The “Right to Try” – Compassionate Use of Experimental Medicine, 5th Annual Cathy Shine Lecture

SHINE_headerThe “Right to Try” –  Compassionate Use of Experimental Medicine

5th Annual Cathy Shine Lecture

Thursday, March 19, Noon – 1 p.m.
Boston University Medical Campus Instructional Building
Bakst Auditorium
72 East Concord Street, Boston, MA
Free and open to the public
Reception will follow

Is it fair to use social media or personal connections to get experimental drugs? Is it possible to reconcile so-called “right to try” laws—which allow patients access to novel, unapproved treatments—with evidence-based medicine and a drug-approval process charged with ensuring safe and effective medicines? Professor Caplan examines whether the duty to rescue should play a role in regulatory policies, physician advocacy, and corporate behavior in the US. Continue reading

Bioethicist Art Caplan: Why Are Guns a Taboo Topic on Campaign Trail?

A new piece by contributor Art Caplan on NBC News:

Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.

But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.

Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? [...]

Continue reading here.

Naturopaths — Not What The Doctor Ordered For Vaccine Exemptions

A new piece by contributor Art Caplan in Forbes:

There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.

One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. [...]

Read the full article here.

Thailand Bans Foreign Commercial Surrogacy

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
Guest Blogger

Thailand’s interim parliament recently passed a law prohibiting foreigners from seeking Thai surrogates. The law was proposed and passed in response to several recent scandals and the growing surrogacy industry that has made Thailand one of the top destinations for “fertility tourism.” One of the most publicized controversies was “Gammy’s case,” in which a baby boy born to a Thai surrogate for an Australian man (the baby’s genetic father) and his wife was diagnosed with Down Syndrome. The couple abandoned Gammy but took his healthy twin sister.  The Thai surrogate also claimed the parents asked her to abort both children when she was seven months pregnant.  And in August 2014, authorities discovered that the 24-year old son of a Japanese billionaire had fathered at least a dozen babies by hiring surrogate mothers through Thai clinics.

The law makes commercial surrogacy a crime and bans foreign couples from seeking surrogacy services. The law does not, however, appear to prohibit non-commercial surrogacy among Thai citizens, provided that the surrogate is over twenty-five years old. Violations carry a prison sentence of up to ten years. Wanlop Tankananurak, a member of Thailand’s National Legislative Assembly, hailed the law, stating that it “aims to stop Thai women’s wombs from becoming the world’s womb.” Continue reading

NEW DATE (3/9): Gender (Re)assignment: Legal, Ethical, and Conceptual Issues

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Monday, March 9, 2015 12:00 PM

Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

TOMORROW: Patients with Passports: Medical Tourism, Law, and Ethics

Cohen_Medical_Tourism_slidePatients with Passports: Medical Tourism, Law, and Ethics
I. Glenn Cohen and Dr. Robert Klitzman

Tuesday, February 24, 5:30 – 7:00 PM ET

Carnegie Council for Ethics in International Affairs

Merrill House 170 East 64th Street, New York, NY 10065-7478

Live Video Stream HERE

 

Medical tourism is a growing, multi-billion dollar industry involving millions of patients who travel abroad each year to get health care.

Some seek services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments.

How safe are these procedures? How do you ensure that you will be protected if anything should happen?

I. Glenn Cohen is professor of law at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. He is the author of Patients with Passports: Medical Tourism, Law, and Ethics.

Dr. Robert Klitzman will lead the conversation. He is a professor of psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health and the director of the Masters of Bioethics Program at Columbia University.

This event is part of Carnegie Council’s Global Health Series.

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

PFC_Banner_DrkBlueCheck out the February 20th 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:

child_pediatrician_slide_270_200_85_c1FREE REGISTRATION!
Families Matter: Ethically, Legally, and Clinically

March 18 – 20, 2015
Harvard Medical School
Boston, MA

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter. Continue reading

Problems with fMRI as a tool of lie detection

by Zachary Shapiro

Functional magnetic resonance imaging (fMRI) evidence of lie detection has, appropriately, faced difficulty gaining evidentiary acceptance in criminal courts. While a comprehensive discussion of the case law is beyond the scope of this post, it is important to note that courts have repeatedly refused to admit such evidence, both under a Daubert test, using Federal Rule of Evidence (FRE) 702, as well as under FRE 403.

