Being Mentally Ill In Canada Means We've Lost the Right to Choose

Health Canada has decided that persons with mental illness are incapable of choosing between prescription drugs and alternative therapies‹even if those alternative treatments are approved by a physician. This is the basis for Health Canada's argument against the consumers of a multivitamin and mineral product that approximately three thousand Canadians have been importing from the United Sates. They use it for the treatment of disorders like depression, bipolar affective disorder and attention deficit disorder. But it is only a vitamin and mineral supplement.

Over the past year, personal orders of the supplement have been seized at the US border, university research has been halted for poor and illogical reasons, and Health Canada has harassed the non-profit support organization (Truehope Nutritional Support) for making claims for the use of a vitamin and mineral supplement (not legal in Canada according to the antiquated schedule A of the Food and Drugs Act). According to the act, any nutritional supplement that works for any serious illness is a drug and thus requires a doctor's permission to be taken.

Canadians have begged The Honorable Anne McLellan and the Ministry of Health for continued access to the supplement and responsible legislation that would allow them to stay well without depending on an already burdened medical system. Concerns in hundreds of letters were totally ignored and thousands of callers were sent to a mental health support line that was scripted to say that the caller had a serious central nervous system disorder and needed to be seen by a physician. When supplies of the vitamin and mineral supplement ran out, they were instructed to return to drug therapies and hospitalization if necessary.

On June 11, 2003, nine sensible, rational, and healthy women went to Ottawa hoping to be seen by The Health Minister in person. We were not protesting or lobbying. We hoped to sit quietly and peaceably with the Minister and discuss our situation. When it rained, we became known on Parliament Hill as the Women with the Red Umbrellas. The Honorable Anne McLellan soon made her position known when she told another MP that, "they are just a bunch of sick women on a placebo, just trying to make themselves feel better." A colleague asked why, if the supplement was just a placebo, was she calling it a drug and trying to take it away? We'd also like to know why. Another colleague asked her why she refused to meet with us. She answered, "I don't meet with terrorists." On July 12, MPs Dr. James Lunney and Mr. Reed Elley stood with us inside the Parliament Building where we gave a half hour press conference from the Charles Lynch Room. Many other MPs offered their support and invited us to their offices so we could tell our story.

Health Canada has continued with disrespect and degradation toward the mentally ill whom it claims to protect. Recently, an article was published on the Health Canada website that has convinced us that we will not be heard. The article is full of misinformation, biased, out of context clips from otherwise supportive research and fear mongering statements based on information that Health Canada officials know is irrelevant to the supplement and the protection of our health.

In defense of our right to continued health and our right to feed our children food instead of drugs, we have spent the last five weeks gathering information through the Access to Information Act, the manufacturers information, and even Health Canada's own published research on the safe upper limits of consumption for nutritional ingredients. Knowing what we know now, we cannot fathom what would bring Health Canada to act with such aggression against a multi vitamin and mineral supplement, nor can we understand why they have not rushed to support the research and discovery that may be a phenomenal leap forward in the treatment and prevention of mental illness.

The Red Umbrellas are disheartened and disgusted at the ridicule and lack of credit that Health Canada has given us, and all others who choose to take this vitamin and mineral supplement rather than remain on standard drug therapies. Regardless of Health Canada's motive, as Canadian citizens who are now healthy and well, we declare our right to take vitamins and minerals in any combination, in any quantity that we choose. In a country where alcohol, cigarettes and marijuana can be consumed legally, used for self- medication, and even sold by the government, we declare our right to take vitamins and minerals - even if the consumption of these lowers or eliminates our need for doctor's visits and pharmaceutical treatments.

The following information is comprised of quotes from the Health Canada website and our brief answers to Health Canada¹s statements:

Health Canada Quote:

Q .Why doesn't Health Canada consider the views of people who take this drug feel it is safe and effective?

A. Health Canada recognizes the difficult circumstances faced by people with serious central nervous system conditions, and understands that some may have been using Empowerplus. In recognition of the seriousness of this issue, Health Canada is working to provide these individuals with appropriate referral options to health care professionals and services, and to this end, has set up a toll-free health assistance referral line. That number is 1-800 504-4156.

