• Etats-Unis : l’accord à 26 milliards sur les opiacés prêt pour la prochaine étape

    Trois distributeurs américains de médicaments et le laboratoire Johnson & Johnson ont reçu le soutien d’assez d’Etats pour passer à la prochaine étape de l’accord lié aux opiacés. Ils ont accepté en juillet de payer 26 milliards de dollars pour solder des litiges.

    Ce règlement à l’amiable doit leur permettre d’éviter des milliers d’actions en justice intentées par des Etats américains et collectivités locales qui accusent les entreprises d’avoir un rôle dans cette crise sanitaire, à l’origine de plus de 500 000 morts par overdose en 20 ans aux Etats-Unis.

    #AmerisourceBergen, #Cardinal_Health et #McKesson ont, dans un communiqué commun, expliqué avoir reçu le feu vert de 42 des 49 Etats qui les poursuivaient, ainsi que du district de Washington, la capitale, et de cinq territoires américains.

    Le laboratoire pharmaceutique Johnson & Johnson a indiqué dans un message séparé être aussi prêt à passer à la prochaine étape prévue dans l’accord. « Ce règlement ne constitue pas une admission de responsabilité ou d’acte répréhensible et l’entreprise continuera de se défendre contre tout litige que l’accord final ne résout pas », a souligné la société.

    Aux collectivités locales de se prononcer
    Johnson & Johnson, qui fait partie des laboratoires accusés d’avoir alimenté la crise en produisant des opiacés, a confirmé en juin avoir arrêté la production et la vente de ces substances. Les distributeurs de médicaments sont, eux, accusés d’avoir fermé les yeux sur des commandes d’opiacés suspectes.

    Selon les termes négociés, le versement des 26 milliards de dollars (23,7 milliards de francs) - qui doivent permettre aux Etats et collectivités de financer les traitements rendus nécessaires par ce fléau - dépend du nombre d’Etats américains qui valideront l’accord.

    Chaque Etat participant a maintenant jusqu’au 2 janvier pour demander à leurs collectivités locales respectives si elles veulent aussi être parties prenantes à l’accord. Si les conditions sont remplies, l’accord entrera en vigueur « 60 jours après que les distributeurs auront déterminé qu’il y a une participation suffisante pour procéder », détaille le communiqué.

    S’il se confirme, l’accord sera le plus important de l’épique et complexe bataille juridique engagée par les Etats et collectivités américaines pour faire payer les entreprises.

    #Johnson_&_Johnson #opioides #sackler #big_pharma #purdue_pharma #oxycontin #procès #addiction #opioïdes #santé #pharma #purdue #opiacés #etats-unis #drogue #opioids #mundipharma #marketing #McKinsey

  • Sacklers Face Furious Questions in Rare Testimony on Opioid Epidemic - The New York Times

    Les salauds ont un visage. Mais leur bouche ne sert qu’à évacuer du vent.

    By Jan Hoffman

    Dec. 17, 2020

    Members of Congress on Thursday hurled withering comments and furious questions at two members of the billionaire Sackler family that owns Purdue Pharma, the maker of OxyContin, seeking to use a rare public appearance to extract admissions of personal responsibility for the deadly opioid epidemic as well as details about $10 billion that records show the family withdrew from the company.

    The hearing, before the House Oversight Committee, offered a highly unusual opportunity for the public to hear directly from some members of the family, whose company is a defendant in thousands of federal and state lawsuits for misleading marketing of OxyContin, the painkiller seen as initiating a wave of opioid addiction that has led to the deaths of more than 450,000 Americans. Eight members of the family have been individually named in many state cases.

    The singularity of the Sacklers’ appearance on Thursday was underscored by the likelihood that they may never testify in open court, because the ongoing bankruptcy proceedings and nationwide litigation may resolve in settlements rather than trials. Despite millions of dollars in legal expenses racked up by plaintiffs and Purdue alike — and the company’s subsequent filing for Chapter 11 bankruptcy protection in September 2019 — one obstacle to resolution persists: the refusal of the Sacklers to be held personally or criminally responsible and to turn over substantial portions of their fortune.

    During the tense, nearly four-hour hearing, David Sackler, 40, and his cousin, Dr. Kathe Sackler, 72, who both served on the company’s board for years, testified remotely and largely sidestepped would-be booby traps and deflected blame to “management” and independent, nonfamily board members.

    Or, as Mr. Sackler said, “That’s a question for the lawyers.”

    In the absence of direct admissions of responsibility by the Sacklers — or by Dr. Craig Landau, Purdue’s chief executive since 2017, who also testified — committee members used their questions to highlight the most egregious actions over the years by the company and by Mr. Sackler’s father, Dr. Richard Sackler, a hands-on executive during the cresting period of the epidemic.
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    In particular, they explored the actions that followed a 2007 federal fine of nearly $635 million that the company and three executives paid after pleading guilty to federal criminal charges of “misbranding.” The settlement included no admission of liability by any of the Sacklers.

