MD Canada,  January/February 2004

Pigs Will Fly

Every good product needs a good legend.

By Brad Evenson

The legend goes that Colonel Sanders came up with his secret recipe of 11 herbs and spices while cooking for hungry travelers at a dusty Kentucky crossroads during the Great Depression. Pamela Anderson was "discovered" by a TV cameraman panning the crowd at a football game. Sir Isaac Newton was hit by an apple.

These legends seldom hold together under close scrutiny, but isn't that beside the point? Most people agree that Kentucky Fried Chicken and Pamela Anderson are delicious and that gravity causes things to fall. But not always.

By any standard, the legend of how pigs helped create a nutritional supplement that its developers say can be effective in treating a range of mental illnesses -- bipolar disorder at the head of the list -- is a good one. Whether Empowerplus, as it's called, lives up to its story is another question.

The legend begins in a tiny Mormon church in the tiny farming town of McGrath, Alberta, when Anthony Stephan and David Hardy got talking about their troubled children. Anthony Stephan, a property manager hired to fix up the church, confessed he was desperate. His wife, who had suffered bipolar disorder, had recently killed herself. And now his daughter and son had been diagnosed with the disease. His family was disintegrating before his eyes. David Hardy, a former high school biology teacher and a church volunteer who sold livestock feed to local farmers, listened with interest. The symptoms Anthony Stephan was describing rang a bell with him.

David Hardy said it sounded as though the children had the same nervous symptoms as barnyard hogs suffering from what was generally called "ear-and-tail-biting syndrome". The pigs, he explained, "become hyper-irritable, hyperactive, and they'll actually kill one another, or tear off an ear or a tail, if it doesn't stop."

He told Anthony Stephan that farmers usually cure the disorder with vitamin and mineral supplements in the feed. It sounded as though the kids needed the same thing. Anthony Stephan was inclined to agree. "The medical system, and I'm not being critical... it wasn't helping," he says.

"Here I'd lost my wife. She had been on a number of psychotropic-type medications -- anti-depressants -- and she died. Her father took his life 16 years before she did. I've got a daughter at that time, 23 years of age, who is absolutely lost. What do you do? So to [try] some vitamins and minerals that could very well have been bought out of a store... that's not a real strange thought."

Anthony Stephan decided to put together a series of vitamins and minerals that might help. When he was satisfied he had enough, he tried them on his children.

For months, his daughter, Autumn Stringam, had been unable to care for herself, was suicidal and was virtually ignoring her four-year-old son. According to Anthony Stephan, Autumn showed a marked improvement in just five days. Suddenly she took showers. She lost her suicidal urges. She began speaking "more cognitively" and started taking care of her son. "Within 30 days, this young lady didn't show any symptoms of bipolar," he says.

Anthony Stephan tried the same mixture of supplements on his son, Joseph, then 15, in early 1996. A seething, angry hulk of a boy suffering from bipolar disorder, Joseph weighed 215 pounds and was out of control. Anthony Stephan said he was scared to awaken the boy in the morning. A meeting with the boy's psychiatrist at the time had brought little hope. She had flipped open the DSM-4 psychiatric manual on her desk and informed him plainly that Joseph was not going to be cured. Indeed, he might be becoming suicidal, she warned.

Again, within days of taking the nutritional supplements, Joseph was transformed, says Anthony Stephan. "This is what got David and me so enthralled that we decided we have to do this," he says.

Anthony Stephan and David Hardy formed a company, Synergy Group of Canada Inc., to research and market the pills, which contain 36 ingredients, 34 of them run-of-the-mill vitamins and minerals including Vitamins A, C, D and E, various B vitamins, calcium, iron, magnesium, zinc, copper, potassium and germanium. The other two ingredients are antioxidants. (The formulation has been adjusted or fine tuned since its introduction.)

