STRATEGIES TO CONTROL BUPE ABUSE OUTLINED

WASHINGTON - Amid growing illegal sales and abuse of buprenorphine,
top federal officials outlined yesterday action they might take to
curb problems with the addiction-treatment drug, including more
precise detection methods, improved training of doctors and stronger
warning labels for patients.

"The issue of diversion has been out there since 2004," said Dr. H.
Westley Clark, director of the Center for Substance Abuse Treatment,
which oversees the federal government's buprenorphine initiative.
"We've been concerned about that, and we will continue to be
concerned about that."

Clark spoke to reporters after a two-day, closed-door summit of
experts on buprenorphine, which the government sees as the best
medical treatment for hundreds of thousands of people addicted to
heroin or painkillers.

Introduced in 2003, the drug known as "bupe" has been subject to
increasing misuse and illegal sales as more of it is prescribed by
physicians, The Sun reported in a series of articles beginning in
December. Some patients sell it on the street; buyers use it to get
high or hold off withdrawal symptoms until they can get their next
heroin or painkiller hit.

With tens of thousands of opiate addicts in Maryland, Baltimore and
state officials are investing millions of dollars in bupe treatment.
Experts say it's safer than methadone - the traditional heroin
treatment, normally given out under close supervision - and more
likely to appeal to addicts because they can get bupe from their doctors.

Though Clark and other officials said they are encouraged that bupe
has expanded access to drug treatment, they acknowledged publicly for
the first time a need to tighten safeguards over use of the drug,
sold mainly under the name Suboxone.

Suboxone was developed as a joint project by the National Institute
on Drug Abuse and Reckitt Benckiser Pharmaceuticals Inc. of Richmond,
Va. An estimated 170,000 addicts are taking it.

Many patients and doctors say that bupe pills are extremely effective
in curbing withdrawal sickness and help ease cravings for heroin or
prescription opiates.

The Sun's articles identified a variety of problems the government
hadn't acknowledged when it approved buprenorphine. Some users crush
and inject the drug, a dangerous practice because it can spread
diseases. Many experts told the newspaper that an eight-hour training
course required for doctors who prescribe bupe is not adequate and
that some physicians are contributing to illegal sales of the
narcotic substitute by prescribing it too generously.

Dr. David Fiellin, a Yale University professor who directs the
Physician Clinical Support System, said that "there are physicians
who are practicing outside" the standards of care.

Fiellin said the support system, funded by the government, will work
with private medical societies to teach doctors how to properly store
the medication and to identify patients who might be misusing or
selling the drug.

"There is not an active surveillance system in place to identify
physicians who are practicing outside the guidelines," Fiellin said.
When they are found, he said, his group will work to report them.

Dr. Charles R. Schuster, a former director of the National Institute
on Drug Abuse who tracks abuse of the drug for the manufacturer, agreed.

"We have reports from physicians that they know of other physicians
not practicing within the standards of care," Schuster said.

The biggest problem, according to Schuster, is that some doctors are
prescribing 30-day supplies of the pills to addicts after only a
single visit. While that's legal, Schuster said, doctors should
become comfortable that a patient is not abusing the drug before
prescribing large amounts.

"A small minority of doctors are not practicing good medicine," he
said. "That's a problem we need to be concerned with."

Experts and officials identified other problems, including doctors
who provide little counseling. An official with the NIDA said studies
are showing that buprenorphine works better with pain-pill addicts,
not heroin abusers.

Schuster also said he learned at the two-day conference that federal
government drug-abuse warning systems were considering ways to add
new medications to their watch lists.

"Currently they are designed for detecting the use and abuse of drugs
that have been around for quite a while," he said.

Dr. Celia Winchell, a medical officer for the U.S. Food and Drug
Administration, which approved Suboxone in late 2002, acknowledged
that some abusers are able to crush the pills and inject the drug
despite the presence of a chemical intended to deter that.

"Certainly, we're concerned about diversion and abuse," she said.

Winchell said the FDA is evaluating whether to strengthen warnings on
the drug labels to "prevent diversion" and alert doctors and patients
to adverse effects that accompany misusing it.

"We're exploring if there's anything left unsaid in packaging," Winchell said.

But the government can do little to alter doctors' practices. The
Drug Addiction Treatment Act of 2000, which authorized buprenorphine
treatment, forbids the government from interfering in private medicine.

Federal regulations allow doctors to prescribe a 30-day supply of
buprenorphine and up to five refills, a practice that is far more
lenient than in most countries.

Canada, for instance, requires that a patient be in treatment for two
months before receiving Suboxone to take unsupervised.