Purdue Pharma Made Improper Claims Regarding Painkiller OxyContin, GAO Report Says

Connecticut-based OxyContin manufacturer Purdue Pharma sent physicians promotional videos that made "unsubstantiated claims minimizing the dangers" of the pain medication, according to a General Accounting Office report released Thursday, the AP/Long Island Newsday reports. According to the report, Purdue Pharma officials in 1998 failed to submit one of the videos to the FDA for review, as required, before sending the video to physicians. In the video, a physician states that less than 1% of individuals who take OxyContin become addicted. The report said that the FDA has not confirmed the statement. In addition, the report said that an FDA examination found that a separate video sent to physicians in 2001 "appeared to make unsubstantiated claims regarding OxyContin's effect on patients' quality of life and ability to perform daily activities and minimized the risks associated with the drug." The FDA last year cited Purdue Pharma overstatements about the safety of OxyContin in print advertisements. Lawmakers asked the GAO to study the promotional practices used by Purdue Pharma in response to reports of widespread OxyContin abuse nationwide. According to the report, the potency of OxyContin may have "made it an attractive target for abuse," and a safety warning advising patients not to crush tablets because of the rapid release of a drug component may have "tipped abusers off about how to misuse the drug," the AP/Newsday reports.

Reaction, Recommendations
Purdue Pharma spokesperson Jim Heins said, "There's not a clear indication that our marketing has led to diversion and abuse. Unfortunately, prescription drug abuse has been a problem in the U.S. for a long time." Rep. Hal Rogers (R-Ky.), one of the lawmakers who called for the GAO report, said that the "one thing that upset him was the report's finding that the company didn't analyze physician prescribing reports, which the company regularly uses for marketing purposes, to identify possible abuse of the drug until 1999," three years after reports of widespread OxyContin abuse appeared, the AP/Newsday reports. The report recommended that the FDA encourage pharmaceutical companies to submit plans to the agency to identify potential problems for diversion and abuse of new prescription drugs. FDA spokesperson Kathleen Quinn said that the agency agrees with the recommendation. She added, "We are working to put those types of plans in place" (Zuckerbrod, AP/Long Island Newsday, 1/22).

The GAO report is available online. Note: You must have Adobe Acrobat Reader to view the report.