Petrie-Flom Intern’s Weekly Round-Up: 7/19 – 7/24

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By Aleeza Hashmi

ART, lesbians and justice in the distribution of health care

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In the wake of our seemingly everlasting economic crisis, the Spanish health authorities have decided to exclude single women to access ART treatments – mainly artificial insemination- in the public health care system. “The lack of a male partner is not a medical problem”, has said Ana Mato, our Secretary of Health. Coming from a devout Catholic and extremely conservative politician, her remark, and ultimately, her Department’s policy, have been widely interpreted as another vindication of the idea that only traditional, i. e. heterosexual, families are suitable for rearing children. The spokeswomen of various feminist and lesbian NGOs have entered the public arena to denounce her lesbophobia.

The fact of the matter is that women in Spain, whether married to another woman or single, will still be authorized to be artificially inseminated (in some European countries such as France, Austria or Sweden, for instance, single women are excluded from medically assisted reproduction). Even the fertile, married heterosexual woman might still get artificial insemination – maybe she just wants to do things differently, for a change- although they will all have to bear the costs. The public health care system has, therefore, reconfigured ART as a pure medical remedy for a medical condition: infertility. The days of IA as an “alternative means of reproduction” for “alternative life-styles” are over. But with this new policy the demand made by economically disadvantaged lesbian couples willing to procreate finds an answer along the following lines: “go find a male”. A crude response if there is one. Read More

Shifting the burden of proof regarding placebo controls

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By Annette Rid

Placebo controls usually get special treatment. Almost all ethical guidelines for research specify how to use placebo controls, in particular when an established or proven effective treatment exists. To list just a few: guidance issued by the World Medical Association, CIOMS and the Council of Europe all have provisions dedicated to the use of placebo controls. But is there any reason to consider placebo controls a special case? I believe there isn’t, and I also think the burden of proof is on those who hold that placebos should be evaluated differently from other research interventions.

Using a placebo when an established effective treatment exists deprives the control group of the benefits of that treatment. This poses relative net risks to participants – that is, risks from delaying or foregoing a treatment that participants may have received outside the trial. Some placebo interventions also pose risks themselves, but these risks are typically so low – taking a “sugar pill” or receiving a saline injection through an existing i.v. line, for example – that we rightly focus on the risks of foregoing or delaying treatment. (There are other cases, though, such as certain forms of sham surgery. I won’t consider these cases here.)

So how should we evaluate the risks of using a placebo when an established effective treatment exists? We have general criteria for evaluating the risks of research interventions, in particular:

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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

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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.