SWAPPING POLITICS FOR SCIENCE ON DRUG POLICY

Policy wonks and deficit hawks weren't the only ones paying attention
when President Obama signed the Fiscal Year 2010 Consolidated
Appropriations Act last week. HIV activists, public health experts
and communities of drug users celebrated--not for what's in the
appropriations bill, but for what's not in it: a ban on federal
funding for needle exchange programs, which has appeared in the
federal budget every year since 1988.

After two decades, this change is a historic achievement. Obama had
already missed one opportunity to lift the ban, neglecting to pull it
out of his budget in May. Still, that same month former Seattle chief
of police Gil Kerlikowske was sworn in as the director of national
drug control policy, calling for a new common-sense approach to drug
addiction. When the drug czar calls for an end to the war on drugs,
it's clearly the start of a new era.

Unlike during the Clinton administration, when there was only mixed
support for needle exchange--in 1998, drug czar Barry McCaffrey
convinced Bill Clinton to renege on his stated intention to lift the
ban--all of the top brass in the Obama administration are on record
in favor. Kerlikowske supported Seattle's program of exchanging
needles. FDA Commissioner Margaret Hamburg and CDC Director Tom
Frieden both served as New York City Health Commissioner, and both
used that position to actively promote needle exchange. Still, drug
policy watchers agreed that the president didn't want to force the
question of needle exchange on members of Congress. The White House
was "concerned about making sure that when Congress deals with the
issue, that they can win it," says Harm Reduction Coalition Policy
Director Daniel Raymond.

That left it up to members of Congress to lift the ban themselves,
and in November, the House did just that--sort of. In an attempt to
broaden political support for lifting the ban, Congressman David
Obey, a Democrat from Wisconsin and chair of the committee whose
conference report contains the language, introduced a "thousand-foot
rule," which would have maintained the ban on funding for exchanges
within 1,000 feet of a school, park, library, college or video
arcade. Obey himself acknowledged at the time that the thousand-foot
rule was "unworkable"--since it would simply be a ban by another
name, especially in densely settled urban areas. He said, however,
that he hoped the language could be changed when the House and Senate
versions of the bill went to conference committee. That's precisely
what happened last week.

The new provision prohibits federal funding of needle exchanges "in
any location that has been determined by the local public health or
local law enforcement authorities to be inappropriate for such
distribution." But because needle exchanges "have been operating for
over twenty years with community support and buy-in already," says
Jirair Ratevosian, deputy director of public policy for amfAR, the
Foundation for AIDS Research, this new language essentially ends the
ban. Exchanges "already have support from law enforcement agencies;
they already have support from public health groups, from local
planning committees," Ratevosian noted.

In addition to the much-needed dollars that will start flowing to
needle exchanges, lifting the ban is also of huge symbolic importance
to a presidency whose commitment to a public health approach to drug
addiction has at times amounted to more talk than substance. But
needle exchange is only one intervention among many that have come to
be known as "harm reduction"--taken together, this approach to
addiction is pragmatic rather than punitive. Instead of attempting to
eliminate addiction altogether, it seeks to mitigate the harms--HIV,
hepatitis C, overdose and criminality, among others--that addiction
can cause. Many harm reduction programs have been studied extensively
and are widely understood to be effective but continue to be stymied
by politics, even under Obama and Kerlikowske. That, until recently,
was the fate of needle exchange itself.

Safe injection facilities, for example, take needle exchange to the
next level by offering users a safe place to inject drugs under
medical supervision. There are some sixty-five safe-injection
facilities in forty cities around the world (none in the United
States), and many years of research in those places have demonstrated
that SIFs reduce overdose deaths and risky behaviors and lead to
other positive outcomes. In 2004, while he was Seattle chief of
police, Kerlikowske paid a visit to the only SIF in North America, in
Vancouver, and wrote a cautious but open-minded memo in which he said
that it would be "worthwhile to continue to monitor the Vancouver
drug experience."

