By Frances M. Kamm, Littauer Professor of Philosophy and Public Policy at Harvard’s Kennedy School of Government, Professor of Philosophy in the Harvard University Faculty of Arts and Sciences, and Petrie-Flom Academic Fellow alumna
This book is a collection of Frances M. Kamm‘s articles on bioethics, which have appeared over the last twenty-five years and which have made her among the most influential philosophers in this area. Kamm is known for her intricate, sophisticated, and painstaking philosophical analyses of moral problems generally and of bioethical issues in particular. This volume showcases these articles – revised to eliminate redundancies — as parts of a coherent whole. A substantive introduction identifies important themes than run through the articles. Section headings include Death and Dying; Early Life (on conception and use of embryos, abortion, and childhood); Genetics and Other Enhancements (on cloning and other genetic technologies); Allocating Scarce Resources; and Methodology (on the relation of moral theory and practical ethics).
Additional information and registration available online.
The neonatal SUPPORT trial, which randomized extremely low birth weight infants to lower or higher levels of oxygen saturation as part of their ventilator management raised ethical issues that are turning out to be among the most controversial topics in research ethics in many years. Continue reading →
Are you doing enough to make sure that your patients and their kids are getting vaccinated? Sometimes we leave this for the pediatrician to worry about, but I think that every doctor who sees patients should make it a part of taking the history to ask if they are up to date on vaccinations. Have they gotten their boosters? What are they doing with their kids?
All over the United States, we are tragically seeing the recurrence of diseases that weren’t here 20 years ago. Whooping cough, mumps, and measles are all on the rebound because people don’t vaccinate their kids or they don’t get the booster shots that they need to grant immunity to themselves.
In “Company seeks to make sperm banks safer,” a recent article in the Boston Globe, Bill of Health blogger Dov Fox recently weighed in on new companies that propose to screen sperm donor DNA in an effort to reduce the chance that children conceived with donated sperm will have childhood genetic diseases:
Dov Fox, an assistant professor at the University of San Diego School of Law who studies bioethics, said it is unclear whether genomic understanding will evolve to allow testing such as GenePeeks offers to ever be informative for common diseases caused by a blend of genetic and environmental risk factors. And he, like others, worries that one day such technology will be extended to not just avoiding disease, but selecting the babies parents want. GenePeeks will not cross that line, Morriss said.
As public health concerns over obesity and diabetes continue to rise, physicians, public health organizations, and medical educators are thinking out of the box — and into the kitchen and grocery store. Two stories done by NPR this week feature programs aimed to increase physician influence in patient dietary choices. The first article describes Wholesome Wave, a program in which a physician writes a “prescription” for fruits and vegetables in the form of a voucher for overweight or diabetic children (and their families). The second article reports on a collaboration between Tulane University School of Medicine and Johnson & Wales University College of Culinary Arts. The hope for the two schools is for both groups of students to learn more about nutrition.
Hearing these two stories reminded me of work I did as a student at the Harvard Legal Services Center, working with the Mississippi Food Policy Council to get food stamps accepted at farmers’ markets and improve access to fruits and vegetables. Most would agree (including Michelle Obama) that providing access to fruits and vegetables in “food deserts” is a laudable goal, but I’m struck by the way in which “prescriptions” for healthy foods versus providing access to healthy food changes the level of autonomy patients have in choosing what they eat.
Couple programs like Wholesome Wave with the ACA’s increased incentives for wellness programs, and I wonder how much a doctor, employer, or insurance plan may dictate consuming that one apple (or bunch of kale) per day. As Professor Matt Lamkin described in his work last year, some employer insurance plans contain high deductibles ($4,400 in the example he describes) that are much lower ($400) if a wellness plan is followed, which often includes following a doctor’s recommendations. In the example Lamkin uses, a patient must choose between continuing unpleasant chemotherapy or paying thousands dollars more to satisfy the obligations of a higher deductible. What if patients want to toss out a doctor’s “prescription” for kale and grab a KitKat instead?
While combating obesity and diabetes is of tantamount importance, how much outside influence over what we eat (or what our children eat) is too much influence? I’m not sure where I come down on this issue, but it gives those of us simultaneously concerned with public health and patient autonomy something to chew on . . .
As the world watched Prince William place the new royal baby, reluctantly snug in his car seat, into a vehicle a few weeks ago, my thoughts were not limited to, “Oh, how cute!” After two months researching and collecting a dataset to capture the U.S. laws and regulations for child passenger restraint systems, I also thought, “I wonder if he took a class and knows how to do that correctly?” Perhaps an odd thought, but misuse and faulty installation of child restraint systems is actually a major concern.