The company is now known as Truehope Nutritional Support Ltd. Devout Mormons who wanted to help other families like theirs, the two men vowed to set up so-called Synergy Houses to feed and care for people with bipolar disease, schizophrenia and other mental illnesses. And they sought out researchers to help verify their seemingly miraculous claims.

And so the legend of pig pills was born.

•••

THE CURRENT INCARNATION of the nutrient program is called "Empowerplus" although it sometimes appears as "E.M. Power+". The pills are not cheap, selling for about U.S.$70 a bottle. Patients initially eat up two bottles a month before settling down to the single bottle for maintenance. Like many supplements, they are big and bulky, the ingredients combined with organic molecules that allow the body to absorb them more readily. Stripped to bare essentials, the entire vitamin content of 18 pills could be distilled into a single capsule.

Patients fill out standard psychiatric assessment forms to monitor their progress and have access to 1-800 lines to help with their orders and answer questions. In style if not substance, Truehope bears all the hallmarks of a small but modern pharmaceutical company.

I first heard about Truehope's pig pills in the autumn of 2000 from a psychiatric researcher. As a medical reporter for the National Post newspaper, I hear about hundreds of cures and schemes, most of them bogus. Pig pills sounded ridiculous, a short step up the medicinal food chain from snake oil. "But you don't understand," my source said. "This stuff is being studied at the University of Calgary. They're presenting their stuff tomorrow at the [Canadian Psychiatric Association's] annual meeting."

The road to that presentation began four years earlier, in 1996, at the University of Lethbridge, not far from Anthony Stephan's home in Cardston, Alberta. That's where one of the world's most eminent neuropsychologists, Dr. Bryan Kolb, conducts research in brain regeneration. A fellow of the Royal Society of Canada, his credentials are unimpeachable.

Back in 1995, Dr. Kolb had agreed to meet Anthony Stephan and was touched by the story of his family's plight. He sent him away with some scientific literature about mental illness. Now, a year later, Anthony Stephan arrived with Autumn Stringam and David Hardy in tow, telling a story about his unlikely mixture of supplements. Dr. Kolb was pleased to hear it -- he confirmed Autumn had indeed been diagnosed with bipolar disease. But he doubted the pig pills would help many patients.

Dr. Kolb later explained: "I concluded that whatever gene(s) were bad [were] somehow related to absorption of vitamins and/or minerals and they had stumbled onto it and that was great. But I could see no generality to others and certainly had no enthusiasm for such a proposition."

But Anthony Stephan and David Hardy lobbied hard for Dr. Kolb to test their concoction in patients. Over the years as a medical reporter, I have become acquainted with the pair. They are patient men. They don't get angry easily and they don't go away, either.

Finally, Dr. Kolb agreed.

On June 24, 1996, a group of 13 children diagnosed with attention deficit hyperactivity disorder were assessed for two weeks on their prescribed stimulants. Then, for the next two weeks, they went off medication. Next, they were given the combination of vitamins and minerals used to "cure" the Stephan children.

"To my amazement," Dr. Kolb later reported, "the results looked promising."

Dr. Kolb called a colleague at the University of Calgary's department of pediatrics, research psychologist Bonnie Kaplan, PhD. Bonnie Kaplan, director of the Behavioural Research Unit at Alberta Children's Hospital and a professor in the faculty of medicine at the University of Calgary, had a background in nutrition research. She wanted no part of it. She told him she had dealt with every flake in Alberta in her research. She was tired of it. But when Dr. Kolb sent her results of his brief, five-week trial, she relented.

In recent years, Bonnie Kaplan has endured a lot of criticism for her work and did not respond to e-mails requesting an interview for this article. But we have spoken several times over the years.

At first, Bonnie Kaplan told me, it was difficult to decide who might be a candidate for treatment. "We were trying to figure out what symptoms, which patients," she said. The one thing the supplements seemed to help was regulation of emotions. "It didn't matter what diagnosis a person had... It was the mood effect that we saw right away. It was the most salient change."

