The Family That Built an Empire of Pain | The New Yorker
►https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain
Histoire d’une famille de voyous aux 200 000 morts. De quoi penser autrement le monde de la pharmacie. Il faut stopper les big pharma et revenir à une véritable recherche médicale débarrassée de l’argent, de la publicité et de la complicité des organismes de régulation.
According to Forbes, the Sacklers are now one of America’s richest families, with a collective net worth of thirteen billion dollars—more than the Rockefellers or the Mellons. The bulk of the Sacklers’ fortune has been accumulated only in recent decades, yet the source of their wealth is to most people as obscure as that of the robber barons. While the Sacklers are interviewed regularly on the subject of their generosity, they almost never speak publicly about the family business, Purdue Pharma—a privately held company, based in Stamford, Connecticut, that developed the prescription painkiller OxyContin. Upon its release, in 1995, OxyContin was hailed as a medical breakthrough, a long-lasting narcotic that could help patients suffering from moderate to severe pain. The drug became a blockbuster, and has reportedly generated some thirty-five billion dollars in revenue for Purdue.
But OxyContin is a controversial drug. Its sole active ingredient is oxycodone, a chemical cousin of heroin which is up to twice as powerful as morphine. In the past, doctors had been reluctant to prescribe strong opioids—as synthetic drugs derived from opium are known—except for acute cancer pain and end-of-life palliative care, because of a long-standing, and well-founded, fear about the addictive properties of these drugs. “Few drugs are as dangerous as the opioids,” David Kessler, the former commissioner of the Food and Drug Administration, told me.
Purdue launched OxyContin with a marketing campaign that attempted to counter this attitude and change the prescribing habits of doctors. The company funded research and paid doctors to make the case that concerns about opioid addiction were overblown, and that OxyContin could safely treat an ever-wider range of maladies. Sales representatives marketed OxyContin as a product “to start with and to stay with.” Millions of patients found the drug to be a vital salve for excruciating pain. But many others grew so hooked on it that, between doses, they experienced debilitating withdrawal.
Since 1999, two hundred thousand Americans have died from overdoses related to OxyContin and other prescription opioids. Many addicts, finding prescription painkillers too expensive or too difficult to obtain, have turned to heroin. According to the American Society of Addiction Medicine, four out of five people who try heroin today started with prescription painkillers. The most recent figures from the Centers for Disease Control and Prevention suggest that a hundred and forty-five Americans now die every day from opioid overdoses.
He told me that, though many fatal overdoses have resulted from opioids other than OxyContin, the crisis was initially precipitated by a shift in the culture of prescribing—a shift carefully engineered by Purdue. “If you look at the prescribing trends for all the different opioids, it’s in 1996 that prescribing really takes off,” Kolodny said. “It’s not a coincidence. That was the year Purdue launched a multifaceted campaign that misinformed the medical community about the risks.” When I asked Kolodny how much of the blame Purdue bears for the current public-health crisis, he responded, “The lion’s share.”
Sackler saw doctors as unimpeachable stewards of public health. “I would rather place myself and my family at the judgment and mercy of a fellow-physician than that of the state,” he liked to say. So in selling new drugs he devised campaigns that appealed directly to clinicians, placing splashy ads in medical journals and distributing literature to doctors’ offices. Seeing that physicians were most heavily influenced by their own peers, he enlisted prominent ones to endorse his products, and cited scientific studies (which were often underwritten by the pharmaceutical companies themselves). John Kallir, who worked under Sackler for ten years at McAdams, recalled, “Sackler’s ads had a very serious, clinical look—a physician talking to a physician. But it was advertising.” In 1997, Arthur was posthumously inducted into the Medical Advertising Hall of Fame, and a citation praised his achievement in “bringing the full power of advertising and promotion to pharmaceutical marketing.” Allen Frances put it differently: “Most of the questionable practices that propelled the pharmaceutical industry into the scourge it is today can be attributed to Arthur Sackler.”