According to the CDC, proper restraint use can reduce the risk of death or injury by more than 50 percent. Yet, ongoing studies by the National Highway Traffic Safety Administration (NHTSA) are finding that as many as 20 percent of drivers with child passengers are not reading any of the instructions regarding proper installation, while 90 percent of drivers of child passengers are reporting that they are confident that they are properly installing and using child restraint systems.
Less than an hour ago, Indianapolis prosecutor, Mr. Terry Curry agreed to drop first degree murder charges against Bei Bei Shuai in an agreement that required her to plead to a misdemeanor. The case was a month away from trial in what would have been the first prosecution of a pregnant woman in Indiana for attempting suicide. Ms. Shaui ate several packets of rat poison in a desperate attempt to end her life after being abandoned by her boyfriend. After being saved by friends and doctors, prosecutors filed first degree murder charges against Shuai, because her baby died.
Bei Bei Shuai’s case highlights the turn to criminal prosecution in fetal protection cases as a terrible national phenomenon. Shuai was spared the horrible fate experienced by poor women, many of color, across the U.S., including Regina McKnight, Paula Hale, Melissa Rowland, and others. In a forthcoming article to be published in the California Law Review, I argue that these prosecutions represent the new constitutional battlefronts as they burden pregnant women’s due process interests while also imposing the type of cruel and unusual punishment disallowed by the Eighth Amendment. I have argued in prior works found here and here that such prosecutions often involve racial profiling and create hierarchies among women’s pregnancies. Indeed, most often the pregnant women targeted for threatening harm to their fetuses are so poor that they lack adequate legal representation, relying on overworked public defenders who make valiant efforts, but lack the economic wherewithal to properly aid in these cases. Shuai’s case was different in that she had Linda Pence, a valiant, private attorney, who spent over two years providing excellent pro-bono legal aid.
Bei Bei Shuai’s release from murder charges also represents another victory for Advocates for Pregnant Women, the leading organization advocating on behalf of indigent pregnant women.
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.
A case from the employment discrimination world that might be of interest to health law folks is EEOC v. Houston Funding II, Ltd., 2013 U.S. App. LEXIS 10933 (May 30, 2013). The employee in the case, Donnicia Venters, was told that her position had been filled when she returned to work post partum and requested to use space in a back room to express milk. The issue in the case was whether firing Venters for expressing breast milk is sex discrimination under Title VII of the Civil Rights Act. The district court had concluded that it was not, as a matter of law, and the 5th Circuit reversed. Although at first glance this outcome is apparently a favorable one for women and children, it also reveals ongoing mismatches between anti-discrimination law in the US and the health needs of workers and their families.
The relevant detail of employment discrimination law is that the Pregnancy Discrimination Act (PDA) provides that discrimination “on the basis of” or “because of” sex includes discrimination on the basis of or because of “pregnancy, childbirth, or related medical conditions.” In holding that breastfeeding is a related medical condition of pregnancy, the 5th Circuit stated “Lactation is the physiological process of secreting milk from mammary glands and is directly caused by hormonal changes associated with pregnancy and childbirth.” Thus, on the 5th Circuit’s plain meaning interpretation of the statute, breastfeeding is within the PDA.
Other courts have reached conclusions less favorable to breastfeeding. The district court in Colorado wrote thus in deciding that a refusal to give breaks for breast feeding was not sex or disability discrimination: “A plaintiff could potentially succeed on a claim if she alleged and was able to prove that lactation was a medical condition related to pregnancy, and that this condition, and not a desire to breastfeed, was the reason for the discriminatory action(s) that she suffered.” Falk v. City of Glendale, 2012 U.S. Dist. LEXIS 87278 (D. Colo. 2012). Indeed, understaffing at the Glendale police department was so severe that no one was able to take breaks, even to use the restroom—so the court concluded that Falk’s problem was equal opportunity bad working conditions, not sex discrimination. Continue reading →
UPDATE: A class action lawsuit has been filed in federal court against UAB providers and IRB members on behalf of infants enrolled in the SUPPORT study (through their parents). The Amended Complaint, which was filed May 20, can be found here. In addition, here are two more sets of reactions to the SUPPORT study in the NEJM, both in defense of it, from a group of prominent bioethicists and from NIH. Here is a new post from John Lantos at the Hasting Center’s Bioethics Forum blog. And here is coverage of the most recent developments in the New York Times. I’ll continue to aggregate links as warranted.
