Category Archives: Genetics

Re-Identification Is Not the Problem. The Delusion of De-Identification Is. (Re-Identification Symposium)

Posted on by
1

This is the second post in Bill of Health‘s symposium on the Law, Ethics, and Science and Re-Identification Demonstrations. We’ll have more contributions throughout the week, and extending at least into early next week. Background on the symposium is here. You can call up all of the symposium contributions by clicking here (or by clicking on the “Re-Identification Symposium” category link at the bottom of any symposium post).

Please note that Bill of Health continues to have problems receiving some comments. If you post a comment to any symposium piece and do not see it within half an hour or so, please email your comment to me at mmeyer @ law.harvard.edu and I will post it. —MM

By Jen Wagner, J.D., Ph.D.

Before I actually discuss my thoughts on the re-identification demonstrations, I think it would be useful to provide a brief background on my perspective.

Identification≠identity

My genome is an identifier. It can be used in lieu of my name, my visible appearance, or my fingerprints to describe me sufficiently for legal purposes (e.g. a “Jane Doe” search or arrest warrant specifying my genomic sequence). Nevertheless, my genome is not me. It is not the gist of who I am –past, present or future. In other words, I do not believe in genetic essentialism.

My genome is not my identity, though it contributes to my identity in varying ways (directly and indirectly; consciously and subconsciously; discretely and continuously). Not every individual defines his/her self the way I do. There are genomophobes who may shape their identity in the absence of their genomic information and even in denial of and/or contradiction to their genomic information. Likewise, there are genomophiles who may shape their identity with considerable emphasis on their genomic information, in the absence of non-genetic information and even in denial of and/or contradiction to their non-genetic information (such as genealogies and origin beliefs).

My genome can tell you probabilistic information about me, such as my superficial appearance, health conditions, and ancestry. But it won’t tell you how my phenotypes have developed over my lifetime or how they may have been altered (e.g. the health benefits I noticed when I became vegetarian, the scar I earned when I was a kid, or the dyes used to hide the grey hairs that seem proportional to time spent on the academic job market). I do not believe in genetic determinism. My genomic data is of little research value without me (i.e. a willing, able, and honest participant), my phenotypic information (e.g. anthropometric data and health status), and my environmental information (e.g. data about my residence, community, life exposures, etc). Quite simply, I make my genomic data valuable.

As a PGP participant, I did not detach my name from the genetic data I uploaded into my profile. In many ways, I feel that the value of my data is maximized and the integrity of my data is better ensured when my data is humanized.

Continue reading →

Kudos to This American Life

Posted on by
Reply

A few weeks ago, I blogged about a recent episode of This American Life, “Dr. Gilmer and Mr. Hyde,” about the quest of one Dr. Gilmer (Benjamin) to understand why another, beloved Dr. Gilmer (Vince), had brutally murdered his own father after hearing voices that compelled him to do so. The episode ends (spoiler alert) with the revelation that Vince suffers from Huntington’s, a rare, neurodegenerative disease that causes progressive physicial, cognitive, and psychological deterioration.

Listeners, it seemed to me, could naturally conclude from the episode that it was Vince’s Huntington’s that had caused him to murder his father. That might or might not be true in this particular case. Huntington’s can cause behavioral and mood changes, including irritability, aggression and belligerence. It can also cause (less often) psychosis. But even if Huntington’s caused Vince to murder his father, or somehow contributed to the murder, the extreme violence that Vince displayed — strangling his father, then sawing off his father’s fingertips to preclude identification — is in no way typical of the Huntington’s population as a whole. And so what most troubled me about the episode was its failure to note just how rare this kind of extreme violence is among those with Huntington’s, just as it is very rare among human beings generally. And so I wrote to TAL, requesting a clarification.

I’m happy to report that the TAL producer for the episode, Sarah Koenig — who had not intended to suggest any causal link between Vince’s murder of his father and his Huntington’s, much less between murder and Huntington’s more generally — has issued a clarification on the show’s blog, and promises to make a similar clarification in the episode itself, should they ever re-air it. Kudos to TAL, and many thanks to Sarah for being incredibly gracious in our exchanges.

One clarification deserves another. In my earlier blog post, I also worried that some listeners might  conclude that Vince’s father was similarly driven to commit horrific acts of sexual abuse on Vince and his sister because he, too, was (presumably) suffering from Huntington’s (an autosomal dominant genetic disease). Although I think that a listener who didn’t know better could reasonably conclude that Huntington’s causes people to become sexual predators almost as easily as they could conclude from the episode that Huntington’s causes people to become murderers, nothing in the episode suggests that Sarah, Benjamin Gilmer, or anyone else at TAL believe that Huntington’s causes sexual abuse, or that they intended for listeners to reach that conclusion. I regret anything in my earlier post that suggested otherwise.

