The Collin County Observer

Collin County 380th District Court Judge Charles Sandoval's website lists among his accomplishments, "Responsible for pilot program (Prometa), which has saved Collin County $400,000."

I sent an open records request to the judge asking for any documents that would justify a claim of financial savings to the county.

I received this reply from the Judge, "This office has no records of the Prometa pilot program."

I also sent open records requests to the county, they responded with some assessment data on the program, but their response to the specific question of financial savings was, "No financial data kept by Collin County CSCD [Community Supervisions and Corrections Department]. This would be a 380th District court question."

Sandoval's unsubstantiated claim of savings to the county is, unfortunately, only a very small part of the concerns some are having over the judge's involvement with the Prometa drug treatment program.

Judge Sandoval's response to my
Open Records Request
(Click on image to download full size)

Judge Sandoval's enthusiastic endorsement of Hythiam's Prometa program for treatment of addiction has raised some eyebrows around the county. Hythiam frequently touts Sandoval's praise and Collin County's participation both in marketing Prometa and in marketing Hythiam's own stock.

But not everyone sees the Prometa program in the same light.

For example, Hythiam and Sandoval both are quoted as saying that 14 of the 20 participants were drug free after 90 days. However, urine analysis data collected by the county probation office shows a radically different outcome - only 9 of 20 clean, and with one suicide. In December, the Tacoma News Tribune reported that, "Bob Hughes, director of the probation department in Collin County, gave different numbers to The News Tribune in a recent interview. He said nine of the 20 drug court clients who received Prometa – less than 50 percent – were still clean."

“I kind of reserve judgment till this thing has been around a while,” Hughes said. “It’s too early to tell how it’s gonna turn out. We have some people who are convinced it’s really changed their lives. You can’t really quantify that. I’ve seen a few good things and heard some good things from people. I guess I’m still skeptical.”

I asked Mr. Hughes if he stood by his statements to the News Tribune. He told me that he does.

Also skeptical is Kathryn Cunningham, director of the University of Texas Medical Branch's Center for Addiction Research, who told the Dallas Morning News, "There's been a lot of marketing hype before the evidence exists," she said. "This is not something I'd personally want to spend my taxpayer money on ... I know a lot of scientists in this area, and we're all singing the same tune. This is misguided."

Dallas Judge John Creuzot agrees. In January, the Dallas Morning News quoted him as saying, "I don't think anybody should be spending any amount of money on something that hasn't been clinically researched to be safe and effective," said Dallas Criminal District Judge John Creuzot, who was approached about the pilot program but refused to participate. He said the company marketing the treatment is "in the business of making money, and they did a great sales job on some well-intended legislators in Texas."

It appears they did a great job on one Collin County Judge too.

Ethics issues have followed Hythiam's attempts to market Prometa in other jurisdictions. Tacoma, Washington abandoned its Prometa program when the data was called into question and it was learned that key decision makers in the county owned large blocks of stock in Hythiam. In Indiana, one key state employee was hired by Hythiam soon after the company declared a pilot program in Gary a success.

The data used to market the Prometa program has also been called into question. Prometa is not FDA approved for addiction treatment. There are no "peer reviewed, double-blind, placebo controlled" studies that scientists and the FDA say are needed to prove the effectiveness of drugs used on humans.

Outcomes for Participants Completing less than 60 days
(Click on image to download full size)

Hythiam and Sandoval's claims of a 74% Collin County success are disputed. But it is difficult for an independent observer to make a judgment on the competing success rate claims, since Hythiam and its vendors keep and analyze all test data, it is not made available to the public. The doctor who ran the test program and reported data sells the Prometa program out of his Dallas clinic...he has a personal financial interest in the success of Prometa.

I did receive one Hythiam document in response to my open records request. It lists 9 individuals who dropped out of the 90 day program in the first 60 days. If 9 of 19 failed in the first 60 days, how can Hythium claim 14 passed?

It appears that Hythiam is counting many of those who's probation was revoked for drug use as successes. A Hythiam Corp.press release dated Sept. 17, 2007 claims that, "Of the 19 individuals that participated in the pilot program, 74% (14) did not test positive for drug use during the pilot. Of the 218 drug screens that were collected, 96% (210) were negative for drugs. Twenty individuals initially volunteered for the pilot, one of whom was excluded by the court as not suitable to participate. One individual who did not test positive for drugs was incarcerated on a non-drug charge, five individuals were re-incarcerated for drug use, and two individuals who had not tested positive for drugs had outstanding warrants at the end of the pilot."

In other jurisdictions, the data has also been called into question. Fulton County, Georgia told the Tacoma paper that, “We discontinued the program because it had not been effective for our Drug Court defendants,... We do not plan to use the program in the future.”

Tacoma's county auditor reported that the clinical data, once the "placebo effect" was factored in, showed statistically insignificant improvements.

Another aspect of the Prometa pilot programs that cause concern has to do with the ethics of human testing of unproven drugs on prisoners and probationers.

The Prometa is not a simple, benign treatment program, but a 90 day procedure involving the use of 3 powerful prescription drugs (gabapentin, flumazenil and hydroxyzine), one by IV infusion. None of the 3 drugs are approved by the FDA for addiction. The Prometa protocol is not approved by the FDA either.

Many of the participants were in jail immediately before they were enrolled in the Prometa program. What were they promised? Did they have a choice? Were they warned of medical and legal consequences? Were they in a position to refuse without sanction?

In my open records requests to the Judge and to the county, I asked for the protocols, policies and forms that were used in recruiting participants. Collin County responded with, "Collin County CSCD has no such documents. This exchange would have been between the 380th District Court and the defendant." The response from the judge was, "This office has no records of the Prometa pilot program.".

Collin County and the 380th District Court have applied to the State of Texas for a grant that could be used for additional Prometa testing. They have been awarded the funding, but I can not find any detailed plans for or about these future tests.

I believe it is proper to ask if it is right to use our taxpayer dollars and court resources for testing unapproved medical treatments on prisoners. I believe we need to require that our elected judges seek input from the local community and authorities before entering into testing and marketing programs with drug companies.

And I believe there is a lot more we need to find out about Prometa before any additional prisoners are experimented on.

Bill

Previous Prometa posts:
Politicians and drugs
DMN-Texas' Prometa program for treating meth addicts draws skeptics

Market has doubts too.
Hythiam stock has been in a free fall slide since October when it traded at over $9. It is now worth less than 1/3 that, trading today at less than $3/share.

Prometa sales account for the bulk of Hythiam's revenue.

Bill