Al Gore (Re)Invents Global Climate Change

Go deep! Al Gore is quarterbacking the charge on global climate change

Way back in 1992 global climate change (then known as global warming) seemed finally to have become a truly hot issue. A series of record-warm years in the late 1980's, the arrival of a surprisingly pro-environmental Bush I in the White House, and a rising chorus of scientific evidence culminated in the Framework Convention on Climate Change (FCCC), one of the Rio Trio of global environmental treaties. That same year I attended what may have been Al Gore's Ur-Inconvenient Truth lecture at Harvard's Museum of Comparative Zoology, where he had been meeting regularly with E.O. Wilson. Both the speech and the speaker were compelling.

Al Gore continued to advocate for a strong legal response to global climate change during his subsequent vice-presidency, and was responsible in no small part for the successful negotiation of the Kyoto Protocol to the FCCC in 1997. However, the global warming issue cooled rapidly after that. The Clinton presidency wobbled to an end, Al Gore became the former next President of the United States, Bush II publicly repudiated the Kyoto Protocol, and then all attention turned to the aftermath of the Twin Towers.

Undaunted, Al Gore doggedly stayed on-message, delivering his Inconvenient Truth lecture again and again around the world. Due in significant part to his advocacy, the global climate change issue has heated up again, and 2006 has seen it reach a second boiling point. The success of his film, and supporting actors, Tsunami and Katrina, have again propelled Al Gore and global climate change to the forefront. Now, in the wake of the aptly named Stern Review On The Economics of Climate Change, Chancellor of the Exchequer, Gordon Brown, heir apparent to Tony Blair, has even asked Al Gore to be the British government's special advisor on global climate change, with an eye to negotiating Kyoto II. Brown must be hoping that his embrace of Al Gore will trump a recent husky-hugging Arctic jaunt by David Cameron, the leader of the newly global climate change-conscious opposition Tories.

Forget the internet; Al Gore has reinvented the global climate change issue.

Every Sperm Is Sacred

XY Inc. is a Colorado company offering "sex-selection techniques in non-human mammals, including cattle, horses, pigs and endangered species." The company uses flow cytometry (characterization of individual cells based on how the cells scatter light from a laser) to detect differences in sperm cell DNA content (sperm containing X chromosomes tend to possess measurably more DNA than those containing Y chromosomes) in precisely oriented sperm cells. The result is an accurate method of discriminating between X chromosome-bearing and Y chromosome-bearing sperm, effectively allowing the predetermination of sex in non-human mammals.

XY recently received a European patent that includes claims to methods of selecting sperm. For example,

Claim 1. A method for the cryopreservation of sperm comprising : (a) obtaining a selected sperm sample ; (b) cooling said selected sperm sample ; (c) isolating sperm from said selected sperm sample to produce isolated sperm ; (d) adding final extender to said isolated sperm to produce a suspension of sperm ; and (e) freezing said suspension of sperm.

However, tucked at the end of these method claims is a group of claims of a very different sort. Rather than methods, these claims cover sperm cells themselves. Claims 27, 28, and 29 are particularly illuminating:

Claim 27. A frozen selected sperm sample comprising a portion of the sperm present in a source sample, said portion of sperm selected for a characteristic.

Claim 28. The frozen selected sperm sample of Claim 27 wherein said frozen selected sperm sample comprises sex-selected sperm.

Claim 29. The frozen selected sperm sample of Claim 27 wherein said frozen selected sperm sample comprises mammalian sperm.

They are illuminating not just for the claim elements they recite, but for those they omit. Nowhere are the claims limited to non-human mammals. In fact, claim 29 purports to cover all mammalian sperm, including, so it would seem, human sperm. And, the sperm in question is not genetically modified human sperm, but, rather, specifically selected, naturally occurring human sperm.

Though it currently takes more than a sperm to produce a human being, notwithstanding the homunculus theory, many have expressed their outrage at the granting of a patent claiming an unmodified human germline cell. Opposition proceedings filed by Greenpeace (germline patents are immoral), Monsanto Company (gender-selected sperm cells are nothing new), and the European Parliament's Working Group on Bioethics (germline patents violate the European Union Directive prohibiting patents covering human body parts) are currently winding their way through the European Patent Office.

To update a famous refrain by that prescient critic of biotechnology, Monty Python,

Every sperm is sacred.
Every sperm is great.
If a sperm is patented,
Many get quite irate.

Closing Thoughts on Environmentalism vs. Democracy

Governing the Eco-commons
By J.B. Ruhl

Here in Florida we have a November 7 general election ballot item that would amend our state constitution to require that all new constitutional amendments receive a 60 percent vote, rather than the current requirement of only a simple majority. The ad campaign for the amendment (which, ironically, will require only a simple majority to pass) advises voters to "Protect Our Constitution," whereas the campaign against the amendment urges voters to "Trust The Voters."

This about sums up the two themes that have emerged from the ongoing dialogue on "Environmentalism vs Democracy." Many commenters advise taking a "protect the environment" approach that relies on representative democracy, administrative agency expertise, and thus more distance between voters and matters of environmental policy. But about as many commenters adopt the "trust the voters" theme and focus on ways to improve citizen understanding of the complex environmental problems of the day so they will vote to "do the right thing."

Yet another set of commenters posited that the question is not unique to the environment--that "X vs. Democracy" questions are ubiquitous. Anyone would agree that democracy has shown its dark side in many contexts, but I do think the environment is different in that it involves more than law regulating humans in their relation to other humans. The third party involved in this field is not human. This raises value questions that don't often arise in other policy contexts--see, e.g., the Endangered Species Act. It also introduces an astounding level of complexity attributable to a system that extends far beyond what humans do to or with each other. Environmental law, in other words, is fundamentally different from, say, tax law or family law, making it even more important that we get it right, however we go about deciding what it is.

Of course, as with those other fields, the tension between "more" or "less" democracy is playing out in the case of the US in a context of relatively robust democratic institutions (I said relatively). None of the commenters proposed an environmental autocracy.

Hmmmmmm...why not? There are examples, after all, of top-down autocratic governance producing sustainable environmental policies (see Jared Diamond's account in Collapse of the history of Japan's forest management policy). But one commenter suggested the overall tenor of the dialogue in the assertion that "empirically, democracy seems to do a better job of addressing environmental problems than every other system of human governance that's been tried." True? Probably, but the case may not be as compelling as we'd like to think. As the World Resources Institute suggests in a recent study, it's not clear that nations enjoying more democratic institutions also necessarily enjoy better environmental management. WRI points out, for example, that democracy often correlates with wealth, which often correlates with consumption, which often correlates with environmental stress. Still, although democracy can be a mixed bag for the environment, I think most of us will take that over the alternative and ride out the roller coaster of "protect our environment" versus "trust the voters."

With that, I'll close my posts on the topic and enjoy the ride.

Bear country (terrestrial version)

Ah, summer. It's definitely gone now -- soon we will be closer to the winter solstice than to the fall equinox -- but the memories linger. This image comes from the Boundary Waters Canoe Area Wilderness in northern Minnesota. The photographer, Rod Myran, took part in an expedition that included Tom Claeson, Wes Clifton, Kenny Earl, and me. We spent a few nights in early August in the Boundary Waters. We call this spot "The Jacuzzi"; you'll pardon me if I am less than fully forthcoming with its exact coordinates.

And yes, nights in the Boundary Waters are perfect for stargazing. They were made for the celestial wonders that Jurisdynamics is simultaneously praising. The occasional bear in camp or along the trail makes the BWCAW "bear country," in a way vaguely reminiscent of the "bear country" being celebrated on this forum's companion weblog.

