Australia's New Environmental Rudder

For years, the United States has been able to dodge claims that it stood alone against the Kyoto Protocol. Even leaving aside developing countries with no legal obligations under Kyoto, the U.S. could point to its developed brother in nonratification arms: Australia. Soon the U.S. will face the heat of the global climate change treaty issue alone.

Australia's newly minted Prime Minister, Kevin Rudd, has announced that the Lucky Country will finally ratify the Kyoto Protocol. Fluent in Mandarin, and seemingly so cool that even rockstars are joining his band, Labor, Rudd has announced that he will personally lead Australia's delegation to the second United Nations Framework Convention on Climate Change sessional period and Thirteenth Conference of the Parties ("COP-13) that begins on December 4th, 2007. Despite widespread Labor Party allegations that John "Battler" Howard, Australia's newly defeated Prime Minister, doomed his country on the global climate front, even without ratification the country is still on track to meet its Kyoto Protocol greenhouse gas ("GHG") emissions target of 8% above the 1990 baseline level.

Rudd takes the helm with an motley assortment of environmental policies. One might have assumed that an avowedly pro-environment leader, such as Rudd, and a former head of the Australian Conservation Foundation and Midnight Oil lead singer, Peter Garrett, opposed Howard's government's decision to approve the proposed huge Bell Bay pulp mill in Tasmania. After all, the mill will be fed by the liquidation of Tasmanian old-growth forest, and will then pump effluent containing chlorine and dioxins into the Bass Strait. Oddly, however, Rudd and Garrett supported Howard's decision. Anticipating the critics, Environment Minister-in-waiting, Garrett, has tried to reassure his supporters, stating that his environmental policies are not a "betrayal of anything at all including my principles".

Even on global climate change, Rudd's government will face significant credibility challenges. As he ratifies Kyoto in Bali, and pledges to reduce Australia's future emissions of GHGs, he might spare a thought for one of factors underlying his Lucky Country's current boom economy: huge exports of strip-mined coal to energy-ravenous, and future GHG emission champions, China and India. To achieve more environmentally defensible - and consistent - government policies, Rudd, Garrett, and the rest of the Labor Party would do well to ponder some familiar questions:

How can we dance when our earth is turning?
How do we sleep while our beds are burning?

To find the answer, they may find themselves burning the Midnight Oil.

FDA Hearings On Restricting Salt: Should Health Advocates' Demands for Government Restrictions On Salt Be Taken Cum Grano Salis?

The FDA held public hearings this week over the GRAS (generally regarded as safe) status of salt. The hearings are in response to health advocates who argue that salt should be treated as a food additive. This would allow the FDA to set limits on the amount of salt that could be added to foods. In light of the role that salt and sodium play in the development of high blood pressure and subsequent heart disease, those of us who work in the public health arena may be quick to jump on this bandwagon. But is government regulation that limits consumer choice the proper answer in this case? If so, what does this mean for other GRAS ingredients such as sugar and caffeine?

The FDA’s regulatory strategy for food and food additives looks like this:

1. If the product is a traditional food (example, apples, wheat, corn), it existed before national food safety laws were passed and is presumed to be safe for human consumption based on extensive use and experience. Premarket testing of these traditional foods is not required. If the food product is deemed unsafe for human consumption, the FDA will use its seizure and injunctive powers to remove the product from the market.

2. If the product is a food additive, premarket testing for safety is required.

a. A "food additive" is a substance that becomes a component of food or affects the characteristics of food, unless the substance is generally regarded as safe (GRAS).

i. A substance is considered to be GRAS if there is a general consensus among informed experts that a substance is safe for human consumption; or, if the substance was used in food prior to 1958, it is deemed safe by virtue of common experience. Examples are salt, sugar and caffeine.

b. If a substance added to food is considered to be GRAS, it will not be regulated as a food additive and will not require premarket approval.

3. Once a food additive has been evaluated by the FDA and is considered safe and effective at certain levels, it is placed on a monograph and can be used as an ingredient in any food product, but only at the levels or in the amounts that are considered safe by the FDA for human consumption.

So if salt loses its GRAS status and is designated a food additive, the FDA can set limits on the amounts that food processors can add to food. This means that the salt content of many foods will be slashed, with a resulting impact on flavor. And consumers will no longer have the choice to eat foods that are bad for their health based on salt content.

