Check out the March 7 edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.
March 20-21, 2014
Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115
This event will be webcast. Link will be posted here on March 20 and 21.
To register, click here. There is no charge for registration.
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Sunstein to be Keynote Speaker
We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.
How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.
Click here to view the detailed agenda.
By Ching-Fu Lin
Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA). HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements. The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.
Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list. There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”
Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA: Continue reading
By Deborah Cho
[See Part I here]
Last week, I wrote the first of a two-part series on tips that may be helpful for law students and lawyers interested in or working in health/medical law. I continue with Tip #4 here.
4. If you need to learn about a disease, procedure, or drug that you know nothing about, your best starting point is probably Wikipedia. Google will lead you to some incorrect answers, and diagnose-yourself websites will give you answers that are much too broad to use practically in legal practice. Once you have familiarized yourself with the general topic on Wikipedia, you can then go back to your search engine of choice for more specific terms and weed out the wrong information. Starting on PubMed or GoogleScholar probably isn’t the best idea either because most of what you’re reading will be highly technical and the articles you find will likely be about novel uses or instances of whatever you’re searching. Another fantastic source is UpToDate, an evidence-based Wikipedia-like source for healthcare providers, but many people may not have access to all the information on this site.
By Kate Greenwood
Cross-Posted at Heath Reform Watch
Lately it seems that each passing day brings another article about the cost of orphan drugs. Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug Soliris which is, per Staton, “the most expensive drug in the world” at around $569,000 a year. Specifically, NICE seeks “‘clarification from the company on aspects of the manufacturing, research and development costs’” of the drug. According to Staton, this latest development in a review process characterized by “halting progress” is “a departure from NICE’s usual calculations, which typically focus on quality-of-life years and the like.”
Pushback by NICE and other payers notwithstanding, the orphan drug market is growing. As I blogged about here, in 2013 EvaluatePharma estimated that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.” In a recent article in the New England Journal of Medicine, venture-capital investors Robert Kocher and Bryan Roberts note that “more than half of the 139 drugs approved by the FDA since 2009 are for orphan diseases” and suggest that there is a risk of “systematically underinvesting in other important areas of medicine.”
Kocher and Roberts’ explain that one reason that orphan drugs attract investment is that their development costs are low. The problem or potential problem of underinvestment in diseases like depression and diabetes could therefore be addressed, they contend, by bringing the cost of developing treatments for these common conditions in line with the cost of developing treatments for rare diseases. And, they argue, one promising approach to doing so is to reduce clinical trial costs by reducing the size of clinical trials. Continue reading
By Alex Stein
In a recent case, Lawrence v. Mountainstar Healthcare, — P.3d —-, 2014 WL 685594 (Utah App. 2014), Utah’s Court of Appeals sharpened the distinction between two categories of doctors’ statements: (1) “we messed up” statements that acknowledge a complication or fault; and (2) statements expressing the doctor’s benevolence and apology for what happened to the patient. The Court held that fault statements are admissible as a party admission, whereas apology statements are privileged under Utah’s “apology rule”: Utah Code Ann. § 78B–3–422, Utah R. Evid. 409. The “apology rule” renders privileged care-providers’ statements that express “apology, sympathy, commiseration, condolence, or compassion; … and a general sense of benevolence”; or describe “the sequence of events relating to the unanticipated outcome of medical care.”
The Court carried out this analysis in connection with a patient’s malpractice suit against a hospital. The Court ruled that the patient was entitled to adduce the hospital’s “we messed up” statements that acknowledged its nurse’s negligence (but nevertheless dismissed the patient’s appeal).
This decision presents an interesting puzzle. Under Utah law, when a doctor approaches his patient’s spouse and says “I am sorry we messed up,” this sentence will be redacted into the privileged “I am sorry” and the unprivileged “We messed up.” This approach motivates doctors to formulate their apologies narrowly and never apologize spontaneously. But calculated apologies are not what the “apology rule” wanted to incentivize. Calculated apologies are lacking the genuine apologies’ virtue and benefit the patient and her family only when the doctor is insincere. This undesirable consequence is an example of what T.M. Scanlon calls “the teleological paradox” in his book What We Owe to Each Other (1998).
[Ed. Note: On Friday, February 21, the Petrie-Flom Center, the Food Law and Policy Clinic (a division of the Center for Health Law and Policy Innovation), the Food Law Lab, and the Harvard Food Law Society (with support from the Top University Strategic Alliance and the Dean's Office at Harvard Law School) co-sponsored a conference at HLS called "New Directions for Food Safety: The Food Safety Modernization Act and Beyond." This is the final installment in a series of blog posts from the event; video will follow shortly.]
Dov Fox had a terrific post about taxes on compensation for those who donate eggs and sperm a few weeks ago in reaction to Perez v. Commissioner. I don’t have any particularly new thoughts on this area, but for those of you who haven’t already seen it, I wanted to share the excellent mini-symposium that recently concluded over on the Faculty Lounge on this topic. Kim Krawiec organized, and there’s a series of great posts by several scholars, pointing out, among other things, the strangeness of the fact that there’s still quite a lot of uncertainty about these issues, even though they’ve been around for a while and are not particularly rare. In any case, it’s very much worth reading, even for those who aren’t normally tax wonks.
American University Washington College of Law’s seventh annual Health Law & Policy Summer Institute will run from June 16 to June 28. The Institute’s flexible schedule includes day, evening, and online courses focusing on: (1) pharmaceutical law, (2) bioethics, (3) health care fraud and compliance, and (4) the economics of health care reform.
The O’Neill Institute for National and Global Health Law at Georgetown University is pleased to present two programs this summer: (1) Emerging Issues in Food and Drug Law and (2) U.S. Health Reform – The Affordable Care Act. Now in its third year, the Summer Programs will convene leading practitioners, policymakers, advocates and academics in global food and drug law and US health reform for a series of interactive lectures, panel discussions, and case studies. Held during consecutive weeks, July 14-18 (Emerging Issues in Food and Drug Law) and July 21-25 (US Health Reform – The Affordable Care Act), interested participants may attend one or both programs. Additional details, including schedule, speakers, online application, and program fees may be found here. Questions may be directed to firstname.lastname@example.org.
The Hamline University School of Law Health Law Institute is pleased to offer a variety of condensed health law courses taught by academic and industry experts in Saint Paul, MN. Courses include: (1) Health Care Compliance Institute, (2) Biotechnology Policy, (3) Elder Law, and (4) Health Care Fraud and Abuse. Courses will run from May 27th through June 28th. Additional information, including the application and course descriptions can be found here.
“The Right to Life and the Inter-American Court of Human Rights”
When: March 5, 2014, 12:00-1:00 p.m.
Where: Wasserstein Hall 3007, Harvard Law School, 1585 Massachusetts Ave.
Please join us for a brown bag talk with Professor Paola Bergallo, Faculty of Law, Universidad de San Andrés, Buenos Aires, and HRP Visiting Fellow. Bergallo served as an expert witness in the landmark case Artavia Murillo et al. (“In Vitro Fertilization”) v. Costa Rica, which discusses human rights definitions regarding the right to life, among other health and human rights matters. Professor Gerald Neuman of Harvard Law School will moderate.
This event is being co-sponsored by Harvard Law Students for Reproductive Justice and HLS Advocates for Human Rights.
Official Press Release:
Atlanta – Georgia State University College of Law and its Center for Law Health & Society have selected 10 faculty fellows to participate in the Future of Public Health Law Education: Faculty Fellowship Program. The program is funded by the Robert Wood Johnson Foundation to foster innovations and build a learning community among those who teach public health law at professional and graduate schools. For more information, visit law.gsu.edu/phlfellowship.
The fellows, chosen from across the country, will develop interdisciplinary courses and programs in public health law at their respective universities during the fellowship year. Their projects will strengthen interdisciplinary education in public health law and promote collaborations with public health agencies and organizations in the fellows’ communities.
The fellows are:
In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year. While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.
The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.
The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading
High hopes for overcoming the HIV epidemic rest to a large extent on HIV Treatment-as-Prevention (TasP). Large cluster-randomized controlled trials are currently under way to test the effectiveness of different TasP strategies in general populations in sub-Saharan Africa. At the same time, however, international antiretroviral treatment (ART) guidelines have already moved to definitions of ART eligibility including all – in the US guidelines – or nearly all – in the WHO guidelines – HIV-infected people. In this panel, we are bringing together the leaders of three TasP trials in sub-Saharan Africa, bioethicists, and public health researchers to debate the tension between the policy intentions expressed in these guidelines and the historic opportunity to learn whether TasP works or not. Please join us in considering different options to resolving this tension.
- Till Bärnighausen, Harvard School of Public Health, and Wellcome Trust Africa Centre for Health and Population Science
- Max Essex, Harvard School of Public Health
- Deenan Pillay, Wellcome Trust Africa Centre for Health and Population Science, and University College London
- Velephi Okello, Swaziland National AIDS Programme, Ministry of Health
- Dan Wikler, Harvard School of Public Health
- Nir Eyal, Harvard Medical School
Moderator: Megan Murray, Harvard School of Public Health and Harvard Medical School
Friday, March 7th, 10am-12pm
Kresge G3, Harvard School of Public Health
HEA’s first talk of the semester promises to be a good one, in an area we haven’t covered much before: shaping the far future. In the footsteps of the Future of Humanity Institute, and Nick Beckstead‘s research on the altruistic importance of the far future, we present:
The Future of Life: a Cosmic Perspective
a talk by Professor Max Tegmark
Tuesday, March 4, 7 p.m.
Exploring how we humans have repeatedly underestimated not only the size of our cosmos (and hence our future opportunities), but also the power of our humans minds to understand it and develop technologies with the power to enrich or extinguish humanity.
Known as “Mad Max” for his unorthodox ideas and passion for adventure, his scientific interests range from precision cosmology to the ultimate nature of reality, all explored in his new popular book “Our Mathematical Universe”. He is an MIT physics professor with more than two hundred technical papers and has featured in dozens of science documentaries. His work with the SDSS collaboration on galaxy clustering shared the first prize in Science magazine’s “Breakthrough of the Year: 2003.”
UPDATE, 3/1: DUE TO THE STORM THAT IS CURRENTLY AFFECTING THE EAST COAST, OUR SPEAKER MICHELLE GROMAN HAS HAD TO CANCEL HER TRAVEL FOR MONDAY, 3/3. THE EVENT WILL BE RESCHEDULED FOR LATER IN THE SPRING.
TO BE RESCHEDULED
Austin Hall West (111), Harvard Law School
Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission. Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative. The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.
This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director. Bring your questions!
This event is free and open to the public. Lunch will be served.
For questions, contact email@example.com, or 617-496-4662.
Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.
By Chloe Reichel
1) The Food and Drug Administration has proposed a new format for nutrition facts. The design would prominently feature calorie count and serving size to clearly communicate the nutritional content of the food.
2) A new blood test that screens fetal DNA has been found to be more accurate at predicting Down syndrome and Trisomy 18 than standard blood testing and ultrasounds. This new method of testing is “cell-free” and less invasive than amniocentesis, but positive results would have to be confirmed through traditional methods given the incidence of false-positives.
3) A new method of IVF which utilizes three different sources of reproductive material is being considered by the FDA. The method implants the nucleus of one egg into an enucleated donor egg in order to avoid potential diseases caused by mitochondrial DNA.
4) A glitch with Maryland’s health exchange has left the state without the capacity to decide which of the state’s residents are eligible for Medicaid. The state has decided to keep making payments, despite not knowing the eligibility status of the recipients.
5) Health care co-ops introduced after the implementation of the Affordable Care Act have been struggling to get enrollments. The existence of larger, well-established insurance providers has made it difficult for co-ops to gain a foothold in the market.
6) The San Diego City Council passed legislation this past Tuesday that permits no more than 32 medical marijuana dispensaries to open in the city. This was a revision from the initial plan, which allowed for 131 dispensaries.
7) Gene sequencing has proven itself a valuable technology in diagnosing and informing treatment decisions for uncommon diseases. This technology is predicted to be a promising tool in the realm of more common diseases as well.
8) Mayor Vincent C. Gray, of Washington, D.C., reiterated on Thursday that insurers in the District must cover treatment for gender dysphoria. This policy, which bans medical discrimination on the grounds of gender identity, initially went into effect in March of 2013.
Art Caplan has a new op-ed out on the three-parent baby issue. Here’s an excerpt:
In my view, trying the technique to fix a terrible disease even with risks of failure makes ethical sense. The FDA may ask for more studies in monkeys, but that really wont settle the safety issue in humans. Given the severity of mitochondrial diseases it is worth trying the technique.
The big worry is not so much safety, but where will allowing this form of genetic engineering lead. If we let doctors try to repair defective eggs today, who is to say they won’t be trying to make superbabies or designer babies tomorrow by transferring other genes into eggs?
The answer to that is that how far we go in engineering future generations through genetic manipulations is up to us. We can enact laws and treaties that say yes to gene therapies but no to cosmetic genetic engineering. Holding families hostage by saying they cannot try to repair broken genes to treat diseases because we worry that we cannot put steps or handrails on the slippery slope to designer babies seems wrong to me.
Take a look here.
Coca-Cola has an interesting symbolic presence the world of public health.
Its delivery system is the envy of vaccine programs: the committed global health workers who’ve trekked for days through harsh and inhospitable lands to reach even the most distant communities are likely to find a refreshing, cold Coke already waiting for them at the village store.
For those who focus on non-communicable chronic diseases (NCD), (regular) Coke is the scourge that is providing the extra calories that fuels the obesity epidemic. Many experts believe that eliminating the calories contained in a single, 16oz serving of regular Coke from daily diet would be more than enough to revert the trend towards rising obesity and return average weight in the population back to where it was 30 years ago.
But the symbolic presence of Coca-Cola in US culture and politics is perhaps even more interesting, and the resulting dynamics could have some unexpected consequences in terms of population health.
By Deborah Cho
As a student in the Disability Litigation Clinic, one of the many fantastic clinics here at Harvard Law school, I’ve come to appreciate the value of hands-on experience as an essential component of legal education. One issue that we as students are often faced with, however, is a lack of familiarity with the particular subject matter we are assigned to work with. Now, I know that topic-specific knowledge typically comes on the job, but I’m starting to see that many of us trying to practice law touching the medical field never really have a chance to learn the basics of the medical world and just how essential that basic knowledge really is.
As a short introduction to this post, I will say that I spent several of my college years volunteering and doing research at various hospitals and clinics, went to medical school for two years, have an M.A. in Bioethics (noting this to add to my hours spent in a hospital), have interned in the health care division in state government, have interned in a health law nonprofit firm, and, as noted above, am enrolled in the Disability Litigation Clinic right now. All that to say, please take everything I write here with a grain of salt. I am by no means an expert on this, but have found that this information has helped me throughout my healthcare-related legal experience so far and I hope that this will spark dialogue and interest on this subject.