The Boundary Waters represent an exceptionally enjoyable (and surprisingly accessible) example of federal lands designated as "wilderness" by the Wilderness Act of 1964:

A wilderness, in contrast with those areas where man and his own works dominate the landscape, is hereby recognized as an area where the earth and its community of life are untrammeled by man, where man himself is a visitor who does not remain. An area of wilderness is further defined to mean in this chapter an area of undeveloped Federal land retaining its primeval character and influence, without permanent improvements or human habitation, which is protected and managed so as to preserve its natural conditions and which (1) generally appears to have been affected primarily by the forces of nature, with the imprint of man's work substantially unnoticeable; (2) has outstanding opportunities for solitude or a primitive and unconfined type of recreation; (3) has at least five thousand acres of land or is of sufficient size as to make practicable its preservation and use in an unimpaired condition; and (4) may also contain ecological, geological, or other features of scientific, educational, scenic, or historical value.

Proposals to mechanize the BWCAW arise routinely. The mere suggestion of mechanization raises some of the bitterest political and cultural fissures in the law of public lands and natural resources. Put me squarely on the side of wilderness. The footprint of "civilized" humanity extends to the extremes of the earth. It isn't altogether implausible to defend BWCAW preservation on grounds of biodiversity conservation or ecosystem services. An even simpler defense appeals to me as sufficient and complete in itself: Wilderness is worth protecting simply because it is beautiful and because the loss of natural beauty would impoverish human existence.

Softening school immunization requirements

If I had not given another article the distinction of BioLaw's article of the week, well, within the last week, the following item would plainly qualify. Regardless of nomenclature, it certainly is worth highlighting as a point for further discussion. Indeed, Jurisdynamics picks up the gauntlet that this forum throws down by focusing on this public health issue.

Editor's note: Hat tip to Respectful Insolence.

Saad B. Omer et al., Nonmedical Exemptions to School Immunization Requirements: Secular Trends and Association of State Policies With Pertussis Incidence, 296 J.A.M.A. 1757-63 (2006).


Context. School immunization requirements have played a major role in controlling vaccine-preventable diseases in the United States. Most states offer nonmedical exemptions to school requirements (religious or personal belief). Exemptors are at increased risk of acquiring and transmitting disease. The role of exemption policies may be especially important for pertussis, which is endemic in the United States.

Objective. To determine if (1) the rates of nonmedical exemptions differ and have been increasing in states that offer only religious vs personal belief exemptions; (2) the rates of nonmedical exemptions differ and have been increasing in states that have easy vs medium and easy vs difficult processes for obtaining exemptions; and (3) pertussis incidence is associated with policies of granting personal belief exemptions, ease of obtaining exemptions, and acceptance of parental signature as sufficient proof of compliance with school immunization requirements.

Design, Setting, and Participants. We analyzed 1991 through 2004 state-level rates of nonmedical exemptions at school entry and 1986 through 2004 pertussis incidence data for individuals aged 18 years or younger.

Main Outcome Measures. State-level exemption rates and pertussis incidence.

Results. From 2001 through 2004, states that permitted personal belief exemptions had higher nonmedical exemption rates than states that offered only religious exemptions, and states that easily granted exemptions had higher nonmedical exemption rates in 2002 through 2003 compared with states with medium and difficult exemption processes. The mean exemption rate increased an average of 6% per year, from 0.99% in 1991 to 2.54% in 2004, among states that offered personal belief exemptions. In states that easily granted exemptions, the rate increased 5% per year, from 1.26% in 1991 to 2.51% in 2004. No statistically significant change was seen in states that offered only religious exemptions or that had medium and difficult exemption processes. In multivariate analyses adjusting for demographics, easier granting of exemptions (incidence rate ratio = 1.53; 95% confidence interval, 1.10-2.14) and availability of personal belief exemptions (incidence rate ratio = 1.48; 95% confidence interval, 1.03-2.13) were associated with increased pertussis incidence.

Conclusions. Permitting personal belief exemptions and easily granting exemptions are associated with higher and increasing nonmedical US exemption rates. State policies granting personal belief exemptions and states that easily grant exemptions are associated with increased pertussis incidence. States should examine their exemption policies to ensure control of pertussis and other vaccine-preventable diseases.

Engineering Human Beings

Yesterday, October 25, 2006, Profs. Christopher Holman, Kevin Collins, and I presented a panel discussion entitled "Engineering Human Beings" at the Association for Politics and the Life Sciences (APLS) annual conference, in Bloomington, Indiana. Here is a brief summary of what we discussed.

We began by outlining the various existing biotechnologies capable of deliberately altering the bodies or minds of humans. These can be divided into two categories:

(1) Somatic engineering. This involves alterations that last only a single generation, and can be accomplished by such biotechnologies as somatic cell gene therapy, stem cells, cloning (without genetic alteration), RNAi, tissue culturing, and organ transplantation.

(2) Germline engineering. Alterations to germline tissue can be passed on indefinitely to future offspring and descendants, and can be accomplished by such biotechnologies as germline cell gene therapy and cloning (with genetic alternation), and chimaerization (cellular or genetic fusion of different species).

I presented an overview of the existing legal framework (state, federal, and international) for regulating the use of these biotechnologies to alter and control human beings. Prof. Holman provided an incisive analysis of the dual protective and regulatory role patent law can play with respect to genetic technologies. And, Prof. Collins presented an innovative conceptual framework of how intellectual property can be used (and misused) to "proprietize" and control human thought.

After our presentation, we fielded questions from the audience on issues ranging from the role of patents covering genes, organisms, and thought processes in encouraging society to view such things - perhaps inappropriately - as mere property, the relative ethical implications of different human engineering biotechnologies, and legal control of human thought.

The APLS meeting brought together a wide range of fascinating scholars interested in the intersections of biology with the humanities, social sciences, and law. I encourage anyone with scholarly interests in biolaw to consider attending future meetings.

Flu Season: Jurisdynamics Highlights Recent Developments

With flu season fast-approaching, several recent reports and studies have been released focusing on the potential threat of an influenza outbreak. The reports provide insight into health risks from seasonal flu and the continuing threat of an avian flu outbreak in humans. On Monday, October 23, the World Health Organization released a report concluding that global vaccine supplies are woefully inadequate. Just this morning, my local Kansas paper reports that flu shot clinics have been cancelled due to vaccine shortages. Results of a study on the safety and effectiveness of influenza vaccination in young children appears in yesterday's JAMA. The WHO report and a collection of several other recent pandemic flu reports appear at Jurisdynamics.

Article of the week -- Press/Pulse: A General Theory of Mass Extinction?

With a hat tip to Science Daily, I highlight this item from the 2006 annual meeting of the Geological Society of America, Philadelphia, October 22-25:

Nan Crystal Arens & Ian D. West, Press/Pulse: A General Theory of Mass Extinction? (Paper 230-1)

Previous discussions of mass extinction mechanisms focused on events unique to the extinction they explain. To propose and test a general mechanism of mass extinction, we borrow a pair of concepts from community ecology: Press disturbances alter community composition by placing multigenerational stress on ecosystems; pulse disturbances are sudden, catastrophic, and can alter communities by causing extensive mortality. We hypothesize that the coincidence of press and pulse events is required to produce the greatest episodes of dying in Phanerozoic history. To test this hypothesis, we compiled generic extinction rates for each age of the Phanerozoic based on data from the Compendium of Fossil Marine Animal Genera (Sepkoski, 2002). Cratering events served as a proxy for pulse disturbances as the effects of such impacts would be instantaneous and potentially catastrophic. Episodes of continental flood volcanism producing large igneous provinces stood in for press disturbances; these events are geologically long-lasting and have been linked with extensively discussed extinction mechanisms such as climate change. Average extinction rates were similar during geologic ages in which either press or pulse events occurred alone. Extinction rates during these times were statistically indistinguishable from rates associated with ages when neither impacts nor flood volcanism occurred. In contrast, when press and pulse events occurred together, higher average extinction rates were recorded. Interestingly, the size of the associated flood basalt or crater was poorly correlated with extinction rate. Thus, it is the combination of press and pulse events—a geologic one-two punch -- rather than the magnitude of single events that explains Earth's greatest episodes of extinction, including, perhaps, the modern biodiversity crisis.

