Post-AMP, Myriad Files Patent Infringement Suits Against BRCA1 and BRCA2 Testing Competitors

Several developments have followed last month's Supreme Court decision that invalidated Myriad Genetics patent claims to isolated genes; (AMP v. Myriad opinion). Within hours of the Court’s decision, several competitors announced plans to offer BRCA1 and BRCA2 genetic tests. Myriad has recently filed patent infringement suits against Ambry Genetics (California) and Gene by Gene (Texas), based on the assertion of patent claims from ten patents it holds to BRCA1 and BRCA2 related genetic materials and methods (including some with contested claims in the Supreme Court). The complaint against Ambry is here; the complaint against Gene by Gene complaint is here. The suits, filed in Utah federal court, could be an opening play to fully litigate these other patents or a maneuver to create licensing structures for these patented materials and methods. A strategy by Myriad to obtain a preliminary injunction against these companies would have to contend with the more rigorous scrutiny for such requests after eBay v. MercExchange (2006), where the Supreme Court reaffirmed the need to consider "public interest" in the award of injunctions, and the current climate might lend support for such an argument against any injunction. Ambry has indicated that it will “vigorously defend” its right to offer testing services.The Court’s invalidation of some of Myriad’s patent portfolio related to BRCA1/2 testing has clearly led to altered expectations regarding the state of the genetic testing marketplace. Evidence of this is the response from Senator Patrick Leahy, Chair of the Senate Judiciary Committee, to Myriad’s lawsuit, calling for the National Institutes of Health (NIH) to exercise “march-in” rights that it holds pursuant to the Bayh-Dole Act of 1980. That option applies to patents for which NIH provided federal funding (or other federal agencies). Apart from the march-in authority, the U.S. government retains a default mechanism, a compulsory license that allows it to use any patented invention (or authorize 3rd parties to do so) under the statutory authority of 28 U.S.C. 1498, which requires “reasonable and entire compensation for such use and manufacture.” Since the march-in authority has never been exercised by the NIH (see here), it is unlikely to respond to Leahy’s call. Nor is it likely that the government would regard the BRCA1/2 genetic testing controversies as critical enough to trigger the compulsory license mechanism. These disputes are likely to be settled more informally, and more quickly, as the high visibility of these tests will retain public attention and maintain pressure on Myriad to support the expansion of genetic testing options.

BRCA1 and BRCA2 Genetic Testing Field Expanding Rapidly After Invalidation of Myriad Gene Patents

Within a day of the Supreme Court’s decision in AMP v. Myriad, invalidating patent claims to isolated genes (see here), the genetic testing environment for the BRCA1 and BRCA2 genes has shifted noticeably. Before elaborating on that, it’s worth noting some of the characterizations of the decision from the mainstream press, which reveals public perception of the issues and/or significance of the case. Soon after the opinion was released, the Drudge Report shouted “You Can Keep Your Genes” – a type of headline that appeared in other forms around the country – a mistaken impression that patent rights in human genes translated to any ownership of anyone’s person or bodily materials. But in the sense that the “in vitro” BRCA1 and BRCA2 genes could not be used without permission of the patent holder, the headline had some accuracy. Other news accounts noted the bifurcated nature of the decision, invalidating patents on isolated genes, while upholding patent claims to semi-synthetic cDNA molecules, creating a mixed picture for biotech companies, depending on business models (e.g., genetic testing for single genes or producing recombinant proteins?).

Several companies have announced their intention to offer BRCA1 and BRCA2 testing: in the day since the ruling, DNA Traits has already posted “Proud to Bring BRCA1 and BRCA2 Testing to You” on their website; other go-aheads include Quest Diagnostics, Ambry Genetics and GeneDx, which announced “its intention to launch a suite of comprehensive genetic tests for inherited cancers including BRCA1 and BRCA2 genes, given the Supreme Court's ruling in the Association for Molecular Pathology vs. Myriad Genetics case.” Academic researchers are also gearing up, notably Dr. Mary-Claire King of the University of Washington (see here) and Dr. Wayne Grody of UCLA, who noted that his laboratory would also offer tests on other genetic diseases covered by gene patents, such congenital hearing loss, spinocerebellar ataxia and various muscular dystrophies. Reaction from professional organizations that had participated in the case was enthusiastic. From the Association for Molecular Pathology (AMP), lead plaintiff: 

AMP is very pleased with the Supreme Court’s decision in the case. The Court’s decision that human genes are not patentable is a great step forward for the field of molecular pathology, for genomic science, and most important for our patients. We look forward to exciting future advancements in diagnostic testing and therapeutics that will accrue to the benefit of our patients and our field. 

