Louise: Welcome to the Exposing Obesity Incorporated podcast.
Ragen Chastain (she/her): This is episode five Novo's Thievish Third Step.
Louise: I'm Louise Adams.
Ragen Chastain (she/her): And I'm Ragen Chastain.
Louise: And we are exposing the sordid underbelly of the weight loss industry, Obesity Incorporated.
Ragen Chastain (she/her): Now we want to note that the term quote oplesity is stigmatizing and harmful and our podcast is based on exposing the people making a fortune using it. So when we use it in the podcast, we'll use quotations or Louise's brilliant invention oplesity with an eye roll always implied.
Louise: Thank you so much, everyone. We're so thrilled to be doing this podcast and we're loving the feedback so far. We love bringing the filthy laundry of the weight loss industry out into the open. You can support us by telling everyone you know to give us a listen. And if you've got time to rate and review us wherever you are listening to your podcasts, you can even become a Patreon if you're feeling super generous.
Ragen Chastain (she/her): And you can do that at Exposing Obesity Incorporated.com. Patrons get early access and bonus content for every episode. So, today we're gonna continue what we've been talking about with Novo's marketing plan. So far, we covered how in step one, their goal was to create the oplesity market by convincing everyone that simply existing in a higher weight body, regardless of actual health. Is a chronic disease. In our last episode, we revealed how their second step then expanded the market by infiltrating medical education and guidelines, redefining millions more people to be targeted for oplesity quote treatment. And today we're going to look at step three how Novo then exploited that market. And this step relies heavily on the work done in the first two steps. First, they created so-called evidence on the quote science of oplesity. Then they had their stable of paid researchers and doctors proselytizing to spread their new gospel far and wide. So now we're at the, there's just so much evidence and everybody knows stage. And the oplesity workers have all been paid off, and the field of medicine and medical schools has been infiltrated by Novo's key marketing messaging, parading as medical education. The world's oplesity organizations and the organizations they fund, including the American Diabetes Association and the World Health Organization, and many more, are all in lockstep, dutifully speaking from the same script. So Louise, can you tell us a little bit more about this third step?
Louise: It's all so dirty already. I need a shower.
Ragen Chastain (she/her): Ewwww
Louise: So step three is really all about greasing legislative and policy wheels to really exploit the oplesity market that they were working so hard to create. Now, Ragen, you know that I'm a bit of a stickler for history and context.
Ragen Chastain (she/her): Indeed I do.
Louise: Details lady. So I'm going to
Ragen Chastain (she/her): Ha.
Louise: start by sharing more about the history of the weight loss industries playbook because it seriously exposes the filthy underbelly. We can also see that Novo's tactics were well underway well before the 2015 conference where they talked about that marketing plan. Back in episode one, we covered the Fenphen disaster, where pharma influence got Redux approved, even though there were known safety concerns, and that triggered a very undignified weight loss drug frenzy across the United States. And then when people started dying of heart problems, whistleblowers, not the drug companies, raised an alarm. And in 1997, Fenphen got pulled off the market. But unbelievably, at the same time the Fenphen disaster was unfolding, Two more weight loss drugs snuck through FDA approval processes. Hoffman La Roche's Orlistat, I call that oily shat, because it
Ragen Chastain (she/her): I remember
Louise: yeah, you remember that one?
Ragen Chastain (she/her): I well I remember I think the on the box it said that people might want to take an extra pair of pants with them around.
Louise: Yes, yes. It inhibits the absorption of fat, which means you basically sort of I guess fat shat it out. so that was one of them. The other one that made it through was Knolls Sibutramine, which is known as Meridia or Reductil. And you might have noticed, Ragen, that these are the same two companies. who created the industry shopfront organization, the IOTF, who we talked about last time. And they were the ones who pressured the World Health Organization to lower BMI standards. And that created twenty-nine million new Americans who were pronounced as too fat overnight.
Ragen Chastain (she/her): Increasing your market by twenty nine million people. Nice work if you can get it.
Louise: Not bad. So Sibutramine started life as a failed antidepressant and it got rebranded when they noticed it had a small weight loss effect. It works by blocking serotonin receptors. And incidentally, serotonin is the same mechanism used by Fenphen. So this new weight loss drug acting on serotonin. was passing through the FDA process at the same moment another serotonin impacting drug's harms were killing countless people. Yes.
Ragen Chastain (she/her): Ugh why?
Louise: Well, I guess it tells us a lot about how much risk regulators and pharma are willing to take when it comes to fat people's lives. Sadly.
Ragen Chastain (she/her): yes, the FDA willing to harm and kill us to make us a little bit thinner for a little
Louise: If
Ragen Chastain (she/her): bit of time.
Louise: Sibutramine's clinical trials were funded by the manufacturer Knoll, and the clinical trial was authored by our Obesity Incorporated regulars, George Bray and Donna Ryan.
Ragen Chastain (she/her): No way, Louise, we have got to at some point create a bingo card for a play at home game of these researchers.
Louise: Honestly, today is going to be bingo all over the place. I warn you. It's
Ragen Chastain (she/her): Ha ha
Louise: it is insane. So the the clinical trials were just seriously unimpressive. The weight losses barely cleared that 5% threshold. And to make everything worse, Sibutramine raised heart rate and blood pressure. With such dismal outcomes, the FDA's medical advisory committee recommended that it should not be approved. But Knoll appealed and the FDA ended up approving, once again overruling their own experts. Does that sound familiar?
Ragen Chastain (she/her): You know, it really sadly does.
Louise: Redux all over again. So
Ragen Chastain (she/her): Yeah.
Louise: Meridia hits the US market in 1998 and it has a warning that it should not be used by anyone with cardiovascular issues. The
Ragen Chastain (she/her): Because there's no one who has cardiovascular issues that is not diagnosed. Like yikes.
Louise: yeah, exactly. So no one was happier than the Fenphen pill mill doctors, who were thrilled.
Ragen Chastain (she/her): Of course.
Louise: Dr. Donald Jensen, whose weight loss chain had shrunk from 19 clinics down to four in the aftermath of the FDA recall, told the LA Times, We're gonna write prescriptions as soon as pharmacies will honour them. Everyone's gun shy, he said, but everyone's looking for something to replace Fenphen.
Ragen Chastain (she/her): why were they gunshy, Donald? Why was it the dead people? Tell us. Ugh
Louise: Well, the unbridled joy of the weight loss industry was short-lived. So in 2002, a whistleblowing organization called Public Citizen used freedom of information and they uncovered almost 400 serious reactions and 29 deaths from sibutramine, mostly from guess it, cardiovascular stuff. Unbelievable.
Ragen Chastain (she/her): No way.
Louise: Sarcasm alert. So
Ragen Chastain (she/her): Yes.
Louise: th they demanded that the FDA ban it and the FDA did nothing. in Europe, people were dying there, but instead of pulling the drug off the market, the EU regulators ordered Abbott, who was the drug company that had taken over Knoll, to run a five-year safety trial on Sibutramine called Scout. So this was funded by the drug company Abbott, and its lead author was none other than W. Philip James.
Ragen Chastain (she/her): Ooh, another one. I think I might have bingo already.
Louise: Okay, Obesity Incorporated's granddaddy and IOTF frontman. So Abbott's number one fan gets to run the safety trials for the company whose drug he'd helped create the market for.
Ragen Chastain (she/her): Sounds legit.
Louise: What what could go wrong? god. I need to talk about the scout methodology and I know I'm a bit off, but I need to talk about it because it's kind of unhinged. So cardiovascular events in general are rare. So in order to get answers about safety risks quickly, Scout deliberately recruited people with existing heart problems. The exact population, the FDA said, shouldn't take it. Yeah. Yeah.
Ragen Chastain (she/her): I can't if you're not watching on YouTube, my jaw just dropped open. That is a choice.
Louise: Uh-huh. That is a deliberate choice. there's also another sneaky trick woven into the methodology. Before they divided their victims, I mean subjects, into treatment and control groups, they did a run-in period where all 10,000 people got six weeks of sibutramine so they could screen out anyone who couldn't tolerate the drug. and then they ran the trial. So, this kind of methodology Can you see problems here?
Ragen Chastain (she/her): add this to the things that would get a freshman research method student failed methodologies of the drug companies.
Louise: Imagine a scenario where scientists are worried because they're like, this mostly ineffective drug might be making people suicide. So in order to find that out, let's deliberately recruit people who are at really high risk of suicide. And then if they do suicide early on, let's not count them and then then do the safety study. This is, this would not make it through ethics approval at all.
Ragen Chastain (she/her): No, what IRB was involved in this? Like this is
Louise: Yeah.
Ragen Chastain (she/her): unhinged is barely touching how terrible this is.
Louise: Yes. So the scout results themselves, they were horrific. People taking subutramine were 16% more likely than those taking placebo to have heart attacks and strokes. Instead of raising the alarm, Phil James's paper recommended business as usual. Let's keep selling the drugs to the public, let's keep the cardiovascular warnings, of course, and let's not even consider the risks for people without existing diseases of cardiovascular natures. Abbott even put out a press release. Okay. Which said that the results of their own Brace Brace.
