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Such innovations have fueled a revolution of sorts within the treatment community. The American Medical Association first defined alcoholism as an illness in 1956, but for decades, the predominant treatment models combated the problem as a psychological condition or moral weakness. Alcoholics Anonymous became the most reputable way to help addicts live stable, productive lives, and one-on-one psychotherapy was incorporated into residential and outpatient treatment programs. While the 12 steps and behavioral modification remain central to treatment, the emerging paradigm considers addiction a biological condition as chronic and medically treatable as diabetes or high blood pressure.
"You can't say this is a medical disorder and then say the treatments won't be medical," says Dr. Bryon Adinoff, distinguished professor of alcohol and drug abuse research at UT Southwestern Medical Center at Dallas and a psychiatrist on the substance abuse team at the Dallas Veterans Affairs Medical Center. "Even 12 Steps says this is a medical disorder. I think of it like a blood pressure disorder—getting people to eat right, take meds, et cetera. Every chronic condition takes a combination of medical and psychosocial treatments."
Prometa is perhaps the most contentious new treatment. Hythiam claims the protocol curbs cravings and helps addicts stay clean and sober through a combination of pills and injectable medicines combined with follow-up psychological and nutritional counseling. Most medications used to manage substance abuse must be taken continuously, but Prometa takes the "drugs for drug abuse" approach to a new level: Do one round of the 30-day protocol, Hythiam and supportive clinicians say, and your brain is definitively altered.
Yet researchers, physicians and public officials say Hythiam may be taking too large of an intuitive leap with Prometa. They've criticized the company for marketing the treatment, which can cost up to $15,000 per person, to governments and private clinics without first proving its efficacy through the gold standard in medical research: a series of double-blind, placebo-controlled trials that are peer-reviewed and published in a medical journal. Those studies test two groups, one given a placebo and the other the real drug, while the subjects and researchers are uncertain which is which until the end of the trial.
Each of the three medications used in the Prometa Protocol has been separately approved to treat anxiety and seizure disorders, but the Food and Drug Administration hasn't evaluated using the combination for addiction. Doctors commonly use medications or drug cocktails for purposes other than what they were developed to treat, as many oncologists do for cancer, but rarely does a company license a specific combination and put major marketing muscle behind it, as Hythiam has done.
The company—led by Chief Executive Terren Peizer, who began his career as a bonds salesman and made headlines in the '80s by testifying against financier Michael Milken in the savings and loan debacle—bought the protocol four years ago from a Spanish researcher. Dr. Juan Jose LeGarda found that injecting patients with flumazenil—used for overdoses of drugs like Xanax or anesthesia—helped alcoholics abstain from drinking. (Other scientists had experimented with flumazenil to treat alcoholism but produced few positive results.) The program's other two medications, taken orally, are gabapentin, an anti-seizure drug, and hydroxyzine, an antihistamine used for anxiety.
Drug abuse alters the brain's receptors for GABA, the neurotransmitter that acts as the brain's brakes to inhibit impulsive behavior. Hythiam claims flumazenil changes the receptors back to their normal state while the hydroxyzine counters its side effects and the gabapentin curbs cravings.
"If they've figured out something that no one else has, then my hat's off to them," says Dr. Frank Vocci, director of pharmacotherapies for the National Institute of Drug Abuse. "But they don't have the evidence yet."
Chris Hassan, Hythiam's senior executive vice president, says the company didn't want to spend 10 years on traditional research channels before delivering a product that worked.
"Alcoholism is one of the top three leading causes of death in the U.S.," he says. "We believed this was a moral imperative. The patient responses were there; the recoveries were robust. This was real."
Hythiam also is betting a stronger market exists for addiction treatments than major pharmaceutical companies suppose. Though researchers say this is changing, many large drug companies have shied away from developing addiction-related medicines because of the stigma linked to alcohol and drugs.
"Guys in the trenches treating patients were at a loss because there wasn't much research being done on alcohol," Hassan says. "Our hope was, if we could make this medicine a success and help a lot of patients, maybe big pharma would realize the stigma is gone and there's money to be made."
Since late 2003, some 3,000 people have been treated with Prometa. Of those, several hundred have undergone the program at a handful of clinics in Dallas. Hythiam jump-started its effort to make Prometa a staple of health plans across the country when in May it won its first managed-care reimbursement deal with Dallas-based Cigna Healthcare. The health plan began covering qualifying patients for Prometa in July. Hassan expects to secure more deals as additional research is released.