DEA, COMPANY FIGHT DRUG'S ABUSE

Abuse of a popular pain drug manufactured by Purdue Pharma has state
and federal officials poised to take action and has caused the drug
company to pull the pills containing the highest dosage of the
medication from pharmacies.

The federal Drug Enforcement Agency is considering limiting
distribution of the time-release drug OxyContin - an unprecedented
move for a single drug - until the company introduces an
abuse-resistant version of the pill.

State Attorney General Richard Blumenthal said his office is
conducting a Medicaid fraud investigation related to the drug, after
state agencies became concerned about a spike in usage and possible
illegal use and sale of OxyContin.

Days after the company outlined a 10-point program to help curb the
growing illegal use of the drug, which can give a heroin-like high if
it is crushed and ingested, Stamford-based Purdue Pharma L.P. last
week decided to take its highest-dosage version of the medication off
the shelves.

DEA officials call the illegal use of the drug - which has become
prevalent in at least six states - a top priority and might take the
unprecedented step of controlling distribution of the medication,
they said last week.

"The widespread use and (illegal distribution) of OxyContin is
directly related to its increased availability," said Terrance
Woodworth, deputy director of the DEA's Office of Diversion Control.
"As a result, (the) DEA has recommended that the distribution of
OxyContin be limited during the period of reformulation of a less
abusable product."

The company, though praised for its efforts to control the illegal
spread of OxyContin and other drugs, is fighting back.

Purdue officials stress that they initiated meetings with the DEA and
have been working for three years to create a harder-to-abuse version
of OxyContin.

"We should not allow criminals and drug abusers to influence drug
policy for everyone else in this country," said J. David Haddox,
Purdue's medical director. "It's a travesty."

The five-year-old OxyContin has been hailed by many in the medical
field as a landmark pain drug, particularly for those who suffer
extreme or chronic pain.

Its hardened layers allow for gradual absorption into a patient's
bloodstream, requiring the pill be taken only once or twice a day, as
compared with every four or six hours, like other pain remedies.

But if the pill is crushed and then injected, taken intravenously or
swallowed, it can give a high similar to such drugs as heroin or
cocaine. The addiction potential of OxyContin, when taken
incorrectly, is the same as heroin, the DEA has said.

On the street in at least a half dozen states, OxyContin is sold for
$1 per milligram, or about 10 times more than in a pharmacy, for its
illegal use, officials said.

The pill has grown exponentially in popularity, tallying more than $1
billion in pharmacy sales last year - topping Pfizer's Viagra. The
pill accounts for about 80 percent of Purdue Pharma's revenues.

After the introduction of OxyContin in 1996, the drug has at least
doubled in sales every year. Its $1.1 billion figure last year ranked
22nd on the U.S. prescription market, according to Westport-based IMS
Health, which tracks the health-care industry.

Its popularity enabled Purdue to crack the top 20 U.S. pharmaceutical
companies last year, according to IMS Health.

The privately held Purdue says it has other drugs in its pipeline,
which officials declined to discuss in detail. They said
reformulating OxyContin is the company's top priority.

"DEA may have said they've asked us to do this, but we've had this
program in place for the last three years," Haddox said. "It's not as
simple as some people want to make it seem."

DEA officials have described a pill that would release a "reversal
agent," which would reduce or eliminate the medication's addictive
qualities if it were crushed.

Haddox said the addition of such an agent could create a ceiling to
the drug's effectiveness for pain treatment.

"That's our No. 1 research priority now, and we have a whole team of
scientists working full time on this problem," he said. "But we don't
have the answer yet, probably in a couple of years. Then there are
the regulatory hurdles to get through."

Until that new drug is ready, federal officials are considering a
"central pharmacy" system of distribution of OxyContin, in which the
medication will be available in select locations.

Officials said their efforts will not prevent those in need from
getting the medication.

Purdue earlier this month announced a 10-point plan to control
illegal use of the drug, including the creation of tamper-resistant
prescription pads, radio advertisements, educational brochures and
informational programs and changing the color of tablets shipped to
foreign countries to help identify illegal reimportation of the drug.

The central pharmacy concept is not likely to address the main
concerns of the government and law enforcement, Purdue said.

Neither prescription fraud, where patients alter or copy
prescriptions, nor so-called doctor shopping - in which sophisticated
criminals call doctors to try to obtain medication - would be
prevented through a central pharmacy, Haddox said.

"The patients are the ones who will get hurt," he said.

In Connecticut, Blumenthal said his office believes abusers are
"doctor shopping" or contacting physicians to try to collect large
amounts of the medication.

"We've received very specific reports of abuse and misuse of
OxyContin," Blumenthal said last week. "We have some doctors who are
concerned about some of their colleagues. We have some sources in
state government who have suspicions about misuse of state funds to
purchase the drug for illegal use in some cases."

Blumenthal declined to discuss specifics.

He did point to a sharp increase in Medicaid funds for OxyContin prescriptions.

In the last fiscal year, more than $3.7 million in Medicaid funds
were used for the drug, almost a 400 percent increase from the year
before.

After the first six months of the current fiscal year, Medicaid
already has paid for another $3.7 million worth of OxyContin,
Blumenthal said.

Leo Roberge, director of the drug control division of the state
Department of Consumer Protection, said Connecticut is not facing the
crisis other states have encountered.

"We've looked at other parts of the country and are worried," he
said. "We don't have anything like that going on, but we do have some
investigations going on."