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.
The most sophisticated medical technologies are available in the United States. The luxury afforded elite health care consumers is best captured by “executive health care” and “personalized” medicines. Given the tailored health care afforded top-tier health care consumers, consciously or unconsciously those at the other end of the spectrum might be overlooked.
For example, the Centers for Disease Control and Prevention issued a report this year that places some US states in the range of Third World countries for health outcomes with mothers and babies. The report, Infant Mortality Statistics From the 2008 Period Linked Birth/Infant Death Data Set, exposes a sad reality; race disparities persist in medicine. The neonatal mortality rate of African Americans is about 2.5 times that of whites. What’s more—class matters. But here’s the interesting part. Class matters at both ends of the scale.
The report exposes how Mississippi, the nation’s poorest state, leads the nation in babies that will die before reaching their first birthday. According data collected by CNN, “for every 1,000 Mississippi babies born in 2011, 9.4 died before their first birthday.” One reporter found that such data “makes Mississippi’s infant mortality rate more comparable to countries such as Costa Rica (9.2), Sri Lanka (9.5) and Botswana (10.5) than the United States (6.0).” The common answer to the challenges of infant mortality looks toward poverty—and in part such analysis is right. However, wealth matters too and sophisticated reproductive choices can lead to dangerous outcomes. One of the leading causes of infant mortality is womb-crowding caused by multiple gestations, which has dramatically increased as a byproduct of assisted reproductive technologies. Those who can afford these sophisticated technologies are usually upper-income individuals, who can afford the multiple rounds of treatments, which are usually required before a pregnancy results. In fact, ART related births are associated with the 100-fold increase in higher order births in the United States. Low birth-weight, one of the leading causes of infant distress, is a common feature of multiple births—as are pre-term deliveries. As we think about solutions to these challenge public health concerns, it will be important to look at both ends of the socio-economic scale.
[Ed. Note. 11/12/12: Just to be clear, retweeting should not be read as an endorsement of or agreement with the content of the original tweet.]
With Election Day now come and gone, our bloggers were tweeting this week about the results, in addition to the greater happenings in health law and ethics. Read below for this week’s round-up:
Arthur Caplan (@ArthurCaplan) retweeted a post about the recent clinical trial done on chelation, a “fringe” heart disease treatment whose popularity often hinges on a patient’s distrust of conventional medicine. Evidence of the treatment’s effectiveness looks to be marginal, at best. (11/4)
Michelle Meyer (@MichelleNMeyer) retweeted an article that explained the problems in the intersection between neuroscience and law, namely how emerging technologies in neuroscience are not being used appropriately to understand criminal behavior. The author advocates for a renewed look at how neuroscience and law can work together, not only to evaluate defendants effectively, but also to customize plans that can serve the interests of both the defendant and the public. (11/5)
Dan Vorhaus (@genomicslawyer) linked to a new piece he co-authored on clinical data and genetics, entitled “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?” (11/6)
Michelle Meyer (@MichelleNMeyer) aptly summarized the results of Massachusetts’ ballot questions with her tweet: “Sick folk in MA can now smoke pot but, it seems likely, not have the aid of their doc in controlling the timing & nature of their death.” (11/6)
Daniel Goldberg (@prof_goldberg) linked to a study done on children with epilepsy and their families. Goldberg noted that the study’s results indicate a serious “ethically pernicious” problem that in fact worsens the condition of those afflicted with epilepsy more so than may be originally perceived: stigmatization. (11/7)
Frank Pasquale (@FrankPasquale) tweeted a blog post that talked of the need to increase the FDA’s power in order to curb the fungal meningitis outbreak now affecting individuals nationwide. Lamentations of the state-based system’s inability to handle the problem had undertones of concern for future situations similar to this one sprouting up again. (11/8)
Frank Pasquale (@FrankPasquale) also published a news update from Georgia, where legislators are ending the discount on license renewal prices that had previously been given to motorists who signed up to be organ donors. While many expressed fear that the policy would decrease the number of donors, others in the medical community admitted that there had been no demonstrated link between the policy and increases in donor sign-ups. (11/10)
Here’s the abstract: Can parents who choose not to vaccinate their children be held legally liable for any harm that results? The state of laboratory and epidemiological understanding of a disease such as measles makes it likely that a persuasive causal link can be established between a decision to not vaccinate, a failure to take appropriate precautions to isolate a non-vaccinated child who may have been exposed to measles from highly vulnerable persons, and a death. This paper argues that, even if a parent chooses to not vaccinate a child under a state law permitting exemptions, that decision does not create complete protection against liability for the adverse consequences of that choice.
Countless regulations have been enacted over the past 35 years to protect children from unnecessary clinical testing. Federal regulations, the Belmont Report, and professional guidelines all state that children should be enrolled in clinical trials only when the research is a high imperative. Federal research regulations insist that absent a potential for direct benefit to the participating child, research should take place only if there is “minimal risk” or “minor increase over minimal risk.”
