Author Archives: lawandbiosciences

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Questioning the Shaming of Nadya Suleman

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The traditional arguments don’t seem to apply in the case of Nadya Suleman, the 33 yo woman who delivered 8 babies last week after undergoing IVF.  Normally, I would say “stop targeting a single mom and focusing a disproportionate amount of attention on her.”  But the fact that Ms. Suleman is a single mom actually matters.  Who will help her care for 14 young children?  Apparently Ms. Suleman’s parents have their hands completely full taking care of the 6 she already has, while Nadya is in the hospital recovering.  The fact that she is not married should not be the issue, but rather whether both she and the children will have adequate social support.

However, the support she receives can be dictated by our social response.  Recall that when Nkem Chukwu had octuplets following IVF in 1998, she was given a great deal of corporate support through free diapers and a new home.  Was the public enthusiasm there because she was married, religiously motivated to keep all of the children, because this was novel, or because we were in better economic times in 1998, when access to government resources was not on everyone’s lips?  (One thing that interests me is that we really know nothing about why Ms. Suleman decided to keep all 8 embryos, rather than selectively terminating some, but perhaps because we know she is single, people are making all kinds of assumptions about what her reasoning must have been).

The second argument I would pull from the archives would be, “We don’t want to turn into China with the government regulating how many children we each have.  Let her decide whether IVF is a good option for her…we don’t know her unique circumstances.”  But we do know she already had 6 kids through IVF.  Can it really be that the government would allow a physician to insert 8 embryos into this woman, knowing the serious risks it would pose not just to her, but also to the developing fetuses?

During an interview on MSNBC, Ms. Suleman’s neighbors brought up the big elephant in the room, that few ethicists want to talk about, which is the cost.  Who is going to pay for the health care and education of these children?  This is related to the paragraph above, as state-sponsored, utilitarian assessments of how many children we can conceive would probably not pass a 14th Amendment substantive due process challenge, and it would appropriately be met with a very strong (and negative) social response.

Ms. Suleman has hired a spokesperson, who says that the mother did not know she would be having multiple births, and it was just as much a “surprise to her” as it was to everyone else.  This cannot be true, unless the IVF clinician was negligent in explaining the process to her.  If Ms. Suleman had 6 babies previously through IVF, and she knew she had 8 embryos implanted this time, she had to at least be aware of the strong possibility of having more than one child.  But should we be investigating her motives or decision making process at all, or should we just focus on the potential harm to her and to her children?

Should it matter that she already had undergone IVF, and is the public outcry in response to a sense that she is “being greedy?”   Recall that the Duggar family, highlighted on the show “17 Kids and Counting” had even more children, though none were conceived using IVF.  On the show’s website, the Duggar’s choice is explained this way: “With values rooted in their strong personal faith, Jim Bob and Michelle firmly believe that every child is a gift to be cherished.”  Why were they a “pop culture phenomenon” and generally well received, when Ms. Suleman is being publicly shamed?   Surely it cannot be because their births were “natural.”  Relying on what’s natural in this case confuses the issues – first, because the word is almost meaningless, and second, because we do not shame any number of other medical interventions that interrupt the “natural” course of our lives.  What’s different here? Perhaps the difference between the two families is that Ms. Suleman is single and her support system has been questioned (though, I cannot claim to know what it will actually be – for all I know she has a huge support system of extended family…)

What should be done in these delicate situations, where we want to balance the privacy and liberty rights of the mom-to-be against the rights of the children she will be raising, and the government’s interest in protecting them?  Should there be a limit on the number of embryos that can be implanted if it’s your first time?  Or only if it’s your second time using IVF?  Should we rely on tort law to sue negligent IVF clinicians, or should we have tighter regulations in place at these clinics for the safety of the mom and the babies?

Please send us your thoughts, and let’s hope that the babies and the new mom continue to do well.  Right now as she recovers and attends to her small children, I hope she is insulated from all of the public shaming.  – Teneille

***

p.s. – Thanks to Dov Greenbaum for directing me to the article, IVF Results: Optimize, Not Maximize.  As David Magnus points out in the MSNBC link above, there are lots of professional norms about implating embryos, and implanting 8 is apparently well outside of the norm.  Could this be malpractice if it’s outside of the standard of care?  Absent any legal bite, there will be clinicians who will push the ethical limits.

Welcome to the CLB blog from the Director, Hank Greely

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What the Heck Is “Law and the Biosciences” – and Why Do We Need It?

When I tell people that I work in “law and the biosciences,” I see confusion.  I quickly add “I work on the legal, ethical, and social implications of advances in the biological sciences, particularly genetics, neuroscience, assisted reproduction, and stem cell research.”  Most people then look a bit less confused, but I sure wish I didn’t have to explain.  I think we would be better off if the phrase were commonly understood – and if law schools wanted to hire professors in “law and the biosciences” and to teach courses on “law and the biosciences.”  Here are my reasons, lawyerly separated into substantive and procedural – but I could be wrong.

