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.
The World Health Organization (WHO) has requested that countries across the globe increase their vigilance in monitoring avian flu in birds and the spread of the disease to humans. Almost 40 new outbreaks in wild birds have been reported since November with at least one case of human infection in China. According to NBC News, WHO Director-General Margaret Chan reports that "the rapidly expanding geographical distribution of these outbreaks and the number of virus strains currently co-circulating have put WHO on high alert." Tomorrow, the Consortium will be kicking off our lecture series on Emerging Diseases with a talk by evolutionary biologist Andrew Dobson of Princeton, who will discuss the emergence of pathogens like avian flu in the context of climate change. The event is free and open to the public; learn more and register here.
The long-awaited updated version of the Common Rule – the regulations safeguarding individuals who participate in research – was announced today by the US Department of Health and Human Services. The goal of the revision is to strengthen protections of research participants without adding undue administrative burdens for researchers, particularly in low-risk studies. The Common Rule revisions will inform the expert presentations at the Consortium's research ethics events on March 8-9, consisting of a national conference, "The Future of Informed Consent in Research and Translational Medicine" on March 8 and the University of Minnesota's "Annual Research Ethics Day" on March 9. These events will be webcast; for more information and to register, visit the Consortium's events page. The Annual Research Ethics Day on March 9 will conclude with in-person workshops and trainings on practical research topics. To learn more, visit z.umn.edu/researchtr
"Trace levels of pharmaceuticals and other chemicals may be harming fish in Minnesota rivers and lakes, according to a study released Thursday by the Minnesota Pollution Control Agency (MPCA)," reports Minnesota Public Radio. The new study confirms that such chemicals as antidepressants, insect repellent and the X-ray contrast agent iopamidol are commonly found in the state's rivers. MPCA lead scientist Mark Ferrey asserts, "Chemicals, even at those concentrations, can cause adverse effects in fish and wildlife that we're really just starting now to be able to understand." New developments in genetics allow scientists to examine the effects of this pollution. Prof. Dalma Martinovic-Weigelt of the University of St. Thomas is doing such a study, exposing fathead minnows to contaminated water and tracking the genetic response. Her research has the goal of pinpointing "what you should be worried about. Because there's so much information about these chemicals and their effect." Her study shows changes in minnow genes related to reproduction, growth and tumor formation among fish exposed to the contaminants. The entire MPR article can be found here.
A 2.3% excise tax on medical devices is among the many aspects of the Affordable Care Act (ACA) likely to be repealed during the current congressional session. The tax was collected starting in 2013, with the intention of offsetting expected ACA-driven profits for companies benefiting from expanded federally-funded Medicare and Medicaid payments. However, Congress passed a two-year repeal of the tax that was enacted in 2015 in an effort led by legislators representing states, like Minnesota, with robust medical device industries. According to the Star Tribune, "With [medical device excise tax] collections set to start again in January 2018, [Republican GOP Representative Erik] Paulsen is going for the coup de grace with a GOP-controlled House, Senate and White House that have made repealing the ACA a top priority." The article notes that the bill's co-sponsors, Paulsen and Wisconsin Democrat Ron Kind, "adopted the industry’s talking points in opposing the tax as a job killer that also took money away from research and development."