Pubdate: Fri, 01 Apr 2005
Source: Wired Magazine (US)
Copyright: 2005 The Conde Nast Publications Inc
Contact:  http://www.wired.com/
Details: http://www.mapinc.org/media/505
Author: Douglas McGray
Bookmark: http://www.mapinc.org/heroin.htm (Heroin)
Bookmark: http://www.mapinc.org/find?131 (Heroin Maintenance)

THE BITTER PILL

Buprenorphine could end heroin addiction, curb disease, and cut crime. But 
bureaucrats, doctors, and much of the treatment industry are just saying 
no. A case study in why the best technology doesn't always win.

At 28, Joe has become something of an expert at heroin detox - he's tried 
it nine times. Between programs, he's attempted to quit on his own. Once, 
when the cravings got the best of him, he tried to knock himself out by 
hitting his head against a brick wall. So late last year, when Joe checked 
himself into a New York outpost of Phoenix House, the country's largest 
residential rehab program, he knew exactly what to expect: the plastic cups 
of methadone to wear down his dependence, the sedated days and sleepless 
nights, the chill of the toilet seat, the sickening sight of food. But then 
a doctor handed him a medication he'd never heard of. Something called 
buprenorphine - or simply, bupe. No way, Joe thought. No way this little 
orange pill is going to do the job.

That first day at Phoenix House, Joe remembers, his last heroin high was 
wearing off. He felt the familiar beads of sweat. Nausea began to creep to 
his throat. Perfect conditions, his doctor said; bupe works only when 
patients are in withdrawal. So Joe curled back his tongue, placed the 
little hexagonal tablet underneath, and waited. He felt it slowly soften to 
a gritty paste and disappear. It still amazes him how quickly it worked. He 
didn't feel high, didn't feel withdrawal symptoms, didn't even feel 
medicated; he just felt better. "It took away the pain," he says. "It even 
took away the craving. I had my strength back, and I was eating sooner than 
I ever had in detox. I got clarity when I took that first pill." The 
details of his addiction - kicked out of high school, stripped of a college 
basketball scholarship, and ultimately sent upstate to prison - already 
seem like stories from someone else's life.

Bupe won approval as an addiction treatment in late 2002. Sold by British 
firm Reckitt Benckiser and prescribed under the brand name Suboxone, bupe 
is a synthetic opiate that pushes the same buttons as heroin or painkillers 
like Vicodin, Percocet, or OxyContin, only without the high or any other 
significant side effects. It frees recovering addicts from cravings and 
crashes, allowing them to focus on counseling, work, and relationships. "It 
is the first real innovation in treatment in 40 years," says Phoenix House 
medical director Terry Horton.

Before bupe, there was mainly methadone, an amber syrup that offers similar 
relief from opiate cravings but is highly habit-forming. By law, methadone 
must be dispensed at special clinics and, for most patients, only in single 
daily doses. Widely prescribed beginning in the 1970s, methadone was 
medical science's first real attack on addiction, and study after study 
showed it prevented relapses and deaths by overdose. But public opinion 
swelled against it. Neighborhood groups battled methadone clinics, where 
patients congregate daily for their meds. Politicians charged that junkies 
were merely swapping one habit for another. Methadone has been 
controversial among addicts, too. Some rejected it for producing a powerful 
sedative effect that makes it difficult for a recovering addict to perform 
job duties. Others took methadone illegally as a cheap tranquilizer. 
"People get a methadone habit because it feels like what you were taking 
before," says Solinda, a former Wall Street office manager, heroin addict, 
and occasional methadone abuser who also went through bupe detox at Phoenix 
House.

Patients on bupe do become physically dependent on the pill - as do people 
taking medication for most chronic conditions. Suboxone, though, has no 
strong side effects. Nor can users get high by taking a larger dose - in 
other words, no inching up from dependence to addiction. Bupe is also safer 
than methadone - which, like any strong opiate, suppresses breathing if too 
high a dose is taken - and easier to taper off. And instead of visiting a 
treatment center every morning or quitting cold turkey, addicts can get a 
bupe prescription from their regular doctor. This offers real appeal to 
addicts, particularly white-collar ones, who cringe at the stigma of 
methadone lines. "You're just taking medication," Solinda says. "You don't 
feel sick. You don't feel high. It makes you feel stronger as a person."

