|KICKING IT: Dr. Harold C. Urschel III has conducted trials of the drug. “I was very skeptical,” he says. “So it made me the perfect person to study the treatment.”
photography by Elizabeth Lavin
Simon woke up one day nearly two years ago and knew he was about to die. He was rail thin, having lost 40 pounds. His skin had turned yellow. He was a world-class substance user—he could recite a mind-boggling list of drugs he had shot, snorted, or smoked. “I called myself a human garbage can,” says Simon, 30. The only question he had was whether his wife would leave him before he killed himself with his addictions.
Now clean for 20 months, Simon (not his real name) gazes into the distance, his youthful face a frame for dark green eyes suddenly gone sad. He describes how his drug abuse began when he got drunk for the first time at age 16 by stealing sips from the grown-ups’ drinks at one of his parents’ parties.
He went through the standard array of drugs during the next decade and a half or so. But nothing took over his life the way crack cocaine did. For almost two years, Simon smoked the drug every day, sometimes all day. His parents sent him to rehab several times, but he always relapsed. They gave him money to live, which he spent on his habit. When he needed more cash, he dealt crack.
“I didn’t care about myself,” he says. “I didn’t care about anybody else. I didn’t care about anything but the drug.”
That all changed in November 2006, when Simon began undergoing a controversial new treatment in Dallas. At the Urschel Recovery Science Institute in Preston Center, off Northwest Highway, Simon began a drug protocol called Prometa. Within days, Simon’s cravings diminished. His mind cleared. His thoughts were more coherent. Simon believes that Prometa, combined with traditional therapy, has helped him stay clean.
“Prometa gave me back my life,” says Simon, a Polo shirt and shorts hanging loosely on his still painfully thin frame, which he has folded into a leather chair in one of the clinic’s counseling rooms. “I’d be dead without it.”
Stories like Simon’s have roiled the world of addiction treatment, fueling the hopes of addicts desperate for anything that might propel them toward recovery. Marketed for alcohol, cocaine, and methamphetamine addiction, Prometa elicits passionate testimonials from patients who describe its effect with words like “miraculous” and “godsend.” Some, like Simon, say their cravings dissipated gradually in the days and weeks after treatment. Others say they felt the effect immediately. Doctors licensed to administer Prometa say they have seen firsthand the impact on their patients.
“We’re not calling it a cure, but Prometa has a robust effect on patients,” says Chris Hassan, chief strategy officer of Los Angeles-based Hythiam Inc. Hassan says doctors who prescribe Prometa report about a 70 percent success rate getting addicts off drugs and keeping them clean for at least a year.
But the Prometa treatment and research, much of it administered and studied for the first time at Dallas’ Urschel institute and its affiliate Research Across America, have sparked an intellectual civil war among clinicians, researchers, and other experts, dividing the self-described “addiction community” into something more closely resembling enemy camps. Critics call Prometa an unproven, largely untested treatment that preys on the hopes of desperate people. Hythiam managed to sidestep the lengthy FDA approval process because Prometa is not a new medicine but a cocktail of three drugs already approved but used “off-label,” or for a purpose other than the ones for which they were originally intended. The treatment, which includes a regimen of nutritional supplements and other therapy, also comes with a $15,000 price tag.
During the last two years, Dr. Harold C. Urschel III, founder and CEO of the Urschel Recovery Science Institute, has stepped into this contentious swirl as one of the most visible defenders of Prometa, extolling the drug at medical conferences and in press articles and recommending the treatment for patients. In doing so, he has made Dallas ground zero in the war over how Prometa will be made available to addicts.
Urschel compares the Prometa controversy to the one surrounding the FDA’s resistance to approving new AIDS medications at a time when AIDS sufferers had few treatments available.
“A dying person has the right to seek any treatment that may save them,” he says. “It makes no sense to say, ‘You can’t be treated because we haven’t finished the research.’ ”
It hasn’t helped Prometa’s credibility that Hythiam’s founder and CEO, Terren Peizer, sold junk bonds for Michael Milken and also was involved in a company that made extravagant claims for an anti-AIDS drug called Immunitin in the late 1990s. Immunitin remains in the research phase.
Hythiam has aggressively marketed Prometa, generating national media coverage in 2006 with billboards in Los Angeles that pictured the actor and comedian Chris Farley, who died of a drug overdose in 1997. Emblazoned on the sign were the words “It wasn’t all his fault.” A 60 Minutes segment last December took a skeptical view of Peizer and Hythiam.
“The fact that Prometa hasn’t been approved by the FDA, the fact that Hythiam skipped the clinical trial phase, it rubs people the wrong way,” says Dr. Carlos Tirado, assistant professor of psychiatry at UT Southwestern Medical Center and medical director of Nexus Recovery Center in Dallas.
“Putting together a cocktail of unproven drugs and expecting them to improve outcomes for three disparate addictions requires a far stretch of the imagination,” says Dr. Lori Karan, a researcher at the Drug Dependence Research Laboratory at the University of California San Francisco.
Urschel dismisses the idea that Hythiam might be a miracle cure, arguing that addiction is a chronic disease that has to be managed for an entire lifetime, more like diabetes than the measles. But he says he has seen the role Prometa can play in helping patients manage cravings as part of more comprehensive treatment.
