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Prescription For Addiction
Prometa is touted as a new treatment for addictions, especially to meth, but some doctors say its claims are unverified, even though addicts and other doctors say it works. Scott Pelley reports.

60 Minutes

(CBS) 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."