RESTRICTIONS MUTE DRUG'S PROMISE

When it appeared on the market two years ago, the medication sounded
too good to be true: a little hexagonal pill that could subdue
addicts' cravings for heroin or prescription painkillers, with little
risk of abuse and without creating a new long-term dependency.

For many of those who have used it, buprenorphine has lived up to its
promise as a powerful new weapon against opiate addiction with major
advantages over methadone, long the main medical option for addicts.
Buprenorphine can be taken at home rather than at clinics because it
is less prone to abuse; it is easier to wean off of after a few
months; and it leaves users less groggy, giving them the clarity of
mind to start rebuilding their lives.

But buprenorphine has reached only a small fraction of those who
could benefit from it, in part because of restrictions imposed by
Congress when it approved use of the drug.

Related Links Lavonne Young Photo Darryl Graves Photo That
might change under a bill before Congress that would lift one of its
key restrictions: the 30-patient limit on prescribing the medication
that applies to teaching hospitals, community health centers and one
of the nation's largest managed-care groups.

The lifting of the so-called group practice cap - a restriction that
lawmakers say they never intended to be so broad - could have a
particularly large impact in Baltimore and other cities where many
addicts tend to seek help from the clinics and hospitals most
constrained by the law.

Baltimore has an estimated 40,000 heroin users, making the opiate by
far the city's biggest drug problem, but the number of people
receiving buprenorphine at any given time has been in the hundreds.

"It's very, very important," Dr. Peter L. Beilenson, the city's
health commissioner, said of the legislation. "There's no question
about it. It would not be a panacea, but it would certainly improve
the situation."

The bipartisan bill would leave in place other limitations on the
medication's use, most notably a restriction on the number of clients
that an individual physician could treat with the drug.

And the bill would not address what substance abuse experts say are
the other factors limiting its use: the drug's high cost and the
reluctance of many primary care physicians to become certified to prescribe it.

Addictions specialists say lifting the limit on group practices would
significantly increase buprenorphine's availability, at a time when
the need for it is growing.

Although the number of heroin users nationwide has remained steady in
recent years at about 800,000, the number of people abusing
prescription painkillers such as OxyContin has increased sharply, to
more than 4 million. (Addiction to cocaine, which is not an opiate,
is not treatable with buprenorphine.)

By contrast, about 100,000 Americans have used buprenorphine since it
was introduced in the United States in 2003, according to the
medication's manufacturer, the British company Reckitt Benckiser.

Lifting the group practice cap "is the single thing you could do to
make the most change in the shortest period of time" toward
broadening access, said Shaun Thaxter, the company's vice president
for marketing.

With legislative action on the horizon, the company is preparing a
major marketing campaign for the medicine, which is sold as Suboxone
and Subutex.

The legislation faces little opposition in Congress, where even
skeptics of drug treatment acknowledge buprenorphine's worth in
curbing addiction and the crime, public health problems and other
social costs that come with it. But last year, the bill stalled in
the House for lack of attention. It is up for review again this spring.

"We've got so many people on opiates, and just here in Baltimore so
many on heroin, that you've got to find ways to expand treatment,"
said Rep. Elijah E. Cummings, the Baltimore Democrat who is
co-sponsoring the legislation in the House with Rep. Mark E. Souder,
an Indiana Republican. "And it seems like this drug is one that works
for many people."

Allays cravingsBuprenorphine, discovered as an addiction treatment in
the 1970s, is a synthetic opiate that allays an addict's cravings by
occupying the brain receptors that heroin and other opiates adhere
to. In this, it resembles methadone, a syruplike opiate used to curb
cravings that, by law, can be dispensed to most addicts only at
regulated clinics. Almost 200,000 people nationwide and 6,500 in
Baltimore receive methadone.

Buprenorphine - pronounced byoo-pre-NOR-feen and nicknamed "bupe" -
has chemical advantages over methadone. Its effect lasts longer than
methadone's, so many users need to take a pill only every two or
three days. The drug's staying power helps guard against relapse - if
someone takes heroin a day after taking buprenorphine, the medication
will still block the high.

