Aubrey: Hi, everybody. Welcome to Maintenance Phase. I'm, oh shit. [laughs]
Michael: [laughs]
Aubrey: I was trying to decide in the moment, whether to say description first or name first [giggles]. Anyway, hi, everybody. Welcome to Maintenance Phase. We're going to explore the many rabbit holes past and present around health, wellness bodies, and weight loss. My name is Your Fat Friend. I'm a writer and columnist for SELF magazine. I am a fat lady.
Michael: And my name is Michael Hobbes. I'm a reporter for The Huffington Post and the cohost of another podcast called You're Wrong About.
Aubrey: Yay, welcome.
Michael: And today, we are talking about-
Aubrey: Fen-Phen.
Michael: -Fen-Phen.
Aubrey: [laughs] Fen-Phen.
Michael: Which sounds like the name of a zoo animal or something. Everyone I've told about this has no idea what it is.
Aubrey: Really?
Michael: Yeah.
Aubrey: Oh, my gosh. It was a huge force in my life.
Michael: Yeah.
Aubrey: Fen-Phen was a combination of diet drugs that were prescribed by a doctor. They were a huge deal for about three years, and those were three years that I was in high school, and I got put on it. So, I have personal history with Fen-Phen and Redux.
Michael: So, you were given this? You didn't go to the doctor and ask, "What is was like? We're concerned about your weight. Here's these weird pills that you a 17-year-old should start taking."
Aubrey: I was 14.
Michael: Oh, wow.
Aubrey: I had been told to be concerned about my weight. So, I was. I was in high school, which is not a high point in critical thinking about values around appearance.
Michael: [laughs]
Aubrey: There was this miracle drug and I was like, "Well, shit, yeah. I'll try that." There was a cover story of Time Magazine and the title was "The New Miracle Drug?"
Michael: Oh, no.
Aubrey: It was a huge media splash.
Michael: That's the thing where they can make a completely absurd claim. But as long as you put a question mark after it, you're not necessarily saying it.
Aubrey: [laughs]
Michael: A picture of you on the cover of Time with like a child molester?
Aubrey: [laughs]
Michael: That doesn't actually make it any less defamatory.
Aubrey: That's right.
Michael: So, did it work for you?
Aubrey: Oh, I don't remember, because I was on it for a really short time.
Michael: Okay.
Aubrey: I was on it, I think it was the last month that it was on the market. I absolutely remember many, many, many women, adult women and teenage women in my life were on it. I absolutely remember one person getting very, very angry when it was pulled from the market and we'll talk about why. What she said was, "Sure, it was a problem for some people, but it was the only one that really worked."
Michael: Right.
Aubrey: I was like, "Ah."
Michael: Yeah.
Aubrey: So, we'll talk about the phrase. Sure, it was a problem for some people.
[laughter]
Aubrey: The problems that it was for some people were big.
Michael: Do you remember its effects on you? Is it one of those diet pills that basically speed and it just makes you weird, and jumpy, and shaky?
Aubrey: Fen-Phen, when people say Fen-Phen, they're referring actually to three drugs.
Michael: Oh.
Aubrey: Two pills, three drugs. Fen-Phen itself was a combination of two existing diet pills. One called phentermine, that had been introduced in 1959. It had been around for a while.
Michael: Okay.
Aubrey: People didn't like it. It was unpopular, because so many people experienced racing hearts, shortness of breath. It was like a very unpleasant to be on. The other Fen in Fen-Phen is fenfluramine, which had been introduced in the 60s or 70s. It was unpopular because the weight loss that it caused was dramatic, but it was short lived. Essentially, as soon as people went off the drug, the weight just came back.
Michael: As opposed to diets, which last forever.
Aubrey: [laughs]
Michael: As we all know.
Aubrey: These two things were pretty unpopular diet drugs until they were combined in the early 90s and a third medication was added. That third medication is dexfenfluramine. Its sale name was Redux. That's what really set this all off. The first two, phentermine and fenfluramine are amphetamines. The third one dexfenfluramine, I believe is a downer.
Michael: Oh.
Aubrey: There was a predecessor to dexfenfluramine to Redux, I should say, that was called Pondimin. It was effective in weight loss, but the side effects were so dramatic that people didn't want to take it. The main side effect was that, it would put people to sleep. People reported sleeping 12 to 18 hours a day on Pondimin.
Michael: Oh, but they looked amazing.
Aubrey: [laughs] They looked gorgeous asleep in their beds, yes.
Michael: [laughs]
Aubrey: This was such a big thing that the one of the developers of Redux in selling it would say, "Well, of course, people are losing weight on Pondimin. They have to be awake to eat."
Michael: [laughs]
Aubrey: That was just like, "They're just losing weight, because they're asleep oftentimes. [laughs]"
Michael: [laughs]
Aubrey: Because Fen-Phen, combined medications of Fen-Phen were existing drugs as was Redux. It was a revision of Pondimin. The manufacturers, researchers said that, they assumed that those drugs were safe, because they had been approved by the FDA. Their early internal tests were just for the effectiveness of weight loss. They didn't test for safety early on. The manufacturers Wyeth and Interneuron sunk a ton of money into developing these drugs.
Michael: So, when was all this development taking place?
Aubrey: This was all happening in the early 90s leading up to a 1995 approval of Redux. That's what sets all of this off. This is also happening in the 80s and 90s, when more and more people are getting more and more concerned about their weight, their health, their attractiveness. That is taking center stage.
Michael: This is the origin story of the wellness industrial complex.
Aubrey: Yes, absolutely. It's a very fraught time culturally and totally is kind of a fraught time from thinking and [crosstalk] talking about health and bodies. But this was a real crescendo.
