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

The Supreme Court and Contraceptive Coverage—Take 2

Supreme Court

Flickr/Creative Commons – Andrew Raff

by Gregory M. Lipper

Today the Supreme Court granted review in seven challenges to the accommodation offered to those with religious objections to the Affordable Care Act’s contraceptive coverage regulations. I won’t rehash my earlier posts about why I (and seven of eight federal appeals courts) think that these challenges, brought under the Religious Freedom Restoration Act, are bunk. For now, a few observations about the cases and today’s cert grants:

1. These cases involve challenges to a religious accommodation, not the coverage requirement itself. In Burwell v. Hobby Lobby Stores, the Supreme Court said that the government couldn’t enforce the contraceptive coverage regulations against for-profit corporations with religious objections. The Court pointed to a less-restrictive alternative: the accommodation, offered to nonprofit organizations, through which the organization submits a written objection and government arranges for the objector’s insurance company or plan administrator to provide the coverage at no cost to either the objector or its employees. The plaintiffs in these cases are challenging the accommodation itself. By analogy, this is like a conscientious objector challenging the process for opting out of the draft.

2. Oddly enough, Hobby Lobby didn’t officially resolve RFRA challenges to the accommodation. You might think that since the Supreme Court’s decision in Hobby Lobby pointed to the accommodation as the less-restrictive alternative, then the Court must have also made clear that the accommodation itself complied with RFRA. But the majority opinion did not do so. Instead, after pointing to the accommodation as a less-restrictive alternative, the majority said, “We do not decide today whether an approach of this type complies with RFRA for purposes of all religious claims.”

3. And/But: Justice Kennedy, the deciding vote in Hobby Lobby, suggested more clearly that the accommodation complies with RFRA. Although he joined the majority opinion, Justice Kennedy also wrote separately and appeared to bless the accommodation. Here’s what he said:

  • “That accommodation equally furthers the Government’s interest but does not impinge on the plaintiffs’ religious beliefs.”
  • “Yet neither may that same [free exercise] unduly restrict other persons, such as employees, in protecting their own interests, interests the law deems compelling. In these cases the means to reconcile those two priorities are at hand in the existing accommodation the Government has designed, identified, and used for circumstances closely parallel to those presented here.”

If Justice Kennedy holds to his view in Hobby Lobby, then the plaintiffs in these cases will probably lose.

4. Although the plaintiffs in these cases are nonprofit organizations, the result will affect employees of for-profit corporations. As instructed by the Supreme Court in Hobby Lobby, the government extended the accommodation to closely held for-profit corporations such as Hobby Lobby. But neither Hobby Lobby nor the other for-profit plaintiffs have said that they will accept the accommodation, and most of them are represented by the same organizations representing the nonprofit challengers to the accommodation. So if the Supreme Court doesn’t uphold the accommodation as applied to nonprofit organizations, employees of objecting for-profit corporations will almost certainly go entirely without contraceptive coverage as well.

5. “[Y]ou are not entitled to your own facts….” Today the Becket Fund, which represents Little Sisters of the Poor and several other plaintiffs, issued a press release entitled “High Court to decide if Government can force nuns to provide contraceptives.” This is false—full stop. Under the accommodation, contraceptives are provided by the employer’s insurance company or plan administrator; employers aren’t paying for the insurance coverage, let alone handing out the insurance coverage, let alone handing out contraceptives themselves. Whether or not you think that the accommodation resolves employers’ religious objections, it is simply not true that—as a matter of fact—objecting nuns are required “to provide contraceptives.” (This is not, I should add, the first time that the Becket Fund has made this claim in a press release.) I will be curious to see whether Becket Fund repeats this claim in its briefs to the Court.

Greg Lipper is Senior Litigation Counsel at Americans United for Separation of Church and State. You can follow him on Twitter at @theglipper.

