IN CANADA, TRUEHOPE'S MICRONUTRIENTS SHOW PROMISE FOR BIPOLAR AND OTHER MOOD DISORDERS

MONTREAL – Tony Stephan’s life was coming unglued.

In 1994, the 40-year-old engineer from Cardston, Alta., thought his 210-pound teenage son might kill him.

Joseph, 15, had been diagnosed with bipolar disorder and although medicated had violent mood swings. Once a gentle giant of a kid, he would explode into violent rages.

“He assaulted my wife. We were all afraid for our lives,” Stephan said in an interview. “My son was insane.”

But that was just the half of it. Severe bipolar disorder runs in the family.

Stephan’s wife, Deborah, and daughter Autumn Stringam, 22, had also been diagnosed with the condition. Autumn hallucinated and saw “demons” coming out of a hole in her chest. Then one day, Deborah committed suicide, asphyxiating herself in the family van in a provincial park.

Stephan was losing it. He had just buried his wife. It seemed to him his son and daughter were next. What he did to apparently save his kids – taking them off their medications and giving them micronutrients (concentrated daily doses of a vitamin and mineral formula) – is now being heralded as either a scam or a revolution.

Stephan is not a doctor or a scientist, but a new wave of international research suggests this “regular guy” from rural Alberta could be part of a significant breakthrough in the way we see and treat mental illnesses. Stephan claims mental illnesses may not be life-long conditions but potentially treatable nutritional issues. But Health Canada, some doctors and some mental health experts have disagreed, warning against Stephan’s micronutrient approach.

Micronutrients sound like something out of a Hollywood script: A “cure” for terrible diseases discovered by the families of those suffering with the illnesses, not medical professionals. That remarkable claim is getting support from preliminary studies at universities in Canada, the U.S. and New Zealand.

Taking risks with medication is naturally dangerous and worthy of extreme caution and this story does not suggest people with mental illnesses stop taking prescribed medication. But a new approach may be on the horizon and with the announcement of a major clinical trial of treating Attention Deficit Hyperactivity Disorder with micronutrients, it’s time to take a look at the bigger picture.

Studies at three major universities have now concluded the micronutrient approach to mood disorders merits serious examination. Results of preliminary research into treating people suffering from ADHD with the Canadian treatment approach, reported in January at the University of Canterbury, caused a stir in New Zealand.

“People … made ‘remarkable’ improvements by taking a daily dose of nutritional supplements rather than conventional medicines, a trial has found,” an Auckland newspaper reported.

Now, a double-blind, placebo-controlled study – the accepted standard for testing new treatments – is taking place in New Zealand, testing Stephan’s treatment on people with ADHD. (In such a clinical trial, neither the patients nor the researchers know who is getting a placebo and who is getting the treatment, so the results aren’t tainted by expectations.)

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“The normalization of the mentally ill via nutrient supplementation would be the most significant breakthrough in the field of mental illness since the beginning of time,” states Bonnie Kaplan – a professor in the faculty of medicine at University of Calgary who has conducted research into Stephan’s micronutrient treatment – in conference materials for Micronutrients for Mental Health, held in San Francisco in December.

Kaplan co-authored a study with New York University economics Professor Dermot Gately, published in November 2009, examining 358 adults with bipolar disorder who were using Stephan’s approach. The study showed that symptoms of bipolar disorder were “45-per-cent lower after six months” of taking micronutrients, according to their report in the journal Clinical Medicine: Psychiatry. This involved daily doses of vitamins and minerals that could be sourced from almost any drugstore.

Although this treatment originated in Canada, other countries might be in the process of legitimizing it. But at home, Stephan has been shut down and called a fraud, a charlatan, and even accused of exploiting the horrors of his family ordeal for profit, he says.

“There was a lot of excitement about this stuff when it first came out,” said Bill Ashdown, vice-president and founder of the Mood Disorders Society of Canada, an advocacy group. But Ashdown notes sufferers of mental illnesses and their families have frequently been let down by “exciting new treatments.” Could this be different?

After looking at copies, sent to him by The Gazette, of some University of Calgary and Canterbury studies done over the past decade that show Stephan’s micronutrient approach has promise, Ashdown said he liked what he saw so far.

“The more I looked at the studies, the more encouraged I am. It’s obvious this is a whole area that needs further study.”

Stephan claims that today 60,000 people worldwide are using his treatment and “80 per cent have lives that have returned to some kind of normalcy.”

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Mental illnesses will be the No. 2 cause of death and disability by 2020, according to the World Health Organization. Along with many common mental illnesses, bipolar disorder, also known as manic-depressive disorder, is becoming more common. One in every five Canadians will have a mental health problem at some point in their lives and about one per cent will experience bipolar disorder, according to the Canadian Mental Health Association.

