Legal Dimensions of Big Data in the Health and Life Sciences

By Timo Minssen

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

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Animals are Already Legal Persons: On Steven Wise, the Nonhuman Rights Project, and Misguided Personhood Debates

The New York Times Magazine has just published an interesting piece on the Nonhuman Rights Project and Steven Wise, whose mission is to change the common law status of at least some nonhuman animals from “mere things” to “legal persons.”  (I have previously written on their work here).  It is widely agreed, among both advocates and opponents of Wise’s work, that granting legal personhood to animals would be revolutionary.  I think that this view is mistaken.  To understand why, it is helpful to clarify and differentiate between three possible conceptions of what it might mean to be a “legal person”—a term that is often used in imprecise ways.  Doing so reveals that animals are already legal persons, and that personhood does not itself count for very much. Continue reading

Killing for Species Health

In the past few months, the Copenhagen Zoo has killed a giraffe and four lions in order to protect the genetic health of their breeding populations, generating significant international backlash and highlighting difficult questions about the value of species preservation.

The international controversy surrounding the zoo’s actions began in February, when it killed a healthy 18-month old giraffe with a bolt pistol, performed a public autopsy on his body (video), and then fed his remains to the zoo’s lions and other big cats in front of the public (video).  A bolt pistol was used, rather than an injection, so that his meat would be safe to eat.  A statement from the zoo explained that it had decided to kill this giraffe because his genes were “well represented in the breeding programme,” such that allowing him to grow into an adult and breed was “unwanted.”  Zoo officials turned down adoption offers from other zoos on the grounds that this would have left open the door to inbreeding and potentially removed a place for a giraffe whose genetic makeup was more valuable in terms of future offspring in captive breeding programs.  (The statement also addresses a variety of other interesting “health law” questions, such as “Why are the giraffes not given contraceptives?”).

The controversy gained further momentum two weeks ago, when the zoo announced that it had killed four lions—a 16 year-old male lion, a 14 year-old lioness, and their cubs—to clear the path for a newly arrived young male lion.  (It is unclear whether these specific lions were among those who had previously eaten the giraffe).   A statement from the zoo explained that it had decided to kill these lions based on several population-level concerns, including that the 16 year-old male might have someday mated with his female offspring creating a problem of inbreeding, or that the new young male might have mated with the 14 year-old lioness instead of younger females with greater reproductive fitness.

While the idea that these types of killings can be justified on the grounds that they protect the health of the genetic populations of which the individual animals are a part is fairly common, it is unclear whether “health” is actually an appropriate concept to apply to an entity such as an animal’s species.    Continue reading

Japanese Whaling and the International Court of Justice

Yesterday, the International Court of Justice ruled that the Japanese government must halt its whaling program in the Antarctic pursuant to its obligations under the International Convention for the Regulation of Whaling.

At issue in this case was Article VIII of the Convention, which allows a member state to issue permits authorizing the killing of whales when it is done “for purposes of scientific research.”   (Commercial whaling has been prohibited since the International Whaling Commission, which implements the Convention, adopted a moratorium in 1982).

Under the Article VIII exception, Japan had established a research program that issued permits for the lethal sampling of Antarctic minke whales, fin whales, and humpback whales.  The program was meant to serve four research objectives: monitoring of the Antarctic ecosystem, modeling competition among whale species and future management objectives, elucidating temporal and spatial changes in stock structure, and improving the management procedure for Antarctic minke whale stocks.   Under the program, Japan had set a kill target of 850 minke whales, 50 humpback whales, and 50 fin whales.   Most of the whale meat from the hunts was sold in Japan, where it is considered a delicacy.