Michael: Right. Double fraught.
Aubrey: We're talking about multiple different drugs. Pondimin being rebranded as Redux is the big starters pistol for all of it. The researchers didn't test for safety. They only measured for weight loss effectiveness, which was high, because it's an amphetamine [laughs] like, "You are going to lose weight."
Michael: How does that work actually? is it just an appetite suppressant or do you burn more calories because your nervous system has sped up?
Aubrey: You know that I don't know. I know what the founders of Redux or the researchers behind Redux hypothesized, which is-
Michael: Okay.
Aubrey: -they believed that the reason that people were not losing weight was that they were using food as a drug to trigger their serotonin. What they wanted to do was up people's levels of serotonin, so that they would be happier without food.
Michael: Yeah, that doesn't sound convincing at all, because then SSRIs, which also had a boom time during this time would have also resulted in weight loss. A lot of them, my understanding is they resulted in the opposite.
Aubrey: Yes. Also, SSRIs not meth.
Michael: [laughs]
Aubrey: They start to move into FDA approval for Redux, in particular. The FDA approval process is pretty standard. You go to an advisory committee, you lobby them, they make a recommendation to the FDA, and then the FDA usually acts on that recommendation. Not always, but usually. There is this advisory committee meeting, where they are inviting people in support and in opposition to approving Redux. The people in support are the manufacturers, the pharmaceutical companies, Wyeth and Interneuron. What they are talking about is, we have an obesity epidemic in this country. They're throwing around this number that there are 300,000 deaths a year caused by being fat, and that this is our one shot to address this emerging epidemic. They are ringing the alarm.
Michael: Right.
Aubrey: Interestingly, the opponents are mostly doctors and they are doctors who have read the research about the predecessors to these drugs and they're cautioning about a few things. They're cautioning about heart disease, which phentermine and fenfluramine were both linked to. They're talking about something called primary pulmonary hypertension, which is a condition that destroys blood vessels in your heart and lungs.
Michael: Ooh, not great.
Aubrey: Not great. One of the main source, I will say, not the only source, but certainly, the main one is a great book called Dispensing with the Truth by Alicia Mundy, who's a reporter, who followed this case for a long time. She describes this as death by slow suffocation.
Michael: Oh, God.
Aubrey: The other thing they're warning about is brain damage.
Michael: What kind of brain damage?
Aubrey: But they find out is that, this is down the line. They don't know it at this point. At this point, the research they have shows that these drugs cause brain damage in lab rats, but they haven't tested for brain damage in humans.
Michael: Seems like you should do that. Yes.
Aubrey: Mm-hmm. They later find out that when people stopped taking Fen-Phen, again, we're talking about an amphetamine, their serotonin levels would plummet and stay low for a really long time, because "an overdose" of Redux, which is just like, "You forgot, you took a pill, and you took another one just to be safe. That's an overdose." A very small amount of Redux, that makes your neurons that produce serotonin, it makes them balloon up, and then they wither, and then they die.
Michael: It's like, that's your ability to feel happiness. So, you're diminishing the extent to which you can be a happy person.
Aubrey: 100%.
Michael: Ooh.
Aubrey: It is a brain damage that will lead to long-term depression.
Michael: Wow. What's interesting about this is, this idea of sacrificing health to focus on weight.
Aubrey: Mm-hmm.
Michael: The story we've always been told about weight is that, it's not necessarily weight itself. It's that weight is correlated with cholesterol, and heart disease, and blah, blah, blah. But then even when we have the cholesterol and the heart disease numbers in front of us, we're like, "No, no, no. It's about weight. The weight has to come down."
Aubrey: Yeah.
Michael: It's like, "Oh, we might cause heart disease by reducing the weight." But if the weight is only a problem, because it causes heart disease, then why would that be a tradeoff we'd be willing to make.
Aubrey: What we see in those hearings is the FDA and doctors grappling in real time with what matters more. If it matters more to get patients thin, but put them at the risk of heart disease, and lung issues, and brain damage in the process or if their heart, and lungs, and brain should be left alone as should their weight.
Michael: Right.
Aubrey: And it's really an open question and people talk about this really openly. There's this quote from that Time Magazine cover story, The New Miracle Drug?
Michael: The Miracle--
Aubrey: [laughs] So, this is the quote from that piece. This is straight from the writer. "That risk of course and the still unquantified chance of brain damage have yet to be weighed against the danger of remaining fat, which is considerable. Severe obesity puts people at risk for heart disease, diabetes, and some cancers. If Redux can help these people get thin, it might be worth the risk."
Michael: Right. Even if it results in all those people getting heart disease [laughs].
Aubrey: And die.
Michael: Yeah.
Aubrey: Part of what's happening, the tentpole story, the human interest story that holds up a lot of the Fen-Phen and Redux panic is a young woman named Mary Linnen, who starts taking Fen-Phen and Redux in the lead up to her wedding. She's 29 years old. Very quickly, she starts to lose energy for wedding planning. Within a month or so, she starts having shortness of breath just walking up a flight of stairs, which was not normal for her. And within a year of taking the drugs, she actually passes away from primary pulmonary hypertension. She does not get to get married.
Michael: Wow. So, she kept taking it even as she had all these worsening side effects?
Aubrey: Here's the trick about Fen-Phen and Redux. These side effects set in with as little as two months on the drugs and the maximum prescription advised by Wyeth and Interneuron is three months.
Michael: Oh, wow.
