December 28, 2011

Presidential Commission Advocates Compensation for Human Subject Injuries in Federal Research

The Presidential Commission for the Study of Bioethical Issues released its report, Moral Science, on the state of human subject research in federally-funded studies. The report was commissioned following the revelations that the U.S. Public Health Service had conducted unethical research studies in Guatemala in the 1940’s, in which individuals were deliberately infected with venereal disease in order to study prevention and treatment. Following that report, a formal apology from the U.S. government to Guatemala was issued by Secretaries Clinton and Sibelius (State and Health and Human Services). This new report from the Commission concluded favorably that many protections are in place for human subjects (chiefly underpinned by the Common Rule norms of informed consent, independent ethical review and the minimization of risks) but that some further measures could increase transparency and monitoring. Over 55,000 federally-funded studies were identified by the commission, including medical and social science research. Specifically, the report strongly urges the U.S. to follow the lead of other countries which have established formal compensation schemes for victims of unethical research conduct. In that vein, this move echoes an earlier report here on the North Carolina state compensation fund for victims of state-mandated sterilization procedures. There is precedent for this commission and its work: a long line of bioethics-related advisory commissions established by the executive or legislative branches for the last forty years. These groups can respond to presidential requests for timely expert advice on new developments in life sciences (e.g., Clinton and human cloning; Bush and embryonic stem cell research).  An interesting note to this report is the commission's acknowledgement that some of its work duplicates earlier recommendations of other advisory panels regarding formal compensation for research-related injuries: it calls on the executive branch to "publicly release reasons for changing or maintaining the status quo." This might be a useful mechanism to insert in other studies where redundancy of effort is apparent (a special trap for advisory committees without formal power) and the requesting party (here, the Obama administration) should be held accountable for a formal response to the committee's work, rather than silence, which often translates to disregard.

December 21, 2011

NIH Advisory Committee: Limit Publication of Flu Virus Research

There is an update to an earlier report here regarding the creation of a novel H5N1 influenza virus by Ron Fouchier and colleagues in the Netherlands that may exhibit the properties of human transmissibility and high lethality (i.e., pandemic-grade). Although the native H5N1 virus has a high mortality rate (around 60%), it is not readily contagious, a fact that has limited its potential threat to humans. Now, this new H5N1 virus has been genetically modified in the laboratory so that it is readily infectious in ferrets, a mammalian model of virus infection that can be predictive for human health. Recent reports of the research led to an immediate referral to the National Science Advisory Board for Biosecurity, an National Institutes of Health (NIH) advisory committee that reviews dual-use research (scientific work with both salutory and pernicious uses) for publication risk. Now, NSABB has recommended that the virus research be published in a redacted fashion, omitting key details and methodology in order to frustrate rogue attempts to duplicate the virus as a bioterrorist weapon. The leading journals Science (statement here) and Nature have agreed to the recommendations (two different scientific groups are separately publishing the work in these journals). Mechanisms will be established to allow researchers in the field to have access to the full report. This is the first time that the NSABB has issued this recommendation, and the restricted publication has benefits (possible deterrence of those who would produce the virus for destructive purposes) and drawbacks (a precedent that runs against scientific norms of open access and free flow of information). Virologists are divided on the issue: some argue for suppression of critical information on the virus because of the risk of misuse; other virologists assert that publication is not dangerous because the research itself is less troubling than it first appears. My own view is that the reported details of the engineered virus will surface online; however, without confirmation from the original research, it will be hard to verify the accuracy of a stray report. It appears that those scientists who receive official access are likely to observe the publication blackout of the virus details. Either way, this NSABB action and the cooperation by scientists and journals results in a novel and informal prior restraint on scientific publication that particularly encapsulates the post-9/11 concern with dual-use research. In an unrelated but very timely report, efforts to design a universal vaccine against flu viruses (useful against seasonal or pandemic strains) are showing progress.

December 14, 2011

N.C. Task Force to Set Compensation for Victims of Eugenics Program

North Carolina is confronting the legacy of the eugenics-inspired compulsory sterilization program it operated from 1929-1974, in which thousands of citizens were deemed to require mandatory sterilization at the order of the state.  Individuals in prisons and mental hospitals were targeted; the N.C. program also allowed social workers to designate individuals for sterilization. Approximately 85% of the victims were female (including rape victims). For background, eugenics (Latin, for good birth) is grounded in the assumption that a genetic basis exists for many characteristics which makes an individual good or bad – thus, the attempt to engage in social genetic engineering by trying to prevent the birth of the unfit (negative eugenics) and to promote the birth of the fit (positive eugenics). In the early 20th century, the U.S. experienced a wave of eugenic fervor that saw its implementation in over 30 state eugenics programs which authorized forced sterilization of “undesirables.”  I recommend a look at the Eugenics Archive at the Dolan Center of the Cold Spring Harbor Laboratory; see, also, for example, the minutes of the N.C. Eugenics Board in 1950. The famous case of Buck v. Bell at the Supreme Court in 1927 presented a constitutional challenge to Virginia’ s program for forced sterilization of the mentally retarded as applied to Carrie Buck, a patient institutionalized in a state mental hospital; her challenge under equal protection and due process failed in one of the Court's most notorious opinions.

The last N.C. compulsory sterilization law was repealed in 2003. Fast forward to 2011. This year, the governor signed an executive order establishing a task force to decide on compensation for the victims of the program. Claimants can file on behalf of themselves or others. Task force hearings have been held, and claimants have testified on the lasting damage they incurred under the program. What remains to be seen is the compensation figure (N.C. is the first state to institute this mechanism of redress for victims); the task force has considered payments between $20,000 and $50,000.  If this is the first state-sponsored compensation scheme, the payments may signal a complicated monetization of fundamental rights, victim status, delay, and shame that sets a precedent, even with an acknowledgement that it is not possible to establish any precise figure for what was lost to these victims. More broadly, the seemingly archaic U.S. eugenics programs of the 20th century remain very socially and legally relevant as modern genetics provides fertile ground for new theories of human fitness and possible misuse by state authorities.