Again, I’m very grateful to Sarah and everyone else at TAL for hearing me (and other listeners) out and for agreeing to make the clarification — and just in time for HD Awareness Month!

Online Symposium on the Law, Ethics & Science of Re-identification Demonstrations

Posted on by
Reply

Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place here at the Bill of Health the week of May 20th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

Misha Angrist
Madeleine Ball
Daniel Barth-Jones
Yaniv Erlich
Beau Gunderson
Stephen Wilson
Michelle Meyer
Arvind Narayanan
Paul Ohm
Latanya Sweeney
Jennifer Wagner

I hope readers will join us on May 20.

Privacy and Progress and the Deidentification of Whole Genome Sequence Data

Posted on by
Reply

[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.

Continue reading →

Live Blogging from FDA in the 21st Century Conference, Plenary 2: Alta Charo on Integrating Speed and Safety

Posted on by
Reply

[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

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 →

Why North Dakota’s Ban on Genetic Selection Matters (Online Abortion and Reproductive Technology Symposium)

Posted on by
Reply

[Ed Note: Posted on behalf of Jaime King]

On March 26, 2013, North Dakota Governor, Jack Dalrymple, signed into law two of the nation’s most restrictive abortion bills. The first, HB 1456, prohibits providers from performing an abortion once a fetal heartbeat can be detected, which can be as early as six weeks gestation (Fetal Heartbeat Ban).  The second, HB 1305, prohibits providers from knowingly performing abortions sought solely because of the sex of the fetus or because the fetus has been diagnosed with a genetic abnormality or the potential for a genetic abnormality (Sex and Genetic Selection Ban).

Much of the press coverage and discussion of these unprecedented laws has focused on the Fetal Heartbeat Ban. This is largely because the prohibition eliminates nearly all access to abortion in the state and poses a direct challenge to a woman’s right to choose to have a pre-viability abortion free from undue state interference, as delineated in Planned Parenthood v. Casey.   Viability has typically been established around 24 weeks gestation, which is generally considered the end of the second trimester. The sweeping nature of this prohibition essentially negates the impact of a prohibition on sex or genetic selective abortions, as testing for those conditions, even with non-invasive prenatal testing techniques, cannot be performed reliably prior to nine or ten weeks gestation. By that point, the Fetal Heartbeat Ban would already prohibit any form of selective abortion.

But we should not ignore this law, as it is the more insidious of the two. As a direct threat to abortion access for all women, the Fetal Heartbeat Ban is very likely to be found unconstitutional, short of a complete overturning of Roe v. Wade. The Sex and Genetic Selection Ban, however, is subject to more debate. Since Roe, we have largely assumed that women can have an abortion for any reason prior to viability, but the courts have never directly addressed the issue.  Recent polls have found that over 3/4 of Americans would support bans on sex selective abortions,[1] and five states have already passed sex selection bans.[2]  The question of whether a woman’s reason matters is upon us.

Opening the door to permit states to invade and assess women’s private thoughts regarding her reasons for having an abortion strikes directly at the heart of the reproductive liberties protected by the Fourteenth Amendment. If states can regulate access to abortion based on a woman’s reasons for having it, they can significantly limit access in a piecemeal fashion – slowly and deliberately circling in on the right. Continue reading →

Impact of the “Lander Brief” in the Myriad Case – and an answer to Justice Alito’s Question

Posted on by
Reply

 [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 →

Will Your Law Firm (or Other Employer) Pay for Your Egg Freezing? Should It? (Online Abortion and Reproductive Technology Symposium)

Posted on by
Reply

As John Robertson mentioned in his post earlier this week, in order to avoid age-related infertility many women are considering or will soon consider using egg freezing, as the technology has dramatically improved. As compared to freezing preembryos, for example, this is an attractive option since many of these women (heterosexual or otherwise) may not yet have chosen a reproductive partner, and also may want to hedge their bets to have options should they divorce. Still, the technology is not cheap.

At least one participant at the the bricks-in-mortar symposium reported to me that they knew of one Am Law 100 firm that will cover egg freezing for its lawyers. I would be grateful if folks in the comments section could indicate whether they knew whether their firm covers it as well. [Ed. Note: If you have any trouble with the comment function on the blog, which is still giving us trouble, send a note and we'll get it posted for you through the admin account.] My own impression is that this is not yet widespread, but that might change as the practice becomes more common and thus the market converges (perhaps with a push from Above the Law).

Should law firms cover egg freezingt? I have made the argument elsewhere for coverage of reproductive technologies by insurance more generally from a moral and economic perspective. In the case of law firms, I am curious about the PR implications for the firm. Would potential female associates welcome this option knowing that they can work hard early on and still reproduce, if they so desire, later on? Or would they take this as a signal that the firm thinks that working there as an associate and pregnancy are incompatible? Would this option help remedy the deficits faced by women who want to have children on the partnership track or would it in fact exacerbate discrimination against women who do choose to have families early on while at the firm, with the thinking being “she could have waited.” More generally, would this be a blow for or against gender equity at law firms?

