Part II- Medicine’s Battle of the Experts: A Patient’s Perspective on Navigating Conflicting Medical Advice

In Part I, I described my testicular cancer diagnosis and pre-operation experience in an attempt to demonstrate how defragmentation in healthcare could reduce patient emotional and psychological stress.  In Part II, I describe my post-surgery experience, consulting specialists with conflicting opinions as to the optimal post-operation treatment regimen.

In various law school courses we discuss a problem sometimes referred to as the “battle of the experts.”  In a courtroom, a jury generally hears testimony from experts on both sides of a case, presenting different statistics and opinions for the jury to consider.  The jury, comprised of lay people, is likely ill-equipped to contextualize these opinions scientifically, and possibly resorts to heuristics, such as judging the experts’ levels of confidence, demeanors and comprehensibility, when deciding between them. A nuanced testimony delivered by a sweaty expert, when compared to a simple testimony delivered suavely, could be discredited for legally irrelevant reasons.[1]  As a patient weighing my post-surgery treatment options, I felt like a lay jury, asked to decide among the opinions of experts, with my own health hanging in the balance.

Read More

Upcoming, Feb. 6 – Drug Use and HIV: A Tale of Toxic Law

THE NORTHEASTERN PROGRAM ON HEALTH POLICY & LAW PRESENTS:

HIV/AIDS Policy Grand Rounds: Drug Use and HIV: A Tale of Toxic Law

In the wake of the HIV epidemic, legal and policy tools became critical in combatting the epidemic. The HIV/AIDS Policy Grand Rounds is an interdisciplinary series of workshops designed to explore the history, application, and current debates in the use of structural, human rights, biomedical, and public health approaches to combat the epidemic. Each workshop consists of a faculty presentation followed by comments by an invited expert and an open discussion.

The third workshop in the series will focus on the role of drug policy as a driver of the HIV epidemic among injection drug users. Leo Beletsky (Asst. Professor of Law and Health Sciences, Northeastern University School of Law and Bouvé College of Health Sciences) who will be joined by guest expert Robert Heimer (Professor, Yale School of Public Health). The speakers will will explore the interface of drug policy, HIV risk and human rights, with special focus on the role of law and law enforcement in fueling the epidemic in the US and Eastern Europe.

What: HIV/AIDS Policy Grand Rounds: Drug Use and HIV: A Tale of Toxic Law

When: Wednesday Feb 6 at noon; The workshop will run 90-100 minutes.

Where: 250 Dockser Hall, Northeastern University School of Law, 400 Huntington Ave.

Lunch will be served.

To assure an adequate food order, please RSVP by Feb. 5 by emailing Sue Council at s.council@neu.edu with “Grand Rounds” in the subject.

Playing Sports Now a Civil Right

Art Caplan and his colleagues at the NYU Sports & Society Program have an interesting new essay up at Forbes:

Obama Administration: Playing Sports Is Now A Civil Right

The United States Department of Education has released aguidance requiring schools to make “reasonable modifications” to include students with disabilities in mainstream athletics programs or provide parallel options. That may sound like just another boring piece of paper that oozes off the desk of a government bureaucrat on any given day. But this is very different. The guidance proclaims that access to interscholastic, intramural, and intercollegiate athletics is a civil right.
Asserting access to athletic programs as a civil right is a big step forward for our education system and, of course, for people with disabilities. It highlights the important role that sports can play in the development of young people as functioning and contributing members of society. It also serves to help decrease the stigma too often associated with physical, mental, and emotional disabilities.

The limitation of a guidance is that it clarifies existing laws, but doesn’t create new ones. So, although it’s not a “toothless tiger,” it’s questionable as to whether anyone will be able to file a lawsuit based on it. And there are sure to be lawsuits because it’s inevitable that the guidance is going to create a host of issues about classification and definition such as: What is a disability? What is a “reasonable modification”? What is a reasonable “accommodation”? What will get modified: the sport, the arena, or the people eligible to play?

Keep reading…

The ACA’s Immigration Quirk

By Wendy Parmet

I was amused but not surprised to read that in announcing her support for expanding Arizona’s Medicaid program, Governor Jan Brewer pointed to the fact that without the expansion, only non-citizens with incomes under the poverty level would be eligible for insurance under the ACA. What Brewer didn’t say, was that the ACA’s apparent preference for non-citizens results from precisely the type of anti-immigrant laws with which Gov. Brewer is usually associated.

