Robert I. Field

A Proposed Ethical Framework for Vaccine Mandates: Competing Values and the Case of HPV

Debates over vaccine mandates raise intense emotions, as reflected in the current controversy over whether to mandate the vaccine against human papilloma virus (HPV), the virus that can cause cervical cancer. Public health ethics so far has failed to facilitate meaningful dialogue between the opposing sides. When stripped of its emotional charge, the debate can be framed as a contest between competing ethical values. This framework can be conceptualized graphically as a conflict between autonomy on the one hand, which militates against government intrusion, and beneficence, utilitarianism, justice, and nonmaleficence on the other, which may lend support to intervention. When applied to the HPV vaccine, this framework would support a mandate based on utilitarianism, if certain conditions are met and if herd immunity is a realistic objective.

Impact of shortages of injectable oncology drugs on patient care.

PURPOSE Results of a survey regarding shortages of injectable oncology drugs in U.S. hospitals and health systems are presented. METHODS An online survey was sent to all members of the American Society of Health-System Pharmacists self-identified as directors of pharmacy. Survey participants provided information on the extent to which their facilities were affected by oncology drug shortages, strategies for responding to shortages, and the effects of shortages on costs, patient safety, and outcomes. RESULTS Ninety-eight percent of the 358 survey respondents reported at least one drug shortage during the previous 12 months, with 70% reporting instances of an inadequate supply to treat patients and 63% reporting that their facility had completely run out of at least one injectable oncology drug. Sixty-two percent of respondents reported using alternative drug regimens due to shortages; 46% reported drug dosage changes, 43% reported treatment delays, and 21% reported patient referrals to or from other facilities as a result of shortages. Survey respondents indicated the use of various strategies to manage oncology drug shortages (e.g., increasing inventories of certain drugs, identifying alternatives and substitution protocols, altered purchasing practices), all of which have led to cost increases. Twenty-five percent of respondents reported safety events resulting from oncology drug shortages. Only 40% of respondents agreed that currently available information is useful in mitigating the effects of shortages. CONCLUSION Shortages of injectable oncology drugs appear to be widespread and to be having a significant impact on patient care. Currently available information about shortages does not meet administrative or clinical needs.

Evidence-based decision making for vaccines: the need for an ethical foundation.

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.

What the Doctor Didn't Say

Imagine that you have recently been diagnosed with a debilitating illness. Your physician recommends that you enroll in a clinical trial of an experimental new drug that may offer the only real possibility of remission or cure. Would you jump at the chance? On first blush, it might seem an easy decision. However, you might feel differently after reading What the Doctor Didn’t Say by Jerry Menikoff and Edward P. Richards. At the least, you would ask your physician a list of probing questions before agreeing to take part. Clinical research to evaluate new medical treatments is a far riskier and murkier proposition for subjects than most people outside the medical world may realize. Many studies offer subjects no therapeutic benefits but present serious risks. These are aspects of research that doctors often do not reveal, and this book tries to make up for that. Professors Menikoff and Richards catalogue a litany of risks inherent in clinical trials with reference to numerous actual studies. They also describe the legal framework governing research, which leaves subjects with limited protection. The book is written largely in lay terms for a general audience, perhaps including many patients who must decide whether to become research subjects. However, it does not skimp on legal details and would also be useful and informative for those knowledgeable in the field. The book’s ultimate goal is to provide more than a set of scare stories of abuses, and it ends with suggestions for changes in the way research is conducted. It is particularly effective at highlighting the risks to subjects

What you see is what you fear.

Visual imagery can powerfully shape perceptions of risks as is clearly demonstrated by research on the use of graphic warnings on cigarette packs. Government efforts to counteract public fears of vaccines could harness this phenomenon by using public information campaigns that present visually the effects of vaccine-preventable diseases. Visual representations can also be used to communicate the relative risks of vaccines, which are generally negligible, and of the diseases they prevent. Such initiatives have the policy advantage of minimizing the sense of government intrusion that measures such as vaccine mandates and social restrictions could engender and the legal advantage of avoiding claims of infringement on civil liberties. Government policy should take advantage of this important and accessible tool.

How Genetic Variant Libraries Effectively Extend Gene Testing Patents: Implications for Intellectual Property and Good Clinical Care

Genetic testing for inherited cancer susceptibility is an increasingly valuable tool in medical oncology. The identification of mutations in the BRCA1 and BRCA2 genes, for example, leads to specific clinical recommendations for screening or surgery that can improve survival.1 However, genetic testing can also identify variants of uncertain significance (VUS), changes in the genetic code that have an unknown effect on disease risk. Roughly 7% of women tested for BRCA1 and BRCA2 have one of these variants.2 Test results with VUS increase, rather than decrease, uncertainty for the patient in a situation with particularly high stakes and present a challenge to the clinician in devising appropriate responses.

Brief Report: Service Use and Associated Expenditures Among Adolescents with Autism Spectrum Disorder Transitioning to Adulthood

This study compared Medicaid service utilization and expenditures among adolescents with autism spectrum disorder (ASD) to adolescents with intellectual disability (ID) as they aged into adulthood. Medicaid Analytic eXtract (MAX) data was used to identify a national cohort. Winsorization was utilized to control for expenditure outliers. A greater proportion of adolescents with ASD utilized most services. Decreases in the use of key services, including psychiatric outpatient services, were observed for both groups. Changes in medical services, such as increases in inpatient and long term care services, among the ASD cohort suggest medical needs of adolescents with ASD change as they age. Information remains lacking on changing ASD symptom presentation during the transition to adolescence.

Factors Associated With Pediatrician Responses to Alternative Immunization Schedule Requests

We conducted a cross-sectional online survey among 4 chapters of the American Academy of Pediatrics from July through October 2014 to describe characteristics of pediatricians and practices associated with practice-level responses to alternative immunization schedule requests. Among 374 pediatricians, 58% reported frequent alternative immunization schedule requests and 24% reported feeling comfortable using them. Pediatricians who work in practices that accommodate alternative immunization schedule requests have increased odds of having a high frequency of alternative immunization schedule requests, and beliefs that relationships with families would be negatively affected if they refused requests. Practices that discontinue care to families who request alternative immunization schedules have increased odds of being a private group practice and having a formal office vaccine policy. Pediatricians are frequently asked to use alternative immunization schedules and many are not comfortable using them. Practice-level responses to alternative immunization schedules are associated with characteristics of pediatricians and practices.

The Ethics of Expanding Health Coverage through the Private Market.

The Affordable Care Act broadens health coverage primarily through market mechanisms, building on the public-private partnership in service of an important policy goal.

The frontiers of genetics and the transformation of medicine and business

The Human Genome Project will revolutionize much of medicine and business. Genetic technologies will let pharmaceutical companies customize products, clinicians predict health outcomes, insurers estimate future health costs, and employers select disease-resistant workers to enhance productivity. However, there are significant costs. Genomic drugs will be expensive, genetically-based insurance underwriting may leave some uninsurable, and genetically-based worker selection may leave some unemployable. Legal protections enacted to date are incomplete, because controlling genetic technologies will require more than new legal rules. It will necessitate rethinking many aspects of medicine and business, including medical data ownership, pharmaceutical development, health insurance, and worker productivity.