    The committee chairwoman, Representative Carolyn B. Maloney, Democrat of New York, asked Mr. Sackler whether in 2008, after the company’s federal settlement, the family was concerned about state investigations. Mr. Sackler denied knowing that investigations had been mounting.

    But then Ms. Maloney read from an email exchange between Mr. Sackler and other relatives in 2007, just a week after that settlement. Referring to courtroom activity, he wrote: “We’re rich? For how long? Until which suits get through to the family?”

    Last month, Purdue pleaded guilty to three felonies involving kickbacks and fraud related to promotion of its opioid and failure to report aberrant sales. The Justice Department settled with the company for $8.3 billion in criminal and civil penalties, and family members for $225 million in civil penalties. The Sacklers did not admit any wrongdoing. The amount they paid represents about 2 percent of the family’s net worth.

    Maura Healey, the attorney general for Massachusetts, the first state to name individual Sacklers in litigation, said that the Sacklers want “special treatment.” In a letter to the House committee she wrote: “If we let powerful people cover up the facts, avoid accountability, or create a government-sponsored OxyContin business — that’s not justice. This time, we have to get it right.”

    #Opioides #Sackler #Purdue_Pharma

  • The company that makes OxyContin could become a ’public trust’ – what would that mean?

    Purdue Pharma, which makes OxyContin and other potentially addictive prescription opioids, has declared bankruptcy. It’s also facing thousands of lawsuits for its leading role in creating the opioid crisis.

    The company is trying to reach a broad settlement with the many jurisdictions now suing. The settlement it’s proposing would transform the company from a profit-seeking privately held company into a “public beneficiary trust” that serves the public good.

    I study the history of prescription drugs. Although there are some recent efforts to establish nonprofit drugmakers to help make certain pharmaceuticals more readily available, I know of no historical precedent for a big drugmaker like Purdue becoming a nonprofit public health provider.

    But two similarly ambitious efforts to build alternatives to the profit-driven pharmaceutical model during and immediately after World War II suggest the potential limits of how well this arrangement might work.

    By all accounts, the new trust would be a for-profit entity. Indeed, profits from continued sales of pain medicines like OxyContin and addiction treatment medications like buprenorphine and naloxone – estimated by Purdue to be up to US$8 billion per year – are crucial as the “payment” Purdue is offering to compensate the public for the company’s share of the costs of the opioid crisis.

    In other words, to achieve its mission, the new Purdue would have to pursue profits just like the old Purdue. And since all pharmaceutical companies officially declare themselves to be dedicated to serving the public good, how different would it really be?

    Then, too, the new trust would still be Purdue Pharma, a company with a well-entrenched culture of maximizing sales and profits even as the opioid crisis grew. One could make a credible case that Purdue’s innovations – the “value” it brought to the table – were not related to any special therapeutic breakthrough in the drugs it developed but instead lay in its genius with marketing these products.

    I can see why it is tempting to be excited about the prospect of a new public-benefit trust devoted to addressing addiction.

    But for this proposed arrangement to make sense, Purdue would need the tools and expertise required to pursue a radically different mission than it was designed to serve. And history does not offer much assurance that isolated public-sector and nonprofit drugmakers can make a big difference in a pharmaceutical system designed for and powered by profit.

    #Purdue_pharma #Sackler #Opioides

  • La pilule de l’obéissance

    À l’origine, le remède ne devait concerner que les #enfants « hyperactifs », une pathologie relativement rare. Mais depuis quelques années, aux États-Unis, tout bambin quelque peu turbulent peut se voir prescrire de la #Ritaline, un #médicament voisin des amphétamines qui fait également fureur sur les campus. Après avoir inondé le marché américain, la pilule miracle se répand en France.

    #santé #enfance #hyperactivité

    • Déjà en cours il y a une dizaine d’années. Je ne connais pas l’ampleur du problème, mais j’avais rencontré une mère abandonnée — je trouve ça mieux que « mère célibataire » qui peut laisser penser que sa situation était un choix — épuisée qui n’arrivait pas à contrôler l’énergie de son petit dernier (essentiellement par manque d’aide et de ressources). Elle était soulagée par la mise sous Ritaline de son gosse. C’était effrayant de voir ce gosse domestiqué façon robot, mais je ne pouvais absolument rien dire à ce sujet à cette mère qui était déjà dans une grande souffrance.

