Reproducing After One’s Suicide

If you live long enough you really do see it all. News.Com.Au reports that an Australian judge has permitted a widow to extract sperm from the body of her husband who recently committed suicide to be used for In Vitro Fertilization (IVF) of the woman. According to the report “The woman, whose name has been suppressed, had spent the past two years trying to conceive and recently began in vitro fertilisation (IVF) treatment when her husband, who suffered from severe bouts of depression, committed suicide.”  From the article there is a report on some of the reasoning of the court

Under the Human Tissue and Transplant Act, a designated officer at a hospital (usually a senior doctor) may authorise a request from a next of kin for the removal of human tissue from a deceased person for medical procedures. Judge Edelman said sperm fell under that scope. The only restriction is when a person dies in sudden or suspicious circumstances. In those cases permission needs to be given by the State Coroner who did not object to the sperm being removed and stored. Because of the short turnaround time for the hearing, Judge Edelman said the Health Minister did not have an opportunity to appear at the proceeding. He said the Minister would have an opportunity to be represented at any future hearing concerning the use of the sperm for IVF.

This case raises a number of very interesting questions.

First, I think the court’s reasoning distinguishing the extraction of sperm (permitted) versus its eventual use through IVF (which seems may be subject to prohibition later) interestingly implicitly makes a distinction I have drawn in my own work between a bodily integrity right related to one’s reproductive material and a non-use right I have called “The Right Not to Be a Genetic Parent?” The Court seems to suggest a default rule where extraction is permitted as a matter of course (no posthumous bodily integrity) but perhaps a different rule as to the Right Not to Be a Genetic Parent. Second, the case raises the more general question of the nature of the interests of the would-be genetic parent in posthumous reproduction. In The Right Not to Be a Genetic Parent I argued that the strongest argument for such a right is connected to what I call “attributional parenthood,” the attribution by the genetic parent, the child, and third-parties of parenthood to him/her on the basis of the genetic tie. Posthumous parentage, though creates some special problems with this argument. As I suggest in a rather lengthy footnote (n. 64) in that article:

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Genetic Testing as Social Networking

By Elizabeth Sepper

In the market for discount genetic testing?  Want to share your genetic markers with friends?  No?  You might soon be alone.

Last week, I got an email from the mega-discounter Groupon advertising 68% off a “DNA Self-Discovery Kit.”  The company, ConnectMyDNA, allows Groupon users to send in a cheek swab and receive back information on their genetic markers and how those markers compare to people around the world (what they call a “Gene RingTM”).

The big selling point:  sharing results with friends on social media and making new connections to people with similar genetic markers.  ConnectMyDNA’s website says, “You can use your Gene Ring™ as your personal badge anywhere you’d like—on your business card, email signature, or you can even create a cool T-shirt!”

This all seems fairly harmless.  But I wonder if sharing genetic information will represent the next step in the race to the bottom of privacy expectations.  People already regularly disclose extensive medical information related to illness, recovery, and injury on Caringbridge, Facebook, and public blogs.  As genetic tests come down in price and become more commercially available, will genetic information be next?  How will law and ethics respond to protect family members who share genetic information or shield those predisposed to disease from discrimination in this context?  Today, genetic screening raises ethical issues and contention among family members at risk, for instance, for hereditary breast or ovarian cancer.  Tomorrow, sharing one’s genome with Facebook friends, twitter users, and the public may be the norm.

At $28,000 a Dose, How Effective Is Acthar?

By Jonathan J. Darrow

In a well-researched, recent post, Patrick O’Leary addresses the FDA’s efficacy requirements as applied to an old drug, Acthar (corticotropin), that was first approved in 1952 and granted an orphan designation in 2010 for the treatment of infantile spasms. The initial approval therefore occurred before the Drug Amendments of 1962, which instituted a “new” statutory requirement of efficacy (more on this below). O’Leary points out that Acthar’s “grandfather” status does not entirely exempt it from the FDA’s efficacy requirements, and that the drug did survive an efficacy evaluation under the DESI program. But how effective is Acthar?

