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FDA Form 483 – Notices of Inspectional Findings

(yes, of course more are going to be posted...)

Bickle, Paula R

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Eggers, Arnold E., M.D.

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Great Lakes College of Clinical Medicine IRB & L. Terry Chappell M.D.

Great Lakes College of Clinical Medicine IRB & L. Terry Chappell M.D.

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Alkis Togias M.D.

Chi Van Dang M.D. Ph.D.

Chi Van Dang M.D. Ph.D.

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Paula R Bickle Cont.

Bickle was a member of the Great Lakes College of Clinical Medicine IRB, above.

The sponsor of Bickle's clinical trials, Heyltex Incorporated (US division of Heyl Chemisch pharmazeutische FabrikGmbH & Co. KG), was inspected by the FDA on 1998-10-27 – 28. As a result, Heyltex was subject to administrative action via this FDA Warning Letter issued to Robert Z Martin/Heyltex Incorporated [2000-09-20]. pdf icon


Arnold Eggers MD Cont.

Testimony of Arnold Eggers MD before the House Committee on Government Reform [1998-02-04] (temporary link)

Read more:
Index of Official Publications of the House Committee on Government Reform, On the web site of the Government Printing Office – 104th to 108th Congress


Great Lakes College of Clinical Medicine IRB & L Terry Chappell MD Cont.

An index of documents related to the Great Lakes College of Clinical Medicine IRB is taking shape on BioethicsWatch. Correspondence between FDA and the IRB continued for over a year after the March 2000 warning letter, and up until the Great Lakes College of Clinical Medicine decided to shut down in January 2001. This correspondence alone includes hundreds of pages. And then there are the studies themselves... the investigators ... medical board actions etc.

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 research, particularly in the case of 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.

FDA instituted disqualification proceedings against one investigator, initiated 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. (1 )

People might be shocked to learn how many trials the Great Lakes College of Clinical Medicine IRB approved, and who they approved to conduct them. How many realize that this same IRB approved Dr. Henry Heimlich's notorious maleriotherapy for HIV/AIDS research?

More documents will be posted soon — stay tuned and check back often.

On 1999-03-10, Dr Chappell and Theodore Rozema MD, also a member of the Great Lakes College of Clinical Medicine IRB, testified before the House Committee on Government Reform about their research testing the drug Endrate ® as a treatment for various disorders, including peripheral vascular disease and coronary artery disease.
Hrg. No. 106-33 — Cardiovascular Disease: Is the Government Doing More Harm Than Good? EDTA Chelation Therapy pdf icon
Hrg. No. 106-33 — Cardiovascular Disease: Is the Government Doing More Harm Than Good? EDTA Chelation Therapy [Text/HTML]

One major impetus behind this hearing appears to have been the Federal Trade Commission's action against the American College for Advancement in Medicine (ACAM), a 501 C (6) nonprofit professional organization, on charges of false advertising. Dr Chappell served as president of ACAM between 1995 and 1997, and as indicated in the federal hearing transcript, he founded the ACAM institutional review board in 1993. The issue of false advertising is especially troubling in connection with the review, approval, and oversight of research. Advertising and recruitment of subjects is the beginning of informed consent, and as such, demand IRB review and approval. False advertising in the recruitment of research subjects taints informed consent, and in extreme cases, can vitiate it. Possibly the most disturbing thing is that ACAM, having undertaken responsibility for the rights and welfare of human research subjects through its IRB, should also be involved with the dissemination of false and misleading information about the safety and efficacy of a drug with which its members may have been conducting clinical trials.

More information on advertising, recruitment, and informed consent is available in the FDA's Guidance for Institutional Review Boards and Clinical Investigators 1998 Update, Recruiting Study Subjects

This press release of 1998-12-08 by the Federal Trade Commission describes the objectionable claims made by ACAM.

Medical Association Settles False Advertising Charges Over Promotion of Chelation Therapy

The American College for Advancement in Medicine (ACAM) has agreed to settle Federal Trade Commission charges that it made unsubstantiated and false advertising claims that non-surgical, EDTA chelation therapy is effective in treating atherosclerosis, and that the effectiveness of the therapy has been proven by scientific studies. The proposed settlement would prohibit ACAM from representing, in advertising, that chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to support the representation. In addition, ACAM would be prohibited from making any representation about the efficacy or comparative efficacy of chelation therapy for any disease of the human circulatory system unless supported by competent and reliable scientific evidence.