    • #shit_storm en vue

      Le petit dernier, l’Adhansia, sort des usines de Purdue Pharma , le laboratoire de l’OxyContin, considéré comme le principal responsable de la crise des #opioïdes (400 000 morts en vingt ans) (11). « Je viens d’un programme où on essaie de baisser les doses, de favoriser les thérapies comportementales, d’arrêter les médicaments, poursuit Mme O’Rourke. Mon but, c’est qu’ils soient capables d’être des enfants, de jouer et d’apprendre. Je n’ai jamais vu d’effets négatifs à long terme, excepté une croissance perturbée. Le plus grand problème, ce serait l’addiction, surtout pour les adolescents, ainsi que la revente. » Pour elle, ça ne fait pas de doute, « la télévision est responsable en grande partie du TDAH. C’est la première baby-sitter du pays ». Dans sa salle d’attente, encore un garçon. Jayden, 12 ans, « ne tient pas en place ». Diagnostiqué hyperactif, il est sous psychotropes depuis quatre ans. Sa mère, Tasha, commente : « Quand il ne les prend pas, il est insupportable. » L’école ? « Je pense que c’est ennuyeux, répond Jayden. Lire est ennuyeux. Rester assis toute la journée est ennuyeux. Je préfère jouer au base-ball avec mon père, ou à Fortnite, World of Warcraft ou NBA 2K [des jeux vidéo] avec mes copains. »

    • On ne parle que des garçons par rapport à ces produits. C’est peut être une solution que les femmes (mères, personnel enseignant et personnel medical qui sont largment fémininisés) ont trouvé pour rendre un peu moins insupportables les comportements masculins.

      « Je préfère jouer au base-ball avec mon père, ou à Fortnite, World of Warcraft ou NBA 2K [des jeux vidéo] avec mes copains. »
      Il me semble qu’il y a une histoire de domination masculine dans tout ceci, les filles sont « rithalinés » sans chimie par la culture du viol.

    • Quand même @monolecte il y a aussi des femmes qui foutent le père dehors, souvent avec raison d’ailleurs ! et même si il est très content de retrouver sa « liberté » et qu’il ne paye pas la pension, j’estime que cela n’en fait pas une « femme abandonnée » pis on dirait qu’on parle d’un chien. Non plus qu’une femme célibataire, d’ailleurs. #famille_monoparentale c’est pas mal parce que oui, même seule avec un enfant c’est une famille, n’en déplaise à certaines pourritures de psys. Alors disons #mère_monoparentale ?

    • @mad_meg

      les filles sont « rithalinés » sans chimie par la culture du viol

      Affreusement d’accord avec toi :/


      It is estimated that half to three‐quarters of all women with attention‐deficit/hyperactivity disorder (ADHD) are undiagnosed. Boys are more likely to be given an ADHD diagnosis (13.2%) than girls (5.6%). Girls are also diagnosed, on average, 5 years later than boys (boys at age 7, girls at age 12) (Foley, 2018).

  • Inside Purdue Pharma’s Media Playbook : How It Planted the Opioid “Anti-Story” — ProPublica

    In 2004, Purdue Pharma was facing a threat to sales of its blockbuster opioid painkiller OxyContin, which were approaching $2 billion a year. With abuse of the drug on the rise, prosecutors were bringing criminal charges against some doctors for prescribing massive amounts of OxyContin.

    That October, an essay ran across the top of The New York Times’ health section under the headline “Doctors Behind Bars: Treating Pain is Now Risky Business.” Its author, Sally Satel, a psychiatrist, argued that law enforcement was overzealous, and that some patients needed large doses of opioids to relieve pain. She described an unnamed colleague who had run a pain service at a university medical center and had a patient who could only get out of bed by taking “staggering” levels of oxycodone, the active ingredient in OxyContin. She also cited a study published in a medical journal showing that OxyContin is rarely the only drug found in autopsies of oxycodone-related deaths.

    “When you scratch the surface of someone who is addicted to painkillers, you usually find a seasoned drug abuser with a previous habit involving pills, alcohol, heroin or cocaine,” Satel wrote. “Contrary to media portrayals, the typical OxyContin addict does not start out as a pain patient who fell unwittingly into a drug habit.”

    The Times identified Satel as “a resident scholar at the American Enterprise Institute and an unpaid advisory board member for the Substance Abuse and Mental Health Services Administration.” But readers weren’t told about her involvement, and the American Enterprise Institute’s, with Purdue.

    Among the connections revealed by emails and documents obtained by ProPublica: Purdue donated $50,000 annually to the institute, which is commonly known as AEI, from 2003 through this year, plus contributions for special events, for a total of more than $800,000. The unnamed doctor in Satel’s article was an employee of Purdue, according to an unpublished draft of the story. The study Satel cited was funded by Purdue and written by Purdue employees and consultants. And, a month before the piece was published, Satel sent a draft to Burt Rosen, Purdue’s Washington lobbyist and vice president of federal policy and legislative affairs, asking him if it “seems imbalanced.”