The American Medical Association (AMA), which filed an amicus brief) reacted: 

The AMA is pleased that the justices saw through the flawed premise that resulted in Myriad’s exclusive patent awards and affirmed that human genes are products of nature and not patent eligible. Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights.  

The College of American Pathologists (CAP) noted the significance for advances in genetic testing:

Genomic medicine has the potential to be a cornerstone of medical testing, treatment, and clinical integration, but the question of ‘who owns your genes’ needed a definitive answer. Now we have it. 

International reaction includes efforts to push for the amendment of the Patent Act in Australia to prohibit gene patents, following a February court decision in that country that had upheld Myriad patent claims against a patentable subject matter-type challenge from Cancer Voices Australia. Testing access is not the only issue at stake in the gene patent controversy. Myriad Genetics, in establishing itself as the central provider and repository for U.S. genetic testing for the BRCA1 and BRCA2 genes, did not maintain a reliable, accessible database of all the mutations in these genes that it had collected over the years. The Sharing Clinical Reports Project, a public effort to get patients and physicians to report genetic mutations to a public database, was announced in April, 2013. The loss for Myriad of its gene patent claims will certainly accelerate the efforts to establish a credible, dynamic BRCA1 and BRCA2 database which is critical for identifying the sites of genetic mutations, their frequency, and the associations between mutations and diagnosis or prognosis. It’s fair to say, at this point, that the BRCA1 and BRCA2 field is now supercharged as a result of yesterday’s decision, and will rapidly correct for the lag and underdevelopment that it has experienced in the nearly 20 years since the first Myriad patents issued.

Unanimous Supreme Court Invalidates Gene Patents; Genetic Testing Options Will Expand

Today, the Supreme Court ruled that isolated human genes are not patentable. The case is Association for Molecular Pathology v. Myriad Genetics, a challenge to gene patenting based on the patentable subject matter doctrine of 35 U.S.C. 101. Plaintiffs argued that isolated human genes are natural products which cannot be patented, and that Myriad Genetics' patents on the BRCA1 and BRCA2 (breast cancer) genes were thus invalid. U.S. patent law denies patents for products or laws of nature ("laws of nature, natural phenomena, and abstract ideas are not patentable"). Today’s unanimous opinion was written by Justice Thomas.  Most centrally, the opinion states that Myriad’s patent claims to isolated genes fall within the product of nature and law of nature exceptions to patentable subject matter – as a result, they are invalid. In the ongoing debate over whether genes are simply chemicals or genetic repositories of information (see here), the Court clearly chose the genetic characterization: 

Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. 

The Court further noted that “[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule." I have argued that this is the most relevant characterization to considering the patent eligibility of genes (and did so in the amicus brief that I filed in at the Court). In resolving the issue of whether an actual invention was present, the Court did not find Myriad's work to be inventive, in contrast to the work that produced a genetically engineered bacterium in Diamond v. Chakrabarty: 

In this case, by contrast, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention. 

This absence of invention was fatal: 

We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material. 

The opinion is helpful in reiterating that discovery and invention are not identical, which is a point that many of us had argued: 

Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

The Court rejected any deference to the U.S. Patent and Trademark Office’s issuance of patents on isolated genes, noting that Congress had not spoken to the issue and that the executive branch itself was divided, with the U.S. Solicitor General arguing against the patenting of isolated genes. In holding that isolated genes are not patentable, the Court did hold that cDNAs (complementary DNA molecules with exons left in and introns removed) are patentable because they are not naturally occurring; that aspect of the decision will be important for biotech applications using cDNA to produce recombinant proteins (such as pharmaceuticals or gene therapy). In a broader sense, this decision now enters the lineage of patent decisions from the Supreme Court that squarely define the limits on patentable subject matter, but it's also one more opinion that does not elaborate in detail on any required line-drawing. The decision is a reaffirmation that natural subject matter may not be patented - but it contains no shortcuts to defining "products of nature" or "laws of nature" - undoubtedly leading to further eligibility disputes.

