Malcolm investigates the origins of what the U.S. Secretary of Health and Human Services believes (and doesn’t believe) about viruses. Get ad-free episodes to Revisionist History by subscribing to Pushkin+ on Apple Podcasts or Pushkin.fm. Pushkin+ subscribers can access ad-free episodes, full audiobooks, exclusive binges, and bonus content for all Pushkin shows. Subscribe on Apple: apple.co/pushkinSubscribe on Pushkin: pushkin.fm/plusSee omnystudio.com/listener for privacy information.
Chapter 1: What is the iHeart Podcast about?
This is an iHeart Podcast.
Chapter 2: Who is Safi Bakal and what are his credentials?
I recently called up my friend Safi Bakal. I wanted to see if he could correctly guess the answer to a puzzle. First of all, before we start, I just wanted to briefly establish your bona fides for this conversation. You have a PhD from MIT, is that correct? Stanford. Stanford, Stanford. And you went on to work on the development of a number of different drugs, is that correct? I did.
Safi ran a drug company for a long time that worked on some of the hardest problems in cancer treatment. In preparation for our call, I sent Safi the package insert for something called Rotatec. As I'm sure you've noticed, when you get a prescription drug, there's a leaflet inside the box, all folded up, tiny print. That's the package insert.
It tells you in great detail every benefit, every side effect, every clinical study associated with your medication. The Food and Drug Administration and drug companies spend years working out the exact wording of that leaflet. And I'm assuming you've never read this before. Never read it before.
I just saw it 20 minutes ago or whenever you sent it.
Chapter 3: What is Rotatec and how does it work?
Rototec is a vaccine to protect babies against a very nasty intestinal bug called rotavirus. What Safi first noticed was how well it worked.
Where I go to right away that's interesting is the efficacy data, which is post-marketing, adverse events, description, drug interactions, clinical studies, section 14. Yeah, that's amazing. You look at table eight on page 10 or whatever.
Yeah.
There was one incidence... of any grade of diarrhea or gastroenteritis, which is what this virus is supposed to protect, and 51 on the placebo arm. Oh, wow. So it's 50 times higher, 50 times higher more kids will get some serious or moderate diarrhea or gastroenteritis compared to those who got the vaccine. That tells me, of course I want the vaccine for my kid.
Yeah. If I told you you had a drug under development that had efficacy data where there was a 50X difference between treatment and control, what word would come out of your mouth?
That's absolutely astonishing. That's just jaw-dropping. You almost never see that kind of efficacy in a therapeutic for treating active disease. You see it once in a generation. You know, a 50x improvement is incredible.
And now that Safi knew what we were talking about, it was time to see if he could answer my little puzzle. A puzzle connected to the co-inventor of Rototech, a man named Paul Offit. I want to read to you, now that we've done this, I want to read to you from a book. I'm going to have to tell you who wrote it, but it's someone in a position of real authority in the world.
The best evidence indicates that Dr. Offit's rotavirus vaccine causes negative net public health impacts. In other words, Dr. Offit's vaccine almost certainly kills and injures more children in the United States than the rotavirus disease killed and injured prior to the vaccine's introduction.
That's just complete bullshit. I don't know what else to say. That's just, you look at this data. This is extremely robust, careful data. You look at the statistics published in all of the numbers and tables here. That is just absolute nonsense.
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Chapter 4: What are the adverse events associated with Rotatec?
Chapter 5: What are the historical impacts of rotavirus on child health?
Does it rhyme with genity?
Oh, Safi, you win the prize. My name is Malcolm Gladwell. You're listening to Revisionist History, my podcast about things overlooked and misunderstood. This episode is the very strange story of Rodotech, a vaccine that every American infant is supposed to get three times in their first eight months of life.
or rather, the very strange campaign waged against Rodotech by Robert F. Kennedy Jr., the Secretary of Health and Human Services, the man in charge of every aspect of health, medicine, and research in the United States. If you are the parent of small children in the developed world in the 21st century, Diarrhea is not high on your list of things you worry about.
But that was not true of your parents when you were a child. Or your parents' parents. Or anyone else, for that matter, going back as far as human beings go. Particularly those living in the poorest parts of the world. This is what it used to be like.
There's one vivid memory that I can actually think of. is going into these pediatric wards and you had patients, these children, literally to the point that you would actually have a diarrhea ward, a separate diarrhea ward, because that was the quantum of cases that you would see in hospitals without exception.
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Chapter 6: How did the rotavirus vaccine change pediatric care?
This is Vishwajit Kumar, a pediatrician and public health researcher in Uttar Pradesh, one of the poorest states in India, remembering his days as an intern in the 1980s.
You have babies who come in dehydrated. severely dehydrated. And the first thing, you know, sunken eyes, you know, you could just pull their skin and you'll find that, you know, they just don't retract because there's no turgor pressure.
Chapter 7: Why does Robert F. Kennedy Jr. oppose the rotavirus vaccine?
A small child would get sick with the rotavirus. They would run a fever. They would start vomiting. They would develop severe diarrhea as the virus wreaked havoc in their stomach and intestines. That's three sources of dehydration, suddenly and simultaneously. And if the child was far from a hospital and already malnourished, they were in trouble.
The best estimates at the time were the children in developing countries had between four and eight episodes of severe diarrhea in their first five years of life, each lasting from two to ten days. For Dr. Kumar, this meant a giant room full of shrunken infants, two and sometimes three to a bed.
So you have these sweepers whose job is to just keep cleaning the mess or the parents would do it or the parents would clean it, you know. And of the children in that ward in that era, how many would you lose? Okay. So let's say there is a hundred of them who come in with severe and life-threatening diarrhea. You'd lose 10% for sure. Oh my goodness.
I mean, to lose one, To be a doctor and lose one baby is emotionally overwhelming. You're talking about over the course of working in a ward, you would lose dozens of children over the course of months.
Yes. So to give you an example, so we do these verbal autopsies because hospitals don't have good records. And so essentially reconstruct that event so that then experts can sit around and say this possibly could have led to the death. I have never been able to go through one verbal autopsy in one city. What do you mean?
It's so heartbreaking because you're like, oh, you know, this could have been so, this could have been prevented. You know, it's like you look at these cases and see every newborn dies. There is one mother who also in some ways, there is some part of it dies with her.
The battle against rotavirus took years. First, the virus itself had to be identified, separated out from all the other pathogens that can cause diarrhea in young children. Then a vaccine had to be constructed from that newly identified virus. Another time-consuming task. One of the leading groups working on the problem was at the Children's Hospital of Philadelphia, at a lab run by Paul Offit.
2006.
2006. How long did you work on that? 26 years. Wow. Why was that a hard problem to solve?
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Chapter 8: What data supports the safety of Rotatec?
page five, the SAE, serious adverse events. And you would just look at that table and you would say, no difference.
The table is a comparison of side effects in the kids who got the vaccine and the kids who didn't.
Numerically, if anything, there were more SAEs on the placebo than the control arm, but it's insignificant. It's like the difference between eating a banana or an apple.
Yeah.
No difference.
Together, we went through every one of the medical problems listed on the chart. We kept finding the same thing. No difference. No difference. Any difference? Let's see, 0.6, 0.6.
No, no difference.
And seizures.
Let's see, where are you? Next page. Yeah, seizures. Yes. Numerically, maybe a little higher. But the SAEs were exactly the same.
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