    Purdue’s tactics are reminiscent of the oil and gas industry, which has been accused of promoting misleading science that downplays its impact on climate change, and of big tobacco, which sought to undermine evidence that nicotine is addictive and secondhand smoke is dangerous.

    Media spinning was just one prong of Purdue’s strategy to fend off limits on opioid prescribing. It contested hundreds of lawsuits, winning dismissals or settling the cases with a provision that documents remain secret. The company paid leading doctors in the pain field to assure patients that OxyContin was safe. It also funded groups, like the American Pain Foundation, that described themselves as advocates for pain patients. Several of those groups minimized the risk of addiction and fought against efforts to curb opioid use for chronic pain patients.

    She has become an influential voice on opioids, addiction and pain treatment. Her writings have been published in The Wall Street Journal, USA Today, The Atlantic, Slate, Health Affairs, Forbes, Politico and elsewhere. She frequently appears on panels, television shows and in newspaper articles as an expert on the opioid crisis and pain prescribing guidelines. “We’ve entered a new era of opiophobia,” she recently told The Washington Post.

    Satel has been a resident scholar at the American Enterprise Institute since 2000. Among the notable figures who have spent time at AEI are the late Supreme Court Justice Antonin Scalia and former Trump national security adviser John Bolton. Current fellow Scott Gottlieb returned to AEI this year after serving as commissioner of the U.S. Food and Drug Administration, which approves and regulates prescription drugs like OxyContin.

    Purdue said its annual payments of $50,000 to AEI were part of the institute’s corporate program. That program offers corporations the opportunity to “gain access to the leading scholars in the most important policy areas for executive briefings and knowledge sharing,” according to the institute’s website.

    Purdue’s counterattack against an ambitious investigative series about OxyContin abuse may have contributed to that drop. An October 2003 series in the Orlando Sentinel, “OxyContin Under Fire,” found that Purdue’s aggressive marketing combined with weak regulation had contributed to “a wave of death and destruction.”

    The series, however, was marred by several errors that were detailed in a front-page correction nearly four months later. The reporter resigned, and two editors on the series were reassigned. While acknowledging the mistakes, the newspaper did not retract the series, and its review upheld the conclusion that oxycodone was involved in a large number of the overdoses in Florida.

    Dezenhall Resources, in an email, took credit for forcing the newspaper to issue the corrections. “Dezenhall’s efforts resulted in a complete front-page retraction of the erroneous 5-day, 19-part, front-page Orlando Sentinel series,” Hershow wrote in a 2006 email summarizing Dezenhall’s work for Purdue under the subject line “Success in Fighting Negative Coverage.”

    Purdue officials and the company’s public relations agencies came up with a 13-point plan to generate media coverage of the errors. It included getting a doctor to talk about how the series “frightened and mislead (sic) the people of Florida” and having a pain patient write a newspaper opinion column on the subject. The Sentinel series, one Purdue official wrote to other company executives and Dezenhall’s Hershow, was an opportunity to let the country know about “all of the sensational reporting on OxyContin abuse over the past 4 years. The conclusion: this is the most overblown health story in the last decade!”

    In the six years after Purdue challenged the Sentinel’s findings, the death rate from prescription drugs increased 84.2% in Florida. The biggest rise, 264.6%, came from deaths involving oxycodone. The state became a hotbed for inappropriate opioid prescribing as unscrupulous pain clinics attracted out of state drug seekers. The route traveled by many from small towns in Appalachia to the Florida clinics was nicknamed the “Oxycontin Express.”

    In 2017, 14 years after the Sentinel series was published, the Columbia Journalism Review described it as “right too soon” and said it “eerily prefigured today’s opioid epidemic.”

    Purdue also added Stu Loeser to its stable. The head of an eponymous media strategy company, Loeser was press secretary for Michael Bloomberg when he was mayor of New York City, and he is now a spokesman for Bloomberg’s possible presidential bid.

    Soon after Loeser began representing Purdue, Satel wrote in a 2018 piece for Politico headlined, “The Myth of What’s Driving the Opioid Crisis,” about “a false narrative” that the opioid epidemic “is driven by patients becoming addicted to doctor-prescribed opioids.”

    Loeser told Purdue executives in an email that “we are going to work with AEI to ‘promote’ this so it comes across as what it is: their thoughtful response to other writing.” His team was working to target the Satel story “to land in social media feeds of people who have searched for opioid issues and potentially even people who have read specific stories online,” he added.

    Loeser said in an interview that he didn’t end up working with AEI to promote the story. He said Purdue is no longer a client.

    Une belle bande d’ordures accoquinée avec une brochette de journaux peu regardants (quoique parmi les meilleurs du monde, ce qui est encore plus inquiétant).

