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Oxycontin, Purdue Pharma, the Sackler family, and the FDA

I just read this horrifying magazine article by Patrick Radden Keefe: The Family That Built an Empire of Pain: The Sackler dynasty’s ruthless marketing of painkillers has generated billions of dollars—and millions of addicts.

You really have to read the whole thing, because it’s just one story after another of bad behavior, people getting rich off others’ misfortunes.

But there was one thing that caught my eye, after the profiteering and the astroturf lobbying and the million-dollar lawsuits and the sleazy public relations and the deceptive advertising and the planted stories in the trade press:

Purdue, facing a shrinking market and rising opprobrium, has not given up the search for new users. In August, 2015, over objections from critics, the company received F.D.A. approval to market OxyContin to children as young as eleven.

On one hand, this seems just terrible. But I guess the point is that Purdue Pharma can act strategically, trying out different plans to increase the number of addicts and sell more pills; but regulators are required to consider each decision on its own merits. And, after all, if there were no potential for abuse, maybe it would make sense to approve, and even market, this opioid for use by children. It’s an interesting asymmetry.

P.S. Full disclosure: some of my research is supported by pharmaceutical companies.

27 Comments

  1. KLen says:

    “But I guess the point is …” (?)

    …well, a rather vague “point’. A sample size of one subjective book might be inadequate for broad conclusions.

    Private businesses have wide latitude to do what they want, but Federal Regulators (like FDA) are weak and hamstrung ? That is highly incorrect.

    There are bad actors in private business, but not in government regulatory departments; private business can do widespread harm, but government regulatory actions are never seriously harmful to the public ?
    Also incorrect.

    People who are defrauded or harmed by a business product have no effective legal recourse against that business. Incorrect.

  2. Alex C. says:

    In a somewhat related topic, a recent report (issued by the Centers for Disease Control) showed a shocking increase in the suicide rate in the United States. This increase is consistent with the hypothesis that psychiatric drugs may act to hinder recovery from mental illness. See, Anatomy of an Epidemic: Magic Bullets, Psychiatric Drugs, and the Astonishing Rise of Mental Illness in America, by Robert Whitaker.

  3. Keith O'Rourke says:

    Worrisome story – but I believe its really all about poor regulation, governance and enforcement that failed to trigger.

    We should all know better than to trust our lives and those of loved ones to individuals that stand to earn billions of dollars while facing penalties in the paltry millions that may follow many years later. (Now I am not sure if there was not more uncertainty around many of the issues discussed).

    Actually, we already do that widely on a lower scale – trust our lives and those of loved ones to individuals that stand to earn hundred plus thousand dollar a year salaries while facing penalties in the paltry thousands or just embarrassment that may follow many years later.

    Simply by allowing studies to be published in academic journals without auditing or verifying in any real sense what is being claimed in the papers reflects what actually happened.

    P.S. Full disclosure: I work in regulatory capacity.

    • Michael Lew says:

      Keith, that is an interesting take on the issue, but I really cannot agree. Regulation is essential, but as a last-resort defence against corporate misbehaviour. The cause of the opiate crisis lies in the corporate actions, not in the failures of regulation and enforcement.

      The activities of Purdue should be treated as criminal offences, in my opinion, and the penalties should involve jail for the prime movers and confiscation of _all_ profit. Purdue is nowhere near large enough for the “too big to fail” argument against penalties commensurate with the harms that allowed the financial sector to survive the global meltdown with scarcely a bruise even while millions of people lost their homes, savings and livelihoods.

      The political influence of rich families like the Sacklers is spent on making sure that their corporate crimes can continue to go unhindered and unpunished. We should not treat this as a simple problem of regulation and enforcement.

      • Dzhaughn says:

        “Confiscation of all profit” equals “shutting down the company.” If a majority of shareholders believed that such a proposed punishment would stick, they would vote to liquidate the assets.

        On the bright side, in that case, it would be easy to enforce the confiscation of all zero dollars in profit for many years to come.

        Is ruthless marketing a crime, per se?

        • Anonymous says:

          Shutting down a company that preys upon society so openly and so maliciously as Purdue would be a good result.

          Ruthless marketing may not be a crime under some sets of laws, but what Purdue did was immoral. Is there a law against cancer? No, but we fight it any way we can.

        • Emmanuel Charpentier says:

          > “Is ruthless marketing a crime, per se?”

          _Grosso modo_, yes.

  4. Paul Alper says:

    From the New Yorker article’s beginning paragraph:

    “The Brooklyn-born brothers Arthur, Mortimer, and Raymond Sackler, all physicians, donated lavishly during their lifetimes to an astounding range of institutions, many of which today bear the family name: the Sackler Gallery, in Washington; the Sackler Museum, at Harvard; the Sackler Center for Arts Education, at the Guggenheim; the Sackler Wing at the Louvre; and Sackler institutes and facilities at Columbia, Oxford, and a dozen other universities. The Sacklers have endowed professorships and underwritten medical research. The art scholar Thomas Lawton once likened the eldest brother, Arthur, to ‘a modern Medici.’ Before Arthur’s death, in 1987, he advised his children, ‘Leave the world a better place than when you entered it.’”
    Read on for more irony embedded in this article which was published over six months ago. Columbia University is mentioned three times; Rudolph Giuliani appears twice: “Rudolph Giuliani had tried, on Purdue’s behalf, to get the lead prosecutor to scuttle the case.”

