The Ethics of Punking the Diet-Research Media Complex (and Millions of Readers)

ScaleA 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

Faculty Director I. Glenn Cohen: New Blood-Donor Policy, Same Gay Stigma

Faculty Director I. Glenn Cohen has co-authored a new Op-Ed in the New York Times:

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. […]

Read the full article here.

Two Cheers for Corporate Experimentation

Rubin's vase2I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

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

Check out the latest news from the Petrie-Flom Center!

Check out the May 15th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

brain_pain_slide_270_174_85REGISTER NOW!
Visible Solutions: How Neuroimaging Helps Law Re-envision Pain

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.

Agenda

The full agenda will be announced in the coming weeks. Check back here for news!

Registration

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Cosponsored by the Center for Bioethics at Harvard Medical School, and with support from the Oswald DeN. Cammann Fund. 

 For more on news and events at Petrie-Flom, see the full newsletter.

The ACA, The ADA, And Wellness Program Incentives

A new post by Kristen Madison on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Wellness programs have been enthusiastically embraced by employers seeking to promote health and hoping to control costs. On April 20, 2015, program proponents received long awaited news: the Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying how the Americans with Disabilities Act (ADA) would apply to wellness programs. Many large employers likely breathed a sigh of relief upon reading the rule, but the rule is not final and may reignite a longstanding debate over the appropriate use of wellness incentives.

Wellness programs have become common in the workplace. A 2014 Kaiser Family Foundation survey found that among large employers offering health benefits, just over half offered an opportunity to complete a health risk assessment (HRA), a questionnaire that is often a gateway for the provision of health risk information and other wellness program components (Exhibit 12.8 in the Kaiser survey). A similar fraction offered biometric screenings (Exhibit 12.1), such as tests for cholesterol or blood pressure, or measurement of body mass index. Some screening programs test for cotinine, which is associated with nicotine exposure.

Some wellness programs offer financial incentives such as premium adjustments or gift cards. The 2014 survey found that more than half of large employers using HRAs provide incentives for their completion, and more than a third of these incentives equaled or exceeded $500 (Exhibit 12.10). A federally commissioned report prepared by RAND suggests that incentives are effective in increasing HRA completion. […]

Read the full article here.

Bioethicist Art Caplan: A Potential Solution to the Shortage of Solid Organs for Transplantation

A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:

In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.

More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.

However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]

Read the full article here.

Exploring The Significant State-To-State Variation In Marketplace Enrollment

A new post by the Petrie-Flom Center’s Academic Fellow Matthew J. B. Lawrence on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

What role did geography, advertising, community, Navigators, and the controversy surrounding the Affordable Care Act (ACA) play in consumers’ decisions whether to purchase health insurance in the individual marketplaces? The percentage of potential exchange marketplace enrollees who actually made use of the marketplace to purchase insurance varied widely from state to state for 2014 and 2015.

As of February 22, 2015, for example, there were eight states with enrollment at 50 percent or greater and eight states with enrollment at 25 percent or lower. (Per the Kaiser Family Foundation, the top eight were Vermont, Florida, Maine, DC, Delaware, Pennsylvania, New Hampshire, and North Carolina. The bottom eight were Colorado, Ohio, Alaska, Hawaii, North Dakota, Minnesota, South Dakota, and Iowa).

It would be an interesting and challenging task to explain this variation empirically. Generating reliable statistical inferences from inter-state comparisons is notoriously difficult, and the variables at play here range from the easily measured (percent of population eligible for subsidies, navigator grant amounts, number of participating insurers, premiums) to the not-so-easily measured (enthusiasm for Obamacare, efficacy of state or federal outreach efforts, geography, education, availability and usefulness of charity care and emergency Medicaid, functionality of state exchange website, population health, availability of health services). […]

Read the full post here.

