Update 2006-06-18: Dr. Bonnie Kaplan Ph.D. received funding to conduct studies with EmPowerPlus from the Alberta Science and Research Authority in 1999. Six years later … where are we? Deja vu perhaps, as Dr. Kaplan once again recruits research subjects to test EmpowerPlus (or MCN36). Dr. Kaplan registered her trial with the U.S. clinical trial registry at ClinicalTrials.gov. Medical journal editors require registration of clinical trials as a condition of publication as of 2005. Registration through ClinicalTrials.gov is available to all investigators who wish to register their trials, regardless of location, sponsor, funding source, or whether or not an IND or IDE application is required.
Dr. Kaplan's clinical trial registration:
Clinical Trial of a Nutritional Supplement in Adults with Bipolar Disorder. Available from http://www.clinicaltrials.gov/ct/show/NCT00109577?order=1
Dr. Kaplan is also advertising her trial at closer to home. According to this advert, the trial is sponsored by the University of Calgary in Alberta, CA. Many IRB and REB members might insist that Dr. Kaplan remove all those upper case letters in her advert to prevent potential research subjects from misunderstanding that they were being recruited into a randomized placebo controlled trial testing an experimental drug for bipolar disorder. Some might also insist that the prohibition against concommittant pyschotropic medications at enrollment and for the duration of the study be made more explicit.
Dr. Kaplan's trial clinical web site: http://www.moodstudy.com/
According to the database of Non-Clinical Trial Protocols Approved Since Jan. 1st, 2005 at the Calgary Health Region's Centre for Advancement of Health, Dr. Kaplan's trial was approved by the Conjoint Health Research Ethics Board (CHREB) on 2005-03-24: http://www.ucalgary.ca/md/CAH/research/files/reports/CumulativeApprovals_nonCT_05.html
On 2005-05-04 Health Canada issued a Drug Identification Number for the Natural Health Product Truehope EMP
to The Synergy Group of Canada Inc.: http://www.truehope.com/npn/documents/NPN-A.pdf
Truehope EMP is not the same product as EmpowerPlus. According to The Synergy Group of Canada Inc., boron has been removed and by weight, the formulations are 99.998 percent the same.
Source: Truehope EMP NPN Questions and Answers. Available from http://www.truehope.com/npn/npn_faq.asp
As of 2006-06-18, The Synergy Group of Canada Inc. is not yet selling Truehope EMP: http://www.truehope.com/npn/npn_faq.asp
At same time it appears EmpowerPlus is still for sale: http://www.truehope.com/_empowerplus/empOrder.asp
Go figure.
before and afterbehavior, and if true, this would be a dubious use of a human being.
industry partneryet Melaleuca is nowhere in evidence in the clinical trials. Why is this?
Documents released by Alberta Innovation and Science under the Freedom of Information and Protection of Privacy Act:
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.pdfAlberta 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.pdfAlberta 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
What's to notice here?
EmpowerPlus is a bit of a misnomer, given that it
isn't a single entity at all, but rather a hodgepodge of things that changed over time. As far as we can document, it's earliest incarnation consisted of a combination of commercial products from T J Clark Inc., Body Systems Technologies Inc., and Meleuca Inc., with a total of some 96 ingredients. One of these products was a colloidal mineral preparation, which for the uninitiated is shale leachate containing upwards of 77 elements — lovely stuff like ytterbium, lead, erbium, thulium, zirconium, yttrium, rubidium, strontium, antimony, and god help us, mercury. Neither T J Clark nor Body Systems Technologies Inc has a DIN (Drug Indentification Number) on file with Health Canada, and this makes us wonder how it was obtained and sold or used in clinical research.
You can find more information about colloidal minerals at Quackwatch: Pontolillo J. Colloidal Mineral Supplements: Unnecessary and Potentially Hazardous. 1998-12-11. Available from http://www.quackwatch.org/01QuackeryRelatedTopics/DSH/colloidalminerals.html
In addition to the regulatory actions mentioned in the Quackwatch article, the U.S. Federal Trade Commission filed charges against Body Systems Technologies in 1999:
FTC vs Body Systems Technologies Inc., William E. Chace and James D. Davis, File No. 982 3177. Docket No. C-3895. 1999-09-20. Available from http://www.ftc.gov/os/caselist/c3895.htm
In our opinion FDA puts the matter succinctly:
FDA's enforcement efforts to date have covered a wide array of supplement products. Based on its experience in this area, the agency has identified certain products that are clearly problematic and which warrant close scrutiny. They include the following:
…
Colloidal Minerals: These products are specified for diseases including fibromyalgia, breast cancer, Alzheimer's, and ovarian cancer. The products claim to provide essential minerals and are premised on the false assertion that foods today do not contain needed nutrients because of soil depletion. This assertion gives rise to pervasive economic fraud.Source: http://www.fda.gov/oc/nutritioninitiative/report.html
In case anyone didn't notice, Dr. Kaplan and Synergy/Truehope offered this very claim as the likely mechanism of action for EmpowerPlus in the initial 2001 Journal of Clinical Psychiatry article.
