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Perspectives on Hythiam's Prometa Treatment for Addiction VOL. 33/NO. 1 • FALL 2006 THE VOICE FOR TREATMENT QUARTERLY NEWSLETTER OF THE CALIFORNIAnews SOCIETY OF ADDICTION MEDICINE CSAM Introduces New Forum for Dialogues in Addiction Medicine Perspectives on Hythiam’s Prometa Treatment for Addiction BY TIMMEN CERMAK, MD, EDITOR As the new editor of CSAM’s Newsletter, I am excited to and most especially introduce the FORUM. Each newsletter, I will choose an issue when the treatment has that would benefit from being elevated to the surface, where not yet met the most open discussion of different perspectives can advance our rigorous tests for safety understanding of the issue, and of each other. Views will be and efficacy. This issue ADDICTION MEDICINE presented not in a Pro-Con, Point-Counterpoint framework, transcends addiction but rather as examples of differing perspectives. Dialogue will medicine, pervading the be the most important goal for each FORUM. whole of medicine. We FORUM will not resolve it on our FORUM Commentary own without a resolution that involves the entire pharmaceu- tical industry’s relationship to medicine. However, where we There are two important themes threading through the feel the best interests of those suffering from addictive disease two perspectives on Hythiam’s Prometa that possess par- are being impacted, we have an obligation to identify and de- ticular relevance for addiction medicine, both in terms of bate that impact. The issues here are complex. In a free society, their impact on the practice of treating addiction and the it is often difficult to distinguish between brave and innovative special expertise practioners in our field can bring to an approaches being championed by a few and treatments that understanding of these themes. Both themes are far larger are being prematurely promoted for financial gain or out of than the issues presented by Hythiam’s Prometa; but the unrealistic enthusiasm. We have two effective, though often perspectives expressed by Smith/Torrington and Rawson/ slow, mechanisms for making this distinction: scientific re- McLellan, on pages 2-3 of this newsletter, clearly illustrate search and our collective clinical judgment, arrived at through the two themes. open dialogue. Thus - the CSAM Addiction Medicine FORUM. The first theme involves the question of what standards of evidence need to be met for a treatment to achieve “evi- dence-based” status. By submitting itself to the rigors of About Prometa evidence-based medicine, the addiction field has substan- he Prometa treatment for addiction (based on tially increased its credibility. The more clarity we develop flumazenil, gabapentin, and hydroxyzine) was regarding the different standards of evidence required for T empirically developed by Dr. Legarda in Madrid a potential treatment to warrant further investigation, clin- about 6 years ago. Hythiam is a publicly traded healthcare ical trials, widespread adoption as an available treatment, management and services corporation formed about 3 years or being recognized as the standard of care, the easier task ago that promotes and provides Prometa treatment. To date, we will have evaluating Hythiam’s claims for Prometa’s more than 700 patients have undergone the treatment in the safety and efficacy. Even Prometa’s advocates support US and more than 2000 worldwide. the need for more rigorous, double-blind and properly Important questions and strong opinions about Prometa controlled studies. As with all new and potentially helpful and Hythiam, in a spectrum from positive to negative, have treatments, we can hope that the results of these stud- been circulating without producing much constructive ies will be positive while simultaneously evaluating them dialogue. The following FORUM is designed to raise whatever through a highly critical, even skeptical lens. issues exist to the level of productive debate. The second theme involves the role of marketing new therapies, especially direct marketing to the consumer, continued on pages 2 and 3 Biologic Intervention is Warranted BY DAVID SMITH, MD AND MATT TORRINGTON, MD ADDICTION MEDICINE FORUMhe National Institute on Drug Abuse has championed blind clinical trial of Prometa for the treatment of metham- the medical model of substance dependence: Addic- phetamine dependence is being conducted by Walter Ling, T tion is a Brain Disease. The American Society of Addic- MD at UCLA and a randomized double blind clinical trial of tion Medicine stresses that this illness has biologic, psycho- Prometa for the treatment of alcohol dependence is being logical and social elements and needs corresponding biologic, conducted by Raymond Anton, MD at the University of psychological and social treatment interventions. If this model South Carolina. Moreover at Cedars Sinai in Los Angeles, CA, is to be embraced in the United States, scientifi c and medical Jeff Wilkins, MD is comparing the effi cacy of Prometa to that inquiry should follow the approach used with other chronic, of acamprosate and long acting depot naltrexone. In addi- relapsing and potentially fatal