The Zika Virus Vaccine Research Agenda and Pregnant Women
Editor

EDITOR’S NOTE: This guest post by the Ethics Working Group on ZIKV Research & Pregnancy is cross-posted with the Canadian Bioethics blog Impact Ethics. The Ethics Working Group on ZIKV Research & Pregnancy provides recommendations to ensure that pregnant women are responsibly and equitably included in the ZIKV vaccine research and development agenda. Its 15 expert members include Little, Drapkin, and Lyerly, whose 2008 IJFAB article on the inclusion of pregnant women in research had a significant impact not only in bioethics but also in the mainstream media at the time. The group also includes scholars and physicians from throughout the Americas including Argentian philosopher and bioethicist Florencia Luna whose article on vulnerability in IJFAB, and 2016 keynote at the World Congress of Bioethics on responses to Zika, mark her as notable in this particular area. The working group’s advice is well-informed by feminist bioethics.

This image is a screen cap of the cover for the Working Group’s ethical guidance on priorities, inclusion, and evidence generation. It can be downloaded from http://www.zikapregnancyethics.org/.

Zika virus (ZIKV) vaccine development is proceeding rapidly, with a number of vaccine candidates already moving into Phase II clinical trials. These are trials that are designed to look for evidence of efficacy.

As the public health community races to develop ZIKV vaccines, now is a critical time to ensure that research and development (R&D) efforts adequately address the needs of pregnant women and their offspring. To this end, the Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health and ethics, has developed Ethics Guidance for including the needs and interests of pregnant women and their offspring in the ZIKV vaccine research and development agenda: Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.

This Guidance argues that global concern about the devastating effects of ZIKV infection in pregnancy for normal fetal development, pregnant women and their offspring is not enough. Pregnant women and their babies should also be front and center in ZIKV vaccine development.

Unless specific actions recommended by the Working Group are taken soon, pregnant women and their offspring will not be able to share fairly in the benefits of whichever vaccines prove efficacious. They and their clinicians will lack the evidence they need to make informed decisions about using these vaccines.

Conducting research studies with pregnant women has been historically challenging and ethically complex. The vast majority of clinical trials for all biomedical interventions, including vaccines, have excluded pregnant women from studies. As a consequence, many drugs and biologics enter the market with little to no data on safety and efficacy in pregnancy – and it can take decades to generate this evidence post-authorization. The Working Group’s Guidance provides a pathway for a more proactive and inclusive approach for ZIKV vaccine development.

The Guidance tackles two critical questions: (1) What specifically is required to ensure that the interests of pregnant women and their offspring are adequately protected and fairly taken into account in the ZIKV vaccine research agenda? (2) Under what conditions is it ethically acceptable, if not required, to include pregnant women in ZIKV efficacy trials?

To address these questions, the Ethics Guidance includes three moral imperatives, each with concrete recommendations directed to policymakers, research funders, researchers, oversight bodies, regulatory authorities and the global public health community: to pursue and prioritize development of ZIKV vaccines that will be acceptable for use during pregnancy; to ensure timely collection of data to inform judgments about safety and efficacy of ZIKV vaccine administration in pregnancy; and to ensure pregnant women have fair access to participate in ZIKV vaccine trials that offer the prospect of direct benefit.

ZIKV vaccines are expected to be a critical part of the response to prevent future ZIKV outbreaks and epidemics. Adequately addressing the specific interests of pregnant women in ZIKV vaccine R&D efforts is not only essential to mitigating the potential harms faced by pregnant women and their offspring, it is also a matter of justice and respect.

Through concerted and proactive efforts, we can ensure that pregnant women are responsibly and equitably included in ZIKV vaccine research and development efforts and that, as a consequence, pregnant women and their offspring will benefit from the global investment in ZIKV vaccines.

