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