Law, Politics, And The Life Sciences

On October 24th and 25th the Association for Politics and the Life Sciences (APLS) will hold their annual conference in Bloomington, Indiana. The APLS represents a broad array of interdisciplinary scholars united by an interest in issues at the intersection of biology and the social sciences.

The presentations scheduled for the conference provide a glimpse of current scholarship relevant to biolaw. These include Biophysical and Institutional Factors Affecting Environmental Outcomes, Evolution and War, Biobehavior, Engineering Human Life, Experimental Studies of Common Pool Resources, Action Toward Bioethical Pluralism: Breaking Open the Black Box of Research Ethics, Biology and Political Communication, Biopolicy, Regulation of Biomedical and Behavorial Science, and Evolution and Rationality.

Perhaps the most interesting aspect of the program is the fact it includes two distinct presentations entitled "Evolution and War". Though the topic sounds thoroughly fascinating, it's hard to escape the sense that its scholarly popularity reflects a more sober time.

Darwin's practical joke

After a long hiatus, the Jurisdynamics series, Genesis for the rest of us, has resumed. The adaptive origins of creationst mythology is now appearing at BioLaw's partner weblog. It isn't altogether inappropriate to think of religion and its origins in human adaptation to natural selection as Darwin's practical joke on religiously motivated detractors of evolution.

Ecosystem Disservices

Ecosystem services are regularly invoked in policy and legal debates to justify an economic basis for conservation of biological diversity. The argument often takes the following form:

1. Ecosystems provide services (e.g., clean water, clean air, pollination) vital to humanity and other organisms.

2. The true value of ecosystem services tends to be undervalued on markets.

3. If ecosystem services were accurately valued on markets, it would be economically efficient to conserve them to a greater extent than is done at present.

In September, Douglas J. McCauley, a researcher in the Department of Biological Sciences at Stanford University, published a commentary entitled "Selling out on nature" in the journal Nature. McCauley argued against the current emphasis on ecosystem services as an argument for conservation. He suggested that an honest accounting of ecosystem contributions should include ecosystem disservices:

Trees take water out of watersheds; forests may be contributing to global temperature increases; wild animals kill people and destroy property; and wetlands can increase the risk of disease.

He noted that an ecosystem service can go from hero (e.g., pollination of a coffee plantation) to zero (e.g., irrelevancy of pollination to a pineapple plantation replacing a coffee plantation after a decline in coffee prices) very quickly. He expressed skepticism that ecosystem services could reliably maintain their market value in the face of technological development:

The entire history of technology and human 'progress' is one of producing artificial substitutes for what we once obtained from nature, or domesticating once-natural services.

Finally, McCauley cautioned that the valuation of ecosystem services is often relative, with a loss of value for some (e.g., scientists who lament the decimation of cichlid fish species in Africa's Lake Victoria by the invasive Nile perch) perceived as a net gain for others (e.g., local African fishermen whose profits from fishing have improved with introduction of the Nile perch).

So, on what arguments would McCauley rely instead to conserve biodiversity? He champions reliance on moral and aesthetic values, arguing that "[nature] has an intrinsic value that makes it priceless, and this is reason enough to protect it." As he states:

Some will argue that this view is simply too optimistic. They may believe that the best way to meaningfully engage policy-makers driven by the financial bottom line is to translate the intrinsic worth of nature into the language of economics. But this is patently untrue - akin to saying that civil-rights advocates would have been more effective if they provided economic justifications for racial integration. Nature conservation must be framed as a moral issue and argued as such to policy-makers, who are just as accustomed to making decisions based on morality as on finances.

The track record of achievements by conservationists motivated by a moral imperative to protect nature for nature's sake is impressive: consider the international ban on commercial whaling, the national parks of the United States, and the CITES ivory-trade ban. Meanwhile, the only 'successful' large-scale ecosytem-service-based conservation project yet achieved is the imperilled Catskill watershed. But this 'nugget' may turn out to be fool's gold.

McCauley's commentary has sparked a fierce debate in the Correspondence section of the journal Nature, with conservation luminaries such as Walter Reid, Robert Costanza, and Peter Kareiva arguing for a dual reliance on the market valuation and moral valuation of ecosystem services to maximize the chances for conservation.

While my sympathies lie with those who seek to marshal all cogent arguments in favor of conserving biodiversity, I do find worrying McCauley's suggestion that reliance on economic rationales for conservation can be illusory, and, even worse, can sometimes undermine what may be more powerful and convicing moral rationales. At the very least, McCauley has forced advocates of ecosystem services to double-check their calculus.

National Geographic on Intelligent Design

Carl Zimmer, science writer extraordinaire, has an accessible (that is, short and sweet, but not simplistic) article in this month’s National Geographic engaging intelligent design advocates’ most commonly cited arguments. The article is available without subscription here. Additional comments from Zimmer, and suggested resources, are available on his science blog, The Loom.

San Diego HCP struck down

In a sharply worded decision, Senior Judge Rudi Brewster has enjoined operation of an Incidental Take Permit issued in 1997 to the City of San Diego under section 10 of the ESA, insofar as the permit allows development of vernal pool habitat.

The City's plan is one portion of a massive Multi-Species Conservation Plan covering more than half a million acres. Judge Brewster found that the ability of the plan to protect two fairy shrimp species and five native plant species was critically dependent upon the assumption that Clean Water Act section 404 permits would be required for vernal pool development. The Supreme Court's ruling that Clean Water Act does not extend to at least some isolated wetlands in Solid Waste Agency of Northern Cook County v. Army Corps of Engineers, 531 U.S. 159 (2001), reaffirmed by a fractured court in Rapanos v. United States, ___ U.S. ___ (2006), undermines that assumption. Although "the precise contours of federal jurisdiction over wetlands in general and vernal pools in particular remain unclear," Judge Brewster was persuaded that the Corps of Engineers "will not undertake review through its CWA permit process of impacts to isolated vernal pools that seasonally fill with water on San Diego's mesas."

In addition to demanding re-initiation of consultation, Judge Brewster concluded that the "no surprises" assurances included in the Incidental Take Permit are not binding under these circumstances. Having avoided consideration of the impacts of development on vernal pool species by punting that task to the Corps of Engineers in the permit, FWS could not then play the "shell game" of arguing that it is precluded from changing the terms of the permit when it turns out that the Corps cannot play its assigned role. He also found that FWS had arbitrarily and without explanation adopted a practice of allowing destruction of up to 12% of the vernal pool area covered by the plan. Finally, Judge Brewster ruled that the City had not provided adequate assurances of funding for creation of the planned reserve.

It seems clear from Judge Brewster's opinion that the plan as it currently stands will not adequately protect vernal pool species, and that the Fish and Wildlife Service failed to adequately evaluate the impact of the permit on those species.

The decision's emphasis on the duty to re-initiate consultation, however, puts it in the middle of an on-going dispute about the scope of the ESA's section 7 consultation duties. The Ninth Circuit recently held in Defenders of Wildlife v. EPA, 420 F.3d 946 (9th Cir. 2006), that the duty to consult applies "when the agency engages in an affirmative action that is both within its decisionmaking authority and unconstrained by earlier agency commitments." The National Association of Home Builders has sought certiorari on the Defenders decision, challenging that broad description of section 7. But taking it at face value for the moment, is approval of an incidental take permit the type of "agency commitment" that can constrain future agency discretion, and thereby narrow the scope of the consultation duty in the future? If not, a permit would provide essentially no assurances for the permittee, since its terms would constantly be subject to re-evaluation.

An alternative approach would be to impose more stringent demands at the time the initial permit decision is made. One way to read this decision is as requiring that FWS not rely on any restrictions not explicitly and enforceably set forth in the permit to protect the covered species against jeopardy. If it's too much to ask that FWS anticipate and provide for the potential loss of all exogenous sources of legal authority when evaluating the permit, then it may make sense to say that fundamental changes in the law that alter the conservation context require re-evaluation of the agreement.

