Month: July 2013

Art Caplan on GlaxoSmithKline research conduct in China

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An article in today’s New York Times explores allegations of improper research practices at GlaxoSmithKline’s research and development center in Shanghai, China. The article quotes Art Caplan in reference to evidence that researchers proceeded with drug trials in humans before animal studies were complete:

“If that’s true, it’s a mortal sin in research requirements,” said Arthur L. Caplan, the head of the division of medical ethics at NYU Langone Medical Center. He served as the chairman of an advisory committee on bioethics at Glaxo from 2005 to 2008. “No one could approve human trials without having that information available, scientifically or ethically. That’s kind of a Rock-of-Gibraltar-sized ethics violation.”

Read the full article here.

Whole Lot o’ Shakin’ Goin’ On

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By Scott Burris

Over the weekend, my social science friends were all emailing about Nicholas Christakis’ op ed about how we should “shake up the social sciences.”  On one level, the piece is easy to mock. Christakis makes a big deal out of the contrast between the academic organization of the natural and social sciences: the former have hybridized: “Departments of anatomy, histology, biochemistry and physiology have disappeared, replaced by innovative departments of stem-cell biology, systems biology, neurobiology and molecular biophysics.” In contrast, sociology is still sociology, economics is still economics, etc.  So? As one friend notes, Chistakis’ own Yale Sociology Department sure seems to be keeping up with the interdisciplinary times:

Well, so, the sociology department in which Christakis now sits describes its scholarly endeavor as follows:  “Comparative and Historical Sociology; Culture/Knowledge; Economic Sociology and Organizations; Family/Gender/Sexuality; Global, Regional and Transnational Sociology; Health, Medicine, and Biosocial Interactions; Law and Criminology; Methods; Political Sociology and Social Movements; Race and Ethnicity; Religion; Social Networks; Social Stratification; Theory.”

Whatever that all amounts to, I think it’s slightly disingenuous to suggest that this enterprise is somehow fettered and hampered by calling it “sociology”, or by the fact that its practitioners (including Christakis) call themselves “sociologists,” or by having an academic department that’s indulgent and elastic enough to claim all these people and pay them for teaching and being public intellectuals that write op-eds in the New York Times.

Even more grin-worthy is his claim that we should declare knowledge victory and move on to new topics: “everyone knows that monopoly power is bad for markets, that people are racially biased and that illness is unequally distributed by social class.” Another friend sends that up like this:

This is wonderful news.  Somehow I missed it in all the papers, but it appears that we’ve agreed on the basic mechanics of macroeconomics and understand exactly how much government spending is needed to keep an economy out of recession.  Thank goodness that subject is ‘settled’.  Time to move on.   Next, we can put the basic economics of healthcare to rest.  For that to happen all we have to do is not change how we pay for healthcare, not give patients new rights, not allow any new diseases, and — most importantly — not develop new cures for existing diseases.

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Art Caplan: Anti-Smoking Advocates Have Misused Science

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Art Caplan has a new piece at time.com discussing a recent study that examines the scientific evidence behind claims that smoking in public harms non-smokers–and finds it wanting:

[…] as a new paper by tobacco control proponents Ronald Bayer and Kathleen E. Bachynski of Columbia’s School of Public Health, in the respected journal Health Affairs shows, the left can play games with science too. And when it does, it needs to be called out for doing so since shaping science to fit moral goals, even laudable ones, weaken the trust and credibility of the most respected source we have for facts in public policy debates—science.

Read the full column.

The Merit of Merit Affidavits

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By Alex Stein

Similar to many other states, Oklahoma has a statute prescribing that suits alleging medical malpractice must be verified by an affidavit from a qualified medical expert. Suits unaccompanied by a proper affidavit must be stricken out. This statute is part of what I call – and commend – as a procedural tort reform: it allows courts to get rid of unmeritorious suits against doctors and hospitals early in the process. The statute, however, recently became a dead letter after being pronounced unconstitutional by Oklahoma’s Supreme Court for the second time in a row (Wall v. Marouk, — P.3d —-, 2013 WL 2407160 (Okla. 2013)). Evidently, this Court does not view merit affidavits as favorably as I do.  Let’s see why. Read More

Art Caplan: Ease US Blood Supply Shortage by Lifting Gay Donor Ban

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Art Caplan has published an opinion piece at NBCNews.com calling for an end to the ban on blood donation by gay men in the United States:

The United States is facing a health care crisis.

