Setbacks plague drug addiction remedy

Kari Huus Reporter • Profile • E-mail

A trial of a controversial drug cocktail designed to treat meth and cocaine addiction has been halted after an audit found that the treatment’s success rate had been “greatly exaggerated.”

The action was a major blow to Hythiam Inc., which licenses the “Prometa protocol” to private doctors and stands to benefit financially if it can gain access to public funding of drug treatment across the country.  Coupled with subsequent media reports that public officials who championed the pilot program owned stock in Hythiam, the news sent the company’s shares plummeting from more than $8 a share in October to about $2.75 this week.

As first reported by msnbc.com in February 2007, the Prometa treatment has stirred both excitement and skepticism since its debut in 2003.

Touted by Hythiam as the first effective treatment for methamphetamine and cocaine addiction, it quickly won converts among some drug treatment specialists who reported “phenomenal” results from its use and from investors who know how profitable it would be to have a magic bullet for the drug addiction scourge.

Hythiam doesn't own or produce the three drugs used in the treatment – gabapentin, flumazenil and hydroxyzine -- but claims ownership of a proprietary formulation and delivery of them.  It licenses doctors to deliver the drugs orally and by intravenous infusions, a process that the company says suppresses addicts’ cravings, thus allowing them to focus on therapy and recovery. While the drugs are common and cheap, private patients pay $12,000 to $15,000 for the outpatient regime, which includes follow-up therapy.

But Prometa also has generated alarm among many substance abuse experts because it headed to market without undergoing rigorous scientific testing. The drug combination required no approval from the Food and Drug Administration because of an exemption that allows for "off label" prescription of drugs for purposes other than those for which they were originally intended.

A public vote of confidence
The $800,000 program in Pierce County, Wash., for offenders referred by the county’s drug courts, approved by local officials in mid-2007, was seen by both advocates and critics as a strong vote of confidence in the treatment’s efficacy. It also was a centerpiece of Hythiam’s marketing of Prometa.

But in November, Pierce County suspended funding for the program after county auditors reported the Pierce County Alliance, the nonprofit administering the program, and Hythiam had “greatly exaggerated” its success rate in a prior test program that helped secure the funding. The County Council quickly froze the remaining $575,000 in funding and suspended the pilot, though the Alliance continues to treat private patients with Prometa.  Another $500,000 budgeted by the state for testing and evaluating Prometa in family dependency cases is intact, but has not yet been spent.

The findings of the audit were “alarming” said Pierce County Councilman Shawn Bunney, who called for the performance review. “It’s clear to me that we are much more involved in a marketing scheme … rather than testing real results.”

Officials of Hythiam and the Pierce County Alliance continue to defend Prometa, saying that county officials misinterpreted their reports and predicting that the treatment will be proven effective when results of ongoing studies are made public later this year.

“The people who are using it — the doctors, patients, administrators, and drug court judges  — … are seeing an impact with it, so I think the treatment will carry it at the end of the day,” said Hythiam Executive Vice President Richard Anderson.

At dispute in the suspension of the Pierce County program is how the Alliance, with Hythiam’s assistance, portrayed the success rate of the 40 people in felony and family drug court who received the treatment.

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