Micronutrient supplement for bipolar illness draws controversy.In 1997, Canadians Tony Stephan and David Hardy started Truehope Nutritional Support to make and sell a vitamin-mineral supplement called EMPowerplus. The ingredients are akin to many multivitamin supplements sold by wholistic practitioners and in health food stores. But the product's claim to help people with mental disorders, particularly manic depression (bipolar illness), has generated a storm of controversy and attracted the ire of CAM skeptics and foes.
Stephan and Hardy developed the formula to help two of Stephan's children, both of whom seemed to have inherited mood disorders from their mother. Stephan's wife committed suicide after struggling with manic depression. Her father had killed himself years before. Hardy, a hog-feed manufacturer and former high school science teacher, knew that vitamin-mineral supplements were used to calm aggressive pigs. The two men decided to mix a human equivalent using supplements from local health-food stores. Stephan then gave the mixture to his 15-year-old son, who was prone to violent outbursts despite being on medication for manic depression. After 30 days of taking the test batch, "all symptoms of [Joseph's] illness were gone." Stephan also gave the supplement to his 22-year-old daughter Autumn after she was released from a psychiatric hospital. Her hallucinations ended within four days. "Nine years later, both Autumn and Joseph remain symptoms free, medication free, and devoted to taking what they call 'the nutrients' each day," according to an article by S. Freinkel for Discover.
Before they started Truehope, Stephan and Hardy contacted scientists and asked them to study their mixture. Bonnie Kaplan, a research psychologist at the University of Calgary (Alberta, Canada), met with them and was convinced by their desire to help people with mental illness. She began giving the supplement to patients who were not responding to conventional treatments. After a few months of observing the supplement's effect on these patients, Dr. Kaplan decided to run a six-month, clinical study with 11 bipolar patients who could not keep their symptoms under control with conventional treatment. At the end of the study, all 11 showed improvement. Most had reduced their conventional medications. Some had quit using drugs completely. Charles Popper, a Harvard University psychopharmacologist who studies bipolar disorder, also began giving EMPowerplus to bipolar patients who did not respond to psychotropic drugs. He observed improvements in about 80% of the patients. Those who improved did so very quickly. Dr. Popper and Dr. Kaplan published their observations independently in The journal of Clinical Psychiatry during 2001. For their willingness to consider nutrient therapy for bipolar illness, both scientists have been attacked by HealthWatcher.net and others.
Research has stalled. A US-Canada double-blind, placebo-controlled clinical study of EMPowerplus was canceled in March 2009, because of an inability to recruit enough participants, according to clinicaltrials.gov. This was the only trial listed (as of September 27, 2009) that was investigating a multinutrient supplement.
Stephan and Hardy have had an ongoing fight with Health Canada (the Canadian equivalent of the US FDA) since 2002. The agency has not authorized the sale of EMPowerplus. Stephan and Hardy have applied for a Drug Identification Number (DIN) and a natural product number. The agency had yet to grant either, as of the 2005 Discover article. Truehope is able to sell EMPowerplus because of an exemption from minister Pierre Pettigrew. In 2006, Alberta Provincial Court Judge G. M. Meagher upheld Truehope's right to sell its product despite Health Canada's attempt to shut down the company. The supplement's critics are concerned that bipolar patients will discontinue their medication without being supervised by licensed physicians, leading to a worsening of their condition. New legislation moving through Canada's House of Commons, such as the Consumer Product Safety Act introduced in 2008, could threaten people's access to EMPowerplus, a supplement that they have found helpful.
Hardy and Stephan continue to encourage discussion about the use of supplemental nutrients to treat mental disorders. Truehope is sponsoring the 1st forum on Micronutrients for Mental Health in San Francisco, California, on December 4-5, 2009 (see www.mmhforum.org). Speakers include Drs. Scott Shannon, Carol Banyas, Charles Popper, Bonnie Kaplan, and Julia Rucklidge, with a keynote address, "Micronutrients and Brain Function," by Dr. Joyce C. McCann, associate staff scientist in the Nutrition and Metabolism Center of the Children's Hospital Oakland Research Institute (Oakland, California).
Freinkel S. Vitamin cure? Discover. May 2005. Available at: www.truehope.com/truehope_bipolar_disorder_press_article_1.aspx. Accessed April 13. 2009.
Howard C. Going Natural. Albertaviews. November 2008. Available at: www.truehope.com/truehope_bipolar_disorder_press_article_8.aspx. Accessed April 13, 2009.
briefed by Jule Klotter