Purdue Pharma L.P. , formerly the Purdue Frederick Company (1892–2019), was an American privately held pharmaceutical company founded by John Purdue Gray. It was sold to Arthur , Mortimer , and Raymond Sackler in 1952, and then owned principally by the Sackler family and their descendants.
101-453: The company manufactured pain medicines such as hydromorphone , fentanyl , codeine , hydrocodone and oxycodone , also known by its brand name, OxyContin. The Sacklers developed aggressive marketing tactics persuading doctors to prescribe OxyContin in particular. Doctors were enticed with free trips to pain-management seminars (which were effectively all-expenses-paid vacations) and paid speaking engagements. Sales of their drugs soared, as did
202-564: A deal would force states to suspend efforts to investigate members of the family and hold them accountable. In August 2021, US Representatives Carolyn Maloney and Mark DeSaulnier introduced a SACKLER Act to try and prevent people who have not filed for bankruptcy from being released from lawsuits brought by states, municipalities or the U.S. government. Maloney claimed that the Sackler family were using "a loophole in our bankruptcy system to protect their billions of dollars in wealth," and accused
303-533: A 2017 article in The New Yorker , Purdue Pharma is "owned by one of America's richest families, with a collective net worth of thirteen billion dollars". Many US states allege the family is worth more than $ 13 billion. In 2016, Forbes magazine listed the Sacklers as one of the 20 wealthiest families in the U.S. and noted that the Sacklers have contributed money to museums, universities and cultural institutions around
404-544: A Department of Justice appeal to the United States Supreme Court, of a 2nd U.S. Circuit Court Of Appeals ruling that the bankruptcy proceedings may continue. The company's downfall was the subject of the 2021 Hulu miniseries Dopesick , the 2021 HBO film The Crime of the Century , the 2023 Netflix series Painkiller , and several documentaries and books. Purdue Pharma had no relation to Purdue University or
505-427: A board of five members. Purdue Pharma manufactures pain medicines such as hydromorphone , oxycodone , fentanyl , codeine , and hydrocodone . It makes drugs such as MS Contin, OxyContin, and Ryzolt. In 1972, Contin (a controlled drug-release system) was developed. The most commonly abused medications that the company produces are MS Contin and OxyContin. Both can be abused by crushing, chewing, snorting, or injecting
606-506: A company owned by Richard Sackler, and Sackler's attempted manipulation of Wright through various means to win FDA approval of oxycontin. Wright was played by actor Brian Keene in an episode of docudrama series Dopesick on Hulu . The scene alleges that Wright met with Richard Sackler and Purdue executives in 2001 to discuss how they could continue the Purdue marketing strategy for OxyContin despite
707-443: A conjecture, but if there is evidence, you usually make some statement that there is evidence." According to Wright, the sentence was included on OxyContin's FDA-approved label as the result of "back and forth iterations between Purdue and the FDA." He didn't remember if Purdue requested the sentence, nor if he himself was its author, although he admitted he could have been. Wright further stated that he still at that time (2003) believed
808-720: A criminal violation and agreed to pay a total of US$ 34.5 million in fines. Friedman, Udell, and Goldenheim agreed to pay US$ 19 million , US$ 8 million and US$ 7.5 million , respectively. In addition, three top executives were charged with a felony and sentenced to 400 hours of community service in drug treatment programs. On October 4, 2007, Kentucky officials sued Purdue because of widespread OxyContin abuse in Appalachia. A lawsuit filed by Kentucky then-Attorney General Greg Stumbo and Pike County officials demanded millions in compensation. Eight years later, on December 23, 2015, Kentucky settled with Purdue for $ 24 million. In January 2017,
909-413: A drug." The ambiguous text "is believed to reduce the abuse liability" became a key issue in subsequent lawsuits against Purdue and was quoted in the 2007 felony conviction of the company for criminal misbranding. David Kessler, FDA commissioner at the time, later said of the approval of OxyContin: "No doubt it was a mistake. It was certainly one of the worst medical mistakes, a major mistake." OxyContin
1010-458: A few. In 2017, Wright consented to a brief interview in Esquire magazine about the Sackler family and Purdue Pharma roles in the opioid epidemic: "At the time, it was believed that extended-release formulations were intrinsically less abusable. It came as a rather big shock to everybody—the government and Purdue—that people found ways to grind up, chew up, snort, dissolve, and inject the pills. In
1111-676: A lawsuit against Purdue Pharma which also claimed eight members of the Sackler family were "personally responsible" for deceptive sales practices and in fact had "micromanaged" a "deceptive sales campaign". In response, the company said there was a "rush to vilify." Purdue started the OxyContin "Savings Card" program in 2008, with patients receiving discounts on their first five prescriptions. Internal company data showed these discounts led to 60 percent more patients staying on OxyContin for longer than 90 days. The court filing for Massachusetts stated, "Purdue determined that opioid savings cards worked like
SECTION 10
#17328591468991212-699: A lieutenant. Wright completed his surgical internship at the Naval Regional Medical Center in Portsmouth, Virginia in 1978, where he received training in undersea medicine and substance abuse treatment. By 1983, Wright had attained the rank of lieutenant commander in the United States Navy. He received a master's degree in public health from the Johns Hopkins School of Hygiene and Public Health in 1986, where he also completed his residency
