October 30, 2011
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
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
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
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
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
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
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
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.