Prescription For Addiction

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.

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."

Produced By Henry Schuster and Rebecca Peterson