    #Opioides #Sackler #Purdue_Pharma #Médias #Fake_news #Conflits_intérêt #Complicités #New_York_Times #Public_relation

  • AP key findings about Mundipharma’s OxyContin sales in China

    This Sept. 24, 2019 photo shows 40-milligram Oxycontin tablets sold in China in Hunan province. China fought two wars in the 19th century to beat back British ships dumping opium that fueled widespread addiction. Today, the cultural aversion to taking drugs, in Chinese, literally “sucking poison”, is so strong addicts can be forced into police-run treatment centers. (AP Photo/Mark Schiefelbein)

    SHANGHAI (AP) — The Sackler family’s opioid empire in the United States is collapsing under an avalanche of litigation over marketing tactics. Their Purdue Pharma company is in bankruptcy, but the family continues to profit from sales of their signature painkiller OxyContin abroad. Sales reps at their international affiliate, Mundipharma, have been chasing profits in China using many of the same tactics that Purdue was forced to abandon in the U.S. as the death toll from opioid overdoses soared, interviews and documents obtained by the AP show.

    Here are key findings from those documents and interviews.

    — Purdue and its executives paid a historic $635 million in legal penalties in the U.S. for misrepresenting OxyContin as less addictive than other opioids and pledged never to do it again. That didn’t stop Mundipharma sales reps from making the same pitch to doctors in China more than a decade later.

    — Mundipharma managers required sales reps to copy patients’ private medical records without consent to better target sales, in apparent violation of Chinese law.

    — Faced with fast-rising sales targets, OxyContin reps in China sometimes disguised themselves as medical staff, putting on white coats and lying about their identity to visit patients in the hospital.
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    — Mundipharma aggressively pushed high doses of opioids in China, despite warnings that higher doses carry higher risks of overdose and death. The year after the U.S. Centers for Disease Control said that taking even 33mg of OxyContin a day at least doubles the risk of overdose, Mundipharma ran a campaign to promote sales of 40mg pills in China.

    #Sackler #OxyContin #Marché_mondial #Purdue_Pharma #Mundipharma

  • En ciblant Purdue Pharma, « l’appareil judiciaire américain s’attaque au capitalisme débridé »

    Aujourd’hui, face à une crise qui à elle seule a réussi à faire chuter l’espérance de vie aux Etats-Unis, la quasi-totalité des Etats du pays a lancé des poursuites pour réclamer des dédommagements au nom du million de familles touchées par ce fléau. Au total, 2 600 plaintes ont été enregistrées. Pour tenter d’éteindre l’incendie, la société a demandé, dimanche 15 septembre, à être placée sous la protection du chapitre 11 de la loi sur les faillites. Et elle propose une résolution globale spectaculaire : la nationalisation de Purdue.
    Nationalisation des pertes

    Il s’agirait de confier la gestion de l’entreprise et l’ensemble de ses gains futurs à un trust représentant les Etats, l’ensemble des bénéfices leur étant reversés pour financer l’aide aux victimes et la recherche sur la lutte contre l’addiction. La transaction est évaluée à dix milliards de dollars et la famille Sackler a promis d’y ajouter trois milliards. Vingt-neuf Etats et territoires ont accepté la transaction, mais 26 autres s’y opposent formellement, dont celui de New York.

    Ils ne sont pas du tout d’accord avec cette nouvelle version de la privatisation des gains et de la nationalisation des pertes. Car, durant toutes ces années, la famille Sackler a vu sa fortune exploser, pour représenter, selon Forbes, près de 13 milliards de dollars. Elle doit rendre gorge, exigent les procureurs généraux, sortes de ministre de la justice des Etats. D’autant que l’enquête de celui de New York affirme que près d’un milliard de dollars aurait été discrètement envoyé en Suisse pour échapper au fisc.

    #Purdue_Pharma #Opioides #Capitalisme_sauvage #Sackler

  • A Nun, a Doctor and a Lawyer — and Deep Regret Over the Nation’s Handling of Opioids - The New York Times

    PENNINGTON GAP, Va. — Years before there was an opioid epidemic in America, Sister Beth Davies knew it was coming.

    In the late 1990s, patient after patient addicted to a new prescription painkiller called OxyContin began walking into the substance abuse clinic she ran in this worn Appalachian town. A local physician, Dr. Art Van Zee, sensed the gathering storm, too, as teenagers overdosed on the drug. His wife, Sue Ella Kobak, a lawyer, saw the danger signs in a growing wave of robberies and other crimes that all had links to OxyContin.

    The Catholic nun, the doctor and the lawyer were among the first in the country to sound an alarm about the misuse of prescription opioids, the beginnings of a cycle of addiction that would kill 400,000 people in the ensuing two decades as it spread to illegal opioids like heroin and counterfeit versions of fentanyl. They led a burst of local activism against Purdue Pharma, OxyContin’s maker, that the company ultimately crushed. It would eventually help kindle national awareness that led to a wave of legal actions that are still awaiting resolution.

