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Category: Health Law

Weighty Matters

Here is an interesting article on BMI from the UK:

The body mass index has been around since Belgian scientist Adolphe Quetelet invented it in the 1830s and was designed to approximate whether people have a healthy weight.  Nick Trefethen of Oxford University’s Mathematical Institute has identified a flaw in the basic formula for BMI, and has created a new calculation which he says better accounts for the relationship between height and weight.

According to Mr Trefethen, the current formula to calculate the score (weight/height2) is incorrect because “it divides the weight by too large a number for short people, and too small a number for tall people. So short people are misled into thinking they are thinner than they are, and tall people are misled into thinking they are fatter than they are.”

Of course, even the new BMI isn’t that great an indicator.  Dr. Robert Lustig argues for a more granular approach, focused on visceral fat. Expect more controversy over biomarkers and wellness programs, as well as the inevitable privacy concerns about close monitoring of weight, waistlines, and more.

Goldacre on Pharma Research Credibility

Ben Goldacre is once again arguing that pharmaceutical “industry-funded trials are too common, can’t be trusted — and bring pills to market that likely don’t work.” The NY Times features his argument today. He has exhaustively compiled problematic practices that add up to a shocking claim: “the entire evidence base for medicine has been undermined by a casual lack of transparency.” For example, here’s one vignette from his most recent book:

In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation — searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators — they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.

When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.

I have not come across a convincing industry, FDA, or Richard Epstein response to Goldacre’s work. (I don’t find this brief letter particularly compelling.). He offers several case studies like the reboxetine one. Isn’t it time to fund systematic reviews of the evidence of effectiveness on all drugs?

A recent lawsuit against the FDA will test its usual trade secret rationale for failing to require drug companies to release all data from trials. If it succeeds, systematic reviews may be easier to complete, and will help save patients from the scourge of unnecessary or ineffective drugs. In the current information environment, perhaps the best hope we have is big data leading to more personalized comparisons of treatment effectiveness.

Implementing Health Reform

The Commonwealth Fund has recently reported on how states are lagging in implementing consumer protection aspects of the ACA.  In case you are looking for a comprehensive overview of the options open to a state as it implements the MLR provisisons of the ACA, check out my colleague Tara Adams Ragone’s policy brief The Affordable Care Act and Medical Loss Ratios: Federal and State Methodologies.  Though the piece focuses on New Jersey, its structure suggests the issues that will come up for many other states:

As part of sweeping health care reform in 2010, Congress established MLR requirements for health insurance issuers offering coverage in the group and individual health insurance markets, including grandfathered but not self-insured plans, hoping to increase the value consumers receive for their premiums and to improve transparency. Medical loss ratio refers to a measure of the percentage of premium dollars that a health insurance company spends on health care as distinguished from administrative expenses and profit, including advertising, marketing, overhead, salaries, and bonuses. Prior to the ACA, some states but not the Federal government regulated loss ratios. The new Federal MLR law, which went into effect on January 1, 2011, for the first time established a national MLR standard, which varies from existing state MLR requirements in important ways.

This Policy Brief analyzes the new Federal MLR requirements and how they intersect with and affect New Jersey law and its insurance markets. After providing background on medical loss ratios and highlighting the major similarities and differences between the existing Federal and New Jersey MLR regulatory schemes, this Brief examines several requirements and policy options that New Jersey must consider as it implements the Federal requirements. This Brief also includes appendices that provide more extensive details regarding the components of the Federal MLR requirements, New Jersey’s MLR legal structure, and research regarding experiences with loss ratios nationally and in New Jersey, pre- and post-the ACA.

My former student Ina Ilin-Schneider has also posted on the MLR, after authoring a very interesting paper on the state waivers granted (and denied) by HHS.

Finally, a quick note to recommend Ann Marie Marciarille’s several recent posts at PrawfsBlawg on ACA implementation and health policy generally.  It’s hard to write about these topics gracefully and for a general audience, while conveying the expertise of a scholar.  I think of her posts as real models on both counts.

X-Posted: Health Law Profs.