The result doesn't seem inconsistent with the intuition behind "no surprises" assurances that "a deal's a deal." To the extent that the Corps truly has lost jurisdiction over isolated wetlands (an issue that is far from resolved), the developers would be gettting a windfall by being allowed to develop free of restrictions that everyone saw as part of "the deal."

Themes from "Environmentalism vs. Democracy"

Governing the Eco-Commons
By J.B. Ruhl
October 23, 2006

Having culled through comments and e-mails prompted by my post (on BioLaw and elsewhere) about Environmentalism vs. Democracy, several overarching themes emerged as diagnoses of the condition and prescriptions for recovery. Below are some very quick summaries of factors commenters identified as contributing to disconnects between the two value sets. None of them is particularly new on its own, but collectively they strike me as quite consistent with the conception of the problem as being how to design one complex system (environmental law) to regulate the way another set of complex systems (economy and society) behaves toward yet another complex system (environment). They appear in no particular order:

Experts: A number of commenters observed that one barrier to matching environmental and democratic values is that the communication of environmental conditions to democratic institutions generally demands some level of involvement from experts, whereas those institutions may not always be receptive to either (a) listening to experts or (b) letting experts make the final decisions.

Scale: Transboundary effects abound in environmental settings, given that environmental conditions do not obey political boundaries. This opens up the probability that actors at one political scale (e.g., local) will reach decisions causing externalities or other problems at other scales (e.g., state). The fact that the decision may be derived from democratic processes and make perfect sense at the scale at which it is made does not avoid or mitigate the trans-scale effects.

Cumulative Effects: Many environmental issues involve the aggregation of discrete actions each of which has small effects, but which accumulate to have significant effects over larger geographic scales. This makes it difficult for the individual actor participating in democratic processes to appreciate that he/she/it is contributing to a significant and costly environmental degradation.

Short Term Bias: Many decisions about the environment are decisions about intertemporal choice requiring us to decide how and by how much to take into account long-term and next-generation interests. Unfortunately, few "rational actors" exist in reality to apply perfectly designed discount rates taking all possible future trajectories, costs, and benefits into account. If the idea is to achieve a sustainable ecological base into next generations, these commenters believe democratic institutions frequently are making poor intertemporal decisions.

Industry Power: Many commenters derided "industry" as seeding misinformation in democratic institutions and using their relative power (i.e., relative to environmental groups) to either influence outcomes in democratic processes or shield certain issues from such processes. Of course, one has to expect the interests that are targets of regulation to exhibit some "push back" in the coevolutionary process. The concern here seems to be that some interests have become quite successful at it.

Environmental Groups: Many commenters (frequently those who also derided industry) were critical of major national environmental groups as having "lost their way" in terms of putting fundraising above mission and engaging in scare tactics that have desensitized democratic institutions to their message.

People Just Don't Get It: Several commenters put much of the blame on a consumption-oriented society that just won't put its money where its mouth is. On the one hand, surveys show high levels of support for the environment and "government doing more" about the problems, but in terms of dollars and votes the environment often fades into the background. Citing Jared Diamond's Collapse (mentioned many times in my posts on Jurisdynamics), they suggest we might be like the many other societies in the past that did not put two and two together on their environmental conditions before it was too late.

Next: A post summarizing the main themes regarding solutions.

Taxon of the week: Shortia galacifolia

Shortia galacifolia is Jurisdynamics' taxon of the week. Click the picture to find out why.

Purity At A Price

Europeans tend to pride themselves on the quality of their food. From the hundreds of cheeses that Charles De Gaulle thought made France ungovernable to the hundreds of obscure cuts of meat one can choose from in a German butchershop, European food and culture are often seen as inextricably linked. This commitment to artisanal food may go some distance towards explaining why the European Union ("EU") continues to fight to prevent imports of genetically modified ("GM") food.

Recently, discovery of LL Rice 601, a genetically-modified rice strain resistant to some herbicides, among rice destined for the EU has further harmed the image of food imported from the U.S.. Particularly damaging was the fact that the USDA had previously certified the rice to be non-GM. The EU now looks certain to raise the barriers to non-EU agricultural imports even further.

However, Europeans may find that their even more stringent import standards can be met by fewer and fewer countries with exportable food surpluses. The reason for this is that GM-crops are increasingly displacing non-GM crops not just in the U.S., Canada, Brazil, and Argentina - major sources of agricultural imports into the EU - but also in the Ukraine, Russia, China, and other developing countries to whom the EU might turn as replacement sources for wheat, rice, corn, and soy. In fact, the EU recently discovered another strain of GM-rice, BT63, in imported food. However, this time the U.S. was not to blame; this GM-rice came from one of the EU's fastest growing non-US food sources: China.

As the EU's options for non-GM food imports narrow further and further, prices of EU food will likely continue to rise. It will be fascinating to see just how much Europeans are willing to pay for their culture of pure food.

Ozone troubles

The ozone hole in the southern polar region, according to NASA and NOAA, has broken records for area and depth.

From September 21 to September 30, 2006, the average area of the ozone hole was the largest ever observed, at 10.6 million square miles. On September 24, the Antarctic ozone hole matched the single-day record of 11.4 million square miles, previously set on September 9, 2000.

On October 8, NASA's Aura satellite recorded another record: the most severe ozone hole observed to date, in the sense of the least amount of ozone. Aura observed a low value of 85 Dobson Units (a measure of ozone levels above a fixed point in the atmosphere) in a region over the East Antarctic ice sheet. This severe ozone hole (depicted in the graphic accompanying this post) resulted from the very high levels of ozone-depleting chlorine and from record cold conditions in the Antarctic stratosphere.

According to the NASA/NOAA report, international environmental law has played an ameliorative role, albeit a limited one, in remedying the problem. Thanks to the Montreal Protocol and its amendments, concentrations of ozone-depleting substances (mainly chlorine, bromine, and their precursors) in the troposphere peaked around 1995 and are decreasing in both the troposphere and stratosphere. These gases are believed to have reached peak levels in the Antarctica stratosphere in 2001.

But ozone-depleting substances typically have very long lifetimes in the atmosphere. They last more than 40 years. As a result, the ozone hole is expected to close very slowly -- perhaps by 0.1 to 0.2 percent for the next five to 10 years. These declines are dwarved by annual fluctuations in the Antarctic stratosphere.

According to the 2006 World Meteorological Organization/United Nations Environment Programme Scientific Assessment of Ozone Depletion, ozone hole recovery would be masked by annual variability for the near future. This assessment predicts full ozone hole recovery in approximately 2065.

Editor's note: This item has been posted simultaneously at Jurisdynamics and at BioLaw.

A cool site on a hot topic

A Snake Mystery

The Virgin Islands Tree Boa (Epicrates monensis granti) is a beautiful little snake (up to about 1 meter in length) found only on several small Caribbean islands directly east of Puerto Rico. One of its largest remaining populations is located on Saint Thomas, the northwesternmost of the United States Virgin Islands. Already threatened there by the invasive Indian Mongoose (Herpestes auropunctatus), Black Rat (Rattus rattus), and Norwegian Rat (Rattus norvegicus), its last stronghold, in the dry, coastal forest of eastern Saint Thomas, is now the site of a planned major subdivision of luxury vacation homes.

This Tree Boa, one of the United States' only native tropical snakes, would seem an ideal candidate for protection under the Endangered Species Act ("ESA"). The snake would seem an ideal candidate for listing under the ESA. And, it is indeed listed as Endangered throughout its range. Based on its Federal listing, one might assume that there is hope for the Tree Boa.

However, what hope there might be for the snake's survival owes nothing to the ESA. In fact, as the U.S. Fish and Wildlife Service's website states:

MANAGEMENT AND PROTECTION: There have been no direct conservation efforts to protect the Virgin Islands tree boa in the U.S. Virgin Islands.

Why has the Federal government failed to act to protect the Virgin Islands Tree Boa, despite officially listing it as an Endangered Species? I will explore this mystery over the next few weeks because it reveals a lot about the Endangered Species Act, the Fish and Wildlife Service, federalism, and the neglected status of the United States' overseas territories.

