Thursday, November 30, 2006


In a continuing battle to establish a methadone clinic in Princeton, West Virginia, one has to be concerned over the defensiveness of the sponsoring program's VP for Operations, who responded to criticism that methadone just substitutes one drug for another by saying, "There's a portion of the opiate population that will always be on some kind of drug. . . . The larger percentage of patients will not be." (Bluefield Daily Telegraph, Nov. 24) It would seem hard to support the claim that "the larger percentage of patients" will achieve and maintain abstinence after any kind of treatment - opiate agonist based or drug free. Statements like this tend to come back to haunt the proponents that make them.

Wednesday, November 29, 2006


On Nov. 27, 2006, FDA issued an "advisory" on methadone for the management of pain. It and the associated new "patient information" issued by Roxane Labs actually divert attention from the only major change that has recently been introduced: a marked reduction in "usual" starting dose from a maximum of 80mg to a maximum of 30 mg per day.

Neither the FDA Advisory nor the manufacturer's information sheet makes any reference to any specific dosages - let alone is there mention of the dramatic reduction in what is considered to be an appropriate "usual" starting dose. It's hard to imagine why, since this flurry of activity is clearly in response to the recognition that 80 mg on day one is potentially lethal. One would imagine banner headlines on both documents proclaiming 30 MG METHADONE IN FIRST 24 HOURS TOP OF THE RANGE FOR INITIATING TREATMENT FOR PAIN; HIGHER DOSES CAN HAVE FATAL OUTCOME. Sure, one would want to leave flexibility to the individual practitioner - but the generalization of high, potentially fatal, risk should have been highlighted and extreme caution urged before exceeding the “usual” range. Instead, as noted, dosages were not even mentioned! What did receive great attention, as reflected in the very title of the FDA advisory, are references to allegedly life-threatening "heart beat" irregularities, though we have been unable to identify a single report in the professional literature of any death attributed to methadone-induced cardiac effects.

So where does one find the dramatic new dosage references? Only on page 15 of a 17-page, very fine print, comprehensive, description of methadone (Dolophine, to be exact). There, under the heading "initiation of therapy in opioid non-tolerant patients,” is written: "...the usual oral methadone starting dose is 2.5 mg to 10 mg every 8-12 hours slowly titrated to effect." Until now, the same section read : 2.5-10 mg every THREE TO FOUR HOURS. Thus, the top of the range for initial management has been reduced from 80 mg to 30 mg – but no hint of this very substantial reduction is alluded to by either FDA or Roxane.

Clearly, the "advisory" and "patient information" notices are far too little in not spelling out up front precisely what new message must be heeded to protect patients. The notices are also far too late - certainly, too late for some of those patients who may have been prescribed the previously noted "usual" doses, and/or who relied on the FDA-approved "package inserts" that spelled out the same total day one range of 15-80 mg, and who may have suffered an overdose as a result. Note that a 2003 study (Ballesteros et al, JAMA, July 2, 2003) of deaths "due to methadone" in North Carolina, reported by CDC, found that of almost 100 patients for whom information was available "75% had been prescribed methadone by a physician." One can only speculate whether at least some of these deaths might have been avoided had the "usual" dosages specified by FDA and the manufacturer been consistent with what has been known for decades. Indeed, FDA itself puts a 30mg day one limit on starting doses of methadone for opioid-dependent (and thus opioid tolerant!) individuals beginning maintenance treatment (see, for example, the US Department of Health and Human Services “Treatment Improvement Protocol TIP 43," 2005, p. 67; and also the 1999 Federal Register, July 12, 1999, vol. 64, number 140, p 398401). The evidence regarding initial methadone dosages that are least likely to cause serious adverse effects is massive, consistent and worldwide; it was embodied years ago in the clear and concise Province of Ontario methadone maintenance guidelines: "START LOW, GO SLOW".

Monday, November 20, 2006

NIMBY Strikes Again

NIMBY NEVER DIES, despite court victories declaring discrimination against methadone clinics to be illegal. In the Pittsburgh suburb of Hampton the local Council just redefined a museum as a park and a commercial travel agency as a school (!) and thus ruled that a methadone clinic, originally approved 3 years ago, could not be established in the neighborhood. Full story: Pittsburgh Tribune Review, 16 Nov 2006

Thursday, November 16, 2006


"Deaths spur new scrutiny of clinics" (Nov. 7), one is reminded of the person looking for a coin a block away from where it was dropped, "because the light's better." Deaths attributed to methadone, nationwide, have been found by exhaustive review of the Substance Abuse and Mental Health Administration to be associated overwhelmingly with medication prescribed for pain, and not that provided by programs treating opiate dependence. Accordingly, it is irrational to react to the "rising tide of prescription drug deaths" in Utah by "looking to tighten regulation of its nine methadone clinics."

Methadone clinics save lives and are an enormous boon to patients, their families and the entire community. Every effort should be directed at making them more readily accessible to everyone who wants and needs their help - not "tightening regulations" that will make treatment availability more difficult.

