GAO: OxyContin Claims UnsubstantiatedJan 22, 2004 | AP The maker of OxyContin sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug, according to a congressional investigation released Thursday.
The General Accounting Office also found that in 1998 Stamford, Conn.-based Purdue Pharma failed to submit one of the videos to the Food and Drug Administration for review, as required, when the company started circulating it to thousands of doctors.
The company said failure to get approval was an oversight. It did submit a 2001 video for FDA approval but the agency did not review it "because of limited resources," the report said.
On the 1998 video, a doctor says that less than 1 percent of people who take pain relief medication like OxyContin become addicted. That's a figure the FDA says has not been substantiated, the report said.
The FDA looked at the later video at the request of GAO investigators and found it "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."
OxyContin was hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. But the drug has become a problem in recent years after users discovered that crushing the time-release tablets and snorting or injecting the powder yields an immediate, heroin-like high.
Lawmakers asked the GAO, the investigative arm of Congress, to study Purdue Pharma's marketing of OxyContin because of widespread abuse, especially in Appalachian states.
Purdue Pharma is facing more than 300 lawsuits for its marketing of OxyContin, the report said. Plaintiffs allege the company used improper sales tactics to promote the drug and failed to take steps to prevent people from becoming addicted.
The report said the company didn't analyze physician prescribing reports, which it routinely uses for marketing purposes, to identify possible abuse until six years after the drug hit the market.