1313-490: A moral, if not legal obligation to take effective steps and address addiction and abuse even as it works to reformulate the drug." In 2004, the West Virginia Attorney General sued Purdue for reimbursement of "excessive prescription costs" paid by the state. Saying that patients were taking more of the drug than they had been prescribed because the effects of the drug wore off hours before the 12-hour schedule,
1414-548: A neuropharmacologist at the Washington University School of Medicine in St. Louis who said that when it doesn't last 12 hours, patients can suffer both a return of their underlying pain and "the beginning stages of acute withdrawal." Cicero said. "That becomes a very powerful motivator for people to take more drugs." The Times suggested that this problem gives "new insight into why so many people have become addicted." Purdue
1515-613: A pharmaceutical company that was eventually acquired by Pfizer . In December 1998, he was hired by Purdue Pharma and eventually attained the position of executive director for Risk Assessment and Health Policy. After leaving Purdue, Wright joined Javelin Pharmaceuticals Inc. in September 2005 as vice president of risk management and regulatory affairs. According to documents of the Securities and Exchange Commission, from 2008 Wright
1616-707: A pharmaceutical consulting company under his own name in Gloucester, Massachusetts. The company was dissolved in 2018, either under a court order or by order of the secretary of the Commonwealth of Massachusetts. On December 3, 2002, U.S. Attorney John L. Brownlee , who headed the United States District Court for the Western District of Virginia , subpoenaed Purdue Pharma for their corporate records relating to OxyContin, consisting of millions of pages. With
1717-653: A plant located in Wilson , North Carolina ; the P.F. Laboratories, Inc., in Totowa, New Jersey ; and Rhodes Technologies L.P., in Coventry , Rhode Island . Purdue Pharma L.P. also has research labs in Cranbury, New Jersey . OxyContin is currently distributed throughout the U.S., Canada, and Mexico. Distribution takes place from the P.F. Laboratories in Totowa, New Jersey. Rhodes Pharmaceuticals
1818-413: A plea deal was arranged by Purdue's attorneys, former U.S. Attorneys Rudy Giuliani and Mary Jo White in 2007 to instead charge Purdue Frederick, a minor subsidiary of the company, with a felony and reduce the charges against the three Purdue Pharma executives to misdemeanors . The plea deal was confirmed and ordered on July 23, 2007, by Chief U.S. District Judge James Parker Jones , and Purdue Frederick
1919-412: A prevalence of 130,000 addicts in the population." "Acute exposure to opioids carries a very low risk, but is so common an event that it poses a significant public health problem. The street value (the amount a stranger in a bar will pay for a tablet) of diverted opioids is substantial, ranging from $ 1 up to $ 20 per tablet (prices vary depending on strength, desirability, and the current supply). Given that
2020-501: A private meeting without a consumer safety officer present. According to Purdue documents cited, Wright met from January 31 to February 2, 1995, with Purdue Pharma representatives in a hotel room near the FDA offices in Rockville, Maryland, and allowed the company to help draft his medical officer's review (MOR) of OxyContin for the FDA, which included approving the wording of certain texts to be used in OxyContin's package insert, or label. It
2121-696: A reenactment of Wright's alleged January 31 to February 2, 1995, secret meeting with Purdue representatives in a hotel room in Rockville, Maryland. There are multiple pages discussing Wright's role in the FDA and Purdue Pharma in nonfiction books such as Patrick Radden Keefe's Empire of Pain (2021), Barry Meier's Pain Killer (2003, reprinted 2020), and Sam Quinones' Dreamland (2015). Articles in newspapers, magazines and other news outlets discussing Wright are too numerous to mention, but have featured in articles in The New York Times and HuffPost , to name
SECTION 20
#17328591468992222-553: A settlement involving eight states plus the District of Columbia. Under the terms of the settlement agreement, the Sacklers would be required to pay between $ 5.5 and $ 6 billion to a trust that will be used to pay the claims of opioid creditors, including states, victims of addiction, hospitals, and municipalities. The decision would shield the Sacklers from personal civil liability, but not from potential criminal liability. Hydromorphone Too Many Requests If you report this error to
2323-573: A settlement with the Sackler family, insurance payments and ongoing business operations and would eliminate the family's exposure to civil litigation. The settlement was overturned in December 2021 by Judge Colleen McMahon of the U.S. District Court for the Southern District of New York, on the basis that the bankruptcy code did not permit a judge to release the Sacklers from civil liability. In March 2022, U.S. bankruptcy judge Robert Drain approved
2424-561: A settlement with the attorneys general of 47 states, the District of Columbia, and five territories to pay $ 537 million and to agree not to work with certain narcotics manufacturers. Kevin Sneader, the McKinsey's global managing partner, stated, "With this agreement, we hope to be part of the solution to the opioid crisis in the U.S." Purdue claimed that one dose of OxyContin relieved pain for 12 hours, more than twice as long as generic medications. It
2525-457: A study that found that "76 percent of those seeking help for heroin addiction began by abusing pharmaceutical narcotics, primarily OxyContin" and drew a direct line between Purdue's marketing of OxyContin and the subsequent heroin epidemic in the U.S. According to The New York Times , based on a confidential Justice Department report that was revealed in May 2018, Purdue was also aware of "reports that
