New BoH Feature: Monthly Round-Up of What to Read on Pharma Law and Policy

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.  We are thrilled to announce that PORTAL (specifically Aaron Kesselheim and Ameet Sarpatwari) will being posting these curated round-ups at Bill of Health each month, with a full posting including abstracts/summaries at their website.

Below are the abstracts/summaries for papers identified from October.  The selections feature topics ranging from the cost-utility of specialty drugs, to the association between financial conflicts of interest and favorable assessments of newer influenza treatments, to the clinical evidence supporting biomarker testing reported in FDA drug labels.  We thank Lara Maggs and Nazleen Khan for their contributions to this review.

  1. Chambers JD, Thorat T, Pyo J, Chenoweth M, Neumann PJ. Despite high costs, specialty drugs may offer value for money comparable to that of traditional drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1751-60.
  2. Chang CQ, Tingle SR, Filipski KK, Khoury MJ, Lam TK, Schully SD, Ioannidis JP. An overview of recommendations and translational milestones for genomic tests in cancer. Genet Med. 2014 Oct 23. [Epub ahead of print]
  3. Dunn AG, Arachi D, Hudgins J, Tsafnat G, Coiera E, Bourgeois FT. Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews. Ann Intern Med. 2014 Oct 7;161(7):513-8.
  4. Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1770-8.
  5. Miladinovic B, Kumar A, Mhaskar R, Djulbegovic B. Benchmarks for detecting ‘breakthroughs’ in clinical trials: empirical assessment of the probability of large treatment effects using kernel density estimation. BMJ Open. 2014 Oct 21;4(10):e005249.
  6. Naci H, Alexander GC. Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy. 2014 Oct;34(10):1005-11.
  7. Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Ensuring patient privacy in data sharing for postapproval research. N Engl J Med. 2014 Oct 23;371(17):1644-9.
  8. Starner CI, Alexander GC, Bowen K, Qiu Y, Wickersham PJ, Gleason PP. Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums. Health Aff (Millwood). 2014 Oct 1;33(10):1761-9.
  9. Wang B, Canestaro WJ, Choudhry NK.Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels.JAMA Intern Med. 2014 Oct 13. [Epub ahead of print]
  10. Woodcock J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov. 2014 Oct 31;13(11):783-4.
  11. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Association of medical students’ reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study. PLoS Med. 2014 Oct 14;11(10):e1001743.

Introducing New Blogger Ameet Sarpatwari

AmeetAmeet Sarpatwari, J.D., Ph.D., is a research fellow at Harvard Medical School and member of the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research] in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Ameet graduated from the University of Virginia, where he was a Jefferson Scholar. He studied epidemiology at the University of Cambridge, receiving an M.Phil. in 2006 and a Ph.D. in 2010. His doctoral work centered on uncovering disease progression, treatment effectiveness, and co-morbid burden among adults patients with primary immune thrombocytopenia—a rare autoimmune disease—through the establishment of a national disease registry. He subsequently studied law at the University of Maryland, with a focus on health law, as a John L. Thomas Leadership Scholar, graduating in 2013.

Ameet’s work has appeared in such top peer-reviewed medical journals as the New England Journal of Medicine, Clinical Pharmacology and Therapeutics, and Blood.  He is the recipient of Robert Wood Johnson Public Health Law Research grant to examine the public health implications of variation in state drug product selection laws. Among other projects, he is also currently assessing the impact of risk evaluation and mitigation strategies on competition and off-label prescribing, and legal and ethical issues surrounding the use of financial incentives to promote physician use of generic drugs.

Welcome, Ameet!

Introducing New Blogger Aaron S. Kesselheim

ASKAaron S. Kesselheim, M.D., J.D., M.P.H. [Twitter: @akesselheim], is an Associate Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). Within the Division, Aaron leads the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research], an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law.

Aaron graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. He is also a Patent Attorney and member of the New York State Bar.

Aaron has received wide recognition for his work, which frequently appears in top peer-reviewed medical journals like the New England Journal of Medicine, JAMA, and Annals of Internal Medicine. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. Aaron has testified before Congress on pharmaceutical policymedical device regulation, and modernizing clinical trials, and served as a consultant for the NIHFDAInstitute of MedicineUSPTO, and numerous state government offices.  In 2010, he received AcademyHealth’s Alice S. Hersh New Investigator Award from AcademyHealth, given annually to an outstanding health services researcher under age 40 in the US.

Aaron also serves as a faculty affiliate for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health.  In the 2014-2015 academic year, he will be a Visiting Associate Professor of Law at Yale Law School, where he will teach Food and Drug Administration Law.

