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Associated Press, Jan. 23, 2004
from the Richmond Times-Dispatch
Report Questions Claims On Drug
WASHINGTON - The maker of OxyContin sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug, congressional investigators said yesterday.
The General Accounting Office also said 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 its failure to send the video to the agency was an oversight. It did submit a 2001 video for FDA examination, but the agency did not review it "because of limited resources," the report said.
On the 1998 video, a doctor says 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 FDA looked at the later video after GAO investigators inquired about it. The agency said 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."
The FDA also publicly cited Purdue Pharma last year for overstating OxyContin's safety in print ads.
OxyContin was initially hailed as a breakthrough in the treatment of severe chronic pain when it was introduced in 1996. The drug has become a problem in recent years, however, after users discovered that crushing the time-release tablets and snorting or injecting the powder yields an immediate, heroin-like high.
Lawmakers asked GAO, the investigative arm of Congress, to study Purdue Pharma's marketing of OxyContin because of the drug's widespread abuse, especially in Appalachian states.
The report said it was difficult to pinpoint the relationship between the increase of OxyContin prescriptions in recent years and the diversion of the drug to abusers.
Purdue Pharma spokesman Jim Heins said that lack of information about why the drug has been abused means critics should not point fingers at the company without obtaining more proof.
Heins confirmed that Purdue Pharma is facing roughly 340 lawsuits for its marketing of OxyContin, but he said 70 of them have been dismissed.