The PROMETA® Treatment Program (PTP) for treating drug and alcohol addiction has been the subject of recent misunderstanding. Below are the facts about the PROMETA® Treatment Program:
Clinical studies have been conducted and a significant, growing body of data support the utility of the PROMETA® Treatment Program (PTP).
These data come from a variety of sources and indicate that the PROMETA® Treatment Program is a promising treatment for alcohol, cocaine and methamphetamine dependence. In addition to over 2,500 patients who have been treated in private physician offices, and numerous drug court and commercial pilot programs, there have been three clinical studies of the PROMETA® Treatment Program – two open label studies and one double-blind, placebo-controlled study from which top-line data are available:
1. In a recent 134-patient double-blind, placebo-controlled study conducted by Dr. Harold C. Urschel, III and Research Across America in Dallas, Texas the PROMETA® Treatment Program was shown to be effective in reducing methamphetamine cravings.*
a. Individuals who completed the treatment had an average 60% reduction in their cravings.
*Based upon initial analysis of 88 treatment completers in a 30-day double-blind placebo controlled study of 134 methamphetamine dependent subjects conducted by Harold C. Urschel, III, M.D.
2. A separate 50-patient open label study conducted by Dr. Urschel and Research Across America was published in the October, 2007 issue of the Mayo Clinic Proceedings. Overall, the treatment was well tolerated: No subject discontinued the treatment program because of side effects, and no serious adverse events occurred during any portion
of the pharmacological treatment.
The top-line results of the study are:
a. 85% of patients completed the 4-week treatment program
b. Complete data on cravings was available for 31 subjects at 84 days. Of these, 30 subjects — 97% reported a decrease in frequency of cravings, including 4 who reported zero cravings at study completion.
c. Among the 30 subjects whose cravings decreased, the mean reduction in cravings from the first visit to study completion was 66%.
3. A 30-patient open label study conducted by Dr. Jeffery Wilkins, Department of Psychiatry and Behavioral Neuroscience, Cedars-Sinai Medical Center, showed a substantial reduction in cravings and alcohol use among subjects treated with the medical portion of the PROMETA® Treatment Program.
Highlights of the study are:
a. An 86% decrease in median cravings from baseline to week 1 was reported, decreasing further to a 94% reduction in median cravings at the end of 30 days.
b. Alcohol use was substantially reduced in all subjects with an 82% reduction in mean percentage of drinking days and an 85% reduction in mean standard drinks per day at the end of the 16 week study.
While we are very encouraged by this data, additional clinical studies are underway to evaluate the effectiveness of the PROMETA® Treatment Program. Three additional double-blind, placebo-controlled studies will be completed in the next 12 months and we eagerly anticipate the results.
Click here to learn about our ongoing studies.
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Clinical data indicates that the PROMETA® Treatment Program is well tolerated and effective.
The initial studies on the PROMETA Treatment Program are very encouraging, and many participants have experienced positive results. No patients have reported any major adverse events or had to discontinue the treatment due to side effects in any of the studies and pilot programs. We are conducting additional clinical research at leading medical centers to confirm the initial results we have already attained.
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Initial clinical studies provide support for the PROMETA® Treatment Program as an effective treatment for methamphetamine cravings.
Both the peer-reviewed published study and the top-line data from the double-blind, placebo-controlled study indicate that the PROMETA Treatment Program appears safe and is effective in reducing cravings for methamphetamine. We are not aware of any other published study showing such results. Moreover, no patients have reported any major adverse events or had to discontinue the treatment due to side effects. In addition, over 2,500 patients have been treated in private physicians’ offices, with similar results.
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Particularly high ethical standards govern the clinical development of the PROMETA Treatment Program.
In keeping with our commitment to scientific integrity, the protocols for all of our clinical trials were reviewed and approved by an Investigational Review Board (IRB) composed of independent experts in clinical trials and medicine. The IRB will continue to monitor all of our trials to ensure that the protocols are followed and that the resulting data are reliable.
In a step to further ensure the integrity of the clinical data, the independent physicians who are conducting clinical trials of the PROMETA Treatment Program own their study data and have complete control over the resulting data. The physicians will conduct independent analyses of the clinical data and will share this information with Hythiam only after the results have been determined. We know of no other example in which the sponsor of a clinical trial has established this degree of arms-length separation from the physicians conducting the studies.
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The PROMETA® Treatment Program is consistent with regulatory rules and requirements.
Some critics inaccurately suggest that the PROMETA Treatment Program somehow gets around a regulatory loophole. This is false. The PROMETA Treatment Program is a comprehensive approach to the treatment of alcohol, cocaine and methamphetamine addiction that integrates psychosocial, nutritional and pharmaceutical products. It is a patented tool that we provide to physicians for use in their own practices at their own discretion. There are numerous examples of other healthcare organizations providing similar patented approaches to patient care.
