Start Now to Avoid the Next Purdue Pharma Debacle


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

The owners of Purdue Pharma, the Sackler family, pay $ 4.5 billion in fines and the company is shut down, although the family has been granted immunity from liability. Despite being the biggest fine ever imposed on a pharmaceutical maker, the Sacklers will remain one of the richest families in the world.

Unfortunately, this was not the first time – and it will not be the last – that a drug or medical device company has knowingly or inadvertently put the well-being of millions of people at risk. The United States must begin to prepare and prevent the next tragedy from happening and wreaking havoc on society.

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The opioid epidemic isn’t just a statistic for me, especially given the unprecedented surge in opioid overdoses this year. In my work as a cardiologist specializing in heart transplantation, I see more and more donated hearts from young men and women found by family and friends with their hearts not beating due to an opioid overdose. National data confirms my grim experience: In 2020, one in five hearts 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 big miscarriage of justice that shows how the United States has two legal systems: one for the ultra-rich and one for everyone else. The decision gives the green light to other players in the biomedical industry eager to make a profit, regardless of the human cost. However, punishing Purdue and the Sacklers on their own fails to capture the extent of the corruption across the healthcare system that has helped spread the opioid epidemic. To recover from the current opioid epidemic and prevent more from occurring in the future, a larger calculation is needed and the structures that allowed the Sacklers to dope America must be dismantled.

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The opioid epidemic in part reflects the enormous control the pharmaceutical industry has over how physicians practice medicine. The more opioid makers provided money (or even donuts) to doctors in a given area, the more fatal overdoses occurred there. The lie that prescription opioids are not addictive has become a fundamental tenet of medical education. It became so entrenched that a doctor berated me in an interview with NPR for suggesting that opioids may slow breathing, saying “morphine and other pain relievers are completely safe.”

To get Americans hooked on opioids, Purdue and others knew the easiest way to do it was to influence physician practice, which is remarkably easy to do with financial incentives. The Sacklers have also provided lucrative donations directly to universities in the United States, many of which have branded the Sackler name on their institutes.

The opioid epidemic could have been avoided – or at least its edge could have been blunted – had the Food and Drug Administration exercised due diligence. Even though opioids like OxyContin killed thousands of Americans a year, the FDA continued to approve new opioids, including sufentanil, which is five to 10 times more potent than fentanyl, due to the pressure of the Pentagon. Last August, the FDA approved another powerful new opioid.

While the agency continued to ignore calls for a moratorium on new opioid approvals, programs the FDA had instituted to ensure safe prescriptions were deeply flawed and ineffective. Even though the FDA’s own advisory group voted 25-10 against designing a program to reduce the harms of opioid abuse, the FDA did move forward.

The FDA has come under scrutiny for its approval of a controversial Alzheimer’s disease drug with revelations of an uncomfortably tight coordination between the company and the FDA. But the agency has played a similar role in igniting 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. What’s also troubling is that shortly after the FDA approved 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, has been appointed acting FDA commissioner by President Biden.

Beyond clinicians and regulators, the Sacklers have found many to encourage their criminal ploy, including pharmacies and drug distributors who have flooded small towns with mountains of opioids. McKinsey has designed a program for Purdue Pharma to offer discounts to distributors for every overdose their users experience. At every turn, Purdue Pharma has found an accomplice.

The Biden administration must make tackling the opioid epidemic a priority. In the short term, providing economic relief to Americans struggling with unemployment, homelessness, ill health and loneliness is critical, placing them at high risk of inappropriate painkiller use or drug abuse. illicit drugs. Keeping drug treatment centers open and making it easier for clinicians to prescribe drugs known to reduce risk, such as naloxone and buprenorphine, are other important advances.

In the long run, the most difficult tasks will be preventing ineffective or unsafe drugs and devices from being approved by regulatory bodies and reaching patients, and preventing pharmaceutical and medical device companies from tampering with medical education, d ‘influence clinical guidelines, thwart skeptical voices, promote key opinion. leaders and shape clinical practice.

Conflicts of interest have tainted the heart of American medicine, and disclosure has not curbed the damaging effects of the pharmaceutical and medical device industries on physicians. What is needed is leadership from the FDA that can deactivate the increasingly weak relationship between the pharmaceutical industry and those charged with controlling its influence. To prevent the next Purdue Pharma is to sever the increasingly intimate relationship between the biomedical industry and the American healthcare system.

Haider Warraich is a physician and researcher at the VA Boston Healthcare System and Brigham and Women’s Hospital, 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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