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EmpowerPlus Document Index

Documents related to clinical trials testing EmpowerPlus retrieved through FOIA, ATI, or otherwise publically available are indexed on this page.

Alberta Science and Research Authority (ASRA)

Alberta Innovation and Science. Response to Request for Information on funding for study titled Nutraceutical Treatment of Mental Illness. 2002-03-14. Available from http://www.circare.org/FOIA/asraati_cov.pdf

Alberta Innovation and Science Disclosure / Bonnie J. Kaplan Ph.D. Application for funding for study titled Nutraceutical Treatment of Mental Illness, supporting letters A through C, and statement of support from the University of Calgary. 1998-11-30. Available from http://www.circare.org/FOIA/asraati_bjkappl.pdf

Alberta Innovation and Science Disclosure / Bonnie J. Kaplan Ph.D. Re-application for funding for study titled Nutraceutical Treatment of Mental Illness. 1999-03-30. Available from http://www.circare.org/FOIA/asraati_bjkappl2.pdf

University of Calgary

Archer K. Reply to Marvin Ross re: studies conducted by Bonnie Kaplan Ph.D. 2001-09-07. Available from http://www.circare.org/FOIA/uc_archer20010917.pdf

Munn Gafuik J-A. University of Calgary Response to Access Request 01-010. 2001-11-07. Available from http://www.circare.org/FOIA/ucati_01-010.pdf

Munn Gafuik J-A. University of Calgary Response to Access Request 01-015. 2002-02-25. Available from http://www.circare.org/FOIA/ucati_01-015.pdf

Clinical Trial Documents

Akoury M. Health Canada letter to Ian Mitchell with attached document, Information Request to Bonnie J. Kaplan Ph.D., re: studies titled Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder and Fibromyalgia Clinical Study. (2001-10-25) 2002-01-04. Available from http://www.circare.org/FOIA/hc_cta_20020104.pdf

EmpowerPlus Clinical Trial Consent Forms

University of Calgary Access Request 01-010 Disclosure. Kaplan BJ. Consent Form. Nutraceutical Treatment of Mental Disorders in Adults: An RCT with Bipolar Disorder. 2001-11-07. Available from http://www.circare.org/FOIA/uc_137_139.pdf

University of Calgary Access Request 01-010 Disclosure. Kaplan BJ. Consent Form. Open Trials of a Nutraceutical Treatment for Mental Disorders in Adults. 2001-11-07. Available from http://www.circare.org/FOIA/uc_133_134.pdf

University of Calgary Access Request 01-010 Disclosure. Kaplan BJ. Consent Form. Open Trials of Nutritional Supplements for the Treatment of Children with Anxiety/Mood Problems. 2001-11-07. Available from http://www.circare.org/FOIA/uc_135_136.pdf

[OCR of same to enhance readability] Kaplan BJ. Consent Form. Open Trials of Nutritional Supplements for the Treatment of Children with Anxiety/Mood Problems. 2001-11-07. Available from http://www.circare.org/FOIA/ucati1_13536_ocr.pdf

University of Calgary Access Request 01-010 Disclosure. Kaplan BJ. Consent Form. A Randomized Controlled Trial of a Nutrient Supplement in the Treatment of Fibromyalgia. 2001-11-07. Available from http://www.circare.org/FOIA/uc_131_132.pdf

U.S. Office for Human Research Protections (OHRP)

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

Poster Presentations of Clinical Trials Testing EmpowerPlus

Kaplan BJ, Simpson JSA, Ferre R, Gorman CP, McMullen D. Successful Treatment of Bipolar Disorder with a Nutritional Supplement: Ten Cases. Poster presented at the Canadian Psychiatric Association annual meeting in Victoria, B.C. 2000-10-04. Available from http://www.circare.org/FOIA/cpa_2000_FINAL_poster.pdf

[OCR to enhance readability] Kaplan BJ, Simpson JSA, Crawford SG, Ferre RC, Fisher GC. Improved mood stability in 9 children with a broad-based nutritional supplement. Abstract. European Congress of Psychology. London, UK. 2001-07-1 through 6. Available from http://www.circare.org/FOIA/bpa_conf01_ocr.pdf