During the sixties, Arthur got rich marketing the tranquillizers Librium and Valium. One Librium ad depicted a young woman carrying an armload of books, and suggested that even the quotidian anxiety a college freshman feels upon leaving home might be best handled with tranquillizers. Such students “may be afflicted by a sense of lost identity,” the copy read, adding that university life presented “a whole new world . . . of anxiety.” 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. The Senate held hearings on what Edward Kennedy called “a nightmare of dependence and addiction.”
Richard Sackler worked tirelessly to make OxyContin a blockbuster, telling colleagues how devoted he was to the drug’s success. The F.D.A. approved OxyContin in 1995, for use in treating moderate to severe pain. Purdue had conducted no clinical studies on how addictive or prone to abuse the drug might be. But the F.D.A., in an unusual step, 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.
A 1995 memo sent to the launch team emphasized that the company did “not want to niche” OxyContin just for cancer pain. A primary objective in Purdue’s 2002 budget plan was to “broaden” the use of OxyContin for pain management. As May put it, “What Purdue did really well was target physicians, like general practitioners, who were not pain specialists.” In its internal literature, Purdue similarly spoke of reaching patients who were “opioid naïve.” Because OxyContin was so powerful and potentially addictive, David Kessler told me, from a public-health standpoint “the goal should have been to sell the least dose of the drug to the smallest number of patients.” But this approach was at odds with the competitive imperatives of a pharmaceutical company, he continued. So Purdue set out to do exactly the opposite.
Almost immediately after OxyContin’s release, there were signs that people were abusing it in rural areas like Maine and Appalachia. If you ground the pills up and snorted them, or dissolved them in liquid and injected them, you could override the time-release mechanism and deliver a huge narcotic payload all at once. Perversely, users could learn about such methods by reading a warning label that came with each prescription, which said, “Taking broken, chewed or crushed OxyContin tablets could lead to the rapid release and absorption of a potentially toxic dose.” As more and more doctors prescribed OxyContin for an ever-greater range of symptoms, some patients began selling their pills on the black market, where the street price was a dollar a milligram. Doctors who were easily manipulated by their patients—or corrupted by the money in play—set up so-called pill mills, pain clinics that thrived on a wholesale business of issuing OxyContin prescriptions.
The company did not pull the drug from shelves, however, or acknowledge that it was addictive. Instead, Purdue insisted that the only problem was that recreational drug users were not taking OxyContin as directed. “Their rap has always been that a bunch of junkies ruined their product,” Keith Humphreys, the Stanford professor, said. In 2001, Michael Friedman, Purdue’s executive vice-president, testified before a congressional hearing convened to look into the alarming increase in opioid abuse. The marketing of OxyContin had been “conservative by any standard,” he maintained. “Virtually all of these reports involve people who are abusing the medication, not patients with legitimate medical needs.”
Doctors who prescribed OxyContin were beginning to report that patients were coming to them with symptoms of withdrawal (itching, nausea, the shakes) and asking for more medication. Haddox had an answer. In a 1989 paper, he had coined the term “pseudo-addiction.” As a pain-management pamphlet distributed by Purdue explained, pseudo-addiction “seems similar to addiction, but is due to unrelieved pain.” The pamphlet continued, “Misunderstanding of this phenomenon may lead the clinician to inappropriately stigmatize the patient with the label ‘addict.’ ” Pseudo-addiction generally stopped once the pain was relieved—“often through an increase in opioid dose.”
But Purdue didn’t need the media’s help to know that something was seriously off with the distribution of OxyContin. For years, it had maintained a contract with I.M.S., a little-known company, co-founded by Arthur Sackler, that furnished its clients with fine-grained information about the prescribing habits of individual doctors. Purdue’s sales representatives used the data to figure out which doctors to target.
Such data could also be used to track patterns of abuse. “They know exactly what people are prescribing,” Kolodny said. “They know when a doctor is running a pill mill.” At the 2001 hearing, James Greenwood, a Pennsylvania congressman, asked Friedman whether Purdue would take any action if, say, I.M.S. data revealed that a rural osteopath was writing thousands of prescriptions.
Friedman replied that it was not up to Purdue to assess “how well a physician practices medicine.”