Urschel, whose company Research Across America has conducted some two dozen trials of new anti-addiction medications over the past eight years, says he had never heard of Prometa before Hythiam approached him about doing the first of what ultimately would be two Prometa studies. Both focused on the treatment’s claims to reduce cravings in meth addicts.
“Originally I didn’t think it had a snowball’s chance in hell of working,” he says. “I was very skeptical. So it made me the perfect person to study the treatment. Ultimately I was convinced.”
Proponents believe Prometa acts on one of the brain’s neurotransmitters called the GABA system, which is thought to have a relaxing, anti-anxiety effect. According to the theory, alcohol and stimulant abuse can damage the receptors in the GABA system, which contributes to a rise in cravings and anxiety. Prometa repairs the GABA receptors, restoring the brain’s natural balance and reducing cravings. But the hypothesis can’t be proven, and the brain’s complexity makes all such theorizing highly speculative.
Patients treated with Prometa get about an hour of intravenous infusion for three straight days, followed by a month of oral medication and nutritional supplements. At the end of the month, the patient returns for two more infusions, though the protocol varies depending on which addiction the treatment is for. The drug in the IV is flumazenil, originally approved to treat drug overdoses. The other medications are gabapentin, an anti-seizure medication, and hydroxyzine, an antihistamine.
Research Across America doctors say results of the first 50-patient Prometa trial, published in 2007, were nothing short of astonishing. Subjects in the “open-label” (or non-control-group) study reported a 66 percent drop in cravings. Just as amazing, say the doctors, was the high percentage of patients who continued to take part for the full 12-week trial.
“One of the hardest things about working with methamphetamine addicts is keeping them in treatment, because they almost immediately feel such uncomfortable withdrawal symptoms,” says Dr. Larry Hanselka, a Research Across America psychologist who worked on the study. “The fact that so many patients continued with the trial showed us that something beneficial was taking place—at least something worth studying further.”
This past June, Urschel presented the results of the first-ever double-blind, placebo-control trial of Prometa during a conference of the College on Problems of Drug Dependence in San Juan, Puerto Rico. The study involved 135 meth addicts. Patients who got Prometa reported their cravings diminished by 54 percent, compared to a 35 percent drop for the placebo group. (The figures are based on complicated statistical formulas and describe an aggregate response.)
“The subjects of the study were chronic methamphetamine users for anywhere from two to seven years,” Urschel says. “Based on the results, there should be no more controversy.”
Not everyone sees it that way.
“It’s an indication of something, but it’s not a gold medal,” says Dr. Frank Vocci, director of the Division of Pharmacotherapies and Medical Consequences for the National Institute on Drug Abuse. “It wouldn’t even make it to the Olympic trials. And it wouldn’t clear a drug hurdle with the FDA.”
“Given all the claims that Prometa has made about its effectiveness, I’d have expected the Prometa group to have gotten at least twice the results of the placebo group,” says Dr. Richard De La Garza, an associate professor at the Baylor College of Medicine in Houston. De La Garza, who attended the San Juan conference, also noted that Hythiam funds the Research Across America trials. “I’m waiting for an entirely independent lab to do the same kind of study.”
Hythiam is continuing to fund research on Prometa, and results are expected from a number of new trials now underway, including an analysis of Prometa’s effects on alcoholics by Dr. Raymond Anton at the Medical University of South Carolina and another methamphetamine study by Dr. Walter Ling of UCLA, among others. Hythiam’s chief strategy officer, Chris Hassan, says his company follows strict ethical guidelines in funding research, and results will be released whether or not they’re beneficial to Hythiam.
Last year the Texas Legislature appropriated $2 million for a pilot program to treat drug felons with Prometa as a condition of release, though the funds have yet to be tapped. In May, Cigna Behavioral Health Insurance, an affiliate of Cigna Health Insurance, said it would begin covering Prometa treatments in Dallas.
While the medical dispute goes on, doctors continue to prescribe Prometa, and many addiction sufferers continue to swear by it. At the Urschel Institute, one of three Hythiam-licensed clinics in Dallas, patients get flumazenil in a small room with a reclining leather chair positioned in front of a TV and video player. An IV bottle hangs next to the chair and a blood pressure monitor is pushed against the far wall. Uniformed nurses and doctors dressed in colorful short-sleeved shirts monitor the treatment.
Erica, a self-described “very successful businesswoman over 50,” returned to the clinic this summer for a second round of treatments, days after suffering a relapse in which she started drinking again for the first time in 14 months. Erica (not her real name) struggled with alcohol abuse for two years, beginning when she stopped working and began to spend more time at home.
After she got her first round of Prometa in April 2007, she remembers feeling “extremely calm.”
“I did have cravings,” she says, “but they were minimized by 2,000 percent.”
Erica’s relapse occurred after “a very stressful period,” but three weeks after beginning her second round of treatment, she says she feels better than ever.
“I have a better psychological handle on what went wrong,” she says. “There is really no quick fix for addiction, but Prometa definitely helps.”
For his part, Simon says the combination of Prometa and other therapy has allowed him to begin thinking about building a future for the first time in his life. He wants to become a chef.
At the end of our interview, Simon asks if I will include one more quote in the article. “Please tell my dad I’m sorry for everything I put him through,” he says. “But I’m myself again. I’m back now.”
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