Aubrey: Because they're like, "We know that they lose effectiveness anyway after three months, so, we're just going to cut it off there." The FDA committee meets, the advisory committee meets. They take in all the testimony, they vote 5:3 to reject Redux for approval. But a few hours later, a few of the committee members go to the chair of the committee and say that they have uneasy feelings about how they manage this and they want to reopen the conversation. They schedule another meeting for two months later. It's in direct conflict with a major neuroscience conference. In addition to that, opponents are saying that they weren't invited to the second meeting. Both it was scheduled in conflict with something that opponents would care a lot about and folks were not getting invited to speak again. So, only the manufacturers showed up and the vote flips.
Michael: Shit.
Aubrey: Yup.
Michael: So, that's how we got Fen-Phen that they scheduled this meeting on Superbowl weekend for brain doctors.
Aubrey: [laughs] Yeah. That's right. That's exactly right. It's also worth noting at this point that France and England were already publicly considering taking similar drugs off the market. The US is behind the times.
Michael: Right. The only issue on which we are behind the times.
Aubrey: [laughs] Yeah. That's the only one.
Michael: And then we stopped doing that, because it's bad.
Aubrey: The FDA was not legally bound to take this recommendation. It's an advisory committee. They can decide to take that advice or not.
Michael: But it's basically, what you're saying is, it's the same set of facts. They say, "The drug isn't safe," and then a couple months later, they're like, "Whoops, it's safe." But nothing in the underlying information has actually changed. It's just the makeup of who showed up to a little conference room that day.
Aubrey: Yeah, there's no new information.
Michael: Right.
Aubrey: The FDA takes the recommendation, takes the advisory committee's recommendation. Interestingly, they take it over the objections of their own staff, particularly, scientists and researchers on staff who were like, "Hey, I have some big research questions to answer here."
Michael: Yeah, there's a lot of depressed rats that have some input on this process.
Aubrey: But part of the reason that it gets approved seems to be that there is this cultural shift happening in the FDA. In the 80s and 90s, they shift from talking about themselves as a consumer watchdog group to using this phrase, the industry are our customers.
Michael: Ooh.
Aubrey: Right. They're saying that like drug manufacturers are their customers and that they have to provide customer service to their customers.
Michael: Which means consistency and speed.
Aubrey: Mm-hmm.
Michael: All of the things that essentially work in opposition to the public interest.
Aubrey: Absolutely. And also, if they refuse to approve Redux, because the chemical formula is so similar to Pondimin, they would also have to recall Pondimin, which would basically just be a bunch of work.
Michael: Right. It's a hassle.
Aubrey: It's a big hassle, it's a big headache.
Michael: Wow.
Aubrey: Once Redux is approved, these two drug companies, the manufacturers of Fen-Phen and Redux launch a gigantic marketing campaign.
Michael: Oh, are these those ads that they show on TV where it's like, "Lovely, and we're playing in fields, and you won't ever be fat anymore, and everything is great. And then the dude comes on, who talks really fast." And he's like, "This might cause you to kill all of your children."
Aubrey: [laughs]
Michael: I was like, wait, what?
Aubrey: Part of what they do, this is a thing that I got really hung up on. They define their ideal customer and they talk about it internally as Roxanne Redux is the name.
Michael: [laughs] I'm imagining a Rosie the Riveter character.
Aubrey: 100%.
Michael: She's just really depressed from taking this drug for too long.
Aubrey: Having a hard time breathing. Yeah.
Michael: I haven't felt pleasure in three years, but look how skinny I am.
Aubrey: [laughs] They define Roxy and Redux as their perfect customer. They say, she's "pink collar" like Middle America. 35 to 54 needs to lose 50 or more pounds and they include the phrase "tried everything."
Michael: Oh, my God.
Aubrey: They're specifically marketing to people who are disillusioned.
Michael: Yeah, and desperate.
Aubrey: And very desperate, right?
Michael: Yeah.
Aubrey: Part of their marketing strategy is that they do these "roadshow of diet seminars" that are designed to sell Redux. This is like, when they describe it, it sounds to me very much like a motivational speaker--
Michael: Yes. [laughs]
Aubrey: --seminars, where they're like, "Come to the Red Lion on Sunday afternoon. Join us at the Sheraton." The interesting thing about the Redux seminars is that they have all the facilitators are sales reps, but they all wear white lab coats, and they don't tell people that their sales reps unless they are asked.
Michael: No way.
Aubrey: Right. They are very clearly presenting themselves as medical authorities. That's a clear signal. And they're only addressing that if the thought crosses someone else's mind enough for them to ask.
Michael: That's like walking around downtown in a police officer's uniform and then being like, "Why would you assume that I'm a police officer, sir? I'm just giving you orders about what to do. You haven't even asked me if I'm a real police officer." [laughs]
Aubrey: Right. It's medical stolen valor.
Michael: [laughs]
Aubrey: So, not anything they're saying, but just the approaches that they're taking these white lab coats. The whole thing just feels gross to me.
Michael: Have they said anything? Is there any information on what happens after these three months? It feels extra predatory to me to be like, "Oh, we need to find desperate women, who need to lose 50 pounds." These are going to be people that are in extremely vulnerable emotional places. And then even if it works, the minute you stop taking it, surely, if you're not taking amphetamines anymore, everything goes back to normal, you're not like hopped up.
Aubrey: Right.
Michael: All the weight comes back. So, what are you actually doing?
Aubrey: Right. That's a big part of this. And again, it brings me back to that family friend, who was like, "It's the only one that really worked." I'm like, "Ooh, we need to have a conversation about what it really worked means to you."
Michael: Right. What's worked. Yeah.
Aubrey: The other part that I will say that really struck me about their PR campaign. We haven't talked about this yet is that, a big part of it is investing in what Alicia Mundy this reporter calls Obesity Inc.
Michael: Right.
Aubrey: Because there is now an "obesity epidemic," there is a little industry that is cropping up around like, "Okay, this is now a medical thing. How do we make money off of this medical thing."