Buprenorphine is only a partial narcotic and therefore is less
addictive than methadone and easier to taper off of after a few
months. Those on buprenorphine also tend to feel more clearheaded
than they do using methadone, making it easier to go to work.

"It's way better. Methadone feels like a Mack truck hit you," said
Darryl Graves, 40, a recovering addict from East Baltimore who was
given buprenorphine at the Park West health center in Park Heights
last fall. After using heroin for 18 years, he takes pride in using
the money he earns doing car repairs to buy new clothes for himself
rather than drugs.

The inability for addicts to get a discernible high from
buprenorphine also makes it much less prone to black market resale
than methadone is. Methadone has caused an increasing number of fatal
overdoses in recent years among those abusing it for a high, but
buprenorphine has a "ceiling" effect: Addicts can't get an extra kick
by taking large amounts of it.

Studies of buprenorphine in the United States have found that it
works as well as methadone for maintaining all but the hardest-core
addicts, some of whom might not respond to buprenorphine because it
is not potent enough to stop their cravings.

Buprenorphine's proponents also point to its success in France, which
approved it in 1995. Within four years, 60,000 people were on the
medication in a country with one-fifth the population of the United
States, and fatal overdoses dropped 80 percent.

The drug's proponents caution that buprenorphine is not a miracle
drug. It will help only those who want to do something about their
addiction. Those who haven't reached that point might get a few days'
relief from the medication but will then, despite not having
cravings, return to opiate use because they miss the high.

Other factors Even those who do want to quit cannot rely on the drug
alone, recovering addicts say. They must follow up with counseling
and support groups to deal with problems or behaviors that helped
lead them into drug use in the first place.

The wonder of the drug, proponents say, is that it gets addicts over
the pain of withdrawal so that they can begin to address the other
half of the equation.

Park Heights native Lavonne Young, 43, had tried several times to
kick a 10-year heroin habit before being prescribed buprenorphine for
90 days by the Park West clinic last summer. She has been clean for
eight months and attends daily support groups at the clinic's
Reisterstown Plaza branch.

"It completely took away the cravings. This is why I was able to
function," she said of the drug. "Once the cravings were gone, it was
like life showed up."

After years of study by regulators, Congress passed a law in 2000
revising a 1914 law banning the prescription of opiates to treat
addiction. That cleared the way for regulators to approve
buprenorphine for regular, 30-day prescriptions two years later.

The hope was that the drug's approval would vastly broaden public
access to treatment for opiate addiction. For the first time in
almost a century, opiate addicts would be able to take a treatment
drug at home, without the inconvenience or stigma of visiting a
methadone clinic. As it is, many addicts haven't even been able to
obtain methadone because funding shortages and community opposition
have limited the number of clinics.

The high hopes for the drug haven't been met, in part because of the
restrictions Congress imposed while approving its use. With the Drug
Enforcement Administration anxious about legalizing even a mild
opiate for addiction treatment, the authors of the 2000 law required
that physicians take an eight-hour class before prescribing it and
that they treat no more than 30 patients at a time. The thinking was
that a limit would keep unscrupulous doctors from running prescription mills.

The legislation explicitly applied the 30-patient limit not just to
individual physicians, but also to physician "group practices."
Legislators and aides involved in drafting the bill say that was
meant to keep doctors from pooling their 30-patient limits to open
prescription mills.

The bill's authors say they never intended that restriction to have
the effect it has: severely limiting big teaching hospitals,
community health clinics, health maintenance organizations and other
large entities where physicians are classified as being part of a
single group practice.

The most eye-catching example is Kaiser Permanente, an HMO that
technically consists of eight group practices around the country.
Under the law, it can prescribe the drug to 240 of its 8.2 million members.

The effect of the group-practice restriction is also felt in
Baltimore. Johns Hopkins Hospital can prescribe the medication to
only 30 people. If the group-practice restriction were lifted, at
least a half-dozen doctors in the psychiatry department alone would
want to prescribe the drug, says department member Dr. Eric Strain.
That would result in 180 prescriptions at the hospital, not counting
those written by doctors in other departments.