Thoreau stated that if he was sure that " ... a man was coming to my house with the conscious design of doing me good, I should run for my life ...."

In his essay Persuasion and Coercion for Health: Ethical Issues in Government Efforts to Change Life-Styles, 56 Health and Society, 303-38 (1978) [reprinted in Rolf Sartorius, Paternalism (U. Of Minn. Press 1983)], Daniel Wickler gives some excellent guidance on when governmental interference with individual life-style choices is justified ... and when it is not.

Professor Wickler gives two reasons why our society values autonomy of decision making: first, because we believe we are the best judges of what is good for us and, second, because the right to make the choice is a good in and of itself. This is translated into our common moral concept of a right of non-interference so long as one does not adversely affect the interests of others.

One view is that an individual’s choice of what to eat or not is self-regarding behavior (does not harm third parties). When a choice is self-regarding, it should be protected from interference from others, even if the decision is unwise.

It is true that there may be situations where we lose the capacity for competent self-direction. Then, as Ulysses did when he approached the sirens, we rely on others to protect us from harming ourselves. This is the basis for guardianship of children and the mentally disabled where the guardian makes the rational choices that would have been made if the individual’s autonomy were not compromised by mental disability.

When a consumer chooses a food with a high salt content (think of french fries that are usually loaded with salt) is this a situation of free and voluntary risk taking, or behavior that is not under the consumer’s control? Or could this be a situation where consumers lack the capacity to make an informed choice?

Unlike the situation with nicotine and its addictive properties where health advocates argue that the choice to smoke is not voluntary, health advocates’ position with regard to salt intake is that consumers lack the capacity to make a wise and rational decision because consumers are not well enough informed.

Does this rationale support the intervention of the government to take the choice to consume salty foods away from competent adults? If it is true and there is a capacity problem based on ignorance, isn’t the solution education?

While regulation to limit the use of salt blocks the harm, education corrects the disability and restores the choice and, therefore, autonomy. Based on the strong value that our society places on freedom of choice, should regulators be obligated to use the less restrictive choice of education, if they can?

Phillus Aureolus Theophrastus Bombastus von Hohenheim (1493-1541), a.k.a. Paracelsus, is well-known for the phrase Alle Ding' sind Gift und nichts ohn' Gift; allein die Dosis macht, dass ein Ding kein Gift ist. It translates as All things are poison and nothing is without poison, only the dose permits something not to be poisonous. Now, this phrase is commonly shortened to "the dose makes the poison."

Finally, issues surrounding life style choices raise the subjectivity of the notion of harm. Professor Wickler explains:

The same experience may be seen as as harmful by one person and as beneficial by another: or, even more common, the goodness (or badness) of a given eventuality may be rated very differently by different persons. Although we as individuals are often critical of the importance placed on certain events by others, we nevertheless hesitate to claim special authority in such matters. Most of us subscribe to a pluralistic ethic, for better or worse, that has a central tenant that there are multiple, distinct, but equally valid concepts of what is good and what is the good life. It follows that we must use our personal preferences and tastes to determine whether our health related practices are detrimental.

If the FDA decides to revoke the GRAS status of salt, what does that mean for sugar, which is equally, if not more, harmful? And there are multiple studies that demonstrate that caffeine in excess has significant health effects. What could this mean for those of us who live for that morning cup of coffee or tea?

For those who love salt, adding an extra dash with a personal salt shaker provides a partial remedy. But for those of us who love coffee and tea, finding a way to exercise personal choice could be a bit harder.

When it comes down to an individual life style choices, should the FDA take the views of health advocates cum grano salis? After all, any substance in excess can become a poison.

Facilitating Species Migration: Adapting to Climate Change & Benefiting Biodiversity

IPCC's recently completed Fourth Assessment Report paints a grim picture of climate change impacts (the summary of the synthesis report is available here). IPCC Working Group II’s contribution estimates: “on average 20% to 30% of species assessed are likely to be at increasingly high risk of extinction from climate change impacts possibly within this century as global mean temperatures exceed 2°C to 3°C relative to pre-industrial levels.” With a rise of 4°C or more above pre-industrial levels, models suggest 40-70% extinction rates. Popular media, such as Scientific American, also highlight the biodiversity impacts of climate change.

Hopefully, the completion of the IPCC report will spur significant advances in the international legal response to climate change, as previous reports have. Because existing mechanisms for combating biodiversity loss have proven largely ineffective, the climate change regime presents one of the best hopes for near-term action to stem global biodiversity loss from both climate and non-climate causes.

