Purdue Pharma

Purdue Pharma L.P.
Native name
 Purdue Pharmaceuticals L.P.
Private
Industry Pharmaceuticals
Founded New York, New York, USA (1892 (1892))
Founders John Purdue Gray
George Frederick Bingham
Headquarters Stamford, Connecticut, USA
Key people
 Dr. Craig Landau (President & CEO)
Arthur Sackler
Mortimer Sackler
Raymond Sackler
Revenue Increase $3 billion (2017)
Number of employees
 5000 (worldwide)
Website purduepharma.com (Global website)
Footnotes / references

    Purdue Pharma L.P. is a privately held pharmaceutical company owned principally by parties and descendants of Mortimer and Raymond Sackler.[1][2] In 2007 it paid out one of the largest fines ever levied against a pharmaceutical firm for mislabeling its product OxyContin, and three executives were found guilty of criminal charges. Although the company has shifted its focus to abuse-deterrent formulations, Purdue continues to market and sell opioids, and continues to be involved in lawsuits around the opioid crisis.

    History

    Purdue Pharma is a privately held company founded in 1892 by physicians John Purdue Gray and George Frederick Bingham in Manhattan as the Purdue Frederick Company.[3]

    In 1952, the company was sold to two other physicians, Raymond and Mortimer Sackler, who relocated the business to Yonkers, New York. Their older brother, Arthur Sackler, also held a one-third option in Purdue Pharma, which, after his death, was sold to his brothers.[4] In the intervening years the company opened additional offices in New Jersey and Connecticut. The headquarters are in Stamford, Connecticut.

    The present-day company, Purdue Pharma L.P., was incorporated in 1991, and focuses on pain management medication, calling itself a "pioneer in developing medications for reducing pain, a principal cause of human suffering". In September 2015, the company's website said it has some 1,700 people on its payroll.[5]

    In September 2015, the company announced it would acquire VM Pharma, thereby gaining access to worldwide development and commercial rights to an allosteric selective tropomyosin receptor kinase inhibitor program, i.e., the Phase II candidate VM-902A. The deal could generate more than $213 million for VM Pharma.[6]

    Structure

    The company's branches include Purdue Pharma L.P., The Purdue Frederick Company, Purdue Pharmaceutical Products L.P., and Purdue Products L.P. The company's manufacturing takes place at three sites: Purdue Pharmaceuticals L.P., 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 was established in Rhode Island in 2007. The company is one of the largest producers of off-patent generic opioids in the US. [7]

    Management

    Craig Landau was appointed CEO on June 22, 2017. He joined Purdue Pharma L.P. in 1999. During his fourteen years with the U.S. organization, he has served as Chief Medical Officer and as Vice President of R&D Innovation, Clinical and Medical Affairs. In this role and as part of the Company's Management Team, he and the R&D organization were responsible for a number of health policy initiatives as well as product registrations in the U.S. and other regions, including Butrans, reformulated OxyContin, Targiniq ER and Hysingla ER. In 2013, he was appointed President and CEO of Purdue Pharma (Canada).

    Craig earned his B.Sc. in Physiology and Anatomy from Cornell University and his M.D. from Mount Sinai School of Medicine. He completed his Anesthesiology residency at Yale University, with specialty training in chronic pain management, obstetric and peripheral vascular anesthesia. He is also a U.S. Army Veteran, having concluded a distinguished 14-year career in 2005.

    Controversy

    Purdue Pharma makes pain medicines such as hydromorphone, oxycodone, fentanyl, codeine, and hydrocodone. It is widely known for the production of drugs such as MS Contin, Oxycontin, and Ryzolt. In 1972, Contin (a controlled drug-release system) was developed. In 1984, its extended-release formulation of morphine, MS Contin was released. In 1996 its extended-release formulation of oxycodone, OxyContin was released.[5]

    The controversy behind the company emerged as a result of the drugs that they made and how they carried high potential for abuse by drug abusers and people with a history of addiction. The most commonly abused medications that the company produces are MS Contin and OxyContin. Both can be abused by crushing, chewing, snorting, or injecting the dissolved product. This is a significant risk to the abuser because it 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. Along with 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 suffering from severe acute and cancer pain.[8]

