The FDA de-regulates the first genetically-engineered animal

By Joanna Sax

On November 19, 2015, the FDA de-regulated the AquAdvantage Salmon.  This salmon is genetically engineered to grow faster.  This is the first time the FDA has de-regulated a genetically engineered animal.

Let me just say from the outset that the scientific consensus is clear that genetically engineered food is as safe as conventional food.  Despite the onslaught of public outrage against GMO food, most of the main arguments against GMO food are just hype.

The genie came out of the bottle a long time ago and it’s not going back in.  This happens time and again with scientific advances.   Over the past few decades, our ability to understand, manipulate, edit, and otherwise employ the DNA of various organisms to facilitate human understanding has grown exponentially.  Efforts to resist, combat, or villain-ize the application of biotechnology to impact society might delay, but will not ultimately succeed in keeping the application of scientific discoveries at bay.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we welcomed W. Nicholson Price, an Assistant Professor at the University of New Hampshire School of Law with a J.D. and Ph.D. (Biological Sciences) from Columbia University. Nicholson’s work on both IP and health care covers a wide array of important issues and was recently featured in a New York Times article.

Nic led off with a tour de force analysis of the recent LabMD decision by an ALJ at the FTC, challenging apocalyptic post-mortems of the case in light of Wyndham & extant FTC common law. Frank riffed on Tim Jost’s recent Health Affairs post on deductibles and legislative rulemaking and called for a bit more service journalism at the New York Times when it covers health and education finance.

We then discussed black box medicine and the new challenges posed to both health and patent law by opaque predictive analytics. Consider, for instance, the challenge in even describing such practices for “written description” purposes. Nicholson offered a big picture view on the relative value of patent and trade secrecy law in incentivizing innovation here.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Vulnerability, Coercion, and Undue Influence: From the Mud into the Muck?

According to the NPRM, “the only vulnerability that needs to be considered is vulnerability to coercion or undue influence, and not other types of vulnerability.” It therefore replaces all standalone uses of “vulnerable” with “vulnerable to coercion or undue influence.” This change is justified on the basis that it will “provide greater consistency and clarity in IRB consideration of vulnerability of subject populations in research activities and appropriate protections,” where the vulnerable populations in question are “children, prisoners, pregnant women, physically or mentally disabled persons, or economically or educationally disadvantaged persons.”

Two provisions of the Common Rule (§107.a and §111.a.3) currently discuss vulnerability without further specification, whereas one (§111.b) discusses vulnerability to coercion and undue influence. Deleting §111.b’s reference to coercion and undue influence, however, would achieve consistency while making even fewer changes than the NPRM proposes. The proposed revisions, then, rest on improved clarity rather than improved consistency.

I doubt that narrowing vulnerability by adding the terms “coercion” and (in particular) “undue influence” adds much clarity. Rather, these changes may reduce protections against research flaws other than coercion and undue influence without offering counterbalancing advantages for the research enterprise. Continue reading

FDA Releases Report Detailing Problematic Laboratory-Developed Tests

Last week, the FDA issued a report presenting 20 case studies of laboratory-developed tests (LDTs) that have or may have harmed patients, in support of its ongoing efforts to impose greater regulatory oversight on LDTs.  The report came just before yet another House Energy & Commerce Committee hearing on the issue, and the timing of its release may have been motivated in part by questions FDA officials faced at the last Congressional hearing, about the existing evidence of harm to patients.  The report categorizes the 20 case studies into seven groups, organized by the primary problem posed by the LDT: those with a high degree of false positives (the test yields a positive result when the disease is not present), those with a high degree of false negatives (the test yields a negative result when the disease is present), those which yield both false positives and false negatives, those which test for a factor seemingly unrelated to the disease in question, those linked to treatments based on disproven scientific concepts, those which affirmatively undermined the drug approval process, and of course, “other.”

