HEROIN'S NEW FIX

WASHINGTON - Scientists are ready to usher in a generation of
anti-addiction drugs that could significantly improve the prognosis
for the nation's 1 million heroin addicts at a time when use of the
opiate is rising.

Analysts say the new drugs are superior, less-addictive alternatives
to methadone, the once-a-day narcotic that has been used for decades
to block the craving for heroin's euphoric effects.

"This could be the biggest advance in the last 10 years," says Alan
Leshner, director of the National Institute on Drug Abuse, part of the
National Institutes of Health. "It will tremendously add to the
clinical toolbox. We're very optimistic. Everyone's very excited."

The new medicines are emerging as federal officials prepare to give
physicians more authority to dispense drugs that help addicts, a move
that could dramatically change the face of drug treatment across the
USA. By shifting the focus of treatment from methadone clinics to
doctors' offices, health officials hope to better serve a new
generation of heroin addicts, including tens of thousands of suburban
teenagers, who often are reluctant to visit urban clinics.

The moves by government and science reflect not only officials' alarm
at the recent rise in heroin use, but also longstanding frustrations
with methadone and the way it is distributed. Methadone, the most
common treatment for heroin, is just as addictive, many doctors say.
Addicts who drink daily doses to curb heroin cravings often can't give
up methadone without going through a painful withdrawal.

Scientists and health officials say the new drugs could diminish
methadone's role as well as that of clinics, which usually are in
run-down neighborhoods because no other areas will have them.

A combination of two drugs in a once-a-day pill could be approved by
the Food and Drug Administration as early as September. The combined
drugs mute the craving for heroin and throw users into withdrawal if
they try to abuse the pill by smashing it, adding liquid and injecting
it like heroin. Some test subjects have reported mild side effects
such as nausea.

Another drug, which is injectable, is being tested. It lasts 30 days,
blocks cravings for heroin and, by not letting heroin into the nervous
system, makes it nearly impossible for a relapsed user to overdose.
The drug could be on the market by 2002.

Federal officials, while excited over the promise of such drugs,
acknowledge that they are not a cure-all for heroin addiction.
Anti-addiction drugs should be one part of a recovery program that
also includes psychological treatment, vocational training and social
rehabilitation, says Barry McCaffrey, director of the White House
Office for National Drug Control Policy.

Westley Clark, director of the Center for Substance Abuse Treatment, a
division of the Department of Health and Human Services (HHS),
compares drug-addiction treatment to diabetes treatment. Besides
taking insulin, Clark says, a diabetic must watch his diet and
exercise. Though Clark expects the new drugs to help thousands, he
agrees that addicts also need counseling to address social and
psychological problems.

"It's not as simple as, 'Give it a pill and it's fixed, hallelujah,'"
Clark says. "None of these things are a panacea."

Heroin is purer, cheaper and more popular than it has been in three
decades, thanks largely to what amounts to an underground sales
campaign by traffickers in Colombia and Mexico.

Young adults, along with suburban middle- and high-school students,
have driven the rise in heroin use over the past several years. Heroin
use remains rare overall. A University of Michigan study last year
indicated that about 2% of U.S. youths ages 12-17 had tried it.
However, that was more than double the rate of 1992.

In 1997, the latest year for which such statistics are available, the
number of addicts seeking heroin treatment in the USA surpassed the
number of those seeking treatment for cocaine problems, federal
officials say. In 1999, an estimated 240,000 addicts sought treatment.

Problems With Methadone

Methadone, the most common treatment for heroin addiction, occupies
opiate "receptors" in the body that can crave heroin. Methadone gives
users a mild high that does not interfere with their ability to work
or function. Most users become dependent on it.

Methadone programs, which have been around since the 1970s, have had
only moderate success. A study published recently in the Journal of
the American Medical Association said that 50% of those in a San
Francisco methadone program had used an illicit opioid drug such as
heroin, opium or morphine at least once a month while in treatment.
Scientists called the finding "not encouraging."

New treatment drugs have surfaced periodically, but they haven't been
enough of an improvement over methadone to have much of an impact. The
last new product, called LAAM , was released in 1993. It is similar to
methadone except that it needs to be taken only once every three days.
Just 5,000 recovering addicts across the nation are being treated with
it.

Addiction experts say the newest drugs offer much more
hope.

The drugs, which are new formulations of drugs already approved for
other uses, are far more difficult to abuse than methadone because
they are much less addictive. There also is less risk of death by
overdose because the new drugs don't depress breathing. Doctors in
hospitals use an injectable form of one of the drugs, a mild narcotic
called buprenorphine, to treat pain.

Although manufacturers have not priced the new drugs, they will be
more expensive than methadone, which no longer is under patent
restrictions and costs just pennies a dose.

The combination pill nearing FDA approval is called Suboxone, and is
made up of buprenorphine and naloxone . Buprenorphine competes with
heroin for space on the opiate receptors in the brain and body, which
douses any high that heroin provides. It also blocks withdrawal pains
by keeping the receptors occupied. The naloxone remains inactive
unless a recovering addict tries to abuse the drug by crushing it into
a powder, adding a liquid and then injecting it. The activated
naloxone starts an extraordinarily painful withdrawal. In effect, it
punishes those who misuse their treatment.