Greenwood then observed that, in a recent case involving a Pennsylvania doctor, Richard Paolino, who was wantonly overprescribing OxyContin, a local pharmacist had alerted the authorities. “He looked at this data and he said, ‘Holy God, there is some guy in Bensalem called Paolino, and he’s writing prescriptions out the wazoo,’ ” Greenwood said. “Now, he had that data and he blew the whistle. And you had that data. What did you do?”
Purdue had not alerted the authorities. Clinicians like Paolino were breaking the law—he was sentenced to a minimum of thirty years in prison. But overprescribing generated tremendous revenue for the company. According to four people I spoke with, at Purdue such prescribers were given a name that Las Vegas casinos reserve for their most prized gamblers: whales.
Given the sometimes fractious nature of the Sackler family, it was striking that they were united in their silence on the subject of OxyContin. These were urbane, expensively educated, presumably well-informed people. Could they conceivably be unaware of the accumulated evidence about the tainted origins of their fortune? Did they simply put it out of mind? “Greed can get people to rationalize pretty bad behavior,” Andrew Kolodny had told me. Someone who knows Mortimer, Jr., socially told me, “I think for him, most of the time, he’s just saying, ‘Wow, we’re really rich. It’s fucking cool. I don’t really want to think that much about the other side of things.’ ”
Purdue had long denied that the original OxyContin was especially prone to abuse. But, upon receiving its patents for the reformulated drug, the company filed papers with the F.D.A., asking the agency to refuse to accept generic versions of the original formulation—because they were unsafe. The F.D.A., ever obliging, agreed, blocking any low-cost generic competition for Purdue. For more than a year, Purdue continued to sell the original formulation of OxyContin in Canada. According to a recent study, OxyContin sales in Windsor, Ontario—just across the border from Detroit—suddenly quadrupled, a clear indication that the pills were being purchased for the U.S. black market. Through I.M.S. tracking data, Purdue would have been able to monitor the Canadian surge, and to deduce the reason for it. (The company acknowledges that it was aware of the spike in sales, and maintains that it alerted authorities, but will not say when it did so.)
By the time Purdue reformulated OxyContin, the country was in the middle of a full-blown epidemic. Andrew Kolodny, the addiction specialist, told me that many older people remain addicted to the reformulated OxyContin, and continue to obtain the drug through prescriptions. These people purchase the drug legally, and swallow the pills whole, as instructed. “That’s Purdue’s market now,” Kolodny said. Younger people, who can less readily secure prescriptions for pain—and for whom OxyContin may be too expensive—have increasingly turned to black-market substitutes, including heroin.
Purdue and other pharmaceutical companies have long funded ostensibly neutral nonprofit groups that advocate for pain patients. The C.D.C. guidelines were nonbinding, yet many of these organizations fought to prevent the agency from releasing them. This kind of obstruction is typical at both the state and the federal level. A recent series by the Associated Press and the Center for Public Integrity revealed that, after Purdue made its guilty plea, in 2007, it assembled an army of lobbyists to fight any legislative actions that might encroach on its business. Between 2006 and 2015, Purdue and other painkiller producers, along with their associated nonprofits, spent nearly nine hundred million dollars on lobbying and political contributions—eight times what the gun lobby spent during that period.
The Times report described Joseph Pergolizzi, Jr.—a Florida doctor who runs a pain-management clinic and hawks a pain-relieving cream of his own invention on cable TV—giving paid talks in places like Brazil about the merits of OxyContin. In Mexico, Mundipharma has asserted that twenty-eight million people—a quarter of the population—suffer from chronic pain. In China, the company has distributed cartoon videos about using opioids for pain relief; other promotional literature cites the erroneous claim that rates of addiction are negligible. In a 2014 interview, Raman Singh, a Mundipharma executive, said, “Every single patient that is in emerging markets should have access to our medicines.” The term “opiophobia” has largely fallen into disuse in America, for obvious reasons. Mundipharma executives still use it abroad.
#Opioids #Big_pharma #Capitalisme_sauvage #Addiction
