Prometa: Unproven meth, cocaine ‘remedy’ hits market

[tre2005be]

By Anne Harding
NEW YORK (Reuters Health) - A new treatment that can be given on an outpatient basis resulted in a statistically significant reduction in methamphetamine use by addicted individuals, according to the first clinical study of the protocol.
Of the 50 patients who entered the study, 36 men and women completed the study. The subjects reported using meth on 80% of the 90 days prior to treatment, but they used the drug on just 28% of the 84 days following the first day of treatment, representing a 65% reduction in drug use.
"I think we've found the first clinically effective treatment for methamphetamine addiction," the study's lead author, Dr. Harold C. Urschel III, told Reuters Health. Urschel, an addiction psychiatrist, works for Research Across America, a Dallas-based company that performs independent clinical research, reported the findings last week at the annual meeting of the College on Problems of Drug Dependence in Scottsdale, Arizona.
Previously, he noted, if he had got a 25% to 30% reduction in drug use among meth addicts with treatment, "I'd be just jumping for joy. Urine tests showed that the study participants were telling the truth about their use or abstinence about 85% of the time.
PROMETA consists of a series of intravenous and oral treatments given in a doctor's office over the course of 30 days. Developed by the for-profit company Hythiam, Inc., it consists of FDA-approved drugs used "off-label," meaning the FDA has not approved their use for this condition.
PROMETA consists of an anti-anxiety drug from the class known as benzodiazepine antagonists, and a drug that modulates one of the brain's main signaling systems, GABA. Also included are nutritional supplements.
Among the 31 people who completed a series of questionnaires measuring their drug craving, 30 reported a reduction in craving, while one reported no change.
Meth addicts often drop out of treatment in the first few days, Urschel noted, largely because the drug has damaged their brain so concentration is extremely difficult. But in the current study, he said, "the patients' memory and concentration almost uniformly across the board came back," as soon as the first day of treatment. "That alone allows the people to focus on sitting in intensive outpatient treat and learn the skills necessary to staying sober."
While the mechanism for the protocol's effectiveness is not clear, Urschel said the main hypothesis is that it somehow restores the function of the GABA system, which has been damaged by drug or alcohol use. In healthy people, he noted, the neurotransmitter helps people to stay calm and relaxed. Treatment may restore its function, reducing anxiety.
The current study did not include any psychosocial interventions, which are usually part of the PROMETA protocol. Urschel said that the results would probably be better if the drug compound was given with these interventions.

Reputation Comments on this post:

Good find, very interesting

[Cure20]

Wow a 65% reduction rate in the first day of treatment is very impressive.

[~lostgurl~]

SWIM found Effexor significantly reduced meth cravings, I wonder if this is somehow similar to how Prometa works?

[Tokyo-expat]

http://www.msnbc.msn.com/id/15310599/

A drug cocktail that backers say is the first effective treatment for methamphetamine and cocaine addiction is dividing substance abuse experts into two hostile camps — those who say they have seen it work miracles and those who say it has been rushed to market without any scientific testing.

The strident debate over the "Prometa protocol," manufactured by the Hythiam Corp., is complicated by the checkered Wall Street career of the company's CEO, Terren Peizer, who previously championed an anti-AIDS drug that has yet to make it to market.

Hythiam, which is based in Los Angeles, launched Prometa in 2003 in private clinics, where meth and cocaine addicts, as well as alcohol abusers, pay $12,000 to $15,000 for a one-month outpatient treatment.

Now the company is aggressively pushing Prometa for the mass market, and asking governments and insurers to foot the bill. Already, four county and municipal programs have launched pilot programs and are offering powerful testimonials for the treatment.

The company has a huge receptive potential customer base in health and law enforcement officials in countless small communities that have been broadsided by the costly and seemingly intractable meth and "crack" cocaine epidemics. And it has big ambitions in this grim landscape.

“We believe strongly that one day Prometa will be a standard of care, and should be available to everyone,” Peizer said.

But critics note that the field of addiction treatment is littered with "miracle cures" that ultimately failed or, in a few cases, caused harm to test subjects. And they warn that Prometa has never been subjected to double-blind, placebo-controlled testing — the gold standard for determining whether therapies are safe and effective.

‘It preys on ... desperate patients’
“The marketing is way ahead of the science,” said Lori Karan, a physician-researcher at the Drug Dependence Research Laboratory at the University of California San Francisco. “It preys on the needs of desperate patients, sets unreasonable hopes and expectations and takes advantage of scarce economic resources.”

