The Truehope Trial - Our Take
On Friday July 28, 2006 Alberta Provincial Court Judge Gerald Meagher read the salient points of a decision on a prosecution between Health Canada and Truehope Nutritional Support before a full courtroom of Truehope supporters, and a few reporters.
Health Canada had charged Truehope with selling a drug product to the public prior to receiving a Drug Identification Number (DIN). Truehope was marketing a vitamin supplement known as EM Power in 2003 at the time of a Health Canada raid on their Raymond premises. However, the Truehope issue has always been that they were marketing a supplement to the mentally ill community as a treatment for serious mental illnesses without adequate scientific proof of either safety or efficacy.
The Truehope people are a group of well-intended, southern Alberta families, somewhat rural, and very family orientated. They are a sincere, and well-mobilized group that legitimately believe are helping people fight serious mental illness with their product. Much of Truehope's belief about the effectiveness of the product comes from satisfied customers, in the form of testimonials. As sincere, and well-intended as the Truehope group are, (and they are well-intended), the Truehope group tend not to have people educated in science, and the group as a whole, in our opinion, tend to not appreciate the degree of controlled studies that are required to validate a product as safe and effective for a medical condition. Within the group, testimonials are much more compelling evidence of product effectiveness than the "double blind clinical trial".
The scientific effectiveness of the product has been the subject of vigorous debate - interestingly much of the debate has gone on between concerned activists and scientists who seem to be "aligned" or at least in regular contact with the company. Curiously, the government has only been peripherally involved in this debate.
The long awaited trial on this matter took place in March of 2006. Health Canada demonstrated with no difficulty that Truehope was indeed selling the product without the required DIN. However, the main issue of the trial was the defense by Truehope, that they were compelled by necessity to continue selling the product, as people were benefiting it, and there would be more harm than good done if Truehope indeed had obeyed the law, and stopped selling the product. On the main issue of the trial, Health Canada, in its infinite wisdom, chose to not show up.
While Judge Meagher said there were complex issues in the trial, the decision was really an easy one to conclude. It was no contest.
Health Canada chose to only have three witnesses testify - two were inspectors involved in the search and seizure under warrant in July of 2003, and one other person was involved with issuing DIN's. Health Canada clearly showed that the product was being sold without a DIN.
· Had no expert witnesses testify to the risks of selling a product with little formal scientific proof to the seriously mentally ill,
· Did not address the issue of Truehope having a call center staffed with support people giving medical advice to customers, even though the support people have no formal health science training,
· Did not address the problem of adverse reactions that have been reported with the product, including one particularly dramatic case in the Ottawa area,
· Neglected to bring up the issue of Truehope people recommending customers cease their prescription drug therapy and instead use EM Power, at great potential risk to their health.
In fact, Health Canada had nobody even attend the trial after their three witnesses testified, and they had no representation on the day of the judgment.
Health Canada should have known that Alberta Children's Hospital child psychologist Dr. Bonnie Kaplan would be testifying for the defense. Kaplan could have, and probably should have, been grilled on the many shortcomings of her preliminary research on EM Power. Shortcomings which include, among other issues, the very low numbers of participants in the studies, the number of drop outs, and the fact that the studies were not double blind studies.
The relationship of Dr. Kaplan to Truehope has always been an issue for this writer - she never did answer a question put to her in court asking if she was aligned with the Company (she answered by saying "I don't know what you mean by being aligned...") Certainly, giving Dr. Kaplan a free ride in this matter was not in the public interest.
Another expert witness called by the Defense, a Boston area psychiatrist Dr. Charles Popper wasn't even cross-examined by the prosecutor who was representing Health Canada. Dr. Popper's observations are not scientific, and not controlled in any way. They are just anecdotal observations by a clinical psychiatrist. These expert witnesses did not address the issue of whether the product should be sold as a treatment to the mentally ill population by non-professional people without any professional control.
Other points where Health Canada was severely criticized by the Judge included the fact that Truehope had tried to have meetings with Health Canada, and that there were few alternatives suggested to solve the dispute. While some of these meeting requests were simply political grandstanding, (such as the "Red Umbrellas" trip to Ottawa, and a demonstration at then Minister of Health Anne McClellan's Office), we do agree that Health Canada should of been more user-friendly to seek out alternatives to this matter. Health Canada has always had a black and white vision of the world, which serves no useful purpose today.
The failed prosecution now means that the Health Canada Compliance and Enforcement Unit has not had a successful prosecution of any kind since 1997. The Health Canada Compliance Unit, imaginatively known as "The Inspectorate", has continued to be out of the loop on most of the investigative health product issues over the last 15 years. The Montreal diet fraud problem, which Rainbow Investigations has covered for years, is only one of a whole bunch of situations where fraud artists have simply made business decisions to market fraudulent products, taking full advantage of the dysfunctional Enforcement Unit. The Enforcement Unit badly lacks the skill set to do a proper investigation leading to a prosecution.
Health Canada flatly refuses to engage in any effective communication in the public domain so that Canadians know both sides of complex stories like the Truehope matter.
There do appear to be some cosmetic changes recently to Health Canada's Compliance and Enforcement Unit. However, at this point, Health Canada, or the politicians for responsible for Health Canada, really have only one choice on the plate. Either they completely remodel this Unit from top to bottom, and update its 1960's style of doing business, or throw in the towel before we get any more embarrassments! At this point, in the year 2006, the $15 million spent annually on the Inspectorate can probably be better spent elsewhere.
The Truehope trial has demonstrated what many of us have known for some time - the Canadian marketplace, for all intents and purposes, remains a voluntary compliance market with respect to food, health and drug products. If the government cannot enforce any rules, the rules only apply to those who wish to follow them.
Voluntary compliance markets, such as we have in Canada for food, drugs and health products, does have implications for parties who should have interests in such products. Certainly the professional medical community and the mental health support community should have an interest in issues like the Truehope matter. Yet, both these groups have been virtually silent in this matter, choosing to not get involved publicly. Stakeholders must keep in mind that if they choose to not get publicly involved, they will have no chance of having their concerns addressed. This is especially true when dealing with people like the Truehope proprietors', who, as we all know, are very comfortable in the public domain.
In closing, while we are somewhat less uncomfortable with the Truehope operation than we were a few years ago, we still have grave concerns with the implications of having a voluntary compliance market for food, drug, and health products.
We really believe Canada is ripe and waiting for a scenario far more sinister and far more notorious than anything we have seen yet.
August 8, 2006
Posted By: Ron Reinhold
of Story: Ron Reinhold