[Relatively illegible original version of same] Kaplan BJ, Simpson JSA, Crawford SG, Ferre RC, Fisher GC. Improved mood stability in 9 children with a broad-based nutritional supplement. Abstract. European Congress of Psychology. London, UK. 2001-07-1 through 6. Available from http://www.circare.org/FOIA/bpa_conf01.pdf

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Health Canada ATI A-2001-0845/ms

Snider M. Cover Letter Health Canada ATI file number A-2001-0845/ms. 2002-05-17. Available from http://www.circare.org/FOIA/hcati1_cover.pdf

ATIP1003, ATIP1004, ATIP1005: Health Canada. Internal Correspondence re: initial assessment of Truehope, The Synergy Group of Canada Inc., and EmpowerPlus. 2000-06-06. Available from http://www.circare.org/FOIA/hcati1_003005.pdf

ATIP1009, ATIP1010: Peterson RG. Health Canada. Letter to The Synergy Group of Canada Inc. re: clinical trials at the University of Calgary without required Investigational New Drug Submission (IND). 2000-07-24. Available from http://www.circare.org/FOIA/hcati1_009010.pdf

ATIP1011, ATIP1012: Ho M, Carta M. Health Canada. Briefing Note re: regulatory action against The Synergy Group of Canada Inc. Undated. Available from http://www.circare.org/FOIA/hcati1_011012.pdf

ATIP1026, ATIP1027, ATIP1028, ATIP1029. Health Canada / Corporate registration, The Synergy Group of Canada Inc. 2000-09-23. Available from http://www.circare.org/FOIA/hcati1027029.pdf

ATIP1036, ATIP1037, ATIP1038: Health Canada Printed Material (2000-10-11), Nutritional Supplement Yields Positive Results for Treatment of Bipolar Disorder in University Study. The Synergy Group of Canada Inc. Press Release. 2000-10-05. Available from http://www.circare.org/FOIA/hcati1_036038.pdf

ATIP1050, ATIP1051, ATIP1052, ATIP1053, ATIP1054, ATIP1055, ATIP1056: Brousseau ME. Health Canada. Investigation Report re: The Synergy Group of Canada Inc. 2000-10-12. Available from http://www.circare.org/FOIA/hcati1_050056.pdf

ATIP1060, ATIP1061, ATIP1064, ATIP1065, ATIP1066: Brousseau ME. Health Canada. Investigation Documents re: The Synergy Group of Canada Inc. Email between M. Brousseau and A. Stringham, Truehope Research Assistant; purchase invoice for EmpowerPlus from Evince International LLC; EmpowerPlus label. 2000-10-04. Available from http://www.circare.org/FOIA/hcati1_060066.pdf

ATIP1067, ATIP1068, ATIP1069, ATIP1070, ATIP1071, ATIP1072, ATIP1073, ATIP1074: Brousseau ME. Health Canada. Investigation Document re: The Synergy Group of Canada Inc. Stringham DH. Truehope Nutritional Supplement Support Booklet. © 2000. Available from http://www.circare.org/FOIA/hcati1_067074.pdf

ATIP1079, ATIP1080: Peterson RG. Health Canada. Letter to AF. Stephan and Synergy Group of Canada Inc. re: clinical trials at the University of Calgary without required Investigational New Drug Submission (IND). 2000-10-20. Available from http://www.circare.org/FOIA/hcati1_079080.pdf

ATIP1083: Stephan AF. Truehope/The Synergy Group of Canada Inc. Letter to Health Canada re: sponsorship of research. 2000-11-07. Available from http://www.circare.org/FOIA/hcati1_083.pdf

ATIP1111, ATIP112, ATIP113: Health Canada. Internal Correspondence re: Investigational New Drug application [IND] required for clinical trials of EmpowerPlus by B. Kaplan at the University of Calgary; detention of investigational product addressed to B. Kaplan labeled For Experimental Use, Not For Resale, Capsule Dosage 8; origin and shipping details of investigational product. 2001-03-22. Available from http://www.circare.org/FOIA/hcati1_111113.pdf

ATIP1119, ATIP1123, ATIP1124, ATIP1125, ATIP1129, ATIP1130: Health Canada. Internal Correspondence re: status of unapproved clinical trials with EmpowerPlus; information provided to B. Kaplan by Health Canada employees P. Waddington, P. Chan, and S. Mithani. 2001-04-05. Available from http://www.circare.org/FOIA/hcati1_119130.pdf