    OxyContin, introduced in 1995, was Purdue Pharma's breakthrough palliative for chronic pain. Under a marketing strategy that Arthur Sackler had pioneered decades earlier, the company aggressively pressed doctors to prescribe the drug, wooing them with free trips to pain-management seminars and paid speaking engagements. Sales soared.[9] The drug was marketed as "smooth and sustained pain control all day and all night" when taken on a 12-hour schedule and as having lower abuse potential than immediate-release oxycodone because of its time-release properties, even though there was no scientific evidence backing that conclusion.[10] In these early years, Purdue Pharma was aware of OxyContin abuse, including "reports that the pills were being crushed and snorted; stolen from pharmacies; and that some doctors were being charged with selling prescriptions," according to the New York Times, based on a confidential Justice Department report that was revealed in May 2018. Over a hundred internal company memos between 1997 and 1999 included the words "street value," "crush," or "snort."[11]

    At the start of 2000, widespread reports of OxyContin abuse surfaced. The results obtained from 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.[12] In 2012, New England Journal of Medicine published a study that found that "76 percent of those seeking help for heroin addiction began by abusing pharmaceutical narcotics, primarily OxyContin"[13] and drew a direct line between Purdue's marketing of OxyContin and the subsequent heroin epidemic in the U.S.

    In 2003, the Drug Enforcement Administration found that Purdue's "aggressive methods" had "very much exacerbated OxyContin's widespread abuse."[14]

    A 2016 Los Angeles Times investigation 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 journalists suggested that this problem gives "new insight into why so many people have become addicted." Using Purdue documents and other records, they claim that Purdue was aware of this problem 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."[15]

    OxyContin became a blockbuster drug. Purdue had increased its earnings from a few billion in 2007[16] to US$31 billion by 2016.[17] That had increased to US$35 billion by 2017.[18] According to 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".[18]

    In 2018, Purdue Pharma patented a new form of buprenorphine, which controls cravings and is used to treat addiction to opioids such as OxyContin.[19]

    Purdue has been involved in measures against prescription drug abuse, particularly of Oxycontin, an addiction-causing prescription drug which is among the drugs most commonly cited in connection with overdose deaths. In 2001, Connecticut Attorney General Richard Blumenthal issued a statement urging Purdue to take action regarding abuse of Oxycontin; he did note that while Purdue seemed sincere, there was little action being taken beyond "cosmetic and symbolic steps."[20] After Purdue announced plans to reformulate the drug, Blumenthal noted that this would take time and that "Purdue Pharma has a moral, if not legal obligation to take effective steps and address addiction and abuse even as it works to reformulate the drug."[21]

    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, 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 for programs to discourage drug abuse, with all the evidence remaining under seal and confidential.[15]

    In May 2007, the company pleaded guilty to misleading the public about Oxycontin's risk of addiction and agreed to pay US$600 million 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, a criminal violation and agreed to pay a total of US$34.5 million in fines.[22][23] 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.[24]

    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.[25] Eight years later, on December 23, 2015, Kentucky settled with Purdue for $24 million.[26]

    In January 2017 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 include not following legal agreements to track suspicious excess ordering or potential black market usage. False clinics created by unscrupulous doctors using homeless individuals as 'patients' to purchase oxycontin, then sell to the citizens of Everett was the factual basis of the suit. The blackmarket sale of the drug out of legal pharmacies based in Los Angeles with distributions points in Everett is also part of the experience of the city. 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 is asking 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 the loss of life or compromised quality of life of the citizens of the city directly.[27][28][29]

    In May 2018, with 16 lawsuits by U.S. states and Puerto Rico already filed, six additional states - Florida, Nevada, North Carolina, North Dakota, Tennessee and Texas - also filed lawsuits charging deceptive marketing practices. Furthermore, three other states - California, Massachusetts and New York - have lawsuits in the works.[30][31]