"What’s being touted here is what people have always wanted for addiction ... something dramatic that is going to fix their brain," agreed Peter Banys, director of substance abuse programs at the VA Medical Center in San Francisco. "I would never recommend that someone spend $15,000 on this with the current state of data (and) I think it’s improper to spend public money on this product at this time."

Prometa has made its way to consumers quickly because of an exception in FDA regulations that allows physicians to prescribe drugs “off-label” — that is, for purposes other than the one for which they were originally approved. For example, Botox, best known as a wrinkle eraser, originally was approved as a treatment for an eye muscle problem but is used off-label to treat migraine headaches.

However, Hythiam is exploring new territory by grouping three FDA-approved drugs for off-label purposes in Prometa. The company doesn't own or produce the three drugs — flumazanil, gabapentin and hydroxyzine — but claims ownership of the process by which they are delivered into a patient's system along with nutritional supplements. It licenses the protocol to individual doctors and clinics, grants franchise rights and administers the treatment at its Prometa centers.

The company, which is seeking a U.S. patent on its “proprietary dosing algorithm,” is secretive about the specific details of the treatment. But it broadly describes it as a process in which patients receive about one hour of intravenous infusion for three straight days, followed by about a month of oral medications and nutritional supplements. Near the end of the month the patient returns for two more IV infusions. The formulation varies, depending on whether it is being used to treat meth, cocaine or alcohol dependency.

Hythiam's doctors aren't sure how Prometa works, but they hypothesize that it repairs the damage to neurotransmitters in the gamma-aminobutyric acid (GABA) receptor complex — the part of the brain that inhibits or calms — caused by extended drug and alcohol abuse.

The effect, they believe, is to halt cravings for the drug and allow addicts to think clearly enough to concentrate on changing their lifestyles.

“It resets the receptors and they stay reset,” Matthew Torrington, medical director of the flagship Prometa Center in Los Angeles, told a group of Washington state and local legislators at a recent presentation. By quelling the cravings, he said, "It intensifies the prowess of psychosocial treatment."

Try it now, prove it later
Hythiam is now conducting double-blind studies at UCLA and the University of South Carolina in an effort to establish the efficacy of Prometa and rule out the “placebo effect,” where patients who believe they are receiving a treatment for a medical condition show improvement even when they are given an inert substance.

But those results may not be final until 2008, and the company argues that the results of its field trials are so compelling that use of Prometa should not wait.

“Counties don’t care about double-blind placebo-controlled data," said Peizer. “What’s interesting about Prometa is that out in the field — in the counties, justice systems, private centers — the clinical relevance is being shown daily."

Already, according to Hythiam, more than 1,000 people have undergone treatment with Prometa, with providers reporting unheard of abstinence rates of between 60 percent and 80 percent. Thousands more will receive the treatment in the next year in private settings alone, it says.

The company also is making inroads in the government sector.

Fulton County, Ga., which has a cocaine epidemic and an emerging meth problem, announced in October that it was launching a Prometa pilot program for its parole and probation programs in an effort to curb high recidivism rates.

__________________________________________________ _______________

This is unreal, they dont know how it works or even if it is safe. They dont even know what the long term effects on humans will be. But they have rushed this to the market. Well, more victims in this insane illogical war on drugs.

[Paracelsus]

Originally Posted by Tokyo-expat

Hythiam's doctors aren't sure how Prometa works, but they hypothesize that it repairs the damage to neurotransmitters [...]

If the producers aren't sure how it works, it might be dangerous to make it a standard in drug addiction treatment, but it doesn't mean 100% it's a dangerous product. Piracetam and LSD are compounds whose action on the brain isn't fully known yet, but they both have been proven to be quite safe and non-toxic.

Study on Prometa (don't know how impartial it is): http://www.hythiam.com/media/RAA_URSCHEL062106.pdf

It is weird why they don't have any formula for Prometa. I mean what it contains. Not on the Hythiam Official Website and not on the Prometa Website. Dubious.

[BobTheGreat]

Originally Posted by Paracelsus

If the producers aren't sure how it works, it might be dangerous to make it a standard in drug addiction treatment, but it doesn't mean 100% it's a dangerous product. Piracetam and LSD are compounds whose action on the brain isn't fully known yet, but they both have been proven to be quite safe and non-toxic.

Study on Prometa (don't know how impartial it is): http://www.hythiam.com/media/RAA_URSCHEL062106.pdf

It is weird why they don't have any formula for Prometa. I mean what it contains. Not on the Hythiam Official Website and not on the Prometa Website. Dubious.

