The Medical Innovation Act: Addressing the Shrinking NIH Budget

Senator Elizabeth Warren (D-MA) recently introduced a new bill, the Medical Innovation Act, which would require pharmaceutical companies who settle with the government after committing certain illegal activities to reinvest additional money into the NIH.  Senator Warren views the bill as a “swear jar” for drug companies, seeking to target those who commit certain types of wrongdoing, including violating the anti-kickback statutes or defrauding Medicare and Medicaid, in order to increase government support for research at a time when the NIH’s budget has been falling.  Scholars and researchers who have lamented the shrinking of the NIH’s budget will find much to love in the bill, and they may even wish it had gone farther.

The Medical Innovation Act would be triggered under the following set of circumstances: drug companies (1) who sell at least one drug whose annual net sales exceed $1 billion, (2) where that drug can be traced at least in part to federally funded research (the Act refers to such products as “covered blockbuster drug[s]”), and (3) who enter into a settlement agreement of at least $1 million with the government after committing certain types of wrongdoing, would pay an additional penalty.  As a threshold matter, the Act will not affect companies unless they appear to have broken the law.  But even where companies have committed various forms of wrongdoing, the Act would not affect smaller drug companies, those who developed their drugs without the aid of the federal government, those who engaged in minor wrongdoing (and therefore only have small settlements), or those who take the government to trial rather than settling.

Affected companies would be required to pay an additional fine on top of the value of their settlement, paying 1% of the company’s profits multiplied by the number of covered blockbuster drugs sold by that company each year for five years.  Because the annual profits attributable to these companies are typically very high, even with the Act’s various carve-outs, Senator Warren estimates that if the Act had existed for the past five years, it would’ve provided an additional $6 billion every year to the NIH, a full 20% increase in its budget.  Going forward, this number might be smaller, if some companies respond to the Act’s incentives by committing less wrongdoing (a positive development in itself) or taking the government to trial (a relatively unlikely outcome, but possible in some cases), but the total amount is still likely to be substantial.

Continue reading

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.”

Despite the fact this new move in Thailand is viewed as a success and as an important means to protect Thai women and children born via surrogacy, it remains to be seen whether the law will be implemented, enforced, and successful in achieving its goals. First, “[l]aw enforcement in Thailand is famously lax.”  Commercial surrogacy was supposedly banned by Thailand’s Medical Council in 1997, yet a booming surrogacy industry developed. Second, will the law actually prevent commercial and foreign surrogacy in Thailand, or will it simply cause it to go underground, making is less visible and less regulated, thus increasing the risk of coercive and abusive practices? And third, should Thai surrogates be paid something for their time, efforts, and for undertaking the risks inherent in pregnancy? That is, should surrogacy be solely an altruistic gesture?

The “rule of law,” or “law on the books” is often not enough to impact law in action and social practices.  Merely enacting laws and policies prohibiting commercial surrogacy will not end the practice, as clearly illustrated by Thailand’s history. If the country’s leaders are actually committed to ending the practice, they must take the time and expend the resources to enforce the law and regulate the surrogacy practices still allowed by law.  Nevertheless, even if the law is implanted and enforced, the question remains whether it is wise or whether it will do more harm than good.

Remembering Jacobson v. Massachusetts

By Deborah Cho

In light of the measles outbreaks in California and now in Nevada, many, including myself, have wondered how we’ve come to this point where a completely preventable disease seems to threaten the lives of so many.  While there are recognized legitimate reasons to opt-out of receiving vaccinations, such as for medical and religious reasons, several states allow for opting-out based only on personal beliefs against a scientifically proven fact.  As California suffers from the greatest measles outbreak in this country in over a decade, lawmakers have begun to consider repealing the personal belief exemption.  If repealing the provision proves to be impossible, seeing as how the parents of over 10,000 kindergarteners in California have already chosen to take advantage of the exemption for non-religious reasons, it may be necessary to consider other strategies to encourage a rate of vaccination high enough to maintain herd immunity within our communities.