Ragen Chastain (she/her): Feel like I'm like watching this with my hands over my eyes. I can't Okay, I'm ready. Let's go.
Louise: brace for impact, okay. So Abbott put out a press release which said that the results of their own safety study, the one that they designed and run on purpose, couldn't actually be generalized to anyone taking Sibutramine because it had studied people with cardiovascular disease and of course they shouldn't be taking it.
Ragen Chastain (she/her): sweet fluffy lord.
Louise: no, I know, so cheeky.
Ragen Chastain (she/her): They are there is no low. There's no low too low for these people. That is that is
Louise: Hmm.
Ragen Chastain (she/her): unbelievable.
Louise: I know. I can't help but wonder though, if they'd found the opposite results, they would be absolutely falling alone themselves to assure the public about safety.
Ragen Chastain (she/her): yeah. Even in people with cardiovascular issues. Yeah, no, you're a hundred percent right. This was
Louise: so
Ragen Chastain (she/her): they knew this was a foregone conclusion. They designed it this way. They knew what they were gonna do either way to keep marketing their drug, I believe.
Louise: Ugh. Luckily the European regulators didn't buy the excuses and they pulled Sibutramine off the market in January 2010. when the scout results got published in the New England Journal of Medicine, there was this incredibly scathing editorial which pointed out that for less than four kilos of weight loss, people were risking a 1 in 70 chance of having a heart attack or stroke due to this drug, and that the odds would increase to one in 52 for customers with known heart disease. But Phil James was still merrily defending it, telling the LA Times The normal prescription requirements, as long as they're followed by doctors and patients, are fine. Mm, such confidence.
Ragen Chastain (she/her): I need a definition of fine here.
Louise: By now, even the FDA had disagreed, and in October 2010, after thirteen years on the market, it finally got pulled. Dr. Sidney Wolfe from Public Citizen, who had been like fighting since 2002, called the move quote, commendable but dangerously too late. More than three million prescriptions had been filled in the eight years since he'd raised the alarm. And he said so many patients had inevitably had heart attacks or strokes. We don't know how many, but it's just wild.
Ragen Chastain (she/her): That is yeah, just just wow.
Louise: Mm-hmm. So yeah. That was Sibutramine. so 2010 was a pretty dark time for the pharmaceutical weight loss industry. In the same month that Sibutramine got pulled, the FDA rejected two new diet drugs, Belviq from Arena and Qysmia from Vivus. Qysmia had issues with elevated heart rates and birth defects. Belviq also had potential cancer signals that they were a bit worried about. And both drugs had dismal weight loss averages, struggling again to hit that 5%. And then in February 2011, Orexigen, which had developed another one called Contrave, also got rejected. It seemed like the FDA had just finally had a gut full of the weight loss industry's antics.
Ragen Chastain (she/her): Late to the party, but glad you're here.
Louise: Well, Ragen, this simply wouldn't do. The weight loss industry had to up the ante. You know how like a group of crows is called a murder?
Ragen Chastain (she/her): I do, yes.
Louise: What's the collective noun for a gang of oplesity organizations?
Ragen Chastain (she/her): I don't know, but I'm excited to learn.
Louise: Okay. I'll give you a clue. It starts with C.
Ragen Chastain (she/her): Hmm. Nothing I'm thinking of is really an airable word, so I will turn it back over to you.
Louise: You can't get past that C word.
Ragen Chastain (she/her): I re can't.
Louise: these groups they love calling themselves a collective, a consensus, a continuum. They're always C-words. But the technical term for a group of oplesity shopfront organizations is a ca-ching. Mm-hmm.
Ragen Chastain (she/her): my god, accurate and funny. This is the kind of excellence I always expect from you.
Louise: Well, it's all, you know, evidence based. So the ca-ching is
Ragen Chastain (she/her): Unlike weight loss industry research.
Louise: The ca-ching is essentially what happened. So after the FDA rejection bonanza, pharma companies and oplesity organizations just started banding together and they got together this kind of strength in numbers strategy designed to increase the pressure on regulators. So in 2011, the Oplesity Care Continuum, or OCC, was unleashed. This was a ca-ching. Of NOVO-funded organizations, including star players like the OAC, the Oplesity Society, the tossers, the ASMBS, the American Dietetic Association, which at the time was being funded by NOVO and a whole array of pharma companies. So the OCC were able to claim that they represented 125,000 healthcare professionals, researchers, educators, and patient advocates. According to the Wayback Machine, because finding information on the OCC is quite difficult, the OCC is, quote, dedicated to promoting access to and coverage of the continuum of care surrounding the treatment of overweight and oplesity. The OCC also challenges weight bias and stigma-oriented policies whenever and wherever they occur.
Ragen Chastain (she/her): I'm sure that they just do a bang up job of that.
Louise: What could go wrong?
Ragen Chastain (she/her): Yeah. Fox, hen house, blah blah blah.
Louise: yeah, we're just like tacking on that weight stigma a bit at the end.
Ragen Chastain (she/her): Yes.
Louise: Yeah. After like, we're gonna grease all of these wheels, but you know, in the name of weight stigma.
Ragen Chastain (she/her): Yeah, don't treat fat people badly, but absolutely make billions of dollars trying to eradicate them from the earth, but not in a stigmatizing way, because that would be
Louise: Mm-hmm. Yeah.
Ragen Chastain (she/her): wrong.
Louise: So the OCC it's not a formal organization. It's just a sort of cobbled together group that put out press releases mainly via the OAC. the OCC's dedication, funded by Novo and various other weight loss drug companies, it definitely was opening doors. So on the OAC website, I found a press release which announced that on the 18th of July 2011, the OCC quote again met with the FDA to discuss expanding treatment options for patients with Serious medical oplesity. So the OCC has managed to swing meetings with senior FDA officials, including Janet Woodcock, who was the FDA Director of Drug Evaluation. The press release quoted tireless lobbyist Joe Nadglowski, the
Ragen Chastain (she/her): joe.
Louise: bingo.
Ragen Chastain (she/her): I I think I've got bullshit bingo.
Louise: Yep, so Joe's the OAC president. and the press release says that, quote, OCC and the FDA discussed numerous topics, including improving the benefit-risk ratio of oplesity drugs by limiting the medications to those with serious oplesity health-related issues. What?
Ragen Chastain (she/her): Aren't those issues that people of all sizes get that get called serious oplesity related issues when fat people have them, Louise?
Louise: That is absolutely true. And we also need to remember that the people with serious oplesity-related health issues were the exact same ones who just got killed by Sibutramine. Okay, this makes sense. and then the press release also admits that the oplesity society, the tossers, handed a list of 40 oplesity experts. that the FDA could use as potential advisory committee members in future weight loss drug approval meetings.
Ragen Chastain (she/her): And the FDA being ethical said,
Louise: Yeah.
Ragen Chastain (she/her): Yeah, we're gonna bin this because obviously that's ridiculous, right?
Louise: Well, it's it is mind-boggling to look at the reach that this industry-funded ca-ching got straight into the FDA's senior leadership ears and to hear Joe Nadglowski and the OCC pushing for weight loss drugs for sicker fat people after the scout results, I'm I just sort of speechless.
Ragen Chastain (she/her): Yeah. I mean, 'cause there's no there are no words that really capture like how unethical and unhinged and wrong this whole thing is.
Louise: There's a few C words, you know.
Ragen Chastain (she/her): Yeah. There are words, yes, but for the sake of our rating.
Louise: ca-ching is safe. So, and that
Ragen Chastain (she/her): Yes.
Louise: list advising the FDA who they should get on to like vote. Holy mother of God. But this is just the start. the pharma companies obviously very, very unhappy with the FDA clampdown, especially Novo, who had Saxenda in their pipeline. So The companies did what the weight loss drug industry always does. They went back to the lab to improve their drug safety and efficacy. Just kidding. They went to Washington
Ragen Chastain (she/her): Yeah, I was like, What? When did they do that?
Louise: with stacks of money.
Ragen Chastain (she/her): That sounds that sounds more accurate, yes.
Louise: there was a very aggressive lobbying campaign. Between 2011 and 2012 alone, they gave $20 million to the Senate.
Ragen Chastain (she/her): Wow.
Louise: miraculously, in autumn 2011, the Senate Appropriations Subcommittee on Agriculture, which controls FDA funding, issued the FDA directive calling the quote absence of novel medicines to treat oplesity a concern. They ordered the FDA to report back on quote steps it's going to take to support the development of new treatments of oplesity. So yeah, really unbelievable.
Ragen Chastain (she/her): Wow, look what money can buy.
Louise: So it's a one year out from the Sibutramine recall. Sorry. It's just really funny. So it's just one year out from the Sibutramine recall, and we have Congress telling the FDA in writing that it's a terrible shame. that there aren't more oplesity drugs on the market. And the FDA writes back to the Senate promising, quote, to working with pharmaceutical companies to bring new oplesity drugs with favorable benefit risk profiles to the market. So yeah.
