Biotechnology

The GIF That Keeps on Giving: The Problem of Dealing With Incidental Findings in Genetic Research.

December 10, 2016
Biotechnology, Ethics, Healthcare, Privacy

Angela Fralish, MJLST Invited Blogger

The ability to sequence a whole genome invites a tremendous opportunity to improve medical care in modern society. We are now able to prepare for, and may soon circumvent, genes carrying traits such as Alzheimer’s, breast cancer and embryonic abnormalities. These advancements hold great promise as well as suggest many new ways of looking at relationships in human subject research.

A 2008 National Institute of Health article, The Law of Incidental Findings in Human Subjects Research, discussed how modern technology has outpaced the capacity of human subject researchers to receive and interpret data responsibly. Disclosure of incidental findings, “data [results] gleaned from medical procedures or laboratory tests that were beyond the aims or goals of the particular laboratory test or medical procedure” is particularly challenging with new genetic testing. Non-paternity for example, which has been found in up to 30% of participants in some studies, result in researchers deciding how to tell participants that they are not biologically related to their parent or child. This finding could not only impact inheritance, custody and adoptions rights, but can also cause lifelong emotional harm. Modern researchers must be equipped to handle many new psychosocial and emotional variables. So where should a researcher look to determine the proper way to manage these “incidentalomas”?

Perspectives, expectations, and interests dictating policies governing incidental finding management are diverse and inconsistent. Some researchers advocate for an absolute ban on all findings of non-paternity because of the potential harm. Others argue that not revealing misattributed paternity result in a lifetime of living with inaccurate family health history. These scenarios can be difficult for all involved parties.

Legal responsibility of disclosure was indirectly addressed in Ande v.Rock in 2001 when the court held that parents did not have property rights to research results which identified spina bifida in their child. In 2016, an incidental finding of genetic mutation led a family to Mayo Clinic for a second opinion on a genetic incidental finding. The family was initially told that a gene mutation related to sudden cardiac death caused their 13-year-old son to die in his sleep, and the gene mutation was also identified in 20 family members. Mayo Clinic revealed the gene was misdiagnosed, but the decedent’s brother already had a defibrillator implanted and received two inappropriate shocks to his otherwise normal and healthy heart. Establishing guidance for the scope and limits of disclosure of incidental findings is a complex process.

Under 45 C.F.R. §§ 46.111 and 46.116, also known as the Common Rule, researchers in all human subject research must discuss any risks or benefits to participants during informed consent. However, there is debate over classification of incidental findings as a risk or benefit because liability can attach. Certainly the parents in Ande v. Rock would have viewed the researchers’ decision not to disclose positive test results for spina bifida as a risk or benefit that should have been discussed at the onset of their four-year involvement. On the other hand, as in the Mayo Clinic example above, is a misdiagnosed cardiac gene mutation a benefit or risk? The answers to these question is very subjective.

The Presidential Commission for the Study of Bioethical Issues has suggested 17 ethical guidelines which include discussing risks and benefits of incidental finding disclosures with research participants. The Commission’s principles are the only guidelines currently addressing incidental findings. There is a desperate need for solid legal guidance when disclosing incidental findings. It is not an easy task, but the law needs to quickly firm-up a foundation for appropriate disclosure in incidental findings.

Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

December 4, 2016
Agriculture, Biotechnology, Food and Drug Law, New Technology, Public Health

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy. Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops. The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations. This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions. However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled. It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive. It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.

Copycats to Copycows: The Cloned Livestock Industry Emergence

October 17, 2016
Biotechnology, Ethics, New Technology

Ryan Dowell, MJLST Staffer

In the two decades since Dolly, a comically named sheep, animal cloning has remained little more than fiction to the average person. Behind the scenes, however, the field has progressed tremendously. Success rates today are estimated to be 70% or higher, compared to less than half a percent when cloning Dolly and her siblings. As the technique has been perfected, the obvious result has occurred: animal cloning has become a nascent industry.

