Saturday, January 12, 2008

Vote of No Confidence For Prometa


Addiction drug loses major funding.

It is composed of three common and inexpensive drugs used for other purposes. It has never been subjected to clinical double blind testing. It costs thousands of dollars for the full treatment package, and the company that markets it says it cures about 80 percent of the drug addicts who use it.

If that description sounds familiar—if it seems to give off a faint whiff of blue-green algae and multi-level marketing—such concerns have not stunted the promotion and acceptance of the anti-addiction drug Prometa. But MSNBC reported last week that Prometa, the drug “cocktail” designed to combat addiction to cocaine and methamphetamine, was dealt a severe blow when accountants in Pierce County, Washington froze the funding for an $800,000 pilot program, citing irregularities in testing.

The treatment involves intravenous infusions of Flumazinil, a reversal agent for benzodiazepines like Valium and Klonopin. The second drug, hydroxyzine, is an antihistamine, and the third, sold as Neurontin, as an anti-seizure medication frequently used “off prescription” as a treatment for a number of ailments, including alcoholism and hearing loss.

The treatment does not require approval by the Food and Drug Administration (FDA) because all three ingredients are already in common use in clinics and hospitals. The Prometa Regimen marketed by Hythium involves formulating the protocol and contracting with doctors to deliver the medications.

To date, there is no published clinical data to support treatment for addiction with these three drugs in proprietary combination.

Marketed heavily by anecdote and personal testimonials, the Prometa marketing campaign included ads in 2006 featuring the late comedian Chris Farley, who died of a drug overdose.

Hythiam, the company that markets Prometa, has touted the treatment with claims of success rates as high as 98 per cent, but Pierce County Councilman Shawn Bunney found the results of the county audit “alarming,” according to MSNBC. “It’s clear to me that we are much more involved in a marketing scheme…”

Hythiam Executive Vice President Richard Anderson disagreed. “The people who are using it,” he said, “the doctors, patients, administrators, and drug court judges—are seeing an impact with it, so I think the treatment will carry it at the end of the day.”

The dispute centers on the manner in which dropouts were counted in surveys done by Hythiam’s non-profit arm, the Pierce County Alliance. The Alliance had been responsible for administering the Prometa program in Pierce County drug courts. According to county auditors, dropouts and no-shows (patients who fail to show up for drug testing) were not included in the Alliance’s final report on 35 patients over a 14-month period. In Pierce and neighboring counties of Washington, drug courts record no-shows as equivalent to positive drug tests. This was not how the alliance scored it, although alliance spokespeople have insisted that county officials have misunderstood the mechanics of the study.

An investigation by the Tacoma News Tribune threw more cold water on the Prometa numbers. “According to the multiple public statements by the alliance,” wrote Sean Robinson, 86 percent of the Prometa clients ‘remained drug-free’ at the end of the 14-month program. According to county auditors, the number was 50 percent.”

Furthermore, the alliance “defined success in the Prometa program as 60 or more days of clean drug tests…. In Pierce County, drug-court clients must show 90 days of clean drug tests… In Snohomish and Thurston counties, drug-court clients must show six months.”

Investors in Hythiam, which is publicly traded, were counting on the Pierce program after similar programs in Fulton County, Georgia, and in Idaho failed to get off the ground. Things only got worse when the Tacoma News Tribune revealed that several county officials who had gotten behind the program also owned Hythiam stock.

Small rural communities that have felt the impact of meth sales and production in their communities are looking for help, and represent a significant market for an anti-addiction medication. However, in the case of Prometa, “The marketing is way ahead of the science,” claimed Lori Karan of the Drug Dependence Research Laboratory at the University of California-San Francisco.

Double-blind studies of Prometa are underway at the University of California-Los Angeles and at the University of South Carolina.

17 comments:

Bill said...

