Wonder Drug

Standing outside of Man Alive on Maryland Avenue on a cold March morning, it is impossible to divine what goes on inside. The facade is pure bricks and mortar, concrete, and unembellished stone. There's no signage anywhere. The only clue that this unremarkable facade fronts one of the largest methadone clinics in the city is a note posted on the entrance stating you must take a number to get medicated.

A man named Michael Scott stands outside the door smoking a cigarette, squinting in the surprisingly harsh morning wind, his eyes barely visible above half-moon dark circles. Asked how often he comes to Man Alive to get methadone, he answers nonchalantly, "Seven days a week--what are you gonna do?"

Not much. If you're addicted to heroin in Baltimore, or anywhere else in the United States, you have, up until recently, one of three options: detox and quit cold turkey, sign on for methadone maintenance treatment, or stay on a path that frequently leads to overdose, HIV infection, or a premature death.

Cold turkey sounds good in theory, but the recidivism rate, meaning the number of people who try to quit and end up using again, can soar higher than 70 percent for that approach. Methadone maintenance is a medically proven, widely accepted treatment that cures the craving for heroin; the catch is if, like Scott, you're lucky enough to find an available treatment slot (most in Baltimore have months-long waiting lists), you may end up having to go to a clinic day in and day out for the rest of your life. The third option is one that the U.S. Department of Health and Human Services' Drug Abuse Warning Network says contributed directly or in part to the deaths of 411 people in Baltimore City in 2002--a toll substantially higher than the city's well-publicized annual homicide rate.

Those were the options, until buprenorphine.

Buprenorphine isn't new. It's been around for almost 25 years, a mild analgesic drug for treating moderate pain. In 1978, Baltimore physician Dr. Donald Jasinski published a paper on the drug's possibilities as a treatment for opiate addiction. More than 15 years of research, much of it conducted here in Baltimore, followed. In May of 2003, the U.S. Food and Drug Administration finally approved Suboxone, a sublingual (meaning taken as a pill placed under the tongue) version of buprenorphine for treatment of heroin abuse. In theory, if buprenorphine can be made widely available, a person addicted to heroin could visit a doctor, pick up a prescription to be refilled once a month, and go home, for all intents and purposes, cured.

This may not sound revolutionary, but in a city with as many as one in 10 residents addicted to heroin according to the U.S. Drug Enforcement Agency, and a chronic shortage of treatment slots, it could be. That's why city Health Commissioner Dr. Peter Beilenson says his department is currently in the process of hiring a "buprenorphine coordinator." A variety of local health organizations are also granting money to train local doctors to prescribe it, and they have good reason to believe it could make a difference. In France, the widespread use of buprenorphine for treating heroin addiction has helped the nation cut its overdose rate by 80 percent between 1994 and 1999. In this city, that could mean possibly hundreds fewer deaths each year, not to mention all the lives bettered and crime reduced by ending active habits.

As simple as it sounds, there are still many obstacles to widespread buprenorphine treatment, obstacles that have as much to do with the history of our cultural and legal attitudes toward drug addiction as with pharmacology. There are regulations to overcome, like the FDA rule stating that, even now, a certified doctor or group of doctors may prescribe the drug to only 30 patients--meaning that an entire hospital, such as Johns Hopkins Medical or Maryland General, with hundreds of doctors on staff, can only prescribe buprenorphine to 30 addicts. There is the difficult process of spreading awareness of the drug among the habitually hard to reach population of those currently addicted. And there is the uphill climb to win over and educate doctors themselves, particularly the prized solo practitioners who are what Beilenson calls "the key to the buprenorphine equation."



It's not even 8 a.m. on a chilly February Saturday, and the conference room at MedChi's headquarters, the armorylike structure on Cathedral Street that houses Maryland's practicing physician trade group, is already buzzing. Some 70 doctors, a mixed bag of family practitioners, psychiatrists, and internists bundled in tattered sweaters and casual pantsuits, commune in a collectively severe case of early-morning unkempt suave. Attendees linger over platters of bagels in quiet conversation well after the conference's official start time of 8:30, but as Dr. Peter Luongo, the director of the Maryland Alcohol and Drug Abuse Administration, amps up the volume halfway into his introductory remarks, the undertone of low murmurs in the room stops.

"Buprenorphine helps push an agenda that needs to be pushed," he says passionately. "1914 was a long time ago, and doctors are still living with the consequences of it today."