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Monday, 11/23, HLS Health Law Workshop with Amanda Pustilnik

PustilnikHLS Health Law Workshop: Amanda Pustilnik

November 23, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “And If Your Friends Jumped Off a Bridge, Would You Do It Too?”: How Developmental Neuroscience Can Inform Regimes Governing Adolescents (co-authored with Michael N. Tennison)

Amanda C. Pustilnik is an Associate Professor of Law at the University of Maryland School of Law, where she teaches Criminal Law, Evidence, and Law & Neuroscience. Her current research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Prior to joining the University of Maryland, she was a Climenko fellow and lecturer on law at Harvard Law School. Before entering the legal academy, she practiced litigation with Covington & Burling and with Sullivan & Cromwell, where she focused on white collar criminal matters. Prof. Pustilnik also clerked for the Hon. Jose A. Cabranes on the United States Court of Appeals for the Second Circuit. She graduated Yale Law School and Harvard College, and has been a visiting scholar at the University of Cambridge, Emmanuel College, in the History and Philosophy of Science department. Prof. Pustilnik has also worked at McKinsey & Company as a management consultant and is a member of the board of directors of the John Harvard Scholarships. In 2014-2015, Pustilnik was the inaugural Senior Fellow in Law and Neuroscience at the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at MGH and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Introducing NPRM Symposium Blogger Govind Persad

GPersad 8-23-12Govind Persad will contribute to Bill of Health’s symposium on the 2015 notice of proposed rulemaking (NPRM) on human subjects regulations.

Govind is a postdoctoral fellow at Georgetown University and will be an Assistant Professor (beginning 2016) in the Department of Health Policy and Management and Berman Center for Bioethics at Johns Hopkins University. His research is at the intersection of political philosophy, applied ethics, and health law.

Govind has been a visiting scholar at the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He holds a JD/PhD from Stanford, where he was a student fellow at Stanford’s Center on Law and Biosciences; he was a pre-doctoral fellow at the Department of Bioethics, National Institutes of Health.

Representative publications:

Should a patient have a right not to know genetic information about him or herself?

By Benjamin E. Berkman, JD, MPH

While promising to eventually revolutionize medicine, the capacity to cheaply and quickly generate an individual’s entire genome has not been without controversy.  Producing information on this scale seems to violate some of the accepted norms governing how to practice medicine, norms that evolved during the early years of genetic testing when a targeted paradigm dominated.  One of these widely accepted norms was that an individual had a right not to know (“RNTK”) genetic information about him or herself.  Prompted by evolving professional practice guidelines, the RNTK has become a highly controversial topic.  The medical community and bioethicists are actively engaged in a contentious debate about the extent to which individual choice should play a role (if at all) in determining which clinically significant findings are returned.

In a recent paper published in Genetics in Medicine, my coauthors and I provide some data that illuminates this and other issues. Our survey of 800 IRB members and staff about their views on incidental findings demonstrates how malleable views on the RNTK can be.  Respondents were first asked about the RNTK in the abstract: “Do research participants have a right not to know their own genetic information?  In other words, would it be acceptable for them to choose not to receive any GIFs?”  An overwhelming majority (96%) endorsed the right not-to-know.  But when asked about a case where a specific patient has chosen not to receive clinically beneficial incidental findings, only 35% indicated that the individual’s RNTK should definitely be respected, and 28% said that they would probably honor the request not to know.  Interestingly, the percentage of respondents who indicated that they do not support the RNTK increased from 2% at baseline to 26% when presented with the specific case.  The percentage of people who are unsure similarly jumps, from 1% to 11%.

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How broad can consent be?

By Nanibaa’ A. Garrison, Ellen Wright Clayton and Ingrid A. Holm

Based on today’s publication of the paper A systematic literature review of individuals’ perspectives on broad consent and data sharing in the United States in Genetics in Medicine. 

The recent Notice of Proposed Rule Making (NPRM) issued by the Office of Human Research Protections proposes to require researchers to obtain informed consent from virtually every patient and research participant for use of biospecimens for research. The proposed regulations also permit obtaining broad consent for future uses, without any IRB oversight unless individual results are going to be returned so long as an elaborate consent form is signed. The NIH Genomic Data Sharing Policy, which went into effect earlier this year, requires almost all investigators who receive NIH funding to seek broad consent from participants to allow their data to be shared with other investigators. Thus, in a short period of time, two major policies promoted broad consent for biobank research, changes in the practice of recruiting participants for research that make us take notice. They also raise new questions, including: What do research participants think about having their biospecimens and data shared, and about giving broad consent to do so?