This American Life and Stigma

Posted on by
3

Update: TAL has made a clarification. Please see this post for more.

Let me begin by saying how much I absolutely adore This American Life. I listen to it religiously. I particularly had been looking forward to the most recent pocast episode of TAL: Dr. Gilmer and Mr. Hyde. As the episode’s blurb teases, “Dr. Gilmer and Mr. Hyde” concerns a doctor — Benjamin Gilmer — who takes over the rural South Carolina practice of Vince Gilmer (no relation). Vince is no longer available to see patients because he is serving a prison sentence for killing his father. As Benjamin gets to know Vince’s — and now his — patients, he forms a picture of Vince that’s at odds with his status as a convicted father murderer. How could this doctor who was so devoted to his patients have so brutally murdered his own father?

This episode is right up my alley. True crime? Check. Forensic psychology? Check. The intersection of law and medicine? Yes, please. So when I awoke yesterday morning at 5 am and couldn’t go back to sleep, I eagerly cued up the podcast. The episode recounts, in TAL’s  typically-riveting fashion, the story of Benjamin’s search for the truth behind Vince’s murder of his father. I enjoyed every minute of the episode until the last five minutes or so, when I became troubled by one critical omission.

Spoilers  follow after the jump; listen to the episode first. Continue reading →

Myriad (Gene Patent) Oral Argument and the “Lander Brief”

Posted on by
1

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.

Continue reading →

John Robertson on Cohen and Adashi on Made-to-Order Embryos for Sale

Posted on by
Reply

[Ed. Note: Posting on behalf of John Robertson]

Glenn Cohen and Eli Adashi have an interesting Sounding Board piece in the latest NEJM[i] on made-to-order embryos for sale.  A California clinic offering this option has garnered enormous publicity.  It might, however, have stimulated more bioethical thinking than actual demand for its services.

On the bioethical side, Glenn and Eli survey the relevant issues and conclude that what is most “new and unique here is the lack of clear legal guidance as to the parentage of the embryos in question.”[ii]  My impression is different– existing laws give sufficient support about parentage, if anyone wants to use them.  The clinic creating the embryos from separate gamete donations will have dispositional control of them, but no parenting questions arise until the embryos are gestated and brought to term.  True, there are few state laws on embryo donation as such. But in states with no specific embryo donation laws, those who have commissioned gestation will most likely have rearing rights and duties once a child is born until they arrange for an adoption.[iii]

Nor would the gamete donors in such states be able to claim rearing rights or be subject to rearing duties after such a birth.   Most states recognize gamete donor relinquishment of rearing rights and duties in resulting children with their consent to donation.  After the birth of a child, the gamete donors ordinarily would have no right to change their mind and acquire rearing rights or be subject to rearing duties, whether the donation was of sperm or egg separately or both combined into an embryo.

One aspect of this transaction that is ethically unique is that divvying up embryos created from the same egg and sperm donor would lead to different recipients giving birth to full rather than half siblings, as is the usual situation with gamete donation (it could happen with excess embryos donated after successful IVF by an infertile couple, but that is rarer). Whether it creates a higher risk of full sibling consanguinity would depend on clinic practices in distributing embryos from the same batch to different recipients.  As Glenn and Eli note, donor registries might solve this problem, but none yet exist in the United States.

Continue reading →

New Paper in the New England Journal of Medicine “Made-to-Order Embryos for Sale — A Brave New World?”

Posted on by
Reply

The New England Journal of Medicine just published a new article by me (and my frequent co-author Dean Eli Adashi) entitled “Made-to-Order Embryos for Sale — A Brave New World?”  As we note in the article:

The proliferation of commercial gamete sources (e.g., sperm and oocyte banks) has opened the door to a made-to-order embryo industry in which embryos are generated with a commercial transaction in mind. This prospect of a for-profit embryo bank is no longer theoretical. Indeed, as recently as November 2012, the Los Angeles Times reported on one such clinic that “sharply cuts costs by creating a single batch of embryos from one oocyte donor and one sperm donor, then divvying it up among several patients.” The report went on to state that “the clinic, not the customer, controls the embryos, typically making babies for three or four patients while paying just once for the donors and the laboratory work.

The paper then analyses the legal and ethical issues raised by the development of these kinds of banks. In so doing, a key question we ask is how this practice is similar or different from embryo donation (sometimes called “embryo adoption”), the sale of sperm and eggs for reproductive purposes, and the use of sperm and egg to produce stem cell lines that require embryo destruction.

This one is sure to be controversial, and while this short piece in the New England Journal is now published I would love to hear readers’ thoughts as I may write more on the subject.