Bonnie Kaplan and psychiatrist Dr. Steven Simpson recruited 14 patients with bipolar disease, of whom 11 stayed in the trial. The results were quite striking, she told me. The patients improved substantially. Some of the patients were taken off their prescription medications.

One of these patients was a 32-year-old Calgary man, Steve Morton, who had previously failed on various drug regimens. "I had been on so many other medications... that I said, 'What have I got to lose?'" he told me.

Steve Morton said it felt as though a cloud lifted from before his eyes. He went from taking nine medications to low doses of just two. When I contacted him recently, Steve Morton reported he was still taking Empowerplus and still doing well.

But when Bonnie Kaplan presented her research at the Canadian Psychiatric Association meeting in Victoria in 2000, she was met with a frosty response. Skeptics said studies treating patients with psychiatric illnesses using nutrients had not produced very impressive results.

In one of her last public statements on the matter, Bonnie Kaplan called the results "generally positive" but also "very preliminary."

•••

THE ALBERTA GOVERNMENT took a more optimistic view. In the fall of 2000, the Alberta Science and Research Authority chipped in more than $540,000 to fund a larger, more rigorous clinical trial that would include about 100 people.

In 2001, however, Health Canada started looking into what it considered an unauthorized clinical trial. There had been no application for such a trial. Health Canada contacted the University of Calgary and the Truehope people to inform them of the regulatory requirements.

Health Canada evidently provided "extensive guidance", according to its website, but officials say no application was ever received.

Then, early in 2002, Health Canada pulled the plug. It ordered the trials at the University of Calgary to cease and patients to be transferred to "an appropriate professional who can place them on standard therapy."

•••

STILL, BACK IN 2000, during a speaking engagement in Boston, Bonnie Kaplan met Charles Popper, a Harvard Medical School psychiatry instructor who was willing to try her approach. One of Dr. Popper's patients was a 10-year-old boy -- the son of a colleague -- who was having uncontrollable temper tantrums. The episodes lasted from two to four hours a day.

Bonnie Kaplan gave him some samples.

Within two days of beginning the nutrient regimen, the boy's tantrums softened. After five days, the outbursts disappeared. Neither the father nor Dr. Popper could see a trace of the previous anger in the child.

Intrigued, Dr. Popper tried the supplement in 22 bipolar patients in his private practice. Of this group, 19 showed a positive response, he said. Nine months later, of 15 patients who took medication for their disease, 11 were stable without any drugs at all except for the supplements.

"What if some psychiatric patients could be treated with inexpensive vitamins and minerals rather than expensive patented pharmaceuticals?" he wrote in a commentary in the Journal of Clinical Psychiatry in December, 2001. "The economic implications, for... patients and for the pharmaceutical industry, are difficult to overlook."

Dr. Popper cautioned the supplements could interfere with drugs. More research was needed to learn how to transition patients off their medications, he added.

By now, the pig pills legend was taking to the airwaves. TV news programs put Empowerplus on their shows, dutifully showing video footage of lovable pigs in their pens, as though Wilbur had suddenly sprung from the pages of Charlotte's Web, with "TERRIFIC" spooled in spider silk above his head.

•••

ONE OF THESE BROADCASTS bothered Dr. Terry Polevoy to no end.

A physician who practises in Kitchener and London, Ontario, Dr. Polevoy is better known as a gadfly who operates a series of anti-quackery websites, including healthwatcher.net, chirowatch.org and dietfraud.com. Trained in pediatrics, Dr. Polevoy took a personal interest in the alternative medicine industry in the 1970s and has spent decades crusading against health scams. A CTV news item late in October, 2000, got to him.

"I just listened to the way it was presented," he says.

It bothered him that psychiatric patients, including Steve Morton, were being "paraded" on the air. "And that's what started me," he says, "not because I doubted that there could be any nutritional aspects of mental illness, which I think there probably are, but because of the way it was presented in the media."

The next day, Dr. Polevoy put a series of questions on one of his websites, raising doubts about the pig pill legend.

