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.