Prometa is the controversial, unproven drug treatment regimen involving a "cocktail" of drugs delivered intravenously and sold by Hythiam, an upstart company founded by Terren Peizer, a stock and bonds whiz kid.
Hythiam argued that it didn't need FDA approval, instead the company aggressively marketed Prometa to government agencies.
Former Collin County district Judge Charles Sandoval liked Prometa. He experimented with it, using convicted meth addicts as guinea pigs, even though the drug program had not been approved by the FDA.
After a series of scandals and setbacks, there are to the best of my knowledge no government agencies that are testing or using Prometa any more.
For several years now, Hythiam has promised to release peer reviewed, double blind testing results that will prove that Prometa is effective. Instead all it has published are more promises and hypes for its stock. The few test results it has released have not been peer reviewed. (Hythiam has the disconcerting habit of using its financial marketing group to write scientific sounding press releases that end with financial disclaimers.)
So what is Hythiam doing now?
Well mostly, it appears to be trying to stay afloat. Its sales are down and operating losses are up. The company has changed its marketing emphasis from selling to governments to HMO's. The number of clinics licensed to sell the Prometa program are down from 70 in 2007 to 49 in 2008.
Back in 2007, Hythiam stock was trading for about $9.00 per share. When the Collin County Observer published its first article in January of 2008 questioning the use of Prometa on probationers, the stock was trading at about $3.00.
...and Peizer is still trying to sell the stuff (Both the stock and the drugs).
2008's Top Ten reasons why there is a Collin County Observer. Most of these stories were first covered here, a few were only covered here.
10. Commissioners forcing the resignation of the Teen Court Coordinator because he was gay.
9. Commissioners refuse to enact an Equal Employment Opportunity Policy, shortly before they force the gay guy out.
8. Lovejoy ISD fighting Open Records requests, banning a parent and firing a teacher.
7. District Judge Charles Sandoval pushing experimental drugs on probationers.
6. Commissioners sitting quietly while Commissioner Hoagland rants against A-rabs and Indians.
5. Judge Mark Rusch issuing search warrants against the defense attorney in a capital case, and then refusing to recuse himself.
4. Commissioners awarding, without competitive bid, over a million dollars in federal grant money to the son of Sam Johnson for Fusion Center software.
3. DA Roach fighting against new trial of defendant sentenced to death in a trial conducted by a judge and DA who are playing coochie-coochie in secret.
2. Commissioners spending $300,000 to sue the Auditor, loosing the suit twice, and still appealing.
1. County pushing for SH 121 tolling only to have the Attorney General refuse to allow the county to get any of the $2 billion in toll funds it was promised.
No one in Collin County remembers the last time that a sitting District Court Judge was opposed in a primary election. It's just not done here - at least not until this year.
Judge Charles Sandoval, a 12 year incumbent District Court Judge, lost his bid for re-election Tuesday, when he was defeated in the Republican primary.
The Prometa protocol is a controversial treatment program for methamphetamine, cocaine and alcohol addiction. It uses a combination of 3 powerful prescription drugs with nutritional and counseling therapies. The program uses FDA approved drugs "off-label" (for treatments not approved by the FDA). Critics (including this writer) maintain that the program is untested, unproven and little more than a scheme to sell Hythiam stock.
Judge Sandoval's judicial career is the latest of a series of Prometa casualties nationwide.
Last week, the Washington state legislature killed the already approved $500,000 state funding for Prometa.
In October, 2007, Pierce County, Washington suspended a $400,000 Prometa test program after a county audit determined that their was little evidence the program was effective. The death knell for Pierce County's program came after a chain of ethical wrongdoings by Hythiam and county officials were uncovered.
In February, 2007, Fulton County, Georgia discontinued its Prometa program. The court spokesman wrote 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.”
“[Hythiam] proposed that we pay them about $80,000 for the pleasure of having them experiment with some of our felons in our drug court program,” said Judge Ron Wilper, a member of Idaho's drug court coordinating committee.
“We’re hicks, I grant you that,” he added. “But we didn’t just fall off the turnip truck. I said, ‘Give us a buzz when you prove it.’”
Judge Sandoval contacted Hythiam last year and with little public input or oversight, began a pilot program on 20 probationers in his court. On his website, Sandoval claimed to save the county $400,000 in the pilot tests.
Attempts by The Collin County Observer to see documentation of the financial claims were answered by Sandoval with, "This office has no records of the Prometa pilot program."