Cloning has long been present in human society, in a form that many people may not recognize: plants. From simple home-garden cutting & replanting to industrial-scale cultivation from tissue samples; these techniques produce genetically identical individuals (i.e. clones) used as floral cultivars, tree planting, and especially foods. A large number of plants grown for human consumption are clones—which means that you, dear reader, have probably eaten a clone. Plant cloning has not encountered the same scrutiny as that with animals, perhaps due to its natural occurrence or millennia-long history of human use.

Dolly was merely the proverbial ‘dipping our toe into’ animal cloning. True to the writings of Michael Crichton (or the movies, if one so prefers), it didn’t take long for Jurassic Park-esque attempts to clone endangered and extinct animals. Cloning was not limited to such an idealistic use—a market emerged. Grieving pet owners could, at significant cost, get clones of their beloved pets. Despite the cost (still a five-digit price tag), a market for such services has continued to develop. Further demonstrating the human capacity for expensive animal-keeping hobbies, equine cloning has emerged as a means to “insure that prized horse and its unique qualities.” If one were to stop here, cloning seems to be a niche market for the wealthy.

The emerging cloning industry has not stopped at pets and exotic creatures. With the science complete and industrial production moving forward, livestock cloning is set to erupt in the coming years. A ‘cloning factory’ is opening in China. This factory is intended to produce not only pets and horses, but also prime beef cattle and drug-sniffing dogs. Following the same reasoning underlying farming’s predilection for plant clones, elimination of genetic variations could significantly improve farming techniques—maximizing yield, minimizing labor and resource inputs, matching strains to specific regions, and so on. In a world with mounting concern over the meat sustainability, improvements to production are key and cloning provides the means to significantly advance the field.

In many emerging fields, law and regulation react to the development and often impede progress. Fortunately, the issue of animal cloning has already been addressed—the FDA regulates the field & was essentially prescient. In 2008, the FDA released a guidance stating “meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.” The FDA examined cloning (also known as somatic cell nuclear transfer or SCNT), under the umbrella of assisted reproductive technologies (ART), which have long been utilized by farmers. The analysis noted that these animals would have essentially identical genetics to the source, unless reprogramming occurred (which can be done with other ARTs); that risk associated with the cloned animals is no different than the source organism. It was noted that cloned offspring have higher risk of adverse health issues early in life compared to offspring from other ARTs. However, none of these issues are unique to clones and other than early-life issues, clones are as healthy as non-clones. Livestock cloning has passed FDA scrutiny and manufacturing infrastructure is in place; it is poised to develop rapidly.

Public opinions may prove to be the final hurdle for livestock cloning. If one tells a fruit-eater that he or she is eating a clone (or as a botanist might put it the ovary of a clone), the fruit-eater will likely be unaware of this fact and less than pleased that his or her enjoyment of that fruit has been disrupted by the interjection. Alternatively, a substantial portion of the population believes GMOs are not safe for them to consume, which is untrue (see here, here, here, here, and here). A similar scenario to either of these might present itself here: (1) everyone blissfully consumes food without the need for nitty-gritty detail of its origin (since there is no discernable or material difference), or (2) misinformation is allowed to spread and ‘poison the well.’ The deciding factor will likely be education; the current state of affairs presents the opportunity to preemptively educate the public on the FDA’s findings and regulations.

Livestock cloning is poised to expand rapidly in the future and now we face a crucial time in its acceptance: a public educated on the issue will be equipped to fairly determine whether such livestock should be consumed, without a torrent of pseudo-science obscuring the decision. The FDA has examined clones and found them to be nearly identical to non-clones (pun very much intended) in regards to human consumption.

Food “Hot Off the Printing Press”: Insights Into 3-D Printed Food

October 15, 2016
3-D Printing, Agriculture, Biotechnology, Food and Drug Law

Theodore Harrington, MJLST Managing Editor

Would you food hot off the 3D printing press? In Jaspers Tran’s article, 3-D Printed Food, he explores the potential legal issues surrounding the commercialization of 3D printed food. (see here).