The date 1914 comes up several times over the course of the eight-hour conference, along with its significance: the passage of a little-known law called the Harrison Narcotics Act. The Harrison Act has barred doctors from treating opiate addiction directly for the past 90 years.

The law was not intended as legislation to control the treatment of drug addiction. In fact, it was enacted ostensibly to tax the then-legal and booming international trade in opiates. But a seemingly innocuous clause in the act limiting any physician to prescribing opiates in "the course of his professional practice only" became a veritable political football in the hands of the U.S. Treasury Department. Since addiction was not then considered a disease, treating morphine addicts with legal opiates was not normal "professional practice" under the Treasury's interpretation, and arrests of physicians followed. After two 5-4 U.S. Supreme Court decisions in 1916 and 1919 held that prescribing opiates to comfort an addict was a violation of the "good faith" of the practice of medicine, and thus a crime, Treasury agents began conducting raids at such a despairing rate that by 1938 some 25,000 doctors had been arrested for prescribing opiates.

In 1953, Rufus B. King, one of the first anti-drug law crusaders, published an article titles "Jailing the Healers and the Sick" in the Yale Law Review. One of the first retrospective overviews of the Harrison Act, King's article accused the Treasury's Narcotics Division of turning "the nation into a happy hunting ground, stocked with addicts as fair game," by pushing "the medical profession out of the way." The idea of a "dope fiend" was unheard of prior to 1914, King wrote, even though thousands of people were taking morphine legally up to that time.

Thus narcotics addiction was primarily a criminal-justice problem long before it was considered a medical one. And despite the advances made in medical science over the last century, treatment of heroin addiction has changed little since the discovery in 1964 that methadone, a substitute for morphine invented by German scientists to ease shortages of painkillers in the latter half of World War II, could be used to alleviate cravings for opiates. Substituting methadone for heroin at clinics heavily regulated by the FDA soon became the standard treatment for heroin addiction, a position it holds to this day.

According to Dr. Eric Strain, a professor of psychiatry and behavioral science at the Johns Hopkins School of Medicine who spoke at the MedChi conference, buprenorphine has proven to be as effective or better at curing the craving for heroin than methadone in clinical trails. And as the presenters unleashed a fusillade of lectures and pharmacological charts, the evidence was compelling.

Picture the brain as a huge field of receptors--like satellite TV dishes--all waiting for input to process and relay back to the other parts of the body. Heroin and other opiates bind to those receptors, causing the body to experience pleasurable, mind-numbing sensations. Without opiates in the bloodstream, the receptors of a habitual user, used to comfort, send out a sort of distress call that results in the total-body breakdown known as spontaneous withdrawal, an amazingly unpleasant condition that a doctor at the MedChi conference described as "fluids coming out of every orifice except the ear."

Methadone works by binding to the same receptors in the same way that opiates do, with more mild results. Without a daily dose of methadone to mimic the effects of heroin, however, the body goes into the same sort of withdrawal. As beneficial as methadone treatment is, it is highly addictive itself.

Like methadone, buprenorphine binds remarkably well to the receptors that cause the most trouble for people who experience physiological cravings for heroin and withdrawal, preventing both. Unlike methadone, it binds poorly to the receptors that cause pleasure. Thus it has that best-of-both-worlds quality that seems so elusive in both society and science--it helps while not hurting. It stays in the body longer than methadone as well; with the proper dosage, patients can be medicated once every three days, instead of the normal methadone regime of once a day, making it more convenient to administer. Less inherently addictive, it also affords patients an easier time when they stop using it altogether.

The Controlled Substance Act, passed in 1970 to categorize and control the use of narcotic drugs, is augmented by a handy drug classification system called "the schedule." Schedule 1 includes "substances with a high potential for abuse with no known medical use" like cocaine, heroin, and their unwieldy third cousin marijuana. The next level is the class of opiates and other medications that have some established medical use but still have a high potential for abuse; methadone sits regally in second class, a great treatment for drug addiction but stuck in the regulatory combine that requires regulated clinics to dispense it. Buprenorphine is Schedule 5, the least restricted level of control, due in part to its low level of "abuse potential." This means that certified doctors can prescribe it anytime, anywhere--no daily visits to heavily regulated clinics necessary.

