Harvard Law School's Petrie-Flom Center announces its latest venture: a new blog, Bill of Health. I'm happy to say that I am among Bill of Health's large and diverse roster of bloggers, and will be cross-posting relevant content both here and there.
From the press release:
Our goal is to provide a one-stop shop for readers interested in news,
commentary, and scholarship in the fields of health law policy,
biotechnology, and bioethics. You can expect to find regularly updated
posts reacting to current events, testing out new scholarly ideas,
reviewing the latest books, and announcing conferences, events, and job
openings. We also hope to cultivate a strong community of commenters,
so that the blog becomes an interactive discussion forum.
A widely collaborative effort, Bill of Health
features content from Petrie-Flom affiliates, as well as leading
experts from Harvard and beyond. Institutional collaborators include HealthLawProfs Blog, the Yale Interdisciplinary Center for Bioethics, and the Robert Wood Johnson Foundation's Public Health Law Research program at Temple. We've also lined up a stellar cast of bloggers so far, including: Tom Baker, Cansu Canca, Arthur Caplan, Daniel Carpenter, Amitabh Chandra, Greg Curfman, Einer Elhauge, Richard Epstein, Nir Eyal, Michele Goodwin, Rebecca Haffajee, Russell Korobkin, Greg Koski, Katie Kraschel, Stephen Latham, Ted Marmor, Max Mehlman, Michelle Meyer, Abby Moncrieff, Efthimios Parasidis, Wendy Parmet, Frank Pasquale, Suzanne Rivera, Al Roth, Ted Ruger, Bill Sage, Laura Stark, Erin Talati, Nicolas Terry, Katharine Van Tassel, and Daniel Vorhaus. In
addition, we'll be joined by some great guest bloggers in the coming
months, including Mark Hall, Allison Hoffman, Adam Kolber, Jon Kolstad,
Kristin Madison, Anup Malani, Arti Rai, Annette Rid, Chris Robertson,
Nadia Sawicki, Seema Shah, Talha Syed, Dan Wikler, and Susan Wolf, as
well as a several Petrie-Flom graduate student affiliates. Read more
about our team here.
The Bill of Health bloggers will be introduced in batches in the coming days. We hope you'll visit and comment often.
(1) I hate the title of the draft paper. It's hideous. I long for the concise elegance of Prison Vouchers or some of the others mentioned here. The companion paper is tentatively titled "Research Contracts." That's followed by the usual boring descriptive subtitle, of course, but I consider it a victory at least to have begun with the kind of title I aspire to. For the posted draft, though, I can't even manage to do that. "Hey, IRBs: You're Doing It Wrong (But It's Not Your Fault)" is a fair description, but seems a little glib for a law review article. So I'm all ears if anyone comes up with a less jargonistic, sleep-inducing title. (More importantly, and in all seriousness, I'm very open to feedback on the paper itself.)
(2) Toshiba is on my s*** list. Partly because I'm a die hard Mac person, but mostly because of Toshiba's latest ad campaign, embedded above, which stereotypically portrays research participants as the passive objects of mad scientists -- that is, as proverbial guinea pigs. Like other historically disempowered groups, career research participants have reclaimed that moniker. But Toshiba's customers don't know that, and its ad helps perpetuate the image of research participation as terribly dangerous and degrading and as something that only someone who is either irrational or desperate (and willing to be exploited) would agree to. In reality, research participants can and do initiate research, and in the increasingly popular Citizen Science and Quantified Self movements, the distinction between researcher and "subject" disappears altogether. It's also closer to the truth (ahem, Time Magazine) to say that a lack of experimentation has turned millions of us into human guinea pigs in the realms of health care and legal services, and as the subjects of any number of laws, regulations, and policies (see the "Legal Experimentation" prospectus, linked above). /Rant
two years ago to the day, Chief Judge Royce Lamberth of the D.C. District Court
shocked the human embryonic stem cell (hESC) research community by preliminarily
enjoining NIH funding of that research, on the grounds that plaintiffs were
likely to succeed on the merits of their argument that hESC research violates
the so-called Dickey-Wicker Amendment (on which more below). Today, the D.C.