Thus, it was surprising that one year ago, the National Biodefense Science Board (NBSB), an advisory panel to the Secretary of Health and Human Services, recommended that HHS develop and implement a study of pre-exposure anthrax vaccine in pediatric populations. Such a vaccine would subject children to risks with little potential for therapeutic benefit. The matter is now in front of the President’s Commission for the Study of Bioethical Issues, at the request of Secretary Kathleen Sebelius, who in May visited the Commission to ask for advice regarding the ethical issues raised by this potential study. The Commission’s recommendation is expected early next year.
Much of the controversy surrounding anthrax-vaccine testing in the pediatric population relates to the issue of timing. Since the vaccine can be used either prophylactically or as a post-exposure treatment, the government is considering whether children should be tested now to determine safety, efficacy, and dosing levels in a structured, controlled environment, or whether it is best to avoid subjecting children to the risks of the testing and to face an (unlikely) anthrax attack without the knowledge that would be gained from such a study.
In my last post, I puzzled over the boundaries of the state’s right to step in to protect the interests of children over the religious wishes of their parents, prompted by the question of whether it would be appropriate to prophylactically transfuse the child of a Jehovah’s Witness in order to minimize the risk of future harm. As I continue to think about this question, I remain convinced that the boundaries are exceedingly fuzzy and do not necessarily seem to distinguish circumstances in a way that favors action “in the best interests of the child.” Rather, in looking at another situation in which the interests of the child may come into conflict with the religious or other interests of the parent, on the whole, it seems that the decision to intervene rests more on the legal basis for intervention rather than overall promotion of the best interests principle.
Take, for example, the general approach to vaccine refusals by parents. The rights of parents to refuse vaccines for their children, generally, can be grounded in medical, philosophical, or religious objections. Medical exemptions, based on medical contraindications to vaccination, remain the most robust mechanism of parental refusal. All states permit exemption from mandatory vaccination on the basis of medical exemptions. Exemption for medical contraindication is consistent with the best interests principle as vaccination in these cases arguably is not in the best interests of the child. Fewer states permit vaccine refusal on the basis of moral or philosophical objections. In almost all states, excepting Mississippi and West Virginia, parents can refuse vaccines for religious reasons, with states requiring varying levels of support for refusals grounded in religious objection. It seems reasonable that, from the standpoint of protection of individual liberties, states would preference religious beliefs of parents in allowing refusals. Still, when either a religious or philosophical objection are not concurrently accompanied by a medical contraindication to vaccination, neither justification for refusal promotes action in the best interests of the child.
Greenpeace, perhaps best known for its battles at sea to protect whales and the oceans, has gotten itself involved in a huge controversy over genetically modified food.
The group is charging that unsuspecting children were put at risk in a “dangerous” study of genetically engineered rice in rural China. It’s a serious claim, because it is putting research seeking to put more nutrition into food at risk.
Genetically engineered rice has the potential to help solve a big nutritional problem—vitamin A deficiency. A lack of vitamin A kills 670,000 kids under 5 every year and causes 250,000 to 500,000 to go blind. Half die within a year of losing their sight, according to the World Health Organization. I think Greenpeace is being ethically irresponsible and putting those lives at continued risk.
In the intensive care unit, almost every decision can be made into life or death. For some children whose parents are Jehovah’s Witnesses the need for a blood transfusion becomes quite literally a life or death decision. As clinicians, we struggle with maintaining a relationship with the family, while advocating for what we believe is in the best interests of a sick child. Asking a family taxed by the knowledge that their child is critically ill to step back and to choose to sin to save the life of their child or instead to choose death seems impossible; and, usually, we don’t expect families to make this decision. In many situations where a blood transfusion is required to protect a child from what is thought to be imminent death, a variety of approaches have allowed hospitals and courts to remove decision making power from the family to permit blood transfusion of a child against the family’s religious beliefs.
Decisions over transfusion of Jehovah’s Witness children are not new. A long line of cases dating to the late 1960s examines the balance between parental domain over decisions for their children and the interest of the state to protect the best interests of children. Since the 1960s, the debate has taken many forms. In life threatening situations, precedent allows doctors and hospitals to take some form of protective custody over a child in order to do what is thought to be best for the child. Early iterations of the debate focused on state intervention into the private sphere of the family only when the medical community agreed on the proposed intervention, the intervention would be the right decision for the child, and the child would face imminent death without the intervention. The justification for this approach is that while parents are generally best suited to determine what is in the best interests of their children, when the parents beliefs endanger a child’s future ability to decide for himself, the state can step in to protect the future interests of the child.
The decision to allow transfusion of children of Jehovah’s Witnesses over the wishes of their parents, however, is not universal. Continue reading →