Pubdate: Sun, 13 May 2001
Source: Greenwich Time (CT)
Copyright: 2001, Southern Connecticut Newspapers, Inc
Contact:  http://www.greenwichtime.com/
Details: http://www.mapinc.org/media/697
Author: Thomas J. McFeeley
Bookmark: http://www.mapinc.org/find?186 (OxyContin)

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."
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MAP posted-by: Josh Sutcliffe