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Great Lakes College of Clinical Medicine IRB Document Index

2009-07-29: URLs to documents on the FDA website may be dead; we're working on correcting them. Sigh.

Quick Index

What's in a Name?

According to the Ohio Secretary of State Business Name search, the correct name of the Great Lakes College of Clinical Medicine was the Great Lakes Association of Clinical Medicine Inc. On 2001-11-26 the organization changed their name to The International College of Integrative Medicine Inc.

Follow this link to find state medical board actions against physicians associated with the Great Lakes Association of Clinical Medicine and the Great Lakes Association of Clinical Medicine Institutional Review Board

Great Lakes Association of Clinical Medicine IRB: Form FDA 483s, Notices of Inspectional Findings, and Establishment Inspection Report

Form FDA 483 Issued to L. Terry Chappell M.D. and Great Lakes Association of Clinical Medicine Institutional Review Board. 1994-12-21: http://www.circare.org/foia2/483_glccm19941221.pdf

Form FDA 483 Issued to L. Terry Chappell M.D. and Great Lakes College of Clinical Medicine Institutional Review Board. 1999-12-01: http://www.circare.org/foia2/483_glccm19991201.pdf

FDA Establishment Inspection Report, Great Lakes College of Clinical Medicine IRB. 1999-12-01: http://www.circare.org/foia2/glccm_fdaeir19991201.pdf

FDA Warning Letter to GLCCM IRB and Related Correspondence

Masiello SA. FDA Warning Letter to L. Terry Chappell, M.D., Great Lakes College of Clinical Medicine IRB. 2000-03-09: http://www.circare.org/foia2/fda_glccm20000309.pdf

Chappell LT. Great Lakes College of Clinical Medicine IRB to FDA. 2000-03-17: http://www.circare.org/foia2/glccm_fda20000317.pdf

Masiello SA. FDA to L. Terry Chappell, M.D., Great Lakes College of Clinical Medicine IRB. 2000-04-13: http://www.circare.org/foia2/fda_glccm20000413.pdf

Chappell LT. Great Lakes College of Clinical Medicine IRB to FDA. 2000-05-26: http://www.circare.org/foia2/glccm_fda20000526.pdf

Masiello SA. FDA to Jack Hank, Great Lakes College of Clinical Medicine IRB. 2000-07-21: http://www.circare.org/foia2/fda_glccm20000721.pdf

Hank J. Great Lakes College of Clinical Medicine IRB to FDA. 2000-08-11: http://www.circare.org/foia2/glccm_fda20000811.pdf

Masiello SA. FDA to Jack Hank, Great Lakes College of Clinical Medicine IRB. 2000-09-05: http://www.circare.org/foia2/fda_glccm20000905.pdf

Chappell LT. Great Lakes College of Clinical Medicine IRB to FDA. 2000-10-26: http://www.circare.org/foia2/glccm_fda20001026.pdf

Masiello SA. FDA to Barbara Grunewald, Great Lakes College of Clinical Medicine IRB. 2001-01-02: http://www.circare.org/foia2/fda_glccm20010102.pdf

Grunewald B. Great Lakes College of Clinical Medicine IRB to FDA. 2001-02-07: http://www.circare.org/foia2/glccm_fda20010207.pdf

Chappell LT. Great Lakes College of Clinical Medicine IRB to FDA. 2001-07-17: http://www.circare.org/foia2/glccm_fda20010717.pdf

Grunewald B. Great Lakes College of Clinical Medicine IRB to FDA. 2001-07-20: http://www.circare.org/foia2/glccm_fda20010720.pdf

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Royal Offspring? Daniel Royal, D.O. and the Nevada Institutional Review Board

If you thought it ended here, you'd be wrong. On 2006-03-24, former GLCCM IRB investigator Daniel Royal D.O. gave a talk titled Formation of a National Institutional Review Board that You Can Use at a conference sponsored by the International College of Integrative Medicine. You can read more in the program schedule at: http://icimed.com/conferences_2006_schedule.php

The national institutional review board to which the programs refers is surely the newly minted Nevada Institutional Review Board, the brainchild of the Nevada Board of Homeopathic Medical Examiners and Nevada State Senator Michael Schneider. The Nevada IRB is unusual: it doesn't look like an IRB, its mission isn't the same as an IRB, and the IRB members seem unlike other IRB members. The Nevada Board of Homeopathic Medical Examiners recently published this flyer soliciting funds for the Nevada IRB, and it offers insight into what's intended: http://www.nvbhme.com/pdf/NIRB_fund_raiser.pdf

Thanks to the bizarre legislation passed by the state of Nevada, the mission of the Nevada IRB includes, among other things, promotion of stem cell therapy and alternative medicine for the benefit of the citizens of Nevada. In addition to the IRB per se, which will promote research and establish the standard of care, plans were in place fund a stem cell research institute and a twice-disciplined osteopath from California had been selected to run it.

