Faculty Bibliography

Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.

Discovering the genetic variations that create profiles of risk and drive individual responses to drugs and vaccines has proven more difficult than many initially presupposed. Rhetoric about the prospect of personalized medicine has exceeded the ability to deliver on that vision. There also remain significant ethical and policy obstacles that may hinder the arrival of personalized medicine. The emergence of new prenatal genetic tests make the resolution of these ethical challenges imperative.

Promising advances have been made in recent years for a unique class of immunotherapies that use vaccination to combat substance-use disorders. Although such vaccines are potentially useful for addictions, they raise a variety of ethical and social questions.

Evidence-based decision making (EBDM) is a tool to assess the value of medical interventions by weighing costs and health outcomes that has increasingly been applied to vaccines. However, many of the ethical considerations that support EBDM when used to evaluate therapeutic care do not readily translate to prevention. This mismatch can result in policy decisions that produce unanticipated negative consequences, including public resistance. In its emphasis on quantifiable outcomes, EBDM invokes the ethical principle of rule-utilitarianism, which values the optimal long-run balance of benefit over harm. Vaccines raise a number of competing ethical concerns in ways that individual medical treatments do not. They rely on widespread compliance for effectiveness, which can limit individual autonomy, emphasize population over individual effects, which can obscure the imperative of beneficence to help the vulnerable, require a just allocation process within populations, and sometimes challenge strong social norms. For EBDM to effectively guide vaccine policy makers, such as the Advisory Committee on Immunization Practices (ACIP) in the United States, an ethical foundation is needed that systematically considers all relevant values and transparently places vaccination recommendations in the context of social norms and individual concerns.

The practice of transplanting organs from executed prisoners in China appears to be widespread. We vigorously condemn this practice and, effective immediately, will not consider manuscripts on human organ transplantation for publication unless appropriate non-coerced consent of the donor is provided and substantiated.

End-stage organ failure is a key challenge for the medical community because of the ageing population and the severe shortage of suitable donor organs available. Equally, injuries to or congenital absence of complex tissues such as the trachea, oesophagus, or skeletal muscle have few therapeutic options. A new approach to treatment involves the use of three-dimensional biological scaffolds made of allogeneic or xenogeneic extracellular matrix derived from non-autologous sources. These scaffolds can act as an inductive template for functional tissue and organ reconstruction after recellularisation with autologous stem cells or differentiated cells. Such an approach has been used successfully for the repair and reconstruction of several complex tissues such as trachea, oesophagus, and skeletal muscle in animal models and human beings, and, guided by appropriate scientific and ethical oversight, could serve as a platform for the engineering of whole organs and other tissues.

AIMS: To determine the success threshold at which a theoretical course of deep brain stimulation (DBS) would provide the same quality of life (QoL) and cost-effectiveness for heroin dependence as methadone maintenance treatment (MMT). DESIGN: We constructed a decision analysis model to calculate QoL after 6 months of MMT and compared it to a theoretical course of DBS. We also performed a cost-effectiveness analysis using societal costs of heroin dependence, MMT and DBS. SETTING: Systematic literature review and meta-analysis. PARTICIPANTS: Patients (n = 1191) from 15 trials administering 6 months of MMT and patients (n = 2937) from 45 trials of DBS for movement disorders. MEASUREMENTS: Data on QoL before and after MMT, retention in MMT at 6 months, as well as complications of DBS and their impact on QoL in movement disorders. FINDINGS: We found a QoL of 0.633 (perfect health = 1) in heroin addicts initiating MMT. Sixty-six per cent of patients completed MMT, but only 47% of them had opiate-free urine samples, resulting in an average QoL of 0.7148 (0.3574 quality-adjusted life years (QALYs) over 6 months). A trial of DBS is less expensive ($81,000) than untreated (or relapsed) heroin dependence ($100,000), but more expensive than MMT ($58,000). A theoretical course of DBS would need a success rate of 36.5% to match MMT, but a success rate of 49% to be cost-effective. CONCLUSIONS: The success rate, defined as the percentage of patients remaining heroin-free after 6 months of treatment, at which deep brain stimulation would be similarly cost-effective in treating opiate addiction to methadone maintenance treatment, is estimated at 49%.