Category Archives: Empirical

Politics and Science

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By Joanna Sax

On April 29, Scott Burris blogged about a new bill that would allow Congress to set the scientific agenda, which would replace the traditional peer review process.  I echo his expressed concerns, but want to add more.  The idea that politicians, and not scientists, could determine the advancement of science is, frankly, a disaster.  In the past we have seen political leaders spar with scientists over many things – such as whether the earth is round, whether the earth is the center of the universe, etc.  If scientists did not or could not answer those questions, we might think we are walking on a flat earth.

Even now, there is a strong interaction between politics and science.  Evolution, a scientific theory with unequivocal consensus among the scientific community, still faces political opposition.  Recently, I’ve been thinking and writing in this area, that is, the interaction of politics and science.  Questions for scientific inquiry should be determined by scientists.  How we allocate and manage our resources requires, as others have argued, experts in many areas, including economics, management, and public policy.

To look at the interaction of science and politics, I conducted an empirical analysis comparing the type of information communicated to the public versus the consensus in the scientific community to determine whether politics is playing a role in scientific inquiry.  The study centers on the debate regarding the funding of embryonic stem cell research.  If you are interested in this area, please check out a recent draft here.  It’s an early draft and I welcome comments – you can email comments to me at jsax@cwsl.edu

Online Symposium on the Law, Ethics & Science of Re-identification Demonstrations

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Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical aspects of the demonstrations themselves. As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place here at the Bill of Health the week of May 20th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

Misha Angrist
Madeleine Ball
Daniel Barth-Jones
Yaniv Erlich
Beau Gunderson
Stephen Wilson
Michelle Meyer
Arvind Narayanan
Paul Ohm
Latanya Sweeney
Jennifer Wagner

I hope readers will join us on May 20.

Too Young for Sex, But Old Enough for the Sex Offender Registry, Part I

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This post is the first in a three part series on the use of criminal law to police teen sex.

A recent study by Human Rights Watch suggests that statutory rape law is a poor tool for reducing teen sexuality.  Their study and my forthcoming article, Law’s Limits: Regulating Statutory Rape Law, published by the Wisconsin Law Review concur on this point.  Consider an unfortunate case that underscores the importance of revisiting statutory rape law prosecutions in the United States.  In 2011, J.L. was adjudicated a delinquent, charged with first‑degree rape, and convicted under the South Dakota statutory rape statute. According to the South Dakota Supreme Court, J.L., a fourteen-year-old, “engaged in consensual sexual intercourse with his girlfriend, who was twelve” and only fifteen months his junior.  Despite both adolescents consenting to sex in this case, in the state of South Dakota, J.L.’s conviction will result in legal and extralegal penalties far more severe than that of an adult rapist who commits a sexually violent act against a college peer, a random woman, or during the commission of another crime.  This is because J.L.’s “victim” was under the age of thirteen.

In a provocative commentary, buried in a footnote, the South Dakota Supreme Court references the harsh penalties J.L. and other minors who engage in consensual sex with minors will encounter. The court explains, “[i]t appears that J.L. will be required to register as a sex offender for life.” In other words, J.L.’s “mark” as a sexual predator burdens him with the same potent and socially stigmatic punishment as that of a convicted, middle-aged pedophile who rapes a minor.  This prosecution and others similar point to the absurd results in many statutory rape cases involving teens who have consensual sex with teens.

As I note in the forthcoming article, had J.L.’s girlfriend been an adult and a nonconsensual sexual act occurred, he could qualify for release from the sex offender registry list after only ten years, rather than the life-term that now serves as his punishment.  In South Dakota, consensual sex between minors may result in a more severe punishment than nonconsensual sexual encounters either between adults or between a teenage male and an adult woman.   But, are such outcomes just?  Do they reflect broad social consensus?  Or do such prosecutions lead to absurd, untenable results?

In the coming week, my blog posts will address these and other relevant questions.

