DRUG SHOWS PROMISE IN FIGHTING ADDICTION

Most people round up beach umbrellas, fishing rods or camping gear before
they go on vacation. Mike stocked up on pills.

A financial planner who lives in Prince George's County, Mike schemed,
begged and hoarded to make sure he wouldn't be stranded in New England with
fewer than 350 painkillers.

Although he had kicked alcohol with 12-step meetings and grit, he could not
shake his addiction to prescription narcotics. Then, a year ago, he signed
up at the Kolmac Clinic in Silver Spring for an innovative treatment that
has not yet been approved by the Food and Drug Administration. That
treatment, according to the Drug Enforcement Administration, is against the
law.

"It was the first time I could function without my body being wracked with
so much pain that your mind couldn't function. I thought, 'Jiminy
Christmas, I might not have to die suffering to death,' " said Mike, a
58-year-old Laurel resident who agreed to be interviewed on the condition
that his last name not be published.

For the past four years, George Kolodner, medical director of the Kolmac
Clinic, has been offering an unorthodox treatment for people addicted to
heroin or other narcotics. To help them kick the habit, addicts who enroll
in the clinic's outpatient rehab programs receive little green Jello-like
squares with doses of buprenorphine, a medicine that has long been used in
injectable form in hospitals as a painkiller.

Kolodner is one of an unknown but small number of U.S. doctors who
regularly administer buprenorphine for opiate detoxification - a practice
known as an "off-label" application because it involves a medicine that's
already on the market but gives it a purpose that has not been specifically
approved by the FDA.

Off-label applications are common. But the use of buprenorphine for
addiction treatment flies in the face of federal drug laws that prohibit
the use of any narcotic, except methadone or a methadone derivative known
as LAAM, to treat narcotics addiction.

That's likely to change soon, however.

The FDA and Congress are moving toward approval of buprenorphine
(pronounced byoo-preh-NOR-feen) for treatment of opiate addiction.

Last month, the House voted 412-1 to approve a measure, sponsored by Rep.
Thomas J. Bliley Jr. (R-Va.), that would allow doctors to prescribe
buprenorphine in their offices. The Senate is expected to reconcile the
bill with a similar measure when Congress returns from recess.

Meanwhile, the U.S. Department of Health and Human Services is developing
regulations to govern office-based use that would stipulate which
physicians could offer the drug.

The change could significantly alter addiction treatment by helping addicts
in the privacy of doctors' offices rather than sending them to storefront
clinics or requiring them to check into treatment centers.

Addiction specialists believe it would provide a powerful new incentive to
get more people into treatment, particularly the upwardly mobile, suburban
addict whose habit dwells in the shadows of a caring family and a career.

It also would turn back the clock to the time when family physicians dealt
with their patients' drug habits in consulting rooms, not
government-sanctioned clinics - a practice under attack at least since the
Harrison Narcotic Drug Act of 1914 enshrined addiction as a moral vice, not
a biological phenomenon.

"I think we're going to see the treatment of narcotics addiction as
mainstream medicine," said Frank J. Vocci, director of the treatment
research and development division at the National Institute on Drug Abuse.

Hailed in research studies as a promising alternative to methadone,
buprenorphine mimics the effects of heroin, but in a much milder way, and
so curbs an addict's craving for an opium-induced high. The risk of
addiction is lower than with methadone, as is the risk of overdose,
particularly because buprenorphine suppresses breathing significantly less
than morphine-like drugs.

When combined with naloxone - a drug that precipitates withdrawal and the
painful symptoms that go with it - buprenorphine also poses fewer risks of
being abused for its own sake.

The drug is produced by Reckitt Benckiser Pharmaceuticals Inc., a
Richmond-based division of a conglomerate that also sells mustard and
Lysol. While not expected to replace methadone or its derivative
levo-alpha-acetyl-methadol (LAAM), buprenorphine could become an attractive
alternative for the estimated 500,000 to 1 million heroin addicts in the
United States. Only about 200,000 are in treatment, officials say.

"So the hope is, it will bring into treatment some of those hundreds of
thousands of addicts who do not want to or are not willing to come in,"
said Herbert D. Kleber, a Columbia University professor and former deputy
director of the National Drug Policy Office. "I think it's important that
we don't think of this simply for the more well-to-do addict. Because
there's no reason why it can't be prescribed by medical clinics, for example."

Buprenorphine would enter the treatment picture at a time when the medical
and legal establishments have noted an alarming increase in heroin use,
particularly among the young, not seen since the late 1960s.