This landmark decision invalidates Myriad’s patent claims to the isolated BRCA1 and BRCA2 genes – an outcome which will open up the genetic testing options for patients for the BRCA1 and BRCA2 genes, expand the research opportunities for scientists, and provide physicians with more diagnostic options than they currently have. The constricted clinical climate created by Myriad’s patents have taken a demonstrable toll on the development of the genetic testing field for the BRCA1 and BRCA2 genes, and this clinical field has not enjoyed a competitive testing environment, in contrast to other clinically significant cancer-related genes. That should change quickly, and clinical developments in the BRCA1 and BRCA2 field should rapidly accelerate. Already, researchers (including Dr. Mary-Claire King, whose pioneering research first established a genetic basis for some breast cancers) are declaring that they will expand their testing portfolio to include BRCA1 and BRCA2 gene testing. The consequences of this decision are very real for women who seek BRCA1 and BRCA2 testing in order to determine if they have a high risk of early onset breast and/or ovarian cancer: more testing choices, coupled with likely lower testing costs in a competitive marketplace. The decision now renders all patent claims to isolated genes invalid, using the logic of the opinion, and this outcome will remove a key patent-related obstacle to the progress of clinical genetics.

Supreme Court: DNA Collection from Arrestees is Constitutional

Today, the Supreme Court issued its opinion in Maryland v. King, a constitutional challenge to Maryland’s statute authorizing DNA collection from those arrested for a “crime of violence, an attempted crime of violence, a burglary, or an attempted burglary.” Maryland processes the DNA sample obtained from an arrestee and uses it for identification by comparing it to DNA profiles held in the federal DNA database, CODIS. In addition to storing offender profiles, CODIS contains DNA profiles from crime scene samples, so the comparison of a DNA sample to those from unsolved crimes might yield a “hit” on an otherwise cold case. The collection of DNA from arrestees has expanded to 28 states and the federal government (with most statutes restricting collection to those accused of felonies or violent crimes). When King was arrested on a assault charge, his DNA was taken and his profile compared to those of unsolved crimes. It matched an unsolved rape case from years earlier (and others), and King was charged with rape (and convicted). His legal challenge alleged that the warrantless and suspicionless search accomplished by his DNA collection at arrest violated a reasonable expectation of privacy, and thus King’s 4th Amendment rights (see here). The court ruled that the practice does not violate the 4th Amendment's prohibition against unreasonable searches and seizures. The 5-4 opinion was written by Justice Kennedy: 

In light of the context of a valid arrest supported by probable cause respondent’s expectations of privacy were not offended by the minor intrusion of a brief swab of his cheeks. By contrast, that same context of arrest gives rise to significant state interests in identifying respondent not only so that the proper name can be attached to his charges but also so that the criminal justice system can make informed decisions concerning pretrial custody. Upon these considerations the Court concludes that DNA identification of arrestees is a reasonable search that can be considered part of a routine booking procedure. When officers make an arrest supported by probable cause to hold for a serious offense and they bring the suspect to the station to be detained in custody, taking and analyzing a cheek swab of the arrestee’s DNA is, like fingerprinting and photographing, a legitimate police booking procedure that is reasonable under the Fourth Amendment.  

The basis for claims that a reasonable expectation of privacy is violated by the DNA collection has encompassed both the collection procedure and the state's access to a DNA profile of the accused. Pivotal to these challenges is how the reasonable expectation of privacy is defined for a particular claimant – parolee, arrestee, etc. Challenges to DNA profiling of those convicted of crimes have largely failed, with courts defining and relying on a diminished expectation of privacy held by parolees, probationers, and now, arrestees. Here, as in earlier DNA cases, the Court did not consider the actual procurement of the sample by cheek swab to be intrusive. With respect to the claim of privacy to the DNA profile itself, the Court noted that “while science can always progress further, and those progressions may have Fourth Amendment implications” and that “the argument that the testing at issue in this case reveals any private medical information at all is open to dispute,” it followed the general consensus that the 13 short tandem repeat (STR) sites used in DNA profiling are not generally informative beyond establishing identification. It further noted that the authorizing statute prohibits the use of DNA profiling for purposes other than identification: 

In light of the scientific and statutory safeguards, once respondent’s DNA was lawfully collected the STR analysis of respondent’s DNA pursuant to CODIS procedures did not amount to a significant invasion of privacy that would render the DNA identification impermissible under the Fourth Amendment. 

