Faculty Bibliography

Patient access to experimental drugs outside of clinical trials is called compassionate use or expanded access. Compassionate use/expanded access presents a powerful ethical dilemma in that it involves competing claims that both have moral weight: specifically, an individual patient's very understandable desire to try to extend his or her life versus the orderly and efficient functioning of a drug development and clinical trial system that benefits much larger numbers of patients. Patient advocates, the FDA, pharmaceutical trade groups, and state and national legislators in the US are all currently weighing in on patient access to experimental drugs, and new guidelines and rules are being introduced. In this editorial, we discuss the impulse to rescue individual patients facing dire diseases and underscore the ethical questions that such rescue efforts raise.

Recent instances of governments and others refusing humanitarian assistance to refugees and IDPs (internally-displaced persons) unless they agreed to polio immunization for their children raise difficult ethical challenges. The authors argue that states have the right and a responsibility to require such vaccinations in instances where the serious vaccine-preventable disease(s) at issue threaten others, including local populations, humanitarian workers, and others in camps or support settings.

[...]there is the lunatic osteopath Jack Wolfson, who told The Arizona Republic that diseases like measles are nature's way of building up the immune system: "We should be getting measles, mumps, rubella, chickenpox; these are the rights of our children to get it."

Especially when they speak on TV. Because lives hang in the balance, medical speech is held to a higher standard. Vaccines do not cause autism; measles is dangerous and contagious; inoculating against the disease is neither pointless nor riskier than abstention