Health

Start now to prevent the next Purdue Pharma debacle


Start now to prevent the next Purdue Pharma debacle

The judgment finalizing the Purdue Pharma bankruptcy case is a likely bitter end to litigation stemming from the company’s role in fomenting the opioid epidemic, which has claimed half a million lives since 1999 and tethered millions of Americans to opioid painkillers and illicit narcotics.

The owners of Purdue Pharma, the Sackler family, are paying $4.5 billion dollars in fines and the company is being shuttered, though the family has been granted immunity from any liability. While this is the largest fine ever levied on a pharmaceutical manufacturer, the Sacklers will remain one of the richest families in the world.

Sadly, this wasn’t the first time — nor will it be the last — that a medical drug or device company knowingly or inadvertently put the well-being of millions of people at risk. The U.S. must begin to prepare and prevent the next tragedy from coming along and ravaging society.

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The opioid epidemic isn’t just a statistic to me, especially given the unprecedented spike in opioid overdoses this year. In my work as a heart transplant cardiologist, I see more and more donated hearts coming from young men and women found by family and friends with their hearts not beating because of an opioid overdose. The national data confirm my grim experience: in 2020, every fifth heart donated for transplantation came from a young person dying of a drug overdose, the highest proportion in U.S. history.

The Purdue Pharma deal is a grand miscarriage of justice that shows how the U.S. has two justice systems: one for the ultra-rich and the other for everyone else. The ruling provides a green light for others in the biomedical industry willing to pursue profit no matter the human cost. However, punishing Purdue and the Sacklers alone fails to capture the scope of corruption throughout the health system that helped spread the opioid epidemic. To recover from the current opioid epidemic and to prevent others from occurring in the future, a broader reckoning is necessary and the structures that enabled the Sacklers to dope America need to be dismantled.

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The opioid epidemic reflects in part the enormous control the pharmaceutical industry has over how physicians practice medicine. The more money (or even donuts) opioid manufacturers provided to physicians in a particular area, the more fatal overdoses occurred there. The lie that prescription opioids do not cause addiction became a core tenet of medical education. It became so entrenched that a physician berated me during an NPR interview for suggesting that opioids can cause one’s breathing to slow down, saying that “morphine and other pain medications were entirely safe.”

To hook Americans on opioids, Purdue and others knew that the easiest way to do that was to influence physician practice, which is remarkably easy to do with financial incentives. The Sacklers also provided lucrative donations directly to universities around the U.S., many of whom branded the Sackler name on their institutes.

The opioid epidemic could have been prevented — or at least its sharp edge could have been blunted — had the Food and Drug Administration done due diligence. Even as opioids like OxyContin were killing thousands of Americans a year, the FDA continued to approve newer opioids, including sufentanil, which is five to 10 times more powerful than fentanyl, due to pressure from the Pentagon. Just this August, the FDA approved another potent new opioid.

As the agency continued to ignore calls to place a moratorium on new opioid approvals, programs the FDA had instituted to ensure safe prescriptions were deeply flawed and ineffective. Even as the FDA’s own advisory panel voted 25-10 against the design of a program meant to curb the harms of opioid abuse, the FDA moved forward with it anyway.

The FDA has come under sharp scrutiny for its approval of a controversial Alzheimer’s drug with revelations of uncomfortably close coordination between the company and the FDA. But the agency played a similar role in inflaming the opioid epidemic. According to testimony from a Purdue official, the FDA itself added a statement to the OxyContin label — without any evidence — that it was less addictive than other narcotics. Also troubling is that shortly after the FDA’s approval of OxyContin in 1995, the FDA reviewer for the drug was hired as a senior executive by Purdue. And the FDA official who ultimately oversaw many of these failures, Janet Woodcock, far from being punished, was appointed as the FDA’s interim commissioner by President Biden.

Beyond clinicians and regulators, the Sacklers found many to abet their criminal scheme, including pharmacies and drug distributors who flooded small towns with mountains of opioids. McKinsey devised a scheme for Purdue Pharma to offer rebates to distributors for every overdose that their users experienced. At every turn, Purdue Pharma found an accomplice.

The Biden administration must make curbing the opioid epidemic a priority. In the short term, it is essential to provide economic relief to Americans struggling with unemployment, homelessness, poor health, and loneliness — which puts them at high risk for using painkillers inappropriately or turning to illicit drugs. Keeping addiction treatment centers open and making it easier for clinicians to prescribe drugs known to reduce harm, such as naloxone and buprenorphine, are other important steps forward.

In the long run, the harder tasks will be to prevent ineffective or dangerous drugs and devices from being cleared by regulators and reaching patients, and preventing pharmaceutical and medical device companies from tainting medical education, influencing clinical guidelines, stymieing skeptical voices, promoting key opinion leaders, and shaping clinical practice.

Conflicts of interest have stained the heart of American medicine and providing disclosures has not curbed the malignant effect pharmaceutical and medical device industries have on physicians. What’s needed is leadership at the FDA that can disable the increasingly cushy relationship between the pharmaceutical industry and those charged to check its influence. Preventing the next Purdue Pharma means breaking the increasingly intimate relationship between the biomedical industry and the American health system.

Haider Warraich is a physician and researcher at the VA Boston Healthcare System and Brigham and Women’s Hospital, an assistant professor of medicine at Harvard Medical School, and author of the forthcoming book, “The Song of our Scars: The Untold Story of Pain. (Basic Books, April 2022).




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