June 2013

Recent Grantee Articles, June 2013

Blumenthal-Barby JS, Cantor SB, Russell HV, Naik AD, Volk RJ. Decision aids: when ‘nudging’ patients to make a particular choice is more ethical than balanced, nondirective content. Health Aff (Millwood) 2013;32:303-10.  http://kennedyinstitute.georgetown.edu/programs/kiej/home_files/22.4.blumenthal-barby.pdf

             When patients have several options that are medically sound, decision aids may assist them in making these difficult decisions. According to current guidelines, decision aids should be balanced, neutral, unbiased, and nondirective. Prof. Jennifer Blumenthal-Barby and colleagues at Baylor College of Medicine argued that in several clinical situations, decision aids that favor some options over others are ethically appropriate. First, one treatment option may not be considered by patients or offered to them; for example, active surveillance of early stage prostate cancer. Second, one option may be strongly supported by clinical evidence; for example, screening for colorectal cancer. Third, when a patient’s habits, concerns, preferences, or goals may favor a particular option, a decision aid could identify and encourage that value-based choice.

            Prof. Blumenthal-Barby offered several arguments to justify decision aids that nudge patients to certain choices in such situations: developers of decision-aids have a fiduciary responsibility to use their skills for the clinical benefit of patients, patients and physicians have existing biases that must be counteracted if patients are to make a balanced decision, and the complete neutrality is impossible because choices must be presented in some framework.


Gymrek M, McGuire AL, Golan D, Halperin E, Erlich Y. Identifying personal genomes by surname inference. Science 2013;339:321-4. http://www.sciencemag.org/content/339/6117/321.full.pdf

            Detailed or complete genomic sequencing is becoming increasingly feasible in research. In order to facilitate further discoveries, the National Institutes of Health and professional guidelines require detailed genomic sequencing data to be entered into repositories that are accessible to approved investigators.

            Amy McGuire at Baylor was part of a multidisciplinary team that provided proof of principle that males can often be re-identified from detailed genomic sequencing, by identifying short tandem repeats on the Y chromosome (Y-STR haplotypes) and matching them to publicly available recreational genetic genealogy databases. The research team showed that male surnames can be identified with a high degree of probability in about 12% of males whose Y-STR haplotype is known. Furthermore, the team identified the individuals associated with five of ten male genomes whose Y-STR haplotype had been sequenced in detail and made available to other investigators. The re-identification used free, publicly available Internet resources: record search engines, obituaries, genealogical Web sites, as well as year of birth and state of residency, which were available from the genomic data repository. Each re-identification took required only 3 to 7 hours work by a single person.

            The authors urged that for genomic research to continue to progress, there should be clear policies for genomic data sharing, better public education about benefits and risks of genetic studies, and legislation of proper usage of genetic information.


Evans BJ. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act. Am J Law Med 2012;38:577-606. http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2021986

            The Food and Drug Administration (FDA) may order pharmaceutical companies to conduct drug safety studies after drugs are approved. Observational studies that examine patients’ insurance claims data and clinical records can show whether drugs are safe in actual clinical practice. Barbara Evans of the University of Houston showed that such observational studies, while improving drug safety, raise ethical and privacy concerns.

            Because of federal privacy regulations, pharmaceutical companies will not have reliable access to data needed for these studies. If companies do obtain needed data, serious privacy concerns arise because such observational studies are not covered by federal regulations that protect persons whose data are used in research. Consequently, the FDA might have to rely on clinical trials to assess safety after a drug is approved. Such trials would be inefficient, costly, and inappropriately risky to participants.

            Prof. Evans suggested a new approach to addressing these ethical and practical problems with post-marketing safety studies. The FDA can negotiate a collaborative agreement to carry out the study itself, impose appropriate ethical and privacy protections, and require the manufacturer to reimburse the FDA for study costs.

            Prof. Evans argued that bioethicists should overcome their instinctive objections to using public health resources in commercially sponsored research and turn their attention to protecting persons whose data are used in such safety studies. Using FDA resources may be the least objectionable way to carry out post-marketing safety studies that Congress has authorized.