Although the condition varies greatly, bipolar disorder is generally accompanied by dramatic mood swings often from depressive to manic states, which can come with psychosis, delusions and hallucinations. It is tied to elevated rates of depression and suicide. There is no known cure for bipolar disorder but many have their condition stabilized through medication, traditionally pharmaceutical variations on the mineral lithium.

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“My son was on 900 milligrams of lithium a day and was absolutely out of control,” said Stephan. His daughter, who was on a mix of pharmaceutical drugs, believed her husband was plotting to murder her.

Fearing his children were headed for oblivion, Stephan says he found something that saved his kids. What he discovered was outside medical practice, and at first glance sounds totally loony.

While discussing new carpeting for his church basement, Stephan told his desperate story to David Hardy, an animal feed specialist. Hardy observed Joseph’s bipolar condition sounded a bit like ear-and-tail-biting syndrome in pigs. Yes, pigs. Pigs often behave badly, something that can be regulated by changing their diets. Using Hardy’s background in feed supplements, the two would then create a human version of a pig nutritional regimen, which they administered to Stephan’s children while weaning them off their medication, which had not been effective. The supplement was heavy in micronutrients.

As opposed to major nutrients like proteins and carbohydrates, micronutrients are the tiny trace amounts of minerals and vitamins that some believe are essential to health and balanced mental function. They include selenium, zinc, chromium, manganese, magnesium and molybdenum among many others. The theory is that people who lack certain micronutrients lose healthy brain function, and may develop mental and mood disorders. Some people simply need them more than others.

Within about 30 days on a daily high-dosage micronutrient supplement, Joseph’s symptoms were gone, Stephan says. Autumn had been in a psychotic state, convinced there was a portal to hell in her chest. After four days of treatment, she says, her hallucinations subsided. Autumn would later write a book about her ordeal, A Promise of Hope, published by HarperCollins in 2007, where she describes waking up after taking the supplements for several days: “I push my arms under the blankets to feel my chest. There is no hole. Just me, in bed with a mid-morning sun on my face.”

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“New treatments come along all the time,” said Professor Hani Iskandar, coordinator of undergraduate medical education in the department of psychiatry at McGill University and a Douglas Hospital clinician and researcher in mood disorders. “It’s important to be very cautious.”

New treatments do follow a clear and careful route in the medical world, and Iskandar said the micronutrient approach has yet to gain appropriate credibility.

But in the U.S., there are now several hundred doctors prescribing micronutrients, says psychiatrist Charles Popper, a clinical associate at McLean Hospital, a Harvard University psychiatric teaching hospital.

Dr. Scott Shannon treats adults and children with bipolar disorder in Fort Collins, Colo., and is an associate professor in psychiatry at the University of Colorado. He says he now regularly prescribes Stephan’s micronutrients to those patients: “It is so much safer and effective, and it’s really a shame that it’s not more well known.”

Shannon says unlike pharmaceutical medications, which often cause “weight gain and cognitive clouding, the only side effects we get is some soft stools because magnesium, one of the ingredients, is a laxative.”

Shannon said he personally has treated more than 150 patients with mood disorders with the micronutrient approach.

“I would say 70 to 80 per cent respond robustly,” he said. “After two years they often don’t need me anymore.”

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After Stephan’s kids returned to “normal,” Stephan and Hardy decided to seek scientific validation for their discovery.

They began by approaching scientists, contacting Kaplan, then director of behavioural research at Alberta Children’s Hospital. Kaplan would initially tell a reporter: “I told them to take their snake oil somewhere else.”

But in 1996, Kaplan, on the recommendation of a scientist friend, met with the two men, and they convinced her it at least merited investigation. She tried the micronutrient treatment on people who had not responded well to conventional medication for bipolar disorder, two young boys with mood disorders and explosive tempers. After taking the supplement, Kaplan said, their rages diminished.

Kaplan was intrigued, and in 2000, began a small open-label clinical trial of 11 bipolar patients who had also not responded to standard medications. After six months, all 11 patients were both less depressed and less manic according to Kaplan’s study, which was published in the Journal of Child and Adolescent Child Psychopharmacology.

Kaplan would tell Discovery Channel: “In a word, they got better. It somehow corrects an imbalance that these people are predisposed to have.”

Stephan and Hardy also met with psychiatrist Popper. After testing the Canadians’ micronutrient treatment on 22 patients suffering from bipolar disorder, Popper wrote in the December 2001 Journal of Clinical Psychiatry: “What if some patients could be treated with inexpensive vitamins and minerals rather than expensive patented pharmaceuticals?”