Ragen Chastain (she/her): the real wide view of what favorable means, I notice.
Louise: Yeah, this this is so important to talk about this side of things, which we never hear about. So brace yourself again. This results in a series of meetings at George Washington University, which is a private university just a few blocks away from the White House. And their Department of Health Policy has a history of lending its name to industry-funded consensus reports. So between 2011 and 2012, FDA and government officials repeatedly met with pharma companies and reps from oplesity organizations, and you guessed it, this includes Joe Nadglowski from the OAC.
Ragen Chastain (she/her): Dang I already have him on my bingo card.
Louise: Ted Kyle from the Oplesity Society.
Ragen Chastain (she/her): Teddy.
Louise: Million Dollar Donna was there, of course. And Louis Aronne, who I think you know, Ragen.
Ragen Chastain (she/her): I do indeed know him. I will save that rant for another time.
Louise: So these meetings all were paid for by the pharma companies with their weight loss drugs in the wings. There was Eisai who had Belviq. There was Novo, of course, with Saxenda. There was Orexigen and Takeda who were hoping to bring Contrave onto the market. And there was Vivus with Qysmia. And the OAC. So all of them pulled their money for these meetings. So just to summarize, the companies whose rejected drugs were sitting there in FDA limbo essentially pay off Congress and then fund nine months of meetings where they get to tell the FDA how their weight loss drugs should be evaluated. And this this produces a consensus report called Oplesity Drug Outcome Measures. The consensus report comes up with 11 considerations. Another C word. some of the highlights from the report were to stop calling their products weight loss drugs. Instead call them oplesity medications. What a nice rebrand, huh?
Ragen Chastain (she/her): Mm-hmm. yeah, this is and now we see that like just every strand of spaghetti on the wall of what we're gonna call these drugs to try to make them more palatable.
Louise: And the talking point from the OCC meetings that higher risks could be acceptable for sicker fat people, that was a key takeaway from the report. And they also suggested that the FDA could do a workaround by using risk management strategies. So why hadn't they thought of that before? So things like limiting off-label prescription for their drugs or using something called a REMS, a risk evaluation and mitigation strategy. REMS, it's an FDA program that lets a drug get approved despite known safety risks, in exchange for the manufacturers promising to put extra controls around how it's prescribed and distributed. So essentially, REMS is like a workaround which lets companies get their drugs. on the market now and deal with any fallout later.
Ragen Chastain (she/her): Great. If so I should point out that we're laughing to keep from crying because
Louise: Mm-hmm.
Ragen Chastain (she/her): it just wouldn't be a great podcast if we were just like crying over these disasters for, you know, 30
Louise: Mm-hmm.
Ragen Chastain (she/her): to 40 minutes. But this is horrific, especially predicating risk on size. That,
Louise: Mm.
Ragen Chastain (she/her): you know, as weight gets higher, someone's life becomes less valuable and more riskable, and that that's gonna be the FDA's approach. That's horrific.
Louise: Mm-hmm. Among among so many other layers of horrificness. Apart from the abject corruption. So
Ragen Chastain (she/her): Yeah. Yes.
Louise: this pressure worked. Weeks after the meetings, Belviq and Qysmia were quickly waved through FDA approval, both of them with a REMs attached. The authors of the consensus report could not help boasting. Scott Kahan, who was listed on the report as an academic from George Washington and John Hopkins University, without disclosing that he was also on the scientific advisory boards for Vivus and Eisai, published a self-congratulatory article in an Oplesity journal bragging about this dastardly process, and he says, quote, that it played a valuable role in FDA's approvals of Qysmia and Belviq, both approved within weeks of our final meeting. He's just, you
Ragen Chastain (she/her): congrats, dude. Whatever.
Louise: know, career highlight there. the drugs are not safer. And they're not more effective. The only thing that changed in the 18 months between rejection and approval was a whole lot of ca-ching. There's a nice PS to this too. Belviq got taken off the market in 2020 after it was confirmed that the risks of cancer did in fact outweigh the benefits.
Ragen Chastain (she/her): Yes, after it
Louise: Okay.
Ragen Chastain (she/her): The words all at the same time. it's such a cycle, right?
Louise: Mm-hmm.
Ragen Chastain (she/her): The trials show potentially very dangerous side effects. The drug gets approved anyway, and then the drug gets pulled from the market for those exact same dangerous side effects. Like nobody needed to be exposed to that because we knew early on, but with this, you know, exactly what you're talking about with the FDA loosening up approval, what could have possibly gone wrong? wait, this.
Louise: Well, Ragen, REMs worked really well, okay? 'Cause this is the logic.
Ragen Chastain (she/her): Having a little trouble believing that
Louise: This is the logic. It's unbelievable. So getting FDA approval pathways unblocked was a big win, but it's not the whole battle for Pharma. So since Fenphen, Medicare had banned the coverage of all weight loss drugs. And to unblock that barrier, the companies had to keep convincing insurers and the government that their drugs were medical necessities. So Novo and its pharma bodies needed a big medical organization to put its name behind the idea that oplesity was a disease. And major medical organizations at the time were being showered with drug industry cash. One of them was the American Association of Clinical Endocrinologists, or AACE. In 2013 alone, AACE got $3.2 million from weight loss drug makers, including Novo. That was 30% of its whole funding for that year. And the AACE were busily also lobbying Congress. And when asked about it, the AACE president, Dr. R. Mack Harrell told the media, quote, there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, It is a commonality of interest that is healthy, desirable, and beneficial.
Ragen Chastain (she/her): It's common we like money and they're willing to give it to us. Commonality.
Louise: Commonality, another C-word. so Ragen, let's take a close look at this desirable and beneficial commonality of interest in action.
Ragen Chastain (she/her): Let's do.
Louise: So in 2012, the AACE publishes a position statement, which claimed that oplesity met the American Medical Association's criteria for disease status. Two of its four authors disclosed financial conflicts with novo nordisk. A third of them, Dr. Timothy Garvey, declared no conflicts. But I found papers published on either side of this one saying that he was an active advisor to Novo, Vivus, and Eisai. Yeah?
Ragen Chastain (she/her): Yeah. Yeah, I know that I know his name very well, so how interesting.
Louise: So the AMA's criteria for a disease were pretty simple. Diseases have to impair how the body normally functions, produce recognizable signs or symptoms, and cause actual harm. The AACE paper claimed that there was, quote, an overabundance of clinical data meeting these criteria. But inconveniently, at the same time, the AMA was actually already looking at this data. And investigating the same question using its own Council on Science and Public Health, which did not have any industry funding to conduct a full review of research evidence. And the council's report concluded that oplesity did not meet criteria for disease. Storing excess fat and the body's resistance to weight loss are normal biological adaptions, not dysfunctions. BMI was a blunt tool, very poorly correlated with actual health. Associations with diseases are one thing, but not the same thing as being a disease itself. And causal stuff was extremely conflicting. The council also warned that disease labels could, quote, intensify patient and provide a reliance on presumably costly pharmacological and surgical treatments. The council's report even called out the AACE 2012 paper, quote, AACE's conclusion appears to be based less on new knowledge about oplesity than on differences in their interpretation of the definition of disease. Nice swipe there.
Ragen Chastain (she/her): Yes.
Louise: So, you know, this was getting Oplesity Incorporated quite worried. One of the AACE paper's authors, Jeffrey Mechanick, admitted to the media that Oplesity Inc. were worried. Quote: A lot of organisations feared the AMA would defer or simply not declare it a disease, which we felt was important.
Ragen Chastain (she/her): Yes, but for that piece where they said it would create dependence on these
Louise: Hmm?
Ragen Chastain (she/her): treatments. That that's you know, I'm sure they wish to take just that piece and import it into a much more positive paper.
Louise: Yes. So, fueled by drug company money, in June 2013, the AACE brought a resolution directly to the AMA meeting urging them to declare oplesity a disease, and they recycled all the arguments that they were using in their 2012 paper. And apparently the debate in this AMA meeting was heated. Dr. Robert Gilchik, who chaired the council's report, told delegates Quote, why should a third of Americans be diagnosed with a disease if they're not necessarily sick? Just being of increased weight if there's no impaired function doesn't fit any of those definitions of a disease. But Gilchik got outnumbered. He listened as pharma backed delegate after pharma backed delegate just took the podium to talk. There was Dr. Jonathan Leffert of AACE. He said, quote, The scientific evidence is overwhelming. And then Dr. Ethan Lazarus of the ASBS, do we remember them? From last
Ragen Chastain (she/her): Mm indeed we do.
Louise: he gave my favourite rationale, it's very circular. Quote Calling oplesity a disease, we'll send the message that this is a chronic disease.
Ragen Chastain (she/her): I mean, hard to argue with, but also what?
Louise: Mm-hmm. so when the votes got cast, two hundred and seventy-six yes, a hundred and eighty one against, and the motion carried and oplesity was declared a disease by the AMA.
