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The drug treatment is what doctors call "an acute treatment," as opposed to drug-for-drug replacement treatments like methadone or maintenance therapies that require repeated doses, like Vivitrol. And the drugs are only a portion of the Prometa treatment. "Prometa isn't just the medicines," Schwartz says. "Prometa is the medications coupled with a psychosocial program and nutritional recommendations. What patients tell me clinically is that they are better able to engage in the behavioral component of therapy."
The explanation goes like this: The medicine allows patients to deal with any psychosocial issues that may have led to addiction in the first place — say, the trauma of child abuse — without the interference caused by irrational cravings. The psychosocial programs can be meetings with the staff therapist or group counseling.
"This isn't a magic bullet," says Hythiam executive Hassan. It's important for patients to know that addiction is multifaceted and that the biological aspect treated by the Prometa drugs is only part of the treatment, he says. "You've got to do the nutritional; you've got to do the psychosocial. You've got to do the aftercare."
A 53-year-old lawyer who had the treatment more than a month ago describes the effect as being like the initial booster rocket on a space shuttle. Prometa helped get him through the first few layers of atmosphere in the recovery process.
"AA just wasn't working for me," says the lawyer, who asked that his name not be used. "I would sit through meetings where people talked about how they lost their jobs and their kids and their houses; then I'd go outside and hop into my Mercedes and drive home. It works for some people; it just wasn't the right environment for me."
In March, he got his first Prometa shot. Now when it comes time to unload at the end of a busy day, he doesn't need several glasses of wine like he used to. With the boost from Prometa, he says, he can propel himself through recovery.
Nearly 3,000 patients have been treated with Prometa nationwide since 2003. Hassan says Prometa patients are more focused when they enter group therapy. "People who run the meetings and aftercare providers will tell you that people who have had Prometa are totally different in groups than people who haven't."
Hythiam purchased the protocol from Dr. Juan Jose LeGarda, the Spanish researcher who developed it. He wasn't the first doctor to try using flumazenil to treat addiction, but he experimented with different ways of delivering the drug. "What he found over time was that this had a significant, robust effect on patients," Hassan says. "He saw the outward effect on human beings. We now have clinical results that document why those results were the way they were."
In 2005, Hythiam CEO Terren Peizer took his company public, raising $150 million by reminding investors that this was a way to make money and help people. In the '80s, Peizer worked for (and later testified against) Michael Milken, who went to prison for securities fraud.
Hassan says Hythiam's mission is to make Prometa available to anyone who wants to get sober. Earlier this month, Hythiam announced its first managed-care reimbursement program with CIGNA HealthCare in Dallas. CIGNA will reimburse qualified patients who receive the Prometa treatment at a few clinics in Dallas and will study the clinical and financial results.
Schwartz already participated in a small pilot study in New Jersey with Blue Cross and Blue Shield. The study examined expenditures in the 12 months before treatment and the 12 months after treatment to see which would potentially be less expensive for insurance companies. The results?
"It's difficult to give any kind of meaningful statistics," Schwartz says. "In general, it seems that 70 percent are able to stay sober right out of the gate. Some people have slips and come back to sobriety. And some people don't stay sober, which is the nature of addiction."
Prometa's lack of "meaningful statistics" doesn't sit well with Dr. Frank Vocci of the National Institute on Drug Abuse in Washington, D.C. In addition to his work at NIDA, Vocci has been an FDA reviewer and a researcher in the clinical neurosciences branch of the National Institute on Mental Health.
"There have been companies like Hythiam before making claims that they have the medical solution to addiction," he says. "And in the absence of any significant data, they can claim anything they want." The addiction community, however, won't be satisfied with anything short of double-blind studies. A placebo-controlled, double-blind study has half the patients receiving the medication and half receiving something with no physical effect, like a sugar pill. Neither the doctors nor the patients know who got what.
"They've got studies that show this working in animals, but they make some big leaps by saying it's the same in humans," Vocci says. "It's those leaps I have a problem with."
By marketing the treatment before testing it, he says, the desperate addict is left to decide how much he trusts the doctors who will profit from this unproven, expensive treatment. Patients are told over and over before the treatment, You'll feel good. You'll feel so good. So it comes as no surprise that when asked how they feel after the treatment, they say, I feel good.