ACAM, based in Laguna Hills, California, is an association comprised principally of physicians who administer traditional and complementary/alternative medical therapies including chelation therapy. ACAM promotes chelation therapy in brochures and promotional materials and by maintaining a Web page on the Internet. Chelation therapy involves the intravenous injection of a prescription drug, ethylene diamine tetra acetic acid (EDTA), which is approved by the Food and Drug Administration for the limited use of ridding the human body of excess heavy metals.

According to the FTC's complaint detailing the charges, ACAM's advertisements and promotional materials for chelation therapy contained such statements as:

• Chelation therapy is a safe, effective, and relatively inexpensive treatment to restore blood flow in victims of atherosclerosis without surgery;

• Every single study of the use of chelation therapy for atherosclerosis which has ever been published, without exception, has described an improvement in blood flow and symptoms; and

• Chelation therapy promotes health by correcting the major underlying cause of arterial blockage. Damaging oxygen free radicals are increased by the presence of metallic elements and act as a chronic irritant to blood vessel walls and cell membranes. EDTA removes those metallic irritants, allowing leaky and damaged cell walls to heal. Plaques smooth over and shrink, allowing more blood to pass. Arterial walls become softer and more pliable, allowing easier expansion. Scientific studies have proven that blood flow increases after chelation therapy.

Through the use of such statements, the FTC alleged, ACAM has represented that EDTA chelation therapy is an effective treatment for atherosclerosis, and that ACAM possessed and relied upon a reasonable basis when making the representations.

The FTC charged that the representations are false and misleading because ACAM did not possess and rely upon a reasonable basis to substantiate the claims.

The proposed settlement, announced today for a public comment period, would prohibit ACAM from representing that EDTA chelation therapy is an effective treatment for atherosclerosis without possessing and relying upon competent and reliable scientific evidence to substantiate the representations. In addition, the proposed settlement would require ACAM to possess competent and reliable scientific evidence to support any claims about the effectiveness or comparative effectiveness of chelation therapy for any disease of the human circulatory system.

The proposed settlement would also prohibit ACAM from misrepresenting the existence, validity, results, or contents of any test, study, or research in connection with the advertising or promotion of chelation therapy.

The settlement addresses issues raised by claims ACAM made in brochures and other materials distributed to the public. It does not attempt to regulate how doctors use or prescribe drugs in the course of treating their patients or other choice of therapy issues.

The settlement would permit ACAM to make representations permitted in labeling by the FDA.

The Commission vote to accept the proposed settlement and place it on the public record for comment was 4-0. An announcement regarding the proposed consent agreement will be published in the Federal Register shortly. The agreement will be subject to public comment for 60 days, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580.

Source: Federal Trade Commission Press Release, 1998-12-08
URL: http://www.ftc.gov/opa/1998/12/acam.htm
FTC Docket in the matter of the American College for Advancement in Medicine: American College for Advancement in Medicine, File No. 962 3147, Docket No. C-3882

Related Material

Unproven care
Stephanie Stapleton, American Medical News, 1999-02-08
URL: http://www.ama-assn.org/amednews/1999/pick_99/feat0208.htm


Alkis Togias MD Cont.

FDA Warning Letter Issued to Alkis Togias MD [2003-03-31]

JHU Researcher found to have violated rules. FDA proposes restrictions; study resulted in death
Julie Bell, The Baltimore Sun, 2003-04-18
URL: http://www.sunspot.net/news/ local/bal-md.hopkins18apr18.story

Final FDA/CDER action against Alkis Togias MD (2003-09-10)
For 3 years; restrictions in part, … will not serve as principal clinical investigator for more than one FDA regulated clinical study per year...
URL: http://www.fda.gov/ora/compliance_ref/bimo/restlist.htm


Notes

  1. FDA Disqualified or totally restricted list for clinical investigators

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Last Updated: 2005-03-30