Pubdate: Thu, 11 Sep 2003
Source: New York Times (NY)
Copyright: 2003 The New York Times Company
Contact:  http://www.nytimes.com/
Details: http://www.mapinc.org/media/298
Author: Gardiner Harris

PANEL REJECTS PLEAS TO CURB SALES OF A WIDELY ABUSED PAINKILLER

A federal drug advisory panel yesterday rejected pleas from members of 
Congress and drug enforcement officials that sales of the widely abused 
painkiller OxyContin be severely restricted.

But officials from the Bush administration told the panel they were 
seriously considering even broader rules requiring doctors to get special 
training before being allowed to prescribe OxyContin or any other 
controlled narcotic. The changes are intended to stem a growing tide of 
prescription drug abuse.

OxyContin is responsible for 500 to 1,000 deaths a year, a panel member 
estimated yesterday. Some two million people used narcotics recreationally 
in 2001, the last year for which figures were available, up from 1.5 
million in 1998 and 400,000 in the mid-1980's, according to data presented 
to the panel.

Introduced in 1995, OxyContin is a pill that gradually releases steady 
amounts of narcotics for 12 hours. Before OxyContin, patients were required 
to take pills every four hours to achieve significant pain relief. By 
crushing OxyContin pills, drug abusers can get the full, 12-hour narcotic 
effect almost immediately. Snorting or injecting the crushed pill can lead 
to overdose and death.

Some panel members suggested that the death rate could swell substantially 
if Purdue Pharma, the maker of OxyContin, was allowed to sell Palladone, a 
new, more powerful painkiller that Purdue has asked the Food and Drug 
Administration to approve for sale. Most panel members, however, gave tepid 
support to Purdue's plan to introduce Palladone slowly. Several suggested 
the drug's initial introduction period should be extended to a year from 
the company's proposed four months.

The active ingredient in Palladone is identical to that in Dilaudid, "the 
drug of choice for addicts," said Laura Nagel, deputy assistant 
administrator of the Drug Enforcement Administration's office of diversion 
control, who participated in the panel discussions.

In an interview, Ms. Nagel said the possible approval of Palladone "scares 
law enforcement people to no end."

The panel heard testimony from Representative Hal Rogers, a Kentucky 
Republican, who said OxyContin had devastated communities in his district, 
which encompasses much of Appalachian Kentucky.

Mr. Rogers and Ms. Nagel had asked the panel to restrict sales of OxyContin 
and other pills like it to patients who suffer from severe pain. OxyContin 
is now approved for sale to patients with moderate to severe pain. Mr. 
Rogers and Ms. Nagel also asked the panel to ban family doctors and other 
nonspecialists from prescribing the pills. The Food and Drug Administration 
opposed both recommendations. The panel voted 13 to 5 against restricting 
OxyContin's use to patients in severe pain. "I'm uncomfortable with people 
with moderate pain having to beg for access to these drugs," said Dr. 
Steven Shafer, an anesthesiologist from North Carolina. "And I'm concerned 
that taking moderate off would be an invitation to prosecution by the D.E.A."

Nearly all panel members spoke against restrictions that would stop family 
doctors from prescribing the drugs. Panel members noted that patients in 
rural areas who do not have access to specialists would effectively be 
denied the medicine if the power to prescribe the pills was limited to 
specialists.

Mr. Rogers said he thought the panel's conclusions were a mistake, adding, 
"I advocated both of those positions and obviously I was unsuccessful."

The panel largely agreed that OxyContin should be given only to patients 
who have already tried less powerful, faster-acting narcotics but found 
that such pills did not deliver the pain relief they needed.

The panel responded enthusiastically when Ms. Nagel revealed the Bush 
administration's plans to require doctors to get training before 
prescribing controlled narcotics. "We came up with this idea two months 
ago," Ms. Nagel said in an interview, "but we're getting resounding support."

A spokeswoman for the American Medical Association said she could not 
comment on the proposal since she had not seen it. Mr. Rogers said the 
proposal "sounds like a good suggestion" but could not comment more until 
he saw it.

A senior Food and Drug Administration official confirmed that the policy 
was under consideration. "Appropriate prescribing is changing rapidly," he 
said, "and we need to make sure doctors have the latest information about 
these drugs."

Under the administration's proposal, doctors would have to prove that they 
had taken a painkiller class before receiving permission from the Drug 
Enforcement Administration to prescribe controlled narcotics. Such 
permission is now granted routinely without special training. The agency 
requires that doctors register for this permission every three years, and 
under the administration's proposal, the agency would require that doctors 
undergo refresher training every three years.

"We should restrict the prescriptions of these drugs to the educated 
physicians," said Dr. Carol Rose, a panel member and an anesthesiologist 
from Presbyterian University Hospital in Pittsburgh.
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MAP posted-by: Keith Brilhart