Without intervention, climate change will enhance other factors driving biodiversity loss. For example, climate change in fragmented ecosystems will likely favor those species that move with relative ease – the same weedy species that are already speeding the depletion of biodiversity.

One element of adaption to climate change must be combating habitat fragmentation to allow species to respond through migration, or range shifts, as has occurred in previous periods of climatic change (discussed here and here). In general, this requires a reassessment of protected area priorities to combat fragmentation and ensure that as species find current ecosystems uninhabitable, they will have somewhere to run. Focus on improving protected areas in a climate regime is a sensible response to climatic impacts on biodiversity. It also provides a route to combat habitat destruction – currently the primary driver of species loss.

At the domestic level, preserving habitat for migration might be integrated into Endangered Species Act implementation through critical habitat designations, as J.B. Ruhl notes in an article on FWS’ options for responding to climate change. At the international level, providing migration options could be combined with efforts to preserve or reinvigorate forests as a means of storing or sinking carbon dioxide.

Channeling some of the funds and initiatives aimed at climate change toward activities benefiting biodiversity can create incentives for developing countries that will seek compensation for loss of development opportunities (as Indonesia and Ecuador plan to do, for example). This might be achieved through more directly valuing biodiversity benefits in CDM projects that facilitate sustainable development. Likewise, carbon credits with enhanced value for projects providing biodiversity benefits would allow industrialized countries to benefit from investing in projects that foster species adaption while reducing greenhouse gas emissions.

Even with increased legal and policy support for preserving habitat to facilitate migration, several scientific limitations complicate prediction of migration options for species threatened by climate change. First, substantial uncertainty remains in identification of areas that can provide future range to species requiring migration to survive climate changes. Second, some recent scientific literature suggests that current species richness is strongly correlated with historic climactic conditions, particularly for species with limited range. If so, a significant proportion of species may be unable to migrate to more suitable conditions as the climate changes. Accordingly, assisted migration options should be developed to sustain such species.

Despite these limitations, working fragmentation concerns into the climate change regime offers a way to foster natural species adaption, preserve options for assisted migration and address other root causes of biodiversity loss. It can be factored into the value of credits for CDM projects or carbon storage in forests, or other compensation provided for forgoing deforestation. In this way, perhaps the momentum on climate change can be harnessed to jumpstart international biodiversity preservation.

Will the FDA Bar The Door When Stem Cells Produced From Therapeutic Cloning Come Knocking?

Semos (named after the god in Planet of the Apes) is the rhesus monkey who donated the skin cells used in the therapeutic cloning study.

David Cyranoski summarizes two exciting new studies in his article "Race to Mimic Human Embryonic Stem Cells:"

Two much-anticipated scientific firsts announced this week bring the dream of regenerative medicine a step closer. The production of cloned primate embryonic stem cells and the reprogramming of adult human cells both represent important milestones in the quest to produce 'pluripotent' cells, which can develop into almost any of the body's roughly 200 cell types. Human embryonic stem cells have this property, and those used in research are usually extracted from leftover embryos created during in vitro fertilization. But researchers want to create pluripotent cells that are genetically matched to individual patients. Such cells could then be transplanted to treat disorders such as Parkinson's disease and diabetes, or be used by researchers to model disease progression. Cloning offers one way to create these cells. This week, a team led by Shoukhrat Mitalipov of Oregon Health & Science University in Beaverton report the first creation of embryonic stem cells from cloned monkey embryos .... Until now, cloned embryonic stem cells had been created only in mice.

***

But there is another promising route to creating pluripotent cells that does not require eggs or the controversial destruction of embryos. On Tuesday, Shinya Yamanaka of the University of Kyoto in Japan reported that his team had created pluripotent cells from human skin cells and, on the same day, a team of researchers led by James Thomson at the University of Wisconsin, Madison, reported the same. Yamanaka's work builds on his exciting discovery last year that introducing four transcription factors into mouse skin cells 'reprogrammed' the cells into an embryo-like state. Early this summer, Yamanaka and two other groups reported using the same four factors to create cells that seemed to be indistinguishable from embryonic stem cells.

