Check out this recent Bloomberg piece from Cass Sunstein: Don’t Mandate Labeling for Gene-Altered Foods. He raises a number of arguments that came out during the Q&A following our recent conference panel on food regulation. Video should be posted soon!
[Posted on behalf of Elizabeth Pike and Kayte Spector-Bagdady from the Presidential Commission for the Study of Bioethical Issues - and cross-posted here.]
In the most recent issue of the Hastings Center Report, Drs. Amy Gutmann and James Wagner of the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission), contributed to the lively debate surrounding the identifiability of genetic data. In Found Your DNA on the Web: Reconciling Privacy and Progress, Gutmann and Wagner, Chair and Vice-chair respectively, argue that the paradigm of identifiability has become less relevant to individual privacy protections than restrictions on access and use.
In their commentary, Gutmann and Wagner continue the public deliberation of the Bioethics Commission’s report, Privacy and Progress in Whole Genome Sequencing, in which the Bioethics Commission took a forward-looking approach to the privacy concerns raised by whole genome sequencing—issues that have come to the forefront of this important science.
Under current law, health information that is deidentified—information for which there is “no reasonable basis” to believe it can identify an individual or that has been stripped of traditional identifiers—is afforded different legal protections than identifiable health information. However, whole genome sequence data are unique to only one person, making them more vulnerable to reidentification.
Recent articles have cast doubt on the extent to which whole genome sequence data can be deidentified. For example, in Identifying Personal Genomes by Surname Inference, published in Science in January, Melissa Gymrek, et. al. successfully uncovered full identities of 50 individuals.
Day two of PFC’s FDA in the 21st Century conference begins with a morning plenary by the very fabulous Alta Charo, of the University of Wisconsin Law School, who is speaking on “Integrating Speed and Safety.”
Today Alta is presenting what she calls “more of an initial idea than an actual proposal,” and she notes that she’s very interested to hear responses to it, so comment away or contact her offline. She wants to integrate into the usual and longstanding “FDA speed versus safety” debate some concerns that should be of interest to industry. “In other words,” she said, “I’d like to be nice to the drug people.”
Alta begins with a brief history of the speed versus safety debate, which turns out to be quite cyclical. Before 1906, she asks us to recall, we had true snake oil: products with high toxicity and little or no efficacy. Often these products were nevertheless perceived as effective because they contained alcohol or other drugs, so made you feel better at least, but of course that’s part of what made these products so dangerous, especially for children.
And so with the Federal Food and Drugs Act of 1906, we get post-market remedies for misbranding, although they require proof of intent. And then in 1937 over 100 children die from elixir of sulfanilamide. And the following year we get the Food, Drug, and Cosmetic Act. But the FDCA targets only safety. (Although rightly Alta notes that it’s hard to see how regulators were truly only looking at safety and not also at some form of efficacy, since there is no such thing as safety in the abstract, only safety relative to purpose for which someone is taking the drug.) Continue reading
[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]
First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”
He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?
Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.
Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.
Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.
In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Continue reading
[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]
Lewis Grossman, FDA in the Age of the Empowered Consumer
Begins his analysis by comparing a hypothetical consumer in 1960 and today.
Consumer was passive. Today’s consumer is active, more unmediated choice, more direct citizen involvement.
Why the change? 1970 was the decade of advocacy, culminating in 1972 Patient’s Bill of Rights from AMA. Central them was informed consent and thus complete information from physician.
1998 saw disruption of WebMd and now even more disrupted by web search technology which is how most patients get there info.
Food: 1966, recipe standards. Relatively little variety and consumer choice. Very little info on nutrition, “batman white bread.” Turning point was 1969 White House conference that led to more choice and more info.
Health clams as the portal where 1st Amendment law entered into FDA law. The image of the intelligent consumer who need not be shielded from information.
Changes in standard by which FDA decided if something was misleading. Until 2002 unsure if reasonable or gullible consumer standard. In 2002 for food FDA chose the reasonable consumer standard.
Liberal and conservatives got scrambled on these matters in interesting ways.
Also a revolution in advertising, leading to revolution of patient’s relationship to his or her drugs.
Blackjack players who “count cards” keep track of cards that have already been played and use this knowledge to turn the probability of winning in their favor. Though many casinos eject card counters or otherwise make their task more difficult, card counting is perfectly legal. So long as card counters rely on their own memory and computational skills, they have violated no laws and can make sizable profits.
