What is the PROMETA® Treatment Program? What Is the PROMETA® Treatment Program designed to treat?
The PROMETA® Treatment Program is an innovative, medically supervised treatment program for adults specifically designed to help relieve cravings, improve cognition, restore nutritional balance, and initiate psychosocial counseling, so that patients can focus on their recovery instead of their addiction.
The PROMETA® Treatment Program involves three components: medical, nutritional and psychosocial. The medical component involves an initial IV therapy session lasting approximately 2 hours for three consecutive days (for treatment of alcohol dependence) and an additional two consecutive days for treatment of stimulants or a combination of alcohol/stimulants (approximately 3 weeks later). Patients receiving the treatment will also be placed on nightly oral medications for approximately one month. The nutritional component involves nutritional supplementation as well as dietary education. In addition, patients need to enroll in recovery-oriented therapy to address the behavioral aspects of addiction. Patients or family members interested in receiving the PROMETA® Treatment Program should remember that only a practitioner licensed to perform the PROMETA® Treatment Program can determine if they are appropriate for treatment.
How are the treatments done?
Prior to initiation of treatment with PROMETA® Treatment Program, all potential patients are screened by licensed practitioners. The treatment provides that this screening includes the following:
- A History and Physical by a physician
- Blood work (including liver function panels)
- Urine drug screen
- Urine or serum pregnancy testing (for females of childbearing age)
- An EKG
- Any other testing deemed appropriate by the physician, based on the results of the History and Physical
The initial administration of IV medication is done in a medically supervised setting over a period of three consecutive days for those patients being treated for alcohol dependence only. Oral nutritional supplements and nightly oral medications are begun on the first day of treatment as well.
For those patients being treated for stimulant dependence or a combination of alcohol/stimulant dependence, they return for two more consecutive infusions of IV medications in the medically supervised setting in approximately three weeks. They will continue taking the oral nutritional supplements and nightly prescription oral medications in the interim.
How is the PROMETA® Treatment Program different from more traditional treatments for addiction?
The PROMETA® Treatment Program is a unique outpatient treatment for alcohol, cocaine and methamphetamine dependence that integrates medical, nutritional, and psychosocial therapies, designed to help patients meet their individual therapy needs.
The PROMETA® Treatment Program is specifically designed to help relieve cravings, improve cognitive function, restore nutritional balance, and initiate psychosocial counseling, so that patients can fully engage in the entire recovery process.
Don’t you charge a high price for a treatment that is not proven to work?
There are many treatment options 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. Neither of these options conducts clinical studies on their outcomes, nor fund such research through unrestricted grants, as Hythiam does. We believe the Prometa Treatment Program is fairly priced for a treatment that has shown its effectiveness in published literature. In addition, Hythiam offers a patient assistance program, which provides our treatment at a reduced price to individuals who can demonstrate financial hardship.
Is the PROMETA® Treatment Program a Cure for Addiction?
There is no cure for addiction to alcohol or stimulants. Rather, the PROMETA® Treatment Program offers a promising new approach to helping patients with the management of the chronic disease of addiction.
How successful is PROMETA®/Have there been any clinical trials or formal studies?
There have been three clinical studies on the PROMETA® Treatment Program – two open labels studies and top-line data is available for one double-blind, placebo-controlled study.
In an open-label study, there is no placebo control, and both the researcher and participant know the full details of the treatment. This contrasts with "double-blind," placebo-controlled studies, where neither the participant nor the researcher knows if the participant is receiving the treatment or a placebo (e.g., a sugar pill). The reason for using blinding and placebo controls is to be able to know (as much as possible) if any benefits observed in the study are due to the treatment itself, and not other factors.
Now that you understand that:
- A 50-patient open label study* conducted by Dr. Harold C. Urschel, III and Research Across America was recently 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 pharmacologic treatment. The highlights 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%.
- A 30-patient open label study* conducted by Dr. Jeffery Wilkins, Department of Psychiatry and Behavioral Neurosciences, 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.
c. Top-line results were released from a 30-day double-blind, placebo controlled study conducted by Dr. Harold C. Urschel, III and Research Across America that showed a statistically significant reduction in meth cravings.
While we are very encouraged by this data, additional clinical studies are underway to evaluate the effectiveness of the PROMETA® Treatment Program
In addition, we have received a lot of positive feedback from our patients and from referring physicians, therapists. We have a number of individuals who would be more than happy to discuss their experiences with you. In respecting their confidentiality, we cannot give you their contact information. However, if you would like to speak with them directly, we can have them contact you at a time and number that you specify is convenient for you. In addition, we can send you written or video testimonials from patients who have been treated with the Prometa Treatment Program.
How successful are more traditional treatments for addiction?
Most of the traditional treatment options for addiction don’t conduct clinical studies, publish their outcomes, nor fund such research through unrestricted grants, as Hythiam does. Hythiam is subjecting itself to high level of scrutiny by providing unrestricted grants to distinguished researchers who will independently publish their finding on the Prometa Treatment Program. If you are interested in other treatment options, you might want to ask them for copies of their published studies.
Why do you charge so much public money for a treatment that doesn’t have as much research as other tool available to local and state governments?
Unfortunately, it has often been mis-reported that Prometa costs $15,000 per person for those treated under government contracts or drug court pilots. 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 Prometa available to anyone that needs it, and we hope that it is a tool 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. Usually, we provide several no cost treatments so everyone making decisions has direct experience with Prometa. Then the actual cost for the program, including any fees paid to Hythiam, as well as physician’s fees, is typically between $4-$5,000. This is all public record.
Is the PROMETA® Treatment Program a replacement for traditional treatment approaches?
