Pubdate: Mon, 21 Jan 2008
Source: Dallas Morning News (TX)
Copyright: 2008 The Dallas Morning News
Contact:  http://www.dallasnews.com/
Details: http://www.mapinc.org/media/117
Author: Emily Ramshaw, The Dallas Morning News
Bookmark: http://www.mapinc.org/meth.htm (Methamphetamine)
Bookmark: http://www.mapinc.org/rehab.htm (Treatment)

COUNTIES NOT SOLD ON METH CURE

Pilot Plan For Breaking Addiction Attracts Texas Funds, Skeptics

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
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MAP posted-by: Jay Bergstrom