Under Daubert, which governs the admissibility of expert testimony, courts have found that fMRI lie detection falls short in meeting the necessary standards, including the identification of error rates and maintenance of uniform testing standards. Courts have also pointed out that the motivation to lie may be different in research v. real-world settings.[1] In a laboratory experiment, one can assume that the participant is complying with investigator directions. However, if the scan is to be used in the courtroom, the subject will have a personal interest in the outcome, and may try to employ counter measures, or disregard instructions, in order to “fool” the scanner. Recent research shows that this task may not be hard, at least not for those who know how to effectively “trick” the scanner.

Judges have highlighted that while there are peer-reviewed studies of fMRI lie detection, said studies have very small patient bases (all N<60), and included a range of participants who were not representative of the general population. Courts recognize that neuroimaging, for the purposes of lie detection, is still not generally accepted by the scientific community.[2] Both of these factors limit the applicability of the results to the general population, and to any individual defendant in particular.

Continue reading

Dying: Closing the Gap between What We Know & What We Do

By Susan M. Wolf, JD (University of Minnesota), Nancy Berlinger, PhD (The Hastings Center), and Bruce Jennings, MA (Center for Humans and Nature)

Time is running out on fixing the way we die. As readers of this blog know, the courts first declared a right to refuse unwanted life-sustaining treatment in the 1976 Quinlan case. Nearly 4 decades later, too many people are still burdened with treatments they don’t want, can’t get support for care at home, and are dying without good relief of pain and suffering. So it was no surprise that the highest court in Canada finally threw in the towel. In its Feb. 6 opinion in Carter v. Canada, the court found people still “suffering intolerably as a result of a grievous and irremediable medical condition.” The court thus recognized a right to physician aid in dying. Canada now has a year to set up a system that will permit the practice while protecting the vulnerable from abuse.

Regardless of your views on physician aid in dying, too large a gap remains between what we know is high-quality care at the end of life and what we actually do to care for dying people. The Feb. 12 issue of the New England Journal of Medicine included four articles on the problem, including our analysis of “Forty Years of Work on End-of-Life Care: From Patients’ Rights to Systemic Reform.”  Continue reading

Unexpected Channels of Patient Misinformation

by Vadim Shteyler

As a medical student on the wards, physicians often recounted stories of horrifying acts of paternalism from the days of their training. Though paternalism is far from abolished, the progress we have made as a profession has become a source of some pride. On the wards, autonomy has become exalted as a sacred right and invoking paternalism can end most debates. Though autonomy is a complicated and frequently debated concept, most agree that the cultural shift is a step in the right direction. And though perhaps we should be proud of our steps towards protecting the way patients receive information in clinic, we should be more aware of other sources of patient information as well.

Of course, it may not come as a surprise that a lot of the medical information available to patients is less than accurate. With the Internet, ubiquitous misinformation about anything should be expected. However, when we think about the sources of that misinformation we often think about random websites found during quick Google searches, Wikipedia, sensationalized media coverage, and pharmaceutical advertisements (the later will be discussed further below). A few recent studies are bringing attention to more surprising culprits: Hospitals and Academic Institutions. Continue reading

AGENDA NOW AVAILABLE! 2015 Annual Conference: Law, Religion, and Health in America

2015 Annual Conference – Law, Religion, and Health in America

stethoscope_bible_slideMay 8 – 9, 2015

Milstein East BC
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA 02138 [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, and anticipated edited volume, will aim to: (1) identify the various ways in which law intersects with religion and health care in the United States; (2) understand the role of law in creating or mediating conflict between religion and health care; and (3) explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.

Special sessions include:

  • Thursday, May 7, pre-conference session on the Supreme Court’s Hobby Lobby decision
  • Friday, May 8, Keynote: Douglas Laycock, University of Virginia School of Law - Religious Liberty, Health Care, and the Culture Wars
  • Saturday, May 9, Plenary Session: Adèle Keim, The Becket Fund for Religious Liberty, and Gregory Lipper, Americans United for Separation of Church and State – The Contraceptives Coverage Mandate Litigation

 A full agenda is now available on our website

The conference is free and open to the public, but space is limited and registration is required. REGISTER ONLINE.

Pre-conference session co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb Initiative on Religious Freedom and Its Implications at the Harvard Kennedy School Center for American Political Studies.

The full conference is supported by the Oswald DeN. Cammann Fund.