Circuit affirmed Chief Judge Lamberth’s (reluctant) grant of summary judgment
for the government, a holding that he had been essentially forced into by an
earlier panel of the D.C. Circuit. (My co-guest blogger covers the other big
decision coming out of the D.C. Circuit today, below.) Since it is extremely
unlikely that the D.C. Circuit will review the decision en banc or that the
U.S. Supreme Court will accept cert., today’s decision effectively ends
litigation that caused utter chaos to erupt in labs all over the country in the
wake of the preliminary injunction, and continued to cause significant
uncertainty even after the D.C. Circuit quickly stayed that preliminary
injunction. Congress could, of course, act to clarify the ambiguity in
Dickey-Wicker. But this seems highly unlikely given the current partisan split
between the House and the Senate. Indeed, the draft HHS appropriation bill that
passed the subcommittee, on
which I blogged previously, contains Dickey-Wicker’s familiar language, to
the letter. The ambiguity regarding the legality of federal funding of hESC
research seems, then, to have reached its low water mark during the past couple
of years, and should stay that way…at least until November.
For those of you who are close observers of this litigation:
as you were (or skip to the section on today's opinions, below). For the uninitiated-but-interested: Some background. Federal
policy regarding funding for hESC research has, since the beginning of this
research in 1998,
been extremely contentious, wrapped up as it is with ethical, political and diverse religious
positions on the moral status of human embryos and other aspects of “abortion
politics.” An embryonic stem cell line is so called because the line is derived
from an embryo (really, a five-day or so blastocyst), and this process
necessarily destroys that embryo. Despite that — or because of it — the funding
policies under the Clinton, Bush and Obama administrations have been remarkably
similar. In this
article, published in September 2009 — one month after the litigation that
no one thought would have legs had commenced — political scientist James
Fossett and I analyzed these extent to which the Obama Administration’s
guidelines for funding hESC research, then just announced by NIH, were likely
to achieve two of their stated goals: (1) expanding NIH support for hESC
research after what had been widely perceived by the science community as strict
limits on it during the Bush Administration, and (2) ameliorating the patchwork
of state and private regulatory standards that had come to govern this research
in the absence of federal funding.
Today the D.C. Circuit ruled 2-1 against the FDA, finding that proposed graphic warnings on cigarette packages were unconstitutional. According to the FDA, graphic images showing the harmful health consequences to smoking would essentially drive users to quit - and stop underage smokers from starting in the first place. Per the Wall Street Journal, the images "include pictures of diseased lungs, a body on an autopsy table and a man blowing cigarette smoke out of a tracheostomy hole in his neck that will be combined with stronger wording such as smoking can kill you.” Also on the package would be a phone number of the National Cancer Center Institution's quit-smoking telephone line (1-800-QUIT-NOW).
According to the majority, the case involves novel questions of the scope of governmental authority to force a manufacturer to go beyond factual statements and disclosures, undermining its business interests and bearing the costs of "making every single pack of cigarettes in the country a mini-billboard for the government's anti-smoking message." The court devoted a good deal of time to settling on the appropriate level of scrutiny for such a regulation of commercial speech, but landed on the intermediate (under which the government must state a substantial interest justifying the regulation on commercial speech and also show the regulation directly advances that goal).
Here, the FDA's express goal/substantial interest was preventing consumers from smoking. Personally, I don't smoke: never have, never will. But I'd think that seeing pictures graphically showing the consequences of doing so upon picking up a pack of cigarettes would certainly make a person think twice about purchasing it. Yet causation is a knotty thing to prove. And the FDA, according to the court, failed to show the graphics would directly cause a decrease in smoking rates: thinking about quitting (or not buying) is not tantamount to following through on the thought, and large graphics were not proven more effective than existing labels. Speculation about the greater results is, as so often is the case, not enough.
So what evidence would have convinced the majority? The only thing I can think of is some sort of focus-group or similar research study as to the effect of graphics v. words on the human brain, tracked over the long term for links to behavioral choices. It might also necessitate testing a difference between types of graphics, the nature of the behavior under study (i.e. habitual, occasional, socially pressured, health v. other risks, etc.), the demographics of the target consumers (are pictures more effective on older or younger, educated or less-educated users) .... the variables are seemingly infinite. Intermediate scrutiny seems perhaps the most difficult of the three levels to grapple with when it comes to predicting how to marshal sufficient evidence in a given case - or before a given court.
