In July, I reported on the possibility that alternative medicine may have led to death in the case of Jordan Ramsey in Vancouver. Ramsay murdered his father and severely injured his mother while in a schizophrenic psychotic state. He had stopped his prescription medication at that time in favour of a vitamin product, Empowerplus ® (EMP), being touted as an alternative treatment for prescription medication. The real culprit, however, may actually be Health Canada, which seems to have been unable to enforce the law.
In that earlier article, I mentioned writing an e-book with Dr Terry Polevoy and Ron Reinhold on Truehope/Synergy based on extensive research and internal documents obtained from Health Canada and the University of Calgary through Access To Information (ATIP). Details about Empowerplus®, health claims and marketing can be found in our book or in a fairly extensive review of our book done by the former National Post medical writer Brad Evenson calledPigs Will Fly. A more recent and very good critique can be found on the Neurocritic Blog
The key question is why this product is still being sold in Canada. Section Three of the Canadian Food and Drug Act stipulates that companies cannot make treatment, preventative or cure claims for food, drug, cosmetics or devices for conditions like acute psychotic conditions and depression as set out in Schedule A without preapproval. Truehope/Synergy has been doing so for years with no scientifically reliable proof for their claims.
Truehope points to publications to support their claims but none of those articles report using the definitive standard of controlled trials designed to show cause and effect. The only completed randomized controlled trial was conducted in subjects with fibromylagia and was presented at the American College of Rheumatology meeting in New Orleans in 2002. That study of 99 patients found that Empowerplus® failed to measurably improve subjects' symptoms, and yet Truehope/Synergy never mentions this negative trial. Nor is there any mention that 34 of the 99 subjects dropped out due to gastrointestinal complaints such as diarrhea.
Dr. Charles Popper of Boston, one of Truehope's fans who apparently uses Empowerplus® in his clinical practice, stated in testimony under oath for the defendants in the 2006 criminal trial against Truehope/Synergy that Health Canada lost that:
"I would not at this stage say that based on my anec -- my own clinical observations, that this is a treatment that I would recommend as an established treatment. You know, in medicine we want strong data before we recommend a treatment as an established treatment and that's not what we have here".
Strikingly, their own expert witness does not think Empowerplus® health claims have been proven and, in fact, they have not. And, Dr. Philip Long of Vancouver stated a few years earlier that this "is a total medical fraud. There is absolutely no scientifically sound (double blind, randomized) clinical trial that has shown this vitamin mixture to be effective."
In July, 2003 the RCMP executed a search warrant on the office of Truehope and seized the company computer drives. Health Canada also issued their first health hazard advisory warning people about Empowerplus® and the dangers of going off prescribed medication. Health Canada laid a series of charges against the company but dropped all but one prior to trial in 2006. In a defence of necessity, Health Canada lost.
In 2010, Professor Ian Freckleton, a Fellow of the Australian Academy of Law, wrote an article on the legal proceedings involving Empowerplus® and Truehope in the Journal of Law and Medicineand expressed surprise that Health Canada did not appeal. He opined that "it appears that Health Canada may not have called the witnesses who might more effectively have alerted the court to the preponderance of expert views about the scientific status of the supplement" and added that Health Canada has still not demonstrated if the claims are false, misleading or deceptive.
Since that trial, Health Canada issued another Health Risk Assessment of Empowerplus ® in 2007. In its lengthy evaluation, it pointed out that there were nine reports of serious adverse reactions associated with the use of this product. Health Canada also pointed out in its internal documents that among the complaints it had received were complaints from Truehope/Synergy employees themselves.
On May 11, 2007, Health Canada sent a letter warning the company to stop instructing people to go off psychiatric meds. Later in December 2007, Health Canada wrote Truehope/Synergy Group directing them to stop representing that Empowerplus® is safe for pregnant women, as was done in the company's presentation to the North Peace Tribal Council. Truehope/Synergy responded with a letter in which they asserted Health Canada's accusations against them are false and that they are compliant with applicable law and regulation.