ATIP1123, ATIP1124: Health Canada. Internal Correspondence re: responses to questions from unnamed politician/supporter of The Synergy Group of Canada about seizure of research product at border. 2001-04-10. Available from http://www.circare.org/FOIA/hcati1_123124.pdf

ATIP1135, ATIP1136: Brousseau ME. Health Canada. Letter to AF. Stephan and Synergy Group of Canada Inc. re: clinical trials at the University of Calgary without required Investigational New Drug Submission (IND). 2001-04-27. Available from http://www.circare.org/FOIA/hcati1_135136.pdf

ATIP1143, ATIP1144: Brousseau ME. Health Canada. Letter to B. Kaplan re: clinical trials at the University of Calgary without requisite Investigational New Drug Submission (IND); violations of The Food and Drugs Act. 2001-04-27. Available from http://www.circare.org/FOIA/hcati1_143144.pdf

ATIP1181, ATIP1182, ATIP1183: Health Canada. Briefing Note re: marketing of an unauthorized drug by The Synergy Group of Canada Inc. 2001-05-15. Available from http://www.circare.org/FOIA/hcati1_181183.pdf

ATIP1214, ATIP1222, ATIP1224, ATIP1226, ATIP1228, ATIP1231: Health Canada. Internal Correspondence re: meeting on clinical trials testing EmpowerPlus; letter from B. Kaplan explaining history of involvement with The Synergy Group of Canada Inc. and EmpowerPlus. 2001-05-23. Available from http://www.circare.org/FOIA/hcati1_214231.pdf

ATIP1250, ATIP1251, ATIP1294: Bissett RG. Reply to Health Canada letter of 2001-04-27 on behalf of The Synergy Group of Canada Inc.; response of Health Canada. 2001-05-29. Available from http://www.circare.org/FOIA/hcati1_250294.pdf

ATIP1262, ATIP1361: Health Canada. Internal Correspondence re: Status Determination of EmpowerPlus — A new drug; not a Product Subject to Special Measures (PSSM). 2001-08-31. Available from http://www.circare.org/FOIA/hcati1_262361.pdf

ATIP1237: Jarvis S. Health Canada. Internal Correspondence re: concerns about The Synergy Group of Canada Inc. 2001-05-26. Available from http://www.circare.org/FOIA/hcati1_237.pdf

ATIP1240: Health Canada. Internal Correspondence re: summary of meeting with B. Kaplan and The Synergy Group of Canada Inc. 2001-08. Available from http://www.circare.org/FOIA/hcati1_240.pdf

ATIP1299, ATIP1300, ATIP1301, ATIP1302: Health Canada. Internal Correspondence re: receipt of news story titled Pig minerals totally cure bipolar disorder describing B. Kaplan and and clinical trials testing EmpowerPlus. 2001-07-04. Available from http://www.circare.org/FOIA/hcati1_299302.pdf

ATIP1312, ATIP1313: Health Canada. Internal Correspondence re: videoconference with B. Kaplan about EmpowerPlus research. 2001-07-19. Available from http://www.circare.org/FOIA/hcati1_312313.pdf

ATIP1380, ATIP1381: Peterson R. Health Canada. Letter to B. Kaplan re: required submission of Clinical Trial Application within four weeks. 2001-09-10. Available from http://www.circare.org/FOIA/hcati1_380381.pdf

ATIP1438A, ATIP1438B: Health Canada. Internal Correspondence re: providing information about clinical trials conducted by B. Kaplan to University of Calgary Conjoint Research Ethics Board. 2001-10-11. Available from http://www.circare.org/FOIA/hcati1_438a438b.pdf

ATIP1442, ATIP1443: Peterson R. Health Canada. Letter to I. Mitchell M.D. re: required Clinical Trial Application from B. Kaplan for clinical trials with EmpowerPlus. 2001-10-11. Available from http://www.circare.org/FOIA/hcati1_442443.pdf

ATIP1456: Medical Liaison. The Synergy Group of Canada Inc. Sales material re: new clinical trial information. 2001-07-20. Available from http://www.circare.org/FOIA/hcati1_456.pdf

ATIP1154B, ATIP1154C: McRae L. Letter to Health Canada on behalf of Bonnie Kaplan Ph.D., re: warning letter of 2001-04-27 (2001-05-08); Health Canada reply to L. McRae. 2001-05-08 (2001-06-20). Available from http://www.circare.org/FOIA/hcati1_154b292.pdf

