Raid!

First by halting a Calgary trial and then by seizing product shipments, Health Canada has pulled the plug on a controversial neutraceutical being sold as a treatment for mental health disorders. Now protractors and supporters of the product are making their concerns heard

By Barbara Kermode-Scott

RAYMOND, ALTA. – Some cheered, others jeered after RCMP officers and Health Canada investigators raided and searched the offices of a company here that has been supplying a nutritional supplement that about 3,000 Canadian customers use for their health problems.

The raid, on July 15, was the latest flashpoint in a continuing struggle. It was certainly welcomed by critics of the company. But many users and defenders of the product were angry and dismayed.

Health Canada and the critics say the product, which is being used as a drug, is unapproved, unproven and unsafe. They fear Canadians with mental health problems will stop taking their medications while using the vitamin supplement, and thus risk suicide.

The product's supporters argue it's a miracle cure. They believe people who lose access to the supplement will be at risk for suicide.

The marketer of the product, Truehope Nutritional Support Limited (also known as Synergy), is based here. Truehope has been selling its product, Empowerplus (also known as EM Power+ and EM Power), by mail to people who use it to treat various mental health and central nervous system disorders.

Participants in the Truehope "program" take the product for bipolar disorder, anxiety disorder, panic attacks, attention deficit disorder, schizophrenia, autism, Tourette's syndrome, fibromyalgia and obsessive compulsive disorder.

Truehope claims its "complete and balanced nutrient program" covers multiple deficiencies in numerous areas of the body, including the central nervous system. The product is a nutraceutical based on a supplement first used in aggressive, irritable pigs.

Containing 13 vitamins, three amino acids and 17 minerals in a chelated form, the product is sold in Alberta but made in Utah.

According to Truehope, many users are able to completely stop using their psychiatric medications due to a reduction or elimination of symptoms while taking Empowerplus. Health Canada believes Canadians could be putting their health at risk if they do this.

In January 2002, the Therapeutic Products Directorate of Health Canada terminated a University of Calgary research trial investigating the use of Empowerplus in bipolar patients. This past spring, Health Canada began seizing individual shipments of Empowerplus coming into Canada.

On June 6, Health Canada advised consumers not to use Empowerplus, explaining its efficacy and safety had not been shown and that it had not been approved for sale in Canada. Health Canada stressed that serious central nervous system conditions are best treated under the supervision of a health-care provider and should not be self-medicated or self-diagnosed.

On July 15, when Health Canada investigators raided Truehope's offices, they seized the company's paper and electronic business records. Health Canada stated Truehope had refused to comply with the Food and Drugs Act and Regulations, despite repeated requests to do so, and was continuing to illegally advertise and sell Empowerplus in Canada. Health Canada set up a toll-free health assistance referral line for those individuals who had been using Empowerplus.

"Our main concern deals with the unproven health claims being made about Empowerplus, and the recommendation that patients decrease the dose of, or eliminate altogether, medications prescribed by their doctors," said Health Canada in a news release on July 15. "This can result in serious adverse health consequences."

Challenging Truehope

Dr. Terry Polevoy, Marvin Ross and Ron Reinhold—the authors of the e-book Pig Pills, Inc., The Anatomy of an Academic and Alternative Health Fraud (www.pigpills.com/index.html) — have spent several years and money from their own pockets researching and challenging Truehope and the University of Calgary over this issue. Pig Pills Inc. went on sale in April 2003 and was forwarded to Health Canada in June.

The 250-page text refers to interviews and documents obtained from Health Canada, the University of Calgary and the government of Alberta, as well as corporate filings and court documents from across North America, as evidence in its case condemning Truehope's sales strategies and research as marketing.

The three authors (a physician, medical writer and health fraud investigator) were delighted by Health Canada's raid on Truehope.

"We're ecstatic," said Ontario medical writer Marvin Ross, who has also written for the Medical Post.

Ross, a member of the Schizophrenia Society of Ontario (SSO) and president of the Hamilton Chapter of SSO, first began researching Truehope after he discovered that a young man in Ottawa had attempted suicide when he stopped his medication in favour of this supplement.

Ross said he felt it was dangerous and unethical to substitute something that was not approved by government regulators for medication that was scientifically safe and efficacious. He said he was also appalled by media coverage touting this nutraceutical as a medical breakthrough.

Ontario pediatrician Dr. Terry Polevoy first started asking questions about Truehope in October 2000, after watching a television broadcast regarding a preliminary University of Calgary study suggesting bipolar disorder could be improved with vitamins and minerals. The study came to the media's attention when it was presented at the Canadian Psychiatric Association annual meeting.

Dr. Polevoy, who operates five "anti-quackery" Web sites (including Health Watcher, www.healthwatcher.net), teamed up with Ross in March 2001.