Since the results of these studies were announced, the news is replete with stories covering the ethical issues that swirl around stem cell technologies and the promises that they hold for the treatment of a broad range of medical conditions. Another interesting question that is little discussed but always lurks behind these new advancements is how the FDA will deal with these innovative technologies. Will the method that is used to generate the stem cell technology make a difference to the FDA’s approval of human clinical trials?

The FDA’s new regulatory structure put in place to capture jurisdiction over new technologies like stem cells generally tracks like this:

1. Tissues that are only "minimally manipulated" and are intended for "homologous use" are covered under the FDA’s "good tissue practice" regulations 21 C.F.R. Part 1271 promulgated under Section 361 of the Public Health Service Act authorizing regulation to prevent the spread of communicable diseases. Minimally manipulated tissues will not be considered drugs or devices and will not be subject to the pre-market approval process.

a. "Homologous use" is the "replacement or supplementation of a recipients cells or tissues with a HCT/P [human cells, tissues and cellular and tissue based products] that performs the same basic function or functions in the recipient as in the donor." 21 C.F.R. 1271.3(c).

b. "Minimal manipulation" with respect to cells and nonstructural tissues is defined as "processing that does not alter the relevant biological characteristics of cells or tissues." 21 C.F.R. 1271.3(f)(2).

i. "For purposes of determining whether a structural tissue product is minimally manipulated, a tissue characteristic is ‘original’ if it is present in the tissue of the donor. A tissue characteristic is ‘relevant’ if it could have meaningful bearing on how the tissue performs when utilized for reconstruction, repair, or replacement. A characteristic of structural tissue would be relevant when it could potentially increase or decrease the utility of the original tissue for reconstruction, repair or replacement."

Office of Combination Products and Center for Biologics Evaluation and Research, Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update (2006).

2. If processing has altered an original, relevant characteristic of a structural tissue (the so called "kick-up factors"), it will be considered to have been more than minimally manipulated. In this case, the structural tissue will be regulated as a drug, device and/or biological product and will be subject to the pre-market approval process.

Stem cells that have been created from bone marrow are already being tested in controversial human clinical trials. The FDA has categorized these stem cells as investigational new drugs (INDs) by applying the above kick-up factors. Designation as a new investigational drug means that scientists must file an IND application and obtain the FDA’s approval prior to starting human clinical trials.

Will the method that is used to generate the stem cell technology make a difference in whether the FDA approves the IND application? In light of current questions regarding the role of politics in FDA decision-making, some may wonder.

The FDA’s current position is that it will apply the same procedures that it has long followed for the clinical testing of new drugs. This reliance on pre-existing law, rather than proposing a new regulatory strategy specifically tailored to this new technology based on therapeutic cloning, appears to bar the FDA from playing any role in the broader ethical and moral debate. As such, regardless of whether the stem cells were generated through reprogramming of human skin cells or from cloning a human embryo, the role of the FDA in approving clinical trials is statutorily limited to performing a risk analysis focusing solely on the issue of safety. Moral and ethical issues should be irrelevant to this calculus.

But what if the FDA approves clinical trials of stem cells from reprogrammed skin cells, but not those derived from therapeutic cloning that results in the destruction of human embryos? Would this denial be ‘end game’ for these scientists?

According to an article written by Richard A. Merrill and Bryan J. Rose, entitled FDA Regulation of Human Cloning: Usurptation or Statesmanship, 15 Harv. J.L.Tech. 85 (2001), maybe not. Professor Merrill suggests that the FDA strategy for the regulation of therapeutic cloning technologies may be suspect. Merrill posits that the FDA’s failure to provide notice and comment on its claimed authority to regulate this new technology may place this issue squarely into the realm of cases like Syncor International Corp. v. Shalala, 127 F. 3d 90 (D.C. Cir. 1997) and Northwest Tissue Center v. Shalala, 1 F. 3d 522 (7th Cir. 1993) which confront rule making’s substantive-interpretive distinction. The FDA’s strategy also suffers from vagueness problems with its ‘minimally manipulated’ dichotomy.

Adding to Merrill’s critique, any decision based on the method of production rather than the end product itself would run counter to the general theme of bioequivalency that pervades the FDA’s regulation of all of the products under its aegis.

All this leaves one to wonder whether, in the race to mimic human embryonic stem cells, will crossing the finish line mean a showdown with the FDA over therapeutic cloning? If so, will who wins the race determine whether people with life threatening diseases also become winners?

The avian cost of environmentally friendly architecture

Environmentally friendly buildings are often bird killers, according to the Atlanta Journal-Constitution.