ATIP1155: Health Canada. Internal Correspondence re: email between B. Kaplan, P. Waddington, and I. Mitchell about ethical approval for clinical trials with EmpowerPlus from University of Calgary Conjoint Health Research Ethics Board. 2001-05-07. Available from http://www.circare.org/FOIA/hcati1_155438b.pdf

ATIP1155, ATIP1156, ATIP1161, ATIP1197, ATIP1198, ATIP1200, ATIP1201, ATIP1204: Health Canada internal email correspondence between Dr. Siddika Mithani, Ms. Sharon Chard, and Dr. Phil Waddington. 2001-05-07 to 2001-05-17. Available from http://www.circare.org/FOIA/hcati1_155204.pdf

  1. ATIP1155: Dr. Siddika Mithani. Corrections regarding previous discussions of IND with Bonnie Kaplan.
  2. ATIP1156: Dr. Siddika Mithani. Reiterated corrections regarding previous discussions of IND with Bonnie Kaplan.
  3. ATIP1161: Dr. Siddika Mithani. Bonnie Kaplan and previous discussion of IND.
  4. ATIP1197: Dr. Sidikka Mithani. Corrections regarding previous discussions of IND with Bonnie Kaplan.
  5. ATIP1198: Dr. Sidikka Mithani. Previous discussions with Bonnie Kaplan RE: absence of sufficient data to support IND.
  6. ATIP1200: Health Canada employee Sharon Chard claims she never spoke to Bonnie Kaplan, only Anthony Stephan, Synergy Group Inc.
  7. ATIP1201: Anonymous email message to Sharon Chard directing her to establish a clandestine contact within Health Canada, but outside the Therapeutic Products Directorate, to whom Synergy Group co-directors Stephan and Hardy would send their research data.
  8. ATIP1204: Phil Waddington. Reiterating that Synergy's investigational product used by Bonnie Kaplan in clinical trials was regulated by the Therapeutic Products Directorate [drugs].

ATIP1175, ATIP1176: Health Canada. Internal Correspondence re: email from B. Kaplan to P. Waddington; notice from P. Waddington of contact from The Synergy Group of Canada Inc. 2001-05-14. Available from http://www.circare.org/FOIA/hcati1_175176.pdf

ATIP1178B, ATIP1178C: Internal Correspondence re: chronology of EmpowerPlus by Synergy Group of Canada Inc. Undated. Available from http://www.circare.org/FOIA/hcati1_178b178c.pdf

ATIP1179D: Health Canada. Briefing Note re: marketing of an unauthorized drug by The Synergy Group of Canada Inc. Available from http://www.circare.org/FOIA/hcati1_179d179f.pdf

ATIP1181: Health Canada. Briefing Note re: marketing of an unauthorized drug by The Synergy Group of Canada Inc. 2001-05. Available from http://www.circare.org/FOIA/hcati1_181183.pdf

ATIP1200, ATIP1201: Health Canada internal email. Anonymous email message to Sharon Chard directing her to establish a clandestine contact within Health Canada, but outside the Therapeutic Products Directorate, to whom Synergy Group co-directors Stephan and Hardy would send their research data. 1999-09-22. Available from http://www.circare.org/FOIA/hcati1_200201.pdf

ATIP1299, ATIP1300, ATIP1301, ATIP1302: Health Canada internal documents / Ottawa Citizen news story reprint: Mineral pills for pigs 'totally cure' bipolar disorder. Joanne Laucius. The Ottawa Citizen. 2001-07-04. Available from http://www.circare.org/FOIA/hcati1_299302.pdf

The Synergy Group of Canada Inc. Explanatory Notes Regarding Documents Released in Health Canada ATI file number A-2001-0845/ms.

