METHADONE: PREVENTION OF HIV INFECTION

Australians colleagues have just published a review of 28 studies and concluded: "Methadone maintenance treatment for injecting drug users significantly reduces the risk of transmission of HIV ..." Gowing et al, J Gen Intern Med 2006; 21:193-195

HEROIN "VS" METHADONE: flawed trial methodology

Several prominent trials in recent years have demonstrated quite convincingly that heroin maintenance is feasible and associated with favorable outcomes. The problem arises when comparisons are made between heroin and methadone, since the difference between "subjects" receiving heroin and "controls" who are given methadone couldn't be greater. This is made clear by the following headline and first paragraph of a report in Der Tagespiegel of 13 April (http://archiv.tagesspiegel.de/archiv/13.04.2006/2469331.asp):

"DRUGS BY PRESCRIPTION: HEROIN INSTEAD OF METHADONE TO HELP LONG-TERM ADDICTS? THIS IS SUGGESTED BY RESULTS OF A LARGE STUDY
Sven-Uwe sits in a Hamburg drug clinic where he participates in a heroin trial, and smiles. He feels like he's won the jackpot. He was picked at random to receive heroin, and not the control group that gets methadone. Like almost all other subjects, this trained carpenter, with a history of 20 years of opiate dependence, has had several failed attempts with methaodne treatment behind him."

In other words, the comparison is between the effects of heroin maintenance, which is what motivates volunteers to participate in the trial, and methadone, which they not only don't want but which has proven(repeatedly for most) to be unsuccessful.

The rationale that's been given for this methodology in Germany, Canada and elsewhere is that there's an ethical obligation to test a proposed new treatment against "the best currently available" treatment - and for opiate dependence that's clearly methadone maintenance. The rationale, however, does not apply to this particular group of subjects. There is no evidence to suggest that for those who have repeatedly failed to benefit from methadone maintenance, methadone remains the most promising treatment. Maybe long-acting codeine (used in Germany for years before methadone was legal) would be a better choice, or acupuncture, or buprenorphine, or whatever. There's no basis for believing methadone is "best" for these individuals, and given its prior ineffectiiveness common sense suggests it's not.

Basically, this is flawed science, leading to unjustified conclusions, that very likely will add to the bias against methadone as a medication - one among many! - for opioid dependence.

UNATHORIZED BUPREN COMPOUNDING IN US

In a CSAT letter dated 3 April the Director warns that "certain pharmacies may be compounding and selling buprenorphine and buprenorphine/naloxone combination products in various strengths, colors, and flavors."

CSAT states that the only buprenorphine and buprenorphine/naloxone products that are authorized are Subutex and Suboxone, produced by Reckitt Benckiser Pharmaceutical (RBPI) Other formulations "present potentially serious public health and safety issues," and that "the use of unapproved buprenorphine products circumvents the public health purpose of the [RBPI] Risk Management Program." It is not clear what physicians are to do about this problem. Even more perplexing is why DEA seems to be uninvolved. Even if there were no safety issues or circumvention of Risk Management protocols, one would think that DEA would nevertheless move swiftly and decisively against the pharmacies imnvolved.

LIMITING LIFE-SAVING RX

An article appeared in the Mar 22 issue of the Times Argus (St. Johnsbury, Vermont) under the headline: Methadone program nears peak capacity. The "maximum capacity" of 150 patients is almost reached, and the Town Manager is quoted as saying "law enforcement has not seen increased crime [in the area of the clinic], and nobody has complained."

Is there any parallel in American medicine where arbitrary "capacity" limits restrict a potentially life-saving medical treatment? Imagine waiting lists for insulin prescriptions, anti-epileptic medication or cardiac drugs. It's tough to comprehend - particularly since most clinics, even those that generate the greatest fear before they open, function without adverse impact on the community, as is the case here.

PUBLIC POLICY CONFLICTS

NOT JUST IN CHINA! The Chinese Heath Ministry's commitment to massively expand methadone treatment and needle exchange is being pursued vigorously (see current posting on website www.opiateaddictionrx.info). But the Security Ministry (the cops) is not on board, and creates problems for patients/clients.

A similar conflict exists in USA: Deseret Morning News reports (March 22) patients exiting a Provo (Utah) methadone program are routinely being "targeted by a Utah County sheriff's deputy." The practice of the Deputy was brought to the attention of authorities by a woman who routinely drives her daughter and 19 year-old grand-daughter to the program for their care, and felt obliged to speak out for patients who "absolutely don't have a voice and [who] deserve a chance to get better. They shouldn't be afraid to come to the clinic to get better." Darn right! Shame on the cop! Good on grandma!