The article suggests that “. . . the 3D printer may become the fundamental daily appliance in every household . . . .” The pros are easy to see—As the demand for food increases at an exponential rate, the ability to create food quickly and avoid the current environmental impacts caused by food production would be a game-changer. The benefits here are fairly obvious and easy to wrap our heads around. However, large barriers still remain.

A tougher point for me to grasp is Tran’s suggestion that 3D printing will solve issues related to malnutrition, particularly over-nutrition, or obesity. Tran seems to leap from personalized nutritional food (tailored to an individual’s exact nutritional needs) to an obesity solution. This reminds me of the old adage, “you can lead a horse to water, but you can’t make him drink.”

Even if 3D printers end up in every household, my gut-feeling is that it will be a very long time before people are accepting of the idea of eating food that was just spit out of a machine (although there is a large amount of processing in today’s food, it goes on behind closed doors. Ignorance is bliss.). As Malcolm Gladwell suggests in his book Blink, the way we taste food is as much psychological as it is physical (see example of declining sales in a pork product when a life-like pig was placed on packaging instead of a cartoon pig).

Something to chew on.

The Comment on the Note “Best Practices for Establishing Georgia’s Alzheimer’s Disease Registry” of Volume 17, Issue 1

April 27, 2016
Biotechnology, Data, Ethics, Healthcare, Privacy, Public Health

Jing Han, MJLST Staffer

Alzheimer’s disease (AD), also known just Alzheimer’s, accounts for 60% to 70% of cases of dementia. It is a chronic neurodegenerative disease that usually starts slowly and gets worse over time. The cause of Alzheimer’s disease is poorly understood. No treatments could stop or reverse its progression, though some may temporarily improve symptoms. Affected people increasingly rely on others for assistance, often placing a burden on the caregiver; the pressures can include social, psychological, physical, and economic elements. It was first described by, and later named after, German psychiatrist and pathologist Alois Alzheimer in 1906. In 2015, there were approximately 48 million people worldwide with AD. In developed countries, AD is one of the most financially costly diseases. Before many states, including Georgia, South Carolina, passed legislation establishing the Registry, many private institutions across the country already had made tremendous efforts to establish their own Alzheimer’s disease registries. The country has experienced an exponential increase of people who are diagnosed with Alzheimer’s disease. More and more states have begun to have their own Alzheimer’s disease registry.

From this Note, the Registry in Georgia has emphasized from the outset, the importance of protecting the confidentiality of patent date from secondary uses. This Note explores many legal and ethical issues raised by the Registry. An Alzheimer’s disease patient’s diagnosis history, medication history, and personal lifestyle are generally confidential information, known only to the physician and patient himself. Reporting such information to the Registry, however, may lead to wider disclosure of what was previously private information and consequently may arouse constitutional concerns. It is generally known that the vast majority of public health registries in the past have focused on collection of infectious disease data, registries for non-infectious diseases, such as Alzheimer’s disease, diabetes, and cancer have been recently created. It is a delicate balance between the public interest and personal privacy. It is not a mandatory requirement to register because Alzheimer is not infectious. After all, people suffering from Alzheimer’s often face violations of their human rights, abuse and neglect, as well as widespread discrimination from the other people. When a patient is diagnosed as AD, the healthcare provider, the doctor should encourage, rather than compel patients to receive registry. Keeping all the patients’ information confidential, enacting the procedural rules to use the information and providing some incentives are good approaches to encourage more patients to join the registry.

Based on the attention to the privacy concerns under federal and state law, the Note recommend slightly broader data sharing with the Georgia Registry, such as a physician or other health care provider for the purpose of a medical evaluation or treatment of the individual; any individual or entity which provides the Registry with an order from a court of competent jurisdiction ordering the disclosure of confidential information. What’s more, the Note mentions there has the procedural rules designated to administer the registry in Georgia. The procedural rules involve clauses: who are the end-users of the registry; what type of information should be collected in the registry; how and from whom should the information be collected; and how should the information be shared or disclosed for policy planning for research purpose; how the legal representatives get authority from patient.

