DEA CONSIDERS OCYCONTIN CUTBACK

The head of the U.S. Drug Enforcement Administration is considering an
order that would mean a significant cut in production of the prescription
painkiller OxyContin, which has become a target of serious abuse in Eastern
Kentucky and other areas around the country.

Some groups interested in pain management oppose the move, saying it could
make it more difficult and more expensive for people in pain to get OxyContin.

Police and prosecutors, however, say cutting the supply could help combat
widespread illegal use of the powerful drug.

Donnie Marshall, director of the DEA, told members of Congress on May 17
that he was considering rolling back the annual quota DEA sets on
production of OxyContin. Marshall has taken no action since, but the move
is still under consideration, said DEA spokeswoman Rogene Waite.

Marshall said he was thinking of reducing the quota to the 1996 level
unless the maker of OxyContin, Purdue Pharma LP of Stamford, Conn., does
more to help reduce abuse of the drug. That would be a whopping cut;
requests for production quotas of OxyContin have gone up 1,800 percent in
the last five years, Marshall said.

"That's a drastic step and it would be a very controversial step, because
there is the need for this drug out there," Marshall said. "But I am
seriously considering that."

Marshall made the comment while testifying on budget issues before a
Congressional subcommittee.

The potential for a quota cutback is not clear. Marshall, a Clinton
administration appointee, will be replaced soon; President Bush has
nominated former U.S. Rep. Asa Hutchinson, R-Ark., to succeed Marshall.

OxyContin, a synthetic morphine, went on the market in 1996 for treatment
of moderate to severe pain expected to last more than a few days. Doctors
and patients alike say it has been a boon for people suffering from cancer,
crippling arthritis and other problems.

Sales skyrocketed, topping $1 billion in 2000 to become the top-selling
narcotic painkiller in pill form in the U.S.

However, OxyContin has become one of the most-abused drugs in some areas of
several states including Kentucky, Virginia and Maine because of the
powerful high and accessibility. Abusers often grind up the pills and snort
or inject the drug.

Police and prosecutors say abuse of OxyContin has contributed to scores of
overdose deaths, an increase in prescription fraud and thefts by people
stealing to get money for the drug. Authorities are particularly concerned
that a large number of teen-agers are abusing the drug.

"In the current state of drug abuse in Eastern Kentucky, the demand for
OxyContin is astronomical," said Assistant U.S. Attorney Roger West, lead
federal prosecutor in an investigation that produced more than 200
OxyContin-related arrests in February. It was the largest drug roundup in
Kentucky history.

At the May 17 hearing, Republican U.S. Rep. Harold "Hal" Rogers, who
represents Eastern Kentucky's 5th District, called OxyContin abuse "a
full-blown epidemic" in the area and asked Marshall what the DEA is doing
about the problem.

Marshall said the agency has taken a number of steps, including
investigations of doctors, pharmacies and drug dealers.

The DEA has also asked Purdue Pharma to consider a number of things, such
as providing more education and information for doctors on the potential
dangers of OxyContin, limiting how it distributes and markets the drug, and
looking into the potential to reformulate the drug to make it harder to abuse.

Marshall said Purdue Pharma has cooperated on some issues, but balked on
others.

"If we can't find some more middle ground in this area, I am seriously
considering rolling back the quotas that DEA sets ... until we do find ways
to control this," Marshall told Rogers.

Marshall said the huge increase in production of OxyContin was driven in
part by legitimate attempts to treat pain an increasing priority in health
care. But some of the increase "is stuff that's going then into the black
market," Marshall said.

Purdue Pharma spokesman Jim Heins said the company has gone to great
lengths to try to reduce illegal diversion of OxyContin: providing
education for doctors and the public, funding research on drug abuse and
prescription-monitoring programs, providing tamper-proof prescription pads,
and changing the markings on pills shipped to Canada and Mexico to prevent
smuggling. The company is also spending tens of millions of dollars to
develop drugs with less potential for abuse, Heins said.

Heins said the company is concerned about the potential for a cut in the
OxyContin production quota. He declined to comment on whether Marshall's
statement may have been merely a way to prod cooperation from Purdue Pharma.

The statement got attention elsewhere in the world of pain control.

Richard S. Weiner, executive director of the American Academy of Pain
Management in Sonora, Calif., sent a letter to Marshall last week saying it
would be unethical to cut the amount of OxyContin available.

Weiner said Purdue Pharma has taken impressive measures to combat abuse of
its product. Reducing the supply of OxyContin would make it more difficult
for people in pain to get it, leaving thousands of people with less
adequate remedies and hurting their quality of life, he said.

"That would be very dangerous and wrong-headed policy," Weiner said.

Waite, however, said DEA officials have made clear the agency has no
intention of keeping medication from people who need it.

Weiner said another concern is that Marshall's statement would apply to a
cutback not just in OxyContin, but the production quota of oxycodone the
ingredient in OxyContin and other drugs possibly limiting access to a
number of medications.

Waite agreed any rollback would be on the amount of oxycodone. But within
that quota, DEA can control the amount allocated to a specific company, she
said.

Heins said Purdue Pharma assumed Marshall was talking only about cutting
production of OxyContin.

Reducing the supply of OxyContin would help curb abuse because there would
be less of the drug available to divert for illegal use, West said.

"It would be a massive step in the right direction," he said.