Late last month, Pennsylvania state Senate Republicans -- and one Senate Democrat -- held a press conference at the statehouse in Harrisburg to roll out their "Methadone Accountability Package." The package, they said, aims at increasing safety and fiscal accountability and reducing the illicit use of methadone and methadone overdose deaths. A related Senate resolution is also calling for a moratorium on new methadone treatment centers. But methadone treatment advocates and researchers are cautioning that the package may be unnecessary, and are calling for any legislation on methadone to be based on facts and scientific evidence -- rather than overheated rhetoric and anecdotes.

Drug overdoses have risen nationally in recent years, with the increase generally being attributed to increased use of prescription medications such as methadone and buprenorphine. Advocates have suggested overdose prevention approaches such as "Good Samaritan" policies protecting people who call for help -- Washington state's legislature enacted one this week -- or distribution of the overdose antidote naloxone, as ways of stemming the tide. But the PA package announced this week goes a different direction.

While the bundle of bills addresses keeping track of methadone-related deaths (SB 1293), diversion control (SB 1376), driving while using methadone (SB 1377, SB 1378), and micromanaging methadone maintenance treatment (SB 1382, SB 1383), the bill that strikes most directly at methadone maintenance treatment for opiate-dependent individuals, is SB 1294, the Methadone Addiction Prevention and Treatment Act, introduced by Sen. Mike Stack (D-District 5). Stack's bill would mandate that:

• Potential patients be addicted to opiates for at least one year before methadone treatment is considered;
• Potential patients must have twice failed other forms of treatment;
• Patients have a written plan with goals and dates to be free from drug dependence, including methadone, within two to three years;
• Patients must have a designated driver come with them to the clinic for the first two weeks of treatment; and
• Driving under the influence of more than the prescribed dose of methadone be a violation of state driving under the influence laws.

"Pennsylvania needs better laws to prevent methadone abuse and provide patients with the proper protections and treatment plans they need to achieve a lifetime of sobriety," Sen. Stack said. "This package of bills is a solid step toward achieving those goals."

"Pennsylvania's law has not kept pace with the changes in the prescription of methadone -- and too frequently with deadly consequences," said Sen. John Eichelberger (R-District 30). "Methadone is a drug with its own unique properties. One pill or one dose can kill a non- or low-opiate-tolerant person. Even a day or two after the drug is taken, it has led to fatalities for those who mix alcohol or other drugs."

The senators cited reports from the National Drug Intelligence Center that unlawful diversion of methadone had more than doubled between 2003 and 2007 and from the National Center for Health Statistics that the number of methadone overdose deaths had increased nearly five-fold, with OD deaths among young people (15-24) increasing eleven-fold.

Not so fast, say experts. "Let's be careful about this; there are a lot of lives at stake here," said Eric Hulsey, director of performance, evaluation, and program development at the Institute for Research, Education, and Training in Addictions in Pittsburgh. "If the intention behind this stuff is better clinical care, that's a great thing, but we have to caution that it needs to be grounded on evidence-based practice."

Hulsey and National Association for Medication Assisted Recovery president Roxanne Baker also questioned some of the specifics in SB 1294. For Baker, the objections are a bill-killer.

"I would have to oppose this bill because it's too restrictive," she said. "There are already state and federal regulations on methadone treatment centers. Medicine is best left to doctors, not legislators."

Baker objected to the bill's provision for pushing methadone maintenance patients to get off the drug. "They really push the methadone abstinence schedule, don't they," she said. "Here in California, they just say it would be 'harmful to the patient' to taper off. I don't know why that needs to be in there; they don't make you taper off thyroid medication or insulin."

Hulsey didn't see a lot of evidence that methadone maintenance clinics are behind the problems being cited by the politicians. "Methadone prescribing has gone up seven-fold around the country, and we've seen all these methadone overdoses. Most of the federal reports and researchers have concluded that this is coming from the pain management clinics, yet everyone wants to crack down on the methadone treatment clinics."

Methadone treatment clinics are operated under different and stricter sets of regulations than pain clinics, Hulsey said. "It's unclear what the pain clinics are doing to prevent adverse incidents at their facilities, but it is clear that most diverted meds are coming from pain management, therefore, let's legislate against methadone maintenance clinics?"

Not that cracking down on pain clinics is the answer either, according to NAMA's Baker. Pointing out that methadone maintenance clinics are not the problem is fine, she said, but let's not be too quick to go after pain doctors. Citing the massive under-treatment of chronic pain in this country and her own decades-long experience with methadone in both the treatment and the pain clinic milieus, she said methadone patients already face enough barriers.

