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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, Ren�e,
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." Ren�e'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 Ren�e, there
were always psychiatrists and drugs waiting in the wings. As part of Truehope's
program, Ren�e 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, Ren�e'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 Ren�e 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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