shandon southern

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those in favor. Congress is proposing legislation but unfortunately is not quite clear on what should be pro- posed. At the closing session of the National Academy of Science confer- ence on recombinant DNA research, the statement was made by Donald Kennedy, who had then been desig- nated to be the new FDA Commis- sioner, that the NIH guidelines are "regulations in intent and to some de- gree in practice ... why should there be more regulation? The simple an- swer I think is because it is politically inevitable". This sort of basis for an action that 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 than on scientific facts; it would be to Harvey who dared not publish his findings on circulation until 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 support of Copernicus that the earth was not the center of the universe. Let me briefly mention a different type of regulation that, in the short terms, worries me as much as many of the things I have discussed. The In- ternal Revenue Service has recently published a regulation which says that unless research is specifically required to be done in the United States, they will only credit one-half of the re- search expenses against the income of the United States corporation—and in future years the proportion to be credited will be reduced even more. On the other hand, most foreign countries will not allow expenses in- curred in the United States for re- search to offset income derived from sales or products in their countries. This will result in a large proportion of the research expenses of high tech- nology corporations such as those in the electronics, computer, and phar- maceutical industries being nondeduc- tible for taxation purposes. This can, in effect, almost double our costs. One solution to this is to move the research to foreign countries so that we can ob- tain the appropriate tax credit. This will accelerate a process that has been going on for the last decade and can result in the export of scientific posi- tions and the diminution of our scien- tific and technological preeminence— especially in basic research. This trend is seen in our organization, where the international research budgets have increased at twice the rate of the Unit- Shandon electrophoresis unit at a new, low price Here's real versatility. This unit- designed for maximum flexibility, convenience and economy—easily performs these six techniques: (1) Cellulose Acetate . . . adjust the length of the separation to suit your technique . . . unit is ideal for large-scale, small-scale and micro techniques, also short distance HVE; (2) Starch, Agar and Polyacrylamide Gels . . . for superb reso- lution . . . and for immuno techniques; (3) Paper . . . for unrivaled economy; (4) Micro-immuno and Crossed-over Techniques . . . special accessories do the job with no trouble; (5) Thin Layer (TLE) . . . fast set-up time, fine results with 1000 volts; (6) Cooling System . . . to maintain constant temperature. Catalog U77 details the advantages and accessories. Write Shandon Southern Instru- ments, Inc., 515 Broad St., Sewickley, PA 15143. ^P* SHANDON SOUTHERN A member of the Plantation Holdings Group ed States research budget during the last five years. I started out by saying that there is a need for regulation. Without this we will revert to those conditions that called for the regulations in the first place. What we ask is that in applying the laws that affect research, good science and common sense should pre- vail. I will close with a quotation writ- ten by Thomas Jefferson in 1821 when he was an elder statesman, 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 president of Warner-Lambert/Parke-Davis Phar- maceutical Research Division. Dr. Hodges has a broad medical back- ground, having served on the staff of several hospitals. He has also held teaching appointments at the Univer- sities of Washington and Ottawa. Be- fore coming to Parke, Davis and Co., Dr. Hodges was associate director of the Bureau of Medicine, Food and Drug Administration. CIRCLE 191 ON READER SERVICE CARD 540 A · ANALYTICAL CHEMISTRY, VOL. 50, NO. 6, MAY 1978

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Page 1: SHANDON SOUTHERN

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 -

Shandon electrophoresis unit at a new, low price Here's real versatility. This u n i t -designed for maximum flexibility, convenience and economy—easily performs these six techniques: (1) Cellulose Acetate . . . adjust the length of the separation to suit your technique . . . unit is ideal for large-scale, small-scale and micro techniques, also short distance HVE; (2) Starch, Agar and Polyacrylamide Gels . . . for superb reso­lution . . . and for immuno techniques; (3) Paper . . . for unrivaled economy; (4) Micro-immuno and Crossed-over Techniques . . . special accessories do the job with no trouble; (5) Thin Layer (TLE) . . . fast set-up time, fine results with 1000 volts; (6) Cooling System . . . to maintain constant temperature. Catalog U77 details the advantages and accessories. Write Shandon Southern Instru­ments, Inc., 515 Broad St., Sewickley, PA 15143.

^ P *

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.

CIRCLE 191 ON READER SERVICE CARD

540 A · ANALYTICAL CHEMISTRY, VOL. 50, NO. 6, MAY 1978