Month: December 2017

The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

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By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Read More

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

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Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Morality, Maturity, and Abortion Access in the US

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by Clíodhna Ní Chéileachair

In the complex web of restrictions on abortion access, parental consent laws and judicial bypass mechanisms play a small, but hugely significant part. States are entitled to enact parental consent and notification laws in relation to abortion care for minors, as long as they allow minors to ‘bypass’ this requirement judicially, an attempt to account for the myriad circumstances in which it will be impossible, difficult or dangerous for teens to tell their parents about their pregnancy and their wish to end it. Finding different justifications in different contexts, some laws appeal to the perceived immaturity of the individual in arriving at a decision without adult intervention; other legal schemes emphasize the critical importance of respecting the family unit, and by extension, the ability of parents to determine the medical treatment their child will receive. The exact stats, state by state, are available here.

The patchwork regime which governs the US rules on abortion access, administered by local courts presiding over the individual applications of pregnant teenagers, is a highly dysfunctional one, where standards of judgment can be entirely capricious. Judges are, after all, not medical professionals, nor are they therapists, health experts or developmental psychologists. The standard criteria pronounced upon by a judge at a bypass hearing is whether the minor is ‘mature enough, and well enough informed to make her abortion decision, in consultation with her physician, independent of her parents knowledge’ or that ‘even if she is not able to make this decision independently, the desired abortion would be in her best interests’. The gateway for unchecked judicial discretion is gaping. Markers of maturity are wholly subjective determinations, as are the metrics to determine whether a minor is sufficiently informed, or where her best interests lie. After all, for a staunchly anti-abortion judge, it is entirely possible that no-one could be informed about the process of abortion and yet rationally seek it, or that it could never be in an individual’s best interests to receive abortion care as a minor. The controlling law doesn’t foreclose on these possibilities.

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Genomic Screening: What’s Age Got To Do With It?

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By Margaret Waltz, PhD, R. Jean Cadigan, PhD, Anya E. R. Prince, JD, MPP, Debra Skinner, PhD, and Gail E. Henderson, PhD

Age is an important consideration in medical screening, but calls for population based preventive genomic screening programs do not mention an upper age limit. Should such programs employ upper age limits, as occurs in other clinical screenings, on the assumption that older individuals would not benefit clinically? To address this question, our Genetics in Medicine paper analyzed data from GeneScreen, a research study of preventive genomic screening aimed at adults. We focused on how the researchers who designed the study and 50 individuals who joined the study understood and valued age in relation to screening.

GeneScreen used a screening panel of 17 genes associated with 11 rare conditions for which treatment and/or prevention options were available, like Hereditary Breast and Ovarian Cancer, Lynch Syndrome, and Long QT Syndrome. GeneScreen researchers initially suggested an upper age limit, reflecting the assumption that older individuals were unlikely to clinically benefit from the results. One clinician worried that without an upper age limit, GeneScreen might reinforce the desire for screening among older adults and the misconception that screening “does a lot of good when you’re 80.” This was reconsidered when they discussed familial benefit. As one researcher said, participation “might not actually save the 80-year-old that we test, but [it] could save his grandchildren.” The recognition of familial benefit motivated the decision to not exclude adults based on age.

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The CVS/Aetna Deal: The Promise in Data Integration

The Petrie-Flom Center Staff Leave a comment

By Wendy Netter Epstein

Earlier this month, CVS announced plans to buy Aetna— one of the nation’s largest health insurers—in a $69 billion deal.  Aetna and CVS pitched the deal to the public largely on the promise of controlling costs and improving efficiency in their operations, which they say will inhere to the benefit of consumers. The media coverage since the announcement has largely focused on these claims, and in particular, on the question of whether this vertical integration will ultimately lower health care costs for consumers—or increase them.  There are both skeptics  and optimists.  A lot will turn on the effects of integrating Aetna’s insurance with CVS’s pharmacy benefit manager services.

But CVS and Aetna also flag another potential benefit that has garnered less media attention—the promise in combining their data.  CVS CEO Larry Merlo says that “[b]y integrating data across [their] enterprise assets and through the use of predictive analytics,” consumers (and patients) will be better off.  This claim merits more attention.  There are three key ways that Merlo might be right. Read More

Reflecting on Behind Bars: Ethics and Human Rights in U.S. Prisons

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By Gali Katznelson

Is it justifiable to chain women as they give birth? How about confining people in a way that is proven to be psychologically devastating and torturous? These are just two of the questions raised last week during the conference, Behind Bars: Ethics and Human Rights in U.S. Prisons, a conference sponsored by the Center for Bioethics at Harvard Medical School.

To kick off the two day event, Dr. Danielle Allen delivered a moving keynote in which she urged us to question two key issues: the ethics of the treatment of those behind bars, as well as the ethics of using bars. In addressing this second point, Dr. Allen tasked everyone attending the conference with a ‘homework assignment’: to read Sentencing and Prison Practice in Germany and the Netherlands: Implications for the United States, in order to encourage us to “think the unthinkable,” namely a more humane way to treat people who have committed crimes.

From this report, I learned that in Germany and the Netherlands, incarceration is seen as a last resort for individuals convicted of crimes. Alternative non-custodial sanctioning and diversion systems such as fines and task-penalties exist – and are effective. In 2010, 6% of sanctioning resulted in incarceration in Germany and in 2004, 92% of sentences were for two years or less. These incarceration systems are organized around the principles of resocialization and rehabilitation. Time spent in prison is meant to be as similar as possible to community life, and incarcerated people are encouraged to cultivate relationships within and outside of prison. In prison, individuals can wear their own clothes, structure their own days, work for pay, study, parent their children in mother-child units, vote, and return home occasionally. In these systems, respect for persons, privacy, and autonomy are strongly held values. Solitary confinement is rarely used, and cannot exceed four weeks a year in Germany, and two weeks a year in the Netherlands.

