Documents released by Health Canada under the Access to Information and Protection of Privacy Act on 2002-05-17. ATI file number A-2001-0845/ms. Dates covered: June, 2000 to November, 2001.
Ms. Margery Snider, Assistant Coordinator, Access to Information and Privacy Center, Health Canada, writes in the cover letter to the ATIP:
Please note that explanatory notes have been provided by Synergy Group of Canada and/or Health Canada for pages 9-10, 50-56, 79-80, 123, 135-36, 250-51, 361, and 456. In the case of Synergy Canada statements, these are being provided at the request of Synergy, and Health Canada is not responsible for their accuracy.
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
The explanatory notes provided by The Synergy Group of Canada are available below.
Documents are identified by Bates numbers wherever possible. File names correspond to Bates numbers in the ATIP. For example ATIP1100
is a scan of ATI A-2001-0845/ms, page 000100. With the exception of quoted text set off by indentation, titles are meant to offer a brief description of the document or highlight important information.
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
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
research data.
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
Last Updated: 2007-04-01
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