By contrast, if players use a device to count cards, like a smartphone, they have committed a serious crime. For example, several iPhone apps helps players count cards and at least one has a “stealth mode” that lets users surreptitiously enter data and receive feedback. In response, the Nevada Gaming Control Board issued an open letter reminding the public that using such an app when betting at blackjack violates the state’s antidevice statute which provides for up to 6 years imprisonment for a first offense. Somehow using a device to augment our abilities to remember and to calculate turns a perfectly legal activity into an offense with a very serious penalty.
The fact that we do not criminalize natural, unassisted card counting raises interesting questions of criminal and constitutional law: Could we criminalize natural card counting without violating fundamental principles that protect thought privacy? (Email me for a manuscript on that question.) In this recently published paper, however, I focus on a puzzle about technological enhancement. Namely, can we justify criminalizing device-assisted card counting but not unassisted card counting?
The importance of the question extends beyond the world of blackjack and casino gaming because it appears, at least superficially, that antidevice statutes criminalize a kind of technological enhancement. Some ethicists distinguish therapies that seek to return us to normal, healthy functioning from enhancements that promise to give us extraordinary abilities. People are often much more comfortable with therapies (e.g., drugs or devices to treat attention deficit disorder) than with enhancements (e.g., drugs or devices to give us better-than-normal concentration).
As a historical matter, casinos lobbied for antidevices statutes in the 1980s to protect their revenue as computers were becoming more popular and accessible. I focus on a deeper question: Is there any moral justification for permitting an activity, like card counting, when it uses only our natural abilities but severely punishing the activity when it is technologically enhanced? I consider a couple of possible justifications for the differential treatment and suggest that both are lacking.
[Adapted from Criminalizing Card Counting at the Blackjack Table; Originally posted at Prawfsblawg]
[Cross posted at Prawfsblawg.com]
The Supreme Court heard oral arguments on April 15 in Association of Molecular Pathology et al. v Myriad, concerning whether human genes are patent-eligible subject matter. The case focused on Myriad’s patents on two genes, BRCA1 and BRCA2, involved in early-onset breast cancer.
Surprisingly, many of the Court’s questions for Myriad’s counsel focused on what Justice Breyer dubbed the “Lander Brief” – an amicus filed on behalf of neither party by one of the country’s leading scientists, Dr. Eric Lander. (Lander was one of the leaders of the Human Genome Project and co-chair’s the Presidents Council of Advisors on Science and Technology.) [Full Disclosure: I am one of the authors of this brief.] Justices Breyer, Ginsburg and Alito referred to the brief by name, and several other Justices were clearly influenced by the information in the brief.
I believe that the “Lander brief” was a hot topic of conversation because the Justices realized that it was central to applying the Court’s product-of-nature doctrine to DNA. Importantly, the brief demolished the scientific foundation of the Federal Circuit decision on appeal. The Federal Circuit panel held that human chromosomes are not patent-eligible because they are products of nature, but a majority found that “isolated DNA” fragments of human chromosomes (such as pieces of the breast cancer genes) are patent-eligible. The Federal Circuit’s distinction rested on its assumption that (unlike whole chromosomes) isolated DNA fragments do not themselves occur in nature, but instead only exist by virtue of the hand of man. Continue reading
First, and unrelated to this post, I wanted to say that like everyone here in Boston (and it seems throughout the U.S.) my heart goes out to the folks injured by Monday’s blast and their friends and family.
Now on to the substance. I have participated in a number of Supreme Court amicus briefs both in my life as a litigator and as an academic. In big name cases the Court is often inundated with them, and one can only hope that the brief is read, let alone put to good use. This is why I was incredibly happy and honored that the Supreme Court devoted a significant chunk of its oral argument time on Monday in the Association for Molecular Pathology v. Myriad Genetics, No. 12-398, the gene patent case, to discussing the brief I authored with Gideon Schor and Vern Noviel on behalf of Dr. Eric S. Lander. As Nature reported on the argument:
“The justices seemed to have been heavily influenced by a friend-of-the-court brief filed by Eric Lander, genomics whiz and founding director of the Broad Institute in Cambridge, Massachusetts. The brief argued against a lower court’s ruling that a snippet of DNA isolated from its chromosome does not occur in nature and is therefore patentable. To the contrary, wrote Lander, isolated DNA fragments do exist and are found circulating free in the blood. Indeed, a search of two public databases of DNA sequence data obtained from fetal DNA circulating in maternal blood revealed fragments that contained the BRCA1 and BRCA2 genes. “I think that raised a whole new ‘oops’,” said Robert Cook-Deegan, a policy researcher who has studied the case at Duke University in Durham, North Carolina. The justices never heard a proper response to Lander’s argument from Myriad’s attorney, who seemed to have either misunderstood the Lander brief or confused it with another when questioned.”
