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.