From the Editor

Opioids and us: Designed to fail


 

AIDS, the Vietnam War, whatever your preferred scale for measuring horrific events, the numbers from the opioid crisis are as grave or worse. And, once again, it is the young who are dying. How we got to this point is an unbelievable story of corporate greed, government incompetence, regulatory commission overreach, and, unfortunately, physician ignorance.

Every one of us has contributed to this tragedy, and most of us still do. There are some easy first steps surgeons can take, but first let’s review the mistakes made that drove our country into addiction.

Bottles of opioids/pills BackyardProduction/Thinkstock

In 1995, as their patent on MS Contin was set to expire, Purdue Pharma gained Food and Drug Administration approval for OxyContin (“contin” is pharma talk for continuous). At this time, opioids generally were considered to be dangerous and mainly prescribed for cancer or end-of-life patients. Purdue representatives began an aggressive marketing campaign to break out of this niche. They were aided in this pursuit by the FDA, which wrote in the package insert that iatrogenic addiction was rare and the delayed absorption of OxyContin “is believed to reduce the abuse liability of a drug.” These statements were made without the backing of any clinical trials. But with an on-label statement of reduced addiction risk, representatives could sell OxyContin based on a diminished potential for abuse.

In addition to oncologists, the drug was now marketed to rheumatologists, primary care physicians, and surgeons. OxyContin, therefore, broke through the cancer barrier and became one of the most widely prescribed painkillers in the United States. While generating billions in profits, OxyContin also would become one of the most abused drugs in history.

There were several issues with OxyContin that led to its widespread misuse. The preparation contained up to 160 mg of oxycodone per pill, 16 times more than the strongest Percocet formulary. The tablet also could easily be crushed, overcoming the delayed-release formulation. Because of the FDA insert, sales representatives were free to report an addiction risk of less than 1%, which they did. Widely.

But what science backed this claim? The study referenced was not a study at all. The citation was a one-paragraph, five-sentence letter to the editor published by the New England Journal of Medicine in 1980. In it, the authors briefly described their experience with inpatient opioid therapy. No reference was made to outpatient opioid prescriptions. Still, this letter has been scientifically cited more than 600 times, with a spike starting in 1995, the year OxyContin was released. Even as thousands of Americans were dying each year from opioid use, the “study” continued to be offered as proof of a low risk of addiction. As recently as 2014, the letter was cited in the journal OncoTargets and Therapy to support the statement, “In reality, medical opioid addiction is very rare.”

Maybe if we knew our history we could avoid repeating it. Previously, the drug diacetylmorphine was introduced as a safe, nonaddictive substitute for morphine by Bayer Pharmaceutical in the late 1890s. Diacetylmorphine is better known by its trademarked name, Heroin.

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