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Addiction treatment, novel but unproved

Prometa's promoters point to anecdotal success. But critics want to see hard numbers.

October 09, 2006|Shari Roan | Times Staff Writer

The drug treatment first raised eyebrows several months ago with its provocative marketing campaign. Featuring deceased comedian Chris Farley and the message "It wasn't all his fault," the billboard, radio and Internet advertisements were a bold departure from the often understated ads used to market addiction treatment.

But since then, it's been the therapy itself, known as Prometa, that has caught the attention of the public and the medical community alike, drawing both anecdotal reports of success and sharp criticism.

The philosophy of Hythiam, the small Santa Monica company that developed the treatment, is that drug addiction is a brain-based disorder that cannot be overcome by willpower alone. That belief isn't unusual, but the company maintains that three specific medications -- used in a certain sequence and dosage -- can treat brain dysfunction and break addictions to alcohol, cocaine and methamphetamine.

Doctors using Prometa "have never seen anything this dramatic," says Terren Peizer, Hythiam's chairman and chief executive. "This is changing the way we approach this disease."

The drugs aren't approved for addiction treatment, and the company makes doctors who use their method sign a disclosure agreement promising not to divulge details. The company also charges up to $15,000 for the two to five outpatient visits that form the core of the treatment.

Critics point out that no randomized studies pitting Prometa against standard treatment or a placebo have been done to show that the method is safe, or useful, in helping addicts achieve sobriety.

"Controlled studies where participants have paid similar amounts of money and have equally high expectations of treatment have not been completed or published," says Dr. Lori D. Karan, a researcher in the Drug Dependence Research Laboratory at UC San Francisco. She suggests there is a high likelihood of a strong placebo effect.

Prometa's secrecy and lack of a track record worry doctors.

"They are using a procedure that has yet to be proven effective, charging an inordinate amount of money and making promises they are not able to keep," says Dr. Rick Chavez, medical director of the Pain Institute in Redondo Beach. He says some of his patients tried the Prometa approach and relapsed.

Hythiam officials and proponents of Prometa say critics are worrying needlessly. Not only are no promises made, they say, more than 1,000 of people in the United States have safely undergone the treatment. They say word-of-mouth reports show it works where most other treatments have failed.

An outpatient treatment

Peizer launched Hythiam three years ago after searching worldwide for a better way to treat drug addictions. Although he has no background in addiction treatment, Peizer was looking for an investment opportunity and was intrigued by the idea that addictions could be treated with medications. Before starting Hythiam, he directed several other science or biotechnology companies.

Prometa is based on research by a Spanish doctor who believed that medications that control the gabaminergic system of the brain could help break addictions. The treatment involves administration of an intravenous medicine, flumazenil, and two oral drugs, gabapentin and hydroxyzine, in an outpatient setting. The patient also receives vitamins and minerals and is urged to begin traditional psychosocial counseling and group support meetings to augment recovery.

The medications, which are approved by the Food and Drug Administration for treating other disorders but not drug addiction, are aimed at quieting cravings and improving mental clarity, Peizer says.

Hythiam has applied for a patent to protect its unique use of the three medications and the specific dosing regimen. The company licenses the protocol to addiction treatment centers or doctors for a fee and, so far, has about 45 licensees nationwide, Peizer says.

Peizer points to data compiled by several doctors using the protocol that show it works. Data from a drug court (a specialized court designed to handle cases involving offenders who abuse substances) in Pierce County, Wash., showed that 98% of methamphetamine and cocaine addicts achieved clean urine screening tests for three months after the Prometa treatment provided by Hythiam. That data was presented in June at the National Assn. of Drug Court Professionals' annual conference.

Another 12-week nonrandomized study by Research Across America, a clinical research company, on methamphetamine-dependent patients showed that 80% of patients "experienced a significant clinical benefit" with the medication alone (without behavioral therapy). The benefit was defined as decreased cravings, reduction in methamphetamine use and staying in treatment. The study, which was also undertaken and paid for at the request of Hythiam, was presented in June at the annual meeting of the College on Problems of Drug Dependence.

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