I reproduce some snippets from the actual transcript below the fold discussing our brief and its significance for how the Court rules.
[Posted on behalf of Art Caplan]
On January 7, 1610 Galileo Galilei, the Italian physicist and astronomer, aimed his new invention, the telescope, at the sky and became the first human to observe three of the moons orbiting the planet Jupiter. His discovery created a sensation since he had shown that there were objects in the universe that were not circling the Earth – throwing into doubt the view that his church, the Roman Catholic church, taught that the Earth was the center of the universe.
If Galileo had been alive today he might have been working for a private science company. If so there is little doubt that they would have insisted he seek a patent for the marvelous telescope that revealed amazing secrets about the world. If that company had been Myriad genetics they might have insisted that he not only patent the telescope but also everything he found when he looked through it, including Jupiter and its moons. In a way, that is what Myriad did when in 1994 it, along with the University of Utah, sought a patent on an association scientists had discovered between a set of genetic mutations and a high risk of developing breast cancer.
The patents Myriad received have earned the company a pretty penny. They have had a monopoly over all genetic testing for breast cancer for nearly two decades. Doctors and patients have complained bitterly that Myriad’s high priced tests have limited access for many women and hindered efforts to conduct research that might have more rapidly improved the accuracy of testing.
I think the Myriad patents should not have been awarded. Nor should any patent that relies solely on looking at genes as they exist in nature and finding associations with the risk of getting a disease. The standard for a patent is not discovery but making something useful out of a discovery. Patenting genes is too close to trying to patent the moons of Jupiter which Galileo discovered but did not create. Myriad’s early patent arguably hindered the willingness of others to aggressively explore better tests for a terrible disease. Other patents on other gene sequences could have the same effect.
If Myriad discoveries the equivalent of the genetic testing telescope then great—let them have their patent. But finding what is out there in nature be it Jupiter, the moon, or a sequence of genes gets you a place in history but not a patent.
Guest Blogger: Allison M. Whelan*
So much of the political and legal debate about reproductive choice centers on abortion. In doing so, these debates obscure so many other reproductive choices women must make. And the choices are not easy—and the stakes are even greater in an era where any prenatal missteps might lead to aggressive state action, including criminal sanctions. There are thorny situations that confront medicine and ethics. For example, how should we think about families that choose to carry terminal fetuses to delivery only for the fetus to expire shortly after birth? Should such pregnancies be terminated early given that doctors and even the intended parents know the fetus will not survive? Where does the law stand on such issues? What is morally permissible?
Thousands of women and families face lethal prenatal diagnoses and perinatal loss every year. In 2006, there were 25,972 reported fetal deaths at twenty weeks or later. An additional 19,041 live-born infants died at less than twenty-eight days. Birth defects such as congenital malformations and chromosomal abnormalities are the leading cause of fetal-infant deaths. Lethal anomalies (i.e., Trisomy 13; anencephaly; hypoplastic left heart syndrome) are a subset of birth defects characterized by a radically shortened lifespan. In 2005, there were 6,925 fetal and infant deaths attributable to lethal anomalies in the U.S.
Advancements in prenatal diagnosis coinciding with improved access to legal abortions create medical options for patients, but also spur challenging ethical questions. For example, therapeutic abortions have become the “management of choice” for many women whose fetuses experience a “lethal condition”. However, termination may not be the preferred choice for all women and families. The concept of perinatal hospice fills this void and offers women valid options after a terminal fetal diagnosis. Although the concept is still relatively novel and unknown in much of the health profession and lay population, the development of perinatal hospice programs is growing.
Perinatal hospice is worth taking seriously. For example, perinatal hospice programs are multidisciplinary and their services begin at the time of diagnosis (rather than death), in recognition of “anticipatory grief,” a term describing the grieving process that begins prior to death when a death is probable or imminent. Those who have used these services say that perinatal hospice provides a supportive environment for parents to grieve and appreciate any time they have with their infant. Further, they say It affirms their role as parents and acknowledges that their loss is “as real” as the loss of any other loved one. Maybe perinatal hospice is a safe place where parents can “be parents.” It’s worth thinking about.