His concerns went beyond his usual interest in quackery. A few months earlier, Dr. Polevoy's own son had a brush with suicide. "He got in with the wrong people, and he overdosed," he says. It bothered him that Truehope was treating serious mental illness with such cavalier disregard for clinical trials and ethical drug development. What if Zyprexa or Risperdal were put on the market this way?

But Dr. Polevoy wasn't the only one bothered by Truehope's claims. Marvin Ross, a medical writer whose work includes the book, "The Silent Epidemic: A Comprehensive Guide to Alzheimer's Disease," wrote a sharply critical article in The Medical Post about the Empowerplus nutrients and the research surrounding them. Marvin Ross also has a son who suffers from schizophrenia and he has been president of the Hamilton Chapter of the Schizophrenia Society of Ontario.

"We each, in our way, had an interest in what these people were trying to do, and how they seemed to be trying to be doing the right thing, but manipulating the situation," says Dr. Polevoy.

In a strange way, Marvin Ross and Dr. Polevoy were mirror images of Anthony Stephan and David Hardy, motivated to act largely out of the suffering of their children. The pair decided to get together with Ron Reinhold, an Alberta private investigator, to look into Empowerplus. The result is an online book, entitled "Pig Pills, Inc.; The Anatomy of an Academic and Alternative Health Fraud."

And so the legend began to unravel.

•••

AT ITS HEART, Pig Pills Inc. is a thought-provoking book. It takes a skeptical look at ear-and-tail-biting syndrome among pigs, for example, and concludes the evidence is pretty thin for using nutrients as a cure. According to pig specialists they consulted, the syndrome is probably caused by boredom. A simple change in the taste of feed can work the same effect, they were told. Indeed, the European Union has ordered pork farmers to put toys in the pigpen to relieve porcine boredom. While some farmers use trace minerals in feed to prevent the ear- and tail-biting behaviour, there's not a lot of scientific evidence to support it.

Truehope doesn't really deny this.

"We've never purported that ear-and-tail-biting syndrome in the literature is attributed just to [nutrient] deficiencies," says David Hardy. "But if you talk to any feed company out there, and ask them what their number-one suggestion is for ear-and-tail-biting syndrome, they will almost invariably tell you they've found trace minerals are effective."

Dr. Polevoy, Ron Reinhold and Marvin Ross also take a critical look at my reporting in the National Post. Their remarks are fair comment, concluding more or less that I was not skeptical enough about Truehope's activities. I was mildly surprised to learn from the book that the Truehope people had posted my articles on their website as marketing material. But this practice is not confined to purveyors of pig pills. From drug makers to dressmakers, businesses have done it for decades. Look at the movie ads.

Yet Dr. Polevoy raises some excellent points.

In particular, he notes David Hardy and Anthony Stephan seem to find personal parables whenever they need to make an argument. For example, years before Anthony Stephan came up with the idea for pig pills, he had a well publicized dispute with Revenue Canada over back taxes. When his wife, Deborah Stephan, committed suicide in 1994, he told reporters the taxman had driven his wife to the brink. Deborah had left a note telling him to use her life insurance policy to pay off the taxes. Anthony Stephan threatened to sue Revenue Canada over the death. The terrible saga ended up in the pages of Reader's Digest.

"Later, that story was changed to claim that her death was blamed on improperly treated bipolar affective disorder," the book claims. "But -- and that's an important 'but' -- that was after Truehope began selling a possible 'cure' for that disease."

What bothers Dr. Polevoy is how neatly the family histories of the pig pills partners seem to fit into anecdotal testimonies for their products. It would seem they have an unusually high density of mental illness in their family circles to contend with. Two of Anthony Stephan's children had bipolar disease, he says, while two had attention deficit hyperactivity disorder. One of David Hardy's children had schizophrenia. David Hardy's wife suffered from anxiety. All were cured within days of taking Empowerplus.

Or so the legend goes.