Neither O’Leary nor the New York Times article on which his post is based dig very far into the clinical trial data accepted by the FDA as supporting the efficacy of the drug as a treatment for infantile spasms, and I was curious to know what the evidence says about Acthar in this regard. Clinical trial data is presented—or perhaps more accurately, “buried”—in Section 14 of a drug’s FDA-approved label; in the case of “H.P. Acthar Gel” (NDA 022432), that label can be found here. What does the clinical trial data reveal?  The section is brief, just half a page, and notes that of “[t]hirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002).”  Nonresponders were then given the other treatment, with the following results. “Seven of 8 patients (87.5%) responded to H.P Acthar Gel after not responding to prednisone,” while “[o]ne of the 2 patients (50%) responded to the prednisone treatment after not responding to Acthar.”  As the p-value (0.002) indicates, the first figures, at least, are statistically significant.  These figures were also better than I expected: 86.7% efficacy with Acthar does seem much better than 28.6% efficacy with prednisone.  Read More

Where Are We Now: Post 4, Looking in the Mirror, or 3 Games in Public Health

By Scott Burris

In a well-known exchange, Richard Epstein argued that modern public health had strayed far outside its traditional and proper work of preventing epidemics and injuries into a realm of social engineering in which it lacked both competence and legitimacy. William Novak, the historian, disagreed, emphasizing the continuity of our public quest for well-ordered, salubrious (and virtuous) communities. Deciding whether public health is winning or losing in the legal arena – and figuring out how we win more often — depends to some degree on what game it is we think we are playing – that is, on whether Epstein or Novak is right.

I think they both are, and it is worth considering how. I suspect that most of us think, without going too deeply, that we’re doing pretty much the same thing that Lemuel Shattuck was doing at the dawn of modern American public health: marshaling collective resources to use data to diagnose, treat and prevent harm to public health.  And if that’s what you think you’re doing, his report is still an excellent guide to making the case for legal action: evidence shows that we can prevent morbidity and mortality in a cost-effective way that does not significantly interfere with anyone’s rights and makes our society stronger and more competitive.

But law, at least, is a very good area for asking whether we are doing something quite different than our grandmother’s public health.  The use of law as a tool of intervention in public health – as a way of creating safer products and environments and incentivizing healthier behavior — has exploded since the 1960s. Yes, you can find public health law at work in the early 17th century, but when I was born in 1956, there was no OSHA, no EPA, no NHTSA. No warning labels on dangerous products. No safety belt standards or laws. Minimal limits on drinking and driving. No federal clean water or air standards. An unrecognizable FDA. And so on it goes.  In the great Novak-Epstein debate, Novak is right that we have a rich tradition of public health regulation, and plenty of paternalism and interference with individual rights based on epidemiological evidence of preventable harms. This is public health as sic utere, then and now largely a matter of showing how someone is doing something that demonstrably imposes costs on others. That’s why the debate Shattuck was waging sounds so familiar to contemporary ears. (And, by the way, that extends to the moralism implicit in our “scientific” recommendations about healthy lifestyles.)

But Epstein is right, too, I think, to observe that something is different. Public health is now a pillar of the regulatory state and the risk society, deeply enmeshed in the project of defining and minimizing risks great and, let’s face it, small.  We deploy complex regulatory systems, some of which work and some of which we continue to defend anyway, in spite of our own commitments to evidence. As matters like obesity and inequality take intervention further and further from proximate to distal links in the causal chain, our ability to back our proposals with evidence, and evidence that speaks to an everyday sense of causality, becomes severely attenuated. Much of what we propose rests on a vision of the good – salus populi – that is as much a matter of values as it is of evidence.  Failing to own that, we fool ourselves without winning over our audience.

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American Society for Bioethics and Humanities – Call for Proposals

The 2013 ASBH Call for Proposals is now open. Details regarding the call can be found on the ASBH homepage (www.asbh.org). There you will find a link to the abstract submission site as well as a PDF containing the submission guidelines, including instructions for the Student Paper Competition. Abstracts will be accepted until 4:00 pm (CST), March 4, 2013.