Volume 60, Issue 2 (December 2012)

Volume 60, Issue 2 (December 2012)


The Battle Over Taxing Offshore Accounts Itai Grinberg 304
The Structural Exceptionalism of Bankruptcy Administration Rafael I. Pardo & Kathryn A. Watts 384
Patients’ Racial Preferences and the Medical Culture of Accommodation Kimani Paul-Emile 462


“Not Susceptible to the Logic of Turner”: Johnson v. California and the Future of Gender Equal Protection Claims From Prisons Grace DiLaura 506

Prohibitions on Egg and Sperm Donor Anonymity and the Impact on Surrogacy

Egg and sperm donations are an integral part of the infertility industry. The donors are usually young men and women who donate relying on the promise of anonymity. This is the norm in the United States. But, internationally things are changing. A growing number of countries have prohibited egg and sperm donor anonymity. This usually means that when the child who was conceived by egg or sperm donation reaches the age of eighteen he can receive the identifying information of the donor and meet his genetic parent.

An expanding movement of commentators is advocating a shift in the United States to an open identity model, which will prohibit anonymity. In fact, last year, Washington state adopted the first modified open identity statute in the United States. Faced by calls for the removal of anonymity, an obvious cause for concern is how would prohibitions on anonymity affect people’s willingness to donate egg and sperm. Supporters of prohibitions on anonymity argue that they only cause short-term shortages in egg and sperm supplies. However, in a study I published in 2010, I showed that unfortunately that does not seem to be the case. My study examined three jurisdictions, which prohibited donor gamete anonymity: Sweden, Victoria (an Australian state) and the United Kingdom. It showed that all these jurisdictions share dire shortages in donor gametes accompanied by long wait-lists. The study concluded that although prohibitions on anonymity were not the sole cause of the shortages, these prohibitions definitely played a role in their creation.

In a new article, titled “Unintended Consequences: Prohibitions on Gamete Donor Anonymity and the Fragile Practice of Surrogacy,” I examine the potential effect of the adoption of prohibitions on anonymity in the United States on the practice of surrogacy. Surrogacy has not been part of the international debate on donor gamete anonymity. But the situation in the United States is different. Unlike most foreign jurisdictions that adopted prohibitions on anonymity, the practice of surrogacy in the United States is particularly reliant on donor eggs because of the unique legal regime governing surrogacy here.  Generally, there are two types of surrogacy arrangements: traditional surrogacy and gestational surrogacy. In a traditional surrogacy arrangement the surrogate’s eggs are used and she is the genetic mother of the child, while in gestational surrogacy the intended mother’s eggs or a donor’s eggs are used and the surrogate is not the genetic mother of the conceived child. Most U.S. states that expressly allow surrogacy provide legal certainty only to gestational surrogacy, which relies heavily on donor eggs, while leaving traditional surrogacy in a legal limbo. Without legal certainty, the intended parents may not be the legal parents of the conceived child, and instead the surrogate and even her husband may become the legal parents. Infertility practitioners endorse the legal preference for gestational surrogacy also for psychological reasons, believing that a surrogate who is not genetically related to the baby is less likely to change her mind and refuse to hand over the baby.

The adoption of prohibitions on anonymity in the United States could destabilize the practice of surrogacy in a way that did not occur in other countries that adopted these prohibitions. If, as has happened elsewhere, prohibitions on anonymity will play a role in creating shortages in donor egg supplies in the United States, this could affect the practice of surrogacy in two ways. Individuals seeking surrogacy may need to resort to traditional surrogacy, which does not rely on donor eggs, with the accompanying legal uncertainty. Alternatively, those deterred by the uncertainty enveloping traditional surrogacy may refrain from seeking surrogacy altogether, resulting in a significant contraction of  the practice of surrogacy in the United States. These potential complications suggest that those supporting the adoption of prohibitions on anonymity in the United States, should consider these changes with great caution and think beyond the traditional debate about the privacy of the donors, the privacy and procreational interests of the intended parents, the best interests of the children and the direct effect on gamete supplies.



Why Did Egg Freezing Wait So Long?

Thank you to the permanent bloggers of Concurring Opinions for having me back. It is great to be here.

Egg freezing has become the new hot trend in the infertility industry. Although infertility practitioners first used  egg freezing in the mid 1980s,  it was only recently that success rates have significantly risen making this an attractive option for women.  A woman can now freeze her eggs at any age and use it a few years later or much later with the sperm of her then chosen partner or a donor to have a baby through IVF. Using egg freezing technology, a woman can today have a baby at a time that best suits her career and family situation.