. One was approved to treat overdoses of sedatives, another to treat seizures, the other to calm anxiety.

On 60 minutes they showed the drugs: Flumazenil, gabapentin, and Hydroxyzine hydrochloride respectively.

Full article: http://www.cbsnews.com/stories/2007/...n3590535.shtml

Cliff notes: guy rushed it to market because he want to make millions and do it fast.

The drug works instantly and while on it. After 14 months the drug was pulled by the county that approved it in court because it only cured 57% of patients. It was pushed by people with stock in it. But got dropped for funding because it wasnt better than treatments already used.

A double blind study was done and waiting publishing. It was done by a pychiatrist that uses prometa as a treatment at his clinic.

Guy was emotional when talking about helping patients. He probably has gotten good at acting... He seemed like a snake in the grass from the report and all other doctors said it needed the gold standard(double blind study) for FDA approval before used. IMO it needs to be done by someone not finacially linked to the drug. No need for possibly motivated test admins.

Also it doesnt mean anything until a year and no drug Im aware of cant keep people off forever. It is a change in life style and burning the bridges to your unwanted past to get over the drugs that haunt the human race and monkeys and mice for that mater(btw I dont oppose it. survival of the fittist.... Not that taking a life should be an easy decision ever.)

(CBS) Word is spreading fast about a new therapy that is said to break the grip of drug addiction in a simple treatment. Addicts who have tried everything and remained hopelessly hooked say their drug cravings ended almost overnight.

The therapy is called "Prometa." As correspondent Scott Pelley reports, it's being promoted by Terren Peizer, a former junk bond salesman whose business is business, not medicine. He skipped the usual medical research and government approvals to rush Prometa to market.

Why the shortcuts? Peizer, who stands to make millions, says there's no way he can sit on Prometa when he believes it's the miracle treatment that millions are dying for.



"And if you had a son. If you had a son or a daughter, and maybe you do. If he's strung out on meth. And he's going to kill himself. Would you, if you had the opportunity. And I said to you, will you treat your son with Prometa?" Peizer asks. "Would you take that option for your son?"

Terren Peizer is selling hope to the desperate. If what he says is true, he's hit on the first medical treatment for methamphetamine addiction -- a therapy that he says works for cocaine and alcohol, too.

An alcoholic getting treatment with Prometa visits a clinic three times, getting one drug, flumazenil, by infusion, and two more, gabapentin and hydroxyzine, in the form of pills; meth and cocaine addicts require two additional treatments later in the month. And patients take gabapentin daily for a month. Prometa's treatment plans also call for nutritional supplements and counseling sessions.

The drugs have been around for years, but none of them was developed to treat addiction.

Dave Smart tried Prometa. He'd been hooked on meth for 20 years. "I tried NA. I tried AA. I tried in-patient treatment centers. I tried outpatient treatment centers. I've been to jail and to prison many times for different crimes due to meth," Smart tells Pelley.

"But, Dave, you've got a wife of more than 20 years. You've got children. You've got grandchildren. None of that was worth quitting for?" Pelley asks.

"All of that is worth quitting for. But it has such a strong hold on me. It did have such a strong hold on me that I couldn't quit. Believe me, I tried. I hated it. I hated my life on dope," Smart says.

Almost two million Americans used meth last year. In Tacoma, Wash., Smart took Pelley to see the damage meth can do.

"We tore this place apart," Smart tells Pelley, outside an unoccupied house.

Addicts swarmed the unoccupied house like locusts, stripped it, and sold the scrap. "All the wiring we took out of there, the wiring out of the house, there was TVs and all kinds of things in the house, all taken out," Smart explains.

"You stole it and you sold it all," Pelley asks.

"That's the bottom line, yes," Smart says.

"You know this is the kind of thing I've seen in Baghdad," Pelley remarks.

"Yeah, that's what we do to get our dope," Smart says.

Eight months ago, Smart was on his way to buy dope when he stopped at a Prometa clinic. He'd heard about it on TV. After about an hour at the clinic, instead of going on to his meth dealer, he went home.

Smart says the cravings were gone overnight. "That's the way it worked for me," he says.

"Dave, you have to understand how that sounds too good to be true," Pelley remarks.

"I do understand how it sounds too good to be true," Smart says.

"You never would have believed it," Pelley asks.

"No, no," Smart says. "I never would have believed it. You're right. But it happened."

