July, 2013 - Bill of Health

Art Caplan on teen organ transplants

July 31, 2013July 31, 2013 acaplan Leave a comment

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

July 30, 2013August 7, 2018 jskopek 9 Comments

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? Read More

The Laches Defense not Available in Medical Malpractice Actions

July 29, 2013August 7, 2018 astein 1 Comment

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. Read More

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

July 26, 2013July 26, 2013 Dov Fox Leave a comment

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?

Rape and Abortion: Negating a Myth

July 26, 2013August 3, 2018 acaplan Leave a comment

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?

Importing unapproved drugs: lethal injections and shortages

July 25, 2013July 25, 2013 W. Nicholson Price Leave a comment

By Nicholson Price

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. Read More

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

July 25, 2013July 25, 2013 I. Glenn Cohen 1 Comment

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?

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

July 24, 2013July 24, 2013 The Petrie-Flom Center Staff Leave a comment

By Aleeza Hashmi

The Journal of the American Medical Association published a study that examined characteristics associated with differences in survival among black and white women with breast cancer . Although it is well known that the cancer survival rates of black women are lower than those of white women, this article suggests that it is not only due to a large number of black women receiving inferior cancer care, but getting less health care overall. Furthermore, effective programs to catch cancer early are not reaching black communities.
The FDA announced on Tuesday that it is closer to making its decision on whether to ban menthol in cigarettes. In its scientific review, the FDA noted that menthol in cigarettes made it easier to start smoking and distinctly harder to quit. It also requested public opinion about the “potential regulation” of cigarettes containing menthol.
The British National Health Service announced that it will reject the introduction of the meningitis B vaccine into the UK. The Joint Committee on Vaccination and Immunization (JCVI) stated that the vaccine, Bexero, was not cost-effective and advised the NHS not to adopt it. Professor David Salisbury, the director of immunization at the Department of Health, suggested that more evidence of the vaccine’s effectiveness is needed.
A new report released by HHS Secretary Kathleen Sebelius demonstrates that competition in the Health Insurance Marketplace lowers premiums by nearly 20 percent. This suggests that consumers will have better coverage at a lower cost in 2014 due to reforms in the Affordable Care Act.
With shortages in primary care providers in the United States, the Department of Health and Human Resources announced that $12 million in Affordable Care Act funding will go towards primary care residency programs in 32 Teaching Health Centers across the nation, doubling the number of residents this year over last year.
A year since the death of a 16-year old girl who was denied chemotherapy when diagnosed with leukemia while pregnant, women’s rights campaigners have filed a lawsuit on behalf of the girl’s mother, Rosa Hernandez, against the doctors and hospitals responsible for her care in the Dominican Republic. The nation bans abortions in all circumstances, even when the mother’s life or health is endangered. Treating the cancer with chemotherapy would possibly kill the fetus, regarded as a crime in the country.

ART, lesbians and justice in the distribution of health care

July 24, 2013July 24, 2013 pdelora 4 Comments

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

July 23, 2013July 17, 2018 arid Leave a comment

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:

Month: July 2013