:00:00] In this segment, Adam and I discuss his experience sounding the alarm on Makena

[00:00:06] and working towards its ban by the FDA 20 years after it came out, which launches us

[00:00:13] into a discussion of the widespread influence that pharmaceutical companies

[00:00:18] have in the cycle of profits benefiting the regulatory agencies, the professional

[00:00:23] medical societies, the key opinion leaders and so many others at the expense of scientific integrity.

[00:00:31] We talk about how some of the same plays from the pharmaceutical playbook around Makena

[00:00:38] and so many other historical drugs were pulled out to try to push every American to get vaccinated,

[00:00:45] including an odd stance on vaccinating children that persists today, despite the fact that the rest of Europe,

[00:00:52] the rest of the world does not recommend children to be vaccinated against COVID and makes us a major outlier.

[00:01:00] Though these issues are never addressed by the CDC or the FDA, probably because they don't have any sort of reasonable answer to it, honestly.

[00:01:10] Hope you enjoy. Somebody get this guy some help.

[00:01:17] You're in a really unique position in the current culture around medical research.

[00:01:28] What is true research? What is manipulated coming to good clinical conclusions?

[00:01:33] We're kind of seeing a cancel culture pervade throughout medicine where those who question the, you know, quote unquote status quo tend to be ostracized.

[00:01:43] Folks like David Healy in my field, Eric Topol with Vioxx, who made his way back but dealt with a lot of backlash trying to call out a drug he saw was killing his patients

[00:01:55] and bringing light to uncomfortable but really important clinical care issues.

[00:02:01] And a lot of the times you can be labeled as a spreader of misinformation or pegged as a conspiracy theorist who goes home every night and dons your tinfoil hat.

[00:02:11] I can imagine that when you were seeing the situation unfold early in your career with Makena post 2003, you probably got Galileo'd yourself a couple of times or face threats of backlash for publicly voicing your opinion.

[00:02:28] But you had the courage to stick to your guns to fight for your patients.

[00:02:35] And of course, Makena just for our listeners is a drug used for preterm labor that had a flawed initial clinical trial and some subsequent bad anecdotal evidence, some of which you saw for those providers who actually ended up using it between 2003 and 2023.

[00:02:53] Very ironic. That's typically the time period that a patent has exclusivity and how long a drug maker can make all of the profits off of that drug.

[00:03:03] I seriously I cannot thank you enough or encourage you for standing up for what is right for your patients. But ultimately it puts you in a unique position because you have the clout, you have been right on a major issue that so many told you you were wrong about for so long.

[00:03:23] And ultimately you were proven right. Can you give us the bare bones about what happened with Makena?

[00:03:30] Sure. No, I appreciate your introducing it. It's an important issue. Preterm birth is the major problem in obstetrics. It accounts for the vast majority of neonatal morbidity and mortality.

[00:03:42] And so it's a major issue and people have tried for years to look for ways that we can prevent preterm birth. Most of those ways have failed over time.

[00:03:53] In 2003, there was a study that came out where they looked at using Makena as you said, 17-hydroxyprogesterone to see whether or not that could prevent recurrent preterm birth in women who had a prior preterm birth.

[00:04:08] And the trial was seriously flawed, very seriously flawed. But it did show this flawed trial that Makena might work and based on that trial, it started to come into regular use. This was back in 2003.

[00:04:23] It subsequently got FDA approval, became a branded drug, and then started making that drug company a lot of money as you were pointing out.

[00:04:33] It was hundreds and hundreds of millions of dollars per year for a while. And when you look at that first trial right out of the gate, I looked at that first trial and I thought, you know, there's really something wrong here.

[00:04:45] This is a very poor trial, poorly done. And even the FDA reviewer initially didn't think it should be approved based on that initial trial.

[00:04:54] But once these things start to get used, they take on a life of their own, in particular when you get a drug company involved. Because then with the profits from the drug, they start to be able to establish a conventional wisdom.

[00:05:09] And what it is, is it's a corporate conventional wisdom that they're creating by using their profits to, for example, sponsor key opinion leaders or sponsor the professional societies in the area, sponsor research.

[00:05:26] So you end up getting this sort of corporate conventional wisdom where everybody's using it.

[00:05:31] And I was one of the few voices at the time looking at this and saying, look, it shouldn't have been approved out of the gate. And there are real concerns with that first trial.

[00:05:42] And also there are concerns about injecting pregnant women with a synthetic hormone. These medications, I always make the comment that medications are chemicals and chemicals have consequences.

[00:05:55] And that's particularly true for developing babies. And when you're injecting pregnant moms with a synthetic hormone, that's a real risk.

[00:06:03] And we know from the arc of history, the arc of history in obstetrics bends towards showing medications to be harmful over time when you study them for long enough.