Michael: Right.
Aubrey: So, part of why its marketing plan is that, they make huge donations to anti-obesity organizations. They are very aware and very conscious that the more that they can ramp up anxiety about an obesity epidemic, the more they can make it seem like a serious medical problem, the more that they can sell.
Michael: And the more that they can cast themselves as the good guys, because all we're trying to do is make Americans healthier. That's it. We're just trying to save lives.
Aubrey: Right. We're just trying to help.
Michael: Yeah.
Aubrey: Yep, exactly. Within three months of the introduction of Redux, it catches on like wildfire. Also, at this point, it has been 23 years since the FDA last approved a diet drug.
Michael: Oh, wow. So, people are just like clamor-- It's like the people in Mad Max under the waterfall [crosstalk] standing there with a bucket like, "Gimme anything."
Aubrey: And all they've been hearing all the time is like, "If you don't drink water, you're going to be real unhealthy. You're probably going to die real soon, if you don’t drink some water."
Michael: Yeah. [laughs]
Aubrey: They know, but also the anxiety is getting ramped up so much. Within a few months of the introduction of Redux, according to Time Magazine, doctors were writing 85,000 prescriptions a week.
Michael: Oh, wow.
Aubrey: And by 1997, they are projecting $220 million in sales of Redux alone. Not even Fen-Phen. Just Redux.
Michael: Nice.
Aubrey: So, they are printing money.
Michael: Aubrey, you're good at this. This is fun.
Aubrey: Oh, yay, thanks, buddy.
Michael: This is dope.
Aubrey: Appreciated.
Michael: Yeah.
Aubrey: I just stumbled into this thing and I was like, "Oh, this story is bitching."
Michael: I can tell how much you love this. It's such a good story.
Aubrey: I really love it. I might die of heart failure later, because I took it. Who knows?
Michael: [laughs]
Aubrey: [laughs]
Michael: It's worth it. [laughs]
Aubrey: It's worth it. Avenge me.
[laughter]
Aubrey: The other thing that feels important to highlight here is that, Fen-Phen and Redux seriously fed pill mills.
Michael: I have been wanting to write an article about this. Tell me what pill mills are.
Aubrey: Pill mills, my understanding of pill mills is that they are essentially like doctors' offices that are mostly just fronts to get people prescriptions that they want. So, in this case, it provided doctors with this easy cashflow, like, you're not going through insurance, you don't have to deal with all of the red tape. It's essentially a retail medicine.
Michael: I have heard various rumors of these over the years, especially when it comes to diet pills, because people are so desperate and that every once in a while, one of these white collar cases will pop up in the news, but there's some doctor, who's writing 25,000 prescriptions a month, to the point where like, "If you were signing these, it would be physically impossible to sign that many prescriptions."
Aubrey: Right. In Alicia Mundy's book, Dispensing with the Truth, there are many firsthand accounts of people who are like, "Oh, yeah, I went into a doctor's office. I did not talk to a doctor. I talked to a med tech, who took my blood pressure and some baseline vitals. And then they gave me a prescription." It becomes such a big deal that there are 800 numbers that you can call, 1-8-8-8-4-FEN-FEN?
Michael: Oh, my God.
Aubrey: It's one of the numbers. You just call them and they send you diet pills or they get you a prescription.
Michael: Wait, isn't that too many letters 4-FEN-PHEN? Is it FEN-FEN?
Aubrey: Yeah, they misspelled that.
Michael: Okay.
Aubrey: [laughs] That's something to get around it, is they misspelled it.
Michael: Yeah. [laughs] This is a European phone number, I would say. Okay.
Aubrey: [laughs] It also becomes such an issue and such a huge flashpoint around weight loss that weight loss companies like Nutrisystem and Jenny Craig start figuring out how to weave Fen-Phen and Redux into their programs.
Michael: Oh.
Aubrey: This becomes such a big thing that, if you remember Mary Linnen, the one who died before her wedding, her lawyer is married to a woman who's a doctor. At the time of Mary's death, that doctor had already been offered and I quote "a couple $1,000 per month on the side for signing pads of prescription slips for Fen-Phen and Redux."
Michael: Ooh.
Aubrey: That was an offer that was not made by a manufacturer, it was not made by their sales team. It was made by these large weight loss corporations, so that essentially, you could go into one of their diet centers and walk out with a prescription.
Michael: Weight Watchers was just spraying people with Fen-Phen in a mist like produce at the grocery store. Everybody that can ruin their meetings just like-- [crosstalk]
Aubrey: [laughs] Yeah, they're the perfume counter, where they're just like, "Oh."
Michael: If you spray it in front of you and then walk into it. That's the best way to-- [crosstalk]
Aubrey: [laughs] So, interestingly, this is the section in my notes that I've titled "The beginning of the end."
Michael: Ooh.
Aubrey: They do a bunch of research into Fen-Phen and Redux, because they noticed that patients who've been on Fen-Phen and Redux are starting to be diagnosed with heart disease.
Michael: How long has it been on the market at this point?
Aubrey: At this point, I think these reports start to come in at scale in 1996. So, that'd be like a year.
Michael: Okay. So, pretty soon after it's hit the market.
Aubrey: Very soon. And what they find is that, in their one clinic, this clinic called MeritCare in Fargo. Fargo is a city of about 77,000 people. This one clinic finds 11 cases of heart disease. This is a very high incidence.
Michael: Right.
Aubrey: They do a little rough back of the envelope math and primary pulmonary hypertension, which is what they're dealing with here is generally really rare as a naturally occurring phenomenon. So, they do a little math and they find that if their data is right, taking Fen-Phen and Redux increases the risk for primary pulmonary hypertension by 2,300 times.
