Friday, December 31, 2010

Freedom For A Pound Of Flesh

Express'd in the condition, let the forfeit
Be nominated for an equal pound
Of your fair flesh, to be cut off and taken
In what part of your body pleaseth me.
-The Merchant of Venice (Act I, Scene III)

As one of his final acts in office, Mississippi Governor Haley Barbour has suspended the sentences of two sisters, Gladys and Jamie Scott, convicted of assisting in an armed robbery.  As he stated on his website,
At my request, the Parole Board...reviewed whether the sisters should be granted an indefinite suspension of sentence, which is tantamount to parole, and have concurred with my decision to suspend their sentences indefinitely.

Section 124 of the Mississippi Constitution grants the state's governor the right to grant "reprieves and pardons."  Although more a reprieve than a pardon, the grant of an indefinite suspension of sentence itself would seem well within the constitution's grant of powers.  Specifically,
In all criminal and penal cases, excepting those of treason and impeachment, the governor shall have power to grant reprieves and pardons, to remit fines, and in cases of forfeiture, to stay the collection until the end of the next session of the legislature, and by and with the consent of the senate to remit forfeitures. In cases of treason he shall have power to grant reprieves, and by and with consent of the senate, but may respite the sentence until the end of the next session of the legislature; but no pardon shall be granted before conviction; and in cases of felony, after conviction no pardon shall be granted until the applicant therefor shall have published for thirty days, in some newspaper in the county where the crime was committed, and in case there be no newspaper published in said county, then in an adjoining county, his petition for pardon, setting forth therein the  reasons why such pardon should be granted.

Barbour justified his decision by noting that "the sisters have already served 16 years of their sentences," and "the Mississippi Department of Corrections believes the sisters no longer pose a threat to society."  However, Governor Barbour's statement also dropped a stunning bioethical bombshell by demanding a pound of flesh.  Jamie Scott suffers from impairment of kidney function so severe she requires regular dialysis.  Consequently, Barbour specifically conditioned Gladys Scott's release "on her donating one of her kidneys to her sister, a procedure which should be scheduled with urgency."

One might argue that, logically, if Barbour has the right to grant a full pardon without conditions, then he also has the lesser-included right to grant an indefinite suspension of sentence with conditions.  However, the law tends to be especially protective of human bodies and parts thereof.  In many jurisdictions, it is illegal to sell bodies parts, whether from the living or the dead.  Furthermore, the spirit of the Thirteenth Amendment of the U.S. Constitution may resonate with the quid pro quo donation of kidneys.  However, given the prospect of freedom after 16 years in jail, it is unlikely that the Scott sisters will protest.

Thursday, December 30, 2010

The Evolution And Development Of Biolaw

For those interested in a fuller description of the origins, progress, and ambit of "biolaw," below is one recent view, entitled "The Evolution and Development of Biolaw":

Biolaw has come of age as an academic discipline. This rapidly growing legal discipline possesses a Janus nature that encompasses both the law of biology and the biology of law. Advances in the biological sciences, such as genetics, biochemistry, cell biology, synthetic biology, biological engineering, reproductive biology, embryology, developmental biology, systems biology, evolutionary biology, ecology, behavioral ecology, ethology, and neurobiology continually challenge both society and the laws that attempt to order, regulate, and protect it. Biolaw combines the use of biological science to describe, analyze, and improve the law with legal analysis of biological science, its institutions, and its societal implications. It integrates insights from such biologically-informed research areas as law and genetics, law and neuroscience, reproductive law, behavioral economics, cognitive psychology, law and biotechnology, biotechnology patent law, neuroethics, and biodiversity law. Building on early advocacy of the field by academics such as Hank Greely and June Carbone, the field is currently experiencing a renaissance in interest both inside and outside the academy. Indicia of its new prominence include a large and growing constituency among legal academics, academic conferences (i.e., Law and the Life Sciences, held in 2007 at the University of Louisville School of Law; Biolaw: Law at the Frontiers of Biology, held annually at the University of Kansas School of Law in 2007, 2008, 2009, and 2010), weblogs (e.g., Biolaw: Law and the Life Sciences, LEXVIVO), a scholarly listserv (i.e., the Biolaw Listserv), and high attendance at Biolaw “open programs” at the 2008, 2009, and 2010 American Association of Law School ("AALS") annual meetings. A watershed moment for the field of biolaw arrived in the summer of 2010, when the AALS officially recognized the "Section on Biolaw," which holds its inaugural meeting at the 2011 AALS annual meeting in San Francisco.  As advances in the biological sciences increasingly challenge the vocabulary, legal regulation, and understandings of the role of biology in society, and the law increasingly attends to the regulation of these challenges, biolaw is likely to emulate the growth of cyberlaw as an important and prominent scholarly discipline within the legal academy.
This description will require frequent updating as biolaw continues to change and grow.