Substantively, I believe that advances in the biosciences will have increasingly large effects on our society and hence on our law.  Sometimes the effects on law will be direct – think about forensic DNA or the possible effects if neuroscience produces accurate lie detection or bias detection.  Sometimes the effects will be through the growth of new threats or new rights that lead to new kinds of controversies, lawsuits, and policies to avoid lawsuits – think about genetic discrimination in insurance, the invasion of genetic privacy through the collection of “discarded” DNA, “parental” status in complicated IVF/surrogate parent scenarios, or the appropriate use of various “brain-changing” pills or technologies.  And sometimes the effects will be deeper, subtler, and more important, such as a possible cultural shift toward determinism as a result of genetics or a shift away from free will as a result of neuroscience.  I believe – and I have to confess this is more a matter of faith than of empirical proof . . .  maybe I should say I have to believe – that our societies, worldwide, will handle the disruptions and opportunities these technologies present better – or, at least, less poorly – if some legal academics think about them first.  And if law students hear about them and think about them before going out into law firms, in house counsel positions, public interest jobs, or government appointments.

The procedural argument may be harder to make:  why call it “Law and the Biosciences” and think of it as one “thing”?  Because these issues overlap, a lot, and because they don’t fit anywhere else.  Some basic knowledge about and openness to biology is crucial to lawyers who want to deal with any of these topics.  And some of the topics – like privacy, for example –  show real interesting similarities across subject matters.  But, maybe equally important, these issues don’t fit anywhere else – and if issues don’t “fit” into a law school box, they risk getting lost.  They are only a small part of Health Law, of Bioethics, of Intellectual Property, of Law and Science  and none of those will take in more than a small part of law and the biosciences.

So I think we need to talk about this new field – not to make ourselves feel better, but because thinking of it as a field will make our world work better.  But I could be wrong.  I welcome your thoughts – on whether we need a new field and, if so, how we go about creating one.

Hank Greely

DTC Personal Genomics: so which is it, medical information or not?

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In June of this year, California’s Department of Public Health (CDPH) issued cease and desist letters to 13 direct-to-consumer genetic testing companies. The letters laid down the law: in order to continue marketing to California residents, the companies must (i) use labs that are CLIA certified, and (ii) require that a doctor be involved in ordering the genetic tests.  Two of the 13 companies, Navigenix and 23andMe returned from the legal battle triumphant: California’s DPH issued licenses that allowed them to continue operating in the state.  But what exactly the companies promised in return for the green light is not entirely clear.

An article in the NY Times, quoting a senior official in the CDPH, confirmed what many of us had thought likely — the companies argued in part that they are not in the business of providing medical tests.

Really?

So what, then, do we make of 23andMe’s website that has an entire page dedicated to “health and traits,”  and claims to rely on a  “growing list of more than 80 diseases” to provide information on how your genes may affect your disease risk?  Does this not sound medical?  And if Navigenics made a similar legal argument, how does this square with their more upfront desire to provide “clinical information” so you can be “successful on your path to optimal health?”

Perhaps it was the single physician that each company agreed to (or already did) employ that convinced the CDPH that all was copacetic.  But the fact that one person could review each test tells us that either few consumers are biting, or the review is perfunctory.  And what are they reviewing for, exactly?

At the opposite end of the utility spectrum, 23andMe initially promoted their services as “recreational” and “pure fun.”  This may be true if you are testing for SNPs associated with taste for broccoli, but it is certainly not “pure fun” when someone finds out they have an elevated risk for developing colon cancer.

Even so, much of the data that these companies will be providing to consumers (which was recently expanded to include more SNPs) is not very useful for medical decisions.  With the exception of a few conditions such as macular degeneration, information on elevated risk may look something like this: “Most people have a 4.5% risk of developing [x] over the course of their life.  With the presence of this SNP, you have a slightly higher risk, at 6.0%.”  What to do with this information?  There is a call for the online personal genomics companies to provide more genetic counseling to help interpret what these risk percentages mean.  But the truth is, the counselors don’t know what to tell you either.  Eat better?  Exercise more?

Most of the information does not have much clinical utility.

Does this mean a retreat to the initial (and perhaps disingenuous?) “recreational” marketing strategy?  Certainly not.  The emphasis on both Navigenics’ and 23andMe’s website is that this information is meant to inform medical decisions.  But the question remains: interpreted when, and by whom?  Without ICD-9 codes for interpreting information on SNPs, few physicians are going to welcome this daunting interpretive role.

It may be the case that all of the “recreational” and “medical” marketing strategies were really just clever (and not necessarily sinister) methods of subject recruitment.  It does seem that much of the energy is now being channeled to convert the personal genomics information into a social networking research powerhouse.

What happens next will be very interesting.  As the price of 23andMe’s services was just cut to a mere $399, the argument that these early adopters are sophisticated consumers of genetics information may fall apart.  We are all free to make poor consumer investments, but the companies cannot misrepresent what it is they are selling.  Medical information?  Fun facts?  Participation in a large research database?  All of the above? Also, if consumers agree to be part of a genetic networking database, they must very clearly and plainly be told that they are protected through contract or tort, not HIPAA or the Common Rule (unless the companies partner with federally funded programs).

While I agree with many of the arguments for cautious and thoughtful regulation, I do think these companies, and 23andMe in in particular, are trying to have it both ways.  I do not doubt that they are taking their regulatory compliance very seriously.  But it might be a good idea to call them out on their inconsistencies between what they promise, what they can actually provide, and what they expect to do with the consumer’s data.

Tell us your thoughts!

Teneille

Welcome to the CLB blog!

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Welcome to the blog for Stanford Law School’s Center for Law and the Biosciences!  The CLB examines biotech discoveries in the context of the law, weighing their impact on society and the law’s role in shaping that impact.  We will be posting updates of happenings in biolaw, neurolaw, law and tech, and related fields, as well as reports from CLB events, stuff we’re working on, and links of interest.  Thanks for checking out our blog!