Regulation & oversight

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Research Ethics Videos Available

April 19, 2017

Videos are now available for sessions held during the two research ethics conferences presented at the University of Minnesota on March 8 and 9, 2017. At these events, researchers, policymakers, bioethicists, patient advocates and other stakeholders explored best practices for research with human participants. The conferences are The Future of Informed Consent: A Century of Law, Ethics & Innovation (March 8) and The Challenges of Informed Consent in Research with Children, Adolescents & Adults (March 9). The videos are posted at z.umn.edu/researchethicsvideos for free public access.

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FDA Approves Direct-to-Consumer Genetic Tests

April 6, 2017

In a turnaround for the Food and Drug Administration (FDA), the agency has announced it will "allow a company to sell genetic tests for disease risk directly to consumers," according to the New York Times23andMe, a private genomics and biotechnology company based in Mountain View, California, pioneered products to allow customers to learn about their genome without the involvement of a doctor, genetic counselor or other health care professional. There are two levels of test offered; the default will only include the gene variants that could lead to the development of 10 rare conditions such as factor XI deficiency, Gaucher disease type 1 and celiac disease. For the genes associated with illnesses such as Parkinson's and Alzheimer's, there is a separate track that includes access to genetic counselors. An attempt by 23andMe to offer similar direct-to-consumer tests in 2013 was quashed by the FDA because of concerns about how patients might misinterprete potentially bad news without professional guidance. However, according to Dr. Robert C. Green, a Consortium collaborator who has researched the matter, studies since then have "there is some potential for distress, but it is much, much smaller than was anticipated.” Read the entire article here

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Prof. Kingshuk Sinha

Recall of Medical Devices Needs to be More Timely

February 20, 2017

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

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Final Version of Common Rule Announced

January 18, 2017

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

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What Are the Diagnostic Limits of New Technology?

November 18, 2016

"Would you trust an algorithm to help you with a medical diagnosis?" This question is posed by Christina Farr of Fast Company in her discussion of a collaboration between University of California, San Francisco (UCSF) and General Electric with the goal of finding out what Big Data approaches to diagnosis can – and can't – accomplish. The two organizations will be partnering for the next three years to "develop a set of algorithms to help radiologists distinguish between a normal result and one that requires further attention." Knowing the medical community will be skeptical about such machine-learning approaches, not to mention the lack of appropriate regulation for a diagnosis by a non-human, Michael Blum of UCSF notes, "There is a lot of concern from the public and from clinicians that we’ll be developing things to replace doctors. These developments will be focused on supporting clinicians and in developing safer workflows." Read the entire article here

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Medicine capsules

CMS Head Takes Tough Stance on Rising Drug Prices

November 4, 2016

Last night, Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS), addressed the annual Biopharma Congress in Washington, DC. His talk was titled "The Need to Partner on Drug Innovation, Access and Cost." In it, Slavitt addressed what he called "pervasive" cost increases, noting: "Despite all the attention it has generated this year, Mylan’s Epipen is not even on our top 20 list for either high price increases or spending overall in 2015." Rising public outcry and state-level budget crises have led to congressional hearings about the reasons behind spiraling prices; the issue has been especially prominent during the current presidential election. Slavitt cautioned conference attendees, the majority of whom work in the pharmaceutical industry, that he's no longer comfortable defending Big Pharma. He noted that in the past, "I didn’t want this industry to be defined by its worst actors. . . but the more data that’s revealed, the more bad actors you find, and I’m telling you now: it’s too many." What is to be done? According to Modern Healthcare, despite policy positions held by both major-party candidates, significant change is unlikely because of the power of the pharmaceutical industry and ideological divisions in the legislative branch.  

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Nanobot in bloodstream

Chemistry Nobel Prize Goes to Nanotech Scientists

October 5, 2016

Three scientists have been awarded the 2016 Nobel Prize in Chemistry for their work on designing tiny machines "a thousand times thinner than a strand of hair," according to the BBCJean-Pierre Sauvage (Strasbourg University), Fraser Stoddart (Northwestern University) and Bernard Feringa (University of Groningen) will share the prize, which is worth approximately $930,000. Nanotechnology – "the creation of structures on the scale of a nanometer, or a billionth of a meter," as described in the New York Times – could be used to precisely deliver pharmaceuticals within the human body and may lead to entirely new therapeutic approaches. Consortium Chair Susan M. Wolf has led significant efforts, funded by the National Science Foundation and National Institutes of Health, to determine the best way to protect human beings who participate in nanotechnology research. Two major symposia evaluated oversight models using a historical and comparative approach and produced the first systematic, comprehensive recommendations on how to protect human participants in nanotech research. To see all the Consortium's work on nanotechnology, click here