Biolaw Holds Its Coming Of Age Party In San Francisco

Theodosius Dobzhansky, the legendary Drosophila geneticist, famously stated that "Nothing in biology makes sense except in the light of evolution." Similarly, nothing in law makes sense except in the light of biology.

Like cyberlaw before it, biolaw has become a recognized academic discipline. Combining, as it does, both the law of biology and the biology of law, it draws inspiration from such rapidly advancing and culturally disruptive scientific fields as genomics, synthetic biology, reproductive biology, neurobiology, and evolutionary biology, while considering how the law does and should regulate this scientific whirlwind. Biolaw uses both biological science to study and improve the law and legal analysis of biology and its implications on human society. At present, there is no area of law more dynamic, challenging, and significant.

The American Association of Law Schools ("AALS"), which holds its annual conclave of law professors in San Francisco from January 5-8, 2011, will host the inaugural meeting of the newly official Biolaw Section. Here are the details of the exciting program the Biolaw Section has planned:

January 5, 2011 - 2:00-3:45 PM

Section on Biolaw

Title: Synthetic Biology Meets the Law

Section Chair/Moderator: Andrew W. Torrance, University of Kansas School of Law

Speakers: Claes Gustafsson, Vice President, DNA 2.0, Drew Endy, Stanford University, Oliver Goodenough, Vermont Law School, Michele Goodwin, University of Minnesota Law School, Christopher M. Holman, University of Missouri-Kansas City School of Law, Jonathan Kahn, Hamline University School of Law, Eileen M. Kane, Pennsylvania State University The Dickinson School of Law

Topic: Synthetic biology marries biological science to engineering principles. It aims to transform traditional biology into a field where genes, genomes, metabolic pathways, cells, and even organisms may be designed and constructed rapidly and inexpensively. Synthetic biology challenges the law in areas such as intellectual property, open innovation, ownership, biosafety, and biosecurity. A panel of scientists and legal scholars with expertise in synthetic biology issues will discuss the current and future landscapes of the law of synthetic biology.

As biological discoveries and biotechnological innovations continue to fascinate, perplex, and frighten society, and the rough engine of the law is increasingly asked to manage these challenges, the role of biolaw, both as a scholarly discipline and as a body of useful legal tools, grows ever more important.

Tuesday, December 28, 2010

Genetically Modified Food For Legal Thought

The United States Department of Agriculture ("USDA") justifies the Plant Protection Act ("PPA")(7 U.S.C. §7701 et seq.) as "necessary because of the major impact plant pests currently have and could have on the agriculture, environment, economy, and commerce of the United States."  The PPA empowers the Animal and Plant Health Inspection Service ("APHIS") "to prohibit or restrict the importation, exportation, and the interstate movement of plants, plant products, certain biological control organisms, noxious weeds and plant pests."  Under subsections of 7 CFR §440, APHIS presumes certain genetically modified ("GM") crops to constitute plant pests.  However, the owner of a GM crop may petition APHIS to have that GM crop deregulated upon a showing that it poses no plant pest risk.

