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Index of Documents: Great Lakes College of Clinical Medicine IRB

2010-06-28: Links to documents on the FDA website are being corrected. We apologize for the inconvenience.

Introduction

According to the warning letter of 2000-03-09, the Great Lakes College of Clinical Medicine IRB violated federal regulations and failed to protect the rights and welfare of research subjects in the course of their review and approval of human experiments, and particularly in the cases of the studies titled Stimulated Autologous Immune Serum and Autologous Tumor Vaccine in the Treatment of Refractory Solid Tumors (GAT), Gene Activated Therapy (GAT) for the Treatment of Cancer, and Evaluation of the Effect of Immunotherapeutic Technique Enzyme Potentiated Desensitization (EPD) for a Considerable Variety of Illness/Conditions/diagnostic Conditions. Inspection of the Great Lakes College of Clinical Medicine IRB disclosed such serious violations and noncompliance that FDA suspended the IRB's authority to approve new research subject to FDA regulation or enroll new subjects in active clinical trials. ( 1 ) After nine months of correspondence between FDA and the parties responsible for the Great Lakes College of Clinical Medicine IRB, FDA judged the IRB's responses to be inadequate, and concluding that they had no assurance the IRB is adequately protecting the rights and welfare of the human subjects of research, FDA terminated all seven active studies subject to FDA regulation. ( 2 ) In my experience, termination of a study by FDA is extremely rare, and appears to be used only in extreme situations.

In addition, FDA instituted disqualification proceedings against one investigator, took administrative action against two more, and indicted a fourth on 22 criminal counts in federal court. Two of these investigators were also members of the Great Lakes College of Clinical Medicine IRB: George Kindness was indicted for manufacturing and sponsoring tests of experimental vaccines, and IRB member Paula Bickle was inspected in her capacity as principal investigator in IND studies in which she failed to report the death of a subject, failed to obtain informed consent, failed to maintain essential documents, and somehow managed to fail to obtain IRB approval in several instances. She has also been charged with practicing medicine without a license in two different states. On two different occasions. Go figure. Dr. Page (below) was permanently disqualified from conducting experiments with products to be submitted to FDA for approval or revised indications – though it may sound like a lot of paper rustling (which it is), disqualification is reserved for the most egregious violations or harm to research subjects.
(3 )

IRB Members

FDA Form 483s Issued to the Great Lakes College of Clinical Medicine IRB

Correspondence Between FDA and The Great Lakes College of Clinical Medicine IRB

Research Approved the the GLCCM IRB

Lawsuits Related to GLCCM IRB-Approved Research

Audrey M. Snow Civil No. 03CV00474 USDC Southern District AL 2003-06-23

Purported Informed Consent Agreement signed by Ms. Snow to enroll in the clinical trial of Stimulated Autologous Immune Serum conducted by Dr. Page. 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. It's believed that the Stimulated Autologous Immune Serum was manufactured by Amscot Medical Laboratory, owned and operated by GLCCM IRB member George Kindness. Kindness was indicted in US federal district court on 22 criminal counts stemming from his actions in clinical trials testing several cancer vaccines:
CR. NO 03-20433BV: US v George Kindness and Amscot Medical Labs Inc. (2003-11-19) pdf icon

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Notes

1. Based on the deficiencies found during this inspection, we have no assurance that your IRB procedures are adequately protecting the rights and welfare of the human subjects of research. For this reason, in accordance with 21 CFR 56.120(b)(l) and (2), and effective immediately,

• no new studies that are subject to Parts 50 and 56 of the FDA regulations are to be approved by your IRB, and
• no new subjects are to be admitted to ongoing studies that are subject to 21CFR Parts 50 and 56 until you have received notification from this office that adequate corrections have been made.

FDA Warning Letter to Great Lakes College of Clinical Medicine IRB, L. Terry Chappell, M.D., Secretary [2000-03-09], p. 13 pdf icon

2. FDA to Great Lakes College of Clinical Medicine IRB, Barbara Grunewald, Executive Director [2001-01-02], p. 2 pdf icon

3. DISQUALIFIED/TOTALLY RESTRICTED LIST FOR CLINICAL INVESTIGATORS

FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices. Physicians and other qualified experts (clinical investigators) who conduct these studies are required to comply with applicable statutes and regulations intended to ensure the integrity of clinical data on which product approvals are based and to help protect the rights, safety, and welfare of human subjects.

The following list contains the names of all clinical investigators who have been disqualified or totally restricted. FDA may disqualify a clinical investigator if the clinical investigator has repeatedly or deliberately failed to comply with applicable regulatory requirements or the clinical investigator has repeatedly or deliberately submitted false information to the sponsor or, if applicable, to FDA. A disqualified clinical investigator is not eligible to receive investigational drugs, biologics, or devices. In the past, the phrase totally restricted was also used to refer to clinical investigators who had been disqualified. Where an investigator has been reinstated, it is so noted.
Accessed 2004-11-07 at: http://www.fda.gov/ora/compliance_ref/bimo/disqlist.htm

Last Updated: 2005-03-30