Saturday, October 28, 2017

Organized Crime and the Opioid Crisis

In "the old days," thirty to forty years ago, use of heroin was a fringe problem associated with edgy jazz musicians and rich rock stars who clearly had more money than they knew what to do with. Few back then could have imagined a world where heroin would have seemed as popular and available as marijuana. Tying the explosion of opioid use to supposed downward trends in morals, "traditional family values" and corrosive public assistance that destroys individual responsibility might be an easy straight line to draw and might be politically useful but such connections have nothing to do with reality.

 

Like everything else in life, when a trend emerges out of seemingly nowhere and grows exponentially beyond normally understood sources to support its growth, you aren't looking at magic -- or genius, or "evil". You're looking at a baseball field through a knothole and seeing nothing but home plate.

Two stories, one from The New Yorker and one from NPR, make it very clear the roots of the opioid crisis stem from a pattern of organized crime. Not "Organized Crime" as in the mafia -- the mob could never muster the combination of intellectual property and legal muscle required -- just organized crime. Big business (BIG) with an existing understanding of a market, understanding of the science underlying the behavior of their product, understanding of marketing techniques to customers (patients) and distributors (doctors) and an understanding of regulations and laws needed to cynically profit without any concern for anything beyond their bottom line.

Links to the stories are provided below:

The Family That Built an Empire of Pain

Pharmaceutical Founder Arrested In Alleged Nationwide Opioid Scheme

The New Yorker story focuses on decades of business strategy on the part of the Sackler family, which owns privately held Purdue Pharma which reaps billions in profits from the current opioid epidemic. The story provides the history of Purdue's creation of OxyContin in 1995 and their subsequent efforts to squelch bad news about the drug's consequences but goes back further in the company's history to make the case that their "success" with OxyContin was no fluke. Purdue Pharma was founded by people who studied medicine -- many family members are trained doctors -- but also studied marketing and specifically created promotional strategies aimed at obscuring the drug's addictive qualities and encouraging wider use in circumstances previously considered to not warrant "big gun" pain killer medication.

In tracing the history of the family and its business, the story mentions that one family member, Arthur Sackler, was instrumental in the marketing of Librium and Valium in the sixties.

The ad ran in a medical journal. Sackler promoted Valium for such a wide range of uses that, in 1965, a physician writing in the journal Psychosomatics asked, “When do we not use this drug?” One campaign encouraged doctors to prescribe Valium to people with no psychiatric symptoms whatsoever: “For this kind of patient—with no demonstrable pathology—consider the usefulness of Valium.” Roche, the maker of Valium, had conducted no studies of its addictive potential. Win Gerson, who worked with Sackler at the agency, told the journalist Sam Quinones years later that the Valium campaign was a great success, in part because the drug was so effective. “It kind of made junkies of people, but that drug worked,” Gerson said. By 1973, American doctors were writing more than a hundred million tranquillizer prescriptions a year, and countless patients became hooked.

Sound familiar?

Purdue created OxyContin as a replacement for an existing drug it sold called MS Contin which delivered morphine using a "Continuous" release formulation. The MS Contin formulation was patented but the patent was expiring, jeopardizing the firm's cash flow. OxyContin was designed to use oxycodone rather than morphine. However, instead of just offering tablets with low 10mg doses, they also created HUGE doses of 80 and 160mg. (Uh oh...)

Purdue conducted no studies to confirm any tendencies of patients to become addicted to the new formulation, especially with the jumbo doses. The launch of the product benefited from two inexplicable quirks of fate. First, despite no clinical tests being performed regarding its addictive properties, the FDA at the time

approved a package insert for OxyContin which announced that the drug was safer than rival painkillers, because the patented delayed-absorption mechanism “is believed to reduce the abuse liability.” David Kessler, who ran the F.D.A. at the time, told me that he was “not involved in the approval.” The F.D.A. examiner who oversaw the process, Dr. Curtis Wright, left the agency shortly afterward. Within two years, he had taken a job at Purdue.

Purdue's marketing not only pushed the drug for a much wider set of uses beyond cancer but actively targeted physicians who were not experts in pain management and even the public itself.

A major thrust of the sales campaign was that OxyContin should be prescribed not merely for the kind of severe short-term pain associated with surgery or cancer but also for less acute, longer-lasting pain: arthritis, back pain, sports injuries, fibromyalgia. The number of conditions that OxyContin could treat seemed almost unlimited. According to internal documents, Purdue officials discovered that many doctors wrongly assumed that oxycodone was less potent than morphine—a misconception that the company exploited.

Problems with the drug became apparent across the country in 3-4 years. Purdue itself was aware of the problems from the start.

A recent exposé by the Los Angeles Times revealed that the first patients to use OxyContin, in a study conducted by Purdue, were ninety women recovering from surgery in Puerto Rico. Roughly half the women required more medication before the twelve-hour mark. The study was never published. For Purdue, the business reason for obscuring such results was clear: the claim of twelve-hour relief was an invaluable marketing tool. But prescribing a pill on a twelve-hour schedule when, for many patients, it works for only eight is a recipe for withdrawal, addiction, and abuse. Notwithstanding Purdue’s claims, many people who were not drug abusers—and who took OxyContin exactly as their doctors instructed—began experiencing withdrawal symptoms between doses. In March, 2001, a Purdue employee e-mailed a supervisor, describing some internal data on withdrawal and wondering whether or not to write up the results, even though doing so would only “add to the current negative press.” The supervisor responded, “I would not write it up at this point.”

The New Yorker story is quite lengthy and well worth reading. Perhaps the best point made in the story involves a final barrier to holding the family accountable for the damage done by its products and its conduct -- the fact the company has billions to give away to universities and charities.

“It’s amazing how they are left out of the debate about causation, but also about solutions,” Allen Frances, the Duke psychiatrist, said of the Sacklers. “A truly philanthropic family, looking at the last twenty years, would say, ‘You know, there’s several million Americans who are addicted, directly or indirectly, because of us.’ Real philanthropy would be to contribute money to taking care of them. At this point, adding their name to a building—it rings hollow. It’s not philanthropy. It’s just a glorification of the Sackler family.”

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The NPR story provides details on the arrest of John Kapoor for fraud and racketeering charges related to his firm's promotion of off-label uses of Subsys which delivers the highly potent drug fentanyl in spray form. From the article,

But according to prosecutors, Kapoor and several other former high-ranking executives at the company conspired to bribe doctors to write "large numbers of prescriptions for the patients, most of whom were not diagnosed with cancer." They also allegedly "conspired to mislead and defraud health insurance providers who were reluctant to approve payment for the drug when it was prescribed for non-cancer patients."

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There really is no mystery to the opioid crisis. This isn't an opioid crisis at all. It's an organized crime crisis, brought about by big businesses that knew the health risks to the public and decided to go for cash rather than public safety and systemically lied to regulators and corrupted professionals in the field with an efficiency the mob could never imagine, much less achieve.