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."