The Nevada Institutional Review Board: http://www.nevadainstitutionalreviewboard.com/

Susan Gallagher provides thought-provoking commentary on the The Nevada Institutional Review Board: http://faculty.uml.edu/sgallagher/NIRB.htm

Dr. Woo Suk Hwang and his circus-like fraud of fake cloned dogs and stolen ova don't look so bad in this light.

It was Dr. Daniel Royal's conduct of research to which FDA objected at the beginning of the warning letter sent to the GLCCM IRB on 2000-03-09: http://www.circare.org/foia2/fda_glccm20000309.pdf

Dr. Royal's research achieved national notoriety of sorts because of his co-investigator William Job Leavitt. Leavitt and Royal are listed as co-investigators in the list of investigators approved by the GLCCM IRB with active studies enrolling research subjects as of December 1998: http://www.circare.org/foia2/glccmstudies_ml.pdf

These news stories include brief descriptions of the research conducted by Dr. Royal and Mr. Leavitt.

Doctor never believed bacteria was anthrax. Art Nadler. The Las Vegas Sun. 1998-02-24. Available from http://www.lasvegassun.com/sunbin/stories/special/1998/feb/24/506873287.html

SUN profile: Leavitt's mother says son innocent. Denise Cardinal. The Las Vegas Sun. 1998-02-20. Available from http://www.lasvegassun.com/dossier/crime/bio/leavitt.html

SUN profile: Rockwell's credibility probed in anthrax arrests. Denise Cardinal and Art Nadler. The Las Vegas Sun. 1998-02-23. Available from http://www.lasvegassun.com/dossier/crime/bio/rockwell.html

SUN Profile: Harris' troubled past includes mail fraud, white supremacy. Larry Henry. The Las Vegas Sun. 1998-02-23. Available from http://www.lasvegassun.com/dossier/crime/bio/harris.html

Las Vegas Sun Story Archive on the Anthrax Case, William Job Leavitt, and Larry Wayne Harris. Available from http://www.lasvegassun.com/dossier/crime/bio/archive.html

Leavitt a family man, eccentric entrepreneur. Susan Greene. The Las Vegas Review-Journal. 1998-02-20. Available from http://www.reviewjournal.com/lvrj_home/1998/Feb-20-Fri-1998/news/6991074.html

Beyond Anthrax: Extremists and Bioterrorism Threat. Larry Wayne Harris. The Harris Hoax. Law Enforcement Agency Resource Network. Anti-Defamation League. 2001. Available from http://www.adl.org/learn/Anthrax/Harris.asp?xpicked=3&item=5

Just as the dust settled from the anthrax scare, Leavitt's name was in the media again. The Las Vegas Sun reported that the Nevada Medical Board revoked the license of William Murray, D.O. for aiding and abetting the unauthorized practice of medicine by William Leavitt.

Doctor loses license to practice in Nevada. Ed Koch. The Las Vegas Sun. 1999-12-06. Available from http://www.mormonstoday.com/991212/D2Murray01.shtml

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GLCCM IRB Meeting Minutes

GLCCM IRB Minutes of 2000-05-05. [Dallas, TX. meeting of the American College for Advancement in Medicine.]: http://www.circare.org/foia2/glccm_irbmin20000505orig.pdf

GLCCM IRB Minutes of 2000-02-25. [Atlanta, GA.]: http://www.circare.org/foia2/glccm_irbmin20000225.pdf

GLCCM IRB Minutes of 1999-03-13. [Asheville, NC.]: http://www.circare.org/foia2/glccm_irbmin19990313.pdf

Physician Investigators Approved by the GLCCM IRB

GLCCM IRB mailing list of principal investigators and studies enrolling research subjects as of December 1998. [OCR]: http://www.circare.org/foia2/glccmstudies_ml.pdf

Standard Operating Procedures of the GLCCM IRB

GLCCM IRB Rules: http://www.circare.org/foia2/glccm_rules.pdf

Research Approved by the GLCCM IRB

List of studies approved by the GLCCM IRB and enrolling subjects in March 2000 when FDA suspended the IRB's authority. [OCR]: http://www.circare.org/foia2/glccmstudies.pdf

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Gene Activated Therapy (GAT) for the Treatment of Cancer

Roy Page M.D. was the principal investigator for the studies titled Gene Activated Therapy (GAT) for the Treatment of Cancer and Stimulated Autologous Immune Serum and Autologous Tumor Vaccine in the Treatment of Refractory Solid Tumors. These cancer vaccines were manufactured by Amscot Medical Laboratories, one of the businesses owned by GLCCM IRB member George Kindness. An FDA inspection of Dr. Page's office showed that Dr. Page failed to protect the rights and welfare of research subjects and deliberately and repeatedly violated FDA regulations governing the conduct of research with investigational new drugs. Following the inspection FDA notified Dr. Page the agency intended to begin proceedings to debar him.

FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain to Roy C. Page, M.D. 2000-03-06: http://www.circare.org/fdawls3/page_20000406.pdf

FDA Notice of Opportunity for Hearing to Roy C. Page, M.D. 2002-01-08: http://www.circare.org/fdawls3/page_20020108.pdf

FDA Notification of Disqualification/Total Restriction of Roy C. Page, M.D. 2003-04-10: http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm#rpage

Roy C. Page, M.D.; Debarment Order 73 FR 71008 2008-11-24: http://www.circare.org/fdawls3/page_debarment.pdf

Criminal charges were subsequently filed against Dr. Page.

The United States of America v. Roy Page M.D. Case No. 04CR20056. United States District Court. Western District of Tennessee. Western Division. [Docket sheet.]: http://www.circare.org/foia2/0420056m1docket.pdf

The United States of America v. Roy Page M.D. Case No. 04CR20056. Plea Agreement. 2005-08-04: http://www.circare.org/foia2/204CR20056-01-MI_plea.pdf

Dr. Page was also sued for fraud and medical malpractice by research subject Audrey Snow.

Audrey M. Snow Civil No. 03CV00474. USDC, Southern District of Alabama. Complaint. 2003-06-25. Available in PACER or use the Webmaster link at the bottom of this page and we'll send you a copy via email attachment.

This is the purported Informed Consent Agreement signed by Ms. Snow to enroll in the clinical trial of Stimulated Autologous Immune Serum conducted by Dr. Page: http://www.circare.org/foia2/cv_03_2238_icf.pdf

According the complaint in this case, a laboratory analysis conducted on 2002-11-04 revealed that the serum for which the research subject Ms. Snow was charged $9,500, contained water, lactic acid, and no protein material. The Stimulated Autologous Immune Serum was manufactured by Amscot Medical Laboratory, owned and operated by GLCCM IRB member George Kindness (see below). Mr. Kindness was indicted in U.S. federal district court on 22 criminal counts arising from violations of FDA regulations in clinical trials testing cancer vaccines.

Follow this link for additional information about Roy C. Page, M.D.

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Enzyme Potentiated Desensitization (EPD) Study

Welman A. Shrader M.D. was the principal investigator for a study titled Evaluation of the Effect of Immunotherapeutic Technique Enzyme Potentiated Desensitization (EPD) for a Considerable Variety of Illness/Conditions/diagnostic Conditions. Between 1994 and 2001 more than 10,000 subjects were exposed to an unlicensed biologic in studies for which no IND application was submitted to FDA. According to Peter Dubinsky, then head of the FDA Center for Biologic Evaluation and Research, the study was originally approved by the GLCCM IRB on the condition that the necessary IND would be obtained. Yet no IND was ever obtained. The unlicensed biologic seems to have been smuggled into the U.S. and research subjects were charged high fees to be exposed to it.

FDA Warning Letter to Welman A. Shrader, M.D. 2001-04-04: http://www.fda.gov/foi/warning_letters/archive/g1069d.pdf

Consent Form for Enzyme Potentiated Desensitization (EPD) study (ca. 1998): http://www.circare.org/foia2/epd_consentforms1998.pdf

Site Investigators List for Enzyme Potentiated Desensitization (EPD) study (ca. 1998): http://www.circare.org/foia2/epd_siteinvestigators.pdf

The first controlled trial with a significant number of subjects concluded EPD was not beneficial for the treatment of seasonal allergic rhinitis:

Radcliffe MJ, Lewith GT, Turner RG et al. Enzyme potentiated desensitization in treatment of seasonal allergic rhinitis: double blind randomized controlled study. BMJ. 2003;327:251-4. Accessed on 2005-10-02 at: http://bmj.bmjjournals.com/cgi/content/full/327/7409/251

Potential or actual research subjects in the U.S. may have been confused about the status of EPD products in the UK. Dr. Shrader and other EPD proponents assert that EPD immunotherapy is now the only allergy immunotherapy permitted to be used in a physician's office outside a hospital setting in the United Kingdom. This does not mean, however, that EPD products were approved for sale or use or otherwise sanctioned as accepted medical treatment for allergies by UK regulators.