The FDA is reviewing drug applications for the combination pill and
another one containing only buprenorphine; both are produced by
Reckitt & Colman Pharmaceuticals of Richmond, Va. Versions of the
drugs have been given to addicts in France, where the approval process
for drugs is less complicated than in the USA.

"This is cutting-edge because it's different from methadone," says
Charles O'Brien, chief of psychiatry at the Philadelphia VA Medical
Center and an expert on treating heroin addiction. "You almost can't
overdose on heroin when you're on buprenorphine. It's really been a
huge success. People can function totally normally and be very alert
if it's properly dosed."

Another drug, NALTREL , manufactured by DrugAbuse Sciences in Los
Altos, Calif., is a time-released, injectable version of naltrexone,
which blocks heroin from binding to receptors in the body. That
prevents the user from getting high or overdosing.

The FDA has approved daily naltrexone tablets to treat heroin and
alcohol abuse. The injectable version, designed to last 30 days, would
eliminate

daily trips to methadone clinics and, health officials hope, increase
the number of addicts seeking treatment. Drug Abuse Sciences is
conducting clinical trials in substance-abuse patients this year and
intends to file for FDA approval in early 2001, company documents indicate.

"It's a wonderful drug. Even if addicts take a shot of heroin, they
won't feel it," O'Brien says. He adds that the drawback of the new
drugs is "that doctors have to learn to prescribe (them) properly."

The promise of less-addictive treatment drugs has fueled the efforts
to shift treatment from clinics to doctors' offices. Federal rules
prohibit doctors from prescribing narcotics to treat addictions to
other narcotics anywhere except clinics regulated by the Drug
Enforcement Administration (DEA).

Methadone regulations require addicts to stop in each day at one of
about 900 clinics nationwide to retrieve their daily dose. Officials
say that is a discouraging burden, particularly for relatively stable
addicts who have recovered enough to hold down a job or care for a family.

Methadone clinics have become a common target of "Not In My Back Yard"
debates. Seven states have banned them. Many of the clinics are in
drug-infested neighborhoods - to get their daily dose of methadone,
addicts must face temptations outside.

"There are a lot of people who would rather not come to methadone
programs," O'Brien says. "You're going to a place with a lot of heroin
addicts. They offer to sell you heroin right outside the door of the
clinic. By taking it out of that environment, it will open up
treatment to more people who don't really consider themselves addicts,
people who consider themselves nice, normal Americans who don't want
to be hooked."

'Time To Change The Rules'

When Erin Allen, 21, of Wilmington, Del., sought treatment for her
heroin addiction in 1997, doctors had little more to offer than
therapy and methadone. Allen bounced in and out of detoxification
programs, her mother, Marie, recalls.

Allen spent four months on methadone but grew tired of daily visits to
a Wilmington clinic.

"I know methadone helps tons of people, but it wasn't helping Erin,"
Marie Allen recalls. "She had to go every morning. She would have to
wait in line an hour, an hour and a half. She didn't want to be on
methadone the rest of her life."

Erin suffered a fatal overdose of heroin three days after leaving a
treatment program. Now her mother wonders whether other drugs, and
another approach to treatment, could have saved her.

The methadone program is "a 30-year-old system," Clark says. "It's
time to change the rules."

HHS officials say the DEA now is willing to do just that, and allow
certified physicians to prescribe drug-treatment medication. Instead
of lining up each day at a clinic, an addict could get a prescription
from a doctor for several days of treatment drugs and pick them up at
a pharmacy.

Health officials expect to officially announce the policy changes
soon. Sens. Carl Levin, D-Mich., and Orrin Hatch, R-Utah, have
proposed legislation that would bypass some regulatory hurdles and let
some physicians dispense buprenorphine and combination drugs once the
FDA approves them.

Law enforcement agencies fret that recovering addicts who are allowed
to take medication home will sell or trade it for street drugs.

"With naloxone, it's almost non-addictive," Levin says. "It's got
almost no street value, unlike methadone, which is addictive."

McCaffrey says that the benefits of increasing access to methadone,
and eventually other treatment drugs, outweigh any risks of increased
abuse.

He said that the longer addicts don't get treatment, the more it costs
society. Many users will steal to feed their habit and wind up in
jail, lose their jobs and end up on welfare, he says.

Prison costs taxpayers about $26,000 a year per inmate, he says, while
drug treatment costs $18,000 annually. "From a taxpayer's perspective,
it makes more sense for you to get the chronic addict into treatment."

Moving addiction treatment into doctors' offices and out of clinics
represents a giant leap for science, Leshner says.

"Ten years ago, you could not speak about treating addiction in a
doctor's office because people just thought it was a failure of
willpower: 'You don't need a doctor, you need someone to yell at these
people,'" he says. "Science is teaching us that this is a medical illness."