2626-462: A sworn deposition under oath for the U.S. District Court in the Northern District of Mississippi in the case of Terri Lynn Poston v. Purdue Pharma . At the time, Wright was an employee of Purdue Pharma. The deposition was conducted by the plaintiff's attorney, Robert J. McNamara. Purdue attorneys Donald I. Strauber and Jay R. Henneberry were present representing Wright and had coached him prior to
2727-536: A video interview with Wright published on November 8, 2023, on the WMUR-TV website about the opioid epidemic in Littleton, New Hampshire , Wright's town of residence, Wright stated: "No regrets... I did my job. I never saw anything that I would not want to do. I do not know what the truth is... I have been treated very well by all parties concerned. I am now retired. It is a difficult, terrible situation, and I am so sorry for
2828-485: A year. Wright testified that his Purdue salary started at $ 185,000 a year and by the time of the deposition in 2003 was about $ 200,000 a year. According to Ogrosky's Department of Justice summary of the 2006 prosecution memo, Purdue records show Wright's starting compensation package at Purdue Pharma to have been in excess of $ 379,000. While employed by Purdue Pharma he was rewarded, in addition to his salary, 14 patents related to opioids, nine of them for inventions improving
2929-407: Is a partial outtake of the lecture, quoted verbatim: "Most physicians agree that iatrogenic addiction is an uncommon event in the clinical management of acute pain states, with an incidence of perhaps 1:10,000 patients treated. Being so uncommon, it is assumed to represent a negligible risk. This is a grave error. Iatrogenic addiction ceases to be a rare and negligible problem as soon as the size of
3030-619: Is a sister company that was established in Rhode Island in 2007. The company is one of the largest producers of off-patent generic opioids in the US. Sister companies to Purdue that are also controlled by descendants of the Sackler brothers are Napp Pharmaceuticals in the United Kingdom and Mundipharma that are selling opioids globally. New drugs are being developed under other company names, such as Adlon Therapeutics and Imbrium. Both are based in
3131-462: Is required to consider American public health. The Sacklers will not be permitted to be involved in the new company. In 2021, the Sacklers sought a controversial ruling from judge Robert D. Drain to grant them immunity and protect their assets from lawsuits linked to the opioid crisis. The Sacklers were seeking bankruptcy-like protection from the court without actually filing for personal bankruptcy. A number of state attorneys general argued that such
Purdue Pharma - Misplaced Pages Continue
3232-427: Is to fast release opioids as standard cocaine is to controlled-release opioids such as OxyContin, with the latter having "lower liability" for abuse. As to the ambiguous text " is believed to reduce the abuse liability," Wright stated that no studies were performed, nor was it generally accepted, but that "believed" means "just that. It's believed. Might be a consensus belief, it might be an expert opinion. It's more than
3333-606: The Uniformed Services University of the Health Sciences , and from 2006 as an adjunct clinical instructor at Tufts University School of Medicine . Wright's first government job after receiving his bachelor's degree at Haverford in the 1970s was as a research chemist for the National Institute of Mental Health , a U.S. governmental agency responsible for biomedical and health-related research. After leaving
3434-787: The United States House of Representatives introduced a bill that would stop the bankruptcy judge in the case from granting members of the Sackler family legal immunity during the bankruptcy proceedings. The House Judicial Committee referred it to the Subcommittee on Antitrust, Commercial, and Administrative Law in October 2021. The bill lapsed at the end of the 117th Congress in January 2023. In September 2021, Purdue Pharma announced that it would rebrand itself as Knoa Pharma . As of August, 2023, Purdue Pharma remains in chapter 11 bankruptcy, pending
3535-519: The opioid crisis . Purdue filed for bankruptcy in White Plains, New York , a few days after reaching this tentative settlement. However, many states refused the terms of the proposed settlement and vowed to pursue further litigation to recover additional money, much of it alleged to be hidden offshore. States are seeking to hold individual family members personally liable for the costs of the opioid epidemic, regardless of Purdue's bankruptcy. They contend
3636-667: The 12 hour cycle, but prescribe a stronger dose, thereby exacerbating their addiction. Reports of OxyContin abuse began to surface at the start of 2000. A proactive abuse surveillance program called Researched Abused, Diversion, and Addiction-Related Surveillance (RADARS) sponsored by Purdue Pharma L.P. pronounced Oxycontin and hydrocodone the most commonly abused pain medications. In 2003, the Drug Enforcement Administration found that Purdue's "aggressive methods" had "very much exacerbated OxyContin's widespread abuse." In 2012, The New England Journal of Medicine published
3737-422: The 2007 felony conviction of the company for criminal misbranding. In Wright's 2003 Mississippi deposition, he stated that he didn't think such language would be used on any other controlled release opioid label, for the reason that Purdue was following Wright's request as an FDA official to "talk somehow about the abuse liability of their product instead of just oxycodone." Wright made the analogy that crack cocaine
