by Robert Baker, Professor of Bioethics and Director Emeritus of the Center for Bioethics and Clinical Leadership
As this post is being written, Princeton University is plagued by an outbreak of type B bacterial meningitis, a disease that has a 10% mortality rate in a college-age population. The first and only vaccine against this form of meningitis, Bexsero®, was approved last year in the two jurisdictions where type B meningitis is most prevalent: Australia and the European Union. The US Food and Drug Administration (FDA), however, has not approved the vaccine for use in the US. Consequently, Princeton’s trustees are seeking emergency authorization from the US Centers for Disease Control and Prevention (CDC) to use the vaccine.
One of America’s best-known bioethicists, Arthur Caplan, has written two blog posts on the subject — here and here. He contends that since Bexsero, “has not been approved by the FDA or other federal advisory agency…[those vaccinated] should be treated more as research subjects than as patients.” Here, Caplan is referencing regulations enacted in the aftermath of a notorious incident: the thalidomide tragedy of 1960. Back then, a newly hired FDA bureaucrat, Francis Oldham Kelsey, refused to rubberstamp a pharmaceutical company’s application for the morning sickness drug, even though the drug had been approved for use in over twenty countries. Intrepidly insisting on a comprehensive review, Kelsey uncovered data indicating that thalidomide was linked to severe birth defects. She single handedly squelched FDA approval, and is thus credited with preventing birth defects in thousands of American babies. (Next July she will celebrate her 100th birthday.) After the thalidomide incident, Congress required that the FDA independently review drugs approved in other jurisdictions before permitting their sale in the US. Bexsero is currently under review by the FDA but has not yet been approved for use in the US, so the Princeton trustees are appealing for an exemption from this requirement.
The circumstances surrounding the thalidomide case differ from those surrounding the Bexsero exemption. Thalidomide alleviated the symptoms of morning sickness, a non-lethal and non-infectious condition (albeit one that can be quite debilitating for some women). Delaying FDA approval to gather additional information on thalidomide’s safety did minimal harm to most pregnant women and protected the health of their unborn babies. Delaying an emergency exemption for Bexsero, by contrast, would allow the spread of an infectious disease that threatens the lives and health of the Princeton community, even though the known data offers no reason to suspect that the vaccine poses a safety risk.
Mindful of these facts Caplan concludes that Bexsero® should be offered to the Princeton students who, on his analysis, should be treated as if they were volunteering to serve as subjects in a study of an experimental drug. As potential subjects the students would be cautioned about unknown side effects and encouraged to reflect on their right to refuse to participate. I think this is the wrong model. Princeton students are not volunteering for a scientific study. They are members of a community at risk for contracting a sometimes disabling and often-fatal infectious disease. Emergency vaccination should thus be presented to them as the recommended choice. Students should of course be informed of the vaccine’s probationary status and of their right to refuse it; however, they should also be notified that if they refuse, unless they are isolated they may place not only their own health at risk but also the health of others. The Princeton trustees framed the issue properly when they notified students that, if the CDC grants an exemption, they recommend “students…receive a vaccine that helps protect against meningococcal disease caused by serogroup B.”