Once the doctors at the MedChi conference leave with certification in hand, they'll be able to do what their medical predecessors have been barred from doing for close to 100 years--treat an opiate addict with privacy and dignity. And when Strain remarks casually that "the Harrison Act was the wrong idea, and we need to undo it," it becomes clear that buprenorphine is perhaps the best hope for allowing physicians, rather than politicians and police officers, to make things better.


"I started working with buprenorphine when my youngest child was in elementary school, and it was approved when my grandchild entered kindergarten," Dr. Edward Johnson says. "It's strange."

Johnson, one of the first physicians to test buprenorphine in clinical trials for treating opiate addiction, has a veteran's perspective on the drug's slow, circuitous path toward FDA approval and the front lines of treatment. In 1978, his colleague Dr. Donald Jasinski, now a member of the Hopkins Medical faculty and director of its Center for Chemical Dependency, published a paper on the possible use of buprenorphine as a "potential agent for treating narcotic addiction" in the Journal of American Psychiatry. According to Edwards, Jasinski discovered the drug's efficacy somewhat by accident: "He was testing it simply as a treatment for withdrawal symptoms--it just worked so well."

"It had less physical potential dependence and it was less toxic than methadone," Jasinski says. "So I concluded it might be useful to treat opiate addiction."

Jasinski, along with Edwards, worked on buprenorphine initially at Addiction Resource Center, a federally funded drug abuse research center in Lexington, Ky. Upon Jasinski's relocation to Baltimore to head the Center for Chemical Dependency at Johns Hopkins Hospital in 1979, Jasinski and Edwards continued to study buprenorphine here through numerous clinical trials for more than 15 years, despite what Jasinski calls "political and conceptual" resistance from the methadone community.

After Johnson proved conclusively in a study conducted in 1992 that the drug was a suitable and possibly even safer substitute for methadone, the National Institute of Drug Abuse partnered with U.S. manufacturer of the drug, Reckitt Benckiser (where Johnson is now a vice president), to push for congressional approval of its use in treating opiate addiction. This began a circuitous slog through the legislative process, beginning in 1995, that included five failed attempts to win passage by burying what was known as the "buprenorphine bill" in a myriad of unrelated appropriations legislation. Finally, after being attached to a bill known as the "Children's Health Act" (a law aimed to strengthen the availability of drug and mental health services for children) in the summer of 2000, the buprenorphine bill passed the House and Senate, and was signed into law by then-President Bill Clinton on Oct. 17th, 2000. As Jasinski notes without irony, "Sometimes ideas take a long time to play out."

By early 2003 the FDA approved Suboxone, a drug with four parts buprenorphine and one part naloxone (an anti-overdose medication mixed in to prevent abuse) for treatment of addiction, with the radical provision still intact that allowed it to be prescribed directly by the primary care physician. "That's the key to this whole thing . . . primary care," Johnson says.

Of course, buprenorphine has been so promising that not every primary care physician has been waiting for approval, especially given the epidemic proportions of heroin abuse in cities like Baltimore, which the Drug Enforcement Agency pegged as the having the highest per-capita heroin use rate in the nation in 2000.

Darting across the Maryland General Hospital campus in a torn white lab coat, Dr. Michael Hayes resembles some kind of medical anarchist. The medical director of Maryland General's detox center since 1992, Hayes speaks in broad strokes, calling the current system of drug treatment in this country "cruel. . . . In the midst of an obvious epidemic it's absurd, our treatment of drug addiction in this country--it debases the patient."

In addition to his work with the detox program, Hayes is a consulting physician for the Glass Counseling methadone clinic and an adviser to MedChi's buprenorphine outreach program for doctors. With 30-plus years of experience treating all forms of addiction, he not only has historical perspective, but the medical profession's version of street credibility, dealing hands-on with the victims of opiate addiction at the detox clinic every day. As such, he is intimately familiar with the limitations of the currently available treatments for opiate addictions, including methadone. "Methadone is a great treatment, but with the current system of regulation it changes dependency from the drug to clinic," he says.

Hayes has been an advocate for buprenorphine for many years. Though not involved in the local research into the drug, he happened upon its effect in 1995 while treating his detox patients for symptoms of withdrawal.

"I've learned everything I know about addition medicine from my patients," he says. "So when some of the younger ones started asking me for the needle 'like they got at Hopkins,' I did some research to find out what they were talking about."

