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Alzheimer's Research Uses Innovative Clinical Design, Precision Medicine Tools

September 5, 2018

Recent research has raised hopes that new drugs can help slow or reverse the symptoms of Alzheimer's disease. While promising breakthroughs abound in this arena, what distinguishes the development of one of these drugs, BAN2401, was the clinical trial's "adaptive design." That approach "ensured that when new subjects were recruited, they were more likely to be assigned to arms of the trial that showed the greatest promise," according to the Los Angeles Times. Advocates for adaptive design note it can make clinical trials more flexible, efficient and ethical because it makes effective treatments more readily available to patients. Critics are concerned that such adaptation opens the door to biased studies. To read a recent symposium on challenges to the conduct of high-quality laboratory research, click here. The other promising drug, Anavex 2-73, was developed using precision medicine approaches. "Researchers [focused on studying a small group of] Alzheimer’s patients who bear a few 'actionable genetic variants.'" These variants were identified by genomic sequencing intended to find participants most likely to have a positive response to the drugs. On Nov. 29, the Consortium is co-sponsoring a free, public conference and webcast, "Law, Genomic Medicine & Health Equity" that will discuss some of the implications of precision medicine for traditionally underserved populations; co-sponsors are the Meharry-Vanderbilt Alliance, Vanderbilt Health, and the Minnesota Precision Medicine Collaborative. The event will be held at Meharry Medical College in Nashville, TN; to learn more and register, click here

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FDA Complaint on MN Ketamine Research Conducted Without Patient Consent

July 25, 2018

The advocacy group Public Citizen has filed a complaint with the FDA and Office for Human Research Protections about trials conducted at Hennepin Healthcare (formerly Hennepin County Medical Center), in which paramedics used the sedative ketamine to treat "prehospital agitation." The letter is signed by dozens of bioethicists and medical experts, including Carl Elliott and Leigh Turner of the University of Minnesota Center for Bioethics, a Consortium member. According to reporting in the Washington Post, during the 4-year study "paramedics used either the anesthetic ketamine or a different powerful drug to sedate patients. . . . Patients or caregivers were not asked for permission to participate, and they were informed only later that they had become part of a medical experiment." Previous research, also conducted by Hennepin Healthcare, demonstrated that ketamine frequently causes complications that require patients by intubated. Regarding the recently halted study that was the catalyst for the complaint, Leigh Turner notes, “Even if there’s a case for using these drugs, there’s a case for being very judicious about when to use it.” He also expressed concern about the danger of the study influencing decisions by paramedics: “That’s going to lead to a reduction in the scope of clinical judgment, where EMS doesn’t have the full array of medications. The study is playing a role in which medication people get,” Turner said.

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Thomas Hosley, administered ketamine without his consent

Ketamine Study, Performed Without Patient Consent, Raises Alarms

June 25, 2018

An article in the Minneapolis Star Tribune describes concerns over a program in which paramedics from Hennepin Healthcare administer the sedative ketamine when responding to reports of extremely aggressive or agitated people. The newspaper obtained a draft report that examined the protocol, which was apparently driven by a study "which began last August, requires no consent from patients whose data can be used for research, but gives the subject the option to opt out afterward." The report alleges that in some cases, police encouraged or directed use of the drug. Representatives of Hennepin Healthcare explain that ketamine and and other sedatives "can be a lifesaving tool when paramedics encounter people showing signs of 'excited delirium,' a condition when severe agitation can lead to death." However, "a recent paper published by the hospital [noted that] 57 percent of study patients given ketamine required intubation — inserting a tube in the throat to help deliver oxygen." According to Carl Elliott, who is on the faculty of the Center for Bioethics, a Consortium member, “If I were asked to consent to this study in advance, I would refuse. I would never want to be in this study. And yet they’re describing it to people like it’s so uncontroversial that they can enroll them without even asking them.”

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Bill of Health Symposium Describes How to Improve Reproducibility

May 29, 2018

The Petrie-Flom Center of Harvard Law School has posted a symposium based on last March's national conference on research integrity and trustworthy science. The conference was the third annual all-University research ethics event, and was sponsored by the Office of the Vice President for Research, the Consortium and the Masonic Cancer Center. The symposium is introduced by Consortium Chair Susan M. Wolf and features perspectives by Prof. John P.A. Ioannidis (Stanford University), Prof. Barbara A. Spellman (University of Virginia) and Prof. C.K. Gunsalus (National Center for Professional and Research Ethics - NCPRE & University of Illinois). Videos of plenary talks and all conference sessions are available here