In 2004, Monsanto petitioned APHIS to have two types its GM Roundup Ready Alfalfa ("RRA") granted nonregulated status.  After drafting an environmental assessment of the environmental impact of granting this petition, and soliciting public comments on the issue, APHIS granted Monsanto a "Finding of No Significant Impact," and the RRAs were deregulated.  Several seed farms and environmental groups filed suit in the federal district court for the Northern District of California, winning a preliminary (and, later, a permanent) injunction largely banning any planting of the RRAs until APHIS complied with NEPA (the "National Environmental Policy Act", 42 U.S.C. §4321 et seq.) by preparing an environmental impact statement ("EIS") on RRA deregulation.  On appeal, the Ninth Circuit Court of Appeals affirmed, after finding that the district court below had not abused its discretion.  In Monsanto v. Geertson Seed Farms (decided on June 21, 2010), an almost unanimous U.S. Supreme Court reversed the judgment of the Ninth Circuit, finding that "the District Court had abused its discretion in enjoining APHIS from effecting a partial deregulation and in prohibiting the possibility of planting [RRAs] in accordance with the terms of such a deregulation," and remanded the case.

On December, 2010, APHIS released its final EIS, which found the RRAs substantially equivalent to non-GM alfalfas.  Normally, such a finding of substantial equivalence would warrant deregulation.  However, the USDA expressed its preference that deregulation of the RRAs be accompanied by safeguards to prevent genes from GM alfalfa from contaminating neighboring organic crops.  The issue of colliding GM and non-GM crops has already reached the courts on several occasions, most notably in In re Starlink Corn Products Liability Litigation (N.D. Illinois 2002) and Monsanto v. Schmeiser (Supreme Court of Canada 2004).  Like the English Railway Fires Acts, which were intended to provide modest compensation to owners (often farmers) whose lands were damaged by sparks from steam engines, while simultaneously preventing tort liability from discouraging the perceived economic progress offered by railways, the PPA deregulation pathway could become a method of encouraging the expansion of GM crops.  The decision by APHIS to deregulate, but only with potentially onerous conditions, has even raised the ire of, among others, the Wall Street Journal, which led its December 27, 2010, editorial page with an indictment of USDA's decision to rely on non-scientific factors alongside scientific ones.  The editorial warns that "[i]f nonscience criteria are introduced as considerations for allowing the sale of biotech crops, the effect would be disastrous for the USDA's regulatory reputation."

If GM crops continue to be rapidly adopted around the world, legal issues involving colliding crops are sure to become more common.  Managing the legal consequences of such collisions awaits solutions.

Sunday, December 26, 2010

FDA Slams Brakes On Avastin's Accelerated Approval

Sunday New York Times editorials are often the venue for weighty issues of broad interest, such as war, peace, growth, recession, and politics.  Seldom do they tackle the technical considerations of the drug approval process administered by the U.S. Food and Drug Administration ("FDA").  However, on December 26, 2010, a full third of the Times' influential editorial space was devoted to the paper's views on a drug used to treat metastatic breast cancers.

Bevacizumab is a recombinant humanized mouse monoclonal antibody that binds to vascular endothelial growth factor ("VEGF"), a protein that promotes angiogenesis, the growth of new blood vessels.  By binding to VEGF, bevacizumab blocks binding at the VEGF receptor.  Under some circumstances and for some specific cancers, AvastinÒ (the brand name under which Genentech - recently aquired by Roche - markets bevacizumab) has been observed to inhibit angiogenesis in cancerous tumors, thereby slowing tumor growth.

