Recommendations to Improve Safety of Biological Products

W. John Martin, M.D., Ph.D.

Presented at the Healthcare Workshop Session
American-Russian Foundation for Progress and Cooperation
Beverly Hills CA July 29, 1997

A review of the development of polio vaccines within the United States has identified major deficiencies in the roles of Government and Industry. The following recommendations are provided to help ensure the future safety of viral vaccines and other biological products.

1. The basic flaw in the regulatory process must be addressed-the FDA must be responsive to the medical-scientific community's need for accurate information regarding the potential hazards of products released for use in society. In the event that public health and safety issues arise, industry should waive its right to maintain proprietary intelligence. This would enable the FDA to disclose more information concerning the safety of FDA regulated products to the medical-scientific community. Such a proposal should be included in all pending and future FDA reforms. Martin, WJ. Forward to book "Emerging Viruses: AIDS and Ebola" by L.G. Horowitz. Tetrahedron Rockport MA 01966.

2. The scientific capabilities of FDA will continue to lag well behind that of the international scientific community. Archived biological products, as well as presently manufactured products, must be made available for specialized safety testing in independent laboratories. Given the considerable international trade in biologics, this issue needs to be addressed on world wide. Prior to 1985, it was permissible to export unlicenced biological products from the United States. Such products must be included in an international safety review.

3. The use of fresh animal tissues to produce live viral vaccines for either human or veterinary use should be strongly discouraged.

4. The increasing international trade in biologics should be viewed with concern for its potential consequence of rapidly disseminating new pathogens throughout the world.

5. FDA and industry respond slowly to reports of apparent complications of the use of vaccines and other biological products. Examples include the unwillingness to vigorously pursue reports of SV-40 and simian cytomegalovirus infections in humans. Undue delays occurred in the response to finding hepatitis C virus in gamma globulin preparations. The contentious issue of gamma globulin inoculations as a source of stealth viral infection in veterans afflicted with the Gulf War Syndrome has also been avoided by those in authority. Pressure from Industry could be eased if the threat of litigation for unintentional actions was removed.

6. Additional comments and suggestions are welcome via e-mail to

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