Regular readers may recall that recently, OHRP sent a determination letter to one of multiple sites (the University of Alabama at Birmingham (UAB)) involved in an RCT (the SUPPORT study) of optimal oxygen levels for premature infants (prior coverage here, here, and here). OHRP’s criticism itself led to considerable criticism among many research ethicists and physician-researchers (see, e.g., here, here, and here), as well as the SUPPORT researchers themselves (here), while others defended OHRP to varying degrees (here, here, and here).
Now, in a new letter to UAB, OHRP clarified that it has no objections to the study design; its objections, instead, pertain to what parents were told in the informed consent documents. Then, in a remarkable move, it announced that it is suspending its compliance actions against UAB, and plans no further action vis-a-vis other SUPPORT sites, pending its issuance of new guidance to address the risks that must be disclosed when conducted clinical trials like SUPPORT. OHRP promises not only the usual notice and comment period following the draft guidance but also an open public meeting, presumably in advance of the draft.
As of Friday, June 28, this post is closed to further comments. We want to thank the many readers who have engaged in a vigorous and civil discussion on the recent posts to the Bill of Health that engage questions related to the debate over vaccines. In general, we do not moderate discussions on the site. However, due to an increasing number of comments that violate our policies regarding abusive and defamatory language and the sharing of personal information, we are closing these posts to comment.
In President Obama’s State of the Union address, he discussed creating affordable pre-school to all children. Studies have shown that early childhood education is associated with academic success. This is an important policy initiative; it’s also very expensive.
In an effort to reduce the disparity in the academic profiles of children, there may be some initiatives that can be started while the proposal for publicly funded early childhood education works its way through Congress. One approach that is being tested is talking to your baby.
A recent NY Times article described a scientific study concerning how talking to your baby is correlated with achievements in school. It turns out, according to the article, that low-income parents of children speak fewer words to their babies compared to high-income parents and that by the time the children are of school-age, the children from poorer families have heard millions of fewer words. This means that by the time the child is 3, they have heard 10s of millions of fewer words and the article suggests that this is correlated with IQ and academic success.
This is an issue that can be addressed! Creative problem solving can be used to create programs to educate lower-income parents to talk more to their babies. The increase in words alone might provide advantages to lower-income children that they didn’t have before. This study provides a good example of the application of a scientific study to address social, health and economic issues.
“[OHRP's] response is disappointing, because it does not take into account either the extent of clinical equipoise at the time the study was initiated and conducted or that the consent form, when viewed in its entirety, addressed the prevalent knowledge fairly and reasonably. At the time, as explained in the principal investigator’s response to the allegations and in a related letter to the editor in the Journal, there was no evidence to suggest an increased risk of death with oxygen levels in the lower end of a range viewed by experts as acceptable, and thus there was not a failure on the part of investigators to obtain appropriately informed consent from parents of participating infants. Through hindsight (and essentially faulting investigators for not informing parents up front of a risk later uncovered by the trial itself), the OHRP investigation has had the effect of damaging the reputation of the investigators and, even worse, casting a pall over the conduct of clinical research to answer important questions in daily practice. . . . The OHRP has a duty to investigate questions of research impropriety, but we strongly disagree with their determination of inadequate informed consent in this case.”
“With regard to SUPPORT, the OHRP is asking that research be described as riskier than it really is and is suggesting that the parents were duped into enrolling their frail infants in dangerous research. Not only is that not true, but it also poses substantial risk to the conduct of valuable comparative effectiveness research both for premature infants and for the general public who continue to face too many treatments where uncertainty prevails about what is best.”
By now, most of you have heard about the controversial study that sought to evaluate how much oxygen to give premature newborns to preserve both their lives and their sight. Below, Laura Stark lays out some of the key details about the study and OHRP’s response, and concludes that part of the problem may have been a result of the difficulties associated with approving multi-site research.
Maybe so, but let me offer a more fundamental challenge: perhaps IRBs are just ineffective – or not as effective as we hope they would be – at protecting human subjects. In retrospect, it looks like all 23 IRBs that reviewed the study, all of which were applying the same regulatory standards, failed to do what OHRP, many news outlets, and as awareness grows, much of the public thinks they ought to have done to protect the babies and families involved in this study. How could they all have gotten it wrong? Are the regulations insufficient? Are the procedures insufficient? Is it all just a matter of interpretation?
These questions lead to another fundamental issue: the lack of empirical evidence on IRB effectiveness. We have data on whether IRBs follow the regulations, data on adverse events, data on OHRP warning letters, data on IRB-imposed research burdens and delays – but these all nibble around the edges of the real questions: what are IRBs supposed to be doing, are they doing it well, and how would we know? The counterfactual – a world without IRB review – is pretty tough to study, but I’m working with a group of colleagues at the Petrie-Flom Center and elsewhere to think through some empirical methods to get at precisely these issues. And we’d love to hear your thoughts!