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1009, ATIP1010. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_0910.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1050, ATIP1056. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_050056.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1079, ATIP1080. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_079080.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1123 and following. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_123.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1135, ATIP1136. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_135136.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1250, ATIP1251. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_250252.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1361. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_361.pdf

The Synergy Group of Canada Inc. Explanatory Notes for ATIP1456. Available from http://www.circare.org/FOIA/hcati1_sgcnotes_456.pdf

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Health Canada ATI A 2002-00199/ms

Snider M. Cover Letter Health Canada ATI file number A-2002-00199/ms. 2002-11-13. Available from http://www.circare.org/FOIA/hcati2_cover.pdf

ATIP2059, ATIP2085, ATIP2086: Health Canada. Internal Correspondence re: videoconference with B. Kaplan et al.; advertising and personal importation of EmpowerPlus; lack of DIN; status of sale and distribution of EmpowerPlus. 2001-11-20. Available from http://www.circare.org/FOIA/hcati2_059086.pdf

ATIP20125, ATIP20126: Health Canada Internal Correspondence re: B. Kaplan email to P. Waddington (Health Canada) thanking him for assistance. 2001-12-07. Available from http://www.circare.org/FOIA/hcati2_125126.pdf

ATIP2159: Peterson R. Health Canada. Letter 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

ATIP2201, ATIP2202, ATIP2203: Health Canada. Internal Correspondence re: Synergy update. 2002-02-14. Available from http://www.circare.org/FOIA/hcati2_201203.pdf

ATIP2220, ATIP2221, ATIP2227, ATIP2228: Health Canada. Internal Correspondence re: verification that clinical trials of EmpowerPlus have stopped. 2002-02-28. Available from http://www.circare.org/FOIA/hcati2_220228.pdf

ATIP2236: Health Canada. Internal Correspondence re: 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. Internal Correspondence re: confirmation that B. Kaplan stopped clinical trials; jubilation upon receipt of confirmation that B. Kaplan stopped clinical trials with EmpowerPlus. 2002-03-14. Available from http://www.circare.org/FOIA/hcati2_238240.pdf

ATIP2255, ATIP2254: Health Canada. Internal Correspondence re: The Synergy Group of Canada Inc. and certain Health Canada records to be released under the Access to Information Act. 2002-04-04. Available from http://www.circare.org/FOIA/hcati2_054055.pdf

ATIP2263, ATIP2268, ATIP2269: Eleanor McMahon, Consultant to The Synergy Group of Canada Inc. Email to Health Canada re: 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

Health Canada. Explanatory note of potential relevance to ATIP2269 re: claims by The Synergy Group of Canada Inc. Undated. Available from http://www.circare.org/FOIA/hcati2_263269.pdf

ATIP2279, ATIP2280, ATIP2281: Health Canada. Question Period Note. CBC TV's Health Matters on EmpowerPlus. 2002-05-25. Available from http://www.circare.org/FOIA/hcati2_279281.pdf

ATIP2283, ATIP2285, ATIP2286, ATIP2287, ATIP2288, ATIP2289: L. Wall and M. Alberti, Schizophrenia Society of Ontario. Letter to the Honorable Ann McLellan, Minister of Health, re: EmpowerPlus; expression of concern for safety of constituents; summary of independent laboratory analysis. 2002-03-08. Available from http://www.circare.org/FOIA/hcati2_283289.pdf

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The Synergy Group of Canada Inc.

Synergy Group of Canada Quad M.S. Research Program. A Non-Medical Nutritional Program. ©1996 The Synergy Group of Canada Inc. Available from http://www.circare.org/FOIA/SGCMSQuad.pdf

Kaplan BJ. (Purported) Testimonial re: her discovery of immense magnitude or importance. 1999-01-14. Available from http://www.circare.org/FOIA/MelBK.pdf. (This was allegedly read during the Melaleuca January 14, 1999 satellite launch to approximately 150 locations across Canada and the United States.)

Health Canada Miscellaneous Documents

Mueller TC. Health Canada Health Hazard Assessment of EmpowerPlus. 2002-07-21. Available from http://www.bioethicswatch.org/uc/hc_hhe_20020718.pdf

Shelley D. Health Canada Inspectorate Memorandum: A Meeting with Truehope/Synergy Directors at HPFBI WOC Burnaby, B.C. 2003-01-14. Available from http://www.circare.org/FOIA/hcls_176_179.pdf. (Documents submitted by Health Canada in federal case T-880-03 Truehope Nutritional Support Ltd et al. vs A.C.G et al. June-July 2003.)

Hon. Ann McLellan, Minister of Health. Reply to Ron Reinhold. Board of Directors, Schizophrenia Society of Alberta, and Rainbow Investigations Inc. 2002-12-12. Available from http://www.circare.org/FOIA/mclellan_20021212.pdf


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Last Updated: 2012-08-12

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