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Limited Seats Still Available, Register Now! 12/12: Sixth Annual Health Law Year in P/Review

The Petrie-Flom Center Staff Leave a comment

AGENDA NOW AVAILABLE: Sixth Annual Health Law Year in P/Review imageHealth Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event

The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

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Soliciting Surrogacy in the Hallowed Halls of Congress

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By Judith Daar

Joining the ever growing circle of workplace misconduct targeting women’s bodies is the revelation that Representative Trent Franks (R-Ariz.) will resign his seat amid allegations that he solicited two female staffers to serve as gestational carriers and bear his children. In a characteristically defensive resignation letter, Franks bemoans the difficulties he and his wife experienced in forming their family, detailing their multiple miscarriages, failed attempts at adoption, and ultimately joy at the birth of twins with the help of a “wonderful and loving lady” who carried the couple’s children to birth. Wanting to grow their family when the twins reached three, the congressman admits that he “broached a topic that, unbeknownst to me until very recently, made certain individuals uncomfortable.” Those individuals were subordinate female employees who have the right to work in an environment where their boss cannot ask without warning, “Will you be my surrogate?”

Aside from the obvious addition to the constellation of misconduct premised on the assumption that the female body is fair game in service of male desires, this latest affront holds an irony that should not be lost on us, as well as lessons for the broader regulation of assisted reproductive technologies. As to irony, Arizona is one of a dozen states that outlaws surrogate parenting arrangements. The state’s family code provides, “No person may enter into, induce, arrange, procure or otherwise assist in the formation of a surrogate parentage contract.” This means that surrogacy agreements are unenforceable at law, but legal experts report that intended parents – like the Franks – are willing to take the risk and hope a court will recognize their legal parentage either before or after the children are born. While Rep. Franks did not reveal if his surrogacy contract was executed under Arizona law, odds are he and his wife sought judicial approval of their parental rights in the state he represents in Congress. Read More

2017’s Word Of The Year In Health Law And Bioethics: Uncertainty

The Petrie-Flom Center Staff Leave a comment

This is the first post by Carmel Shachar and I. Glenn Cohen that appears on the Health Affairs Blog in a series stemming from the Sixth Annual Health Law Year in P/Review event to be held at Harvard Law School on Tuesday, December 12, 2017.

2017 was a year of tremendous uncertainty for many areas of public policy. Health care policy was no exception, most prominently with an almost successful push by Congressional Republicans to radically revise the Affordable Care Act (ACA). Medical research and bioethics also faced uncertainty, with the struggle to ethically engage with new technologies and to better understand the boundaries around self-determination. As we look over the past year and anticipate the coming one, the overarching question remains: Is it possible to run a health law and health care system given this level of flux?

Healthcare Policy in Flux

2017 saw a new presidential administration and Congress. Seeking to capitalize on the Republican control of the White House and both Houses of Congress, Congressional Republicans sought to make good on their campaign promise to “replace and repeal” the ACA. The proposed legislation would have dramatically reshaped our health care landscape, including ending Medicaid’s financial status as an entitlement program, and undercutting the health insurance Marketplaces championed by the Obama administration. Despite the fact that the ACA is not yet a decade old, this would have been a seismic shift in the way many Americans receive their health care. […]

Read the full post here.

We will be discussing these issues and more at the Sixth Annual Health Law Year in P/Review conference, held on December 12, 2017, at Harvard Law School in Cambridge, MA. If you find these issues interesting, we invite you to join us as the event is free and open to the public (registered required). For those unable to join us in Cambridge, some of our conference presenters will participate in a blog series to follow  at the Health Affairs Blog. Stay tuned!

Islam and the Beginning of Human Life

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When does human life begin?

One of the more contentious bioethical and legal issues is about the beginning of human life. Nor is it difficult grasp why, for beyond political rhetoric it is a subject of considerable philosophical and legal debate and raises a number of questions which are profoundly difficult to answer. Biomedicine can roughly differentiate when life becomes viable, that is, at which point a fetus could survive as an infant if a mother gave birth prematurely; it can likewise recognize potential complications either in the development of the fetus or the health of the pregnant woman. Yet other questions are not as easy to answer, precisely because they tend to fall more in the spectrum of philosophy or personal belief: what constitutes a human being? What is a person? Is a potential life accorded the same rights as an actual life? For that matter, are there rights to begin with automatically, or are there criteria that must be met in order to procure rights? In short, questions that strike at the very core of who we are.

A number of these questions were debated by Muslim theologians and legal scholars in the pre-modern world when considering contexts of abortion or issues surrounding paternity. In the modern world, these questions have grown to include in vitro fertilization and surrogacy amongst others. Muslim scholars continue to grapple with these bioethical questions as the medical sciences grow more advanced and technology allows us to have ever more control over the basic aspects of reproduction, growth, and development. Per the question, When does human life begin? for example, Mohammed Ghaly analyses in an important article, “The Beginnings of Human Life: Islamic Bioethical Perspectives” some of the newer discussions and positions Muslim scholars have taken vis-à-vis contemporary bioethics and independent legal reasoning (ijtihad). Complementing this discussion is also a seminal article by Ayman Shabana, “Paternity Between Law and Biology: The Reconstruction of the Islamic Law of Paternity in the Wake of DNA Testing.” Shabana shows how classical rulings pertaining to paternity issues continue to hold higher authority, even despite the advent and availability of modern technology that would ostensibly challenge that authority. This is interesting for a number of reasons, not least of which is the possible change in perspective with regard to how religious authority is derived and its relationship to the medical sciences. Read More