In one of the more interesting cases I’ve read about recently, a judge in the Northern District of Ohio granted an injunction against Case Western Reserve University, forbidding Case from expelling a medical student (a former classmate of mine) for his failures in professionalism. As a brief summary of the case, a medical student just weeks from graduating from Case was convicted of driving while impaired. He reported the conviction to the residency program he had matched at, and the program then notified Case before the student reported it to the school himself. Case took the position that failing to alert the medical school of the arrest merited expulsion and withholding the medical degree that the student was to receive with distinction the very next month. Although reporting such arrests was not a requirement of graduation, the school believed that he should have reported the arrest and prosecution, particularly in light of the fact that the student had a history of other infractions throughout his time as a medical student. Continue reading
Art Caplan has a new opinion piece on NBCNews on the controversy over the case of Jessie Herald, in which he was offered a plea bargain that involved sterilization for a reduced sentencing. From the piece:
Jessie Lee Herald was facing five years or more in prison after a crash in which police and prosecutors said his 3-year-old son was bloodied but not seriously hurt. But Herald cut a deal. Or more accurately, the state agreed to reduce his sentence if he would agree to be cut. Shenandoah County assistant prosecutor Ilona White said she offered Herald, 27, of Edinburg, Virginia, the opportunity to get a drastically reduced sentence if he would agree to a vasectomy. It may not be immediately clear what a vasectomy has to do with driving dangerously and recklessly. It shouldn’t be. There is no connection.
Read the full article.
By now, most of you have probably heard—perhaps via your Facebook feed itself—that for one week in January of 2012, Facebook altered the algorithms it uses to determine which status updates appeared in the News Feed of 689,003 randomly-selected users (about 1 of every 2500 Facebook users). The results of this study—conducted by Adam Kramer of Facebook, Jamie Guillory of the University of California, San Francisco, and Jeffrey Hancock of Cornell—were just published in the Proceedings of the National Academy of Sciences (PNAS).
Although some have defended the study, most have criticized it as unethical, primarily because the closest that these 689,003 users came to giving voluntary, informed consent to participate was when they—and the rest of us—created a Facebook account and thereby agreed to Facebook’s Data Use Policy, which in its current iteration warns users that Facebook “may use the information we receive about you . . . for internal operations, including troubleshooting, data analysis, testing, research and service improvement.”
Some of the discussion has reflected quite a bit of misunderstanding about the applicability of federal research regulations and IRB review to various kinds of actors, about when informed consent is and isn’t required under those regulations, and about what the study itself entailed. In this post, after going over the details of the study, I explain (more or less in order):
- How the federal regulations define “human subjects research” (HSR)
- Why HSR conducted and funded solely by an entity like Facebook is not subject to the federal regulations
- Why HSR conducted by academics at some institutions (like Cornell and UCSF) may be subject to IRB review, even when that research is not federally funded
- Why involvement in the Facebook study by two academics nevertheless probably did not trigger Cornell’s and UCSF’s requirements of IRB review
- Why an IRB—had one reviewed the study—might plausibly have approved the study with reduced (though not waived) informed consent requirements
- And why we should think twice before holding academics to a higher standard than corporations
Art Caplan, and his coauthor Dorit Rubinstein Reiss, have a guest column over at Daily Kos on the NY bill that would allow adolescents to receive treatment – including preventive treatment like vaccines for HPV – against a sexually transmitted disease without their parents’ or guardians’ knowledge or consent. Take a look.
At first glance, last Thursday’s decisions by the Supreme Court in McCullen v. Coakley and the New York Court of Appeals in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Department of Health and Mental Hygiene, have little in common. McCullen, which struck down a Massachusetts law establishing a 35 foot buffer zone around reproductive health clinics, was a First Amendment case that dealt with the always contentious issue of abortion. In contrast, N.Y. Statewide Coalition, which upheld a lower court decision striking down a regulation of the New York City Board of Health barring the sale of large portions of sugary soda, was decided on state administrative law grounds, with the court finding that the Board exceeded its authority.
On closer inspection, however, the two cases share several features in addition to their date of decision. One is the failure to give substantial weight to the state’s interest in protection health. In his opinion for the Court in McCullen, Chief Justice Roberts accepted that the buffer zone law was content neutral and therefore not subject to strict scrutiny. Nevertheless, a unanimous Court held that the Massachusetts law was not narrowly tailored to serve the government interests of protecting public safety and access to health care. In reaching this decision, the Court focused on the “toll” that the buffer zone placed on the abortion opponents who tried to dissuade woman from having abortion, rather than the impact of the lack of such a zone on woman seeking reproductive health care. Equally important, the Court showed no willingness to defer to the state’s contentions that alternative regulatory approaches had proved unsatisfactory. Rather the Court insisted that given “the vital First Amendment interests at stake, it is not enough for Massachusetts simply to say that other approaches have not worked.”