Similarly constrained are the seven networks of community health
centers in Baltimore that serve many of the city's addicts. The
networks typically have a half-dozen doctors who could prescribe
buprenorphine, meaning that each network could prescribe it to at
least 150 additional addicts were it not for the cap.

Patients turned away Directors at several community networks say they
have had to turn away some people who come asking about buprenorphine
because they are bumping against the limit. They have also refrained
from getting out word about the medication for fear of being swamped
with addicts whom they would have to rebuff.

At several networks, the limit has forced physicians to move
recovering addicts off the medication after a few weeks - much sooner
than the minimum 90 days recommended for recovery - to make room for
other addicts seeking the medication for detoxification.

"We have more demand than we can meet. It's a really bad limiting
factor," said Lelin Chao, medical director for People's Community
Health Centers, which could prescribe to 150 people without the limit.

Many substance-abuse experts say more needs to be done beyond lifting
the group-practice limit to broaden access to buprenorphine. For
starters, the drug is expensive, about $300 a month for a typical
dosage. Maryland is one of a minority of states that cover it for
Medicaid recipients, and some large private insurers have yet to
decide whether to cover it.

In addition, substance-abuse experts say, the government needs to
encourage more primary care physicians to prescribe the medication.
About 4,500 physicians, many of them psychiatrists, have obtained
certification.

At most, 70 percent of these doctors are prescribing the drug,
surveys have found; even fewer have consented to be on the "physician
locator" Web site that lists participating doctors, http:
//buprenorphine.samhsa.gov.

Maryland has one of the highest rates of physician participation.
About 140 doctors, most of them in the Baltimore area, are listed on
the physician locator.

Many doctors are reluctant to prescribe the medication because they
are wary of attracting addicts to their practices or because they
feel they lack expertise in addictions treatment, said Dr. Yngvild
Olsen, a Hopkins substance-abuse specialist who recently surveyed
doctors about buprenorphine.

Dr. Donald Jasinski, a substance-abuse specialist at Johns Hopkins
Bayview Medical Center, argues that government needs to encourage
buprenorphine prescription the way it supports methadone treatment,
with grants that, for instance, could pay for a nurse dedicated to
buprenorphine patients.

"What you're depending on now is the altruism of physicians," said
Jasinski, who was among the first to discover the medication's power
to treat addiction. "You'd get a lot more people interested in doing
it if there were more support."

Other physicians specializing in substance abuse say it is
unrealistic to expect general practitioners to embrace the drug. The
only way to make it more available, they say, is to lift the
30-patient limit for those who are prescribing it.

"There's no other illness I can think of where they say you can only
treat so many people," said Dr. Michael Hayes, a substance-abuse
specialist at Maryland General Hospital. He said he could handle 100
patients but that as a one-man practice, he can prescribe
buprenorphine to only 30 people, even if the group limit is lifted.
"To do that in a town that has epidemic levels of the disease -
that's ludicrous."

Another look in D.C. In Washington, legislators and regulators say
they might reassess the 30-patient limit for individual doctors. For
now, officials say, the priority is trying to eliminate the group-practice cap.

Just getting the attention of lawmakers to make that one change isn't
easy, legislative aides say, in an environment where the needs of
addicts are outranked by other issues. Passage hinges on approval by
the House Judiciary Committee, where the bill stalled last year. The
Senate passed it last year and is expected to do so again.

Addictions specialists are growing impatient. At a two-day
government-sponsored summit on the status of the drug this month in
Rockville, several doctors vented their frustration.

"They call it just a snafu" in the language of the original law, said
Dr. Andrew Kolodny, who is overseeing buprenorphine for the New York
City Health Department. "But people really are dying because of it."

Buprenorphine

Advantages:

# Can be taken at home instead of a clinic like methadone.
# Is harder to abuse than methadone; easier to wean off.
# Leaves users feeling clear-headed.

Barriers:

# Prescribers are limited to treating 30 patients at a time.
# Many doctors are reluctant to prescribe.
# Medication is expensive.
# Many states don't cover it under Medicaid.