An example of this is posted on Dr. Shrader's web site: http://www.epdallergy.com/pr02.htm Other examples are:

Nutrition Associates Limited, Enzyme Potentiated Desensitisation: http://www.naltd.co.uk/EPD.pdf

Ron Kennedy, M.D., The Doctor's Medical Library. Allergy Medicine: http://www.medical-library.net/specialties/framer.html?/specialties/_allergy_medicine.html

On 2001-01-02 FDA directed the GLCCM IRB to terminate the EPD study:

Masiello SA. FDA to Barbara Grunewald, Great Lakes College of Clinical Medicine IRB. 2001-01-02: http://www.circare.org/foia2/fda_glccm20010102.pdf

It appears, however, that some physicians persisted in purchasing investigational EPD products. On 2002-05-02 FDA Import Alert #57-15 notified field personnel that all EPD products were subject to Detention Without Physical Examination: http://web.archive.org/web/20080129234425/http://www.fda.gov/ora/fiars/ora_import_ia5715.html

Dr. Shrader published the results of the EPD study in summary form on this web site: http://www.epdallergy.com/pr03.htm
He also published these results on his newer web site: http://www.drshrader.com/details.htm

Apparently undeterred by this experience, Dr. Shrader continued to conduct research and in 2004 he published a paper on the treatment of asthma.

Shrader WA. Short and long term treatment of asthma with intravenous nutrients. Nutrition Journal 2004;3:6. Accessed on 2005-09-26 at: http://www.nutritionj.com/content/pdf/1475-2891-3-6.pdf

Leonard Maitland McEwen, BM BCh. produced the investigational biologic products for Dr. Shrader's Enzyme Potentiated Desensitization (EPD) study. On 2006-09-01 the General Medical Council found Dr. McEwan's fitness to practice to be impaired as a result of failure to maintain patient confidentiality and improbity in soliciting patients to invest in the manufacture of components of EPD, in which latter Dr. McEwan had a significant financial stake. Among other things, the council determined that:

The Panel has heard that you have worked for a number of years as a private practitioner offering medical advice and treatment for allergies and food intolerances. During the course of your work you saw patients and provided them with Enzyme Potentiated Desensitisation (EPD) treatment, which was manufactured by a small family company, McEwen Laboratories Ltd. The Panel has heard that you were the Scientific Director of, and a shareholder of, McEwen Laboratories Ltd, owning 34% of the company. You were one of four Directors of the company, the others being your wife and two of your sons.

The EPD Study Office of McEwen Laboratories maintained a database of patients in order to assist in the evaluation of the efficacy of EPD treatment. The information held on this database was drawn from treatment evaluation forms completed by patients who had received EPD treatment. This included forms from patients who had received EPD treatment from you. You were responsible for obtaining this information and the use of the information supplied for clinical purposes.

In 2004 a group of patients who had commenced EPD treatment received a letter. You were the first signatory of this letter in your capacity as a doctor. The letter indicated that in order to secure the future of EPD treatment, McEwen Laboratories Ltd needed to take steps towards the full licensing and marketing of the product, intended to raise capital through a new company, Epidyme Ltd, and that Epidyme Ltd needed to raise approximately 300,000 in order to commence operations. The letter stated that the minimum level of investment was 5,000 and that the capital raised was intended to begin the process of exploiting on a commercial scale the intellectual property of McEwen Laboratories Ltd.

A decision was taken in June 2004 by the Directors of McEwen Laboratories Ltd, at a Board meeting, to use information held on the database as the source material for the letter soliciting funding. You were present at the meeting in your capacity as Chairman/Managing Director and Scientific Director of McEwen Laboratories Ltd. You acquiesced to the use of the information held on the database and therefore permitted McEwen Laboratories Ltd to use the names and contact details of the patients, all of whom had received EPD treatment.

The EPD patients were informed in the letter that we are writing to you because we believe that you have received one or more shots of EPD and that we hope you have benefited from EPD and would like the treatment to remain available. The letter concluded with the sentence that we know that without this capital the production of EPD will not be able to continue. You thereby encouraged patients to invest in Epidyme Ltd, in which McEwen Laboratories Ltd would be the majority shareholder, by implying that, without such investment, their treatment would no longer be available.

The Panel has found that by your actions you have breached the confidence of patients and that your actions were inappropriate and unprofessional.

General Medical Council. Fitness to Practise Panel decision of 2006-09-01: http://www.gmc-uk.org/concerns/hearings_and_decisions/ftp/ftp_panel_mcewen_20060829.asp

See also: Epidyme Ltd.

