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.
No-shows, dropouts weren't counted
Alliance press releases, some of which were reviewed or written by Hythiam, repeatedly stated that 98 percent of the urinalysis screens taken from the subjects were negative. That statistic, it turned out, did not count subjects who failed to show for required tests or dropped out of the program before completing it.
The auditors also were troubled by the changing number of subjects cited in the press releases. The auditors said they eventually discovered that “drug free,” by the Alliance’s definition, did not mean that the subject had not returned to using meth or cocaine — and some had indeed relapsed — only that they had not tested positive in the 60 days prior to the end of the program.
Pierce County Alliance administrators say they were blindsided by the audit and the freezing of funding for the program and were not given adequate time to explain their position. They argue that relapse is common in drug treatment and that the relatively few failures in the pilot program did not indicate that that Prometa was not effective.
“There were some who did well with Prometa, though they had some positive (urinalysis) after receiving treatment,” said James Boyle, the Alliance deputy director. “The auditors view those folks as not being successful. What we were trying to explain to them was that not every person who enters chemical dependency treatment will be drug free from Day One. … It’s a process over time.”
The program in Pierce County is not the only one to encounter problems. A program announced by Fulton County, Ga., in mid-2007 and hailed in Hythiam press releases was halted without explanation after a handful of treatments. The state of Idaho tentatively budgeted for a pilot program in its drug courts in early 2007, but abandoned the idea after drug court officials opposed it, citing the lack of scientific evidence.
Adding to the controversy over Prometa was report by the Tacoma News Tribune newspaper shortly before the suspension of the Pierce County program that Terree Schmidt-Whelan, the executive director of the Pierce County Alliance, another administrator of the nonprofit and key county and state officials who had heartily endorsed the program all had purchased stock in Hythiam.
‘I did believe we had found magic’
The only one who apparently violated a law in doing so was state Rep. Dennis Flannigan, who failed to file a public disclosure statement of his $28,000 stock purchase. He said a legislative attorney had approved the purchase and acknowledged no wrongdoing other than poor record keeping.
"I had no interest in promoting anything that didn’t work," said Flannigan, who has extensive experience in drug treatment. "I did believe we had found magic."
Schmidt-Whelan and John Neiswender, the Alliance’s chief financial officer, both of whom purchased Hythiam stock, did not respond to calls seeking comment. Boyle, the Alliance’s deputy director, said the nonprofit has no policy against such purchases.
Pierce County Executive John Ladenburg, who asked the County Council to fund the Prometa pilot program and also bought stock in the company, also did not respond to calls seeking comment.
The use of public funds for the program was controversial from the start because the drug combination reached the market without review or approval by the FDA and because Prometa had not been subjected to double-blind, placebo-controlled studies – the gold standard of scientific testing.
In the absence of such review, Hythiam relied on testimonials from recovered addicts and drug treatment practitioners to market Prometa.
The Alliance’s Schmidt-Whelan was among the early converts. In an interview with msnbc.com for the February 2007 article, she described the results of the first Prometa test as “phenomenal.”
Boyle, her deputy, said he remains convinced that the drug combination will eventually be shown to be effective.
“It’s one of the most encouraging things I’ve ever seen and I’ve been working in chemical dependency and criminal justice in this county since 1968,” he said.
A popular option for private patients
Such endorsements have made Prometa an increasingly popular option for those seeking private treatment for drug addiction. Hythiam says that about 2,500 private patients has been treated with Prometa at the four rehabilitation centers it operates or by about 70 other doctors licensed to administer the treatment. The company does not release data from private treatment facilities.
But Hythiam has aggressively sought to make Prometa available as an option to the more than 2,000 drug courts in the country that offer treatment to offenders as a means of keeping them out of jail or providing a path for them to regain custody of children.