illnesses. tion to these studies there are pilot projects looking into the The Prometa treatment protocol for the treatment of benefi t of adding the Prometa treatment protocol to existing alcoholism and psychostimulant addiction is based on a clini- psychosocial models in the criminal justice system. Pilot stud- cally derived theory from Spain and involves multiple FDA-ap- ies in Geary Indiana drug court and in Pierce County, Wash- proved medications administered in a unique combination ington, were so overwhelmingly positive that both programs with nutritional support and psychosocial interventions. adopted the Prometa protocol. The Prometa Protocol embraces “best practices” in addiction Clearly, more study of this biologic intervention is war- medicine treatment by emphasizing the need for biologic, ranted. We are only on the surface of completely under- psychological and social interventions. Thus far clinical results standing how and why this intervention is so helpful to our for patients suff ering from alcohol, cocaine and methamphet- patients. Unfortunately, the real message of the Prometa amine dependence have been overwhelmingly positive. treatment protocols has been lost in the current debate. We cannot change the fact that market forces infl uence every “We are only on the surface of aspect of the fi eld of medicine. We can not change the fact completely understanding how and why this that many of the treatments we use today (i.e. residential intervention is so helpful to our patients.” treatment, nutraceuticals, etc.) are not yet evidence based. We can however, continue to do what we can to help those For patients who have relapsed following multiple episodes of who suff er so much. traditional treatment and for those with severe psychostimu- As data continues to accumulate, more and more patients um lant addiction, for which there is no approved pharmacothera- hopefully will gain access to biologic interventions with such py, the benefi t of the treatment has been especially striking. robust eff ects on craving. or How does Prometa work? The hypothesized mechanism For the sake of our patients, we hope we can move the of action of the biologic aspect of the Prometa treatment is fo- debate in the addiction fi eld beyond ideologies about market cused on the GABA A alpha subunit. Preclinical data suggests forces to a patient-centric, scientifi c level. ß that prolonged exposure to alcohol and psychostimulants can cause changes in GABA A alpha subunits. Specifi cally, these David E. Smith, MD, Founder, Haight Ashbury Free Clinics, San Fran- cisco and Sr. Vice President, Medical Director, Hythiam subunits change from “functional” GABA A alpha 1 subunits to “dysfunctional” GABA A alpha 4 subunits. Matthew A. Torrington, MD, is in private practice specializing in Preclinical data has illustrated the ability of the protocol to patients with substance use disorders and is a medical director of reverse this change in the GABA receptors. Clearly the dys- the Prometa Center in Santa Monica. function of the GABA system to inhibit limbic desire to con- Editor’s note: Drs. Smith and Torrington are investors in Hythiam tinue to use drugs is at the heart of the problem in substance and have opened a new medical practice that operates an outpa- dependence. Although the restoration of GABAergic function tient facility in Los Angeles managed by Hythiam. does not explain the dramatic reduction or elimination of limbically mediated craving for alcohol, cocaine and metham- phetamine that patients report, it is what we understand thus Introducing CSAM’s FORUM Blog far. As an experiment, CSAM will be hosting a moderated blog to How is this being studied? Hal Urshel presented an open provide members an avenue to register their own comments, label controlled study of Prometa for the treatment of meth- questions, and perspectives related to the above Forum. If amphetamine dependence at the annual College on Problems you wish to enter the dialogue, e-mail your contribution to of Drug Dependence meeting in June. His high quality study [email protected] or visit www.csam-asam.org and click ddiction Medicine F illustrated safety in the outpatient model, high adherence to on “CSAM BLOG”. If you would like to send a letter to the edi- the protocol and a dramatic reduction in methamphetamine tor address it to: CSAM attn: CSAM News Editor, 575 Market A use confi rmed by urine drug screening, in a trial conducted Street, Suite 2125, San Francisco, CA 94105. without a specifi c drug abuse counseling element. Random- The Communications Committee will review and post all per- ized double blind clinical trials, funded by unrestricted grants spectives that advance the dialogue opened by this FORUM. are currently underway. A multicenter randomized double When enough perspectives are posted to generate a substantial discussion, we will send an email alert to members with instruc- tions on how to access the blog. 2 CSAM NEWS • FALL 2006 Biologic Intervention is Warranted Insuffi cient Scientifi c Evidence for Prometa BY DAVID SMITH, MD AND MATT TORRINGTON, MD BY RICHARD RAWSON, PHD AND A.
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