Who is comfortable with Broad Consent?
The Electronic Medical Records and Genomics (eMERGE) Network’s Consent, Education, Regulation, and Consultation (CERC) working group set out to find some answers. As a part of this effort, we conducted a systematic review, which revealed that males, whites, older individuals, and more affluent individuals are generally pretty comfortable with broad consent that can be found here. By contrast, Asian and African American individuals are less comfortable with broad consent. Will these different levels of concern create a divide between those who will and will not participate? The consequences of lack of participation are clear – we will know less about how genetic variation in groups that do not take part affects health and less about how to provide optimal care. Continue reading

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Texas, Self-Induced Abortion, and an Ode to Justice Powell

Flickr/Creative Commons—Edson Chilundo

Flickr/Creative Commons—Edson Chilundo

By Gregory M. Lipper

With the Supreme Court ready to review the constitutionality of restrictions on abortion providers in Texas, new research from the Texas Policy Evaluation Project suggests that between 100,000–240,000 Texas women age 18–49 have attempted to terminate a pregnancy on their own (that is, without help from a licensed medical professional). According to the authors, “the populations we found to be most familiar with abortion self-induction are among those that have been most directly affected by the closure of abortion clinics in the state.” As a result, the study predicts, “abortion self-induction will increase as clinic-based care becomes more difficult to access.”

This data reinforces that efforts to ban, restrict, or otherwise interfere with efforts to obtain legal abortion don’t stop abortion—they often push women to obtain abortion by other means that are far more dangerous.

Those consequences, as it turns out, are what led one conservative Supreme Court Justice, Lewis Powell, to support abortion rights. Justice Powell was no right-to-privacy diehard; he infamously cast the deciding vote upholding the Georgia sodomy ban in Bowers v. Hardwick. But when it came to reproductive freedom, Justice Powell joined the majority opinion in Roe v. Wade and continued to support abortion rights while sitting on the Court.

According to Justice Powell’s biographer, an incident from earlier in his career reinforced that if women lacked access to legal abortion, the result would be unsafe, off-the-books procedures:

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Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola

Flickr/Creative Commons—Nicola

by Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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‘The Week in Health Law’ Podcast

By Nicolas Terry

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This week we welcomed back Brietta R. Clark, Associate Dean for Faculty and Professor of Law at Loyola Law School in Los Angeles. Brie is an expert on health care law and inequality.  Her research focuses on the structural defects and biases that create inequity in our health care delivery and financing systems, and the role that law and government regulators play in ensuring equitable access to health care resources.

We began the show with our “lightning round” by discussing a Kentucky Supreme Court case limiting nursing home arbitration agreements in some scenarios. (Interested readers should check out Nic’s prophetic article on malpractice arbitration, and later work citing it.) We briefly mentioned the contraceptive cases granted cert this term, and hope to return to them in a later episode. Continue reading

Identified versus Statistical Lives at the Movies

Imagine you had 10 million dollars to spend to save the life of one person whose name you knew or 10,000 whose name you didn’t? How would you spend it? What would you think of a government policy that chose to save the 1 person rather than the 10,000? I would think pretty badly of such a government, but that’s exactly what happens in some popular new movies. And the expectation of the filmmakers (and my own take on audience reaction) is that the audience cheers.

sq_martianFirst, The Martian (spoiler alert) where America spends tens of millions and diverts the entirety of the space program to bring back one man left behind on Mars. Second, the new movie 33, which I have not seen yet but is based on a true story involving the successful attempt to save 33 Chilean miners trapped in a mine collapse at a huge financial cost. Continue reading

Monday, 11/16, HLS Health Law Workshop with Seema Shah

HLS Health Law Workshop: Seema Shah

November 16, 2015, 5:00 PM
Lewis International Law Center, Room 214A
1557 Massachusetts Ave, Cambridge MA 02138

Download the paper: “Uncertainty and the Eighth Amendment”

Seema Shah is a faculty member in the National Institutes of Health Clinical Center Department of Bioethics and has a joint appointment at the Division of AIDS. Her research focuses on the ethics of international research, the ethics of research with children, and the intersection of law and bioethics. She currently serves as a consultant for the Division of AIDS on its clinical sciences review committee and as an ethics consultant for the Clinical Center.