Ragen Chastain (she/her): I just wanna go back and point out in opposition to a year long investigation by their own committee on science and public health. And what do they know about science and public health? 'Cause you're just the committee on science and public health. Sorry, I'm gonna crash out.
Louise: Yeah. Cool wet grass. Yes. Deep
Ragen Chastain (she/her): Do you hear anything?
Louise: breaths. So Dr. Douglas Martin, who chaired the committee overseeing the whole debate, even says, quote, let's acknowledge that there's not a lot of science, not a lot of literature that we can point to. Let's also recognize that there's consensus in the House of Medicine where it should be identified as a disease, unquote. the C words. Yes.
Ragen Chastain (she/her): All the C words, many, many words coming to mind right now. None of them good words, none of them words you necessarily want to say on the air.
Louise: The very next day, AACE and the OAC issued synchronized press releases, how cute, celebrating
Ragen Chastain (she/her): No.
Louise: the AMA's historic decision, urging lawmakers to act quickly to, quote, improve access to oplesity treatment. Within 24 hours, the Treat and Reduce Oplesity Act, or TROA, which was a motion to put the weight loss drugs back on Medicare, was before Congress. Using the AMA's endorsement as leverage. The AMA's decision made the front page of the newsletter, which called the timing of the TROA lobbying coincidental to the AMA's decision. What a coincidence.
Ragen Chastain (she/her): Right. I that's really easy to believe. Sarcasm.
Louise: my god, nothing could be further from the truth. Scientific evidence had just been outmaneuvered by pharma money. Novo's thievish third step was progressing beautifully. So I want to land today on September 11, 2014, at the FDA approval to approve Novo's drug saxenda. Contrave had glided through FDA approval the day before, and now it was showtime for Novo. I managed to track down the transcript of the proceedings and it was fascinating. Just seeing who was there and what was said. Million Dollar Donna was one of the first speakers. So the same Donna who had those cozy meetings at George Washington University and helped write the risk framework this drug was about to get judged against. So the open hearing where people were talking just in favor generally about passing saxenda was like a medley of the Novo funded oplesity organizations. There was Joe NadGlowski of the OAC. He admitted
Ragen Chastain (she/her): Sigh.
Louise: He admitted that OAC was funded by about 50 companies, he said, including today's sponsor. So he's like, hey, if there's many people funding, it's it's okay. There was another person, yes, yeah.
Ragen Chastain (she/her): Yeah. How much, Joe? How much did they give you?
Louise: I know, but like, I think this is another reason why the ca-ching strategy is used, because if you have a lot, then the more strategic funders get kind of you know, they're just one of many, There was a woman called Domenica Rabino who was speaking on behalf of the OCC. She admitted that she was also running one of Novo's clinical trials at the same time. there was George Grunberger from the AACE and he was speaking in support of this need for oplesity drugs. He told the panel that the AACE, yes, had paid for his trip to attend the meeting, but quote, there's no other conflict of interest I have here today. I guess all that money funding the AACE, it just is not relevant.
Ragen Chastain (she/her): Hmm.
Louise: So we had Ted Kyle, who spoke twice. first, he introduced himself as an active member of the TOS and the chairman of the OAC. He said he had, quote, no financial interest in the sponsor. But then he immediately added that he quote provided advice to the sponsor. So it's just, it's just all the same players here in the room. Novo said that their drug, Saxenda, cleared the FDA 5% efficacy benchmark for weight loss. But the FDA's own statistician disagreed because his independent analysis came back at 4.6 to 4.8%. It's well below the bar. But apparently that wasn't enough to concern the committee. There was also this slightly pesky problem of cancer. In animal studies liraglutide caused thyroid tumours in rats and mice. And this seemed to be dose-dependent, which was a bit of a concern, seeing that Saxenda is a mega dose of Liraglutide. 15 people voted, and 14 said yes. So one of the voting members was Susan Yanovsky, and she was from the National Institute of Health, and she was there at the George Washington meetings. Her yes vote used almost the exact same language of the framework that she watched. get built like this idea of a favorable risk benefit and the idea that concerns about risk can be addressed post-marketing by a REMS.
Ragen Chastain (she/her): Uh-huh.
Louise: Yeah. You know, one of the things that really surprised me was that Lynn McAfee was at this meeting and as we know she's a very cherished fat activist and a patient rep who spent so many years of her life advocating and she'd taken Sibutramine and she'd had heart problems that she talked about in this meeting. but she voted yes.
Ragen Chastain (she/her): That is interesting. So
Louise: Mm-hmm.
Ragen Chastain (she/her): it makes me wonder. So I actually had the honor of getting to meet Lynn several times and I interviewed her for a project. And it makes me wonder if it was somehow strategic. Like I mean, Lynn has passed away, for those who don't know. I mean, so we'll never be able to ask her. But I also know that she did a lot of these meetings. She was a very strategic person. And since it was fourteen to one I wonder if there was something strategic about her voting yes to get something else that she wanted done or to, you know, get allies or something. I mean, we'll never know. But it is curious.
Louise: Yeah, I think it was clear as she's speaking that she is absolutely not bought into the hype. she talks about the profit motive, she talks about being concerned with the health risks. So she's definitely one of the stronger, more critical voices in the meeting that day. So yeah, but I I wonder, you know, as I was reading it, I wonder if. If she knew about some of the things that we were talking about today, what she would have done.
Ragen Chastain (she/her): Yeah.
Louise: But as you said, we'll never know. And
Ragen Chastain (she/her): Yeah.
Louise: just yeah, a huge thank you for people like Lynn out there.
Ragen Chastain (she/her): Yeah.
Louise: So there was one no vote. A guy called Dave Kelson, he said there just wasn't enough data to rule out cancer risk. And others agreed with him, but voted yes anyway. So as a condition of Clearing the drug, the FDA ordered Novo to run a 15-year thyroid cancer registry to track in the real world how many cancer diagnoses happen after it comes onto the market. And we're going to be following up on that in later episodes. So there we have it. We're landing with all of this greasing from Novo and its pharma bodies and its ca-ching kind of manipulation and we have a triumph. It's novo's thievish third step and seriously they're only just getting started. We've got so much more.
Ragen Chastain (she/her): Sadly, yes. And it I mean, you've so beautifully illustrated how they did it. They created their own evidence and then convinced people who are well meaning, because there are people in that room, not as many
Louise: Yeah.
Ragen Chastain (she/her): as you'd hope, who are not funded by them, who really believe this is the best thing and that being higher weight is so dangerous that it's worth risking people's lives and quality of life. And that is the sort of gold nugget of Novo's plan that not only are they influencing people with money, but then they're using that money to influence ideas at every level. It's so dangerous and unfortunately it's been so effective.
Louise: It is. And you know, it's shocking because we we joke today about bingo, but it is a small number of people who have been
Ragen Chastain (she/her): Mm-hmm.
Louise: able to wield untold influence in spaces like this. And seriously, I hope that we can wield power the other way with casting a fresh eye on all kinds of stuff like this, because I don't agree that C words should triumph over like science, evidence and safety.
Ragen Chastain (she/her): Yeah. Yeah, science and safety. Can we please get back to some S words? Ethical evaluation. We could use some E words, like really any other words.
Louise: Sensible. Mm-hmm. We will alliterate. Yes. Yeah. So that's it, I'm spent for today, my god.
Ragen Chastain (she/her): Fair. This is a lot. All right.
Louise: As it always is, yeah.
Ragen Chastain (she/her): So don't miss the next episode of Exposing Obesity Incorporated. We're going to uncover the clinical data and the enormous frenzy that surrounded the release of Ozempic and Wegovy, which have been the so-called game-changing blockbuster drugs. And we'll be exposing all that behind-the-scenes shenanigans that you need to know about.
Louise: Can't wait.
Ragen Chastain (she/her): New episodes of Exposing Obesity Incorporated drop every two weeks on the first and fifteenth of each month. So please tell your friends, tell your colleagues, tell everyone. And if you can't wait for the first and fifteenth, you can again join our Patreon to get early access to episodes plus bonus content. If today's episode got you thinking, we'd love to hear from you. Please send your feedback. Questions, topics you want us to cover. And if you have insider information, if you worked for a pharmaceutical company or professional organization, a clinic or patient advocacy group or a marketing agency, and you've seen something that the public should know about, we want to hear about it. You can visit our obesileaks portal at speakpipe.com. That's S-P-E-A-K-P-I-P-E.com. Forward slash obesileaks O B E S I L E A K S and you can leave us a voice message that's completely anonymous. It's also totally free and we listen to every message. You can also email us at obesityincorporated at gmail.com. For show notes, resources, a quick link to oplesity leaks and more, you can head to exposing obesityincorporated.com and you can find a post for each of our episodes as well as all of that information. we want to remind you that the views and opinions expressed here are our own. All claims are alleged unless otherwise specified, and this podcast is for informational purposes only and doesn't provide medical, psychological, legal, or financial advice. Please do consult with a professional for specific advice tailored to your situation. See you next time.