Our supply of blood is dangerously low. The American Red Cross reports that across the nation blood donations were down an estimated 10 percent in June — about 50,000 fewer donations than in May.

In the face of a blood supply shortage that is bad and likely to get worse, there is a group of people — gay men — who might ease the situation, if only they were allowed to help.

Gay men who want to donate blood are forbidden because of an outdated, non-scientific regulation that bans anyone who has had sex “even once” with another man since 1977.

It is long past time to let those who want to help others by donating blood do so.

Read the full column.

Legal Scales: An Empirical Methods Question

Temple University Center for Public Health Law Research 5 Comments

By Scott Burris

The most important topic we did NOT address in our PHLR methods book was valid methods for rating laws for characteristics like “stringency.”  I am not aware of any general work on this.  Nonetheless, it is not uncommon for researchers to create scales purporting to measure the distribution of some characteristic(s) over a group of laws. It seems often to be done by some facially plausible means (e.g., penalties) or through a Delphi or similar expert process.  For example, Woodruff and colleagues1 developed a stringency scale for tanning laws that distributes characteristics of laws (age covered, standards for eye protection) on 2-5 point scales based on a priori judgments.  Chriqui and colleagues used an expert advisory committee to rate the strength of clean indoor air laws.2 For alcohol control policies, Nelson et al used a Delphi method.3  As a field, however, I can’t see that we have much consensus on how to create and validate such scales. So to start a discussion, some thoughts on a basic typology of scales, with some possible measures and examples off the top of my head:

 

Approach Possible Measures Examples
Assessment based on apparent features of the legal text Magnitude of penalty Fine; imprisonment
Comprehensiveness of coverage of categories of actors engaged in the regulated activity Distracted driving: all drivers, novice drivers, bus drivers
Comprehensiveness of coverage of specific behaviors constituting or relating to the regulated activity Distracted driving: all device use; manual use; texting
Procedural efficiency Number of distinct steps required to enforce or comply with law
Legal assessments Consistency with other requirements (constitutionality or preemption, for example)
Qualitative assessments “Clarity” or “specificity” of rule
Assessment based on evidence, expert knowledge or prediction of the implementation of the law by legal agents Incentives for enforcement Resources, required reporting of enforcement actions/outcomes
Social marketing investment MADD social marketing against drunk driving
“Technical” feasibility of enforcement Consistency with mechanisms/methods already in use, cost, procedural complexity
“Social” feasibility of enforcement Normative consistency with current practices or values,* political constraints
“Legal” feasibility of enforcement Probability of legal challenge, procedural complexity
Qualitative assessments “Clarity” or “specificity” of rule as perceived by enforcers
Assessment based on evidence, expert knowledge or prediction of the reaction to the law of regulated parties Likelihood that regulated parties will learn of the law Social marketing, publicity, high enforcement levels
Consistency with general theories of compliance Deterrence, legitimacy, procedural fairness, expected utility of compliance
Social support for compliance Consistency of required behavior with current norms*
Feasibility of compliance Availability of technology,
Qualitative assessments “Clarity” or “specificity” of rule as perceived by regulated parties
Hybrid methods

* The normativity of the required behavior or enforcement mechanism would not be a stable measure, since we would expect passage and enforcement of the law to change norms over time (e.g., drunk driving)

 

Has my admittedly quick search for methods guidance on this missed some good sources? How does this rough typology and examples strike you?  I’d be very happy to get some comments and suggestions.

 

1.            Woodruff SI, Pichon LC, Hoerster KD, Forster JL, Gilmer T, Mayer JA. Measuring the stringency of states’ indoor tanning regulations: Instrument development and outcomes. Journal of the American Academy of Dermatology. 2007;56(5):774-780.

