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,

Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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Interpreting Fiorina’s Comments on Vaccination Law

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

Pain-o-meters: How – and Why – Should We Develop Them?

By Karen Davis

The prevalence of chronic pain is staggering.  The Institute of Medicine reported in 2011 that 100 million Americans suffer from chronic pain – more than those with heart disease, cancer and diabetes combined.  The report also highlights that the annual costs for medical care, lost wages and productivity is more than $600B.  These enormous personal and societal costs of chronic pain has driven an effort to “prove” if and how much pain an individual is suffering from for health care providers, insurance companies and legal actors.  This is challenging because pain is a personal and subjective experience.  Ideally, self report would be sufficient to establish the “ground truth” of the pain experience.

However, some are not able to provide self reports accurately, and the potential financial gain associated with claims of pain has tarnished the perceived authenticity of subjective reports.  This has led some to develop brain imaging-based tests of pain – a so-called “painometer.”  Yet, current technologies are simply not able to determine whether or not someone has chronic pain.  Here, I consider specifically how we could develop a brain-imaging based painometer – and whether we would want to do so.  As we ask: “Can we do it?,” we should always ask, “Is this the right thing to do?”

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Bioethicist Art Caplan: Why Jim Carrey is Wrong About Vaccines

A new opinion piece by contributor Art Caplan on NBC News:

California has decided one large epidemic scare is enough. After the frightening outbreak of measles that started at Disneyland and sickened 147 people, Californians rejected the irrationality of anti-vaccine zealots and decided to restrict parents’ ability to exempt their children from school vaccinations.

The new law signed by Governor Jerry Brown throws out religious and philosophical reasons to exempt. Only health concerns will be permitted and those must be verified by a physician. If you simply don’t want to vaccinate your kids, you will have to home school.

The new law is all to the good. No major religions have heartburn over vaccination. Most see it as an obligation in order to help the community. And philosophical exemptions were nothing but an open door for those who are ill-informed, addicted to misinformation on the internet or just plain selfish. […]

Read the full article here.

The ACA Survives — But With A Note Of Caution For The Future?

Academic Fellow Rachel Sachs has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell. From the piece: 

Chief Justice Roberts has once again saved a core provision of the Affordable Care Act (ACA). In King v Burwell, a majority of six Justices upheld the validity of an Internal Revenue Service (IRS) rule interpreting the text of the ACA to permit tax credits to be distributed through both state and federal insurance exchanges. As a result, the millions of Americans receiving subsidies through federally established exchanges in the states that have not chosen to establish their own exchanges will continue to receive them.

Much of the briefing and argument in King involved the legal principle known as Chevron deference, in which courts generally defer to agencies’ reasonable interpretations of statutes if the statutory language is ambiguous. In this case, the government first argued that the statutory language clearly permitted tax credits to be made available on federally established exchanges. But even if the statute was ambiguous, it contended, Chevron counseled deference to the IRS’ reasonable interpretation of the statute.

Read the full piece on the Health Affairs Blog!

Happy about the Supreme Court’s ACA decision? Thank a law professor

By Rachel Sachs

[Originally published on The Conversation].

The core of the Affordable Care Act (ACA) has now survived its second trip to the Supreme Court.

Chief Justice John Roberts wrote for the majority in King v Burwell, holding that the federal government may provide subsidies for citizens to purchase health insurance on exchanges that were established by the federal government, rather than by their own state.

A ruling for the challengers (the “King” in King v Burwell) would not only have stopped the flow of subsidies to 6.4 million people currently receiving them, but it would also have disrupted the functioning of the individual insurance markets in the 34 states that have not established their own exchanges. Continue reading

Health Law Year in P/Review: Until Next Year

This new post by Holly F. Lynch, I. Glenn Cohen, and Gregory Curfman appears on the Health Affairs Blog as the final entry in a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

It’s been our great pleasure to collaborate with the Health Affairs Blog on this series stemming from theThird Annual Health Law Year in P/Review symposium at Harvard Law School. This annual event takes a look back over the prior year and previews the year to come with regard to hot topics in health law.

After the symposium, we asked our speakers to keep the conversation going online by expanding on their topics from different angles or by honing in on particularly intriguing features. These pieces were published on the Health Affairs Blog through the spring and into summer.

We heard more from Kevin Outterson on how to promote innovation in the development of new antibiotics, from Rachel Sachs on whether the Food and Drug Administration’s proposal to regulate laboratory-developed tests will really stifle innovation, and from Claire Laporte on the impact of recent Supreme Court decisions on bio-IP.

George Annas weighed in on the Ebola outbreak, which has already almost faded from public consciousness but offers important public health lessons, while Wendy Parmet and Andrew Sussman tackled important developments in tobacco control. […]

Read the full post here.

The Impact of Broccoli II and Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: A grand finale of a juicy patents tale?

I am pleased to announce our recent paper entitled “The Impact of Broccoli II & Tomato II on European patents in conventional breeding, GMO’s and Synthetic Biology: The grand finale of a juicy patents tale?”, which is available on SSRN, and forthcoming in Biotechnology Law Report, Vol. 34, Number 3 (June 2015), pp. 1-18.

Our analysis deals with a seminal judgment on the controversial and sometimes even emotionally debated European “Broccoli” and “Tomato” patents, which has captivated the European patent and plant science communities for many years: On March 25, 2015, the EBA of the European Patent Office (EBA) finally issued its much awaited decisions on the consolidated referrals G2/12 (“Tomato II”) and G2/13 (“Broccoli II”), clarifying the exclusion from patentability of essentially biological processes, such as conventional crossing and selection, and in particular its impact on the patentability of claims for products resulting from such processes. The so-called “Tomato II” case concerned an invention entitled “method for breeding tomatoes having reduced water content and product of the method,” whereas the so-called “Broccoli II” case involved an invention of a “method for selective increase of the anticarcinogenic glucosinolates in brassica species”. Continue reading