What prompted the Times' editorial was a recent decision by the FDA to reverse its previous accelerated approval for the use of AvastinÒ to treat metastatic breast cancers.  In 1992, the FDA introduced "accelerated approval" as a means to speed up the regulatory approval of some drugs and biologics.  As provided for in 21 CFR 314.510, accelerated approval is a pathway through which a drug applicant carrying out clinical trials can temporarily substitute a "surrogate endpoint" - a marker indicating a clinically meaningful outcome - for an actual "clinical benefit" to gain preliminary approval.  A similar pathway for the accelerated approval of biologics is set out in 21 CFR 601.41.  This approval pathway is especially valuable in the case of drugs whose clinical benefits may not fully manifest themselves for years.  Upon accelerated approval, the drug may be marketed with a label listing the specific disease indication evidenced by the surrogate endpoint.  However, the applicant must then conduct post-marketing (or "phase 4") confirmatory clinical trials.  If these phase 4 clinical trials support an actual clinical benefit, then the FDA grants the drug regular, full, approval.  In the case of AvastinÒ, the FDA judged phase 4 trials non-confirmatory, and has announced its intention to withdraw its preliminary approval in the case of metastatic breast cancers.

Without FDA approval, by law Genentech will have to remove the metastatic breast cancers indication from the drug's label.  Unless the FDA is forced to reverses its decision as a result of the scheduled hearing, or after Genentech's further legal appeals in federal court, insurance companies will soon drop their coverage for AvastinÒ treatment, which can cost more than $100,000 per patient per year, and has generated blockbuster earnings for Genentech.  The FDA has suffered much passionate criticism of this decision, including from patient advocates and Roche.  Nevertheless, the Times supports the FDA's reversal, and believes the agency "has shown courage in following the scientific evidence on this highly emotional issue."

In recent years, the FDA has been criticized - even demonized - for limiting access to experiment drugs, even to those for whom such drugs might be their only hope of survival.  An especially contentious, and tragic, example of this ongoing controversy culminated in  the Abigail Alliance v. Eschenbach (D.C. Circuit 2007;  en banc) decision, in which the court held that there was "no fundamental right...of access to experimental drugs for the terminally ill."  Though the facts surrounding the preliminary approval differ markedly, the current regulatory dispute over AvastinÒ may generate similar emotional echoes.

Friday, December 24, 2010

Nutcracker v. Mouse King

In addition to the Sugar Plum Fairy and Gingerbread Soldiers, the traditional Christmas ballet, The Nutcracker, has a dark side:  a shockingly violent scene of nutcracker-on-rodent violence.  Are the Nutcracker's martial actions wholly unconstrained by law?  Even with respect to muriregicide, the U.S. Code is far from silent.

If the Nutcracker wishes to employ more subtle means of exterminating the Mouse King, he may be well advised first to consult FIFRA (the federal Insecticide, Fungicide, and Rodenticide Act, at 7 U.S.C. §136 et seq.), the statute that regulates which pesticides are available for poisoning mice and other "pests".  FIFRA imposes registration, labeling, and application restrictions supervised by the Environmental Protection Agency.  However, stabbing with a toy sword is probably outside the scope of FIFRA

If the particular species of mouse attacked by the Nutcracker happened to be federally listed as endangered under §4 of the ESA (the federal Endangered Species Act, at 16 U.S.C. §1531 et seq.), then anyone harming that rat might risk committing a "taking" under §9, and thereby be subject to civil and criminal penalties under §11.  For example, production of The Nutcracker in Southwest Florida that tapped local mouse talent might be advised to exercise caution if its Mouse King were a Key Largo Cotton Mouse (Peromyscus gossypinus allapaticola), a species the Fish and Wildlife Service officially lists as endangered.  In defense of the Nutcracker, his taking, done, as it was, in defense of Clara, might fall within the exemptions or exceptions provided for in §10.

In addition, a growing web of animal welfare laws at the federal, state, and local levels, not to mention ever strengthening norms against animal cruelty, might give the Nutcracker pause, perhaps convincing him to call in the local animal control agents rather than resort to deadly self-help.  Finally, the Nutcracker should probably verify whether or not the state in which he uses deadly force against the Mouse King imposes a duty of retreat, even in his own home.

Happy Holidays!