For all these reasons, doctors and mental health professionals expected 
bupe to take off quickly. But that has not been the case. While Reckitt 
Benckiser won't disclose sales data, Shaun Thaxter, vice president of 
pharmaceutical marketing, says that 5,000 doctors are now prescribing 
buprenorphine. However, according to two prominent bupe researchers, 
sources inside the company late last year said only half that number is 
prescribing either Suboxone or Subutex, a form of pure bupe often used at 
hospitals for detox. And Herbert Kleber, director of the substance abuse 
division at Columbia Medical School, says the company told him it had 
recorded only about 1,500 prescribing doctors nationwide last summer.

Reckitt Benckiser estimates that since bupe was introduced, 100,000 
patients in the US have used it, whether in the form of a single dose 
during detox or in ongoing treatment. But Yale scientist David Fiellin, a 
longtime bupe researcher, says that medical privacy laws make it impossible 
for the company to accurately count the number of patients taking the drug. 
"They can't know," he says. A more reliable indicator is the number of 
prescriptions filled by pharmacies, which are required to report their data 
to state health agencies. In New York City, home to an estimated 200,000 
heroin addicts and perhaps two to three times that many prescription opiate 
addicts, some 34,000 people were on methadone maintenance throughout 2004, 
while only about 1,000 people filled a bupe prescription last year. "It's 
depressingly few," says Lloyd Sederer, New York City's deputy executive 
commissioner for health and mental hygiene.

So why has bupe's progress been so sluggish when it's clearly a superior 
innovation? There are several reasons. The general practitioners who were 
meant to write most of the prescriptions have proved ambivalent, at best, 
about treating addicts. Lawmakers have bungled regulations; at one point, 
there was even a federal law barring methadone clinics from dispensing 
bupe, despite their experience and reach within addiction circles. 
Meanwhile, Reckitt Benckiser has been conservative in marketing the new drug.

It's all enough to drive Sederer crazy. Reducing the number of active 
addicts in the city would help check the spread of HIV and other diseases 
that hang out on dirty needles. It would lessen the number of deaths by 
overdose. It would cut crime; 20 percent of all convicted felons in New 
York test positive for opiates. It might even save money. The National 
Institute on Drug Abuse estimates that every $1 spent on drug treatment 
erases $7 in social costs ranging from unpaid ER bills to prison overhead.

But Sederer remains hopeful. He and Andrew Kolodny, a city health 
department psychiatrist, have launched a campaign to place at least 60,000 
New Yorkers on bupe maintenance by 2010 - nearly double the number on 
methadone. They are turning city staffers into part-time drug reps to push 
bupe to health workers and patients at needle exchanges, methadone and HIV 
clinics, residential treatment centers, hospital wards, even prisons. They 
figure that if the bupe brand surges in these settings, then the 
harder-to-reach patients like white-collar professionals will hear about 
it, either when they make the occasional foray from their middle-class 
world to buy drugs, or when the city's inroads on addiction make headlines. 
Then these patients will ask their doctors for prescriptions, which in turn 
will make the medical community more comfortable with treating addiction as 
an illness.

"We're doing all the work for the drug company," Sederer says laughing. 
"Here you have a couple of psychiatrists launching a marketing campaign!"

Andrew Kolodny looks uncomfortable at the head of a long conference table 
in the city's Department of Health and Mental Hygiene, where staffers are 
filing in for a final briefing on the bupe campaign. Soft-spoken, with a 
shy demeanor and a disarming smile, Kolodny, 36, joined the health 
department a couple of years ago while doing a fellowship at Columbia 
Medical School for doctors interested in clinic or government work. 
Tomorrow, the city's marketing literature, written by health department 
staff, will arrive from the printer. "Hopefully, by the time we're done 
today, everyone will feel comfortable delivering this information," Kolodny 
begins encouragingly.

It's cram time. Kolodny reminds his colleagues of the drug's advantages. He 
stresses that bupe in the form of Suboxone is safe and almost impossible to 
abuse, a huge selling point at many of the clinics they will visit. 
Suboxone has a second active ingredient in the mix, he explains, an 
anti-overdose drug called naloxone. It does nothing if you take bupe as 
directed. But if you sniff bupe or inject it or otherwise try to pack 
enough into your bloodstream to get high, the naloxone acts like a chemical 
booby trap, erasing the effects of any opiate, bupe included, and bringing 
on sweaty, nauseating withdrawal. "That's the last time you'll do it," 
Kolodny says dryly. The length of treatment varies, with some doctors 
preferring a short detox and others believing addiction is best treated as 
a chronic condition - like depression or diabetes - with ongoing medication.