Hair, Stress, and the Law

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A new study has found a relationship between cortisol levels in our hair and prevalence of metabolic syndrome (a cluster of abnormalities that increase the likelihood of developing diabetes and heart disease). Here’s how the New York Times describes the study:

High levels of cortisol — the so-called stress hormone — have been associated with cardiovascular disease in some studies, but not in others. This may be because measuring cortisol in blood or saliva at one point in time may pick up acute stress, but it fails to account for long-term stress. . . . Now Dutch researchers have assessed cortisol levels over several months by analyzing scalp hair samples. . . . The researchers measured the cortisol content in hair samples corresponding to roughly three months of growth from 283 older men and women, average age 75. They also gathered self-reported data about coronary heart disease, stroke, peripheral artery disease, Type 2 diabetes, lung disease, cancer and osteoporosis. . . . Compared with those in the lowest quarter for cortisol, those in the highest quarter had about three times the risk for cardiovascular disease and diabetes.

In the actual paper, the researchers say little or nothing about “stress,” and if I recall correctly, the relationship between cortisol and stress can be complicated. But the research raises the possibility that we will someday identify reliable measurements of chronic stress over time. Of course, we may need more than just your hair. But in what I call the experiential future, such evidence—combined perhaps with other physiological, neurological, and psychiatric data—may enable us to make better assessments of chronic stress levels than we can now.

Better measurements of chronic stress could transform the way we measure damages in tort cases and measure punishment severity in criminal cases. Billions of dollars change hands every year based on difficult-to-verify assertions about pain and stress. Similarly, we adjust the severity of incarceration by changing the duration of sentences and pay almost no attention to the very different ways in which prisoners experience confinement. Measurements of stress levels could also help determine when an interrogation tactic constitutes torture.

Of course, forensic techniques encourage people to use countermeasures. In the cortisol-hair study, for example, one measurement was apparently affected by rates of shampooing while another was not. So I’m not suggesting there will be a silver bullet that solves all measurement problems. When evaluating the scientific research, however, it is important to remember just how bad we are at measuring stress levels now, despite the fact that we make such assessments every day. The technology need hardly be perfect to represent an improvement.

A New Collection of PHLR

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By Scott Burris

The latest issue of the Journal of Health Politics, Policy and Law showcases the range of projects and researchers filling out the field of Public Health Law Research.  An excellent introduction by the editors, Michelle Mello and Wendy Parmet, says it better than I could, but here’s a taste:

Two studies look at public health policy-making – Abiola et al on HPV vaccination, and VanSickle-Ward and Amanda Hollis-Brusky on statutory ambiguity in contraceptive mandates.   Two studies evaluate local legal interventions to address lead poisoning – a sweeping ordinance in Rochester and a novel specialty enforcement court in Philadelphia.  Sampat and Amin quantitatively examine the impact of a provision of Indian patent law that was widely expected to prevent evergreening, finding signs that the law on the books may not be working as advertised in practice.  Finally, Cannon and colleagues bring new methods and attention to the question of whether zoning laws can deliver better health, in this instance through increasing the walkability of neighborhoods.

The group of authors includes doctors, lawyers, economists, sociologists, historians and health researchers. Mello and Parmet offer some pithy thoughts on what all this shows us about the current state of PHLR’s development.  Worth a read.

Live Blogging from FDA in the 21st Century Conference, Panel 8: Food, Supplement, and Tobacco Regulation

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[Live blogging off-the-cuff, so apologies in advance for any errors in summarizing, typos, etc]

Moderated by Emily Broad Leib, Harvard Law School

Robin Craig, Leslie Francis, and Erika George, University of Utah The FDA’s Authority Over Labeling: Current Ironies and Future Improvements:

Goal is to look at FDA authority over safety and labeling of Genetically Modified (GM) foods argue that FDA should do more, and argue for human right to food approach.

By GM we mean rDNA modification not husbandry and not careful selection.

