Given the drama of the past several weeks, during which Congress wrestled with repealing, replacing or reforming the Affordable Care Act (ACA), it's an opportune time to look at the trajectory of that legislation. On March 23, the seventh anniversary of the ACA's signing, the former General Counsel for the US Department of Health and Human Services (HHS), William B. Schultz, lectured at Harvard Law School in an event sponsored by the Petrie-Flom Center. He described what he saw from his front-row seat during five years at HHS, during which time the repeal of ACA was the number one priority of the Republicans in Washington, and it was deeply unpopular across the nation. Mr. Schultz also considered what's likely to happen now that the Republicans have control of all branches of government and the repeal agenda is complicated by the new support for the law by voters and some Republican governors. He concluded with a discussion of health policy options for the future. A video of the lecture and discussion can be viewed here.
Multisite clinical trials are a powerful way to drive the discovery of new therapies, but ensuring that the health and privacy of study participants are protected across multiple Institutional Review Boards (IRBs) has slowed things down in the past. Today, the NIH reached a major milestone: all of their Clinical and Translational Science Awards program sites have agreed to a new authorization agreement, SMART IRB. The agreement – whose acronym stands for Streamlined, Multisite, Accelerated Resources for Trials IRB – "will enable all participating study sites to rely on the ethics review of one IRB for each study, making it possible to initiate multisite studies within weeks instead of months. For patients waiting to enroll in a study, this could make a life-saving difference." Among the signatories on the agreement is Consortium member the Clinical and Translational Science Institute (CTSI).
Renowned epidemiologist Michael T. Osterholm, PhD, MPH, director of Consortium member the Center for Infectious Disease Research and Policy (CIDRAP), has published a new book laying out how humanity can protect itself against catastrophic infectious disease and pandemic. In Deadliest Enemy: Our War Against Killer Germs, Prof. Osterholm applies knowledge and strategies acquired during his fights againt bioterrorism, pandemic influenza, Ebola and other public health emergencies. His goal? To describe "the latest medical science, case studies, policy research, and hard-earned epidemiological lessons. . . we need to develop if we are to keep ourselves safe from infectious disease." You can view a lecture delivered yesterday by Prof. Osterholm on the subject of the book here. He will be moderating a lecture on a closely related topic, Combating Microbial Terrorists, by former head of the Centers for Disease Control Julie Gerberding, MD, MPH, on April 13; register to attend or view the webcast here.
A safe food supply is a cornerstone of a secure society. The annual Food Defense Conference, sponsored by Consortium member center the Food Protection and Defense Institute, brings together experts from around the world to share strategies for the prevention, protection, mitigation, response, and recovery of the food system from intentional acts and adulteration, including those resulting from terrorism and criminal activities. The 2-day event is being held held on May 3-4, 2017 on the University of Minnesota-Twin Cities campus, and provides a unique and intimate opportunity for scholars, policymakers, regulators, and members of the food industry to network and learn from each other about the current state of food defense. Learn more and register here.
A symposium published today on Bill of Health, a blog edited by the Petrie-Flom Center at Harvard Law School, expands on discussions held at the Consortium's Deinard Memorial Lecture last December, "How Patients Are Creating Medicine’s Future." The Deinard lecture featured four speakers – Ernesto Ramirez of Fitabase, Jason Bobe of the Mount Sinai School of Medicine, Barbara Evans of the University of Houston Law Center, and Kingshuk K. Sinha of the Carlson School of Management at the University of Minnesota. The Bill of Health symposium provides commentary on their lectures and further reflections on the ways citizen science and wearables are transforming both health care and medical research. A video of the entire Deinard lecture can be viewed here.
A new study described by The Atlantic as "part philosophical treatise and part shot across the bow," argues that neuroscientists have been led astray by new research technologies. The authors point to the need for "a more pluralistic notion of neuroscience when it comes to the brain-behavior relationship: behavioral work provides understanding, whereas neural interventions test causality." Lead author John Krakauer notes, "People think technology + big data + machine learning = science. And it’s not." One example is mirror neurons, "the most hyped concept in neuroscience," in which "interpretation is being mistaken for result." Read the study, published in Neuron, here.
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.