1) Following orders from FDA, 23andMe will no longer market genetic tests using health analyses. The company will, however, continue to sell genetic tests related to ancestry.
2) Families with children who have seizure disorders are flocking to Colorado. There, these children can legally receive medications containing extracts from marijuana, which are believed to reduce the occurrence of seizures.
3) A bill is being debated in the New York City Council that would ban the use of electronic cigarettes in public spaces. Supporters of the ban say that electronic cigarettes pose a public health risk, while opponents say that they are harmless.
4) Chemotherapy will not be forced on an Amish girl with lymphoblastic lymphoma. The family decided to stop treatment because of the side effects, and the court-appointed guardian of the girl has decided to drop the case against her parents because they are not locatable.
5) Error rates for those who filled out enrollment forms on the Healthcare.gov online insurance marketplace were at 25 percent for October, although representatives say that these error rates have since declined.
6) Legislators who are opposed to the Affordable Care Act are planning to utilize funds allocated by the federal government for Medicaid expansion to instead purchase private health insurance plans for people who are of low socioeconomic status. This Friday, Tom Corbett, governor of Pennsylvania announced this plan, and Arkansas legislators have already enacted an analogous plan.
On May 29th, HHS issued the final rule governing wellness incentives in group health plans. While the incentives themselves are not a surprise, the scope they are given is worthy of ongoing attention. Wellness incentives have been controversial because of their potential for intrusion into individual choice, their subtle (or not so subtle) coerciveness, their valorization of a particularly model of health, and the possibility that they will impose differential burdens and costs on people with disabilities or other disfavored groups. The final rule attempts to meet these objections in several helpful ways.
Nonetheless, the final rule still will allow programs that are differentially burdensome as a result of factors other than health status. It will also allow programs under which it is more difficult for some than for others to obtain rewards because of their states of health. In programs that give rewards for health outcomes, alternatives must be available for those who do not meet targets—but the reasonableness standard for these alternatives permits requirements that may be differentially burdensome so if they are medically appropriate and follow the recommendations of the patient’s personal physician. HHS supports wellness programs as engaging individuals in their health, as encouraging them in healthy behaviors and discouraging them in unhealthy behaviors, and as incentivizing people to make use of recommended health care services such as screenings. Continue reading →
Governance of Tobacco in the 21st Century: Strengthening National and International Policy for Global Health and Development
February 26-27, 2013
Harvard University, Cambridge, MA, USA
Dr. Nkosazana Dlamini-Zuma
Chairperson, African Union Commission
Dr. Margaret Chan
Director-General, World Health Organization
How do international laws and institutions regarding tobacco, trade, investment, agriculture and economic development intersect? What are the implications for global tobacco control efforts? How should public health concerns be taken into account in international economic policymaking? What is the proper balance between a government’s obligations to protect the health of its citizens and other international agreements to which it has subscribed? What are the broader implications for global governance and for global health?
This conference will bring together representatives from governments, intergovernmental organizations, civil society, business, and academia to explore these questions with the objective of:
Enhancing knowledge, information-sharing, network-building and learning across countries, contexts and policymaking arenas
Identifying strategies to strengthen the governance of tobacco at national and international levels;
Fostering greater policy coherence among actors working in health, trade and investment to ensure the protection of global health
The conference is being hosted by the Harvard School of Public Health’s Center for Global Tobacco Control and the Harvard Global Health Institute’s Forum on Global Governance for Health, with advice and support from the World Health Organization’s Tobacco-Free Initiative.
Additional support is provided by: American Legacy Foundation; American Cancer Society; the International Development Research Centre Canada; Campaign for Tobacco-free Kids; Harvard Law School; Framework Convention Alliance; O’Neill Institute for National and Global Health Law, Georgetown University; Institute for Global Tobacco Control, Johns Hopkins University; International Tobacco Control Policy Evaluation Project, University of Waterloo, Canada; Southeast Asia Tobacco Control Alliance (SEATCA).
Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).
The BU Law conference (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements. Speakers include some of the world’s leading public health experts on this topic:
Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
Micah Berman, New England School of Law
Scott Burris, Temple University Beasley School of Law
Julien Chaisse, The Chinese University of Hong Kong
Richard Daynard, Northeastern University School of Law
Samantha Graff, NPLAN
Jane Kelsey, University of Auckland Faculty of Law
Lara Khoury, McGill University Faculty of Law
Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
Jonathan Liberman, Cancer Council Victoria
Benn McGrady, Georgetown University Law Center
Ted Mermin, Public Good Law Center
Kevin Outterson, BU School of Law
Robert Stumberg, Georgetown University Law Center
Allyn Taylor, Georgetown University
Tania Voon, University of Melbourne Law School
George Annas, BU School of Law and BU School of Public Health
Leonard Glantz, BU School of Law and BU School of Public Health
Wendy Mariner, BU School of Law and BU School of Public Health
Alexandra Roberts, BU School of Law
Keynote Speaker: Dr. Michael Siegel, BU School of Public Health
The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.
The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive. I have pulled the district court order and posted it here, along with this appendix. The order provides the exact language of the mandated advertisements, but no analysis. Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.
In a Perspective in this week’s New England Journal of Medicine, Michelle Mello and Glenn Cohen, both professors at Harvard, write about the prospects for using the constitutional Taxing Power to adopt innovative laws to advance public health objectives. Cueing off the Supreme Court’s decision in the Affordable Care Act litigation, Mello — who is also a member of PHLR’s Methods Core — and Cohen write that the Court appears to have opened the door for “more targeted, assertive interventions to promote public health” under the Taxing Power than Congress has previously pursued. “For example, instead of merely taxing tobacco sales, the federal government could require individuals to pay a tax penalty unless they declare that they haven’t used tobacco products during the year. It could give a tax credit to people who submit documentation that their bodymass index is in the normal range or has decreased during the year or to diabetic persons who document that their glycated hemoglobin levels are controlled. It could tax individuals who fail to purchase gym memberships. …These strategies depart from traditional uses of taxes by targeting omissions and noncommercial activities that are important drivers of chronic disease.” Read the full article online at the New England Journal of Medicine online.
The D.C. Circuit’s recent decision vacating the FDA’s graphic labeling requirements has prompted a flood of valuable commentary about compelled speech doctrine, including Richard Epstein’s, below. While analysis of the First Amendment issues is important, I view the R.J. Reynolds case instead as an example of how emphasis on formal legal arguments may detract attention from the underlying source of public opposition.
My current research focuses on the state’s use of emotionally-gripping graphic imagery in medical and public health contexts. I focus on two examples – the “fear appeal,” exemplified by the FDA’s graphic tobacco labeling requirements; and appeals to positive emotions, such as maternal bonding, exemplified by state laws requiring that women view ultrasound images and hear the heartbeat of their own fetus before consenting to an abortion.
Both types of appeals to emotion have faced constitutional challenges – as violations of First Amendment compelled speech doctrine, or imposition of undue burdens on reproductive liberty interests. But these formalistic constitutional tests do not, in my opinion, get at the heart of the public’s concern about government persuasion using emotional imagery. Few contemporary commentators are willing to challenge requirements for scientifically valid textual warnings. Rather, it is the use of images – diseased lungs, cadavers, fetal heartbeats – that strikes a chord of concern among many critics. Whether designed to inspire fear, love, or disgust, the government’s use of these images to persuade seems to run counter to the principles of democratic discourse.
The entire question of the FDA’s tobacco regulation is likely to spur extended commentary, given the split of opinions between the D.C. Circuit, which knocked out the packaging labels by a divided vote in RJ Reynolds v. FDA, and the earlier decision in the Sixth Circuit, that sustained the regulation. The packaging regulations have to be resolved once and for all on a national level, so the case will go up even, I think, if the D.C. Circuit decides to follow the Sixth Circuit in an en bank opinion. So what then should be done?
The issue is one that I have approached before. In the interests of full disclosure, I am a fierce opponent of smoking, who worked in from the mid-1980s into the early 1990s as a consultant for the tobacco lawyers on tort liability issues. After that time, I worked on a number of other issues, in some instances taking positions adverse to the industry. This particular post is done solely and wholly on my own.
In thinking about this case, much of the doctrinal dispute revolved around the much mooted Central Hudson test used in too many First Amendment Cases.