 In 1996, shortly after California passed the notorious Proposition 187 which denied state public benefits to undocumented immigrants, Congress enacted the Personal Responsibility and Work Opportunity Reconciliation Act, better known as the Welfare Reform Act.  Among other things, this law imposes a 5 year waiting period before most legal permanent residents can enroll in the federal Medicaid program. The law also barred many other immigrants who are lawfully residing within the U.S. from Medicaid altogether.

The ACA did not repeal the provisions in the Welfare Reform Act limiting immigrants’ access to Medicaid. Instead, Congress sought to provide coverage to lawfully residing immigrants by permitting those with incomes under 100% of the Federal Poverty Level to receive subsidies to purchase insurance on the exchanges. Those subsidies were not necessary for citizens with such low incomes because Congress assumed that they would be brought into the Medicaid program.

Read More

Reverse settlements, Part 2: drug company profits

In my second post, I want  continue my discussion of reverse settlements.  Recall that the basic argument against reverse settlements is that they extend the duration of a pioneer drug company’s patent beyond what it might expected to be if there were no settlement.  (Elhauge and Krueger (Texas Law Review, 2012) have a nice description of the settlement process that yields this result.  For now I will take it as given.)  In my first post I questioned whether drug patents reduce total welfare.  In this post I question whether extending drug patents raise producer welfare at the expense of consumer welfare.  I will argue that the profits pioneer drug companies make under patents overstate producer surplus.  Producer surplus depends on not competition in the drug market but rather on how competitive the market for research and development for the drug was.  But we have little evidence on how competitive that market is.  It is possible that that market is perfectly competitive, in which case, in expectation, drug companies are making no supra-competitive profits.  No such profits would mean no excessive producer surplus, and no antitrust concern, even with its consumer surplus focus.

At the risk of being repetitive (and thereby pedantic), let me restate the conventional tradeoff when setting patent duration, but from the perspective of producer versus consumer surplus as conventional antitrust analysis sees it.  An innovator – in drugs or another product – gets a patent if they come up with a valuable innovation.  This patent allows the innovator to charge a high (monopoly) price and thereby earn supra-competitive profits.  These profits are treated as producer surplus (though I will question that).  The high producer surplus comes at the cost of low consumer surplus.  This is partly because surplus is a zero sum game: total surplus is either consumer surplus or producer surplus.  This partly because the high prices that generate high producer surplus reduce total surplus by pricing consumers out of the market (ignoring my first post on reverse settlements).  When a patent ends, competition starts and the market price of the previously patented drug falls.  This increases consumer surplus, at the expense of producer surplus.  If total sales also rise, total surplus also rises, which also favors consumers.  Thus the duration of a patent determines how long producers enjoy high producer surplus and when high consumer begins.

Given this background, it is possible to see why antitrust law cares about the duration of patents.  Antitrust law and antitrust authorities – for distributional reasons it appears to me – favor consumer surplus over producer surplus; I will take this preference as given.  The more quickly a patent ends, the sooner consumers start earning higher surplus.  For this reason, antitrust law is opposed to reverse settlements if they increase the expected duration of patents.

The problem with this logic is that the producer surplus created by patents is not fully producer surplus.  The purpose of this producer surplus is to encourage innovation.  In the absence of innovation, consumers would be worse off because they would not have the innovation required to generate high consumer surplus once patents expire.  Thus, antitrust law should not judge producer surplus in the patent setting the same as it is in the non-patent setting.  It should not be judged against a baseline of zero-producer surplus.  Instead, it should be judged against a baseline of innovation with shorter patents.  If patent duration is shortened, consumers will obtain less innovation and less consumer surplus.  That reduced consumer surplus should be subtracted from producer surplus observed due to patents and credited as consumer surplus.  (If this were not the case, antitrust law would want to eliminate all patents!).

Read More

Twitter Round-Up (1/20-1/26)

By Casey Thomson

Though simply the consequence of bad translation, the story of the Harvard geneticist George Church looking for a woman to act as surrogate for a Neanderthal clone shocked the internet bioethics world. A look at the problems with this hypothetical situation is just one of the components of this week’s Twitter Round-Up.