From this Note, we have a deep understanding of Alzheimer’s disease registry in the country through one state’s experience. The registry process has invoked many legal and moral issues. The Note compares the registry in Georgia with other states and points out the importance of protecting the confidentiality of patient data. Emphasizing the importance of protection of personal privacy could encourage more people and more states to get involved in this plan.

Biosimilar Licensing

April 14, 2016
Administrative Law, Biotechnology, Food and Drug Law, Intellectual Property

Jeff Simon, MJLST Staffer

On February 18^th, Sandoz filed a petition for certiorari appealing to the supreme court to revisit the Federal Circuit’s holding in Amgen v. Sandoz. Prior to Sandoz’s petition for certiorari, the Federal Circuit denied a rehearing of the case en banc back on October 16^th. Sandoz is seeking the Supreme Court to review the Federal Circuit’s holding that it could not market Zarxio, the biosimilar equivalent of Amgen’s patented biologic Neupogen, until 180 days after Zarxio received FDA approval.

Sandoz will most likely take the stance that the Federal Circuit misinterpreted the BPCIA and particularly 42 U.S.C § 262(l)(8)(A). This paragraph states that a subsection (k) biosimilar applicant seeking approval under the BPCIA shall provide notice of marketing to the reference product sponsor (biologic brand manufacturer) not later than 180 days before the date of the first commercial marketing of the licensed biological product. According to Sandoz, the Federal Circuit incorrectly held that notice shall not be given prior to FDA approval of the biosimilar. The Federal Circuit noted that the statute uses the term “licensed” biologic product, implying that the biosimilar must first obtain FDA licensure before notice of commercial marketing can be given. Sandoz argued that the statute does not require the biosimilar applicant to stay notice until 180 days of licensure, and that such an interpretation would grant the reference product sponsor a six-month extension of exclusivity on the biologic product. Accordingly, Sandoz contends that such an interpretation would result in consequences unintended by the drafters of the Biologics Price Competition and Innovation Act, stating that if such was the intention of Congress, the BPCIA would have been drafted to include a fourteen-and-a-half-year exclusivity period. It’s important to note that the Federal Circuit was unanimous regarding its decision on 180-day notice of commercial marketing.

Earlier, Amgen declined to seek a petition of certiorari regarding the Federal Circuit’s holding that the Patent Dance provisions of the BPCIA are not mandatory. However, on March 24, 2016, Amgen asked the Supreme Court to review both portions of the Federal Circuit’s opinion, including its holding regarding the Patent Dance provisions of the Act. Amgen’s cross petition came in response the Sandoz’s petition for certiorari. In its opinion, the Federal Circuit held that the information exchange and patent dispute resolution mechanisms of the BPCIA were not mandatory, and that a subsection (k) applicant may avoid these provisions subject to the consequences contemplated by the BPCIA.

Amgen v. Sandoz was the first case regarding these provisions of the BPCIA as Neupogen was the first marketed biologic to come of patent since the passing of the BPCIA. If the Supreme Court is to review the decision of the Federal Circuit, it may elect to delay until the decision of pending cases such as Amgen v. Apotex. Regardless, the possible grant of certiorari has important implications for the biotechnology and pharmaceutical industries, as a looming patent cliff is set for the biologics industry in the next 5 years.

USPTO to Decide Who Will Own the Pioneer Gene Editing Patent for the Next Billion-Dollar Industry

January 28, 2016
Biotechnology, Competition, Intellectual Property

Na An, MJLST Staffer

Earlier this month, the United States Patent and Trademark Office (USPTO) declared an interference to determine which one of the two research groups will be awarded the patent protection of one of the most important scientific discoveries in the past decade: CRISPR technology. This technology enables deletion, repair or replacement of genes in such a precise fashion that it could be worth billions of dollars in human health, agriculture and biotechnology industries.