The investigational drug
changed over time, a fact that appears to be nowhere disclosed – not to the provincial funding agency, the research subjects, nor in journal publications. It's difficult to understand how data from drug X can provide meaningful information about drug Z.
When Truehope (in Canada) and Evince International went their separate ways in October 2002, Evince kept the formula but changed the name to Equilib; Truehope became the owner of the trademarked name EmpowerPlus
which they applied to a different formula manufactured under contract by Horizon Laboratories in California.
Source: 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.)
The point here is that Truehope does not currently sell the product that was used in the clinical trials, yet they advertise their current product on the basis of these clinical trials. At best, this is misleading.
This is an early version of EmpowerPlus, perhaps the original combination, comprised of several different commercial brands and including the colloidal mineral preparation. This combination, called the Synergy Quad Program
resembles what was tested in the 1997 ADHD study, and likewise seems to resemble what is described in the published case report of a single subject with fibromylagia.
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.)
This is the newer formula of EmpowerPlus with 32 ingredients, and it's plain this isn't what earlier studies tested:
E M Power+ dietary supplement ingredients. Evince International LLC for the Synergy Group of Canada Inc. April, 2000-2002. Healthwatcher.net. Available from http://www.healthwatcher.net/Quackerywatch/Synergy/Ingredients/vitlist.html
Evince International is/was not in fact the manufacturer of EmpowerPlus, but rather was incorporated in December of 1999 by several of the principals of Cornerstone Nutritional Labs – the actual manufacturer – and seems to have functioned as a subsidiary to distribute EmpowerPlus. Cornerstone Nutritional Labs is one of the largest contract manufacturers of dietary supplements in the US, though perhaps the company is best known as the producer of Stevens Gormet Cocoa ®. As you'll see below, Cornerstone is the result of mergers between several large food and beverage corporations, and there is nothing wrong with any of this — except to the extent consumers or research subjects are confused or misled about the identity of the investigational drug's manufacturer or the conditions of the drug's manufacture.
Hand in hand with troubling concerns about the difference between food manufacturing (e.g. dietary supplements like EmpowerPlus) and pharmaceutical standards go concerns with the training of key personnel. Dr Gary Bradley appears to have been the person in charge of new formulas at Cornerstone Nutritional Labs when EmpowerPlus was created there.
Curriculum vitae of Gary Bradley Ph.D.:
Doctor of Philosophy Oregon State University / Corvallis, OR. 1994
Major: Poultry Science (Emphasis: Turkey Nutrition/Management)
Minor: Statistics
Dissertation:Evaluation of Turkey (Meleagris gallopavo) Breeder Hen and Market Male Performance When Fed Diets Supplemented With a Yeast Culture Containing Saccharomyces cerevisiae.Work Experience:
Research Assistant Professor: Utah State University Turkey Research Center, Ephraim, UT. September 2000 to present. Extension Poultry Specialist. Turkey nutrition/management.Director of Research and Development. Cornerstone Nutritional Labs, Farmington, UT. March 1998 to September 2000. Supervising the preparation of experimental products and managing the formulation and specification databases.
Financial Products Sales and Service. Various insurance companies in northern Utah. July 1996 to March 1998. Sold mutual funds, car insurance and life insurance products.
Territorial Sales Manager. Alltech, Inc., Nicholasville, KY. February 1995 to June 1996. Managed major accounts in Utah, Oregon, Idaho and Washington. (snipped)
Source: Utah State University web page. 2006-06-18. Available from http://web.archive.org/web/20040516035421/http://advs.usu.edu/advs/FACULTY/gbradley.html
With all due respect to Dr. Bradley and Cornerstone Nutritional Labs, it's unclear that a doctorate in poultry science is adequate to the task of designing drugs to treat serious illness in humans.
