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In a newsletter published by the California Society of Addiction Medicine, Dr. Richard A. Rawson, a UCLA psychiatry professor, wrote of Prometa: "Claims of effectiveness not substantiated with FDA-style testing results are inconclusive at best, misleading at worst. As decisions are made by policy makers to pay for new treatments with taxpayer dollars... it may be considered inadvisable to allow public reimbursement for experimental procedures."
At Research Across America, a clinic in Dallas that runs tests for drug companies and government agencies, Dr. Urschel has been testing Prometa longer than anyone in the country. Last year, he published the first study of Prometa in the Mayo Clinic Proceedings medical journal. He gave the Prometa drugs — but not the psychosocial therapy — to 50 adult meth addicts for one month, then kept track of them for two more months. He says the results were "phenomenal."
Of the 50 subjects, 31 completed the 90-day program, an unheard-of retention rate for a methamphetamine addiction study. Patients in similar studies often drop out and begin using again in a number of days. The problem with the Dallas research: This was an open-label study. The patients and the doctors knew everybody was getting the medication, and there was no way to measure the placebo effect.
Urschel will publish the first double-blind study on Prometa later this year. He won't reveal specific findings before publication but says: "The results are very positive. We had a significant decrease in cravings across the board in the Prometa group over the placebo group."
Other studies are scheduled for publication this year. The studies are funded by Hythiam through unrestricted research grants, meaning that Hythiam has no control over how the results are disseminated. None of the studies has a sample size larger than 120.
Urschel says he's had positive results in both his research and in his private practice, where he offers Prometa to patients, among other treatment options. He says he keeps the research completely separate, in buildings ten miles apart. Vocci says a doctor testing a treatment at a research facility and prescribing the same treatment in a separate private practice is "not uncommon."
What is uncommon, though, is the frankness with which Urschel discusses how quickly popular ideas in the industry can come and go. Without being able to see what's going on in the brain, he says, all we have are hypotheses.
"All these findings and understandings, they may change in a year or two," he says. "They used to put leeches on people to cure them."
Urschel says there is significant data from studies on rats addicted to methamphetamine that show the GABA receptors work better with these doses of flumazenil. "But," he adds, "who knows what's really happening or why things are working?
"As scientists, we really have such a very minimal understanding of truly how the brain works. We don't really know how Tylenol works or how aspirin works, much less the other medicines. We as humans tend to think of things in very simplistic terms so we can understand them."
Dr. Matthew Torrington says he doesn't need to understand how the chemistry works. He just knows it does. As medical director for the Prometa Center in Santa Monica, California, Torrington has treated more patients with Prometa than anyone in North America. The only person in the world who's treated more patients with Prometa is Dr. LeGarda, the Spanish man who devised the treatment.
"It's the most fascinating biologic intervention I've ever seen," says Torrington, whose passion for the subject leads to occasional bouts of shouting. Before working at the Prometa Center, where he receives a consulting fee from Hythiam, Torrington attended Jefferson Medical College in Philadelphia. He did his residency at Christiana Care in Wilmington, Delaware, with a focus in family medicine. He is also a research fellow at UCLA.
"Make no mistake, this is not a fucking cure," he says. He speaks in fast, rhythmic sentences occasionally seasoned with beach-dude profanity. "Prometa just helps with the physical dependence," he tells his patients. "It doesn't change your psychologic situation. It doesn't change your social situation. It doesn't change your spiritual situation. If you don't change those things, if you don't move out of the crack house, it doesn't matter how good Prometa is. It's not gonna work." His voice gets louder. "You gotta move out of the crack house! Or you're gonna die!"
He says the first problem people have with Prometa is that it sounds "too good to be true."
"It's just part of the solution," he says . "Fixing somebody's brakes doesn't do shit for their steering or their bald tire or their bent rim or the bad guidance system in their Nav computer. All that stuff has to be fixed, and addicts are suffering from all those things. It's just one piece of the puzzle."
He takes the GABA-brake system metaphor to entertaining, poetic lengths while explaining the type of patients for whom Prometa is most effective. "Sometimes you see people who've been busting their ass, they've got every other piece, but they still keep failing, because when they hit that steep left turn, they don't have enough braking tone to keep it on the road, and they end up crashing into the guardrail or going over the side," Torrington says. "When you get their brakes working again, they go around that turn and they're fine."