"This tool is different. This tool has a unique and powerful biological response that is very robust," says Dr. Matthew Torrington, the medical director of the Prometa Center of Los Angeles.

Dr. Torrington has done addiction research at UCLA. He started prescribing Prometa two years ago. Torrington says for an addict, Prometa is like brakes on a car.

"You're asking them to go down the arduous road of recovery without the ability to stop. And their brain says 'Go,' and it's on! Okay, and they just don't have the
ability to say no," he says. "Because their brain told them that they were hungry for drugs the way you would be hungry for air with a plastic bag over your head. Okay?"

The three drugs used in Prometa were approved by the FDA years ago, but not for addiction treatment. One was approved to treat overdoses of sedatives, another to treat seizures, the other to calm anxiety. In the 1990’s, a Spanish doctor put them together. The theory is they alter brain chemistry to end craving.

One patient explained it to Torrington like this: "He said, 'Look, Torrington, before the treatment my thought went, cocaine, cocaine, cocaine, cocaine, cocaine, cocaine, cocaine, after the treatment my thoughts went cocaine, I wonder what happened to that rental car I lost, I wonder what happened to my cell phone I wonder what happened to my luggage boy I met my mom is mad at me, boy am I hungry, boy am I tired, cocaine.' It wasn’t like he couldn’t remember cocaine anymore, it was that cocaine went from all he could think about to being just another thing on the list," Torrington explains.
The first Prometa patients were treated in 2003. Now, 70 doctors offer Prometa. And about 2,500 addicts have had the therapy. Pelley met some at a support group meeting Dave Smart had organized at his apartment.

Matt Wild lost an eye in a meth lab explosion. But he didn't stop using until Prometa. "I just don't got no cravings. I mean, it's personally, for me, it's a wonder drug. I've been addicted to it for 30 some years," Wild tells Pelley.

Wild's wife Melanie couldn’t stop either.

"You went to prison three times, you got burned in a meth fire," Pelley remarks.

"I lost my children, my children were seven, six, and two. I couldn’t even stay clean, as much as I loved my children," she says.

The state took her children. Melanie says, after she was burned in the fire, she left the hospital burn unit to go straight to her meth dealer. Now, after Prometa, she says she's been clean for five months, and Matt for two.

"You just can't help feeling good about what you're doing," Terren Peizer says.

Terren Peizer had barely sat down for our interview, when he seemed to be overcome at the first mention of patients. "You get away from the clinical and you get down to the personal. And it -- there's nothing like it. So, yeah, it's a lot of people say, well, you know, 'Why do you, why are you doing this?' Like - and say how can I not do it?" he says.

Peizer is better known as a steely eyed financier, a former bond salesman who worked for, then testified against Michael Milken, infamous in the junk bond scandal of the 1980’s. When Peizer heard about the drug therapy, he started a public company called "Hythiam." He raised $150 million from investors. The name Prometa is Greek, meaning "positive change." For patients it's not small change: the therapy can cost $15,000.

Peizer has enormous plans: Prometa centers across the nation, one day accepted by health insurance and the courts.

In Tacoma, he convinced Pierce County to be a model of the future. The county put up $400,000 to offer Prometa to addicts in drug court.

"You could talk to 100 physicians out there using it. You could talk to 2,000 patients using it. If your son had it, would you want him to do it?" Peizer asks.

"You believe most people would," Pelley says.

"Would you?" Peizer asks.

"I'd be happier if I knew it was approved by the FDA, personally," Pelley replies.

"They’re just saying this stuff works without actually subjecting it to the proper kinds of trials," says Dr. John Mendelson, who says the science doesn’t match Prometa’s promotion.

He's a professor of medicine at UC San Francisco and senior scientist at the Addiction Pharmacology Lab at the California Pacific Medical Center. He tests therapies for the National Institute on Drug Abuse.

"You don’t think there is anything special about this combination of drugs?" Pelley asks.

"So far the evidence would suggest no," Mendelson says.

Mendelson says none of the drugs used in Prometa seem to effect addiction.

"Terren Peizer says he wants to make Prometa the standard of care," Pelley tells Mendelson.

"That is his goal, he wants to make it the standard without any evidence," Mendelson replies. "And he’s spending money to recruit the treaters and to recruit the insurance payers but not to prove that the treatment works."

Proving it works would require what scientists call a "placebo controlled, double blind study." That's a human trial in which half the patients take a placebo, or sugar pill -- neither the patients nor doctors know who got the real drugs until the end. Peizer went to market without that kind of study and without asking the FDA to approve his method or marketing.