Australia brought suit against Japan in the International Court of Justice, alleging that its program simply cloaked commercial whaling in the veil of science, and the Court agreed.  It is worth noting, however, the Court did not base its decision on a rejection of the scientific merit of the program’s objectives or methods.  (On this score, it held that the program could “broadly be characterized as ‘scientific research” and that lethal methods of sampling could be justified).  Rather, the Court based its decision on its determination that the permits were not issued “for purposes” of scientific research. Continue reading

Antibiotics, Farm Animals, and the FDA

On Wednesday, the Food and Drug Administration announced that 25 pharmaceutical companies that manufacture animal drugs will participate in voluntarily phasing-out the use of antibiotics for growth promotion purposes in farm animals.

The companies are acting in response to voluntary guidelines that the FDA issued in December, requesting that the companies change their labeling of “medically important” antibiotics in two ways: (1) removing production uses (e.g., animal growth promotion) from the approved indications for the drugs; and (2) requiring veterinary oversight, rather than allowing over-the-counter distribution, for the remaining therapeutic uses.

Of the 26 companies targeted by these guidelines, 25 have agreed to comply by either revising their labels or withdrawing the drugs from animal use completely.   The FDA did not name the one company that has not agreed to comply.

While this is undoubtedly an important step forward in the FDA’s efforts to reduce non-necessary uses of antibiotics in livestock production—and hopefully slow the evolution of drug-resistant bacteria—it is important to note that there are potential loopholes in the FDA’s approach, as I have previously discussed. Continue reading

De-extinction

A few weeks ago, the New York Times Magazine ran a fascinating piece titled “The Mammoth Cometh,” which tells the story of a growing number of scientists around the world who are working on projects of “de-extinction.”   Significant progress has been made, and some scientists estimate that we will be able to revive certain species, such as the dodo or the passenger pigeon, within 10-15 years.

But is reviving species from extinction a good thing to do?  The way in which this normative question is treated in the NYT article is interesting.   While some of the key dangers of reviving extinct species are identified and discussed, the underlying narrative seems to accept that if these dangers could be avoided, de-extinction would be a good thing.   What its value is, however, is never spelled out in particularly clear terms.

The primary value identified by many advocates of de-extinction is the environmental value of “conservation.”   Steward Brand, for example, states that de-extinction could provide “a beacon of hope for conservation.”  But two different conceptions of conservation appear to be at work in the entangled arguments about the value of reviving extinct species. Continue reading

FSMA Conference Part 4: Benefits, Challenges, and Gaps in FSMA’s Approach

[Ed. Note: On Friday, 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 week, we will be sharing a series of blog posts from the event, and video will follow shortly.]

By Jeffrey Skopek

Lewis Grossman, Washington College of Law, American University – New Governance, New Challenges

Professor Grossman opened the panel by locating FSMA in the context of the “new governance” movement that has arisen in response to the limits of command and control regulation.   Continue reading

Hard Paternalism

Is hard paternalism in medicine ever justified?   In a recent NYT op-ed titled “When Doctors Need to Lie,” cardiologist and author Sandeep Jauhar provides a thought-provoking perspective on this question.

Dr. Jauhar begins with a description of a case in which the father of a 22-year-old patient requested that Jauhar temporarily lie and tell the patient that was going to be fine, even thought he was suffering from severe heart failure.  Jauhar agreed on grounds that the patient was not yet psychologically ready to hear the news and that withholding the information was therefore justified by the central principle that “physicians must do no harm.”

This example of temporary lying provides an avenue into a general discussion of the role of paternalism in medicine, which Jauhar argues should not be wholly displaced by respect for patient autonomy.   He argues that “when a doctor believes that a paternalistic approach is justified, he should aim to keep it as ‘soft’ as possible,” but that “there may be a place in medicine for hard paternalism, too.”

In support of hard paternalism, Jauhar describes a case in which one of his patients was bleeding into his lungs and was going to die without a breathing tube.   Jauhar knew that the patient had previously told other doctors that he never wanted to be intubated, but he did not know the quality of their discussion and could not find out because the patient was nearly unconscious.   So he intubated the patient, thereby saving his life.  And in the end, the patient thanked him.