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Drugmakers Use Legislative Strategies to Weaken Opioid Regulation

September 21, 2016

A new, in-depth investigation by the Center for Public Integrity and the Associated Press details the methods by which pharmaceutical companies and their allies weaken and defeat restrictions on opioid access. According to the article, "Deaths linked to addictive drugs like OxyContin, Vicodin and Percocet had increased more than fourfold since 1999, accounting for more fatal overdoses in 2012 than heroin and cocaine combined." Part one of the two-article series describes "a statehouse playbook of delay and defend that includes funding advocacy groups that use the veneer of independence to fight limits on the drugs," a strategy executed by "an annual average of 1,350 lobbyists in legislative hubs from 2006 through 2015." Part two focuses on similar efforts at the federal level, outlining how drug lobbies "reinforced their influence with more than $140 million doled out to political campaigns. That combined spending on lobbying and campaigns amounts to more than 200 times the $4 million spent during the same period by the handful of groups that work for restrictions on painkillers. Meanwhile, opioid sales reached $9.6 billion last year." The spike in opioid deaths has led President Obama to declare Sept. 18-24 Prescription Opioid and Heroin Epidemic Awareness Week and request $1.1 billion in new funding for treatment programs. 

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Creating an Ethical Framework for Artificial Intelligence

September 6, 2016

A new group in the high-tech industry is laying the groundwork for the ethical use of artificial intelligence (AI). An article in the New York Times notes, "While science fiction has focused on the existential threat of A.I. to humans, researchers at Google’s parent company, Alphabet, and those from Amazon, Facebook, IBM and Microsoft have been meeting to discuss more tangible issues, such as the impact of A.I. on jobs, transportation and even warfare." The group is trying to get ahead of government regulation, in hopes self-policing will minimize the need for formal legal or statutory measures. One of the tools they're using is a report out of Stanford University, One Hundred Year Study on Artificial Intelligence, which reassuringly states "Contrary to the more fantastic predictions for AI in the popular press, the Study Panel found no cause for concern that AI is an imminent threat to humankind." 

Lecture

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Drug capsule

A Brief History of TV Drug Ads

August 30, 2016

Direct-to-consumer drug ads have been legal in the US since 1985, but according to the World Health Organization, they really "took off in 1997 when the Food and Drug Administration (FDA) eased up on a rule obliging companies to offer a detailed list of side-effects in their infomercials." A new, short video on Vox.com provides a history of these ads and the regulatory and legal decisions that allow them. Those include the landmark 1976 Supreme Court ruling in Virginia State Pharmacy Board v. Virginia Citizens Consumer Council, which for the first time held that "commercial speech" is protected by the First Amendment. The video shows some of the earliest TV drug ads and outlines empirical research about their effects. The upshot? As annoying and ubiquitous as they are, these ads aren't necessarily bad for us – and in some cases they actually help. View the video here

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Public Invited to Weigh in on Toughest Medical Ethics Decisions

August 24, 2016

In the aftermath of Hurricane Katrina, health care providers at Memorial Medical Center in New Orleans faced a grim choice: in the midst of a crisis, who among their patients should be evacuated to better conditions? For many in the general public, news coverage (and later a book) about what happened at Memorial was the first time they truly became aware of medical rationing. The first article in a new collaboration between the New York Times and Radio Lab, "Playing God," describes an unusual public debate on the subject being led by Dr. Lee Daugherty Biddison and her colleagues at Johns Hopkins Hospital. Dr. Daugherty Biddison is leading a task force that will "make recommendations for [Maryland] state officials that could serve as a national model." She and her team are holding a series of public forums to hear opinions from laypeople on topics like: should a doctor be able to remove one person from a ventilator to give it to another with a better chance of surviving? During cancer drug shortages, how should doctors choose which patients receive them? Should such decisions be randomized, through a lottery, or based on a patient's age or likelihood of survival? Renowned bioethicist Ruth Faden of Johns Hopkins Berman Institute of Bioethics praised the effort, noting “It’s a novel and important attempt to turn extremely complicated core ethical considerations into something people can make sense of and struggle with in ordinary language.”

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Gender card from Nagano winter olympics confirming an athlete is female.