3838-534: The 2023 American drama limited series made for Netflix and created by Micah Fitzerman-Blue and Harpster. The six-episode series, which is based on Patrick Radden Keefe's New Yorker article "The Family That Built an Empire of Pain" and Pain Killer: An Empire of Deceit and the Origin of America's Opioid Epidemic, the 2018 book by Barry Meier, focuses on the birth of the opioid crisis, with an emphasis on Purdue Pharma,
3939-415: The FDA in October 1997 and was offered a position in October 1998 by Purdue Pharma. In his 2003 Mississippi deposition, Wright states that an unnamed job recruiter contacted him sometime after he left the FDA and offered to arrange a job interview for Wright with Purdue. Wright said he could only guess about the amount of his previous salary at the FDA as having been "somewhere between" $ 140,000 and $ 158,000
4040-435: The FDA's threat to give the drug a black box warning label. There is no known documentation for Wright's presence at that meeting, but according to Wright's 2018 Ohio deposition, he was not on the OxyContin team at the time and was only aware of any details of any such meetings if somebody asked him "some question." The 2021 two-part HBO documentary film The Crime of the Century featured an unknown actor playing Wright in
4141-412: The FDA, which included approving the wording of certain texts to be used in OxyContin's package insert, or label. Wright resigned from the FDA a year later, and was subsequently employed as a consultant at Purdue with a substantially higher salary. The information label approved by the FDA contained the text "Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of
Purdue Pharma - Misplaced Pages Continue
4242-414: The FDA. According to Sackler's recollection of the events, Purdue waited "two or three years" before hiring Wright. Wright spoke at a U.S. government symposium in 1999 that was subsequently published. His lecture warned that the widespread prescribing of opioids will lead directly to widespread addiction in the general population. At the time of this assessment, Wright was an employee of Purdue Pharma. This
4343-628: The Justice Department give them a copy of the memo, stating it is "purported to include evidence that Purdue Pharma executives may have lied when they told Congress that they had no knowledge of the extensive abuse and diversion of OxyContin before it was made known to them in 2000". The memo recommends that Purdue executives Michael Friedman, Paul Goldenheim and Howard Udell should have been charged with felonies that could have sent them to prison. By 2019, over 1,000 lawsuits have been initiated against Purdue by state and local governments. States across
4444-450: The Phase II candidate VM-902A. The deal could have generated more than US$ 213 million for VM Pharma. OxyContin became a blockbuster drug. "Between 1995 and 2001, OxyContin brought in $ 2.8 billion in revenue for Purdue Pharma." Cumulative revenues had increased to US$ 31 billion by 2016 and US$ 35 billion by 2017. All of the company's profits go to Sackler family trusts and entities. According to
4545-427: The Sackler family, McKinsey consultants suggested that Purdue pay pharmaceutical distributors a rebate for every overdose attributed to the pills the distributor sold. Purdue's vice president of sales and marketing expressed hesitation "on the need to turbocharge sales," but Sackler family members and other executives pushed on with the promotion. Sales soared, while more than 450,000 people died. In 2021, McKinsey reached
4646-478: The Sackler family. In August 2019, Purdue Pharma and the Sackler family were in negotiations to settle the claims for a payment of $ 10-$ 12 billion. The settlement would include a Chapter 11 filing by Purdue Pharma, which would be restructured as public beneficiary trust and the Sackler Family would give up any ownership in the company. Addiction treatment drugs currently developed by the company would be given to
4747-467: The Sacklers knew litigants would be pursuing Purdue's funds and committed fraudulent conveyance . In September 2019, the office of the New York Attorney General accused the Sackler family of hiding money by wiring at least $ 1 billion from company accounts to personal accounts overseas. A December 2019 audit from AlixPartners , hired by Purdue for guidance through Chapter 11 restructuring, said
4848-404: The Sacklers withdrew $ 10.7 billion from Purdue after the company began to receive legal scrutiny. In October 2020, Purdue agreed to an $ 8 billion settlement that includes a $ 2 billion criminal forfeiture, a $ 3.54 billion criminal fine, and $ 2.8 billion in damages for its civil liability. It will plead guilty to three criminal charges, and it will become a public benefit company under a trust that
4949-579: The USA have filed claims for more than $ 2 trillion in the Purdue Pharma bankruptcy case. In 2001, Connecticut Attorney General Richard Blumenthal issued a statement urging Purdue to take action regarding abuse of OxyContin. He observed that while Purdue seemed sincere, there was little action being taken beyond "cosmetic and symbolic steps". After Purdue announced plans to reformulate the drug , Blumenthal noted that this would take time and that "Purdue Pharma has
5050-496: The United States Navy, Wright joined the Food and Drug Administration in December 1989 and by late 1996 had attained his highest position as acting director of its Division of Anesthetic, Critical Care, and Addiction of Drug Products. This FDA department was responsible for protecting and promoting public health through the control and supervision of prescription pharmaceutical drugs. Under Wright's tenure, Purdue Pharma's application to sell
