A costly drug cocktail touted as the first pharmacological treatment for cocaine and methamphetamine addiction is at the center of a raging national debate.
The treatment, called Prometa, is not approved by the Food and Drug Administration as an addiction therapy, nor has it undergone extensive scientific testing. But officials at Los Angeles-based Hythiam Inc., the company that sells the treatment protocol, say it can work miracles for people struggling to break their addiction.
David Smart turned to Prometa when he hit rock bottom eight months ago. Smart had lost everything — his wife, his family, his job and his home. By his own estimate, he had failed at least two dozen times to overcome his meth addiction.
“I had tried everything and nothing worked for me,” said Smart, 41, of suburban Tacoma, Wash. “But Prometa has.”
Mario Acosta Jr. also tried Prometa but relapsed within days of completing treatment.
“They told me it would work for everything,” said Acosta, 44, a longshoreman in San Pedro, Calif., who was battling alcoholism and heroin addiction.
He took out a $5,000 loan to help pay for it. “What a waste of money that was,” he said.
As many as 3,000 people have tried Prometa, up from about 1,000 a year ago, a Hythiam spokesman said. Prometa was first offered in 2003 as the HANDS Protocols.
More than 70 physicians nationwide have been licensed by the company to treat patients. Hythiam promotes Prometa as a 30-day outpatient treatment for addiction to alcohol, cocaine, heroin and meth, also known as crystal meth.
Doctor: ‘Marketing scheme’
But some treatment professionals say the company rushed to treat patients with Prometa before it had undergone greater scrutiny.
“I don’t think Prometa is a drug treatment for addiction; I think it’s a marketing scheme,” said Dr. Alex Stalcup, a California-based expert on methamphetamine addiction.
Some addiction experts said the treatment is reminiscent of controversial methods promoted in the past.
“There is an attempt to create hype before there is actual evidence, make a buck and move on,” said Chicago addiction specialist Dr. David Ostrow, who attended a meeting here organized by Hythiam last month. “These kinds of treatments have come and gone like garden weeds in the field of addiction.”
Hythiam officials said the company’s attention-grabbing marketing shouldn’t be confused with its treatment.
“People are dying [from drug abuse], and this [treatment] seems to be making a dramatic difference,” said Dr. Matthew Torrington, medical director of the Prometa Center in Santa Monica, Calif., one of four such treatment centers.
Jim Pickett, chairman of the Chicago Crystal Meth Task Force, says Hythiam is pushing an untested treatment on people when they are at their lowest point. His outrage grew after he saw a full-page ad for Prometa in Gay Chicago Magazine.
“They are preying on vulnerable people,” Pickett said. “People in the throes of crystal meth addiction — and their families — are extremely vulnerable, and they are taking advantage of it.”
Natalie Bauer, a spokeswoman for Illinois Atty. Gen. Lisa Madigan, said the office has seen a rising number of questionable claims of successful treatments for meth addiction.
“Atty. Gen. Madigan shares the concern expressed by treatment professionals and Chicago Crystal Meth Task Force members that Hythiam has undertaken an aggressive marketing campaign on behalf of Prometa without first showing that Prometa is an effective treatment for addiction to methamphetamine or other substances,” Bauer said.
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Hythiam launched a marketing campaign last year that included a Los Angeles billboard ad featuring the late comedian Chris Farley, who died in 1997 of a drug overdose.
The ad was “tasteless,” said UCLA psychologist Richard Rawson, who specializes in addiction. “Certainly the suggestion that this procedure, which has not been tested, could have saved his life was over the top.”
Last year, an estimated 23 million Americans abused or were dependent on alcohol, illegal drugs or prescription medication, according to the federal Substance Abuse and Mental Health Services Administration. About 2.5 million of them sought help at specialty treatment facilities.
Experts agree that controversy over Prometa has highlighted the need for effective medical treatments for addiction, especially for those hooked on meth, which has become a scourge in many rural areas, including parts of Illinois.
Three-medication cocktail
So far, the FDA has approved four drugs to treat alcoholism and three drugs to treat addiction to opiates.
It is Prometa’s cocktail of three medications — flumazenil, gabapentin and hydroxyzine — that is generating controversy.
Flumazenil reverses the sedative effects of general anesthesia and is used to treat overdoses caused by benzodiazepines such as Valium. Gabapentin is an anti-seizure medication. Hydroxyzine, an antihistamine, also is used to treat anxiety.
The drug cocktail is being used “off label,” meaning the medications have been approved by the FDA to treat other disorders, but not addiction. Hythiam doesn’t own or manufacture the drugs but says it owns the treatment protocol.
It has been studied in three company-funded clinical trials. Two open-label studies reported fewer days of meth use and reduced cravings. Open-label studies are considered preliminary research.
A third study reported reduced cravings among Prometa users at the end of 30 days of treatment, compared with those who took a placebo. That study of Prometa was its first randomized, double-blind, placebo-controlled trial, considered the gold standard of medical research.
Critics said the results were unimpressive and were critical of the focus on self-reported cravings instead of drug abstinence.
“Everyone wants to see abstinence,” said Dr. Harold Urschel III, chief executive of the Urschel Recovery Science Institute in Dallas, which conducted the research. Urschel also treats patients with Prometa under a licensing agreement with the company. “But that’s just one factor in treatment success.”
Urschel hypothesizes that Prometa repairs a receptor in the GABA system, the primary inhibitory neurotransmitter in the brain. Scientists believe the receptor is damaged by repeated drug use.
Urschel said patients treated with Prometa lose their cravings and are more clear-headed.
Frank Vocci of the National Institute on Drug Abuse said claims about Prometa’s ability to reverse changes in the receptor are not backed up by science.
“There is an implied claim that the flumazenil-induced changes in the GABA receptor are associated with the yet-to-be-proven efficacy,” said Vocci, director of the institute’s Division of Pharmacotherapies and Medical Consequences of Drug Abuse. “They are not measuring changes in the brain or in the functions of receptors. There is a loose association between what flumazenil may be doing from a biochemical standpoint and how that may be therapeutic for these individuals.”
The company says additional studies under way will confirm the treatment’s effectiveness. Results from a study being conducted at UCLA are expected as early as next year.
Hythiam has opened treatment centers in Santa Monica, San Francisco, New Jersey and Florida, with plans to open more. Alcoholism treatment costs $13,000; cocaine and meth treatment costs $15,000.
Private insurance doesn’t cover Prometa, but Blue Cross Blue Shield plans in New York and New Jersey are considering doing so, a Hythiam spokesman said.
The company also is seeking public funding to cover treatment of Medicaid patients, parolees and others.
Criticism of such programs has mounted in recent weeks.
Last month, the Pierce County Council in Tacoma ended funding of a Prometa pilot project for drug offenders after a report by auditors concluded there was no evidence it worked. Hythiam said the report was politically motivated.
“As a general rule with these kinds of things, it’s caveat emptor,” said Dr. Mark Willenbring, director of the division of treatment and recovery research at the National Institute on Alcohol Abuse and Alcoholism, referring to unproven drug treatments. “Let the buyer beware.”
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Dependency
Americans older than 12 who say they are dependent on:
ALCOHOL: 1 in 13
MARIJUANA: 1 in 59
COCAINE: 1 in 143
HEROIN: 1 in 1,000
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Estimates based on national survey of self-reported drug use.
Source: 2006 National Survey on Drug Use and Health, U.S. Substance Abuse and Mental Health Services Administration
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