Third World Reproductive Health Outcomes

By Michele Goodwin

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.

Twitter Round-Up (11/4-11/10)

By Casey Thomson

[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)

Art Caplan on Liability for Non-Vaccinators

Art Caplan has a new article out in the Journal of Law, Medicine, and EthicsFree to choose but liable for the consequences: should non-vaccinators be penalized for the harm they do?” (subscription required)

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.

Weighing Risks in a Pediatric Anthrax Vaccine Clinical Trial

by Brendan Abel, JD

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.

Read More

Refusals and Reasons: Is the Best Interests Principle the Best Standard?

By Erin Talati

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.

Read More

Greenpeace Out to Sea on GM Rice Issue

[posted on behalf of Art Caplan]

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.

Read the rest over at NBCNews Vitals.

Pushing the Boundaries: Revisiting Transfusion of Blood Products in the Children of Jehovah’s Witnesses

By Erin Talati

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. Read More