The Ongoing Push for E-Cigarette Regulations

By Katherine Kwong

Last week, the American Academy of Pediatrics publicly joined the group of advocates for federal regulations on e-cigarettes. The AAP urged the government to ban the sale of e-cigarettes to everyone under age 21 and prohibit advertising to minors, and advocated for high taxes on e-cigarette products similar to those on other tobacco products. In its announcement, the AAP cited developing brains’ vulnerability to nicotine and the potential harms to long-term health as reasons for its recommendations to keep e-cigarettes away from youths. It also recommended that smoke-free laws governing secondhand smoke explicitly include e-cigarettes, saying, “[t]he aerosol emitted from e-cigarettes is not harmless; it contains a variety of toxic chemicals, including some carcinogens and significant amounts of nicotine.”

A recently released poll found that a majority of Americans (57%) believe e-cigarettes should be regulated like tobacco products, while less than 25% of respondents felt they should not be. The Food and Drug Administration proposed e-cigarette regulations in 2014, and recently sent the regulations to the Office of Management and Budget for review. While the final form of the regulations is still unknown, the proposal banned the sale of e-cigarettes to minors and required e-cigarette labels include a list of ingredients and a disclosure that they contain nicotine.

There is growing concern about the potential health risks posed by e-cigarettes. Advocates for restrictions on e-cigarettes have long warned that unregulated e-cigarettes frequently expose users to the harmful effects of nicotine, as well as toxic chemicals such as formaldehyde, benzene, and other carcinogens. There have also been warnings about the risk that e-cigarette use may lead to greater social acceptance of smoking and higher rates of tobacco use. (Despite frequent claims that e-cigarettes may help with smoking cessation, longitudinal studies consistently find no evidence that e-cigarette use increases quitting rates.) Anecdotal evidence has linked e-cigarette use to pneumonia and other lung problems. Forty percent of e-cigarette users reported having health concerns about their use.

Continue reading

The Good, the Bad, and the Ugly: Physician Coverage under the ACA

By Elizabeth Guo

A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.

Here’s where it gets ugly.

Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.

The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Continue reading

The Right to Health and Free Speech: Supreme Court of Argentina Rules Against Tobacco Advertising

by Martín Hevia (Universidad Torcuato Di Tella)

In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.

In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.

On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.

In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.

Our Curious Medicare Vaccine Reimbursement System

By George Maliha, Harvard Health Law Society

As flu season begins, we are bombarded by ubiquitous reminders to get our flu shot. So, it is a good opportunity to reflect on how we provide vaccines to our fellow citizens 65 and older. By law, Medicare Part B covers 4 preventive vaccines (flu, two pneumococcal, and hepatitis B for medium-to high-risk patients). Part D picks up the rest, namely shingles, TDaP, and any other commercially available vaccine. But, that’s where the trouble begins.

When Congress passed Part D, the vaccines recommended for those 65 or older were basically covered by Part B. Now, they aren’t. In 2006, the zoster (or shingles) vaccine came onto the market. In 2010, the recommendations for the TDaP (the P for pertussis or whooping cough being the most relevant here) changed to include the elderly.

But, so what, they’re still covered, right? Continue reading

Public Safety and Public Health

This morning I saw an announcement about a new initiative called “Law Enforcement Leaders to Reduce Crime and Incarceration” and thought it was an important thing to share on this blog. This alliance consists of 120 top current/former police commissioners and prosecutors, including both district attorneys and state attorneys general. These law enforcement leaders have come together to influence legislation and public opinion around mass incarceration. Their first project: supporting the Sentencing Reform and Corrections Act of 2015, a bipartisan bill currently moving through the Senate. This issue matters because there are currently over 2.2 million people in American prisons and jails.

The United States incarcerates more of its citizens than any other nation on earth, and by a disturbing margin: we have just 5 percent of the world’s population, but 20 percent of the world’s prisoners. What’s more, our prison population has grown by over 500 percent since 1978. At any given moment, one in 35 Americans is in prison, on parole, or on probation.

Why is criminal justice a health policy issue? Well, there are many reasons, but let’s start with the fact that the largest mental health provider in the United States is the Cook County Jail. This does not reflect well on our criminal justice policy or our health policy.

