Tuesday, November 22, 2011

Prometa or Promota? Hope You Didn't Spring for It

A new study just released found that Prometa, a proprietary combination of currently available drugs and nutrients, was no better than placebo in the treatment of methamphetamine addiction. This parallels the negative finding in treatment of alcohol dependence (although most subjects in the alcohol study did worse on Prometa than placebo.) Prometa contains two drugs widely prescribed among people with alcohol dependence, gabapentin (Neurontin) and hydroxyzine (Vistaril.) The third drug, flumezanil, is widely used to reverse the effects of benzodiazepines (such as alprazolam or lorazepam.) However, it can only be given intravenously so it is primarily used to help wake people up after procedures such as colonoscopy where "conscious sedation" is used instead of putting the patient to sleep. The folks at Hythium, Prometa's parent company devised a series of intravenous infusions of these drugs followed by oral medication. They also added various nutrients. Underwritten by wealthy investor Terren Peizer, Hythium hyped Prometa very successfully and in the complete absence of any credible evidence. Prometa is very costly, in the range of $12,000-15,000 or more per month, but enough people addicted to alcohol, methamphetamine or cocaine coughed it up out of desperation, driving the stock very high initially. Those of use who know something about psychopharmacology always knew this was a bunch of horse manure but that doesn't matter much in the addiction treatment world. Prometa wasn't greeted with universal acclaim to say the least. A headline on MSNBC.com in 2007 read: "Unproven meth, cocaine ‘remedy’ hits market. Researchers debate quick fix: Is it good medicine or just marketing?" It took 4 years, but now high quality studies have debunked any claim to efficacy for alcohol or methamphetamine. The meth study, by Ling et al. (Addiction, published online in advance of print, 11/15/11), randomly assigned 120 meth addicts seeking treatment to either the Prometa protocol or a similar set up (with the iv infusions and all) but using placebo instead. As expected, Prometa was no better than placebo. At least it did better in this study than in the study by Anton et al. (J Clin Psychopharmacol 2009;29:334-342,) where for most study subjects, those receiving Prometa had significantly worse outcomes than those receiving placebo! So does this take the wind out of their sales? Of course not! Hythium has the nerve to quote these studies on their website as though they prove than Prometa works, when they show the opposite. That takes real chutzpah. But then again, it's no different than all the treatment centers who offer nutritional supplements, yoga, life coaching, equine therapy etc. as effective for treating addiction. And people keep flocking to them, and paying for them. So until consumers (and payers) wise up, I guess they'll keep selling their snake oil as long as people are buying it.

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