But does this story actually offer support for hard paternalism? Continue reading

Genetically Modified Crops

The USDA’s Animal and Plant Health Inspection Service (APHIS) has released a Draft Environmental Impact Statement associated with its deregulation of a new generation of genetically modified herbicide-resistant crops.   While many in the agricultural industry hail this as a much-needed step in the development of new weed-control technologies, critics worry that it will accelerate an “herbicide treadmill” at the cost of more sustainable management strategies.

As a bit of background, the development of the first generation of genetically modified (GM) herbicide-resistant crops revolutionized agricultural weed management in the mid 1990s.  Prior to this development, weed management required significant skill and knowledge.  Farmers had to not only carefully manage the timing of various herbicide applications, but also integrate other nonchemical control practices.  Herbicide-resistant crops, by contrast, were effective and easy to use.

During the initial phase of development, a variety of GM options came to market, but Monsanto’s “RoundupReady” varieties (which are resistant to a broad-spectrum herbicide known as “glyphosate”) quickly became dominant.   By 2008, 63% of corn fields and 92% of soybean fields in the US were being planted with RoundupReady seeds.  The outcome of this single-track approach to weed management has been a dramatic increase in the number of weed species that are resistant to the herbicide glyphosate.

In response to the evolution of these “super weeds,” Congress has held hearings to assess whether additional government oversight is needed to address the problem.  The response of the seed and agrichemical industries, by contrast, has been to develop new GM seeds that are resistant to other broad-spectrum herbicides for which weeds have not yet developed resistance.  Continue reading

Antibiotics in Livestock

Last week, the Food and Drug Administration finalized a long-awaited guidance document that aims to reduce non-therapeutic uses of antibiotics in livestock production and thereby limit the evolution of drug-resistant bacteria.

As I discussed in a previous post, the use of antibiotics in livestock production is often not for the therapeutic purpose of curing disease, but rather for the purpose of speeding growth or increasing feed efficiency.   Current estimates are that livestock production consumes 30 million pounds of antibiotics per year, representing 80 percent of the total volume of antibiotics sold in the United States for any purpose.  The FDA policy that allows non-therapeutic uses of antibiotics in livestock has in recent years been subject to intense scrutiny by outside advocates, former FDA officials, government investigators, and judges.

The FDA has now taken action to address these concerns by finalizing industry guidelines that it first proposed over a year ago.   Under the guidelines, animal pharmaceutical companies would change the labeling of “medically important” antibiotics in two ways.  First, the labeling would no longer list production uses (i.e., growth enhancement and feed efficiency) in the approved uses for the drugs.  Second, the labeling would require veterinary oversight for therapeutic uses (i.e., the prevention, control, or treatment of a disease), rather than allowing over-the-counter distribution.  These changes in labeling would in turn require changes in agricultural use by virtue of other FDA regulations that prohibit off-label use for production purposes.

While the FDA’s action is a step in the right direction toward eliminating non-therapeutic uses of antibiotics in food animals, there are a few features of its strategy that are worth highlighting as they might significantly limit its impact.     Continue reading

Animals in Court: Does Personhood Matter?

In 1386, a female pig was put on trial in France for causing the death of a child by tearing his face and arms.  Trials such as this were not uncommon in medieval Europe. As E.P. Evans describes in The Criminal Prosecution and Capital Punishment of Animals, the same procedural rules applied to human and animal defendants, and the defense counsel for animals often raised complex legal arguments on their behalf.  In this case, the sow was found guilty, and under the law of “eye-for-an-eye,” the tribunal ordered that she be maimed in the head and upper limbs and hanged in the public square.

Animals today hold a very different place in our law.   As the subject of extensive legal protections and the beneficiaries of private trusts, they are no longer defendants in our courts, but rather aspiring plaintiffs.

