New accusations are raining down on Oxycontin maker Purdue Pharma, and a U.S. senator has called on the FDA, the FTC and the DOJ all to investigate. The latest claim? That Purdue downplayed evidence the painkiller wore off much faster than its labeled 12 hours in many people, making them more likely to get addicted.
Sen. Edward Markey, whose state of Massachusetts has been hard hit by opioid addiction problems, has sent separate letters to each agency, asking them to look into evidence discussed in a Los Angeles Times story that the drugmaker knew that for many patients, the drug did not work for 12 hours. The claim was the key differentiator for the drug as well as the basis for its higher price.
The stories said even in the first clinical trial of the drug, it wore off early in about half of those who were given the addictive painkiller. When faced with complaints from doctors and outside research that highlighted the problem, the newspaper says Purdue recommended patients be given a higher dose, not more frequent doses. The newspaper pointed to evidence that those who get higher doses of opioids are at a higher risk for overdosing.
In a response to the LA Times, Purdue said it also was concerned about the opioid epidemic but pointed out that the FDA had approved Oxycontin for 12-hour use and that is how it is sold. “We promote our medicines only within the parameters approved by FDA and, given FDA has not approved Oxycontin for eight-hour use, we do not recommend that dosing to prescribers,” the statement said.
Many experts blame overprescribing by doctors for much of the problem of opioid abuse in the country, but others put much of the blame on drugmakers. Nearly a decade ago, Purdue pleaded guilty to one felony count of fraudulently misbranding Oxycontin for suggesting it was less addictive and less abused than other painkillers, while the CEO and two other execs also pleaded guilty to a federal misdemeanor for misbranding. The company paid $635 million to settle the legal entanglements.
But in his letter to the DOJ, Sen. Markey said if there is new evidence that Purdue hid risks of the drug then they should be investigated.
“Oxycontin’s leading role in this epidemic is well-established, caused in large part by Purdue’s aggressive--and illegal--marketing efforts,” the senator said in the letter posted on his website. “If Purdue’s wrongdoing has continued and resulted in further damage to the United States, the Department of Justice should seek additional compensation.”
Markey’s call for an investigation is just the latest in the onslaught on opioid drugmakers and opioid abuse, which many link to higher rates of heroin use in the U.S. and growing numbers of overdose deaths. Both the FDA and the CDC have changed their prescribing guidelines for the drugs, telling doctors that other pain meds should be tried first and opioids saved for only the most difficult cases. There is evidence these changes and the backlash over their widespread use is beginning to cut into sales of the drugs.
Special Report: Pharma's Top 11 Marketing Settlements - Purdue Pharma - OxyContin
New Hampshire AG launches investigation into opioid marketing
Endo to declare Opana ER addiction risks to settle opioid probe by NY
Chicago makes second run at Allergan, J&J, Purdue and others with painkiller lawsuit
CDC guidelines call for drastic cuts in opioid painkiller use
FDA sets new limits on use of immediate-release opioids