I put it to you: what evidence and proof of causation/relationship would you expect to see in this kind of intermediate scrutiny case? Does it make a difference that the issue involves an affirmative obligation rather than a negative bar? How much does cost matter? More fundamentally, is intermediate scrutiny for commercial speech the right standard here when there is already broad recognition of the dangers associated with smoking and the effects of express warning labels? What makes graphics different? It's been said that a picture is worth a thousand words. It seems that the old adage is now the question of the day, at least for the FDA.
Full text of the decision here. Note the dissent's construction of the effect of graphics and the additional role of conveying health hazards as independent from decreasing smoking rates.
I generally refrain from posting on work that I don't have at least some expertise in, but I've been reading Greg Duhl's courageous (that's one of the words for it, and I might add powerful and haunting) essay, "Over the Borderline — A Review of Margaret Price’s Mad at School: Rhetorics of Mental Disability in Academic Life." It's partly a memoir and I think you may also want to read it. Here is Duhl's abstract:
This essay is about “madness” in higher education. In Mad at School: Rhetorics of Mental Disability in Academic Life, Professor Price analyzes the rhetoric and discourse surrounding mental disabilities in academia. In this essay, I place Price’s work in a legal context, suggesting why the Americans with Disabilities Act fails those with mental illness and why reform is needed to protect them. My own narrative as a law professor with Borderline Personality Disorder frames my critique. Narratives of mental illness are important because they help connect those who are often stigmatized and isolated due to mental illness and provide a framework for them to overcome barriers limiting their equal participation in academic life.
While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media.
A genetic cancer test. In a fascinating series on genetics in medicine, Gina Kolata reported in the New York Timeson a genetic test for ocular melanoma. The test distinguishes between curable and fatal forms of the melanoma, yet some physicians do not offer the test to their patients (though they disclose the availability of the test).
Of course, some patients may choose not to know which type of melanoma they have. Both curable and lethal types are treated in the same way--surgical removal--and knowing that death is certain may be too unsettling for a number of patients with the fatal form.
But to not even offer patients the chance to know seems odd. If the diagnostic test were not a genetic one, I suspect the physicians would act differently. For example, if doctors were able to distinguish between curable and fatal forms of ocular melanoma when tumor cells were sent to the pathology lab for standard cellular analysis, there would not be the same reluctance to offer patients the opportunity to find out which kind of tumor they had.
To be sure, the fact that a particular medical test is genetic may increase the potential for concerns with the test. But many genetic tests do not pose any special problems. Physicians should not let a genetic label mislead them.
Fighting dengue fever. A second example of problematic thinking about genetics appeared in the New Yorkerin an article by Michael Specter about genetic modification of the Aedes aegypti mosquito to eliminate dengue fever. If the mosquito can be eradicated, so can the dengue fever virus, which kills many and for which there is no vaccine or antiviral therapy.
The fellowship is designed for applicants who have the intellectual focus to make top-rate academics in health law policy, bioethics or biotechnology, and who would benefit from time to develop their ideas and writing before they enter the academic job market. Our prior fellows have found homes on the law faculties at Harvard, Berkeley, BU, UCLA, the University of Arizona, Cornell and the University of Illinois. The fellowships include stipends of $60,000/yr for two years, a research budget, limited benefits and access to the full range of the Center's and Harvard's facilities and research resources.
If you know of any well-suited candidate who might be interested, please direct them to the call for applications (pdf) to learn more.
In all the attention given in the past couple of years (to say nothing of the past couple of months) to the individual mandate and its effect on health care access, other key features of PPACA, which address other aspects of the health care system, have received less attention than they deserve. Two remarkable things happened yesterday that highlight the importance of addressing health care quality.
First, newly published research suggests that each year in the U.S., more than 100,000 men undergo expensive, invasive surgeries that leave many of them impotent and/or incontinent, all without increasing their chances of survival or providing other clinical benefits.
The New England Journal of Medicine published the results of what one oncologist not involved with the study called a potentially “game-changing” experiment involving men with early-stage prostate cancer. Most new diagnoses of prostate cancer are early-stage, and about 90% of those who receive this diagnosis choose immediate treatment with surgery (or radiation). But despite the considerable financial and human costs of the surgery, it’s not clear that the surgery actually improves patients’ odds or duration of survival.