December 9, 2011

U.S. Supreme Court Confronts Biotech Patenting Controversies

Two significant developments in life science patenting this week: first, the Supreme Court heard oral argument in Prometheus v. Mayo, which involves an attempt to patent a method of optimizing drug treatment by monitoring the metabolism of the drug. At issue is whether Prometheus received a patent on a natural phenomenon, that is, the relationship between metabolite levels and drug effectiveness. U.S. patent law does not allow the patenting of natural phenomena or laws of nature, so this lawsuit challenges the validity of the patent claims. At stake here are implications for many kinds of patent claims in medical testing, all of which are increasing as molecular medicine continues to uncover the foundational relationships between molecules and unravels how molecules achieve clinical effect. The Federal Circuit had endorsed the patent eligibility of the claims, so the Supreme Court is reviewing that decision. In the second life science patenting development, the plaintiffs in AMP v. Myriad Genetics (a coalition of patients, researchers, physicians, the ACLU and PubPat) had challenged the patent eligibility of the breast cancer-susceptibility genes (BRCA1/2) and some genetic testing methods, arguing that these were not patentable because they are either products of nature or natural phenomena. In a victory for the plaintiffs, the lower court ruled that both kinds of patent claims were not patentable subject matter; the Federal Circuit this year reversed the ruling on genes, declaring that genes are not patentable subject matter, deciding that isolated genes are not products of nature. I filed an amicus brief in support of the plaintiffs in that case; link here. This week, the plaintiffs filed a petition for certiorari to the Supreme Court, asking that it review the issue of genes as patentable subject matter. If the Court agrees to also hear this case, it would mean that the biotechnology field could expect a pair of rulings that would clarify several of the most vexing and controversial types of patenting in the life sciences.

December 4, 2011

9th Circuit: Bone Marrow Donation Technology Avoids Compensation Ban on Organ Donation

The 9th Circuit has ruled that the law which prohibits commerce in organ donation does not extend to modern techniques for hematopoietic (blood) stem cell donation. This is an important ruling which is likely to result in an increase in potential donors for blood stem cells. Flynn v. Holder challenged the applicability of the federal statute which prohibits compensation for organ donation to modern blood stem cell donation. The National Organ Transplant Act (NOTA), passed in 1984, prohibits any sale of human organs in interstate commerce. This has traditionally been interpreted to forbid any compensation for bone marrow donors. The treatment of many blood diseases, including cancers such as leukemia, involves the destruction of the patient’s own blood cells and replacement with blood stem cells from bone marrow provided by a genetically matched donor. (Note that this technology is unrelated to the controversy over embryonic stem cell research; this is a kind of adult stem cell donation). The plaintiffs included cancer patients seeking bone marrow stem cells and a bone marrow registry which intends to offer financial incentives for donations and to increase efforts to target ethnic groups that may be underrepresented in current banks. The plaintiffs argued that modern cell sorting technologies now allow the harvesting of hematopoietic stem cells directly from blood, and thus avoid the traditional procedure of bone marrow withdrawal to recover these cells. In essence, these technical advances mean that the donation of bone marrow stem cells can be accomplished through blood donation (which can be legally compensated) and no longer requires the painful and risky medical procedure of bone marrow aspiration (which could not be compensated). The distinction was critical to the analysis of whether the new stem cell donation technology avoids the label of “organ donation” and thus escapes the compensation ban. Several constitutional claims were also advanced. One claim was an equal protection claim which alleged unequal treatment of bone marrow as opposed to blood donations, arguing that compensation for renewable biological specimens is legal, and bone marrow should fall within that description. Another constitutional claim was rooted in a substantive due process claim of a violation of the right to seek medical treatment. The 9th Circuit avoided the constitutional questions, but decided that the modern blood-based method of stem cell donation did not qualify as an “organ donation” for which compensation is prohibited. One of the plaintiffs has announced the availability of scholarships and other financial remuneration to recruit stem cell donors, strategies that can now proceed legally, according to the 9th Circuit. 

December 1, 2011

FDA Endorses DNA Barcoding Technology to Combat Food Fraud

The technology of DNA barcoding has been around for several years. In short, it is the use of DNA sequence analysis to provide a unique identifier for biological species, whether animal, plant, etc. The idea is that the use of a short, standardized sequence of DNA from a large genome is enough to create an individually unique tag that can be used to trace and to identify biological origin. Traditional taxonomy (e.g., Darwin, the classification of species) relied on the use of morphology (visual, structural analysis of an organism). Modern genetic science has now provided an efficient and precise measurement to speed and systematize species identification using a DNA signal. One use of this technology relates to the integrity of the food supply (potential food fraud) – where claims of origin (what kind of animal, fish or plant?) matter not only for commercial purposes, but for public health. Here’s a report from Oceana on the prevalence of seafood fraud. Estimates are that 84% of the American seafood supply is imported, and studies have shown as much as 70% mislabeling of some popular species. That’s why the recent FDA endorsement of DNA barcoding for the identification of seafood species represents a convergence of the technological promise with the regulatory mechanisms charged with oversight of the food supply. By offering products which have been subject to DNA barcoding verification, suppliers and restaurants will be able to represent that their menu offerings have been genetically verified in this manner. The effort by the FDA to promote voluntary genetic verification of food origin is likely to increase market-based disincentives to mislabel food and deceive consumers.

This development at the FDA also dovetails with a growing attention on the part of the government to what is called “economic adulteration” – the deliberate alteration of food and/or drugs undertaken for economic gain (weighing irregularities, substitution with cheaper ingredients) – this is a theoretical labeling of conduct that naturally arises as a consequence of an increasingly complex supply chain design in modern commerce. Here’s a recent analysis by the Government Accountability Office (GAO) of the problem, where it recommends more focus by the FDA on the circumstances where the public is likely to be deceived regarding product integrity – not because of deliberate sabotage or negligent manufacturing practices, but by conscious, economically-driven rationales. While motive is legally irrelevant to whether a food supplier is engaged in deceptive practices, this theorizing does help by conceptualizing the broad range of actors that might be involved.

November 27, 2011

Novel Deadly Flu Virus and Publication Controls on Dual-Use Research of Concern

Post 9/11, the assessment of bioterrorism risks has also encompassed considering whether the publication of scientific research that provides a road map for the creating of deadly pathogens should be constrained. It’s hard to ignore the increase in reports of laboratory research that has created a novel and deadly influenza virus that could pose a human influenza pandemic risk. For background, there are several strains of influenza, not all of which pose a threat to human health. H5N1 influenza virus has long been a most virulent (deadly) form of influenza, but largely found in birds (avian flu) – fortunately, it has not been capable of efficient transmission from animal to human or spread between humans. Thus, although the virus has a high mortality rate (around 60%), it is not readily contagious, a fact that has limited its potential threat to humans. Now there are reports of the laboratory creation of a deliberately mutated H5N1 virus that was developed by Ron Fourchier and colleagues at the Erasmus Medical Center in the Netherlands which they reported at an influenza virus conference in September - in which they discovered that only 5 genetic mutations were required for a relatively inert H5N1 to acquire the capability of efficient spread among ferrets, long used as an animal/mammalian model of human influenza. Here is the short news report from the conference proceedings. Thus, it is possible to extrapolate that this novel virus has the properties of high lethality and efficient transmissibility in humans. No scientific report has been published to date. But there is reaction from the U.S. National Science Advisory Board for Biosecurity (NSABB), a federal advisory body created post-9/11 and located under the auspices of the NIH.  The NSABB is charged with evaluating what is known as “dual-use” research of concern (DURC) – work that is motivated by scientific inquiry but also offers the possibility of adverse use if the results are used in a dangerous manner; the NSABB can recommend that scientific work not be published (but it cannot prevent it).  A prime example of NSABB concern would be the creation of a novel virus, in which researchers attempt to learn what genetic changes separate a benign from a deadly virus – but in order to do so, they create the deadly virus and publish the experimental details. To date, it is reported that the NSABB has been asked to evaluate the risk of publication of this influenza work.