Wednesday, December 22, 2010

Lex Libris

A number of exceptional books relating to genes, demes, or memes have been published in 2010.  Here is the LEXVIVO list of the top three:

Genes.  The $1,000 Genome:  The Revolution in DNA Sequencing and the New Era of Personalized Medicine.  In this tour de force tour of genomics, Dr. Kevin Davies, Ph.D. (University of London) molecular geneticist and Editor-in-Chief of Bio-IT World (a LEXVIVO must-read), masterfully charts the recent, explosive, and fascinating rise of rapid DNA sequencing technology, explains the wealth of genomic information it enables, interviews the entire cast of characters driving progress in the field, and then frames this powerful technology and its myriad implications for individuals and society in scientific, cultural, ethical, and legal context.

Demes.  Greening through IT:  Informational Technology for Environmental Sustainability.  In this wonderful book, Professor Bill Tomlinson (Informatics Department, Bren School of Information and Computer Sciences, University of California Irvine), a Ph.D. graduate of the MIT Media Lab, brilliantly shows how code, both alone and in conjunction with law, can promote environmental sustainability.

Memes.  The Rational Optimist:  How Prosperity Evolves.  Dr. Matt Ridley (Ph.D. Oxford University), who has written widely and boldly on human evolution (e.g., The Red Queen:  Sex and the Evolution of Human Nature), genetics (e.g., The Agile Gene:  How Nature Turns on Nurture), and the genome (e.g., Genome:  The Autobiography of a Species in 23 Chapters), here posits an elegant, eloquent, and challengingly controversial evolutionary explanation for economic growth via relentless innovation.  If one prefers moving pictures to thousands of words, here is Ridley's cheekily named TED talk, "When Ideas Have Sex."

Enjoy these wonderful books.

Tuesday, December 21, 2010

House Passes The FDA Food Safety Moderization Act

Today, the U.S. House of Representatives passed the "FDA Food Safety Modernization Act" by a decisive 215 to 144 vote margin.  As discussed yesterday, in "Senate Votes For Mom And (Safer) Apple Pie," this legislation represents the most significant overhaul to food-related regulation in the history of the Food, Drug, and Cosmetic Act.  When President Obama signs these amendments into law, as he is sure to do, LEXVIVO will discuss further the new paradigm of food safety regulation this Act will represent.

Monday, December 20, 2010

Senate Votes For Mom And (Safer) Apple Pie

In a surprise to many, late on December 19, 2010, the United States Senate unanimously passed a modified version of S.510, the "FDA Food Safety Modernization Act," by voice vote.  If passed by the House, this bill will constitute perhaps the most significant overhaul to the food regulation provisions of the Food, Drug, and Cosmetic Act since its inception in 1938.  Soon after becoming President in 2009, Barack Obama came under intense pressure to improve regulation of food safety in the wake of a deadly Salmonella outbreak that contaminated peanut butter and melamine contamination of food imports from China.  Titles I and II attempt to strengthen the capacity of the Food and Drug Administration to avoid food safety problems, and Title III focuses on the safety of food imported from other countries.  LEXVIVO will provide additional coverage of this bill if it is approved by the House during this session of Congress, which approval now seems likely.  President Obama strongly supports this bill, assuring that it will become law if passed by the House.

Sunday, December 19, 2010

The Scopes Trial Through The Looking Glass

On July 21, 1925, in The State of Tennessee v. John Thomas Scopes, judge John T. Raulston found biology teacher John Scopes guilty of teaching evolution under the state's Butler Act.  Since then, evolution has largely displaced creationism as a required part of school science curricula in the United States.  Although opponents of teaching evolutionary biology still exist, cases such as Tammy Kitzmiller, et al. v. Dover Area School District, et al. (M.D.Pa. 2005;  Judge John E. Jones III) have found that teaching creationism in public school biology classes violates the Establishment Clause of the U.S. Constitution's First Amendment.

