Category: Michelle Meyer

Whose Business Is It If You Want To Induce a Bee To Sting Your Penis?

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Photo source: WikiMedia Commons

By Michelle Meyer

You might think that the answer to this question is obvious. Clearly, it’s your business, and yours alone, right? I mean, sure, maybe it would be considerate to discuss the potential ramifications of this activity with your partner. And you might want to consider the welfare of the bee. But other than that, whose business could it possibly be?

Well, as academic empiricists know, what others can do freely, they often require permission to do. Journalists, for instance, can ask potentially traumatizing questions to children without having to ask whether the risk to these children of interviewing them is justified by the expected knowledge to be gained; academics, by contrast, have to get permission from their institution’s IRB first (and often that permission never comes).

So, too, with potentially traumatizing yourself — at least if you’re an academic who’s trying to induce a bee to sting your penis in order to produce generalizable knowledge, rather than for some, um, other purpose.

Yesterday, science writer Ed Yong reported a fascinating self-experiment conducted by Michael Smith, a Cornell graduate student in the Department of Neurobiology and Behavior who studies the behavior and evolution of honeybees. As Ed explains, when, while doing his other research, a honeybee flew up Smith’s shorts and stung his testicles, Smith was surprised to find that it didn’t hurt as much as he expected. He began to wonder which body parts would really smart if they were stung by a bee and was again surprised to learn that there was a gap in the literature on this point. So he decided to conduct an experiment on himself. (In addition to writing about the science of bee stings to the human penis, Ed is also your go-to guy for bat fellatio and cunnilingus, the spiky penises of beetles and spiders, and coral orgies.)

As Ed notes, Smith explains in his recently published paper reporting the results of his experiment, Honey bee sting pain index by body location, that

Cornell University’s Human Research Protection Program does not have a policy regarding researcher self-experimentation, so this research was not subject to review from their offices. The methods do not conflict with the Helsinki Declaration of 1975, revised in 1983. The author was the only person stung, was aware of all associated risks therein, gave his consent, and is aware that these results will be made public.

As Ed says, Smith’s paper is “deadpan gold.” But on this point, it’s also wrong. Read More

Update on Litigation in Looney v. Moore (SUPPORT Trial Class Action)

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By Michelle Meyer

For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.

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Would Marlise Munoz’s Fetus Have Survived? Should It Have?

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By Michelle Meyer

This is post is part of The Bioethics Program’s ongoing Online Symposium on the Munoz and McMath cases, which I’ve organized, and is cross-posted from the symposium. To see all symposium contributions, in reverse chronological order, click here.

Had the hospital not relented and removed the ventilator from Marlise Munoz’s body, could the Munoz fetus have been brought to term, or at least to viability? And if so, would the resulting child have experienced any temporary or permanent adverse health outcomes? Despite some overly confident commentary on both “sides” of this case suggesting a clear answer one way or the other—i.e., that there was no point in retaining the ventilator because the fetus could never be viable or was doomed to be born with catastrophic abnormalities; or, on the other hand, that but for the removal of the ventilator, the “unborn baby” was clearly on track to being born healthy—the truth is that we simply don’t know.

Before getting into the limited available data about fetal outcomes in these relatively rare cases, a bit of brush clearing. The New York Times juxtaposed reports about possible abnormalities in the Munoz fetus with the hospital’s stipulation about the fetus’s non-viability in ways that are likely to confuse, rather than clarify:

Lawyers for Ms. Muñoz’s husband, Erick Muñoz, said they were provided with medical records that showed the fetus was “distinctly abnormal” and suffered from hydrocephalus — an accumulation of fluid in the cavities of the brain — as well as a possible heart problem.

The hospital acknowledged in court documents that the fetus was not viable.

