A remarkable new “sting” of the “diet research-media complex” was just revealed. It tells us little we didn’t already know and has potentially caused a fair amount of damage, spread across millions of people. It does, however, offer an opportunity to explore the importance of prospective group review of non-consensual human subjects research—and the limits of IRBs applying the Common Rule in serving that function in contexts like this.
Journalist John Bohannon, two German reporters, a doctor and a statistician recruited 16 German subjects through Facebook into a three-week randomized controlled trial of diet and weight loss. One-third were told to follow a low-carb diet, one-third were told to cut carbs but add 1.5 ounces of dark chocolate (about 230 calories) per day, and one-third served as control subjects and were told to make no changes to their current diet. They were all given questionnaires and blood tests in advance to ensure they didn’t have diabetes, eating disorders, or other conditions that would make the study dangerous for them, and these tests were repeated after the study. They were each paid 150 Euros (~$163) for their trouble.
But it turns out that Bohannon, the good doctor (who had written a book about dietary pseudoscience), and their colleagues were not at all interested in studying diet. Instead, they wanted to show how easy it is for bad science to be published and reported by the media. The design of the diet trial was deliberately poor. It involved only a handful of subjects, had a poor balance of age and of men and women, and so on. But, through the magic of p-hacking, they managed several statistically significant results: eating chocolate accelerates weight loss and leads to healthier cholesterol levels and increased well-being. Continue reading →
On Tuesday, the Supreme Court issued its opinion in Commil USA, LLC v. Cisco Systems, Inc., in which it held that a defendant’s belief that a patent is invalid is not a defense to induced infringement of that patent under 35 U.S.C. § 271(b). Four years ago, in a case called Global-Tech, the Court had held that a defendant could not be liable for induced infringement unless it had knowledge not only of the patent’s existence but also that its behavior constituted patent infringement. In Commil, six Justices clarified that a defendant who has knowledge of a patent’s existence but believes it to be invalid may still be held liable for inducing its infringement. (Justice Scalia dissented and was joined by Chief Justice Roberts, with Justice Breyer recused.)
Commil raises several issues for discussion, but I want to talk about just one here: the majority’s fixation on the distinction between infringement and validity. The key passages of Justice Kennedy’s opinion, on pages 9 through 11, seem to rest heavily on preserving the separation between these two issues. Essentially, as Justice Kennedy puts it, “because infringement and validity are separate issues under the Act, belief regarding validity cannot negate the scienter required under §271(b).” Justice Kennedy is clearly correct as a formal matter. We ask different legal questions when adjudicating issues of infringement and validity, we apply different burdens of proof to the two questions, and we involve different parties in their resolution.
But Justice Kennedy’s opinion ignores the close practical relationship between the two issues. By contrast, scholars and practitioners have long recognized the tension between infringement and validity as instantiated in patent litigation. A patentee wants its patent to be construed broadly, to ensure that the defendant’s invention falls within its bounds. Yet at the same time, the patentee must avoid claiming too broadly, or its patent may be invalidated on precisely those grounds. (Defendants typically advocate the opposite positions.)
The Michigan Supreme Court’s recent decision in Krusac v. Covenant Medical Center, Inc., — N.W.2d —- (Mich. 2015), 2015 WL 1809371, foiled an attempt at establishing an “objective fact” exception to the peer review privilege. An elderly hospital patient allegedly rolled off the operating table, fell on the floor, and died shortly thereafter. As part of the hospital’s peer review procedure, one of the nurses compiled an incident report and submitted it to her superiors. The plaintiff in the ensuing wrongful death action subpoenaed that report. The trial judge ruled that the plaintiff was entitled to see the report’s first page that summarized the facts of the incident. The hospital appealed all the way to Michigan’s Supreme Court to vindicate its rights under the state’s peer review privilege, MCL 333.20175(8) & MCL 333.21515, that extends to “records, data, and knowledge collected for or by individuals or committees assigned a professional review function in a health facility or agency, or an institution of higher education in this state that has colleges of osteopathic and human medicine.” These information items are “confidential, … are not public records, and are not subject to court subpoena.” Continue reading →
Solomon Center for Health Law and Policy Yale Law School
The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.
The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine.
The Executive Director, under the supervision of the Solomon Center faculty director, Professor Abbe Gluck, will be responsible for managing the day-to-day activities of the Center. This will include working with and helping to select student and post-graduate fellows, planning events, including workshops and the annual conference, maintaining the website, building the center’s national reputation, working on grants, supervising scholarship and projects of the center, mentoring health law students, working with the many colleagues, organizations, and interested individuals with whom the Solomon Center collaborates, both within the Law School, across Yale University and outside the University. The Executive Director will be an ambassador of the Center. He/she must be outgoing and a self-starter and will be responsible for building a broad network for the program.
Some specific responsibilities of the Executive Director/ Fellow include the following: Continue reading →
As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Continue reading →
A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:
Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.
Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.
The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?
Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.
However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.
Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214
Scott County, Indiana, which only has a few thousand residents, has historically had an average of five HIV cases per year. Since December 2014, however, the county has seen an outbreak, with more than 140 newly diagnosed cases. Dr. Jonathan Mermin, the director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the Center for Disease Control (CDC) calls this “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Dr. Joan Duwve, the chief medical consultant with the Indiana State Department of Health, explained that the abuse of the prescription drug Opana was one of the catalysts for the increase in HIV cases, with some residents injecting it as frequently as 10 times a day, and sharing syringes with other members of their community.