[00:06:15] So I pushed back against McKenna. Eventually, I got together with Public Citizen and we put in a petition to ask for it to be withdrawn from the market.

[00:06:25] The second trial that was done, the confirmatory trial failed, showed that it didn't work. And then eventually over time, it finally got removed from the market in April of 2023.

[00:06:37] So about a year ago. But as you were saying from the get go, it had been used for 20 years in pregnant women. And I often get asked, how do we, how does this happen?

[00:06:49] How does a drug that doesn't work get used for 20 years, get injected into pregnant women? And the answer that I give is that it doesn't work.

[00:06:59] It doesn't work in the sense it didn't prevent preterm birth, but it works in another sense, which is to bring money into a drug company who can then use that to sponsor the professional medical societies, the research and other things like that.

[00:07:17] It works in a different way and it creates a positive cycle where it's working financially for so many people that even though it actually doesn't work for patients in the public, it continues to get used and it takes on a life of its own.

[00:07:33] And if I'm not mistaken, the stage four clinical trial didn't happen until 2019. But then it was another four years until the FDA removes it. And my skeptical brain is just screaming. I wonder why it's 20 years.

[00:07:48] Yeah, you're right on the money as far as what happens with these accelerated approvals. FDA allows accelerated approvals based on one trial. That's what happened with Makena. It was approved based on the first trial. But then the drug company needs to do a second trial.

[00:08:03] But once it's approved and they're selling it and they're making billions off of that, they don't have a lot of incentive to do the second trial, which may show as it did here that it doesn't work. So they dragged their feet. Finally, it got done.

[00:08:17] The real tragedy here is or a part of the tragedy here is that it was in March of 2019 that we all knew the second trial failed. I was expecting once we knew that information in March of 2019, that it was going to be immediately pulled off the market.

[00:08:35] That people were going to say, hold on. We can't be injecting a synthetic hormone into pregnant women that doesn't work. But that's not what occurred in March of 2019. The prolonged study showed that it didn't work. But it took, as you said, another four years, more than four years.

[00:08:54] It wasn't until April of 2023 that the drug finally got pulled off the market. And when I look at that, the poor women who were injected with that thing every single week from 20 after 2019 when we knew it didn't work, it really is outrageous.

[00:09:11] That was allowed to happen in a real tragedy. We still don't know what the outcome is going to be because you have to follow up all the moms and babies who were injected with this synthetic hormone and see what happens.

[00:09:24] And as I said, when we've used hormones in pregnancy before, there's a famous case of diethylstilbestrol, DES. We used that for decades. And then it wasn't until later that we realized it was linked to cancers and uterine anomalies and other health problems in the exposed offspring.

[00:09:45] So we still may not know all of the problems that Makena was causing until we follow this up.

[00:09:53] Yeah, kind of leads into my next question. One of the best clinical principles that I've learned over my life happened way before I ever even considered going to medical school.

[00:10:04] Given to me when I was about 12 years old by my mother, who was a clinical pharmacist, and she always hammered home the point that you don't know the risks of a new drug or a new treatment until it's been out for 15 or 20 years.

[00:10:20] And so you can't effectively say that it's a safe treatment without giving it time. Now, you can certainly argue that there is more potential benefit than risk. But, you know, the hot button issue now is within the COVID vaccine.

[00:10:36] I feel like so many of my local colleagues fall into that all or nothing clinical thinking trap. My biggest issue with the vaccine is that there is a lot of uncertainty and the force and the vitriol with which we were told it's safe and effective within months of it being rolled out before there was anybody who had years of taking this and looking at the outcomes.

[00:11:02] That really rubbed me the wrong way. It just sent alarm bells off in my brain. Hey, this doesn't seem right. Doesn't seem like the CDC and the ACOG and the Society for Maternal Fetal Medicine as of just last month or even more recently are still recommending vaccination at any point during pregnancy for all women.

[00:11:26] Though my understanding is that other countries have different policies. As somebody who has gained a lot of clout and now with a different issue or set of issues, others that we'll talk about later, I don't think people can just look at what you're saying and come back and say, no, Adam, you're wrong.

[00:11:46] You've never been right about anything before. No, you've had a 20 year journey of sounding the alarm trying to be silenced and ultimately you were right. So as a harbinger of truth and a truth seeker, what does the data in the science show? What do we know? What do we not know? And if you were to lift up country with the most up to date and accurate information in their COVID policy, where would you go?

[00:12:13] I'm a big believer in information and informing patients, giving them the proper information and then letting them make the best choice for themselves. With the issue of the COVID vaccine in particular, vaccines also more broadly, patients need to be counseled regarding these.

