Editor's note: This guest post is by Jim Pickett who 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.)
Prometa is a controversial and unproven treatment protocol for alcohol, cocaine and methamphetamine addiction that is being heavily marketed by the Hythiam company. Since gay men are disproportionately dealing with crystal meth problems, we are in Hythiam's unscrupulous sites.
So what's the skinny on Prometa?
Basically this drug protocol uses three already FDA approved drugs for an off-label use. Off-label use is the practice of prescribing drugs for a purpose outside the scope of the drug's approved label. The drugs used in Prometa have yet to be proven safe and effective for treatment of crystal meth addiction. That's a big deal. It means that data from randomized, double-blind, placebo-controlled studies have yet to be published. A trial is currently underway at UCLA and we might see some results in the next quarter.
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 or randomization (where neither the patients nor the investigators know who is taking the active agent and who is essentially getting a sugar pill), we can't really know whether the drug treatment being tested actually works or not.
The treatment costs $15,000 for crystal and cocaine treatment and a few grand less for alcohol treatment. It involves three drugs: 1. intravenous infusions of Flumazinil, a reversal agent for benzodiazepines like Valium and Klonopin 2. hydroxyzine, an antihistamine, and 3. Neurontin, as 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.
A Prometa study recently concluded in Dallas (and conducted by a Prometa practioner) showed some diminishment of cravings, but look closely and you will see that the majority of folks in the study continued to use crystal! Cravings be damned.
MSNBC reported that authorities in Pierce County, Washington froze funding for an $800,000 pilot program using Prometa citing "irregularities" in a testing after a damaging audit.
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 email from the wealthy Nigerian widow who wants to give you a percentage of her $15 million for a little help with international banking?
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 before.