5151-616: The Wikimedia System Administrators, please include the details below. Request from 172.68.168.132 via cp1112 cp1112, Varnish XID 392804897 Upstream caches: cp1112 int Error: 429, Too Many Requests at Fri, 29 Nov 2024 05:45:46 GMT Curtis Wright IV Curtis Wright IV (born in 1949) is an American former government official known for his role in the Food and Drug Administration 's approval of OxyContin for Purdue Pharma in 1995, followed by his subsequent employment by
SECTION 50
#17328591468995252-498: The acute opioid analgesic market is taken into account. There are about 130 million prescriptions written for oral medications containing oxycodone, hydrocodone , hydromorphone and propoxyphene every year. If even 1 in ten thousand patients (1/10,000) a year develops de-novo addiction as the result of such treatment, this means 13,000 new addicts each year. Since the duration of addiction, especially to pharmaceuticals, may be as long as 10 years, an incidence rate of 13,000 will predict
5353-703: The citizens of Everett. The black market sale of the drug out of legal pharmacies based in Los Angeles with distributions points in Everett is also said to be part of the experience of the city according to the suit. No intervention was made by Purdue to contact the DEA for years despite knowing of the practice and the overuse and sale of their product. The suit asks for a yet to be determined reimbursement related to costs of policing, housing, health care, rehabilitation, criminal justice system, park and recreations department, as well as to
5454-509: The city of Everett, Washington sued Purdue based on increased costs for the city from the use of OxyContin as well as Purdue not intervening when they noted odd patterns of sale of their product, per agreement in the 2007 suit noted above. The allegations say Purdue did not follow legal agreements to track suspicious excess ordering or potential black market usage. The suit says false clinics created by unscrupulous doctors used homeless individuals as 'patients' to purchase OxyContin, then sold it to
5555-483: The company, which led to portrayals in films and reports in nonfiction books, magazines, and news media outlets of his alleged role as one of the key figures in the current opioid epidemic in the United States . Wright was implicated in a criminal conspiracy outlined in a 2006 United States Department of Justice review document that was first made public in Purdue Pharma's 2019 bankruptcy proceedings. Although that case
5656-481: The cost of most common opioid analgesics is less than $ 0.50 a tablet, there is substantial profit in diversion and resale, at all levels (manufacturer, wholesaler, retail pharmacy, physician and patient). After alcohol, tobacco, inhalants and cannabis (the classic portal agents), oral dosage forms of pharmaceuticals are the most common agents for drug experimentation. They are attractive because they are easily identified, assumed safe (FDA approved!), and readily obtained in
5757-488: The department of Justice of having "been complicit in devising" the settlement plan. As at August 2023, the proposed Act has not passed into law. In September 2021, the company won approval of a $ 4.5 billion (US) plan that will legally dissolve the pharmaceutical manufacturer and restructure it into a public benefit corporation focused on addressing the opioid crisis and repaying individuals and families who were damaged by its products. This restructuring would be financed by
5858-464: The deposition. Richard Silbert from Purdue Pharma and Michael Shane from the FDA were also present. The deposition lasted for approximately seven and half hours, and the transcript consists of 41 pages of two-column text. As part of a class-action lawsuit in the U.S. District Court for the Northern District of Ohio, Eastern Division, Wright was deposed under oath on December 19, 2018, by the plaintiff's attorneys Linda Singer and Michael G. Stewart. Wright
5959-441: The dissolved product. These ingestion methods create a significant risk to the abuser; they can result in overdose and death. Drug-seeking tactics that addicts undergo to obtain the medication include " doctor shopping ", which is visiting a number of different physicians to obtain additional prescriptions and refusal to follow up with appropriate examinations, using " pill mills ", and prescriber practices with lax controls. Along with
6060-408: The drugs giant Purdue Pharma may have committed multiple crimes, including wire fraud and money laundering, to boost sales of OxyContin. The document confirms that a $ 654m settlement between Purdue and the government over deceptive marketing claims in mid-2007 fell far short of what prosecutors had actually sought just six months earlier. In 2019, Senators Sheldon Whitehouse and Maggie Hassan requested
6161-528: The efficacy of Oxycontin. On August 28, 2015, Richard Sackler , one of the owners and a former chairman and president of Purdue Pharma, testified in the Commonwealth of Kentucky v. Purdue Pharma trial. Sackler stated that Wright contacted them about possible employment while Wright was still employed by the FDA, but that Sackler discussed the matter with Paul Goldenheim and concluded Purdue should not immediately hire "someone who had reviewed our product and left"
SECTION 60
#17328591468996262-534: The evidence for these charges was not released to the public and remains confidential. Rick Ogrosky's 2006 internal Department of Justice Fraud Division review of Brownlee's 2006 memo, however, was released to the public as part of Purdue Pharma's 2019 bankruptcy proceedings in the Southern District of New York and shows that the 2006 memo has numerous references to Wright. Ogrosky concludes that Wright colluded with Purdue to get approval for OxyContin with purposefully false label statements. On July 25, 2003, Wright made
