Mark R. W. Orders-Woempner
U.S. News /29 Apr 2019
04.29.19

Purdue Pharma and the Sackler Family. America’s Scapegoats.

Just about every day there seems to be a new article about how Purdue Pharma and the Sackler family are responsible for the opioid epidemic. There is no doubt they played a role but to focus primarily on them absolves all others responsible including the FDA, the DEA, opioid distributors, state medical boards, physicians, professional medical societies, and America’s declining society. This article is not a defense of Purdue and its owners but examines other causes of the opioid crisis.

Purdue Pharma is a family-owned pharmaceutical company that introduced the world to OxyContin. In 1952, physician brothers Mortimer and Raymond Sackler purchased the Purdue Frederick Company, and in 1991 it became known as Purdue Pharma L.P. OxyContin, an opioid analgesic used for pain management was approved by the Food and Drug Administration in 1995. OxyContin is an extended-release version of oxycodone which was developed in Germany in 1916 and given the name Eucodal. There are journal articles from the 1940s which discuss the addictive quality of oxycodone. An article from January 1942, in the Indian Medical Gazette entitled, “A Note on Eucodal Habit in India” reads, “It was generally believed that this drug was not liable to produce habit formation in the same way as morphine. It has, however, been found that this belief is not justified. There is practically no difference between morphine and eucodal in this respect and its sale should be submitted to the same restrictions.”

In 1987, Purdue launched MS Contin, an extended-release morphine sulfate medication for pain, and a 1990 article in the journal Cancer entitled “Recovery of Morphine from a Controlled-Release Preparation,” discusses how addicts could transform the tablet into an aqueous solution and be injected. The article states, “MS-Contin has become a highly desirable preparation for opioid abuse in the Cincinnati area,” and asks if other sustained-release formulations could also be abused in a similar manner. Prior to Purdue creating an abuse-deterrent formulation of OxyContin in 2010, people would often crush and snort the pill or create an aqueous solution and inject it.

Purdue Pharma deceptively marketed OxyContin to healthcare providers and according to the Department of Justice, United States Attorney, Western District of Virginia, the claim that its drug was, “…less addictive and less subject to abuse and diversion was false.” As a result, the company and three of its employees were prosecuted by the DOJ and paid a total of $634.5 million in 2007 to settle both civil and criminal charges for their “misbranding” of OxyContin. Purdue Pharma has settled multiple lawsuits thus far and has paid $20 million to 26 states, $10 million to West Virginia, $24 million to Kentucky, and $270 million to Oklahoma. Currently, close to 2,000 lawsuits are pending against Purdue and/or the Sackler family and as a result, Purdue is considering filing for bankruptcy protection. In January 2019, a Connecticut judge dismissed lawsuits filed by 37 Connecticut cities and towns against Purdue and other drug companies for the “indirect harm” of the opioid crisis. The judge wrote, “Their lawsuits can’t survive without proof that the people they are suing directly caused them the financial losses they seek to recoup.”

In 2012, the number of opioid prescriptions peaked at over 255 million; and according to the CDC, in 2017, 47,600 Americans died from an overdose involving an opioid, with the majority of those deaths being caused by illicit fentanyl and heroin. The rise in heroin overdose deaths began in 2010, and illicit fentanyl deaths began to increase in 2013. Furthermore, in 2017, the number of overdose deaths involving a prescription opioid was 17,029, and many of those deaths also included illicit fentanyl as part of the drug mix.

According to the Food and Drug Administration’s website, the FDA regulates prescription drugs and is “…responsible for protecting the public health by assuring the safety, effectiveness, quality, and security of human and veterinary drugs, vaccines and other biological products, and medical devices.” In 1995, Dr. Curtis Wright, a medical review officer for the FDA, recommended the use of OxyContin for moderate to severe pain. Two years later he was employed by Purdue Pharma. According to an article in the Clarion-Ledger, dated January 26, 2018, Dr. Andrew Kolodny, an addiction expert and Co-Director of Opioid Policy Research at Brandeis University, was quoted as saying, “I believe we wouldn’t have an opioid epidemic if the FDA had done its job properly.” He further stated that the FDA should have allowed the drug to be used only in palliative care, not for moderate pain. In the same article, Dr. David Kessler, who was the FDA Commissioner at the time of the OxyContin approval, admitted that the FDA should have never allowed the promotion of OxyContin. Kessler also said that the FDA made many mistakes and should have acted sooner. In a 2018 article from the Food and Drug Law Journal entitled, “Implementing a Public Health Perspective in FDA Drug Regulation,” the authors write, “Although FDA monitors and regulates prescription drug advertising, examples of troubling marketing of opioids and related products have continued to arise.”

The U.S. Drug Enforcement Administration has many responsibilities including licensing and regulating controlled substance manufacturers and distributors, prescribers and pharmacies, and enforcing laws regarding illegal drugs. The DEA has been a failure on many levels as illicit drugs are readily available and relatively inexpensive, and pill mills were actively pumping out opioids to the public for years before being shut down. Leo Beletsky, Director of Health in Justice Action Lab at Northeastern School of Law and his colleague Jeremiah Goulka, write in a New York Times article in 2018, “The Drug Enforcement Administration, the agency that most directly oversees access to opioids, deserves much of the blame for these deaths. Because of its incompetence, the opioid crisis has gone from bad to worse.”

