Happy Public Health Week: “We’re Good Enough, We’re Smart Enough, and Doggone It, People Like Us”

By Scott Burris

We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.

Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences.  Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.

Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity.  These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)

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Disseminating Where It Matters

By Scott Burris
Public Health Law Research funded Dr. Caleb Banta-Green to evaluate the implementation and initial effects of a Washington State “Good Samaritan 911” law meant to encourage people witnessing a drug overdose to call for help. The research results are getting out in the usual way, but it was great to see Dr. Banta-Green talking about his findings and what the might mean on the blog of the Office of National Drug Control Policy. Overdose is a huge health issue in the US, but solving it will require the buy in of law enforcement and legislators who defer to law enforcement on drug issues.  It’s great to see research producing the right conversation in the right place.

Oral Arguments in FTC v. Actavis (SC pay for delay case)

By Adriana Benedict

As Jonathan Darrow notes below, on Monday, the Supreme Court heard oral arguments in Federal Trade Commission (FTC) v. Actavis, the “pay for delay” case questioning whether or not reverse payment settlements in Hatch-Waxman litigation should be presumptively anticompetitive, a question on which the Circuit Courts are divided.  This particular case involves Solvay Chemicals Inc., whose patent on AndroGel cream, a synthetic testosterone formulation (set to expire in 2020) was challenged by three generic pharmaceutical companies that filed ANDA applications in 2003 for generic version of AndroGel (which is 1/6 the cost of the branded version).  Following a 30-month stay triggered by Solvay’s subsequent infringement lawsuit, the FDA approved the generic version of Androgel in 2006, at which point the generic companies’ motion for summary judgment on the validity of Solvay’s patent was ready for decision.  Instead of risking the judgment, the parties settled, with the generic companies agreeing to stay out of the market until 2015 in return for an estimated $186 – 252 million from Solvay over the course of six years.  The FTC, expressing concern that consumers would ultimately bear the costs of delayed generic entry, unsuccessfully challenged this settlement as presumptively unlawful restraints of trade.  The Eleventh Circuit affirmed the District Court’s decision in 2012, which rejected the FTC’s approach in favor of a “scope of the patent” test.  Several months later, though, the Third Circuit reached the opposite verdict in a similar case, accepting the FTC’s position that reverse payment settlements are presumptively unlawful agreements not to compete. The Supreme Court granted cert to resolve this conflict.

I found a couple features of yesterday’s oral arguments particularly striking.  First was Justice Breyer’s statement that he thought one of the four briefed scenarios in which a reverse payment settlement may rebut an anticompetitive presumption was “neutral”:

JUSTIC BREYER: [B]the person’s already in the market thinks that the next year or two or three years is worth $100 million a year, and the person who’s suing thinks it’s worth 30 million a year. And so he says, hey, I have a great idea, I’ll give him the 30 million and keep the 70. And — and that, I don’t see why that’s anticompetitive if that’s what’s going on.

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Birth Control for Men?

By Dov Fox

We’re not talking vasectomies or condoms.

Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that promises fewer side effects, according to scientists. Clinical testing into its safety and efficacy, assuming the FDA grants permission, would take at least five to ten years before the agency could consider approving the drug for use.

The availability of male birth control would make it possible for men and women to share responsibility for contraception. Today, women alone shoulder the considerable physical and other burdens that come with the Pill. And only women enjoy the security that control of its use affords over the likelihood of unwanted pregnancy. Tomorrow, we could even things out a bit. That’d surely be a development worth embracing. Or would it? Sharing responsibility for contraception means leaving it to men to take the necessary measures to prevent the reproductive consequences that in our society fall far more heavily on women.

We might suppose that some such men, who have less at stake than their female partners, would be less vigilant about birth control and forget to take the pill. There is also evidence to suggest that other men might use greater control over conception for abusive purposes. A 2010 study found that 15% percent of respondents women ages 16-29 who sought care in several Northern California family planning clinics reported that their male partners had damaged condoms or otherwise sabotaged their birth control.*

Would birth control for men be cause for celebration, or concern? Would it revolutionize sexual equality, or change little at all?