She earned her bachelor’s and juris doctor degrees from Stanford University. She previously served as a federal law clerk in the Eastern District of California and a predoctoral fellow in the NIH Department of Bioethics.

She has lectured on the ethics of clinical research at conferences run by PRIM&R, ASBH, IAB, ASTMH, and internationally in such locations as Botswana, South Africa, Vietnam, Japan, Indonesia, and Mali.

The ACA’s Nondiscrimination Rule: A Right In Search of a Remedy

Every law student learns the ancient adage that there is no right without a remedy. Section 1557 makes clear that individuals have rights against discrimination in healthcare and a private right of action to enforce them. But it’s less clear as to when and how they have remedies.

Section 1557 provides individuals protection against discrimination on “the ground prohibited under” four preexisting civil rights statutes–Title VI of the Civil Rights Act, Title IX of the Education Amendments, the Age Discrimination Act, and Section 504 of the Rehabilitation Act. The statute also makes available “the enforcement mechanisms provided for and available under” these four civil rights statutes. This language makes two things clear. First, Section 1557 prohibits discrimination on grounds of race, color, or national origin (Title VI); sex (Title IX); age (Age Discrimination Act); and disability (Rehab Act). Second, as district courts have agreed, the statute authorizes both private rights of action and agency enforcement as “enforcement mechanisms.”

So far, so good. But each statute has its own specific legal standards, and remedies. For example, a plaintiff alleging age discrimination under the Age Discrimination Act must first exhaust administrative remedies. By contrast, a plaintiff can file a private suit directly when suing under Title IX. And private parties can’t bring lawsuits targeting policies with disparate impacts on racial minorities under Title VI. But people with disabilities can allege disparate impact pursuant to Section 504.

The text of Section 1557 is ambiguous: either (1) claims that Section 1557 has been violated are treated uniformly across prohibited grounds or (2) plaintiffs have different rights and remedies depending upon whether they allege race, sex, disability, or age discrimination. Courts have already divided on this question.

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Changes in seasons, changes for children: Developments at the intersection of behavioral science, developmental neuroscience, and juvenile justice

By Robert Kinscherff

It is fitting that I am writing this first blog of my time as Senior Fellow in Law and Applied Neuroscience as we transition through the change of seasons.  It is a privilege to have the time afforded by this joint Fellowship between Harvard Law School (Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics) and Massachusetts General Hospital (Center for Law, Brain, and Behavior) to focus upon the intersections of behavioral science, developmental neuroscience, and juvenile justice.  The autumnal change of seasons is a fitting metaphor for the slow but profound changes occurring in juvenile justice which have been spurred in large measure by emerging neuroscience increasingly describing the neurobiology of adolescence.  This neuroscience provides the biological complement to what developmental psychologists have well described and what parents have long known:  Children are different.

This emerging neuroscience has become a quiet but increasingly pervasive force in helping us understand why most delinquent youth desist with maturation—even adolescents who are chronically delinquent and violent.  It helps us understand why punitive “tough on teen crime” approaches born of fears in the 1990’s of the rise of violent teen “super-predators” actually compromises public safety over time—especially when youth are tried as adults and incarcerated with adults.  And, it helps us understand why mass detention and incarceration of youth—many of them for non-violent offenses—not only harms those youth but tends to increase their risks of continued misconduct and of later deep penetration into the adult criminal justice system. Continue reading

Actions for Sexual Assault Incidental to Medical Treatment Placed Outside the Scope of Medical Liability

By Alex Stein

Ex parte Vanderwall, — So.3d —- 2015 WL 5725153 (Ala. 2015), is a new important decision that defined “medical malpractice” to identify suits adjudicated under special defendant-friendly rules. As I explained hereherehereherehereherehere, and in a foundational article on the subject, categorizing a suit as sounding in “medical malpractice”—as opposed to “ordinary negligence,” “assault” or “battery”—determines whether the plaintiff must satisfy rigid limitations and repose provisions, comply with special requirements with regard to expert testimony, face the difficult burden of proving the defendant’s deviation from professional customs, and, in the end, suffice herself with the compensation amount limited by the statutory cap on damages.