The Jurisdynamics Network welcomes Elizabeth Weeks

The Jurisdynamics Network welcomes Elizabeth Ann Weeks of the University of Kansas School of Law. Her research interests include health care financing and regulation, public health, and disaster response. Professor Weeks will be a regular contributor to Ratio Juris and to BioLaw. In addition, her posts will appear on Jurisdynamics.

Please join the entire Network in welcoming Elizabeth Weeks.

Pollinators in the Spotlight

A committee convened by the National Research Council has just issued a report on the Status of Pollinators in North America. The report is making news (see Washington Post story) because it concludes that populations of both "managed pollinators" (the honey bee) and some wild pollinators (native bees, butterflies, bats, and hummingbirds) are declining.

The pollinator story illustrates the practical challenges of responding to loss of ecosystem services, even when doing so makes economic sense. Ecosystem services will only be protected if they are recognized, threats to them are understood, and the people responsible for those threats see altering their behavior as both desirable and possible. The consequences of managed pollinator decline are fairly obvious -- the costs to farmers of honeybee rental have gone up. Yet there is little interest in moving to alternative managed pollinators or making better use of wild pollinators, in part because those pollinators are simply unfamiliar.

The impact of wild pollinator declines is harder to measure. Some wild bees appear to provide silent ecosystem services, enhancing the yield of crops that are generally considered self-pollinating. Greenleaf & Kremen, Biological Conservation 133:81-87 (2006), report that visits by wild bees increased the yield of field-grown tomatoes, and note that the presence of bees depends directly on the proximity of the field to natural habitat. Other pollinators are important to the survival of native plants, but most of those relationships are poorly understood.

The NRC committee recommends (among other things) that the Natural Resources Conservation Service (and presumably state and county extension offices as well) should educate farmers in pollinator-friendly practices, and that pollinator habitat protection should be incorporated into the USDA's conservation incentive programs. For that to work, as the committee notes, NRCS and USDA will need to build their expertise in ecology.

Photo credit: Sarah Greenleaf.

Stem Cells Around The World

Much controversy surrounds stem cell policy in the United States. The Federal government restricts its funding to stem cell lines to those created prior to a magic date. In response, states, as the "laboratory of federalism", have picked up the baton of stem cell research. California has allocated $3 billion to stem cell research, and begun to set up a cordon sanitaire to prevent contamination by Federal funds, personel, and materials (see The New Quarantine), while Missouri is attempting to amend its state constitution to limit restrictions on stem cell research (see Big Effects of Little Stem Cells and Ev'rythin's Up To Date In Kansas City). But how is law in the rest of the world regulating stem cell research?

According to a map published by the University of Minnesota Medical School, as Caesar said of Gaul, the stem cell world can be divided into three parts:

1. Permissive countries. These include the United Kingdom, Belgium, Sweden, Iran, Israel, India, Singapore, China, Japan, South Korea, and South Africa, whose population totals about 2.7 billion. These countries allow "various embryonic stem cell derivation techniques including somatic cell nuclear transfer (SCNT), also called research or therapeutic cloning. SCNT is the transfer of a cell nucleus from a somatic or body cell into an egg from which the nucleus has been removed".

2. Flexible countries. These include Australia, Brazil, Canada, France, Spain, The Netherlands, and Taiwan, whose combined population totals about 700 million. These countries permit "derivations from fertility clinic donations only, excluding SCNT, and often under certain restrictions".

3. Restrictive countries. These include (in order, from most to least restrictive) Austria, Ireland, Norway, Poland, Germany, Italy, and the United States, whose combined population totals about 500 million. The laws of these countries "range from outright prohibition of human embryo research to permitting research on imported embryonic stem cell lines only to permitting research on a limited number of previously established stem cell lines".

Most other countries lack formal legal regulation of stem cells as yet.

Rapidly developing countries form the majority of the "permissive" countries, while developed European countries dominate the list of "restrictive" countries. Currently, at least at the level of national law, the United States has placed itself among the latter.

It all adds up

Any thought that the "small stuff" doesn't matter ought to be dispelled by this recent news of a study focusing on the mixing effect of phytoplankton and other organisms swimming in the ocean--a perfect example of cumulative effects extending from the microscopic scale to the global scale:

Physical and biological oceanographers led by FSU Professor William Dewar have found that the marine biosphere -- the chain of sea life anchored by phytoplankton -- invests around one percent (1 terawatt) of its chemical power fortune in mechanical energy, which is manifested in the swimming motions of hungry ocean swimmers ranging from whales and fish to shrimp and krill. Those swimming motions mix the water much as cream is stirred into coffee by swiping a spoon through it. And the sum of all that phytoplankton-fueled stirring may equal climate control. "By interpreting existing data in a different way, we have predicted theoretically that the amount of mixing caused by ocean swimmers is comparable to the deep ocean mixing caused by the wind blowing on the ocean surface and the effects of the tides," Dewar said.

In fact, he explained, biosphere mixing appears to provide about one third the power required to bring the deep, cold waters of the world ocean to the surface, which in turn completes the ocean's conveyor belt circulation critical to the global climate system. Along with the new calculations that point to the marine biosphere's bigger-than-expected role in ocean mixing and climate control, Dewar and his colleagues also suggest that human and environmental decimation of whale and big fish populations may have had a measurable impact on the total biomixing occurring in the world's oceans.

Findings from the FSU-led study ("Does the marine biosphere mix the ocean?") will appear in the forthcoming issue of the Journal of Marine Research, adding the role of major power broker to phytoplankton's already impressive credentials.

I suppose one solution would be to encourage people to swim in the ocean more often.

How obvious is too obvious?

Over at Ratio Juris, I've posted a brief preview of KSR International Co. vs. Teleflex Inc., the Supreme Court's first case in a generation on "obviousness" under 35 U.S.C. § 103(a). Herewith a brief note on the controversy's significance to the biotechnology industry, courtesy of ScienceNOW Daily News:

The issue is important to scientists because biotech inventions, among other technical innovations, usually rest upon novel combinations of existing elements, such as a known antibody and a known protein target. PTO examiners make the first call on the obviousness of such technologies, followed by courts. Both groups must examine the science and technology at the time of a patent. Decades of court rulings have instructed the PTO to look in the public record for a clear indication of whether a particular invention might have been suggested. If the office can't find such an example, the invention is ruled sufficiently nonobvious.

The RNAge

Two weeks ago, in RNA Rising, I offered a rough estimate of relative patenting trends for inventions involving RNAi and genes, and suggested that RNAi inventions were increasing their representation while non-RNAi gene inventions were decreasing theirs. Recent data from the United States Patent and Trademark Office now adds more detail to this trend (Nature Biotechnology 24(10): 1190 (2006)).

From 2004 to 2005 (the most recent full year-on-year comparison possible), newly issued patents and newly published patent applications covering RNAi inventions rose by an amazing 63% and 36%, respectively. Meanwhile, corresponding increases were 28% and 6% for HIV-related inventions and 21% and 5% for stem cell inventions. By contrast, newly issued patents on gene-related inventions showed little change, with nucleic acid inventions growing by 4%, nucleotide inventions by 3%, and genomic inventions decreasing by 1%. Data on issued patents tends to be a lagging indicator of patentings trends, while data on published patent applications tends to be a leading indicator. Thus, it is striking that newly published patent applications on gene-related inventions are uniformly in decline, with nucleic acid inventions decreasing by 4%, nucleotide inventions by 5%, and genomic inventions by 7%.

If this data is indicative of trends over more than a single year, it would appear that biotechnology inventions are undergoing a changing of the guard. After the Gene Rush, biotechnology is entering the RNAge.

Big Effects Of Little Stem Cells

It's Claire McCaskill versus Jim Talent in the Missouri Senate race

Last week, in Ev'rythin's Up To Date In Kansas City, I discussed the stem cell ballot initiative in Missouri. The New York Times devoted a long article to the issue in its October 15, 2006, Sunday paper: "Missouri Candidates Step Lightly on Stem Cell Measure".

