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COMMENTARY AND DISCUSSION Regulatory Encumbrances to Pharmaceutical Research A. JOHN NELSON* In this commentary, I shall present the viewpoint of a physician concerned with supervising clinical research on investigational drugs within the context of a pharmaceutical company. The pharmaceutical industry is unique among industries in this country in having both its marketed drugs and its research on investigational drugs under federal regulation. In order to survive—and survival depends upon investment, profitability , and further investment in a free economy—the industry continues to rely on its own initiatives in research and development. Through its talents, laboratories, equipment, and methodologies, the industry has made important contributions to drug development and will, in all probability, continue to do so. However, innovative discoveries are becoming less frequent, R&D costs are escalating, patents on major products are expiring, and governmental regulation is becoming ever more onerous. While some governmental supervision of new drug development must be regarded as being in the public interest, increased bureaucratic control can only have a detrimental effect on the industry's future and contribution to society. Sonnenreich has outlined specific areas in which the clinical investigator has lost control over the design and implementation of his future research. Additional considerations apply to pharmaceutical research , and I would like to comment upon these. Informed Consent Informed consent is a difficult and contentious issue and appears likely to become more so. Apparently it is not enough that the clinical *Vice President Medical Affairs, Hoechst-Roussel Pharmaceutical, Inc., Route 202-206 North, Somerville, New Jersey 08876.© 1980 by The University of Chicago. 0031-5982/80/2322-0162$01.00 S150 I A.John Nelson ¦ Regulatory Encumbrances investigator has (a) accepted an increasing degree of responsibility by way of implied consent (given by any patient who places himself under the care of a physician), verbal consent (patient uninformed), written consent (patient informed verbally), and now written consent (with patient informed in writing); and (b) complied with the stipulations of the Nuremberg code, the Helsinki code, his own conscience, and peer review . Sonnenreich notes that the "mechanisms of control established consequent to the reports of the National Commission on the Protection of Human Subjects place the hand of the federal government in almost every research protocol" in calling for third-party intervention (the socalled "consent auditor" or "advocate"); in the possible extension of regulatory standards (explicitly applied to HEW grant research or research submitted to regulatory agencies) to all clinical research; and in providing advice on whether compensation and medical treatment is available if physical injury occurs in biomedical or behavioral research. Some of these issues are already beginning to show up in clinical research sponsored by the pharmaceutical industry. The intervention of consumer groups in the matter of informed consent given by individual patients is also potentially troublesome. Informed consent is essential to the ethical conduct of clinical research, but the objective is not to have the matter of obtaining informed consent made so difficult that clinical investigations will cease forever. Restriction on Patient Popuhtions Undoubtedly, there has been some restriction of the patient populations available for clinical research. The DHEW has already issued regulations that limit testing on fetuses, pregnant women, and women who have a high potential for becoming pregnant. The FDA is developing additional regulations, due this year, on clinical investigations in children . For the pharmaceutical industry, prisons traditionally have provided human subjects for the early phases of new drug investigation and for special studies, for example, bioavailability. We have always contended that prisoners can give informed consent voluntarily, that their wishes should be taken into consideration, and that the safety record for industry-sponsored research is both documented (e.g., at Jackson State Prison) and unblemished. The exclusion of prison populations from nontherapeutic biomedical research does represent a significant loss of appropriate and available subjects for legitimate and ethical research. Institutional Review Boards Institutional research sponsored by pharmaceutical companies comes under the supervision of institutional review boards (IRBs). Over the Perspectives in Biology and Medicine ¦ Winter 1980 ¦ Part 2 | S151 past few years, there has been increasing delay in obtaining approvals from such review committees. To some extent, this probably reflects the increased workload imposed upon them; part of the...


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