In Vanderwall, this categorization determined whether a patient could use past instances of sexual misconduct incidental to medical treatment to prove that the therapist responsible for that misconduct sexually assaulted her as well. Continue reading

Premiums in Medicaid: The (not so) Recent Trend

By Emma Sandoe

Requiring Medicaid beneficiaries to pay premiums and other cost-sharing for medical services is not new to the Medicaid expansion debate. Premiums were introduced as part of the Tax Equity and Fiscal Responsibility Act of 1982. Previously, states were prohibited from imposing enrollment fees, premiums, or deductibles for any categorically eligible individual in the Medicaid program. This law allowed states to implement minimal cost-sharing for waiver demonstrations, but prohibited states from denying medical care due to an inability to pay.

Since this law was passed, the Centers for Medicare & Medicaid Services (CMS) has clarified that certain populations including pregnant women and children were exempt from most cost-sharing. Additionally, certain services are exempt from copayments and coinsurance entirely. The maximum amount that can be charged varies based on wage and type of service and where the beneficiary seeks treatment.

Prior to Indiana’s 1115, approved in 2014, CMS did not allow state waivers to charge premiums to individuals making under 50% of the federal poverty line (FPL). Indiana’s expansion plan is unlike any other state’s waiver plans. It requires individuals to pay a “monthly contribution” of $1 a month or 2% of a family’s income which ever is greater. When a beneficiary that has been paying these monthly contributions uses medical services, they are not required to pay co-payments. Previously, Indiana lowered the income eligibility for premiums during its 2013 waiver when it required premiums for individuals making between 50-100% of FPL. Arkansas and Iowa saw that precedent set by Indiana and lowered their cost sharing levels from 100% of FPL to 50%. Continue reading

The ACA’s Nondiscrimination Rule: Hobby Lobby 2.0?

Should healthcare providers, researchers, and insurers be able to engage in sex discrimination for religious reasons? HHS asked the public to weigh in on this question with regard to the ACA’s nondiscrimination provision.

The answer is no for three important reasons. First, the statute doesn’t allow additional exemptions. Not only is the text clear, but Congress also considered and rejected broader religious exemptions. Second, authorizing sex discrimination for religious reasons is bad health policy with damaging effects for women and LGBT people. Third (as I argued in separate comments with a group of law and religion scholars), granting religious exemptions here runs into constitutional limits set by the Establishment Clause.

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The ACA’s Nondiscrimination Rule: Puzzling Misreading of the Statute

Like other healthcare civil rights statutes, the Affordable Care Act’s Section 1557 links nondiscrimination requirements to federal funding. Programs that receive “federal financial assistance” can’t discriminate against individuals based on their race, sex, age or disability. HHS has proposed to exclude Medicare Part B payments from “federal financial assistance.” As a result, physicians’ offices would be outside Section 1557’s reach. The statute, however, bars this puzzling and contradictory interpretation.

For almost fifty years, HHS has taken the position that Medicare Part B payments to physicians are “contracts of insurance.” Because previous civil rights statutes—like Title VI of the Civil Rights Act and the Rehabilitation Act—explicitly excluded “contracts of insurance” from the definition of “federal financial assistance,” physicians were exempted from compliance. Payments under Medicare Part B and other insurance contracts did not suffice to create nondiscrimination obligations.

HHS’s interpretation of Section 1557 would again exclude Medicare Part B payments from the ambit of “federal financial assistance.” But, this time, the statute doesn’t allow it. Section 1557 specifically states that federal financial assistance includes “contracts of insurance.” HHS can’t have it both ways, defining Part B as “contracts of insurance” when the statute excludes them and defining Part B as something else (it’s not clear what) when the statute includes contracts of insurance. The only permissible interpretation of Section 1557 means providers who participate in Medicare can’t discriminate.

In a series of posts this week, we’re blogging on the proposed HHS Nondiscrimination Rule. You’ll find our first post here. Look for our next posts on religious exemptions and remedies under Section 1557 later this week.