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Meth Ad Criticized; Company Responds
by Andrew Davis

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A member of the Chicago Crystal Meth Task Force ( CCMTF ) and a local addiction expert have sounded off against a meth addiction advertisement that has appeared in various gay publications.

An ad for PROMETA®, which bills itself as a 'comprehensive addiction treatment,' shows one man holding another ( who appears to be an addict ) along with the line 'He means the world to you. Meth means the world to him. How will you treat it?' In the lower left part of the ad, PROMETA is described as 'a promising new treatment protocol that includes medical, nutritional, and psychological aspects.' However, part of the fine print ( on the right-hand sidee of the ad ) reads, 'Clinical studies are underway to evaluate PROMETA and to confirm reports from physicians using PROMETA in their practices.'

For the past two weeks, local gay publications, including Windy City Times, ran a letter from the CCMTF that warned people, in part, that ' [ d ] espite how wonderful something may appear, there is no 'magic formula' when it comes to treating addiction. If it sounds too good to be true, maybe it is.'

CCMTF's Jim Pickett told Windy City Times that the letter was to make sure that 'people are smart consumers of treatment. [ The letter ] was really spurred by the introduction of these PROMETA ads and the knowledge that Chicago is being targeted by PROMETA.'

Among Pickett's problems with the ad is what's in the fine print. 'If you don't read the small type of the right-hand edge, you won't know that [ this protocol ] is [ un ] proven. Scientific studies and clinical trials are still happening,' he said. ' [ Also, ] the ad is a powerful image of two men; one guy clearly looks sick and pale, and he has pimples and marks on his body. Then you have [ this ] tagline. It's an enticing piece of advertising and we want people to ask questions.'

Pickett added that 'PROMETA still doesn't acknowledge that it's an intervention that's supposed to quell cravings for crystal. They're using FDA-approved drugs off-label. They also don't address all the other psychosocial issues about why people use crystal; you need things like counseling, psychotherapy and group therapy so you can unpack how you got to this point. [ Addiction ] is more than biological. We're complex human beings.'

Dr. Kevin Osten of Lakeshore Hospital's VALEO recovery program agreed with Pickett that there are shortcomings regarding the PROMETA program. ' [ Although ] the medications they're using [ can ] help in terms of calming the craving center of the brain, it's a pretty short program and [ PROMETA's ] pretty secretive about what kind of nutritional counseling they do, what kind of vitamins they give, [ etc. ] ,' he said. 'It's being promoted as this 'quick fix,' and there is no pill or medication that's going to fix addiction. It may help people manage their cravings better, but it doesn't seem to address the ongoing lifestyle changes that need to be made. There's a reason we have people attend 12-step [ programs ] and have them think about their triggers.'

Osten also commented about PROMETA-related studies, saying that 'the initial one was not a controlled experiment, and there was just a 90-day follow-up, so it's not known what the long-term benefits are. I just don't agree with [ the approach that ] you market first and then ... . If you want to have people join the study, that's one thing—but to charge $15,000 for a treatment that hasn't gone through clinical trials is just [ risky ] .'

In addition, he said that 'having a program fit [ the addict ] , versus trying to get them to conform to a certain program' is vital.

Pickett and Osten are not the only ones with doubts about PROMETA. Nora Volkow of the National Institute of Drug Abuse ( NIDA ) testified before a U.S. House subcommittee last year that 'there is no randomized study that has proven the effectiveness of PROMETA,' and that initial studies showing positive results are trials in which 'the placebo effect is likely to compound the results,' according to the California Society of Addiction Medicine Web site. When asked how she feels about PROMETA today, a representative from NIDA e-mailed Windy City Times that the organization 'stands by its testimony.'

To get the company's reaction to the criticisms, Windy City Times spoke with Sanjay Sabnani, senior vice president of strategic development for Hythiam, Inc., which developed the PROMETA protocol. After an initial conversation, Sabnani conferred with several others who he felt would be better equipped to answer the various questions asked him, and e-mailed an official statement.

The statement read, in part, that 'Hythiam agrees that there is no 'magic formula' for the treatment of methamphetamine addiction. It is a complex, multi-factorial disease with many components that may require individualized treatment approaches.

'... The PROMETA treatment programs include nutritional supplements, FDA-approved oral and IV medications used off-label and separately administered in a unique dosing algorithm, as well as psychosocial or other recovery-oriented therapy chosen by the patient and his or her treatment provider.

'As described above, the PROMETA treatment program is not a drug or device; thus, it is not subject to FDA approval. Hythiam is not the manufacturer of the drugs used in the protocol, so it is not our place to seek approval of existing drugs for other indications, nor is it Hythiam's practice to market any drugs.

'Hythiam has intellectual property that it licenses to a treatment provider; it is up to individual physicians to determine whether the entire protocol—including the drugs included—are appropriate for use with their respective patients.

The statement also mentions NIDA: 'We have profound respect for NIDA and understand that it is their responsibility to scrutinize every major breakthrough or treatment paradigm with respect to addiction from an unbiased, research point of view. In October of this year, we believe they will benefit from top-line data from the first randomized, double-blind placebo controlled study of the PROMETA treatment program released by leading investigator Harold Urschel, M.D. ...'

In addition, Hythiam's statement read, 'Currently, there are almost 90 licensed treatment providers in the United States. [ Using ] the PROMETA program in any particular situation is an individualized decision for the doctor and patient.'

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