Ragen Chastain (she/her): This is episode five Novo's Thievish Third Step.
Louise: I'm Louise Adams.
Ragen Chastain (she/her): And I'm Ragen Chastain.
Louise: And we are exposing the sordid underbelly of the weight loss industry, Obesity Incorporated.
Ragen Chastain (she/her): Now we want to note that the term quote oplesity is stigmatizing and harmful and our podcast is based on exposing the people making a fortune using it. So when we use it in the podcast, we'll use quotations or Louise's brilliant invention oplesity with an eye roll always implied.
Louise: Thank you so much, everyone. We're so thrilled to be doing this podcast and we're loving the feedback so far. We love bringing the filthy laundry of the weight loss industry out into the open. You can support us by telling everyone you know to give us a listen. And if you've got time to rate and review us wherever you are listening to your podcasts, you can even become a Patreon if you're feeling super generous.
Ragen Chastain (she/her): And you can do that at Exposing Obesity Incorporated.com. Patrons get early access and bonus content for every episode. So, today we're gonna continue what we've been talking about with Novo's marketing plan. So far, we covered how in step one, their goal was to create the oplesity market by convincing everyone that simply existing in a higher weight body, regardless of actual health. Is a chronic disease. In our last episode, we revealed how their second step then expanded the market by infiltrating medical education and guidelines, redefining millions more people to be targeted for oplesity quote treatment. And today we're going to look at step three how Novo then exploited that market. And this step relies heavily on the work done in the first two steps. First, they created so-called evidence on the quote science of oplesity. Then they had their stable of paid researchers and doctors proselytizing to spread their new gospel far and wide. So now we're at the, there's just so much evidence and everybody knows stage. And the oplesity workers have all been paid off, and the field of medicine and medical schools has been infiltrated by Novo's key marketing messaging, parading as medical education. The world's oplesity organizations and the organizations they fund, including the American Diabetes Association and the World Health Organization, and many more, are all in lockstep, dutifully speaking from the same script. So Louise, can you tell us a little bit more about this third step?
Louise: It's all so dirty already. I need a shower.
Ragen Chastain (she/her): Ewwww
Louise: So step three is really all about greasing legislative and policy wheels to really exploit the oplesity market that they were working so hard to create. Now, Ragen, you know that I'm a bit of a stickler for history and context.
Ragen Chastain (she/her): Indeed I do.
Louise: Details lady. So I'm going to
Ragen Chastain (she/her): Ha.
Louise: start by sharing more about the history of the weight loss industries playbook because it seriously exposes the filthy underbelly. We can also see that Novo's tactics were well underway well before the 2015 conference where they talked about that marketing plan. Back in episode one, we covered the Fenphen disaster, where pharma influence got Redux approved, even though there were known safety concerns, and that triggered a very undignified weight loss drug frenzy across the United States. And then when people started dying of heart problems, whistleblowers, not the drug companies, raised an alarm. And in 1997, Fenphen got pulled off the market. But unbelievably, at the same time the Fenphen disaster was unfolding, Two more weight loss drugs snuck through FDA approval processes. Hoffman La Roche's Orlistat, I call that oily shat, because it
Ragen Chastain (she/her): I remember
Louise: yeah, you remember that one?
Ragen Chastain (she/her): I well I remember I think the on the box it said that people might want to take an extra pair of pants with them around.
Louise: Yes, yes. It inhibits the absorption of fat, which means you basically sort of I guess fat shat it out. so that was one of them. The other one that made it through was Knolls Sibutramine, which is known as Meridia or Reductil. And you might have noticed, Ragen, that these are the same two companies. who created the industry shopfront organization, the IOTF, who we talked about last time. And they were the ones who pressured the World Health Organization to lower BMI standards. And that created twenty-nine million new Americans who were pronounced as too fat overnight.
Ragen Chastain (she/her): Increasing your market by twenty nine million people. Nice work if you can get it.
Louise: Not bad. So Sibutramine started life as a failed antidepressant and it got rebranded when they noticed it had a small weight loss effect. It works by blocking serotonin receptors. And incidentally, serotonin is the same mechanism used by Fenphen. So this new weight loss drug acting on serotonin. was passing through the FDA process at the same moment another serotonin impacting drug's harms were killing countless people. Yes.
Ragen Chastain (she/her): Ugh why?
Louise: Well, I guess it tells us a lot about how much risk regulators and pharma are willing to take when it comes to fat people's lives. Sadly.
Ragen Chastain (she/her): yes, the FDA willing to harm and kill us to make us a little bit thinner for a little
Louise: If
Ragen Chastain (she/her): bit of time.
Louise: Sibutramine's clinical trials were funded by the manufacturer Knoll, and the clinical trial was authored by our Obesity Incorporated regulars, George Bray and Donna Ryan.
Ragen Chastain (she/her): No way, Louise, we have got to at some point create a bingo card for a play at home game of these researchers.
Louise: Honestly, today is going to be bingo all over the place. I warn you. It's
Ragen Chastain (she/her): Ha ha
Louise: it is insane. So the the clinical trials were just seriously unimpressive. The weight losses barely cleared that 5% threshold. And to make everything worse, Sibutramine raised heart rate and blood pressure. With such dismal outcomes, the FDA's medical advisory committee recommended that it should not be approved. But Knoll appealed and the FDA ended up approving, once again overruling their own experts. Does that sound familiar?
Ragen Chastain (she/her): You know, it really sadly does.
Louise: Redux all over again. So
Ragen Chastain (she/her): Yeah.
Louise: Meridia hits the US market in 1998 and it has a warning that it should not be used by anyone with cardiovascular issues. The
Ragen Chastain (she/her): Because there's no one who has cardiovascular issues that is not diagnosed. Like yikes.
Louise: yeah, exactly. So no one was happier than the Fenphen pill mill doctors, who were thrilled.
Ragen Chastain (she/her): Of course.
Louise: Dr. Donald Jensen, whose weight loss chain had shrunk from 19 clinics down to four in the aftermath of the FDA recall, told the LA Times, We're gonna write prescriptions as soon as pharmacies will honour them. Everyone's gun shy, he said, but everyone's looking for something to replace Fenphen.
Ragen Chastain (she/her): why were they gunshy, Donald? Why was it the dead people? Tell us. Ugh
Louise: Well, the unbridled joy of the weight loss industry was short-lived. So in 2002, a whistleblowing organization called Public Citizen used freedom of information and they uncovered almost 400 serious reactions and 29 deaths from sibutramine, mostly from guess it, cardiovascular stuff. Unbelievable.
Ragen Chastain (she/her): No way.
Louise: Sarcasm alert. So
Ragen Chastain (she/her): Yes.
Louise: th they demanded that the FDA ban it and the FDA did nothing. in Europe, people were dying there, but instead of pulling the drug off the market, the EU regulators ordered Abbott, who was the drug company that had taken over Knoll, to run a five-year safety trial on Sibutramine called Scout. So this was funded by the drug company Abbott, and its lead author was none other than W. Philip James.
Ragen Chastain (she/her): Ooh, another one. I think I might have bingo already.
Louise: Okay, Obesity Incorporated's granddaddy and IOTF frontman. So Abbott's number one fan gets to run the safety trials for the company whose drug he'd helped create the market for.
Ragen Chastain (she/her): Sounds legit.
Louise: What what could go wrong? god. I need to talk about the scout methodology and I know I'm a bit off, but I need to talk about it because it's kind of unhinged. So cardiovascular events in general are rare. So in order to get answers about safety risks quickly, Scout deliberately recruited people with existing heart problems. The exact population, the FDA said, shouldn't take it. Yeah. Yeah.
Ragen Chastain (she/her): I can't if you're not watching on YouTube, my jaw just dropped open. That is a choice.
Louise: Uh-huh. That is a deliberate choice. there's also another sneaky trick woven into the methodology. Before they divided their victims, I mean subjects, into treatment and control groups, they did a run-in period where all 10,000 people got six weeks of sibutramine so they could screen out anyone who couldn't tolerate the drug. and then they ran the trial. So, this kind of methodology Can you see problems here?
Ragen Chastain (she/her): add this to the things that would get a freshman research method student failed methodologies of the drug companies.
Louise: Imagine a scenario where scientists are worried because they're like, this mostly ineffective drug might be making people suicide. So in order to find that out, let's deliberately recruit people who are at really high risk of suicide. And then if they do suicide early on, let's not count them and then then do the safety study. This is, this would not make it through ethics approval at all.
Ragen Chastain (she/her): No, what IRB was involved in this? Like this is
Louise: Yeah.
Ragen Chastain (she/her): unhinged is barely touching how terrible this is.
Louise: Yes. So the scout results themselves, they were horrific. People taking subutramine were 16% more likely than those taking placebo to have heart attacks and strokes. Instead of raising the alarm, Phil James's paper recommended business as usual. Let's keep selling the drugs to the public, let's keep the cardiovascular warnings, of course, and let's not even consider the risks for people without existing diseases of cardiovascular natures. Abbott even put out a press release. Okay. Which said that the results of their own Brace Brace.