Michael: Oh, shit.
Aubrey: Right.
Michael: It's like one of those towns that's next to a nuclear waste site-
Aubrey: Totally.
Michael: -where all the kids are born with eyeballs facing inwards or whatever. It's just really obvious.
Aubrey: [laughs] Then the Mayo Clinic starts looking into it, and then the New England Journal of Medicine publishes something about it, and the story breaks in this huge way on July 9th 1997. So, it's on 60 minutes, it's on the Today's show, it's on CNN, it is a humungous new story. Wyeth, one of the manufacturers responds to it. One of their VPs says, "This isn't a study. It's just an observation."
Michael: [laughs] What do you think studies are?
[laughter]
Michael: How do you think people study things? [laughs]
Aubrey: So, he says that there's further study that's needed blah, blah, blah, blah, blah. And Wyeth also starts releasing these little sound bites. They start testing little phrases. One of the big ones that catches on is they say, "You have almost twice as great a chance of getting hit by lightning and [crosstalk] of getting primary pulmonary hypertension from a weight loss medication."
Michael: That might be true, but still, you're not supposed to increase people. You can't just compare the risk of your drugs to some other thing that's going to kill them. "Look, we're killing you. But an axe murderer might also kill you." So, I don’t think it the problem is. That's not how morality, or medicine, or anything works.
Aubrey: Totally. No, I will tell you, this is as an aside.
Michael: Mm-hmm.
Aubrey: My dad, when he and my mom were splitting up, and she would ask him to do things differently, and the lead up to their divorce, he would be like, "I don't know why you're on my case. You could have married Charles Manson." She was like, "That's not the bar."
Michael: [laughs] There are some men in between you and Charles Manson. There are more than one man on that spectrum. [laughs]
Aubrey: [crosstalk] I thought you would appreciate that.
Michael: [laughs]
Aubrey: So, within 16 days of the story breaking, the FDA essentially instructs Wyeth to add a warning to their label, because there's not a warning on the label.
Michael: Oh, God, don't go too hard FDA. Really cracking down like, "Sorry, this might kill you."
Aubrey: Totally.
Michael: But proceed.
Aubrey: So, Wyeth does that because they don't really have a choice. They add a warning to their label and they also have their PR firm write what they call a dear doctor's letter, which is update to doctors about the status of this medication is changing, here's what you need to know. So, they're explaining the label change. One of the phrases that they include is that, "the evidence is inconclusive," which is technically true, but the whole letter is designed to downplay concerns.
Michael: This is the tobacco company playbook that one of the things that you learn when you look into the big fights, decade long fights over tobacco is that, what the tobacco companies have always said is that, "The evidence that cigarettes cause cancer is unclear." It actually is that scientists still do not know exactly why cigarettes cause cancer. What they know is that, people who smoke are more likely to get cancer, people who smoke more are more likely to get cancer. States, which have more smokers have higher cancer rates, etc. There's a million of these correlations and there's always something that we don't know.
But what companies always do is they latch on to these ordinary things in the scientific process that like, "We literally can never know everything." And they pick those areas, where there is still debate and areas where there's still uncertainty and they're like, "Oh, we couldn't possibly make a decision until we get clarity on this." It's like, "No, guys. If people who are taking your drug are dying a lot, that's probably enough for us to pull back," just like, "Let's start over."
Aubrey: At the same time that they are releasing this dear doctor's letter, their lobbyists are also lobbying Congress to get Pondimin and Redux de-scheduled by the DEA.
Michael: Wait, what is what does that mean?
Aubrey: That means, it would no longer be a controlled substance.
Michael: Meaning, what you could buy it over the counter?
Aubrey: Meaning that they could extend prescription timelines past those three months.
Michael: Oh, shit,
Aubrey: Right. So, their internal math that's later found in trial discovery shows that getting the drugs de-scheduled could increase their sales by 25%.
Michael: What you're saying is, they basically got FDA approval by being like, "Don't worry about the side effects. People are only going to be taking this for three months. It might be bad in the long term, but people are only taking in the short term. Don't freak out." And then once it's approved, it'd been like, "Oh, yeah, we're just going to let people take this forever, okay."
Aubrey: Yeah, that's right. That's right. They also train their sales staff very, very briefly. It's about five minutes of training that they get.
Michael: Nice.
Aubrey: It's essentially training on how to redirect concerned questions and how to reassure doctors and customers.
Michael: Dude, yes. When I sold frozen steaks over the phone as a college student, they had a literal script for every objection that people would make like, "I don't think I could make this decision without consulting my wife." We were supposed to say like, "Well, I think your wife would want you to buy steaks, because steaks are good." We would have this little flowchart of all of their objections. I guess, it's the same thing.
Aubrey: Sidenote. "At some point, I would like to hear many stories about selling frozen steaks over the phone."
Michael: I did it for one night. I lasted one night. Now it's like, "This is gross." Then I stopped.
Aubrey: [laughs] There is this big media story now. Wyeth, of course, they have more money than God at this point. They swipe back, they build $100,000 counterattack plan.
Michael: Nice.
Aubrey: They are paying for media blitzes, about the dangers of obesity, they are making those splashy, high dollar contributions. Over the years ahead, lawsuit after lawsuit after lawsuit is filed from people who've gotten PPH and heart disease, it becomes so big that they essentially pulled together a conference of 500 attorneys from around the country, who are all managing Fen-Phen and Redux cases.
Michael: So, there's like, it's so big that there's a summer camp of people that are fighting against this one pill.
Aubrey: 100%. They have doctors there to present, they have researchers, they're gathering everyone together, there are breakout sessions. It's a whole big thing.
Michael: No way.