Post-9/11, there was an effort to create more awareness of the dangers of publishing such dual-use research in the life sciences – possible bioterrorism applications were in mind. Earlier concerns attached to such publication as the artificially constructed poliovirus and research that dissected the smallpox virus to identify the genes that confer such lethality. Although there is no scientific paper by Fouchier and colleagues yet, it remains to be seen what the NSABB will recommend, and whether the details of the scientific work will be made public, either formally or informally. Should we know what 5 mutations will convert a benign flu virus to a malignant version? Pro: yes, because this is part of learning how to counter and monitor the already-existing biological threats to human health; nature could generate a mutant virus with pandemic risk, even without human intervention; the work required to engineer such a virus is high-tech and formidable, not readily undertaken by rogue actors. Con: the dangers of such knowledge (and production of viral stocks) outweigh the intellectual gain - there is no containment of knowledge. My own view is that a deeper understanding of the pathology of microorganisms is irresistible if we are to fully capture and integrate how the microbial world coexists with humans and continues to generate health risks. Further attention to this reported virus is likely to refocus efforts on what we have (or need) in vaccines and antivirals (which is hard to do in the absence of some perceived imminent risk). We'll watch to see what further details emerge.

November 25, 2011

FDA Revokes Avastin Approval as Breast Cancer Treatment

The FDA has finally pulled the plug on approval of the biotech drug Avastin for treating advanced breast cancer. Avastin is a monoclonal antibody which works by targeting and shrinking the blood vessels required for tumor growth.  What was interesting about this drug was that it was approved on the FDA fast track in 2008 at a time when it looked to be a promising therapy for the treatment of advanced breast cancer.  In June, an FDA advisory committee recommended that the FDA remove its endorsement for use in metastatic breast cancer, citing studies in which Avastin had shown very little effect on survival time. What is important about this whole episode from the regulatory perspective are several facets: the use of a fast track FDA approval process to capture a promising lead on a biotech drug while minimizing delay in clinical studies, hence the initial approval in 2008; the promise to condition final approval on studies which more thoroughly teased out whether the drug did significantly lengthen survival time (the studies did not support the promised effect) and the extensive public scrutiny of the FDA decision by a powerful patient constituency (pro-approval petition by some breast cancer advocates) and a biotech company (Genentech) which surely did not want to lose its FDA imprimatur and actively campaigned to keep drug approval. But Commissioner Margaret Hamburg sided with the advisory committee in ending the FDA approval, publishing a lengthy document which outlines the reasoning for the decision. Of course, physicians may continue to prescribe Avastin off-label for treatment of breast cancer, but the drug can no longer be legally advertised for such use. Notably, not all breast cancer advocates opposed the FDA's decision; the National Breast Cancer Coalition expressed support. Of most immediate concern for breast cancer patients who still want to receive Avastin is that the lack of FDA endorsement will cause most insurance plans to not cover the cost of the drug (about $88,000 per year). What's also interesting about Avastin (and potentially other biotech drugs which target the support system for cancer cells) is that its mechanism would appear to have wide applicability (be able to generally limit tumor growth) but in actual clinical trials, the effects may be quite heterogeneous (Avastin retains FDA approval for use in treating colon, lung, kidney, and brain cancers).

November 14, 2011

Stem Cell Protagonists in Wisconsin Senate Race

The Wisconsin 2012 Senate race is featuring a particularly sharp contrast between the leading candidates regarding stem cell research, whether the stem cells are derived from existing adult cells or from embryos. The issue of embryonic stem cell research remains controversial as it requires the use of (and possible deliberate creation of) an embryo. Many “pro-life” advocates include an opposition to embryonic stem cell research as part of a platform which opposes the right to abortion. In the Wisconsin 2012 Senate race, former governor Tommy Thompson is the current frontrunner for the GOP nomination to run against Democrat Rep. Tammy Baldwin. Thompson has become not only an advocate, but a sponsor, of recent efforts to increase adult stem research. This was illustrated by his appearance last week at the adult stem cell conference convened by the Vatican, which has entered the stem cell debate through a 5-year, $1 million partnership with NeoStem, Inc., a New York-based adult stem cell biotech company. His remarks took aim at embryonic stem cell research in favor of promoting adult stem cell research: "That’s what I love about adult stem cells – we’re using the divine wisdom inside of us to supercharge our bodies and wipe away disease.  And as we do this, not one single human embryo is destroyed. " Here's an eyewitness report from Art Caplan of the University of Pennsylvania on the dubious scientific merits of the conference. Thompson has also called for a federal commission to be established that would specifically advance adult stem cell research.  Wisconsin Democrats have criticized Thompson's overt association with Vatican venture. Rep. Baldwin has been an advocate for embryonic stem cell research; of note is that one of the first successful efforts in isolating embryonic stem cells took place at the University of Wisconsin in 1998 and that Wisconsin has had a significant stem cell sector ever since. If Thompson secures the GOP nomination and Senate race is between Baldwin and Thompson, the stage could be set for a fairly explicit referendum on official policies toward adult vs. embryonic stem cell research. With Thompson standing with the Vatican efforts to elevate adult stem cell work and Baldwin being a firm proponent of embryonic stem cell research, this race would recast the stem cell debate in a novel and idiosyncratic context. Beyond the politics, what's important to remember is that research into both sources of stem cells is worth conducting and funding, but the scientific merits of each (and funding decisions to follow) may be interpreted through ideological filters which distort actual results. Thus, the relative merits of each may not emerge for years.

November 8, 2011

Litigation Continues to Challenge Planting of GE Crops in Wildlife Refuges

A coalition of plaintiffs continues a series of lawsuits that challenge the practice of granting permission for the planting of genetically engineered (GE) crops, including soybeans and corn, in the federal wildlife refuges (see complaint). The current lawsuit alleges that the U.S. Fish and Wildlife Service has allowed the planting of GE crops in 66 Midwestern refuges without conducting an Environmental Impact Statement (EIS) as required by the National Environmental Policy Act (NEPA). These plantings have occurred as part of a FWS program which designates a portion of a refuge for agricultural purposes. NEPA, passed in 1970, requires that any action undertaken by a federal agency that may have environmental consequences be thoroughly evaluated by conducting a rigorous environmental review of possible impacts and consideration of alternatives. NEPA effectively allows for citizen challenges to a broad range of federal actions that pose environmental risk through the use of a procedural objection, as exemplified by this lawsuit. No EIS was prepared here; this pattern has been followed by FWS in granting permissions for GE crops is refuges across the U.S. To date, the plaintiffs have won rulings in earlier challenges to the planting of GE crops in the refuges, where the courts have ordered FWS to conduct the requisite EIS (earlier this year, the U.S. District Court in Delaware ordered a halt to such plantings, pending the completion of an EIS). One might guess that the FWS would decide as a matter of national policy to prepare an EIS for any proposed designation of refuge property for GE plantings. The FWS, however, has been unwilling to establish such a national policy that would routinely institutionalize EIS preparation - instead, the individual lawsuits must seek adjudication to get an EIS prepared, and any GE plantings underway halted (one estimate is that GE crops are planted in 75 national wildlife refuges). This lawsuit is the fourth such legal action, and it is likely that courts will continue to conclude that the planting of any GE crop on land that is designed to house and maintain natural habitats is exactly the kind of intervention that demands the strictest legal review.