EVENT NEXT WEEK (2/25): Measles, Vaccines, and Protecting Public Health

15.02.25, measles posterMeasles, Vaccines, and Protecting Public Health

Wednesday, February 25, 2015, 4:00 PM 

Wasserstein Hall, Room 1010 Harvard Law School 1585 Massachusetts Ave., Cambridge, MA

The recent measles outbreak centered around Disneyland in California has reignited the contentious debate over childhood vaccination in the United States. Join us for a discussion of the ethical, legal, and public health issues surrounding vaccines, including mandates, exemptions, parental rights, and the role of misinformation in modern medicine.

Panelists:

  • George Annas, Boston University School of Public Health, School of Medicine, and School of Law
  • Nir Eyal, Harvard Medical School
  • Dyann Wirth, Harvard School of Public Health
  • Moderator: Ahmed Ragab, Harvard Divinity School

This event is free and open to the public. Refreshments will be served.

Tomorrow (2/12): A Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

MorseA Dialogue on Agency, Responsibility, and the Brain with Stephen Morse

Thursday, February 12, 2015, 12:00 PM

Wasserstein Hall, 3019                       Harvard Law School                                       1585 Massachusetts Avenue                     Cambridge, MA 02138 [Map]

Join guest speaker Professor Stephen J. Morse, JD, PhD, former MacArthur Foundation Law & Neuroscience Project co-Chair and co-Director of the Center for Neuroscience and Society and CLBB Faculty members Judge Nancy A. Gertner and Professor Amanda C. Pustilnik for a conversation about how – or whether – new knowledge about the brain is changing legal concepts of agency and responsibility.

Stephen J. Morse is the Ferdinand Wakeman Hubbell Professor of Law; Professor of Psychology and Law in Psychiatry; and Associate Director, Center for Neuroscience & Society at the University of Pennsylvania. Morse works on problems of individual responsibility and agency. Morse was Co-Director of the MacArthur Foundation Law and Neuroscience Project. Morse is a Diplomate in Forensic Psychology of the American Board of Professional Psychology; a past president of Division 41 of the American Psychological Association; a recipient of the American Academy of Forensic Psychology’s Distinguished Contribution Award; a member of the MacArthur Foundation Research Network on Mental Health and Law; and a trustee of the Bazelon Center for Mental Health Law.

This event is free and open to the public. Lunch will be provided.

Part of the Project on Law and Applied Neuroscience.

CANCELED: Gender (Re)assignment: Legal, Ethical, and Conceptual Issues – TO BE RESCHEDULED

Update: Monday, February 9, 2015, 8:15pm: Due to severe winter weather Harvard Law School is closed on Tuesday, February 10. This event is canceled, but will be rescheduled for a later date. Check back here or sign up for our newsletter for updates!

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

Minnesota Takes Further Steps to Protect Pregnant Inmates

Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
Guest Blogger

A legislative advisory committee is set to present an amended bill to the Minnesota State Legislature this session that raises the standard of care provided to incarcerated pregnant women in Minnesota prisons.

The amendment seeks to clarify language of a law passed on May 8, 2014 seeking to ensure incarcerated pregnant women receive the same standard of care they would receive outside a correctional facility.  The Minnesota Senate and House unanimously passed the bill, which was described as “a first step toward providing a healthy start in life for the babies born to the estimate 4,200 women per year in [Minnesota] who are pregnant at the time of their arrest.”  It was the first law to consider the unique needs of pregnant inmates. Continue reading

The Great Vaccination Debate Rages On: Is There Any Solution?

By: Allison M. Whelan, Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law, Guest Blogger

For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines.  Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris Christie, are also wading back into the debate.

Most recently, five babies who attend a suburban Chicago daycare center were diagnosed with the measles. As a result, anyone in contact with these infants who has not received the MMR (measles, mumps, rubella) vaccine must remain home, essentially quarantined, for the next twenty-one days—the incubation period for measles. All five of these infants were under the age of one and therefore did not yet have the chance to receive the vaccination, which is not administered until one year of age.

The Chicago outbreak is a prime example of why public health officials emphasize the reliance on herd immunity to protect those who are not yet, or cannot be, vaccinated for legitimate reasons. Unfortunately, the United States has reached a period where it can no longer place much reliance on herd immunity, particularly as more parents decide not to vaccinate their children against very contagious, yet highly preventable diseases. Illness and death are two of life’s certainties, but why should they be given that they are preventable in this situation?  What are the strongest, most rational arguments in this debate? What policy solutions should states consider?  Several options have been proposed over the years, some more feasible and likely than others. Continue reading