Tuesday, November 14, 2006

NIMBY (Not in My Backyard) NEVER ENDS

This time it's Greensburg Salem, Pa, where an elementary school board voted 9-0 to object to a proposed methadone clinic that would operate a quarter-mile away. Fear was expressed that the facility would "pose a serious danger to students, employees and others," and place at risk "students [who] would be walking past the clinic or driving by it with their parents." It's difficult to comprehend just what the basis is for the near-universal revulsion of methadone treatment facilities, especially since there appears never to have been any news report, from anywhere in the nation, of harm having come to schools as a result of methadone clinics or their patients. Full story: Tribune-Review (Greensburg, PA, Nov. 9)

Thursday, November 09, 2006


There’s been a lot of coverage to the statement of a prominent Scottish “drugs expert” to his alleged finding that “Methadone helps just 4%” (the headline of an Oct. 29 article in the Glasgow Sunday Herald). In essence, a group of methadone treatment admissions were assessed three years after starting treatment to see how many were “drug-free.” The outcome, which could have been predicted, read as follows in the introductory sentence: “A shocking new study has revealed the true extent of methadone programme failure in Scotland, with only a tiny proportion of addicts becoming drug-free through the heroin substitute.

Ignored by the “expert” and by the article is the fact that addiction is recognized by the World Health Organization and by governments throughout the world as a chronic, notoriously relapsing, eminently treatable but as yet incurable disease. To condemn methadone – or any medication used in treating any other chronic illness – if, in the words of this article, “it isn’t helping [patients] become drug-free” is simply misguided. Imagine using this yardstick for determining efficacy of insulin, or anti-hypertensives, or cardiac medications, or l-dopa, or anti-seizure medication, or . . . .

As with alcoholism, one measures success in treating opiate addiction one day at a time. Methadone helps restore health, enables productive social functioning and sharply reduces the spread of HIV-AIDS and other blood-borne diseases. It saves lives and yields enormous savings to the community.

SAMHSA Could and Should Correct Misperceptions

The Salt Lake Tribune story (Nov 7th), "Deaths spur new scrutiny of clinics - tough rules proposed for opiate-addict treatment." ( provides gross misinformation.

I believe SAMHSA has an obligation and a responsibility to correct this misinterpretation, which clearly will lead to action threatening to impair treatment access and quality.

SAMHSA, to its great credit, spent a fair bit of money and time and effort and convened a group of experts that took a year to come up with a crystal clear summary: when it coms to methadone deaths "clinics are not the culprit."

Surely SAMHSA could correct the misperceptions through a brief Letter-to-the-Editor, that will otherwise lead State officials to "mandate more frequent urinary analyses of clients and face-to-face visits with doctors and counselors." Worse than these unnecessary, often demeaning, expensive (money and staff), time consuming rules for patients ("clients") is the strongly negative message conveyed by stories like this to a public already very hostile to addiction treatment and those who receive it.

We ask your assistance by writing to SAMHSA representatives and asking them to take action (westley clark

Monday, November 06, 2006


We have seen a noticeable increase in inquiries on our website regarding addiction to pharmaceutical opiates. In response to those inquiries we have added a link on our site over to pain medicine specialists Russell Portenoy, MD, and Perry Fine, MD website - COMPREHENSIVE GUIDE TO OPIOID ANALGESIA, INCLUDING OXYCONTIN (generic name oxycodone). A clinical guide to OPIOID ANALGESIA, McGraw-Hill Companies. This Guide has been posted in its entirety and can be accessed at

ACTION NOW: Putting the Right Emphasis on the Institute of Medicine Report of IDU and HIV

Then following Letter to the Editor appeared in Lancet 4-10 Nov 06: The Lancet Intravenous drug use and HIV

BYLINE: Robert G Newman SECTION: Pg. 1574 Vol. 368 No. 9547 ISSN: 0140-6736

Your Editorial (Sept 30, p 1127) on the recently released report by the US Institute of Medicine (IOM) about intravenous drug use and HIV incorrectly describes methadone and buprenorphine as opioid antagonists; in fact, methadone is a pure agonist and buprenorphine a mixed agonist-antagonist.

What is of more importance, however, is that the body of the Editorial seems to water down the message embodied in the title: "evidence for action now". Thus, you state that "there is some evidence that continuous drug-dependence treatment protects against seroconversion", whereas the IOM clearly and unequivocally concluded: "Strong and consistent evidence from a number of well-designed, randomized controlled trials shows that opioid agonist maintenance treatment-including methadone and buprenorphine-is effective in reducing illicit opioid use... There is also strong evidence that this treatment reduces drug-related risk behavior."

As for the unambiguous recommendations that flow from the IOM's review, they are not consistent with your call for "more robust studies" while nations "devise and implement multicomponent programmes that reflect their specific economic, cultural, and social circumstances." The IOM concludes without mincing words: "We do not end [the report] with 'More research is needed'... We say instead, 'Action is needed.'" Yes, indeed!

I declare that I have no conflict of interest.