The company has made inroads in the public sector by signing on some influential players to advocate for Prometa. It appointed Andrea Grubb Barthwell, a former deputy director at the Office of National Drug Control Policy at the White House, and retired Judge Karen Freeman-Wilson, former CEO of the nonprofit National Association of Drug Court Professionals (NADCP), which represents about 20,000 drug court workers across the country, to serve on its Board of Directors. The company also hired the NADCP’s former membership coordinator, Arlandis Rush.
While still with the NADCP, Freeman-Wilson and Rush helped Prometa get its first day in drug court — a pilot program involving 30 people in Gary, Ind., that started in November 2005 and was deemed a big success.
Judge Deidre Monroe, who ran the city’s drug court, said the treatment combined with drug court was about twice as successful as drug court alone in getting people to quit drugs.
But the trial was far from conclusive, since people who complete drug court-ordered treatments typically leave the system at that point, leaving their ultimate outcomes unknown.
Msnbc.com ran into that obstacle in trying to find out how a young woman who underwent the Prometa treatment last year was faring. The Pierce County Alliance made Suzanne Younker available for interviews for msnbc.com’s article in February 2007, at which time she was entering her sixth month of sobriety, in an effort to regain custody of her infant son. But Younker did not answer calls from msnbc.com over the past month.
Studies to decide Prometa's future
While the once stellar prospects for Prometa have been dimmed by the Pierce County debacle, the treatment still has influential proponents.
Among them is psychiatrist Harold Urschel III, an addiction specialist and researcher in Texas who treats patients with Prometa at a private facility.
He said that in addition to seeing the treatment’s successes first-hand, he has conducted a double-blind study that he says show Prometa significantly curbs cravings among addicts. The results of the study have not yet been peer reviewed.
Researchers at UCLA and the University of South Carolina also are conducting double-blind testing of Prometa and are expected to being reporting their results later this year.
Urschel’s close relationship with Hythiam – the company funds his research and organizes press interviews through its public relations firm -- has raised questions about his impartiality.
Urschel, who defended his data and analysis in an interview with msnbc.com, became part of the controversy in November, when organizers canceled two of his three research presentations slated for a conference sponsored by the American Academy of Addiction Psychiatry.
Organizers said they canceled the presentations after receiving an e-mail from a Hythiam employee on behalf of Urschel that drew attention to his close relationship to the company and to the fact that his research involved a commercial product, a conflict with rules barring research that may be influenced by pharmaceutical companies.
Concern about ‘outside influences’
“The bottom line is that we are a guild organization for addiction psychiatrists and allied health professionals," Elinore McCance-Katz, president of the AAAP, said in statement to msnbc.com. "We’re very concerned that what is presented at our meetings not be tainted by outside influences.”
In an interview with msnbc.com, Urschel was unapologetic about his relationship with Hythiam and said that controversy had obscured the big issue, which is the deadly problem of meth and cocaine addiction.
"The bottom line here is that I think we have the ability to help save lives with Prometa,” he said. “... For people to squelch the data is really kind of kindergarten, really rinky-dink."
Hythiam characterized the incident as a misunderstanding and said it would “never seek to manipulate or influence either the data or process involved in professional research collection, presentation, dissemination or publication.”
The controversy surrounding Prometa has also caused the National Association of Drug Court Professionals to distance itself from Hythiam. Since the departure of Freeman-Wilson as CEO, successor West Huddleston has informed Hythiam that it is no longer welcome as a corporate sponsor — and will not be until it had more science to back up its claims for Prometa.
Despite such setbacks, the power of testimonials continues to propel Prometa, even where public dollars are paying for it. In Texas, after a 20-person pilot program in Collin County — funded by Hythiam and administered by Urschel — the state budgeted $2 million for the use of Prometa in drug courts over the next two years.
“The Washington people have the right to their opinions,” said Texas state Rep. Jerry Madden, who led the charge for the Prometa funding and stated he has no shares or financial interest in Hythiam. “In Texas, we’re doing what we think is Texas smart.”