Texas' Prometa program for treating meth addicts draws skeptics
11:28 PM CST on Sunday, January 20, 2008

By 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."

Few takers
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

[This message was edited by JB on 01-21-08 at .]

Should public tax dollars pay for a private company's experiment, allowing stockholders to increase the value of their investment through a government subsidy? And, should a public official offer his/her support for a for-profit company?

Here are the results of one past experiment in State sponsored products:

Former Prisons Chief, Viapro Exec Acquitted
September 09, 2005 10:52 PM EDT
HOUSTON - A federal judge acquitted a former Texas prisons chief and a Canadian businessman accused of running a kickback scheme in the mid-1990s, tossing aside their 2001 conviction.

U.S. District Judge Lynn Hughes wrote that the government's case against former Texas Department of Criminal Justice head James "Andy" Collins and Yank Barry, president of Montreal-based Vitapro Foods Inc., was too flimsy.

If the decision to acquit the pair is overturned on appeal, "the defendants will receive a new trial. Justice requires it," Hughes wrote in the opinion released late Thursday.

Nancy Herrera, spokeswoman for the U.S. Attorney's Office in Houston, said prosecutors were considering their options.

Jurors convicted Collins of taking at least $20,000 from VitaPro Foods in exchange for pushing through a five-year, $33.7 million contract to distribute a soy-based granular substance to Texas inmates to cut food costs. Barry was convicted of the same charges - bribery, money laundering and conspiracy - for allegedly paying the bribes.

Both men testified they did nothing wrong and said it was a legitimate business deal to save Texas prisons money.

They have been free on bond since the trial, and their sentencing was indefinitely delayed because an error-riddled trial transcript left no accurate record. Hughes' ruling was in response to a three-year-old request for acquittal or a new trial.

"This is well worth waiting for, as you can imagine," William White, who represented Collins at trial, said Friday of the acquittal.

Patrick Graham, who Hughes described as "a convicted con artist and a freelance government agent," had testified at trial that Collins and Barry told him about the alleged scheme and solicited his advice. He had earned commissions selling VitaPro to Louisiana prisons. No other witnesses or documents corroborated the claim.

Collins was forced out as executive director in 1995 when Texas prison officials learned that, while still on the state's payroll, he had agreed to run a private prison venture in Louisiana upon his retirement.

The VitaPro scandal broke the next year. Inmates didn't like the soy-based meat substitute. In 1999, the Texas Supreme Court ruled the VitaPro contracts were invalid.

[This message was edited by JB on 01-21-08 at .]

If they have $150 million to promote these meds surely they could step up and pay the $1 million/year cost of this experiment.

Well, it's less than that, because I'm assuming the one million includes their profit, not the actual cost. Again, why should the State pay, through taxpayer funds, a profit to a company that has yet to prove it has a workable product?

There was talk about a DWI-specific prison last session; maybe they ought to look into this, too ...


Program at East St. Louis prison 'writing the book on meth treatment'

By Bethany Krajelis, The Southern (link)

Wednesday, January 16, 2008 11:28 PM CST

EAST ST. LOUIS - From the outside, Southwestern Illinois Correctional Center looks like what you'd expect of a prison. But what lies behind the locked gate and barbed fence is something that no other prison in the nation offers.

The minimum security prison in East St. Louis is one of about a dozen in the United States that provide substance abuse treatment and the only facility with a program specifically designed for methamphetamine.

In October 2006, the former high school-turned prison opened its meth treatment house. Out of the prison's nearly 700 inmates, Warden James Davidson said about 200 inmates, several from Southern Illinois, are participating in the program that is "writing the book on meth treatment."

"It's cutting edge," Davidson said from his office earlier this month. "We are taking a proactive approach instead of not reacting. We are trying to get ahead of the trend and stop recidivism."

This "innovative" approach that Davidson proudly speaks of is evident from the name inmates gave the prison. Outside the doors leading to the seafoam green colored hallways of the facility hangs a sign, explaining what the inmates of "Turning Point" are struggling to do.

"The men in Southwestern Illinois Correctional Center/Turning Point have a difficult job to do," the sign reads. "They are here to confront their drug and alcohol addiction and criminal behavior ? please respect and support the challenges they face."

