January 29, 2012

Organic Farmers File Lawsuit to Clarify Trespass by GE Crops

Here is an update on the lawsuit Organic Seed Growers & Trade Association, et al. v. Monsanto, filed in federal court last spring. A hearing on the matter in New York is scheduled this week. Here, the plaintiffs have filed a declaratory judgment action against the biotechnology company Monsanto (owner of numerous patents on genetically engineered (GE) crops, such as those for glyphosate-tolerant plants that resist the application of the Monsanto herbicide Roundup Ready), among others. With the backdrop of numerous lawsuits that have been filed by Monsanto against farmers for various patent-related claims, this suit is a proactive attempt by a coalition of organic farmers to clarify their status against the company, particularly for instances of inadvertent contamination of their crops by transgenic seed, which has led Monsanto to successfully sue numerous American farmers for patent infringement (facts include, e.g., saving seed beyond license agreements; trespass by GE crop contamination). This suit asks that a number of relevant Monsanto GE crop patents be declared invalid, alleging numerous bases for so finding, including that the inventions are not “useful” within the understanding of that term in U.S. patent law, drawing on many published accounts of harms with such crops: “Thus, since the harm of transgenic seed is known, and the promises of transgenic seed's benefits are false, transgenic seed is not useful for society.” Monsanto has challenged the standing of the plaintiffs, and issued a letter that disputes the existence of controversy, noting that it has pledged not to sue where “trace amounts of its patented seed or traits are present in a farmers field as a result of inadvertent means.”  Not surprisingly, this has not settled the matter.

January 27, 2012

Genetically Engineered Food Labels: State and Federal Pressure Points

There is one more effort to require the labeling of genetically engineered (GE) foods. This time it occurs in the state of Washington, where Senate Bill 6298 has been introduced, which would require that agricultural commodities or processed food containing genetically modified ingredients be labeled with the word "genetically engineered.”  This effort lines up with other state initiatives, such as the New York state GE labeling bill, for example, introduced last year but not enacted. There are several distinct approaches to the GE food labeling which illustrate the pressure points available. One other state approach in 2012 is a pending California ballot initiative which would require labels on GE food. To date, no state has enacted a mandatory labeling law for GE food, with the exception of Alaska’s law that requires the labeling of genetically engineered salmon. Last week, the California legislature shelved a similar bill regarding the labeling of GE salmon. No American regulatory body or legislature has implemented any such requirement.  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." At the national level, there are two pressure points for change: a citizen petition filed at the FDA asking that the agency implement mandatory labeling of GE food under its current statutory authorities, and a federal bill, the Genetically Engineered Food Right to Know Act, introduced in Congress this year (as well prior sessions) which would explicitly mandate This fact contrasts with developments in the international regime for GE food labeling, where, despite U.S. opposition, the Codex Alimentarius Commission (an international organization of food safety regulators that establishes international standards) reached an international consensus last year on labeling guidelines for GE food; this was significant because it eliminated any challenge to national food labeling as a barrier to trade, actionable under the auspices of the World Trade Organization. So the legal picture for resolving GE food labeling remains turbulent, with a significant degree of international agreement emerging that contrasts with a continuing domestic impasse.

January 21, 2012

Scientists Announce 60-Day "Pause" on New H5N1 Influenza Research

A new development has emerged in the ongoing controversy over the creation of a new H5N1 influenza virus which appears to have the pandemic potential long feared by public health officials. The new virus, created by Ron Fourchier and others, has the attributes of being highly infectious in humans and high mortality rate. According to the investigators, only a few mutations from a normal virus were required for the virus to adopt the new phenotypes, meaning that such a pandemic-level virus might emerge naturally much sooner than was previously thought. The debate over the publication of this work has gone on for weeks, as the National Advisory Board on Biosecurity (NSABB) recommended to both Science and Nature that they withhold publication of key details of the work if they were to publish the papers that describe the research. So far, both journals are reviewing the submitted publications, but have not decided how or whether to publish them. Nature has recently published a series of expert commentaries that consider how security and disclosure can coexist with respect to this kind of pathogen research. Lost in some of the early debates over publication was the fact that the new virus is now a scientific reality, and issues of physical containment and security are important in order to ensure that the existing stocks remain sequestered in laboratories.  Now, Fourchier and other virologists have announced a 60-day "pause" on any further work on these highly pathogenic H5N1 influenza viruses: "We realize that organizations and governments around the world need time to find the best solutions for opportunities and challenges that stem from the work." So we are returning to a primary and threshold question – should these viruses have been created and should similar work be encouraged (i.e., funded) in the future?  What international mechanisms can be put in place for proactive decision-making regarding dual use bioterrorism-related research? The World Health Organization has recently indicated that it will also be involved in these questions going forward. In the quest to understand pathogens, novel and dangerous strains may be created and are points of vulnerability, even if the underlying scientific data is never published. That’s what this episode has revealed, and the stakeholders in this debate go well beyond granting agencies and peer reviewers.

January 4, 2012

FDA Black Box Warning for Genetic Testing in Plavix Use is Challenged

Did the FDA jump the gun when it recommended genetic testing to accompany the use of Plavix (clopidogrel), a widely prescribed blood thinner drug?  In March, 2010, the FDA issued a post-marketing black box warning for Plavix, suggesting that prescribers consider CYP2C19 genotyping (a  genetic test for mutations in the gene) to identify “slow metabolizer” patients who remained at risk for heart attack, stroke, and other cardiovascular events. The theory was that a subset of patients with a particular genetic profile in the CYP2C19 gene for whom the drug was prescribed because of cardiovascular risk could not properly metabolize the drug; thus they were not protected by the drug against possible heart attacks. This warning followed reports and lawsuits over the use of Plavix (adverse side effects and ineffectiveness). A black box warning is the strictest warning that can be added to a drug label, short of recalling the drug. Such a warning may decrease use of the drug, sometimes without need. Therefore, its use (e.g., adverse reactions to drugs, contraindications for use) is optimally reserved for instances where the level of risk, as supported by data, warrants the elevated monitoring. The FDA recommendation for the genetic test was not supported by leading medical associations, specifically the American Medical Association and the American College of Cardiology, which stated that the evidence was insufficient to support a sweeping recommendation, but did issue guidelines for practitioners who prescribed Plavix. Now, research reports in the British Medical Journal and the Journal of the American Medical Association (JAMA) show that the data does not support the conclusion that the CYP2C19 genetic test results correlate with a population with increased cardiovascular events, as the underlying theory would predict. A JAMA editorial criticized the “irrational exuberance” of the FDA in its recommendation of the genetic testing and noted that “the pharmacogenomics approach to drug therapy must undergo the same rigorous testing for efficacy and cost-effectiveness that is required for other therapies. Overzealous adoption based on limited biochemical data does not serve the public interest.” Any recommendation for genetic testing immediately presents issues of cost and insurance coverage, so that patients may face a more complicated access scenario (and delay). So far, the FDA has not responded to the new research with any revisions in its recommendations. However, the episode is certainly a cautionary tale for the agency, which must balance its growing accommodation of the phamacogenetic dimension of drug prescribing with thorough attention to scientific rigor.