Whether intentionally or not, the nation’s newspaper of record implies — wrongly, I think — that the hospital conceded that the fetus would never be viable because of these reported abnormalities. In court, the hospital and Erick Munoz stipulated to a series of facts, including that Marlise was then 22 weeks pregnant and that “[a]t the time of this hearing, the fetus gestating inside Mrs. Munoz is not viable” (emphasis added). The hospital conceded nothing at all about any fetal abnormalities. In short, the Times, and many other commentors, have conflated “non-viability” as a function of gestational age with “non-viability” as a way of characterizing disabilities that are incompatible with life. As I read this stipulation, the hospital was not at all conceding that the fetus would never have been viable, had the ventilator remained in place. Rather, given the constitutional relevance of fetal viability, the hospital was merely conceding the banal scientific fact that the Munoz fetus was, at 22 weeks, not currently viable. There is nothing surprising in the least about the hospital’s “concession” about “viability” in the first sense, above: 22-week fetuses are generally not considered viable. Read More

Online Symposium on Munoz and McMath Cases

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By Michelle Meyer

UPDATE: Following Friday’s court order (discussed below), the hospital today (Sunday, Jan. 26, 2014) removed the ventilator from Marlise Munoz, who has met the criteria for brain death since Nov. 28, 2013.

Two high-profile, rapidly evolving cases involving death by neurological criteria — better known as “brain death” — raise vexing and sometimes novel legal, ethical, and medical questions at the edges of life and death. I’m organizing an online symposium on these cases over at The Bioethics Program Blog, and will be cross-posting my contributions here, beginning with this introduction to the symposium, which brings readers up to date with legal developments through today. Please contact me if you’re interested in participating.

The Marlise Munoz Case

On November 26, 2013, Erick Munoz found his wife, Marlise, unconscious on their kitchen floor. She was then 14 weeks pregnant with their second child. Erick resuscitated her and she was transported, alive, to John Peter Smith Hospital, where she was placed on a ventilator to assist her breathing and given other life-sustaining treatment. Not long thereafter, however, Erick says that the hospital told him that Marlise was brain dead.

Although Marlise did not have a written advance directive, according to Erick, both he and Marlise had

worked as paramedics during their marriage, and thus were knowledgeable of and had personally witnessed injuries that resulted in death, including brain death. Erick and Marlise frequently discussed their requests, beliefs and desires with each other, and expressed clearly to each other, family members and friends, their respective desires not to be resuscitated should either of them become brain dead.

Erick requested, with the “full support” of Marlise’s parents, that the ventilator be removed from her body and that he be given possession of it for burial.

The hospital refused. It argued that § 166.049 of the Texas Advance Directives Act (TADA) — which provides that “a person may not withdraw or withhold life-sustaining treatment under this subchapter from a pregnant patient” — prohibits it from removing the ventilator. It was not entirely clear whether the hospital believed that Marlise was in fact dead or not. The media was reporting as late as December 24 that the hospital had said that Marlise was in “serious condition,” and the hospital had not released Marlise’s medical records, which Erick said would show a diagnosis of brain death, to him.

After the jump, this week’s developments in the Munoz case, the McMath case, and a list of symposium participants.

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My Comments on HHS’s Proposed Rule Criminalizing Trade in Blood Stem Cells

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Professor Nalini Ambady (1959-2013)
Professor Nalini Ambady (1959-2013)

By Michelle Meyer

Bonjour de Toulouse, where I’m visiting this month at the Institute for Advanced Study (IAST), which is hosted by the Université de Toulouse Capitole and physically (and in many senses conceptually) situated inside the Toulouse School of Economics. That setting is a particularly good one for this post on markets in human tissue.

In early October, I wrote about a rule that the Department of Health and Human Services has proposed that would amend the National Organ Transplant Act (NOTA) to criminalize compensation for providing peripheral blood stem cells (PBSCs) given through apheresis. Compensating those who allow their bone marrow to be aspirated — the other major source of hematopoietic stem cells (HSCs) — is already explicitly criminalized under the statute. At the end of the post, I promised to follow up with a second post on why I’m skeptical about this rule, as a matter of policy. This is that post.