The Ethics Working Group on ZIKV Research & Pregnancy is 15-member Working Group comprised of international experts in bioethics, public health, philosophy, pediatrics, obstetrics, maternal-fetal medicine, vaccine research, and maternal immunization tasked with developing concrete ethics guidance for including the needs and interests of pregnant women in the ZIKV vaccine research agenda. Details on the members of the Working Group and a copy of the Guidance and the Executive Summary can be found at: www.zikapregnancyethics.org

You can follow the project on Twitter: @pregnancyethics

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Things That Ought Not Be
Anna Gotlib

“Tolerance becomes a crime when applied to evil.”
― Thomas Mann, The Magic Mountain

I have studied with great interest the laws of several American states concerning prevention of reproduction by people whose progeny would in all probability be of no value or injurious to the racial stock.

While I have not returned to that topic for a while, a recent news story caught my attention:

There are few things that are more blatant than what is going on in White County, Tenn., where inmates are apparently given a reduced jail sentence if they agree to get either a vasectomy or a birth control implant.

According to News Channel 5, back in May, General Sessions Judge Sam Benningfield signed a standing order permitting inmates to get 30 days’ credit toward jail time if they agreed to a birth control procedure. The program has since been called “unconstitutional” by the American Civil Liberties Union.

Women who agree to participate in the program receive a free Nexplanon implant in their arm, which helps to prevent pregnancies for up to four years, while men who volunteer are given a free vasectomy by the Tennessee Department of Health.

Officials say that since the program began, some 32 women have gotten the implant, while 38 men are waiting to have their vasectomy performed.

In fact,

To hear Judge Benningfield tell the story, he claims that he is trying to break the cycle of repeat offenders who come into his courtroom on drug-related charges but cannot afford child support or have trouble finding jobs.

“I hope to encourage them to take personal responsibility and give them a chance, when they do get out, to not to be burdened with children. This gives them a chance to get on their feet and make something of themselves,” Benningfield told the news station.

Benningfield decided to go ahead with the program after speaking with officials at the Department of Health.

 “I understand it won’t be entirely successful, but if you reach two or three people, maybe that’s two or three kids not being born under the influence of drugs. I see it as a win-win,” he added.

 

I will not offer a lengthy analysis of this travesty  —  I think that to most people, it speaks for itself. But I do want to add this thought:  Aside from the obvious racist, classist, and eugenicist labels that clearly apply to this crime (and yes, I take it to be a crime, even though the law is, as always, lagging behind moral outrage), there is this sense that some things, some practices, just ought not be.  They ought not exist as facts, as practices in our world  —  and if they do, they ought to be torn to smithereens by our disgust, our resistance, our rage.

But this is just not the case.  Even though the ACLU protested, and District Attorney Bryant Dunaway was deeply troubled, if the reader scrolls through the comments that follow the story (yes, something that one ought never do, I know), what becomes apparent is that some people, enough people, too many people, are simply all right with this practice, or at least are not too troubled by it. They weigh the pros and cons.  They assess.  In the end, they tolerate.  They buy into the eugenicist ideology that makes it acceptable for some people  —  not us! not people like us, of course!  —  to become not only dispensable, but disposable.  They must earn their humanity, and if we find them wanting, we can, without much moral tribulation, make them disappear altogether.

Hitler studied us, the eugenicists.

Apparently with good reason.

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Link to recent review of important new book in disability studies

This text shows an image of the cover of Barnes's book which is a photograph of many different body types and sizes showing visible disability. It is accompanied by a quote from Hirschmann's review: "[Barnes's] attempt to moderate a path between the physical body and social constructivism, and to combat a generalized skepticism in the field of philosophy about the possibility that disability might be a good thing for some people... is an unapologetic and strong case for disability positivity."Earlier this year (2017), Hypatia Reviews Online did a review of Elizabeth Barnes’ 2016 book The Minority Body: A Theory of Disability. The review itself, by Nancy J. Hirschmann, is of great value to those of us trying to figure out where to put our money and time in terms of which books to read.

