Art Caplan on teen organ transplants

Art Caplan has a new opinion piece up at nbcnews.com. In “Ethicist: Teens have high failure rates after organ transplants — but cut them some slack,” Caplan responds to a recent study showing that teen organ recipients have much higher failture rates than recipients in other age groups:

Remember the long fight over whether Sarah Murnaghan, the little 10-year-old girl from suburban Philadelphia who was dying from cystic fibrosis, should have a shot at getting a transplant from lungs taken from an adult? The fight hinged in part on whether there was sufficient evidence to show that adult lungs would work as well in Sarah, who is still struggling to recover from two lung transplants, as they would in another adult where they would fit better. Some, including me, argued that the best way to allocate scarce lungs for Sarah or anyone else is to determine who is most likely to live if they get them.

That may seem a sensible ethical policy to use when there are not enough organs for all. But there is a new study out that calls into question the merits of an efficacy-only rationing policy.

Read the full article here.

Chimpanzee Research and Animal Rights

Last month, two federal agencies took steps that together may come close to ending research on chimpanzees in the United States.

First, the Fish and Wildlife Service (FWS) proposed to list all chimpanzees, including those in captivity, as endangered.   (Currently, only wild chimpanzees are listed as endangered, while captive chimpanzees are listed as threatened).  This would require that almost all research on chimps be done with a permit, and the agency has suggested that these permits may only be granted for research that enhances the propagation or survival of the chimpanzee species.

Second, the National Institutes of Health (NIH) decided that more than 300 of the approximately 360 research chimpanzees that it owns will be retired and moved into sanctuaries.  This decision was based on an Institute of Medicine report finding that most current research on chimpanzees is unnecessary, and that chimps should be used only when public health is on the line, no other animals are appropriate, and ethical experiments on humans are not possible.  On the basis of these findings, the NIH is planning to keep a colony of about 50 chimps available for research that is not possible in any other way.

Comparing these two agency actions raises an interesting question:  In evaluating whether research on chimpanzees is ethical, does it matter whether the beneficiary of the research is the chimpanzee or the human species, and if so, on what grounds?   Continue reading

The Laches Defense not Available in Medical Malpractice Actions

By Alex Stein

The DC Court of Appeals has ruled last week that the laches defense does not apply in actions for medical malpractice: Naccache v. Taylor, — A.3d —-, 2013 WL 3820942 (D.C. 2013). The Court reasoned that laches is only available in equity proceedings but not in actions at law. For actions at law, held the Court, the applicable time bars are set by the statute of limitations. This statute, the Court explained, accounts for all relevant tradeoffs between plaintiffs’ and defendants’ interests. Hence, “To import laches as a defense to actions at law would [improperly] pit the legislative value judgment embodied in a statute of limitations … against the equitable determinations of individual judges.” In making this ruling, the Court also took notice of the fact that forty-eight states bar laches as a defense for actions at law.

This ruling appears impeccable, but it has a wrinkle. Continue reading

Fox discussed in The Atlantic article on Brain Imaging and the Right to Silence

A new article in The Atlantic, “Could the Government Get a Search Warrant for Your Thoughts?: Why remain silent if they can just read your mind?“, cites Bill of Health blogger Dov Fox’s research on brain imaging.

Last year, a Maryland man on trial for murdering his roommate tried to introduce results from an fMRI-based lie detection test to bolster his claim that the death was a suicide. The court ruled the test results inadmissible, noting that the “fMRI lie detection method of testing is not yet accepted in the scientific community.” In a decision last year to exclude fMRI lie detection test results submitted by a defendant in a different case, the Sixth Circuit was even more skeptical, writing that “there are concerns with not only whether fMRI lie detection of ‘real lies’ has been tested but whether it can be tested.”

So far, concerns regarding reliability have kept thought-inferring brain measurements out of U.S. (but not foreign) courtrooms. But is technology the only barrier? Or, if more mature, reliable brain scanning methods for detecting truthfulness and reading thoughts are developed in the future, could they be employed not only by defendants hoping to demonstrate innocence but also by prosecutors attempting to establish guilt? Could prosecutors armed with a search warrant compel an unwilling suspect to submit to brain scans aimed at exploring his or her innermost thoughts?

Continue reading

Rape and Abortion: Negating a Myth

Cross-post from bioethics.net.

Sabine Hildebrandt, MD
William Seidelman, MD
Arthur Caplan, PhD

A recurring assertion in the ongoing debate on abortion in the United States is the statement that pregnancy is an uncommon consequence of rape. Rep. Trent Franks, R-Ariz., has recently argued on the floor of the House of Representatives that an exception for rape wasn’t necessary in a proposed law banning abortions after 20 weeks because “the incidence of rape resulting in pregnancy are very low.”

Why do so many Americans believe this claim? Where does it come from?

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Importing unapproved drugs: lethal injections and shortages

In a unanimous opinion (pdf) in Cook v. FDA, the DC Circuit just held that FDA must prohibit the importation of misbranded or unapproved new drugs, including those made by unapproved manufacturers abroad. In this case, a set of prisoners on death row sued FDA to require it to prohibit the importation of sodium thiopental, the first drug in the three-drug cocktail used in most states for lethal injection (and the only drug typically used in states with one-drug protocols).  Since 2009, no domestic company has made thiopental, and the foreign source used by most states is not registered with FDA, which makes it “misbranded” under 21 U.S.C. §§ 331(a), 352(o).  In 2011 FDA stated that it wouldn’t block importation of thiopental, using its enforcement discretion.  The DC Circuit rejected this approach, holding the statute compels FDA to inspect the drugs and prohibit their importation.  The opinion relates to both lethal injections and, less obviously, drug shortages – but though at first glance the implications look potentially significant, I have a hard time seeing how they’ll make much of a practical difference in either scenario. Continue reading

Anthony Weiner, Sexting, Medicalization, and Legal Moralism, Or (To Be Provocative) “What’s So Wrong About Sexting?”

Like most people, I am both amused and shocked by the latest Anthony Weiner sexting revelations and scandal. It is like a car crash where it is hard to look away even though you know you should.

Most germane to Bill of Health’s readership, I am fascinated by the “medicalization” of Weiner’s behavior by some sectors, this CNN clip with therapists is to me a good example. The words “sexual addiction,” “exhibitionism,” comparisons to alcoholism, “not in control of his actions” are bandied about. This to me has fascinating echoes of the medicalization of homosexuality in the 70s and also the medicalization of the choices made by the transgendered. There like here the strategy is fraught. The patient has to perform the “sick role” as a way of excusing himself from responsibility and/or earn governmental support.

The comparison, though, prompts the following question (and yes I am purposefully trying to be provocative so take it with the appropriate grain of salt): As with homosexuality, what is the underlying problem here that calls out for condemnation? Is this merely legal moralism rearing its head again? What’s so Wrong About Sexting?

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

By Aleeza Hashmi

ART, lesbians and justice in the distribution of health care

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. Continue reading

Shifting the burden of proof regarding placebo controls

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:

Continue reading

Art Caplan on GlaxoSmithKline research conduct in China

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

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

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

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. Continue reading

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

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

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”

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

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. Continue reading

Thinking about brain death

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. Continue reading