But before discussing appropriate policy for addressing the problem of the 3,000 Americans who die each year for want of a bone marrow transplant, and for reasons I’ll explain near the end of my post, I want to say something about one particular person: Professor Nalini Ambady, a Stanford social psychologist who, about one year ago, began an international search for a compatible, willing HSC donor to treat her leukemia.

Because she is South Asian, and because few Asians and other racial and ethnic minorities are listed in the U.S. bone marrow registry — South Asians comprise only 2% of the U.S. registry — she had a difficult time finding a match. She nevertheless found 12 potential matches in the U.S. bone marrow registry, and apparently at one point had scheduled the transplant. In the end, however, half were ruled out as imperfect matches — and each of the remaining six matches declined to donate.

Having exhausted the U.S. registry, Ambady and her supporters sought a match in South Asia registries — but even fewer people are registered in that region than in the U.S. Of India’s 1.2 billion people, for example, only about 45,000 are registered. Nevertheless, a potential thirteenth match was found in an Indian registry. He matched at least 6 of 10 HLA markers; he would need a blood test to determine whether he was a complete match. Unfortunately, after a worrisome week of silence about whether he was indeed a complete match, Ambady and her family learned that the potential donor had backed out.

And then a potential fourteenth match:

Weeks later, it happened with another potential match for Nalini, this time an 8/10 and so an even likelier match. This man wanted to watch someone else donate their bone marrow before making up his mind. A registry chief actually arranged this for him in early May. Somehow, it wasn’t persuasive enough. He, too, decided not to donate.

Professor Ambady died on October 28 after eight compatible or potentially compatible registered donors ultimately declined to donate.

Apparently, declining to donate after agreeing to be listed in a registry and being found to be a match is quite common. According to one registry chief, the attrition rate is 50% in the U.S., Europe, and India. Would a financial incentive have tipped any of these vaccillating prospective donors towards a decision to donate? Although we can’t say, this is an eminently answerable question. Unfortunately, the Department seems uninterested in learning whether a compensation scheme would save lives — or have ill or counterproductive effects — or not.

In its Notice, the Department lists the following policy reasons for expanding NOTA’s list of “organs,” the exchange of which for valuable consideration is prohibited, to include PBSCs: (1) preventing commodification; (2) curbing opportunities for coercion of PBSC providers and (3) exploitation of PBSC recipients; (4) encouraging altruistic donations, and (5) decreasing the likelihood of disease transmission resulting from paid donations. My responses to these arguments are after the jump. I end with some thoughts about alternative policy tools for increasing the supply of PBSCs in the absence of a legal compensation scheme.

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In Memoriam: Adrienne Asch

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By Michelle Meyer

I’m sorry to report that Adrienne Asch, director of the Center for Ethics at Yeshiva University and the Edward and Robin Milstein Professor of Bioethics, died yesterday of cancer. A social psychologist by training (but no relation to Solomon Asch), Professor Asch’s scholarly focus was the ethical, legal, and social implications of human reproduction, especially as it intersects with disability studies. An interdisciplinary scholar (as most bioethicists are), she taught courses at Wurzweiler School of Social Work, Cardozo School of Law, and Albert Einstein College of Medicine.

I didn’t always agree wth Adrienne, but she was an important scholar. As Sam Bagenstos noted, her death is “a huge loss for the disability world.” Among other things, she challenged pro-choice scholars and activists to rethink the implications of some of their policies and theories for people with disabilities in present and future generations. Here is one example of many.

Adrienne was also a lovely person. Some years ago, I picked her up from Wellesley (where she then taught) and drove her to Dartmouth (where I was a college senior) for a brief visit. It was, from start to finish, an epic fail on my part. In my defense, her assistant gave me terrible directions, I was then unfamiliar with the joy that is Boston rush “hour” traffic (including the fact that it begins at 3pm and lasts until 7pm), and this was before either cell phones or GPS. Nevertheless, what was supposed to be a three-hour drive that left time for her to change clothes at the hotel before her first talk became a four-hour tour during which I grew increasingly anxious about the prospects of getting her to the church on time, as it were. Adrienne was blind (hence my driving her), and this raised the additional issue of what to tell her, and when, about our travels. Ever the intellectual and mentor, as soon as she got into the car, she wanted to hear about the honors thesis I was writing. Alas, I turned out to be utterly incapable of navigating Boston’s traffic and discussing French existentialism at the same time, and soon we were hopelessly lost. I stopped at a gas station for directions (remember when you had to do that?), but by then we had hit rush hour traffic. We finally reached the highway and I managed to make up some time. As we discussed all manner of topics bioethical, I did the math and figured that if I, ahem, flirted with the speed limit, I could just have her to her talk on time.