Could such a program take shape in this country? Several harm
reduction activists in New York City say that it already has, under
the radar: much the same way as groups of drug users organized
informal needle exchanges in the '80s, long before they were legal,
groups of savvy users have become lay EMTs and have stocked what
might otherwise be considered "crack houses" with clean needles and
medications to reverse the effects of overdose. In May, a coalition
of harm reduction organizations in New York City sponsored a
conference at John Jay College of Criminal Justice to explore the
possibility of opening a legal safe-injection facility in New York.
San Francisco's health department sponsored a similar conference in
2007. Given that state legislation to legalize safe- injection
facilities is not likely to be forthcoming anytime soon, legal
scholars who study the issue believe it would be possible to
establish some legal basis for opening such a facility in the United
States if a state or local health department were to issue a
regulation authorizing it for public health reasons. Or an academic
medical center could set up a safe-injection facility as a research
project, which would insulate it from certain legal problems.

While research suggests that funded needle exchanges will cut down on
deaths due to drug-related infectious disease, neither AIDS nor
hepatitis is the leading cause of death among drug users. In fact,
overdose has that distinction--and opiate overdoses can be reversed.
Inject Narcan--i.e., naloxone--into the muscle of someone who is
dying of a heroin or OxyContin overdose, and within seconds he is
awake and very much alive. Narcan has been used for decades in
ambulances and emergency rooms to reverse opiate overdose. If those
with severe allergies can carry Epi-pens with them, advocates ask,
why can't drug users themselves carry Narcan? Legally they can, with
a prescription from a doctor. And yet, prescriptions are not nearly
as common as they should be.

In more than fifty programs in seventeen states, doctors prescribe
Narcan to drug users in conjunction with education about overdose.
Several states, including New York, have passed Good Samaritan laws
that provide legal immunity to physicians who prescribe Narcan and to
lay people who administer it in good faith. But the majority of
states lack legislation on the issue, so a person administering
naloxone to someone else may be vulnerable to prosecution should
something go wrong. Still, an overdose-prevention working group
chaired by the Substance Abuse and Mental Health Services
Administration is looking at releasing best practices on overdose
prevention, and states could begin to look there for legislative
guidance. Dr. Sharon Stancliff, medical director of the Harm
Reduction Coalition--who herself prescribes Narcan--is a member of
the group. "I actually have a lot of hope that Narcan will be widely
adopted in the near future," she says.

The same cannot be said for heroin maintenance, another public health
approach to addiction backed by years of research. At least a
half-dozen countries, including the Netherlands, Switzerland, and the
UK, allow prescription of pharmaceutical heroin, known as
diamorphine, to users who have failed to improve using all other
available treatment options. Diamorphine is prescribed to "people who
have been through methadone, been through jail, been through drug
free [treatment facilities], been through the whole gamut of things,
and for whom nothing was working," says Ethan Nadelmann, the
executive director of the Drug Policy Alliance (DPA), which worked in
partnership with a group in Canada to set up that country's first
clinical trial of heroin maintenance. (The trial enrolled 250 users
in two cities; early results show a significant reduction in
participants' criminal involvement and an increase in their health.)
As recently as this year, both the German and Danish parliaments
voted to allow prescription of heroin to those who have not responded
to other treatments. Nadelmann is hopeful that a clinical trial
similar to Canada's can be set up in the US in the coming years. but
Columbia University associate professor of clinical neuroscience Carl
Hart is not so sanguine. "People have been brainwashed [into
thinking], 'These awful drugs that are causing so many
problems--you're going to give it as a medication?'" he says, citing
deepseated public fears.

That precisely describes methadone. Methadone and heroin operate in
identical ways on opiate receptors in the brain. They are both "full
agonists," meaning they fill up opiate receptors in such a way as to
make the user high. The main difference between heroin and methadone
is not their chemical composition but their legality. The daily
hustle for heroin often forces users into other illegal activity,
like petty drug dealing, prostitution and burglary, to support their
habit, and creates an expensive, unproductive revolving door between
prison and the street. Methadone, covered by insurance, frees people
from this cycle. Because methadone is administered by physicians, it
can be dispensed in amounts precisely calibrated to someone's
addiction to make that person feel "normal," rather than high, and
eliminates the craving and withdrawal symptoms that drive people to
use. Heroin, sold on the black market, is "cut" with adulterants; at
best, the cut (like baby powder or quinine) is itself harmless but
causes wide variation in the strength of the heroin--which makes it
impossible for a user to know exactly how much he is using.

