The Faculty Lounge

House Saves Grandpa From the Death Panels—And Makes Him a Guinea Pig Instead

    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.”

Broadening What We Talk About When We Talk About Innovation Law and Policy

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.

IP Scholars Forum

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.

Law Professors Comment On The Supreme Court's Health Law Decision

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.

Mike Dorf here

Jonathan Adler here

Tim Jost here

Randy Barnett here

Larry Solum here, here, here, and here

Richard Epstein here

David Bernstein here

Laurence Tribe here

Adam Winkler here

Nicole Huberfeld here

Rick Hills here

Howard Wasserman here

Alan Morrison here

Tom Smith here

Rick Hasen here

The Administrative Law of Sterilization

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.

Consent?

Political Spin and the Constitution

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?

Kidney Now!

 

HT: Al Roth

Flynn V. Holder Rehearing Denied

Earlier this week, the 9^th 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 9^th Circuit holding, perhaps the government will simply let it be (a possibility discussed in this post and in the comments to it). 

My thanks to Glenn Cohen for the tip.

 

ACA Oral Argument

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

[cross-posted at Health Law Profs]

 

There Really Is No There There

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.

Parents and the Privacy of Children

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.

[cross-posted at Health Law Profs blog]

How to Tell if Someone is a "Slut" - For the Visual Learner

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:

Eureka!

Bending the Cost Curve: In which Direction?

There always have been good reasons to doubt the cost-containing impact of Obamacare. While the Affordable Care Act will do much to ensure access to health care coverage for the uninsured, it will do far less to address the high costs of health care in the United States. Just as with Medicare and Romneycare, Obamacare largely left cost containment for another day. A recent study suggests that even the limited cost savings expected from the new law may not materialize. Many experts have touted electronic medical records as a way to reduce spending, and proponents frequently cited an estimate of $80 billion in annual savings. However, researchers found that electronic medical records can encourage physicians to order more tests for their patients, resulting in greater spending. As the authors recognized, the jury is still out on the effect of electronic records. Still, the results are consistent with the view that the greatest threat to the health care law lies not in the constitutional challenges but in the law’s design defects.

 [cross-posted at Health Law Profs]

Physician-Assisted Suicide and the Slippery Slope

Last week's ruling by the Georgia Supreme Court provides further evidence that the slippery slope is not a real problem with a right to physician-assisted suicide. Since 1994, Georgia's assisted suicide ban prohibited the public promotion and provision of assisted suicide services, but did not reach the private decision of patient and physician to choose physician-assisted suicide. The court struck the law down on first amendment grounds--since it targeted those who publicly advertised or offered services but not others--but even while the law has been in force, there have not been any reports that physicians have misused their freedom to provide physician-assisted suicide privately.

According to a 1994 article in the Georgia State University Law Review, the legislature had rejected a broad ban, in part because it was worried about chilling palliative or other legitimate end-of-life care, but also because it did not want to interfere with private decisions of patient and physician for physician-assisted suicide.

The statute was passed at a time when Jack Kevorkian was actively assisting suicides in Michigan, and the legislature was concerned about him, or someone like him, promoting the practice in Georgia.

Georgia's experience with physician-assisted suicide adds to reassuring evidence about the slippery slope from other states and other end-of-life practices. Oregon has permitted assisted suicide by statute for nearly 15 years, and the state's annual reports tell us that patients rarely use physician-assisted suicide (about 1/5 of one percent of deaths in Oregon), and that it has not placed vulnerable patients at risk. Users of assisted suicide are just as likely to have health insurance or receive hospice care as other terminally ill patients, and they tend to be better educated. Washington and Montana have permitted assisted suicide by statute or court decision for only a few years, but in neither state is there evidence of a slippery slope.

Prosecutors and Pregnancy

As national elected officials clash over access to contraception, a criminal case in Indianapolis also illustrates the price that women can pay for the politicization of reproduction.

In December 2010, Bei Bei Shuai was pregnant and living with her partner, the father-to-be of the child. Instead of marrying her as he had promised, the partner disclosed that he was married to someone else and was ending his relationship with Ms. Shuai. Driven to despair and believing herself worthless and blameworthy, she attempted suicide by swallowing rat poison. Fortunately, friends found her and took her to the hospital. Doctors were able to save her life, and they delivered her 33-week old fetus by cesarean section. Unfortunately, the baby survived for only a few days before dying.

In most cities in this country, Ms. Shuai would have received the mental health care that she needs.  In Indianapolis, the prosecutor has described her as a “cold-blooded” killer and filed murder charges that carry a minimum sentence of 45 years, with the possibility of a death sentence or life in prison without parole.  

After nearly 11 months of jail time for Ms. Shuai, the Indiana Court of Appeals has paved the way for her to be released on bail. However, the court declined to dismiss the murder charge.

(I co-authored an amicus brief on behalf of medical organizations and health care professionals supporting Ms. Shuai.)

What Does Services Does Planned Parenthood Really Provide?

With the renewed attention on Planned Parenthood, as a result of the Susan Komen controversy, the Washington Post republished a chart that shows the distribution of services provided by the organization.  In this chart, which counts the totality of services - rather than bundling services by recipient - we learn that of the 11.4 million services rendered by PP, 35% are for STD diagnosis or treatment, 35% are for contraception, 16% for cancer screeening and prevention, and 3% for abortion services. 

Methodology is everything, of course, and those critical of PP argue that you shouldn't unbundle services because, for example, a person who seeks an abortion may also be receiving other services.  This appears to be true because these 11.4 million services were rendered to a total of 3 million clients.  Of that number, 329,000 received abortion services - something like 11% of all patients.

