September 26, 2011
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
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
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
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
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
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
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
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
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."
Labels: Genetic Literacy
September 2, 2011
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.