The ruling will likely undermine challenges to the constitutionality of other state DNA collection statutes authorizing collection at arrest. What certainly lies ahead will be deeper scientific insight into the human genome, such that previously uncharacterized regions of the genome will be characterized as revealing medically or physically informative attributes of the individual (see here). To the extent that the forensic sites of interest (currently the 13 CODIS STR sites) are further annotated by genomic science, one part of the constitutional argument alleging a privacy violation will be strengthened by claims that medically revealing information could be obtained. However, it is still likely that a court could rely on the statutory limitations to the uses for a DNA profile in finding that 4th Amendment safeguards are sufficient. The practical implication of today’s rulings are immediately apparent: likely, more states will expand their DNA collection practices to include arrestees. An increased ability to solve crimes with high recidivism is likely, as advocates of arrestee DNA testing and advocates for sexual assault survivors have argued (and with particular force for sexual assault crimes, where serial crime patterns have been established through crime scene sampling (even decades-old), but for which no perpetrator identity has yet matched to a series of profiles. The ruling particularly impacts efforts to reduce violence against women. The City of Chicago conducted a study on preventable crimes in 2005, concluding that DNA sampling on arrest could have prevented at least 53 murders and rapes committed by those with multiple (and unprofiled) felony arrests (similar results were reported in a study by the Denver District Attorney).

Briefing Developments in Supreme Court Gene Patent Litigation

In November, the Supreme Court agreed to hear the challenge to gene patents in the case of Association for Molecular Pathology v. Myriad Genetics (see here). The grant of review followed several years of the patentable subject matter litigation initiated by a coalition of plaintiffs that made its way through the lower courts, ending this summer with the Federal Circuit upholding the gene patents (again, following the Supreme Court remand to reconsider in view of Mayo v. Prometheus). The plaintiffs include researchers, genetic counselors, patients, cancer survivors, breast cancer and women's health groups, and scientific associations. Now, as the case gets ready for oral argument later this spring, the briefs from parties and amici are being filed. The ACLU filed the Petitioner's Brief last week at the Court. The brief outlines the arguments of the plaintiffs as to why genes are not patentable subject matter and the patent claims on the BRCA1 and BRCA1 genes should be invalidated. The Court must consider how to define an an isolated gene (isolated DNA) – as either a product/law of nature (not patentable) or a nonnaturally occurring processed product (patentable). The ACLU brief presents several arguments that invoke the Court's exclusions and apply them to the genes at issue. They further argue that although the USPTO has issued gene patents for several decades, the Court need not be guided by any deference to the USPTO. Lastly, they argue that a First Amendment issue is presented because gene patent claims can control the use of knowledge, a violation of that constitutional clause. The oral argument will likely occur around April; no exact date yet.