    The three also believe that the Justice Department could have changed the behavior of other opioid makers if it had charged executives of Purdue Pharma in 2007 with felonies, as federal prosecutors had recommended, in connection with OxyContin’s illegal marketing.

    Instead, department officials negotiated a deal under which the executives pleaded guilty to misdemeanor charges that did not include jail time. In the years that followed, executives of other opioid makers and distributors kept shipping millions of addictive pain pills into towns like this one apparently without fear of serious penalties.

    “I think the trajectory would have been completely different,” Dr. Van Zee said recently. “It would not have reached the magnitude that it did.”

    A local pharmacist, Greg Stewart, said a sales representative for Purdue Pharma had told him that OxyContin was safe because it was a long-acting narcotic and so would not appeal to drug abusers who liked Percocet and other short-acting pain pills because they delivered a quick high. But teenagers and others in town quickly discovered that crushing an OxyContin pill released large quantities of the narcotic oxycodone.

    Sister Beth recalls getting a phone call from Mr. Stewart as she was starting to see people addicted to the drug.

    “Beth, believe me,” she recalled him saying, “this is going to be the worst disaster that ever hit Lee County.”

    Sister Beth, Dr. Van Zee and Ms. Kobak, who is now retired, have been reading with fascination the new documents about Purdue Pharma and its owners, members of the wealthy Sackler family, that have recently emerged in lawsuits and elsewhere. As it turns out, it was in 2001, the year they and others in town confronted Purdue Pharma executives about the overzealous marketing of OxyContin, that a son of one of company’s founders, Dr. Richard Sackler, wrote a now infamous email about the need “to hammer on the abusers in every way possible” for the drug’s problem.

    “You lie so much you believe your own lies,” Sister Beth said. “That’s what devastates me; it was always profits over people.”

    Both Purdue Pharma and a representative for Dr. Sackler insist that the email and others cited in recent lawsuits have been taken out of context.

    The lawyers assured him, he said, that they wanted exactly what he did: to finally see all of Purdue Pharma’s internal documents brought to public light.

    “I was impressed by what looked like their commitment to get some type of accountability and responsibility,” he said.

    But that never happened. In March, Purdue Pharma agreed to pay $270 million to settle. As a result, all its internal documents remain sealed. Oklahoma state officials said they struck the deal because of concerns that Purdue Pharma, which faces thousands of lawsuits, might soon file for bankruptcy.

    #Opioides #Purdue_Pharma

  • The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy

    Un article scientifique de 2009 sur le marketing d’Oxycontin.

    OxyContin’s commercial success did not depend on the merits of the drug compared with other available opioid preparations. The Medical Letter on Drugs and Therapeutics concluded in 2001 that oxycodone offered no advantage over appropriate doses of other potent opioids.3 Randomized double-blind studies comparing OxyContin given every 12 hours with immediate-release oxycodone given 4 times daily showed comparable efficacy and safety for use with chronic back pain4 and cancer-related pain.5,6 Randomized double-blind studies that compared OxyContin with controlled-release morphine for cancer-related pain also found comparable efficacy and safety.7–9 The FDA’s medical review officer, in evaluating the efficacy of OxyContin in Purdue’s 1995 new drug

    application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing.10 In a review of the medical literature, Chou et al. made similar conclusions.11

    The promotion and marketing of OxyContin occurred during a recent trend in the liberalization of the use of opioids in the treatment of pain, particularly for chronic non–cancer-related pain. Purdue pursued an “aggressive” campaign to promote the use of opioids in general and OxyContin in particular.1,12–17 In 2001 alone, the company spent $200 million18 in an array of approaches to market and promote OxyContin.❞

    From 1996 to 2001, Purdue conducted more than 40 national pain-management and speaker-training conferences at resorts in Florida, Arizona, and California. More than 5000 physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue’s national speaker bureau.19(p22)

    In much of its promotional campaign—in literature and audiotapes for physicians, brochures and videotapes for patients, and its “Partners Against Pain” Web site—Purdue claimed that the risk of addiction from OxyContin was extremely small.43–49

    Purdue trained its sales representatives to carry the message that the risk of addiction was “less than one percent.”50(p99)

    In 1998, Purdue distributed 15 000 copies of an OxyContin video to physicians without submitting it to the FDA for review, an oversight later acknowledged by Purdue. In 2001, Purdue submitted to the FDA a second version of the video, which the FDA did not review until October 2002—after the General Accounting Office inquired about its content. After its review, the FDA concluded that the video minimized the risks from OxyContin and made unsubstantiated claims regarding its benefits to patients.19

    When OxyContin entered the market in 1996, the FDA approved its original label, which stated that iatrogenic addiction was “very rare” if opioids were legitimately used in the management of pain. In July 2001, to reflect the available scientific evidence, the label was modified to state that data were not available for establishing the true incidence of addiction in chronic-pain patients. The 2001 labeling also deleted the original statement that the delayed absorption of OxyContin was believed to reduce the abuse liability of the drug.19 A more thorough review of the available scientific evidence prior to the original labeling might have prevented some of the need for the 2001 label revision.