Of course, another interesting implication of this data is that individuals who come in for abortion services may also be receiving STD or cancer screening.  This suggests that while abortion services may draw individuals to PP, PP is then able to expand ther services to include procedures that that presumably everyone agrees are positive. If this is true, it suggests that a ban on abortion might reduce abortions but could also cause a spike not only in unregulated abortion services but a dip in provision of these other health-improving services offered by PP and received by patients as an unintended (but desirable) byproduct of seeking legitimate abortion services in the first instance.  (Of course, there is an argument that women who, as a result of an abortion ban,  carry to term,  might receive some of these collateral services anyway - either during prenatal care or at delivery.)  

Why So Little Concern About Downer Pigs?

With all of the attacks on the federal government’s power to mandate the purchase of health care insurance, one might have expected more criticism of the Supreme Court’s decision last week in National Meat Association v. Harris.

In that case, a unanimous Court invalidated California’s effort to exclude unhealthy, "downer" pigs, sheep and goats from the food supply, on the ground that Congress had reserved regulatory authority over slaughterhouses to the federal government. Even though California’s law was prompted by video footage documenting the ineffectiveness of federal regulation, the Court denied Americans the ability to turn to their state legislatures for protection.

Why so little concern? Perhaps the health care mandate is more salient, while the risks from food poisoning seem remote. Still, from a federalism perspective that worries about an expansive national government, the preemption of state regulation seems particularly troublesome in National Meat Association. State governments traditionally have assumed responsibility for protecting the public health. After the federal government has seized that responsibility and failed to carry it out properly, critics of federal power should be especially angry.

From my perspective, it would be better if efforts to contain Congress were directed at policies that compromise the public's health rather than at those that will enhance it.

[cross-posted at Health Law Profs blog]

 

Uterine Transplants?

Inspired by Kim Krawiec's example, I thought I'd share a topic from my course on Social Regulation of the Body:

Should surgeons transplant a uterus into a woman who was born without a uterus or has had a hysterectomy and wants to become pregnant? The debate reminds us that efforts to promote family values often neglect the interests of the infertile.

Transplanting life-extending organs, like hearts, livers, lungs and kidneys, has become well-accepted, but ethicists have raised additional questions about transplantation for life-enhancing body parts like faces and hands. It's one thing to assume health risks for the possibility of a longer life, but are the risks of being a transplant recipient justified by improvements in the quality of life?

As surgeons contemplate uterine transplants, the closer scrutiny can make sense--for example, what risks are posed to the child from the drugs that the woman must take to prevent her body's immune system from rejecting the transplanted uterus? (Proponents of uterine transplants, like Dr. Giuseppe Del Priore, observe that kidney and other organ transplant recipients who take the same drugs have become pregnant and given birth without harm to their children.) We should be careful before adopting a new kind of transplantation.

On the other hand, it's troubling to see scholars question uterine transplants on the ground that giving birth to one's own child is not that important an interest. According to an ethics professor, "tons of people have perfectly normal lives without gestating a biological child." Yet, the alternative for the woman lacking a functioning uterus is to have children with the participation of another woman. This may work for many women, but the legal battles that can follow gestational surrogacy illustrate the risks of that alternative, as well as the significant role that gestation plays in forming motherhood.

On to Bone Marrow

So, my Taboo Trades class has finished blood and is now moving on to bone marrow.  To celebrate the occasion, I’ll be posting some thoughts, links to  Flynn V. Holder, which held that the National Organ Transplant Act did not prohibit payments to certain bone marrow donors, and miscellaneous entertaining stuff my students brought in this week.  I’m starting with the cartoon below, courtesy of Duke Law 3L,Benjamin Wood:

 

Of course, giving bone marrow isn’t the task it once was, a point made clear in Flynn v. Holder.  There are two methods of donation: peripheral blood stem cells (PBSC) and bone marrow aspiration.  According to the Court:

Until about twenty years ago, bone marrow was extracted from donors’ bones by “aspiration.” Long needles, thick enough to suck out the soft, fatty marrow, were inserted into the cavities of the anesthetized donor’s hip bones. These are large bones with big central cavities full of marrow. Aspiration is a painful, unpleasant procedure for the donor. It requires hospitalization and general or local anesthesia, and involves commensurate risks.

See this video from marrow.org, the National Marrow Donor Program, on traditional bone marrow donation.

 

However, according to the Court, in a new technique, now used for at least two-thirds of bone marrow transplants, none of the soft, fatty marrow is actually donated. This new bone marrow donation technique, developed during the past twenty years, is called “peripheral blood stem cell apheresis.”  This procedure begins with five days of injections of a medication called a “granulocyte colony-stimulating factor” into the donor’s blood. The medication accelerates blood stem cell production in the mar- row, so that more stem cells go into the bloodstream. Then, with no need for sedatives or anesthesia, a needle is inserted into the donor’s vein. Blood is withdrawn from the vein and filtered through an apheresis machine to extract the blood stem cells. The remaining components of the blood are returned to the donor’s vein. The blood stem cells extracted in the apheresis method are replaced by the donor’s bone mar- row in three to six weeks. Complications for the donor are exceedingly rare. 

See this video from marrow.org, the National Marrow Donor Program, on peripheral blood stem cell apheresis.

 

I'll be back with more later on why this distinction matters to the question of paying bone marrow donors.

North Carolina Sterilization Victims Compensation

There is some forward progress in the movement to provide compensation to people who were sterilized in North Carolina.  The LA Times' story is here and CNN's is here.  Here is the home page of the North Carolina Justice for Sterilization Victims Foundation and their reports are here.