Red Umbrella Answer:
We also understand the serious condition of mental illness. Each of us has experienced the effect of standard health care and has felt the increased benefit of using our vitamin and mineral therapy over the benefit of prescription drugs. The health assistance line gives advice that is irrational when it tells healthy, productive, well people to stop taking a vitamin and mineral supplement and to return to drugs and hospitalization. We are offended by the suggestion that our diagnosis of mental illness allows the government to discount our views and disregard our concerns for our personal health.

Health Canada Quote:
* Health Canada's responsibility is to ensure that drugs sold in Canada are safe and effective. To do that, we require drug manufacturers to provide us with scientific evidence that the drug is safe, effective and of acceptable quality. Red Umbrella Answer: We encourage Health Canada to continue trying to ensure that drugs sold in Canada are safe and effective. Each of us, having taken prescription drugs for mood stabilization, understands that Health Canada is challenged by this task. Addiction, organ damage, and ineffectiveness are all issues that become evident when being treated with drug therapies. Overdose and the threat of adverse drug reactions are also life-threatening realities in the process of standard drug therapy. Thus, we feel safer using a therapy that consists of a vitamin and mineral combination. Our chosen therapy consists of natural ingredients that have been consumed by Canadians safely for decades without a single incident of adverse drug reactions, deadly overdose, or addiction. We feel confident that our current choice of therapy is safer than standard therapy. Furthermore, we do not believe that vitamins and minerals can be classified and treated in the same category as drugs.

Health Canada Quote:
* Empowerplus is sold by the company Truehope Nutritional Support Limited (also known as Synergy). The company has not provided evidence of Empowerplus' safety, effectiveness or quality, and has also failed to stop the promotion and sale of Empowerplus - despite Health Canada's request on several occasions that it do so. Red Umbrella Answer: Empowerplus is a nutritional supplement produced in the United Sates and offered for sale from the United States. Truehope Nutritional Support is a non-profit company that was established for the support of persons with mental illness. Some of the people receiving support from Truehope also receive free supplement through their USA based 501(c)(3) charity called Truehope Institute. Nothing that Truehope does in the support of the mentally ill legally constitutes the definition of Œsale¹ in Canada. The safety of the supplement has been well established through the submissions on safety from the University of Calgary when they requested permission to continue researching Empowerplus. Furthermore, the issues of safety have been well addressed for participants like ourselves through the Truehope document entitled Nutrient Profile which proves safety and efficacy of each ingredient with a culmination of 155 scientific references. We are satisfied that it is safe for our personal consumption.

Health Canada Quote:
* The drug is being sold to treat serious disorders, such as bipolar disorder, anxiety disorder, panic attacks, attention deficit disorder, schizophrenia, autism, Tourette's syndrome, fibromyalgia and obsessive compulsive disorder. Red Umbrella Answer: The supplement is produced as a vitamin and mineral supplement. It happens to work well for us for a myriad of reasons. If we choose to take a vitamin and find that it resolves painful and deadly illness, it does not make the vitamin a drug. Health Canada Quote: * Serious central nervous system disorders should not be self-medicated or self-diagnosed. They are best treated under the supervision of a health care provider.

Red Umbrella Answer:

We have not self-diagnosed or self-medicated. Our psychiatrists and medical professionals did that for us. Many of us still have the support of our physicians as we have moved from drug therapies and frequent hospitalizations to the use of the vitamin and mineral supplement. There are many types of self-medication that Health Canada should be concerned with. Alcohol abuse, prescription drug overdoses, marijuana and other street drug use should be of far greater concern to Health Canada than the use of a vitamin and mineral supplement.

Health Canada Quote:
* Health Canada's main concerns are the unproven health claims being made for Empowerplus, and the recommendation that patients decrease the dose of, or eliminate altogether, medications prescribed by their doctors. This can result in serious adverse health consequences. Red Umbrella Answer: We claim that the use of Empowerplus has, for us, reduced or eliminated the symptoms of mental illness better than previous drug therapies. If we no longer require drug therapy and are able to safely, and with the help of our physicians, eliminate the use of such drugs ­ then we have the right to do so. Health Canada need not interfere in a healthy doctor patient relationship, nor do they have the right to demand that any Canadian remain on unnecessary medical therapies.