Hirschmann notes–rightly, I think–that many books and articles in philosophy on disability take a very negative view of disability. We need only think of classic uses of a right to an open future and other arguments that indicate it is morally wrong to bring a child into the world who has a trait that is disabling. Hirschmann also rightly notes that the common reaction to these negative views is to emphasize the social model of disability, which she nicely summarize in her review. Of particular interest is that Barnes doesn’t neatly subscribe to either of these approaches. You’ll have to read the review for Hirschmann’s overview of the argument, but this may be enough to make you want to do so.

Even if we decide not to read this book in full, we are better scholars to be aware of its arguments and Hirschmann’s review makes that possible.

 

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IJFAB discounted subscription rates

Hi, folks. I just got this in my e-mail and thought I’d share it more widely in case anyone is interested in the IJFAB subscription discount that University of Toronto Press is offering this summer. The full advert includes pictures of an ice cream cone and a beach. I  guess we can all imagine curling up on a chaise lounge on the beach with the soft sussuration of waves and an ice cream cone held perilously over the cover of the most recent copy of the International Journal of Feminist Approaches to Bioethics? Actually that sounds pretty good to me. For folks not in the same hemisphere as UT Press, where it is actively winter just now, perhaps imagine being bundled up in a parka and fingerless gloves with a mug of hot chocolate as both the drink and your breath produce steam while you read the most recent issue of IJFAB. 

UTP press has 25% off deals on a 2-year subscription

The link in the image is not clickable, but if you go to http://www.utpjournals.press/summer-savings you can see all the many journals that UTP publishes which are on sale right now including IJFAB.

 

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None of us are getting out of here alive. But who goes first, and why? New JAMA article.

Did you catch the Journal of the American Medical Association article on the Association Between Income and Life Expectancy in the US, 2001-2014?

Spoilers: there is one. This piece tries to break it down further using deidentified tax records to look at race, income, sex, ethnicity, and more. The sample size is magnificently large: 1.4 billion (not a typo) people.  Here are the key findings from the abstract:

The gap in life expectancy between the richest 1% and poorest 1% of individuals was 14.6 years (95% CI, 14.4 to 14.8 years) for men and 10.1 years (95% CI, 9.9 to 10.3 years) for women. Second, inequality in life expectancy increased over time. Between 2001 and 2014, life expectancy increased by 2.34 years for men and 2.91 years for women in the top 5% of the income distribution, but by only 0.32 years for men and 0.04 years for women in the bottom 5% (P < .001 for the differences for both sexes). Third, life expectancy for low-income individuals varied substantially across local areas. In the bottom income quartile, life expectancy differed by approximately 4.5 years between areas with the highest and lowest longevity. Changes in life expectancy between 2001 and 2014 ranged from gains of more than 4 years to losses of more than 2 years across areas. Fourth, geographic differences in life expectancy for individuals in the lowest income quartile were significantly correlated with health behaviors such as smoking (r = −0.69, P < .001), but were not significantly correlated with access to medical care, physical environmental factors, income inequality, or labor market conditions. Life expectancy for low-income individuals was positively correlated with the local area fraction of immigrants (r = 0.72, P < .001), fraction of college graduates (r = 0.42, P < .001), and government expenditures (r = 0.57, P < .001).

This is an important and potentially useful effort. It doesn’t get us much detail on what could be done differently clinically or in terms of access to health  care–indeed, access to health care seems less influential than health behaviors–but as a careful look at social determinants of health it is a critical piece of any attempt to make death, well, more fair.

Click through to the above link for detailed results, and bear in mind that the results of a single study, however magnificent the sample size, are not sufficient. Other people might crunch the same data set differently, or different data sets might show different results and contain different measures (tax records are a pretty narrow set of data).

None of us are getting out of here alive. But who goes first, and why? Do we want to accept a world in which some of us go unjustly early? Where are the levers we can move the most?

