A new study by Consortium collaborator Kingshuk Sinha illustrates troubling lags in the recall of flawed medical devices. In the paper, Prof. Sinha, a professor in the University of Minnesota's Carlson School, "applied digital analytics to millions of medical device product reports and recall records" to reveal what Sinha calls "under-reaction bias," according to the Minneapolis Star Tribune. The article details efforts by the Food and Drug Administration to use data-mining to improve surveillance of health technology. However, despite robust evidence that problem devices can have significant negative health effects, such adverse-event reports aren't consistently sought or entered into the federal tracking system, known as MAUDE. Prof. Sinha was one of the presenters in the recent Deinard Memorial Lecture on Law & Medicine, How Patients Are Creating Medicine’s Future, during which he shared Big Data and supply chain perspectives on health improvement; a video of that event can be viewed here.
An article in The Nation, "What’s Killing America’s Black Infants?" provides a sobering analysis of the disproportionately high death rate among African-American babies. Despite decades of interventions and public health initiatives, the racial infant mortality gap actually grew during the 1980s and 90s: during that time, "Black women who received prenatal care starting in the first trimester were still losing children at higher rates than white women who never saw a doctor during their pregnancies." This led to research into whether black women have a genetic predisposition to poor birth outcomes, which was largely disproven. However, more recently, "a growing body of evidence points to racial discrimination, rather than race itself, as the dominant factor in explaining why so many black babies are dying." The article profiles efforts in Milwaukee, Wisconsin, which has one of the worst infant-mortality rates of all US cities, to reverse the trend.
Both of the legal project assistants (LPAs) currently working with Consortium chair Susan M. Wolf, JD, have received staff appointments for volume 102 of the Minnesota Law Review, an honor indicating high achievement in legal studies. Caroline Bressman was selected as Symposium Articles Editor, and Lauren Clatch is Lead Articles Editor. Ms. Bressman is a graduate of St. Olaf College who clerked at Nichols Kaster last summer. Ms. Clatch graduated from Washington University in St. Louis and interned for Chief Judge John R. Tunheim at the U.S. District Court in Minneapolis last summer. Both are assisting Prof. Wolf with research related to the LawSeq grant. Congratulations to these law students on this well-deserved honor!
Videos of the first two lectures in the Consortium's lecture series on Emerging Diseases in a Changing Environment are now available for online viewing. The first, Finches, Dogs, Lions and Zika: An Ecologist Looks at Emerging Disease, was delivered by Prof. Andrew Dobson (DPhil, Princeton) on Jan. 24, 2017. Prof. Jonna Mazet (DVM, MPVM, PhD) gave the second, Ending the Pandemic Era: Science at the Animal-Human-Environmental Interface, on Feb. 7, 2017. Please register for the final lecture and webcast in the series by former head of the Centers for Disease Control and current Executive Vice President at Merck, Julie L. Gerberding, MD, MPH. Her topic is Combating Microbial Terrorists: How to End Our Preparedness Stalemate, and she will bo on campus April 13, 2017. Co-sponsored by the University of Minnesota’s Center for Infectious Disease Research and Prevention (CIDRAP), the Institute on the Environment (IonE), and the Food Protection and Defense Institute.
On March 8th and 9th, 2017, the Consortium will present two related conferences on frontier issues in research ethics. Building on the sold-out Research with Human Participants conference held in December, 2015, the March events will bring together renowned speakers from a variety of disciplines to address how informed consent ethics and policy have developed over the past century and what tools are needed to improve patient and research protections going forward. Discussion will include recent changes to the Common Rule governing research, including changes on informed consent and broad consent. On March 8, an all-day conference and simultaneous webcast will address The Future of Informed Consent in Research and Translational Medicine. The morning of March 9 will kick off the University of Minnesota's first-ever Research Ethics Day with a half-day conference and webcast on The Challenges of Informed Consent. Research Ethics Day concludes in the afternoon with trainings and workshops designed to provide concrete, actionable and hands-on approaches to the everyday challenges of properly conducting research with human participants. To learn more and register, visit our conference website.
Just in time for next Sunday's Superbowl game, a new paper published in the University of Pennsylvania Law Review explores the legal and ethical aspects of a hypothetical National Football League (NFL) player's health. The authors, who include Consortium collaborator I. Glenn Cohen of Harvard Law School, ask "What are the current legal standards for employers collecting and acting on an individual’s health- and performance-related information?" They draw upon disability law, privacy law and other disciplines to provide recommendations to better protect the health and privacy of professional football players. The authors find that "it appears that some of the existing evaluations of players, both at the NFL Scouting Combine (Combine) and once drafted and playing for a club, seem to violate existing federal employment discrimination laws." To correct this, they recommend both adherence to current laws and changes to existing statutory schemes. Read the entire article here.