*Allison Whelan is a graduate student, University of Minnesota School of Law and Center for Bioethics
An important case was decided yesterday that may have a significant impact on access to medicines for patients in developing countries. India’s high court rejected an appeal by the pharmaceutical company Novartis to grant a patent for its cancer drug Glivec.
The case involved a challenge to Section 3(d) of the Indian Patents Act which was designed to prevent patent holders from extending the duration of their patents by making minor changes to existing formulations—a practice referred to as “evergreening.” Section 3(d) stipulates that “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not eligible for patent protection.
The drug Glivec was initially invented and patented as a compound in its free base form. Novartis subsequently obtained a patent in the U.S. and Europe on a beta crystal version of the compound, which was found to possess 30% greater bioavailability. In yesterday’s case, one of the central questions before the court was whether the “new” drug form qualified for a new patent under Section 3(d). The court ruled that it did not.
To arrive at this conclusion, one of the more interesting issues the court had to resolve was how to define efficacy. It elected to define efficacy as therapeutic efficacy, but even within that definition the court was presented with multiple visions.
On the one hand, efficacy could be thought of as the capacity of a drug to produce an effect. That is, the property of a drug that causes a stimulus at a receptor site, as distinct from characteristics such as affinity, potency, and bioavailability. A broader conception of efficacy would include considerations such as improved safety or reduced toxicity.
Theoretically, I suspect a more holistic approach is justified.
That’s what CNN called yesterday’s report with science writer Emily Anthes about her new book, Frankenstein’s Cat, which examines “genetically modified this, or cloned that,” as she put it, or “creatures that combine electronic bits and biological ones.” Wrestling with the ethics of such cases, Anthes explains, “reveals that we’re deeply conflicted about the role that animals play in our lives.” Yet she laments that this tension supplies no satisfying answers to underlying questions like “Is this unnatural?” and would “that make it wrong?”
Our confusion lies, I’ve suggested, in the failure of animal welfare discourse to capture the sense many of us share that animal “nature” has value apart from its happiness or well-being. If its welfare were all that mattered, then we shouldn’t be troubled by animals designed to experience less frustration living in the conditions for which they’re destined. Consider three examples of designer animals that are currently being developed: cows with stunted sentience, less apprehensive of going off to slaughter; chickens that lack nesting instincts, more satisfied to a life confined to laying eggs in a battery cage; and pigs without legs, better suited for a sedentary existence as ham and bacon in potentia.
The dominance of the animal welfare view obscures a reason to resist such creations: to preserve animal integrity. Cows should be able to fear danger, pigs to play in the mud, and chickens to peck about in the sand, according to this view, less because those capacities make the animals happy than because they are integral to an intrinsically valuable way of being. To deprive a cow of its responsiveness, or a pig of its limbs, or a chicken of its proclivity for pecking would, on this account, violate its essential “cowness” or “pigness” or “chickenness,” even if those animals were perfectly content in their designated roles.
For thoughts on why animal nature may indeed be worth preserving, and implications for conventional breeding (e.g., dogs for companionship, or horses for racing), and what all of this means for designer children and embryonic stem cell research, check out the article.
Rebecca Skloot, author of the very interesting and well-written bestseller The Immortal Life of Henrietta Lacks — a book about the poor and badly treated black woman whose cells became the famous (and very heavily used) HeLa cells, medicine and the treatment of African-Americans, and who owns products derived from one’s genes — had an interesting op-ed in the New York Times on March 23, with the clever title The Immortal Life of Henrietta Lacks, the Sequel. As Skloot writes:
“On its own, the HeLa genome doesn’t say anything specific about Lacks: it’s a string of billions of letters that detail the genetic information that makes up a HeLa cell, which is useful for science. A news release from the European Molecular Biology Laboratory, where the HeLa genome was sequenced, said, “We cannot infer anything about Henrietta Lacks’s genome, or of her descendants, from the data generated in this study.”
But that’s not true. And a few scientists decided to prove it. One uploaded HeLa’s genome to a public Web site called SNPedia, a Wikipedia-like site for translating genetic information. Minutes later, it produced a report full of personal information about Henrietta Lacks, and her family. (The scientist kept that report confidential, sharing it only with me.) Until recently, few people had the ability to process raw genome data like this. Now anyone who can send an e-mail can do it. No one knows what we may someday learn about Lacks’s great-grandchildren from her genome, but we know this: the view we have today of genomes is like a world map, but Google Street View is coming very soon. . . .