To examine that question, investigators randomly assigned 731 men either to surgical removal of the prostate or to an observation group, where the cancer was monitored but not treated unless it showed signs of progressing. After 15 years, there was no statistical difference between the two groups in terms of either overall mortality or mortality due to prostate cancer. A secondary analysis, however, suggested that surgery may benefit men with high Prostate Specific Antigen (PSA) levels.
The results are complex, and an accompanying editorial argues that the sample size of 731 rendered the study insufficiently powered to draw conclusions about the comparative efficacy of surgery and watchful waiting. Notably, the investigators sought 2,000 subjects, but could only recruit 731, presumably because, in the face of a cancer diagnosis, being randomized to “watchful waiting” seems risky. But it’s precisely the point of health services research — and analogous research in other areas, including legal services, see, e.g.,Greiner and Pattanayak’s RCT of Harvard legal aid offers — that what seems, based often on not much more than mere intuition (and perhaps a cognitive bias that favors action over inaction), to be the most effective option is not always so in fact.
The second remarkable thing that happened yesterday is that the House proposed to gut federal involvement in health services research, a diverse category of research of which the prostate cancer study is but one example. And this, despite the fact that, historically, health services research has received only about 1% of the budget of NIH, the largest funder of basic biomedical research. Health services research evaluates, and often compares, actual health services delivery systems and interventions (e.g., treatments, diagnostics, or screening and other preventative measures), as they are implemented in actual practice settings.
The House Subcommittee on Labor, Health and Human Services, Education and Related Agencies passed the spending bill for fiscal year (FY) 2013; it goes to full committee next week. Among other cuts, section 227 of the bill (see pp. 90-93) eliminates, effective October 1, 2012, the uber-wonky, but critically important, Agency for Healthcare Research and Quality (AHRQ). Located within HHS, the mission of AHRQ (which had a $405 million budget in FY 2012) is to improve health care quality, safety, efficiency, and effectiveness. AHRQ is the major funder of health services research. Among many, many other studies, for instance, it helped fund the prostate cancer study discussed above. It also studies, and tries to prevent, the medical errors that kill more than 100,000 people a year. The House bill, moreover, prohibits other agencies within the subcommittee’s jurisdiction from assuming AHRQ’s duties unless they already have statutory authority to do so.
The vote to pass the bill fell along party lines, with the exception of Rep. Jeff Flake (R-Ariz.), who sided with the Democrats in voting against the bill because he wanted even deeper cuts. And indeed, one possible explanation for the House’s decision is that cutting AHRQ is a somewhat lamentable, but ultimately wise, choice in tight economic times. After all, why spend scarce time and money studying an intervention after it has been marketed, often after having endured rigorous approval processes like those imposed by the FDA?
This thinking is short-sighted — and dangerous. Much medical practice — like surgeries — was never subjected to rigorous study before it became the standard of care. Much of medicine, in short, isn’t evidence-based. Hence the need for an active movement towards “Evidence Based Medicine.”
Thanks very much to Dan and the other loungers for having me, and to Al for that very generous introduction. Owing to other projects, I’ll be posting a bit more sporadically, but hanging out a bit longer, than some other guests.
I have varied interests, but of late, I’ve been obsessed with what is generally known as “human subjects research” (HSR) and with the institutional review boards (IRBs) that review it. I’ll talk about some of my own work in this area in later posts, but for now let me explain why readers of The Faculty Lounge care about HSR and IRBs — even if you don’t know it.
In legal scholarship and education, innovation law and policy is almost synonymous with intellectual property in general, and with patent law in particular. This, I think, is a mistake.
We can all agree that incentives to engage in knowledge-producing activities are important, even as we disagree about whether the current patent system in fact provides optimal incentives and about what values we should be trying to maximize when we establish those incentives. But one of the things that gets lost in our focus on patents, technology transfer, and so on is the next step in the innovation chain: optimal incentives to engage in knowledge-producing activities will be of little use if the regulation of knowledge-producing activities themselves is suboptimal.