In a sign of how evolutionary biology's ascendancy may have legal limits, a federal judge in Kentucky has now allowed a religious discrimination lawsuit filed by Dr. C. Martin Gaskell, an astronomer and astrophysicist (Ph.D. from the University of California at Santa Cruz), to proceed against the University of Kentucky.  Gaskell's complaint, filed on July 10, 2009, alleges that, during an interview for the position of Director of the MacAdam student observatory at the University of Kentucky, he was asked, and warned, about his personal religious beliefs.  He did not get the job.  The complaint also discusses an email, sent to Gaskell by a University of Kentucky faculty member, revealing that "members of the Biology Department were consulted as to Gaskell's qualifications...[and] expressed great concern about some of Gaskell's religious beliefs" (Complaint, paragraph 25).  Gaskell's "action is brought persuant to Title VII of the Civil Rights Act of 1964...and the Civil Rights Act of 1991, for employment discrimination based on religion."

The past few years have seen the publication of several high-profile books that attempt to use scientific evidence to challenge the legitimacy of religious belief.  Foremost among these is Oxford University Professor Richard Dawkins' (D.Phil in biology from Oxford University) "The God Delusion."  Meanwhile, others have argued that acceptance of science and religious belief are not mutually exclusive, including the Director of the National Institutes of Health Dr. Francis Collins (Ph.D. in physical chemistry from Yale University), in "The Language of God:  A Scientist Presents Evidence for Belief."  At the moment, the law may be more tolerant of the Collinsian than the Dawkinsian perspective.

Saturday, December 18, 2010

Prometheus Patents Unbound

The Titan Prometheus suffered from a chronic liver condition.  The diagnosis was fairly straightforward:  every day, a great eagle would devour his liver, which then regenerated, affording the eagle its next meal.  Preventive medicine to avoid this condition might have involved Prometheus not stealing fire from the gods, and then giving it to humanity, since these actions caused Zeus to impose his brutal aquiline punishment.

On December 17, 2010, a more modern Prometheus, Inc. - a San Diego-based biotechnology company - received news that its torment in the Federal court system might ease.  In Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Prometheus v. Mayo"), the Court of Appeals for the Federal Circuit ("Federal Circuit") reversed a district court's grant of summary judgment that claims in Prometheus' exclusively licensed patents (U.S. Pat. Nos. 6,355,623 and 6,680,302) were invalid because they were drawn to non-statutory subject matter under 35 U.S.C. §101.  In an eagerly anticipated decision, a unanimous Federal Circuit panel, made up of Chief Judge Rader and Circuit Judges Lourie and Bryson, "again [held] that Prometheus' method claims recite patentable subject matter under §101."  The court's previous finding that Prometheus' claims constituted statutory subject matter was successfully appealed by defendants-appellees Mayo Collaborative Services and Mayo Clinic Rochester (hereafter, "Mayo") to the Supreme Court, which vacated and remanded the Federal Circuit's decision on April 29, 2010, "for further consideration in light of Bilski v. Kappos," a business method patent case the Supreme Court had decided the day before.

The claims at issue cover methods for determining the optimal dosage of thiopurine drugs, such as 6-mercaptopurine and azathiopurine, used to treat inflammatory bowel diseases that include Crohn's disease and ulcerative colitis.  For example, claim 1 of the '623 patent involves (1) administering a drug capable of producing 6-thioguanine inside a patient suffering from a gastrointestinal disorder, (2) determining the concentration of 6-thioguanine in the patient's blood, and (3) indicating the need to increase or decrease the drug's dosage depending on whether the drug's blood concentration is outside of the therapeutically desired range of 230-400 pmol per 80,000,000 red blood cells.

The Federal Circuit's decision in Prometheus v. Mayo supports the potential patentability of inventions that claim "therapeutic methods that determine the optimal dosage level of a course of treatment," (Opinion, page 24) including the inventions claimed in Prometheus' patents, that is, "a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs (Opinion, page 25).  More broadly, this decision may raise optimism within the biotechnology and pharmaceutical industries that methods of personalized medicine, including individually tailoring therapies based on specific genomic information, may be patentable, and, thus, worth investment in research and development.    