Rio Olympics Raise New Questions About Sex-testing Athletes

August 4, 2016

Controversies about athletes' gender have been part of the Olympic Games since the "Nazi Olympics" in Munich, 1936. That's the year two runners, Stella Walsh of Poland and Helen Stephens of the United States, were rumored to be men because of their "remarkable athleticism, 'male-like' muscles and angular faces," according to the New York Times Magazine. 80 years later, our culture seems to be more aware of the complex nature of gender expression, but woman athletes are still subjected to testing to insure they're sufficiently female. Concerns abound that high levels of testosterone can provide an unfair advantage for women competing against other women. In the current Rio Olympics two runners, Caster Semenya of South Africa and Dutee Chand of India, have been required to undergo "gender verification" and have been subject to unwanted, intrusive media attention as a result. A new article in JAMA reviews the history of gender determination in Olympic sport and discusses the science behind what are termed "disorders of sex development," which can lead to intersex people being raised as a gender that doesn't necessarily match their chromosomes. For this year's games, rules around gender verification have been suspended, so Semenya and Chand will be able to compete. 

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Field of corn

The Unfulfilled Promise of Corn-based Biofuels

July 28, 2016

According to an article in Bloomberg, "More than a decade after conservationists helped persuade Congress to require adding corn-based ethanol and other biofuels to gasoline, some groups regret the resulting agricultural runoff in waterways and conversion of prairies to cropland – improving the odds that lawmakers might seek changes to the program next year." The federal Renewable Fuel Standard (RFS), which led to mass production of corn-based ethanol, has proven to be sadly ineffectual; in fact, groups like the Environmental Defense Fund and the National Wildlife Federation have begun to realize that the use and manufacture of biofuels has had "severe, unintended consequences," partly as a result of the way regulatory regimes were implemented. Despite a political divide between legislators from the Corn Belt and others, a revamped RFS appears to be moving forward in the House of Representatives.  

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Weak Sperm Bank Regulations Cause Havoc for Some Users

July 25, 2016

Because frozen sperm is lightly regulated, some users have had their lives upended because of lost vials, misleading donor descriptions, misappropriation, and careless record keeping. An article in the New York Times describes some of the worse cases, in which women have been inseminated with sperm carrying highly heritable, serious illnesses without their knowledge or consent. Bioethicist Arthur Caplan, PhD (New York University) notes, “Even in New York, when they inspect [sperm banks], they’re looking at hygienic conditions not record-keeping. Nobody confirms that you have what you say you have. It’s absurd that we have these materials so valuable that people pay to store them, but we run it like a 19th-century grocery.” While the official position of the American Society of Reproductive Medicine is that no further regulation is needed, several lawsuits are moving forward, and the Donor Sibling Registry has become an crucial resource for families who used the same donor to connect and share information.  

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Obama Lays Out Next Steps for the Affordable Care Act in JAMA

July 12, 2016

In an article that "is apparently the first by a sitting president to be published by the [Journal of the American Medical Association (JAMA)]" according to NPR, Barack Obama, JD, reviews the effects the Affordable Care Act (ACA) has had since it was passed in 2010. He notes, "Since the Affordable Care Act became law, the uninsured rate has declined by 43%, from 16.0% in 2010 to 9.1% in 2015, primarily because of the law’s reforms." The article goes on to describe remaining "major opportunities to improve the health care system," including offering a government-run insurance plan, the so-called public option, as part of the ACA. While Obama advocates for Congress to revisit the idea of "a public plan to compete alongside private insurers in areas of the country where competition is limited," the public option has been controversial thus far and was dropped from the health law prior to its passage because of fears it represented a step toward fully government-run system.

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LawSeq to Clarify Consent, Standards, Liability in Genomic Medicine

July 6, 2016

An article in GenomeWeb provides a comprehensive overview of the LawSeqSM project, a 3-year, $2 million grant recently awarded to Consortium chair Susan M. Wolf, JD, and two co-PIs, Ellen Wright Clayton, MD, JD (Vanderbilt) and Frances Lawrenz, PhD (University of Minnesota). The methodology will be a "combined approach involving empirical work, analytic research, and negotiation to reach consensus" within the national working group; the effort will also be informed by prior research in the field of genomic medicine by both Wolf and Clayton. The resulting guidelines will inform case law, fill gaps in current regulations and shape those developed in the future. Another important outcome will be "a public-facing website that simply describes in detail the current state of the law in relation to genomics and genome sequencing." 

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