All the sources available to us agree on what was in EmpowerPlus circa April 2000-October 2002. What's more, on p 1 of her poster presented at the Canadian Psychiatric Association in 2000, Dr Kaplan writes that EmpowerPlus was first available for use in April 2000.
Source: 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
Synergy Group of Canada's E M Power+ Ingredients, as disclosed in response to customer inquiry (June 2000): http://groups.google.com/groups?q=truehope&start=50&hl=en&lr=&ie=UTF-8&selm=01BFCCE3.AC67F5C0.ahimsa%40easystreet.com&rnum=53
At this point, around October, 2002 the drug product EmpowerPlus
changed its formula, and it's this more recent product Truehope promotes today.
Truehope Nutritional Support Ltd., notice to customers of termination of affiliation with Evince International and Cornerstone Nutritional Labs. October, 2002. Available from "http://www.circare.org/FOIA/tnspc_200210.pdf
Empowerplus supplement ingredients per 3 capsules. Truehope Nutritional Support/Synergy Group of Canada. 2006-06-18. Available from http://www.truehope.com/_empowerplus/empIngredients.asp
Reorganization of Evince International LLC and introduction of Equilib, new improved formula. Evince International LLC Brochure. 2002-10-23. Available from http://www.circare.org/FOIA/evince_20021023.pdf
Equilib Product Information per 8 capsules. Evince International LLC. 2002-12-24. Available from http://web.archive.org/web/20021224212745/http://www.evince.org/productinfo.html
Evince International Brochure / Introduction of Equilib Powder. 2003-03-08. Available from http://www.circare.org/FOIA/einp_20030308.pdf :
… Suggested Use: The Equilib Powder Orange Drink Mix is designed for use by individuals who are under 12 years of age, are capsule intolerant, or prefer variety in their daily regimen …
… Research: Like the Equilib capsules, this product is intended for use with the Equilib open label study
One hopes this investigational drug-powdered-drink mix is sold in a child-proof canister — especially since they market it for pediatric use.
Evince International LLC, S.A.F.E CALL (abandonment). 2004-09-14. Available from http://tarr.uspto.gov/servlet/tarr?regser=serial&entry=78068126
Evince International LLC, EMPOWER PLUS (wordmark / abandonment). 2004-07-02. Available from http://tarr.uspto.gov/servlet/tarr?regser=serial&entry=78127585
Evince International LLC, Truehope (wordmark / abandonment). 2004-04-22. Available from http://tarr.uspto.gov/servlet/tarr?regser=serial&entry=76175152
Evince International LLC, E. M. Power+ (wordmark / abandonment). 2004-04-05. Available from shttp://tarr.uspto.gov/servlet/tarr?regser=serial&entry=76174753
Other trademarks registered to Evince International LLC are available through the TESS (United States Patent and Trademark Office, Trademark Electronic Search System) search at http://www.uspto.gov/main/trademarks.htm
Evince International LLC, Truehope (wordmark) reassignment. 2002-11-04. Available from http://strategis.ic.gc.ca/SSG/1103/trdp110328200e.html
The Synergy Group of Canada, EMPOWERPLUS (design). 2002-11-04. Available from http://strategis.ic.gc.ca/SSG/1158/trdp115835700e.html
What's to notice here?
Anyone reading around on the internet is likely to find strong statements that Health Canada and some alleged cartel of pharmaceutical interests have unfairly suppressed a promising treatment out of economic self-interest or evil intent, or are otherwise bullying the little guy
Truehope. The merits of EmpowerPlus remain to be judged by science but we reject the rest of this claim. Vitamins and minerals are initially manufactured by large pharmaceutical corporations, so they stand to profit from sales. In the United States the dietary supplement industry generates roughly $18 billion in annual sales.
The point is that there are no little guys
here: Cornerstone Nutritional Labs is one of the largest contract manufacturers in the US; several of the principals of Evince International [Brad Brower and Craig Ballard] are wealthy businessmen with numerous corporate interests; and as for Truehope, in a 2003 interview with Joanne Laucius, director Anthony Stephan said the for-profit Synergy Group of Canada Inc. made $300,000 a month in revenue.