Clustered regularly-interspaced short palindromic repeats system (CRISPR) is a mechanism used by the immune system to resist invading viruses by recording their genetic information and then specifically target these exogenous genetic elements in bacteria, mammals and other organisms. It provides a reliable and precise tool for editing genes. Upon its discovery, CRISPR has been adopted for a wide range of applications from creating animal models with human cancers and turning specific genes on and off to genetically modifying plants.

In 2015, companies rushed to invest and occupy early markets of this potentially billion-dollar industry. The first was Novartis, who signed two deals with gene-editing start-ups to use CRISPR for engineering immune cells and blood stem cells, and as a tool for drug discovery. Soon after, AstraZeneca shook hands with the Wellcome Trust Sanger Institute, the Innovative Genomics Initiative, the Broad and Whitehead Institutes, and Thermo Fisher Scientific to identify and validate new targets in preclinical models with CRISPR. Simultaneously, immunotherapy firm Juno Therapeutics made deals with Editas and Vertex Pharmaceuticals to create anticancer immune cell therapies with an agreement that could be valued at $2.6 billion.

Amid the fast surge of research and commercial opportunities, a patent fight over CRISPR simmers in the background, which raises great uncertainties of the future market structure and commercial potential. The UC Berkeley team, lead by chemist Jennifer Doudna, filed a patent application (No. 13/842,859) on March 15, 2013 with a priority date of May 25, 2012. The application contained broad claims to CRISPR technology, but described only “genetically modified cells that produce Cas9,” an enzyme crucial to CRISPR mechanism, and “Cas9 transgenic non-human multicellular organisms.” On October 15, 2013, the MIT researcher Feng Zhang filed his own patent application (No. 14/054,414) with a priority date of December 12, 2012. Unlike the Doudna application, Zhang contemplated specifically adapting CRISPR in eukaryotic cells. Through Accelerated Examination, USPTO granted Zhang a patent on April 15, 2014, even though Doudna had an earlier invention date and filing date. After several amendments to Doudna application in response to two third-party submissions, the world has been waiting on the USPTO to make a decision. On January 19, 2016, the patent office finally agreed to conduct an interference to decide who was the rightful applicant to award the patent protection on CRISPR.

Since both applications have priority dates prior to March 16, 2013, the patent will be granted on a “first to invent” basis. Interference cases are historically rare and could stretch out for years, considering the high probability that the losing party will appeal the decision. It is unclear what the result will be. Mari Serebrov, regulatory editor at Thomson Reuters BioWorld, said “if the courts rule the technology isn’t patentable, it could chill investment. On the other hand, if one group is allowed the patent, it could result in a monopoly and will probably make licenses more expensive or discourage research because the patents could lock up the field, depending on how broadly they are written.” Faced with the great uncertainty, Monsanto has limited CRISPR’s applications until a decision is made. Tom Adams, vice president of global biotechnology at Monsanto, said “until we understand the intellectual property it’s hard to do much.”

As more capital is pouring in and risks skyrocketing, companies and researchers need to use caution in their inventive and investment activities relating to CRISPR.

The “Patent Dance” for Now: Rehearing Denied in Amgen v. Sandoz

November 9, 2015
Biotechnology, Food and Drug Law, Health Law, Patents

Jeff Simon, MJLST Staffer

On July 21, 2015, the Federal Circuit’s decision in Amgen v. Sandoz established that a biosimilar applicant does not have to follow the patent dispute resolution procedures set forth by the Biologics Price Competition and Innovation Act. The BPCIA’s “patent dance,” located at 42 U.S.C. § 262(l)(2)(a), sets forth procedures requiring biosimilar applicants to disclose the biosimilar application and information describing the methods and procedures of its production to the sponsor of the reference biologic drug. The Federal Circuit’s fractured decision denied the compulsory nature of the “patent dance,” while still holding that biosimilar applicants are required to provide the biologic drug sponsor 180 days advanced notice of the first commercial marketing of its biosimilar product in accordance § 262(l)(2)(a).

