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those in favor. Congress is proposing legislation bu t unfortunately is not qui te clear on what should be proposed. At the closing session of the National Academy of Science conference on recombinant DNA research, the s ta tement was made by Donald Kennedy, who had then been designated to be the new FDA Commissioner, t ha t the N I H guidelines are "regulations in in ten t and to some degree in practice . . . why should there be more regulation? T h e simple answer I th ink is because it is politically inevitable". This sort of basis for an action t ha t could profoundly affect scientific knowledge and perhaps have a significant effect on the future of mankind would be familiar to Charles Darwin whose theory of evolution was a subject of considerable controversy more on moral and political grounds t han on scientific facts; it would be to Harvey who dared not publish his findings on circulation unti l he was nearing the end of his life, many years after the discoveries were made, and to Galileo who was arrested and forced to recant his suppor t of Copernicus t h a t the ear th was not the center of the universe.
Let me briefly ment ion a different type of regulation tha t , in the short t e rms , worries me as much as many
of the things I have discussed. T h e Interna l Revenue Service has recently publ ished a regulation which says t h a t unless research is specifically required to be done in the United States , they will only credit one-half of the research expenses against t he income of the Uni ted Sta tes corporat ion—and in future years the proport ion to be credi ted will be reduced even more. On the other hand, most foreign countries will not allow expenses incurred in the Uni ted Sta tes for research to offset income derived from sales or products in their countries. Th i s will result in a large proport ion of t h e research expenses of high technology corporations such as those in the electronics, computer , and pharmaceutical industr ies being nondeductible for taxat ion purposes. This can, in effect, a lmost double our costs. One solution to this is to move the research to foreign countries so t h a t we can obtain the appropr ia te tax credit. This will accelerate a process t h a t has been going on for the last decade and can result in the export of scientific posit ions and the diminut ion of our scientific and technological preeminence— especially in basic research. This t rend is seen in our organization, where the internat ional research budgets have increased a t twice the ra te of the Uni t -
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SHANDON SOUTHERN A member of the
Plantation Holdings Group
ed Sta tes research budget during the last five years.
I s ta r ted out by saying t ha t there is a need for regulation. Wi thou t this we will revert to those conditions t ha t called for the regulations in the first place. W h a t we ask is t ha t in applying the laws t h a t affect research, good science and common sense should prevail. I will close with a quotat ion written by T h o m a s Jefferson in 1821 when he was an elder s ta tesman, full of years and, I hope, wisdom, "Were we directed from Washington when to sow and when to reap we should soon want for bread".
References
(1) Irving Kristol, "A Regulated Society", Regulation, Vol 1, # 1 , pp 12-13, 1977.
(2) J. F. Sadusk, Jr., ' 'The Effect of Drug Regulation on the Development of New Drugs", in "Principles and Techniques of Human Research and Therapeutics", F. Gilbert McMahon, Ed., Future Publ., 1974.
(3) R. M. Hodges, Gemfibrozil-Proceed-ings of the Royal Society of Medicine, Supplement # 2 , Vol 69, pp 1-2, 1976.
(4) Wardell, in Drug Development and Marketing", R. B. Holmes, Ed., pp 165-81, Pub. American Enterprise Institute, 1975.
(5) FDC Reports, March 1976. (6) Philipson et al., "Transplacental Pas
sage of Erythromycin and Clindamycin", New England J. Med., 288,1219-21.
Presented at the Fourth Federation of Analytical Chemistry and Spectroscopy Societies Meeting, Detroit, Mich., November 1977.
Robert M. Hodges is pres ident of Warner -Lamber t /Parke-Davis Phar maceutical Research Division. Dr. Hodges has a broad medical background, having served on the staff of several hospitals. He has also held teaching appoin tments a t t he Universities of Washington and Ottawa. Before coming to Parke , Davis and Co., Dr. Hodges was associate director of the Bureau of Medicine, Food and Drug Administrat ion.
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540 A · ANALYTICAL CHEMISTRY, VOL. 50, NO. 6, MAY 1978