The New Hampshire state police were not accommodating of this plan, however. Mere yards from our final exit I saw flashing lights in my rearview mirror. Feeling the car slowing down as I pulled over, Adrienne asked brightly, “Oh, are we there?” Mortified, I told her that no, in fact, I was being pulled over for speeding and that we would now certainly be at least a few minutes late for her talk. She would have been well within her rights to be furious with me, but was instead remarkably understanding. (The administrative director of Dartmouth’s Ethics Institute, by contrast, chided me for acting unethically by speeding.) Here‘s a great interview with Adrienne that captures some of her personality, as well as her views about disability and her experiences living with a disability.

Yeshiva University’s notice of Adrienne’s death, along with funeral and shiva details, is here. Tributes are being collected here. She will be missed.

[Cross-posted at The Faculty Lounge]

Twitter Round-Up 11/5

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The Affordable Care Act continues to be a popular topic of discussion amongst Bill of Health contributors, who also recently touched on issues of drug approval, vaccine improvements, and provider decision making.

Frank Pasquale tweeted an article about the extremely low-cost health insurance policies that will be available to some people under the Affordable Care Act. Millions of people will be eligible for free-premium plans, but an associated risk is that people will opt for these at the expense of plans that cover necessary care. (11/4)

Art Caplan tweeted his agreement with Robert Kuttner’s blog post about the Affordable Care Act. Building on private insurance was a mistake, according to Kuttner, whereas simply extending Medicare would have been a more favorable approach. (11/4)

Art Caplan also tweeted the results of a new study from Costa Rica suggesting that just one dose of the HPV vaccine might be enough to protect women from the virus. In his tweet, Caplan suggests that such a change might make the vaccine, which is currently taken in three doses, more widely accessible around the world. (11/4)

Michelle Meyer posted an article about the difficult balance between the FDA approval process and patient needs. The author describes his experience as part of a promising trial for a treatment for polycystic kidney disease, only to be let down by the Administration’s decision not to approve the drug. (11/2)

Frank Pasquale tweeted the results of a study revealing that half of clinical decision support (CDS) alerts are inappropriately overridden by providers. CDS alerts highlight things like patient allergies, drug interactions, etc., and can be potentially dangerous when erroneously ignored. (11/3)

Amitabh Chandra posted an article comparing the rollout of the Affordable Care Act to that of Massachusetts’s healthcare program in 2006. The author highlights, among other things, differences in the laws themselves, the websites designed to implement them, and the political context of the time. (10/30)

Twitter Round-Up 10/9

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By Sara Providence

This round-up features our bloggers’ key tweets from the past two weeks, ranging from the Affordable Care Act to issues of life and death:

Frank Pasquale tweeted the article, “40 Percent of Doctor Practices Unsure About Obamacare Exchanges.” According to the author, more than 80% of doctors participating in a study were unsure about how they would be paid by the exchange plans, and 40% don’t know if they’ll accept the plans at all. (10/8)

Art Caplan posted the article “Euthanasia for emotional pain: Mercy or a ‘culture of death’?” The harrowing piece continues the conversation about the ethics of assisted suicide, this time through the lens of a transgender man’s story. (10/7)

Frank Pasquale tweeted the article “When the Machine That Goes Ping Causes Harm: Default Torts Rules and Technologically-Mediated Health Care Injuries.” In the piece, author Nicolas Terry discusses the liability questions brought to light by the increased use of technology in healthcare delivery. (10/7)