Of his 22 patients, “19 showed what I believe to be a positive response. (2 mild, 7 moderate, 10 marked improvement),” Popper wrote.

“I’m in full agreement with being skeptical about new wild-eyed claims,” he said in a recent interview. “But it’s clear that this merits research.”

These results are still considered “anecdotal” by medical research standards, which usually require a major double-blind, placebo-controlled study like the one now under way in New Zealand.

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Stephan and Hardy, who happen to be Mormon, in 1996 co-founded Truehope, a religious-sounding Alberta nutritional supplement company, to sell their micronutrient treatment for bipolar disorder, EMPowerplus, which they manufacture in Los Angeles. It’s a mixture of vitamins and minerals that sells for about $150 for a month’s daily supply. The mixture contained relatively high doses of 34 vitamins and minerals including B vitamins, calcium, iron, magnesium, copper and potassium. Truehope quickly became controversial because of its advice to clients taking EMPowerplus to go off their regular medication, due to possible side effects of overmedication.

On its website, Truehope claims its products not only help resolve bipolar disorder but also migraines, schizophrenia, depression and other conditions.

“Yes. It got us into a lot of trouble,” with Health Canada, which requires testing of products for which medical claims have been made, said Stephan, who says he believes that most mood disorders may have a nutritional basis. “We had people coming to us with depression who wanted to try our product. When it seemed to work, it was hard to say ‘no.’ ”

Truehope does suggest that people go off their meds, though with the help of their doctors. The obvious danger of the micronutrient approach occurs when people go off their medication because of it.

“We try to work with people’s doctors when we can. I do believe in science,” he said. “But I believe in helping people, too. The mindset about mental illnesses is there’s no cure for them and there never will be. I obviously disagree.”

Why would a nutritional supplement, based on one given to pigs, work on human bipolar disorder when medical science can seemingly only manage it?

Generally speaking, common mental illnesses are seen as life-long conditions. They cannot be cured, but can be treated and sometimes moderated by modern medicine. Nobel Prize winning scientist Linus Pauling had another idea in the late 1960s. He speculated that some people have a stronger genetic-based need for vitamins and minerals than others. He suggested some mental illnesses could simply be results of failing to meet these requirements. Scientists have observed that nutritional deficiency in otherwise healthy people can quickly produce mental issues. Almost anyone will experience mood swings when very hungry.

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Back in Calgary in 2001, Kaplan was ready to go to the next stage, and launch a major double-blind study. But in March 2001, Health Canada lowered the boom.

“We started the study,” said Kaplan. “And then I found out the formula had been stopped at the border by Health Canada. Health Canada shut down our trial. They confiscated the formula, raided Truehope’s office, and ordered everyone to go off the formula,” Kaplan said in an interview.

Kaplan was floored. She said she had assumed at the very least that checking the effectiveness of the micronutrient approach was a reasonable subject of study.

For the thousands of people already using the product, there was panic, says Stephan, as fear spread that users would be cut off.

Tony Rider, a Toronto real-estate agent and bipolar sufferer said in an interview he was so desperate for the supplements he would smuggle them across the border.

“I used to drive back to Canada with it under the seat of my car,” said Rider, who credits micronutrients for his current stable mental health.

A June 2003 public advisory on Health Canada’s website states: “Health Canada is advising consumers not to use EMPowerplus, also known as EM Power+ and EM Power. It is a drug. …

“The main concern with Empowerplus is that the product is being promoted for the treatment of serious psychiatric disorders without having undergone the rigorous testing necessary for all drug products.”

Acting, it says, out of concern for the well-being of patients advised to go off their medications, Health Canada alerted the RCMP, which in July 2003 raided the Truehope office in Raymond, Alta. Truehope was charged with violations of the Food and Drug Act, for selling a drug without government approval. In July 2006, a provincial court judge dismissed the charges, ruling the firm had no reasonable legal alternative to selling its EMPowerplus without regulatory approval, accepting the defence’s arguments that clients may have become ill or even died without it.

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“Why don’t they (Stephan and Hardy) just go away?” Dr. Terry Polevoy said in an interview. Polevoy is a pediatrician who operates the Acne Care Clinic in Kitchener and a fervent opponent of Truehope. He runs one of Canada’s main anti-quackery websites, Healthwatcher.net, and is incensed at what he sees as Truehope’s non-medical approach to treating serious illnesses.