Supreme Court Will Review Gene Patent Challenge: AMP v. Myriad

Today, the Supreme Court granted the petition for certiorari in the gene patent litigation, Association for Molecular Pathology (AMP) v. Myriad Genetics et al. The case focuses on the Myriad Genetics patents on the BRCA1 and BRCA2 (breast cancer) genes. This grant of review follows several years of the patentable subject matter challenge from a coalition of plaintiffs that has made its way through the lower courts, ending this summer with the Federal Circuit upholding the gene patents (again, following the Supreme Court remand to reconsider in view of Mayo v. Prometheus). Three questions were presented in the petition to the court: the patent eligibility of the genes, the eligibility of some method claims, and the last question involving the clarification of standing in the case. The Court will only consider the first question: Are human genes patentable? The Court must consider how to define an an isolated gene (isolated DNA) – as either a product/law of nature (not patentable) or a nonnaturally occurring processed product (patentable). Earlier this year, the Court issued its opinion in Mayo, invalidating a patent claim to a method of optimizing drug dosage which had the effect of preempting a law of nature (a natural correlation). At stake in AMP is how to define the product of nature doctrine in modern biotechnology - whether genes are to be defined by structure (the chemistry argument) or function (the genetic argument). The Federal Circuit took the chemistry route this past summer in its AMP decision, finding enough chemical alteration of an isolated gene to confer patent eligibility. In an amicus brief I filed this summer, I argued that the genetic fidelity (natural DNA sequence) of the isolated genes means that such patenting preempts the genetic code (law of nature), and, in addition, the genetic fidelity further characterizes the molecule as an unpatentable product of nature. From either analytic route, I conclude that genes are not patentable: the genes have a specific patent ineligibility because such patenting preempts a law of nature, and they have a general patent ineligibility because they are products of nature. The first theory (preempting a law of nature) resonates with Mayo; the latter theory (product of nature) resonates with Funk Bros. v. Kalo (1948). Genetic fidelity is not trivial; it is essential to the use of an isolated gene as a testing reagent.

What will the Supreme Court decide? The Supreme Court has exhibited a sensibility which accords significant weight to its role in protecting a public domain in science (the Court has established and refined a set of judicially-created exclusions - laws of nature, natural phenomena, abstract ideas - from patentable subject matter over the years, despite statutory silence). In Mayo, the Court stated that "even though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the basic tools of scientific and technological work’” (quoting Gottschalk v. Benson (1972). The Court did not hesitate to strike a blow against business method patents in Bilski v. Kappos (2010), despite more than a decade of such patenting. With reference to Mayo - and to Justice Breyer's public domain-centered dissent in Labcorp v. Metabolite (2006) - there is a fair chance that the Court could side with the 2010 district court opinion, which found that the "claimed isolated DNA is not markedly different from native DNA as it exists in nature," and, as a result, the gene patent claims were invalid. AMP v. Myriad is not only important for the further clarification of the patent eligibility doctrine, but it has implications for the genetic testing industry (business models that depend on patenting isolated biological molecules) and for women's health (possible future development of a robust marketplace and an unfettered research climate for genetic testing involving the critical BRCA1 and BRCA2 genes). The case has also been a model for assembling a complex coalition of plaintiffs (researchers, genetic counselors, women patients, cancer survivors, breast cancer and women's health groups, and scientific associations) whose diverse interests illustrate the real-world consequences of what may appear to be solely theoretical patent law doctrines.

Genetics or Chemistry? Federal Circuit Again Upholds Gene Patents

The Federal Circuit has just issued its newest opinion in the gene patent case, Association for Molecular Pathology v. Myriad Genetics (AMP v. USPTO). This case was reargued before the court in late July, so this is a quick turnaround (see here). This case is a challenge from a coalition of patients, researchers and medical organizations to the validity of granting patents on isolated genes; specifically, the BRCA1 and BRCA2 breast cancer genes. The Federal Circuit had previously issued a ruling in 2011 which upheld patent claims to genes and DNA primers, while it invalidated method claims that relied on comparing DNA sequences to identify mutations.This latest appeal was directed to the decision on the genes (compositions of matter in patent terms) – and followed a petition to the Supreme Court, which remanded back in view of the Mayo v. Prometheus decision this year. In an opinion again authored by Judge Lourie, the court has returned to much of its reasoning in 2011, holding that isolated genes are not “products of nature” and also do not bear on a law of nature. The court rejects the arguments that the native coding sequences of the isolated genes are identical to natural DNA sequences (and make them products of nature), and finds that the laboratory manipulations that produce the extracted gene are enough to qualify as inventive work. Judge Moore, while concurring, was more receptive to considering how Mayo, although directed to method claims, provides analytic help in evaluating the patentability of genes. She dissected the various patent claim types (primers, cDNAs, genes) to find that the patenting of genes is most problematic because the isolated gene has most of the natural character, and continues to find them valid. There is a hint that she might have ruled against the gene claims ("on a blank slate"), but is constrained by the awareness of the long-standing PTO practice and “settled expectations;” she declares an implicit approval of gene patenting by Congress after its failure to carve out any special legislative treatment for genes, despite a number of bills that have been introduced to do so. Judge Bryson dissented and would have invalidated the patent claims to isolated genes and DNA fragments that mimic natural molecules. He suggests a focus on genetics, not chemistry, in evaluating function, not just structure, and because function is retained, he concludes that the isolated gene is a natural compound ineligible for patenting (that is also my analysis of these patent claims, as I argued here). Bryson also rejects any deference to the PTO or undue concern for any settled practices, noting that there can be no adverse possession claim for patent rights. The ACLU (lead attorneys for plaintiffs) was disappointed in the ruling, calling it a "devastating decision for a woman's health" (PubPat is co-counsel on the case). What’s next? A likely appeal for an en banc review by the full Federal Circuit or another petition for certiorari to the Supreme Court. The Supreme Court will take a more expansive view of the similar policy underpinnings between its Mayo decision and the AMP case, and could take the opportunity to clarify broad principles of patent eligibility that transcend claim categorization.  

