INTERNATIONAL MEDICAL TRIBUNE 641 LEXINGTON AVENUE NEW YORK, N.Y. 10022 PHONE: (212) 421-4000 ARTHUR M. SACKLER. M.D. international Publisher A, —_—_— Dr. Joshua Lederberg Rockefeller University 1230 York Avenue New York, N. Y. 10021 Dear Joshua: J April 16, 1979 tam becoming more and more convinced of the urgency and critical importance of your thoughts and desire to do something to lodge the concept of compara- I know you are probably very busy but would appreciate your letting me know when you have I have been out "beating the drums" for your idea and find I get very recep- I have the clear-cut reaction that yours tive toxicology. written for the grant we had discussed. tive responses, is "an idea whose time has come." a In respect to comparative toxicology, I think you would be interested in the following. In my work on Medical Tribune, I have become concerned not only with the double standards, but with the lack of consistency in application of existing stan- dards, of our toxicologic findings signify. and the absence of clear criteria as to what much I was astonished to discover that the intermedi- ates and end-products of the fluoridination and chlorina- tion of drinking water have not been studied with the same technology and criteria as used to determine carcinogen- icity, teratogenicity and mutagenicity of essential pre- scription therapeutic agents. The rigid criteria applied to new, potentially life-saving medications (whose re- search and entry into medical therapeutics have thereby been delayed or excluded or terminated) have not been applied to drinking water. MEDICAL TRIBUNE and Medical News HOSPITAL TRIBUNE New York, N.Y., U.S.A. MEDICAL NEWS-TRIBUNE Great Britain London, Engiand MEDICAL TRIBUNE international Edition Atrica London, England MEDICAL TRIBUNE International Edition Scandinavia London, Engiand MEDICAL TRIBUNE Internationale Wochenzeitung- Ausgabe fiir Deutschiand Wiesbaden, West Germany TRIBUNE MEDICALE Paris, France MEDICAL TRIBUNE Internationate Wochenzeitung- Ausgabe fir die Schweiz Baden, Switzerland MEDICAL TRIBUNE Internationale Wochenzeitung- Ausgabe fiir Osterreich Vienna, Austria Japan International MEDICAL TRIBUNE Tokyo, Japan yr In 1975, I first interviewed Dr. Theodore Cooper, then Assistant Secretary for Health, and raised the ques- tion as to whether the tests which FDA required for INDs and NDAs had been applied to drinking water to which the fetus is exposed from conception and the individual through his entire life. Dr. Cooper indicated surprise and promised to investigate. Subsequently, he checked with Dr. Schneid- erman of the National Cancer Institute and other relevant government agencies and unofficially informed me that he could locate no such information. It now seems that I may have finally been able to confirm that the tests and criteria used to approve clini- cal pharmacologic investigations on new therapeutic agents have not been applied to drinking water. The following question was posed to the current Com- missioner of the FDA: "Have the standard procedures used in respect to prescription drugs been applied to determine mutagenicity, carcinogenicity and teratogenicity of fluorides and/or chlor- ine, fluoridated water and/or chlorinated water and the sub- stances found in water as a result of fluoridation and chlor- ination? ' After my interview with the Commissioner on June 24, 1977, and my letter of September 29, 1977, * I finally received the following response: "The answer is no. "! From his letter nf December 22, 1978. ** In effect, at this point I believe two issues arise: 1. Why the failure to apply basic tests and criteria to drinking water, the commonest substance known to man and used without restriction in the United States when such tests have been used to delay or refuse permission for clinical research, to stop research, or remove from testing important therapeutic agents? 2. Of equal importance, why, despite my information from Dr. Cooper, did it subsequently take one and one-half years to obtain from FDA a direct, unequi- vocal reply, and then with qualifications and explan- ations? * See Appendix I ** See Appendix II Iam enclosing, as background, some off-the-record material and other sections not published from my interview with Dr. Donald Kennedy (see Appendix III). Published sec- tions were in Medical Tribune, Oct. 5, 12, 1977. After receipt of the statement from Dr. Kennedy that "The answer is no", I was contacted by the Commissioner's office and asked for a personal discussion of the matter. Following a meeting with a member of this agency, I was informed that I would receive another communication from the FDA. Whenthis communication is received, I will pass it on to you. Tam sending this material to you and to a few other scientists whom I hold in high regard. I would appreciate your reactions to the significance of the situation as it exists and to the problems posed in respect to (1) realistic, balanced, regulatory processes for new drug research, therapeutics, food and water; and (2) the imperative that responsible questions relat- ing to these be forthrightly and promptly addressed. Sincergly, / a