Finally, as a side note, one point that seems to be getting lost in coverage of this preemie story is that although there seems to have been some major problems with the consent process, the study question itself was a very important one to ask.
Institutional Review Boards are in the top news at outlets such as the New York Times, as a research debacle unfolds. I looked through the documents that are publicly available to figure out what happened and what to expect.
Researchers at 22 universities or hospitals in the US enrolled premature babies in a randomized controlled trial between 2004 and 2009. This was the second part of a broader study, but the first part of the study “raised no concerns” according to the US Office of Human Research Protections on page 2 of its determination letter to the lead institution, University of Alabama-Birmingham. OHRP is the federal agency in charge of enforcing human-subjects regulation.
For the second part of the study, though, OHRP found that all 23 IRBs that approved the study (at 22 research sites) violated federal regulations: IRBs should have made researchers tell the parents that they knew their babies would be at higher risk of death, neurological damage, or blindness if they enrolled in the study (pages 2 and 10 of UAB letter). OHRP has only posted a determination letter for UAB at this point, but it explains that at all of the sites, the agency found violations with consent documents “similar to those described” to UAB. The UAB IRB is in especially hot water because it seems first to have first approved the 2.5-page template consent form, which the other institutions used (page 5). If you read the last page of UAB’s letter, you can make a good guess at who may officially be getting bad news from OHRP soon.
So much of the political and legal debate about reproductive choice centers on abortion. In doing so, these debates obscure so many other reproductive choices women must make. And the choices are not easy—and the stakes are even greater in an era where any prenatal missteps might lead to aggressive state action, including criminal sanctions. There are thorny situations that confront medicine and ethics. For example, how should we think about families that choose to carry terminal fetuses to delivery only for the fetus to expire shortly after birth? Should such pregnancies be terminated early given that doctors and even the intended parents know the fetus will not survive? Where does the law stand on such issues? What is morally permissible?
Thousands of women and families face lethal prenatal diagnoses and perinatal loss every year. In 2006, there were 25,972 reported fetal deaths at twenty weeks or later. An additional 19,041 live-born infants died at less than twenty-eight days. Birth defects such as congenital malformations and chromosomal abnormalities are the leading cause of fetal-infant deaths. Lethal anomalies (i.e., Trisomy 13; anencephaly; hypoplastic left heart syndrome) are a subset of birth defects characterized by a radically shortened lifespan. In 2005, there were 6,925 fetal and infant deaths attributable to lethal anomalies in the U.S.
Advancements in prenatal diagnosis coinciding with improved access to legal abortions create medical options for patients, but also spur challenging ethical questions. For example, therapeutic abortions have become the “management of choice” for many women whose fetuses experience a “lethal condition”. However, termination may not be the preferred choice for all women and families. The concept of perinatal hospice fills this void and offers women valid options after a terminal fetal diagnosis. Although the concept is still relatively novel and unknown in much of the health profession and lay population, the development of perinatal hospice programs is growing.
Perinatal hospice is worth taking seriously. For example, perinatal hospice programs are multidisciplinary and their services begin at the time of diagnosis (rather than death), in recognition of “anticipatory grief,” a term describing the grieving process that begins prior to death when a death is probable or imminent. Those who have used these services say that perinatal hospice provides a supportive environment for parents to grieve and appreciate any time they have with their infant. Further, they say It affirms their role as parents and acknowledges that their loss is “as real” as the loss of any other loved one. Maybe perinatal hospice is a safe place where parents can “be parents.” It’s worth thinking about.
*Allison Whelan is a graduate student, University of Minnesota School of Law and Center for Bioethics
According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.
States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.
When I read Susannah Meadows’s article in last week’s New York Times Magazine, The Boy with a Thorn in His Joints, I was at a bit of a loss how to respond. The article is Meadows’s account of dealing with her son’s juvenile idiopathic arthritis, and describes how, wary of the side effects of the treatment recommended by two well-regarded pediatric rheumatologists, she put her son on an alternative-medicine regime instead. Meadows relates how, on a regimen of probiotics, sour Montmorency cherry juice, fish oil, and something called four-marvels powder, her son underwent a near total recovery.
It should be noted, to her credit, that Meadows goes out of her way to acknowledge the anecdotal character of her experience. And, likewise to her credit, Meadows continued to work with her son’s doctors and take their concerns seriously throughout her son’s experiment with alternative medicine. But in spite of Meadows best journalistic instincts and her thorough reporting, her article perpetuates a dangerous misunderstanding. Throughout her article, Meadows makes an implicit distinction between pharmaceuticals and the substances (cherry juice, fish oil, four marvels powder) she was putting in her son’s body. But here’s the thing: the single most important distinction between the methotrexate her doctors recommended and the four marvels powder she chose to administer to her son is that the former has been proven safe and effective in “adequate and well-controlled investigations,” while the latter is essentially unregulated. The active ingredients in both substances are chemicals with hard-to-pronounce Latin names, the difference is just how much we know about these chemicals.
