May 30, 2012
The American Heart Association (AHA), a leading professional organization focused on cardiovascular (disease) medicine (CVD) has published an interesting and comprehensive overview of many relevant issues at the intersection of genetics, law and medicine that is worth looking at (published in the AHA journal, Circulation). The professional medical organizations (e.g., American Medical Association and others) have lent their expertise and engaged in advocacy on genetic legal issues over the last decade. They have been visible in the gene patent litigation, Association for Molecular Pathology v. U.S. Patent and Trademark Office (AMP v. USPTO) (headed back to court this summer), where they have largely opposed the granting of gene patents and filed amicus briefs in this ongoing litigation. Now, the AHA has provided its professional analysis and policy recommendations on the central legal/political debates in genetic medicine: gene patents (oppose the granting of gene patents); the possible use of genetic information to discriminate in employment and health care (supports the federal Genetic Information Nondiscrimination Act (GINA), and recommends its expansion to life and long-term insurance policies); the very critical issue of regulatory oversight of genetic tests in the marketplace (recommends that the FDA exercise its enforcement discretion to review and advise on the clinical validity of the laboratory-derived tests in genetic testing); further attention to the establishment of solid pharmacogenetic correlations before genetic information is used to guide drug prescribing and to solid research before genetic risk classifications become routine; further work on a consensus patient consent mechanism that would allow study participants to clearly understand the limits and benefits to participation in large-scale genetic studies; some standardization for insurance payment schemes for genetic tests, and, lastly, the AHA calls attention to the need for deeper practitioner training in genetics. Here are links to some earlier stories here on these issues: FDA regulation; pharmacogenomics, genetic discrimination. Some of the issues discussed in the AHA article require legal resolution (gene patents? FDA oversight?) while others are challenges and overtures to the professional field itself (the AHA calls for increasing development of the specialization of CVD and genetics). In sum, this article is a useful cataloging of the issues confronting all practitioners who increasingly make genetically-informed medical decisions (e.g. oncologists, neurologists, etc.) and provides a template and scorecard to monitor these issues.
May 21, 2012
The nation is watching California, where a citizen’s initiative to enact a genetically engineered (GE) food labeling law has now qualified for the November ballot. In order to place the California Right to Know Genetically Engineered Food Act on the ballot for the November election, 500,000 signatures were required, and the organizers exceeded that in turning in a petition with nearly a million signatures. The proposed law declares that, as of July 2014, “any food offered for retail sale in California is misbranded if it is or may have been entirely or partially produced with genetic engineering and that fact is not disclosed.” The law would require that raw genetically engineered agricultural commodities be labeled with Genetically Engineered” on the front of the packaging; it would further require that processed foods made with genetically engineered ingredients be labeled with “Partially Produced with Genetic Engineering” or “May be Partially Produced with Genetic Engineering.” Exemptions from the labeling requirement include “a raw agricultural commodity or food derived therefrom that has been grown, raised or produced without the knowing and intentional use of genetically engineered seed or food.” This provision acknowledges the possibility of inadvertent contamination of non-GE crops by GE crops in proximity (see here for legal issues involving such contamination). The proposed bill further declares that the use of “natural” or similar terms for foods with genetically engineered ingredients consitutes misbranding. A number of states have pending legislation to require GE food labeling, but none have brought a referendum to ballot as California has; Vermont’s bill has emerged from committee and will be taken up in the next legislative session. On a nationwide level, efforts continue to recruit public pressure on the FDA to mandate the labeling of GE food on a nationwide basis (which it does not); a formal petition has been filed with the FDA and a consumer petition drive continues. If California does acquire the labeling requirement, we can expect possible constitutional challenges from affected industries along First Amendment lines (compelled speech arguments, commercial speech doctrine review) as well as potential dormant Commerce Clause arguments (is such a state food labeling scheme preempted by federal law or authority?). For reference, the dairy industry succeeded in a First Amendment challenge to a 1994 Vermont law requiring milk products to be labeled when animals had been given recombinant growth hormone (rBST); the courts did not find a substantial state interest in Vermont’s assertion of consumer interest as a justification for the labeling requirement.