*This “pregnancy coercion,” as the researchers call it, differs in respect of the gestation, abortion rights, and sex-differentiated social expectations involved from the reverse-gender cases that Glenn Cohen has analyzed in which courts “have imposed legal parenthood [] on fathers deceived into believing that their partners could not conceive” or under circumstances in which “conception took place without meaningful consent.”

Reminder, Upcoming Conference on Universal Health Coverage in Low-Income Countries

A reminder that the Harvard University Program in Ethics and Health annual conference, Universal Health Coverage in Low-Income Countries: Ethical Issues, will be held in Boston on April 18-19, 2013.

AGENDA

https://peh.harvard.edu/events/2013/universal_coverage/agenda.html

REGISTRATION

No fee. Space limited. Registration required. Please register on our registration website.

The U.S. Should Cover the Cost of IVF (for Gays and Lesbians Too)

By Dov Fox

Glenn Cohen and I make the case in this morning’s Huffington Post:

This week the United Kingdom joined the ranks of countries like Canada, Israel, and Sweden that provide in vitro fertilization (IVF) treatment to citizens under a certain age (42 in the U.K.) who can’t have children without it. That includes gays and lesbians. When it comes to helping people form the families they long for, the United States is woefully behind. The U.S. has among the lowest rates of IVF usage of any developed country in the world, owing in part to boasting the highest cost for the procedure, on average $100,000 for each successful pregnancy.

Among the handful of states that require insurers to cover IVF, many carve out exclusions for same-sex couples and people who aren’t married. These singles, gays, and lesbians are sometimes called “dysfertile” as opposed to “infertile” to emphasize their social (rather than just biological) obstacles to reproduction. The U.S. should expand IVF coverage for the infertile, and include the dysfertile too.

The U.S. Supreme Court has held that the inability to reproduce qualifies as a health-impairing disability under the Americans with Disabilities Act. The commitment to universal health care that we renewed in President Obama’s health reform act invites us to understand the infertile and dysfertile alike as needing medicine to restore a capacity—for “[r]eproduction and the sexual dynamics surrounding it”—that is, in the words of the Supreme Court, “central to the life process itself.”

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Is Obama Winning or Losing on Medicaid Expansion Under the Affordable Care Act?

By: Katie Booth

The Obama administration announced in February that it would allow Arkansas to use the federal money intended for Medicaid expansion to buy private health insurance plans for individuals with incomes up to 133% of the federal poverty level. This week, Florida’s senate rejected the Medicaid expansion but left open the possibility that it would try to negotiate a similar deal with the Obama administration. Indiana and Ohio may follow suit.

At first glance, this seems like a political loss for Obama. Several states with Republican governors may now expand healthcare for the poor using a private payer model—the type of model Mitt Romney supported during the 2012 presidential race. Yet Obama’s compromise in Arkansas may ultimately be a win for the president. All of the 14 states that are not participating (as of now) in the Medicaid expansion have republican governors. The private insurer model would allow these governors to save face while ultimately expanding access to healthcare for the poor.

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Court Enjoins N.Y. Ban on Large Sugary Drinks

By Wendy Parmet

New York State Supreme Court’s Justice Milton A. Tingling’s decision last night in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Dpeartment of Health and Mental Hygiene, to enjoin New York City’s controversial ban on the sale of large sugary beverages should not have been surprising. As Scott Burris has noted here, “the public health side has been getting killed wherever law is made.” Defeats for new public health regulations, especially new regulations that impinge against powerful economic interests, are becoming the norm.

Still, there were some surprising and troubling, from a public health perspective, notes in Justice Tingling’s opinion, which relied heavily on Boreali v. Axelrod, a 1987 opinion by the New York Court of Appeals striking down a ban on indoor smoking, to find that the Department lacked authority to issue the regulation.