Friday, December 17, 2010

Council Of Europe Reports Human Organ Atrocities

The Council of Europe is an organization with 47 member countries that "seeks to develop throughout Europe common and democratic principles based on the European Convention on Human Rights and other reference texts on the protection of individuals."  On December 16, 2010, the Committee on Legal Affairs and Human Rights of the Parliamentary Assembly of the Council of Europe released a chilling report entitled "Inhuman treatment of people and illicit trafficking in human organs in Kosovo."  The report, by Swiss rapporteur Dick Marty, alleges the involvement of organized crime in atrocities committed to procure body parts from prisoners of war, and presents disturbing logistical details, such as these:

164. The practical dimension of the trafficking enterprise was relatively simple. Captives brought as far as the Fushë-Krujë area (which entailed an arduous drive of several hours onwards from Rripe or Burrel) were first held in the “safe house” facility. The proprietor of this property was an ethnic Albanian who allegedly shared both clan ties and organised criminal connections with members of the “Drenica Group”.
165. As and when the transplant surgeons were confirmed to be in position and ready to operate, the captives were brought out of the “safe house” individually, summarily executed by a KLA [Kosovo Liberation Army] gunman, and their corpses transported swiftly to the operating clinic.
166. The surgical procedures thereupon performed – cadaver kidney extractions, rather than surgeries on live donors – are the most common means through which donor organs and tissues are acquired for transplant purposes – except for the criminal method of obtaining the cadavers. Eminent organ transplantation experts whom we have consulted during our inquiry described these procedures to us as efficient and low-risk.
167. Sources stated that the Fushë-Krujë axis was chosen to host these facilities because of its proximity to the main airport servicing Tirana. The facilities at the hub of this organ-trafficking ring – the “safe house” and the operating clinic – therefore offered accessibility for incoming international visitors and outgoing shipments alike.  [Footnotes omitted.]
One of the most explosive allegations in the report is the finding that Hashim Thaçi is the man "the "Drenica Group" had as its chief."  [Report, Paragraph 58].  Exit polls suggest that Thaçi was reelected as Prime Minister of Kosovo in the election held on December 12, 2010.

The involvement of organized crime in procuring and supplying human organs has a long history and a broad geography.  Michele Goodwin's brilliant book, "Black Markets - The Supply and Demand of Body Parts," is the definitive study of how the law can variously discourage and encourage illicit trade in parts of the human body.  Tragically, the law has been largely silent so far on the human organ atrocities reported by the Council of Europe.

Thursday, December 16, 2010

PCSBI Report: Synbio Much Ado About Not Much Yet

In its first report, released today, the Obama administration's Presidential Commission for the Study Bioethical Issues ("PCSBI") largely ratifies the current legal environment in which synthetic biology operates, while also urging close monitoring and future study of this rapidly evolving field.  The PCSBI's mission is "to identify and promote policies and practices that ensure scientific, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner."  On May 6, 2010, the J. Craig Venter Institute ("JCVI") quietly deposited the full genome sequence of "Synthetic Mycoplasma mycoides JCVI-syn1.0 clone sMmYCp235-1" into GenBank.  Then, on May 20, 2010, the JCVI surprised the world by announcing, and publishing in Science, its successful "Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome."  The White House responded immediately by requesting that the PCSBI study relevant ethical issues raised by this biological breakthrough, and complete its study by November 20, 2010.  On December 16, 2010, the PCSBI released the results of its first mandate from President Obama.  Prepared with the assistance of two consultants, Alison Davis (Ph.D. in Cell Biology from Johns Hopkins School of Medicine) and Kathi E. Hanna (Ph.D. in Business and Public Management from George Washington University), and a public relations firm, Burness Communications, the report is entitled "New Directions - The Ethics of Synthetic Biology and Emerging Technologies."