Athlete concussion under-reporting and pressure from stakeholders

By: Christine Baugh

As concussions are increasingly seen as a public health problem, under-reporting and under-diagnosis of concussion is recognized as one barrier to improving the safety of sports participation. A number of studies have previously characterized the extent of under-reporting of concussions among athletes, particularly at the collegiate level. Furthermore, existing research has examined the applicability of theories of behavior change to concussion reporting and created relevant frameworks for examination. Although a growing body of evidence suggests that reporting (or not reporting) a concussion is a decision actively made by the athlete weighing relevant factors, the extent to which interpersonal, intrapersonal, environmental, or policy factors influence athletes’ decisions about whether or not to report a concussion is not fully understood.

A recent study, on which I am a co-author, titled “Concussion under-reporting and pressure from coaches, teammates, fans, and parents,” published in Social Science and Medicine aimed to understand one possible contributory factor to athlete under-report of concussion: pressure on athletes from relevant stakeholders. (Abstract available here.) The survey-based study queried a sample of 328 athletes from 19 contact or collision sports teams (notably excluding football and hockey teams) at 4 colleges in the northeast region of the United States. Among other things, the study asked athletes whether they experienced pressure to return to play after a head impact, specifically asking about pressure from coaches, teammates, parents, and fans. Continue reading

No Jab, No Pay: Australia’s Misguided Approach to Vaccine Refusal

Australia’s recently announced “no jab, no pay” policy offers a potent reminder of the all-too-common tendency to penalize vulnerable populations for public health problems. Like many other countries, Australia has experienced a worrisome increase in the number of families deciding not to vaccinate their children.  In response, the government of Prime Minister Tony Abbott has announced a program of carrots and sticks. The carrots include increased payments to physicians to incentivize them to urge families to vaccinate their children. The sticks include tightening the religious exemption (Australia does not provide an exemption for personal belief) and the “no jab, no policy” which will deny families whose children aren’t vaccinated certain income-based childcare and family tax benefits.

Governments have long used the denial of public benefits – traditionally public education – to push parents to vaccinate their children.  Studies have shown that laws conditioning attendance in schools and daycares on vaccination can increase vaccination rates, although the particular formulation of the law (especially how difficult it is to receive an exemption) matters.

To be sure, laws that require children to be vaccinated to attend schools or daycare impose heavier burdens on poor families who are more apt to need daycare and are less able to homeschool their children. Still, these laws reach broadly, especially when they apply to private schools. Homeschooling remains relatively rare. Significantly, school-based vaccine laws do not single out low-income families. Continue reading

Harvard U Effective Altruism presents: Derek Parfit discusses altruistic giving

PArfitFacebook RSVP

When: Tuesday, April 21, 6:00pm Where: Harvard campus, Science Center E

Oxford and Harvard philosopher Derek Parfit is described by Encyclopaedia Britannica as “the most important moral philosopher of the 20th and early 21st centuries”.  The New Yorker called his books “the most important works to be written in the field in more than a century.”  He will be discussing personal identity, future generations, ethics  and Effective Altruism in a fireside chat moderated by ethicist Nir Eyal, Associate Professor of Global Health and Population at the Harvard T.H. Chan School of Public Health.

This event is co-sponsored by Harvard University Effective Altruism (HUEA) and Harvard College Effective Altruism (HCEA), and is open to the public.

Mainstreaming Medical Legal Partnerships (MLPs)

Last week, I had the opportunity to speak at the 10th Annual Summit of the National Center for Medical Legal Partnership in McLean, Virginia. The summit brought together more than 400 people working to “mainstream” medical legal partnerships (MLPs). The theory of change is that through these partnerships, the health care sector can begin to more systematically address social, behavioral and environmental determinants of health. Particularly on behalf of patients who are low-income, legal professionals address root causes of illness by working with utilities companies, landlords, social service agencies and the court system.

