Documents released by Health Canada under the Access to Information and Protection of Privacy Act on 2002-11-13, ATI file number A-2002-00199/ms. Dates covered: 2001-10-31 to 2002-05-24.
Snider M. Cover Letter ATI file number A-2002-00199/ms. 2002-11-13. Available from http://www.circare.org/FOIA/hcati2_cover.pdf
The cover letter to ATI file number A-2002-00199/ms draws attention to two issues, the first of which is:
In the course of our consultations with the University of Calgary concerning certain of these records, we were advised that the university does not agree that Dr. Kaplan's actions in respect of the clinical trials contravened any requirements of the Food and Drugs Act. For additional information on the University's position you may wish to contact:
Lynn McRae
The University of Calgary
HS CG381, 2500 University Dr. NW
Calgary, Alberta
T2N 1N4
(403) 220-2590
The second issue is Health Canada's opinion of the representations made by The Synergy Group of Canada, Inc.:
Please note that the explanatory note has been provided by Synergy Group of Canada in respect of information on page 269. Health Canada is not responsible for accuracy of Synergy statements.
The explanatory note provided by Synergy/Truehope:
Health Canada. Explanatory note of potential relevance to ATIP2269 regarding claims by The Synergy Group of Canada Inc. Undated. Available from http://www.circare.org/FOIA/hcati2_263269.pdf
Documents are identified by Bates numbers wherever possible. File names correspond to Bates numbers in the ATIP. For example ATIP2100 is a scan of ATI A-2002-00199/ms, page 000100.
Toward the end of 2001 Dr. Kaplan arranged for Phil Waddington, director the Natural Health Products Directorate, to participate in a teleconference regarding objections to her Clinical Trials License Application. This corroborates Dr. Waddington's statement to the Standing Committee on Health in April, 2004, namely that he was involved with the review of the clinical trial application and was aware of the circumstances and objections. This makes us wonder all the more why his recollection does not accord with that of the Health Canada reviewers, as outlined in correspondence to Dr. Ian Mitchell at the University of Calgary and copied to Dr. Kaplan. Follow this link to read what Phil Waddington told Standing Committee on Health.
ATIP2059, ATIP2085, ATIP2086: Kaplan BJ. Email correspondence re: advertising and personal importation; lack of DIN; legality. 2001-10-31. Available from http://www.circare.org/FOIA/hcati2_059086.pdf
Dr. Kaplan thanked Phil Waddington and sent him the URL for her just-published clinical trial of EmpowerPlus in the Journal of Clinical Psychiatry in December, 2001. It was in this article that Drs. Kaplan and Ferre published results of the adult trial which the University of Utah refused to approve, and for which the U.S. Office for Human Research Protections issued a determination letter in August, 2002. How precisely did Dr. Waddington assist Dr. Kaplan in the publication of non-consensual disapproved research conducted on American citizens? And more importantly, why did he do so?
ATIP20125, ATIP20126: Kaplan BJ. Email correspondence thanking Phil Waddington at Health Canada. 2001-12-07. Available from http://www.circare.org/FOIA/hcati2_125126.pdf
McNeilly PJ. Office for Human Research Protections Determination Letter to the University of Utah re: Kaplan BJ, Simpson JS, Ferre RC, Gorman CP, McMullen DM, Crawford SG. Effective mood stabilization with a chelated mineral supplement: An open-label trial in bipolar disorder. Journal of Clinical Psychiatry. 2001;62(12):936-944. 2002-08-19. Available from http://www.hhs.gov/ohrp/detrm_letrs/YR02/aug02e.pdf
Dr. Kaplan was concerned about a media onslaught
that would ensue upon the release of her first publication of an open label trial of EmpowerPlus, specifically she was concerned that she would get questions about the unauthorized RCT to which this publication adverts — though it's unclear why she could not simply say no comment.
It's quite striking that Dr. Kaplan promised she wouldn't tell the media that those annoying people in Ottawa stopped our clinical trial.
Dr. Kaplan would speak gently,
and say something to the effect that they are working with Health Canada to improve our ability to improve patient safety … something like that.
Dr. Kaplan's awkward jest tells the tail: the responsibility to protect the rights and welfare of the human subjects enrolled in her unapproved trial the regulator is attempting to terminate does indeed appear to be an annoyance
to her.
ATIP2159: Peterson R. Health Canada correspondence to Ian Mitchell M.D., Director, Office of Medical Bioethics, University of Calgary re: notification that clinical trials with EmpowerPlus must be terminated. 2002-01-04. Available from http://www.circare.org/FOIA/hcati2_159.pdf
A three page running summary of Truehope's activities in violation of the Food and Drug Act.
ATIP2201, ATIP2202, ATIP2203: Health Canada. Synergy Update. 2002-02-14. Available from http://www.circare.org/FOIA/hcati2_201203.pdf
It appears that Dr. Kaplan did not reply to Health Canada's directive to terminate her unapproved trials, whereupon the Inspectorate attempted to confirm that she had in fact terminated them.
ATIP2220, ATIP2221, ATIP2227, ATIP2228: Health Canada Inspectorate seeks verification that clinical trials of EmpowerPlus have stopped. 2002-02-28. Available from http://www.circare.org/FOIA/hcati2_220228.pdf
ATIP2236: Health Canada report of Anthony Stephan crossing border with EmpowerPlus powder. 2002-03-14. Available from http://www.circare.org/FOIA/hcati2_236.pdf
ATIP2238, ATIP2239, ATIP2240: Health Canada Inspectorate continues to seek confirmation that Bonnie Kaplan has stopped clinical trials; Bonnie Kaplan confirms she has stopped all clinical trial work with EmpowerPlus; having received confirmation of same, Inspectorate celebrates. 2002-03-14. Available from http://www.circare.org/FOIA/hcati2_238240.pdf
WOW! It must be Friday! This, below is good news. A confirmation that the unauthorized trial is finally stopped. I'll spare you the zillions other docs on that file.