May 18, 2012
There are more developments in North Carolina as the state attempts to compensate for the eugenics program that it maintained from 1933 until the 1970’s, in which individuals were ordered to undergo forced sterilization. To date, the Eugenics Compensation Task Force has convened, held hearings, and issued recommendations for payments of $50,000 to victims of the forced sterilizations (see final report here). Now the legislature is weighing in to implement such a payment scheme. A bill, H.B. 947, has now been introduced, noting in its preface that “the General Assembly wishes to make restitution for injustices suffered and unreasonable hardships endured by the asexualization or sterilization of individuals at the direction of the State between 1933 and 1974.” Of the over 7,000 victims in the state, it has been estimated that 1,500 to 2,000 of the victims may still be alive. Under the legislation, the payments would not be subject to taxes nor counted against other government benefits. Hearings on the legislation will be held next week. If the payment scheme is finally approved, it would make North Carolina the first state to provide compensation to the victims of its eugenic sterilization program. All of this occurs, however, against a backdrop of eugenics programs that were adopted by at least 30 states during the early 20th century. In a modern illustration of linking official benefits to reproductive status, Sweden maintains a law requiring transgendered individuals to be sterilized before their gender identity will be recognized by the government; this has been widely opposed but is still the current policy.
May 9, 2012
The long-awaited publication of the first H5N1 influenza paper resulting from months of debate over research justification and publication risk has occurred (more background here). Nature has published the article from the laboratory of Yoshihiro Kawaoka at the University of Wisconsin, who has succeeded in creating an H5N1 virus with an altered surface protein (HA) that allows for ready transmissibility in the ferret animal model of influenza (long used as an approximate model of human influenza behavior). The actual virus is a hybrid of H5N1 and H1N1 (responsible for the 2009 pandemic) and thus exhibits features of both. What the scientists were asking was whether an influenza virus can pick up the transmission characteristics of the seasonal flu with the mortality characteristics of more deadly influenza strains. The answer is yes, in that the new influenza could be spread in droplets between animals (like seasonal spread). The lab identified the precise mutations in the HA surface protein which account for its new properties. Of note is the commentary in the article that advocates for this kind of research in order for science to anticipate the composition of new pandemic strains that could arise in the wild. Interestingly, the novel virus showed susceptibility to an existing antiviral – Tamiflu – as well as reactivity with some existing vaccine compositions. Now that the data has been released, we can expect more policy responses on several fronts: 1) How should influenza research be managed – for example, as a select agent subject to certain controls and oversight (an example is the reconstructed replication competent forms of the 1918 pandemic influenza virus containing any portion of the coding regions of all eight gene segments; 2) Continued refinement of the NIH-originated dual-use research policy to focus on the experiments that are most likely to create pathogens with elevated risk profiles 3) More attention to biosafety (laboratory) management, as debate ensues over when high-risk influenza research should require the highest level BL-4 containment facilities, rather than the current BL-3; 4) Journal-level publication strategies that recognize the risk of data dissemination but seek critical risk review in addition to standard peer review, and 5) Further refinement of NSABB procedures and deliberative processes (as suggested by a a critical assessment of the recent H5N1 deliberations and the NIH response to the criticism; and 6) Increased attention to public health surveillance efforts to determine whether they fully exploit new knowledge that has been generated (such as the H5N1 mutations now identified in the article which alter transmissibility) so as to further justify the risks incurred with dual-use research. From the Kawaoka et al. article: "Our findings emphasize the need to prepare for potential pandemics caused by influenza viruses possessing H5 HA, and will help individuals conducting surveillance in regions with circulating H5N1 viruses to recognize key residues that predict the pandemic potential of isolates, which will inform the development, production and distribution of effective countermeasures."