Aubrey: They do all of this and you can actually see if you look up the adverse drug experience reports. You can see this massive crescendo of like, as soon as the media coverage hits, that same year, the adverse drug experience reports skyrocket. They go up to 10,000. Because now, people know what to look for.
Michael: Right,
Aubrey: A lot of the symptoms of primary pulmonary hypertension are just like fatigue, and shortness of breath, and things that don't necessarily strike people as emergency conditions. But if you don't address it, it will kill you, potentially.
Michael: Right. These stories come out, everybody starts putting two and two together of like, "This is why I feel like this."
Aubrey: Yes. So, as these stories start to come out and as these cases start to move forward, trial discovery starts happening. In trial discovery, it becomes clear that Wyeth and Interneuron both have known about this since before even advocating for the approval of the drug.
Michael: Oh, my God. I want to gasp or something, but this is such not a twist.
Aubrey: [laughs]
Michael: I feel every time we have these things like corporate malfeasance, it's never like-- And in the discovery phase, it turned out, the company had no idea and they're acting in good faith all time. It's always just like, "Kill them." These emails from Palpatine have just like, "Fuck these lives." This happens every time. [laughs]
Aubrey: It's 100% the case. Actually, one of the things that shows up in the files I will say and this is something we should talk about on a full episode, their attorneys and researchers both checked them on the use of this 300,000 deaths a year number and everyone says, "This is unsubstantiated."
Michael: So, even their basis for the obesity epidemic is killing so many people, there's actually not a clear number for that.
Aubrey: There's not good data. They advise them to say, "Obesity contributes to X number of the top 10 causes of death," which you can say right potentially.
Michael: Right.
Aubrey: But this is straight up inaccurate and people internally were like, "This isn't accurate. We shouldn't be saying it."
Michael: My two rules for this are, anytime you see a statistic with contributes to or at risk of, you should run in the opposite direction.
Aubrey: Totally and miracle drug.
Michael: Yes.
Aubrey: We're just creating a list of watchwords.
Michael: Yeah.
[laughter]
Aubrey: Here are the things that Wyeth knew. We'll just run through it real fast, because you're exactly. No one's clutching their pearls being like, "Can you believe this giant pharmaceutical company didn’t have their [crosstalk] patients in mind."
Michael: A pharmaceutical company? Actually, bad. How dare you?
Aubrey: They knew that the drugs lost effectiveness after three months. They knew that most people who took it regained the weight that they lost. They internally acknowledge that while PPH might be a health concern, they haven't researched it and they will push back publicly against any label warnings. They will push back publicly against basically, any restriction on distribution of this drug.
Michael: Whoa. So, we don't know, but we're going to fight this accusation in the press.
Aubrey: 100%. So, that written out all in one memo.
[laughter]
Aubrey: All in one. It's not like, "Oh, here's one document," and then a couple years later, "Here's another." It's like, "No, here it is. The Vice President of this department wrote this memo."
Michael: It's like those summary mails you right after conference calls, you're like, "Hey, guys, I just want to put all of the evil stuff we're doing in one place. [Aubrey laughs] You can refer to it later. I don’t see why this would be a problem at all."
Aubrey: Here's one of the things that genuinely shocked me. You might be unshocked.
Michael: [laughs]
Aubrey: I have super shocked at this. Part of their budget, and this is very clear in discovery documents is that, they hired an outside PR firm to hire medical experts to write papers in praise of Fen-Phen and Redux, and get them published in journals.
Michael: Ooh, that's rough.
Aubrey: Yeah, the Ethics Chair at the AMA, the American Medical Association publicly freaks out and loses it on Wyeth and Interneuron, and they say, "These are advertisements that are being couched as valid scientific papers," which is super dangerous.
Michael: Extremely bad. Yeah.
Aubrey: And they're paying 20 grand per paper, which is both more and less than I would like to say.
Michael: [laughs]
Aubrey: I will say a bunch of these came up in the research for this record.
Michael: Oh, yeah.
Aubrey: When you're reading scientific research, the titles are incredibly dry. They're not making big bold statements. They're like, "This might be true under these conditions. We still need to study more in these ways." These are two actual titles of papers about Fen-Phen and Redux. One of them was called Rushing to Judgment on Fen-Phen and the other one says, "The Fen-Phen diet drug combination is not associated with valvular heart disease."
Michael: Nice.
Aubrey: Which is, again, you and I have talked to enough researchers to know, that is not researcher language. That's PR language.
Michael: It's like, you're wrong about Fen-Phen basically.
Aubrey: Totally. You're wrong about our products. So, buy it.
Michael: Yeah.
Aubrey: All of this happens, Fen-Phen and Redux are both finally pulled from the market. From start to finish, from approval of the drug to being pulled from the market, the whole thing is about three years, which is so fast for these processes.
Michael: This is my cynical take on it, but I'm imagining that the company made more money in those three years than they ended up paying in lawsuits and stuff. Do we know?
Aubrey: I do know. Because and will skip ahead. They essentially have to shutter their operation over this settlement. There is a massive class action lawsuit.
Michael: Okay.
Aubrey: In 2000, a federal judge approves a settlement for this huge class action lawsuit. The settlement is $3.75 billion. According to Reuters, it is the third largest pharmaceutical settlement in the nation's history.
Michael: [laughs] It's funny that it's not the first, because pharmaceutical companies are so fucking bad.
Aubrey: [laughs]
Michael: This is barely in the top five. Great job, guys. [laughs]
Aubrey: Ultimately, they find that 45,000 people, who took Fen-Phen and Redux developed either primary pulmonary hypertension or heart valve damage.
Michael: Holy shit.
Aubrey: 45,000 people end up with heart conditions as a result of this.
