SOUTHWEST VIRGINIA DOCTOR FINDS LITTLE SUPPORT FOR BAN

FDA Opens Hearings On Oxycontin, Painkillers, Similar Drugs

Essentially, The Advisory Committee's Mission Is To Ensure That The
Powerful Narcotics Do Not Fall Into The Wrong Hands.

GAITHERSBURG, Md. - A country doctor from far Southwest Virginia who wants
OxyContin off the market found little support Wednesday as the Food and
Drug Administration convened hearings on the use of opium-based painkillers.

Dr. Art Van Zee of Lee County, who is organizing a petition drive to have
OxyContin recalled, told an FDA advisory committee about abuse of the
prescription medication, which has caused fatal overdoses and widespread
crime. "It would be very difficult to overstate the level of devastation
this has brought to Central Appalachia," he said.

But as the FDA's Anesthetic and Life Support Drugs Advisory Committee began
a two-day hearing to discuss the use of opiate painkillers, the prospect of
recalling OxyContin was not on the table.

"The goal of the meeting is not to take any particular drug off the market
and not to focus on any particular drug," said Nathaniel Katz, a Harvard
Medical School professor who is leading the hearings.

Despite those opening remarks, much of Wednesday's discussion involved
OxyContin - and the fear by many that the FDA will restrict the drug's
availability to curb abuse, only to cause untold suffering by legitimate
patients who rely on it to lead normal lives.

John Giglio of the American Pain Foundation said calls to his organization
from concerned patients have doubled since OxyContin abuse became the topic
of national media attention last year. "Some literally threatened suicide
as they spoke to us," he told the panel.

The foundation estimates that 50 million Americans suffer from chronic
pain, and the general consensus among health care experts is that pain has
been undertreated for years. That is now changing, experts say, as more
doctors are using opiates and other methods.

Approval of OxyContin by the FDA in 1995 came during a "sea-change in the
way pain specialists have viewed opiate drugs" for the treatment of pain,
said Dr. Russell Portenoy of the Beth Israel Medical Center in New York.

But as OxyContin sales skyrocketed to more than $1 billion in 2000 and
abuse spread from isolated rural areas to other parts of the country, the
FDA and law enforcement came under increased pressure to ensure that the
powerful narcotics do not fall into the wrong hands.

That essentially is the advisory committee's mission. Although it will not
make any formal recommendations to the FDA, the committee is being asked to
address a number of questions. Among them: How to identify the patients
best suited for opiate drug treatment; how to determine the risk of
addiction those patients face; to what degree opiate drugs should be used
to treat children; and steps the FDA might take to reduce abuse of opiates
without restricting access to legitimate patients.

A transcript of the hearing will be used to guide the FDA in future decisions.

When the hearing resumes today, officials from the Drug Enforcement
Administration will discuss prescription drug abuse. A representative from
Purdue Pharma, the Connecticut company that makes OxyContin, will also
address the committee.

During a public hearing Wednesday, Van Zee was vastly outnumbered by
speakers who implored the committee not to restrict OxyContin. Some did not
seem convinced by assurances from the FDA that a recall is not being
considered. Some states have already cut back on Medicaid coverage for
OxyContin prescriptions, they said, and bad press the drug has received is
making doctors reluctant to dispense it.

While some say physicians are afraid of getting in trouble for prescribing
potent drugs, numbers presented by Dr. Bruce Levy, former head of the board
of medicine in Texas, did not support that theory. Of the 4,617
disciplinary actions taken against doctors nationwide in 2000, only 319
involved prescriptions of controlled substances.

"They are old wives tales, they are fear tactics, but they are not
occurring," Levy said of reports that doctors are facing increased
scrutiny. Levy did not have figures on the number of doctors who have been
charged criminally.

In Western Virginia, where more than 60 fatal overdoses have been linked to
OxyContin's active ingredient, five doctors have been convicted of
overprescribing painkillers in recent years.

While police say careless or unscrupulous doctors are the main source of
the region's OxyContin problem, Van Zee lays equal blame on Purdue Pharma,
which he says has excessively marketed its best-selling product while
downplaying its propensity for abuse.

Using marketing data, the company has identified doctors who prescribe
large amounts of opiates and have dispatched sales representatives to their
practices, Van Zee said. A Purdue Pharma sales representative who makes
$50,000 a year pitching OxyContin to doctors can earn another $100,000 in
bonuses for high sales, the doctor said.

To back his assertions, Van Zee points to figures from the DEA that show
the average use of OxyContin in some of Virginia's coalfield counties is
25,000 grams per 100,000 residents - far more than the national average of
about 3,074 per 100,000.

Purdue Pharma, which has defended its promotion of OxyContin as
conservative and responsible, maintains the number of prescriptions is not
a reliable indicator of whether its drug 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, the
company says.

Van Zee, who sees the impact of OxyContin addiction through his patients at
a clinic in the small coal-mining town of St. Charles, says about 8,000
people have signed his petitions asking the FDA to recall OxyContin. He has
not presented the petitions to the agency yet.