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Dimercapto-propane sulfonate (DMPS) Clinical Trials

Paula R. Bickle, Ph.D., a member of the GLCCM IRB, was the principal investigator for IND studies of Dimercapto-propane sulfonate (DMPS). Chief among the deficiencies in her clinical trials discovered during FDA inspection was her failure to report the death of a research subject to FDA.

FDA Form 483 Issued to Paula R. Bickle, Ph.D. and Cascade Consultants Research Foundation. 1999-09-08: http://www.circare.org/foia2/483_bickle.pdf

FDA inspected Heyltex Incorporated, the sponsor of Paula Bickle's clinical trials. Evidently the agency didn't like what they found:

Woollen SW. FDA Warning Letter to Robert Z. Martin and Heyltex Incorporated. 2000-09-20: http://www.fda.gov/foi/warning_letters/archive/m4226n.pdf

According to Ms. Bickle, the following document is a list of Physicians (MD or DO) Dentists (DDS/DMD) and Doctors (ND or DC) who have successfully completed the authorized training program regarding Mercury toxicity.

List of investigators conducting clinical trials testing Dimercapto-propane sulfonate (DMPS): http://www.circare.org/foia2/glccm_bickledmpsinvestig.pdf

The list was published on the website of the Cascade Health Group, the health care business of GLCCM IRB member Paula R. Bickle, Ph.D. The list dates to 1998-12-05: http://web.archive.org/web/19981205184244/www.cascade-web.com/referral.html

In 1996 and 1998 Ms. Bickle was charged with practicing medicine without a license by the states of Washington and Oregon, respectively. In 2000 Ms. Bickle signed a consent agreement with the Oregon Attorney General in which she agreed to cease diagnosing, prescribing, and administering IV treatment to patients, pay a $7,500 penalty, and refrain from owning or managing any facility at which persons engage in the practice of medicine. A background article on Ms. Bickle by the National Council Against Health Fraud is available at: http://www.quackwatch.org/11Ind/bickle.html

Additional information provided by the following sources:

1. A description of the GLCCM DMPS Mercury study from the old website of the Great Lakes Association of Clinical Medicine, e.g., the Great Lakes College of Clinical Medicine:

Mercury and DMPS Usage

It is important to be involved in this project if you are using or are thinking about using DMPS

Would you consider using EDTA Chelation Therapy in your office without learning how to properly dose a patient, the proper procedures, laboratory tests required and adjunctive care necessary to make the treatment successful? Of course not!

Should DMPS be treated any differently?

DMPS is not an FDA approved chemical, however, it is considered a custom compound. This puts this molecule in a very gray area. Patients who present mercury toxicity or sensitivity are understandably the most difficult and complicated patients in your practice.

The symptoms of mercury poisoning can include: 1. tremor in fine voluntary muscle movement, 2. depression, 3. fatigue, 4. moodiness, 5. inability to concentrate, 6. birth defects, and 7. nephritis. The Environmental Protection Agency (EPA) has set a safe exposure level to mercury vapor at 10 nmol/ day. The Federal Government now admits that the average US adult receives 20 nmol/day, just from their amalgam fillings!

Because of these factors, it was felt that proper procedures and a specific protocol for the use of DMPS must be devised and properly tested. At GLACM it was decided that an IRB study and protocol should be submitted to properly study the safety and effectiveness of a treatment protocol to detoxify the mercury toxic/sensitive patient.

We are pleased to announce that in February of 1995, the Board approved the study to go multi-center.

The writings, protocols, lectures and computer collection. data have been put together without funding from outside sources; therefore, the results of this study will have no one trying to dictate its outcome.

This offers you, the clinician, the chance to take part in a possible history changing study. It will also teach you how to treat these very ill and complicated patients safely.

Currently, researchers from 26 states and 3 foreign countries have been trained. We invite you to join us in this project. The next seminar is September 18th & 19th, 1996 at the Milwaukee Hilton just prior to the GLACM meeting. The cost is only $695 (preregistered and paid) or $770 at the door for physicians and dentists ($350 for staff).

For reservations, call: (360) 253-4445
Paula R. Bickle, RDH, Ph.D., Principal Investigator

Source: Great Lakes Association of Clinical Medicine. Mercury and DMPS Usage. 1999-03-20. Accessed on 2006-01-31 at: http://web.archive.org/web/19990302080253/www.arxc.com/glacm/dmps.htm

2. Correspondence from Ms. Pam Floener, Heyltex Incorporated, to customers regarding reports of adverse reactions experienced by users of Dimercapto-propane sulfonate (DMPS) formulated for transdermal application. 2004-08-26: http://www.circare.org/foia2/heylfloener.pdf

3. The perspectives of research subjects on clinical trials testing Dimercapto-propane sulfonate (DMPS) are available at DMPSBackfire.com, a website created by J. Nestlerode, J.D.: http://www.dmpsbackfire.com/default.shtml

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Criminal and Civil Litigation Related to GLCCM IRB-Approved Research

Roy Page, M.D.

