60 MINUTES Investigates New Treatment

Addicts and doctors say it works, but a prominent addiction doctor says the Prometa Treatment is unverified and puts marketing before science.

An increasingly popular drug protocol that addicts and some doctors say has been effective in curbing drug and alcohol cravings is an unverified treatment that a former junk bond salesman is marketing through a loophole in federal drug regulations, several prominent addiction doctors say. One of them, Dr. John Mendelson, who specializes in addiction medication, tells Scott Pelley that the treatment, called Prometa, has little science to back its claims in a 60 MINUTES report to be broadcast Sunday, Dec. 9 at 7:00 PM on WFMY News 2.

Prometa is touted as new treatment for methamphetamine, cocaine and alcohol addiction. It is a combination of three drugs already approved by the FDA. Mendelson says none has been proven effective individually against addiction. Could there be something special about taking them in combination? "So far, the evidence would suggest no," says Mendelson, who tests addiction treatments for the National Institute on Drug Abuse. What's special, says Mendelsohn, is the way its marketers have sold Prometa. "Their pathway...has been to...open Prometa centers so they can...dose people in their special clinics," he tells Pelley, "and to stay completely outside the scientific and regulatory framework."

The Prometa treatment did not have to pass muster from the FDA because all three of its drugs are already approved and their prescription by doctors for addiction - called off-label use - is perfectly legal. Mendelson wants more scrutiny. "They're just saying this stuff works without actually subjecting it to the proper kinds of trials," says Mendelson. "It is shocking. I've never seen anyone actually try it...this is one of those loopholes that may exist because no one has had the chutzpah to go out and actually try it...up until now," Mendelson tells Pelley.

Terren Peizer is the man who tried it. He raised $140 million to market Prometa, which can cost private patients up to $15,000. The former bond salesman, who once worked for junk-bond king Michael Milken, and his investors will make millions if they can persuade the health insurance industry and the government to accept Prometa. The regimen works and that's the important thing, Peizer says. "You could talk to 100 doctors out there using it. You could talk to 2,000 patients using it," he tells Pelley.

60 MINUTES did talk to doctors who say they've seen results with Prometa. Dr. Matthew Torrington, a former addiction researcher who directs the Prometa Center in Los Angeles, tells Pelley how it worked for one patient. "It wasn't like he couldn't remember cocaine anymore. It was that cocaine went from all he could think about to being just another thing on the list." Dave Smart, who says he was addicted to methamphetamine for 20 years, puts it another way. "The cravings were gone. I mean, overnight. That's the way it worked for me," he tells Pelley. "I never would have believed it. You're right, but it happened," says Smart.

Still, researchers are dismayed over the marketing process and the fact that no independent test on the treatment has been done. There is a placebo-controlled, double-blind study under way that will apparently support some of Prometa's claims, but it was run by a researcher who also owns an addiction clinic that uses Prometa, among other treatments. He denies there is any conflict. In addition, the 2006 annual report for Hythiam, Peizer's company, says that four other double-blind clinical studies of Prometa are underway: two in Los Angeles at the University of California and at Cedars -Sinai Medical Center; one at Medical University of South Carolina; and one at the Institute of Addiction Medicine at the University of Pennsylvania.

Another potential impediment seems to be that supporters of the treatment sometimes have bought its company's stock. That conflict of interest, coupled with an auditor's finding that Prometa was no better than other treatments, was enough for a county addiction program in the state of Washington to discontinue funding for Prometa.

Told by Pelley that to some he's a revolutionary and to others he's selling snake oil, Peizer replies, "Let the patients decide. If [Prometa] shows dramatically better results, shouldn't every state be using it to get patients better...lower healthcare costs....Isn't that what it's really about?" he asks. "So, snake oil? I think not," he tells Pelley.

Source: CBS and WFMY News 2

Copyright: 2007 digtriad.com



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    on February 11, 2008 at 3:29 PM