Polevoy, who claims Truehope is simply a scam preying on the desperation of the mentally ill, co-wrote an online exposé book, titled Pig Pills, Inc., The Anatomy of an Academic and Alternative Health Fraud (2003). Polevoy says Stephan is not a doctor, but he and his staff act like medical professionals dispensing “cures” for mental illnesses for profit.

“It’s dangerous. Because there’s no proof and these people aren’t scientists.”

Stephan counters that he expected opposition but he was surprised how “ballistic” it was. Not only was he targetted personally and professionally by Polevoy, but anyone who took up research in the micronutrient area was targetted, too.

The two researchers who originally opened the door to micronutrient research regarding mental illness were both subjected to what they characterize as harassment.

Polevoy wrote letters to deans and research ethics committees at the University of Calgary attacking Kaplan’s research and conducting Access to Information requests for all her documentation. Similar letter campaigns sent to Harvard targetted Charles Popper’s work. As a result, both researchers spent months defending their work to academic bodies, they said.

“We were always exonerated,” said Kaplan. “There’s never been a charge upheld against any of us.”

Popper characterized the campaign against micronutrient research as “anti-science.”

“Their names were being associated with sales of the product (EMPowerplus),” said Polevoy, explaining why he targetted Kaplan and Popper.

The Pig Pills author was stunned to hear that New Zealand was now conducting clinical trials with EMPowerplus. “I don't believe it,” he said, adding he doubted micronutrients would ever gain legitimacy. “No big drug company is going to study this because there’s no money in it – it can’t be patented.”

Kaplan has recently moved on to an Alberta government-supported

$ 5-million study of nutrition and pregnancy, where she leads a 16-member academic team. She said she felt the crux of the furor over EMPowerplus was that the treatment came from regular people, Stephan and Hardy, not the medical community.

“It infuriates their critics that these people aren’t doctors and they’re helping people,” she said.

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David Thomas, a media-relations officer for Health Canada, said although Health Canada allows a version of Truehope’s product to be sold in Canada, it still recommends against the use of EMPowerplus.

“The safety and efficacy of EMPowerplus has not been shown,” he said.

Truehope claims it’s caught in a Catch 22. Critics attack the company, saying it doesn’t have appropriate research backing its claims, but the same critics have campaigned against that very research even taking place, Stephan says.

Marvin Ross, a science writer and author of Schizophrenia: Medicine's Mystery – Society's Shame (2008), co-wrote Pig Pills. He says he and Polevoy got interested in the story when they attended an information session staffed by Truehope in Hamilton.

“They were encouraging people to go off their meds,” said Ross.

In 2007, Health Canada issued another warning about EMPowerplus: “Health Canada has received nine case reports of serious adverse reactions associated with the use of EMPowerplus. … The worsening of these symptoms could be related to taking the product and discontinuing prescription medications.”

Ross says the numbers of former bipolar sufferers who swear by EMPowerplus does baffle him.

“I don’t explain it because I can’t,” he says. Ross did speculate that by its nature bipolar is a condition that “waxes and wanes.” People who experience a natural improvement in their condition might attribute it to EMPowerplus while it may be coincidence.

“Take vitamins if you like,” he said. “But don’t go off your meds. Yes, there are anecdotes about people who have gotten well. But anecdotes don’t make science.”

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Research has taken root at Ohio State University, as well as at New Zealand’s University of Canterbury.

Professor Mary Fristad at Ohio State completed a study in 2009 on Truehope’s EMPowerplus, which showed positive results.

“This report adds to accumulating preliminary evidence that further basic science and clinical studies of micronutrient supplements are warranted,” says her study, published in the Journal of Child and Adolescent Psychopharmacology.

Fristad is now working on finding funding for a full clinical trial of Truehope micronutrients as treatment for bipolar disorder.

Child psychiatrist Arnold, also at Ohio State, says Canada has missed the boat on this one. “There’s been some intemperate claims about nutritional supplements in the past, which may have caused a backlash,” he said. “But a lot of good people are on top of this. I think Canada missed the opportunity to be the leader in the area and now other countries are taking over.”

The formal clinical double-blind, placebo-controlled study, treating ADHD with the micronutrient approach, is now in progress at the University of Canterbury under Professor Julia Rucklidge, a former graduate student of Bonnie Kaplan. Rucklidge says she’s been inundated with over 500 requests from people who want to be on the study, so they can access the treatment.

“It’s been quite amazing,” she said.

As a Canadian, Rucklidge says, she was baffled by what she called Canada’s “crushing” of micronutrient research.

“To try and shut down a natural line of investigation doesn’t make sense,” she said in an interview. “Right or wrong, it’s in the best interest of everyone to find out.”



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