As seasoned medical researchers know, the plural of "anecdote" is not "data". And while Truehope has a supply of heartwarming stories that would make the authors of Chicken-Soup-For-The-Soul envious, they lack solid, double-blinded controlled trial data.

Pig Pills also assails the efforts of Anthony Stephan and David Hardy to portray their work as charitable. During interviews and sales seminars, they often describe their efforts in non-profit terms, as though Truehope were a kind of religious outreach program, not a company selling expensive products to ill people. Although Truehope was registered in 2001 as a research-oriented charity in the U.S. state of Nevada, it is not a Canadian charity. Anthony Stephan says the company expects to be granted charitable status by February, 2004.

And Anthony Stephan and David Hardy argue they give away Empowerplus to some people. "We got over 80 families that we support on our 1-800 line at no charge and we supply them with product every week," says Anthony Stephan. "We make sure that these people are nutrited. They don't pay five cents for that." (Reports suggest the company currently has around 3,600 paying clients, down from a high of over 8,000 two years ago.)

Yet Dr. Polevoy and his colleagues also have a habit of pushing things into deep waters. While demanding a high standard of proof from Truehope, he doesn't burden himself with any such constraints. In interviews for this article, Dr. Polevoy suggested darkly that Deborah Stephan had come into harm's way and that her death might not necessarily have been a suicide. Similarly, he felt free to tar Bonnie Kaplan's reputation as a clinical researcher, saying he had "a high index of suspicion" -- from information passed to him -- that Bonnie Kaplan had treated her own son with Empowerplus.

It's worth remembering amid this conspiratorial whispering that Empowerplus is basically just a big multivitamin -- like Flintstones chewables or One-a-Day.

And while Dr. Polevoy and Marvin Ross don't like Truehope's sales tactics, the bad optics reflect both ways. During an Ottawa speech at which he denounced Empowerplus, Marvin Ross acknow-ledged that a pharmaceutical company helped cover his travel costs. Indeed, he has often written for pharmaceutical companies which might, on the surface, appear to have a vested interest in putting companies like Truehope out of business.

"What is [a drug company] doing paying for Mr. Marvin Ross to put on an anti-Truehope campaign?" asks David Hardy.

The book also ignores a critical fact: the nutrient pills sometimes seem to work.

•••

SHEILA STANLEY, a Toronto writer, was struggling with her young daughter, Renée, when she read an article I wrote about the pig pills.

"When she was a teenager, in Grade 9 and 10, she started going through depressions," she says. Not wanting to pathologize the simple state of being a teenager, she and her husband opted to wait and see how things turned out.

Things got worse.

"In Grade 13, she was just melting down," says Sheila Stanley. "She was crying and she couldn't concentrate and she was hysterical." Renée's doctor diagnosed bipolar disease. He prescribed lithium. "I thought, oh no," she says. "Because I've seen what happens. It just seemed like a life sentence."

She decided to try Empowerplus, reasoning that if it didn't work for Renée, there were always psychiatrists and drugs waiting in the wings. As part of Truehope's program, Renée filled in psychiatric assessment charts to characterize her emotional state. Seeing those forms hit Sheila Stanley hard. "It was then that I realized how she was suffering; she just internalized everything," she recalls.

Gradually, Renée's mood improved. She pulled her marks up and organized herself to apply to Dalhousie University in Halifax. She was accepted, but her mother worried about her daughter being so far away from home.

"She's halfway across the country and they've got these keg parties and whatnot, but she's fine," says Sheila Stanley.

"She's getting incredible marks now. She phoned me last week and she got a 90% in her international development class, which is astonishing. I mean, her marks were always horrible. And now she's doing really well."

Sheila Stanley confesses she finds the phenomenon puzzling. How could a bunch of multivitamins have such a profound effect on a disease as invasive and extreme as bipolar disorder? Although she thought about it, she dismisses the notion this could be a placebo effect.

"First of all, placebo effects don't last for two years," she says, adding Renée still takes Empowerplus.