The article mentions that "polls indicate that a majority of Missourians support" the initiative. It also suggests that the issue of stem cell research is so controversial that both Senatorial candidates, Democrat Claire McCaskill and Republican Jim Talent, are largely avoiding the issue on the campaign trail. Despite such reticence, however, the candidates' positions on stem cell research (McCaskill supports it, while Talent opposes it) will almost certainly influence who wins Missouri's Senate seat in November. And, who wins in Missouri could determine whether or not the Democrats regain control of the Senate.

Success for the stem cell research initiative probably favors victory for McCaskill, in Missouri, and the Democrats, in the Senate. Increasingly, tiny stem cells are having a big impact on politics and the law in the United States.

Long-period astronomical forcing of mammal turnover

The following Nature article, which has strong implications for legal responses to climate change and biodiversity loss, is attracting an unusually high amount of attention to The Scientific Lawyer. That's all the more reason to highlight it here at Jurisdynamics and BioLaw:

Jan A. van Dam et al., Long-period astronomical forcing of mammal turnover, 443 Nature 687-91 (Oct. 12, 2006) | doi:10.1038/nature05163; Received 16 January 2006; Accepted 11 August 2006:

Mammals are among the fastest-radiating groups, being characterized by a mean species lifespan of the order of 2.5 million years (Myr). The basis for this characteristic timescale of origination, extinction and turnover is not well understood. Various studies have invoked climate change to explain mammalian species turnover, but other studies have either challenged or only partly confirmed the climate–turnover hypothesis. Here we use an exceptionally long (24.5–2.5 Myr ago), dense, and well-dated terrestrial record of rodent lineages from central Spain, and show the existence of turnover cycles with periods of 2.4–2.5 and 1.0 Myr. We link these cycles to low-frequency modulations of Milankovitch oscillations, and show that pulses of turnover occur at minima of the 2.37-Myr eccentricity cycle and nodes of the 1.2-Myr obliquity cycle. Because obliquity nodes and eccentricity minima are associated with ice sheet expansion and cooling and affect regional precipitation, we infer that long-period astronomical climate forcing is a major determinant of species turnover in small mammals and probably other groups as well.

Milankovitch cycles or oscillations -- also known as Milanković cycles -- hold the key to this study. Astronomers such as Milutin Milanković have computed regular variations in the eccentricity, axial tilt, axial orientation, and orbital orientation of Earth's path around the sun. The predictability of these variations, see Ferenc Varadi, Bruce Runnegar & Michael Gil, Successive Refinements in Long-Term Integrations of Planetary Orbits, 592 Astrophysical J. 620–30 (2003), DOI: 10.1086/375560, underlies attempts to relate these variations to climate change.

In other words, as the earth's tilt and orbit change, so does its climate. As usual, NOAA has collected much of the data needed for this sort of sophisticated modeling.

Two caveats are in order. First, at least in the short run, anthropogenic effects are likely to outweigh astronomical forcing. Second, our inability to understand the mechanism by which astronomical forcing affects climate undermines our confidence in models purporting to relate climate change to Milankovitch cycles.

The Biotech Patent Pie

The biotechnology industry represents a powerful threat to the pharmaceutical industry. As generic companies eat into sales of existing branded drugs, biotechnology companies are increasingly the locus of new drug development. And, in addition to new drugs, the biotechnology industry has become a prodigious producer of new patents. A recent paper by Saurabh Aggarwal, Vinay Gupta, and Sharmistha Bagchi-Sen (Nature Biotechnology 24(6): 643-651 (2006)) provides a fascinating glimpse of the landscape of biotechnology patents, and challenges a common misgiving about the biotechnology industry along the way.

In the five years from 1995 to 2000, the number of patents issued to publicly-traded biotech firms increased from 393 to 1 674, or more than 425%. Newly issued patents reached a peak of 1 939 in 2002, before subsiding to 1 434 in 2005 (still an increase of more than 364% over 1995). Although Aggarwal et al. do not parse biotech patents by particular biotechnology, I suggested in RNA Rising that the relative representation of various biotechnologies can change rapidly.

An oft-voiced fear is that a small number of big biotechnology companies, such as Monsanto, Genentech, and Amgen, would use their patenting strategies to dominate the areas of medicine and agriculture. However, the relative patent positions of such big biotechnology companies has actually decreased, rather than increased, over time. Aggarwal et al. show that the relative shares of biotech patents owned by Monsanto, Genentech, and Amgen in 1995 (19%, 8%, and 7%, respectively) had decayed significantly by 2005 (6%, 5%, and 4%, respectively). In the meantime, the relative shares of biotech patents owned by small biotechnology companies rose from 45% in 1995 to 49% in 2005. As Aggarwal et al. put it, "[the] patent pie is getting bigger but the slices are getting smaller".

Obviously, this gross-level analysis does not reveal concentration of patent ownership in particular biotechnological areas, such as genes, polypeptides, RNAi, aptamers, or genetically modified organisms. However, it does suggest that monopolies may be difficult to assemble in biotechnology.

From in vivo to in silico biology and back

In the interest of completing a thought that Andrew Torrance began earlier this week with his post, "Lexoinformatics," I'd like to share this item I encountered in BioLaw's feedcatching website, The Scientific Lawyer:

Barbara Di Ventura, Caroline Lemerle, Konstantinos Michalodimitrakis and Luis Serrano, From in vivo to in silico biology and back, 443 Nature 527-533 (5 October 2006) | doi:10.1038/nature05127:

The massive acquisition of data in molecular and cellular biology has led to the renaissance of an old topic: simulations of biological systems. Simulations, increasingly paired with experiments, are being successfully and routinely used by computational biologists to understand and predict the quantitative behaviour of complex systems, and to drive new experiments. Nevertheless, many experimentalists still consider simulations an esoteric discipline only for initiates. Suspicion towards simulations should dissipate as the limitations and advantages of their application are better appreciated, opening the door to their permanent adoption in everyday research.

Correspondence to: Luis Serrano, European Molecular Biology Laboratory, Meyerhofstrasse 1, 69117 Heidelberg, Germany.

Incidentally, the USDA holds an annual conference on biological systems simulation.

Ev'rythin's Up To Date In Kansas City

On November 7, 2006, voters in Missouri will do far more than chose between the usual Democrat and Republican suspects. They will vote on whether or not to amend the Missouri constitution to allow, protect, and implicitly promote stem cell research in the state. In fact, this Red state may trump all Blue states except California by passing Amendment 2: The Stem Cell Research and Cures Initiative, which limits legal restrictions on stem cell research.

Why would Missouri and its largely Republican political class promote stem cell research? The answer is simple: the Stowers Institute For Medical Research. The Stowers Institute was set up in Kansas City by mutual fund moguls - and cancer-survivors - Jim and Virginia Stowers, who have been donating the fortune they made from their company, American Century Investments, to the Institute. Currently, the Stowers Institute has an endowment fund in excess of $2 billion, making it the second wealthiest private medical research institution in the world, and future donations may raise it above the reigning champion, the Howard Hughes Medical Institute. Stowers already has about 60 000 square meters of premium laboratory space, and plans to add an additional 60 000 square meters every decade, "in perpetuity". However, there is one significant caveat: the Institute - and its founders - have let it be known in no uncertain terms that expansion can only be assured upon successful passage of Amendment 2. Rumors of expanding in California or Massachusetts have concentrated the minds of politicians and voters alike.

The Stowers Institute is on a roll. A star Harvard Medical School researcher, who has been recruited by the Stowers Institute, described the recent rate of successful recruitment as "one Harvard or Stanford professor per month". Kansas City is enjoying its newfound status as a center of cutting-edge biomedical research. And, the governments of both Missouri and Kansas, whose border Kansas City spans, are planning for the myriad economic benefits they expect to flow from biotechnology - most notably stem cell technology - developed at, and spun-off from, Stowers.

