Pubdate: Mon, 21 Aug 2000
Source: Washington Post (DC)
Copyright: 2000 The Washington Post Company
Contact:  1150 15th Street Northwest, Washington, DC 20071
Author: Fredrick Kunkle, Washington Post Staff Writer


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 

"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that his last name not be published.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 

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 

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 

"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 

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 

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 

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 

"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 
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