Subject:   Concerns Regarding a Nutritional Cure
Date:   2002-06-27

Update Available

CIRCARE is concerned about clinical trials at several sites in the US and Canada in which participants diagnosed with severe psychiatric disorders were treated with an investigational drug lacking approval from the FDA, or its Canadian counterpart, Health Canada. Our concerns, based on information in the public record, are:

1. The developers and distributors, along with the PI, claim that the drug was developed from a nutritional cure for swine afflicted with tail-biting syndrome, a previously overlooked porcine model for bipolar disorder in humans. But there is no public record of evidence to substantiate the claims of an animal model. In fact, leading swine researchers are unaware of any data to support these ideas.
2. Adults and children diagnosed with disorders of schizophrenia, clinical depression, ADHD, bipolar disorder, Tourettes Syndrome, autism, and fibromyalgia have been solicited to participate in self-funded research with claims of efficacy and safety, yet there is no data support these claims.
3. We are particularly concerned that preliminary, limited research on humans is being used as a marketing tool to promote sales of the drug. In addition, the mixing of advertising and testimonials for research recruitment distorts the informed consent process.
4. There is no indication of the identities of the investigators, or IRB/REB oversight in the research conducted by the manufacturer and distributors. Currently,investigators affiliated with the University of Utah, the University of Calgary, and non-medical personnel with the Utah manufacturer, Evince International, and distributors, Synergy American Truehope Center LLC, and The Synergy Group of Canada, have been involved, or are involved in research and promotion of the drug.
5. Study participants are warned that severe adverse events result from the interactions between the investigational drug and prescription psycho-tropic medication, and so they are counseled to stop taking prescription medications by affiliated Research Assistants.

We thank the Schizophrenia Society of Ontario and consumer watchdog Dr. Terry Polevoy for bringing this matter to our attention, and we will provide updates as more information becomes available.

Elizabeth Woeckner MA, CIRCARE Board of Directors

Michael A. Susko MS, CIRCARE President
(410) 499-4895

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Updated Information

• Office for Human Research Protections Determination Letter Issued to the University of Utah. 2002-08-19. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/aug02e.pdf. OHRP determined that Richard Ferre M.D. conducted clinical trials with EmpowerPlus without adequate informed consent or Institutional Review Board approval.
• Mona Akoury M.D. Health Canada. Correspondence to Bonnie J. Kaplan, Ph.D. Unsatisfactory Clinical Trials License Application for studies titled Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder and Fibromyalgia Clinical Study. 2002-01-04. Available from http://www.circare.org/FOIA/hc_cta_20020104.pdf
• Browse our Index of Documents on Research With EmpowerPlus

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Last Updated: 2006-02-26