Ross D. Silverman is joining Bill of Health as a regular contributor.
Silverman is Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI, and holds a secondary appointment as Professor of Public Health Law at the Indiana University Robert H. McKinney School of Law. His research interests include legal, ethical and policy issues in public health and medicine, mobile health law and policy, interdisciplinary curriculum development, professional school admissions, medical humanities, human rights, and patient safety. He serves numerous leadership positions in the field of public health law, including as a mentor in the Robert Wood Johnson Foundation/Georgia State University Future of Public Health Law Education: Faculty Fellowship Program, as a member of the American Public Health Association Action Board, and as past chair of the American Public Health Association Law Section. From 1998-2013, he was faculty at Southern Illinois University Schools of Medicine and Law, where he last held the positions of Professor and Chair of the Department of Medical Humanities and Professor of Psychiatry at SIU School of Medicine, and Professor of Medical Jurisprudence at SIU School of Law. While in Springfield, Illinois, he served as an appointed Commissioner to the Springfield Disabilities Commission, a board member of the Springfield School District Foundation, and as a member of the Memorial Medical Center Human Values and Ethics Committee.
Recent Publications: Continue reading
The proponents of the Affordable Care Act (ACA) tax subsidies law suits (currently pending in both the D.C. and Fourth Circuits and which I have discussed here, here, here, and here) have seized on the Court’s recent decision in Utility Air Regulatory Group v. EPA—going so far as to file letters of supplemental authority with both courts highlighting the case as additional relevant authority for the subsidies suits. We should hope that the courts understand the ACA—and the specifics of the subsidies challenge—well enough to understand how different these cases are. There is also much in Utility Air, not mentioned by the challengers, that supports the Government’s position in the ACA case, and that should resonate with even the most textualist of judges.
The ACA challengers’ filings and blog posts highlight the part of Utility Air in which the Court refused to let EPA “tailor” the Clean Air Act’s explicit pollution thresholds (raising them higher than the statutory allowance because greenhouse gas emissions are much greater than conventional pollutants). They also highlight the Court’s invocation of the so-called “major questions” rule—the presumption that Congress does not delegate decisions to agencies of vast economic and political significance without making that delegation clear.
The subsidies challenges present completely different facts. The issue in those cases is whether a line in the ACA that provides that the subsidies shall be available to individuals enrolled in insurance “through an Exchange established by the State under section 1311,” clearly also excludes individuals enrolled through federally-operated exchanges. The challengers have made this argument because more than half of the states are using federal exchanges and denying the subsidies on those exchanges would be lethal to the ACA’s operation. Both HHS and the IRS have interpreted the statute as providing the subsidies on the insurance exchanges operated by both the state and the federal governments. Their interpretation is based on the fact that numerous other provisions of the statute, as elaborated in the government’s briefings, would be nonsense and superfluous under the challengers’ reading. One of many possible examples is ACA §36B(f), which provides that: Continue reading
Abbe R. Gluck is joining Bill of Health as a regular contributor.
Abbe R. Gluck is a professor at Yale Law School. She joined Yale Law School in 2012, having previously served as an associate professor of law and the Milton Handler Fellow at Columbia Law School since January 2010. She is an expert in Congress and the political process, legislation, federalism, state and local government, civil procedure, and health law. She has extensive experience working as a lawyer in all levels of government. Prior to joining Columbia, Professor Gluck served in the administration of New Jersey Governor Jon Corzine as the special counsel and senior advisor to the New Jersey Attorney General. She also served in the administration of New York City Mayor Michael Bloomberg – as chief of staff and counsel to the Deputy Mayor for Health and Human Services, senior counsel in the New York City Office of Legal Counsel, and deputy special counsel to the New York City Charter Revision Commission. Prior to law school, she worked in the U.S. Senate for Senator Paul S. Sarbanes of Maryland.
Before returning to government work after law school, Professor Gluck was a litigation associate at Paul, Weiss, Rifkind, Wharton & Garrison. She earned B.A. degrees in English and International Studies from Yale University, summa cum laude, where she was editor-in-chief of The Yale Herald, and her J.D. from Yale Law School. Following law school, she clerked for then-Chief Judge Ralph K. Winter on the U.S. Court of Appeals for the Second Circuit, and for U.S. Supreme Court Justice Ruth Bader Ginsburg.Her recent writing has used federalism as lens through which to study both statutory interpretation theory and health law. Most recently, Professor Gluck conducted the most extensive empirical study in history about the realities of the congressional law-making process, the results of which were published in two articles in the Stanford Law Review.