Still, if a person takes more than her prescribed dose of methadone,
she can get a high quite similar to heroin's. And when used in
conjunction with other drugs, or when diverted--which is to say, sold
on the street--methadone can cause overdose, just like heroin. This
is why methadone is so tightly regulated. Unlike most other
medications (including OxyContin, also a full agonist), there are
almost no circumstances under which a physician can prescribe
methadone for home use. Users enrolled in methadone programs must be
physically present at the clinic each morning for their dose of methadone.

Over the years, a cottage industry of ancillary services has grown up
around methadone clinics. Everything from talk therapy to medical
care to Narcotics Anonymous meetings to group picnics and bowling
excursions has come to be understood as a necessary component of the
treatment of such a psychosocially complicated problem as addiction.

But part of the public health approach touted by Kerlikowske and his
boss in the White House is to treat addiction like any other chronic
illness. Scientists have been looking for years for a gene or a pill
that can treat the disease without all the messy and unpredictable
psychological baggage that the meetings and talk therapy are designed
to address. The closest thing we have right now to a litmus test for
whether such a thing is even possible is a medication called
buprenorphine. "Bup," as it's known (pronounced byoop), is a "partial
agonist," which means that, unlike methadone or heroin, it can only
make a person so high. What's more, the formulation available in the
United States is mixed with naloxone--the very same drug used to
reverse overdose--so that someone who tries to abuse the drug will go
into withdrawal. It's not foolproof--it is possible to abuse bup--but
because it's much safer than methadone, bup eliminates methadone
clinics' primary reason for existence: safety. So the FDA has
cautiously opened the door to allowing physicians in to prescribe bup
like any other medication, for patients to take at home. When the
drug was approved by the FDA in 2002, it became the only opiate
addiction treatment that may be prescribed outside of the tightly
policed boundaries of the methadone clinic. A small pill that
dissolves under the tongue, bup in the first few days is taken in
increasingly higher doses each morning until the user feels "normal,"
but not high.

What will happen when users can sidestep the counseling and the
clinics, and just take the "anti-addiction pill" that their local
primary care doc prescribes along with their blood pressure
medication? Bup could be providing preliminary answers to that
question. But it's not, because it is still tightly regulated in a
way that limits its integration into mainstream medical practice.

Nurse practitioners and physician assistants, who do a lot of "on the
ground" prescribing, are not allowed to prescribe bup. Rather than
encouraging the mainstreaming of addiction treatment, the FDA
requires that physicians demonstrate expertise in addiction and
attend a day-long training before they may prescribe bup (as of this
writing, there were no in-person trainings scheduled anywhere in the
country, though online trainings are available). And even then, a
single practice--no matter how many physicians are on staff--is
limited to a maximum of thirty patients on bup at a time in the first
year, 100 in the second year.

Which is to say that instead of treating addiction like any other
chronic disease to be managed, the current regulations require
physicians to have to jump through enough hoops that they have to
really, really want to prescribe bup. And most don't. "Doctors are
afraid to treat addicts," says Dr. Stancliff of the Harm Reduction
Coalition. "We don't learn anything about it in medical school. It's
hard to convince them that it's incredible: prescribe someone
buprenorphine today, and they come back in a week and say, 'that's a miracle.'"

When Obama signed the appropriations bill on Wednesday, it signaled
that he's serious about his administration's new approach to
addiction--and perhaps opened the door for other, more
forward-thinking, programs. "If you take Obama's commitment, of no
longer subordinating science to politics, and if you apply that
seriously to drug policy," says the DPA's Nadelmann, "then there is
no legitimate basis whatsoever for the federal government not to be
supporting heroin maintenance and safe injection--research, at
least--in the way that these other countries have. There's no
legitimate basis whatsoever."