Clinician shortage affects drug research A manpower shortage and its effects on drug research with humans were subjects of a two-day conference on clinical pharmacology, held in Washington, D.C. Funding and recruitment problems were held to be major causes of the shortage of clinical pharmacologists. An important effect is the difficulty that drug companies have had in recent years with getting Food and Drug Administration approval of clinical evidence on drug safety and efficacy. The conference, which brought together representatives from the pharmaceutical industry, government, and medical schools, was sponsored by the Drug Research Board of National Academy of Sciences-National Research Council. As defined by a World Health Organization report published earlier this year, "clinical pharmacology is concerned with the scientific study of drugs in man." Research in this field takes several directions. Pharmacokinetic studies, for instance, are concerned with drug absorption, distribution, metabolism, and excretion. These studies, which have become increasingly sophisticated during the past decade, may involve interactions of one drug with another, or drug metabolism and excretion as a function of age, diet, or disease. Such studies have led, for instance, to an appreciation of the importance of the concentration of a drug in the blood as a determining factor in dosages and efficacy of the drug. Pharmacodynamic studies, on the other hand, concern the effects of a drug and may include studies of the mechanism of a drug's action. And beyond carrying out these basic studies, a clinical pharmacologist is a specialist in the methodology of carrying out clinical trials of a new drug in man. Manpower shortage. In light of the extreme importance of expertise in drug testing with humans, it might be expected that there are numerous practitioners of clinical pharmacology. Instead, there are probably no more than 220 full-time clinical pharmacologists in the nation's approximately 100 medical schools, Dr. Daniel L. Azarnoff told the Washington, D.C, conference. Dr. Azarnoff, professor of medicine and pharmacology at University of Kansas medical center, Kansas City, disclosed figures from two manpower surveys undertaken by the American Society for Pharmacology and Experimental Therapeutics (ASPET). The organization was one of several cosponsors of the Washington conference.
In a trial run for a broad survey of manpower needs for pharmacologists to be made early next year, ASPET sent questionnaires to chairmen of pharmacology departments in six medical schools. In addition to the estimate of 220 full-time clinical pharmacologists, responses to the questionnaire indicated that clinical pharmacologists are being trained at a rate no greater than 0.5 men per school per year. If this rate were to continue through this decade, each medical school will produce a maximum number of 5.5 clinical pharmacologists by 1980, Dr. Azarnoff points out. This, he says, would correspond to a total of approximately 550 new clinical pharmacologists. The six pharmacology department chairmen also replied that their departments will need an average minimum increase of 4.6 clinical pharmacologists during the 1970-80 period, and an optimum increase of 7.8 men. At best, therefore, the pharmacology departments may barely be able to meet their own manpower needs—although the chairmen also replied that the training rate might be increased by 12 times the present rate by 1975 if the pharmacology departments were to function at full capacity every year until then. When other factors are considered, however, "these rough estimates sug-
Dr. Charles C Edwards, Jr. Results are questionable
gest a bleak outlook for producing an adequate number of clinical pharmacologists during the next decade," Dr.' Azarnoff says. The estimates assume that all the newly trained clinical pharmacologists will be employed only in medical schools, and that older clinical pharmacologists won't leave the field or die. The training rates also assume a one-year training period, whereas a two-year period would be more realistic, he says, and this longer period would halve the estimated rates. In the most recent report of another ASPET survey, there were 131 positions available for training in clinical pharmacology at 36 medical schools as of December 1969. Of these positions, 101 were filled. Assuming a two-year training period, the present yearly output is approximately 50 clinical pharmacologists. Recruiting. Spokesmen for federal agencies and private foundations offered little hope that funding would be increased for research and training in clinical pharmacology. And clinical pharmacology departments are having a difficult time recruiting wellqualified M.D/s or Ph.D/s for training, according to Dr. John A. Oates of Vanderbilt University's medical school in Nashville, Term. Long-term salary commitments would help the situation, he says, as would funding for research programs to create a stimulating environment in clinical pharmacology units. Because of the shortage of clinical pharmacologists, about 85% of clinical testing for the pharmaceutical industry is done by medical specialists who are clinicians but who are not necessarily aware of the needs of drug research, estimates Dr. Harold F. Hailman, vice president of Geigy Pharmaceutical Co., Ardsley, N.Y. Testing in prisons accounts for about 10% of the total, while clinical pharmacology departments do only about 5% of the testing for the drug industry. The drug industry presently needs 5000 to 10,000 clinical studies of drugs, he says, but clinical pharmacology departments can probably handle only approximately 150 clinical studies of drugs in a given year. The result is that data supplied by drug companies to FDA frequently lack the type of information that a clinical pharmacologist would provide, according to Dr. Charles C. Edwards, Jr., FDA commissioner. The drug studies represent considerable effort and expense, he says, but the results are of questionable use in evaluating the drugs. DEC. 14, 1970 C&EN
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