Innovations with the potential to affect human welfare at some point generally have to involve human beings. That’s where HSR comes in. In the law school curriculum, HSR tends to be relegated to the final weeks of courses in health law or FDA law (themselves often marginalized in the curriculum, if they are offered at all). But this curricular choice rests on a conflation of HSR with biomedical research in general, and with pharmaceutical drug trials in particular.
This narrow focus doesn’t remotely match the regulatory reality, which is that virtually every research methodology (not only randomized, controlled trials but also data collection and analysis, online Stroop tests, surveys, interviews, and even simple observation) and academic discipline (not only biomedicine and psychology but every social science, many humanities and, yes, empirical legal studies) is subject to federal regulation, including prospective review by an IRB.
In later posts, I’ll have more on the breadth of the current regulatory framework, what that framework entails, how we got here, what’s wrong with the current system, and what might be done about it. For now, let me suggest that the regulations governing HSR should be of concern to scholars of innovation law and policy (because HSR is a critical link in the innovation chain), to virtually all other scholars (because their work is, or easily could be, considered HSR and thus subject to regulation, even if many of them don’t realize it), and — most importantly — to citizens (because you presumably want the laws and policies to which you are subject to be evidence-based, and that depends on being able to conduct well-designed, generalizable HSR without undue delay, cost, or restriction).
Thanks again to Dan, Al, and the other loungers for letting me hang around the lounge. I look forward to the conversation.
If you have an interest in the intersection of intellectual property and public health, then you may wish to attend the Sixth Annual IP Scholars Forum, sponsored by our friends at the University of Akron School of Law’s Center for Intellectual Property & Technology in October. Details here.
Not surprisingly, this has been a field day for law professors who have an opinion on the Justice Robert's opinion in the ACA case. For convenience, we've brought links to commentary together in one convenient place. They're in no particular order and readers are encouraged to add additional links within the comments.
Continuing on a series of posts on the North Carolina sterilization victims compensation movement, I want to talk some about the administrative law of sterilization -- particularly the process by which people were selected for sterilization and how the approval process worked. This is a topic on which there is less information than I'd like, because -- completely understandably -- the patient records are not generally available. Johanna Schoen provides important information on this in her book Choice & Coercion: Birth Contrl, Sterilization and Abortion in Public Health and Welfare.
What we do have, in addition to the statute, are two administrative manuals that told state officials how to proceed with sterilization petitions before the Eugenics Board, which was the body that had to give approval for publicly-funded sterilization. The 1948 Administrative Manual is here, courtesy of the fabulous North Carolina State Library. It's the first one that the state produced. It has a brief history of the North Carolina movement for sterilization -- and points out in particular that North Carolina was influenced by California's experience. The Manual cites the 1935 pamphlet, Eugenical Sterilization in North Carolina, which relies on Gosney's and Popenoe's study of 6000 sterilizations in California.
Following the North Carolina statute, the 1948 manual details who may be sterilized -- the "feebleminded, epileptic, and mentally diseased" -- and the circumstances in which this may happen: "when it is believed that such an operation would be for the best interests of the individual concerned, or for the public good, or when it is believed a child or children might be born who would have a tendency to serious mental or nervous disease or deficiency."
Then the manual gives specific instructions regarding who has the responsibility and power to file sterilization petitions -- the executive head of a penal or charitable organization or the county superintendent of public welfare and it gives instructions regarding the forms to use depending on whether the person to be sterilized is institutionalized or resident in the community. Form 1 was for institutionalized individuals; form 2 was for people resident in the community. The instructions for filing out those forms note that "the social information presented by the petitioner should contain all of the circumstances surrounding the person's life insofar as they have a bearing upon ... A. The likelihood of the person to procreate a child or children who would have a tendency to serious physical, mental, or nervous disease or deficiency, and B. The reasons why it is considered to be for the public good that the individual have the operation." I guess it's telling that the instructions do not call for specific evidence of why this is in the best interest of the individual, even though the sterilization statute says that is one reason supporting sterilization.
Oral arguments last week suggest an activist decision by the Supreme Court in the challenges to the Affordable Care Act. Indeed, in their response to the taxing power argument, the justices seemed poised to adopt a rather intrusive doctrine of policing political speech by elected officials. While some critics claimed that the mandate could not have qualified as a valid tax however it was characterized, the mandate has failed as a tax primarily because Congress called it a penalty and expressly disclaimed any intent to invoke its taxing power.
