GAO: OXYCONTIN CLAIMS UNSUBSTANTIATED

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 Thursday.
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."

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."