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Ohio State Seeks Founding Director of New Program on Data, Law, Ethics and Policy

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By:  Efthimios Parasidis

The Ohio State University Moritz College of Law seeks a mid-level to senior tenured professor to serve as Professor of Law and founding director of the Program on Data, Law, Ethics and Policy (“DLEAP”) at the College, part of the Ohio State University’s Translational Data Analytics Discovery Theme initiative. The successful candidate will demonstrate excellence in scholarship and a commitment to outstanding teaching.   The position, a 51% FTE appointment, will begin in the 2016-17 academic year.

As a faculty member the successful candidate will be expected to teach core and specialized courses in the law curriculum. The research and teaching interests of the successful candidate will likely focus on privacy law and regulation, information- and cyber-security, big data and data mining, and/or related health law and intellectual property issues.   As the director of DLEAP, he or she will be responsible for building the research program, with a small staff and an assortment of affiliated faculty. A successful candidate must be capable of leading DLEAP in employing legal, regulatory, and policy expertise to focus on the social and ethical impact of big data and in serving as a complement and resource for other Translational Data Analytics initiatives at Ohio State and to the broader data analytics community. Read More

How Well Do You Know Your Turkey?

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by Efthimios Parasidis

In the United States, over 250 million turkeys are slaughtered each year, with over 45 million just for Thanksgiving. The overwhelming majority of these birds (over 99%) are a genetically engineered and industrially-farmed breed known as Broad Breasted White. As the name suggests, this breed of turkey has an unnatural abundance of white breast meat.  In many ways, industrial turkey farms are similar to industrial chicken farms–typically there are thousands of birds packed into a closed space with no natural light, no access to the outdoors, and mechanized feed and water (often laced with antibiotics and growth hormones). Adult turkeys in an industrial farm typically cannot walk properly or reproduce on their own, and artificial insemination is the norm. The eggs are hatched in an incubator and newborns have no contact with their mother. Shortly after birth, the young turkeys are placed into a large dark warehouse that will be the only space they will ever know. Their toes and beaks are cut without pain killers. Due to the grotesque environment, millions of birds die from “stress-induced conditions“. Those that survive grow at an astonishing rate, attaining market weight in just 12-18 weeks. The adults often are blind, due to lack of natural light and other factors (such as pecking fights in the tight quarters). According to one study, if a 7 pound human newborn grew at the same rate as an industrial turkey, it would be 1,500 pounds at 18 weeks of age.

A small but growing number of turkeys are non-genetically engineered Heritage Breeds. Heritage Breeds were in existence prior to the industrial-farming practices introduced in the 1960s, with some breeds tracing their roots to the 1800s. Standard farming practices for Heritage breeds include liberal roaming of pastures, humane growing conditions, and no antibiotics or growth hormones. Heritage turkeys are difficult to find, with some farmers requiring advanced notice (often months in advance) to purchase. The higher cost of Heritage turkeys (about $7 a pound, compared to approximately $1.50 a pound for industrial birds) reflects the higher cost of raising them, as well as insufficient subsidies for farmers employing organic and/or sustainable practices (along with over-subsidization of industrial and corporate farms).

It’s important to note that an organic turkey is not necessarily a Heritage breed. An organic turkey is any breed that has been fed an organic diet. Similarly, a free-range turkey is not necessary a Heritage breed. In fact, free-range does not mean that the turkey has actually stepped foot on a pasture. Rather, under USDA regulations, a bird can be labeled free-range if it lives in a space where there is access to the outdoors. Reaching the outdoors is immaterial. If knowing your turkey matters to you, be sure to ask the right questions, including the breed of the turkey, what feed the turkey has been provided (including whether the feed was comprised of genetically-modified ingredients), whether the turkey has been given antibiotics or other drugs or hormones, and whether the bird actually foraged in a pasture.

Haiti in a Time of Cholera

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By: Efthimios Parasidis

In the midst of “the world’s worst and fastest-spreading cholera epidemic“, with more than 685,000 infected and approximately 8,400 dead, five Haitian families are suing the United Nations in federal court in the Southern District of New York. The families are seeking $2.2 billion for the Haitian government’s relief efforts and unspecified damages for Haitian families affected by the outbreak. Despite evidence which indicates that cholera was introduced by UN peacekeepers, the UN has yet to admit responsibility and has denied compensation to the victims, though it continues to provide assistance to Haiti. The UN argues that immunity precludes legal recourse, and undoubtedly will move to dismiss the complaint. Aside from the legal arguments regarding immunity, the question remains whether the UN has a moral responsibility to provide compensation and more robust remediation measures, particularly because there were “documented sanitation deficiencies” at a UN camp that has been identified as the source of the outbreak. As we await a decision from the court, and a response from the UN, cholera continues to kill nearly three Haitians each day.

 

Call for Abstracts: 2013 Health Law Scholars Workshop

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The Center for Health Law Studies at Saint Louis University and the American Society of Law, Medicine & Ethics (ASLME) are pleased to announce the 2013 Health Law Scholars Workshop. The Health Law Scholars Workshop is a collegial forum in which junior faculty who are new to health law and bioethics scholarship present works-in-progress and receive in-depth advice from experienced scholars and teachers in the field of health law and bioethics. The workshop encourages health and bioethics scholarship, fosters the professional development of emerging scholars and furthers the sense of community among health law academics. The full brochure may be found here.

A nominating committee selects the papers to be presented at the workshop. The committee looks for papers that have an original thesis and will contribute to scholarly literature. The workshop is designed primarily to provide feedback on articles intended for spring submission to law review journals. The workshop is not designed to review published work or papers already accepted for publication.