No one at the company has ever said it "cured" anyone. It HAS been double-blind tested, and showed significant benefit in doing so. The Prometa Treatment program has been clinically shown to reduce cravings for alcohol and stimulants. The funding loss at Pierce County was a political fight. The auditors who admitted they had no experience with tracking success rates in the drug court system, never took into account that the Prometa patients were the most hard-core users in the drig court system. They also assumed that a failure to continue the drug court system was a failure when, in fact, many of the Promet treated patients went back to work or left the area. Your statements here are incomplete and predjudiced by your lack of information. You make no attempt to provide fairness in your blog. Over 3000 paqtients will tell you that the treatment helped them get sober by relieving anxiety and cravings. No other medical treatment has shown an ability to do that.

Dirk Hanson said...

If there are any errors of fact in my post about Prometa, kindly point them out to me. Your assertion that I "make no attempt to provide fariness" in my blog is untrue, as a more careful reading of the Prometa post clearly demonstrates.

I support your interest in double-blind studies, but the president of Hythiam, Terren Peizer, apparently doesn't share your view. He told MSNBC: "Counties don't care about double-blind placebo-controlled data." I would have assumed that county health and medical officials would be just as interested in reputable scientific studies as anyone else.

Bill said...

Thank you for giving me the opportunity to discuss this. I do however have some specific that I think need to be addressed.

1: You claim that Hythiam claims an 80% "cure" rate. No one at Hythiam even suggests that an addict is cured.

2: You claim there is no published data supporting the scientific rationale. Raymond Anton and Harold Urschel have both completed double-blind studies. Both showing significant reduction in cravings.

3: You state that Hythiam claims success rates as high as 98%. What is your source for this statement?

Your article touts the Tacoma News Tribunes assertion that the success rates were inflated when the success rates that were provided were provided by the drug court themselves. The discrepency in the numbers was created when financial auditiors who were admittedly ill-equipped to analyze treatment data were asked to compare Prometa treated offenders with those who were not. The auditors were not made aware that the segment that was treated with Prometa were those who were deemed to be the most at-risk of relapse. Some of these patients had 60 or more arrests. They were being compared to first-time offenders. The "findings" of the auditors were that there was no significant difference in outcomes between Prometa patients and the general drug-court populace. The concept that a hard-core addict with multiple arrests should be compared to first-time offenders is falwed in itself. It should also be mentioned that the audit also counted any absence of an appearance for a drug test as a "failure". This is potentially unfair when no mention is made of the patient's status. Many Prometa patients returned to work and left the drug court system entirely.

You imply that the ownership of Hythiam stock by Pierce County Alliance staff is in some way evidence that they supported the program as a means of personal profit. These individuals purchased Hythiam stock on the open market. They made the purchases on their own at full market price independent of the contract. There was no impropriety involved here. Hythiam stock ownership is not forbidden by PCA staff. They recognized the benefits of Prometa and they invested in it. To suggest otherwise is unfair.

You quote Lori Karan as saying the marketing is ahead of the science yet you make no mention of the fact that Dr. Cheryl Smith has published a study that clearly defines the mechanism of action involved in the Prometa treatment. Frankly, the mechanism of action in Prometa is more clearly understood than that of household aspirin.

Your quote from Terren Peizer suggesting that testing isn't important is taken out of context. The point he was making was that the drug court system is focused on results in their population. Hythiam is spending significant money and resources to provide the clinical data that proves the efficacy of the treatment program. While the marketing of Prometa has been aggressive (indeed ahead of the results of some testing) there has never been a reluctance to confirm the results seen in treatment.

Dirk Hanson said...

The Anton-Urschel clinical studies are available, so I stand corrected on that.

