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Bioethicists will explore the issues and lessons of the Zika crisis

April 14, 2016

The emerging Zika virus epidemic is bringing to light a longstanding ethical challenge in medical research: the inclusion of pregnant women. With new funding from the Wellcome Trust, an interdisciplinary team of scholars will focus on issues of ethics and research in pregnancy and women of reproductive age, beginning with the current Zika context and later expanding to general public health research.

"The Zika epidemic is highlighting a long-time problem in medical research - the exclusion of the interests of pregnant women from the research agenda," says Ruth Faden, Director of the Johns Hopkins Berman Institute of Bioethics and co-principal investigator on the research team. "While the legal and ethical issues involved in testing new vaccines and drugs in this population are complex, that is not a justification for failing to generate evidence that is badly needed to meet the distinctive health needs of pregnant women, who are often at heightened risk during a public health crisis."

Working with Faden and her co-principal investigator, obstetrician-bioethicist Anne Lyerly, Associate Director of the University of North Carolina Center for Bioethics, are bioethics colleagues with training in law, philosophy, public health, and religious ethics. The co-investigators are: Margaret Little, Director of the Kennedy Institute of Ethics at Georgetown University; Anna Mastroianni, University of Washington School of Law; and Leslie Meltzer Henry, Johns Hopkins Berman Institute of Bioethics and the University of Maryland Francis King Carey School of Law.

With a £1.2 million grant from the Wellcome Trust, the scholars will spend two years developing guidance for conducting research with pregnant women in the midst of a public health crisis.

The research team will also include advisors from Central and South America as well as experts in vaccinology and infectious disease, maternal-fetal medicine, and public health emergency response. The scholars plan to conduct 50 consultations in Zika-affected countries and in the United States, and convene a series of expert working groups to help develop and refine guidance for addressing the health interests of pregnant women in Zika and other public health emergency research agendas.

Several members of the research team have worked for more than a decade on these issues; in 2008 Faden, Lyerly, and Little launched the Second Wave Initiative, referencing the "first wave" of efforts of the early 1990s to include women in the biomedical research agenda. The three scholars authored multiple opinion articles on the issue of pregnant women receiving the H1N1 "swine flu" vaccine in 2009, noting the high fatality rate and four-fold risk of hospitalization for pregnant women with H1N1, and the shortage of research specifically informing prevention and treatment of influenza in pregnant women.

"Pregnant women's bodies are different," notes Lyerly, "and often respond differently to medication and vaccines. Further, the fetus is susceptible to risk from medication or untreated disease. Knowing which preventives and treatments are safest and most effective in pregnancy requires conducting research with pregnant women. Not doing that research just shifts risk to the general population - where pregnant women take on unknown risks for themselves and the children they bear. That is hardly an ethical state of affairs."

"For me this is a matter of both personal and public health, Faden says. "When I was pregnant with my first child, I developed deep vein thrombosis and had to have regular drug injections as treatment. My physicians had little evidence to support their decision, which was very scary. That was decades ago and unfortunately little has changed. I want other parents-to-be to have more peace of mind than I did."

Dan O'Connor, Head of Humanities and Social Science at the Wellcome Trust, adds, "The suspected link to serious birth defects has shown that pregnant women are particularly vulnerable to the complications of Zika virus. Yet this group is often the last to benefit from new treatments and vaccines because they are excluded from most medical trials. We urgently need a new set of ethical guidelines to ensure pregnant women are included in, and able to benefit from, medical research wherever possible in a public health emergency."
-end-
Experts Available For Comment:

Ruth Faden, PhD, MPH
Director
Johns Hopkins Berman Institute of Bioethics

Media Contact:

Leah Ramsay
lramsay@jhu.edu
202-642-9640
Online bio: http://www.bioethicsinstitute.org/people/ruth-faden-4?doing_wp_cron=1457729456.4185979366302490234375

Anne Drapkin Lyerly, MD, MA
Associate Director
University of North Carolina Center for Bioethics

Media contact:

Thomas Hughes
Tom.Hughes@unchealth.unc.edu
984-974-1151
Online bio: http://www.med.unc.edu/socialmed/people/anne-lyerly

Margaret Little, BPhil, PhD
Director
Kennedy Institute of Ethics at Georgetown University

Media contact:


Kelly Heuer
Kelly.Heuer@georgetown.edu
631.258.6117
Online bio: https://kennedyinstitute.georgetown.edu/people/maggie-little/

Anna Mastroianni, JD, MPH
University of Washington School of Law
Contact: amastroi@uw.edu
Online bio: https://www.law.washington.edu/directory/Profile.aspx?ID=144&vw=bio

Leslie Meltzer Henry, JD, MSc
Johns Hopkins Berman Institute of Bioethics
University of Maryland Francis King Carey School of Law

Media contact:


Leah Ramsay
lramsay@jhu.edu
202-642-9640
Online bio: http://www.bioethicsinstitute.org/people/leslie-meltzer-henry?doing_wp_cron=1457729718.4104199409484863281250

May 2009 New York Times op-ed "A Custom Drug": http://www.nytimes.com/2009/05/10/opinion/10faden.html?_r=2

September 2009 New York Times op-ed "Pregnancy Is No Time to Refuse A Flu Shot": http://www.nytimes.com/2009/09/29/health/views/29essa.html?ref=todayspaper

Second Wave Initiative: http://secondwaveinitiative.org/Home.html

Johns Hopkins Berman Institute of Bioethics: http://www.bioethicsinstitute.org/

The Wellcome Trust: http://www.wellcome.ac.uk/

Johns Hopkins Medicine

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