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Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

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Artemisinin: Worthy of Nobel Prize, but Growing Concerns About Resistance

Artemisinin, a drug used to treat malaria, has been a recent topic of public discussion after its discovery was recognized with the Nobel Prize in Physiology or Medicine on October 5. The 2015 prize was awarded to three researchers who developed treatments for parasite-caused diseases, with half the award going to Youyou Tu, who is credited with the discovery of artemisinin. Artemisinin has benefited hundreds of millions of people around the world. Yet the recognition for artemisinin’s discovery comes at a time when public health officials are becoming more concerned about its ongoing effectiveness and struggling to implement policies to slow the spread of artemisinin resistance. Continue reading

Regulating Tobacco Standards: An Easy Fix in a Scientifically Uncertain Field

Last week, the New England Journal of Medicine published a study finding that smokers using reduced nicotine cigarettes smoked 30% fewer cigarettes and had reduced cravings at the end of the study compared to smokers using standard cigarettes. The lower-nicotine cigarettes had 0.4 mg of nicotine/gram compared to 15.8 mg of nicotine/gram for the standard cigarettes. Commentators were quick to point out that such studies could provide the evidence FDA needs to establish new nicotine standards for combustible cigarettes.

FDA has explicit authority from Congress to set low nicotine standards for cigarettes. The Family Smoking Prevent and Tobacco Control Act (FSPTCA) allows FDA to set “tobacco product standards,” including provisions for “nicotine yields of the product” where such standards are “appropriate for the protection of public health.” With a mountain of evidence showing that combustible cigarette addiction can lead to cancer, heart disease, and death, FDA should have no problem proving that nicotine standards for combustible cigarettes are appropriate.

FDA may have a harder task trying to show that nicotine reduction standards for other tobacco products are “appropriate for the protection of public health.” As one commentator noted, if the nicotine in combustible cigarettes declines, addicted smokers might switch to other nicotine-containing products, including smokeless-tobacco products, e-cigarettes, and e-pipes. Currently, no study has conclusively shown that smokeless tobacco products are safe or unsafe. Some studies suggest that smokeless tobacco products may lead to smoking later in life, while other studies show that smokeless tobacco may be helpful for smokers hoping to quit.

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For Vaccines, Public Health Protection Trumps Religious Freedom (Again)

This week, the Supreme Court appropriately declined to hear an appeal of a 2nd Circuit decision upholding the right of the state to require vaccination as a condition of enrollment in public schools, and to exclude exempted children from attending school during an infectious disease outbreak.

Tony Yang and I wrote in the New England Journal of Medicine about the January 2015 Federal appeals court decision (Phillips v. City of New York). As we wrote at the time:

Under the Constitution, states have police power to protect the public’s health, welfare, and safety. A long-standing use of this authority is to protect communities from risks related to vaccine-preventable illnesses. In addition, when an infectious-disease outbreak occurs, states may use their police power to interrupt further transmission of the disease by restricting the movement of individuals. All states have incorporated this concept of social distancing into their school immunization laws. Schools can prohibit an unvaccinated child, who is more susceptible to acquiring highly infectious vaccine-preventable illness and more likely to become a carrier and vector for it, from coming to school until the danger subsides. Such measures, coupled with ready availability of vaccines, reduce the potential spread of serious disease in a vulnerable and tightly packed community. Continue reading

RFRA Jumps The Shark: The 8th Circuit Strikes Down the Contraception Accommodation (Part 2)


Flickr/Creative Commons – Bill Ward

By Gregory M. Lipper

Thomas Jefferson famously said that “[i]t does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.” Note what Jefferson did not say: “my neighbor is entitled to pick my pocket and break my leg, so long as the government can refill my pocket and pay for a cast on my leg.”

But the latter formulation seemed to influence last week’s Eighth Circuit ruling that the Religious Freedom Restoration Act (RFRA) bars the government from implementing an accommodation for employers with religious objections to including contraception in their health plans. In my previous post, I explained why the Eighth Circuit reduced RFRA’s substantial-burden requirement to a mere formality, potentially subjecting any and every federal law or regulation to strict scrutiny. Once things get to strict scrutiny, the Eighth Circuit goes even further, suggesting that a federal regulation cannot be sustained if the government could, in theory, provide the benefit or service itself.