Ragen Chastain (she/her): Feel like I'm like watching this with my hands over my eyes. I can't Okay, I'm ready. Let's go.
Louise: brace for impact, okay. So Abbott put out a press release which said that the results of their own safety study, the one that they designed and run on purpose, couldn't actually be generalized to anyone taking Sibutramine because it had studied people with cardiovascular disease and of course they shouldn't be taking it.
Ragen Chastain (she/her): sweet fluffy lord.
Louise: no, I know, so cheeky.
Ragen Chastain (she/her): They are there is no low. There's no low too low for these people. That is that is
Louise: Hmm.
Ragen Chastain (she/her): unbelievable.
Louise: I know. I can't help but wonder though, if they'd found the opposite results, they would be absolutely falling alone themselves to assure the public about safety.
Ragen Chastain (she/her): yeah. Even in people with cardiovascular issues. Yeah, no, you're a hundred percent right. This was
Louise: so
Ragen Chastain (she/her): they knew this was a foregone conclusion. They designed it this way. They knew what they were gonna do either way to keep marketing their drug, I believe.
Louise: Ugh. Luckily the European regulators didn't buy the excuses and they pulled Sibutramine off the market in January 2010. when the scout results got published in the New England Journal of Medicine, there was this incredibly scathing editorial which pointed out that for less than four kilos of weight loss, people were risking a 1 in 70 chance of having a heart attack or stroke due to this drug, and that the odds would increase to one in 52 for customers with known heart disease. But Phil James was still merrily defending it, telling the LA Times The normal prescription requirements, as long as they're followed by doctors and patients, are fine. Mm, such confidence.
Ragen Chastain (she/her): I need a definition of fine here.
Louise: By now, even the FDA had disagreed, and in October 2010, after thirteen years on the market, it finally got pulled. Dr. Sidney Wolfe from Public Citizen, who had been like fighting since 2002, called the move quote, commendable but dangerously too late. More than three million prescriptions had been filled in the eight years since he'd raised the alarm. And he said so many patients had inevitably had heart attacks or strokes. We don't know how many, but it's just wild.
Ragen Chastain (she/her): That is yeah, just just wow.
Louise: Mm-hmm. So yeah. That was Sibutramine. so 2010 was a pretty dark time for the pharmaceutical weight loss industry. In the same month that Sibutramine got pulled, the FDA rejected two new diet drugs, Belviq from Arena and Qysmia from Vivus. Qysmia had issues with elevated heart rates and birth defects. Belviq also had potential cancer signals that they were a bit worried about. And both drugs had dismal weight loss averages, struggling again to hit that 5%. And then in February 2011, Orexigen, which had developed another one called Contrave, also got rejected. It seemed like the FDA had just finally had a gut full of the weight loss industry's antics.
Ragen Chastain (she/her): Late to the party, but glad you're here.
Louise: Well, Ragen, this simply wouldn't do. The weight loss industry had to up the ante. You know how like a group of crows is called a murder?
Ragen Chastain (she/her): I do, yes.
Louise: What's the collective noun for a gang of oplesity organizations?
Ragen Chastain (she/her): I don't know, but I'm excited to learn.
Louise: Okay. I'll give you a clue. It starts with C.
Ragen Chastain (she/her): Hmm. Nothing I'm thinking of is really an airable word, so I will turn it back over to you.
Louise: You can't get past that C word.
Ragen Chastain (she/her): I re can't.
Louise: these groups they love calling themselves a collective, a consensus, a continuum. They're always C-words. But the technical term for a group of oplesity shopfront organizations is a ca-ching. Mm-hmm.
Ragen Chastain (she/her): my god, accurate and funny. This is the kind of excellence I always expect from you.
Louise: Well, it's all, you know, evidence based. So the ca-ching is
Ragen Chastain (she/her): Unlike weight loss industry research.
Louise: The ca-ching is essentially what happened. So after the FDA rejection bonanza, pharma companies and oplesity organizations just started banding together and they got together this kind of strength in numbers strategy designed to increase the pressure on regulators. So in 2011, the Oplesity Care Continuum, or OCC, was unleashed. This was a ca-ching. Of NOVO-funded organizations, including star players like the OAC, the Oplesity Society, the tossers, the ASMBS, the American Dietetic Association, which at the time was being funded by NOVO and a whole array of pharma companies. So the OCC were able to claim that they represented 125,000 healthcare professionals, researchers, educators, and patient advocates. According to the Wayback Machine, because finding information on the OCC is quite difficult, the OCC is, quote, dedicated to promoting access to and coverage of the continuum of care surrounding the treatment of overweight and oplesity. The OCC also challenges weight bias and stigma-oriented policies whenever and wherever they occur.
Ragen Chastain (she/her): I'm sure that they just do a bang up job of that.
Louise: What could go wrong?
Ragen Chastain (she/her): Yeah. Fox, hen house, blah blah blah.
Louise: yeah, we're just like tacking on that weight stigma a bit at the end.
Ragen Chastain (she/her): Yes.
Louise: Yeah. After like, we're gonna grease all of these wheels, but you know, in the name of weight stigma.
Ragen Chastain (she/her): Yeah, don't treat fat people badly, but absolutely make billions of dollars trying to eradicate them from the earth, but not in a stigmatizing way, because that would be
Louise: Mm-hmm. Yeah.
Ragen Chastain (she/her): wrong.
Louise: So the OCC it's not a formal organization. It's just a sort of cobbled together group that put out press releases mainly via the OAC. the OCC's dedication, funded by Novo and various other weight loss drug companies, it definitely was opening doors. So on the OAC website, I found a press release which announced that on the 18th of July 2011, the OCC quote again met with the FDA to discuss expanding treatment options for patients with Serious medical oplesity. So the OCC has managed to swing meetings with senior FDA officials, including Janet Woodcock, who was the FDA Director of Drug Evaluation. The press release quoted tireless lobbyist Joe Nadglowski, the
Ragen Chastain (she/her): joe.
Louise: bingo.
Ragen Chastain (she/her): I I think I've got bullshit bingo.
Louise: Yep, so Joe's the OAC president. and the press release says that, quote, OCC and the FDA discussed numerous topics, including improving the benefit-risk ratio of oplesity drugs by limiting the medications to those with serious oplesity health-related issues. What?
Ragen Chastain (she/her): Aren't those issues that people of all sizes get that get called serious oplesity related issues when fat people have them, Louise?
Louise: That is absolutely true. And we also need to remember that the people with serious oplesity-related health issues were the exact same ones who just got killed by Sibutramine. Okay, this makes sense. and then the press release also admits that the oplesity society, the tossers, handed a list of 40 oplesity experts. that the FDA could use as potential advisory committee members in future weight loss drug approval meetings.
Ragen Chastain (she/her): And the FDA being ethical said,
Louise: Yeah.
Ragen Chastain (she/her): Yeah, we're gonna bin this because obviously that's ridiculous, right?
Louise: Well, it's it is mind-boggling to look at the reach that this industry-funded ca-ching got straight into the FDA's senior leadership ears and to hear Joe Nadglowski and the OCC pushing for weight loss drugs for sicker fat people after the scout results, I'm I just sort of speechless.
Ragen Chastain (she/her): Yeah. I mean, 'cause there's no there are no words that really capture like how unethical and unhinged and wrong this whole thing is.
Louise: There's a few C words, you know.
Ragen Chastain (she/her): Yeah. There are words, yes, but for the sake of our rating.
Louise: ca-ching is safe. So, and that
Ragen Chastain (she/her): Yes.
Louise: list advising the FDA who they should get on to like vote. Holy mother of God. But this is just the start. the pharma companies obviously very, very unhappy with the FDA clampdown, especially Novo, who had Saxenda in their pipeline. So The companies did what the weight loss drug industry always does. They went back to the lab to improve their drug safety and efficacy. Just kidding. They went to Washington
Ragen Chastain (she/her): Yeah, I was like, What? When did they do that?
Louise: with stacks of money.
Ragen Chastain (she/her): That sounds that sounds more accurate, yes.
Louise: there was a very aggressive lobbying campaign. Between 2011 and 2012 alone, they gave $20 million to the Senate.
Ragen Chastain (she/her): Wow.
Louise: miraculously, in autumn 2011, the Senate Appropriations Subcommittee on Agriculture, which controls FDA funding, issued the FDA directive calling the quote absence of novel medicines to treat oplesity a concern. They ordered the FDA to report back on quote steps it's going to take to support the development of new treatments of oplesity. So yeah, really unbelievable.
Ragen Chastain (she/her): Wow, look what money can buy.
Louise: So it's a one year out from the Sibutramine recall. Sorry. It's just really funny. So it's just one year out from the Sibutramine recall, and we have Congress telling the FDA in writing that it's a terrible shame. that there aren't more oplesity drugs on the market. And the FDA writes back to the Senate promising, quote, to working with pharmaceutical companies to bring new oplesity drugs with favorable benefit risk profiles to the market. So yeah.