After hearing from the Lacks family, the European team apologized, revised the news release and quietly took the data off-line. (At least 15 people had already downloaded it.) They also pointed to other databases that had published portions of Henrietta Lacks’s genetic data (also without consent). They hope to talk with the Lacks family to determine how to handle the HeLa genome while working toward creating international standards for handling these issues.
The publication of the HeLa genome without consent isn’t an example of a few researchers making a mistake. The whole system allowed it. Everyone involved followed standard practices. They presented their research at conferences and in a peer-reviewed journal. No one raised questions about consent.”
Skloot then quotes a number of scientists and bioethicists decrying the practice. I actually think things are not quite as Skloot sees them. Let me explain why:
by Adriana Benedict
Today, Professor Glenn Cohen announced on this blog that he, in conjunction with two others, filed an amicus brief in AMP v. USPTO (Myriad), a case concerning Myriad’s patents on isolated DNA and cDNA. In a paper I have been writing on the natural phenomenon doctrine as applied to biotechnology patents, I arrived at this conclusion about the doctrine’s implications for Myriad:
According to Mayo v. Prometheus, the preemption rationale for the natural phenomenon doctrine suggests that any patent on a diagnostic biotechnology product or process should be limited to the inventive use of that product or process as defined by its associated process or product, respectively. As applied to Myriad, this qualified interpretation of the natural phenomenon doctrine would suggest that ideally these patents ought to be limited to Myriad’s one remaining valid method claim, namely claim 20 of the ‘282 patent, “a method for screening potential cancer therapeutics.” The unavoidable and unsettling problem with such a conclusion, of course, is that at this stage in litigation, it is not possible for the Court to limit Myriad’s gene patents in this way. This procedural limitation sheds some light on the elephant in the natural phenomenon doctrine: If the doctrine was meant to exclude certain categories of discoveries from patentability before Congress had the opportunity to refine more specific patent validity rules, then perhaps it should be limited to carrying out that function at the outset of a patent prosecution. The natural phenomenon doctrine serves the important purpose of ensuring that patents do not contravene their Constitutional objective by too broadly preempting the use of “basic tools of science.” It does so by balancing the scope of preemption against the scope of invention, and ensuring that the scope of preemption does not exceed that which is justified by the inventor’s handiwork in applying natural phenomena. At the patent prosecution stage, the natural phenomenon doctrine is a useful “catch-all” analytical tool that allows flexibility in promoting the spirit of patent law when the letter of patent law has not kept pace with the progress of science. But at the litigation stage, its Achilles heel is that it may prove too much: In the absence of a procedural option to limit a patent at this stage, the natural phenomenon doctrine is forced to err on either the side of all or nothing. While the doctrine may be useful at the patent prosecution stage, it was not (as other statutory patentability requirements were) appropriately designed to assess the validity of patents once they’ve been issued in a way that is compatible with today’s patent litigation procedures. As a doctrine of limitation, it must in this context either fall, and prove nothing at the expense of unwarranted preemption, or rise, and prove too much at the expense of patent holders who have been reasonably relying on guidance from the USPTO regarding gene patents for many years.
I am unable to find any commentary exactly on this point, but some issues concerning the jurisdictional authority of §101 have been raised in response to both Mayo and CLS Bank v. Alice. While these cases concern biotechnology processes and software, respectively, they are extremely relevant to Myriad if we consider isolated genes / cDNA to be the equivalent of biological software. Indeed, Professor Ronald Mann observed that “Though most of the attention to …[Mayo] has focused on its immediate implications for medical providers, the broader effect of the case probably will be on the software industry.”
I am pleased to announce that Gideon Schor, Vern Noviel, and I filed an amicus brief on behalf of Dr. Eric S. Lander in a pending Supreme Court case that will address whether human genes are patentable. The case is Association for Molecular Pathology v. Myriad Genetics, No. 12-398 and will be argued April 15, 2013. Lander is a leading genomics researcher and is President and Founding Director of the Broad Institute of Harvard and MIT. We think the brief will play a key role in helping the Supreme Court chart a path through this legal thicket. The full brief can be downloaded here http://www.americanbar.org/content/dam/aba/publications/supreme_court_preview/briefs-v2/12-398_neither_amcu_lander.pdf. Here is an excerpt from the brief, the Summary of the Argument:
This case hinges on a scientific question: whether DNA fragments from a human chromosome are (1) products of Nature or (2) at least similar enough to products of Nature that they should not be considered “markedly different.” Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980).