"It's mind over matter, it does exist. But... when people who have been popping pills for the last 10 years, why would they not get the same placebo effect with everything else that they've taken over the years? Why would they suddenly get a placebo effect with this?"

•••

IF EVERY STORY ENDED like Sheila Stanley's, few people would object to Empowerplus. Unfortunately, some end up like Caro Overdulve. Diagnosed with schizophrenia in his early 20s, Caro Overdulve disliked taking his meds, complaining they caused him to get fat and prevented him from sleeping. The young Ottawa-area man didn't think his doctors were paying attention.

In September, 2001, he decided to try taking Empowerplus instead.

Although David Hardy and Anthony Stephan have no studies to prove their product works on schizophrenia -- their meagre experience had been with hyperactive kids and bipolar disorder sufferers -- they do not hesitate to recommend it to all comers. Indeed, they argue schizophrenia is just a more severe form of the manic phase of bipolar disorder.

"We think that it's just more of the same, but they just lose more neural control," says David Hardy, launching into a story about a neighbour they "cured" of schizophrenia in just 90 days.

They also advise schizophrenia patients to quit taking their medications soon after starting on their nutrient program.

"As chemistry restores," says David Hardy, "if you don't get the medications out of the way, they become interfering. You couldn't take psychotropic medications as a normal person and neither can anyone else."

Caro Overdulve believed this story. Selling his old Chevrolet Cavalier to raise the money -- so the story goes -- he began buying Empowerplus. His parents hesitantly agreed to cover the rest of the cost with their credit card, spending almost $3,000 over the next year.

However, the supplements did little to curb his erratic and sometimes dangerous behaviour.

When his parents visited his house, they found it filthy and neglected, with the kitchen covered in rotting food and mould. Empowerplus capsules were scattered all over the floor. He had also spent $600 on telephone calls to a customer support line for the company. Angry at the cost and discouraged by their son's lack of progress, the Overdulves refused to pay any more.

Over the ensuing year, Caro Overdulve drifted from place to place, staying in rooming houses, tiny apartments and even shelters. Three times he was admitted to hospital. After a short stint on anti-psychotic medications, he again stopped taking his meds.

This time, he accused his father of being a Mafia underling and threatened a family member. In May, 2002, he was charged with assault, mischief and criminal harassment. A man in his apartment complex complained Caro Overdulve had hit him and carved obscenities into his apartment door with a knife.

His mother, Anne Overdulve, says Truehope has divided the family.

"He listens to them, not to us," she told the Ottawa Citizen the day before her son's court appearance in June, 2003. "There is no getting beyond it. Anyone who knew him before doesn't even recognize him now."

David Hardy and Anthony Stephan seem to keep a cool and clinical detachment from such stories.

"We're not telling you that this is the cure-all, or magic bullet," says Anthony Stephan, noting his own wife committed suicide while taking medication under a doctor's care.

Says David Hardy: "When it comes to schizophrenia and someone says, 'Maybe you shouldn't be working with schizophrenia', tell me, as the parent of a schizophrenic, that you wouldn't try practically anything, because the medications frankly don't work. You show me a functional schizophrenic on medication who is able to function over a long period of time and I'll show you a very rare bird indeed."

•••

HEALTH CANADA sent its first warning letter to Truehope before the company made any headlines. On July 24, 2000, the federal regulator told the company to stop making medical claims for its products. It followed up a few months later. None of the warnings seemed to change the company's mode of operation.

In January of 2002, it ordered the "clinical trials" at the University of Calgary -- the ones funded by that half-million dollar grant from the Alberta government -- to stop.

On June 6, 2003, the government issued a health advisory on the potential risks of the pills to the media and such organizations as the Canadian Medical Association and the Schizophrenia Society of Canada.

In July, Health Canada officials and RCMP computer experts raided the company's headquarters in Raymond, Alberta, to gather computer and paper files and shut down Truehope's call centre.