"I've been taking methadone since 1974," she said. "I stood in those methadone treatment lines, but now I get my medication from a pain specialist. A lot of people want to do that because they treat you better -- if you can find one who will treat you at all."

And that is a problem, Baker said. "A lot of doctors don't want to treat pain patients because they have the DEA breathing down their necks. We don't need more obstacles."

"This is misdirected legislation," said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence. "Methadone treatment programs have been functioning for more than 40 years with a considerable degree of safety. There have been at least four federal studies showing that increasing methadone mortality is based on that fact that it is increasingly being used in pain management. If the legislation doesn't address the cause of the problem, it has no basis for existing."

"The science doesn't support a hard and fast rule to get off licit opiates," said Hulsey. "It can be very dangerous to put arbitrary deadlines on that. Treatment has to be individualized to promote recovery."

For Hulsey, the bill's requirement that potential patients first twice fail at treatment is just not good policy. "I am not aware of science that supports 'you fail first' policies," he said. "If you go to the expert consensus guidelines for management of methadone facilities, and more importantly, accepted patient placement criteria, you must demonstrate a year's dependency, as well as other thresholds, and that is what should determine appropriate placement. 'Fail first' doesn't capture the full range of factors that experts have agreed upon as the best approach for opiate-dependent individuals."

The consensus guidelines Hulsey cited were SAMSHA/CSAT's Treatment Improvement Protocol 43 and the American Society of Addiction Medicine's Patient Placement Criteria.

"Those are the gold standard for treatment," he said. "They provide a six-dimensional approach to dependence, and you would need to meet those criteria to be appropriately placed in methadone maintenance. It's not appropriate for everybody. Some people may require a detox approach rather than long-term maintenance."

For Hulsey, having the designated driver requirement for new patients was "good risk management," but creating methadone-impaired driving offenses seemed unnecessary. "There are already laws on the books regarding impairment," he said.

Nobody thought the moratorium on new methadone maintenance clinics was a smart move. "They shouldn't do that," said NAMA's Baker. "They don't put moratoriums on doctors who prescribe treatments for diabetics. But there is a lot of NIMBYism in Pennsylvania."

"Addiction is a chronic disease that is treatable when appropriate evidence-based treatment approaches are applied," said Hulsey. "We want to promote recovery and support people rather than limiting access. If we limit the treatment opportunities, we make these people criminals."

Parrino didn't think much of the moratorium idea, either. "You can have a moratorium, but that doesn't reduce the demand for treatment, so what's the rationale for restricting access to care? Do we think the number of people who need this has capped out? That state has to be careful saying that a moratorium seems smart, especially when the problem is not related to the treatment programs you're dealing with," he said.

But methadone maintenance clinics make convenient targets for a number of reasons, said Parrino. "There is NIMBYism, and there is a general stigma about treating addiction, which increases markedly when you talk about the use of medications to treat opiate addiction," he pointed out.

"And elected officials always feel like 'we must do something,'" he continued. "But unless the legislature is able to be more precise in identifying the problem and how to deal with it, I would suggest that they are not addressing the real source of the problem, but doing what seems manageable and convenient. It's easy to say let's put more restrictions on top of a system that is already highly regulated, but pain doctors aren't regulated at all."

So faced with mounting methadone mortality and increasing diversion not linked to methadone maintenance clinics, Pennsylvania legislators are aiming squarely at those clinics. The legislature and the people of Pennsylvania would be better served if this package of bills went back to the drawing board.

With California facing a $19 billion budget deficit, Gov. Arnold Schwarzenegger (R) last month proposed saving the state $53 million by cutting off Medi-Cal funding for methadone maintenance for most heroin addicts. That would cause the loss of more than $60 million in matching federal funds. The move was fiercely resisted by methadone advocates -- including a former drug czar -- and public policy analysts, and the proposal was defeated last week in committee votes in the state Senate and Assembly.

But California gives the governor the power to veto individual budget items, so advocates are not resting yet. Instead they are reaching out to the administration in hopes they can enlighten it and persuade the budget axe-wielding Schwarzenegger to aim elsewhere.

Schwarzenegger isn't the first top-tier elected official to go after methadone maintenance. Back in 1999, then New York City Mayor Rudy Giuliani vowed to wean all of the city's methadone patients off it in three months. While Giuliani acted for ideological rather than budgetary reasons -- he said he wanted "drug freedom," not drug dependence -- the pugnacious mayor later changed his tune, admitting the idea was "maybe somewhat unrealistic."