Considering that the decision of the court was split by favoring the biosimilar applicants regarding the issue of the “patent dance” while favoring the biologic sponsor when it came to market disclosure, the decision was far from a satisfying result for either party as neither party came out as the clear victor. As such, both Amgen and Sandoz filed petitions for an en banc rehearing on August 20, 2015. Amgen’s petition for review once again contended that the language of § 262(I)(2)(a) as stated by congress, specifically the use of the word “shall,” indicates that the “patent dance’s” procedures are mandatory. Sandoz contended among other things that the 180-day provision necessarily increases the exclusivity period from 12 years to 12 and a half years and further that the court incorrectly asserted that notice was mandatory and enforceable. Both parties submitted amicus curiae briefs in agreement that, as a matter of first impression, it was appropriate for an en banc rehearing.

However, despite a fractured panel deciding a matter of first impression, Federal Circuit denied a rehearing in decision on October 16, 2015. The decision came as surprise to many of those associated with the biologic drug industry, especially considering the novelty and discord upon the issues. Considering the fact that both parties sought a rehearing, the court may have decided that the issue was undeserving of the court’s continued interest and resources. Both parties may file petitions for certiorari.

In regards to the future implications of the decision, it’s important to note that many of the high revenue pioneer biologic drugs are set to have their US patents expire within the next few years. This expected “patent cliff’ is certain to drive momentum within the biosimilar market. This wave of biosimilar applications is sure to have large implications upon the BPCIA, and particularly whether the “patent dance” is optional. All considered, the issues presented in Amgen may be approaching a level of importance that draws the attention of SCOTUS. It’s possible that a grant of certiorari may be in order to settle the debate on the BPCIA’s “patent dance” and market disclosure requirements, particularly considering the economic ramification of the anticipated biologics’ patent cliff.

Stuck in Between a Rock and a Genomic Hard Place

March 18, 2015
Biotechnology, Privacy

Will Orlady, MJLST Staff Member

In Privatizing Biomedical Citizenship: Risk, Duty, and Potential in the Circle of Pharmaceutical Life, Professor Jonathan Khan wrote: “genomic research is at an impasse.” Though genomic research has advanced incrementally since the completion of the first draft of the human genome, Khan asserts, “few of the grandest promises of genomics have materialized.” This apparent lack of progress is a complex issue. Further, one may be left asking whether, within the current economic and regulatory scheme, genomics actually has promising answers to give. But Khan’s work cites to biomedical researchers, claiming that what is needed to propel genomic research forward is simple: more bodies.

Indeed, it is a simple answer, but to which question–or questions? Khan’s article explores the “interconnections among five . . . federally sponsored biomedical initiatives of the past decade in order to illuminate critical aspects of the current drive to get bodies.” To be sure, the article provides the literature with a fine starting analysis of public biomedical programs, synthesizing much of the previous research on biomedical research participation. It further evaluates previously proposed methods for increasing genomic research participation. Khan’s article, however, left me with more questions than answers. If the public and private sectors cannot work together to produce results, then who is left to ensure progress? Is progress currently feasible? Are we being too hasty and impatient demanding results from an admittedly young scientific discipline? And, ultimately, if study participants/subjects are expected to participate with their own genetic material or bodies, what do they get in return?

Khan’s article attempts to address the final question. That is, if we are to create a legal or social obligation to contribute to genomic research for the sake of the public, what benefit (or, at the least, what safety assurance) do contributors receive in return for their contribution? Clearly, issues associated with creating a system of duties while providing no corresponding rights are aplenty. Underlying this discussion is the notion that to ensure the timely progress of genomic research mandated participation in such research might be necessary. Herein lies a problem: “[t]hese duties effectively privatize citizenship, recasting service to the political community as a function of service to [an] . . . enterprise of biomedical research. . . . ” What is more, Khan is keen to point out that time and time again, promises of genomic advancement in the hands of collaborating private and public entities have failed to produce promised results.