November 6, 2011

Precision Medicine: The Patient as Data Repository

The era of defining the human patient as a data repository continues; this recharacterization represents the convergence of massive molecular (including genetic) data with digital information capacities (electronic medical records), creating an era of “precision medicine.” At the request of the National Institutes of Health, the National Academy of Sciences was tasked to develop an entirely new view of human disease, less informed by a collection of symptoms and a general description of malfunction and centered instead on a molecular-driven profile of a patient.  They have issued a report, Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease that proposes a new disease classification system that is informed by the collection of genetic, proteomic, microbial and other biological states – the end result is to more sharply define disease states and allow for treatment that is more personalized, with a higher likelihood of success. As part of this effort, the report calls for the use of existing patient data to build an information commons which provides the intellectual foundation for reunderstanding human medical processes.  But how to get there?

The evolving imperative is to integrate patient care and data collection into a giant information commons, where every patient, if you will, is part of the ongoing “clinical trial” that becomes the modern medical enterprise. Of course, actual clinical trials, in which an individual agrees to become a research subject for scientific/medical investigation, are a well-established pillar of medical science and they are conducted using norms of consent, transparency, and privacy; an overview here). What does this mean for the law? The report does note a need to "initiate a process within appropriate federal agencies to assess the privacy issues."  Existing legal privacy protections are several (HIPAA, regarding the privacy of medical records, GINA, regarding does provide some assistance as Title I addresses unfair uses of genetic information by health insurers regarding premiums, etc.).The upshot is that rewriting human disease in molecular language is intellectually appealing, but the conversion of patients into information subjects has obvious privacy implications.  Treatment consequences include a kind of adverse typecasting with consequences for receiving medical care (or insurance for).  The proposed federal initiative is now new. An example of a private effort to integrate patient records into a genetics research program is underway by Kaiser Permanente in California, in which insured patients can consent to having their deidentified patient records entered into their genetic research program. The program provides formal privacy guarantees, and has its own internal Institutional Review Board (IRB) which reviews protocols. As the era of molecular medicine redefines the patient as a data repository, the law must supply the requisite human norms of privacy, risk, and choice to accompany such a transformation.

October 30, 2011

Mississippi's Ballot Initiative Would Confer Personhood on Fertilized Egg

The Mississippi Amendment 26 ballot initiative has attracted much attention. The amendment, up for vote on November 8th, establishes personhood for a fertilized egg, with the objective of ending abortions in the state and eliminating birth control options that interfere with the implantation of a fertilized egg. A similar ballot amendment was defeated twice in Colorado. If Amendment 26 becomes effective, its proponents note that “the Amendment would confer due process rights on the unborn.” Already, fetal homicide laws exist in at least 38 states. Such laws can effectively criminalize abortion. A useful commentary from Jessica Valenti summarized the various scenarios in which pregnant women who do not seek an abortion still can have their pregnancy-based health decisions affected, or prohibited by such laws. The scenarios for law enforcement include the prosecution of an Indiana woman charged with fetal homicide after a suicide attempt and a class of women charged under the Alabama chemical endangerment statute because of drug abuse during pregnancy, or the use of such laws in Mexico to prosecute Mexican women for miscarriages. Stem cell research advocates are also weighing in against Amendment 26, with Stem Cell Action noting that the attachment of legal rights to the fertilized egg would adversely affect embryonic stem cell research, access to in vitro fertilization (IVF) procedures, including interfering with the right of couples seeking to donate unused embryos for stem cell research. The Amendment, if passed, provides one more template for institutionalizing the unborn (fertilized egg, fetus) as a class of legal actors whose rights are set against established norms of reproductive autonomy for women, as well as against the scientific community that seeks to harness the power of embryonic stem cells for promising (but not necessarily imminent) therapeutic applications. Such laws also raise the specter of a diffuse spread of liability for many women (pregnant or not), medical professionals, and scientists.

October 26, 2011

Settlement of Litigation Over Genetically Contaminated U.S. Rice Crop

An update on the litigation involving the genetic contamination of the commercial rice crop in the U.S. by genetically engineered (GE) rice, specifically LibertyLink, produced by Bayer CropSciences. LibertyLink was engineered with a gene that confers herbicide resistance, meaning that weed killers can be used on the field without injury to the crop. The initial complaint alleged the contamination of native rice crops by the GE rice. The harms to rice farmers were numerous, including an immediate export ban imposed by the EU. The multi-district litigation, In re Genetically Modified Rice Litigation, ended in a settlement in which Bayer must pay $750 million; the time frame for farmers to register a claim will end in November; a stipulation of the settlement is that 85% of an identified set of claimants must register for the settlement to take effect. This litigation took several years in federal court, under the jurisdiction of the Eastern District of Missouri. The contamination was discovered in 2006. The Bayer GE rice was classified as a nonregulated crop by the Animal and Plant Inspection Service (APHIS), an agency with the U.S. Department of Agriculture (USDA). APHIS refused to deregulate the crop in 2006, despite calls to do so.  By 2007, APHIS confirmed the contamination of the native rice crop by the GE strains. Bayer's corporate predecessor, Aventis Crop Science, was the source of the Starlink contamination of the U.S. corn crop in 2000.