A no-brainer

Over the past decade, Southern Illinois has been hit with what some officials refer to as a methamphetamine epidemic, a problem Davidson said sparked prison officials to try a new approach.

"We can't just send them back with the same problem," Davidson said, adding that the state recently started a re-entry program to help inmates find jobs and adjust once released. "It's a challenge, but we don't give up on them."

But the biggest challenge is making the public understand that the treatment actually works, Davidson said. Not only is it not wasting tax dollars, as some may assume, but Davidson said the program could save money by stopping repeat meth offenders by treating their addiction first.

It costs the state prison about $28,315 to house each inmate annually, according to the Illinois Department of Corrections. The treatment provider, CiviGenics, is contracted by the state.

"It's a seven to one ratio. For every $1 spent on treatment, the state will save $7," Davidson said. "It's a no-brainer."

A new lifestyle

The meth treatment program is a learning process for inmates and administrators alike, said CiviGenic's Ron Vitale, who serves as director of the prison's meth treatment program.

While empirical data show the treatment has the potential to work, Vitale said it is too early in the program's existence to record recidivism results.

"We're all in this thing together," he said. "It's new to us and them. It's a new lifestyle to some of these guys."

This new lifestyle starts when inmates apply to the program. They have to meet certain requirements and may have to wait, Davidson said. There are between 60 and 80 Illinois inmates on a waiting list, he added.

Five Southern Illinois inmates said some of their peers are only there to benefit from the promise of getting good time. The warden said about one in three inmates get good time for participating, which often results in a shorter sentence.



Right living treatment

If an inmate is approved, Vitale said, he will be assessed and given an individualized treatment program, which includes several hours of group and private counseling as well as activities, school and responsibilities.

"It's all about right living," Vitale said as he stood in the meth treatment wing. "It's not rocket science stuff. These are things that we do every day and don't even think of."

Davidson said methamphetamine changes the way people think.

"They think differently than you and I, and we are just trying to make them understand the right way," Davidson said. "There are 670 guys in here with 670 different problems."

The four-phase program includes assessment, orientation, treatment and re-entry and usually takes about one year to complete, Vitale said. Inmates in the meth program differ from other substance abusers because meth users tend to lose their cognitive ability, he said.

Vitale said the treatment, which emphasizes repetition and visual examples, can help inmates regain cognitive ability, which rarely is restored back to 100 percent.

An inside perspective

Sitting at a table in the facility's visiting room, five Southern Illinois inmates shared the stories that got them in prison and the hopes they have for once they get out.

The inmates - Lindell Lingle, 47, of Anna; Thomas Haynes, 33, of Ullin; David Dillard, 30, of West Frankfort; Rico Riggio, 33, of Murphysboro; and Shawn Flatt, 30, of Carterville - said they are all in the program to rid themselves of the drug that destroyed their lives.

Flatt said he is thankful for the treatment program.

"I am actually honored to be part of the program. I am happy to live in Illinois and have this," he said. "It shows there is hope out there for guys like me."

The five men are each serving time for meth-related crimes and agreed the treatment program works for those willing and ready to make the change.

"I was under the impression the treatment would be like a pill, that I would take medicine and it would be over," Riggio said with a chuckle. "I've learned it's not like that."

For Dillard and many other inmates, the program made him realize how drug use affected his family.

"I have a greater appreciation for the blessings I do have and I won't take it for granted anymore," he said.

The treatment program appears to have given some of the inmates a new perspective on life.

"I've been doing (drugs) since I was 13 and I finally am getting to know myself," Riggio said. "After 20 years of getting messed up, I can finally smile from the inside out."

Update on the Prometa issue: After the Lege put $2m toward funding its use in Texas, the one judge that was using it has been relieved of duty by his constituency:


Prometa Judge defeated at polls
03/06/08

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.

For the rest of the article, click here:
Collin County blog

A program like this should raise real medical/ethical/legal questions. If people are being offered "treatment" with Promenta as an alternative to punitive sanctions (like jail), then they are not truly "volunteering" to be guinea pigs. This is just a twist on prisoner experimentation - strong arming people without real choice into being cheap (indeed, profit generating) test subjects.

They probably wanted to test the stuff on hapless Africans, but couldn't find enough Meth addicts over there. So they recruit a few judges to help them find subjects....