Ragen Chastain (she/her): the real wide view of what favorable means, I notice.
Louise: Yeah, this this is so important to talk about this side of things, which we never hear about. So brace yourself again. This results in a series of meetings at George Washington University, which is a private university just a few blocks away from the White House. And their Department of Health Policy has a history of lending its name to industry-funded consensus reports. So between 2011 and 2012, FDA and government officials repeatedly met with pharma companies and reps from oplesity organizations, and you guessed it, this includes Joe Nadglowski from the OAC.
Ragen Chastain (she/her): Dang I already have him on my bingo card.
Louise: Ted Kyle from the Oplesity Society.
Ragen Chastain (she/her): Teddy.
Louise: Million Dollar Donna was there, of course. And Louis Aronne, who I think you know, Ragen.
Ragen Chastain (she/her): I do indeed know him. I will save that rant for another time.
Louise: So these meetings all were paid for by the pharma companies with their weight loss drugs in the wings. There was Eisai who had Belviq. There was Novo, of course, with Saxenda. There was Orexigen and Takeda who were hoping to bring Contrave onto the market. And there was Vivus with Qysmia. And the OAC. So all of them pulled their money for these meetings. So just to summarize, the companies whose rejected drugs were sitting there in FDA limbo essentially pay off Congress and then fund nine months of meetings where they get to tell the FDA how their weight loss drugs should be evaluated. And this this produces a consensus report called Oplesity Drug Outcome Measures. The consensus report comes up with 11 considerations. Another C word. some of the highlights from the report were to stop calling their products weight loss drugs. Instead call them oplesity medications. What a nice rebrand, huh?
Ragen Chastain (she/her): Mm-hmm. yeah, this is and now we see that like just every strand of spaghetti on the wall of what we're gonna call these drugs to try to make them more palatable.
Louise: And the talking point from the OCC meetings that higher risks could be acceptable for sicker fat people, that was a key takeaway from the report. And they also suggested that the FDA could do a workaround by using risk management strategies. So why hadn't they thought of that before? So things like limiting off-label prescription for their drugs or using something called a REMS, a risk evaluation and mitigation strategy. REMS, it's an FDA program that lets a drug get approved despite known safety risks, in exchange for the manufacturers promising to put extra controls around how it's prescribed and distributed. So essentially, REMS is like a workaround which lets companies get their drugs. on the market now and deal with any fallout later.
Ragen Chastain (she/her): Great. If so I should point out that we're laughing to keep from crying because
Louise: Mm-hmm.
Ragen Chastain (she/her): it just wouldn't be a great podcast if we were just like crying over these disasters for, you know, 30
Louise: Mm-hmm.
Ragen Chastain (she/her): to 40 minutes. But this is horrific, especially predicating risk on size. That,
Louise: Mm.
Ragen Chastain (she/her): you know, as weight gets higher, someone's life becomes less valuable and more riskable, and that that's gonna be the FDA's approach. That's horrific.
Louise: Mm-hmm. Among among so many other layers of horrificness. Apart from the abject corruption. So
Ragen Chastain (she/her): Yeah. Yes.
Louise: this pressure worked. Weeks after the meetings, Belviq and Qysmia were quickly waved through FDA approval, both of them with a REMs attached. The authors of the consensus report could not help boasting. Scott Kahan, who was listed on the report as an academic from George Washington and John Hopkins University, without disclosing that he was also on the scientific advisory boards for Vivus and Eisai, published a self-congratulatory article in an Oplesity journal bragging about this dastardly process, and he says, quote, that it played a valuable role in FDA's approvals of Qysmia and Belviq, both approved within weeks of our final meeting. He's just, you
Ragen Chastain (she/her): congrats, dude. Whatever.
Louise: know, career highlight there. the drugs are not safer. And they're not more effective. The only thing that changed in the 18 months between rejection and approval was a whole lot of ca-ching. There's a nice PS to this too. Belviq got taken off the market in 2020 after it was confirmed that the risks of cancer did in fact outweigh the benefits.
Ragen Chastain (she/her): Yes, after it
Louise: Okay.
Ragen Chastain (she/her): The words all at the same time. it's such a cycle, right?
Louise: Mm-hmm.
Ragen Chastain (she/her): The trials show potentially very dangerous side effects. The drug gets approved anyway, and then the drug gets pulled from the market for those exact same dangerous side effects. Like nobody needed to be exposed to that because we knew early on, but with this, you know, exactly what you're talking about with the FDA loosening up approval, what could have possibly gone wrong? wait, this.
Louise: Well, Ragen, REMs worked really well, okay? 'Cause this is the logic.
Ragen Chastain (she/her): Having a little trouble believing that
Louise: This is the logic. It's unbelievable. So getting FDA approval pathways unblocked was a big win, but it's not the whole battle for Pharma. So since Fenphen, Medicare had banned the coverage of all weight loss drugs. And to unblock that barrier, the companies had to keep convincing insurers and the government that their drugs were medical necessities. So Novo and its pharma bodies needed a big medical organization to put its name behind the idea that oplesity was a disease. And major medical organizations at the time were being showered with drug industry cash. One of them was the American Association of Clinical Endocrinologists, or AACE. In 2013 alone, AACE got $3.2 million from weight loss drug makers, including Novo. That was 30% of its whole funding for that year. And the AACE were busily also lobbying Congress. And when asked about it, the AACE president, Dr. R. Mack Harrell told the media, quote, there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, It is a commonality of interest that is healthy, desirable, and beneficial.
Ragen Chastain (she/her): It's common we like money and they're willing to give it to us. Commonality.
Louise: Commonality, another C-word. so Ragen, let's take a close look at this desirable and beneficial commonality of interest in action.
Ragen Chastain (she/her): Let's do.
Louise: So in 2012, the AACE publishes a position statement, which claimed that oplesity met the American Medical Association's criteria for disease status. Two of its four authors disclosed financial conflicts with novo nordisk. A third of them, Dr. Timothy Garvey, declared no conflicts. But I found papers published on either side of this one saying that he was an active advisor to Novo, Vivus, and Eisai. Yeah?
Ragen Chastain (she/her): Yeah. Yeah, I know that I know his name very well, so how interesting.
Louise: So the AMA's criteria for a disease were pretty simple. Diseases have to impair how the body normally functions, produce recognizable signs or symptoms, and cause actual harm. The AACE paper claimed that there was, quote, an overabundance of clinical data meeting these criteria. But inconveniently, at the same time, the AMA was actually already looking at this data. And investigating the same question using its own Council on Science and Public Health, which did not have any industry funding to conduct a full review of research evidence. And the council's report concluded that oplesity did not meet criteria for disease. Storing excess fat and the body's resistance to weight loss are normal biological adaptions, not dysfunctions. BMI was a blunt tool, very poorly correlated with actual health. Associations with diseases are one thing, but not the same thing as being a disease itself. And causal stuff was extremely conflicting. The council also warned that disease labels could, quote, intensify patient and provide a reliance on presumably costly pharmacological and surgical treatments. The council's report even called out the AACE 2012 paper, quote, AACE's conclusion appears to be based less on new knowledge about oplesity than on differences in their interpretation of the definition of disease. Nice swipe there.
Ragen Chastain (she/her): Yes.
Louise: So, you know, this was getting Oplesity Incorporated quite worried. One of the AACE paper's authors, Jeffrey Mechanick, admitted to the media that Oplesity Inc. were worried. Quote: A lot of organisations feared the AMA would defer or simply not declare it a disease, which we felt was important.
Ragen Chastain (she/her): Yes, but for that piece where they said it would create dependence on these
Louise: Hmm?
Ragen Chastain (she/her): treatments. That that's you know, I'm sure they wish to take just that piece and import it into a much more positive paper.
Louise: Yes. So, fueled by drug company money, in June 2013, the AACE brought a resolution directly to the AMA meeting urging them to declare oplesity a disease, and they recycled all the arguments that they were using in their 2012 paper. And apparently the debate in this AMA meeting was heated. Dr. Robert Gilchik, who chaired the council's report, told delegates Quote, why should a third of Americans be diagnosed with a disease if they're not necessarily sick? Just being of increased weight if there's no impaired function doesn't fit any of those definitions of a disease. But Gilchik got outnumbered. He listened as pharma backed delegate after pharma backed delegate just took the podium to talk. There was Dr. Jonathan Leffert of AACE. He said, quote, The scientific evidence is overwhelming. And then Dr. Ethan Lazarus of the ASBS, do we remember them? From last
Ragen Chastain (she/her): Mm indeed we do.
Louise: he gave my favourite rationale, it's very circular. Quote Calling oplesity a disease, we'll send the message that this is a chronic disease.
Ragen Chastain (she/her): I mean, hard to argue with, but also what?
Louise: Mm-hmm. so when the votes got cast, two hundred and seventy-six yes, a hundred and eighty one against, and the motion carried and oplesity was declared a disease by the AMA.