"Any questions?" he asks. One employee is still confused about why Reckitt 
Benckiser needs help marketing its drug. If anything, pharmaceutical firms 
promote their products too well, turning millions of otherwise sensible 
Americans into Googling hypochondriacs, and doctors into vending machines.

"They are not a pharmaceutical company," Kolodny replies. "They make Lysol."

"Woolite, also," adds another employee. "And French's mustard," Kolodny 
says, smiling a bit. The room breaks up laughing. "How did they come up 
with this?" another staffer asks. "Were they injecting Woolite?"

"I hope they're not making all this stuff in the same lab," a guy in the 
back mutters.

Reckitt Benckiser, "the world's number one in household cleaning," 
according to company literature, stumbled upon the compound in the 1970s. A 
few years later, scientists at Kentucky's Addiction Research Center 
discovered that buprenorphine reduced opiate craving. It bound tightly to 
the brain's opiate receptors - nerve endings designed to catch the body's 
pain-easing, pleasure-pumping endorphins - so that even a low dose blocks 
the effects of heroin or anything else a relapsing addict might take.

In the early 1990s, when bupe began its slow path toward FDA approval, it 
faced more obstacles than the average drug. Until the early 20th century, 
you could order just about any narcotic you wanted from the Sears, Roebuck 
& Co. catalog: morphine, heroin, opium. But in 1914, Congress passed the 
Harrison Narcotic Act, barring doctors from prescribing opiates to known 
addicts. Congress amended the act in 1966 to permit methadone as an 
addiction treatment and again in 2000, to allow doctors to prescribe bupe. 
But it tacked on strict conditions in 2000, partly in response to 
methadone's troubled history.

First synthesized in the 1940s by German scientists and scooped up after 
the war by pharmaceutical giant Eli Lilly, methadone attracted attention in 
the addiction community in the 1960s. That's when a husband and wife team, 
doctors Marie Nyswander and Vincent Dole of Rockefeller University, found 
that with a daily dose of methadone and some counseling, opiate addicts had 
a much better chance of staying clean. Public health officials heralded the 
discovery as a revolution. To get methadone to the masses, Congress created 
a class of tightly regulated health clinics to treat nothing but addiction 
and barred them from issuing any prescription but daily single doses of 
methadone.

Some 40,000 New Yorkers were signed up by the mid-1970s. But the public 
success fizzled as NIMBY neighbors protested the location of clinics, 
illicit methadone hit the street, and critics slammed maintenance programs 
as nothing more than legalized addiction paid for by the government. 
"Methadone is stigmatized, destroyed," says Edwin Salsitz, a leading 
methadone expert based at New York's Beth Israel hospital and a regular 
instructor in buprenorphine licensing classes. "It's a medical tragedy."

Meanwhile, methadone regulations effectively ostracized addiction treatment 
from the medical mainstream. Most med schools leave it off the curriculum 
for all but psychiatry students, who get a mere four weeks of exposure. 
When young doctors train at big-city hospitals, most of their encounters 
with addicts are hard cases showing up in the ER in the middle of the 
night. "The top attendings make fun of them," Salsitz says.

An opportunity to bring addiction treatment back into the mainstream 
appeared when lawmakers amended the Harrison Act in 2000 to enable bupe to 
come to market. It made a step in that direction by allowing general 
practitioners to prescribe the new drug. Yet it barred methadone clinics 
from prescribing the pill at all. This set the stage for some treatment 
centers to view private-practice physicians as rivals. Yale's David 
Fiellin, who attended several early training courses, recalls clinic 
workers standing up to share horror stories about hardcore addicts and 
suggesting that family physicians, if they prescribed the new drug, could 
expect the same in their waiting rooms.

After bupe had been on the market a year, the law was amended to permit 
methadone clinics to prescribe it, but only under the same rules used for 
methadone (one dose per visit), which erases one of bupe's major advantages 
- - that you don't have to schlep to a clinic every day. Meanwhile, many 
methadone providers have remained openly skeptical of the new med, fearing 
that it will further stigmatize methadone, or siphon off their most stable 
patients. The government reimburses methadone programs for the number of 
patients they oversee, not for the specific services they provide, so the 
payment for a stable patient who takes a dose and goes to work subsidizes 
treatment for more fragile clients with multiple addictions, mental 
illness, housing and unemployment issues, and more.