[00:12:32] Your mom actually made a great point there. Like my mom with the attitude of gratitude, your mom telling you that you don't know how safe something is until it's been out for 15 years. I think your mom's making a great point. What happens with the COVID vaccine or with any pharmaceutical product is you have to see it as part of a corporate rollout.

[00:12:53] When corporations are rolling out a product, when the pharmaceutical industry is rolling out a product, they want the public to think that it's completely safe, highly effective and going to lead to health benefits basically with no downside.

[00:13:10] That's how you're going to get in as many people to use the product as possible, get the vaccine and maximize profits, which is what the drug companies are trying to do. So you saw this in classic fashion with the rollout for the COVID vaccine.

[00:13:27] We were told initially that it was basically 100% a back down, come out of the gate. And essentially there was no downside, no side effects, no risks to it. I'm laughing now because the absurdity of it, you're injecting people with this news, it's synthetic chemical compound. It's got the lipo, I'm missing the term for the point.

[00:13:56] Unlike anything we've ever used before.

[00:13:59] And it got rolled out. Look, the thing is basically like a miracle in a vial. It's going to be 100% effective. It's going to be completely safe, health benefits to both mom and baby. And it's like they didn't know any of that coming out of the gate.

[00:14:17] And then over time, those numbers just started dropping off. And there are people who have put together these things on the internet of videos where they're showing montages where it drops down 100.

[00:14:31] Then you see the people say actually it's more like 90%, but the 90% is strong and then it's 80%, 70% going down, down, down. And then they introduced, no, you got to get another one.

[00:14:42] And then you got to get another one after that, the boosters, etc. And so that's all to be expected. I told people at the time that's the direction it's going to go. And you saw that with McKenna.

[00:14:53] When McKenna came out of the gate, it was basically look, this is completely safe, highly effective at preventing preterm birth and you get healthier moms and healthy babies.

[00:15:03] And then as people looked at the data over time in an observational fashion, waiting for the second trial to be done, we saw that there were safety concerns with injection site reactions, with depression by giving progesterone, with blood clots, with other health concerns by injecting McKenna into pregnant women.

[00:15:24] And then it didn't look particularly effective. So we see this with McKenna, we see this with Vioxx, we see this again and again and again. And you saw this with the COVID vaccine. It was another pharmaceutical rollout that took the same trajectory that you would expect, which is that over time as you watch it, you realize that the initial rollout is designed to get everybody in, maximize profit, but that over time what you'll find is it's not as safe as they build it, it's not as effective.

[00:15:53] It's not as effective as they build it, and it may not be the best thing for health as initially built. And so where does that leave you with the counseling that I do? I talk to patients, I tell them we just don't know things like long-term effects.

[00:16:09] Every patient has a different level of concern and level of trust in terms of taking pharmaceuticals. So I review with them in my office what the risks are that I perceive, and we don't have a lot of great data. There hasn't been a randomized controlled trial on pregnant women, so we just don't have that data.

[00:16:27] But you talk about what the risks can be or may be, unknown risks of vaccination, what the benefits may be in terms of providing some protection. If that's there, I think it's hard to study. As I said, we don't have a randomized controlled trial.

[00:16:40] And then what alternative approaches are for health and review that, and then patients make their best decision. I generally support my patients.

[00:16:48] I will tell you the question pregnant women ask, and I hear this day after day, is what they want to know is can this affect the baby? And with a lot of these things when we're using pharmaceuticals, when we're using vaccines, we don't know necessarily what the long-term effects are going to be because they just have been understudied.

[00:17:07] So we don't really know. So that always has to be weighed into the equation for patients. I tell my patients in general, when you're pregnant, you don't want to be putting things in your body, whether it's medication, vaccination or whatnot, unless you're sure that they've been proven fairly definitively to be safe, to be effective, and to have a health benefit for the mom and the baby.

[00:17:29] And that's a general rule of thumb. And then you describe those things, you let the patient make up her mind what she wants to do. And then I think you support her as her physician.

[00:17:38] I don't think a lot of Americans realize that other countries do have significantly different policies around COVID or vaccination. Could you point to a country that you feel like has a very reasonable policy on vaccinating pregnant women?

[00:17:57] I don't know all of the set policies from the countries, but I think just looking in general, for example, if you look at the approach that the United States has taken with child vaccination for COVID vaccine compared to the rest of Europe, the rest of the world, we're an outlier.

[00:18:16] That we've got these recommendations in place that are not running along with the rest of the world. And in fact, the rest of the world is not recommending it for young children, for children, and it continues to be recommended here.

[00:18:30] I think the suspicion what people are concerned about is the recommendations from the CDC and the FDA seem to be more aligned with what is going to maximize profit for the pharmaceutical industry than they do seem to be aligned with what is going to maximize what's best for patients in the public or public health.