The members of the Federal Circuit panel below agreed that the DNA of a whole human chromosome was a product of Nature. But the majority held that isolated DNA fragments of a human chromosome were not products of Nature.
Because the majority made (without citing scientific support) a foundational assumption that isolated DNA fragments of the human genome do not themselves routinely occur in Nature, it considered whether they are similar enough to products of Nature. Employing analogies, the panel members debated whether isolated DNA cleaved from a chromosome was akin to a leaf plucked from a tree, or a kidney surgically removed from a human body.
The Family, Privacy, Secrets, & The Law Roundtable (March 7-8. 2013) was a great success. Kudos to the brilliant presenters and commentators who came together for this important, groundbreaking session, including Lori Andrews, Glenn Cohen, June Carbone, Laura Rosenbury, Camille Gear Rich, Martha Field, Deborah Epstein, Martha Ertman, Gaia Bernstein, Taunya Banks, Naomi Cahn, Michael Pinard, Karen Czapanskiy, and Eleanor Brown. Thanks to all who attended and contributed to this excellent meeting. Coverage can be found here and here.
Join us for an important meeting:
Roundtable: Family, Privacy, Secrets & the Law March 7-8, 2013
March 7-8, 2013
University of Maryland
Francis King Carey School of Law
500 West Baltimore Street
Baltimore, MD 21201
March 7, 5 p.m. - Book Reading and signing by Jonathan Odell, author of The Healing
March 8, 9 a.m. – 4 p.m. – Roundtable discussions
Family, Privacy, Secrets & the Law roundtable engages the intersections of medicine, criminal law, family law, and constitutional law. The conference faculty will chart contemporary issues that span genetic privacy, disclosure of parental identity in assisted reproduction cases and DNA conscription to domestic violence and child sexual abuse.
There are times in which the law protects secrets, such as between a lawyer and client, doctor and patient, or clergy and congregant. Yet, there are times when the law demands that secret-keepers reveal their confidences such as the increasing demand on doctors to disclose confidential medical information on pregnant women to law enforcement. How should we understand the contours and boundaries of these dynamics within the law? On one hand, law tends to address secrets through the lens of legal duties to protect the vulnerable via its regulations governing abuse and neglect. On the other hand, this set of laws captures only a small percentage of secrets held by family members and other trusted “secret keepers” (doctors, clergy, extended family, neighbors) who, for a variety of reasons elect not to inform the state.
This roundtable interrogates states’ obligations to protect the vulnerable and at what cost. It considers the ways in which the law promises/owes protection and the success, failure or harms it brings about when endeavoring to intervene and offer protection. Against that backdrop, the law also has the obligation to honor individual and family autonomy and privacy.
By Casey Thomson
This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:
- Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
- Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
- Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
- Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
- Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
- Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
- Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
- Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
- Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)
In my final post on reverse settlements I want to offer three thoughts that are more directly related to the legal question of how to treat reverse settlements under antitrust law.
First, it strikes me as odd that we scrutinize reverse settlements of Paragraph IV challenges differently than settlements of patent suits of non-drug, even non-health products. As Einer acknowledges in his Texas Law Review piece, nearly all patent litigation affects market structure and thus both the level of competition and the amount of consumer welfare (Elhauge and Krueger 2012). In each of those cases, because the public is not party to the litigation, settlements between patent holders and alleged infringers will – in theory and perhaps in practice – tend to hurt consumers. (The monopoly-duopoly wedge that gives rise to the problem of reverse settlements is by no means unique to the drug market.) Yet my patent law colleagues tell me there is no systematic review of non-drug patent settlements as is being urged of drug settlements in the FTC v. Watson case. It seems that under the FTC view, drug patents would be treated more harshly than other patents. I am not sure why that should be the case under antitrust law.
Second, the critical question in the antitrust litigation is the baseline against which reverse settlements are judged. Reverse settlements are only problematic under antitrust law if they extend patent duration or scope beyond some baseline. Should that baseline be expected duration with full litigation and no settlement – as critics of reverse settlements urge – or something else? For expected litigation to be the baseline, one has to assume that Hatch-Waxman modifies patent law and that patent duration after litigation is what is now required. I am not sure these assumptions are appropriate.