And that’s the point that Michelle M. Francl, a professor of chemistry at Bryn Mawr College, articulates far more eloquently and forcefully than I possibly could in her recent Slate article: Don’t Take Medical Advice From the New York Times Magazine: The dangerous chemophobia behind its popular story about childhood arthritis. Francl’s article is a must-read, and makes several extremely valuable points, but I particularly want to highlight just one of these. Susannah Meadows is an intelligent and experienced journalist, a wonderful commentator on politics and publishing, and clearly a mother whose love for her children is boundless. But she is not a doctor or a scientist, nor is she even a health or science reporter. Yet her anecdotal account of her own child’s illness is now probably the most widely disseminated article about treating juvenile arthritis ever, and it is one that perpetuates a basic and dangerous misunderstanding about the nature of medicine.
Just a quick note to let you know about a great resource provided by the librarian at Boston Children’s Hospital. Each month, she compiles recent articles related to bioethics in general and pediatric bioethics in particular. You can find her compilations here. Take a look!
This week’s Twitter Round-Up features an “American Idol-style” selection of research grant winners, the problems facing children in Syria attempting to be vaccinated, and a review of where we stand with current patient health information privacy and security.
Michelle Meyer(@MichelleNMeyer) retweeted an article about a newly emerging landmark case in the United Kingdom. In the suit, a childless couple denied IVF funding due to the woman’s age is suing Health Secretary Jeremy Hunt (because he is “ultimately accountable for healthcare in England”) on the basis of age discrimination. Thought to be the first venture to sue the Health Secretary concerning decisions about this NHS fund rationing, this case also will be the first instance where age discrimination laws have been employed to try for fertility treatment. (12/3)
Alex Smith (@AlexSmithMD) shared an article about a problem patients must deal with when approaching post-hospitalization care: Medicare’s offer to pay for hospice care or for a Skilled Nursing Facility (S.N.F.), but only rarely at the same time. Not only does the choice create a financial predicament, but it also has extensive repercussions for the patient’s health. Calls for a combined benefit process between hospice/palliative care and S.N.F. have been made, including a proposed “concurrent care” demonstration project in the Affordable Care Act. (12/6)
Dan Vorhaus (@genomicslawyer) linked to a summary of the Ponemon Institute’s Third Annual Benchmark Study on Patient Privacy & Data Security, reporting on the challenges still being faced to safeguard protected health information (“PHI”). (12/6)
Michelle Meyer (@MichelleNMeyer) additionally retweeted a link explaining Brigham and Women’s Hospital’s attempt to deal with the rising difficulty of choosing which research grants to support: an “American Idol-style” public online voting. With almost 6,500 votes cast, the public engagement experiment picked a project hoping to research methods for integrating genomic sequencing into newborns’ routine medical care. When future grant holders are struggling to award between a set of equally deserving project proposals, this push for public involvement (after having confirmed scientific rigor) may have intriguing implications. (12/6)
Daniel Goldberg (@prof_goldberg) also linked to a study in Denmark testing the relationship between socio-economic status (SES) and blood pressure levels. Despite having a healthcare system that is free and equal-access regardless of factors like SES, the study found that SES had a “significant effect on BP [blood pressure] control” in this survey. (12/7)
Arthur Caplan(@ArthurCaplan) posted a report by UNICEF on the efforts by parents in the Syrian Arab Republic to get their children vaccinated. With many medical centers destroyed by the conflict, and with health practitioners having to operate and transport supplies in the dangerous environment, children have been unable to receive routine vaccinations for several months. This campaign aims to provide such vaccinations (specifically for measles and polio) to children, having advertised via churches, mosques, schools, television, and even by SMS to get greater coverage. (12/7)
Frank Pasquale(@FrankPasquale) included a book review of Pharmageddon by David Healy, a look at how pharmaceutical companies are excessively influencing the medical industry particularly with “diagnostic categories and clinical guidelines.” The result, according to Healy: a society where people “think about their bodies as a bundle of risks to be managed by drugs,” with a workforce that is “getting ‘sicker,’” and with “major pharmaceutical companies…banking on further overdiagnosis and overtreatment,” all “undermining universal health care.” (12/8)
Note: As mentioned in previous posts, retweeting should not be considered as an endorsement of or agreement with the content of the original tweet.