Criminal charges were filed against Dr. Roy Page arising from violations of FDA regulations while conducting the study titled Gene Activated Therapy (GAT) for the Treatment of Cancer. Subsequently Dr. Page was permanently debarred by FDA. In addition in January 2008 Dr. Page was fined and surrendered his medical license.

Clinical Investigator Roy C. Page, M.D., Sentenced. FDA Enforcement Story, Center for Biologics Evaluation and Research, 1.5. 2005: http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM091058.pdf

The United States of America v. Roy Page M.D. Case No. 04CR20056. United States District Court. Western District of Tennessee. Western Division. [Docket sheet.]: http://www.circare.org/foia2/0420056m1docket.pdf

The United States of America v. Roy Page M.D. Case No. 04CR20056. Plea Agreement. 2005-08-04: http://www.circare.org/foia2/204CR20056-01-MI_plea.pdf

Page, Roy C., M.D. (CBER, NIDPOE) 2000-04-06: http://www.circare.org/fdawls3/page_20000406.pdf

Page, Roy C., M.D. (NOOH) 2002-01-08: http://www.circare.org/fdawls3/page_20020108.pdf

Smith. PS. FDA Establishment Inspection Report, Form FDA 483, and Correspondence, Roy C. Page, M.D. Accessed on 2009-02-05 at: http://www.circare.org/foia2/page_eirand483_19991209.pdf

FR Vol. 73 No. 227. 2008-11-24. U.S. Food and Drug Adminstration. Roy C. Page, M.D.; Debarment Order. 71008-71009. Accessed on 2009-02-05 at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-27803.pdf

Dr. Page was also sued for fraud and medical malpractice by research subject Audrey Snow.

Audrey M. Snow Civil No. 03CV00474. USDC Southern District of Alabama. Complaint. 2003-06-25: Available in PACER or use the Webmaster link at the bottom of this page and we'll send you a copy via email attachment.

This is the purported Informed Consent Agreement signed by Ms. Snow to enroll in the clinical trial of Stimulated Autologous Immune Serum conducted by Dr. Page: http://www.circare.org/foia2/cv_03_2238_icf.pdf

According the complaint in this case, a laboratory analysis conducted on 2002-11-04 revealed that the serum for which the research subject Ms. Snow was charged $9,500, contained water, lactic acid, and no protein material. The Stimulated Autologous Immune Serum was manufactured by Amscot Medical Laboratory, owned and operated by GLCCM IRB member George Kindness (see below). Mr. Kindness was indicted in U.S. federal district court on 22 criminal counts arising from his actions in clinical trials testing cancer vaccines.

Before the Tennessee Board of Medical Examiners in the Matter of Roy C. Page, M.D. Amended Agreed Order. 2008-02-24: http://www.circare.org/pd/page_20080124.pdf

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William J. Mauer, D.O.

In 1993 Rodney Trovinger sought ultraviolet blood cleansing treatment from Dr. Mauer believing (bizarrely) it would cure him of advanced AIDS. Dr. Mauer initially turned Mr. Trovinger away because of his HIV status; Mr. Trovinger sued under the ADA and unfortunately for him he won, only to die of sepsis within days of his hard-won access to treatment.

Rodney Trovinger v. William Mauer, D.O. Case No. 94CV2239. United States District Court. Northern District of Illinois, Chicago. [Docket Sheet]: http://www.circare.org/foia2/trovingerdocket.pdf

Nobody seemed to notice that Dr. Mauer hadn't obtained an IDE to conduct his device study, least of all the IRB that approved the study: the GLCCM IRB.

Subsequently, by letter of 2000-08-11, the GLCCM IRB represented to FDA that Dr. Mauer's study titled Phototherapy as a Modality in the Stimulation of the Immune System was terminated due to a lack of response.

Hank J. Great Lakes College of Clinical Medicine IRB to FDA. 2000-08-11. Available from http://www.circare.org/foia2/glccm_fda20000811.pdf

This statement may not have entirely accurate. Dr. Mauer advised the GLCCM IRB in his letter of 2001-02-05 that In response to your request I wish to advise you that I wish to terminate S004 – Phototherapy.

Mauer WJ. Letter to Betsy Angus, Great Lakes College of Clinical Medicine IRB. 2001-02-05: http://www.circare.org/foia2/glccm_mauer.pdf

Strangely enough it seems that Dr. Mauer was responding to a request which for some reason the GLCCM IRB recorded in their meeting minutes of 2000-05-05 as a Termination Notice sent for lack of response to the annual continuing review. Go Figure.