FDA has moved to use guidance and policy. In particular two are relevant here. First, in food additives there is GRAS – Generally Recognized as Safe. E.g., Cinnamon was treated as GRAS. Manufacturers can self-determine a product is GRAS without notifying FDA, or, if in doubt, request a GRAS notice letter from FDA. This was proposed in 1997 and final review never issued, but this is how they do it. Has increased frequency of GRAS review request from FDA. But the process is voluntary and relies entirely on info from producer not scientific separate work by FDA.

In 1992, FDA issued a policy document related to GM foods. Stated no scientific evidence that GM foods have more safety concerns than existing husbandry techniques, so GM technology is NOT material information. This was NOT a conclusion that GM foods were GRAS.

In 1996, FDA issued a guidance for GM foods. Consultation process to determine whether there are material differences between GM version and non, voluntary process, encouraged to get consumer trust. Like GRAS totally voluntary, totally reliant on FDA data. 95 reported consultations between 1996 and 2012.

Alliance for Biointegrity v. Shalala, challenged in 2000 in D.D.C., court deferred to agency on safety questions and whether the info on GM was “material” and therefore needs to be disclosed.

Where would FDA get authority to regulate GM foods? May pose allergy risks? May be relevant to nutrition or quality. Maybe an additive not GRAS. But each of these arguments apply to specific GM food not GM foods as a whole.

Their argument: Consumers have a right to know so they can make their own consumption risks, and consumer or religious views are not merely preferences but a ground for the information that is material to consumers.

On why this is best understood as Human Right to Food. Adequate right to food is an HR right framed after WWII about enough food that is not adulterated and not against your faith or ethics (kosher, halal, vegan) and respectful of environment. U.S. is not part to Socioeconomic rights convention, which is most explicit protection of this right, but are signatories to other treaties that protect the right more indirectly.

Whole Foods has moved ahead on this as have others. Even if not a worry as GRAS, consumption may be inappropriate. We need a national strategy. More of a precautionary take that understands material to matter to consumers.

Jennifer Pomeranz, Yale, A Comprehensive Strategy to Overhaul FDA Authority for Misleading Food Labels:

Obesity and diabetes is the big problem in public health. And also people showing nutritional deficiencies because too much processed food. Current labeling is misleading makes people think food is healthier than they are. This is a unique public health problem. FDA has very weak authority and power here.

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Live Blogging from FDA in the 21st Century Conference, Panel 2: Preserving Public Trust and Demanding Accountability

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[This is off-the-cuff live blogging, so apologies for any errors, typos, etc]

First up is Mark Lange from Eli Lilly (who notes that he is here in his personal capacity only!), speaking about “Data Transparency and the Role of the FDA.”

He prefaces his talk by noting that when he refers to “data,” he means raw, patient-level data from clinical trials. Most calls for the transparency of such data, he says, reflect a common theme about lack of trust in the pharmaceutical industry. So we might wonder: why doesn’t the pharmaceutical industry simply accede to that request and make their data available?

Mark notes that industry has several concerns. One important one pertains to data exclusivity. In several (if not all) markets, data exclusivity rights are premised on keeping the relevant data confidential, and posting it publicly would be deemed a waiver of those rights. In addition, data exclusivity prevents generic competitors from free riding, and publishing data could allow them to circumvent the very point of data exclusivity.

Moving to privacy concerns, Mark notes that research subjects’ understanding is that their data will be used for particular purposes and shared with regulators, but not be publicly posted on the Internet for anyone to do with whatever they want. Relatedly, there is the potential for interpretation of public data to be biased; research results may be over-interpreted and analyses may be flawed or even erroneous. Competitors might look for fairly trivial flaws the the data and try to use them to their advantage rather than sincerely trying to advance scientific progress and transparency.