All that stands in the way is Amendment 2. In a recent drive through the heart of Kansas City, I conducted a thoroughly unscientific poll by counting lawn-signs favoring ("YES On 2 For Lifesaving Stem Cell Cures") or opposing ("Vote No On Amendment 2 - www.nocloning.org") Amendment 2. The result: 25 Yes and 3 No.

And so, it appears that the citizens of Missouri may ensure that "Ev'rythin's up to date in Kansas City, They've gone about as fur as they c'n go!"

Judge Jones is in the media again, and it’s a good thing, too

About a year ago, I traveled during my fall break from Des Moines, Iowa to Harrisburg, Pennsylvania to watch a bit of the Kitzmiller v. Dover proceedings (the six-week intelligent design trial). When court was called into session, it quickly became clear to me that Judge John Jones was holding everyone in that courtroom--himself, attorneys, parties, witnesses, journalists, community members--to high standards of professional conduct.

Since issuing the ruling in that case last December, Judge Jones has been more visible in the media than most federal judges, and in my opinion, his discussion of his role in deciding the case enhances the credibility of the judiciary at a time when so much of the judiciary seems to be under attack. Most recently, he was interviewed for the magazine of the Evangelical Lutheran Church of America, a mainline protestant denomination of which he is a member. Hat tip, National Center for Science Education.

Article of the week: New evidence for a relationship between Atlantic tropical cyclone activity and African dust outbreaks

NASA's TERRA satelite spots a dust storm (in yellow) off the western coast of Africa. Amato Evan and company suggest that dust storms moving west from the Sahara may help "dampen" hurricanes. Photo credit: NASA via Amato Evan.

Amato T. Evan et al., New evidence for a relationship between Atlantic tropical cyclone activity and African dust outbreaks, Geophysical Research Letters, Vol. 33, L19813, doi:10.1029/2006GL026408, 2006 (Oct. 10, 2006)

Abstract

It is well known that Atlantic tropical cyclone activity varies strongly over time, and that summertime dust transport over the North Atlantic also varies from year to year, but any connection between tropical cyclone activity and atmospheric dust has been limited to a few case studies. Here we report new results that demonstrate a strong relationship between interannual variations in North Atlantic tropical cyclone activity and atmospheric dust cover as measured by satellite, for the years 1982–2005. While we cannot conclusively demonstrate a direct causal relationship, there appears to be robust link between tropical cyclone activity and dust transport over the Tropical Atlantic.

Received 3 April 2006; accepted 30 August 2006; published 10 October 2006.

Index Terms: 0305 Atmospheric Composition and Structure: Aerosols and particles (0345, 4801, 4906); 1620 Global Change: Climate dynamics (0429, 3309); 1637 Global Change: Regional climate change; 1640 Global Change: Remote sensing (1855); 3374 Atmospheric Processes: Tropical meteorology.

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Science Daily offers a succinct summary of this article:

During periods of intense hurricane activity, he found, dust was relatively scarce in the atmosphere. In years when stronger dust storms rose up, on the other hand, fewer hurricanes swept through the Atlantic.

This item has been cross-posted at Jurisdynamics.

GMOs, Food Prices, and the WTO

Genetically modified organisms ("GMOs") provoke strong yin and yang responses. Critics accuse them of being dangerous, both to human health and the environment, while champions emphasize their potential for higher productivity, increased efficiency, beneficial new characteristics, and benefits to the environment. The biological basis for the negative claims is difficult to establish conclusively, and several published studies (including one involving GMO-contamination of pollen crucial to migrating butterflies and another suggesting that GMO-genes had "leaked" into native Mexican maize stocks) have raised the alarm then subsequently been repudiated. However, many consumers and their governments remain wary.

Two events have recently coincided that may change the character - and possibly the outcome - of the GMO debate. First, the price of agricultural commodities, such as wheat, have spiked higher, and show few signs of retreating in the near future. Yesterday, for example, the price of wheat reached its highest point in ten years on U.S. markets. For the first time in years, fears about the price and supply of food have begun to perculate up through even the developed countries. And second, the World Trade Organization released its Panel decision on the European Communities' GM-food regulations, finding that, while it did not necessarily violate international trade rules to regulate GMOs to ensure human and environmental safety, the moratoria (whether explicit or de facto) and unreasonable regulatory delays imposed by Europe did constitute violations. Reflecting the appeal of GM crops not only to developed countries, but to developing countries as well, the Panel's decision together considered complaints from the United States (DS291), Canada (DS292), and Argentina (DS293).

Higher prices for food commodities coupled with looser regulation of GMOs should encourage continued growth in higher crop-yield GM crops worldwide. For opponents of GMOs, the search for credible biological evidence of negative effects will have to intensify if they have any hope of slowing the spread of GMOs around the world. Barring a major (and causally-identifiable) health or environmental catastrophe, or significant changes to international trade rules, the one-two punch of higher food prices and permissive international trade rules may fix the fight in favour of GMOs.

Biotech, IPRs, and Sustainable Development

Calestous Juma recently delivered the 2006 Hinton Lecture in England, entitled "Redesigning African Economies - The Role of Engineering in International Development". Dr. Juma has had a very distinguished career, including having headed the United Nations Biodiversity Secretariat. In his lecture, he addresses how scientific infrastructure, education, institutions, and good governance can contribute to sustainable development in developing African countries. He notes a strong role for biotechnology and bioengineering in curing diseases, improving agricultural output, encouraging science education, and promoting knowledge-intensive industries.

Dr. Juma also makes a refreshing analysis of the role that intellectual property law can play in encouraging sustainable development - an analysis that acknowledges that patent systems and technological development do not always march in lock-step, but do co-evolve to an important extent. As he writes:

Protecting intellectual property rights (IPRs) is a critical aspect of business development and international partnerships. But overly protective systems could have a negative impact on creativity. It is therefore important to design intellectual property protection systems that take the special needs of African countries into account.

To encourage innovation and unlock local capital, individuals and corporations need to feel that their research is protected; where IPRs have been violated, compensation must be provided. Most countries, however, developed without these protections being structured across the economy in any clear way. Indeed, institutional development of patent regimes usually occurred after a country’s firms achieved a significant level of innovation capability and then desired to protect their investments. This line of thinking would lead to a global intellectual property regime that acknowledges the co-evolutionary nature of technological innovation and enforcement of intellectual property rights.

Dr. Juma presents not only an optimistic view of what can be achieved in the developing world, but offers a detailed prescription of some of the factors necessary for sustainable development to be achieved.

Hypoallergenic Cats to the Rescue

In one of its most widely emailed articles, the New York Times reports that Allerca has developed a hypoallergenic cat, or what the compay calls “lifestyle pets.” Purchasers must go through a rigorous screening process, and the hypoallergenic cats are sold neutered (the lucrative trait is apparently readily transmitted in cross-breedings with ordinary cats.) As a cat lover myself, I am sympathetic to those heretofore doomed by biology to be forever deprived of feline companionship. However, when the same paper is full of reports about the horrors and deprivations of Darfur, I can't help wondering at the state of the world. Do we really want to be remembered as a society that cared more about making sure that all Americans had the opportunity to obtain a hypothetical future pet than as a society that stepped up to the plate as a humanitarian crisis unfolded? What does it say about us that the novelty kitty article is the one people pass along to their friends?

But, I digress. The reason that the article caught my eye (not suffering from allergies myself) is that I had been following Allerca for some time. The company made waves early on by proposing to genetically engineer cats to attain the holy grail of catdom--a kitty that produces little or no Fed d1, the most common human allergen. A funny thing happened on the way to the "frankencat" however. Allerca discovered a way to produced its $4000 hypoallergenic kitties through conventional breeding. Turns out good old selective breeding can get the job done.