Currently, nearly 150 methadone clinics provide the heroin substitute to some 35,000 addicts, 55% of whom are on Medi-Cal. Advocates and treatment providers said that clinics would be forced to close if the proposal passed, affecting not only the Medi-Cal patients, but also patients who paid out of their own pockets or through private insurance to be able to get maintenance methadone.

"Methadone isn't a cure," said Roxanne Baker, president of the National Alliance of Methadone Advocates (NAMA), "but much like thyroid medication, as long as you keep taking it, it keeps your disease in check, and opiate addiction is a disease. When you mess with your brain with painkillers, it then doesn't produce the endorphins it should. It's not a matter of will power, it's a disease. You need something to replace those endorphins, whether its methadone, suboxone, or even prescription heroin, although I doubt we'll ever see that here."

Enacting the proposed cuts would be "a disaster," said Baker. "There would be no methadone programs left. More than half the patients statewide are on drug MediCal, and they wouldn't even have a place to go. A lot of these people have their lives in order. This is somebody's brother, somebody's aunt, somebody's mom. Please don't take this from us."

Last week, Clinton-era drug czar Gen. Barry McCaffrey flew into the state to hold a press conference denouncing the cut. "Dumping tens of thousands of opiate addicts back on the street would be an immediate disaster to law enforcement, and to the families of people who have become stable, functioning adults" thanks to methadone, said McCaffrey, who has a consulting firm and serves on the board of directors of an organization that treats chemical dependency.

Legislators were listening, not only to McCaffrey, but to the methadone treatment community. A Senate Budget Committee hearing last week proved tough going for Schwarzenegger's representatives.

"This measure would eliminate the drug MediCal program with the exception of the perinatal and youth funding," said John Wardlaw from the state Department of Finance. "This is not an easy reduction in any way. We are at the point where we are making very difficult reductions."

Committee Chair Denise Moreno Ducheny (D-San Diego) wasn't buying it. "How much federal funding are you giving up?" she asked.

"Sixty-six million dollars," Wardlaw said.

"We save $53 million and lose $66 million?" asked Ducheny.

"That is correct, ma'am."

Ducheny just stared at him for a few uncomfortable moments before moving on to the next witness.

"There would be cost shifts in the area of corrections and child welfare services," Greg Tallivant of the legislative analysts' office told the solons. "The day the clinic closes, those people have to do something. If they can't make it to the next methadone clinic, heroin would be the next choice. You would see people arrested. You would see prison costs and child welfare costs go up."

Assemblyman Mark Leno (D-San Francisco) was visibly irritated by the proposal. "There is a complete lack of interest in any cost-benefit analysis here," he said. "This is reckless and cavalier. It doesn't really make much sense. We have 171,000 people addicted to drugs. This will increase our crime rate; it's a recipe for disaster on our streets. Does the governor have no interest in this or does he not believe that this will impact the safety of our children and communities? We've already zero-funded the base Proposition 36 program. The outcome of this is to have drug offenders with no jail and no treatment."

"This is really a short-sighted proposal that shifts costs from funding treatment to funding law enforcement, jails, and prisons," said Jason Kletter, a member of the Bay Area Addiction Research Team (BAART), which is in turn a member of California Opioid Maintenance Providers (COMP), a nonprofit organization representing opioid maintenance treatment centers. "It is a public safety issue, to say nothing of the humanitarian crisis it would provoke," he said.

"We think if this happened many clinics would close, and the folks who lose access to care would likely relapse and cost the system much, much more in a short time," said Kletter. "We see relapse rates of 80% within a year when clinics close, so it wouldn't even be like we'd be kicking the can three or four years down the road."

"This would have the biggest impact on programs that have a high percentage of Medi-Cal beneficiaries in treatment and would be unable to stay open because more than half their patients, and thus, their revenues, are gone," said Kletter. "You would have a fundamental dismantling of the system."

The cost incurred would be staggering, Kletter said."If 80% relapse in same year, we know that the state will incur $700 million to $1 billion in new costs in the criminal justice system," he said, citing a study from the 1990s that found each dollar invested in treatment produced a seven-dollar return. "The state wants to save $53 million by eliminating drug Medi-Cal and will also turn away more than $60 million in matching funds. That's $115 total program cost. A seven-to-one return on that is close to a billion dollars. "With 80% relapse, we could end up seeing $700 million in new criminal justice and prison costs."

"It's a terrible proposal," said Glenn Backes, a Sacramento-based public policy analyst who works with the Drug Policy Alliance at the Capitol. "California Democrats in both houses have said so. The Senate Republicans didn't do a cost-benefit analysis; they just said we can't afford to give out subsidized health care."