Michael: Yes, but how many people were struck by lightning, you know?
Aubrey: [laughs] And how many of those people are now thin and depressed? [laughs]
Michael: How those people look now, huh? [laughs]
Aubrey: Sure. Many people also died. These are heart conditions and brain conditions.
Michael: Yes.
Aubrey: Really, you can make an argument about liver, or pancreas, or whatever that these are, at least manageable things. If you are messing with your heart and your brain, those are some real baseline functions, right?
Michael: Although, what's also interesting about this is that, we always focus on these extreme side effects, harmful side effects of pharmaceutical drugs. But there's also the basic question of like, "This didn't do what it said it was going to do." If people were taking it, even if they lost weight for three months, presumably, the vast majority of them would have gained it back anyway. So, even by their own standard, I'm assuming it didn't even do what it said on the bottle.
Aubrey: This feels like the dirty little secret of the diet industry or the thing that they're trying to distract people from. We're all dieting all the time. We're all taking part in cleanses, and detoxes, and diets, and weight loss efforts, and whatever. And none of us are actually losing weight in the long term, but we're still buying in. So, they're still taking advantage of that.
Michael: This is partly why we're naming this show. This is because the Maintenance Phase of any diet is the diet that there's no such thing as like, "Jumpstarting your weight loss or kickstarting a diet plan." It's like, "No, the minute your habits go back to a default, your weight is going to default."
Aubrey: Right.
Michael: Again, if you're taking a pill for three months and then you go off the pill, there's no reason to believe that you wouldn't just rebound to your previous weight, because that's how bodies work.
Aubrey: Totally.
Michael: Yeah, it sucks. [laughs]
Aubrey: This was also a major systems failure on the part of the FDA.
Michael: Dude, yes.
Aubrey: Part of this is that Wyeth didn't tell people, but again, shocking, a manufacturer didn't tell someone about their product not working or having harmful consequences, right?
Michael: Right.
Aubrey: The bigger challenge here is, how do 45,000 people end up with heart disease as a result of a drug that they've taken and the FDA doesn't catch it? That's more than half the population of Fargo, North Dakota, I have learned.
[laughter]
Aubrey: It highlighted some major shortcomings in the ways that drug reactions were reported that they were analyzed, they were circulated internally. Some of these reports came in and didn't actually make it back to the advisory committee staffing person, the person who's in charge of regulating this particular drug. So, there's just failure on failure on failure inside the FDA.
Michael: Right, because there's the central question is like, "if their internal data was showing that people weren't, for example, keeping the weight off after they stopped using the drug, why wasn't that part of the packet of information that they were forced to turn over to the FDA?"
Aubrey: Right. Why did it take a class action lawsuit after all of this damage has happened to catch that this was not only possible, but in this case, likely, right?
Michael: Yeah. Send us your Palpatine memos at the beginning of the process.
Aubrey: [laughs] Again, Wyeth gets this huge judgment. But the bottom line here and this is the part that is really haunting to me. The FDA is still approving diet drugs. They approve one, for the life of me, I can't remember the name. It was marketed as Alli was the name of it.
Michael: Yeah, this came up a lot when I was doing reporting on my article. I also forget the name, but it's one of those pills that basically it can help you lose 10% of your body weight. And again, once you stop taking it, you gain all the weight back. It has the same structural limitations as Fen-Phen, although, it's probably not just straight up crack, cocaine in your system, I hope.
Aubrey: Right, totally. It's not going to murder you immediately.
Michael: Yes.
Aubrey: But it's orlistat. That's the name of it.
Michael: and Aubrey: Orlistat.
Michael: Yes.
Aubrey: In 2012, the FDA approved Qsymia, which is another phentermine-based weight loss drug. It's the same amphetamine based. Phentermine is half of Fen-Phen, right?
Michael: Right.
Aubrey: There's this ongoing string of research about whether or not Fen-Phen could be used in treatment of addiction, especially to alcohol and cocaine. There have been studies in the last 10 or 20 years about like, could it be effective here. Actually, this year in France, there is a huge trial happening about another weight loss drug called Mediator, which was pulled from the market in 2010 after causing the numbers vary, but it's up to 2,100 deaths in France.
Michael: Huh?
Aubrey: In a real fun twist, the defendant is Servier International, which is a big drug company based in France. They were Interneuron's partner in buying and selling Redux.
Michael: Ah.
Aubrey: It's truly the same people doing it all, again.
Michael: Like, the literal same people.
Aubrey: Right.
Michael: Like, "Hey, Steve. I know you from the last one of these." [laughs]
Aubrey: Today, phentermine is number 210 on the list of the most prescribed medications in the US.
Michael: Wait, so, it's still around?
Aubrey: Uh-huh. Phentermine is, which is not all of Fen-Phen. It's part of the drug cocktail.
Michael: The Holy Trinity that we were-- Yes.
Aubrey: That's right. And I did a Google search of Fen-Phen as part of this, because I was like, "I wonder what comes up." Two of the suggested search terms in Google are, is Fen-Phen still available and where can I get Fen-Phen?
Michael: Dude, yes. I actually looked into this when I was working on my article and I also found a lot of demand for Fen-Phen and places selling it or pretending to sell. I don't know if they're just selling sawdust pills or whatever. But you can go online and buy "Fen-Phen." I've no idea what you're going to get in the bottle that you get.
Aubrey: There you go. That's the whole story. It got smacked down in a really public way, but it's still around. I feel history is always a nice corrective to this idea that it's like, "We made a mistake as a society, and then we learned, and we never did it again."
[laughter]
Michael: In most of these stories, you're like, "Oh, no, we're still doing literally the exact same thing."
Aubrey: Right.
