Abstract
The attacks that have been directed in recent years against the pharmaceutical industry in the United States include the charge that the research carried out in its own laboratories has been generally unoriginal and of poor quality. This indictment, never supported by any bill of particulars and hence a priori suspect of ignorance or bias, disregards among other things the fact that we owe to this research many outstanding accomplishments of high scientific interest and merit that would do credit to any first-class academic institution. Moreover, the investigations having this distinction were rarely undertaken in the expectation that they would materially contribute to the documentation of therapeutic effectiveness, or enhance the commercial value, of existing products, or necessarily yield clues to the discovery of new such agents. On all these counts they deserve to be classified as basic research.
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References
P. De Haen, Am. prof. Pharm. 33, 25 (1967).
Drug Efficacy Study. Final Report to the Commissioner of Food and Drugs, Food and Drug Administration, from the Division of Medical Sciences, National Research Council. National Academy of Sciences, Washington D.C., 1969. In this study the claims for efficacy made by the manufacturer for 2,824 drug preparations, of which about two thirds were single entity drugs, were assessed; these claims, and not the drugs themselves, were given one of four categorical ratings (effective, probably effective, possibly effective, ineffective) for guiding the FDA in deciding what administrative action should be taken on the drug concerned. No statistical information is as yet available on how many drug preparations (or chemical entities) were judged to be ineffective, or of doubtful efficacy, with respect to all the claims made for them.
a) New York Times, October 17 1967, p. 46; (b) Esquire 72, 117 (March 1969).
E. B. Chain, Nature 200, 441 (1963).
Lord Platt, Br. med. J. 4, 439 (1967).
Thus the Squibb Institute for Medical Research, which started operating in 1938, was established for the pursuit primarily of fundamental medical research, as was made unmistakably clear at the opening ceremony by its founder, Mr. Theodore Weicker, Sr., as well as by the main speaker, the great educator Abraham Flexner, in his address, ‘The Usefulness of Useless Knowledge’. In the Merck Institute for Therapeutic Research, a similar philosophy emphasizing fundamental studies, though mostly in the biological disciplines, has been dominant since its establishment in 1933. No doubt a good deal of basic research, though not specifically so designated, was going on also in some other major firms already at that time.
A picture illustrating this trend can be gleaned from a series of articles describing the history, past contributions, and current research activities of 23 major American drug producers (Med. World News, June 1965 to November 1967 ). Although bearing on this topic only in part and indirectly, the excellent address, ‘The Public Stake in Medical Research’, by Dr. MaxTishler, until recently President of Merch Sharp & Dohme Research Laboratories, in Proc. R. Soc. Med. 61, 691 (1968), July 1968, should also be mentioned in this connection.
Not quite as strikingly pragmatic and simple, though, as a definition of basic research recently supplied by one of the research directors of a major firm (cf. Med. World News, November 11, 1966, 137), probably with the intent of teasing some more conservative colleagues and executives of the old school with the imputation of this definition being most congenial to their thinking habits. It identifies basic research in the industry with ‘any research that does not pay off within the first ten years’. This seemingly very precise definition, based as it is on to-be-accounted-for dollars and cents, is actually nothing of the sort, however. First of all, it disregards the fact (presumably well known to that gentleman) that a good many very expensive projects having strictly and narrowly defined objectives, such as, for instance, screening programs, do not pay off within ten years either, and, furthermore, that cost accounting for such projects is frequently beset with an invisible error stemming from the deep-seated (and quite commendable) habit of young bench scientists - usually the younger ones - of adulterating such utilitarian research, whenever feasible, with a little basic research of their own. Let it be emphasized, however, that in many laboratories very sensibly up to 20% of project time is allowed for such often useful diversions.
Whenever possible, individual investigators, or at least senior members of larger research groups, are given credit for the contributions discussed in this chapter.
With the exception of the Northern Regional Laboratories of the Department of Agriculture in Peoria, 111., where in the 1940s extensive studies on penicillin and other antibiotics were carried out by R. D. Coghill and later F. H. Stodola.
Med. World News, October 1966, 139.
A. D. Welch and E. Bueding, Currents in Biochemistry (Ed. D. E. Green, New York 1946 ), p. 399.
F. E. Hunter and O. H. Lowry, Pharmac. Rev. 8, 89 (1956).
B. Witkop, Am. Scient. 55 /2, 109 (1957).
Reflections on Research and the Future of Medicine (Ed. C. E. Light, MacGraw-Hill Book Co., New York 1967 ), p. 129.
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© 1971 Birkhäuser Verlag Basel
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Wintersteiner, O. (1971). Basic Research in the US Pharmaceutical Industry. In: Jucker, E. (eds) Progress in Drug Research / Fortschritte der Arzneimittelforschung / Progrès des Recherches Pharmaceutiques. Progress in Drug Research / Fortschritte der Arzneimittelforschung / Progrès des Recherches Pharmaceutiques, vol 15. Birkhäuser Basel. https://doi.org/10.1007/978-3-0348-7078-8_6
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