    See also

    References

    1. ↑ "The Secretive Family Making Billions From the Opioid Crisis". 16 October 2017. Retrieved 11 February 2018.
    2. ↑ Keefe, Patrick Radden (2017-10-23). "The Family That Built an Empire of Pain". The New Yorker. ISSN 0028-792X. Retrieved 2018-01-19.
    3. ↑ "About Purdue Pharma L.P." www.purduepharma.com. Retrieved 22 October 2017.
    4. ↑ "Elizabeth A. Sackler Supports Nan Goldin in Her Campaign Against OxyContin". Hyperallergic. 2018-01-22. Retrieved 2018-01-23.
    5. 1 2 "About Purdue Pharma L.P." Retrieved September 8, 2015.
    6. ↑ "Purdue Pharma Acquires TrkA Inhibitor Program for Up to $213M+ - GEN". GEN. Retrieved 22 October 2017.
    7. ↑ Crow, David. "Billionaire Sackler family owns second opioid drugmaker". Financial Times. Retrieved September 15, 2018.
    8. ↑ World Health Organization. Cancer pain relief and palliative care. Geneva: WHO 1990
    9. ↑ Roberts, Sam (19 July 2017). "Opinion - Raymond Sackler, Psychopharmacology Pioneer and Philanthropist, Dies at 97". Retrieved 11 February 2018 – via NYTimes.com.
    10. ↑ Quinoes, Sam. "FRONTLINE DOCUMENTARY "CHASING HEROIN" INVESTIGATES THE OPIOID EPIDEMIC". Retrieved 4 March 2016.
    11. ↑ Meier, Barry (29 May 2018). "Origins of an Epidemic: Purdue Pharma Knew Its Opioids Were Widely Abused". New York Times. Retrieved 30 May 2018.
    12. ↑ Cicero TJ, Inciardi JA, Muñoz A (2005). "Trends in abuse of Oxycontin and other opioid analgesics in the United States: 2002-2004". J Pain. 6 (10): 662–72. doi:10.1016/j.jpain.2005.05.004. PMID 16202959.
    13. ↑ Smith, Jason. "Kingpins: OxyContin, Heroin, and the Sackler-Sinaloa Connection". Retrieved 4 March 2016.
    14. ↑ https://www.newyorker.com/magazine/2017/10/30/the-family-that-built-an-empire-of-pain
    15. 1 2 Harriet, Ryan; Girion, Lisa; Glover, Scott (May 5, 2016). "'You want a description of hell?' OxyContin's 12-hour problem". Los Angeles Times. Retrieved October 18, 2017. This is an in-depth series.
    16. ↑ Meier, Barry (May 10, 2007). "In Guilty Plea, OxyContin Maker to Pay $600 Million". The New York Times. Retrieved October 26, 2017.
    17. ↑ "More than 1 million OxyContin pills ended up in the hands of criminals and addicts. What the drugmaker knew". Los Angeles Times. July 10, 2016.
    18. 1 2 Keefe, Patrick Radden (October 2017). "The Family That Built an Empire of Pain: The Sackler dynasty's ruthless marketing of painkillers has generated billions of dollars—and millions of addicts". The New Yorker. A Reporter at Large. Retrieved October 26, 2017. 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... 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. Indepth-analysis
    19. ↑ Ivanova, Irina (7 September 2018). "OxyContin maker gets patent for drug to treat opioid addiction". CBS News. Retrieved 9 September 2018.
    20. ↑ General, Office of the Attorney. "CT Attorney General". www.ct.gov. Retrieved 22 October 2017.
    21. ↑ General, Office of the Attorney. "CT Attorney General". www.ct.gov. Retrieved 22 October 2017.
    22. ↑ Sue Lindsey, (May 11, 2007) OxyContin Maker, Execs Guilty of Deceit USA Today reproducing and Associated Press report
    23. ↑ Barry Meier, (May 11, 2007) "In Guilty Plea, OxyContin Maker to Pay $600 Million", New York Times
    24. ↑ "domain-b.com : Purdue Pharma fined $634 million for OxyContin deaths; executives punished". www.domain-b.com. July 22, 2007. Retrieved 22 October 2017.
    25. ↑ "Kentucky sues makers of OxyContin - USATODAY.com". usatoday30.usatoday.com. Retrieved 22 October 2017.
    26. ↑ "Kentucky settles lawsuit with OxyContin maker for $24 million". www.cbsnews.com. Retrieved 2016-05-02.
    27. ↑ Harriet Ryan (January 19, 2017), "City devastated by OxyContin use sues Purdue Pharma, claims drugmaker put profits over citizens' welfare", The Los Angeles Times
    28. ↑ Scott North (February 20, 2017), "Everett's suit against OxyContin maker moves to federal court", Everett Herald
    29. ↑ "U.S. City Sues OxyContin Maker For Contributing To Opioid Crisis", Morning Edition, NPR, February 3, 2017
    30. ↑ Bellon, Tina. "U.S. state lawsuits against Purdue Pharma over opioid epidemic mount". Reuters. Retrieved 5 June 2018.
    31. ↑ Moritz, John C. "6 states sue maker of OxyContin as they battle expenses, human costs of opioid crisis". USA TODAY. Corpus Christi (Texas) Caller Times. Retrieved 5 June 2018.
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