"No one of stature ever got up and said this stuff is crap," stressed Dr. Polevoy. "My concern was the risks these patients were putting themselves into and the wild claims being made."

Dr. Polevoy was concerned regarding the failure of the medical community to stop this research or to demand of Health Canada that something be done, and the failure of funding agencies to look carefully at what they were supporting. The province of Alberta funded the research study when Health Canada had not approved the product, he pointed out.

"Alarm bells should go off when lectures are done inside a medical school or inside a hospital," he said. "Why in the world are they giving these people a podium? It makes it look as if it's all kosher, and it's not."

People who are desperate are willing to believe anything. If physicians should find that their patients are drifting toward the alternative health community, then they need to re-establish communications with them, recommended Dr. Polevoy. The chances are if the patient has a mental health problem, drugs have failed them and counselling has failed them.

"There are going to be thousands of people across Canada who are susceptible to this kind of spin," he suggested.

"If anyone in your community or medical school gets involved in something like this, red flares should go up. You should focus on why this is happening and contact Health Canada. Use the Web sites to do your own investigation. If you don't have the time to do that, let me know. I'll be glad to bring the story at least to the public on my Web site."

It's important to discuss with your patients what they're taking, stressed Dr. Donald Addington, clinical head in the department of psychiatry for the Calgary Health Region. "Keep asking people so you have a sense of what they may be taking. Try to keep them out of any major difficulties."

Supporters protest

Supporters of Truehope have set up Web sites (www.empower supporters.com; www.red umbrellas.ca/index.htm; www.friendsoftruehope.com/ media.htm) to share their views and discuss the issues surrounding Empowerplus. They also held protests in Ottawa in June and in Edmonton (outside the office of federal Health Minister Anne McLellan in July).

The "Red Umbrellas," a group of women with bipolar disorder, argued Health Canada's action against Empowerplus was "a bold attempt to herd 3,000 healthy people back" into a burdened medical system.

"We've tried drug therapy. It didn't work for us," they said. "We were ill, suicidal and had no life. Our lives depend on access to this supplement. Health Canada wants to take that away. They claim to protect us, yet they refuse to hear us."

"Health Canada's latest attack on the freedom of Canadians to make their own health choices is intolerable," said former chiropractor Dr. James Lunney, currently MP for Nanaimo-Alberni in British Columbia. "They have resorted to extreme, unwarranted measures to prevent promising, low-risk products from reaching Canadians who require them. This bureaucratic interference is out of control; it is contrary to science and to the public interest."

The Alberta division of the Canadian Mental Health Association (CMHA) has been inundated daily with calls, e-mails and letters supporting Empowerplus, said executive director Ron LaJeunesse. Family members of users talk about "an unbelievable change" in their relatives. For those consumers and families who have seen this dramatic change, there is severe angst about the product not being available, added LaJeunesse.

"I am personally acquainted with about 25 people whose lives have been completely altered with this product. And I believe that for most, if not all, this is not a result of any placebo effect," he said. "I personally have talked to two families who have lost members to suicide, they believe, because of hopelessness associated with the potential inability to obtain the product. I know others who I predict will be hospitalized if access is not available."

Some physicians and psychiatrists are monitoring their patients and allowing them to choose whether to go on this product, according to LaJeunesse.

Don't discount product

"My hope is that doctors would simply not discount the product as being some placebo that's not effective. My appeal to doctors would be to please stay involved and work with their patients to monitor their progress to see whether or not this product is good for them. For some it's not. If the physician simply discourages people from using it, they then will go and use it anyway, without any kind of supervision at all."

The CMHA has never endorsed Truehope. LaJeunesse shares many of the concerns of others regarding the company's marketing approach and price structure. Truehope makes claims that are "drug-like and inappropriate," he said. "Its marketing must change. Cost is also a concern."

The cost of Empowerplus is $63.98 US per bottle for capsules, and $69.98 US per bottle for the powdered drink mix. According to Truehope, in the maintenance phase the average person will use approximately one bottle per month. However, according to LaJeunesse, some families, depending on the dose, spend up to $600 on a month's supply.

"If you're suffering a bipolar depression, money is of no consequence at all," he explained. "We need to do more research—and urgently."

University of Calgary researcher Dr. Bonnie Kaplan, (PhD) a professor in the faculty of medicine (community health sciences/pediatrics), undertook the open label study of this health product with Calgary psychiatrist Dr. Steve Simpson. Dr. Kaplan said she believes further studies of this treatment are warranted. However, Health Canada has not yet approved a clinical trial.

"The research has been very promising," she said. "While the participants in our research generally benefited mentally and remained healthy physically, the results are preliminary."

Case series published by two independent clinicians in the U.S. (in the Journal of Clinical Psychiatry and the Journal of Child and Adolescent Psychopharmacology) have replicated the University of Calgary's findings, she added. An additional manuscript is under review. Formal clinical trials are planned.