[00:18:52] And this is what I hear all the time from colleagues and from patients that they don't buy those recommendations, which is really unfortunate because then people lose faith in our public health bodies like FDA, like the NIH, like the CDC.

[00:19:09] It's unfortunate this occurs, but this is what happens when you have so much influence from the pharmaceutical industry. What the public starts to lose trust because they think these recommendations are designed to maximize corporate profit, not maximize public health.

[00:19:25] And you're actually seeing this, though, Ethan, live and in real time because people aren't getting the vaccine boosters. I think the rates even in the places, the states that are most on board, I think the rates are like 10, 15%, something like that.

[00:19:42] So you've got essentially 80, 90% of the country not listening to the official recommendations from the public health bodies in this country. It's a complete disconnect that's occurred and that disconnect has occurred because the public just isn't buying this what these recommendations are again because they feel like the recommendations aren't for public health purposes, but for corporate profit purposes.

[00:20:10] And so you've essentially got the public turning a deaf ear to this and not listening to these recommendations anymore. And for good reason, actually, the FDA is getting about half of its budget from the pharmaceutical industry.

[00:20:23] So in a sense, you can think of the FDA as a branch of the pharmaceutical industry because they're so heavily funded by pharma. That's how they need to be looked at as somewhat of a branch of pharma and the CDC as well receive significant funding from the pharmaceutical industry.

[00:20:40] The leaders of the FDA, the commissioners of the FDA, I believe it's 10 of the last 11 or 11 of the last 12. When they leave FDA, they go to work for pharma. And so when you've got that level of entanglement between bodies like the FDA and the CDC and the drug companies, the public completely loses faith, stops following the recommendations, which is precisely what we're seeing.

[00:21:08] It's almost like the classic story that I see play out is one kid dies from COVID and then the media just runs with that and creates this culture of fear around it, utilized to rally people to get the vaccine.

[00:21:23] And to play devil's advocate here, I also understand that not everybody has the capability to have the nuance and understanding. They feel that absolute need to create that order. It's either good or it's bad.

[00:21:39] So in some ways I can understand maybe withholding some information, but the amount of information that's been withheld or manipulated or just flat out lied about is absurd. When you pair that with history repeating itself over and over again, it's just hard to trust what we're being told.

[00:22:00] And honestly, I want to know how to counsel my patients on that. But I don't have good data to say how to counsel my patients on that. I don't know what populations it is going to be most effective for and what populations don't need it because the general consensus answer from these large government organizations is it's for everybody.

[00:22:26] I had been thinking about doing this for several years and never really had the courage to go out and actually do it. It's my outlet for some of the problems that I have seen systematically in medicine.

[00:22:43] I wish it was just isolated to psychiatry, which I think it runs a little bit more rampant in my field. But obviously there are countless examples in all kinds of other fields. And so I was familiarized with your work initially from Madden America and really enjoyed your conversation with Joseph Witt-During.

[00:23:04] Yeah, for sure. I think that's great. It's very interesting to me because I've wondered like so you're just a couple of years out. I've wondered if people are going through residency and then they start to like have questions about this model that psychiatry is today. What ends up happening? What do you do?

[00:23:26] You get odd looks from some of your colleagues and some of them want to put a tin foil hat on you. I try to say I'm just asking questions. I'm just appreciating the nuance and all of the huge massive things that we don't know.

[00:23:41] In what I do, and I talk to people every day about their emotional, spiritual problems, their physical problems. And so much of it boils down to what happens uniquely in our human brains where we have an animal brain and then we have this consciousness that allows us to override that animal brain, that more limbic system part of our brain.

[00:24:07] It really desires this order and this certainty, and it almost codes information more like a computer with zeros and ones. And the longer I do this and the more people I talk to, the more evidence that I see of this playing out in the political scene or in the medical research scene is we have such an innate desire for certainty that sometimes we would rather think that we're certain or have an answer for something than to appreciate it.

[00:24:37] I appreciate the fact that, hey, you know, I'm 95% sure about this, but there are a couple of pieces that I'm not certain about that could really change the whole tide of my theory on this thing.

[00:24:48] So I think there's a natural desire for that other entities certainly prey on that natural yearn for order that all of us have.

[00:24:58] Somebody get this guy some help.

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[00:25:39] This presentation is not intended as a substitute for professional medical advice. While I am a medical doctor and many of my guests have extensive medical training and experience, nothing stated in this podcast nor materials related to this podcast, including recommended websites, texts, graphics, images or any other materials should be treated as a substitute for professional medical or psychological advice, diagnosis or treatment.

[00:25:55] All listeners should consult with a medical professional, licensed mental health provider or other healthcare provider if seeking medical advice, diagnosis or treatment, or put more simply, you need help like this guy, call your own doctor.