🚀 go-pugleaf

People who stop taking their psychiatric medications and follow the
advice of individuals or web sites of companies that hawk bogus
vitamin, mineral, and herbal products are at grave risk.

Ilena you forgot to mention the suicide risks of people who are
coached to go off of their pig pills.

http://tinyurl.com/3af3yh

http://www.pigpills.com

http://www.circare.org/FOIA/ATIPindex5.htm

EmpowerPlus Research V
Health Canada Access to Information Request II
Health Canada ATI II / File Number A-2002-00199/ms

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.

top

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:

   1. The law didn't apply to Truehope - in response to which Health
Canada noted no law was cited by Truehope.
   2. The legislation upon which the investigation was launched didn't
apply to Truehope - in response to which Health Canada again noted no
law was cited by Truehope.
   3. The issue of undesirable ingredients in Truehope's product had
been resolved in Truehope's favor - in response to which Health Canada
said no, it had not.
   4. The violations associated with the unapproved clinical trials
didn'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