  5. Paul Alper says:

    Given Andrew’s famous addiction to celery, this caught my eye in the New Yorker article:

    “Purdue’s senior medical adviser, J. David Haddox,…insisted that OxyContin was not addictive. He once likened the drug to a vegetable, saying, ‘If I gave you a stalk of celery and you ate that, it would be healthy. But if you put it in a blender and tried to shoot it into your veins, it would not be good.’”

  6. Martha (Smith) says:

    I haven’t been able to access the article linked.

    Of possible interest to others who can’t access the article: I did find a summary of it and another related article at
    http://www.economicprincipals.com/issues/2017.10.29/2053.html

  7. John says:

    This story is the distilled essence of why profit-seeking and medical care should be kept far apart.

    • jason farnon says:

      it’s one strike against, versus how many reasons for keeping them tethered. i can think of many downsides of linking profit-seeking to X, but how many outweigh the benefits of capitalism.

    • Dzhaughn says:

      Do you really believe that people should not be paid for providing medical care, or for investing in ways to provide it?

      And that forbidding this payment will somehow improve medical care?

      You might find some sympathy for your point of view at your local natural remedies dealer. But we’d stil have to shut them down, too.

      • Medical care costs have skyrocketed in the US without concomitant improvements in health. In fact it’s not hard to argue that health in the us has declined over the last 20 years for wide swaths of people.

        A major component of this is rent seeking behavior, that is, getting the government to treat health related organizations in ways that protect or enhance their profits without them having to actually provide improved health quality.

        Preventing this rent seeking behavior would go a long way towards improving people’s lives, because profit would have to actually be connected to performance of a useful function, instead of say marketing useless multibillion dollar remedies (tamiflu) or even harmful ones like legal smack pills.

  8. Adam S says:

    Skimming through the article, I didn’t see reference to the now infamous 1980 NEJM “correspondence” that was used as a cornerstone by Perdue (and related) in their marketing to mislead many physicians into thinking that opioids were not addictive when used to treat physical pain, whether acute or chronic (e.g. end-stage cancer patients). The letter is just a single paragraph with almost no details but was given undue credence because of where it was published. Basically, a Boston hospital did a chart review of ~40,000 hospitalized patients, found ~12000 who received at least 1 narcotic, and only “four cases of reasonably well documented addiction in patients who had no history of addiction. The addiction was considered major in only one instance.”

    The letter is officially here: https://www.nejm.org/doi/10.1056/NEJM198001103020221
    and reproduced in its entirety here: https://www.theatlantic.com/health/archive/2017/06/nejm-letter-opioids/528840/
    and here: https://retractionwatch.com/2017/06/02/nejm-issues-unusual-warning-readers-1980-letter-opioid-addiction/

    • Martha (Smith) says:

      To elaborate for those not familiar with the problem: That study was used to argue “not addictive” for patients who were not hospitalized (i.e., whose taking of the opioids was not supervised) — and, if I remember correctly, such “information” accompanied urging doctors to have patients (not hospitalized) rate pain on a 1 to 10 scale, and then prescribe painkillers if the patients rated the pain as anything but very low, in order to give “the best care”.

  9. oncodoc says:

    I was a working oncologist and a hospice director during this era. Yes, I received goodies like meals, pens, and note pads from the purveyors of Oxycontin and lots of other pharmaceuticals. Sponsored lectures in the meeting rooms of restaurants did try to convey the message that there was substantial undertreatment of pain. Pharma reps were people who were believable and attractive. The people who paid for this marketing certainly believed it was effective. I was representing a patient population for whom these meds were appropriate, but there were alternatives to the Purdue Fredrick products (i.e. Kadian) that did not garner as much market share due to less marketing. The question that needs to be addressed is whether this marketing became deliberately directed toward blurring the lines of correct use by doctors. If Oxycontin beats Kadian in market share for patients with the correct indications, it is not a problem. Was oxy marketed for wrong indications? Is drug marketing inherently dangerous? These appear legitimate concerns to me.

    • tom finucane says:

      SE Hadland in June 1 JAMA Internal Medicine used data from Open Payments (emoluments from industry for individual doctors)and from Medicare opioid claims data and found, for example, that “Each meal received in 2014 was associated with an increasing number of opioid claims in 2015.”

  10. The economist Dean Baker says that medical research should not be funded by patents. He notes that “In addition, this [new] system would remove the incentive that patent monopolies give companies to lie about the safety and effectiveness of their drugs.” http://cepr.net/blogs/beat-the-press/paying-for-cancer-cures-why-should-it-be-the-victims

  11. tom finucane says:

    OxyContin goes global — “We’re only just getting started” http://www.latimes.com/projects/la-me-oxycontin-part3/ reports that “A network of international companies owned by the family is moving rapidly into Latin America, Asia, the Middle East, Africa and other regions, and pushing for broad use of painkillers in places ill-prepared to deal with the ravages of opioid abuse and addiction.” “The past is never dead. It’s not even past.” WF

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