The move prompted a huge outcry from patients. Dozens of telephone calls and e-mails came to my office in Ottawa (which I suspect may have been directed to me by Truehope supporters). One woman called to say her son, deprived of his nutrient pills, was now suicidal. "His blood will be on the government's hands," she cried, before slamming down the telephone.

In its advisory, Health Canada said Truehope has failed to provide proof its products are safe and effective. "There are other potential risks associated with Empowerplus," department documents say.

"For example, a 'full loading dose' of 32 capsules (i.e., the dose documented by those who have studied the recommended use of the product) provides amounts of vitamins A, D and folic acid that exceed the maximum limit permitted for non-prescription use. Such high doses could cause adverse effects associated with hypervitaminosis when ingested over an extended period of time." Government documents point out the extended use of germanium, one of the components of the pills, is linked to renal failure and 31 reported deaths.Also, says Health Canada, "Empowerplus contains dl-phenylalanine (DLPA), which is a mixture of the essential amino acid L-phenylalanine and its mirror image D-phenylalanine. DLPA (or the D- or L-form alone) has been used to treat depression. This compound can affect mood and the nervous system. Therefore, DLPA should be taken only under medical supervision. Individuals taking prescription or over-the-counter medications should consult a physician before taking DLPA."

The "bottom line," according to Health Canada, is that "the product is being promoted for treatment of serious psychiatric disorders without having undergone rigorous testing necessary for all drug products to demonstrate their safety and efficacy... The distributors of Empowerplus have recommended the discontinuation or lowering of doses of medication prescribed by physicians. This can lead to serious adverse health effects."

Health Canada concedes its actions have caused an uproar. A senior official told me he'd seldom seen such anger and bitterness. "People were going nuts," he said, noting many patients and their families traveled to Ottawa to protest.

So Health Canada has done something extremely unusual. In a bizarre sort of way, it's the Canada-U.S. Internet pharmacy saga in reverse.

To guide Empowerplus users to their pills, it has laid out a kind of road map on its website. Under the "Human Use Drugs for Personal Use Enforcement" directive, people can import Empowerplus directly from the U.S. -- where it can be manufactured because it is regulated as a dietary supplement there -- for their own use or use by their families. "For an importation of Empowerplus to qualify as a personal importation, the permitted quantity is limited to four bottles of 252 tablets, which represents a 90-day supply of the current formulation," the website states. That level of detailed assistance is almost unprecedented in the federal bureaucracy, and it is a deeply humane gesture. Nobody is going to stop Sheila Stanley from getting pills for her daughter, so why not ease the way?

After all, they are vitamins.

Anthony Stephan says Truehope has also sued the federal government over its actions, although it is difficult to see how the company could prevail. A few politicians, such as Canadian Alliance MP James Lunney, a chiropractor, have taken up the cause, arguing there must be more latitude for alternative health care products in Canada.

Do the pig pills live up to their legend?

Perhaps in some cases. And legitimate, peer-reviewed research has long made the link between nutrients and mental health.

In December, a Finnish study published in the journal BioMed Central Psychiatry found depression patients responded significantly better to treatment if they had high levels of vitamin B12 in their blood. I suspect future research will show some mental illness is related, in part, to nutrient deficiency. And two patients with the same diagnosis may be ill for quite different genetic reasons; one may respond to products like Empowerplus, while the other may not.

But the product is represented as effective in treating a wide range of disorders, including attention deficit hyperactivity disorder, anxiety disorder, autism, bipolar disorder, fibromyalgia, obsessive compulsive disorder, panic attacks, schizophrenia and Tourette's syndrome. That's a big red flag all by itself.

If companies like Truehope expect to make a contribution to medicine in the 21st century, they will have to come up with more than anecdotes and legends. Sooner or later, the company and the product will have to put up or shut up: go through formal clinical trials or stop promising to treat some of the most desperate and vulnerable members of our society.

Brad Evenson is a medical reporter for the National Post.

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