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HRO reviews new book by former IJFAB editor Mary Rawlinson on sexual difference
Editor

This image shows the cover of Mary Rawlinson's book "Just Life: Bioethics and the Future of Sexual Difference."  The pullquote from the review is "...Rawlinson does not wish to eliminate an appeal to universality, but rather to reorient it based on two features common to all humans: everyone is born of a woman and everyone must eat other living beings, whether plants or animals, to survive."As you may know, bioethicist Mary Rawlinson saw the International Journal of Feminist Approaches to Bioethics through much of its first decade as Editor. Over at Hypatia Reviews Online, Jordan Liz has a review of Rawlinson’s new book.

Liz notes that Rawlinson sets out to question the Western philosophical touchstone of the universal, sexless human which is the putative foundation of so much social and political philosophy in the Western canon. Rawlinson questions this, working through the implications of acknowledging that this universal, sexless human neither actually exists nor actually gives rise to just societies. How can we attend to sexual difference and yet not end up in patriarchy?

Liz adeptly takes us on a tour of Rawlinson’s critiques of Hobbes, Hegel, and more canonical figures of Western philosophy. Rawlinson brings all this around to bioethics by considering biopower, both in terms of generativity generally and also in terms of food: what we grow, how we decide that, what we eat, and more.

For someone concerned with critiques of liberalism and/or with food ethics, this book may be an interesting place to start. And for someone interested in the book, this review may be a good place to start.

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ACA repeal-and-replace, at least in any of its current forms, will devastate rural Americans
Alison Reiheld

Since 2010, I have incorporated Remote Area Medical (RAM) into my medical ethics teaching. RAM is an organization that relies on corporate donations, individual charitable donations, and time-and-skill donations by health care providers to provide healthcare boot camps for 2-3 days in areas with poor access to care. This poor access to health care can be from lack of insurance coverage or from geographic lack of providers; both tend to be in play in rural communities. The Affordable Care Act (ACA, AKA Obamacare) went some way to alleviating the former. Those gains are now under threat from attempts to repeal it and replace it with legislation that does not provide comparable attention to the needs of rural Americans.

This black and white image shows a female patient with short hair lying on a sheet-draped medical bed. She is facing away from the camera, and her gown is open in the back. Two incisions of 1 to 2 inches can be seen. The walls of the room are temporary fabric tent walls. According to the caption, she traveled a long distance to a RAM camp where a dermatologist took biopsy samples, results for which were later sent to her. This is a diagnostic test she might otherwise not have been able to get due to lack of insurance coverage and geographic scarcity of specialists.

This woman traveled 75 miles to see a Remote Area Medical dermatologist, who removed two lesions from her back and sent them to a pathology lab. After receiving results, RAM’s doctors follow up with patients by phone. Credit Larry Towell/Magnum, for The New York Times

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Behind Closed Doors: A flawed AHCA does nothing to fix the flaws of the ACA, makes things worse for 10s of millions of Americans
Rory Kraft

Many of us in the bioethics community are following along with the political maneuvers in the U.S. Senate on the Republican attempt to “repeal and replace” the Affordable Care Act (ACA/“Obamacare”).  From my perspective it has been more difficult to understand what is happening now, in part because so much of the negotiations has occurred behind closed doors.  This move to write the bill outside the public eye has, of course, been the subject of much controversy.  The Senate Majority Leader, Mitch McConnell, has indicated that he wishes to have the vote on the bill prior to the Senate recessing for a break which begins at the end of this week.

For all of the backroom secret negotiation that we were told was going on, this bill is really not all that different from the House version. So first, the majority of my concerns with the House version stand (my earlier discussion of those issues can be found here and my discussion of the broader ethical questions that should be asked in any attempt to repeal the ACA can be found here).

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Effects of Trump administration policies, including census questionnaire changes, on LGBT elderly populations
Editor

Editor’s Note: SAGE is a group that provides advocacy and services for LGBT Elders, a group often multiply invisible in public policy due to ageism combined with homophobia, biphobia, and/or transphobia as well as other intersecting oppressions. With the group’s permission, IJFAB Blog here reposts their recent press release.