The Eighth Circuit first applied this approach to the process by which employers obtain the religious exemption. Under the current rules, an objecting organization need only send a written notice to the government and identify its insurance provider or third-party administrator; the government then works with the insurance provider or third-party administrator to arrange for the employees to receive the contraceptive coverage to which they are entitled by law.

The Eighth Circuit, however, reasoned that there is a less-restrictive alternative to requiring this information, since the government could identify the necessary insurance providers and third-party administrators on its own—well, maybe: “Even if the [third-party administrators] are not known, the government has not shown at this stage of the proceedings that the inconvenience of identifying the [third-party administrators] likely would create an administrative problem of sufficient magnitude to make its entire scheme unworkable.” According to the Eighth Circuit, then, no disclosure requirement can be sustained unless the government can prove that it would be unable to discover the information after its own investigation.

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I Concur with the Dissent (or, More on Little Sisters)

On September 3, the 10th Circuit declined to rehear en banc several challenges to the contraceptives coverage mandate filed by non-profit organizations, including Little Sisters of the Poor. As SCOTUSBlog explains, these organizations had not themselves asked for en banc review, having already moved on to SCOTUS, but the judges have the option of calling for a vote themselves, which one or more of them must have done.  The vote came down 7-5 in favor of refusal, with the dissenting judges (i.e., those who wanted en banc review) issuing an explanation of their position.  On this issue, I concur with the dissent.  But I still don’t think the objecting non-profits should be off the hook.

When it comes to the contraceptives coverage mandate, non-profits, and now certain for-profits, are accommodated such that they may be relieved of the responsibility to contract, arrange, pay, or refer for contraceptives coverage if they notify the government or their health insurer of their objection to doing so, such that their insurer (or third party administrator of self-insured plans) can provide free contraceptives to their employees, at no cost to and without the involvement of the employer (all further explained here by Greg Lipper).  However, many organizations continue to argue that the accommodation fails to relieve them of complicity in providing contraceptives against their religious beliefs.  They want flat out exemption from the mandate. Continue reading

HHS’ Proposed Anti-Discrimination Regulations: Protective But Not Protective Enough

By Elizabeth Guo

Last week, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule implementing section 1557 of the Affordable Care Act (ACA). Section 1557 applies the Rehabilitation Act of 1973 to the ACA so that a covered entity cannot discriminate against an individual on the basis of a disability in any health program or activity. The proposed rule clarified how OCR intended to enforce and interpret section 1557’s nondiscrimination provision.

As Timothy Jost and other commentators have noted, the government’s proposed interpretation of section 1557 significantly expands the number of health entities that need to meet the Rehabilitation Act’s nondiscrimination requirements. The regulation proposes to encompass all entities that operate a health program or activity, any part of which receives federal financial assistance. The regulation then broadly interprets “federal financial assistance” to include “subsidies and contracts of insurance.” Thus, an insurer receiving premium tax credits or cost-sharing reduction payments through participating in a health insurance Marketplace would need to ensure that all its health plans meet the Rehabilitation Act’s nondiscrimination requirements, regardless of whether the plans are sold through the Marketplace, outside the Marketplace, or through an employee benefit plan. This broad interpretation means that the Rehabilitation Act’s nondiscrimination provisions will now apply to a number of previously excluded plans.

Expanding the number of plans needing to meet section 1557’s nondiscrimination requirements will provide greater protection to more individuals with disabilities. In the United States, the Rehabilitation Act and the Americans with Disabilities Act (ADA) prohibit discrimination against individuals with disabilities. Both acts protect disabled individuals, but courts have consistently interpreted only the Rehabilitation Act as prohibiting insurers from designing their health plans to discriminate against individuals with disabilities. On the other hand, courts have held that the ADA provides a safe harbor for insurers when designing their benefit plans. Thus, some insurers under the ADA may be able to exclude all drugs treating HIV/AIDS from their formulary or place all drugs treating HIV/AIDS on the highest cost-sharing tier, benefit designs that the Rehabilitation Act would likely prohibit. See also Kelsey Berry’s post on this topic.  Continue reading

Government Regulation of Commercial Speech: is Amarin Pharma’s Breakout Moment?