Earlier this week, a series of habeas corpus petitions were filed on behalf of chimpanzees being held in confinement for various purposes in the state of New York.  (Court documents available here). The petitions, filed on behalf of the chimpanzees by the Nonhuman Rights Project, ask the court to recognize that the chimpanzees are legal persons with a right to bodily liberty, and to order that they be moved into the care of the North American Primate Sanctuary Alliance.  This is the first time that a habeas petition has been filed on behalf of an animal in the United States.

Of the many important and interesting issues raised by these petitions, I will in this post focus the significance of granting legal personhood to animals.

While courts in the US have not previously been asked to recognize an animal as a person with a common law right of liberty, they have been confronted with a remarkable number of cases in which animal species are listed as lead plaintiffs—most often in suits brought to enforce provisions of the Animal Welfare Act (AWA) and Endangered Species Act (ESA).  In one such case, the Ninth Circuit ruled that the endangered bird species at issue was a party with “legal status and wings its way into federal court as a plaintiff in its own right.”

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Animals, the WTO, and Public Morality

Last week, a World Trade Organization panel ruled that EU restrictions on the import of seal products are justified under a free trade exception for trade restrictions that are “necessary to protect public morals.”  This is the first time that the WTO has backed a trade restriction grounded on concerns for animal welfare.

At issue in the case was a challenge to EU regulations that generally ban the import and marketing of seal products in the EU, with exceptions to the ban when certain conditions are met (such as when the seal products are derived from hunts conducted by Inuit or indigenous communities, or when the hunts are conducted for marine resource management purposes).

The panel ruled that the EU must alter its application of the exceptions (as it has thus far treated imported and domestic seal products differently), but concluded that the “objective of addressing EU public moral concerns on seal welfare” was a valid ground for imposing trade restrictions.   Thus, if the EU applies the exceptions consistently, the restrictions will be permitted.

One reason that this ruling is significant is that it paves the way for other trade restrictions based on animal welfare concerns.  Continue reading

30 Pound Turkeys, 30 Million Pounds of Antibiotics

Since 1960, the weight of an average live domesticated turkey has nearly doubled from around 15 to 30 pounds.   And current estimates are that 30 million pounds of antibiotics are used in livestock production per year (which represents 80 percent of the total volume of antibiotics sold in the United States for any purpose).  These two facts are related.

The use of antibiotics in livestock is often not for the purpose of curing disease, but rather for the purpose of growth promotion—a practice that has arisen with the intensification of livestock farming.  Although the mechanism underpinning their action is unclear, it is believed that the administration of antibiotics at non-therapeutic doses suppresses sensitive populations of bacteria in the intestines, helping animals digest their food more efficiently.

This non-therapeutic use of antibiotics continues despite clear evidence that the overuse of important antibiotics for humans in the livestock industry spreads dangerous antibiotic resistance. Continue reading

Are Dogs People?

In a fascinating opinion piece in the New York Times this past weekend, neuroeconomist Gregory Berns writes: “For the past two years, my colleagues and I have been training dogs to go in an M.R.I. scanner — completely awake and unrestrained.  Our goal has been to determine how dogs’ brains work and, even more important, what they think of us humans.  Now, after training and scanning a dozen dogs, my one inescapable conclusion is this: dogs are people, too.”

As Berns explains, his research found a striking similarity between dogs and humans in the structure and function of a part of the brain known as “the caudate nucleus.”  It was previously known that in humans, the caudate plays a key role in positive emotions, including the anticipation of things we enjoy, such as food, love, and money.    What Berns and his colleagues discovered is that in dogs, the caudate is activated when they are exposed to hand signals indicating food, the smells of familiar humans, or the return of their owners.   While Berns emphasizes that these findings do not “prove that dogs love us,” he concludes that “using the M.R.I. to push away the limitations of behaviorism” suggests that dogs have “emotions just like us.”