Source (for annual income): The lure of a miracle pill for mental illness. Joanne Laucius. The Ottawa Citizen. 2003-07-21. Available from http://www.healthyplace.com/Communities/Thought_Disorders/schizo/articles/empowerplus.asp
Evince International LLC, 240 South 200 West Ste 200. Farmington, UT 84025 (Nonclassifiable Establisment)
Website (2002-12-02): http://web.archive.org/web/20011202174638/http://www.evince.org/
Status: Active
Registration date: 12/20/1999
Reinstatement: 9/13/2002
Last Renewed: 1/12/2001
Registered Agent/Director: Bradford Brower
The product labels we saw (2001 and 2002) had no street address for Evince International. If a consumer wanted more information and tried directory assistance, they would discover that Evince had no telephone service. From the label, the Evince web site, and the published studies customers could not know that Evince was not the manufacturer of EmpowerPlus, but rather just the distributor for the product produced through contract manufacture by Cornerstone Nutritional Labs, ostensibly its affiliate. These are dubious business arrangements for an entity conducting clinical trials.
Evince International Brochure. July, 2002. Available from http://healthwatcher.net/Quackerywatch/Synergy/EvB/index.html
Evince International Healthcare Professional Product Guide. January, 2002. Available from http://healthwatcher.net/Quackerywatch/Synergy/EvB/empoweresearch.pdf
Synergy American Truehope Center LLC, 56 E 1825 N. Centerville, UT 84014 (Nonclassifiable Establishment)
Status: Expired
Registration date: 6/6/2001
Status/date: Voluntarily Dissolved, 9/30/2002
Registered Agent / Director: Barbara Kay Kovac
Follow this link for more information about Truehope Research Assistant Barb Kovac
Pharos DBT Ltd., 1195 W 850 N. Centerville, UT 84014 (freight transportation and designated trans-shipper of EmpowerPlus at present)
Website (2003-12-07): http://web.archive.org/web/20031207122929/http://pharosdtb.com/index.html
Directions for Canadian EmpowerPlus users (2004-04-02): http://web.archive.org/web/20040402050313/http://pharosdtb.com/empowerplus_usa.html
Status: Active
Registration date: 9/30/2002
Registered Agent/Directors: Brent Milan Kovac, Barbara Kay Kovac (Web site registrants for www.truehope.com; www.truehopehelp.com)
Cornerstone Nutritional Labs LC, 218 S 200 W. Farmington, UT 84025 (Nonclassifiable Establishment)
Website: http://www.modernhealth.com/
Website: http://www.cnlabs.com/
Status: Active
Registration date: 10/15/1999
Registered Agent: Bradford Brower
Managers: Greg R. Cowley, Gary Anderson, Bradford J. Brower, Robert G. Steed (+ additional principals)
Modern Health Strategies LLC, 136 S. Main ST STE 1000. Salt Lake City, UT 84101 (Nonclassifiable Establishment)
Status: Active
Registration date and state: 3/16/1998, Delaware
Expired License Renewal: 5/21/2002
Registered Agent: Stephen Tumblin
Managers/Members: Greg R Cowley, Bradford J Brower (+ additional principals)
Excellent Foods, Inc., 218 S 200 W PO BOX 617 Farmington UT 84025 (Beverage
Manufacturing)
Status: Active
Registration date: 1/21/1992
Expired License Renewal: 4/10/2002
Registered Agent: Robert G. Steed
Officers: Gary C. Anderson, Robert G. Steed
Directors: Gary C. Anderson, Robert G. Steed (+ additional principals)
Earth's Pharmacy, LLC., 240 S. 200 W STE 200 PO BOX 848. Farmington, UT 840250848 (Nonclassifiable Establishment)
Status: Active
Registration date and state: 8/4/1998, Delaware
Registered Agent: Bradford Bower
Managers/Members: Creg R. Cowley, Bradford Bower (+ additional principals)
Source: Utah Department of Commerce Business Entity Search. Available from http://www.utah.gov/serv/bes
Truehope Institute, 3022 Bottom RD. Fallon, NV 89406
Date of Incorporation: April 25, 2001
Business: Nonprofit
Resident Agent: Drew Dahl
Principals: Drew Dahl; Pam Dahl
Source: Nevada State Corporate Search. Available from http://sos.state.nv.us/corpsrch.asp
More information on Truehope Institute, Fallon, NV. EIN: 31-1798310, is available from Guidestar, The National Database of Nonprofit Organizations at http://www.guidestar.org/
What's to notice here?
The Synergy Group of Canada widely represented itself as a non-profit corporation when it was not. Although the principals of The Synergy Group of Canada Inc. incorporated Truehope Nutritional Suppport Ltd. in December 2001, as of January 2003, payment for EmpowerPlus still went to the Synergy Group of Canada.