Consider, then, the following hypothetical version of the mandate's enactment. Suppose Democratic members of Congress discussed the taxing power as a source of authority and came to the incorrect conclusion that they could not use that power but instead had to use the Commerce Clause power to pass a valid mandate. They therefore called the levy for failing to carry insurance a penalty and disavowed any reliance on the taxing power, even though the levy was pegged at 2.5 percent of income (with minimum and maximum levies).
Should the Court really hold Congress to an inaccurate understanding of constitutional law? What would be the harm if the Court upheld the mandate as a valid exercise of the taxing power?
Earlier this week, the 9th Circuit denied the government’s petition for rehearing and rehearing en banc in Flynn v. Holder, the bone marrow donor compensation case that I’ve discussed before here, here, and here. The order is here. Download Flynn v Holder AMENDED
It includes an amendment to the opinion to reject the government’s argument -- contained in the petition for rehearing but not its initial brief -- that because Congress defined “bone marrow” in another statute to include cells found in peripheral blood, “bone marrow” should be given the same meaning in NOTA. That always seemed like a weak argument to me, given the very different purposes of the two provisions, so I’m happy to see it rejected.
Thus, for now at least, it seems that Flynn v. Holder is over. There is, of course, the possibility of appeal or a request for legislative action, though, given the narrow 9th Circuit holding, perhaps the government will simply let it be (a possibility discussed in this post and in the comments to it).
While initial media reports suggest the individual mandate is in big trouble, Justice Kennedy asked questions indicative of someone receptive to the arguments in favor of the individual mandate. So did Justice Roberts. While both of them also challenged the Solicitor General, there still is good reason to think that the mandate could be upheld by a 6-3 vote.
The justices want some limiting principles, but there are more than enough distinguishing features of the health care insurance market to assure them that upholding the mandate will not result in a broad, federal power to force people to buy things they don't want to buy.
For my commentary on yesterday's hearings and further discussion about the mandate, see this post on CNN. For the oral argument transcript, see here
While I agree with Calvin Massey that Linda Greenhouse could have articulated the case in favor of the individual mandate more effectively, I think she’s correct in her bottom line about the challenge to the mandate.
In particular, the constitutional challenge ultimately rests on a flawed premise—that if Congress can require people to buy a good or service solely because they are living in the United States, the commerce clause will be converted into an expansive power to compel just about any purchase. Today, we must buy health care coverage, tomorrow we might have to buy broccoli or GM cars.
But in fact, invalidation of the individual mandate would protect the public from only a few purchase mandates—mandates to purchase some kinds of insurance.
To be sure, a ruling against the mandate would mean that Congress could not force us to go out and buy broccoli or GM cars. But the government already has other ways to make us buy those goods. Congress still would have the power to require grocery stores and restaurants to include broccoli with every sale, and it still would have the power to require automobile dealers to sell only GM vehicles. If Congress really wants to make us buy something, it can find a voluntary economic transaction to regulate. That the individual mandate is not tied to a voluntary economic transaction simply reflects the fact that health care insurance must be procured in advance of the time when health care is needed.
NPR's "Morning Edition" today featured a fascinating book, Fragile Beginnings, about medical care for very premature infants. Written by a physician, the book traces the history of treatment, the remarkable progress that has been made in recent decades, and the ethical dilemmas that parents and physicians face. The book should do much to raise awareness about some of the most difficult moral questions in health care.
Yet as I listened to the author describe his experience with his own daughter, I wondered whether book-writing parents are too quick to divulge the private matters of their children. In this case, the child apparently is doing very well despite a rocky start. But should the whole world know about her medical history?
It may be that on balance the benefits of telling her story outweigh any harms, but shouldn't that be a decision for her to make when she is mature enough to decide? Divulging a child's medical information may be particularly worrisome, but similar concerns are present when parents discuss other details about a child's life. I'm not sure where lines should be drawn on this issue, but I do think it's an issue that needs more consideration.
One thing that I brought with me from practice to the academy is a fondness for charts in helping me decode complex rules. I'm especially loyal to charts that route tax compliance, like this one (details not that interesting to the general reader, but you get the idea):
But really, Tim Murphy's chart over at Mother Jones (here) is much, much better than any chart I've ever made: