This past Sunday, a group of researchers reported in the journal, Nature Medicine, a preliminary technique that uses variation in blood levels of 10 fats to predict the likelihood that elderly individuals would develop mild cognitive impairment (MCI) or Alzheimer’s Disease in the following 2-3 years. The sample size was small and the results may not generalize beyond the narrow age-range and demographics of the study group (i.e. the assay is far from ready for “prime time”), but the study is an important first step towards a lower cost (vs PET imaging) and less invasive (vs spinal tap) predictive biomarker of cognitive decline*. Its publication has also triggered a flurry of discussion on possible ethical ramifications of this sort of blood biomarker. I will not attempt to address these ethical issues specifically here. Rather, I seek to highlight that how ethically troubling one views the technology to be may depend partly on the sort of knowledge one thinks these biomarkers reveal (applied epistemology at its best).
An interview with I. Glenn Cohen on law and bioscience
With the first issue of Journal of Law and Biosciences now available, the Oxford University Press blog has published an interview with I. Glenn Cohen discussing the journal’s focus and format. From the blog:
There are huge changes taking place in the world of biosciences, and whether it’s new discoveries in stem cell research, new reproductive technologies, or genetics being used to make predictions about health and behavior, there are legal ramifications for everything. Journal of Law and the Biosciences is a new journal published by Oxford University Press in association Duke University, Harvard University Law School, and Stanford University, focused on the legal implications of the scientific revolutions in the biosciences. We sat down with one of the Editors in Chief, I. Glenn Cohen, to discuss the rapidly changing field, emerging legal issues, and the new peer-reviewed and open access journal.
Read the full interview.
Pom Wonderful v. Coca-Cola: Will the Supreme Court’s Decision Have Implications Beyond “Pomegranate Blueberry Flavored Blend of 5 Juices”?
By Kate Greenwood
Cross-Posted at Health Reform Watch
On April 21st, the Supreme Court will hear oral argument in Pom Wonderful v. The Coca-Cola Company, a case in which Pom sued Coke under Section 43(a) of the Lanham Act arguing that Coke’s product “Pomegranate Blueberry Flavored Blend of 5 Juices” was misleadingly named. Coke countered that the suit should be dismissed because the name was specifically authorized by the Food and Drug Administration’s regulations governing flavored juice blends, and both the District Court and the Ninth Circuit Court of Appeals agreed.
In its opening brief filed last week, Pom argues that neither the provisions of the Food, Drug and Cosmetic Act governing food and beverage labeling generally, nor the regulations that specifically address juice blends, precludes the application of the Lanham Act to Coke’s misleading juice label. This conclusion, per Pom,
“follows inexorably from this Court’s holding in Wyeth v. Levine … that FDA’s approval of a drug label does not displace state failure-to-warn suits challenging the adequacy of the warning. … Following Wyeth, there can be no serious argument that the provisions of the FDCA are in ‘irreconcilable conflict’ with the Lanham Act. FDA does not even generally review—much less approve—particular food labels; nothing even arguably prevented Coca-Cola from designing its label to avoid misleading consumers; and FDA has given no indication that its juice-naming rules set the outer bounds of labeling regulation.”
In its brief opposing Pom’s petition for certiorari, Coke distinguished Wyeth, noting that the provisions of the FDCA governing drug labeling do not expressly preempt state regulation. The provisions of the FDCA governing food and beverage labels, by contrast, “expressly supplant State laws—including those that imposed more ‘stringent’ requirements[.]” This, Coke argued, shows that the food and beverage statutory provisions and their implementing regulations “were not intended as a ‘floor’ but rather as the exclusive body of regulation to which food and beverage labels would be subject.”
In her latest article, The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, Diana Winters decries the time and money courts deciding food and beverage labeling cases must spend “negotiating the interaction between federal and state law, with inconsistent outcomes”. Read More
Diagnosing Mental Disorders from Internet Use
By Nathaniel Counts
We live in a time when increasingly our personal information is publicly available on the internet. This personal information includes our names and phone numbers, things we’ve written and things we’ve done, along with a good deal of information that only exists because we interact with others on the internet – thoughts that we might not have otherwise externalized, or that we certainly would not have saved so that others could read.
If all of this information is publicly available, all of this information can be gathered. Already advertisers analyze our behaviors to better target products to us. It is not hard to imagine a not so distant future where the government analyzes this data to determine whether we have a DSM mental disorder. By looking at the online behaviors of those already diagnosed – the way the syndrome affects their usage patterns, the sites they visit, and how they interact with others online – it is likely that one can find statistically significant usage patterns that can distinguish individuals with a diagnosis from those without. The available data could then be mined to identify other individuals that exhibit the usage pattern and allow for presumptive diagnosis.
3/27: panel discussion on Current Legal Issues in HIV/AIDS Work
Current Legal Issues in HIV/AIDS Work
Thursday, March 27, 2014, 12:00pm
Wasserstein Hall 1019, Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
More than 30 years have passed since AIDS first appeared in the United States. Today the CDC estimates that 1.1 million Americans are living with HIV/AIDS, and each year 50,000 Americans are newly diagnosed. Despite great strides in education, awareness, prevention, and treatment, people affected by HIV/AIDS still face significant discrimination, including unequal treatment under the law. This panel will explore some of the legal barriers faced by people living with HIV/AIDS in the United States, including FDA’s ban on men who have sex with men donating blood and laws criminalizing HIV transmission. Panelists include:
- Felix Lopez, Director of the Legal Department, GMHC
- Jason Cianciotto, Director of the Public Policy Department, GMHC
- I. Glenn Cohen, Professor of Law and Faculty Co-Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
- Moderator: Aziza Ahmed, Visiting Scholar, Petrie-Flom Center; Associate Professor of Law, Northeastern University School of Law
This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.
This event is cosponsored by Gay Men’s Health Crisis (GMHC). Founded in New York in 1981, GMHC is one of the world’s first and leading providers of HIV/AIDS prevention, care, and advocacy.
Twitter Round Up
This week’s twitter round up features a variety of topics from our contributors, from discussions about the troubles of patient matching to generic drug labeling and the readmission penalty.
Adrian Gropper shared a link to the most recent entry of his The Health Care Blog entitled “What You Need To Know About Patient Matching and Your Privacy and What You Can Do About It” in which he compares patient matching to “NSA surveillance.”
Amitabh Chandra tweeted that “the current readmission penalty, however well-intentioned, sure looks like a tax on minority and indigent serving hospitals.”
Frank Pasquale shared an article about the myths of high-protein diets and the potential consequences, including the quote that there is a “strong association between longevity and a low-protein, high-carbohydrate diet.”
I. Glenn Cohen shared a link to an article about “Intersextion: Germany Allows Patient to Choose ‘No Sex’ on Birth Certificate” and poses the question of whether or not the United States should follow Germany’s example in making such an allowance.
Kate Greenwood retweeted Alexander Gaffney including a link to a discussion of the new arguments being made about the generic drug labeling rule: “Opponents, Proponents of Generic Drug Labeling Rule Unleash New Argument and Supporters.”
Art Caplan: #SaveJosh? Maybe, but What about the Rest?
Art Caplan has a new opinion piece up at MSNBC on the #SaveJosh social campaign that is seeking to get a young cancer patient access to an experimental drug under compassionate use policies. From the article:
If Josh were 67 instead of 7, he would already be out of luck. Those who are not very cute get less attention in their pursuit of unproven drugs. If Josh had parents who did not understand how to use social media, he would already be out of luck. If Josh did not have sharp, well-connected doctors, he would already be out of luck. But he is not in any of these categories, so he may yet get the drug.
All of which is to say, this is no way to handle requests from desperate patients, parents or families to try to save themselves or their loved ones from imminent death by giving them access to unproven, experimental drugs. We need an equitable compassionate use policy for everyone in this country.
Read the full article.
Worth Reading This Week
- Haavi Morreim, Dumping the ‘Anti-Dumping’ Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, SSRN/Min. J L Sci Tech
- David Orentlicher, Health Care Reform and Efforts to Encourage Healthy Choices by Individuals, SSRN/N Carolina L Rev
- Kevin Outterson, New Business Models for Sustainable Antibiotics, SSRN/Centre on Global health Security Working Group Papers
- Diana Winters,The Magical Thinking of Food Labeling: The NLEA as a Failed Statute, SSRN
Introducing New Blogger Jennifer Bard
Jennifer S. Bard contributes to the HealthLawProf Blog, and is joining Bill of Health as a regular contributor.
Jennifer is the Alvin R. Allison Professor of Law and Director, Health Law Program, 2003 and an Associate Professor (adjunct), Department of Psychiatry, TTU School of Medicine. She was formerly Associate Dean for Faculty Research and Development. She is the Director, Health Law Program and JD/MD Program at the law school. In 2009 Professor Bard was elected as a member of the American Law Institute and was also awarded the Texas Tech University President’s Excellence in Teaching Award. In 2008 she received the award for the Best First Year Teacher from the Phi Alpha Delta Law School Honors Fraternity. She is the chair-elect of the American Association of Law School’s section on Law, Medicine, and Health Care. She is also the Book Review editor of the Journal Of Legal Medicine.
Representative publications: Read More
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