Faculty Bibliography

The only curative therapy for diseases such as organ failure is orthotopic organ transplantation. Organ transplantation has been limited due to the shortage of donor organs. The huge disparity between those who need and those who receive transplantation therapy drives the pursuit of alternative treatments. Therefore, novel therapies are warranted. Recent studies support the feasibility of generating human-porcine chimeras that one day would provide humanized vasculature and blood for transplantation and serve as important research models. The ethical issues they raise require open discussion and dialog lest promising lines of inquiry flounder due to unfounded fears or compromised public trust.

WHAT IS KNOWN AND OBJECTIVE/OBJECTIVE:While many countries have central agencies responsible for formulary development, within the United States, each hospital, health care system, or insurance provider has their own pharmacy and therapeutic committee, leading to both inefficiencies and inequalities across formularies. The number and variety of processes within pharmacy and therapeutic committees also increases the likelihood that conflicts of interest will influence the development of formularies. We sought to determine how such influences could be reduced by reviewing international evidence related to the presence and harms of conflicts of interest in formulary development. METHODS:Several approaches have been taken to reduce the influence of conflicts of interest in pharmacy and therapeutics committee processes, including include disclosure, recusal, exclusion, universal consideration and dual committees. The feasibility of each of these approaches is considered in the context of the United States. RESULTS AND DISCUSSION/CONCLUSIONS:A proposal is drawn from the discussion of various approaches to conflicts of interest in pharmacy and therapeutics committees: multicenter formulary development. WHAT IS NEW AND CONCLUSION/CONCLUSIONS:Multicentre formulary development, where resources are pooled across institutions, may lead to a reduction in the influence of conflicts of interest in pharmacy and therapeutics committee processes in the United States, increasing the chances of including the most safe, efficacious and cost-effective drugs on formularies.

Over 115 000 people are waiting for life-saving organ transplants, of whom a small fraction will receive transplants and many others will die while waiting. Existing efforts to expand the number of available organs, including increasing the number of registered donors and procuring organs in uncontrolled environments, are crucial but unlikely to address the shortage in the near future and will not improve donor/recipient compatibility or organ quality. If successful, organ bioengineering can solve the shortage and improve functional outcomes. Studying manufactured organs in animal models has produced valuable data, but is not sufficient to understand viability in humans. Before risking manufactured organ experimentation in living humans, study of bioengineered organs in recently deceased humans would facilitate evaluation of the function of engineered tissues and the complex interactions between the host and the transplanted tissue. Although such studies do not pose risk to human subjects, they pose unique ethical challenges concerning the previous wishes of the deceased, rights of surviving family members, effective operation and fair distribution of medical services, and public transparency. This article investigates the ethical, legal and social considerations in performing engineered organ research on the recently deceased.

Implementing uncontrolled donation after circulatory determination of death (uDCDD) in the United States could markedly improve supply of donor lungs for patients in need of transplants. Evidence from U.S. pilot programs suggests families support uDCDD, but only if they are asked permission for using invasive organ preservation procedures prior to initiation. However, non-invasive strategies that confine oxygenation to lungs may be applicable to the overwhelming majority of potential uDCDD donors that have airway devices in place as part of standard resuscitation. We propose an ethical framework for lung uDCDD by: (1) initiating post mortem preservation without requiring prior permission to protect the opportunity for donation until an authorized party can be found; (2) using non-invasive strategies that confine oxygenation to lungs; and (3) maintaining strict separation between the healthcare team and the organ preservation team. Attempting uDCDD in this way has great potential to obtain more transplantable lungs while respecting donor autonomy and family wishes, securing public support, and enabling authorized persons to affirm or cease preservation decisions without requiring evidence of prior organ donation intent. It ensures prioritization of life-saving, the opportunity to allow willing donors to donate, and respect for bodily integrity while adhering to current ethical norms.

Vaccines for two viruses which cause cancer, human papillomavirus (HPV) and hepatitis B virus (HBV), are recommended for all children in the United States. Numerous parallels exist between the two vaccines in addition to their roles in cancer prevention, including transmission through sexual contact, multiple doses needed for series completion, and vaccine administration in adolescence for HPV and in the initial phase of the HBV vaccination program. All of these factors were viewed as potential barriers to achieving high rates of coverage, yet the ultimate success of the HBV vaccination program led to predictions that similarly high rates of coverage could be achieved for the HPV vaccine. However, currently, only the recommendation for HBV vaccination is supported by mandates for school entry in most states. Uptake of the HPV vaccine has lagged far behind U.S. goals for public health promotion. The aim of this paper is to examine factors which may account for the divergent pathways of the two vaccines. Four main factors are identified: logistical challenges of vaccine administration, attitudes of parents and healthcare providers, safety concerns, and cost. For each factor examined, recommendations are offered to confront similar barriers likely to arise for future vaccines. The authors conclude that gender-neutral state mandates coupled with school-located vaccination programs, stronger gender-neutral messaging from pharmaceutical companies and healthcare providers, and younger age of vaccine administration, if approved, present the most promising approaches to improving uptake of the HPV vaccine, and similar vaccines down the road.