CHRONOLOGY OF EVENTS IN THE SCIENTIFIC EVALUATION OF IPT AND THE TREATMENT OF CANCER
by Dr. Steven G. Ayre, M.D.
October 1989: Poster presentation at the Forty-second Annual Symposium on Fundamental Cancer Research, The University of Texas, M.D. Anderson Cancer Center entitled “Breast carcinoma treated by a regimen of low-dose chemotherapy and insulin: report of four cases and pharmacokinetic considerations”.
December l990: Publication in the European Journal of Cancer (letter) entitled “Neoadjuvant low-dose chemotherapy with insulin in breast carcinomas” (Eur. J Cancer, 26, 1262-1263, 1990).
February 1991: Oral presentation at the Third International Congress on Neoadjuvant Chemotherapy,
June 1991: Began correspondence with Reps. Patricia Schroeder & Constance Morella, co-chairpersons of the Congressional Caucus on Women’s Issues in response to their “Breast Cancer Challenge” which was issued to the medical profession in June, 1991. The “Breast Cancer Challenge” charged American researchers and physicians to come up with an effective treatment for breast cancer by the year 2000.
July 18, 1991: Sent a letter to Susan Love, M.D. of the
October 1991: As a result of the correspondence with the “Breast Cancer Challenge”, I received a copy of a letter from Bernadine Healy, M.D., Director, National Institutes of Health, addressed to Rep. Constance Morella (Dated October 23, 1991). This letter discussed IPT, and mentioned that the matter had been referred to the National Cancer Institute’s Division of Cancer Treatment, Cancer Therapy Evaluation Program (CTEP).
December 2, 1991:
December 2, 1991: Received letter from Susan Love, M.D. in her capacity as coordinator, Breast Cancer Coalition Research Task Force, informing me of the Research Hearings to be held in
December 2, 1991: As a result of correspondence between myself and Dr. Bernadine Healy (dated November 11, 1991), as well as between Rep. Constance Morella and Dr. Healy, I received a letter from Michael A. Friedman, M.D., Associate Director, CTEP, informing me that Ms. Diane Bronzert would be getting in touch to discuss grant application procedures to fund IPT studies.
December 30, 1991: Submission made to Kay Dickerson, Ph.D., of the Breast Cancer Coalition Research Hearings, requesting time to offer oral testimony at the Hearings on the use of IPT with low-dose chemotherapy for the neoadjuvant treatment of breast cancer.
December 31, 1991: FDA rules on
January 24, 1992: Received letter from Charles L. Vogel, M.D., Medical Director,
January 25, 1992: Telephone conversation and subsequent correspondence sent to Michael .J. Hawkins, M.D., Chief of Investigational Drug Branch, Cancer Therapy Evaluation Program, Division of Cancer Treatment, National Cancer Institute. (This is the same division of NIH to which Dr. Healy had referred me in her letter of October 23,1991). My correspondence to Dr. Hawkins included an informational brochure on IPT, plus a copy of the ”on-clinical-hold” breast cancer protocol.
January 28, 1992: Received official written confirmation from Gregory Burke, M.D., Ph.D., Director, Division of Oncology and Pulmonary Drug Products, Office of Drug Evaluation 1, Center for Drug Evaluation and Research concerning the FDA’s ruling placing the lPT/breast cancer protocol on clinical hold. His letter reiterated the recommendation that the most appropriate group of breast cancer patients to first be studied/treated with IPT would be subjects with Stage IV metastatic breast cancer who had failed primary therapy with standard approved treatment modalities.
February 1, 1992: Received correspondence from Dr. Hawkins at CTEP making a similar recommendation as that from Dr. Burke at the FDA. The best breast cancer population to study would be women with metastatic disease who had not previously received chemotherapy for their metastatic disease (adjuvant therapy would be permitted if they recurred more than 6 or 12 months after their last chemotherapy treatment). Also included in this mailing was a document prepared by the CTEP entitled, “Preparation of a Best Case Series and the Conduct of Pilot Clinical Trials Using Unconventional Cancer Treatments”. Dr. Hawkins also offered generous collaboration and assistance in the design and review of protocols for the proposed clinical studies.
February 5 & 6, l992: Breast Cancer Coalition Research Hearings held in
May l, 1992: Submission to the Cancer Therapy Evaluation Program (CTEP) of a “Best Case Series” of IPT treatment involving a variety of different cancers. The intent of this submission was to introduce the CTEP to the historical context of the practice of IPT abroad, and to demonstrate the kinds of clinical results that have been experienced with this practice over the last several decades.
June 25, 1992: Telephone conversation initiated by Michael J. Friedman, M.D., Associate Director of NCI’s Cancer Therapy Evaluation Program, with information to the effect that CTEP was proceeding with an investigation of a number of unconventional cancer therapies, including IPT, and that a decision on their evaluation would be forthcoming by the end of July, 1992.
June 29,1992: Received correspondence from Charles L. Vogel, M.D. of The Mount Sinai Comprehensive Cancer Center in
July 20, 1992: Submitted response to FDA’s letter of 1/28/92 that had put the original IPT protocol submission on clinical hold. In this letter of response, the argument in favor of treating women newly diagnosed with breast cancer was pursued further. The minimal risks of the protocol were emphasized as well as the benefit s (breast conservation, quality of life under treatment). It was argued that theoretical arguments against such a program of study would seem less important than practical observations made over several decades of practice with IPT, and that women with newly diagnosed breast cancer should he given the option of breast-preserving treatment for their disease.