October 22, 2011

Turf Battles in the Regulation of Genetic Testing

The uneven regulation of genetic testing in the U.S. – where most genetic tests are laboratory-developed tests (LDTs), meaning that they are offered as services, rather than products - has meant that many genetic tests are not regulated, in contrast to a retailed medical testing kit (e.g., diabetes test) fully regulated by the FDA as an in vitro diagnostic. The FDA has moved to utilize (effectively expand) its enforcement discretion by issuing guidelines for companion diagnostic tests (genetic testing accompanying the use of a pharmaceutical, e.g., Herceptin) as well as some direct to consumer genetic tests. While the FDA has increased its oversight over these sectors of the genetic testing field, there are other legislative moves that would actually keep the regulation of such tests at the Center for Medicare Services (CMS), the agency that enforces Clinical Laboratory Improvement Amendments (CLIA), which generally regulates laboratory testing in the U.S. A new bill has been introduced – HR 3207 - which would authorize CMS to establish a review and notification process for LDTs – specifically, to review such test for clinical validity- a key phrase in the trilogy of laboratory testing parameters – analytic validity, clinical validity and clinical utility – the upshot is a deeper look into whether a test has a verifiable relationship to the clinical care that is supposed to be supported with the use of the test. So this new bill, supported by industry trade groups, such as the American Clinical Laboratory Association (ACLA) would place this authority at CMS. Would the FDA still have a role to play?  Not clear; what this bill signals is that the slowly evolving regulatory landscape is unstable enough that the leading actors are still to be decided. Of course, the genetic testing industry will not welcome any redundancy of effort (nor should we, as taxpayers). What may finally issue could depend on the finances - that is, in a climate where expenditures dictate policy, the largely unfunded mandate that HR 3207 generates for CMS could fare better against new authorities for the FDA which might be expected to require additional funding. The new bill would have CMS create a registry and require premarket notification (not approval) for LDTs. A genetic test registry is also being created by NIH, to be launched in 2012.

October 18, 2011

European Court of Justice Prohibits Patenting of Embryonic Stem Cells

The European Court of Justice (ECJ) issued its opinion in an appeal from a German court decision regarding the patentability of embryonic stem cells (ESC). Originally, Greenpeace challenged the grant of a German patent on a method for deriving neuronal progenitor cells from ESC, and achieved a favorable ruling from the Federal Patent Court of Germany. That court then referred the overarching policy question on the granting of such patents to the European Court of Justice in view of the Directive 98/44/EC of the European Parliament (the legal protection of biotechnological inventions). This EU-wide directive sets out the standards for patentable subject matter. First, the directive establishes the concept of public morality as a touchstone for patenting decisions (the U.S. lacks any such standard). Article 6.1 of the Directive notes that “Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality” while Article 6.2 prohibits the “uses of human embryos for industrial or commercial purposes.” The court’s summary states that “the use of human embryos for purposes of scientific research which is the subject-matter of a patent application cannot be distinguished from industrial and commercial use and, thus, avoid exclusion from patentability.” This decision firmly halts most patenting efforts in the EU on ESC technologies. Contrast this outcome with the ban on federal funding of ESC research instituted in 2001 by the Bush administration. That was not a patenting decision, but it had great effect on reducing incentives and opportunities for U.S. stem cell research. That ban has since been lifted (see here). While patenting opportunities are limited in the EU, U.S. patenting remains available, and one of the consequences of the ECJ decision will be to offer the possibility of evaluating the costs and benefits (incentives, or lack of) for two sharply contrasting IP environments for ESC research.

October 13, 2011

Listeria Outbreak Occurs Against Evolving Food Safety Regulation

Recent reports of a widespread Listeria (bacterial) outbreak of food-borne illness (at least 116 infected, 23 deaths) from contaminated cantaloupes have generated renewed scrutiny of food safety protocols.  To date, the outbreak has been traced to a domestic source, a producer in Colorado, and consumers are advised that fruit from other sources is safe. Earlier this year, Congress did pass the FDA Food Safety Modernization Act (FMSA), which updates the regulatory powers of the FDA (by authorizing mandatory recall power), strengthens food tracing procedures, heightens scrutiny of imported food, and improves CDC surveillance of food-borne illness. The recent outbreak, however, originates from a domestic supplier. Industry pressure from retailers  is also a source of leverage against food producers who cannot assure their retail customers of the safety of their products.  Here is a useful backgrounder on the patchwork of regulatory powers dispersed among several government agencies.  Already, at least six lawsuits have been filed against Jensen Farms, the source of the contaminated cantaloupes.  Now, there are cautionary voluntary recalls of lettuce which may have contamination.  What's troubling is that, in the midst of one of the worst outbreaks of food-borne illness in the U.S., the laudable progress represented by the FMSA is still subject to the vagaries of federal funding, with pending budget cuts to the FDA likely to dampen the more energetic food safety efforts envisioned by the FMSA.

October 10, 2011

FDA Petition Filed in Renewed Effort for Labeling of GE Food

The Center for Food Safety and a number of other organizations have filed a petition with the Food and Drug Administration, asking for mandatory labeling of genetically engineered food.  The arguments are centered on their reading of the Federal Food Drug and Cosmetic Act (21 U.S.C. § 301 et seq), which prohibits "misleading" food labels; the petition argues that the lack of information regarding genetically engineered ingredients makes a label misleading.  Other arguments center on establishing the level of alteration to the food by genetic engineering; interesting, this argument relies on the use of novelty arguments used in the patenting of GE food for support.  The petition further alleges the presence of environmental harms from such crops to further bolster the need for labeling.  This lawsuit follows other failed attempts to get the courts to order the FDA to require GE food labeling; for example, in Alliance for Bio-Integrity, et. al. v. Shalala (D.D.C. 2000), the court refused to find the FDA's determination that a genetically engineered component is "generally regarded as safe (GRAS)" and not in need of labeling as either arbitrary or capricious.  In a 1992 policy document, the FDA stated that "the agency does not believe that the method of development of a new plant variety (including the use of new techniques including recombinant DNA techniques) is normally material information within the meaning of 21 U.S.C. 321(n) and would not usually be required to be disclosed in labeling for the food."  This summary of recent poll data shows overwhelming consumer support for GE food labeling; the court have not been receptive to this argument as a basis for requiring the FDA to act. See, e.g, International Dairy Foods Association v. Amestoy (2nd Cir. 1996), in which the court was not persuaded that the satisfaction of consumer labeling demands was a significant enough government interest to overcome the First Amendment challenge by dairy farmers to the labeling of milk produced from cows enriched with growth hormone).

October 6, 2011

Is it Real Progress to Personalized Stem Cells?

A reported advance from the New York Stem Cell Foundation in deriving stem cells from cloned embryos is attracting much attention. Here’s the research paper. The researchers were able to transfer a nucleus from a donor cell into an oocyte which retained its nucleus, and get the oocyte to develop into blastocyst level (70-100 cells), from which they extracted stem cells, which would now be embryonic stem cells (ESC).  What’s notable is that this technique of somatic cell transfer leading to stem cell development and harvest had not worked to date with human eggs. That explains much of the attention that this report is generating. However, the catch here is that the researchers found it necessary to maintain the oocyte nucleus while adding in the new nucleus – so the stem cells have extra chromosomes (3 times normal), and are abnormal. It's important to note that the ability to transfer a new nucleus to an existing egg and cause embryo development is the precursor to the long-sought ability to create personalized stem cells. But this report does not put us there. Many of the mainstream news reports oversell the scientific impact here, both reporting it as an unfortunate advance toward the possibility of  human cloning, and a fortunate advance toward producing customized stem cells. Both alarm and hope are triggered, out of proportion to the actual results. It’s worth, noting, however, because the public sense of how science is proceeding can translate into demands for oversight or access; thus demands for legislative attention (see, e.g., 1997 Dolly sheep cloning-inspired legislative flurry, see here for an updated list of state cloning laws, and note the origin of such efforts in 1997, when the cloned sheep was revealed). No federal legislation has been enacted, although President Clinton did issue an executive memorandum at the time banning the use of federal research funds for human cloning; in addition, the FDA maintains its authority to regulate any such attempts.