If we are to go forward privatizing citizenship, creating duties for persons to use their bodies for the benefit of society, we must be careful to ensure that (1) individual rights in the outcome of the research are secured; and, (2) that society will in fact benefit from the collectively imposed obligations.

Although Khan’s article leaves many questions unanswered, I empathize with his weariness of creating a public duty to contribute to biomedical research. Solutions to such complex issues are not easily answered. Torpid genomic research is troubling. But, so is the notion of privatized citizenship ascribing duties without granting corresponding rights. Though more bodies may be needed to further the timely advance genomic research, policymakers academics alike should be cautious creating any programs which compromise the integrity of personal privacy for the sake of public advancement without granting corresponding rights.

Lies, Damn Lies, and Facts

April 10, 2014
Biotechnology, Ethics

David B. Tibbals, MJLST Staff

Apparently Daniel Patrick Moynihan wasn’t referring to the legal profession when he argued that “everyone is entitled to his own opinions, but not his own facts.”

This past week, the U.S. Court of Appeals for the Fifth Circuit issued its ruling in Planned Parenthood v. Abbott, taking exception to the district court’s version of the facts. The court’s ruling upheld some provisions of House Bill 2, the Texas law that inspired the hours-long filibuster by Texas state senator Wendy Davis.

In an opinion authored by Judge Edith Jones, the court ruled as constitutional the law’s requirement of doctors to have admitting privileges at a hospital within thirty miles of wherever they perform an abortion procedure. With a critical view of the district court’s factual assessment, the court held that the thirty-mile admitting-privileges requirement does not “affect a significant (much less “large”) fraction of . . . women, and it imposes on other women in Texas less of a burden than the waiting-period provision upheld in Casey.”

Likewise, the court upheld the law’s proscription of off-label usage of abortion-inducing prescription drugs. Despite a claim that this represented the complete embargo of what may be the only safe abortion procedure for some women, the court characterized this as speculation, cautioning that courts “must base decisions on facts, not hypothesis and speculation.” And, as has been noted in this journal, “while FDA-approved indications cannot be construed to limit medical judgment, states . . . may enact legislation forcing compliance with such indications.”

Given the general awareness of the case, an arguable circuit split, and the torrent of recent state abortion legislation, surely this case seems destined for the Supreme Court. But how can the nine justices possibly reach a conclusion if the two lower courts couldn’t even agree on the facts? Didn’t the Roe Court argue that abortion law must be “free of emotion and of predilection,” premised on factual objectivity? Shouldn’t these questions be easy to answer?

The disagreement within this particular case reflects a greater problem within the nation’s abortion law canon. In the forty years since Roe, courts have struggled to consistently define just what virtues ought to guide abortion law.

Although the Court placed great emphasis on “now-established medical fact” from the outset, a closer look suggests that medical facts haven’t been treated nearly as sacred as one might believe. Indeed, as Forsythe and Kehr note, the factual record in Roe was very much abbreviated and curated: The Court’s ruling “was based on no factual record and no reliable medical data. The Justices did not analyze, let alone regulate, the contrary data; they simply ignored them.”

Over the last forty years, the Court has bandied about terms such as “advanced knowledge” and “substantial medical authority,” suggesting the primacy of medical facts. But regardless of how it has treated the particular facts it has examined, the Court has also failed to consistently adhere to the fundamental objectivity professed in Roe. Although the Court felt its ruling in Casey reaffirmed Roe’s objectivity, its “undue burden” standard introduced a great deal of subjectivity into abortion law. As Justice Scalia articulated in Stenberg, what qualifies as an “undue burden” “cannot be demonstrated true or false by factual inquiry or legal reasoning.”

It is yet unclear whether Abbott will indeed make it to the Supreme Court. No matter your view on the legal status of abortion, this fundamental inconsistency in the application of factual standards ought to be distressing. It is vital that the Supreme Court clarify a jurisprudence once labeled by former Chief Justice Rehnquist as “a virtual Procrustean bed.”

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