    #Opioides #Marketing #Purdue_Pharma

  • Court Documents Show How OxyContin’s Sales Team Pushed “Hope in a Bottle” – Mother Jones

    In 2007, a sales representative for Purdue Pharma visited a family doctor in Kingston, Tennessee, to urge the physician to prescribe more OxyContin. The doctor was interested in pain management, but didn’t prescribe the opioid painkiller because he’d heard that it was often resold on the street. “Asked him why it mattered if thought was going to end on street?” read notes that the rep wrote after the visit. “Point well received.”

    That’s according to a 278-page lawsuit filed in May by the state of Tennessee against Purdue Pharma and made public earlier this month after the company dropped its effort to keep the suit sealed. The opioid maker is facing dozens of lawsuits alleging that it helped plant the seeds of today’s spiraling overdose epidemic, but this appears to be the only complaint that relies heavily on notes that company sales representatives jotted down after each visit with a prescriber or clinic. (It’s not alone in the lawsuits: opioid manufacturers and distributors across the country are facing litigation, including this recent whistleblower case against prescription fentanyl maker Insys.)

    Purdue reps focused their efforts on general practitioners, internal medicine physicians, and other prescribers without pain management expertise, the suit alleges. Physician assistants and nurse practitioners, who Purdue found to be the fastest-growing group of opioid prescribers, were deemed to be “critical to our success; contributing to both volume and growth,” according to a 2015-2016 brand strategy training. “NPs and PAs desperately seek information, typically from sales representatives,” read a 2013 marketing plan.

    #Opioides #Purdue_Pharma #Tennessee

  • Heroin and Opioids - Bloomberg

    Everything about the massive surge in opioid abuse cuts across traditional boundaries of drug use in the U.S. It’s hit white residents in the countryside as well as minorities in cities. It involves long-banned substances like heroin, legally prescribed painkillers like OxyContin and, increasingly, street drugs that mimic powerful synthetic opioids like fentanyl. Their combined death toll now exceeds that of car crashes or firearms and opioid abuse is seen as a prime factor in declining American longevity. Behind the crisis is a tangle of issues from addiction to treatment to enforcement, regulatory policy involving drugmakers and diplomacy with nations where opioids are manufactured.

    Officials of Purdue Pharma Inc., the maker of OxyContin, confirmed in November that they are in settlement talks with a group of state attorneys general and trying to come up with a global resolution of the government opioid claims. States and the federal government have made the opiate-antidote drug naloxone more readily available; it’s been credited with reversing more than 26,000 overdoses between 1996 and 2014. Still, in 2016 fatal drug overdoses jumped by 21 percent, and the rate of deaths from synthetic opioids like fentanyl doubled.

    Extracts of the poppy plant have been a source of trouble since the 19th century Opium Wars. Heroin, first produced in 1898 by Bayer, the German pharmaceutical company, was marketed as a non-addictive substitute for morphine. By the early 1900s, widespread heroin use led states like New York to open addiction centers in hospitals. Heroin’s latest wave arose from changes in prescription opiate use. Opioid painkillers rose in popularity in the 1990s, partly in response to what was seen as widespread undertreatment of chronic pain. In 1996, Purdue Pharma Inc. introduced OxyContin as an alternative to stronger opioids reserved mainly for the dying. Its annual sales surged to $1 billion. In 2007 Purdue paid $600 million in fines and its executives pleaded guilty to federal criminal charges for misbranding the product as less addictive than other painkillers. In 2010, it released a reformulated version that was harder to crush for snorting. A May 2015 study found that while the new version reduced illicit use of the painkiller, it led more people to take up heroin, whose price was dropping. Nearly 90 percent of new heroin users in the U.S. are now white, compared with an equal mix of whites and nonwhites before 1980. Globally, poppy cultivation has reached its highest level since the 1930s.

    #Opioides #Purdue_Pharma #Procès

  • Purdue Pharma Cuts Rest of Its Sales Force in Opioids Pullback - Bloomberg

    Oxycontin-maker Purdue Pharma LP cut the remainder of its sales force this week, the latest move by the company to distance itself from opioids as it faces accusations that it contributed to the nation’s addiction crisis.

    The Stamford, Connecticut-based drugmaker said it will retain about 550 employees after chopping around 350 positions, including about 250 employees focused on promoting the treatment for opioid-induced constipation, Symproic. That product launched last year in partnership with Japan-based Shionogi & Co. The other employees worked in the company’s headquarters.