Source: 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.)
There is absolutely nothing wrong with being a for-profit corporation, but there is something wrong with insisting you are non-profit when you aren't. It's also silly because it detracts from credibility and is likely to confuse the vulnerable consumers targeted by Truehope's sales and marketing program. We also take exception to the lore
of EmpowerPlus' discovery: why claim all over the place that The Synergy Group of Canada Inc. was founded by Anthony Stephan and David Hardy in 1996 when Mr. Hardy quite obviously did not become a director until 1998?
The Synergy Group of Canada Inc., 635 2 Ave W. Cardston, Alberta T0K 0K0
Status: Active
Alberta Corporation Type: Named Alberta Corporation
Registration Date: 1996/5/23
Registered Office: 635 2 Ave W. Cardston, Alberta T0K 0K0
Mailing Address: Box 1254 Cardston, Alberta T0K 0K0
Director: Anthony Stephan, 635 2 Ave W. Cardston, Alberta T0K 0K0
Voting Shareholder: Anthony Stephan, 635 2 Ave W. Cardston, Alberta T0K 0K0Change of Director/Voting Shareholder: 1998-03-10 – Addition – David Hardy, Box 722 Raymond, Alberta T0K2S0
Sources:
- Health Canada ATI file number A-2001-0845/ms. ATIP1026, ATIP1027, ATIP1028, ATIP1029. Corporate registration, The Synergy Group of Canada Inc. 2000-09-23. Available from http://www.circare.org/FOIA/hcati1027029.pdf
- Alberta Corporate Registration System / The Synergy Group of Canada, Inc. Change of Director/Shareholder Proof of Filing. 1998-03-10. Available from http://www.circare.org/FOIA/registrysgc1998.pdf
Truehope Nutritional Support Ltd., 635 2 Ave W. Cardston, Alberta T0K 0K0
Status: Active
Legal Entity Type: Non-profit private corporation
Registration Date: 2001/10/29
Registered Office: 635 2 Ave W Cardston Alberta T0K 0K0
Mailing Address: Box 1254 Cardston Alberta T0K 0K0
Directors: David Hardy, Box 722 Raymond, Alberta T0K2S0; Anthony Stephan, 635 2 Ave W. Cardston, Alberta T0K 0K0Source: Alberta Corporate Registration System / Truehope Nutritional Support Ltd. Incorporation. 2001-12-19. Available from http://www.circare.org/FOIA/registrytns2001.pdf
Better late than never, though it hardly explains this alleged Legal Disclaimer
that was on the truehope.com web site for years:
Truehope Institute Inc.
Disclaimer: The Truehope Institute Inc. is a benevolent group dedicated to assisting the mentally ill and their families. Application has been made for the Institute to act as a charitable non-profit organization. Truehope makes no claims as to the efficacy of it's [sic] research programs and it's [sic] effects on CNS (central nervous system) disorders. All case studies found within this website represent the real life experience of the individual participants. The names of the participants have been changed or withheld to protect the privacy of the individual. The information provided on this website or in any Truehope literature is not to be taken as medical advice and furthermore we encourage all Truehope Research participants to work closely with their medical practitioners.
The Truehope logos are trademarked property. Copyright 1999
ALL RIGHTS RESERVED ®Source accessed 2004-06-08 from http://www.healthwatcher.net/Quackerywatch/Synergy/truehopelegal.html
PS: I believe it's the adjective they want not the verb.
Truehope Institute Inc., Raymond, Alberta.
Date of Letters Patent: August 16, 2002.
Directors: David Hardy, 164 West 100 North Raymond, Alberta T0K2S0; Barbara Margaret Stephan, 635 2 Ave W. Cardston, Alberta T0K 0K0; Autumn Dawn Stringam, RR#1 Sexsmith, Alberta T0H 3C0.
Purposes of Corporation: (A) Education — sponsorship of applied research on the effects of nutrition on mental illness and Central Nervous System Disorders; dissemination of related information via public awareness campaign (B) Relief of Poverty — establishment of treatment and recovery facilities for individuals suffering from mental illness and disorders of the Central Nervous System.
Source: Truehope Institute Inc. Letters Patent. 2002-08-16. Available from http://www.circare.org/FOIA/letterspatent.pdf
Last Updated: 2007-04-01
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