All of the prescription drugs used in PROMETA® treatment have been individually approved by the FDA. Once the FDA approves a drug for prescription use, the practice of medicine requires the physician to decide how to use the drug, based on her or his best judgment. At this time, it is a standard practice and entirely legal in the United States and in many other countries to use drugs off-label, with the exception of certain controlled substances, such as opiates.
It would be a mistake to equate the use of a treatment program that includes FDA approved components with the use of stand-alone pharmaceutical products that have yet to be approved by the FDA. We are committed to following the letter and spirit of FDA regulations to ensure the safety of
our patients.
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Drug treatment experts agree that minimizing cravings is critical to supporting recovery and that decreased cravings are an important indicator of treatment success.
Published clinical research has shown that cravings are a key cause of continued drug use and relapse for those patients trying to end drug use. In a study titled “Craving predicts use during treatment for methamphetamine dependence: a prospective, repeated-measures, within-subject analysis,” published in Drug and Alcohol Dependence [63 (2001) 269-276], it was shown that among the test population craving scores that preceded use were 2.7 times higher than scores that preceded abstinence. This confirms the long-held conviction among clinicians that cravings drive substance dependent individuals to continue to use, even when they truly desire to stop.
In the leading journal, Drug and Alcohol Dependence, Hartz et al. sited leading addiction experts’ view of the role cravings plays in the disease. These experts are sited agreeing on the critical importance of addressing cravings in treatment. Dr. Charles O’Brien from the University of Pennsylvania, stated that “cravings is viewed by many as the primary symptom motivating drug use and the appropriate target of behavioral interventions. Robinson and Berridge refer to craving and subsequent relapse as “the defining characteristics of addiction.”
Additionally, in the Journal of Substance Abuse Treatment, Dackis, et al concluded “Although patients cite many reasons why they use cocaine, the feeling states of craving and euphoria are the primary reinforcers of the addiction.”
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The cost of the PROMETA® Treatment Program has often been exaggerated or misrepresented.
Here are the facts: The PROMETA Treatment Program is available through a number of different channels: private pay, government and managed care. Each market has very different pricing structures and this has unfortunately led to misunderstanding or inaccurate reporting about the pricing of the program.
Private Pay: Many private treatment options are available to individuals suffering from addiction. They range from residential treatments centers, which often cost $30,000 or more for a 30-day program, to AA, which is free. The price of the PROMETA Treatment Program is not set by Hythiam, but by the treating physician. The price for a 30-day program usually ranges from $12,000-$15,000, which includes initial psychosocial counseling for patients. In addition, Hythiam offers a robust Patient Assistance Program, which can reduce the price of the treatment to $6,000 for patients who can demonstrate financial hardship.
This compares to the cost of other private addiction
treatment options:
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Matrix Treatment Program: |
$6,000 |
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Medical Detox: |
$4,500-$7,500 |
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Intensive Outpatient Program: |
$7,500-$10,000 |
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Vivitrol (annualized): |
$8,400 |
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Residential Treatment Program: |
$22,000-$30,000 |
In evaluating the above options, we suggest you review published peer-reviewed literature on success rates of these other treatment programs and compare those to the results of an open label study on the PROMETA Treatment Program published in the Mayo Clinic Proceedings in October of 2007 that show:
• Higher-than-expected participant retention among
PROMETA Treatment Program participants;
• Significant decrease in methamphetamine use; and
• Significant reduction in reported cravings
Government: Unfortunately, it has often been misreported
that the PROMETA Treatment Program costs $15,000 per person for those treated under government contracts or drug court pilot programs. The reality is that the cost per patient in public sector contracts is dramatically less. The reason is simple: governments have limited resources, and with increased volume we are able to reduce the price of
the treatment.
Our goal is to make the PROMETA Treatment Program available to anyone who needs it, and we hope that it is a tool that healthcare providers and governments can adopt easily and affordably. Hythiam has never charged a service provider funded by public money $15,000 for a PROMETA Treatment Program. We usually provide several no-cost treatments to potential participants so that they are able to evaluate the program before deciding to use it. As a result, the actual cost for the program, including any fees paid
to Hythiam, as well as physician’s fees, is typically
$4,000-$5,000.
Managed Care: Hythiam is currently working with a number of managed care companies to have the PROMETA Treatment Program made available to plan members as covered services; and at costs to the plan sponsor that are comparable to the government sector. We have several commercial pilot programs underway and will update the markets on these as results are achieved.
The need for effective dependency treatment is urgent.
Alcoholism is the third-leading cause of death in the United States. Methamphetamine addiction has become a national crisis in our country, destroying lives, families and clogging up criminal and family courts. And the addiction problem just keeps growing. In 2005, an estimated 22.3 million people aged 12 or older were classified with substance dependence or abuse. In addition, more than 100,000 and 17,000
annual deaths were attributable to alcohol and stimulant dependence, respectively.
