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Decade-long battle comes to end |
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Written by Sherri Gallant LETHBRIDGE HERALD
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Friday, April 10 2009, 7:42 PM |
After more than a decade of battles with Health Canada, the southern Alberta makers of a natural treatment for bipolar disorder will soon be able to sell Empower Plus on store shelves here.
The long-awaited natural product number (NPN) has been approved and while it isn’t here yet, when it does arrive for retail, it will carry the name Empower 18-Plus and a label caution advising against giving the nutrients to minors without a doctor’s supervision.
There are more than 50,000 people registered in the database of True Hope, the parent company of Empower 18-Plus, many of them under age 18.
True Hope Nutritional Support began making Empower Plus in 1996, and the company has been waging one war or another with Health Canada ever since. The company was charged under the Food and Drug Act in 2003 because even though the supplement is a food product, federal regulations (which have since changed) stipulated if health claims are made about a product, it must be called a drug. A 2006 court battle saw True Hope emerge victorious and Health Canada opted not to appeal.
Co-founder Tony Stephan and his partner David Hardy developed the supplement after Stephan's wife, Debbie, committed suicide. Debbie Stephan and several of the couple's 10 children suffered from rapid-cycling bipolar disorder and were often suicidal and frequently violent. Hardy knew that violent behaviour in hogs was mitigated well with mineral supplements. The men decided they had nothing to lose by formulating a human version and trying it out on Stephan's kids, who quickly became symptom-free and off psychotropic medications. Several thousand people around the world use the product now.
The company runs a support centre for customers that includes a voluntary self-reporting (of symptoms) system. So far, Canadian customers have had to get their product mailed to them from the U.S., where it’s manufactured, because it’s been limited to purchase for personal use only in this country.
New research out of New Zealand, Calgary and New York published this month shows marked improvement in patients with bipolar disorder and a startling case history of one 18-year-old man who showed remarkable improvement from neurological symptoms of other types.
“We are going after Health Canada to get that stipulation removed so people of any age can take it,” said Stephan. “And we are continuing to push to get the product into the medical system so doctors can start prescribing it.”
In the current issue of the Journal of Anxiety Disorders, Julia Rucklidge, researcher for University of Canterbury in Christchurch, New Zealand, tracked an 18-year-old male with obsessive-compulsive disorder (OCD) who was resistant to conventional therapies. The young man had a year of cognitive behaviour therapy that took his anxiety from severe to moderate, but a year later he’d regressed to severe again, with major depression. At that point, he began a trial with True Hope’s micronutrients and, after eight weeks his mood was stabilized, his anxiety reduced and his obsessions were in remission.
His sever symptoms returned when the treatment was discontinued for eight weeks, and when the formula was re-introduced, his symptoms again improved.
“There are some additional studies due to be published in the very near future as well,” said Stephan. “And everything points to the importance of considering the effect micronutrients have on mental illness.”
In Clinical Medicine: Psychiatry, Bonnie Kaplan of the University of Calgary and Dermot Gately, New York State University, tracked nearly 400 patients with bipolar disorder long term, reporting six months of results.
“Because of the incomplete benefit from pharmaceuticals and from single-nutrient interventions in treating mood symptoms,” the report explains, “and the more promising results from multinutrient formulas, we investigated the long-term benefits of broad-based micronutrient treatment.”
True Hope’s voluntary database was made available to the researchers for analysis. Although a doctor’s confirmation of their diagnosis was not available, 81 per cent of the participants were taking psychiatric medications at the time they started taking the formula, indicating a physician thought their symptoms were severe enough to warrant prescribing medications for them.
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Last Updated ( Monday, August 10 2009, 2:29 PM )
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