ADVISORS MEET APRIL 1-2:
TEAMS FROM OAM VISIT
DOCS IN HOUSTON AND EAST
From The Cancer Chronicles #15
© April 1993 by Ralph W. Moss, Ph.D.
On February 9,  representatives of the National Institute of Health¼s
Office of Alternative Medicine and National Cancer Institute (NCI) conducted
a site visit of the Burzynski Research Institute (BRI) in Houston, Texas.
In attendance from the OAM side were its director Joseph Jacobs, MD, assistant director Daniel Eskinazi, PhD and panel co-chair Frank D. Wiewel. From NCI came Mary McCabe. In mid-March, Jacobs, Eskinazi and Ralph W. Moss, PhD, OAM co-chair and editor of this newsletter, visited Dr. Charles Simone, in Trenton, New Jersey and Drs. Seymour Brenner and Emanuel Revici in Brooklyn, New York.
The purpose of these visits was to explore the possibility of clinical trials of antineoplastons; shark cartilage; and the Revici method of treating cancer.
During the visit to Houston, Dr. Burzynski was extremely cooperative and provided the visitors with complete access to his facility and clinical records, according to Wiewel. The Texas researcher presented documented case studies, verified by outside physicians, of patients who had taken antineoplaston peptide therapy and survived years beyond expected prognoses.
In a previous site visit, in October 1991, NCI neuroradiologist [Nicholas] Patronas had found the evidence „extremely impressive¾ and said that "in 20 years in the business I haven¼t seen anything that looks so promising."
In spite--or because--of this, the Journal of the American Medical Association this winter published a blistering attack on Burzynski and the AMA issued a "Clinical Alert" to doctors, damaging to the Houston physician.
In its initial enthusiasm, NCI said it wanted to fund four clinical trials of antineoplastons on brain cancer. Since then, the proposed trials have become mired in medical politics. For example, NCI announced that the only potential trial sites were Sloan-Kettering and the Mayo Clinic--both well-remembered for their fraudulent and disastrous roles in the laetrile and vitamin C controversies.
"It is extremely important that OAM establish ground rules if we are going to work with NCI or other agencies within the NIH," Wiewel wrote Jacobs on 2/23/93, after returning from the visit. "I believe this evaluation, and all future evaluations by NCI, must involve the active participation of the OAM. It is imperative that the OAM have oversight of the trials."
"It is also necessary that the proponent scientist, in this case Burzynski, have constant, active input and involvement in every phase of the evaluation process," the co-chair of the Pharmacological and Biological Panel continued. "Any efforts to 'separate the man from his medicine,' as NCI has indicated [it might try to do], should be grounds for OAM to withdraw and cancel its financial sponsorship."
In the New Jersey visit, the discussion centered on shark cartilage. Dr. Simone was featured in the '60 Minutes' segment on shark cartilage which aired 2/28/93. An oncologist, he spent 5 years at the NCI and now runs the Simone Cancer Center in New Jersey.
Dr. Revici was born in Bucharest, Romania in 1896. He graduated from medical school in 1920 and has been researching lipids and cancer for over 70 years. Dr. Revici has classified diseases and drugs as either "anabolic" (constructive) or "catabolic" (destructive). According to him, cancer is an "anabolic" disease, which needs to be counteracted by "catabolic" medicines, including lipids and selenium.
The elderly researcher told the Drs. Eskinazi, Jacobs and Moss that he still works every day and is currently writing a new book on the basis of biology.
These OAM site visits are an important step for the new office. At the same time, there are a number of controversies over the direction of the OAM.
Should the emphasis of the office be on-site patient outcome research? Or should it be funding RFAs (requests for applications for grants) and grooming alternative researchers to apply for them?
Should OAM focus on killer diseases such as cancer, AIDS and heart disease (as Congress wishes) or should it orient itself around the alternative professions and disciplines?
Should it work with agencies, such as the National Cancer Institute or through them, compromising its autonomous status?
Should it seek Food and Drug Administration approval to evaluate alternative therapies, even when such approval may not be legally necessary?
Differences over the direction of the office surfaced at a phone conference (2/4) of 20 co-chairs of the OAM panels, chaired by Dr. Eskinazi. During this two-hour meeting, it became clear that there were some differences among the advisors over the direction of the office. While the majority endorsed the staff¼s proposal that the office vigorously and immediately put out RFAs, there was opposition from this newsletter and People Against Cancer.
These issues are likely to arise again when the Program Advisory Board finally meets in the Washington area on April 1 and 2. (The PAC is still "ad hoc" because of a Clinton Administration order freezing all new advisory boards until NIH can explain the need for them.)
There is intense public interest in the activities of the OAM. Hopefully, the Advisory Board will represent the interests of the public as a whole, not just the professional interests of the advisors.
The public pays for this office, as it does for the $10 billion NIH as a whole. Hopes have been raised, but the OAM will have to prove that it serves the public interest by rapidly evaluating promising treatments for major diseases such as cancer, heart disease and AIDS.
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