Michelle Meyer tweeted a blog post by Josiah Neeley, called “How to Avoid Defaultmageddon: Randomize Obamacare.” Written before the government shutdown, it discusses the potential utility of allowing the Affordable Care Act to continue as planned in some states but not in others, in order to observe its effects. (10/3)

Richard Epstein tweeted his piece, “Government overreach threatens lives.” In light of an appeal of the 2012 decision in Regenerative Sciences LLC v. United States, he expresses the opinion that the FDA’s decision to review each individual stem cell procedure performed is bad policy. (10/2)

Stephen Latham tweeted about his appearance on the Melissa Harris-Perry show on MSNBC. He was featured as a discussant in a conversation about the book “Knocking on Heaven’s Door: The Path to a Better Way of Life” by Katie Butler, which addresses the idea that a longer life is not necessarily a better one. (9/28)

HHS Proposes Rule to Amend NOTA, Nullify Flynn v. Holder

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By Michelle Meyer

On October 2, in the midst of the government shutdown—either HHS somehow managed to convince itself that the rule was “necessary for the protection of life” or, more likely, it had already been scheduled for printing—HHS quietly published a Notice of Proposed Rulemaking. The proposed rule would effectively moot the recent Ninth Circuit case of Flynn v. Holder by criminalizing the compensation of bone marrow donors, even when the life-saving stem cells are extracted through a newer, minimal risk procedure. In this post, I’ll explain the medicine, the Ninth Circuit’s decision, and what HHS proposes to do in response. In my next post, I’ll have some reaction to HHS’s policy arguments, about which I’m skeptical, and perhaps a few thoughts about where plaintiffs might go from here.

Section 301 of the National Organ Transplant Act (NOTA) of 1984 criminalizes the transfer of “human organs” for “valuable consideration.” Reimbursement of reasonable out-of-pocket expenses associated with travel and lost wages are okay—as are, since the 2008 amendment of NOTA, paired living donor chains—but any other “valuable consideration” that might incentivize sources of organs is not. Under NOTA, as amended,

‘human organ’ means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ (or any subpart thereof, including that derived from a fetus) specified by the Secretary of Health and Human Services by regulation

(emphases added). HHS has since added to this list “intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.”

So-called “bone marrow transplants”—in reality, infusions of hematopoietic (blood) stem cells (HSCs)—are often life-saving procedures for those with, for example, leukemia or aplastic anemia. (See these sobering statistics compiled by the Institute for Justice, which represented the plaintiffs in Flynn.) When NOTA was passed, the only way to obtain HSCs was through bone marrow aspiration using a long needle thick enough to suck liquid marrow directly from the donor’s pelvic bone. HSCs are then harvested from the marrow. The procedure is done under general anesthesia and so the donor is subject to the usual risks of anesthesia. Although the donor can return to usual activities in two to seven days, discomfort may linger for up to two weeks. Read More

The Troubled Peer Review System, the Open Access Wars, & the Blurry Line Between Human Subjects Research & Investigative Journalism

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By Michelle Meyer

Legal academics who work across disciplines sometimes find themselves in the uncomfortable position of explaining to their stunned colleagues the process by which second- and third-year law students, armed with author c.v.s, decide what gets published and where.

Well, get ready to get your schadenfreude on. For the past 10 months, John Bohannon, a contributing correspondent for Science magazine, has been conducting a sting of (other) science journals and their peer review processes. Much like the famed Sokal hoax, Science submitted to 304 journals a bogus paper written by a fictitious researcher from a nonexistent institution. The paper described “the anticancer properties of a chemical that [the fictitious researcher] had extracted from a lichen,” and according to Bohannon, “[a]ny reviewer with more than a high-school knowledge of chemistry and the ability to understand a basic data plot should have spotted the paper’s short-comings immediately” and rejected it promptly. And yet, over half of the journals accepted the paper. Recall that the bogus paper purports to report on the discovery of the anticancer properties of lichen. Let the prospect of bogus cancer research published in peer reviewed medical journals sink in.  Read More