Introducing Anup Malani

We’re pleased to introduce and welcome Professor Anup Malani, who will be guest blogging with Bill of Health for the month of January.  Anup is the Lee and Brena Freeman Professor of Law at the University of Chicago. He is also a Professor at the University of Chicago Pritzker School of Medicine, a University Fellow at Resources for the Future, Washington, D.C.; a Faculty Research Fellow at the National Bureau of Economic Research; and an editor of the Journal of Law and Economics and the Forum for Health Economics and Policy.

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Regulatory Concepts in the News, Part I: FDA Efficacy Standards for Old Drugs

By Patrick O’Leary

While reading some of the great articles from the health section of the New York Times over the holidays it struck me that such articles, in their need to be concise and accessible, often give only passing treatment to regulatory concepts that can be fundamental to the story. Accordingly, I thought it might be useful to write a series of posts digging down a bit deeper into some of the regulatory foundations of health stories that percolate up to public attention through the news. In this post I’ll begin by looking at an interesting point relating to drug efficacy standards raised by an article about a newly expensive (but decades-old) drug.

In Andrew Pollack’s “Questcor Finds Profits, at $28,000 a Vial” we read that a drug called Acthar, first approved by the FDA in 1952 and used primarily to treat rare infantile spasms, has in recent years become a very expensive and (for it’s maker) lucrative treatment for conditions ranging from multiple sclerosis to rheumatologic conditions. The article is worth a read for its thoughtful discussion of drug pricing, but it also makes passing reference to a some important regulatory concepts that bear further examination. One issue that particularly stood out to me was Pollack’s statement that Questcor, Acthar’s manufacturer, has been able to market the drug for a variety of uses “without being required to prove that the drug actually works” because it was “essentially grandfathered” into an anachronistic efficacy standard by being “approved for use in 1952, before the [FDA] required clinical trials . . . .” On first read, that sounds fairly alarming, so I thought it might be worthwhile to unpack the law around such “grandfathered” drugs a little. While it is true that FDA did not require proof of effectiveness for new drugs until lawmakers included this requirement in the Drug Amendments of 1962, it isn’t the case that pre-1962 drugs simply get a free pass on proving effectiveness. The truth, as one might expect, is somewhat more complicated. Read More

Where Are We Now: Post 3, The Agony (and Potential Ecstasy) of Defeat

By Scott Burris

Law has been an extremely effective mode of public health intervention in the last thirty years, which means that proponents of its use have won more than a few tough political battles.  Nonetheless, it is hard to escape the fact that, in recent years, the public health side has been getting killed wherever law is made. The First Amendment turns out to create a right to mine prescription records for data (Sorrell v. IMS Health), advertise liquor prices (44 Liquormart), keep warning labels off cigarette packs (RJ Reynolds v FDA)  – even operate a tattoo parlor in a city that lacks the resources to regulate its safety.  With the Heller case, the strictest forms of gun control were taken off the table, and there is a lot more litigation ahead to define what can be done. The ACA case raises the possibility of future limits on federal regulation via the spending clause. In the latest and most chilling development, the DC Circuit panel in the FDA label case laid the foundation for questioning whether there is even a rational basis for regulations aimed at discouraging people from using “lawful” but dangerous products:

We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences.

Things aren’t a whole lot better over in the elected parts of government.  State and local health departments have been experiencing steady budget strangulation ever since (and even before) the Great Recession. The federal life-line, the Prevention and Public Health Fund, was raided once already by Congress, and remains a tempting target. Using the money we do get to promote legal interventions for health is under attack: with the help or acquiescence of Democrats, the long-standing restriction on lobbying in the HHS appropriations bill was changed. Despite legal analysis concluding that the old lines – educating public and policy makers is OK, just don’t push for specific legislation – are still in place, broad language about “future” legislation and threatening letters from an outfit called “Cause of Action” has reportedly chilled a lot of funding recipients.

For many of us, the succession of reverses and cuts looks like public health as usual: public health is usually the underdog whatever the topic. On the other hand, there are arguments that things are different now, ranging from the simple claim that the cuts have now reached bone to the belief that there is an active effort to put the “new public health” entirely out of business. So what is happening?

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Petrie-Flom Interns’ Weekly Round-Up: 12/29-1/4

By Hyeongsu Park and Kathy Wang