Mark suggests, however, the choice between privacy and transparency is a false one. A better alternative is available — namely, for objective, expert regulators such as the FDA to receive and vet data in ways that address both audiences and both sets of concerns. The FDA is in fact already experienced in doing this. For example, it determines whether research demonstrates that a drug is safe and effective for a particular use through its marketing application approval mechanism, and it determines the accuracy and adequacy of the portrayal of research results in product labeling and product advertisements. And late last year, it was given responsibility for overseeing clinicaltrials.gov, which includes results from all pre-specified primary and secondary outcomes measures from nearly all clinical trials either conducted in the U.S. or intended to be used in support of an application for marketing approval in the U.S. This new responsibility, Mark suggests, could be a powerful tool, depending on how the FDA uses it. For instance, the FDA could exercise authority to monitor and enforce the absence of required results and the inclusion of false or misleading results data.

In concluding, Mark stresses that, when faced with requests for public access to patient-level trial data, we should consider the important role of regulators as trusted intermediaries who can balance competing concerns. Continue reading →

Sleep No More: Sleep Deprivation, Doctors, and Error or Is Sleep the Next Frontier for Public Health?

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[Cross-Posted at Prawfsblawg]

How often do you hear your students or friends or colleagues talk about operating on very little sleep for work or family reasons? In my case it is often, and depending on the setting it is sometimes stated as a complaint and sometimes as a brag (the latter especially among my friends who work for large law firms or consulting firms). To sleep 7-8 hours is becoming a “luxury” or perhaps in some eyes a waste – here I think of the adage “I will sleep when I am dead” expresses that those who need sleep are “missing out” or “wusses.” My impression, anecdotal to be sure, is that our sleep patterns are getting worse not better and that many of these bad habits (among lawyers) are learned during law school.

One profession that has dealt with these issues at the regulatory level is medicine. In July 2011, the Accreditation Council for Graduate Medical Education (ACGME) – the entity Responsible for the accreditation of post-MD medical training programs within the United States – implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. In a new article with sleep medicine expert doctors Charles A. Czeisler and Christopher P. Landrigan that just came out in the Journal of Law, Medicine, and Ethics, we examine how to make these work hour rules actually work.

As we discuss in the introduction to the article

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts (>16 hours) are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine (IOM) conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission work with the Accreditation Council for Graduate Medical Education (ACGME) to ensure effective enforcement of new work hour standards. The IOM’s concerns with enforcement stem from well-documented non-compliance with the ACGME’s 2003 work hour rules, and the ACGME’s history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME’s 2003 standards in the year following their introduction.

Whether the ACGME’s 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. I would love reactions to our proposals in the paper, but wanted to float the more general idea in this space.

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More on NSF and NIH Funding

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By Scott Burris

Here’s where some in Congress would like us to go:

ScienceInsider reports:

The new chair of the House of Representatives science committee has drafted a bill that, in effect, would replace peer review at the National Science Foundation (NSF) with a set of funding criteria chosen by Congress. For good measure, it would also set in motion a process to determine whether the same criteria should be adopted by every other federal science agency.

Whether or not you think of this as a partisan attack on science, it challenges the idea of science as an independent way of pursuing knowledge. The fact that this is even on the table, and could be taken seriously, shows how effective the attack on science has been.  It seems to reflect a terrible paradox:  on the one hand, social scientists are pissing some people off in a big way, which is a good sign we are doing something right in the inconvenient truth department; but on the other hand, I don’t see a lot of people rising to our defense, which suggest we matter to fewer people than we should.

This bill may or may not go anywhere, but anyone who cares about evidence-informed governance and the ability of the US to solve its problems ought to be concerned.

 

A Tale of Two Polities

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By Scott Burris

Last week, Northeastern University’s effort to convene a much-needed conference on the future of health policy was a casualty of the successful manhunt for the Boston Marathon bombers.  One hardly wants to make too much of a stymied conference given all the human damage of the bombing and its aftermath, but all of us who had gathered for the meeting regretted that we would not hear from the panelists, and sympathized with organizers who had put so much into planning it.  In recognition of that, I am summarizing here what I planned to say there.  It is a tale of two polities that seem to compete for existence in our perceptions of the politics of public health.