SAGE Declares Partial Win on Elder Erasure; Condemns Trump Administration for Continued Trans Exclusion

[NEW YORK, NY] In March, SAGE announced a nationwide effort to oppose the Trump administration’s proposed erasure of LGBT elders from a major federal aging survey, which measures the degree to which key federally funding aging programs like Meals on Wheels are reaching the older adults who most need them. Thousands of people commented and told the administration that LGBT elders would “not be invisible.” Today, SAGE declares a victory on getting a question pertaining to sexual orientation back into this survey – the National Survey of Older Americans Act Participants (NSOAAP).

While SAGE celebrates this achievement, we condemn the Trump administration’s continued removal of gender identity from the 2017 survey. All of our elders, including our trans elders, must be counted. SAGE refuses to let trans older adults, or any of the elders who are part of our community, be invisible.

“Thousands of LGBT elders and their allies forced the Trump administration to reverse course on their discriminatory plans,” said SAGE CEO Michael Adams. “But if the administration thinks that with this partial victory SAGE will now abandon trans elders, it’s in for a big surprise.”

In the next 30-day comment period, SAGE will continue to fight to have all LGBT elders included in this survey. We must not back down. The Trump Administration wants to pretend that transgender elders do not exist, but we won’t let them.

SAGE thanks our sister LGBT advocacy organizations, including the Human Rights Campaign (HRC) and the Center for American Progress (CAP), as well as ally aging organizations, including the National Association of Area Agencies on Aging (n4a) and the National Association of States United for Aging and Disabilities (NASUAD).  We also recognize the steadfast support of the 72-member Leadership Council of Aging Organizations (LCOA).

From LGBT older adults to their allies from across the political spectrum, the people have spoken.  More than 10,000 voices made the Trump Administration reverse course.  We made progress.  But the fight is not over.  Now SAGE will rally tens of thousands more in the next 30-day comment period.  Together, we will continue raising our voices until everyone in our community is counted, including our trans elders.

We will not be erased.

We will not be eliminated.

We will not go quietly.

We refuse to be invisible.

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“Why TrumpCare’s Medicaid Cuts are a Feminist Disability Rights Issue” by Leah Smith and Joseph Stramondo
Joseph Stramondo

This image shows a photo of Leah Smith and one of Joseph Stramondo. Both are little people. The text reads "Leah Smith, MPA, Media Advocate, Center for Disability Rights" and "Joseph Stramondo, PhD, Assistant Professor of Philosophy, San Diego State University

Editor’s Note: Smith and Stramondo have co-authored for IJFAB Blog in the past, with the widely read “Musings on the Value of ‘Awareness’.” You can see a shared bio at the end of today’s blog article.

Until this past Thursday, most folks who aren’t directly involved in the disability rights movement in the United States would be down-right shocked to hear that its biggest priority since the passage of the Americans with Disabilities Act (ADA) has been Medicaid funding priorities. Yet, it seemed like, all at once, America was introduced to the political action that has been happening for more than 25 years to try and produce parity between federal funding spent on nursing homes versus long term care in the community.

This black and white image shows a room packed with protesters, many using wheelchairs, using a sit-in to protest the San Francisco Department of Health, Education and Welfare in 1977. They demanded the government implement existing laws to protect the rights of disabled persons. The protesters are in concentric rings around a woman who is speaking with a microphone. She appears to be standing. There is no empty floorspace. Such techniques have long been used by disability rights activists. In recent decades, they have been used continuously in protests like that of June 22, 2017 at the Capitol, against cuts to Medicaid funding and elimination or reduction in federal protections for how that money is spent on persons with disabilities.

Currently, there are federally funded programs designed to provide long-term care to some disabled people via community based supports and services (i.e. personal care attendants that come into your home to help with non-medical tasks like dressing, bathing, laundry and meal prep). However, federal law is written so that states must provide nursing home care to folks who can’t afford it out of pocket, while the provision of this sort of community based care is optional.

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NY Times article says US Senate Health Bill depends on shifting dollars from poor to rich
Editor

Over in The New York Times, Margaret Sanger-Katz has an analysis of U.S. Senate health care bill which we have been covering recently. In it, she pulls no bunches and yet, this Editor thinks, fairly describes the Republican values and problems with the Affordable Care Act (AKA Obamacare) that underpin the bill in a way that most who hold those values would agree with:

The bill is aligned with long-held Republican values, advancing states’ rights and paring back growing entitlement programs, while freeing individuals from requirements that they have insurance and emphasizing personal responsibility. Obamacare raised taxes on high earners and the health care industry, and essentially redistributed that income — in the form of health insurance or insurance subsidies — to many of the groups that have fared poorly over the last few decades.

This set of value commitments and critiques of the ACA have unavoidable implications for the impact of any repeal-and-replace that addresses them.

The draft Senate bill, called the Better Care Reconciliation Act, would jettison those taxes while reducing federal funding for the care of low-income Americans. The bill’s largest benefits go to the wealthiest Americans, who have the most comfortable health care arrangements, and its biggest losses fall to poorer Americans who rely on government support. 

You can click through to the entire article here to read more. 

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Where’s Lysistrata when you need her?
Laura Purdy

Editor’s Note: We have had a few blogs that reference The Handmaid’s Tale since Season 1 of the Hulu series began in 2017, and one that did so several years ago which had a lively discussion in the comments.  Here, Laura Purdy responds to a new law in Missouri that resulted from a special session called by Governor Eric Greitens for the purpose of addressing abortion legislation. It was in response to a St. Louis city ordinance that would have prohibited discrimination in housing or employment against people who had used birth control or had an abortion. The Governor began calling St. Louis an “abortion sanctuary city” and determined to prevent the city from preventing this kind of discrimination. Also up for debate in the MO legislature is a sweeping abortion bill which contains many other regulations and restrictions on abortion, passed the Missouri House on June 20, 2017, and now heads back to the Missouri Senate.

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Once the mind gets going on something this absurd and horrible, it is hard to get it focused on anything else: “Had an abortion or use birth control? In Missouri, you could be disqualified from a job for that” (or housing). I present this in case anybody still thought that “theocracy,” “war on women,” or allusions to The Handmaid’s Tale were too extreme.

Walking 2 by 2, women in red cloaks with white bonnets, like the costumes worn by Handmaids in the Hulu series, ascend a staircase to enter the chambers of the Missouri Legislature to watch the House debate a bill in May. The picture was posted on the Twitter account of Planned Parenthood Missouri Advocates. The text reads "The handmaids were forced to remove their bonnets before being allowed to watch the Missouri House. #MoLeg #PraiseBe #HandmaidsTale." It is dated May 3 of 2017.

An allusion to The Handmaid’s Tale.

This is a quantum leap beyond anti-abortion politics in general and raises so many questions.

Broadly, and most obviously, since when is religious freedom limited to potential employers/landlords? (Not to mention moral principles . . . . )

More picky: what about HIPAA?

Since when do potential employers/landlords have access to one’s health care records*?

Does this mean new opportunities for those lesbians and nuns and other women who have never had need of contraception or abortion?

Or is this just an opening for more “religious freedom” in the form of required video cams (or smart TV’s) in women’s bedrooms?

Why beat around the bush with these petty incremental restrictions on women’s rights? Why not just come right out with it and repeal the 19th Amendment?

And finally, where’s Lysistrata when you need her; time for a babystrike?

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*Editor’s Note: a colleague with experience in housing and job discrimination notes that this could become an application question, and a true answer could be used to deny while a false one could be used to charge fraud and fire or evict.
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