Pubdate: Tue, 01 May 2001
Source: New York Times (NY)
Copyright: 2001 The New York Times Company
Contact:  http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Barry Meier
Bookmark: http://www.mapinc.org/find?186 (Oxycontin)

U.S. ASKS PAINKILLER MAKER TO HELP CURB WIDE ABUSE

Federal officials have urged the maker of a widely abused narcotic
painkiller to limit how it distributes and markets the drug, which has
played a role in more than 100 fatal overdoses in several states.

Federal officials have also been in talks about withdrawing or modifying
a claim that the painkiller, OxyContin, may be less prone to abuse than
similar narcotics.

The moves come as the officials at the Drug Enforcement Administration
start what they describe as the agency's first effort to curb misuse of
a specific prescription drug. Previously, the agency had sought to
reduce abuse of classes of drugs, but officials of the drug enforcement
agency said the abuse problem involving OxyContin was so grave that it
required unique action.

Terry Woodworth, a top official at the agency, said it was concerned
that the promotion and distribution of OxyContin by its manufacturer,
Purdue Pharma L.P., to doctors like general practitioners might have led
to its wide misuse. The government has said that no prescription drug in
the last 20 years has been so widely abused so soon after its release as
OxyContin.

Mr. Woodworth said the agency had recently asked Purdue officials to
volunteer to limit the drug's distribution to only those specialists who
regularly treat patients for chronic or severe pain.

"D.E.A. is extremely concerned that many doctors are prescribing this
strong narcotic as an initial treatment for many types of pain and that
is a result of how it has been promoted," said Mr. Woodworth, the deputy
director of the agency's office of diversion control.

In a statement responding to questions, officials of Purdue, which is
based in Stamford, Conn., acknowledged the agency's request but declined
to elaborate on how the company would respond.

"We expect to have ongoing, constructive dialogue with the D.E.A. on
this subject," the statement said. "We do not think it would be
appropriate to go into any specifics at this time."

Separately, Purdue officials have said they have taken voluntary steps
in the past year to combat abuse of OxyContin and are working to
reformulate the product.

OxyContin, which was approved by the Food and Drug Administration in
late 1995 for treating moderate or severe pain, is the leading narcotic
painkiller sold in tablet form in the United States. Last year, its
sales in this country exceeded $1 billion.

Medical authorities and law enforcement officials agree that the drug
can be highly effective in treating severe or chronic pain because its
time-released form enables its active ingredient to work over many
hours. It was first thought that such slowed release would deter illicit
use of the drug because abusers prefer the quick euphoric rush that
immediately released narcotics provide.

But in just a few years, abuse of OxyContin has become rampant,
officials say. The treatment's users quickly discovered that they could
defeat the time-released design by crushing or dissolving the tablet.
That gave them immediate access to the drug's active
ingredient, a synthetic form of morphine called oxycodone, which could
then be snorted or injected.

Abusers and others have also been able to obtain OxyContin by going
around to doctors and feigning pain. Experts have said that many family
doctors and general practitioners have little experience in spotting
drug abusers or monitoring how their patients use narcotics.

In recent years, OxyContin has been a factor in more than 120 drug
overdose deaths, the authorities report. Communities in Maine, Kentucky
and Virginia have been devastated by crime waves involving OxyContin
addicts. The treatment has an extremely high street value of a dollar a
milligram; a single 40-milligram pill would cost $40.

Purdue, a privately held company, has aggressively marketed the drug in
recent years by paying the hotel and travel expenses of hundreds of
doctors who attended weekend "pain management" seminars in vacation
spots like Florida.

The company has also held roughly 7,000 seminars around the country for
doctors, including many general practitioners, that advocated the use of
powerful long-lasting narcotics like OxyContin in pain treatment.

Purdue officials say they have responsibly marketed and promoted
OxyContin. In addition, they say they have moved swiftly to combat
misuse of the drug, which they say has brought relief to thousands of
patients who otherwise would suffer needlessly.

Also, the company said, in December it stopped sponsoring trips to
seminars for doctors, after the United States attorney's office in
Maine, where numerous cases of OxyContin abuse have occurred, asked it
to stop doing so.

Mr. Woodworth of the drug enforcement agency said it was still trying to
determine what percentage of OxyContin prescriptions were medically
necessary. But he emphasized that the agency did not want to prevent
those who needed the drug from getting it.

He added, however, that the agency believed the drug had been frequently
prescribed by doctors who could have recommended less powerful drugs
before turning to OxyContin. He said he believed that part of the reason
doctors prescribed OxyContin so readily was their belief that it was
less prone to abuse.

"Your family practitioner and pediatrician don't have a speciality in
the treatment of chronic and severe pain," Mr. Woodworth said. "When you
couple that with the marketing that the drug is less prone to abuse, you
have contributed to some of the problems here."

Officials of both Purdue and the F.D.A. declined to comment on any
contemplated changes to the product's labeling, citing the
confidentiality of discussions between the agency and the companies it
regulates.
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