While Sandoval and Hythiam touted great successes with Collin County's program, others, including the county's own probation manager disputed the data.
In spite of it's spotty record, the last Texas Legislature appropriated $2 million for "Medically Targeted Substance Abuse Treatment" program grants. The grants were written to allow more pilot program testing of Prometa. Collin County received a grant of $158,000 under this program. So far our inquiries have not found any experiments or expenditures of the grant money.
These pilot programs, whether funded by Hythiam or taxpayers are used by Hythiam as marketing tools. Look at the last pilot done in Collin County. All records are kept by the company. Collin County and Sandoval's court have little or no recruitment or results data. All was turned over to Hythiam, which then issued glowing press releases (and no data).
The lack of records is glaring, and troublesome - especially since one of Collin County's test subjects died before the end of the study. (The cause of death was noted as "suicide".)
All attempts by the Collin County Observer to gain insight into how the test subjects were recruited, what promises were made, and what rewards or consequences were offered were rebuffed by the county and court. Collin County and its court had no such records, even though many of the test subjects had just been released from jail - presumably to take part in the program.
Most governments recognize that prisoners have limited capacities to give permission or refuse experimental programs run by their jailers. Most researchers would also discount the word of probationers who could be re-jailed for giving answers that indicated the program wasn't working and they were using drugs.
Sandoval may be Prometa's latest casualty, but given the unscientific standards used in these "pilot programs", I doubt he'll be the last.
Collin County needs to get out of the medical experiment business before more people get hurt.
Previous Prometa posts:
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 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.
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.
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.
Texas' Prometa program for treating meth addicts draws skeptics
Sunday, January 20, 2008
EMILY RAMSHAW / The Dallas Morning News
AUSTIN – It was added to the Texas budget with little notice and no objection: $2 million for an obscure medical treatment touted as a cure for the worst methamphetamine addictions.
But months later, the pilot program for the drug therapy, called Prometa, has yet to get off the ground, halted by skepticism and safety concerns.
Several smaller probation departments have applied to the state to offer the Prometa treatment as a condition of release, but some experts continue to question Texas' judgment.
The medical protocol is a costly combination of drugs and nutritional supplements each approved by the Food and Drug Administration individually, but never evaluated as a combination to treat substance abuse. Many drug treatment experts fear that the regimen was rushed to market without a medical study to its name – and that Texas lawmakers fell for the marketing pitch.
"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."
Rep. Jerry Madden, the House Corrections Committee chairman who requested funding for the program this spring, said only time – and results – will show whether Prometa does what its supporters say it does. An ardent advocate for rehabilitation, Mr. Madden, R-Plano, said he won't take criticism for trying a treatment many addicts swear by.
In the meantime, Mr. Madden has been fielding calls from Wall Street investors and his name has been used as a seal of approval on Prometa marketing materials. Mr. Madden says he has no financial ties to the company.
The statewide pilot "is really just to see if it works or not," Mr. Madden said.
Early tests are promising but limited.
In a 20-person Prometa pilot program in Collin County last year, funded by the treatment company, 16 felony meth offenders were clean after 90 days, Collin County District Judge Charles Sandoval said – a "spectacular" success rate far higher than the state's current drug therapy.
And a growing number of doctors vouch for Prometa's effectiveness. Dallas psychiatrist and addiction specialist Harold Urschel III said he'd been treating meth users for more than a decade with little success when he tried it.
"Use went down. Cravings dropped dramatically," he said.
Dearth of studies
When Terren Peizer sent the Prometa protocol to market in 2003, the former junk bond salesman and keen-eyed financier didn't have stacks of clinical studies. He didn't have government approval to market the drug protocol for addiction. What he had was $150 million in capital – and complete confidence that the three drugs a Spanish psychologist combined in the 1990s to treat substance abuse worked.
Once the FDA approves a drug, a doctor can prescribe it for anything, but it can only be marketed for its original purpose. Officials from Mr. Peizer's company, Hythiam Inc., say they're not marketing any of the medications – they're merely selling information to physicians.
This "information" has found a devoted following, not just among longtime meth addicts, but those who swear it eliminates cocaine and alcohol cravings, too. Today, 2,500 people have been treated with Prometa and 70 doctors offer it. Several U.S. cities including Las Vegas are offering the therapy – a combination of intravenous and oral medications that can cost up to $15,000 – through their probation departments or drug courts.
