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.