But in reality, the situation is even worse, said Backes. "They've killed Proposition 36 funding, drug courts are being slashed. According to the governor's finance director, that's 171,000 patients. The cost-benefit for this is worse than nil. If only one out of a thousand relapses and goes to prison, you've already lost money because prison is so much more expensive than treatment. If only one out of a thousand gets Hep C, the taxpayer loses. If only one out of a thousand gets HIV, the taxpayer loses."

It's easy to lose the human side in all the numbers, Backes said. "If only one out of a thousand ODs and dies, that's 170 California families who have lost a loved one."

And the battle continues. "While both the Senate and the Assembly budget committees have rejected the governor's proposal, in California, the governor has a line item veto," said Kletter. "We are continuing to try to work with the administration to explain the impact of this kind of proposal and get them to understand it is a public safety and cost-shifting issue. We haven't had any direct meeting with them yet, but that's next on our agenda. We want to educate them about them dire consequences of this sort of action."

Even if advocates many to salvage the drug Medi-Cal program, they would be well-advised to be searching for alternative funding sources, and how better than to take money from the drug war? Tough times call for creative solutions, and Backes has one: Use federal Byrne Justice Assistance Grants to fund treatment instead of drug task forces. Every dollar funding more drug war arrests costs $10 additional in spending for courts and prisons, he said.

"Historically, Byrne grant funds have been given to task forces to increase arrests," Backes noted. "The Drug Policy Alliance position is that Byrne funds would be better spent on almost anything other than doing low-level drug sweeps. We would rather see that money go into treatment for people in the system."

On Monday, Denmark opened its first heroin distribution clinic, two years after the Danish parliament passed a law legalizing the distribution of medicinal heroin. The opening was delayed until after the city of Copenhagen agreed to house the program.

Denmark thus joins Germany, the Netherland, and Switzerland, and to a lesser extent, Great Britain, as countries that allow for the provision of heroin to hard-core users who have proven unamenable to the traditional treatments, such as methadone maintenance. A pilot heroin maintenance program is also underway in Vancouver, Canada.

The Copenhagen clinic will serve about 120 of Denmark's 300 or so identified hard-core users. Only addicts who have been referred from a methadone treatment center will be accepted. While subjects will be prescribed heroin, they will have to consume it at the clinic.

"Our objective is not to cure heroin addicts, but to help those who are not satisfied by methadone by providing them with clean heroin, allowing them to avoid disease and the temptation of criminal acts to obtain the drug," a doctor and head of the clinic Inger Nielsen told Agence-France Presse. People in the program will get methadone for the first two weeks "so we can determine how much heroin to prescribe," she added.

The Danish User Association, a group that represents drug users, while supportive of heroin maintenance, criticized the program for requiring users to go to the clinic twice a day, seven days a week, to get their fixes. "This means living like a zombie, without being able to hold down a job or study or have hobbies," said head of the association Joergen Kjaer.

European heroin users are on high alert as the death toll rises from heroin tainted with anthrax. At least eight people have died -- seven in Scotland and one in Germany -- since early December, and another 14 Scottish heroin users have been hospitalized after being diagnosed with anthrax. Meanwhile, drug reform and drug user activists are reporting a cluster of nine suspicious heroin-related deaths in Coimbra, Portugal, although it is unclear at this point whether they are linked to anthrax-tainted heroin.

The Scottish government has responded by urging heroin users to stop using and to seek drug treatment. That advice has not gone over well with drug users and public health and harm reduction advocates, who are demanding an emergency public health response.

The first four Scottish deaths were in Glasgow, but after one person died in Tayside and one in the Forth Valley earlier this month, Health Protection Scotland epidemiologist Dr. Colin Ramsay said: "The death of this patient in NHS Forth Valley indicates further geographical spread of the cases, meaning that heroin users all across Scotland need to be aware of the risks of a potentially contaminated supply. I would urge all users to stop using heroin immediately and contact local drug support services for help in stopping. If any heroin users do notice signs of infection, for example marked redness and swelling around an injection site or other signs of serious infection such as a high fever, they should seek urgent medical advice."

The French government has also reacted, with the General Directorate for Health issuing a statement Tuesday warning that contaminated heroin may be circulating in France and other European countries. Noting the rising death toll, the statement said "the likeliest source is heroin contaminated by anthrax spores."

Heroin users should be alert, the French statement said, because heroin contaminated with anthrax is indistinguishable from other heroin. "There is no outward sign or color enabling the user to tell whether the heroin has been contaminated by anthrax, and contaminated heroin dissolves or is used in the same way as uncontaminated heroin," it said.

