Purdue’s Potemkin Village of Addiction-Prevention: Make Them Pay

The Los Angeles Times has published an appalling albeit impressive investigative piece (http://www.latimes.com/projects/la-me-oxycontin-part2/#nt=oft01a-1gp3; by Ruan, Girion, Glover) regarding Purdue Pharma’s handling of fraudulent Oxycontin prescriptions, and the part that this played in the opioid abuse crisis that has burgeoned in the United States. The piece described in detail the activities of  one such ‘pill mill’, which the reporters estimates provided 1.1 million pills to drug dealers, largely affiliated with LA street gangs and organized crime.The article is titled ‘Inside an L.A. OxyContin ring that pushed more than 1 million pills. What the drugmaker knew.’  As it turns out, they knew quite a lot, and looked the other way as millions of pills were diverted to dealers who then resold them to those who had become addicted. The story depicts a corporate culture that masqueraded concern about Oxycontin’s abuse potential; Purdue had even hired a former US-Attorney and a DEA veteran to be part of a team that had the prevention of Oxycontin diversion as its ostensible mission; this group tracked patterns in Oxycontin prescribing that flagged the near-certainty of fraudulent prescription practices on the part of unethical physicians. We are not going to replicate the Times story here, it is well-written and documented, worth reading in its entirety. We will instead cut to the chase: “Crowley (the ex-DEA agent working in Purdue’s anti-diversion ‘effort’) said that in the five years he spent investigating suspicious pharmacies, Purdue never shut off the flow of pills to any store(emphasis ours).
One might well wonder–why set up a group tasked with identifying and responding to illegal diversion of Oxycontin supplies and then make no attempt to effectively intervene? Even though the DEA had specifically pointed to manufacturers as sharing in the responsibility for the prevention of opioid diversion; and even though Purdue had previously been fined $635 million for misleading physicians regarding the abuse risk presented by Oxycontin; the story quotes Crowley as saying “company policy prohibited employees from reporting pharmacies to the DEA without first consulting their distributors.”  Purdue acted as if it was not their problem to solve, as if their hands were tied, albeit by their own Company policy. The obvious explanation is that they hewed towards the letter of the law without doing anything that would actually impede the flow of profits to Purdue’s bottom-line. Those profits were gargantuan: The reporters state that Purdue has “earned more than $31 billion from Oxycontin” (Forbes estimated that the total is $35 billion, but let’s not quibble about $4 billion). It is not as if Purdue is one of those pharmaceutical companies whose outsize profits on one drug are offset by the losses engendered by other research efforts that went-for-naught; Purdue’s business model is totally focused on opioid analgesia. Of the 67 Purdue Pharma-sponsored clinical trials cited on clinicaltrials.gov, 64 were for opioid-based analgesics, i.e. Oxycontin, its XR and abuse-resistant progeny, and its chemical cousins. Just three clinical trials were for non-opioids, those three were part of a partnership with Rhodes Pharmaceuticals regarding the clinical development of a new extended-release version of methylphenidate, for ADHD. In other words, Ritalin–not exactly a high-risk, innovative, expensive research endeavor. Neither ethics, legal obligations, or research activities were allowed to detract from Purdue’s bottom line.
Thus Purdue Pharma made tens of billions of dollars in profit on the sales of a drug whose abuse was noted and ignored, with few or no corrective actions taken. Purdue and its legal advisors of course publicly state that their behavior was in accordance with the law, which is the rationale often claimed by those who would prefer to not consider the moral bankruptcy of their position. We do not know whether there are grounds for criminal prosecution here, and our suspicion is that, even if there are, such proceedings would simply punish those who executed the wishes of those who created the policies, who created a corporate culture wherein the human toll associated with opioid addiction was not seen as sufficient reason to compromise their revenue stream. This is the kind of sociopathy one would expect to see on The Wire, not from those controlling a pharma company in Connecticut. The Sackler family, who own Purdue Pharma and to whom the profits flowed, should bear responsibility for the immoral corporate culture Purdue has come to embody. Since they chose to operate on the basis of their pocketbooks, that is where the penalty should be exacted. The largest pharma company fine ever paid was GlaxoSmithKline’s $3 billion penalty, back in 2012, for off-label promotion of its antidepressants and the suppression of safety data for a diabetes drug. But the sheer scope of human suffering, death, and societal harm that can be traced back to Purdue Pharma’s negligence makes GSK’s behavior look philanthropic by comparison. What would be a meaningful penalty in Purdue’s case?
This is NIR’s suggestion: The $31 billion of Oxycontin revenue taken in by Purdue over time is close to what the National Institute for Drug Abuse (NIDA) has for their 2016 budget–if multiplied thirtyfold. The Sacklers should return the $31 billion received for Oxycontin, but rather than having that fine disappear into the maw of the federal budget, let it go to NIDA, which is tasked with addressing and correcting some of the damage done by Purdue. We would not be unreasonably draconian about this; let the penalty be paid over the next ten years. That would in essence quadruple the annual funding available to NIDA, even permitting the funding of late-stage clinical trials for addiction therapies, programs that at present receive virtually no support from the pharma industry or investment community. This would not ‘even the score’, because there is no getting back the lives lost and wasted, but it would be a step in the right direction, and send a clear message that there are rules about sacrificing lives in the pursuit of profit.

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