No. The PROMETA® Treatment Program is not considered a replacement for behavioral therapy and is not a cure.
Due to the complexity of substance dependence, individuals may benefit most from a combination of medical, nutritional and psychosocial treatment approaches.
The PROMETA® Treatment Program provides for individualized continuing care treatment (e.g., psychosocial or other recovery-oriented therapy).
While there is no cure for alcohol or stimulant dependence, the PROMETA® Treatment Program offers a promising new approach to helping patients manage alcohol, cocaine or methamphetamine dependence.
Why are you promoting this treatment before all your clinical studies have been completed?
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, making alcoholism the third-leading cause of death in the United States.
At present, there are no FDA-approved treatments for stimulant dependence.
Methamphetamine addiction has become a national crisis in our country. According to a Newsweek article, 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.
We see our educational efforts as providing a critical response to an addiction pandemic that already exists and takes lives daily. There has been criticism of our efforts to communicate information about our treatment, including results we receive from physicians in their own practices, but the reality is that physicians providing care and patients who are suffering from a potentially fatal disease need this information. Hythiam has released results of clinical studies, commercial pilots, and other benchmarks involving the treatment because it is critical information healthcare providers and the public must have to make key decisions in order to save lives. In addition, as a public company, we are required by SEC law to announce certain information that is material to performance of our business, including results of studies.
What is the status with the Pierce County Alliance program?
- We are very proud of the work of the Pierce County Alliance and the work they have done in the criminal justice system. The results from the program have been overwhelmingly positive, especially considering the participants were individuals who had typically failed in prior treatments. We believe it is a good model that can be replicated in other counties across the country and several other places have started their own pilots based on the performance observed there.
- Because a by-product of drug addiction is crime, we provide tools to the criminal justice system to treat defendants and hopefully provide an alternative to incarceration. We will continue to work with local governments and treatment providers to make Prometa available to defendants that need treatment.
- The controversy in Pierce County is a political issue and not relevant to the benefits of the drug court progress. Results showed that it was a very effective tool in helping drug court defendants with their addiction. The report, which was prepared by a county financial auditor instead of someone experienced with addiction treatment, and was the basis for the council action has been refuted in great detail.
- Our drug court programs around the country and in Pierce Country are showing that Prometa is a beneficial tool for probation departments, judges, prosecutors, prison officials and everyone that is connected to managing drug offenders.
The initial studies are positive, but are they enough to justify going to market now?
- The initial studies on the Prometa Treatment Program are very encouraging. They provide support for the Prometa Treatment Program as an effective treatment for methamphetamine cravings. Both the peer-reviewed published study and the topline data from the double-blind, placebo-controlled study show the Prometa Treatment Program is effective in reducing cravings for methamphetamines. We are not aware of any other published study showing such results. We agree more research needs to be done, and we have many more studies underway. In the meantime, this treatment is saving lives.
- It is important to note that the funding Hythiam has provided for research was in the form of unrestricted grants. This means that the researchers and investigators own the results of their clinical studies and Hythiam does not have control over the results. Unlike the pharmaceutical industry which generally does retain control over the results in studies they fund, Hythiam learns of the outcomes along with the general public. In recent years, several very high profile situations involving suppression of data by several pharmaceutical companies has resulted in people incurring injuries and class action lawsuits. Hythiam is deliberately adamant in insuring that cannot happen in relation to any research on its treatment programs. This is a fair, open process.
- In addition, all clinical studies being conducted on the Prometa Treatment Program are monitored by an Investigational Review Board (IRB), which is an independent party that oversees the studies and ensures the integrity of the process. To call into question the results of any study on the Prometa Treatment Program is unethical and calls to question the entire IRB process.
What is Hythiam?
Hythiam is a public company created in 2003 in Los Angeles for the purpose of researching, developing, licensing, and commercializing treatments for the chronic disease of substance dependence.
Hythiam is currently licensing healthcare providers around the United States and Europe to provide its proprietary PROMETA® Treatment Program for alcohol dependence, stimulant (cocaine and methamphetamine) dependence, or combination treatment for dependence on both substances.
Is Hythiam a pharmaceutical company or does it manufacture medications?No. Hythiam is a healthcare services management company and does not manufacture or distribute any medications and has no relationship with manufacturers or distributors of medications used in the PROMETA® Treatment Program.
Is the Prometa Treatment Program getting around and FDA loophole?
The Prometa Treatment Program is a comprehensive approach to the treatment of alcohol, cocaine and methamphetamine addiction that integrates medical, psychosocial and nutritional elements. It is a patented tool that we provide to physicians for use in their own practices at their own discretion. It should be noted that in all studies and pilots completed on the Prometa Treatment Program no patients have reported any major adverse events or had to discontinue the treatment due to side effects.
Is “Owning” the patent on the treatment, while claiming to want to help people ethical?
The Prometa Treatment Program is intellectual property, and that is something that companies develop and commercialize all the time in the medical field. It is routine in the US for various treatments to be “proprietized.” There is even an insulin dosage that is technically proprietized. We feel this is more accepted, because people see diabetes as a “legitimate” disease, and insulin is a long established treatment. In time, we hope more people will view addiction as the disease that is, as well.
Are there any studies on cocaine?
No, however, we are very encouraged by reports we have from patients who have actually received the treatment already. We have a number of individuals who would be more than happy to discuss their experiences with you. In respecting their confidentiality, we cannot give you their contact information. However, if you would like to speak with them directly, we can have them contact you at a time and number that you specify is convenient for you. In addition, we can send you written or video testimonials from patients who have been treated with the Prometa Treatment Program.
