DRUG REMAINS IN THE PIPELINE

Addiction Treatment Awaiting Approval

As addictive substances go, heroin ranks near the top in its ability to
hook people.

At the same time, there are not many treatment options for people who want
to get off the drug.

Even fewer options work long term, especially after repeated substance
abuse has altered brain chemistry.

That is why many treatment experts are excited about buprenorphine, a drug
already available to treat pain.

It now is under consideration by the Food and Drug Administration as a
treatment to help opiate addicts get clean.

Made by the Chesterfield County company Reckitt Benckiser Pharmaceuticals,
buprenorphine is talked about as a drug that could shift treatment of
heroin addiction from methadone clinics to private physician offices.

On the promise of buprenorphine, U.S. drug policy was changed in 2000 to
eventually allow specially trained doctors to offer opiate replacement
therapy from their offices.

"This is a good drug to break the paradigm with," said Dr. Frank Vocci,
director of the treatment research and development division at the National
Institute on Drug Abuse. It has funded much of the research on
buprenorphine's safety and effectiveness.

"It's a very safe drug. It may eventually become the first line of therapy"
for opiate addicts, he said.

Vocci estimates that as many as 6,000 physicians in private practice would
pursue certification to offer buprenorphine-based therapy. Under federal
guidelines, doctors would be able to treat up to 30 patients per practice.

But for the past year or so, U.S. approval of this new use of buprenorphine
has been on hold - tied up, some say, in political wrangling.

More recently, some blame delays on questions about the drug's abuse
potential, in light of problems with OxyContin. That pain medication is
being linked to crime waves across the United States.

Reckitt Benckiser President Charles O'Keefe said he expects the new use of
buprenorphine to be approved next month, far later than originally hoped. A
year ago, there was talk that approval was imminent.

Since then, there have been hurdles.

In December, a Washington law firm representing an undisclosed client asked
the FDA to delay action until more information was made available for
public review.

The law firm's petition takes issue with the drug not going before an FDA
advisory panel of outside experts, as is often done to consider a drug's
merits. The petition also points to buprenorphine overdose deaths in France
as evidence of potential problems in the United States.

"This drug is so unusual and raises such difficult medical and policy
issues that it is hard to fathom the FDA approving it without seeking
advice from one of its expert advisory committees," said attorney David M.
Fox of Hogan & Hartson LLP.

"The fact that it hasn't come to an advisory committee raises in my mind
real questions about the sufficiency of the applications. You have to
wonder, if it went to an advisory committee, whether it would come up well
short of the advisory committee's expectations."

Rumors abound that Fox's firm is representing a group of private methadone
clinics that do not want the competition. Many of the methadone programs
are for-profit operations, run by national chains.

Mark Parrino is president of the American Association for the Treatment of
Opioid Dependence, which represents about 740 of approximately 950 opiate
replacement programs operating in the United States. His group backs
buprenorphine availability, he said, and changed its name last year to
reflect its shift from just methadone treatment.

"Our view is that this is another well-researched, clinically effective way
to treat opiate dependence," Parrino said. Many clinic members want to be
able to offer the drug, he said.

In another recent development, the Drug Enforcement Administration has
proposed stricter prescribing controls for buprenorphine. Public comment on
the DEA notice is being taken through May 22.

O'Keefe, the manufacturer's president, feels neither recent development
poses a serious threat to the drug's approval.

"It's a very good drug as one more drug for the treatment of opiate
dependency," he said. "Physicians need to have more than one drug to use. .
. . For an awful lot of patients, it will be a real lifesaver. It's not a
cure for everybody."

Experts said only a fraction of abusers needing treatment for heroin
addiction are getting it.

Last year, about 4,000 people sought help at the 15 public and private
methadone programs in Virginia.

"That's only through the methadone clinics," said Denise Clayborn, opiate
and adult program services coordinator for the state Department of Mental
Health, Mental Retardation and Substance Abuse Services.

"We have plenty of opiate-addicted persons being serviced through some
residential programs." Typically, she said, treatment experts estimate that
for every person in treatment, there are 10 others who need it but are not
getting it.

"It's not something most people recover from on their first try," said Dr.
James C. May, substance abuse service director for the Richmond Behavioral
Health Authority, which coordinates care for low-income people.

"For younger folks, who perhaps have not been using for quite so long,
where it has taken over their entire lives, you probably have a better
chance of going drug-free."

Dr. Peter Coleman, an addiction treatment expert, also is anticipating
buprenorphine's availability but understands the delays. In his own
practice, he is researching an implant that reduces opiate cravings.

"Any time you have heroin addicts who take an addictive drug, it's a
contentious issue," he said. "Traditionally, success rates treating heroin
addicts are absolutely lousy. Very few people get off heroin and stay off
heroin."