The Mathematics and Science Building, one of Emory University's most environmentally friendly buildings and a hallmark of that school's environmental efforts, has been described as an "avian slaughterhouse." Every year the building's reflective glass kills dozens of birds who confuse the woodsy reflection with the actual forest. In response, Emory installs netting during the migratory season.

The AJC quotes Muhlenberg College ornithologist Daniel Klem for this statistic: between 100 million and 1 billion birds die in the United States each year in collisions with glass.

Buildings that earn LEED certifications, the gold standard for environmentally friendly architecture, often incorporate large amounts of glass. According to Klem, few architects consider the impact of their designs on birds. As a result, avian casualties are an unintended consequence of designing buildings to take advantage of natural light.

Happy Thanksgiving

A nice image, by way of Feminist Law Professors.

Brain Waves Reveal Intensity of Pain: Neural Signal Offers Objective Measure of Subjective Experience.

On the Neuroethics & Law Blog several months ago, Adam Kolber posted the following:

A couple of days ago, the NYT ran an article on the use of real-time functional magnetic resonance imaging (fMRI) to treat pain and perhaps a host of other symptoms like addiction and depression. The technology works like a kind of high-tech biofeedback:

"Here’s how Omneuron uses fMRI to treat chronic pain: A patient slides into the coffin-like scanner and watches a computer-generated flame projected on the screen of virtual-reality goggles; the flame’s intensity reflects the neural activity of regions of the brain involved in the perception of pain. Using a variety of mental techniques - for instance, imagining that a painful area is being flooded with soothing chemicals - most people can, with a little concentration, make the flame wax or wane. As the flame wanes, the patient feels better. Superficially similar to an older technology, electroencephalogram biofeedback, which measures electrical feedback across multiple areas of the brain, fMRI feedback measures the blood flow in precise areas of the brain."

By giving users feedback about their pain, the technique attempts to create a visual representation of an individual's pain. That's pretty impressive! But imagine if we could make interpersonal judgments of pain. That could really change the way we identify malingerers and the way we calculate damages in court. As I've noted, I think that new neurotechnologies may someday move us in that direction.

In the article that Professor Kolber is referring to, he addresses a future which could bring neuroimaging into the court room as objective evidence of the degree of pain that an individual is suffering:

Pain is a fundamentally subjective experience. We have uniquely direct access to our own pain but can only make rough inferences about the pain of others. Nevertheless, such inferences are made all the time by doctors, insurers, judges, juries, and administrative agencies. Advances in brain imaging may someday improve our pain assessments by bolstering the claims of those genuinely experiencing pain while impugning the claims of those who are faking or exaggerating symptoms. These possibilities raise concerns about the privacy of our pain. I suggest that while the use of neuroimaging to detect pain implicates significant privacy concerns, our interests in keeping pain private are likely to be weaker than our interests in keeping private certain other subjective experiences that permit more intrusive inferences about our thoughts and character.

Kolber, Adam J., "Pain Detection and the Privacy of Subjective Experience" American Journal of Law & Medicine (Brain Imaging & The Law Symposium), Vol. 33, p. 433, 2007. Available at SSRN: http://ssrn.com/abstract=976831

The future that Professor Kolber described may have come one step closer as the result of a study that was published this week in Nature:

Brain Waves Reveal Intensity of Pain: Neural Signal Offers Objective Measure of Subjective Experience.

Recordings from electrodes in the human brain may offer the first objective way to measure the intensity of pain. Researchers say that they have found a neural signal that correlates with the amount of pain that an individual feels. The signal could be used to refine pain-relief techniques that involve stimulating the brain with electricity, they say.
Single cells have previously been identified in the human brain that are active in pain, but their response is binary, signaling either pain or no pain. Now, Morten Kringelbach of the psychiatry department at the University of Oxford, UK, and his colleagues have identified low-frequency brain waves that emanate from two regions buried deep within the brain when a patient is in pain. The more pain that is experienced, the longer the waves last.

"It is an objective measure that correlates with a subjective measure."

Published online 14 November 2007 Nature 450, 329 (2007) doi:10.1038/450329b

Certainly, this technology could be a blessing for the millions of us who suffer from chronic back pain. And it could remove the hurdle that claimants face who suffer debilitating injuries but have no objective measures to support their subjective claims of pain. In the dispute resolution context, Professor Kolber concludes that neuroimaging for pain detection should cause less concern over invasions of privacy than other, more invasive uses of this technology.