October 2, 2011

Breast Cancer Awareness Month: New Technologies, Legal Dimensions

October is Breast Cancer Awareness Month, and it’s useful to note that several breast cancer-related advances from molecular biology have become central modalities in the fight against the disease. But it’s also interesting to note that there are accompanying legal/regulatory issues that attend to the intersection of genetics and cancer diagnosis/treatment, not all of which are resolved. For example, the breakthrough treatment of Herceptin, an antibody that targets a protein on the surface of cancer cells, has been around for about 10 years or so, with several collateral dimensions: the cost of a biotech drug (high so far as a singular, uncompeted advance), the possibility of generic alternatives (the pending regulation of biosimilars onto market); the use of accompanying genetic testing to identify the patients who will benefit from the drug (a prototypical pharmacogenomics approach).  A quick look at the use of BRCA1/2 testing to identify high-risk individuals raises the very prominent issue of patent rights in genes (Myriad litigation still in the courts; see here for a paper tracing patent conflicts and breast cancer) and the possible misuse of genetic information, whether workplace or insurance (beginning to be addressed with the Genetic Information Nondiscrimination Act/GINA).  Lastly, the evolving regulatory environment for novel biotech drugs was acutely illustrated this year with the FDA’s decision to withdraw its approval for Avastin as a treatment for late stage breast cancer, with the concomitant loss of insurance coverage for patients seeking use of this high-priced drug.  So this particular field is paradigmatic of many collateral legal and/or regulatory aspects of new cancer-related technologies.

September 26, 2011

Senate Endorsement of NIH Translational Science Focus

The Senate Appropriations Committee has centered on the funding level for NIH in the coming 2012 fiscal year: $30.5 billion.  This near-maintenance of 2011-level funding is useful to note in the current climate of budget-cutting, but the committee also endorsed some specific NIH proposals within the appropriation.  NIH has sought to establish the National Center for Advancing Translational Sciences (NCATS) as a new center within the NIH enterprise, which will will "strive to reengineer the process of developing drugs, diagnostics, and devices."  This has been strongly advocated by NIH Director Francis Collins, who published his argument for a more aggressive role for NIH, noting  "the triple frustrations of long timelines, steep costs, and high failure rates bedevil the translational pathway. he average length of time from target discovery to approval of a new drug currently averages ~13 years, the failure rate exceeds 95%, and the cost per successful drug exceeds $1 billion, after ad­justing for all of the failures."  In shorthand, this push attempts to reduce the classic bench to bedside translation of medical discoveries, and identify the translation process itself as ripe for innovation.  The Senate bill creates the new center; additionally, it authorizes $20 million for a new program, the Cures Acceleration Network (CAN), which grants the Director wide latitude to distribute funds targeted at "High Need Cures." CAN was supported by then-Senator Arlen Spector, who specifically noted the need for efforts to speed up treatments for "cancer, autism, Parkinson's, Alzheimer's, and diabetes" - and embedded its establishment within the Patient Protection and Affordable Care Act in 2009 (health reform bill). Both of these NIH initiatives are likely headed for approval, with the end result being that frustrations with the lab to market pipeline could increasingly lead to novel interventions by the federal research institutes, which cannot per se "go to market" but which can target speed bumps that prevent promising federally funded research discoveries from leaving the laboratory.  It's a recognition of a larger mission for federal science authorities - to ensure that the science that taxpayers are purchasing is actualized in usable form.

September 24, 2011

Appeal Filed in Ongoing Embryonic Stem Cell Funding Litigation

An appeal has been filed in the ongoing challenge to the government's policy of providing funding for embryonic stem cell research (ESCR).  This funding followed the Obama Executive Order in 2009, which ended the Bush-era ESCR funding ban.  Several adult stem cell researchers allege that the federal funding sponsored by the Department of Health and Human Services and the National Institutes of Health (NIH) violates the existing Dickey-Wicker amendment, which prohibits the use of federal funds for any research in which an embryo is destroyed. The NIH Stem Cell Guidelines, published in 2009, reference the amendment, but make it clear that the ESCR research does not violate it:  "These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryo’s destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryo’s destruction, for which federal funding is permitted."  The plaintiffs had won a preliminary injunction against the research in August 2010. In April, the appellate court lifted the injunction, finding that NIH was likely to prevail against the challenge, effectively upholding the research funding, stating that the term "research" in the amendment was ambiguous. The lower court then ruled against the challenge.  This appeal continues the back and forth litigation on this issue; the D.C. Circuit has certainly signaled its pro-ESCR reading of the Dickey-Wicker amendment, and could be expected to maintain this view in the merits challenge now filed.  Reports are that NIH spent around $200 million on ESCR-related research in 2010.

September 22, 2011

Patent Reform Bill Prohibits Patenting of Human Organisms

A provision in the new America Invents Act (AIA) will expressly prohibit the Patent and Trademark Office from issuing any patents on human organism.  The language in Section 33 of the new act is quite sparse: "Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism."  The origin of this provision is found in the Weldon amendment to the patent bill, which has described as necessary by pro-life groups in order to block the patenting of human embryos or genetically engineered humans.  The provision is unusual in its simple declaration of a class of null patents, in that it does not take the more logical route of formally excluding such "inventions" from the classes of patentable subject matter in 35 U.S.C. 101.   However, the PTO does instruct examiners that such patent applications are to be rejected under the formal Section 101 and the new AIA provision. The PTO has previously declared in 1987 that genetically engineered humans are not eligible for patenting; almost 10 years later, when challenged with a 1998 patent application that claimed a human chimera, the PTO rejected the application: "It is the position of the PTO that inventions directed to human/non-human chimera could, under certain circumstances, not be patentable because, among other things, they would fail to meet the public policy and morality aspects of the utility requirement."  In summary, the unusual evocation of a morality requirement in U.S. patent law, the existence of the 13th Amendment which forbids ownership of other humans, and PTO actions to date all counsel that any attempts to patent a human organism - embryo; genetically engineered - will fail, and would have failed even without the recent legislation.