Those interested in presenting a health law or bioethics work-in-progress at the Health Law Scholars Workshop should submit a 500-word abstract of the proposed paper together with a resumé to Cheryl Cooper (ccoope22@slu.edu) at Saint Louis University School of Law by April 1, 2013. Because a blind selection process is used, please do not include the author’s name or institutional affiliation on the abstract. Questions about the submission process should be directed to Prof. Sidney D. Watson at watsons@slu.edu or 314-977-2751.

Are Human Genes Patentable?

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Efthimios Parasidis

The Supreme Court will consider the patentability of human genes when it reviews the Myriad case this term. As Bill of Health readers are likely to know, the Myriad case centers on Myriad’s patents on gene sequences for BRCA mutations that are associated with the propensity to develop breast or ovarian cancer.  Myriad does not claim ownership over the mutations as they exist in nature, but rather on isolated BRCA sequences that the company has “created”. The Myriad case will give the high Court another chance to clarify the scope of subject matter that is eligible for patent protection. The Court’s track record in this area is less than stellar.

As I have argued (here), the legal uncertainty at to the scope of patentability for claims that implicate products of nature is largely the result of the lack of a uniform framework for determining what areas are excluded from patent-eligible subject matter. More specifically, while patent law prohibits patent protection for inventions that equate to a law of nature, natural phenomenon, mental process, mathematical equation, or abstract idea (collectively referred to as the product of nature doctrine), no court has defined these terms adequately. Uncertainty is bad for business and bad for patients — the Court should seize upon this opportunity and offer clear guidance as to the contours of the product of nature doctrine.

With respect to gene sequences, the mere fact that a sequence is isolated is inconsequential.  Rather, courts should analyze the precise subject matter of the isolated gene sequence to determine if it differs substantially from its natural counterpart. I’ve created a three-part test to help make this determination:

  1. Does the isolated sequence exhibit characteristics or contain properties that are substantially different from the non-isolated sequence?
  2. Is the proximate cause of any difference between the isolated and non-isolated sequences the result of natural phenomenon that govern the properties of the sequence when isolated?
  3. Would a patent on the isolated sequence grant a property interest that extends to anything other than the isolated sequence?

If the answer to these questions is anything other than (1) yes, (2) no, (3) no, the claim must be invalidated pursuant to Section 101 of the patent act because the claim does not constitute patent-eligible subject matter. My article explains why…

EPA Seeks Comments on Monsanto’s Request for Experimental Use of Genetically-Modified BT Corn

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Efthimios Parasidis

The Environmental Protection Agency has determined that Monsanto’s request to plant a new strain of genetically-modified corn “may be of regional and national significance.”  As a result, the agency is seeking public comment on Monsanto’s application.

Monsanto seeks permission to test the new corn in Puerto Rico and 22 states over the next two years.  The corn is bioengineered to produce Bacillus thuringiensis (BT), a bacteria that is known to kill rootworm.  The risks of BT-engineered crops are not fully known.  In addition to impacting the biodiversity of the soil and environment, BT toxin is known to kill other insects such as moths and butterflies, and some have argued that crops genetically-engineered to produce BT toxin have led to colony collapse disorder which has devastated beehives all over America for a number of years.

To be sure, naturally-occurring BT-products are allowed for USDA certified-organic production, and genetically modified BT-corn may be more environmentally friendly that other strains of genetically-modified corn since the corn itself produces the toxin, and thus theoretically would require less spraying of pesticides.  However, rootworm is known to adapt quickly and become resistant to bioengineered BT toxin.  In fact, farmers have had to spray their corn with chemical pesticides that the bioengineered BT corn was supposed to avoid. Notably, studies have found that genetically-modified BT crops adversely impact the health of humans and livestock, while BT toxin has been discovered in the blood of pregnant women and fetuses.  Given the widespread health and environmental concerns, to the extent the EPA is inclined to grant Monsanto’s request, the agency should condition the experimental use on funding for independent research that evaluates the long-term effects of bioengineered BT crops on humans, livestock, and the environment.

FDA’s New Dance with Big Pharma: Are Patients the Band?

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Efthimios Parasidis

One week prior to the Supreme Court’s landmark ruling in the health care cases, Democrats and Republicans overwhelmingly voted in favor of health-related legislation (387-5 House; 96-1 Senate).  Industry and HHS were quick to congratulate our elected officials on a triumphant bipartisan achievement, while the FDA enthusiastically welcomed its latest collaboration with Big Pharma.  Lobby groups boasted of their ability to “craft” legislation with FDA and praised the “unprecedented level of public input” into the new law.

We should all be concerned.

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Congratulations to the 2012 Health Law Scholars!

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This past weekend was the eleventh annual Health Law Scholars Workshop, and I wanted to take a minute to congratulate the 2012 Scholars: Alena Allen (Memphis), Leo Beletsky (Northeastern), Christina Ho (Rutgers-Newark), and Lindsay Wiley (American).  Each scholar had two hours dedicated to a discussion of their work, with expert reviewers including Rebecca Dresser (Wash U), Elizabeth Weeks Leonard (Georgia), Kevin Outterson (Boston University), Ted Ruger (Penn), and Rob Schwartz (New Mexico/Hastings), along with the health law faculty at the Center for Health Law Studies, Saint Louis University.  The Workshop is sponsored by the American Society of Law, Medicine & Ethics and SLU’s Center for Health Law Studies, and scholars are selected by a health law committee through blind peer review.  To date there have been 44 scholars, including many contributors to Bill of Health.