Traditionally, the needle scared many neophyte drug users away from heroin.
But injecting the drug is no longer necessary.

The keener purity of heroin these days allows users to get high - and get
addicted - by smoking or inhaling the drug. It's not uncommon to find
heroin on the street that's 80 percent pure, up from less than 10 percent
in the early 1980s.

"The purity of heroin is higher than at any time I've seen in my 35 years
in the field," Kleber said.

And the price has gone down. In Philadelphia, a magnet for some of the
purest heroin in the country, the price has dropped to around $10 a bag
from as much as $40 in the 1980s.

The result: An annual household survey cited by the DEA found that the
number of current users of heroin doubled between 1993 and 1998. And the
average age of first-time heroin users dropped to 17.6 years in 1997 from
26.4 years in 1990.

"There's been nearly a fivefold increase in heroin use in the adolescent
population," Vocci said. "This is now seen by some kids as being less risky."

Opiates home in on the circuits in the brain that light up in pain or
pleasure. Heroin, which is broken down into morphine in the body, offers
the greatest "rush" because it penetrates the brain so quickly - but it
also depresses breathing, sometimes fatally.

What's more, the body builds up tolerance to the drug, making addicts crave
higher doses to obtain the same sensation. After a while, the body needs
the opiate just to function, or it goes into withdrawal. Often described as
being like bad flu symptoms, withdrawal is not fatal, but it tortures its
victims with shakes, chills, nausea and pains that invade the joints.

"As one of my patients said, 'I was afraid I might not die,' " Kleber said.

But buprenorphine's unusual chemical properties ease addicts through
withdrawal - and offer a chance of giving up drugs entirely. Heroin,
methadone and LAAM produce a powerful reaction when they lock onto certain
receptors in the brain. Other drugs, such as naloxone and naltrexone, fit
the same receptors but produce no stimulus. In fact, they block the opiate
from the receptor and starve the brain into withdrawal.

Enter buprenorphine, which shares seemingly contradictory properties of
both types. At low doses, buprenorphine produces a mild narcotic effect.
Yet, as the dose goes up, the drug shifts to block the narcotic effect,
which makes it more appealing in treatment than methadone.

"There's some safety in it. It's safer to use as an outpatient because it's
harder to overdose with it," said Rodney Burbach, medical director at
Suburban Hospital in Bethesda. "It's sort of a way of getting some narcotic
effect so the person gets over withdrawal, but also limiting the withdrawal
effect."

Buprenorphine's effects also last longer. Heroin addicts, for example, need
a fix two to four times a day, and people treated with methadone must visit
a tightly controlled clinic once a day. But buprenorphine can last up to 72
hours.

The drug has been used for detox in several legally and medically
sanctioned clinical trials. George M. Bright, who oversees the Adolescent
Health Center, a Midlothian, Va.-based program for young addicts, is using
buprenorphine as part of a nationwide study.

Thousands of addicts have been treated using buprenorphine in Europe,
although there were also abuses. Some addicts died after dissolving
buprenorphine tablets and injecting the drug - a form of delivery that
speeds the drug to the brain - while abusing other drugs. As an added
safety measure when buprenorphine is marketed here, the tablets will be
available in two forms: alone and in combination with naloxone, as is done
in many clinical trials.

"One of the nice things about buprenorphine is you can't overdose with it,"
said Richard B. Resnick, an associate professor of psychiatry at New York
University School of Medicine who has used the drug in a series of clinical
trials over the last 10 years.

But Resnick said the drug may be better as a substitute for opiates than
for weaning someone from drugs entirely - a criticism often leveled at
methadone.

"We're quite excited about this drug," said H. Westley Clark, director of
the Center for Substance Abuse Treatment, which is working on regulations
that would stipulate training requirements and other guidelines for
physicians who want to dispense the drug.

"We think buprenorphine will offer a revolutionary new contribution to our
ability to offer addicts another treatment to fight addiction," Clark said.
"However, we need to be careful about promoting buprenorphine as a
near-panacea."

Clark said it's too early to say whether the drug could be diverted or
abused once the tablets become available in the United States.

"We do know that it is completely benign," Clark said. But he added: "It's
premature to say that it has zero overdose potential, or has minimal side
effects, because we don't know how addicts will be using it once it's
readily available. . .‚. Our fear is that we neither leave addicts nor the
community with over-expectations."

Other skeptics say many private physicians may not understand the
complexities of working with addicts or the importance of offering a
comprehensive treatment program that includes counseling.

"So the concern is that if patients go into a medical practice setting, all
that's going to happen is the individual may get access to a prescription,"
said Mark W. Parrino, president of the American Methadone Treatment
Association.

The group, which represents 675 clinics, believes doctors should receive
certification from a specialty group such as the American Academy of
Addiction Psychiatry to prescribe the drugs.

"Now, we're not saying the training must be elaborate," said Parrino, who
views buprenorphine as an attractive new treatment, particularly for young
addicts or people who have not been dependent for a long time.

But Parrino also said the drug may be of limited use for the most hard-core
addicts.

Kolodner, who administers buprenorphine to from five to 12 addicts a week
at the clinic, said the drug, combined with comprehensive therapy, has
shown great promise in weaning people from narcotics. He's also aware that
his off-label use of buprenorphine for opiate detoxification could draw fire.

"You feel like you are taking a risk. But at the same time, your patients
are dying," he said. "I haven't been going around trying to stick my neck
out. I've been quietly trying to treat my patients. I'm trying to be real
cautious. But if you feel something's going to help the patient . . . it's
okay to do it."

But the DEA says otherwise.

Rogene Waite, a DEA spokeswoman, said practitioners who dispense, prescribe
or administer the drug for treating opiate addiction could face
administrative, criminal and civil penalties. Kenneth Ronald, DEA
congressional liaison, said the agency has no objection to the
congressional bills that would permit its use.

"It's clearly illegal," said Resnick, the NYU psychiatrist. "But I don't
think anybody's been prosecuted for it. I don't think they're interested in
prosecuting anybody for it."

As medical director at the New Leaf Treatment Center in Concord, Calif., S.
Alex Stalcup has been administering buprenorphine for opiate detox since
1995. He attempted to organize a network of physicians who use the drug for
detox but found no takers.

"Everybody is scared to death of the government. They could come in and
close me down tomorrow," said Stalcup, whose view of the drug war was
shaped by his experience when he was medical director of the Haight Ashbury
Free Clinic in San Francisco. But, he added: "It's unethical for me to
withhold proven, high-quality care."

Even with approval near, Stalcup worries that buprenorphine's promise could
be lost in a thicket of regulations that govern who may dispense it.

"This thing's been studied to death," he said.

"It is embarrassing and frustrating to me that regulators continue to drag
their feet about making buprenorphine available. I mean, we have a health
crisis here. What are we waiting for?"

But as news of buprenorphine travels by word of mouth, some addicts have
been unable to wait, sometimes traveling hundreds of miles to participate
in medical studies or, like Mike, signing up at rehab clinics that quietly
offer the drug.

A broad-shouldered, red-faced bulldog of a man with a wing of silver hair
swept off to the side, Mike looks like a prosperous retiree between rounds
of golf. Even when he was sick, he didn't look it.

Other addicts often eyed him suspiciously, thinking he might be an
undercover officer.

Like most addicts, Mike learned how to hide his problem - even though he
got to the point where he was gulping 50 Percoset pills a day. He made up
stories of injuries and ailments to trick doctors into prescribing drugs,
and he kept elaborate records to avoid using the same doctor or pharmacist
too many times.

"It was like a science. I had the pharmacies down. The dates. I mean, it
got to be a full-time job," he said.

Of course, he had powerful motivation to feign injuries and lie:
withdrawal. The thought alone scared him. It signaled its approach with
chills, wracked his body in aches and pains. He broke out in sweat.

"The fear is absolutely unbelievable, the fear of waiting for withdrawal to
start," he said.

To break the spell drugs had over him, he went through rehab - inpatient
and outpatient - four times.

"Each time, I was voted most likely to succeed," he said. Deciding to give
methadone a try, he woke at dawn and drove an hour from home so that no one
would see him entering the Annapolis clinic.

Ground down by the stigma and the inconvenience of the treatment - and the
discovery that few ever quit - Mike ended up hooked again on pills and the
deceptions necessary to procure them.

After faking a heart attack at Prince George's Hospital, for example, he
wracked up an $18,000 hospital tab but scored no drugs.

So he took a chance on buprenorphine. To his surprise, the drug acted
without any kind of high - but it also kept him from slipping into
withdrawal. After about 12 weeks, in carefully stepped-down doses, he quit
altogether.

"I don't know if it's a miracle drug or what the hell it is, but everybody
I talked to felt the same way," he said. "When you have suffered as long as
I have and you've convinced yourself there's nothing out there, it was a
relief."