FDA TO HOLD OXYCONTIN HEARINGS

Critics Of The Painkiller Say Its Devastating Effect Is Spreading Beyond
The Isolated Areas Where Misuse First Surfaced

Once dubbed "hillbilly heroin" for its illicit use in the mountains and
hollows of Appalachia, OxyContin is now drawing the attention of lawmakers
and federal agencies in the nation's capital.

An advisory committee of the Food and Drug Administration will hold
hearings Thursday and Friday on the use of opium-based prescription drugs
such as OxyContin, a potent painkiller that is easily converted into a
street drug.

Later this year, a U.S. Senate committee will hear testimony about
OxyContin abuse.

The scrutiny comes at a time when critics of OxyContin say the drug's
devastating effect is spreading beyond the isolated areas where misuse
first surfaced, such as the coalfields of far Southwest Virginia.

In fact, reports of OxyContin-related crime and fatal overdoses in Boston
were one reason Sen. Edward Kennedy, a Massachusetts Democrat who heads the
Health, Education, Labor and Pensions Committee, decided to hold hearings.
"Senator Kennedy has a heightened sensitivity to this issue," spokesman Jim
Manley said.

Others say inflated death statistics and overhyped media reports threaten
to undermine the good that OxyContin has done since it was approved by the
FDA in 1995 for treatment of moderate to severe pain.

"We have come too far in this country in the last decade, advancing the
care of people suffering and dying from chronic pain, to take leaps
backward by restricting the availability of OxyContin or other similarly
effective drugs," Richmond physician Stephen Long wrote in a letter to the
FDA committee that will meet this week.

"To punish the millions of deserving patients because of the irresponsible
use and abuse by only a few hundred criminals is medical insanity," wrote
Long, a member a Virginia task force studying prescription drug abuse.

Actually, this week's meeting of the FDA's Anesthetic and Life Support
Drugs Advisory Committee is not about OxyContin specifically, but rather
the broader issue of opium-based drugs.

But with all the attention OxyContin has been receiving, "I'm sure there
will be quite a bit of discussion on how to make this class of drug safer,"
FDA spokeswoman Laura Bradbard said.

The committee, composed of experts from academia and the medical community,
is being asked to discuss the prevalence of addiction among patients who
take opium-based medications as prescribed by their doctors.

Purdue Pharma, the Connecticut company that makes OxyContin, says addiction
is extremely rare - unless the pills are crushed into a powder that is
snorted or injected by abusers.

That view is disputed in lawsuits, including one filed in Lee County
Circuit Court. The lawsuits claim that OxyContin is highly addictive even
when taken as prescribed and accuse Purdue Pharma of ignoring that risk as
it aggressively marketed its billion-dollar selling product.

Earlier this year, Lee County physician Art Van Zee began circulating
petitions asking the FDA to recall OxyContin in light of widespread
addiction, crime and more than 50 fatal overdoses in Virginia attributed to
the drug's active ingredient.

The problem led
(ftp://ftp.senate.gov/member/va/warner/general/warner.html)Sen. John
Warner, R-Va., to request hearings before the Senate committee that he and
Kennedy serve on. No date has been scheduled yet, according to Manley,
Kennedy's spokesman.

Although the issue of a recall may come up at this week's FDA hearing, that
is beyond the committee's purview, according to Richard Merrill, a law
professor at the (http://www.virginia.edu/University of Virginia who once
served as counsel to the FDA.

However, the agency could be influenced by the views of committee members
if it were to consider recalling or restricting the availability of
OxyContin, Merrill said.

A representative of Purdue Pharma, which maintains that many of the fatal
overdoses blamed on its product were actually caused by abuse of other
drugs combined with OxyContin, plans to address the committee.

"Will there be some people there calling for it to be taken off the market?
I wouldn't be surprised," said company spokesman Jim Heins. "Is this the
appropriate forum for that? I don't think so."

The company was taken to task last month by the chairman of a subcommittee
of the House Energy and Commerce Committee, which held a hearing in
Bensalem, Pa. The panel's chairman, Rep. Jim Greenwood, R-Pa., wanted to
know why the company took no action when it became aware that a Bensalem
physician was prescribing inordinately large amounts of OxyContin.

The doctor was arrested after a pharmacist alerted police.

Van Zee said the testimony confirmed his long-held suspicion that Purdue
Pharma keeps tabs on heavy prescribers of OxyContin with an eye on profits
rather than potential abuse.

Similar warning signs were probably evident in Southwest Virginia, Van Zee
said. According to figures the doctor said were provided to him by the Drug
Enforcement Administration, the average use of OxyContin in some coalfield
counties is 25,000 grams per 100,000 residents - far higher than the
national average of 3,704 grams per 100,000.

Purdue Pharma says the number of prescriptions is not a reliable indicator
of whether OxyContin is being abused.

Areas such as Southwest Virginia, which have a high incidence of injuries
from coal mining jobs and other forms of hard labor, are likely to
experience greater use of pain medications than some urban areas.

And economically depressed areas of Appalachia have long experienced
problems with prescription drug abuse, supporters of OxyContin say, so it's
unfair to single the drug out as the sole source of the problem.

But according to the DEA, no other prescription drug has been abused so
extensively so quickly after it was put on the market. Critics say that's
because OxyContin has a high, unfiltered dose of oxycodone, an opium
derivative. Other oxycodone-based drugs, such as Percocet, usually contain
5 mg of oxycodone. OxyContin comes in 20-, 40- and 80-mg doses of pure
oxycodone with a formula that releases the drug gradually over 12 hours.

But addicts who crush the pills into a powder can circumvent the
time-release mechanism for an intense high similar to that produced by heroin.

Earlier this year, the FDA responded to increased reports of OxyContin
abuse by issuing its strongest warning available on the drug's package
insert - literature provided to physicians and pharmacists.

"The FDA is not interested in denying pain relief for any patient who is in
need of it medically," Bradbard said.