Introducing our Online Abortion and Reproductive Technology Symposium

Posted on by
Reply

[Editor's Note: This is Glenn Cohen guest posting on behalf of Kim Mutcherson, what follows below is her post. I will be posting on behalf of several symposium contributors over the next few days.]

On Friday, April 5, a group of almost 30 (mostly legal) scholars gathered at Rutgers Law-Camden to have difficult conversations about abortion and assisted reproduction. The event, sponsored by Rutgers Law and the Law School Initiative of the Center for Reproductive Rights (http://reproductiverights.org/en/our-work/law-school-initiative) sought to initiate discussion about the seeming gulf between those working on issues related to abortion and those working on assisted reproduction and assisted reproductive technology (ART).  Friday’s conversation was the first of at least three planned events with the other two to be sponsored at some future point by the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School and the Program for the Study of Reproductive Justice in the Information Society Project at Yale Law School. If the nature of the conversation at this kick-off event is a harbinger of things to come, I am anticipating that top-notch and cutting edge scholarship related to reproductive rights and reproductive justice will emerge from workshop participants.

While it might seem intuitive that scholars of reproduction would talk often, much of the work in this arena exists in silos. Those writing about abortion have plenty of work to do in keeping up with the flurry of state laws seeking to destroy what remains of Roe v. Wade in a post-Planned Parenthood v. Casey world. And those working in the world of assisted reproduction have to keep abreast of emerging science that is always light years ahead of what the law has done or seems capable of doing. As a consequence, opportunities to study the intertwining and divergence between the right to end a pregnancy and a right to create one are sparse.

And so, in the year that we commemorate the 40th anniversary of Roe, we engaged in a respectful, honest, and richly complex dialogue about the appropriate paradigm for understanding the right to abortion and the right to use assisted reproduction—liberty, equality or some new paradigm that we have yet to fully embrace or articulate.

Continue reading →

New Paper on Sperm Donor Anonymity and Mandatory Paternal Testing for Coital Sex

Posted on by
Reply

I have a new peer-commentary paper in the American Journal of Bioethics, entitled “Of Modest Proposals and Non-Identity: A Comment on the Right to Know Your Genetic Parents.”  This is a response to An Ravelingien and Guido Pennings’s very interesting article “The Right to Know Your Genetic Parents: From Open-Identity Gamete Donation to Routine Paternity Testing” in the same journal, wherein they argue that the same arguments underlying mandatory sperm donor identification should support a regime of mandatory routine paternity testing to deal with the phenomenon of misattributed paternity.

My new piece is behind a pay-wall, but if you’d like to read it shoot me an email as I have a limited number of “free passes” from the publisher. I have also written about these issues in greater depth in this article in the Georgetown Law Journal which is available for free download. Finally, I hope to soon blog about a new paper forthcoming in the Journal of Empirical Legal Studies and co-authored with Travis Coan, where we use experimental methods to examine whether reluctance to become a sperm ‘donor’ where identification is required can be overcome with increased payments to potential ‘donors’.

Henrietta Lacks, Publishing Genomes, and Family Vetos

Posted on by
Reply

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:

Continue reading →

The U.S. Should Cover the Cost of IVF (for Gays and Lesbians Too)

Posted on by
Reply

by Dov Fox

Glenn Cohen and I make the case in this morning’s Huffington Post:

This week the United Kingdom joined the ranks of countries like Canada, Israel, and Sweden that provide in vitro fertilization (IVF) treatment to citizens under a certain age (42 in the U.K.) who can’t have children without it. That includes gays and lesbians. When it comes to helping people form the families they long for, the United States is woefully behind. The U.S. has among the lowest rates of IVF usage of any developed country in the world, owing in part to boasting the highest cost for the procedure, on average $100,000 for each successful pregnancy.

Among the handful of states that require insurers to cover IVF, many carve out exclusions for same-sex couples and people who aren’t married. These singles, gays, and lesbians are sometimes called “dysfertile” as opposed to “infertile” to emphasize their social (rather than just biological) obstacles to reproduction. The U.S. should expand IVF coverage for the infertile, and include the dysfertile too.

The U.S. Supreme Court has held that the inability to reproduce qualifies as a health-impairing disability under the Americans with Disabilities Act. The commitment to universal health care that we renewed in President Obama’s health reform act invites us to understand the infertile and dysfertile alike as needing medicine to restore a capacity—for “[r]eproduction and the sexual dynamics surrounding it”—that is, in the words of the Supreme Court, “central to the life process itself.”

Continue reading →

Rethinking Biotechnology and Software Patents: A Myriad of Jurisdictional Issues Related to Subject-Matter Eligibility

Posted on by
Reply

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.”

Continue reading →

New Amicus Brief Filed on Behalf of Dr. Eric Lander in the Supreme Court in the Myriad (Gene Patent) Case

Posted on by
Reply

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.

Continue reading →