This summer, the San-Diego Union Tribune published a less than savory story about the “Allerca Foundation” a purportedly non-profit foundation administered by Allerca. The Tribune reported that the Foundation may have illegally solicited donations. On its website, the Foundation had claimed to be working with the Audubon Zoo in New Orleans to clone the rare clouded leopard, and with the Feline Conservation Center in Rosamond to add genetic samples of endangered species to the foundation's DNA bank.

When the Tribune reported that neither the Audubon Zoo nor the Feline Conservation Center acknowledged any association with the Allerca Foundation, the company altered its website to omit the claims. Now the website merely provides information about the plight of the snow leopard.

Despite representations that donations were tax deductible, the Tribune could find no evidence that the Allerca Foundation actually was a 501(c)(3) organization. The Foundation no longer accepts donations from the public, claiming to be funded solely from Allerca. The Foundation has no projects pending.

Of course, the Audubon Zoo does use biotechnology in its attempts to preserve highly endangered species. For example, in August 2005, the Audubon Zoo announced that it had successfully bred two endangered African Wildcats that had been produced through cloning. The clones then used “traditional methods” to produce a healthy litter of 8 kittens. One hopes the kitties survived Katrina.

By confirming that clones can breed naturally, the Audubon Zoo took a big step forward in enabling researchers to preserve the shrinking gene pools of species on the verge of extinction. That said, I have very mixed feelings about using cloning to preserve species. For species on the verge of extinction it may well be their best (read only) hope. But, I am afraid that fascination with technology will divert attention from crucial habitat protection initiatives. After all, it is so much easier to believe that technology can fix the biodiversity crisis with just a little innovation. Changing our behaviors is so much harder.

Lexoinformatics

I had a fascinating coversation with a colleague of mine, Bill Tomlinson, who is joining the fields of ecology and informatics. Ecology is a data-intensive field, but the huge quantities of data gathered in studying the structure and function of living systems tend to be under-used. Professor Tomlinson and his collaborators are developing a research program that would use the tools of informatics to mine significantly more informational value from the existing mountains of ecological data, just as bioinformatics has been uncovering patterns hidden within the existing mountains of genetic data.

Perhaps the approach could be extended even further to analyze data on how environmental, natural resource, and land use laws affect living systems. Legislation such as the Clean Air Act, The Clean Water Act, The Endangered Species Act, and the cases, regulations, and rules that interpret and implement them are pregnant with information, as are the many empirical studies that have tried to gauge the effectiveness and efficiency of these laws in achieving their stated aims. I think the insights that could be gained by cleverly applying the powerful approaches of informatics to this third mountain of data could bring a great leap forward in our understanding of law and the living systems it affects.

Aside from Jim Chen, I wonder how many law professors know how to code?

Article of the week: The tropics as cradle and as museum

David Jablonski, Kaustuv Roy & James W. Valentine, Out of the Tropics: Evolutionary Dynamics of the Latitudinal Diversity Gradient, 314 Science 102 (2006), DOI: 10.1126/science.1130880:

The evolutionary dynamics underlying the latitudinal gradient in biodiversity have been controversial for over a century. Using a spatially explicit approach that incorporates not only origination and extinction but immigration, a global analysis of genera and subgenera of marine bivalves over the past 11 million years supports an "out of the tropics" model, in which taxa preferentially originate in the tropics and expand toward the poles without losing their tropical presence. The tropics are thus both a cradle and a museum of biodversity, contrary to the conceptual dichotomy dominant since 1974; a tropical diversity crisis would thus have profound evolutionary effects at all latitudes.

Dan Whipple's summary of this article cuts to the chase:

In the tropics, which wrap around swaths of nearly every continent, animal and plant diversity is abundant, and it declines as one moves toward the North and South poles. Why this difference? Many evolutionary biologists favor one of two explanations: Either the tropics are where most new species originate, or species are less likely to go extinct there than elsewhere. New research suggests that both are true. The finding indicates that the tropics drive biodiversity and that extinctions there may have especially devastating effects.

See also Charles R. Marshall, Fossil Record Reveals Tropics as Cradle and Museum, 314 Science 66 (2006), DOI: 10.1126/science.1133351.

Waxman Hatches A Biologics Bill

Alongside his cosponsors, Senators Schumer and Clinton, House Representative Henry Waxman, best known to the patent fraternity as one half of the Hatch-Waxman Act, has a new proposal. Modestly named the "Access to Life-Saving Medicine Act" (H.R. 6287), this bill proposes to extend favorable legal treatment to some generic "biologics" (also referred to as "biopharmaceuticals" or "biotech drugs"), while weakening the legal rights of holders of biologics patents.

Derived from living cells, biologics are drugs - usually proteins - that tend to possess more complicated chemical structures than traditional small-molecule drugs. H.R. 6287 would introduce into patent and drug law two new categories of biologics: "comparable" (Section 2(4)) and "interchangeable" (Section 2(6)). A comparable biologic lacks "clinically meaningful differences [to] the [patented] reference product in terms of the safety, purity, and potency of the product based upon [specified sources of data]", whereas an interchangeable biologic, among other features, "contains an active ingredient or ingredients with principal molecular structural features comparable to the [patented] reference product..."

At 39 pages in length, the bill would add a new layer of complexity to federal patent and drug legislation. It has not been welcomed by the Biotechnology Industry Organization, which views it as an attack on patent rights covering the most promising source of new drugs. However, portrayed by its three Democratic sponsors as an effort to rein in the prohibitive cost of biologic drugs, H.R. 6287 might alternatively be entitled the "Access to Working and Middle Class Votes Act".

2Can bioinformatics support portal

The 2Can bioinformatics support portal provides a handy introduction to bioinformatics and related topics, courtesy of the European Bioinformatics Institute (EBI). Science magazine offers more details.

HPV Vaccine Legislation Pending in Michigan

Greetings from the University of Mississippi, where I’m visiting this year from Drake University. I’m glad to be part of the BioLaw team and look forward to contributing thoughts about science and education. Recently, I’ve been writing about teaching evolution, creationism, and intelligent design in public schools; if you’re interested, see here, for starters.

Today, though, I’d like to take a different approach to “science and education” and comment about a bill pending in the Michigan legislature. This bill attempts to take advantage of an amazing advance in science—a vaccine that can prevent the transmission of certain strains of the human papilloma virus (HPV), the viral source of about 70% of cervical cancer. The legislatiors proposing the bill hope to achieve a widespread public health impact by requiring all sixth grade girls to receive the vaccine. The bill passed the Michigan Senate by a vote of 36 to 1. Having moved to the Michigan House, it has been sitting in committee for about two weeks. Michigan is the first state to consider such legislation.

Of course, this bill has generated a significant amount of public comment (see the Michigan legislature’s website) because HPV is nearly always transmitted via sexual activity, so opponents view the vaccine as encouraging children to become sexually active. So, why require 11 year olds to be vaccinated? Well, the vaccine’s creators say it should be administered before an individual becomes sexually active in order to be most effective. According to the Kaiser Family Foundation and other sources, slightly less than half of graduating high school seniors report already having been sexually active.

This vaccine is just the latest in a line of scientific advances that have led from the 1940s, when cervical cancer caused more deaths in women than even breast cancer, to today, when cervical cancer often can be treated with great success, if diagnosed early. About 700,000 cases of cervical “precancer” are identified and treated in American girls and women every year. In this same population, about 10,000 cases of cervical cancer are diagnosed annually. Each year, about 4,000 American girls and women die of cervical cancer. The rates of cervical cancer and precancer gradually are on the rise, though.

Requiring that schoolchildren be vaccinated against a host of easily communicable diseases is standard (diphtheria, polio, tetanus, smallpox, chicken pox, typhoid, measles, mumps, rubella), though of course HPV differs as a general matter because it is transmitted through intimate contact. Also standard is that parents who have religious objections to immunizing their children, in other words, religious objections to immunizations per se, not to particular immunizations, are allowed an exemption from the immunization requirement. I wonder, though, whether the general religious exemption would change form in the face of parental protests, allowing parents to pick and choose which immunizations they found objectionable for religious reasons?