But place these new neurotechnologies into the context of programs such as the West Virginia Pilot Project and a different picture could emerge. In early 2007, the federal government approved the West Virginia Pilot Project which provides health care for low-income, medicaid beneficiaries. This program, and ones like it, is an attempt to respond to the ‘obesity crisis’ and the overall rise in health care costs.

The Pilot Project is described as an effort to encourage states to test approaches using more "personal responsibility" in Medicaid programs. West Virginia will ask Medicaid beneficiaries to sign a contract, under which they agree "to do my best to stay healthy" and attend "health improvement programs as directed," seek routine medical checkups and screenings, attend all scheduled physician appointments, and take medications as prescribed. Failure to meet these contractual obligations results in decreased health care benefits.

Will physician directed pain control, weight-loss or anti-smoking programs include undergoing procedures that involve invasions of ‘cognitive liberty’ in the name of public health? The fMRI technique described in the above New York Times article characterizes it as leading to "long-term changes in the brain." And procedures such as transcranial magnetic stimulation (described by Jeffrey Rosen in the New York Times article The Brain on the Stand) are being studied for use in turning off or inhibiting behavior, curing the "defective" brain.

Neuroimaging is already being developed for use in lie detection. As the regions of the brain are being scanned for pain management purposes or to alter eating or smoking behaviors, will information be gathered on lack of compliance with physician and program directives? Will the physician be turned into an agent of the state; a policeman reporting on program violations that will negatively impact a patient’s access to health care?

As Professor Kolber points out, case law is merely suggestive of a right to "thought privacy" and how the courts will deal with this issue is unclear.

Biolaw: Law At The Frontiers Of Biology

The Kansas Law Review 2007 Symposium - Biolaw: Law at the Frontiers of Biology

The past several years have presented a bewildering array of legal issues raising more questions than answers. Should the Food and Drug Administration approve cloned meat for consumption? Are humans patentable? Is it legal for patients to have access to developmental drugs? Should the law allow parents to halt their daughter’s growth using modern scientific techniques? What is the legal status of partial-birth abortion? Are stem cell research and genetic human enhancement legal? How can the current devastating loss of biodiversity be reversed?

The recent explosion of the life sciences and biotechnology has challenged traditional laws, and public opinion concerning proper solutions is far from uniform. Part of the challenge is to approach these unparalleled issues head-on in spite of varying beliefs and tough scientific inquiry. Law, science, and policy, however, should also anticipate future challenges as research and development continue to flourish.

The Kansas Law Review’s 2007 Symposium, Biolaw: Law at the Frontiers of Biology, features world-renowned experts in biolaw, who will address the above questions by exploring such issues as the scope of the field of biolaw, patentability of human life, FDA regulation, laws concerning genetic and non-genetic human enhancement, practical biolaw issues, and biotechnology and bioethics.

The event will begin at 9:00 AM with an introduction and welcome followed by panel presentations. Speakers will present their findings and then open the floor for questions and discussion. The Kansas Law Review will publish the speakers’ papers. Each paper will identify and analyze issues critical to practitioners, policymakers, and the public as a whole.

Schedule of Symposium Speakers
9:00 to 10:00 AM – Biolaw: Cracking the Code (describing the emerging field of biolaw)
Jim Chen, J.D., M.A., Dean, University of Louisville Louis D. Brandeis School of Law

· Founder and administrator of the Jurisdynamics Network, which includes the popular blog entitled Biolaw: Law and the Life Sciences (with Professor Andrew W. Torrance);

· Faculty, University of Minnesota Law School, 1993 to 2007;

· Coauthor of Disasters and the Law: Katrina and Beyond (Aspen Publishers, 2006);

· Dean Chen has lectured in fourteen countries, on four continents, and in three languages. He held a chaire départementale in the Faculté de Droit et des Sciences Politiques of the Université de Nantes; He became the first American law professor appointed at Heinrich-Heine Universität in Düsseldorf

10:00-11:00 AM – Patents & the Future of Human Evolution
Andrew W. Torrance, J.D., Ph.D., Professor, University of Kansas School of Law

· Lecturer at Harvard University from 1999–2005;

· Visiting Professor at Harvard University in 2003;

· Chairs the Scientific and Creative Board of the Darwin Project, a major biodiversity institution planned for downtown Boston;