Recent Publications: Continue reading
By Kate Greenwood
Cross-Posted at Health Reform Watch
In a recent, very moving, post about her son’s diagnosis with autism at age eight, blogger Amy Storch writes: “I guess I should mention the obvious — district services for Autism are much more comprehensive than ADHD.” An autism diagnosis should not, as a matter of law, be the key that unlocks needed special education services. Both autism and ADHD “count” as disabilities under the Individuals with Disabilities Education Act (the relevant regulation is here), and the Act provides that a child with either diagnosis who needs special education services is entitled to an educational program “designed to meet their unique needs.” As a matter of fact, though, an autism diagnosis may mean—as it apparently does in Storch’s school district—a more comprehensive program. An autism diagnosis can also be the key to getting necessary services outside of the school setting, through private health insurance.
According to the advocacy group Autism Speaks, 37 states plus the District of Columbia and the United States Virgin Islands have enacted laws requiring state-regulated private health insurance plans to pay for applied behavior analysis and other therapies children with autism often need. As I blogged about previously here, some of these state insurance mandates are relatively broad—New Jersey’s law requires private insurers to cover applied behavior analysis for children with autism, but also to cover occupational, physical, and speech therapy for individuals with “autism or another developmental disability.” Other states’ mandates, however, are strictly limited to children on the autism spectrum. Daniela Caruso of Boston University School of Law writes about Florida’s decision to limit its insurance mandate to children with autism here, attributing it at least in part to advocates’ success persuading legislators to view autism through a “dual frame of beauty and invasion.”
The Patient Protection and Affordable Care Act’s requirement that individual and small group health insurance plans cover ten essential health benefits, and in particular its requirement that plans cover “rehabilitative and habilitative services and devices,” promised to ease access to applied behavior analysis and other therapies often needed by children by autism. Habilitative care is left undefined in the statute, but it is defined at HealthCare.gov as “[h]ealth care services that help you keep, learn, or improve skills and functioning for daily living,” for example “therapy for a child who isn’t walking or talking at the expected age.”
There is a wrinkle, however. Continue reading
YLS is seeking to hire a Senior Fellow in Health Law, who will taken on director-type responsibilities for YLS’s health program, including conference and event development and management, fundraising and policy-paper writing. The fellow will also have the option of devoting some time to either teaching or his/her own scholarship or policy work. The position is available immediately and, although initially a one-year position, may continue longer term if it proves a good fit. Interested applicants should email their CV and references to email@example.com.
Fairbanks School of Public Health and McKinney School of Law, Indiana University, Indianapolis.
This has been a big year for outbreaks of Vaccine-Preventable Illnesses (VPIs) in the United States. While we are only halfway through 2014, there have been more measles cases this year than we have seen since before 2000, when the Federal government officially declared the United States “measles free” (in other words: there are no more domestically-generated measles cases; all of our outbreaks are imported). We’ve also seen large mumps and whooping cough outbreaks. You can follow all the disease outbreak action, both here and worldwide, via the Council on Foreign Relations’ very cool interactive map.
States use their police power authority under the Constitution to try to minimize our risk of exposure to VPIs. First, every state requires that children demonstrate proof of immunization against many VPIs as a condition of entry into schools, preschools and day cares. States also permit exemptions to these laws – every state allows a child who may be medically susceptible to injury from vaccines to receive an exemption (with proper documentation of vulnerability), and most states allow parents to apply for an exemption based on either religious or broader philosophical grounds. A combination of factors, including: a nearly two decade trend of increasing numbers of families obtaining exemptions and clustering in particular communities (or avoiding vaccine requirements by taking advantage of law loopholes, such as if a state’s vaccine law does not cover private schools); waning effectiveness of vaccination protections over time (as has been seen with whooping cough); increased international travel facilitating ready reimportation of VPIs from abroad; and many more immunocompromised individuals living in our communities; have slightly weakened our overall protection against VPI outbreaks. Continue reading
The First Amendment has been repurposed as a powerful deregulatory tool, especially in health care (NEJM on data privacy) and public health (NEJM on smoking). Amy Kapczynski at YLS has put together a timely and powerful conference, Public Health In The Shadow of the First Amendment. October 17-18 in New Haven. Register here.
Register online now!
