Pubdate: Fri, 23 Jan 2004
Source: Richmond Times-Dispatch (VA)
Copyright: 2004 Richmond Newspapers Inc.
Contact:  http://www.timesdispatch.com/
Details: http://www.mapinc.org/media/365
Author: Associated Press
Bookmark: http://www.mapinc.org/oxycontin.htm (Oxycontin/Oxycodone)

MAKER OF OXYCONTIN MINIMIZED ITS DANGERS IN VIDEOS FOR DOCTORS

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.
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MAP posted-by: Larry Seguin