After a little bit of asking around, Hayes discovered buprenorphine was in clinical trials at Johns Hopkins Medical. With the same sense of purpose that informs his animated conversational charm, and with more than a bit of guts, Hayes began illegally administering it for detox, ignoring the federal law that still precluded physicians from treating drug addiction.

"Once we started using buprenorphine, our numbers picked up," he says. "The patients loved it, and more importantly they came back to complete their treatment"

Yet the risks for Hayes were tangible. In 1996, the same year he started his under-the-radar treatment in Baltimore, the Kolmak Clinic, an addiction treatment center in Washington, D.C., was raided and shut down by the DEA for treating patients with buprenorphine. Still Hayes stayed the course, discovering in the trenches what the researchers at Hopkins already knew--that buprenorphine has potential to be the most revolutionary drug in addiction medicines since methadone.



George C. agrees. A tall, salty-haired 44-year-old who uses a coffee cup as a prop for emphasis, he is enrolled in the now legal Maryland General buprenorphine maintenance program under the purview of Dr. Hayes. Sitting in a cramped examination office at Hayes' clinic, George is unequivocal: "Buprenorphine is absolutely wonderful--it's the best treatment I've ever had. I've gone to over 18 methadone clinics--I should know."

George has been using heroin since his mother's death in 1978, falling into an addiction that sidetracked the career of a promising three-sport high-school athlete. Working odd jobs in between bouts of serious heroin abuse, he has tried methadone maintenance, electric shock therapy, and hypnosis. Methadone in particular didn't do the job. George contends that the treatment put him in a "15-year daze," causing him to stop taking his medication and relapse annually. "I started getting methadone in the disco era and woke up from it when it was hip-hop," he says. "I was in such a nod that I still had bell-bottom pants in my closet."

He discovered buprenorphine three years ago while going through detox at Maryland General. At that time, George told Hayes "if they come out with a pill, I'll take it for the rest of my life." Now he comes to Maryland General once a month to pick up his prescription and check in with Hayes. "It's no different than taking my anti-depressant medication," he says. "The freedom absolutely helps." With the added freedom and stability of buprenorphine treatment, George has got his own home-improvement business up and running and is enjoying what he terms simply "living life."

Rosalind Murray is another Baltimorean who says she has benefited from the efforts to make buprenorphine more widely available. A lean 36-year-old, she wears a poised, slightly measured expression. Sitting in the offices of Health Care for the Homeless, the downtown community health care facility that treated her for heroin addiction, she seems to measure each word of her story as if the ability to tell it succinctly and with composure is inherently therapeutic.

Murray struggled with heroin abuse starting three years ago, getting addicted through a boyfriend with a problem who "passed it on." As she descended into the depths of the disease, her career as a medical assistant in a group home faded quickly into a life of prostitution and homelessness. One night in late November of 2003, after a day spent tricking for money, she refused her pimp sex, which prompted a beating with the end of a broken beer bottle. If not for intervention of a passer-by, she says, "I would have been dead."

This experience motivated a desperate search for a way out. Learning from a friend that Healthcare for the Homeless offered free buprenorphine detox, Murray signed up. "It helped me tremendously," she says. "It worked so well, I stopped taking it early."

Murray says she has been clean ever since. And while 40-some odd days is but a start on an entire life drug-free, every minute she isn't using a needle, prostituting herself, or otherwise living in mortal danger is a better day for her and the world she inhabits. Freedom from addiction has even reawakened her desire to offer her talents for healing massage through her own business, serving elderly patients with back pain, rheumatism, and arthritis. In the meantime, she is thankful to have the option and the dignity of buprenorphine treatment. "I believe that things will get better now," she says. "I can tell."

Stories like George and Murray's are why Dr. Peter Beilenson is aligning the city Health Department's resources behind buprenorphine--it is, in his opinion, "clearly very effective." For now, Beilenson says he is focused on the battle to get buprenorphine into the hands of regular physicians, speaking at what he calls "grand rounds," a training conference similar to but distinct from the MedChi conference, both of which serve to enlighten and legally certify doctors to prescribe it, an FDA requirement. And in addition to the previously mentioned attempt to hire a city "buprenorphine coordinator," Beilenson says his office is compiling a buprenorphine data bank that will "help people who call our regular drug treatment line to find a physician that will prescribe it.