One public health is incredibly popular with citizens and lawmakers alike – demonstrated by polling and passage of legislation.  I’ve recently blogged on this here.  The other public health is the despised nanny state, big government, the sequestered and slashed-to-the bone struggling provider of essential services that don’t get no respect and don’t deserve the meager tax dollars we still pay in. We see this in budget cuts, in hyperbolic allegations of “corruption,” and in disingenuous advocacy for a radical caveat emptor regime for all legal products.

What do we make of these two radically different views of where public health now stands in the public’s regard? My claim is that the former is largely the truth – public health is popular, not despised – but the latter view is what is driving budgets and a lot of policy. The action points follow: a sustained fight to mobilize public support and win more battles over budgets and laws. I see three main strands of work:

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While We Sleep?

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By Scott Burris

Nothing threatens a know-nothing more than the prospect of someone knowing something. Hence there has been increasing pressure on and from some in Congress to reduce government funding of social science research.  I hope every reader of this blog is aware that an appropriations rider added by Tom Coburn has drastically restricted NSF funding of political science research. That’s an ugly development, on par with the scandalous cuts to CDC that put paid to its gun research agenda years ago.

But the big funder of social and behavioral research in health is the NIH. In the past two weeks, I have heard via two different insiders that the agency is under pressure to significantly cut back on social and behavioral research, at least research with any important links to public policy. Now it is true that NIH does far too little policy-relevant research as it stands, but many fine researchers do important work related to law and policy with NIH support, and the important influence of law on health means we need more, not fewer, NIH-supported careers.

So I am hoping I am getting false information. What are you hearing?

Further On the Fake Anti-Government Electorate

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By Scott Burris

In recent posts, I have been pointing to research that suggests that government intervention for public health is actually rather popular as a general matter. Now comes a neat paper that takes on the question of whether politicians actually know what their constituents want.  I read it as further evidence that our politics is being shaped by a lot of well-supported anti-government noise-making that has been allowed to flourish unchallenged.

The paper in brief: the authors surveyed candidates for state-level legislative office, and used a technique called multi-level regression and post-stratification (MRP) to localize opinion poll data to legislative districts. They then compared what candidates think their constituencies believe on key issues (health care reform, gay marriage, welfare reform) with what the polls say their constituents believe.  They find that both conservatives and liberals significantly overestimate the conservatism of the people who elect them:

“In districts where supporters of these policies outnumber opponents by 2 to 1, liberal politicians appear to typically believe these policies enjoy only bare majority support while conservative politicians typically outright reject the notion that these policies command widespread support.”

The paper is worth reading for its findings (and to allow you to personally assess its limitations – this has not yet even been peer reviewed.) A more detailed summary with some of the charts is on Dylan Matthew’s Washington Post blog.

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More Thoughts on the Preemie Study and IRB Review

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By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight.  Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of the problem may have been a result of the difficulties associated with approving multi-site research.

Maybe so, but let me offer a more fundamental challenge: perhaps IRBs are just ineffective – or not as effective as we hope they would be – at protecting human subjects.  In retrospect, it looks like all 23 IRBs that reviewed the study, all of which were applying the same regulatory standards, failed to do what OHRP, many news outlets, and as awareness grows, much of the public thinks they ought to have done to protect the babies and families involved in this study.  How could they all have gotten it wrong?  Are the regulations insufficient?  Are the procedures insufficient? Is it all just a matter of interpretation?

These questions lead to another fundamental issue: the lack of empirical evidence on IRB effectiveness.  We have data on whether IRBs follow the regulations, data on adverse events, data on OHRP warning letters, data on IRB-imposed research burdens and delays – but these all nibble around the edges of the real questions: what are IRBs supposed to be doing, are they doing it well, and how would we know?  The counterfactual – a world without IRB review – is pretty tough to study, but I’m working with a group of colleagues at the Petrie-Flom Center and elsewhere to think through some empirical methods to get at precisely these issues.  And we’d love to hear your thoughts!

Finally, as a side note, one point that seems to be getting lost in coverage of this preemie story is that although there seems to have been some major problems with the consent process, the study question itself was a very important one to ask.

