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The Story of OxyContin, the « HillBilly Heroin »

Nov 6, 2017 by

 

18 October 2017 http://www.esquire.com/news- politics/a12775932/sackler- family-oxycontin/

By any assessment, the family’s leaders have pulled off three of the great marketing triumphs of the modern era: The first is selling OxyContin; the second is promoting the Sackler name; and the third is ensuring that, as far as the public is aware, the first and the second have nothing to do with one another.

After attending medical school on Arthur’s dime, Mortimer and Raymond followed him to jobs at the Creedmoor psychiatric hospital in Queens. There, they coauthored more than one hundred studies on the biochemical roots of mental illness. The brothers’ research was promising—they were among the first to identify a link between psychosis and the hormone cortisone—but their findings were mostly ignored by their professional peers, who, in keeping with the era, favored a Freudian model of mental illness.

In the 1960s, Arthur was contracted by Roche to develop an advertising strategy for a new antianxiety medication called Valium …

The campaign was such a success that for a time Valium became America’s most widely prescribed medication—the first to reach more than $100 million in sales. Arthur, whose compensation depended on the volume of pills sold, was richly rewarded, and he later became one of the first inductees into the Medical Advertising Hall of Fame.

Purdue did not merely neglect to clear up confusion about the strength of OxyContin. As the company later admitted, it misleadingly promoted OxyContin as less addictive than older opioids on the market. In this deception, Purdue had a big assist from the FDA, which allowed the company to include an astonishing labeling claim in OxyContin’s package insert: “Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug.”

The theory was that addicts would shy away from timed-released drugs, preferring an immediate rush. In practice, OxyContin, which crammed a huge amount of pure narcotic into a single pill, became a lusted-after target for addicts, who quickly discovered that the timed-release mechanism in OxyContin was easy to circumvent—you could simply crush a pill and snort it to get most of the narcotic payload in a single inhalation. This wasn’t exactly news to the manufacturer: OxyContin’s own packaging warned that consuming broken pills would thwart the timed-release system and subject patients to a potentially fatal overdose. MS Contin had contended with similar vulnerabilities, and as a result commanded a hefty premium on the street. But the “reduced abuse liability” claim that added wings to the sales of OxyContin had not been approved for MS Contin. It was removed from OxyContin in 2001 and would never be approved again for any otheropioid.

By 2001, annual OxyContin sales had surged past $1 billion. Sales reps were encouraged to downplay addiction risks. “It was sell, sell, sell,” recalled Sherman. “We were directed to lie. Why mince words about it? Greed took hold and overruled everything. They saw that potential for billions of dollars and just went after it.” Flush with cash, Purdue pioneered a high-cost promotion strategy, effectively providing kickbacks—which were legal under American law—to each part of the distribution chain. Wholesalers got rebates in exchange for keeping OxyContin off prior authorization lists. Pharmacists got refunds on their initial orders. Patients got coupons for thirty- day starter supplies. Academics got grants. Medical journals got millions in advertising. Senators and members of Congress on key committees got donations from Purdue and from members of the Sackler family.

Purdue’s greatest competitive advantage in dominating the pain market, it had determined early on, was that OxyContin lasted twelve hours, enough to sleep through the night. But for many patients, the drug lasted only six or eight hours, creating a cycle of crash and euphoria that one academic called “a perfect recipe for addiction.” When confronted with complaints about “breakthrough pain”—meaning that the pills weren’t working as long as advertised—Purdue’s sales reps were given strict instructions to tell doctors to strengthen the dose rather than increase dosing frequency.

When the federal government finally stepped in, in 2007, it extracted historic terms of surrender from the company. Purdue pleaded guilty to felony charges, admitting that it had lied to doctors about OxyContin’s abuse potential. (The technical charge was “misbranding a drug with intent to defraud or mislead.”) Under the agreement, the company paid $600 million in fines and its three top executives at the time—its medical director, general counsel, and Richard’s successor as president—pleaded guilty to misdemeanor charges. The executives paid $34.5 million out of their own pockets and performed four hundred hours of community service. It was one of the harshest penalties ever imposed on a pharmaceutical company.

In 2010, Purdue executed a breathtaking pivot: Embracing the arguments critics had been making for years about OxyContin’s susceptibility to abuse, the company released a new formulation of the medication that was harder to snort or inject. Purdue seized the occasion to rebrand itself as an industry leader in abuse-deterrent technology. The change of heart coincided with two developments: First, an increasing number of addicts, unable to afford OxyContin’s high street price, were turning to cheaper alternatives like heroin; second, OxyContin was nearing the end of its patents. Purdue suddenly argued that the drug it had been selling for nearly fifteen years was so prone to abuse that generic manufacturers should not be allowed to copy it.

On April 16, 2013, the day some of the key patents for OxyContin were scheduled to expire, the FDA followed Purdue’s lead, declaring that no generic versions of the original OxyContin formulation could be sold. The company had effectively won several additional years of patent protection for its golden goose.

The controversy surrounding OxyContin shows little sign of receding. In 2016, the CDC issued a startling warning: There was no good evidence that opioids were an effective treatment for chronic pain beyond six weeks. There was, on the other hand, an abundance of evidence that long-term treatment with opioids had harmful effects. (A recent paper by Princeton economist Alan Krueger suggests that chronic opioid use may account for more than 20 percent of the decline in American labor-force participation from 1999 to 2015.) Millions of opioid prescriptions for chronic pain had been written in the preceding two decades, and the CDC was calling into question whether many of them should have been written at all. At least twenty-five government entities, ranging from states to small cities, have recently filed lawsuits against Purdue to recover damages associated with the opioid epidemic.

The Sacklers, though, will likely emerge untouched: Because of a sweeping non-prosecution agreement negotiated during the 2007 settlement, most new criminal litigation against Purdue can only address activity that occurred after that date. Neither Richard nor any other family members have occupied an executive position at the company since 2003.

In May, a dozen lawmakers in Congress, inspired by the L.A. Times investigation, sent a bipartisan letter to the World Health Organization warning that Sackler-owned companies were preparing to flood foreign countries with legal narcotics. “Purdue began the opioid crisis that has devastated American communities,” the letter reads. “Today, Mundipharma is using many of the same deceptive and reckless practices to sell OxyContin abroad.” Significantly, the letter calls out the Sackler family by name, leaving no room for the public to wonder about the identities of the people who stood behind Mundipharma

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