Jacobson v. Massachusetts was a seminal case in public health law from the early 20th century because it held that the State could mandate vaccinations, or other public health measures, when necessary to protect public health and safety.  The Court recognized some limits to this intrusion of liberty, such as when an individual would suffer harm from the measure or when the individual would be unduly burdened — as in the case of someone with strong religious beliefs against the measure.  Furthermore, the Court articulated some general standards: the measure must have a real and substantial relation to the public health goal and the burden caused must not be disproportionate to the benefit.  The public health measure in Jacobson met these standards — it compelled smallpox vaccination during an outbreak or required payment of a nominal monetary fine for those who refused to comply without a legitimate reason.  As Jacobson had no medical reason to opt-out of receiving the vaccination and had not asked for a religious exemption,  the Court found that he was required to either be vaccinated or to pay the fine.  His skepticism toward the medicine and doubt in the government were not enough.  Jacobson’s reasoning sounds strikingly familiar to the reasoning of many who choose to opt-out today, yet today the science is even more advanced and the benefits of vaccination are even clearer.

Continue reading

Hospital-Based Active Shooter Incidents: Sanctuary Under Fire

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the The Journal of the American Medical Association on active shooter incidents in hospital settings. From the article:

On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.

As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. [...]

The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. [...]

Read the full article here.

Obamacare and States Rights: on the same side of the line this time, in King v. Burwell

By Abbe Gluck

Next week the Court hears a major challenge to Obamacare, King v. Burwell. Readers of this blog know the case has deep importance for health care. But it also is a big case for law. I have previously detailed why the case is the big test for the Court’s current text-oriented statutory-interpretation philosophy known as textualism. Today, in Politico, I explain why the case is also fundamentally about state rights. The question is whether the Court’s many federalism-protecting doctrines–which, let’s not forget, the Court applied against the Government in the last Obamacare case–whether those federalism doctrines, like the Court’s textualist rules, are sufficiently legitimate and objective such they will apply regardless of which side they happen to support, even in a case as politicized as this one. After all, isn’t that the point of having a rule of law in the first place?

Here is an excerpt and a link. Continue reading

Monday 2/23: HLS Health Law Workshop with Robert Truog

HLS Health Law Workshop: Robert Truog

March 2, 2015 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the Presentation: “Defining Death: Getting It Wrong for All the Right Reasons”

Robert D. Truog is Professor of Medical Ethics, Anaesthesiology & Pediatrics at Harvard Medical School and a Senior Associate in Critical Care Medicine at Children’s Hospital Boston. Dr. Truog received his medical degree from the University of California, Los Angeles and is board certified in the practices of pediatrics, anesthesiology, and pediatric critical care medicine. He also holds a Master’s Degree in Philosophy from Brown University and an honorary Master’s of Arts from Harvard University. Dr. Truog’s major administrative roles include Director of Clinical Ethics in the Division of Medical Ethics and the Department of Social Medicine at Harvard Medical School, Director of the Institute for Professionalism and Ethical Practice at Children’s Hospital, and Chair of the Harvard Embryonic Stem Cell Research Oversight Committee (ESCRO). Dr. Truog has published more than 200 articles in bioethics and related disciplines, including recent national guidelines for providing end-of-life care in the Intensive Care Unit. He is Principle Investigator on an R0-1 grant from the NIH to improve end-of-life care in pediatric intensive care units. In his role as Director of the Institute for Professionalism and Ethical Practice, he conducts research and develops educational initiatives related to communication and relational skills. He lectures widely nationally and internationally. His writings on the subject of brain death have been translated into several languages, and in 1997 he provided expert testimony on this subject to the German Parliament. Dr. Truog is an active member of numerous committees and advisory boards, and has received several awards over the years, including The Christopher Grenvik Memorial Award from the Society of Critical Care Medicine for his contributions and leadership in the area of ethics.

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

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

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.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Putting Humpty Dumpty Together Again: Consolidating Regulatory Authority Over Food Safety

By Diana R. H. Winters

[Cross-posted from the Health Affairs Blog]

The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.

Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.

This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.

The President’s Proposal for a Single Food-Safety Agency

The President’s 2016 Budget, released last week, attempts to put the pieces back together and consolidate control over food safety. It proposes a new agency within the Department of Health and Human Services (HHS) that will incorporate the food safety functions of the FDA and the Food Safety and Inspection Service (FSIS) of the USDA.

Continue reading

The Hot Wave of Anti-Abortion Legislation

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

As the majority of state legislatures get back in session, it is clear there will be no dearth of “anti-choice” legislation proposed and considered throughout the country.

