PAINKILLER CRACKDOWN

Together With A Drug Company, The DEA Is Taking Unconventional Steps To
Stop The Abuse Of OxyContin

OxyContin was developed to do good: relieve debilitating pain. But since
the powerful drug debuted in 1996, it has become increasingly known for a
dangerous side effect--the potential for serious addiction ("Playing With
Painkillers," April 9, 2001). Abusers crush and snort the pill to get an
intense narcotic rush. Some "doctor-shop" to get multiple prescriptions;
others buy the drug for up to $1 per milligram on the street. In a new
environment where doctors are being encouraged to treat patients more
aggressively for pain, a critical new dilemma has emerged: can OxyContin be
responsibly prescribed to patients who need it without being "diverted" to
those who don't?

Last week the spotlight on OxyContin intensified as the Drug Enforcement
Administration announced a "national strategy" to combat the painkiller's
illegitimate use, including plans to step up law enforcement at local and
federal levels. "This is a very potent narcotic with a serious potential
for abuse," says Terrance Woodworth, deputy director of the DEA's Office of
Diversion Control. The new initiative, the first against a specific
brand-name drug, "is an indicator of how serious we think the problem is,"
Woodworth says. Purdue Pharma, the drug's manufacturer, joined the campaign
last week, launching its own offensive in a 10-point plan. "We want to do
everything we can to get the bad guys off the street," says Purdue's Robin
Hogen, "and make the product available to patients who need it."

The active ingredient in OxyContin, oxycodone, is also present in other
painkillers, like Percocet and Percodan; for decades, the DEA has been
concerned about the abuse potential of those drugs, too. But none packs the
narcotic punch of OxyContin, a 12-hour time-release version. The DEA's new
initiative, which comes after a recent meeting with Purdue, includes taking
aggressive measures against any doctors and pharmacists responsible for
abuse--revoking DEA licenses and arresting those at fault. The agency is
also recommending that Purdue consider reformulating the pill to make it
less subject to abuse. Other companies have made alterations in the past: a
blue dye, for example, was added to Rohypnol, a so-called date-rape drug,
so that it would be easier to detect if slipped into a drink.

While the DEA says OxyContin is a valuable drug, it is concerned that many
doctors who are prescribing the medication don't know enough about it and
are not conveying the dangers to patients--some of whom become addicted
after taking the drug for routine pain. As a result the agency is
recommending that Purdue present a "more balanced approach" in its
marketing and distribution of the pill, especially in communication between
sales reps and doctors.

Purdue says it wants to work with the agency and is stepping up its own
efforts. The company is using a statistical program that analyzes
demographic data about geographic areas of abuse (rural Kentucky, for
example) to help predict where the next problem locales might be. "We
didn't want to just sit around and wait," says Dr. J. David Haddox,
Purdue's medical director. This week company officials will meet with their
sales reps in some of those areas to educate them about the abuse potential
and how to prevent it. The company is also launching public-service
announcements about abuse aimed at teens, and in problematic areas like
Maine and Virginia it is distributing tamper-resistant prescription pads to
physicians. Purdue, which sold $1 billion worth of OxyContin last year,
according to IMS Health, says it plans to develop new painkillers that
would not be subject to abuse.

It is too soon to tell how effective any of the new initiatives will be.
But the challenge is clear: clamping down on abusers without criminalizing
patients.