JAMA
March 17, 2015, Vol 313, No. 11
http://jama.jamanetwork.com/issue.aspx

Viewpoint | March 17, 2015
Law, Ethics, and Public Health in the Vaccination Debates – Politics of the Measles Outbreak FREE
Lawrence O. Gostin, JD1
[+] Author Affiliations
JAMA. 2015;313(11):1099-1100. doi:10.1001/jama.2015.1518.

[Concluding text]
A TRAGEDY OF THE COMMONS
Parental decisions to opt out of immunizations can have a rational basis. Unvaccinated children avoid rare adverse effects, such as a serious allergic reaction. Moreover, if most children in the community in which they live are immunized, the unvaccinated child also benefits from herd immunity. The dilemma is that if a sufficient number parents act in their own interests by opting out of having their children immunized, then everyone is worse off.

Parents objecting to vaccines often claim the right to informed consent, which is an important medicolegal value. However, consent should not override the rights of others to live safely in their communities. Unvaccinated children put the wider public at risk, violating a basic ethical principle of not imposing harms on others. If an individual’s right ends at the point that its exercise jeopardizes the safety of others, then should states allow parents to opt out? Certainly, states should continue to grant medical exemptions for children particularly susceptible to vaccine adverse effects. However, states do not have to grant philosophical and religious exemptions. The main consideration is whether eliminating exemptions could inflame public opinion, thus undermining vaccine policy.

States would be unwise to overreact to the current measles outbreak by fining or imprisoning parents, or subjecting them to tort litigation, if they fail to vaccinate their children. Harsh penalties could fuel public opposition to vaccine policy. It may not even be necessary to entirely eliminate nonmedical exemptions. The wiser course could be to require a rigorous process for claiming the exemption, relying on behavioral economics to encourage compliance. There are good models of tougher standards, including requiring counseling; explaining the benefits of vaccines; requiring parents to sign an affidavit stating the reasons for opting out; and requiring health department approval. Placing a higher burden on the exemption process would make it more difficult for parents to impose risks on their children’s friends and schoolmates without their agreement.

If exemptions were truly rare, as they should be, then herd immunity would operate. Everyone would be safer. The current system of generous opt outs virtually ensures that infectious disease outbreaks will continue, perhaps increasing in frequency and geographic scope. Childhood diseases that were once common but now rare could gain a foothold, becoming endemic once again.
Research Letter | March 17, 2015
Reporting of Noninferiority Trials in ClinicalTrials.gov and Corresponding Publications
Anand D. Gopal, BS, BA1; Nihar R. Desai, MD2; Tony Tse, PhD3; Joseph S. Ross, MD, MHS2
[+] Author Affiliations
JAMA. 2015;313(11):1163-1165. doi:10.1001/jama.2015.1697.
Noninferiority clinical trials are designed to determine whether an intervention is not inferior to a comparator by more than a prespecified difference, known as the noninferiority margin. Selection of an appropriate margin is fundamental to noninferiority trial validity, yet a point of frequent ambiguity.1,2 Given the increasing use of noninferiority trial designs, maintaining high standards for conduct and reporting is a priority.3,4 Publicly accessible trial registries and results databases promote transparency and accountability by requiring specification of research designs and end points and disclosure of summary results.1,5