Has there been any political influence brought to bear on Health Canada and what is the reason for Health Canada's apparent inability to block the sale of Empowerplus™
There is no question that James Lunney, a Conservative MP from British Columbia, has been one of Truehope's steadfast fans. In an article I wrote for The Scientist in 2005, I pointed out that he had misrepresented data on the efficacy of EMPowerplus®. He told a Parliamentary committee on April 22, 2004 that EMPowerplus® research by Dr. Bryan Kolb at Lethbridge proved that this product could regenerate brains.
The study referred to was a master's thesis done by one of Kolb's graduate students and presented as a poster at the 2003 Society for Neuroscience meeting in New Orleans. The results suggested "that manipulation of diet may facilitate functional recovery and cerebral plasticity after perinatal brain injury." The abstract does not mention the product EMPowerplus but that a "vitamin/mineral enriched diet was given to rats."
In an e-mail to me, Kolb said: "I have never claimed that EMP regenerates brains and we have absolutely no evidence that it does. What we have is less injury in the brain. This could have resulted from some regenerative process but we have not proven that, nor is that in my research plan at present." He noted that he makes "no mention of regeneration and they should not either. I have mentioned this to them on at least two occasions."
What came out at the trial is that Lunney purportedly brokered a deal with the Liberal Health Minister, Pierre Pettigrew, in 2004 which allegedly allowed Truehope/Synergy to continue to market Empowerplus® to Canadians. That document, an e-mail I believe, was entered into evidence but is not part of the transcript. From the examination and cross examination of the witnesses including Lunney, it appears that this permission allegedly allowed individuals to order EMPowerplus® for themselves from the US only provided the supply ordered for personal use was not for more than three months. That, however, has always been the rule under the Personal Use Exemption Directive.
Lunney was asked in cross examination, "Now, you've indicated in your evidence I think that this was the deal that was struck between yourself or your group and Pierre Pettigrew the Minister at
the time, correct?"
After some sparring, the Crown asked, "Is that this agreement appears to actually reflect what the directive says, the personal use exemption directive, do you agree with that?"
Lunney failed to provide a straight answer (see P 1193). If you continue reading the transcripts, you will see that the Crown demonstrated that Mr. Lunney may also have deceived the House of Commons in a debate on Monday, November 29th, 2004 by misrepresenting the status of Truehope/Synergy and of the RCMP raid.
I cannot imagine that any minister in the Canadian government has the authority to exempt anyone from complying with the law. Lunney's email entered as an exhibit in the criminal case needs to be made public. But, after the Conservatives took power, there is reference in the Health Canada ATIP documents to a meeting between the Truehope/Synergy Group and the new Minister of Health, Tony Clement, that was scheduled for November 8, 2006. It is mentioned that a representative from the Prime Minister's Office would attend as well as representatives from Justice. There is no meeting agenda in those documents and no indication that it actually happened or what the outcome was.
Health Canada has failed to enforce Truehope's compliance with applicable law. Why? The U.S. Federal Trade Commission managed to deal with two of the supplement manufactures whose products were previously promoted by the principals of Truehope/Synergy, Anthony Stephan and David Hardy. Our laws on this matter are pretty similar to those in the U.S.; and because of Health Canada's apparent enforcement failure, Canadian citizens with serious mental illnesses are still being encouraged to go off their medications and many are arguably harmed. And need I say that as long as Empowerplus® continues to be sold, the company continues to make money at the expense of the mentally ill.
In an article in the Ottawa Citizen in 2003 now on a mental health website, it was estimated that with 3,000 customers at that time, Hardy and Stephan were grossing $500,000 a month. Stephan disagreed and said, "It's more like $300,000 and a lot of the money goes to pay the 55 'support' workers who operate the phones." But, according to an interview that Stephan gave to Alternative Mental Health in the U.S., the research assistants (mostly former patients), work for expenses only.
Dr. E. Fuller Torrey, a well-known research psychiatrist who is executive director of the Stanley Medical Research Institute in Bethesda, Maryland, told the Citizen that, "In the more than 30 years I have been studying mental illnesses, there have always been some people who have made a good living treating people with schizophrenia with various vitamin mixtures,"
Someone needs to explain to Canadians and to LeeAnn Ramsay, the sister of the murdered man, what happened. As of this moment, according to Health Canada, Empowerplus® is still not authorized for sale in Canada because of the health claims associated with the product. Yet we need to know why it is still for sale now.