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November 13, 2013

NIH LGBTI Research Coordinating Committee

National Institutes of Health
9000 Rockville Pike
Bethesda, MD 20892

Dear Members of the National Institutes of Health LGBTI Research Coordinating Committee,

The Endocrine Society would like to thank you for the opportunity to provide comments and suggestions
regarding the health and health research needs, specific health issues and concerns for lesbian, gay, bisexual,
trans/transgender and intersex (LGBTI) populations. Founded in 1916, The Endocrine Society is the world’s
oldest, largest, and most active organization devoted to research on hormones and the clinical practice of
endocrinology. The Endocrine Society’s membership of 16,000 includes clinical, translational, and basic
scientists, as well as clinicians in practice. Our members include clinicians and researchers dedicated to the
understanding, research and care of individuals with transgender and intersex conditions. The current state of
care for transgender and intersex patients is extremely fragmented, with significant regional and international
disparities in quality and access to care. The Endocrine Society therefore enthusiastically supports the activities
of the NIH LGBTI Research Coordinating Committee and their efforts to advance LGBTI health. Given the
spectrum of expertise from basic science to clinical practice within the Society’s membership, The Endocrine
Society is well positioned to comment on the challenges and opportunities that can be addressed by a NIH LGBTI
Research Strategic Plan.

Although the populations served by a LGBTI Research Strategic Plan likely share many research needs and
opportunities, we would like to focus our comments on the health and research needs of transgender and
intersex populations. Specifically, our comments address some of the barriers to research and care and critical
knowledge gaps that could be handled by the NIH. Furthermore, we provide detailed recommendations that
would facilitate implementation and optimize the ability of the strategic research plan to achieve research goals.

Barriers to Research and Care

Educational Needs of Providers: Patients report that the single biggest barrier to accessing care is that providers
may lack knowledge, or even be unaware of the specific needs associated with the care of transgender or
intersex patients. We do not know the extent to which this is true, or the level of regional variation in provider
knowledge, given that no coordinated national effort currently exists to quantitatively address the problem. A
fundamental educational issue, particularly relevant to the healthcare needs of patients who have variations in
sexual and reproductive development, is the entrenched view within society of the binary concept of gender. It
will therefore be critical for the NIH to assess the education of trainees in biological theories of sex and
mechanisms of gender identification. Ideally the LGBTI Research Strategic Plan would identify best practices
that would then become part of formal training requirements starting in medical school and continuing through
fellowships in medicine, surgery and endocrinology.

Infrastructure Requirements: The NIH is in a unique and critical position to dramatically improve the ability of
researchers to address the needs of LGBTI populations through a strategic research plan; however, the existing
research funding infrastructure at the NIH is not equipped to efficiently allocate resources to researchers
investigating these topics. Researchers studying transgender and intersex health issues currently lack dedicated
contact points and clearly delineated research funding priorities for LGBTI health. Consequently, many LGTBI
research issues are addressed in the context of the mission of the institute to which the researcher applies,
rather than specifically addressing the needs of the LGBTI health community.

Basic Research Needs: The LGBTI research community lacks information from basic biological and mechanistic
research that can inform treatment of individuals. Little research activity is conducted in areas such as the
effects of hormones on the brain, mechanisms of tumor development in the hormonal milieu, and other critical
questions due primarily to a lack of dedicated funding. Animal and cellular models are needed to study chronic
effects of hormone changes and molecular mechanisms underlying gender identity disorders.

Critical Knowledge Gaps

Data Requirements: Because of regional heterogeneity in access to care and low numbers of patients, especially
intersex patients, clinical researchers studying transgender and intersex health lack the sample sizes necessary
to address many critical research questions that could impact patient care. Additionally, the United States
currently lacks a network with mechanisms for researchers to share data for transgender and intersex patients
in a coordinated way. Consequently many research questions that could impact patient care for the broad
LGBTI community and the subpopulations addressed within this response remain extremely challenging to
study.

Specific Research Areas: Many areas of research on LGBTI health needs are still very poorly understood and
suffer from a lack of coordinated efforts and funding. We offer some suggestions for critical research areas that
should be addressed by a strategic research plan. We would also like to draw the Committee’s attention to
additional priorities identified by other stakeholder groups for intersex/Disorders of Sexual Development (DSD)
care in the document attached to this letter.