September 21, 2011

UN Calls Special Session on Non-Communicable Diseases

The annual meeting of the United Nations (UN) General Assembly is underway in New York.  We're used to seeing either the UN - or the World Health Organization (WHO) - play a leading role in the containment of infectious disease outbreaks, whether acute (e.g., H5N1 flu pandemic) or more chronic (HIV/AIDS).  But there has been more pressure for international public health authorities to also focus on the effort to reduct the health burden of non-communicable diseases (NCD) - cardiovascular disease, diabetes, cancer, and chronic respiratory disease.  Advocacy efforts to get the NCD agenda into center stage on the international public health agenda have culminated in the UN responsiveness seen this week.  A 2011 report from the UN declared its new focus: "Non-communicable diseases represent a new frontier in the fight to improve global health. Worldwide, the increase in such diseases means that they are now responsible for more deaths than all other causes combined."  This week, a special UN session was devoted to the NCD public health agenda.  The session had been planned for several years, and a draft political declaration had been prepared in advance for adoption at the meeting this week. While no one quarrels with the recognition that the NCD health burden is staggering, the declaration notes, in so many words, that the prevention of NCD (reducing risk factors, including environmental and social adversities)  and control of NCD (providing medical services and pharmaceuticals) inevitably draws in a large menu of social and political controversies that are no more amenable to consensus now than before.  In that sense, it will be interesting to see how the NCD framing of health disparities summons political will to address the same.  Also, to what extent does the elevation of NCD health issues translate to defining such health conditions as "national emergencies" which could invoke the Article 31 of the TRIPS Treaty - authorizing compulsory licensing mechanisms which have been used to alleviate limitations on drug access for infectious diseases (e.g., AIDS)?  The UN has used language in its statements ("epidemic proportions") which calls attention to the magnitude of the NCD burden; Dr. Margaret Cho, the director of WHO, has called NCDs  "a slow-motion disaster." Thus, this week's meeting and attention accelerates some reframing of public health needs, with the possibility that progress toward allevating both NCDs and non-NCDs ensues, using this egalitarian lens.

September 18, 2011

New Patent Reform Act Authorizes Study of Patent Effects on Genetic Testing

The recently enacted America Invents Act (AIA) contains a provision which testifies to the continuing controversy over the patenting of genes, and particularly the impact of such patenting on the availability of genetic tests.  This issue was amply studied by the Secretary's Advisory Commission on Genetics, Health and Society (SACGHS), which concluded that diagnostic genetic testing was most at risk from gene patents (as opposed to other potential uses of the gene, such as for therapeutic applications in gene therapy).  The SACGHS study addressed the problem  by calling for an "an exemption from liability for anyone who infringes a patent on a gene while making, using, ordering, offering for sale, or selling a genetic test for patient care purposes." One purpose of such use is to provide confirmatory test results for a previous testing result.  Despite their recommendation,  no such immunity has found its way into the patent statute. The new AIA now asks the Commissioner of the Patent and Trademark Office (PTO) to investigate how such confirmatory (“second”) opinions can be provided in a situation where a gene patent exists which is exclusively licensed, thus limiting competing alternatives, such as the procurement of a second opinion.  Section 27 of the Act provided this definition: "confirming genetic diagnostic test activity means the performance of a genetic diagnostic test, by a genetic diagnostic test provider, on an individual solely for the purpose of providing the individual with an independent confirmation of results obtained from another test provider’s prior performance of the test on the individual."  So this investigation will focus on the subset of genetic testing requests that seek to confirm (or refute) an already obtained test result.  Should the study reveal significant barriers to confirmatory testing for patients, one possible outcome would be a renewed push for patent infringement immunity for such activities to be legislated (the PTO is to provide Congress with "recommendations for establishing the availability" of such tests (perhaps along the lines of the immunity provided by 35 U.S.C. 287(c), which limits the enforcement of patents against certain medical activities by medical practitioners). 

September 16, 2011

Pest Resistance to Genetically Engineered Crops Emerges

Genetic engineering (GE) in agricultural production has two possible goals: one is to produce a GE food with superior nutritional properties, while the other is to provide an agronomic benefit that improves crop development.  The The strategy behind the development of the well-known Bt corn, produced by Monsanto, is agronomic:to create a genetically engineered corn stock which contains a bacterial protein that is toxic to the rootworm; the stock essentially producing an insecticide that avoids the need for topical application of a pesticide to the field.   The current U.S. Department of Agriculture (USDA) estimate is that about 65% of the corn planted in the U.S. is Bt corn. A recent research report in PloS One provides the first account of rootworm resistance to the protein, with the consequence that the GE component of the corn is no longer effective.  The results, while preliminary and not yet widespread, are a reminder that genetic alterations, whether through breeding or engineering, function against a dynamic backdrop of evolving organisms, which could out maneuver a strategy that relies on the performance of a single protein. Monsanto replies that the use of Bt corn should occur against a backdrop of complementary tactics, such as crop rotation, possible supplementary GE crops, and attention to refuge requirements.  Since more GE crops are engineered for agronomic purposes than nutritional advantage, demonstrations of ineffectiveness are sure to draw attention, as the shelf life for the intervention is shortened, but the genetic modifications nonetheless persist in the food supply as biochemical artifacts.

September 13, 2011

Alaska Still Fighting FDA Approval of Genetically Engineered Salmon

There's more pushback in Congress against the pending application from AquaBounty for approval of its genetically engineered (GE) salmon (AquAdvantage), in which the growth hormone gene is reengineered so that it is expressed year-round (rather than seasonally), greatly speeding up the maturation process by about half.  A newly engineered growth hormone gene - with a promoter sequence from ocean pout that confers persistent expression - is injected into fertilized eggs, thus ensuring the the gene is permanently taken up into the genome.  More scientific background here.  Or the concise treatment from the FDA, stating that the fish has  "an enhanced growth phenotype when compared to non-genetically engineered (non-GE) salmon which allows them to grow faster. However, at market size the AquAdvantage Salmon are not phenotypically distinguishable from non-GE fish." Shorthand: you can't tell the GE or non-GE fish apart from simple observation.  Detailed DNA analysis is required to identify the genetic identity of an unclassified salmon.

New efforts by the Alaska delegation continue to oppose any approval action by the FDA for the fish.  The FDA locates its authority to regulate GE fish under the Federal Food Drug and Cosmetic Act (FFDCA), stating that "The rDNA construct in the resulting GE animal is thus a regulated article that meets the drug definition; the GE animal itself is not a drug."  The FDA application has been pending now for some 15 years. Yet, the Alaska delegation is concerned about potential mating between the GE salmon and the native Alaska salmon, with the potential to decimate the native genetic structure of the salmon over time.  According to the company, the selected fish would be female and sterile and could not breed with the wild salmon.  But assuming less than 100% ability to properly screen and control the stocks, even a minute number of GE fish that could breed into the wild population could initiate the genetic contamination of the wild-type stock.   The FDA's Veterinary Medicine Advisory Committee held public hearings last year, but the FDA took no action; however, at the time the FDA did issue its conclusion that the GE salmon were indeed safe: "ABT salmon meets the standard of identity for Atlantic salmon as established by FDA’s Reference Fish Encyclopedia. All other assessments of composition have determined that there are no material differences in food from ABT salmon and other Atlantic salmon."  Note the significant phrase of "no material differences" which often appears in regulatory literature describing analyses comparing biotechnology-derived products (such as GE fish) to their native counterparts, and is a conclusion that weakens any claim that special regulation is required for the novel product. Now, Senator Murkowski of Alaska has introduced an amendment that would prevent the FDA from using any resources to approve the salmon; the House of Representative already acted to block any approval. Interestingly, Senator Murkowski will be co-chairing a newly established U.S. Senate Oceans Caucus, which will focus on the multiple issues affecting ocean health and resources.