There is no doubt that egg freezing as a viable option is a huge revolution for women’s autonomy. But the big question is why only now? Why has egg freezing become a really viable option only during the first decade of the Twenty-First Century. We have known how to freeze sperm since the 1950s. And, embryo freezing was first tried out around the same time as egg freezing, during the mid-1980s. Yet, unlike egg freezing, embryo freezing became common practice soon thereafter. So why did we have to wait so long for effective egg freezing technology?

The answer usually given to this question is that it was just too complicated technologically and took a long time to develop. But were technological complications the only cause for delay?  Is it really much harder to freeze and thaw eggs for later IVF use than to freeze and thaw embryos for later use? We tend to be taken by the illusion that science is value neutral — that scientific progress is not affected by choices directed by social values. But even if technological diffiuclties played a role in the delay, could egg freezing technology have been held back because resources were invested elsewhere? Unlike other forms of reproductive technology that promote the reproductive interests of both men and women, egg freezing promotes mainly the autonomy interests of women.  Egg freezing’s impact on women autonomy can be compared only to the revolutionary effect of the birth control pill. At the same time, the infertility industry is comprised overwhelmingly by male practitioners. And while some have no doubt worked relentlessly to promote egg freezing technology, it may be time to stop assuming that technological complications held back this important women emancipating technology. It may be time to begin asking whether  the advancement of egg freezing was placed on the back burner for years because of the type of interests it promotes?


The Contraception Mandate Part II

In my last post, I argued that the requirement that religiously affiliated organizations include contraception in their health insurance plans does not violate the Free Exercise Clause. That’s not such a hard argument to make given the Employment Division v. Smith rule that neutral laws of general applicability are constitutional, no matter what kind of burden they may create for religious practices.

The Religious Freedom Restoration Act (RFRA), on the other hand, is easier to violate. RFRA was passed in reaction to Employment Division v. Smith. Congress wanted to restore the more demanding (at least on paper) pre-Smith test for religious liberty claims. The Supreme Court struck down RFRA  as applied to the states but not as applied to the federal government. Under RFRA, a federal law cannot impose a substantial burden on a person’s exercise of religion unless it passes strict scrutiny.

Saving the question of whether the contraception mandate imposes a substantial burden for another post, would it pass strict scrutiny? Does the contraception mandate advance a compelling state interest in a narrowly tailored way? It is not hard to come up with compelling reasons why women who do not want to become pregnant should have access to contraception. Women’s ability to control their reproduction is essential to their wellbeing, their bodily integrity, and their ability to participate as equals in the social, economic, and political life of the nation. In fact, the failure to cover contraception may well amount to sex discrimination if a health insurance plan covers all basic preventive care except for pregnancy-related preventive care like contraception. (While pregnancy discrimination is not considered sex discrimination for equal protection purposes thanks to Geduldig v. Aiello, it is sex discrimination for Title VII purposes thanks to the Pregnancy Discrimination Act.) Promoting women’s health, liberty, equality, and equal access to health care are all compelling state interests.

Nevertheless, at least one court has concluded that the contraception mandate was not motivated by a compelling interest because it contains too many exceptions, such as the ones for grandfathered plans and small employers. So, while the court acknowledged that “the promotion of public health” is generally a compelling state interest, it held that “any such argument is undermined by the existence of numerous exceptions to the preventive care coverage mandate. . . . A law cannot be regarded as protecting an interest of the highest order when it leaves appreciable damage to that supposedly vital interest unprohibited.” I disagree. The number of exceptions might matter if there were some question about whether the state’s interest really was compelling or not. If we are not sure about the importance of uniform appearance among police officers, numerous exceptions to grooming requirements might lead to the conclusion that it is not as important as the state claims. However, such exceptions should not matter when the state’s goals have long been recognized as compelling — and surely we are past the point of debating whether promoting women’s liberty and equality and preventing sex discrimination are compelling state interests.

Perhaps, then, it could be argued that the law is not narrowly tailored. How strict the tailoring must be under RFRA in not clear. If RFRA is meant to reinstate the pre-Smith test as practiced, then it is not very demanding, since the Supreme Court rarely found that laws failed strict scrutiny in Free Exercise Clause challenges. In any case, one argument that should be rejected is that the law is not sufficiently tailored because the government could provide contraception instead. But that can’t be right. Imagine a bookstore that refused admittance to Hispanics. Or imagine an employer whose insurance covered cancer screenings for white employees but not Asian ones. Now imagine the bookstore or employer arguing that a law banning race discrimination in places of public accommodation or in the provision of employment benefits fails strict scrutiny because the state could sell the books or provide the benefits instead. Such a claim is a distortion of strict scrutiny and should fail.


