Richard L. O'Brien

Is the Use of Placebo Controls Ethically Permissible in Clinical Trials of Agents Intended to Reduce Fractures in Osteoporosis

Substantial progress has been made in developing treatments that reduce the risk of fractures in osteoporosis. However, available treatments are only partially effective, they are not widely used, and there is need to search for more effective means of fracture prevention. Currently known effective means of reducing fractures were found using randomized placebo‐controlled trials. The use of placebo controls in clinical trials has been a subject of significant controversy in recent years. The Declaration of Helsinki revision of October 2000 caused great concern among clinical investigators about the future use of placebo controls if known effective therapeutic agents are available. A working group of ethicists, clinical trial design experts, and clinical investigators examined the current state of knowledge of osteoporosis treatment and trials. They concluded that if placebo controls put subjects at substantial risk of serious outcomes, they are not ethically permissible. Placebo controls in osteoporosis trials with fracture as the measured outcome are permissible only under narrowly defined conditions. Placebo controls may be used if competent, well‐informed patients refuse approved therapies for sound reasons, there is a reasonable basis for substantial disagreement or lack of consensus among professionals about whether approved treatments are better than placebos, or subjects are refractory to known effective agents. Active control trials are permissible and desirable if they can be designed and conducted in ways that overcome the interpretive difficulties often associated with such trials.

Description and evaluation of an interprofessional patient safety course for health professions and related sciences students

Objectives: The structure, process, and outcomes associated with planning, developing, and offering an interprofessional course on the foundations of patient safety is described, including how organizational, structural, cultural, and attitudinal barriers were overcome. Methods: Seventeen faculty members from 7 colleges and schools and medical center participated-from the fields of decision sciences and systems, dentistry, medicine, law, nursing, occupational therapy, pharmacy, physical therapy, social work, health care administration, and outcomes management in health systems. Student assessment included theme analysis of open-ended questions, descriptive analysis of multiple- response option questionnaires, and criterion-based assessment of student performance on case studies. Triangulation of student comments, final course evaluation, and student performance evaluations were performed to learn overarching themes of student experience with the course. Results: The students learned a different way of thinking, found the instructional design and active learning methods useful to learning, and felt prepared to solve problems in the future. Students believed that the content was an essential core knowledge for all health professionals (87%) and should be required for all health professions students (78%). Students achieved an application level of learning (77%) within the cognitive domain and the valuing level within the affective domain. Students agree (96%) that they can define and apply the basic principles and tenets of patient safety, including identification of tools needed to work effectively within the health system and to improve safety and strongly agree (100%) that they value patient safety as a professional practice framework. Conclusion: The universitywide implementation case may offer important lessons to others nationally in health care education.

Ethical dilemma of mandated contraception in pharmaceutical research at catholic medical institutions.

The Catholic Church proscribes methods of birth control other than sexual abstinence. Although the U.S. Food and Drug Administration (FDA) recognizes abstinence as an acceptable method of birth control in research studies, some pharmaceutical companies mandate the use of artificial contraceptive techniques to avoid pregnancy as a condition for participation in their studies. These requirements are unacceptable at Catholic health care institutions, leading to conflicts among institutional review boards, clinical investigators, and sponsors. Subjects may feel coerced by such mandates to adopt contraceptive techniques inconsistent with their personal situation and beliefs; women committed to celibacy or who engage exclusively in non-heterosexual activities are negatively impacted. We propose principles to insure informed consent to safeguard the rights of research subjects at Catholic institutions while mitigating this ethical conflict. At the same time, our proposal respects the interests of pharmaceutical research agencies and Catholic moral precepts, and fully abides by regulatory guidance.

Reticulo-Endothelial Blockade and Capillary Resistance Response to Cortisone and STH.

Summary It is shown that blocking the RE system with India ink diminishes or abolishes capillary resistance response to cortisone and STH. That large doses of cortisone can overcome the block suggests that the RE system functions by increasing sensitivity of tissues to cortisone.