The following key issues and recommendations relate directly to the material in this chapter:
• Changes in regulations for FDA approval should be made if alternative pharmacological and biological treatments are to have a fair hearing.
• To prepare for innovative approaches, the director of OAM should work together with the FDA to develop a memorandum of understanding so that proposed trials that have been approved by OAM can proceed. FDA and State authorities should declare a moratorium on seizures, raids, import alerts, and licensing actions against physicians, researchers, and health care providers whose work has been chosen by OAM for evaluation. In 1992-93, the case of S.R. Burzynski was an urgent case in point (see the "Antineoplastons" section).
• In choosing specific treatments for testing, priority should be given to drugs and vaccines that address major causes of preventable death in the United States: cardiovascular ~disease, cancer, and AIDS. Priority should also be given to testing treatments that particularly show promise for safety and low costs. To gain public recognition and credibility, it is important that OAM achieve some clear successes.