The regulatory problems didn't stop there. Influenced by tales of 
unscrupulous methadone clinics taking on huge case-loads for the 
reimbursement cash, Congress barred doctors from maintaining more than 30 
bupe patients at a time. And in a monumental blunder, the law classified 
giant HMOs like Kaiser Permanente, as well as hospitals, as single 
providers, with the same 30-patient cap that Kolodny has in the solo 
practice he maintains on evenings and weekends. Four years later, the law 
remains unchanged. One clear sign of the law's unintended consequences: The 
world-renowned Addiction Institute of New York (better recognized by its 
old name, Smithers) doesn't mention bupe in its advertising because with a 
30-patient limit, it fears it would have to turn people away.

Meanwhile, even private-practice physicians open-minded enough to seek bupe 
training find that it reinforces old stereotypes. "The courses are a 
disaster," says Columbia's Herbert Kleber, who has a contract from the 
federal Center for Substance Abuse Treatment to redesign the curriculum. 
The classes rely on scenarios instead of letting doctors interact with live 
patients - who tend not to be the monsters that many doctors imagine, 
Kleber says. The message that comes across? "Addicts are a difficult group 
to deal with. They'll rob your office blind and steal your nurse's purse," 
Kleber says, frowning. "You're a general practitioner: Tell me if you're 
going to prescribe."

The result is that bupe faces an uphill battle to find its way into 
doctors' offices.

Kolodny steers a big government sedan through the busy streets of Queens, 
past a billboard that promises, somewhat disturbingly, The World's Boldest 
Corrections Officers, then over the bridge to Rikers Island, where he'll 
talk about bupe to a group of prison docs and nurses. "Best-case scenario, 
everyone hears my speech and thinks this is an amazing treatment," he says. 
"But they may not want to be innovators. They may be content in what 
they're doing." What they're doing is maintaining inmates on methadone, 
trying to tame their addictions before they return to the street. Kolodny 
hopes that with the enticement of meds donated by Reckitt Benckiser - seed 
drugs - the prison will agree to put some inmates on bupe instead. Then, 
when they check out, they can tell their neighbors about it and increase 
the pressure on local doctors to write prescriptions.

A security escort leads Kolodny through two guard stations and a razor-wire 
fence that stands between roughly 17,000 inmates and a postcard view of the 
Manhattan skyline. He hands Kolodny a visitor ID - "Lose this and I'll 
fucking kill you," he instructs - and asks what brings him to Rikers. 
"You're talking about replacing methadone?" he says, skeptically, before 
Kolodny corrects him. "We're pretty anal about change here," the guard 
warns. "We don't like change."

A group of 25 doctors and nurses is already waiting when Kolodny arrives at 
the prison's health offices. He surveys the collection of bored, tired 
faces staring back at him, shuffles his notes, and begins. "With any new 
medication with significant advantages, you'd see ads on TV, like you do 
with Zoloft, you'd see ads in journals, docs would start prescribing it," 
Kolodny says. That obviously hasn't happened with bupe.

The doctors ask about side effects. Good news there. They ask whether it 
shows up on a drug screen (methadone does, so many people who might face a 
urine test at work avoid it). Nope, Kolodny says, a bupe patient's urine 
tests negative - more good news. They ask about the potential for 
black-market dealing; inmates learn to hold their methadone in their 
throat, spit it back up, and sell the spit. That's pretty much impossible, 
Kolodny says, to nods of approval. Will inmates be able to keep receiving 
bupe after they leave prison? Some, but not all, Kolodny says. That's 
because of the nearly 300 doctors in New York licensed to prescribe bupe, 
only a handful will accept Medicaid, even though it covers the treatment. 
Any more - well, the city is working on it.

As he leaves through the tall, steel gates, Kolodny breaks into a smile. "I 
didn't think people would greet us this warmly," he says, genuinely 
surprised. "I don't know if I'd go so far as to say we achieved buy-in, but 
it was a start."

On the drive back to his office downtown, Kolodny's Treo rings twice, just 
minutes apart. Two more people looking for bupe treatment at his private 
practice. "That's weird," he laughs. Or, maybe, an encouraging sign.

Douglas McGray wrote about microcars in issue 12.10. 
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MAP posted-by: Jo-D