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 (11/11-11/17)

By Casey Thomson

Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, as a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet. With that, read on for this week’s round-up…

  • Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
  • Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
  • Dan Vorhaus (@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
  • Daniel Goldberg (@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
  • Kevin Outterson (@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
  • Daniel Goldberg (@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
  • Dan Vorhaus (@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
  • Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system.  Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)

Study Guide on the Guatemala STD Inoculation Studies

Talk about perfect timing.  Just on the heels of Tuesday’s fantastic event at HLS on the Guatemala STD Inoculation studies (video to come soon), the Presidential Commission for the Study of Bioethical Issues has released A Study Guide for “Ethically Impossible” STD Research in Guatemala from 1946 to 1948.  This is the Commission’s first foray into pedagogy, and an absolutely fantastic way to keep the discussion going.  Be sure to check it out, and to share widely.

Open Access to Health Research: Highlights from the NIH Public Access Policy panel

By Adriana Benedict

As of 2008, the NIH Public Access Policy requires “that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.”  Four years later, approximately 80% of NIH-funded research articles make their way into PubMed Central.  Institutional Open Access resolutions such as Harvard’s Open Access Policy have helped accommodate the NIH Public Access Policy requirements, but Harvard Medical School and Harvard School of Public Health have yet to adopt it.

In May, the Harvard Library Faculty Advisory Council issued a public letter calling on faculty to promote open access scholarly publishing, noting that “Many large journal publishers have made the scholarly communication environment fiscally unsustainable and academically restrictive”.  In a Petrie-Flom Center-sponsored Open Access Week panel (moderated by Open Access Liaisons Scott Lapinski and June Casey), Peter Suber, Amy Brand, Winston Hide and Patrick Taylor discussed the challenges and opportunities for progress towards achieving open access to health research.  Highlights from the panel are presented below, and the video should be available on the Petrie-Flom website shortly.

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Reminder, TODAY – The Guatemala STD Inoculation Studies: What Should We Do Now?

TODAY
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to, and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.

New Data Reports on Learning “Research Integrity”

When it comes to research with human subjects, about 60 percent of faculty members and 50 percent of graduate students learned about ethics through online or print resources according to a recent survey. These data could be seen as good or bad news—depending on how you feel about getting your ethics through online training modules, such as CITI. These stats—and many more measures of ethics—are included in a remarkable new data set collected and made publicly available by the Council on Graduate Schools.

The data set is a great resource. Anyone with a browser can build custom tables that include different variables and topics related to “research integrity.” Users can slice data by fields of training (life sciences, social sciences, etc.) and by rank of researcher (faculty members, postdocs and graduate students).

Here is the punch line on human-subjects training—and a few questions about the data (the CGS has covered questions about methodology covered):

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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)

Using Tissue Samples to Make Genetic Offspring after Death

By Yu-Chi Lyra Kuo

Last month, John Gurdon and Shinya Yamanaka were jointly awarded the 2012 Nobel Prize for Medicine for their research on induced pluripotent stem cells (iPSCs).  iPSCs are capturing the public imagination as embryonic stem cells did fifteen years ago, but without the controversy surrounding the destruction of embryos: iPSCs can be garnered instead from living somatic tissue of an organism at any point in its lifespan–even late adulthood.  Yamanaka’s research has shown that somatic cells can be “reprogrammed” to develop into any kind of cell–including an embryo–speaking to the vast research potential of iPSCs.

In light of the research potential of iPSCs, I wanted to highlight the results of a remarkable study (published last month) where scientists induced iPSCs from mice into primordial germ cell-like cells, and aggregated them with female somatic cells to create mature, germinal oocytes. The team was then able to show that these oocytes, after in vitro fertilization, yield fertile offspring. Essentially, the research team created viable mouse embryos from skin cells, and fertilized them using IVF to produce healthy mice, some of which have already produced offspring of their own.

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The Contraceptives Coverage Saga Continues…

Well, hopefully we’ll know the fate of the ACA by tonight.  But even if President Obama wins, there will still be uncertainty about the fate of the contraceptives coverage mandate.

A number of employers claim that the mandate violates their rights to religious freedom by requiring them to offer free coverage for medical products and services they find objectionable, and the administration has taken a number of steps to offer accommodations.  But as a neutral law of general applicability, the mandate doesn’t violate the First Amendment under SCOTUS jurisprudence, and even under the Religious Freedom Restoration Act, there’s a strong argument that the mandate is ok, either on the grounds that it does not actually impose a substantial burden on religious exercise or that  it is supported by a compelling government interest.

Nonetheless, federal courts have reached different conclusions as to the mandate’s permissibility.  In July, a federal district judge in Colorado issued a preliminary injunction blocking enforcement of the mandate against a religious employer running a secular (HVAC) business, while in September, a federal district judge in St. Louis rejected a similar challenge by the religious owner of a mining company.  Last week, a federal district judge in Detroit also issued a preliminary injunction against enforcement, indicating that while neither side had shown a strong likelihood of success on the merits, “The loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”  Several other challenges to the mandate remain pending.

So let’s just add this to the list of uncertainties that will remain after the results of today’s election are in – and to the list of reasons why employer-based health care really ought to be abandoned in favor of a single-payer, public system.

There, now that ought to get some discussion started…

Upcoming Event – The Guatemala STD Inoculation Studies: What Should We Do Now?

Tuesday, November 13, 2012
12:30-2:00
Wasserstein Hall, Classroom 3019
Harvard Law School

In the late 1940s, US and Guatemalan researchers conducted a host of experiments on vulnerable Guatemalan subjects, purposefully exposing them to and infecting them with a number of STDs without their consent.  The experiments were kept hidden for more than half a century, until they were discovered and exposed only recently by historian Susan Reverby.  The US government has since apologized for what happened, but a class action suit brought on behalf of the Guatemalan subjects was dismissed in June and efforts to directly compensate the victims have not been forthcoming.   Please join Harvard Law School’s Petrie-Flom Center and Human Rights Program for a panel discussion of the study and possible legal and political responses that may be available now, both domestically and from an international human rights perspective.  Panelists will include:

  • Susan Reverby, Marion Butler McLean Professor in the History of Ideas, Professor of Women’s and Gender Studies, Wellesley College
  • I. Glenn Cohen, Assistant Professor of Law, Faculty Co-Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center, Lecturer on Law, Harvard Law School
  • Wendy Parmet,  George J. and Kathleen Waters Matthews Distinguished University Professor of Law, Northeastern University School of Law
  • Fernando Ribeiro Delgado, Clinical Instructor and Lecturer on Law, Human Rights Program, Harvard Law School

This event is free and open to the public.  Lunch and refreshments will be served.