Michael: Nothing has changed. [laughs]
Aubrey: Like many things, we get outraged about it in a cyclical way, and then decide to stop paying attention or get some satisfying climax to the story. So, we assume that all the underlying issues are solved, and in this case, they are very much not.
Michael: Does this make you think any differently about your own experience? Are you more mad that this was prescribed to you as a 14 year old now than you were a couple weeks ago?
Aubrey: Oh, I'm more freaked out.
Michael: Yeah.
Aubrey: Because essentially, the effects of primary pulmonary hypertension can have an onset that is long after the first time you take the drug.
Michael: Oh, shit.
Aubrey: In 2012, Wyeth, which is now owned by Pfizer asked a federal judge to bar any Fen-Phen cases from going to trial, if they had developed any symptoms more than nine years after taking the medication.
Michael: Oh, interesting.
Aubrey: Right. They're trying to get anything like barred that feels too far out to them, which I can understand. On the one hand, you can be like, "Listen, they took this drug. It's a really high risk."
Michael: Right.
Aubrey: But on the other hand, you can't know.
Michael: Yeah, it would be difficult to make a strong case for that. Yeah.
Aubrey: It would be very difficult to prove a causal relationship in an individual. I get it and also, I'm like-- But listen, every single thing Wyeth has done so far has been garbage. So, I'm willing to consider that this is also garbage, right? [laughs]
Michael: Every decision that companies make is profit maximization.
Aubrey: Right.
Michael: They're not doing this for public health, they're not doing this for fairness, or accuracy, or legal purity. They're doing it to preserve their profits. However, you feel about that morally, that is what they are doing. So, we should always come into it with that assumption in mind.
Aubrey: 100%. So, how about you? You're like, "Everybody I talked to didn't know what it was?"
Michael: Yeah.
Aubrey: Which is mind blowing to me.
Michael: Well, it's also because most of the people have been asking are men. I think the gendered aspects of this are so interesting, because if the obesity epidemic is this biological thing that is really concerning, etc., 300,000 deaths, then there's no reason why women would be prescribed diet pills more than men. But the fact that this was marketed toward women implies that there's clearly an element of looks, women are judged on their looks to an extent that men are not. And so, you're clearly appealing to that in your marketing while pretending that all you're appealing to is health.
Aubrey: Absolutely. And that's also borne out by the data around bias facing fat people that women who are considered "overweight" by even a small amount, makes significantly less money in the same job. And for men, it takes getting very, very fat before that shows up in their paycheck. And in this case, we're seeing a conscious effort to focus on women.
Michael: Which is just revealing of the exercise, because it's basically a pill that's going to make people look better. And you're selling it as a weight loss pill, because that's what you need to tell the FDA like, "It's public health, blah, blah, blah." But what you're actually promising people is look better in this pill form.
Aubrey: Absolutely. And again, this also feels to me very clearly racialized that's income levels that they're talking about, like, the folks who are primary plaintiffs in this are overwhelmingly white women. They're overwhelmingly educated white women. One of them is a PhD candidate. There's all of these stories of very promising young white women and the way that we like to talk about promising young white people being cut down in their prime. We're talking about a drug that causes hypertension and we're not actually exploring the stories of black people, of Latino people, like, people who are already at higher risk for hypertension and heart disease. The dangers to people of color taking this drug are different and probably much worse. There's not really data around that, that I found at least, but it seems not great.
Michael: So much of this would come back also to insurance status. First of all, insurance of like, who's having access to doctors. But then also, what you come across in literature over and over again is that, fat people, especially fat people of color at doctors are often punished. Like, "I'm not going to give you this diabetes medication. You refuse to lose weight on your own. So, I'm not going to help you." I do wonder if there is an element of like, "Well, I'm not going to give you the diet pill, because I'm holding you to the standard that you should be able to do it yourself. I'm not going to give you the "easy way out," whereas if a wealthy white housewife comes in, it's like, "Oh, she's busy. She's on a bunch of charity boards. She's doing the gardening. I have to help her."
Aubrey: Yes, totally agreed. It feels very paternalistic to me, too. It definitely feels like the medical version of like, "You can have a puppy when you've proven that you can take care of it." [laughs] It's really a gross way of dealing with major health issues.
Michael: Yeah. I just think there's this wind at the back of any weight loss drug or anything that is going to promise an easy solution to this much more complicated problem from the people, who sit on these advisory boards to the people who work in medical journals, to marketers, to doctors themselves. It's like, everybody just wants something quick and easy for this. In a million little ways, I think people reduce their critical thinking to be like, "Yeah, that sounds good. Let's push this through a little bit faster. Let's subject it to a little bit less scrutiny." You add up all those little tiny decisions and it results in this just like greased waterslide of this pill getting onto the market that really had no place being given to large numbers of people.
Aubrey: Absolutely. The fact that there was so little testing of the drugs in combination is fully bananas to me. Again, pharmaceutical companies acting badly. The FDA not requiring more of them is very troubling.
Michael: Just the idea that like, "Well, driving is fine and wearing sunglasses is fine. So, driving while wearing sunglasses, I don't see what the problem is." It's very obvious that drugs have effects in combination with each other that are not predicted by their individual effects. This is not an exotic concept to scientists. But for some reason, it seems everybody's like, "Whoops, I guess, it's fine."
Aubrey: [laughs] Yeah, that's right. Anyway, it's a real bummer. So, bummer of a story.
Michael: It's the only bummer of an episode we're going to have.
Aubrey: Absolutely. Everything else is sunshine and roses.
Michael: After this, it is just going to be, how to get 10,000 steps and how to lose 10 pounds for your wedding.
Aubrey: Step one, get engaged. Step two, lose 10 pounds.
[laughter]