Government regulation of off-label promotion by pharmaceutical companies is now an important First Amendment issue. The Food and Drug Administration (FDA) has historically restricted truthful and non-misleading speech by pharmaceutical companies under the Food, Drug and Cosmetic Act (FDCA). The FDCA prohibits introducing “misbranded” products into interstate commerce. The FDA has interpreted this to prohibit pharmaceutical companies recommending uses not already approved by the agency (these uses appear in a drug’s labeling). Drugs promoted for unapproved uses may also be considered “new” drugs which require FDA approval. Pharmaceutical companies can also face liability under the False Claims Act for off-label promotion.

United States v. Caronia was the first time the FDCA’s misbranding provisions were successfully challenged under the First Amendment. In 2012, the Second Circuit held that the FDA’s regulations failed the test for commercial speech announced in Central Hudson. Namely, the Court held that restricting truthful speech did not directly advance a government interest (rather, the regulations paternalistically prevented dissemination of truthful information), and the Court held that the FDA’s regulations were more extensive than necessary. The Court did not even analyze the regulations under the test announced in Sorrell v. IMS Health, decided by the Supreme Court in 2011, which held that heightened scrutiny was warranted where restrictions are content- and speaker-based. The FDA did not seek en banc review or writ of certiorari.

Almost immediately, the case was heralded as a landmark decision that would have a profound impact on drug regulation. However, that has yet to occur. Since the case was decided the FDA has already generated large settlements with companies like Amgen for violating agency regulations on off-label promotion. That may be because of uncertainty regarding Caronia’s reach, and because for large companies a relatively cheap settlement makes more sense than risking felony indictments and exclusion from government programs. For the agency’s part, it has tried to avoid fully vetting constitutional issues surrounding its regulations. The FDA stated after Caronia that the ruling would not alter its enforcement policy. Although, the agency has stated it is developing new guidances concerning off-label promotion.

The newest development in this story came last month in Amarin vs. United States. Continue reading

Little Sisters: Cato Institute Targets the Affordable Care Act—Yet Again

By Gregory M. Lipper

Fresh off its unsuccessful attempt to gut the Affordable Care Act in King v. Burwell, the Cato Institute is back for more. This time, Cato has filed an amicus brief in support of Supreme Court review in Little Sisters of the Poor Home for the Aged v. Burwell. This is one of the many, many (many) challenges brought under the Religious Freedom Restoration Act (RFRA) by nonprofit organizations to an accommodation, offered by the Department of Health and Human Services (HHS), exempting religious nonprofits from providing contraceptive coverage to their employees. To take advantage of the accommodation, nonprofits need only provide written notice to the government of their objection and the name of their insurance provider or plan administrator. At that point, the government arranges for the nonprofit organization’s insurance company or plan administrator to provide the coverage at no cost to the nonprofit or its employees.

These RFRA challenges to the nonprofit accommodation have been rejected by all seven federal appeals courts to address them. But in this brief backing the challenge by Little Sisters, Cato asks the Supreme Court to dodge the RFRA question entirely, claiming that the case “can be resolved without further engaging in the delicate analysis required by the Religious Freedom Restoration Act.” Instead, Cato makes the following argument: (1) in light of King v. Burwell’s statements about agency deference, HHS had no authority to offer religious accommodations to its own regulations implementing the Affordable Care Act, and (2) without a religious accommodation, the contraceptive coverage requirement is unenforceable against nonprofit organizations with religious objections.

Cato seeks—in the name of religious liberty!—to prevent regulatory agencies from granting accommodations to entities with religious objections to regulations, and then argues that the absence of religious accommodation makes the underlying regulations unenforceable against religious objectors. Cato’s curious argument suffers from two serious flaws.

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DCIS Study Amplifies Questions and Demand for Answers

By Dalia Deak

This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.

Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Continue reading

Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Continue reading

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!

Journal of Law and the Biosciences: Call for Harvard Student Submissions

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised  of  brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s Notes & Developments section in early 2016. In previous years, Notes & Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  Notes & Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant to scholars and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up to four papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch,