Health Canada Red Flags Natural Bipolar Remedy

(March 6, 2007) -- An extended battle between Health Canada and the makers of a controversial natural remedy for bipolar disorder has been stoked again with the regulator issuing new warnings about potential serious side effects from taking the product.

The latest salvo in the struggle comes less than a year after Truehope Nutritional Support Ltd. was acquitted at an unusual criminal trial of selling Empower Plus as a drug without a licence.

The new bulletin says Health Canada has received nine reports of serious adverse reactions in Empower Plus users. Patients saw a spike in symptoms of their psychiatric illness, possibly because they switched from regular drugs to the mixture of vitamins and minerals, the department said.

It also chastised Truehope for allowing its non-medical staff to advise patients to discontinue their prescribed medication.

Meanwhile, a day before Health Canada's "information update" was released, the rural Alberta founders of Truehope rushed out a sharply worded press release saying they were pushing ahead with a Federal Court challenge of the government and its treatment of the firm.

But the department said it remains as concerned as ever about "the health risk posed by this product's promotion, including unauthorized health claims, and medical advice being provided by non-medically qualified staff ... to patients with serious medical conditions."

A leading expert in bipolar disorder also voiced caution yesterday about the nutritional supplement, saying the limited study of the product has far from proven its efficacy. Until there is definitive evidence, patients should be treated with only scientifically proven remedies, said Dr. Lakshmi Yatham, a psychiatry professor at the University of British Columbia, and head of the Canadian Network for Bipolar Disorder.

"People tend to get excited about these so-called natural, nutritional supplements. But the problem is we are dealing here with a very serious illness," he said.

"People who are doing reasonably well should be staying on these [regular] medications. The alternative is to take something that has no proven benefit. It may work, but we don't know for sure."

But Anthony Stephan, one of the two founders of Truehope, vehemently defended the medication, which he said has prevented many suicides, and noted most pharmaceutical drugs that target mental illness generate far more adverse reaction reports.

The positive ruling in last summer's trial underlined the product's credibility and Health Canada is just continuing its pattern of unjustified persecution of the "non-profit" firm, he charged.

Truehope will continue to push the Federal Court for an injunction that would stop the government from ever seizing Empower Plus shipments again.

"We're going to court to protect Canadians from that savage brutality of taking away something that is working," Mr. Stephan said.

"That's what we're fighting for -- the right to live without having some bureaucrat impose ... some far-away-produced policy that isn't even justified in law."

In fact, he said the Health Canada's natural health products directorate -- which was not involved in the failed criminal prosecution -- has indicated it will approve Empower Plus within weeks, under a three-year-old system that certifies natural remedies based on less-stringent evidence than required for drugs.

The most recent developments around Empower Plus add to a tale full of twists and turns, from the alleged "harassment of a university researcher to a Parliament Hill protest by supporters of the pills called the "Red Umbrellas."

The medley of vitamins and minerals was first developed by Mr. Stephan and David Hardy, an animal feed supplier, after Mr. Stephan's wife, a bipolar patient, committed suicide.

Mr. Hardy said a mixture of nutrients given to aggressive pigs effectively calmed them, and wondered if a similar combination could help humans.

They used what would become Empower Plus on two Stephan children with bipolar and reported major improvements, results duplicated on others who tried the supplement.

The company points to a handful of studies that it says proves the pills' efficacy.

Three studies published between 2001 and 2004 by Bonnie Kaplan, a research psychologist at the University of Calgary, found significant improvements on a total of 22 adults and children with bipolar or other mood problems.

Dr. Charles Popper, a Harvard University-linked psychiatrist, reported similar results in 19 of his patients, as did another American psychiatrist.

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But none of the research published so far has involved blinded, controlled trials, the gold standard in the testing of medication, where the effects of Empower Plus would be compared to those of a placebo or another treatment, although Mr. Stephan said one is underway.

After trying to get it to halt sales, Health Canada had Truehope charged with selling a drug without approval.

Relying heavily on testimony by Drs. Kaplan and Popper at last spring's trial, Justice G.M. Meagher of the Alberta provincial court found the company not guilty.

By: Tom Blackwell
Source: National Post

Last updated: 03/07

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