The controversial and unproven treatment protocol for alcohol, cocaine, and methamphetamine addiction -- called Prometa and being heavily marketed by the Hythiam company -- is something you should have on your radar, hons. Since gay men, including those living with HIV, are disproportionately dealing with crystal meth problems -- we are smack dab in the middle of Hythiam's unscrupulous sights.
Don't be a sucker. We all need to be good consumers of substance abuse treatment, and need to be wary of swamp land, snake oil, and anything that comes across as magical or miraculous. If it's too good to be true, it probably is. Would you respond to that e-mail from the wealthy Nigerian widow who wants to give you a percentage of her $15 million inheritance in exchange for a little help with international banking?
So what's the skinny on Prometa?
Recently, MSNBC reported Prometa, the drug "cocktail" designed to combat addiction to cocaine and methamphetamine, got another nail in the cross when authorities in Pierce County, Washington froze the funding for an $800,000 pilot program, citing "irregularities" in testing after a damaging audit.
Basically this drug protocol, using three already FDA approved drugs off-label, has yet to be proven safe and effective. That's a big deal. It means that data from randomized, double-blind, placebo-controlled studies have yet to be published, though there is such a trial currently underway at UCLA now and we might see some results in the next quarter.
Sure, Hythiam has touted a number of studies, that don't meet the above criteria, but as we know, when you don't have a placebo control (where neither the patients nor the investigators know who is taking the active agent and who is essentially getting a sugar pill) or randomization, we can't really know whether the drug treatment being tested actually works or not.
The treatment, which costs $15,000 for crystal and cocaine treatment, and a few grand less for alcohol treatment, involves intravenous infusions of Flumazinil, a reversal agent for benzodiazepines like Valium and Klonopin. The second drug, hydroxyzine, is an antihistamine, and the third, sold as Neurontin, is an anti-seizure medication frequently used "off prescription" as a treatment for a number of ailments, including alcoholism and hearing loss.
Hythiam doesn't need FDA approval for their scheme, because it is only selling a "protocol" and is not the maker, nor the seller of these drugs. So, no approval needed, and Hythiam, by clearly putting profits before proof, doesn't seem to care a rat's patoot about science, though they do pretend. Buyer beware -- the Prometa study recently concluded in Dallas (and conducted by a Prometa practioner) showed some diminishment of "cravings" for crystal, trumpeted far and wide, especially to the financial community. But look closely and you will see that the majority of folks in the study continued to use crystal! Cravings be damned.
Would you spend $15,000 for an appetite suppressant that doesn't diminish your hunger? Would you spend $15,000 for the pleasure of testing a novel HIV treatment that hasn't been proven to be safe or effective?
We all deserve substance abuse treatment that has met the rigorous demands of science and has been proven to work.
Prometa is not the first, and won't be the last, shady marketing scheme to prey on vulnerable people, like gay men and their friends and lovers in the throes of a tina meltdown. It behooves us all to be smart, savvy, and critical.
By the way, if a placebo-controlled, randomized, double-blind clinical trial proves that Prometa is effective at treating crystal meth addiction, I will be in the front of the line doing high kicks and twirling my tassles. But not a second before.
In addition to being advocacy director at the AIDS Foundation of Chicago and being obsessed with rectal microbicide research and development, Jim Pickett runs the LifeLube blog and is co-chair of Chicago's LGBT Task Force on Substance Use and Abuse (formerly the Chicago Crystal Meth Task Force.) Read more recent press in the online version at www.tpan.com.