    #Opioides #Purdue_Pharma #Sackler

  • Under Attack, Drug Maker Turned to Giuliani for Help - The New York Times

    As a celebrity, Mr. Giuliani helped the company win several public relations battles, playing a role in an effort by Purdue to persuade an influential Pennsylvania congressman, Curt Weldon, not to blame it for OxyContin abuse.

    Despite these efforts, Purdue suffered a crushing defeat in May at the hands of Mr. Brownlee when the company and three top executives pleaded guilty to criminal charges.

    In the OxyContin case, Mr. Giuliani’s supporters suggest that as a cancer survivor himself, he was driven by a noble goal: to keep the company’s proven pain reliever available to the widest circle of sufferers.

    “I understand the pain and distress that accompanies illness,” Mr. Giuliani said at the time. “I know that proper medications are necessary for people to treat their sickness and improve their quality of life.”

    #Opioides #Purdue_Pharma #Procès #Rudolph_Giuliani

  • Rudy Giuliani won deal for OxyContin maker to continue sales of drug behind opioid deaths | US news | The Guardian

    The US government missed the opportunity to curb sales of the drug that kickstarted the opioid epidemic when it secured the only criminal conviction against the maker of OxyContin a decade ago.

    Purdue Pharma hired Rudolph Giuliani, the former New York mayor and now Donald Trump’s lawyer, to head off a federal investigation in the mid-2000s into the company’s marketing of the powerful prescription painkiller at the centre of an epidemic estimated to have claimed at least 300,000 lives.
    The Sackler family made billions from OxyContin. Why do top US colleges take money tainted by the opioid crisis?
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    While Giuliani was not able to prevent the criminal conviction over Purdue’s fraudulent claims for OxyContin’s safety and effectiveness, he was able to reach a deal to avoid a bar on Purdue doing business with the federal government which would have killed a large part of the multibillion-dollar market for the drug.

    The former New York mayor also secured an agreement that greatly restricted further prosecution of the pharmaceutical company and kept its senior executives out of prison.

    OxyContin became the go-to drug for people looking for an instant high by snorting or injecting.

    “This was the magic pill, right? This was a long-acting pill that the addicts wouldn’t like and you couldn’t get dependent on, and that is the magic bullet. The reality is it just wasn’t true,” said Brownlee. “It was highly deceptive and then they trained their sales force to go out and to push that deception on physicians.”

    Investigators waded through several million of Purdue’s internal memos, marketing documents and notes from sales representatives. Brownlee’s office discovered training videos in which reps acted out selling the drug using the false claims. “This was pushed by the company to be marketed in an illegal way, pushed from the highest levels of the company, that in my view made them a criminal enterprise that needed to be dealt with,” said Brownlee.

    The US attorney had six meetings with Giuliani. They moved from how to interpret the evidence and questions around discovery to negotiations over the final settlement.

    But Giuliani and his team seemed to be also working their Washington contacts. The Purdue lawyers complained to the office of the then deputy attorney general, James Comey, whose tenure as head of the FBI lay ahead of him, that Brownlee was exceeding his legal authority in pursuit of documents from the company.

    “The defence lawyers contacted Mr Comey unbeknownst to us and said those guys down there are crazy,” said Brownlee. The US attorney went to Washington to explain to Comey in person. Purdue was not instantly recognizable as a pharmaceutical company to most people in DC. The name was easily mistaken for Perdue Farms, a regional chicken producer well known for its television ads featuring the owner, Frank Perdue. “Mr Comey said, why are you prosecuting the chicken guy?” said Brownlee.

    Once that misunderstanding was cleared up, Comey signed off on Brownlee’s actions and Purdue was forced to hand over the documents. Brownlee set the drug maker a deadline in October 2006 to agree to the plea deal or face a trial. Hours before it expired, the federal prosecutor received a call at home from a senior justice department official, Michael Elston, chief of staff to the new deputy attorney general, Paul McNulty.

    Elston asked why the case was being pushed along so rapidly and pressed for a delay. The prosecutor again saw the influence of Purdue’s lawyers at work and cut the call short.

    Brownlee said he did not want to be responsible for taking OxyContin off the market and so agreed with Giuliani to target the prosecution at the parent company, Purdue Frederick. That left Purdue Pharma, cleaved out as a separate painkiller manufacturer in 1991, to continue selling the painkiller without restriction even though opioid deaths were escalating.

    “I didn’t feel as a lawyer I could be in a position to bar anyone from getting OxyContin. Faced with that decision, I was just simply not prepared to take it off the market. I didn’t feel like that was my role. My role was to address prior criminal conduct. Hold them accountable. Fine them. Make sure the public knew what they did. ” said Brownlee.

    Brownlee said he expected federal regulators, particularly the Food and Drug Administration, and other agencies to use the criminal conviction to look more closely at Purdue and its drug. But there was no follow-up and OxyContin went on being widely prescribed .

    #Opioides #Purdue_Pharma