Anthrax is a potentially lethal bacterium that exists naturally in the soil and can also occur among cattle. It is also a potential bio-terror weapon.

The vast majority of heroin consumed in Europe comes from Afghanistan, and while so far evidence is lacking, speculation is that anthrax spores may have been present in bone meal, an animal product sometimes used as a cutting agent. Another possibility is that containers used in the heroin production process were contaminated with anthrax spores. And, given fears that Al Qaeda and its Taliban allies could resort to biological warfare against the West and given the Taliban's role in the Afghan opium and heroin trade, a bio-attack cannot be completely ruled out.

"The anthrax-infected heroin hasn't decreased use, whether people are injecting it or chasing [smoking] it," said Tam Miller, chair of Chemical Reaction, an Edinburgh drug user group, and a member of INPUD (the International Network of People who Use Drugs). "People are scared -- you can be sure of that -- but I think they're more afraid of withdrawing. The Scottish government's advice was for people to stop using heroin, but that won't happen."

Instead, Miller said, heroin users are doing what they can to protect themselves. "Users feel there's not much they can do personally and, as usual, they feel isolated," he said. "A lot are looking up the effects on anthrax on the net and passing on information to people with no internet access. We think the powers that be should put out information on how to spot signs if someone has been in contact with access. Basically, mate, the Scottish government wants little to do with it."

The Scottish government's response so far has drawn a harsh rebuke from the United Kingdom's harm reduction and public health community. In a Tuesday letter to the Scottish government, the International Harm Reduction Association, the drug think tank Release, the Transform Drug Policy Foundation, the UK Harm Reduction Alliance, and individual public health experts called on the government to put in place an emergency public health plan to deal with the crisis.

The letter said the government's advice to heroin users to stop using and enter treatment was "reckless in light of the fact that waiting times in Scotland for opiate substitute treatment (OST) are the longest in the UK. Many of those accessing services are informed that it is a condition of their treatment to engage with the service for a minimum period of time, before they will be entitled to a prescription offering an alternative substitute medication, usually methadone. In some areas of Scotland we have been informed that waiting times for OST can be up to 12 months."

[There is another potential issue with methadone, as well. The antibiotic drug Cipro, used to treat anthrax, interacts with methadone, leading to the possibility of methadone overdoses.]

Given the reality of treatment shortages and delays, it is "unacceptable" for the Scottish government to just tell users to stop or to go to treatment that isn't there, the letter said. "It is clear that this kind of approach can only lead to the death of more vulnerable people."

Instead, the Scottish government must immediately implement a public health plan that includes rapid access and low-threshold prescribing of alternatives to street heroin, the letter-writers advised. They recommended prescribing dihydrocodeine, a synthetic opiate approximately twice as strong as codeine. It is sold in the US under brand names including Panlor, Paracodin, and Synalgos.

"Such an approach will go some way to prevent any more loss of life and will provide greater protection to the public as a whole," the letter said. "Failure to adopt such a policy would mean that the Scottish state would be failing in its duty to its citizens."

Joep Oomen of the European Coalition for Just and Effective Drug Policies (ENCOD) had another suggestion. "The only decent reaction to this kind of episode is to immediately open facilities where people can test their heroin and where they can use in safe conditions, supervised by people who can help if anything goes wrong," he said.

"Hopefully, in the longer term, because of these incidents, authorities will start to see the need for introducing heroin maintenance programs, not as a trial for a limited group of people, but as a permanent service for all those who cannot abstain from heroin for a longer period of time," he added.

Ultimately, said Oomen, prohibition is the problem. "Adulteration is a practice that belongs to the illegal market," he said. "It happens because the people who control the heroin market have no interest at all in the health of their customers."

Dr. Sharon Stancliff of the US Harm Reduction Coalition agreed with her colleagues' assessment of the Scottish government's response. "Telling people to stop is not useful information," she said. "Maybe some occasional users will have a glass of wine instead, but if people are sick and treatment is limited, telling people that heroin is bad for them isn't going to have much impact," she explained.

"At this point, the European harm reduction people should be getting the word out, and the medical people over there need to be on the alert," she added.

Stancliff said she had seen no sign of heroin contaminated with anthrax on this side of the Atlantic, but she was worried. "I hope the DEA is out there buying heroin to see what's in it," she said. "If there is any hint of it here, physicians should be alerted by the Centers for Disease Control as they were with levamisole-tainted cocaine."

If the anthrax-contaminated heroin is coming from Afghanistan, as most heroin consumed in Europe does, US heroin users may catch a break. Most heroin consumed here is of Mexican or Colombian provenance.

But on the other side of the Atlantic, adulterated heroin is killing drug users.