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MobileELSI Explores Ethical Issues in Health Research with Mobile Devices

May 17, 2018

Patient-led medicine, powered by mobile technology like smartphones and wearable fitness trackers, is transforming health research. While these new tools have powerful potential, some of this research is not subject to federal regulations, raising quandaries about how to ensure adherence to independent review, informed consent and privacy standards. A new NIH-funded project, MobileELSIwill develop and disseminate recommendations for the ethical conduct of this emerging research. It's led by Consortium collaborators Mark Rothstein (University of Louisville), Charlisse Caga-anan (National Cancer Institute) and John Wilbanks (Sage Bionetworks); Consortium chair Susan M. Wolf is serving on the Working Group. The Consortium hosted an event, How Patients Are Creating Medicine's Future, in Dec. 2016, featuring four experts in the field; video can be viewed here

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MPMC, Mille Lacs Band Partner to Reduce Lung Cancer Disparities

May 11, 2018

An article in the Brainerd Dispatch describes a new collaboration between members of the Minnesota Precision Medicine Collaborative (MPMC) and the Mille Lacs Band of Ojibwe; together, they will "investigate aspects of lung cancer and nicotine metabolism from commercial tobacco use that may be unique to the American Indian populations in Minnesota." As part of this effort, researchers will conduct two pilot studies, one on the rate of nicotine metabolism in members of the Band and one on a new approach to lung cancer treatment and early detection. Pamala Jacobson, one of the leaders of MPMC, emphasizes the need for researchers to take the time to establish authentic, honorable working relationships within communities affected by health disparities. "For precision medicine approaches to be effective, we have to know how to apply this exciting new science to all populations, not just healthcare systems in metropolitan areas or those serving high income patients," said Jacobson. "Conducting the needed research and implementing precision medicine to benefit the health of American Indians and other minority populations is a priority." In addition to Prof. Jacobson, Consortium chair Susan M. Wolf is also an MPMC leader. To learn more, click here.

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New Symposium on Informed Consent in Research and Genomics

April 25, 2018

The newest issue of the Journal of Law, Medicine & Ethics is a symposium guest edited by Consortium chair Susan M. Wolf, Ellen Wright Clayton and Frances Lawrenz, Principal Investigators on the LawSeqSM project. The title is "The Future of Informed Consent in Research and Translational Medicine;" it was inspired by last year's Consortium-sponsored research ethics conference. Both the conference and the journal issue look back at the evolution of informed consent since the historic Schloendorff case was decided more than 100 years ago. It was in that opinion Justice Benjamin Cardozo declared that a competent adult “has a right to determine what shall be done with his own body” in what is now regarded as the foundational statement of a patient's right to self-determination. Read the entire issue here

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Prof. Wolf Weighs In On New Alzheimer's Research

April 18, 2018

Consortium chair Susan M. Wolf  and Dr. Ronald Petersen (Mayo Clinic) were interviewed yesterday about the practical, ethical and legal implications of new tools for early diagnosis of Alzheimer's disease. The interview was conducted by Kerri Miller of MPR News, and focuses on Dr. Petersen's recently published research, with Prof. Wolf weighing in on the nuances of translating it to clinical practice. Phone calls from people already diagnosed with Alzheimer's and those who have a family history of the disease illuminate the challenges of grappling with this heartbreaking illness. Listen to the entire interview here.

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Carl Elliott

Carl Elliott Awarded Guggenheim Fellowship

April 11, 2018

The John Simon Guggenheim Memorial Foundation has awarded Carl Elliott, MD, PhD, a fellowship in medicine and health. Prof. Elliott is on the faculty of the Center for Bioethics, a Consortium member, and in the Department of Pediatrics; he is also an affiliate faculty member in the Department of Philosophy and the School of Journalism and Mass Communications. During his Guggenheim Fellowship term, Elliott will be working on a book with the tentative title of Lonesome Whistle: Exposing Wrongdoing in Medical Research. Much of Elliott’s scholarship explores philosophical issues surrounding identity, authenticity and justice through the lens of biomedical technology. He is the author or editor of seven previous books, including White Coat, Black Hat: Adventures on the Dark Side of Medicine (Beacon, 2010) and Better than Well: American Medicine Meets the American Dream (Norton, 2003.) His articles have appeared in The New Yorker, The Atlantic Monthly, The London Review of Books, Mother Jones, The New York Times and The New England Journal of Medicine. Guggenheim Fellows are appointed on the basis of prior achievement and exceptional promise; this year, the competition attracted nearly 3,000 applicants. 

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