As reported by Newsweek, more than 12 million Americans have tried crystal meth and more than 1.5 million are regular users. The effects of methamphetamine addiction are felt in communities across this country, particularly in the criminal justice and child welfare systems. In a recent survey of 500 law-enforcement agencies in 45 states conducted by the National Association of Counties, 58% said meth is their biggest problem, while 70% said crime had increased directly related to meth addiction. Similarly, 40% of child welfare agencies reported an increase in children being removed from their homes due to meth. As we see the numbers of patients and families in our communities whose lives are impacted by addiction continue to increase, healthcare providers continue to struggle to identify treatments that can assist these patients in their struggle to regain their lives and to enter recovery. This was the impetus for the development of the PROMETA Treatment Program.
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We see our educational efforts as providing a critical response to an addiction pandemic that already exists and takes lives daily.
Some have criticized our efforts to communicate information about the PROMETA Treatment Program, including results we receive from physicians in their own practices. The reality is that physicians providing care and patients who are suffering from a potentially fatal disease need this information.
Hythiam has released top-line results of clinical studies, commercial pilots, and other benchmarks to the public and submitted more detailed data to peer-reviewed journals in accordance with standard practices for the dissemination of medical information. Top-line clinical results, which in this case are not germane to FDA regulation, have helped healthcare providers and the public make more informed decisions about whether to use the PROMETA Treatment Program.
In addition, as a public company, we are required by SEC
law to announce certain information that is material to the performance of our business, including top-line results of
our studies.
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Patients in desperate need of treatment are benefiting today from the PROMETA® Treatment Program.
Currently more than 130 physicians are approved to use the PROMETA Treatment Program. Including members of the International Society of Addiction Medicine and the American Society of Addiction Medicine (ASAM). Three states and an increasing number of counties are paying for, or are evaluating, the treatment program in their populations. Several large insurance companies are also conducting evaluations in their populations.
To date, over 2,500 patients in the U.S. have benefited from the PROMETA Treatment Program and no reported significant adverse events associated with the proper use of this treatment have been reported. The side effects during the delivery of the treatment are mild, transitory and have not led to patients’ prematurely discontinuing the treatment. There have also been three clinical studies completed on the PROMETA Treatment Program. Click here to learn more.
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The Pierce County Alliance (PCA) program experienced overwhelmingly positive results from their use of the PROMETA® Treatment Program (PTP), regardless of any politically inspired controversy that ultimately evolved there and fueled unjustified doubts about PROMETA®.
Here is what happened: In October 2007, a performance audit of PCA’s use of the PROMETA® Treatment Program was conducted by Pierce County’s financial auditors. The auditors had no prior experience reviewing and evaluating addiction treatment programs, and yet their final report was the impetus for the Pierce County council’s decision to revoke funding. The results of the performance audit report have been refuted by PCA. The majority of the audit results are based on wrong standards applied by the auditors to measure the success of the program participants. In an editorial in the TNT, the editors stated that the committee’s action were a “rush to judgment."
In fact, the results from PCA’S use of PTP have been overwhelmingly positive, especially considering the participants were individuals who had traditionally relapsed and had difficulty completing or participating in prior treatments.
In simplest terms, here are results provided to Hythiam by PCA, which show that during the PROMETA® pilot, 20 out
of 35 participants had no positive urine tests over a
14-month period.
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PCA |
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Outcomes after 14 months of program |
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40 |
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People Enrolled in Pilot |
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(1) |
Recharged on original crime
and ineligible to continue drug court |
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(2) |
Admitted to in-patient mental health
facility for co-occurring disorder |
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(2) |
Did not complete treatment protocol |
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(5) |
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Excluded from Analysis |
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35 |
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Number of participants included |
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5 |
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Failed and dropped from program |
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20 |
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No positive urines |
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6 |
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2 or less positive urines |
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3 |
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3 positive urines |
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1 |
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4 positive urines |
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35 |
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Total participants |
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Source:
Summary tracking sheet for pilot provided by PCA |
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Given these results, it is difficult to understand how anyone with experience in the treatment community could not consider them positive within this population.
We leave evaluation of this data to addiction providers and experts to characterize the impact of PTP on these patients who had failed multiple attempts to achieve sobriety. This is an important distinction that continues to get lost in the discussions: PCA did not employ PTP on their average patients; they chose to utilize the treatment in their more difficult cases to determine how effective PTP would be for their program.
We believe PCA is an effective model that can be duplicated in other jurisdictions across the country, and several other locations have started their own pilots based on the performance observed at PCA.
Our partnerships with drug court programs around the country and in Pierce County are showing that PROMETA® is a beneficial tool for probation departments, judges, prosecutors, corrections officials and other criminal justice representatives who are focused on helping drug addicted offenders achieve recovery. We will continue to work with local governments and treatment providers to make the PTP available to defendants who need treatment.
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