"So if you don't ask the FDA for approval …you can say anything you want?" Pelley asks.

"That's pretty much the damn truth," Mendelson says.

"I think people would be shocked by that," Pelley remarks.

"It is shocking. It is shocking. I, to be honest with you, I've never seen anyone actually try it. And this is one of those loopholes that may exist because no one has had the chutzpah to go out and actually try it. But up 'til now," Mendelson says.
Here’s the loophole: once a drug is cleared by the FDA for one purpose, a doctor can prescribe it for anything. Peizer claims he doesn’t need FDA approval because -- and this is what he says -- he’s not marketing the drugs, he’s selling information.

"We’re providing information of certain medical treatment that they -- a physician, in their discretion, will use in the practice of medicine to treat their patient. We are not a pharmaceutical company," Peizer explains.

"Come on. You're going to these doctors and you're saying here are three drugs. Here's how you administer them. Here's how much you administer. Here's how many days you administer them. And this is how this works. And you’re telling me in this interview that you are not prescribing a drug protocol," Pelley says.

"We’re not prescribing, factually we’re not, only doctors can prescribe," Peizer says.

"You’re playing with words," Pelley says.

"I’m sorry but I don’t think so," Peizer replies. "We make it very clear is this a physicians decision, you’ve talked to physicians that have used it right? What do they say about it?"

"The physicians that we’ve talked to say they’ve seen results, other medical researchers we’ve talked to say they’ve never seen any treatment program developed in this way and they don’t mean that as a compliment," Pelley says.

"So we’re supposed to watch patients die, how many lives do you want to save before it's relevant?" Peizer asks.

"Someone might say, 'Sure, it'll be great to spend five or ten years studying this medication.' But we don't have that kind of time. People are dying by the hundreds and thousands in America from meth addiction," Pelley tells Dr. Mendelson.

"That’s correct," he replies. "They raised an incredible amount of money. They raised $140 million. If they'd spent 100 million of that on research, they would have had their answer today."

"The criticism is the research is weak. There's a simple way to fix that. You do the studies. You do the trials. You go to the FDA. You have the FDA sign off on all of this. Why don't you do that?" Pelley asks Peizer.

"Well, we do have studies in place. We actually…I mean, we're really excited. We just saw the top line data from a double blind placebo-controlled study, which is the gold standard of science," Peizer says.

After more than four years treating patients, Prometa just completed its first double blind study. It's not published yet, but Peizer says the results are positive. The study was done by psychiatrist Harold Urschel. He’s run a number of drug trials for government and drug companies.

But we noticed that while testing Prometa, Dr. Urschel's own addiction clinic was selling Prometa.

"This is the gentleman who’s supposedly doing the independent research to see if it works. Seems like a conflict?" Pelley asks.

"Well, I assure you there’s no conflict," Peizer says. "I can’t speak to what goes on in his medical building. I have no idea."

Dr. Urschel told 60 Minutes he didn’t have a financial interest in his clinic’s Prometa sales and he sees no conflict. But it's not the first time Prometa has hit questions on the fast track to market. Remember the model program in Tacoma drug court? It turns out some of the top people in the private, non-profit group running the program for the county, who were so enthusiastic, were also buying Peizer’s stock.

"My name is John Neiswender. I'm the Chief Financial Officer for the Pierce County Alliance. And, yes, I'm one of those who bought stock," John Neiswender told Pierce County commissioners at a hearing.

The county's commissioners didn't like the sound of that. They didn’t like the results of the county auditor’s report. Forty addicts from drug court had been treated. After 14 months, 57 percent were clean. But the auditor said that’s no better than the usual therapies. After spending nearly a quarter million dollars on Prometa, the commissioners pulled the funding.

"You know, there are some eminent scientists in this field who know the biology of addiction. And they look at the Prometa drug protocol and they say, 'We can't see how this works,'" Pelley tells Dave Smart.

"I don't care how it works. But I know it does work. That's the bottom line," Smart replies. "The alternative is a hopeless life on dope living in my truck."

Terren Peizer has commissioned four more studies, betting his company and $150 million that the medicine will catch up with his marketing.

"Depending and who you talk to, you're either a revolutionary or a snake oil salesman," Pelley tells Peizer.

"Let the patients decide," Peizer says. "If it shows dramatically better results shouldn't every state be using it to get patients better? To lower healthcare costs? So more people could get treated? Isn't that what it's really about? So snake oil? I think not