  • Frank Pasquale (@FrankPasquale) linked to an opinion piece discussing the reasoning behind the United States’ place in the world rankings of life expectancy at different stages of life. The news is a big hit to ideas of American exceptionalism: according to a report by the National Research Council and the Institute of Medicine, Americans have a substantially higher death rate for those younger than 50 as compared to Western Europeans, Canadians, Japanese, and Australians, but once they reach the age of 80, they have some of the longest life expectancies globally. (1/20)
  • Arthur Caplan (@ArthurCaplan) shared his article on why Neanderthal cloning is a bad idea, both in terms of safety and in terms of avoiding cruelty. (1/22)
  • Arthur Caplan (@ArthurCaplan) posted a news story on the reopening of bird flu experimental procedures for vaccine creation. Caplan was quoted in the article as stating: “I have no issue with restarting the research but some issue with where they are going to publish it and where they present it because bad guys can use it too.” (1/23)
  • Daniel Goldberg (@prof_goldberg) included an evaluation as to the medical disparities occurring in Colorado, particularly between races. The article emphasized in its conclusion that the existence of the disparities themselves is quite clear, but discussion on how to erase such differences is noticeably absent. (1/23)
  • Michelle Meyer (@MichelleNMeyer) retweeted a post that attempted to quantifiably compare the quality of care in Medicare options, namely whether Medicare Advantage plans 1) will eventually shortchange patients by skipping out on care quality because of profit motive or 2) have incentives to improve care quality because of the newly implemented systematic quality monitoring, where poor ratings impact them financially. The author found that most existing data makes the second theory more compelling, though the amount of data regarding the subject in general is largely lacking. (1/24)
  • Michelle Meyer (@MichelleNMeyer) also shared a link to an explanation of the intricacies of “personalized regulation” in medicine, which aims to preserve patient choice in an era leaning more and more towards paternalistic medical oversight. Understanding that patients may choose to make rational decisions that diverge from the community or committee consensus is key towards improving medical care to better reflect patient wants, and rights. (1/24)
  • Arthur Caplan (@ArthurCaplan) included a story on the large imbalance in misconduct reports in research between the genders. Men overwhelmingly led the charge, with only nine women out of the 72 faculty members who committed research misconduct. (1/24)
  • Michelle Meyer (@MichelleNMeyer) additionally shared a letter written by the Editor of The Hastings Center’s Bioethics Forum on the reasoning behind publication of a controversial article on the social pressures leading to obesity. The letter calls for the importance of recognizing that publication means that an article contributes to the larger debate on an issue, though does not affirm that the publication medium agrees with the views espoused within; it also encouraged responses to the ideas of the article. (1/25)
  • Stephen Latham (@StephenLatham) posted a video link from Comedy Central on the perils of WebMD and vegetarianism. (1/25)

Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.

Petrie-Flom Interns’ Weekly Round-Up: 1/19-1/25

By Hyeongsu Park and Kathy Wang

A different perspective on reverse settlements

Before I begin my initial post, I want to thank Holly for inviting me to post on this blog.

I want to take up reverse settlements in litigation over pharmaceutical patents.  Circuits are divided on how to treat these settlements under antitrust law (Elhauge & Krueger, Texas L. Rev., 91:283, 285, 2012).  The Supreme Court has decided to take this the topic up this term; it will hear oral arguments in Federal Trade Commission v. Watson Pharmaceuticals on March 25, 2013.  However, this is a topic about which I believe the legal literature has lagged substantially behind the health economics literature.  As a result, I think the conventional (legal) views of such settlements get the economics of pharmaceutical patents and innovation wrong.  (That does not mean they are getting the law wrong. Although the law in this area is highly unsettled, the goal of the law may not coincide with economic prudence.  I am commenting primarily about economic prudence.)

Read More

Quick, Effective Public Health Measures

By Stephen Latham [cross-posted at his blog, A Blog on Bioethics]

I’m freshly back from the annual meeting of the Public Health Law Research program, sponsored by Robert Wood Johnson.

At most academic meetings, I prefer schmoozing in the halls to listening to the talks. That’s part personal vice, and part stage-of-career: at this point, it matters more who I talk to than whose paper I hear. This conference was different, though–perhaps because I’m new to it. A very large percentage of the papers (and posters!) repaid close attention.

But the best session of the conference, to my mind, was the “Critical Opportunities” session. The session, which is apparently an annual affair, is presented as a competition: a handful of public health law scholars are invited to present their best ideas for high-impact, evidence-based public health interventions that have a chance at actual enactment. The audience votes on which one they think is (to put it roughly) most worth peddling to health-policy folk under the banner, “Do it now!”