There is much thought-provoking material to write about in this opinion piece (including the fact that they “treated the dogs as persons,” with consent forms, the right to withdrawal, etc.), but what I want to focus on in this post is the premise that neuroscience can resolve contested questions about the existence of mental states—in animals, or even in humans.

The allure of this use of neuroscience is that it seems to work around a classic philosophical problem known as “the problem of other minds,” which refers to the puzzle of how one knows whether someone or something, other than oneself, has a mind.  Continue reading

Anonymity is Not Privacy (and Why it Matters)

Anonymity is not just an aspect of privacy and recognizing their difference reveals a powerful and poorly understood set of legal tools for facilitating and controlling the production of public goods.  This is the central claim of my newest article (SSRN draft available here).

Three examples illustrate the scope of the under-explored ways in which anonymity is currently used in our law.

  • The first is from June 1997, when many residents in the Boston neighborhood of Allston learned to their anger that Harvard University had spent the previous 8 years secretly acquiring over 50 acres of Allston real estate.  It did so using buying agents, which can generally protect their principal’s anonymity—even by falsely stating that they are not agents.
  • The second is from Election Day 2012, when many voters who had shared photos of their completed ballots on Facebook and Twitter learned, to their surprise, that they had violated their states’ elections laws in doing so.   They did not know that anonymity in voting was not just a right, but also a requirement.
  • The third is from a 2006 lawsuit over the control of thousands of tissue samples being used in research at Washington University.  When many of the research participants sought to withdraw their tissue from future research, in response to what they saw as a breach of their consent, they were shocked to learn that the university could refuse and extinguish their rights of withdrawal by anonymizing their tissue samples.

These varied uses of anonymity in our law—as a right when purchasing land, a requirement in voting, and a trigger than extinguishes rights in biomedical research—may appear to be unrelated.  But I argue that they are in fact all part of a cohesive and previously unrecognized class of rules that use anonymity not to protect privacy, but rather to incentivize or control the production and circulation of information and other socially desirable goods. Continue reading

Chimpanzee Research and Animal Rights

Last month, two federal agencies took steps that together may come close to ending research on chimpanzees in the United States.

First, the Fish and Wildlife Service (FWS) proposed to list all chimpanzees, including those in captivity, as endangered.   (Currently, only wild chimpanzees are listed as endangered, while captive chimpanzees are listed as threatened).  This would require that almost all research on chimps be done with a permit, and the agency has suggested that these permits may only be granted for research that enhances the propagation or survival of the chimpanzee species.

Second, the National Institutes of Health (NIH) decided that more than 300 of the approximately 360 research chimpanzees that it owns will be retired and moved into sanctuaries.  This decision was based on an Institute of Medicine report finding that most current research on chimpanzees is unnecessary, and that chimps should be used only when public health is on the line, no other animals are appropriate, and ethical experiments on humans are not possible.  On the basis of these findings, the NIH is planning to keep a colony of about 50 chimps available for research that is not possible in any other way.

Comparing these two agency actions raises an interesting question:  In evaluating whether research on chimpanzees is ethical, does it matter whether the beneficiary of the research is the chimpanzee or the human species, and if so, on what grounds?   Continue reading

Introducing Blogger Jeffrey Skopek

Jeffrey Skopek received his J.D., magna cum laude, from Harvard Law School, where he served on the Harvard Law Review as Book Reviews and Essays Chair of the Articles Committee.  He also holds a Ph.D. and M.Phil. in the History and Philosophy of Science from the University of Cambridge, where he was a Gates Scholar and Fulbright Scholar, and an A.B. in History, with distinction, from Stanford University, where he was a Truman Scholar.  Following law school, he clerked for Chief Judge Sandra L. Lynch of the United States Court of Appeals for the First Circuit. His primary research interests are in the area of law and the biosciences, which ties together his interests in environmental law, health law, and bioethics, but he also works on issues that cut across these fields and into others, such as questions about the legal functions of anonymity.

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