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

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

Check out the May 28th 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:

NEW EVENT!

glassesofwine_slidePetrie-Flom / Center for Bioethics Reception at ASLME 38th Annual Health Law Professors Conference

June 4, 2015 7:30 – 9:30 PM
Hilton St. Louis at the Ballpark
1 South Broadway, St. Louis, MO

Come learn more about the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School at this jointly-hosted dessert reception at the 2015 annual ASLME Health Law Professors Conference.

We hope to see you there!

For more information, please contact Brooke Tempesta at Brooke_Tempesta@hms.harvard.edu.

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

Petrie-Flom is hiring a new postdoctoral fellow in clinical research ethics!

PFC Logo-RGB-Round-Otlns-NewPetrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

Job Description

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants.  The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields.  Illustrative projects include the following: Continue reading

New from Bioethicist Art Caplan: How State Right-To-Try Laws Create False Expectations

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.

Read the full article here.

Neuroethics Seminar Videos Available Online

In case you couldn’t attend in person, be sure to check out the videos from the Neuroethics Seminar series at the Center for Bioethics at Harvard Medical School! Topics include:

  • Hacking the Brain: Neuroenhancement with Noninvasive Brain Stimulation
  • Does Brain-Based Lie Detection Belong in American Courtrooms?
  • Does Brain Difference Affect Legal and Moral Responsibility?

View these videos and more here.

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.

Rutgers Journal of Bioethics: Call for Papers (8/30)

From the Rutgers Journal of Bioethics:

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.

DEADLINE: AUGUST 30, 2015

Continue reading

International Neuroethics Society Student Essay Contest: Deadline 5/20!

Remember to submit your 2000 word essay for consideration in the INS Student Essay Contest.  The top two submissions will be awarded:

  • $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 administrator@neuroethicssociety.org 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.

Deadline: 5 p.m. ET on May 20, 2015

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

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.

TODAY (5/8-9)! Law, Religion, and Health in America: 2015 Annual Conference

2015 Petrie-Flom Center Annual Conference
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

 Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

TODAY! (5/7) After Hobby Lobby: What Is Caesar’s, What Is God’s? Pre-Conference Session

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6 PM.

This event is free and open to the public, but seating is limitedRegister online.

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

Bioethicist Art Caplan: Deep-Fat Fryers in Schools is Business, Not Freedom

A new piece by contributor Art Caplan on NBC News:

How bad is the obesity epidemic among kids in America?

Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.

And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”

The freedom to develop cardiovascular disease?

School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]

Read the full article here.

Bioethicist Art Caplan: Rein It In, Dr. Oz

A new piece by contributor Art Caplan on Medscape [Note: free registration required]:

Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as “America’s Doctor”—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn’t going to happen.

Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn’t much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let’s face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz. […]

Read the full article here.

TWO EVENTS THIS WEEK (5/7-5/9): “After Hobby Lobby: What Is Caesar’s, What Is God’s?” & “Law, Religion, and Health in America”

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6 PM.

This event is free and open to the public, but seating is limitedRegister online!

 Full Conference:
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

 Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

May 7: Identified Versus Statistical Lives – Book Talk & Discussion

Identified Versus Statistical Lives – Book talk and discussion, featuring co-editors I. Glenn Cohen (Faculty Director), Nir Eyal, and Norman Daniels

Cohen_Identified_LivesThursday, May 7, 12:30 – 1:30 PM
Harvard Chan School of Public Health
Building 1, Room 1208
677 Huntington Avenue
Boston, MA  [Map]

The essays in Identified versus Statistical Lives: An Interdisciplinary Approach address the identified lives effect, namely, the greater human proclivity to assist persons and groups identified as at high risk of great harm than ones who will (or already) suffer similar harm, yet remain unidentified. Because of this effect we often allocate resources reactively rather than proactively, prioritizing treatment over prevention. The practical and the ethical questions this raises extend to almost every aspect of human life and health policy. The book discusses the psychology of the identified lives effect, pits thinkers who deem it to reflect an irrational aspect of our thinking against ones who deem it to be rational, and explores practical questions ranging from environmental health to “treatment as prevention” for HIV/AIDS.

Read the front matter of the book online!

Cassandra C. Goes Home – Connecticut Misses an Opportunity

By Jonathan F. Will

On Monday Cassandra C. was sent home from the hospital.  Her cancer is in remission after responding well to treatments.  Many will recall that those treatments were forced on Cassandra against her wishes and those of her mother.   Back in January, the Connecticut Supreme Court issued a two-page order agreeing with state officials that Cassandra, at seventeen years three months, should be compelled to undergo chemotherapy to treat her Hodgkin’s Lymphoma.

The success of this medical treatment may be viewed by some to vindicate the comments of those like bioethicist Art Caplan and Fox News legal analyst Peter Johnson, Jr., who agreed with the decision.  Indeed, Mr. Johnson, after giving a personal anecdote of his own history with Hodgkin’s Disease, declared this decision to be right on the law, right on the ethics, and right on humanity.

Mr. Johnson gave the impression that a minor should never be permitted to make such a medical decision, while Dr. Caplan at least implied that his conclusion might be different if the refusal was based on religious beliefs.  Then you have a commentator in The Economist who came to the exact opposite conclusion.  He expressed concerns about Cassandra’s liberty and the rights of her mother to make decisions on her behalf.

I’m not so easily convinced by their arguments.

Continue reading

Bioethicist Art Caplan: Chinese Scientists Try To Alter Genomes In Human Embryos

A new piece by contributor Art Caplan in Forbes:

Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.

Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]

Read the full article here.

Ethics for CRISPR and the Big Leap Forward

By Kelsey Berry

This week, a research group in China published a paper describing a significant step forward in one application of the genome editing technique CRISPR: they used it to modify the genome of non-viable human embryos. Now, the scientific community finds itself grasping for ethical and legal foundations in order to evaluate the implications of this work and its possible extensions. Bioethicists and philosophers have been laying these foundations for years. Yet, the key problem, as always, is in translation: as we shift from science fiction to scientific reality, the robust and rigorous literature on the ethics of human population enhancement must find its way to usefully inform the policy debate and scientific practice. Translation between these camps can be thorny, but it must start with convergence on the issues at stake. Here’s a quick primer on the issue:

The spark: A team out of Sun Yat-sen University in Guangzhou led by Junjiu Huang used the CRISPR technique in non-viable human embryos to modify the gene responsible for a potentially fatal blood disorder. Leading journals Science and Nature denied the group publication on ethical grounds; the paper can be found in Protein & Cell. This is the first time that the CRISPR technique has been used to modify the human germline; however, the team specifically selected non-viable embryos in which to conduct the experiment in order to side step some of the most pressing ethical concerns.

The technology: CRISPR, which stands for “clustered regularly interspaced short palindromic repeats” refers to DNA loci that contain repeated base sequences, separated by other sequences called spacers. These spacers are like memories from previous exposure to a virus, and they tell the biological system which invaders to look out for and destroy – a key part of an adaptive immune system. In 2012, a team led by Doudna and Charpentier showed that CRISPRs could also be used to zero in on DNA sequences of their choosing simply by introducing synthetic guide RNA that matched the DNA sequence they wished to target. The CRISPR system would then slice up the targeted DNA sequence, either knocking out a gene entirely or allowing researchers to insert a “patch,” which if incorporated into the DNA sequence would modify the target gene. Since 2012 this technique has been shown to work in several organisms, including in human cells.

Continue reading