Concretely, MLPs are programs in which civil legal aid agencies, health care organizations and public health departments cooperate to train their staffs, treat individuals and identify population level problems. Most often, it is civil legal aid agencies that provide expertise in the laws around housing and public benefits, and spend their resources to ensure access to housing subsidies, food benefits, health insurance and employment. Some law firms also contribute pro bono time to the cause, as do some law schools in the form of clinics.

Continue reading

Highlights from the Consortium of Universities for Global Health Conference: Part III

By Guest Blogger Dan Traficonte 

In this third blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some research from the conference focused on the importance of considering local social practices and belief systems into health policies and interventions.

Faduma Gure, a Master’s student in Interdisciplinary Health Sciences at the University of Ottowa, conducted fieldwork in Somalia to explore awareness of and attitudes to emergency contraception and their implications for health interventions. Somalia’s high fertility rate, high maternal mortality ratio, and low contraceptive prevalence rate coupled with restrictive abortion laws make addressing the lack of family planning services an extreme challenge. In conflict or post-conflict settings like Somalia, emergency contraception can be critical for pregnancy prevention, yet Somalia remains one of the few countries in the world without a registered progestin-only emergency contraceptive pill.

Ms. Gure conducted a qualitative, multi-methods study comprised of structured interviews with key informants, including physicians, non-governmental officials, government officials, local Somali pharmacists, and married and unmarried Somali women. Most participants showed little knowledge of existing family planning methods or emergency contraception, however, once contraception was described, all participants expressed tremendous enthusiasm for expanding access to post-coital contraceptive methods in Somalia. All participants expressed that an available emergency contraceptive would fill a major gap in reproductive health service delivery, and all government officials interviewed indicated that emergency contraception could easily be incorporated into the existing health system.

It is a common belief—and often a misconception—that people in conflict-torn and impoverished countries like Somalia reject modern medical technologies due to conflicting local practices and beliefs. Ms. Gure’s preliminary research indicates that the lack of emergency contraception in Somalia does not result from local beliefs, but from lack of knowledge and access to the technology.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Highlights from the Consortium of Universities for Global Health Conference: Part II

By Guest Blogger Dan Traficonte 

In this second blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some fascinating new research on the relationship between global poverty and population health.

Dr. Joseph Dieleman from the Institute for Health Metrics and Evaluation at the University of Washington presented his research on national poverty rates of 129 countries and their effect on mortality. Typically in the global health literature, a country’s wealth serves as a predictor of population health outcomes—that is, wealth means health. However, the relationship between poverty and health outcomes has not been systematically evaluated in cross-country studies because of insufficient data. Dr. Dieleman sought to address this relationship and show how poverty can explain variation in health using 22 complete poverty and health data series.

Building on the World Bank’s International Comparison Program dataset of 800+ household surveys, Dr. Dieleman used covariates and intertemporal trends to generate a complete data series for 129 countries for 1990-2013. To predict national poverty rates at 51 different income thresholds, 20 variants of three models were supported by out-of-sample validation to choose the best model. Finally, Dr. Dieleman incorporated health data into his model using fixed-effects linear regression techniques to test how national poverty rates are associated with changes in adult and child mortality. Continue reading

Highlights from the Consortium of Universities for Global Health Conference: Part I

By Guest Blogger Dan Traficonte

Recently, the Petrie-Flom Center sent me to the 6th Annual Consortium of Universities for Global Health Conference in downtown Boston, where students, researchers and health professionals from around the world gathered to network and share ideas. The conference’s focus covered a broad range of pressing global health issues, including the Ebola crisis of 2014, food security, and the impact of climate change on the health of populations worldwide. I was able to meet and chat with many people doing fascinating work in the global health field, and I will highlight here a few of the most interesting presentations linked directly to issues of law, governance, and health policy.

Dr. Pooja Agrawal from the Yale School of Medicine presented her research on the impact of the Affordable Care Act on health insurance access, coverage, and costs for refugees resettled in the United States. Dr. Agrawal’s research sought to assess the relationship between refugee resettlement patterns and improvements to health insurance access created by the ACA—specifically, are refugees in the United States generally able to benefit from the enactment of Medicaid expansion and implementation of healthcare insurance exchanges?