GLCCM IRB Minutes of 2000-05-05. [Dallas, TX. meeting of the American College for Advancement in Medicine.]: http://www.circare.org/foia2/glccm_irbmin20000505orig.pdf

On 2002-07-26 Dr. Mauer's Illinois osteopathic license was revoked (upon remand by the Circuit Court of Cook County) for allowing an unlicensed individual to perform medical tasks, gross negligence in the treatment of a patient, and practicing on a non-renewed license for nearly seven months. The revocation of Dr. Mauer's license was accompanied by a fine of $15,000. Source: Illinois Division of Professional Regulation License Look Up for physician William John Mauer, D.O. Accessed on 2006-10-12 at: https://www.idfpr.com/dpr/licenselookup/default.asp

Man says osteopath's methods forced him to have leg amputated. Kevin Davis. Arlington Heights Post. 1997-04-17.
URL: http://archives.pioneerlocal.com/cgi-bin/ppo-story/archives/localnews/1997/ah/04.17.97.4310.html

Doctor says he never made false promises. Kevin Davis. Arlington Heights Post. 1997-04-24.
URL: http://archives.pioneerlocal.com/cgi-bin/ppo-story/archives/localnews/1997/ah/04.24.97.21656.html

Doctor defends alternative medicine. Kevin Davis. Arlington Heights Post. 1997-05-29.
URL: http://archives.pioneerlocal.com/cgi-bin/ppo-story/archives/localnews/1997/ah/05.29.97.33091.html

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George Kindness

George Kindness was member of the Great Lakes Association of Clinical Medicine IRB and the president of Amscot Medical Laboratories, Inc., the company that manufactured the Stimulated Autologous Immune Serum used by Roy Page, M.D. in the study called Gene Activated Therapy (GAT) for the Treatment of Cancer. In 2003 Mr. Kindness was indicted in U.S. federal court on 22 criminal counts arising from violations of FDA regulations in clinical trials testing cancer vaccines. The indictment notes in passing that Kindness falsely represented to FDA that he was a physician. In 2008 Kindness was permanently debarred by FDA.

United States of America v. George Kindness and Amscot Medical Labs Inc. Case No. 03CR20433. United States District Court. Western District of Tennessee, Western Division. Indictment. 2003-11-19: http://www.circare.org/foia2/03_20433BV.pdf

George Kindness and Amscot Medical Laboratories, Inc., Sentenced. FDA Enforcement Story 2006: http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/UCM090838.pdf

United States of America v. George Kindness and Amscot Medical Labs Inc. Case No. 03CR20433. Plea Agreement. United States District Court. Western District of Tennessee, Western Division. 2005-07-06: http://www.circare.org/lex/03cr20433_20050706.pdf

George J. Kindness; Debarment Order 73 FR 71007 2008-11-24: http://www.circare.org/fdawls3/kindness_20081124.pdf

Kindness and Amscot Medical Laboratories, Inc. provided life expectancy estimates for one or more companies selling fraudulent viatical investments. The life expectancy estimates produced by Kindness were alleged to be erroneous and he was subsequently sued for damages by the bankruptcy receiver of Premium of America, LLC.

Premium of America, LLC v. Amscot Medical Labs, Inc., Amscot Medical Labs – Hamilton, Inc., George Kindness et al. Adversary Proceeding No: 04-10454. United States Bankruptcy Court, District of Columbia (Washington, D.C.). 2004-11-19: http://www.circare.org/foia2/02_2358.pdf

In 2004 Kindness was named as a defendent in the viatical securities fraud case filed against Viatical Benefactors et al.

Scheck Investments, et al. vs. Viatical Benefactors, et al. Case No. 04CV21160. United States District Court, Southern District of Florida, Miami. 2004-05-17. The case is available to PACER subscribers and non-subscribers can access many of the case documents on the website set up by the receiver for Mutual Benefit Incorporated: http://mbcreceiver.com/updates.html

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Errata: Promotion of Edetate Disodium EDTA Injection (Endrate™)

Wetherall R. FDA Office of Legislative Services. Letter to the Honorable Robert P. Griffin re: disodium EDTA and constituents' correspondence with FDA. 1977-07-13. Available from http://www.circare.org/foia2/fda_griffin19770713letter.pdf

Attachments:

  1. Disodium Edetate Injection Followup Notice and Notice of Opportunity for Hearing. 39 FR 137. July 16, 1974. Pp. 26056-26057. Available from http://www.circare.org/foia2/fda_griffin19770713fr26056.pdf
  2. Endrate™ Edetate Disodium Injection USP. IND 11355 Front Matter and Table of Contents. National Academy of Science — National Research Council. Available from http://www.circare.org/foia2/ind_11355frontmatter.pdf
  3. Endrate™ Edetate Disodium Injection USP. IND 11355 Panel on Drugs Used in Metabolic Disorders. National Academy of Science — National Research Council. Available from http://www.circare.org/foia2/ind_11355metabolic.pdf
  4. Endrate™ Edetate Disodium Injection USP. IND 11355 Panel on Drugs Used in Correction of Fluid and Electrolyte Balance. National Academy of Science — National Research Council. Available from http://www.circare.org/foia2/ind_11355electrolyte.pdf
  5. Endrate™ Edetate Disodium Injection USP. IND 11355 Panel on Cardiovascular Drugs. National Academy of Science — National Research Council. Available from http://www.circare.org/foia2/ind_11355cardiovascular.pdf
  6. Endrate™ Edetate Disodium Injection USP. IND 11355 Panel on Drugs Used in Rheumatic Diseases. National Academy of Science — National Research Council. Available from http://www.circare.org/foia2/ind_11355rheumatic.pdf
  7. AMA Newsletter. 1983-05-23. Available from http://www.circare.org/foia2/amanewsletter_19830523.pdf

Endrate™ Edetate Disodium Injection USP. Professional Prescribing Information (Before DESI, 1970-01-13). Abbott Hospital Products. Available from http://www.circare.org/foia2/endrate_ppi19700113.pdf

Endrate™ Edetate Disodium Injection USP. Professional Prescribing Information. Abbott Hospital Products. Available from http://www.circare.org/foia2/endrate_ppi.pdf

Calcium Disodium Versenate Edetate Calcium Disodium Injection USP. Professional Prescribing Information. 3M Pharmaceuticals and Hospira Inc. Available from http://www.circare.org/foia2/3M_ca2na_versenate.pdf

United States v. An Article of Drug*** Diso-tate, et al. United States District Court for the Eastern Division of Louisiana. No. 75-1790. Vincent A. Kleinfeld, Alan H. Kaplan & Stephen A. Weitzman. Federal Food, Drug, and Cosmetic Act Judicial Record 1975-1977 (FDLI, Washington, DC 1979). September 28, 1976. Accessed on April 19, 2006 at: http://www.circare.org/tact/17-1790_19760928.pdf

453 F. Supp. 1141. United States of America v. H. Ray Evers, M. D., an Individual, doing business as Ra-Mar Clinic. Civ. A. No. 78-93-N. United States District Court Middle District of Alabama, Northern Division. June 27, 1978. Available from http://www.circare.org/foia2/evers.pdf

Controversial therapy lures problem doctors. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-13.
URL: http://web.archive.org/web/20010203213300/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000107361,00.html

Following a trail of misconduct: the doctors. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-12.
URL: http://web.archive.org/web/20000815235034/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000107050,00.html (2007-04-07: no longer available online.)

Weight-control doctor has troubled past. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-11.
URL: http://web.archive.org/web/20001205052900/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000106680,00.html

Vanity medicine: Hope, hype and risk. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-11.
URL: http://web.archive.org/web/20001205060500/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000106830,00.html

Entrepreneur sees cash machine in longevity care. Fred Schulte. The Sun-Sentinel. 1999-12-11.
URL: http://web.archive.org/web/20001205042400/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000106679,00.html

They wanted to look better, feel better. Fred Schulte and Jenni Bergal. The Sun-Sentinel. 1999-12-11.
URL: http://web.archive.org/web/20001204221900/http://www.sun-sentinel.com/news/daily/detail/0,1136,26000000000106678,00.html


Notes

1. List of studies approved by the GLCCM IRB and enrolling subjects in March 2000 when FDA suspended the IRB's authority: http://www.circare.org/foia2/glccmstudies.pdf. IRB Meeting Minutes of the Great Lakes College of Clinical Medicine Institutional Review Board. 2000-02-25: http://www.circare.org/foia2/glccm_irbmin20000225.pdf

2. Docs from hell. New York Daily News. 1991-11-27.

3. Curriculum Vitae of Steven G. Ayre, M.D. Accessed on 2007-04-05 at: http://www.contemporarymedicine.net/cv_ayre.htm. Pepper, C. Quackery: A $10 Billion Scandal, report by the chairman of the Subcommittee on Health and Long-Term Care of the Select Committee on Aging, House of Representatives, 98th Congress, Second Session, May 31, 1984. Committee publication no. 98-435, pp. 150-151.

4.


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