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."