Using a cross-sectional analysis of 2012 refugee resettlement data from all 50 states, Dr. Agrawal compared resettlement trends for states that have expanded Medicaid and implemented exchange schemes and those states that have not. The results of this analysis indicate that in 2012, more refugees were resettled to states that have not expanded Medicaid or created state health insurance exchanges. Though there is currently no data on the effect of these differences on refugee health outcomes, these results implicate important policy concerns: specifically, the architects of refugee resettlement policies may choose to consider between-state variation in access to insurance as a result of the ACA in devising resettlement strategies. Dr. Agrawal’s research highlights an often-underemphasized area of intersection of law and social policy, and calls for more research on the impact of the ACA on refugee populations in the United States.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Making Connections & Collaborating for the Future of Public Health

As part of the Public Health Law Research program’s participation in National Public Health Week 2015, we have been sharing materials and resources under the daily themes. Today’s theme, Building Broader Connections, is about expanding partnerships and making connections to benefit public health.

We spoke with Laura Hitchcock, JD, Policy Research & Development Specialist for Public Health – Seattle & King County and the King County Executive/Department of Executive Services Partnerships Initiative Lead. We asked her to offer some insight from her work as a lawyer and researcher in a public health department.

PHLR: What role can researchers play in building partnerships with health departments and contributing to the policy-making discussion?

Laura Hitchcock, JD

Laura Hitchcock, JD

LH: Public health researchers can help to support development and refinement of evidence-based policies. Because policies are created in a political process, it is important for public health departments to continue to offer their scientific knowledge to support creation of effective policies, including repeal of ineffective policies or refinement of existing policies to better result in a healthy population by 2030. Health departments may need help to define local or state-focused areas for policy evaluation by working together with researchers, and should contribute to development of research agendas by identifying areas where policy makers, communities, medical professionals and others have concerns about the public’s health, and are likely to need support from researchers to know how to ‘plug in’ to research agenda development. Continue reading

Hopkins faces $1B lawsuit over role in government study that gave subjects STDs

The Petrie-Flom Center’s Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen weigh in on the issue in the

Nearly 800 former research subjects and their families filed a billion-dollar lawsuit Wednesday against the Johns Hopkins University, blaming the institution for its role in 1940s government experiments in Guatemala that infected hundreds with syphilis, gonorrhea and other sexually transmitted diseases. […]

Legal experts said the lawsuit’s arguments could be a stretch. Today, professors who frequently serve on a volunteer basis with the National Institutes of Health, for example, are generally considered to be acting independently and not in their capacity as university faculty, said Holly Fernandez Lynch, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard University Law School.

[…] Because the experiments occurred so long ago, most if not all of the subjects are dead, and it could be difficult for someone to prove that a relative was part of the study, Lynch said. She and colleague I. Glenn Cohen, a professor at Harvard Law School, argued in a 2012 New York Times opinion piece that the Tuskegee experiment and others provide precedent for a fair recourse.

In the Tuskegee case, a legal settlement included lifetime medical benefits for study subjects and their wives, widows and children, as well as federal grants to promote research and health care ethics, they said. U.S. aid applied directly to Guatemalan health could be appropriate in this case, Lynch said.

“Congress and the [Obama] administration must step up more than they have, by offering financial restitution to Guatemalans with plausible claims of harm,” Lynch and Cohen wrote. “Even if the lawsuits were appropriately dismissed, justice has not been done.”

Continue reading

New browser app shines light on conflicts of interest

By: Christine Baugh

A new Google Chrome extension puts the spotlight on conflicts of interest. The browser app, available for free download here, was created at the Hacking iCorruption hackathon event held March 27-29 in Cambridge, MA. The event, co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University and the MIT Center for Civic Media (hosted at the MIT Media Lab) brought together individuals with a variety of backgrounds and skills to work toward the common mission of fighting institutional corruption, in this case by creating practical tools. This project was one of several exciting tools created at the hackathon (information about other projects available here), and it won first prize among the projects.