6363-489: The evidence remaining under seal and confidential. In May 2007, the company pleaded guilty to misleading the public about OxyContin's risk of addiction and agreed to pay $ 600 million (equivalent to approximately $ 882M in 2023) in one of the largest pharmaceutical settlements in U.S. history . The company's president (Michael Friedman), top lawyer (Howard R. Udell), and former chief medical officer (Paul D. Goldenheim) pleaded guilty as individuals to misbranding charges,
6464-468: The following year. This followed with a residency in occupational and general preventative medicine and a fellowship in behavioral pharmacology and drug dependence. Wright's training program in behavioral pharmacology was funded by the National Institute on Drug Abuse . He completed his postgraduate in behavioral pharmacology from Johns Hopkins University School of Medicine in 1989. Wright continued in academia from 1993 to 2000 as an assistant professor at
6565-670: The help of Brownlee's assistants Randy Ramsmeyer and Rick Mountcastle, the evidence, gathered into a 120-page prosecution memo from September 28, 2006, entitled Memorandum for the United States Attorney , was sent to the Department of Justice in Washington DC, where it was reviewed by U.S. Justice Fraud Division attorney Rick Ogrosky. After indicting Purdue Pharma and its executives Michael Friedman, Howard R. Udell, and Paul D. Goldenheim on felony charges of criminal misbranding in 2006,
6666-627: The high potential for abuse among people without prescriptions, there is also a risk for physical dependency and reduced reaction or drug desensitization for patients that are prescribed them. Nevertheless, strong analgesic drugs remain indispensable to patients with severe acute and cancer pain. The first step in the marketing strategy was to seek approval to sell OxyContin from the Food and Drug Administration . Purdue managed to get it approved in 1995, even though no long-term studies and no assessment of its addictive capabilities had been conducted. Approval to prescribe OxyContin for "moderate to severe pain"
6767-462: The highest-prescribing doctors. Purdue also wooed doctors with free trips to pain-management seminars in vacation destinations. According to a study in the American Journal of Public Health , "more than 5,000 physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue's national speaker bureau." In a 2017 presentation to members of
6868-592: The illicit market." In November 2008, Wright co-authored an ostensibly scientific paper entitled "Risk Evaluation and Mitigation Strategies for Drugs with Abuse Liability: Public Interest, Special Interest, Conflicts of Interest, and the Industry Perspective." The paper relied heavily on data from the RADARS system , a program for tracking the abuse and diversion of pharmaceutical products founded by Purdue Pharma. They stated that RADAR studies showed that OxyContin abuse
6969-426: The loss of life or compromised quality of life of the citizens of Everett directly. In May 2018, six states—Florida, Nevada, North Carolina, North Dakota, Tennessee, and Texas—filed lawsuits charging deceptive marketing practices, adding to 16 previously filed lawsuits by other U.S. states and Puerto Rico. By January 2019, 36 states were suing Purdue Pharma. In 2019, Massachusetts attorney general Maura Healey filed
7070-505: The mid-nineties, the very best pain specialists told the medical community they were not prescribing opioids enough. That was not something generated by Purdue—that was not a secret plan, that was not a plot, that was not a clever marketing ploy. Chronic pain is horrible. In the right circumstances, opioid therapy is nothing short of miraculous; you give people their lives back. No company in the history of pharmaceuticals has worked harder to try to prevent abuse of their product than Purdue." In
7171-402: The number of people dying from overdoses. From 1999 to 2020, nearly 841,000 people died from drug overdoses in the United States, with prescription and illicit opioids responsible for 500,000 of those deaths. A series of lawsuits followed. In 2007, Purdue paid out one of the largest fines ever levied against a pharmaceutical firm for misleading the public about how addictive the drug OxyContin
7272-424: The opioid OxyContin was approved and included specific wording in the prescription information that allowed the company broader scope in marketing the opioid as less addictive, and therefore suitable for a wider range of patient pain than any previously FDA-approved opioids of similar strength. Wright left the FDA in October 1997. Wright's first private sector job after leaving the FDA was with Adolor Corporation ,
7373-592: The opioid crisis, photographer Nan Goldin launched the organization P.A.I.N. , to pressure museums and other cultural institutions to divest from Sackler Family philanthropy. As of May 2023, at least 20 institutions have dropped the Sackler name, including the Metropolitan Museum of Art, and Yale University in the USA; and the National Gallery in London. Other institutions have stopped accepting donations from
7474-568: The pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions." Over a hundred internal company memos between 1997 and 1999 included the words "street value", "crush", or "snort". In October 2006, Kirk Ogrosky, Deputy Chief of the Fraud Division at the US Department of Justice, wrote an internal memorandum which shows that government prosecutors found evidence that executives at
7575-402: The public cost-free. All profits of Purdue would henceforth go to the plaintiffs in the case. On top of that, the Sackler family would contribute $ 3 billion in cash. The family would also sell Mundipharma and contribute another $ 1.5 billion from the sales proceeds to the settlement. However, the Sackler family would remain a billionaire family and would not be criminally charged for contributing to