September 11, 2011

New Federal Report on DNA Evidence Backlog

The problem of a backlog in the processing of DNA samples for forensic analysis in law enforcement has been noted for quite a while; the reports of backlogs in the processing of rape kits are at least a decade old. Therefore, the issue has received attention not only from law enforcement, but also from those seeking to reduce violence against women. More generally, delays in processing DNA evidence can occur with samples taken from individuals in the criminal justice system whose profiles will be catalogued, or it can arise from the failure to process the crime scene evidence (rape kits) that are collected from victims. The lack of processing has unequivocally delayed the possibility of identifying perpetrators at an early stage in a criminal career, before committing a series of crimes which are only connected when DNA evidence reveals the pattern of conduct. Notable documentary work has been done by Human Rights Watch, framing violence against women as a human rights issue, and advocating for vigorous attention to the processing of available evidence in order to prosecute such crimes; a recent success story was L.A.'s efforts to eliminate their backlog of rape kits through 2008. Here is a recent commentary by former Manhattan DA Linda Fairstein, who headed the office's Sex Crimes Unit for several decades, in which she notes not only that evidence backlogs delay justice for crime victims, but that exoneration of an innocent individual is another dividend of such work. Now comes a report from the Department of Justice that the federal backlog of over 300,000 DNA samples from offenders and arrestees has been processed and the forensic profiles entered into the CODIS database. The backlogs in rape kit processing remain, even in 2011; California is legislating, even now, in an attempt to speed up processing; this bill would require that all rape kits are tested when the arrest rate for forcible rape drops below a certain percentage. Less than an ideal solution, in its conditional approach; on the other hand, indifference on the part of law enforcement should be expected to show up in arrest rates, and therefore such a numerical trigger is likely to identify pockets of inattention to the prosecution of rape cases.

September 4, 2011

Genetic Literacy in the States: How Are They Doing?

Performing critical analysis at the intersection of law and the sciences involves some knowledge, at the very least, of the underlying technical material, combined with a command of any relevant legal concepts and doctrines. For that reason, as 21st-century medicine is increasingly informed by genetic paradigms, and life science technologies draw on genetic blueprints, the ability of the body politic to respond to crises of regulation, ownership and access requires some genetic literacy. How defined?  The American Society of Human Genetics (ASHG) commissioned a study which reported that the states were largely "inadequate" in their instruction of high school students with genetic concepts.  Concept 1:  "DNA is the genetic material for all species of living organisms."  Concept 2:  Genes are segments of DNA that encode information critical for development. DNA is organized into structures called chromosomes." 19 standard concepts are included in these assessments, most of which tease out the finer processes of genetic sciences; only 7 states were rated as having an adequate set of standards in their genetic currcula.  Top scores?  Michigan and Delaware. Here is the paper.  ASHG is an organization of genetics professionals, and has devoted considerable energy to policy work in such areas as gene patenting and genetic discrimination.  In their press release, they note that  “Healthcare is moving rapidly toward personalized medicine, which is infused with genetics. Therefore, it is essential we provide America’s youth with the conceptual toolkit that is necessary to make informed healthcare decisions."

September 2, 2011

Federal Circuit Rules that Immunization Optimization Methods are Patentable

Following on the decisions in Prometheus v. Mayo and AMP v. USPTO, both of which presented method patent claims to methods for diagnostic or therapeutic applications relying on the use of biochemical correlations - but both of which presented the critical question of whether a scientific correlation or abstract idea (either one unpatentable) was patented (Prometheus: no; AMP: yes), the Federal Circuit has added more layers to the controversy.  The Federal Circuit has added In re Classen, in which the applicant claimed methods of determining whether an particular immunization schedule was beneficial in deterring later-developed immune disease.  The claims that linked the scientific reasoning to an actual immunization step were found patent-eligible, while the claims that only recited the scientific thought process were not.  A vigorous dissent by Judge Moore characterized the patents as creating "preemption by these staggeringly broad and abstract claims"  and further stated her conclusion that the patents covered "a fundamental scientific principle(s) so basic and abstract as to be unpatentable subject matter."  Thus, in the landscape of litigated method claims with relevance to biotech patenting, Prometheus is now slated for Supreme Court review next term, AMP is in the post-appellate stages of attempted rehearings, and Classen may be appealed further up.  Great turmoil in life science method claims, all of which await their Bilski-level review.

August 31, 2011

AMP v. USPTO: Plaintiffs Request Rehearing at Federal Circuit

The plaintiffs in AMP v. USPTO have filed at the Federal Circuit to request a rehearing of the case in which they have challenged the eligibility of the patent claims to the BRCA1 and BRCA2 genes. Petition here. The Federal Circuit decided against the eligibility of the composition of matter claims (genes), with reasoning that relied on a structural differences between native and isolated DNA. The plaintiffs contend now that the court was in error, as the genes are claimed by function ( “codes for a BRCA1 polypeptide"), not structure, and thus they maintain their argument that there is no functional difference between a native residing or isolated DNA molecule, as each is capable of performing (and isolated in order to do so) as a gene/DNA template whether in vitro or in vivo. The petition further calls for a reconsideration as to which of the multiple plaintiffs have standing, asserting that geneticist Ellen Matloff and the American College of Medical Genetics are parties with valid standing to contest the patent claims.

August 30, 2011

Parental Imprint on Children's DNA: Liability?

A report from the University of Wisconsin raises the possibility that epigenetic changes result to the the DNA of children as a function of the stress in their living environment; results are published in the journal Child Development. The DNA of children (from cheekswabs to check for methylation changes to DNA) was measured and analzyed according to the reported stress level in the family environment. Children in more stressful circumstances evidenced greater changes to their DNA.  Epigenetics - does your DNA become marked/tagged/altered in response to stress? - is a more recent sub-field in molecular biology, and it aims to account for the effect of prenatal or lifestyle (writ large) influences on genetic constitution. For example, a gene can become chemically altered by biochemical events in response to stress or environmental injury, with the result that a gene may underperform as a result. These are kinds of genetic modifications that ensue pre-birth, for example, post-birth and are not found in the newborn genome.  It's a kind of stress catalogue. So could a genomic record of epigenetic insult now support theories of legal liability in a genetic tort action for indifferent, stressful or abusive parenting?