Unproven meth, cocaine ‘remedy’ hits market

Kari Huus Reporter • Profile • E-mail

A drug cocktail that backers say is the first effective treatment for methamphetamine and cocaine addiction is dividing substance abuse experts into two hostile camps — those who say they have seen it work wonders and those who say it has been rushed to market without any scientific testing.

The strident debate over the "Prometa protocol," manufactured by the Hythiam Corp., is complicated by the checkered Wall Street career of the company's CEO, Terren Peizer, who previously championed an anti-AIDS drug that has yet to make it to market.

Hythiam, which is based in Los Angeles, launched Prometa in 2003 in private clinics, where meth and cocaine addicts, as well as alcohol abusers, pay $12,000 to $15,000 for a one-month outpatient treatment.

Now the company is aggressively pushing Prometa for the mass market, and asking governments and insurers to foot the bill. Already, four county and municipal programs have launched pilot programs and are offering powerful testimonials for the treatment.

The company has a huge receptive potential customer base in health and law enforcement officials in countless small communities that have been broadsided by the costly and seemingly intractable meth and "crack" cocaine epidemics. And it has big ambitions in this grim landscape.

“We believe strongly that one day Prometa will be a standard of care, and should be available to everyone,” Peizer said.

But critics note that the field of addiction treatment is littered with "miracle cures" that ultimately failed or, in a few cases, caused harm to test subjects. And they warn that Prometa has never been subjected to double-blind, placebo-controlled testing — the gold standard for determining whether therapies are safe and effective.

‘It preys on ... desperate patients’
“The marketing is way ahead of the science,” said Lori Karan, a physician-researcher at the Drug Dependence Research Laboratory at the University of California San Francisco. “It preys on the needs of desperate patients, sets unreasonable hopes and expectations and takes advantage of scarce economic resources.”

"What’s being touted here is what people have always wanted for addiction ... something dramatic that is going to fix their brain," agreed Peter Banys, director of substance abuse programs at the VA Medical Center in San Francisco. "I would never recommend that someone spend $15,000 on this with the current state of data (and) I think it’s improper to spend public money on this product at this time."

Interactive A look at how heroin, cocaine and other drugs affect the body

Prometa has made its way to consumers quickly because of an exception in FDA regulations that allows physicians to prescribe drugs “off-label” — that is, for purposes other than the one for which they were originally approved. For example, Botox, best known as a wrinkle eraser, originally was approved as a treatment for an eye muscle problem but is used off-label to treat migraine headaches.

However, Hythiam is exploring new territory by grouping three FDA-approved drugs for off-label purposes in Prometa. The company doesn't own or produce the three drugs — flumazenil, gabapentin and hydroxyzine — but claims ownership of the process by which they are delivered into a patient's system along with nutritional supplements. It licenses the protocol to individual doctors and clinics, grants franchise rights and administers the treatment at its Prometa centers.

The company, which is seeking a U.S. patent on its “proprietary dosing algorithm,”  is secretive about the specific details of the treatment. But it broadly describes it as a process in which patients receive about one hour of intravenous infusion for three straight days, followed by about a month of oral medications and nutritional supplements. Near the end of the month the patient returns for two more IV infusions. The formulation varies, depending on whether it is being used to treat meth, cocaine or alcohol dependency.

Hythiam's doctors aren't sure how Prometa works, but they hypothesize that it repairs the damage to neurotransmitters in the gamma-aminobutyric acid (GABA) receptor complex — the part of the brain that inhibits or calms — caused by extended drug and alcohol abuse. The effect, they believe, is to halt cravings for the drug and allow addicts to think clearly enough to concentrate on changing their lifestyles.

“It resets the receptors and they stay reset,” Matthew Torrington, medical director of the flagship Prometa Center in Los Angeles, told a group of Washington state and local legislators at a recent presentation. By quelling the cravings, he said, "It intensifies the prowess of psychosocial treatment."

Try it now, prove it later
Hythiam is now conducting double-blind studies at UCLA and the University of South Carolina in an effort to establish the efficacy of Prometa and rule out the “placebo effect,” where patients who believe they are receiving a treatment for a medical condition show improvement even when they are given an inert substance.

But those results may not be final until 2008, and the company argues that the results of its field trials are so compelling that use of Prometa should not wait.

“Counties don’t care about double-blind placebo-controlled data," said Peizer. “What’s interesting about Prometa is that out in the field — in the counties, justice systems, private centers — the clinical relevance is being shown daily."

Already, according to Hythiam, more than 1,000 people have undergone treatment with Prometa, with providers reporting unheard of abstinence rates of between 60 percent and 80 percent. Thousands more will receive the treatment in the next year in private settings alone, it says.

The company also is making inroads in the government sector.

Fulton County, Ga., which has a cocaine epidemic and an emerging meth problem, announced in October that it was launching a Prometa pilot program for its parole and probation programs in an effort to curb high recidivism rates.

That  comes on the heels of a pilot programs in Pierce County, Wash., and Gary, Ind., where local officials said they saw such dramatic results in meth and cocaine addicts that they are seeking to make Prometa a standard offering. Idaho and Maricopa County, Ariz., also are considering testing the Prometa regimen.

The company is pressing its case on two fronts. Hythiam’s senior officers are talking to investors in U.S. financial centers while doctors employed by the company shop Prometa at anti-drug conferences in meth-blighted areas.

“We are in constant dialogue with providers to government and state agencies and third-party payers and we expect to land initial licensing relationships that will contribute to our 2007 revenues,” Peizer said in the company’s second quarter conference call in August. “Keep in mind, each 400 treatments at the government rate of $2,500 will result in $1 million in revenue. At these levels, even initial volumes can accrue quite rapidly.”

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