7676-485: The requirements is that a consumer safety officer be present and the consumer safety officer was tasked with maintaining records of such things." In Wright's 2018 Ohio deposition, he stated he "simply never met with the company alone," meaning with Purdue, and when meeting, always had an FDA consumer safety officer present. In Ogrosky's 2006 Justice Department review of the prosecution memo, however, Purdue records show that Wright contacted Purdue in January 1995 and requested
7777-444: The same building as their parent company in downtown Stamford and share employees. Richard Sackler , the son of Raymond Sackler, started work at the company in 1971. He was named president in 1999 and became co-chairman of the board in 2003. Richard oversaw the research department that developed OxyContin and managed the sales and marketing unit. Craig Landau was appointed CEO on June 22, 2017. He joined Purdue Pharma L.P. in 1999 and
7878-426: The state charged Purdue with deceptive marketing . In his ruling the trial judge wrote: "Plaintiff's evidence shows Purdue could have tested the safety and efficacy of OxyContin at eight hours, and could have amended their label, but did not." The case never went to trial; Purdue agreed to settle by paying the state US$ 10 million (equivalent to approximately $ 16M in 2023) for programs to discourage drug abuse, with all
7979-509: The statement to be true, despite there having been no clinical tests performed as to its veracity. Wright then stated that Purdue was "not comfortable" with the statement, suggesting that they only accepted it because of Wright's recommendation. In Wright's 2018 Ohio deposition, he stated that he didn't know who proposed the "delayed absorption" language in the FDA-approved label, though he again stated that he could have written it. Wright left
8080-401: The teaser rate on a long-term and very high-stakes mortgage." In March 2019, Purdue Pharma reached a $ 270 million settlement in a lawsuit filed by Oklahoma, which claimed its opioids contributed to the deaths of thousands of people. The family's philanthropy has been characterized as reputation laundering from profits acquired from the selling of opiates. In response to the role of Purdue in
8181-589: The time of OxyContin's release, the American Pain Society introduced its "pain as fifth vital sign" campaign. Veterans Health Administration adopted the campaign as its national pain management strategy. In September 2015, the company's website said it had some 1,700 people on its payroll. That same month, the company announced it would acquire VM Pharma in the process gaining access to worldwide development and commercial rights to an allosteric selective tropomyosin receptor kinase inhibitor program, i.e.,
8282-530: The university's college of pharmacy , something Purdue University has made clear on multiple occasions to avoid association. The company that became Purdue Pharma was founded in 1892 by medical doctors John Purdue Gray and George Frederick Bingham in New York City as the Purdue Frederick Company. The company made a tonic compound made with sherry and glycerin. Sixty years later, in 1952, the company
8383-707: The world. However, the Purdue website makes little mention of anyone in the Sackler family or their ownership of the company. Allen Frances, former chair of psychiatry at Duke University School of Medicine, said: “Their name has been pushed forward as the epitome of good works and of the fruits of the capitalist system. But, when it comes down to it, they’ve earned this fortune at the expense of millions of people who are addicted. It’s shocking how they have gotten away with it.” The company's branches include Purdue Pharma L.P., The Purdue Frederick Company, Purdue Pharmaceutical Products L.P., and Purdue Products L.P. Its manufacturing takes place at three sites: Purdue Pharmaceuticals L.P.,
8484-555: Was "confined mostly to rural areas with long histories of prescription drug abuse, and that it was often part of a larger problem of prescription opioid and other drug and alcohol abuse." The authors further concluded that abuse and diversion problems stemmed from doctors overprescribing the drug and engaging in illicit trafficking, as well as pharmacy thefts. The solutions offered by Purdue Pharma were to assist law enforcement and to fund community programs for prevention and intervention. The article concluded "the OxyContin risk-management plan
8585-548: Was a large, complex program suitable for a widely used drug prescribed in the outpatient family practitioner and general practitioner environment." The authors stated potential conflicts of interest: a Purdue Pharma employee, a Javelin Pharmaceuticals employee, and Wright, formerly employed by Purdue Pharma and at the time of writing by Javelin Pharmaceuticals. Wright is a pivotal character played by Noah Harpster in Painkiller ,
8686-487: Was a much larger market than that for cancer-related pain, making up 86% of the total opioid market in 1999. Purdue's promotion of OxyContin for the treatment of non–cancer-related pain led to a nearly tenfold increase in prescriptions for less serious pain, from about 670,000 in 1997 to about 6.2 million in 2002. Purdue enlisted consulting firm McKinsey & Company to decide and implement OxyContin marketing strategies. McKinsey suggested Purdue focus its sales rep visits to
8787-408: Was an executive officer and shareholder in a company called Star Scientific Inc. After the company founder's involvement in a 2014 gifts corruption scandal that resulted in the conviction (later overturned) of Virginia governor Bob McDonnell , the company changed its name to Rock Creek Pharmaceuticals, filing bankruptcy two years later. One month after the federal indictment of McDonnell, Wright formed