Health Canada Quote:
* There are other potential risks associated with Empowerplus. 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 nonprescription use. Such high amounts could cause adverse effects associated with hypervitaminosis when ingested over an extended period of time. The prolonged intake of products containing germanium, has also been associated with renal failure, and even death in at least 31 reported human cases.

Red Umbrella Answer:
The highest recommended dose of the current Empowerplus product is the short-term use of up to 18 capsules per day. Most people use nine capsules per day. According to Health Canada¹s own research on safe upper limits of minerals and vitamins, no ingredient in Empowerplus even comes close to causing a situation of danger or ill health for anyone ­including small children. We have been using this supplement for years and have seen only a steady improvement in our health. Of course all things must be taken with prudence. We are aware that many over the counter drugs taken only once in a high dose can kill an adult. Alcohol taken once in an extreme dose can poison a person, causing brain damage, coma or death. According to the Health Canada website, there are approximately 80,000 hospitalizations every year in Canada associated with the consumption of alcohol. Vitamins and minerals taken once in a large enough dose may cause flatulence or even a stomachache. The issue of Germanium was adequately addressed over a year ago when researchers pointed out that Health Canada was comparing germanium sesquoxide to germanium dioxide. A similar error might be made when a person compares carbon dioxide to carbon monoxide. One is deadly poison; the other is essential to life.  Even we are capable of understanding the difference. We respectfully request that Health Canada research it¹s claims before using ill facts to spread fear among the citizens of Canada.

Health Canada Quote:

* There have been only two studies on Empowerplus that have been reported in the scientific literature to date. Both studies were conducted by the same group of researchers, were exploratory in nature and involved only a small number of subjects. The researchers concluded that more studies were required before the safety and effectiveness of the drug could be determined.

Red Umbrella Answer:
There have been four publishing's in scientific literature to date. Two from the group at the University of Calgary and two others, using larger groups of patients - published by independent researchers. All corroborate the same initial evidence - that Empowerplus has a positive effect on about eighty percent of the patients studied, that drug reduction or elimination is possible in most subjects, and that this may well be a phenomenal breakthrough in mental health research. After the initial studies were published, Health Canada decided that the vitamin and mineral supplement was now a drug and they shut down a double blind placebo controlled study at the University of Calgary which was being funded by a grant from the Alberta government. Health Canada claimed the safety of the supplement was an issue citing germanium as a poison, while ignoring three scientific peer reviews and a mountain of independent research, including their own research on safe upper limits.

Health Canada Quote:
* Health Canada has indicated to Truehope on more than one occasion that it would be willing to evaluate Empowerplus via a new drug submission. Once the supporting evidence has been submitted and assessed, Health Canada will issue a Notice of Compliance and Drug Identification Number (DIN) for the drug product, if the information is deemed to be acceptable. * The information submitted should provide evidence that the benefits of the drug outweigh the risks. Until such time, it is illegal to sell Empowerplus in Canada.

Red Umbrella Answer:
Five years ago Health Canada promised to enact new regulations based on the 53 recommendations of the Final Report of the ONHP Transition Team by eliminating schedule A and sections 3(1) and (2) of the food and drugs act. They have not done so, and continue the archaic practice of defining vitamins and minerals as drugs when the vitamin or mineral is deemed to be more effective than a placebo. Drugs are classified as drugs because of their potential deadly side effects, addictive nature, and chemical composition. Vitamins and minerals are not drugs. To classify Empowerplus as a drug would force well people back to the doctor¹s office, increase the price dramatically, and tie up access to the supplement indefinitely while the government decides whether or not it is safe. They want evidence of effectiveness, yet they refuse to hear from the people who use it and refuse to allow research to move forward. 

Conclusion
In a country where known carcinogens are sold and consumed freely, where alcohol is abused and sold to people in all walks of life, where the government grows and sells marijuana, admittedly with no evidence of effectiveness or safety, where people die every day as a result of drug overdose and suicide, where the health care system is burdened to it¹s limit with people hospitalized and treated for mental illness, where is the sense in restricting access to a safe and effective vitamin-mineral supplement? A supplement that does no harm and that has proven to eliminate the symptoms of a dreadful illness for so many people. We cannot be heard, because we are considered ill, yet unless we are heard, we will surely be ill again. The Red Umbrellas www.redumbrellas.ca The New Face of Mental Illness in Canada.