In Texas, Representative Matt Krause (R-Fort Worth) is pushing a new law that would provide representation to fetuses in court hearings. This law responds to Marlise Munoz’s case, a brain-dead pregnant woman left on life support for two months because doctors refused to honor her family’s request to remove her from life support. Doctors claimed they were prohibited from doing so because Texas law prohibits withdrawing or withholding life-sustaining treatment from pregnant patients, regardless of their previously-expressed wishes.

South Dakota Representative Isaac Latterell (R-Tea) is sponsoring House Bill 1230, which seeks to ban dilation and evacuation (D and E) procedures sometimes used in second-trimester abortions. The bill uses inflammatory and graphic language (for example, making it illegal to “knowingly behead a living unborn child”), arguably intended to provoke disgust over the procedure to increase support for the bill. HB 1230 includes criminal penalties and physicians violating the law may be charged with a Class 1 felony and face fifty years imprisonment.

Fifty Ohio legislators have introduced House Bill 69, a “fetal heartbeat” law that would outlaw abortion after a heartbeat can be detected. This can occur as early as six weeks gestation, before some women even know they are pregnant. Continue reading

Experts Talk Vaccine Opt-Out Parameters

An article in the Harvard Crimson about our panel “Measles, Vaccines, and Protecting Public Health,” convened on February 25, 2015:

There is a delicate balance between preserving individual rights and protecting public health when it comes to vaccines, experts argued at a panel discussion at Harvard Law School on Wednesday.

In the wake of the recent outbreak of measles in California, the panel emphasized the need for Americans to be more informed in their decisions for or against vaccination. While allowing an opt-out option to remain in place, the panel proposed making the opt-out process for vaccines more difficult. [...]

To read the full article, click here.

What Happens When A Retail Pharmacy Decides To Stop Selling Cigarettes?

A new post by Andrew Sussman 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.

The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.

But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.

Read the full post here.

Worth Reading This Week

By Nicolas Terry

BOOK LAUNCH (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach

Book Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.

Youth Sports at a Crossroads (and Project Play Summit streaming today 2/25)

By: Christine Baugh

Youth sports participation comes with a variety of health and social benefits. The position statement put out by the American Medical Society for Sports Medicine (AMSSM) indicates that over 27 million individuals age 8-17 participate in team sports in the United States, and over 60 million participate in some form of organized athletic activity. These youth and adolescent athletes benefit from  better overall health as well as increased socialization and self-esteem. However, a recent report by the Aspen Institute’s Project Play Initiative indicates that there has been a significant decline in sports participation in recent years.

One factor influencing the decrease in participation may be parental concerns. A recent survey of parents conducted jointly by ESPNw and the Aspen Institute characterized these concerns finding a large percentage of parents were worried about the risk of injury, behavior of coaches, cost, time commitment, and the emphasis on winning over having fun. Concussions and head injuries were the most worrisome injury for parents in this study. Despite this concern, very few parents reported keeping their child from participating in sports due to this risk. The AMSSM position statement characterizes the preoccupation with specialization and competition within sports at such a young age as a risk factor for injury and burnout. Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry

twihl 14x14Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher Radio and Podbean, or search for The Week in Health Law in your favorite podcast app.

This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale

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.

NEXT WEEK (3/4): The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility

The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility

drugs_freebasing_slideWednesday, March 4, 2015
12:00 PM 

Wasserstein Hall, Room 3019
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA 02138

Do criminal penalties have any deterrent effect on drug addicts – people who already are willing to throw away their jobs, relationships, or even lives for their “fix”?  What does brain science tell us about addicts’ capacities to exert self control and to be held criminally responsible?  This panel discussion brings together a leading neuroscientist of addiction, a criminal law scholar, and a former judge to ask whether the law should reconsider aspects of responsibility and punishment in light of new science about self-control.

Panelists:

  • Joshua Buckholtz, Assistant Professor, Harvard University Department of Psychology
  • Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience, Petrie-Flom Center/Center for Law Brain and Behavior, and Associate Professor of Law at the University of Maryland School of Law
  • Judge Nancy Gertner, Senior Lecturer on Law, Harvard Law School

Part of the Project on Law and Applied Neuroscience.