8888-479: Was born in 1949. His father was an Ivy League-educated university law professor, and his mother was a psychiatrist and the superintendent of a state mental hospital. Wright received a bachelor's degree in chemistry from Haverford College . He finished a four-year program of medicine in 1977 at George Washington University School of Medicine & Health Sciences prior to joining the United States Navy as
8989-449: Was chief medical officer and as vice president of R&D innovation, clinical and medical affairs. In 2013, he was appointed president and CEO of Purdue Pharma (Canada). In 2018, eight members of the Sackler family were listed as active or former members of the board of directors. Steve Miller became chairman in July 2018. By early 2019, the Sacklers had departed the Purdue Pharma board, leaving
9090-403: Was compared to other pain medications. In response to the lawsuits, the company shifted its focus to abuse-deterrent formulations, but continued to market and sell opioids as late as 2019 and continued to be involved in lawsuits around the opioid epidemic in the United States . Purdue filed for Chapter 11 bankruptcy protection on September 15, 2019, in New York City . On October 21, 2020, it
9191-401: Was granted by Dr Curtis Wright IV , the medical review officer for the FDA. According to Purdue documents in a review conducted in 2006 by the Justice Department, Wright met with Purdue Pharma representatives in a hotel room near the FDA offices in Rockville, Maryland, between January 31 to February 2, 1995. He allowed the company to help draft his medical officer's review (MOR) of OxyContin for
9292-414: Was incorporated in 1991 and focused on pain management medication, calling itself a "pioneer in developing medications for reducing pain, a principal cause of human suffering". In 1984, its extended-release formulation of morphine, MS Contin was released. OxyContin was released in 1996 after Curtis Wright , an employee of the Food and Drug Administration approved its use on a 12-hour dosage cycle. Around
9393-498: Was marketed as "smooth and sustained pain control all day and all night" when taken on a 12-hour schedule. However, most patients found it wore off after eight hours or less. A 2016 investigation by the Los Angeles Times reported that in many people OxyContin's 12-hour schedule does not adequately control pain, resulting in withdrawal symptoms including intense craving for the drug. The Los Angeles Times quoted Theodore J. Cicero,
9494-415: Was reported that Purdue had reached a settlement potentially worth US$ 8.3 billion, admitting that it "knowingly and intentionally conspired and agreed with others to aid and abet" doctors dispensing medication "without a legitimate medical purpose." Members of the Sackler family will additionally pay US$ 225 million and the company will close. Some state attorneys general protested the plan. In March 2021,
9595-478: Was represented by Purdue Pharma attorney Erik W. Snapp, although Wright had not worked for the company for over a decade. The deposition lasted over eight hours and the transcript consists of 80 pages of two-column text. Wright testified under oath in his 2003 Mississippi deposition that he had no documents from his time at the FDA related to communications with Purdue Pharma. He stated that he "never met individually with representatives of pharmaceutical firms. One of
9696-476: Was sentenced to pay a fine of $ 600 million. The executives were given fines and made to perform community service in drug treatment programs. Purdue Pharma and its three executives were originally to be charged with the felony crimes of criminal conspiracy, mail fraud, wire fraud, interstate distribution of a misbranded drug, and two counts of money laundering. Since the case was concluded in a plea agreement and never went to trial, Brownlee's 2006 memorandum detailing
9797-438: Was settled in a 2007 plea agreement deal, members of United States Congress have requested the full 2006 documentation from the Department of Justice with the goal of opening a new case based upon the evidence then gathered. Parts of Wright's sworn depositions in 2003 and 2018 have internal contradictions and differ from documentary evidence described the 2003–2006 U.S. Federal Government investigation into Purdue Pharma. Wright
9898-613: Was sold to three other medical doctors, brothers Arthur , Raymond and Mortimer Sackler , who relocated the business to Yonkers, New York . The brothers all held a one-third share in the company, but Arthur's share passed to his brothers after his death in 1987. Mortimer died in 2010, followed by Raymond in 2017. Under the Sacklers, the company opened additional offices in New Jersey and Connecticut . The headquarters are located in Stamford, Connecticut . The modern company, Purdue Pharma L.P.,
9999-446: Was systematically marketed as if it had very limited potential for addiction or abuse. Purdue trained its sales representatives to convey to doctors that the risk of addiction from OxyContin was "less than one percent." A related feature of this strategy was that, because of the purported low risk, it could be prescribed as an effective treatment for chronic pain from virtually any condition, not just cancer. This "non-malignant pain market"
10100-403: Was the specific wording of these texts that allowed Purdue to successfully market OxyContin as suitable for general cases of pain and as less addictive than other opioids. The first approved label for OxyContin contained the text " Delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug. " This text was exploited by Purdue Pharma and was quoted in
10201-405: Was well aware that OxyContin did not provide pain relief for 12 hours even before the drug went to market, but "held fast to the claim of 12-hour relief, in part to protect its revenue [because] OxyContin's market dominance and its high price—up to hundreds of dollars per bottle—hinge on its 12-hour duration." Instead of prescribing small doses more frequently, doctors were advised to keep patients on
#898101