updated 1/22/2004 5:51:10 PM ET 2004-01-22T22:51:10

The maker of OxyContin sent doctors promotional videos that made unsubstantiated claims minimizing the dangers associated with the pain relief drug, congressional investigators said Thursday.

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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 report said.

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."

Drug's safety overstated, FDA says
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 drug's potency may have made it an attractive target for abuse, the report said, 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 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, because data on drug abuse isn't reliable.

Purdue Pharma spokesman Jim Heins said that lack of information about why the drug has been abused means critics shouldn't point fingers at the company without obtaining more proof.

"There's not a clear indication that our marketing has led to diversion and abuse," Heins said. "Unfortunately, prescription drug abuse has been a problem in the U.S. for a long time, particularly in Appalachia.'

Heins confirmed that Purdue Pharma is facing roughly 340 lawsuits for its marketing of OxyContin, but he said 70 of them have been dismissed.

Republican Rep. Hal Rogers, who represents an eastern Kentucky district hard-hit by OxyContin abuse, is among the lawmakers who called for the investigation.

Rogers said 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. That was three years after reports of widespread abuse surfaced.

"Why did it take the company three years to use their highly detailed data on physician prescribing practices to identify patterns of abuse?" Rogers asked.

The GAO investigators recommend that the FDA encourage drug makers to submit plans to the agency identifying potential problems for abuse and diversion of new drugs.

FDA spokeswoman Kathleen Quinn said the recommendation is similar to one made by an advisory panel.

"FDA does agree with both that committee's recommendation and GAO's in their encouragement of stronger risk management plans," Quinn said. "We are working to put those types of plans in place."

© 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


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