"Listen, people just want to be treated in a humane and effective manner," he says. "For this, buprenorphine is a good tool."



Despite the widespread medical and institutional support, not all opinions of buprenorphine are entirely positive, particularly within the established community of methadone advocates and providers.

"Methadone maintenance is still the gold standard of treatment for opiate addiction," contends Gary Mandell, the director of the Maryland chapter of the National Alliance of Methadone Advocates. A registered nurse for more than 25 years, Mandell works as an unpaid volunteer for the alliance, an organization that according to its Web site seeks "to eliminate discrimination against methadone patients." As far as buprenorphine is concerned, Mandell believes "the jury is still out." He has acquired some anecdotal evidence as to its actual effectiveness, saying, "I think it works for younger people, but from what I've heard from my friends who work at clinics it doesn't help the long-term users."

Susan Gibson, a clinician at JAEL Services, a privately run methadone clinic in Howard County that treats roughly 300 patients, echoes Mandell's opinion. "We have patients that have switched to buprenorphine, and then come back to us," she says. "They don't think [buprenorphine] works because they don't feel as good."

A consensus opinion of the federal National Institutes of Health proclaimed in 1997 that "the safety and efficacy of methadone maintenance has been unequivocally established," yet the treatment remains highly controversial. Prescription of methadone is still highly regulated by the FDA because of its toxicity when misused or abused. Methadone clinics are also subject to stringent regulations from state and local governments, often prompted by objections from communities uneasy with clinics that cater daily to recovering drug addicts. As a result, it is difficult if not impossible to open new clinics, and established clinics often find themselves embattled.

The Pikesville methadone clinic A Helping Hand finds itself currently pitted against the Baltimore County Council in a drawn-out legal struggle for survival. Six hours after A Helping Hand received zoning approval to locate the clinic in Baltimore County on April 16, 2002, the County Council passed Bill 39-02 outlawing any "drug abuse treatment program" from locating within 750 feet of a residential neighborhood. The U.S. District Court enjoined the county on Aug. 30, 2002, stating that the zoning regulation was a violation of the Americans With Disabilities Act, but the struggle to overrule the law completely is still being argued before the U.S. District Court of Maryland, with a motion for an eventual jury trial granted in late December 2003.

Howard County and the city of Westminster have since joined the fray, proposing similar zoning restrictions to block planned clinics in their locales. Just down the road in West Virginia, the state Health Care Authority has instituted a six-month moratorium on new methadone clinics effective January 2004. Such measures mean that there are too few slots for too many addicts; the National Institutes of Health estimate that 115,000 patients currently receive methadone, out of what a 2000 DEA census estimates is nearly 1 million active opiate/heroin addicts nationwide.

Even methadone advocate Mandell concedes that buprenorphine has an advantage in being available directly from a certified physician, anytime, anywhere, without clinics or pressure from governments, politicians, or not-in-my-backyard citizenry. "The methadone system is so over-regulated it hurts people," he says. "All the politics hurts the patient."



If there is any unifying theme behind the effort to get buprenorphine into the hands of people who need it, it's the idea of "harm reduction." Harm reduction philosophy weeds out what Dr. Michael Hayes refers to as the "moralistic" approach to drug treatment and recognizes the problem for what it is--something that can and should be treated with the best medical tools available, one being buprenorphine. With the drug in the hands of more certified physicians and what Hayes calls "unnecessary" restrictions like the 30-patient-per-doctor-group limitation out of the way, many more lives could be improved, even saved. As the Drug Policy Alliance, a nonprofit advocacy group, contends on its Web site, harm reduction is not what's nice, it's what works.

Still, as Hayes finishes off a wan-looking salad in the Maryland General cafeteria, his optimism for buprenorphine is tempered by the unrelenting lack of rationality in the politics, not the science. "The death rate for opiate overdoes is higher than the homicide rate in this city, yet we can't seem to approach the problem pragmatically," he says. "The problem is everywhere, and we need to treat it rationally."

As if to prove his point, on the cover sheet of a fax Hayes sends later that day, a small quote is written on the top of a diagram outlining the different phases of medical treatment for addiction, an epigram that could be interpreted as the Zen syllogism of medical science. It reads the majority of the population prefers the comfort of irrational conviction--to the uncertainty of logical doubt. When asked what this means in the context of buprenorphine, Hayes laughs and says, "Sometimes we're just dumb."

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