Welcome, Aaron!

Protect Those Who Protect Our Food

Check out a new op-ed by our friends, Jacob E. Gersen and Benjamin I. Sachs at Harvard Law School!

CAMBRIDGE, Mass. — EVERY year, 5.5 million people are sickened by norovirus, a highly contagious gastrointestinal bug. According to the Centers for Disease Control and Prevention, norovirus is the leading cause of food-borne illness in the United States and is spread primarily by “infected food workers.” Last year cooks, waiters and other workers were involved in about 70 percent of the outbreaks.

This is just one example of the critical role that food workers play in our nation’s economic and public health systems. And yet, while we often tailor employment rules for work that has a special impact on the public, the law has yet to recognize food workers as a distinct class — an approach that harms consumers, the economy and the workers themselves.

Sick restaurant workers provide a particularly vivid example of the kind of legal reform that’s needed. Until recently, very few restaurant workers had the legal right to paid sick time, which meant that many of them went to work very ill (last week voters in Massachusetts and three cities passed paid-sick-leave laws). Federal law can fix this problem by requiring employers to provide their workers with paid time off. [...]

To read the full op-ed, please click here.

Health and Wealth

By David Orentlicher
[Cross-posted at Health Law Profs blog]

A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.

Is Pregnancy a “Disability” in the Ebola Epidemic?

By Kelsey Berry

Much of the recent Ebola coverage has brought to the forefront principles of disaster triage and served as a reminder of the inescapability of rationing health care resources. A piece in The New Yorker recently highlighted the plight of pregnant women and their apparent exclusion from standard Ebola wards in Sierra Leone. Professor and Ethicist Nir Eyal at Harvard Medical School was quoted discussing the role of disaster triage guidelines in allocating resources for Ebola in the case of pregnant women.

Pregnant women have long been identified as more vulnerable to viral infections than other healthy adults, due perhaps to immune system changes occurring naturally during pregnancy. This may have accounted for the increased mortality rate among pregnant women during the 2009 H1N1 influenza pandemic in the US (17% in pregnant women vs. 0.02% in the general population), and it may impact Ebola survival rates as well. A smaller 1995 Ebola outbreak in Kikwit, Zaire had a case fatality rate among pregnant women of 93%, and anecdotal accounts from the current epidemic in Sierra Leone state a 100% case fatality rate. Recent figures from West Africa put the case fatality rate in the general population at 70%. These statistics, among other concerns for resource utilization, lead to an ethical dilemma: whether and how to allocate scarce resources to pregnant women in the present ebola epidemic in West Africa.

If the mortality rates from Kikwit are accurate, Dr. Eyal notes that it means that, “what’s needed to justify giving regular priority to a pregnant woman is a willingness to allow six other people to perish to save her.” But, he notes, the permissibility of excluding pregnant women is sensitive to these rates; if they are wrong, than so too may be triaging pregnant women last.  Continue reading

Upcoming Fairness Hearing in NFL Concussion Litigation

By Christine Baugh

On November 19, Judge Anita Brody will hold a fairness hearing in the class action lawsuit of National Football League (NFL) Players v. NFL re: concussion injury. This is one of the final steps toward final approval (or rejection) of the settlement in the case. Before final approval Judge Brody must determine that the settlement is fair, reasonable, and adequate for the over 20,000 retired NFL players who are included in the class. A variety of concerns have been brought forth publicly regarding the proposed settlement, which received preliminary approval from Brody earlier this year. Around 140 retired NFL players filed objections to the proposed settlement and around 200 have opted out of the class. This blog post provides a brief overview of the settlement and objections to it.

Settlement terms (summarized):

  • Monetary Awards for those with a qualifying diagnosis. Award amount is determined based on a sliding scale that factors in diagnosis, age, and years played in the NFL.
  • Baseline Assessment Program. Class members who are Retired NFL Players have the option to participate in a baseline assessment and medical monitoring program.
  • Education Fund will be established to promote safety and injury prevention in football.

The long-form settlement document can be viewed here.

Concerns (summarized, non-exhaustive): 

A variety of concerns regarding the preliminarily approved settlement have been brought forth through the media and other channels. These are the types of issues that will likely be discussed at the fairness hearing and that Judge Brody will have to weigh in her determination of whether the settlement is fair, adequate, and reasonable for the class as a whole.

Many concerns regard the categories of diagnosis that are eligible for compensation.

Compensable categories are too restrictive: Under the current settlement agreement, former players can be compensated if they have a qualifying diagnosis of Alzheimer’s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease), death with chronic traumatic encephalopathy (between January 1, 2006 and July 7, 2014), and what are called Level 2 and Level 1.5 Impairment (these categories represent a pattern of performance on a battery of neurocognitive tests that is 2 or 1.7-1.8 standard deviations below normal, respectively). Some have argued that, although the categories included are important to compensate, there are other prevalent problems such as pituitary dysfunctiondepression, and mood and behavioral disorders that are associated with repetitive head trauma and should also be covered by the settlement agreement. Others are concerned that there are characteristics about the existing categories that are problematic (see next two points below).  Continue reading

European Responses to the Ebola Crisis, Part I: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading

What’s Wrong with Selling Organs (and a Taxonomy of Taboo Trade/Commodification Objections)

By I. Glenn Cohen

Many people – non-philosophers especially, but some philosophers as well – loosely use the term “commodification” as an objection to a “taboo trade”. By “taboo trade” I mean the sale of a good or service such as an organ, sperm, egg, surrogacy, prostitution, etc.

This is unhelpful since it means that people often talk past each other and substitute rhetoric for reason.

In my own work I have tried to disentangle various separate objections falling within this family. This is also important in determining what, if any, form of regulation might help combat or minimize the ethical concern. It is also important because it helps us see that some forms of regulation might improve matters as to one of the ethical objections while at the same time worsen matters as to another one of the ethical objections.

For this blog post I wanted to share my taxonomy of ethical objections drawn from a recent paper I did on objections to buying and selling organs and the potential ways various regulatory tools can and cannot be used to deal with them: Regulating the Organ Market: Normative Foundations for Market Regulation, 77 Law and Contemporary Problems (forthcoming Nov 2014)  In the paper itself it is set out more formally with supporting citations, here I present just excerpts more informally.

While I illustrate the taxonomy of arguments using the buying and selling of organs, in fact the same categories can be used for any taboo trade (prostitution, selling eggs, commercial surrogacy, etc):

1. Corruption

The basic idea behind what I have elsewhere called the “corruption” argument is that allowing a practice to go forward will do violence to or denigrate our views of how goods are properly valued. This argument is sometimes labeled the “commodification” argument, but because that term is also used in a way that encompasses some of the other arguments I discuss below, I prefer the more specific label of “corruption.” The American Medical Association, among others, has voiced this kind of objection in the domestic organ-sale context, suggesting paying kidney donors would “dehumanize society by viewing human beings and their parts as mere commodities.”

We can distinguish two subcategories of this objection, which I have elsewhere called “consequentialist” and “intrinsic” corruption. “Consequentialist corruption” justifies intervention to prevent changes to our attitudes or sensibilities that will occur if the practice is allowed —for example, that we will “regard each other as objects with prices rather than as persons.” This concern is contingent and to be successful must rely on empirical evidence, in that it depends on whether attitudes actually change. By contrast, “intrinsic corruption” is an objection that focuses on the “inherent incompatibility between an object and a mode of valuation.” The wrongfulness of the action is completed at the moment of purchase irrespective of what follows; the intrinsic version of the objection obtains even if the act remains secret or has zero effect on anyone’s attitudes.

2. Crowding Out  Continue reading

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Continue reading

Call for Proposals: The 2016 Brocher Foundation Residencies

By Timo Minssen

I have just been informed that a new call for proposals for the 2016 Brocher Foundation residencies has been launched. I can warmly recommend this splendid opportunity to any researcher or group of researchers in the fields of Bioethics, Medical Anthropology, Health Economics, Health Policy, Health Law, Philosophy of Medicine and Health, Medical Humanities, Social Science Perspectives on Health, Medical Ethics, or History of Medicine.

A grant by the Brocher Foundation enables international researchers to carry out their projects for a 1-4 month period at one of the most beautiful places in Europe. The Brocher Foundation’s seat is located in Switzerland at the shores of the beautiful Lake Geneva. The location is very close to the French border and to international organisations particularly relevant to the health sector, such as WHO, WTO, WIPO, UNHCR, ILO, WMA, ICRC, and others.

The following information has been extracted from the webpage of the Brocher Foundation:  Continue reading

Sloppy Thinking about Genetic Therapy

By David Orentlicher
[Cross-posted at Health Law Profs blog]

As NPR reported this morning, researchers in England may soon use genetic therapy to treat diseases that result from defects in mitochondrial DNA.

Mitochondria create energy for cells, and they have their own genes, distinct from the genes that help determine our looks, behavior, and other traits. Because mitochondrial activity is critical to normal cell functioning, abnormalities in mitochondrial DNA can be devastating. Some babies die in a matter of hours.

But because the therapy involves genetic manipulation, it is controversial. While critics are right to insist that we proceed carefully with genetic therapy, many of their arguments are misguided.  Continue reading

Addressing the Dearth of Data on Fetal Death: The Role of Hospitals*

By Kate Greenwood
[Cross-posted at Health Reform Watch]

As I have blogged about before, including last year here, research and public health interventions aimed at preventing stillbirth are stymied by a dearth of data. In an article in this month’s Maternal and Child Health Journal, Erica Lee and colleagues at New York City’s Bureau of Vital Statistics evaluate data collection by New York City hospitals before and after the city’s implementation, in 2011, of the 2003 United States Standard Report of Fetal Death. The Standard Report aids reporters by setting forth “a series of checkboxes for potentially fatal fetal and maternal conditions.” Unfortunately, Lee’s research reveals a persistent and widespread failure to collect basic information when a baby dies in utero.

In New York City, Lee found, “fetal death reports frequently supplied ‘intrauterine fetal demise’, ‘stillbirth’, or other inadequate terms as causes of death.” As Lee points out, words and phrases like this, which merely describe what happened without assigning a cause to it, do not inform public health research. In many cases, of course, what caused a stillbirth truly is unknown. Prior research suggests that this is true 10-40% of the time. In New York City, though, even after the implementation in 2011 of the Standard Report, the percentage of reports with ill-defined causes of fetal death remained troublingly high, at 61%. There was also substantial variation from hospital to hospital. The hospitals that were the best reporters assigned a specific cause 87% of the time, while the worst assigned a specific cause 0% of the time.

As Lee and her colleagues explain,

“public health research aimed at preventing fetal deaths is substantially limited by the data available, particularly poorly-defined and nonspecific causes of fetal death. These data quality concerns have forced researchers to conduct resource intensive cohort studies and/or time consuming chart audits to fully understand the causes behind fetal deaths rather than relying on the more readily-available and routinely collected fetal death records.”

Lee suggests that the variation that exists between hospitals represents an opportunity for improvement, which leads to the question of what policy levers could be used to bring all hospitals up the level of the top performers.  Continue reading

Father Time… Do Men Also Have Reproductive Clocks?

By Michele Goodwin

For centuries, researchers have studied multiple aspects of women’s reproduction.  Research tells us when women are more likely to become pregnant, when infertility kicks in, and even offers significant insights into the psychological dimensions of pregnancy and mothering from the dopamine release associated with breastfeeding to the potential for postnatal depression to occur after birth.  Perhaps for this reason, lawmakers and courts tend to focus on women’s environment and conduct, during pregnancy, as the space to promote fetal health and well-being with an eye toward healthy child development.

Has anything been missing? Until recently, very limited attention has focused on paternity.  Decades-old studies linking paternity to mental health conditions such as schizophrenia are valuable, but sadly overlooked. And recent research linking older paternity to autism is just beginning to gain attention.  Adding to this discourse and carving out unique pathways for understanding paternity is Professor Wendy Goldberg at the University of California at Irvine. 

In her book, Father Time: The Social Clock and the Timing of Fatherhood, she takes up overlooked phenomenon, involving fathering.  For example, do men experience postnatal depression?  It turns out that they do–and more.  Some expecting-fathers experience neuroticism, and even jealousy.   Goldberg studies different age groups to explain how the “social” clock for dads impacts their relationships with offspring, partners, as well as how it impacts fathers’ mental health.  It adds to an important, growing literature.

HLS Health Law Workshop with Leemore Dafny

HLS Health Law Workshop: Leemore Dafny

November 10, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “More Insurers Lower Premiums: Evidence from Initial Pricing in the Health Insurance Marketplaces” (co-authors, Jonathan Gruber and Christopher Ody)

Leemore Dafny is a Professor of Management and Strategy and the Herman Smith Research Professor in Hospital and Health Services at the Kellogg School of Management at Northwestern University. Her research examines competitive interactions among payers and providers of healthcare services, and the intersection of industry and public policy. Dafny’s work has been published in journals such as the American Economic Review and the New England Journal of Medicine, and featured in The New York Times, BusinessWeek, Bloomberg, and The Washington Post.

Current projects include studies of consolidation in the U.S. hospital industry and the kidney dialysis industry, organizational form of provider practices, copayment coupons for prescription drugs, and the implications of for-profit ownership of insurance companies.

Will the Real Evidence-Based Ebola Policy Please Stand Up? Seven Takeaways From Maine DHHS v. Hickox

By Michelle Meyer

Ebola pic

The case I mentioned in my last post, Maine Department of Health and Human Services v. Kaci Hickox is no more. Hickox and public health officials agreed to stipulate to a final court order imposing on Hickox the terms that the court had imposed on her in an earlier, temporary order. Until Nov. 10, when the 21-day incubation period for Ebola ends, Hickox will submit to “direct active monitoring” and coordinate her travel with Maine public health authorities to ensure that such monitoring occurs uninterrupted. She has since said that she will not venture into town or other public places, although she is free to do so.

In a new post at The Faculty Lounge,* I offer a detailed account of the case, which suggests the following lessons:

  1. As Hickox herself described it, the result of her case is a “compromise,” reflecting neither what Hickox nor what Maine initially wanted.
  2. That compromise was achieved by the parties availing themselves of the legal process, not through Hickox’s civil disobedience.
  3. The compromise is not easily described, as it has been, as a victory of science-based federal policy over fear-based state demagoguery. By the time the parties got to court, and perhaps even before then, what Maine requested was consistent with U.S. CDC Guidance, albeit a strict application of it. What Hickox had initially offered to do, by contrast, fell below even the most relaxed application of those guidelines, although by the time the parties reached court, she had agreed to comply with that minimum.
  4. The compromise applies only to Hickox, and was based on a stipulation by the parties to agree to the terms that the court had temporarily imposed after reviewing a limited evidentiary record. Additional evidence and legal arguments that the state might have raised in the now-cancelled two-day hearing could have resulted in a different outcome.
  5. A substantially different outcome, however, would have been unlikely under Maine’s public health statute. Indeed, it is not clear that Maine’s public health statute allows public health authorities to compel asymptomatic people at-risk of developing Ebola to do anything, including complying with minimum CDC recommendations.
  6. “Quarantine” is a charged, but ambiguous, term. It allows us to talk past one another, to shorthand and needlessly politicize a much-needed debate about appropriate policy, and to miss the fact that the CDC Guidance in some cases recommends what could be fairly described as a “quarantine” for people like Hickox and requires it for asymptomatic people with stronger exposure to Ebola (but who are still probably less likely to get sick than not).
  7. It’s not clear who has bragging rights to Ebola policy “grounded in science,” or what that policy looks like.

* The piece is quite long, and I cannot bear the fight with the WordPress formatting demons that it would require to cross-post it here.

Update: Proposition 46

By Emily Largent

I previously wrote about California Proposition 46–which proposed to raise the cap on pain and suffering awards in malpractice cases from $250,000 to $1.1 million, require doctors to check a statewide database of drug prescriptions before prescribing some narcotics, and require doctors to undergo random drug and alcohol testing–here.

What happened?  On Tuesday, voters “soundly defeated a proposal to lift a decades-old cap on courtroom damages for medical negligence, after a multimillion-dollar political duel pitting trial lawyers against doctors and insurers.”  Proposition 46 was defeated by a 2-to-1 margin, with 67% of voters rejecting it. (There is some speculation that an error in translation for voter materials could have affected the way Vietnamese-speaking voters voted on Tuesday; however, there is no suggestion this would have changed the outcome.)

Proposition 46 was the most expensive race in California this election.  The No side spent close to $60 million in its efforts to see the Proposition defeated, almost seven times the spending on the Yes side.

Bioethics on the Ballot

In addition to the closely-watched senate and gubernatorial candidates, 146 ballot questions were up for vote yesterday in 42 states across the nation. Below is a review of the some of the most pressing bioethics issues on the docket and the latest information on what passed according to Politico’s Ballot TrackerContinue reading

Personhood Measures in the 2014 Election Cycle

By Jonathan F. Will
[Cross-posted at The Conversation]

Citizens of three states had the opportunity to vote on measures considered by many to be adverse to abortion rights during the November 2014 election cycle.  While the personhood efforts in Colorado and North Dakota failed, the Tennessee electorate approved an amendment making clear that their state constitution does not protect a right to abortion, and expressly authorizing the state legislature to regulate abortion services.

Unlike the amendment that passed in Tennessee, the state constitutional amendments proposed in Colorado and North Dakota said nothing explicitly about abortion.  Instead, the measures sought to extend the protections associated with a “right to life” to human beings at all stages of development.  Of course, by extending this aspect of legal personhood to the preborn, abortion necessarily becomes problematic.  But these types of personhood measures have failed in every state to attempt them, including Mississippi, which is considered by many to be the most conservative (and anti-abortion rights) state in the country.  So why are personhood measures failing even while the Tennessee amendment passed?  Continue reading