But four years since its arrival in the U.S., the Prometa protocol is still waiting on the results of several major clinical studies. And the drug courts that have tried Prometa have reported mixed – or complicated – results.
The standard for testing drugs are double-blind, placebo-controlled studies – meaning those in which two groups are tested, one gets a false drug, and researchers and subjects are unsure which is which until the experiment is over. One such test on Prometa has been completed, but it found a significant reduction in meth cravings and an 80 percent drop in use. Several studies are under way.
But critics argue Dr. Urschel, the Dallas addictions specialist and author of the first study, has profited from selling Prometa. (Dr. Urschel says he sold Prometa treatments before and after conducting the research, but never during it.) And they note that his study and the others in the works have all been funded by Hythiam, though company executives say they put no restrictions on the research.
Meanwhile, Tacoma, Wash., which agreed to spend nearly a half-million dollars to offer Prometa to addicts in drug court, pulled the program after a year. Auditors determined that it was no more effective than routine drug therapy and that the people running the county program had purchased Hythiam stock and signed a contract to promote it.
Mr. Madden said he owns no stock in Hythiam and has no financial incentive to promote Prometa. He has received two recent campaign contributions from Hythiam lobbyists, each for $500. He first learned of the treatment two years ago, he said, when Collin County's Judge Sandoval returned from a probation conference in Chicago.
Hythiam offered to fund a 20-person pilot program in Judge Sandoval's court, so that Mr. Madden would have local statistics. The program used Dr. Urschel's addiction clinic.
The results were better than either elected official expected.
"For some of these addicts, it was the first time they'd been right in 20 years," Judge Sandoval said. "I'm a judge. I'm skeptical on a lot of things. But I watched this work."
A budget provision authored by Mr. Madden flew through the Legislature this spring. It was intended, at $1 million a year, to curb meth addictions in the state's largest counties, and particularly in North and East Texas. But when state probation officials offered up the money, hardly a single large county bit.
"To invest time and money on Prometa at this time, in my opinion, is premature," Dallas' Judge Creuzot wrote in a July e-mail to the director of the Texas Department of Criminal Justice, suggesting that the buzz around Prometa was "lore and perceptions."
He also warned of possible lawsuits if "someone is hurt or injured because of Prometa."
State officials offered the funding to all 122 of Texas' local adult probation departments, but just a handful of requests trickled in. They awarded more than $500,000 – about half of what they intended to spend this year – to four of the five Texas counties that asked for funding, including Collin.
Dr. Urschel expects the results will be too good to ignore. Many experts are unconvinced.
Kathryn Cunningham, director of the University of Texas Medical Branch's Center for Addiction Research, said it's true that some medical treatments can alter brain chemistry to curb drug cravings. The problem, she said, is that there's little proof Prometa is one of them.
"There's been a lot of marketing hype before the evidence exists. This is not something I'd personally want to spend my taxpayer money on," said Dr. Cunningham.
"I know a lot of scientists in this area, and we're all singing the same tune," she said. "This is misguided."
PROMETA AT A GLANCE
What it is: The Prometa protocol is a combination of drugs and nutritional supplements designed to alter brain chemistry and halt addictions and cravings. It can cost up to $15,000, and its effectiveness has been up for debate.
How it works: Patients receive one drug – flumazenil – intravenously, and two others – hydroxyzine and gabapentin – orally. None of the drugs, which are commonly used for seizures and anxiety, were designed to treat addiction.
Texas pilot program: Four Texas counties will receive funding to offer Prometa as a condition of probation for drug offenders. They are:
Collin County: $185,000
Lubbock County: $104,282
Caldwell County: $154,000
Nueces County: $100,106
Three years ago, a character named Allan Lord appeared in North Texas pushing a cream he said would prevent the spread of anthrax. With endorsements from Congressman Ralph Hall and McKinney police chief Doug Kowalski, Lord's Dallas company, Bio-Germ was selling their cream to police and fire departments nationwide. At least they were until the FDA shut them down. It seems that Bio-Germ started marketing and selling their snake oil before doing any serious clinical research. Bio-Germ was eventually shown to be bogus, it's research doctor discredited, and the product pulled from the market.
You'd think that only 3 years later, local government politicians would have learned their lesson and stayed out of the drug business. NOT!