According to Justice Tingling, Boreali required the court to consider four factors including whether the regulation was based on matters beyond its stated purpose, and whether the regulation was “created on a clean slate thereby creating its own comprehensive set of rules without the benefit of legislative guidance.”   In looking to whether the ban on sugary sodas was based on factors other than its stated purpose, Justice Tingle noted among other things that the Department had cited the “enormous toll” that obesity places on the “economic health” of New Yorkers. To Justice Tingle any regard for the economic consequences of obesity demonstrated that the Department based its regulation “on economic and political concerns” outside the scope of its authority. Thus the very fact that the Department considered the economic consequences of the issue it addressed, a consideration that many scholars would claim is a critical component of sound regulatory policy, helped to doom the ban on large sodas. Would the Court, one wonders, have been more approving of the regulation if the Department had failed to show that obesity had significant economic consequences?  Somehow I suspect not.

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Family, Privacy, Secrets & The Law

Join us for an important meeting:

Roundtable: Family, Privacy, Secrets & the Law  March 7-8, 2013

March 7-8, 2013
University of Maryland
Francis King Carey School of Law
500 West Baltimore Street
Baltimore, MD 21201

March 7, 5 p.m. – Book Reading and signing by Jonathan Odell, author of The Healing

March 8, 9 a.m. – 4 p.m. – Roundtable discussions

Eventbrite - Family, Privacy, Secrets & The Law Roundtable

Family, Privacy, Secrets & the Law roundtable engages the intersections of medicine, criminal law, family law, and constitutional law. The conference faculty will chart contemporary issues that span genetic privacy, disclosure of parental identity in assisted reproduction cases and DNA conscription to domestic violence and child sexual abuse.

There are times in which the law protects secrets, such as between a lawyer and client, doctor and patient, or clergy and congregant.  Yet, there are times when the law demands that secret-keepers reveal their confidences such as the increasing demand on doctors to disclose confidential medical information on pregnant women to law enforcement. How should we understand the contours and boundaries of these dynamics within the law?  On one hand, law tends to address secrets through the lens of legal duties to protect the vulnerable via its regulations governing abuse and neglect. On the other hand, this set of laws captures only a small percentage of secrets held by family members and other trusted “secret keepers” (doctors, clergy, extended family, neighbors) who, for a variety of reasons elect not to inform the state.

This roundtable interrogates states’ obligations to protect the vulnerable and at what cost. It considers the ways in which the law promises/owes protection and the success, failure or harms it brings about when endeavoring to intervene and offer protection. Against that backdrop, the law also has the obligation to honor individual and family autonomy and privacy.

Schedule

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The ADA and Declining Down Syndrome Birthrates

[Posted on behalf of Dov Fox]

Having a child is hard work. It can be especially taxing—“physically, emotionally, and of course, financi[]ally, to bring a child with [disabilities] . . . into the world and raise it,” as commentators have noted in response to an earlier version of this piece that Chris Griffin and I wrote yesterday on Huffington Post. So it is not difficult for many of us to sympathize with the genetic parents who, CNN reported later in the day, offered their surrogate $10,000 to have an abortion when they learned “the baby would need several heart surgeries” and “ha[ve] only about a 25% chance of having a ‘normal life.’”

At the same time, doctors and authors justly celebrate the increasing willingness of those who decide that, for them, it makes sense to bring a pregnancy to term after getting a positive test for a condition like Down syndrome. These advocates explain the perceived shift in social norms by noting that the landmark Americans with Disabilities Act (ADA) provides legal protections to combat employment discrimination and enhance access to public accommodations. What they fail to appreciate is that these protections have not always brought with them the anticipated acceptance of having a child with disabilities.

A study we published in 2009 reveals a 25 percent decline in Down syndrome birthrates nationwide after the first President Bush signed the ADA into law. Controlling for variables from maternal age and marital status to prenatal testing and access to abortion, we found that about 15 fewer children per 100,000 were born with Down syndrome after the law was passed. So here’s the puzzle: Why would fewer children be brought into the world just as they are being afforded greater opportunities in life?

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