The Contraception Mandate Part I

The Affordable Care Act is changing the health care landscape. Among the changes is that employers that provide health insurance must cover preventive services, including contraception. Although the requirement does not apply to religious organizations, it does apply to religiously affiliated ones. This “contraception mandate” has generated a huge outcry from some religious leaders, most notably the United States Conference of Catholic Bishops. They insist that forcing Catholic hospitals, schools, or charities to include contraception in their employee insurance plans violates religious liberty.

It doesn’t. It certainly doesn’t violate the Free Exercise Clause. After Employment Division v. Smith, neutral laws of general applicability are constitutional, regardless of the burden they may impose on religious practices. Indeed, the law upheld in Smith banned a religious sacrament. But it was neutral, in that it did not intentionally target religion, and it was generally applicable, in that it was neither riddled with exceptions nor grossly underinclusive. The regulation requiring employers who provide health insurance to include contraception in that coverage is likewise a neutral law of general applicability.

While a recent Supreme Court decision (Hosanna-Tabor Evangelical Lutheran Church and School v. EEOC) carved out an exception to this “neutral-generally-applicable-laws-do-not-violate-the-Free-Exercise-Clause” rule, it does not apply here. This exception — which holds that religious institutions are immune from neutral, generally applicable anti-discrimination laws when they are sued by their ministers — was designed to protect churches’ ability to pick their leaders without interference from the state. However, the provision by religiously-affiliated organizations of health insurance to their employees, many of whom do not belong to the same faith as their religious employer, clearly does not involve ministers or internal church governance. In short, there is no valid Free Exercise Claim.

What about the Religious Freedom Restoration Act? Stay tuned.

Better, Simpler Disclosure

Here is an apt response to the question: “What would an ideal food label look like?:”

Even the simplest information — a red, yellow or green “traffic light,” for example — would encourage consumers to make healthier choices. That might help counter obesity, a problem all but the most cynical agree is closely related to the consumption of junk food.

Of course, labeling changes like this would bring cries of hysteria from the food producers who argue that all foods are fine, although some should be eaten in moderation. To them, a red traffic-light symbol on chips and soda might as well be a skull and crossbones. But traffic lights could work: indeed, in one study, sales of red-lighted soda fell by 16.5 percent in three months.

Having recently spent time at a roundtable with transparency advocates (including one author of this excellent book), I can attest to the fact that only the clearest signals tend to get through the noise in an era of information overload.


Intellectual Property Theory: An Homage and Reply

I am moved and honored by this deep engagement with my book by this amazing array of scholars. Let me reply to each that has chimed in so far, and seek to situate my work within the broader IP discourse at the same time.

What a difference a few years make! Professor Said, who is younger than I am, arrived on the IP scene more recently, and happily she found a more plural discourse than I saw several years back. In the first few years of the new century, scholars on both the Right and Left seemed unified in their commitment both to the incentives rationale and the ultimate goal–innovation. Scholars on the Left saw the incentives rationale as limiting IP rights, because they argued that intellectual property need not offer rights beyond those necessary to incentivize creation. They also argued that too many property rights might result in an anticommons and erode the public domain. Some public domain scholars—to whom my book is both homage and reply—worried that opening IP to alternative discourses such as human rights might bolster property owners’ arguments rather than limit them.

The public domain scholars opened a space for critique in a field that was “coming of age.” In my new book, From Goods to a Good Life: Intellectual Property and Global Justice (Yale University Press 2012), I seek to both consolidate and expand that critique. I argue that we need to rethink the ultimate goal of intellectual property itself. We should seek not simply to promote more goods, but rather the capability of people to live a good life. To that end, we need to ask new questions beyond just how much intellectual production law spurs, and turn to disciplines beyond law and economics for guidance. Which goods are being produced and which are neglected under market incentives? Even when goods are produced, like AIDS medicines, how can we ensure just access to these knowledge goods? Surely access to essential medicines for people who cannot afford them is important if we believe in the dignity of all human beings. But what about access to culture, such as films, music, and literature? I argue that participation in these cultural activities is just as important – singing and dancing together and sharing stories are activities central to our humanity. They promote learning, sociability, and mutual understanding.

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