The Chrome extension, called Unearth, puts funding and conflict of interest information on the abstract page of PubMed research articles. Christopher Robertson, Associate Professor of Law at the University of Arizona James E. Rodgers College of Law and Edmond J. Safra Center Fellow who was a member of the Unearth team, explains the rationale for the browser extension in this Youtube video. In short, conflict of interest and funding disclosures are often placed at the end of a research article and are generally unavailable on the abstract page. This makes it impractical for physicians and other research scientists to pay appropriate attention to this important information. Research from the Cochrane Collaboration has demonstrated that research studies funded by industry generally describe “greater benefits and fewer harmful side effects” than their non-industry funded counterparts. Thus, taking the source of research funding into account when reading a new research study is critical. Although the extension currently only works for open access articles from PubMed Central, this includes several million research articles for which funding and conflict of interest information was previously much more difficult to obtain. Additionally, the developers plan on expanding the breadth of coverage in the coming weeks. Continue reading

Is concussion protection in Florida too much, too soon?

Today’s New York Times featured a long exploration of “Headgear Rule for Girls’ Lacrosse Ignites Outcry.” As a former lacrosse player and health policy researcher, I read the piece with interest.

Essentially what’s happened is that Florida has instituted a headgear rule ahead of the sport’s national governing body. Florida made this decision in advance of this season based on statistics that show that female lacrosse players experience the fifth-highest rate of concussions of any high school athlete. If you’ve ever held a lacrosse ball, this won’t surprise you.

Still, it is not immediately clear what the actual rate of concussions is in Florida. Identifying girls lacrosse as coming in 5th place doesn’t help the reader judge how pervasive the risk really is if we consider that there could be large gaps between the ordinal rankings. Florida officials have suggested that if even one injury is prevented by the introduction of headgear, the rule would be worth it. I’m not sure I’m so risk-averse. Continue reading

Harvard Undergraduate Bioethics Society event: Big Brother Is Watching–Paternalism and Bioethics

 You are invited to the Harvard Undergraduate Bioethics Society 2015 Conference:

“Big Brother Is Watching: Paternalism and Bioethics”

Saturday, March 28th, 3.30-6.30pm, Harvard Hall 104

RSVP Here

Coffee and desserts will be served

A panel discussion and talks by

David Buchanan, PhD

University of Massachusetts, Amherst

Professor and Chair of the Department of Health Promotion & Policy, and Director of the Institute for Global Health

Sarah Conly, PhD

Bowdoin College

Associate Professor of Philosophy

Wendy Mariner, JD MPH LLM

Edward R. Utley Professor of Health Law at Boston University School of Public Health

Professor of Law at Boston University School of Law

Professor of Socio-Medical Sciences at Boston University School of Medicine

Steven Ralston, MD

Harvard Medical School

Associate Professor of Obstetrics, Gynecology and Reproductive Biology

 

REGISTER NOW: ReSourcing Big Data – A Symposium and Collaboration Opportunity (3/23)

From Harvard Catalyst:

REGISTER NOW!

March 23: Symposium
9:00 AM – 5:00 PM
Joseph B. Martin Conference Center
Harvard Medical School

Extant data is an inexhaustible resource that is not yet very well understood and is underutilized. The focus of this symposium is to explore this area from various perspectives – privacy and security, policy, open clinical trial data, systems and disease-oriented synthetic efforts and individually-provided, aggregated crowd-sourced data. The goal is to engage our biomedical and public health research community in a more nuanced appreciation of these and similar issues.

Topics include: data aggregation, access, annotation, refocusing on novel or unanticipated questions, and recombination with diverse demographic/epidemiologic data. Continue reading