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Doctors prescribing Prometa report seeing the same success stories all the time. At Canterbury, which started treating patients with Prometa in December, they say more than 90 percent of their patients have stayed clean and sober since the first day of treatment. A Palm Beach man in his 20s said he used to snort Adderall, a stimulant prescribed to treat attention deficit disorder. He started abusing the drug in college and wasn't able to stop — until Prometa.
There isn't much in the way of clinical data on Prometa. Early research is promising, but the only published study involves a sample size of 50 patients and didn't have a placebo control. Dr. Harold Urschel of Research America in Dallas and Dr. Walter Ling at UCLA plan to publish studies later this year, but these are preliminary and also based on small sample sizes.
If it works, Prometa will change the way addiction is treated and the way society views addicts, Hythiam executives say. If they have their way, we'd think of a bad cocaine habit or a drinking problem the way we might think of hypertension or diabetes: as a disease that requires a lifestyle change and medical treatment.
The new approach is turning heads in South Florida, home of the largest recovery community in the country. At least five clinics from Miami to Palm Beach now offer the treatment, though the institute in Boca is the first Prometa Center outside of California and New Jersey.
Hythiam's mission is to make Prometa available to everyone who needs it. It foresees centers in every city and insurance companies ponying up for the treatment. It wants courts offering it as an option for drug offenders and would even like to see it integrated into traditional 12-step programs.
But company officials started marketing the protocol, which costs up to $15,000 per patient, based solely on the anecdotal testimony of doctors, patients, and company executives. They say they just skipped the "bureaucracy" — meaning FDA approval, among other hurdles — to get the medicine to sick patients as quickly as possible.
Dr. Matthew Torrington, medical director of the flagship Prometa Center in Santa Monica, says it would be unethical not to treat patients while waiting for clinical study results. "People are dying!" he shouts during an interview.
But by avoiding the traditional regulatory methods of approval, Hythiam also avoided the only thing researchers and health-care providers consider empirical proof: a series of double-blind, placebo-controlled studies published in reputable, peer-reviewed journals.
In theory, these tests are the only reliable way to determine a treatment's effectiveness. A good study has a simple, testable hypothesis. It explains the reasoning behind the theory being tested and describes the method of testing. Then it reports the analyzed data, accounting for any variables, followed by an appropriate conclusion.
Historically, these "evidence-based" studies were the only thing that mattered in the conference rooms where the white coats of medicine meet the white collars of business.
Prometa could change that. By going straight to the free market, Hythiam essentially told the business world, the treatment community, and addicts everywhere to put down the graphs and believe their own eyes.
Donna Butz, the receptionist at the Canterbury Institute, sees patients walk in sick and angry and walk out looking like different people. "By the time they come out, they're so happy," she says.
Why? Because of an immediate change in brain chemistry, says Dr. Mark Schwartz, medical director of Canterbury Institutes in both Boca Raton and New Jersey. He's prescribed Prometa for alcohol and stimulant addiction for more than a year.
"Your brain, my brain, anybody's brain is made of billions of nerve cells called neurons," he explains to patients. "They're like little wires that carry chemical-electric signals. And these nerve cells are hooked up into different patterns, different circuits."
Each circuit performs a different function in the brain. "The way these cells are connected is through a little space where one nerve cell secretes a chemical called a neurotransmitter," he says. "These neurochemicals interact with the next cell in something called a receptor, sort of like pieces that interlock. And they either turn on or turn off the next cell in the circuit."
If your brain were a car, the neurochemical GABA would be your brake system. GABA — gamma-aminobutyric acid — is the brain's primary inhibitory neurotransmitter, which means it helps calm and focus you. Glutamate would then be the brain's gas pedal. GABA keeps glutamate from overexciting you. Too much glutamate can cause a seizure, and too much GABA can put you in a coma.
Every drug of abuse mimics a biological reaction in the brain. Among other things, alcohol mimics the braking system. And when alcoholics use these artificial brakes often enough, the brain stops utilizing GABA — your natural brakes. In an addict's brain, the GABAa-1 receptors fold up into a different configuration. These altered GABA receptors are associated with anxiety, compulsivity, insomnia, irritability, and cravings.
"That's the period of time where you've stopped using alcohol or stimulants — you're abstinent — but your brain hasn't reset," Schwartz says.
Prometa researchers hypothesize that flumazenil, administered intravenously in large doses, changes the GABA receptors back to their pre-abuse state — as if the addict had never met and fallen in love with that drug.