When Purdue Pharma reformulated its signature pain drug OxyContin in 2010, its aim was to make the pill “abuse-deterrent.” But the change may have had an unanticipated and disastrous public health impact, according to a new study: accelerating a nationwide spike in hepatitis C infections.
When the new version of OxyContin became far more difficult to crush or ingest nasally, many opioid users switched to injecting illicit heroin after 2010. That shift, researchers found, caused hepatitis C rates to spike three times faster in states with the highest non-medical OxyContin use.
The new study, published Monday by the RAND Corporation think tank, is the latest evidence that some policy shifts enacted in response to the opioid crisis may have had adverse public health effects. Separate studies have shown that the OxyContin reformulation also drove a spike in heroin-related deaths. More recently, strategies to reduce the supply of prescription opioids have received scrutiny for the same reason: Opioid users with untreated addictions often turn to riskier illicit drugs.
“The shift to injection drug use affects more than just overdose risk,” wrote David Powell, Abby Alpert, and Rosalie Pacula, the paper’s authors. “It also raises the risk of spreading highly lethal diseases that will place an enormous burden on the health care system in the future.”
In the years after OxyContin’s reformulation, hepatitis C rates spiked across the country. Much of the increase in states with high rates of nonmedical OxyContin use, the study showed, was attributable to former OxyContin users switching to injection drug use. States with above-average rates of nonmedical OxyContin misuse saw hepatitis C rates increase by roughly 225 percent after the drug was reformulated. States with below-average OxyContin misuse saw just a 75 percent uptick.
When Purdue reformulated the drug, it pledged that far fewer pills would be diverted for illicit use. The effort did lead to a roughly 40 percent reduction in misuse of OxyContin, according to the study.
But the increased transmission rates of hepatitis C — the deadliest infectious disease in the U.S. by a wide margin — could encourage policymakers to measure their drug epidemic responses using metrics beyond just overdose deaths and overall drug use.
A Purdue spokesman, presented with the study’s findings, pointed to data that showed Oxycontin’s reformulation was one of many inflection points in rates of heroin use, and said the abuse-deterrent formula aimed to facilitate “proper use for people with pain.”
The research comes amid a flurry of damaging revelations surrounding Purdue and its owners, the Sackler family, whose marketing tactics have become infamous as authorities across the country demand answers for an epidemic that takes nearly 50,000 lives each year.
Maura Healy, the Massachusetts attorney general, has won legal rulings forcing the release of marketing documents and evidence that onetime Purdue president Dr. Richard Sackler aimed to unleash “a blizzard of prescriptions” and later called those who developed addictions “reckless criminals.” Last week, a new report showed that the Sackler family had considered entering the addiction-treatment market — meaning that the company effectively sought profits that helped create the crisis and, later, that aimed to help solve it.
As Purdue’s role in the opioid epidemic has been more closely scrutinized, the company has taken steps to mitigate the public relations fiasco. It announced in early 2018 that it would stop marketing the drug to doctors. Last September, the company announced it would donate $3.42 million to a nonprofit that is developing an over-the-counter form of the overdose-reversal drug naloxone.
While the study found statistically significant differences in hepatitis C rates attributable to the OxyContin reformulation, its authors acknowledged their findings may have been limited by underreporting of hepatitis C rates, external factors like the introduction of other medicines used to treat pain or hepatitis C, and a reliance on self-reported data.
Nonetheless, they joined a larger group of physicians, researchers, and patient advocates urging caution as governments recalibrate their policies about pain and addiction treatment.
“As the Food and Drug Administration promotes the reformulation of more opioids and as more policies seek to limit access to prescription opioids, both the medical and the law enforcement communities must recognize the critical transition from prescription opioids to other drugs,” the study authors wrote, “particularly those that are injected.”