BEYOND METHADONE

New Hope For Heroin Addicts Comes In Prescription Tablet -- Clinic Optional

U.S. doctors soon will be able to treat heroin addiction much the same way
they treat other chronic diseases - during office visits. A long-awaited
medicine, approved by the government last fall to treat addiction to heroin
and other opioids, is expected to be available at pharmacies within the month.

"This has been years and years in the making," says Dr. Bryon Adinoff,
medical director of the substance abuse team at the Dallas VA Medical
Center. Although the medicine, buprenorphine, became readily available in
Europe beginning in 1996, "our government has been very slow and reluctant
to respond," he says.

Buprenorphine, already sold as a painkiller, has been found to be effective
in suppressing heroin cravings, and in helping people quit heroin or
methadone with milder withdrawal symptoms. "It's less sedating, there's
less potential for overdose," says Dr. Patricia Chandler, an addiction
medicine specialist in Dallas who is certified to train other doctors in
the use of the drug. Buprenorphine is also effective in treating addiction
to substances similar to heroin, known as opioids, such as the painkiller
OxyContin. Buprenorphine, or "bupe," will be governed by rules far less
stringent than those affecting methadone, the longtime gold-standard
treatment for such addictions.

Decades of use have shown methadone to be safe and effective for treating
heroin addiction, even over the long term. But heavy government regulation
- - and stigma associated with methadone clinics - have prevented many heroin
addicts from seeking treatment, doctors say. Estimates run as high as
almost 1 million chronic heroin users in the United States, with only about
20 to 25 percent receiving treatment.

Despite its proven effectiveness, methadone has remained controversial, Dr.
Adinoff says. So easing its regulation "was politically not viable."
Although methadone, too, is available as a painkiller, for heroin treatment
it is administered only at federally licensed clinics. Those clinics -
which deliver almost all treatment for opioid dependence in the United
States - "are often set aside, they are commonly in bad neighborhoods," Dr.
Adinoff says. And they tend to be out of reach of suburban and rural
populations, where heroin addiction has soared in recent years.

"What was happening with methadone was that people would go to the
methadone clinic - it was separated from regular medicine - and it set up a
whole culture for junkies," adds Dr. Chandler. "So where do you think
dealers go to sell their drugs?"

Consequently, buprenorphine's arrival is being heralded because the drug
will be more easily available to patients. "The big deal about it is that
... these are going to be distributed by any doc who gets credentialed,"
says Dr. Adinoff.

Doctors wishing to prescribe buprenorphine must complete eight hours of
training to qualify for a waiver from laws restricting the use of opioid
drugs. More than 2,000 U.S. doctors have received the training so far,
according to the National Institute on Drug Abuse.

The wider availability of buprenorphine may benefit patients who receive
harsh treatment at some methadone clinics, says Belita Nelson of Plano,
founder and executive director of the Starfish Foundation, which offers
treatment counseling for heroin and other drug problems. If patients are
regarded as second-class citizens, it doesn't help self-esteem issues that
accompany heroin abuse.

"But if you can go to your family doctor in privacy and seclusion and get
treated for this," Ms. Nelson says, "then it puts it more along the lines
of what we all know this is - a disease. That's what diabetics do." Still,
methadone clinics may have at least one advantage over the buprenorphine
program: Patients typically have to come back more frequently, Dr. Adinoff
says. "So you can use that as a way to keep people involved in counseling,
involved with the therapeutic milieu, they can go through frequent urine
drug screens." At private practices, supportive services are less likely to
be as extensive. (Federal law requires doctors prescribing buprenorphine
simply to have the capacity to refer patients to counseling.) "You wouldn't
have that clinic atmosphere," says Dr. Adinoff, a professor of psychiatry
at the University of Texas Southwestern Medical Center at Dallas. And,
because private practitioners are legally limited to treating a maximum of
30 addiction patients with buprenorphine, it "wouldn't be a specialized
practice." Dr. Chandler thinks the new drug will probably be most
successful in primary care practices where doctors know their patients
really well. Addicts need therapy dealing with a host of problems: "They
have legal issues, they have family issues, they have employment issues -
they basically have to jerk themselves out of this crazy world they're in
and reintegrate themselves into society," Dr. Chandler says. "And unless
they have a mechanism to do this, the buprenorphine isn't going to work."
The new medicine will be available in two types of tablets that are
dissolved under the tongue - one is Subutex (pure buprenorphine), and the
other is Suboxone (combined with naloxone, a drug used to treat heroin
overdose). Buprenorphine, like methadone, still has some potential for
abuse. But if someone decides to abuse Suboxone on the street, by grinding
it up and injecting it, the naloxone will negate the effect of the
buprenorphine and put the person into withdrawal quickly, says Dr. Adinoff.
In pill form, naloxone is poorly absorbed by the body, and so won't
interfere with the effects of the buprenorphine.

