fetaldex.org

letters of concern from

adults with mixed markers of sex

 

This letter from adults who were born with atypical sex has been through the facilitation of Advocates for Informed Choice to:

  1. 1.the FDA Office of Pediatric Therapeutics;

  2. 2.the HHS Office for Human Research Protections;

  3. 3.Mount Sinai Medical Center (Dr. New’s current institution);

  4. 4.Weill Medical School of Cornell University (from which much of this treatment appears to have been administered, under Dr. New’s guidance);

  5. 5.Florida International University (where Dr. New is Associate Dean for Clinical Research).



We, the undersigned, are adults whose lives have been powerfully affected by unresearched, unregulated, and unethical medical practices.  Caregivers, while attempting to manage us as children with ambiguous genitals or other mixed markers of sex, worked from a real desire to help us but, in the end, these efforts almost always reflected caregivers’ fear and unqualified panic.  We feel there is nothing about having a larger than typical clitoris, or a smaller than typical penis, that is wrong, or in need of swift medical intervention.  We feel lucky that our bodies can serve us as they have, and we are deeply saddened to learn that yet another experimental procedure is in place whose sole purpose is to “normalize” the genitals of infants.


This new, yet all-too-familiar practice is being carried out under the flag of “managing a child with ambiguous genitals”.  Specifically, we are concerned over reports of possible non-IRB (Institutional Review Board) approved clinical research on pregnant women that is being conducted with the support of Mt. Sinai Medical Center under the direction of Dr. Maria New.


This work involves off-label administration of dexamethasone to pregnant women who may give birth to girls with Congenital Adrenal Hyperplasia (CAH).  It is our understanding that Dr. New has long prescribed dexamethasone in order to prevent genital virilization associated with CAH in 46, XX females. This indication is not approved by the FDA. Human and animal studies have demonstrated that dexamethasone may pose serious risks to the developing fetus, including risk of neurological damage.  While dexamethasone has been given to pregnant women who may give birth to girls with CAH for many years, adequate clinical trials have never been done to determine the risk of this treatment. Genital virilization is a cosmetic issue.  Putting pregnant mothers on dexamethasone does not address any of the very real medical concerns that can affect a child born with CAH.  Prescribing this drug in this way is intended, and promoted publicly, for one outcome: atypical genital prevention.  In other words, pregnant women and fetuses are being exposed to unknown risks, including risk of neurological harm, in order to address a cosmetic issue.  In a possible violation of established bioethical protocols, these pregnant women appear to have been recruited (and perhaps are still being recruited) without the watchful eye of an IRB.  Dr. New has publicly resisted discussion of the details of the information pregnant women and their partners are provided.


We are calling for an investigation into Dr. New’s treatment of pregnant women with dexamethasone at Mount Sinai Medical Center and any other institutions where she may have conducted such treatment including whether this treatment amounted to human research, whether IRB involvement was warranted, and whether the women treated were given adequate information for informed consent.  We believe that any women who have been treated without the protection of IRBs should now be advised of the information that may not have been made available to them at the time of treatment, and that they should be given the most recent information from studies indicating long-term risks to women and children.  Finally, we agree with Dr. Walter Miller, Distinguished Professor of Pediatrics and Chief of Endocrinology at the University of California San Francisco, who has written, “this experimental treatment is not warranted and should not be pursued even in prospective clinical trials.”


The medical community’s treatment of us is driven by a history rife with unethical behavior: undisclosed diagnoses, inaccurate portrayals of our development, and a tendency to lose us all “to follow-up”.  We have all survived and made lives for ourselves despite medicine’s well-intentioned yet drastically misguided efforts. 


Medicine must do better.


Sincerely,

Jim Bruce (corresponding author)

Katie Baratz, Board President, Advocates for Informed Choice

Janet Green, Co-Founder, Bodies Like Ours, DSD/Intersex Patient Advocate and Educator

Sally Gross, Intersex South Africa

Thea Hillman, Former Board Chair, Intersex Society of North America; Author, Intersex (For Lack of a Better Word)

Mani Bruce Mitchell, Director, Intersex Trust Aotearoa New Zealand

David Cameron Strachan, Former Board Member, Advocates for Informed Choice and Intersex Society of North America 

Suegee Tamar-Mattis, D.O.

Kiira Triea, Co-Founder of the Coalition for Intersex Support, Activism, and Education

Peter Trinkl, Bodies Like Ours

Daniela Truffer, President, Zwischengeschlecht.org (Zurich, Switzerland)



Affiliations given for identification purposes only.