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

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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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Times Report Models Worst Practices for Policy Research Reporting

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By Scott Burris

I read the Times daily, and so naturally would like to be able to think it deserves to be regarded as a credible “newspaper of record.”  Today the paper outdid itself to disappoint, in a story by Sam Dolnick headlined “Pennsylvania Study Finds Halfway Houses Don’t Reduce Recidivism.” In the cause of making lemons from lemonade, I am drawing a list of “worst practices” from this little journalistic fender-bender:

Worst Practices Reporting Policy Evaluation Research (Provisional – come on readers, add your own.)

1. Don’t provide a title or author of the study or publication information on the study being described.

The story says only that it was conducted by the PA Department of Corrections and overseen by the state corrections department. There is a link later in the story to what turns out to be the Department’s annual report on recidivism. Not quite a “study” of halfway houses.

2. Don’t clearly describe the study.

The story does describe the study adjectivally – as “groundbreaking.”  It is, first of all, a bit of a stretch to call it a “study” at all. This is not the result of a systematic effort to explore the specific question of whether halfway houses work better than direct release to the street; it certainly was not a peer-reviewed or published study. Rather, the Times story is drawing on one section of an annual report produced by the state on recidivism among all prisoners released through all release mechanisms. The term “study” and the consistent suggestion that the study is important (“groundbreaking” results “so conclusive” that have “startled” leaders and experts) might lull the reader into believing that the “study” was well and deliberately designed to answer the question it supposedly posed – for example, a randomized, controlled and blinded trial of releasing prisoners directly to the street compared to halfway houses. Nope. This report is just a summary of outcome statistics, with a couple of paragraphs reporting in general terms on some statistical analysis meant to control for differences in the prisoners sent to halfway houses compared to those released to the street.

3. Just ignore the obvious problems for causal inference.

The plain and fundamental problem with pumping this study as powerful support for the claim that halfway houses don’t work is that we have no reason to be confident that the prisoners put into halfway houses are, as a group, the same as prisoners released directly to the street. It is elementary that statistical controls for observed differences cannot make up for a non-random, retrospective design that cannot also control for unobserved or unknown differences. Saying that this study “is casting serious doubt on the halfway-house model” is perhaps an attempt at caution, but way too weak a one. This study cannot cast serious doubt on anything, though it certainly points, as the report itself says, to worrisome outcomes in the halfway house system.

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Is Paying For Medical Care Like Buying A Used Car?

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Nadia N. Sawicki

Two recent publications prompt me to ask this question.

The first, forthcoming in JAMA Internal Medicine, is a study by Jaime Rosenthal, a student at Washington University in St. Louis.  Rosenthal and her colleagues set out to obtain pricing data for total hip arthroplasty from 20 top-ranked orthopedic hospitals and 102 representative general hospitals (two from each state and Washington DC).  Rosenthal, posing as the granddaughter of a 62-year old woman without health insurance, contacted each hospital numerous times to inquire about the total cost of the procedure.  Only 45% of the top-ranked hospitals and 10% of other hospitals were able to provide a complete bundled price; price estimates were obtained at 15% of ranked hospitals and 53% of other hospitals by contacting the hospital and physicians separately.  And perhaps most startlingly, the prices quoted for the procedure ranged from $11,000 to $125,798.  The authors’ conclusion is a modest one – that patients “may find considerable price savings through comparison shopping” – but I believe its impact is far greater.  In part because of the way health care is financed in our country, the average American consumer has little awareness of how much any given medical procedure actually costs.  But who can blame the consumer in this market, when those who provide the services themselves have no baseline against which to set costs?