Ragen Chastain (she/her): I just wanna go back and point out in opposition to a year long investigation by their own committee on science and public health. And what do they know about science and public health? 'Cause you're just the committee on science and public health. Sorry, I'm gonna crash out.
Louise: Yeah. Cool wet grass. Yes. Deep
Ragen Chastain (she/her): Do you hear anything?
Louise: breaths. So Dr. Douglas Martin, who chaired the committee overseeing the whole debate, even says, quote, let's acknowledge that there's not a lot of science, not a lot of literature that we can point to. Let's also recognize that there's consensus in the House of Medicine where it should be identified as a disease, unquote. the C words. Yes.
Ragen Chastain (she/her): All the C words, many, many words coming to mind right now. None of them good words, none of them words you necessarily want to say on the air.
Louise: The very next day, AACE and the OAC issued synchronized press releases, how cute, celebrating
Ragen Chastain (she/her): No.
Louise: the AMA's historic decision, urging lawmakers to act quickly to, quote, improve access to oplesity treatment. Within 24 hours, the Treat and Reduce Oplesity Act, or TROA, which was a motion to put the weight loss drugs back on Medicare, was before Congress. Using the AMA's endorsement as leverage. The AMA's decision made the front page of the newsletter, which called the timing of the TROA lobbying coincidental to the AMA's decision. What a coincidence.
Ragen Chastain (she/her): Right. I that's really easy to believe. Sarcasm.
Louise: my god, nothing could be further from the truth. Scientific evidence had just been outmaneuvered by pharma money. Novo's thievish third step was progressing beautifully. So I want to land today on September 11, 2014, at the FDA approval to approve Novo's drug saxenda. Contrave had glided through FDA approval the day before, and now it was showtime for Novo. I managed to track down the transcript of the proceedings and it was fascinating. Just seeing who was there and what was said. Million Dollar Donna was one of the first speakers. So the same Donna who had those cozy meetings at George Washington University and helped write the risk framework this drug was about to get judged against. So the open hearing where people were talking just in favor generally about passing saxenda was like a medley of the Novo funded oplesity organizations. There was Joe NadGlowski of the OAC. He admitted
Ragen Chastain (she/her): Sigh.
Louise: He admitted that OAC was funded by about 50 companies, he said, including today's sponsor. So he's like, hey, if there's many people funding, it's it's okay. There was another person, yes, yeah.
Ragen Chastain (she/her): Yeah. How much, Joe? How much did they give you?
Louise: I know, but like, I think this is another reason why the ca-ching strategy is used, because if you have a lot, then the more strategic funders get kind of you know, they're just one of many, There was a woman called Domenica Rabino who was speaking on behalf of the OCC. She admitted that she was also running one of Novo's clinical trials at the same time. there was George Grunberger from the AACE and he was speaking in support of this need for oplesity drugs. He told the panel that the AACE, yes, had paid for his trip to attend the meeting, but quote, there's no other conflict of interest I have here today. I guess all that money funding the AACE, it just is not relevant.
Ragen Chastain (she/her): Hmm.
Louise: So we had Ted Kyle, who spoke twice. first, he introduced himself as an active member of the TOS and the chairman of the OAC. He said he had, quote, no financial interest in the sponsor. But then he immediately added that he quote provided advice to the sponsor. So it's just, it's just all the same players here in the room. Novo said that their drug, Saxenda, cleared the FDA 5% efficacy benchmark for weight loss. But the FDA's own statistician disagreed because his independent analysis came back at 4.6 to 4.8%. It's well below the bar. But apparently that wasn't enough to concern the committee. There was also this slightly pesky problem of cancer. In animal studies liraglutide caused thyroid tumours in rats and mice. And this seemed to be dose-dependent, which was a bit of a concern, seeing that Saxenda is a mega dose of Liraglutide. 15 people voted, and 14 said yes. So one of the voting members was Susan Yanovsky, and she was from the National Institute of Health, and she was there at the George Washington meetings. Her yes vote used almost the exact same language of the framework that she watched. get built like this idea of a favorable risk benefit and the idea that concerns about risk can be addressed post-marketing by a REMS.
Ragen Chastain (she/her): Uh-huh.
Louise: Yeah. You know, one of the things that really surprised me was that Lynn McAfee was at this meeting and as we know she's a very cherished fat activist and a patient rep who spent so many years of her life advocating and she'd taken Sibutramine and she'd had heart problems that she talked about in this meeting. but she voted yes.
Ragen Chastain (she/her): That is interesting. So
Louise: Mm-hmm.
Ragen Chastain (she/her): it makes me wonder. So I actually had the honor of getting to meet Lynn several times and I interviewed her for a project. And it makes me wonder if it was somehow strategic. Like I mean, Lynn has passed away, for those who don't know. I mean, so we'll never be able to ask her. But I also know that she did a lot of these meetings. She was a very strategic person. And since it was fourteen to one I wonder if there was something strategic about her voting yes to get something else that she wanted done or to, you know, get allies or something. I mean, we'll never know. But it is curious.
Louise: Yeah, I think it was clear as she's speaking that she is absolutely not bought into the hype. she talks about the profit motive, she talks about being concerned with the health risks. So she's definitely one of the stronger, more critical voices in the meeting that day. So yeah, but I I wonder, you know, as I was reading it, I wonder if. If she knew about some of the things that we were talking about today, what she would have done.
Ragen Chastain (she/her): Yeah.
Louise: But as you said, we'll never know. And
Ragen Chastain (she/her): Yeah.
Louise: just yeah, a huge thank you for people like Lynn out there.
Ragen Chastain (she/her): Yeah.
Louise: So there was one no vote. A guy called Dave Kelson, he said there just wasn't enough data to rule out cancer risk. And others agreed with him, but voted yes anyway. So as a condition of Clearing the drug, the FDA ordered Novo to run a 15-year thyroid cancer registry to track in the real world how many cancer diagnoses happen after it comes onto the market. And we're going to be following up on that in later episodes. So there we have it. We're landing with all of this greasing from Novo and its pharma bodies and its ca-ching kind of manipulation and we have a triumph. It's novo's thievish third step and seriously they're only just getting started. We've got so much more.
Ragen Chastain (she/her): Sadly, yes. And it I mean, you've so beautifully illustrated how they did it. They created their own evidence and then convinced people who are well meaning, because there are people in that room, not as many
Louise: Yeah.
Ragen Chastain (she/her): as you'd hope, who are not funded by them, who really believe this is the best thing and that being higher weight is so dangerous that it's worth risking people's lives and quality of life. And that is the sort of gold nugget of Novo's plan that not only are they influencing people with money, but then they're using that money to influence ideas at every level. It's so dangerous and unfortunately it's been so effective.
Louise: It is. And you know, it's shocking because we we joke today about bingo, but it is a small number of people who have been
Ragen Chastain (she/her): Mm-hmm.
Louise: able to wield untold influence in spaces like this. And seriously, I hope that we can wield power the other way with casting a fresh eye on all kinds of stuff like this, because I don't agree that C words should triumph over like science, evidence and safety.
Ragen Chastain (she/her): Yeah. Yeah, science and safety. Can we please get back to some S words? Ethical evaluation. We could use some E words, like really any other words.
Louise: Sensible. Mm-hmm. We will alliterate. Yes. Yeah. So that's it, I'm spent for today, my god.
Ragen Chastain (she/her): Fair. This is a lot. All right.
Louise: As it always is, yeah.
Ragen Chastain (she/her): So don't miss the next episode of Exposing Obesity Incorporated. We're going to uncover the clinical data and the enormous frenzy that surrounded the release of Ozempic and Wegovy, which have been the so-called game-changing blockbuster drugs. And we'll be exposing all that behind-the-scenes shenanigans that you need to know about.
Louise: Can't wait.
Ragen Chastain (she/her): New episodes of Exposing Obesity Incorporated drop every two weeks on the first and fifteenth of each month. So please tell your friends, tell your colleagues, tell everyone. And if you can't wait for the first and fifteenth, you can again join our Patreon to get early access to episodes plus bonus content. If today's episode got you thinking, we'd love to hear from you. Please send your feedback. Questions, topics you want us to cover. And if you have insider information, if you worked for a pharmaceutical company or professional organization, a clinic or patient advocacy group or a marketing agency, and you've seen something that the public should know about, we want to hear about it. You can visit our obesileaks portal at speakpipe.com. That's S-P-E-A-K-P-I-P-E.com. Forward slash obesileaks O B E S I L E A K S and you can leave us a voice message that's completely anonymous. It's also totally free and we listen to every message. You can also email us at obesityincorporated at gmail.com. For show notes, resources, a quick link to oplesity leaks and more, you can head to exposing obesityincorporated.com and you can find a post for each of our episodes as well as all of that information. we want to remind you that the views and opinions expressed here are our own. All claims are alleged unless otherwise specified, and this podcast is for informational purposes only and doesn't provide medical, psychological, legal, or financial advice. Please do consult with a professional for specific advice tailored to your situation. See you next time.
