Tuesday, December 7, 2021

"Dopesick": The story of the marketing of killer opioids will really make you sick. Don't trust any of them!

I have recently been watching “Dopesick”, the Hulu/Disney+ quasi-documentary drama about how the Sackler family-owned Purdue Pharma developed and marketed Oxy-Contin®, and about the efforts of some brave federal prosecutors and DEA and DOJ agents brought them (somewhat) down. Based on the book by Beth Macy, it is a good series, with terrific performances and many sympathetic characters (not the Sacklers, though, none of them) and although I am sure that there fictional elements involving the personalities portrayed, it is essentially factual. It is also infuriating, and nauseating.

If you haven’t watched it, you probably should, but you probably already know the main theme, so what I write won’t be spoilers. It is still worth watching, to understand the extent of the evil, and the way in which the medical profession and federal agencies were “played” successfully as thousands of Americans became addicted and died. A few of the outrages include that when Purdue developed Oxy-Contin, using a delivery scheme developed for MS-Contin®, which was going off patent, they claimed its slow-release delivery mechanism made it essentially non-addictive (less than 1%), and got a first-ever special label for a Class II narcotic from the FDA saying it was less addictive (it was not). They did a very effective job not only marketing (detailing) to physicians with this lie, but created new diseases (conditions) that justified its use. This was also taken from a previous drug and scam, when Arthur Sackler invented the condition “psychic tension” to market Valium®. When, predictably, people first got pain relief, then developed tolerance they invented the condition of “breakthrough pain” which required a higher dose. Then folks got tolerant of that. And when they stopped, they went through awful withdrawal. This is what happens with opiates and opioids. And yet Purdue was able to convince doctors to continue to prescribe it – and prescribe it in increasing amounts.

This was part of a movement going on in the 1990s to address the issue of people not always receiving adequate pain relief. The pain of diseases, such as cancer, that occurs as people approach death, got conflated with the moderate chronic pain that millions have from work related injuries (the focus of the drama is on a mining area of Virginia) and from conditions such as osteoarthritis. These are real problems, but the answer was presented as opioids, and ever increasing doses of them. What was not well-known at the time is that, to a large degree, this “movement” was in fact a campaign funded by Purdue. They funded – and thus heavily influenced -- most of the medical Pain Management groups, as well as the campaign to label pain the “fifth vital sign” (after temperature, pulse, respiration, and blood pressure), an idea they invented. It was a drumbeat that was ubiquitous. The pain movement was essentially, a marketing campaign for a lethal drug. It was successful, in both ways. It made the company, and the family, a lot of money, and it addicted and killed a lot of people.

The Sacklers didn’t seem like the meanest of billionaire families (of course, this is a low bar). They were philanthropists, who gave a lot of money to the arts, and to Israel and Jewish organizations, and health care, and even funded a medical school, the Sackler School of Medicine, part of Tel Aviv University and located in Israel but chartered in NY state. It still exists. They were, however, and remain, avaricious and essentially amoral, continuing to refuse to recognize their evil-doing, while remaining #30 on the Forbes wealthiest list, and managing to retain and hide nearly $11B in their own private money despite the $8.3B settlement. And thousands of people are dead and addicted. The people most affected were poor and working class people, those who work with their bodies and most often experience chronic pain, such as those the series focuses on, miners.

But the story cannot end with the Sacklers, Purdue, and Oxy-Contin. While some of their tactics were particularly creative and perfidious, the effort to market drugs with high profit margins (even when they are often less effective and more dangerous than other existing drugs) is the Holy Grail of the pharmaceutical industry. What Purdue did was possibly more insidious – and effective -- but it was typical in being multi-pronged, targeting consumers, physicians and the federal government.

The government was targeted by lying to them, and knowing they were unlikely to be caught as the FDA’s staff (as the staffs of almost all regulatory agencies) had been decimated by cuts beginning with the Reagan administration, aimed at allowing corporations to have freer rein – to lie, cheat, and profit at the public’s expense in $$ and, in this as in many cases, their health. It was a flagrant example of the corruption of the ubiquitous “revolving door”, where those who are tasked with regulating industries then leave government service and get high-paying jobs in those same industries. Indeed, this is what happened with the FDA official who approved the novel labeling of Oxy-Contin -- he went to work for a big salary at Purdue -- and it happens every day in every field, not just pharmaceuticals. It is, pure and simple, graft.

Doctors were targeted through pharmaceutical sales representatives (“detail” people) who provide them with incomplete and often inaccurate information (e.g., that Oxy-Contin was only 1% addictive), and take them to expensive dinners and even vacation retreats under the guise of medical lectures. And the company, of course, encouraged their own reps to lie with enticements such as vacations. And the public? They present tantalizing, incomplete, and dangerous information through ads, especially on TV.

I have written about TV direct-to-consumer advertising, (e.g, DTC Advertising on TV illustrates the corruption and inequity of the US medical care system, Mar 6, 2021) and think it is pretty much all bad. I think that the marketing of drugs to doctors, to get them to prescribe expensive drugs, is mostly all bad. I have thought that, by the way, pretty much since at least medical school. I didn’t meet with drug reps, was very skeptical of information they provided (which I saw in journal ads and heard from colleagues) and assumed any positive claim was very likely incomplete or untrue. During my career, any number of highly-touted drugs were pulled from the market after causing major morbidity and mortality that was either not predicted in the pre-approval studies or suppressed by the companies. As a teacher of medicine, I sponsored “counter-detailing” to point out the flaws of the pharmaceutical company claims. I was aghast when residents would come back from conferences supposedly sponsored by professional associations but funded by drug companies that recommended the substitution of new expensive drugs for old standards that worked at least as well. This has been recently documented for diabetes (another field in which much of the funding has come from the drug makers) in an article from Reuters, ‘Drugmakers Pushed Aggressive Diabetes Therapy. Patients Paid the Price’, featured by Medscape Nov 5, 2021.

And yet, even so, I was not immune to the campaigns that Purdue funded, especially the idea that pain was being undertreated, although I remained unconvinced that it was the “fifth vital sign”. To be sure, I was much more skeptical than many of my colleagues, and was careful to distinguish between relieving the pain of a terminal cancer patient and addicting a person with chronic moderate pain. But it was a very well-done campaign, and I knew that at least sometimes we were undertreating pain. At Cook County Hospital, where I worked, we saw many patients with sickle-cell pain crises, treated with opiates and opioids, and frequently becoming addicted (interestingly, the chief of pediatric hematology only used aspirin and hydration, but as soon as those children became adults they began to receive narcotics).

We must remember that it was and is not just Purdue. Don’t trust what any drug company (or maybe any company) says in TV ads. Don’t trust what the pharma reps say. And sadly we cannot always trust recommendations of professional organizations when they are getting money from drug companies. This is real conflict of interest, and makes our professional organizations suspect.

It is all about making the most possible money by any means necessary, no matter who gets hurt, what Noam Chomsky calls “gangster capitalism”. You’re better off trusting real gangsters who literally put a gun to your head. At least you know where you stand.

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