Re percentages:
(from http://www.jointogether.org)

"About 45 programs nationwide are licensed to deliver the Prometa treatment regimen, which has been around for about three years. A Pierce County, Wash., drug court, presenting data at the 2006 annual meeting of the National Association of Drug Court Professionals, claimed that 98 percent of clients addicted to methamphetamine or cocaine had three months of clean urines after undergoing the Prometa treatment."
-------
A 92 percent success rate was reported by Dr. Raymond Johnson at an SAM conference in Florida, based on his clinical study of 52 patients who were treated with Prometa for addiction.
-------
A Prometa press release reads:
"Initial results from this study showed no adverse events and that more than 80% of study participants experienced a significant clinical benefit."
-------
Dr. Richard Gracer, in an article that can be found at www.selfgrowth.com, writes:"going over my data for the past 18 months I have close to an 80% success rate for my Prometa and buprenorphine patients...In fact, one study of 50 methamphetamine addicts showed that almost 90 percent got significant positive effects."

I regret that I am in no position to speculate on the motives of the Tacoma newspaper that originally reported the story.

Bill said...

At the risk of beating a dead horse, and quibbling over semantics, all of the statement you cite regarding efficacy are made either by treating physicians or those involved with the clinical testing. The language of your initial article says "Hythiam claims...". Hythiam isn't making claim in an of themselves, they are quoting the studies and written materials that others have produced. This is as it should be. Good or bad, the data, clinical experience and the science behind the treatment are what the program should be judged by.

Dirk Hanson said...

Bill--

Since Hythiam specifically drew attention to some of the clinical findings in a company press release, I felt the construction "Hythiam claimed" was justified. If you are quoting studies by others to support your argument, you are making claims, it seems to me. But anyway, I do see the point you are making. Perhaps "Hythiam referred to the findings in its own promotional literature" would have been technically more accurate?

In any event, we can agree that "clinical experience and the science behind the treatment are what the program should be judged by." I await further studies with interest.

Esther said...

Prometa is a scam. We spent every last cent we had to pay for the treatment and it was done improperly and it didn't work. The doctor and the people from prometa told us different things regarding what we were supposed to do and in the end it didn't do a dang thing. I want our money back and would like some advice from anyone out there who would be willing to help me to do that.

rachel berry said...

okay, so I was one of the twenty out of collin county Texas. I started this program last january, so that would ne 2007 i believe.I completed the program, did everything correctly, finished probation etc. Well I didn't resort to using meth, with which I was a heavy user of before, more than a teener a day if you're familiar... But since the completion, I have had 2 major seziures, FROM ENERGY DRINKS!!! I don't know if this is because of the prometa, but I think it may have something to do with it. Here lately, like last night for instance, I was cooking dinner and had to sit down numerous times. This has happened before since the completion, only it was the worst last night. I stood up longer feeling dizzy to see what would happen... Sure enough, I actually blacked out once, my fiancé was standing me up, and when I came to, I was on the floor. Not too long after, it came back, I tried to go to our bedroom to lay down to shake off the dizziness, but didn't make it. I fell to the floor and passed out. I was literally on the floor twitching in an awkward position. If anyone has done this program and feels or has felt this way, please let me know. I am afraid of what is happening to me is irreversable from the prometa. Anyways please help

moviedoc said...

Almost another year since the last post, and where is the evidence of effectiveness? Why has Hythiam never told the story of how the "Spanish doctor" (actually a PhD, I believe) who supposedly devised the protocol came up with it in the first place. (He also owns a US patent on rapid opioid detox.) And no one has explained why it should work. My theory is that the gabapentin alone may provide some benefit, and the H2 blocker and flumazenil just allowed it to be patented. Somebody study gabapentin monotherapy for meth/cocaine/alcohol dependence. Or head to head with full Prometa protocol.

Anonymous said...

Prometa SAVED my life. I t was a miracle. I was a hard core meth user and the very first treatment cured me of any desire to use. I was lucky to be picked out of, I don't know how many applicants. There is more than just the treatment itself, cutting off the ties to friends and a lifestyle of using, having people around that will support you through it all, meetings , counseling. This what is involved besides receiving the treatment. Support from family is so very important and from your loved ones as well. Prometa WORKS as long as you follow what is expected during and after the treatment. I am very confident with Prometa and I have suggested it to many friends who are still struggling with this disease, this addiction. Thank you everyone from Prometa and EndDependence .