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.

FDA Revokes Avastin Approval as Breast Cancer Treatment

The FDA has finally pulled the plug on approval of the biotech drug Avastin for treating advanced breast cancer. Avastin is a monoclonal antibody which works by targeting and shrinking the blood vessels required for tumor growth.  What was interesting about this drug was that it was approved on the FDA fast track in 2008 at a time when it looked to be a promising therapy for the treatment of advanced breast cancer.  In June, an FDA advisory committee recommended that the FDA remove its endorsement for use in metastatic breast cancer, citing studies in which Avastin had shown very little effect on survival time. What is important about this whole episode from the regulatory perspective are several facets: the use of a fast track FDA approval process to capture a promising lead on a biotech drug while minimizing delay in clinical studies, hence the initial approval in 2008; the promise to condition final approval on studies which more thoroughly teased out whether the drug did significantly lengthen survival time (the studies did not support the promised effect) and the extensive public scrutiny of the FDA decision by a powerful patient constituency (pro-approval petition by some breast cancer advocates) and a biotech company (Genentech) which surely did not want to lose its FDA imprimatur and actively campaigned to keep drug approval. But Commissioner Margaret Hamburg sided with the advisory committee in ending the FDA approval, publishing a lengthy document which outlines the reasoning for the decision. Of course, physicians may continue to prescribe Avastin off-label for treatment of breast cancer, but the drug can no longer be legally advertised for such use. Notably, not all breast cancer advocates opposed the FDA's decision; the National Breast Cancer Coalition expressed support. Of most immediate concern for breast cancer patients who still want to receive Avastin is that the lack of FDA endorsement will cause most insurance plans to not cover the cost of the drug (about $88,000 per year). What's also interesting about Avastin (and potentially other biotech drugs which target the support system for cancer cells) is that its mechanism would appear to have wide applicability (be able to generally limit tumor growth) but in actual clinical trials, the effects may be quite heterogeneous (Avastin retains FDA approval for use in treating colon, lung, kidney, and brain cancers).

Mississippi's Ballot Initiative Would Confer Personhood on Fertilized Egg

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.

New Federal Report on DNA Evidence Backlog

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.

Fetal DNA Gender Testing in an Unbalanced World

This week's Journal of the American Medical Association (JAMA) reports a meta-analysis of prenatal testing methods for predicting gender, concluding that noninvasive (blood-based) DNA testing has progressed to the point where fetal DNA can be reliably detected, as early as 7 weeks, but most reliably at 20 weeks. Abstract. Certainly, prenatal testing that poses less risk to mother and fetus is generally welcome, but, in this case, such testing must be evaluated against the backdrop of global gender ratios of births. Improved methods of gender prediction inevitably lead to increased demand for gender selection of offspring, an issue that consistently shows general societal preferences for male over female offspring. The discussion of "missing women" that has entered global population debates notes that men may outnumber women due to higher mortality for women, undercare for girls, and prenatal selection. Thus, new technologies that make gender selection even more efficient and convenient will only exacerbate the problem. The World Health Organization and other international groups have called for the UN and national authorities to understand the public health dimensions of gender imbalance and work to limit the use of prenatal gender selection technologies.