The application of big data to transform health care delivery, health research, and health policy is underway, and its potential is limitless. The July 2014 issue of Health Affairs, “Using Big Data To Transform Care,” examines this new era for research and patient care from every angle.
You are invited to join Health Affairs Editor-in-Chief Alan Weil on Wednesday, July 9, for an event at the National Press Club, when the issue will be unveiled and authors will present their work. Panels will cover:
- Using Big Data At The Point Of Care
- Research Issues
- The Role Of The Federal Government
- Obstacles/Challenges Of Using Big Data
Among the confirmed speakers are: Continue reading
Thursday, September 18, 2014
Harvard Law School, Wasserstein Hall, Milstein East AB, 1585 Massachusetts Ave.
This event is free and open to the public, but due to limited seating registration is required. Please register online.
Law, policy, and guidance are vague, sometimes conflicting, and generally lacking in concrete solutions for questions regarding post-trial responsibilities. The issues are complex and demand thoughtful discourse to move the clinical trial enterprise towards meaningful solutions. Areas that currently lack clarity include:
- What types of interventions or resources should be included within post-trial responsibilities?
- What is a reasonable duration for post-trial responsibilities to extend?
- What is the mission and purpose of various stakeholders in the conduct of clinical research and how do these roles intersect with post-trial access responsibilities?
This conference will bring together diverse stakeholders to address and develop consensus around some of these questions.
- Melissa M Goldstein & Daniel Bowers, The Patient as Consumer: Empowerment or Commodification? SSRN/JLME
- Carrie H. Colla et al, First National Survey Of ACOs Finds That Physicians Are Playing Strong Leadership And Ownership Roles, Health Affairs
- Young MJ, Scheinberg E, Bursztajn H. Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication, JAMA
- Amitabh Chandra et al, The Economics of Graduate Medical Education, N Engl J Med
Cross post from healthlawprof blog
Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links. The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception. The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.
This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception. Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception. They believe these contraceptives terminate rather than prevent pregnancy. Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.
The cases raise three major issues:
- Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
- Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
- Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?
By Bob Bohrer
Cross-post from Pharmaceutical Policy
There were two stories in The New York Times that, although not directly related, are the basis for today’s post. The first, by Andrew Ross Sorkin, Do Drug Companies Make Drugs, or Money?,appeared in the Business Section on page B1 on June 3, 2014. The second, by Andrew Pollock, New System for Treating Cancer Seen as Hopeful, appeared on the same page of The New York Times on the same day. Sorkin’s provocatively titled article focused on Valeant Pharmaceutical International’s takeover bid for Allergan and on Valeant’s strategy, which Sorkin characterized as buying pharmaceutical companies with revenues produced by active and successful pharmaceutical research programs and then increasing profits by cutting back on R&D. Sorkin’s article, as the title indicated, posited a tension between focusing on rewarding investors with increased profits and investing in the development of new and innovative therapies. My purpose in highlighting Sorkin’s article alongside Pollock’s is not to take issue with Sorkin’s analysis of Valeant’s business strategy, but to respond to the article’s title question. Continue reading
Katherine L. Record, JD, MPH, MA
Shortly after criticizing Massachusetts for incarcerating innocent individuals with substance use disorder (SUD) when drug rehab facilities are full, I received an email from a woman who lost her son to a heroin overdose just four months ago.
“Is preventing an overdose by detaining the SUD sufferer not a better alternative than leaving them to languish?” she asked.
She had found her 24 year-old son cold and blue, just hours after kissing him goodnight. He had been evicted from his sober living home for testing positive for drugs, but his mother did not know he had relapsed when he arrived at her front door. He was, in hindsight, a clear danger to himself – so why did his step-down house let him wander away? Why didn’t anyone call the authorities? Is jail not better than death?
Bob Bohrer is a Professor of Law at California Western School of Law. Having joined the faculty in 1982, Bob was one of the first full-time law teachers in the United States to concentrate on the emerging area of biotechnology law. His research is focused on the way in which drug development is influenced by a number of areas of law, including FDA approval, patent law, insurance and reimbursement, and the First Amendment commercial speech doctrine.
Bob is Chair Elect of the Biolaw Section of the Association of American Law Schools. Continue reading
Harvard Law Today has posted a feature on Cass Sunstein’s keynote address at the 2014 Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy.” Sunstein, who is the Robert Walmsley University Professor at Harvard Law School and the co-author of Nudge: Improving Decisions About Health, Wealth, and Happiness, addressed the opening day of the conference on May 2, 2014, on the subject of “Choosing Not to Choose.”