United States Senator Edward J. Markey has called for a federal investigation of OxyContin’s manufacturers in response to a Los Angeles Times report. The report found that the drug tends to wear off early in many patients, which can expose them to an increased risk of addiction.
According to the LA Times, OxyContin’s main selling point is that it lasts for twelve hours. The investigation found that “when the effects don’t last, patients can suffer symptoms of a narcotic withdrawal, including intense craving for the drug, and experience a cycle of agony and relief that experts say promotes addiction.”
The report states that “Purdue has known about the problems for decades. Even before OxyContin went on the market, clinical trials showed many patients weren’t getting 12 hours of relief. Since the drug’s debut in 1996, the company has been confronted with additional evidence, including complaints from doctors, reports from its own sales reps and independent research.”
Allegations included in the report include the idea that Purdue has held fast to the claim of twelve-hour relief to protect its revenue. They allege that OxyContin’s market dominance and high price rely on the twelve-hour duration and without such a claim, the drug offers little advantage over less expensive painkillers. The report also alleged that Purdue told doctors to prescribe stronger doses, not more frequent ones, if patients complain that OxyContin doesn’t last twelve hours.
In two letters, Senator Markey urged the Department of Justice (DOJ), and the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) to launch probes into Purdue Pharma. As a result of the LA Times report, Senator Markey believes that Purdue made false claims about the longevity of OxyContin’s pain relieving properties.
Senator Markey posited that after investigation, if the allegations included in the LA Times report are found to be substantiated, the DOJ should take legal action against the Purdue Frederick Company, Inc., as well as its pharmaceutical subsidiary Purdue Pharma, L.P., including recouping damages that were sustained by federal healthcare programs that paid for excess OxyContin prescriptions that should have been unnecessary if the drug lasted for the full twelve hours, as Purdue claimed.
The letter to the DOJ also cites to a 2007 criminal proceeding against Purdue, in which Purdue “pled guilty to a felony charge of illegally misbranding OxyContin in an effort to mislead and defraud physicians and consumers.” In that proceeding, Purdue admitted to illegally marketing and promoting OxyContin by falsely claiming that it was less addictive, less subject to abuse and diversion, and less likely to cause withdrawal symptoms than other pain medications. Purdue agreed to pay over $600 million in civil fines, penalties, and forfeitures in connection with that case. Separately, three Purdue executives pled guilty to misdemeanor charges of misbranding OxyContin and collectively agreed to pay $34.5 million in penalties.
The letter to the FDA and FTC urged the groups to immediately take action that would prevent the dissemination of misleading or false information about OxyContin’s duration to those making prescribing decisions, and to patients. Senator Markey also asked the organizations to “warn prescribers, patients, and the general public about the dangerous impact of using higher or more frequent dosing to compensate for OxyContin’s failed claims.”
Senator Markey’s claims and call for an investigation are just the latest in the onslaught on opioid drug makers and opioid abuse. Both the FDA and CDC have changed their prescribing outlines for the drugs; and there is evidence that those changes and the backlash over their widespread use is beginning to cut into sales of the drugs.