HIV is mainly spread either by sexual contact with another person with HIV, or by sharing needles or syringes with someone who has HIV. One way to reduce the spread of the disease is to implement syringe exchange programs (SEPs) that reduce the transmission of blood-borne pathogens like HIV by providing free sterile syringes and collecting used syringes from injection-drug users (IDUs).
Last week, the Food and Drug Administration released highly anticipated draft recommendations that would allow gay men to donate blood after one year of celibacy. While an improvement from the current, highly criticized lifetime ban, the new policy, which was announced in December, still caters to fear and stigma rather than science. It should be reconsidered. […]
As members of the Bioethics Society of Rutgers University, we hope to raise general awareness of issues in bioethics within the Rutgers community by method of discussion and publication. Although the beliefs and opinions regarding bioethical issues of this group are not unanimous, we are united by our ardent belief that the student population at Rutgers should be made aware of the implications of biological research, medicine, and other topics of bioethical controversy. In order to bring to light these issues, we are now accepting any papers that fall under the vast umbrella that is bioethics. All papers will be considered for possible publication. Some example subjects are medical treatment, biological warfare, research ethics, medical sociology, social justice, history of medicine/science, medical case analysis, eugenics, gene therapy, human cloning, medical malpractice, and healthcare policy; however, you are not limited to these topics.
The Affordable Care Act is sprawling. Some of its myriad provisions may (or may not!) reduce healthcare costs. Think of accountable care organizations, the hospital readmission reduction program, or even the preventive services mandate. And so, the Act’s success is often evaluated by asking whether it has helped reduce healthcare costs. (See, e.g., David Cutler here.)
Other of the ACA’s provisions are intended to promote financial security in the face of illness. The Act’s most litigated provisions, requiring that people buy insurance, expanding Medicaid, and creating exchanges, can be understood primarily in this light. And so, the Act’s success is also often evaluated by asking whether it has truly promoted financial security. (See today’s New York Times piece from Margoret Sangor-Katz on the subject of underinsurance post-ACA, or Aaron E. Carroll’s take from December.)
A third way of understanding the ACA’s reforms–and evaluating its success or failure–too often gets left out (as it was by the NY Times here): The ACA can perhaps most coherently be thought of as an equal protection statute.
Medical malpractice victims are generally entitled to recover compensation for emotional harm they endure: see, e.g., Alexander v. Scheid, 726 N.E.2d 272, 283–84 (Ind. 2000). But what about a victim’s close family member? Take a person who suffers emotional distress from witnessing a medical mistreatment and the consequent injury or demise of her loved one. Should the court obligate the negligent physician or hospital to compensate that person for her emotional harm?
This question has no uniform answer under our medical malpractice laws. Some states allow victims’ families to recover compensation for their emotional harm, while others do not. Three weeks ago, the Connecticut Supreme Court struck a middle ground between these two extremes. Squeo v. Norwalk Hosp. Ass’n, 316 Conn. 558, — A.3d —- (Conn. 2015). Continue reading →
Remember to submit your 2000 word essay for consideration in the INS Student Essay Contest. The top two submissions will be awarded:
A $250 Michael Patterson Travel Stipend to attend the 2015 INS Annual Meeting in Chicago, IL (Oct 15-16), where there will be special networking opportunities,
One year free INS student membership,
Essay published in the Kopf Carrier (Newsletter of Kopf Instruments) as part of the “Neuroethics in Neuroscience Series” edited by Judy Illes (Director, National Core for Neuroethics, UBC),
Essay fast-tracked for peer-review if it (or a subsequent draft) is subsequently submitted to the American Journal of Bioethics Neuroscience (AJOB-N); separate submission would be required.
Who can apply: All current post-secondary students of any nationality; a student is defined as anyone enrolled in a degree granting program (undergraduate, graduate, or professional) during the 2014-2015 academic year.
Requirements: Essays must be 2000 words or less, written in English, and double spaced. Cover page and essay should be saved as a single file in the format “Surname_INS_Student_Essay_Prize.doc” and emailed to email@example.com with the subject line: “INS Student Essay Prize”. Additional requirements can be found on the INS website.
Selection Criteria: Essays will be judged on originality of argument, rigor of defense, and quality of prose; a short-list will be generated by the Student Essay Prize Judging Committee and the top two selected from the shortlist through forum discussion.
Earlier this spring, the U.S. Department of Health and Human Services and Department of Justice reported they had recovered nearly $28 billion as a result of anti-health care fraud efforts in FY 2014. The federal False Claims Act played a substantial role in achieving these recoveries: the government recovered $2.3 billion in FCA settlements and judgments, and opened nearly 800 new civil health fraud investigations, in FY 2014 alone. Further, the agencies noted that these anti-fraud efforts—bolstered by increased funding and authority under the Affordable Care Act—are continuing to abandon the “pay and chase” method of fraud enforcement, relying instead on prevention and “real-time data analysis.”
This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).
Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading →
June 30, 2015, 8:00 AM – 5:00 PM Wasserstein Hall, Milstein West A
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]
Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.
The full agenda will be announced in the coming weeks. Check backhere for news!
This event is free and open to the public, but seating is limited and registration is required. Register now!