August 21, 1992: Received notification from the FDA that the July 29
September 25, 1992: Notified by Mary McCabe, R.N., Clinical Trials Specialist with CTEP that their agency was interested in insulin potentiation of chemotherapy, and that a process of review was underway to determine the most appropriate way of scientifically evaluating IPT.
April 23, 1993: Notified by Mary McCabe that CTEP had decided not to proceed with any formal investigation of IPT. (Note: I believe the decision on the part of CTEP here was more of a political one than scientific. CTEP was at that time very much involved with the evaluation of autologous bone marrow transplantation (ABMT) treatment for breast cancer, and didn’t want to take on another therapy for evaluation that would compete with this very expensive and “high-tech” approach to breast cancer treatment.
May 27, 1993: Materials on IPT sent to the newly established Office of Alternative Medicine (OAM) at the National Institutes of Health. In subsequent communications with Dr. Michael Eskinazi at OAM I was given the opinion that IPT was more mainstream medicine than alternative therapy, and that it should be evaluated through established channels for evaluating such medical discoveries.
July 22, 1993: Received a telephone call from Dr. Michael Hawkins – formerly with CTEP, and now with the
August 25, 1993: Received a formal written proposal from Dr. Hawkins concerning the animal study, complete with itemized budget for same. Fund raising efforts for this study were begun through a not-for-profit corporation called Medical Renaissance Foundation, an entity that had been established expressly for the purpose of funding IPT-related research.
December 14-15, 1993: Attended the Secretary’s Conference to establish a National Action Plan on Breast Cancer at the National Institutes of Health in
December 1993: Notified by a friend and business associate, Mr. Rich Moret of the advertising firm of Moret Worldwide and China West in
January 11, 1994: Received a call from Ms. Shirl Thomas at the Office of the Secretary of Housing and Urban Development, in
March 4, 1994: Received a letter from Hassan S. Rifaat, M.D. President of Texas Health Innovators, a private not-for-profit corporation with the following mission statement: 1) To expedite the objective scientific evaluation of health care innovations, 2) To promote the public and professional distribution of such scientific evaluations, 3) To promote and facilitate access to the health care innovations that work. 4) To achieve our goals in the most time and resource efficient way. Dr. Rifaat stated that IPT had been highly recommended to him by Michael J. Friedman, M.D., Associate Director of NCI’s Cancer Therapy Evaluation Program – whose office had declined to formally study IPT back in September 1992. I informed Dr. Rifaat of the ongoing initiatives for the study of IPT with the animal study at
March 24, 1994: Presentation made to the Cancer Treatment Research Foundation of the Cancer Treatment Centers of
April 1994: Collaborative efforts for the study of IPT undertaken with medical personnel at the
May 2, 1994: Acceptance of grant request to the Cancer Treatment Research Foundation to fund an animal study at
May 1996: Completion of the animal study at
January 1997: Tony Mastromarino, Ph.D., Director of Scientific Research, Office of the Vice-President, M.D. Anderson Cancer Center in Houston, Texas, communicated his interest in IPT to Mary Ann Richardson, Ph.D., from the UT School of Public Health, who is co-PI of the OAM-funded Center for Alternative Research in Cancer there. Dr. Mastromarino had been responsible for the 1989 invitation to the Drs. Perez Garcia and Dr. Ayre to prepare their poster presentation for M.D. Anderson’s Forty-second Annual Symposium on Fundamental Cancer Research (see the first entry in this Chronology, page 1).
February 1997: Dr. Richardson conducts a site visit at the office of Dr. Perez Garcia in
August 4-6, 1997: NIH/OAM Conference on “Monitoring and Evaluation Approaches for Integrated Complementary and Alternative Medicine Cancer Practices” held in
September 1997: Protocol for a multicenter prospective clinical trial of IPT in the treatment of stage IV cancers of the breast, lung, and ovary submitted to, and approved by, the Institutional Review Board of the Great Lakes College of Clinical Medicine at their fall meeting – September 16 – 20, 1997, in
April 1999: Received an invitation from Jeffrey D. White, M.D., Director, Office of Cancer Complementary and Alternative Medicine to present a Best Case Series on the clinical experience with IPT before the members of the Cancer Advisory Panel of the
September 18, 2000: Best Case Series on the clinical experience with IPT presented before the members of the Cancer Advisory Panel of the National Center for Complementary and Alternative Medicine at the National Institutes of Health. Recommendations of the Panel were to have a larger prospective trial of IPT conducted on cancer cases, and to have that data presented to the Panel as a Best Case Series.
February 22, 2001: Presentation of a talk entitled “Insulin Potentiation Therapy – a Renaissance in Cancer Chemotherapy” made before the Spring Conference of the International Oxidative Medicine Association in
April 2001: Received a phone call from Paul Carbone, M.D., former Director of the
May 11, 2001: Insulin Potentiation Therapy: A Renaissance in Cancer Chemotherapy. Oral presentation at the Spring Conference of the