Anonymous said...

Just as "Anonymous" stated before me, Prometa saved my life. I will forever be grateful and indebted to Hythiam for having the gull to go against the grain and pursue saving lives. I am not here to rant nor defile anyones name, but people who have never fought addiction nor have sought treatment, have no right to pass judgment on what Prometa is doing. I was a highly successful entrepreneur in the Las Vegas nightclub industry. I unfortunately fell victim, by my own hand, to a meth addiction. I nearly lost everything but my soul in the process. A million dollar home. A beautiful Fiance. Two brand new cars. My bank account. Etc., etc. I tried several times to get treatment, both in-patient and out-patient. Nothing was working. Each time i came out of rehab i would get deeper into it than the time before. Eventually i started shooting over $200 a day of meth into my system. I wanted to die. This was the only way I knew how to stop this overbearing craving. I always wanted to be sober, but my mind would make up its mind to use again before i could rationally say no. One day, by chance, i was searching the net for new types of treatments and ran across Prometa on youtube. It sounded great and i literally had nothing to lose at that point. Problem was, i couldn't afford the treatment. ($15,000) I talked to 2 doctors in Vegas who administer the treatment and neither of them would help me. I have no criminal record and one doctor told me to commit a felony and be charged as guilty so the drug courts would pay for my treatment. The other doctor told me to have my parents refinance their home and get a loan. My parents are retired Indiana farmers! So a friend of mine contacted Dr Torrington at the Prometa clinic in Santa Monica. I have never met a doctor, nor a staff, as kind and as cordial as they were. The finance department said "we will find a way to get him his treatment." Through government grants they were able to get my costs down to $5000. Through the friends and family i had left we gathered up around $4000. The Dr said,"Dont worry. We'll figure it out as we go. Come get your treatment in 2 weeks." Starting from the first injection that i received, i lost all of my cravings. I no longer had night terrors nor the physical illness. I also quickly regained my energy and my appetite. I am now 2 years clean because of Prometa. Prometa is a miracle! It is a gift. But like Anonymus said before, it is a total life style change. If a person goes back to the same friends, the same neighborhood, and the same debauchery, than Prometa wont work. But you cant blame them! At some point people need to take responsibility for their own actions. Prometa helps rid people of the urges and the cravings, but the rest is up to the individual once they walk out of the doctors care. Ignorance and stupidity has no cure, but Prometa gave me a running start. Prometa gave me life. I doubt MSNBC has ever done that for anyone. God bless and Namaste.

Anonymous said...

In 2007, I was one of the youngest people in the United States to undergo the Prometa treatment. I was an extremely heavy methamphetamine user with little to no desire to quit. My parents got desperate after several hospital visits & arrests. They begged me to give Prometa a shot. I walked into the Santa Monica clinic with nothing but doubt. After the first treatment, there was noticeable change in my physical and mental dependency. By the third treatment, all cravings were gone. It took several months of intensive outpatient therapy to help me gain the tools to make the life changes necessary to stay clean... but as I sat in a room with other young addicts struggling to change their lives without the help of Prometa, I realized just how valuable the treatment was. Instead of focusing on quitting the drug, I was able to focus on changing my lifestyle. Prometa saved me. With almost 5 years clean, I am now a student at UCLA and proud to say that I have a bright future. Please, if all other attempts at sobriety have failed you, give Prometa a shot.

chazman4742 said...

prometa may be a flop. but im here to tell you methadone is not a flop. its made my life bearable again and gave me back my life. methadone is a lifesaver for people who want to be saved. not for people who want tuse and take methadone. you cant lead a horse to water and make him drink. he has to want to drink ok.

Anonymous said...