This brings me to the second piece –  Steven Brill’s excellent article in Time Magazine, “Bitter Pill: Why Medical Bills are Killing Us,” which my co-blogger Patrick O’Leary blogged about last week.  ).   Brill spent half a year trying to understand why some nonprofit hospitals seem to function like prosperous businesses – with brand-new facilities, impressive executive compensation, and high profit margins.  He approached this problem by analyzing patients’ medical bills from hospitals, physicians, drug companies, “and every other player in the American health care ecosystem.”  Brill offers a scathing commentary on a system where patients are billed $18 per diabetes testing strip that can be purchased in boxes of 50 on Amazon.com for about 55 cents per strip.  Another example: one patient was billed $7,997.54 for a CT scan stress test that Medicare pays $554 for; and $3 for a reusable pen that marked where an incision would go.  These prices, Brill explains, are based on the chargemaster, a master document of prices kept by every hospital that is the basis for insurance negotiation reductions.  Nearly every executive he spoke with said that the chargemaster prices are irrelevant because “nobody gets charged those prices,” but Brill’s research suggests the contrary. Those without insurance, as we in the health law and policy community have long known, are charged more that those who are covered by insurance.  Brill’s article also follows medical billing advocates who negotiate patient bills down dramatically for patients who are willing to pay their fees; however, not every patient is so lucky.

The findings in Rosenthal’s and Brill’s articles are startling.  Few consumers, I would image, participate in the health care market with the understanding that the costs they might pay vary widely from institution to institution; that the prices they are asked to pay for a given procedure are far in excess of how much federal health programs believe the procedure is worth; or that they can “bargain down” their charges through skilled negotiation by someone with inside knowledge of the system.  Readers of this blog might chafe at the comparison between the market for health care and the market for used cars, but perhaps it is the used car dealer who should feel offended.  His customers, at least, can rely on the Kelley Blue Book.

Xolair for Chronic Itch: Magic Bullet or Marketing Hype?

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By Jonathan J. Darrow

Earlier this week, the New York Times reported that Xolair (omalizumab), a monoclonal antibody approved in 2003 to treat allergic asthma, had recently shown efficacy in relieving hives patients of chronic itch (See Laurie Tarkan, Drug to Treat Asthma Could Relieve Hives Patients of a Chronic Itch, Study Says, N.Y. Times, Feb. 25, 2013, at A5).  The article noted that a Phase 3 trial (usually, the final phase before FDA approval) showed that a monthly injection of Xolair “significantly reduced hives and itchiness.” Quoting the lead author of the study, the article reported that Xolair “is the magic bullet patients have been waiting for for the last 40 years.”  Is it?

An initial concern is the large number of conflicts of interest associated with the study. An examination of the Phase 3 trial as published in the New England Journal of Medicine (NEJM), on which the New York Times article is based, reveals that the trial was “[f]unded by Genentech and Novartis,” both of which sell Xolair.  The lead author and at least one other co-author of the study have received consulting fees from one or both companies, while another of the co-authors (Karin Rosen) is the medical director for Genentech.  Conflicts of interest, however, do not necessarily mean that the drug is in fact ineffective.  To determine efficacy, one must look at the evidence.

The NEJM study reports that test subjects received either placebo or Xolair at doses of either 75 mg, 150 mg, or 300 mg.  Starting from a baseline itch-severity score of about 14, the data were as follows:

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Flu Vaccine Mandates for Health Care Workers

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According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.

States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.

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Impact of the Sequester on Health Care: By the Numbers

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By: Katie Booth 

The looming sequester will have a significant impact on health care, including cuts to Medicare, FDA, CDC, NIH, and Affordable Care Act programs. Budget cuts could slow down the drug approval process, impede the tracking of infectious diseases, and lead to layoffs for hundreds of thousands of workers in the health care sector. Read on for sequestration by the numbers…

Medicare:

  • Medicare cut by 2% ($11 billion) (not set to begin until April 1st, 2013, unlike other sequestration cuts, which are set to begin on March 1, 2013)
  • Physicians’ payments cut by 2%
  • Hospital Medicare reimbursement cut by $5.8 billion
  • Hospitals could end up with especially large cuts under the sequester because other parts of healthcare system run on longer term contracts
  • Loss of almost 500,000 health care sector jobs in the first year of the sequester according to an American Medical Association and American Hospital Association study, including job losses for 40,000 practitioners such as physicians and dentists

