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.

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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

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

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

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

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.

Doctors Conducting Peer Review Can Recover Compensatory and Punitive Damages for Confidentiality Violations

By Alex Stein

The Supreme Court of New Mexico has recently delivered an important decision protecting peer reviewers’ statutory entitlement to confidentiality. Yedidag v. Roswell Clinic Corp., — P.3d —- (N.M. 2015), 2015 WL 691333. The Court ruled that peer reviewers can sue violators of their confidentiality right and recover compensatory and even punitive damages. This ruling applied the common law criteria for identifying statutory violations as a breach of contract. Based on those criteria, the Court categorized peer reviewers as members of the class protected by the peer review statute, who deserve remedies for violations of their confidentiality right. The Court also estimated that the criminal penalty imposed by the statute on the right’s violators was too lenient to discourage violations. The Court projected that allowing peer reviewers to sue violators will compensate for the resulting shortfall in deterrence. As a conceptual matter, the Court decided that peer reviewers’ confidentiality entitlement is a “mandatory rule of law incorporated into physician-reviewer employment contracts.” Continue reading

UCLA, CREA, and FDA

By Emily Largent

Before law school, I worked as a nurse at Ronald Reagan UCLA Medical Center.  The work was interesting, as was the news.  I was there when the Los Angeles Times published an investigation revealing that Japanese gang figures received liver transplants at UCLA and when the Times reported on UCLA employees illegally viewing medical records of celebrities.

This week, UCLA made headlines once again when officials announced that nearly 180 patients may have been exposed to a potentially deadly superbug from contaminated duodenoscopes.  Seven UCLA patients–two of whom died–were infected with carbapenem-resistant Enterobacteriaceae (CRE) after a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).  CRE are a family of germs that are difficult to treat because they have high levels of antibiotic resistance, and CRE can lead to death in up to 50% of patients who become infected.

This problem is not unique to UCLA.  The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014.  Eleven of those patients died.  From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.

The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing.  Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices.  The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.)  Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.

Some have argued that this did not go far enough.  What other options are available to the FDA?

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In Regulating E-Cigarettes, No Easy Fix For The FDA

A new post by Wendy Parmet 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.

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

Read the full post here.

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.

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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

Going for gold: behavioral science reveals new biases in ACA exchange shopping

A new New England Journal of Medicine commentary by Peter A. Ubel, M.D., David A. Comerford, Ph.D., and Eric Johnson, Ph.D. highlights significant flaws in the way information is presented to insurance shoppers on state and federal exchange websites. The authors present original survey data to support the argument that subtle aspects of current website designs inappropriately bias decision making. The authors make their case most strongly in an analysis of the well-known gold, silver and bronze labels:

Consider the decision to lump health plans into categories with names such as bronze (for low monthly premiums and high out-of-pocket costs) and gold (for higher monthly premiums and lower out-of-pocket costs). These labels could have unintended effects on people’s attitudes toward which plans are best. After all, gold, silver, and bronze convey best, second best, and third best through association with sporting events, but the best plan for one enrollee will be different from the best plan for another.

To test whether such associations might influence people’s perceptions of insurance plans, two of us recruited a convenience sample of participants from public buses in Durham, North Carolina, and asked them which category of plans they would look at first if they were shopping for health insurance. To half the people, we described the gold plans as having higher monthly premiums and lower out-of-pocket costs — the language used by many exchanges. For the other half, we switched the gold and bronze plans, describing the gold plans as having lower monthly premiums and higher out-of-pocket costs.

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The Timeline Approach to Medical Malpractice Defenses

By Alex Stein

California’s Court of Appeal has recently delivered a first-impression decision on the conditions under which a patient’s own negligence can be asserted as a defense against medical malpractice allegations. Harb v. City of Bakersfield, — Cal.Rptr.3d —- (Cal.App. 5th Dist. 2015) 2015 WL 302291.  Among the materials cited by this decision was my article, Toward a Theory of Medical Malpractice, 97 Iowa Law Review 1201 (2012). The court used my “timeline approach” to separate the patient’s pre-treatment negligence, upon which providers of substandard medical care cannot rely, from self-injurious behaviors that occur during and after treatment and that can properly mitigate – and in extreme cases, even eliminate – the legal consequences of medical malpractice. Continue reading

Highlights from the 21st Century Cures Act

At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the 21st Century Cures Initiative, during which the Committee has held numerous roundtables and hearings and issued several white papers.  The first discussion draft of the Act, clocking in at nearly 400 pages (even with several sections “to be supplied”), is incredibly wide-ranging, including proposals that could affect every stage of the innovation process.

The discussion draft should be of interest to everyone in the health policy field.  One series of proposals is targeted at the NIH, including more support for the National Center for Advancing Translational Sciences and for the NIH’s BRAIN initiative.  Another set would act on the FDA, including one provision giving new drugs for unmet medical needs the option of 15 years of exclusivity.  This provision, based on the MODDERN Cures Act, is particularly likely to inspire a great deal of controversy and opposition.  The draft also contains a series of proposals designed to promote the development of new antibiotics, in keeping with President Obama’s recent focus on this issue.  Its attention to the use of social media by drug companies and to the FDA’s regulation of health-related software will be of interest to many, as well.

The proposed draft is much too long to catalog fully in this brief blog post, although those who are interested in a broader summary might enjoy the 13-page summary of the Act put out by the Committee, the Science summary by Kelly Servick and Jocelyn Kaiser, or Alexander Gaffney’s comprehensive Regulatory Explainer.  But I do want to highlight one section of the draft which deserves more attention than it has gotten: section 2021, which would create a national Medical Product Innovation Advisory Commission.

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