· Practiced law at the firm of Fish & Richardson LLC; In-house Counsel at Inverness Medical Innovations, a leading multinational medical diagnostics company

11:00-12:00 PM – State of the Art in Food & Drug Law
Peter Barton Hutt, LL.B., LL.M., Professor, Harvard Law School; Senior Counsel, Covington & Burling LLP

· Chief Counsel for the Food and Drug Administration from 1971 to 1975;

· Coauthor of the leading food and drug law text book Food and Drug Law: Cases and Materials (Foundation Press, 1st edition 1980, 2d edition 1991, 3d edition 2007);

· Recipient of numerous prestigious awards and recognition, including the title of the “unofficial dean of Washington food and drug lawyers”;

· Served as a member and participant of many committees, including but not limited to, the Institute of Medicine of the National Academy of Sciences, IOM Executive Committee and other NAS and IOM committees, the FDA Science Board Working Group, various groups at the National Institute of Health, and Panels for White House Conferences; Twice been a councilor of the Society for Risk Analysis and presently Legal Counsel to the Society as well as the American College of Toxicology

12:00-2:00 PM – Lunchtime Address: Against All Odds: The Creation of the United States Virgin Islands Territorial Park System
Senator Adlah Donastorg, Four-Term Senator of the United States Virgin Islands


2:00-3:00 – Law & Human Biological Enhancement
Henry T. Greely, J.D., Professor, Stanford Law School; Courtesy appointment with Stanford University Department of Genetics

· Directs both the law school’s Center for Law and the Biosciences and the Stanford Center for Biomedical Ethics’ Program on Stem Cells in Society, and serves on the leadership council for the university’s interdisciplinary Bio-X Program;

· Specializes in the legal implications of biomedical technologies;

· Frequently serves as an advisor for California, national, and international bioscience policy issues;

· Made partner at the firm of Tuttle & Taylor, and served as staff assistant to the secretary of the U.S. Department of Energy

3:00-4:00 – Cutting Edge Legal Issues in Biotechnology
Rudolf H. Beese [Panel Moderator], Sonnenschein Nath & Rosenthal

Sonnenschein Nath & Rosenthal, a symposium sponsor along with the Kansas Technology Enterprise Corporation ("KTEC"), has generously organized a panel of attorneys with deep expertise in biolaw. Moderated by Rudolf H. Beese, a leading attorney in the areas of life sciences and climate change, this expert panel will offer their valuable insights on how best to meet the challenges of the many complex and complicated legal issues arising from advances in biological sciences and biotechnology.

4:00-5:00 PM – Maybe Medicines: Dealing with the "Uncontroversial" Right to Cutting-Edge Unproven Treatments (discussing unproven technologies overlooked by the court in the Abigail Alliance case, which rejected a constitutional right to unproven treatment)
Jerry Menikoff, J.D., M.P.P., M.D., Director, Office of Human Subjects Research, National Institute of Health; Director, Institute for Bioethics, Law and Public Policy at the University of Kansas School of Medicine

· Professor, University of Kansas School of Medicine and School of Law;

· Authored several books, including the leading textbook of legal bioethics, entitled Law and Bioethics: An Introduction (Georgetown University Press 2001);

· Served as chairperson of the Institutional Review Board at KU

Reception
Following the symposium, the Kansas Law Review invites everyone to attend a reception, in honor of our speakers, in the commons at Green Hall. Jonathan Chester, one of the world’s preeminent polar photographers and explorers, will present some of his breathtaking photography, a presentation you will not want to miss! Refreshments and snacks will be provided.

Publication
Topics presented at this symposium will be published in the Kansas Law Review, Volume 56, Issue 4, April 2008.

For more information about the articles or to order a copy of the April 2008 edition of the Kansas Law Review, please contact Jonathan Grossman, Law Review Symposium Editor, at (785) 864-3463 or grossman.jon@gmail.com .

Reservations
No reservations are necessary to attend the symposium. There is no fee for attending the symposium or the reception.

CLE Credit
This conference will provide 6.5 hours of continuing legal education (CLE) credit in Kansas and 7.2 hours in Missouri. Persons wishing to receive CLE credit can register at the door and obtain materials.

To confirm CLE credit approval prior to the symposium date, please contact Todd Rogers at (785) 864-9257 or by e-mail at tarogers@ku.edu.