Drug distributors purchase medications in bulk from pharmaceutical companies and distribute to pharmacies. Again, the DEA is supposed to regulate both distributors and pharmacies but there is little evidence this has occurred. Opioid distributors are being sued by multiple states as a result of alleged malfeasance including not alerting the DEA of the fact that many pharmacies were purchasing an inordinate amount of opioids. Moreover, drug distributors made a substantial amount of money from their opioid sales. The House of Representatives’ Energy and Commerce Oversight and Investigations Committee found two distributors, McKesson and Cardinal Health, sold over 12 million pills over a five year period to one pharmacy in Mount Gay-Shamrock, West Virginia, a town of fewer than 2,000 residents. The Committee also revealed how a town of 400 residents in West Virginia received 9 million opioid pills over a two year period.

State medical boards license and regulate physicians to practice medicine. Other than infrequent censure and revocation of a physician’s license for prescribing opioids when they were deemed medically unnecessary, there is a lack of evidence they took aggressive action to mitigate the problem. However, many states have sued Purdue, the Sackler family and other opioid manufacturers and distributors for the crisis when their own actions were wanting.

Physicians are the ultimate doorway for the transfer of prescription opioids to the public. In a 2017 article entitled, “Physicians and Opioids, Part of the Solution, but Challenges Ahead,” James Gessner, MD, past President of the Massachusetts Medical Society writes about the opioid epidemic, “There’s no denying it. Despite our well-intentioned motivation to care for our patients and treat their pain, we physicians have played a role in this crisis.” Moreover, doctors have taken a substantial amount of money and gifts from opioid manufacturers and this influences their prescribing habits. According to an article in the Journal of the American Medical Association entitled, “Association of Pharmaceutical Industry Marketing of Opioid Products With Mortality From Opioid-Related Overdoses,” the authors found that as the amount of pharmaceutical marketing dollars increased to physicians, so did the number of prescriptions and overdose deaths.

Doctors may also be influenced by a number of other factors including pharmaceutical salespeople and professional medical societies. It is a fact that Purdue Pharma was dishonest about the potential for addiction and abuse of OxyContin but there was sufficient evidence that this drug had the potential for addiction and abuse. Furthermore, salespeople are known for their puffery, and for a medical professional to believe a salesperson requires one to suspend the use of prudence and common sense.

The American Pain Society and the American Academy of Pain Medicine are among two influential professional medical associations focusing on pain management. According to a U.S. Senate Homeland Security and Government Affairs Committee report entitled, “Fueling an Epidemic, Exposing the Financial Ties Between Opioid Manufacturers and Third Party Advocacy Groups,” between 2012 and 2017, the American Academy of Pain Medicine received approximately $1.2 million from opioid manufacturers, with the American Pain Society taking in close to $1 million. In addition, the American Academy of Pain Medicine Foundation received over $300,000 from opioid manufacturers in contributions and grants between 2013 and 2015; and the president of the Foundation received over $600,000 between 2013 and 2016. In 1997, the American Academy of Pain Medicine and the American Pain Society released a consensus statement that there was a low risk of addiction when using opioids to treat chronic pain, and a paid Purdue speaker was co-author of the statement.

Approximately 47,100 Americans died from suicide in 2017, and in that same year, there were 1.4 million attempts. Suicide is currently the tenth leading cause of death in the U.S. and the suicide rate has increased by approximately 50% between the years 2003 and 2017. According to the CDC, the life expectancy of Americans has been declining over the past few years and it is driven by both opioid overdoses and suicides. In a 2018 article from the American Journal of Public Health entitled, “America’s Declining Well-Being, Health and Life Expectancy: Not Just a White Problem,” the authors discuss how despair among Americans has been steadily increasing and has a negative impact on health and longevity. Income inequality may also play a role. Our American society is in decline and deaths of despair continue to rise. Individuals who are in psychological pain may seek an escape and opioids may be their way out.

There are likely many more entities who share a role in the opioid epidemic that haven’t been discussed in this article and some of those may include other opioid manufacturers; states’ attorneys general, and local law enforcement—both of whom responded too slowly when the crisis was burgeoning; and pharmacies that did not report suspiciously large quantities of opioids being prescribed. Add to that list are people who do not have an addiction disorder but use opioids for recreational purposes. Those individuals are fully responsible for any negative outcomes of their drug use. On the other hand, addiction is a disease and those who have a substance-use disorder need help. Unfortunately, quality medical care for addiction in the U.S. is abysmal and many are unable to find effective care. In addition, Congress has allowed the pharmaceutical industry to advertise directly to consumers and this has likely worsened our drug-addled society. Moreover, physicians have a tendency to throw pills at just about any problem instead of finding alternative treatments.

Purdue Pharma and the Sackler family are consistently blamed for the opioid epidemic but that approach exculpates all other sources responsible including the FDA, DEA, drug distributors, physicians, professional medical societies, and the retrograde American society. There is no doubt that Purdue and the Sacklers played a role, but to use them as America’s scapegoats sets a dangerous precedent that will likely come back to haunt the U.S. in some future crisis.

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