In 2005 another character appeared. His name is Terren Peizer and he is the founder of Hythiam Corporation. Peizer is a former junk-bond salesman who worked for Michael Milken. Several years ago, Mr. Peizer hyped an anti-AIDS drug, Immunitin, but the drug never made it to market. It seems that the marketing got ahead of the research.
Undaunted, Terren Peizer is back, this time selling a treatment for methamphetamine, cocaine, and alcohol addiction called Prometa. Once again, according to his critics, his marketing hype is well ahead of proven clinical research.
Prometa is a "protocol" or treatment regimen consisting of three prescription drugs, (none of which have been approved for addiction treatment by the FDA) along with nutritional and counseling components. Treatment is expensive, usually about $15,000 per patient.
Hythiam Corp. is aggressively marketing Prometa to local counties and state governments. Discounting the need for generally required clinical trials, Peizer has said, "Counties don't care about double-blind placebo-controlled data".
It is hard to tell how successful the marketing has been, because the company often makes claims that are exaggerated or untrue. (For example, Hythiam issued a press release saying the Collin County Probation Department and courts have adopted the Prometa regimen - a claim Collin County denies.)
It is even harder to try to evaluate the research. Almost all Prometa's studies were "open label", that is not randomized, not placebo controlled and not blind. The medical community generally uses "open label" studies for preliminary research. Final FDA approval requires rigorous, "double-blind" research testing procedures. Two ongoing double-blind studies have faced criticism because their researchers also sell Prometa in their own clinics.
"Counties don't care about double-blind placebo-controlled data".
Hythiam founder, Terren Peizer
"I don't think Prometa is a drug treatment for addiction; I think it's a marketing scheme"
Dr. Alex Stalcup, a California expert on methamphetamine addiction
"There is an attempt to create hype before there is actual evidence, make a buck and move on"
Chicago addiction specialist Dr. David Ostrow
"They are preying on vulnerable people. People in the throes of crystal-meth addiction — and their families — are extremely vulnerable, and they are taking advantage of it."
Jim Pickett, chairman of the Chicago Crystal Meth Task Force
In some places, the adoption of the Prometa program has faced local opposition. Pierce County, Washington, attempted to adopt Prometa in its courts, but was stopped when the County Auditor issued a report detailing the ambiguity of clinical data. Ethics became a major issue in the Prometa decision when it was revealed that local and Pierce County officials had purchased Hythiam stock.
A few local governments have approved the use of the regimen, including Gary, Indiana. However, most have decided to wait for further clinical trials.
Preferring not to wait, Collin County's judge Charles Sandoval ran a Prometa pilot program in 2006. The pilot consisted of 20 probationers in a 30 day trial. Sandoval called the pilot program a success.
Sandoval then introduced Rep. Jerry Madden to Hythiam and Madden's House Committee on Corrections promptly budgeted $2 million for further testing.
Now, Judge Sandoval wants to bring Prometa to Collin County. He was quoted in the Plano Star Courier last week as saying, “It only takes about a month to go through the program and it runs about $15,000. The result of my pilot program is that the state of Texas, in the last legislative session, allocated $2 million to this sort of treatment. That $2 million is going to be dispersed throughout the state and Collin County is going to get its fair share of that money,”
"This pilot evaluation of the PROMETA Treatment Program has exceeded both our expectations and the results we have seen from other substance dependence treatments," said Justice Charles Sandoval of Collin County's 380th Judicial District Court. "This is a difficult, non-compliant felony population that historically consumes a lot of our resources. Our hope is that deploying the PROMETA Treatment Program on a wider scale will allow us to better manage this group and reduce the associated criminal recidivism and economic burden."
Hythiam Corp. Press Release
Collin County needs to tread very cautiously here. What the Judge and Hythiam are proposing is using an unproven, inadequately tested, and unapproved drug program on a group of people who can not freely give their permission. Probationers are not lab rats and should never be used as such for unproven drugs.
The ethical issues here are serious. Hythiam has no track record that would cause prudent observers to trust its claims. Hythiam needs to submit Prometa to the FDA for approval. Serious, independent research must be done to prove the safety and effectiveness of the drugs. Ethically reviewed protocols must be written and observed before further testing on drug offenders.
Politicians need to quit listening to slick lobbyists and salesmen and get out of the drug buying business.
Judges, Congressmen, Police Chiefs and Legislators need to do what they were elected to do - and quit hyping drugs. They are not doctors, they are not pushers.
Our taxpayers don't need Judges and Legislative Committees prescribing drugs. They don't know how.
Further reading -