So marks the end of one chapter in this story. A series of clinical trials conducted on adults and children suffering from serious illnesses that began in April 1997 and ended in February 2002, running for nearly 5 full years without requisite Health Canada oversight. Clinical trials testing drugs and devices on humans without proper authorization appear to be an endemic problem in Canada. The price of non-compliance is incalculable: altruism is rewarded by deception, shoddy or dangerous trial design, and the unaudited data generated therein is published in the scientific literature, which in turn may lead physicians to base treatment recommendations on unsound information. In the worst cases, lives are lost needlessly in clinical trials and public confidence in science, academia, and the government is shaken by post-hoc reports of disaster and reckless behavior. These issues should be of great concern to Canadian citizens. And given that so many clinical trials have multi-national sites, this should concern Americans as well.
Health Canada and The Synergy Group of Canada Inc. communicated about records to be released in this ATI disclosure, and as you might imagine, Synergy/Truehope would not be eager to have the details of Health Canada's investigation disclosed. In April, 2002 Synergy/Truehope offered these objections to the records proposed for release:
undesirableingredients in Truehope's product had been resolved in Truehope's favor — in response to which Health Canada said
no, it had not.
unapproved clinical trialsdidn't apply to Truehope — to which Health Canada replied the trials with EmpowerPlus were unapproved.
ATIP2255, ATIP2254: Representations of The Synergy Group of Canada Inc. re: certain Health Canada records to be released under the Access to Information Act; response of Health Canada. 2002-04-04. Available from http://www.circare.org/FOIA/hcati2_054055.pdf
By mid-May it became clear that Health Canada was not going to simply re-write history to rescue Truehope's reputation, whereupon a public relations professional appeared on the scene. Ms. Elinor McMahon expressed concern that the Inspectorate's letter to Truehope of April, 2001 objecting to numerous activities that violated the Food and Drug Act, if released and:
taken out of context, … could have a negative impact on Synergy [Truehope] which we would like to avoid and in point of fact is not an accurate representation of our current relationship with the Regulator.
Because Ms. McMahon believed the release of these documents would incorrectly
give the impression that Truehope was in violation of the law, she asked for a letter from Health Canada saying that Truehope was presently in compliance with the law. Unfortunately 10 days later CBC aired an expose of Truehope and captured them on film engaging in actions to which the Inspectorate's letter had previously objected, and some of the same activities in which Synergy/Truehope had affirmed through counsel they were no longer engaged. Bad timing indeed.
ATIP2263, ATIP2268, ATIP2269: Eleanor McMahon, consultant to The Synergy Group of Canada Inc., request for letter of compliance from Health Canada; clarification re: letter of compliance; corporate status of The Synergy Group of Canada Inc., Truehope. 2002-05-11. Available from http://www.circare.org/FOIA/hcati2_263269.pdf
On 2002-05-27 CBC TV's Health Matters ran two segments on EmpowerPlus and Synergy/Truehope. CBC filmed Truehope representatives taking orders for EmpowerPlus, a product which the company had reassured Health Canada they no longer sold from Canada. CBC also filmed Synergy/Truehope representatives assuring customers that the product could treat clinical depression and advising one such customer to stop prescription medication in favor of EmpowerPlus. The segments also featured the clinical research program of Evince International LLC in Farmington, Utah, which is still ongoing as of June 2004, and apparently still without medical or regulatory oversight.
ATIP2279, ATIP2280, ATIP2281: Question Period Note. CBC TV's Health Matters on EmpowerPlus. 2002-05-25. Available from http://www.circare.org/FOIA/hcati2_279281.pdf
CBC maintains the video clips of Health Matters on the internet at:
EM Power+ Controversy, part 1. CBC Newsworld Healthmatters. 2002-05-27. Available from http://media.cbc.ca:8080/ramgen/newsworld/clips/rm-programs/hm_1empower020527.rm
EM Power+ Controversy, part 2. CBC Newsworld Healthmatters. 2002-05-27. Available from http://media.cbc.ca:8080/ramgen/newsworld/clips/rm-programs/hm_2empower020527.rm
Following suicide attempts by several of their members while using EmpowerPlus, the Schizophrenia Society of Ontario commissioned an independent laboratory analysis of EmpowerPlus in mid-2001. The results were shocking from a research perspective: fully one-third of the 36 ingredients varied from the label by an excess of 10 to 70%. Since several ingredients exceeded the adult Tolerable Upper Limit as labeled, the variance detected was extremely worrisome. Such variance would likely confound data from the clinical trials. None of this is unexpected in a dietary supplement made in the US — it's food so it must be ok, right?
ATIP2283, ATIP2285, ATIP2286, ATIP2287, ATIP2288, ATIP2289: Schizophrenia Society of Ontario. Letter of Concern to the Honorable Ann McLellan, Minister of Health, re: EmpowerPlus; report of concerns for safety of constituents, summary of independent laboratory analysis. 2002-03-08. Available from http://www.circare.org/FOIA/hcati2_283289.pdf
Last Updated: 2007-04-01
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