2.            Chriqui JF, Frosh M, Brownson RC, et al. Application of a rating system to state clean indoor air laws (USA). Tob Control. Mar 2002;11(1):26-34.

3.            Nelson TF, Xuan Z, Babor TF, et al. Efficacy and the Strength of Evidence of U.S. Alcohol Control Policies. American Journal of Preventive Medicine. 2013;45(1):19-28.

 

Einer Elhauge on “Obamacare and the Theory of the Firm”

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Einer Elhauge, Petrie Professor of Law at Harvard Law School and Founding Director of the Petrie-Flom Center, has a new essay on “Obamacare and the Theory of the Firm” in the forthcoming book The Future of Health Care Reform, Malani and Schill, eds. (University of Chicago, 2014).

Abstract:

Health care fragmentation today raises costs and worsens health outcomes. The theory of the firm indicates that cost and quality problems could be addressed by permitting greater vertical integration among complementary health care providers. The puzzle is why such integration does not occur. The answer is that a host of regulatory and payment laws create artificial obstacles to such integration. Various provisions in Obamacare could and should be used to lift these obstacles and allow health care integration that could potentially save tens of thousands of lives and hundreds of billions of dollars.

Proximate Cause in Georgia

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By Alex Stein

Two days ago, Georgia’s Court of Appeals decided Georgia Clinic v. Stout, — S.E.2d —-, 2013 WL 3497703 (Ga. App. 2013).

This tragic case features an elderly patient with an arthritic knee. Her doctors injected that knee with medication drawn from a multi-dose vial. They did so at their clinic under non-sterile conditions that included poor infection controls, failure to maintain sterile field, and poor hand-washing facilities (the clinic had no sinks and alcohol hand cleaners in the examination rooms). As a result, the patient’s knee was infected with methicillin-sensitive staphylococcus aureus (“MSSA”). Four other patients of the same clinic were also infected with MSSA from the same multi-dose vial.

The patient developed excruciating pain in her knee and became depressed. The doctors treated her for the pain in the knee but neglected the depression. They failed to refer the patient to a psychiatrist. After a short period of time, the patient committed suicide by jumping from the window of her 14th floor apartment. She left behind a suicide note saying that she can’t take her pain anymore and prefers to die. Read More

Thinking about brain death

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By Seema Shah

It astonishes me how many people do not realize the controversial nature of “brain death” and the fact that it is not the same as death. There is a substantial body of literature showing that brain death is not the equivalent of death. The President’s Council on Bioethics issued a white paper in 2008 acknowledging the deficiencies with our current approaches to determining death. The literature on the topic is fascinating—some brain dead individuals have gestated babies successfully to viability and gone through puberty. Many brain dead individuals can heal wounds, regulate their body temperatures, and persist on ventilators for many years. (If you are unfamiliar with this literature and want to read further, see the citations provided below.)

Frank Miller and I have argued that best the way to think about the status quo is that brain death is a status legal fiction, much like the legal construct that a corporation is a person. A corporation is similar enough to a person that it is convenient to treat corporations as persons under the law, rather than writing an entirely new body of law meant to apply to corporations alone. We have argued that brain death is similar to death—Frank Miller and Bob Truog express this by saying that a person who is brain dead is “as good as dead.” For this reason, we can ethically and legally treat the two states in the same way for the purposes of determining death and allowing vital organ transplantation.

There are many open and interesting questions about brain death that I will be exploring on this blog for the next few weeks. Michael Nair-Collins has a recent article in the Kennedy Institute of Ethics Journal that argues that the current approach to determining death in the U.S. is paternalistic and, presumably, unjustified. He cites as evidence the kinds of information that are shared with people deciding whether to become organ donors. But is this true, or is there evidence that the public is able to distinguish between brain death and death? Kenneth Kasper, Frank Miller, and I are investigating this at the moment, and we are finding some surprising answers in the literature. Read More