FDA:

  • FDA cut by 8% ($318 million)
  • FDA public funding cut by $206 million
  • FDA industry user fees cut by $112 million (for an interesting discussion of user fee cuts and the sequester, see Patrick O’Leary’s Bill of Health blog post)
  • Cuts by department (assuming 8% across-the-board cuts): $71 million to Foods, $39 million to Human Drugs, $17 million to Biologics, $11.3 million to Animal Drugs, and $26.5 million to Devices
  • Longer drug approval process is likely
  • Layoffs and furloughs likely
  • 2,100 fewer food safety inspections

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Twitter Round-Up (2/16-2/23)

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By Casey Thomson

This week’s round-up discusses the upcoming cases relevant to bioethics in the Supreme Court, the benefits of the Physician Payment Sunshine Act, the surprisingly low effectiveness rate of this year’s flu vaccine, and the problems with ACA’s Accountable Care Organizations. See below for details and more summaries:

  • Frank Pasquale (@FrankPasquale) shared a post on what’s being called the “alcoholism vaccine” being developed at the Institute for Cell Dynamics and Biotechnology at Universidad de Chile. The vaccine, which would have to be administered every 6 months or year, would mimic the alcohol intolerance mutation that prevents the breaking down of acetaldehyde and produces an instant “hangover-type” state. (2/16)
  • Dan Vorhaus (@genomicslawyer) retweeted a timeline from the Center for Law and Bioscience at Stanford Law’s blog giving dates for the upcoming Supreme Court cases relating to biosciences. (2/17)
  • Frank Pasquale (@FrankPasquale) additionally included a piece on the Physician Payment Sunshine Act, a provision of the Affordable Care Act that would “[require] manufacturers of drugs, medical devices and biologics to report the monetary value of gifts and payments to doctors and teaching hospitals on a publicly accessible website.” The author of the piece, a family physician with 15 years of experience, discussed his support for the plan. (2/17)
  • Michelle Meyer (@MichelleNMeyer) retweeted a link explaining the scientific foundations of the Brain Activity Map Project, namely how it aims at “reconstructing the full record of neural activity across complete neural circuits” to better understand “fundamental and pathological brain processes.” (2/18)
  • Arthur Caplan (@ArthurCaplan) posted a news story on police arresting those involved in the illegal harvesting of eggs from women in Bucharest, Romania. The police reports claim that 11 suspects have been implicated in the trafficking, which would harvest the eggs to be sold to Israeli couples with fertility problems. (2/19)
  • Alex Smith (@AlexSmithMD) retweeted a link to his post on asking about a patient’s PPD (preferred place of death), noting that this is not one of the concerns often cited as part of advanced planning procedures. Such a practice was considered “vital” in the UK, in contrast. (2/20)
  • Alex Smith (@AlexSmithMD) shared a link to a post on the blog he co-runs, GeriPal, on “Five Things Patients and Physicians Should Question in Palliative Care and Geriatrics.” The post shares the two lists posted by the American Academy of Hospice and Palliative Medicine (AAHPM) and the American Geriatrics Society (AGS), which Smith claims “provide targeted, evidence-based recommendations to help physicians and patients have conversations about making wise choices about their care in order to avoid interventions that provide little to no benefit.” (2/21)
  • Arthur Caplan (@ArthurCaplan) also included a link reviewing the low effectiveness of this year’s flu vaccine: there was evidence that it was only effective in 56% of the cases, on the low end of the usual 50-70% effectiveness rate. His tweet noted that this was strong evidence in favor of mandating the vaccine for healthcare workers. (2/21)
  • Michelle Meyer (@MichelleNMeyer) posted an op-ed piece by The Wall Street Journal about the problems with Affordable Care Act’s Accountable Care Organizations (ACOs), namely their false assumptions: that success can come without changing doctor behavior, and without changing patient behavior, in a way that will save money. (2/23)