I am a recovering meth addict and what I am seeing here is even if the Pro Meta worked it only deals with one aspect of addiction that is the physical aspect, not the underlying causes and conditions If addiction centers in the mind how is this pro meta changing their thinking I have been clean four and a half years the first try after going to treatment and being offered the twelve step approach to living drug free then 8 and a half yrs now four and a half again. I have never been given a drug that takes everything away, I am living the twelve step method and receive therapy and medication for PTSD, and other disorders that were present, I am willing to do what it takes to change so that I may stay clean. I do not think this company has any idea about what makes a drug addict tick nor an alcoholic. I do not begrudge anyone who has gotten clean with this drug, yet I want to know how many are still clean from the 2006 study, that haven't relapsed and that their thinking has changed without the help of a psychoanalyst type therapy and psychiatry, they are offered no other way to live At least the twelve step approach concerning meth and narcotics does offer a new way to live, and proven. What do you have if you take the drug out of an addict a lying , thieving hood, that has not changed their lifestyle. They are just absent a drug. I have been absent drugs but today I am free within, and happy. I have lost the desire to use drugs. My lifestyle has changed, etc. It is not just a physical problem this has been proven over and over, Pro Meta touted it changes thinking it couldn't have or else Chris Farley would not be dead. He would have been over the rage he felt on a daily basis that caused him to use and eventually die.

H Builder said...

I too found Prometa to be extremely beneficial in getting off Methamphetamine once and for all. I was very fortunate to have been elected to receive the treatment at a substantially discounted cost after making several desperate calls to a Prometa info line. The woman on the other end of those calls went to great lengths to make the treatment a possibility for me and was even willing to discuss everything about Prometa with my Mother in hopes she would lend me the money needed. Within a few days I was driving to Santa Monica,meeting with Dr Torrington and starting treatment. Long story short it worked tremendously for me in that in several attempts to get clean I failed because I could not get past the anxiety,cravings and the depression that follows. Prometa eliminated all of these side effects down to a tolerable level so I could then get healthy physically and mentally. I swear by it in my situation and I had been a daily user for over 5 years,the last 2 intravenously injecting around 10 times. Everyone is different,every brain is different and recovery is different for everyone. I had done a lot of research on the effects methamphetamine had on brain chemistry and I felt very confident that Prometa was right for my case. I only wish it were way more affordable so that others similar to me could benefit from it as well. I am five years clean by taking care of myself (especially my brain) and I owe much of it to the opportunity I had with Prometa.

TXLady said...

I have had the Prometa treatment.. This was back in 2006, 2007? At the time, I had been using meth.. Alcohol, etc etc... I stopped using meth, but continued the alcohol, and pot. I know it isn't supposed to help with the pot. But anyway, my post is in regards to the after effects.. I still occasionally drink, but def not like I used to. But when I do drink, it's ugly.. It's like something in my brain switches, and this could be with only a few pint size light beers.. Also, the next day, I get sick sick sick. Not like any other hangover I had had in the past, but enough for me to not eat anything all day, and get down to the nitty gritty of bile. I don't know if anyone else wonders about the after effects/long term effects that this drug has. But I do know that in my trial run, and where I am now, it makes me think that this drug is not a good one. And the simple fact that, the judge who granted me this program-for free, soon retired after granting this to 20 people in my county.. I don't know if this is still available, but I do know, that it possibly has caused a lot of issues for me after the fact. If anyone reads this and maybe has the same things happening to them, I would love to hear about it. I don't drink often at all, probably will not drink at all anymore because I'm so sick of the day after. But still stinks I can't enjoy a glass or two of wine, or a beer or two with friends occasionally. I don't rec. Prometa to anyone.. Your mind has to be ready to quit anything, there isn't a miracle cure. You have to be ready yourself to quit whatever addiction you may have. Anyway, would love to hear if others have this issue as I do. Thanks.

mom said...

How do I get my son into this program we live in liberty Co TX. He is 35 and heavy user over 15 years.please help

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