Drug wholesalers have been notified that Suboxone and Subutex are available
for shipment, says Charles O'Keeffe, president of Reckitt Benckiser
Pharmaceuticals, which is distributing the drugs. Wholesalers then supply
pharmacies, so the medicines should be available in local drugstores within
a week or two.

The medicines are priced to cost under $10 a day for a 16-milligram dose,
Mr. O'Keeffe says.

Although that may seem expensive, Dr. Adinoff says, "anyone who needs it is
using $40 to $100 a day of heroin."

Angela, a former addict who asked that her last name be withheld, says she
has spent as much as $150 a day on heroin, and was spending about $50 a day
when she entered a clinical trial with Dr. Chandler. Angela first used
"chiva" at about age 16 at a boyfriend's urging. "I didn't even realize it
was heroin. He didn't even tell me." She had gone through six
rehabilitation programs between ages 17 and 21, she says, before
buprenorphine finally helped her kick her habit. "I think it worked great
because I didn't really feel bad when I quit taking it," she says, noting
that her dose was tapered off during her yearlong treatment. "I felt a
little bad, but I could still function; I could still go to work and do
everyday stuff. And it helped with the cravings, too, because I never
thought about it."

Heroin is short-acting, explains Dr. Chandler, an assistant professor at UT
Southwestern. Addicts get sick if they don't use heroin about three times a
day. But with a long-acting medicine like methadone or buprenorphine, they
don't suffer constant withdrawal and heroin cravings. "The only reason why
you use it [heroin] is because you feel bad," Angela says. "You get
addicted to it, and the next thing you know you can't stop using it because
you feel bad."

The 24-year-old Plano woman says that when she began buprenorphine about
two years ago, she was highly motivated to quit heroin. "I was starting
back on a normal life; I had just started a brand new job and I didn't want
to be using anymore."

Buprenorphine doses are required just once a day, sometimes even less
often. Dr. Chandler, who is giving up her addiction specialty to focus on
family medicine, says her research suggests that initial daily doses of
about 16 milligrams a day are effective.

Buprenorphine does have side effects - more likely during the first week or
so of treatment - including headache, body pain, nausea and insomnia.
Moreover, the drug can severely depress breathing (as heroin can). Some
deaths have been associated with buprenorphine, typically when people have
abused the drug by injecting it while also using other opioids, alcohol or
other depressants like Valium.

Heroin addicts are a unique population, Dr. Adinoff says. "It's a hard
population to treat. It can be very frustrating" - for instance, when the
medicines are diverted for abuse on the streets.

But the rewards of successful treatment are profound, Dr. Chandler notes.
She recalls a San Antonio pharmacist describing his experience with
buprenorphine during the clinical trial she worked on. A man in his 40s
first was brought to the drugstore, disheveled, by his 71-year-old mother
to get his medicine. After a month or two he started coming in by himself
to get his prescriptions filled. Several months later he came in with his
wife, and a few weeks later he had his daughters with him, Dr. Chandler
says. "Buprenorphine brought that family together," she says. Still, the
road to heroin recovery is littered with countless failures by addicts. "A
lot of people expect them to be completely abstinent," Dr. Adinoff says.
"But after using a drug for 20 or 30 years I think your brain changes in
some way. You need to acknowledge that, and you need to feed your brain ...
it's gotten used to an opiate being there." As with other chronic diseases,
such as high blood pressure and diabetes, treatment for addiction succeeds
in only a fraction of patients, Dr. Chandler says. "If you look at clinical
outcomes with any chronic disease you're going to get around a 30 percent
success rate," she notes. "About 70 percent of people are not going to do
well with their chronic disease, be it diabetes, high cholesterol, obesity
- - it's lifestyle changes, [and] people don't do it.

"But when somebody relapses with diabetes, they're not considered bad, even
though they didn't comply."

Angela, the former heroin user, says buprenorphine was a key part of her
recovery. "It worked for me," she says. But it wasn't the only part of her
recovery. "It's just like anything else - if you don't want it enough, if
you don't want to stay sober, you're not going to."