• Both the short and long term effects of hormonal therapies, including benefits and harms, require
additional investigation as noted in The Endocrine Society’s Clinical Practice Guideline on Endocrine
Treatment of Transsexual Persons; the effects of hormonal therapies in individuals with intersex
conditions have never been studied systematically. Currently, different hormonal treatment practices
exist across various regions of the world; this represents an opportunity to compare the clinical
outcomes among individuals treated with different hormonal regimens.
• The research and patient communities lack prospective data on the long-term outcomes of gender
assignment and re-assignment in children with intersex conditions (disorders of sex development).
• A meaningful understanding of regional differences in care suffers from a lack of coordinated national
efforts to understand cultural, social, and economic factors that impact access to, and use of, available
 care for both transgender and intersex populations. Research is needed to identify barriers to entry into
the health care system, at what points patients exit the system, and why patients exit the system.
• Many patients with intersex conditions undergo prophylactic gonadectomy on the basis of a
hypothetical increased risk of malignancy. However, actual risk of malignancy has not been clearly
ascertained, and there is currently little objective evidence to guide physicians on whether and when
their patients should undergo this procedure.
• The timing and nature of hormonal therapy (i.e. in childhood, adolescence and/or adulthood) remains a
challenging topic, due in part to a lack of detailed information about when gender identification
becomes solidified.
• Systematic studies of pubertal suppression of children who express gender dissonance prior to onset of
puberty are needed to assess the potential benefits and risks of preventing physical development
contrary to the child’s perceived gender at puberty.

• Research is required to develop appropriate pediatric formulations for hormone replacement therapy.
Recommendations

The Endocrine Society commends the NIH for recognizing the need for a strategic research plan for LGBTI health
and research. In order to address the gaps in knowledge and data requirements that exist, as well as improve
the climate for LGBTI research generally, The Endocrine Society would like to make the following
recommendations to the LGBTI Research Coordinating Committee:

1. The LGBTI Research Strategic Plan should include a long-term investigation of educational practices and
models that include transgender/intersex medicine. Educational practices should be examined at all
levels of training for the extended community of health professionals including medical students,
nurses, physicians in practice (through Continuing Medical Education) and particularly as part of
endocrinology and pediatric endocrinology fellowship training programs. Best practices should be
identified based on outcome measures that include improved access to care and mental health impacts.
Educational deficiencies of providers should be identified and addressed at early stages of training. We
encourage the NIH LGBTI Research Coordinating Committee to work with the American Board of
Internal Medicine (ABIM), the American Board of Pediatrics (ABP), the Association of Program Directors
in Endocrinology and Metabolism (APDEM), and the Education Committee of the Pediatric Endocrine
Society to ensure that identified best educational practices are efficiently implemented.
2. The LGBTI Research Strategic Plan should develop a centralized source of funds for investigators that
addresses the research needs specifically associated with LGBTI health, including the research questions
identified above. If this research plan is to be housed within NICHD and NIMHD, we recommend that
appropriate financial resources be deployed to enable these institutes to successfully implement the
research plan on a long-term basis. Consideration should be given to collaborations with industry,
perhaps through NCATS, to support the development of therapeutics specifically for LGBTI health. We
also suggest that dedicated study sections be utilized to review LGBTI research grants.
 3. The LGBTI Research Strategic Plan will need to have a strong interdisciplinary focus and structure for
research that involves pediatric care. Attention should also be focused on transitions of care from
pediatric to adult care.
4. The LGBTI Research Strategic Plan should allocate funds for the development and implementation of a
nationwide patient registry, enabling investigators to share critical data that address strategic research
priorities. This national registry of transgender patients could be informed by existing collaborations
such as the European network for the investigation of gender incongruence (ENIGI). Indeed, a United
States patient registry could eventually be synchronized with existing international efforts to take
advantage of broader patient populations and comparisons between differences in international
standards of care. Critically, oversight of the patient registry must take into account confidentiality
issues. Similarly, a patient registry or database for individuals with intersex or DSD conditions should be
implemented (optimally, separate from, or alongside, the transgender database) using standardized
data forms to facilitate consistent data collection and analysis among many institutions and practices.
Such a US-based database could link to the already existing International Disorders of Sex Development
(I-DSD) database hosted by the University of Glasgow (www.gla.ac.uk/idsd).
5. The LGBTI Research Strategic Plan should include provisions for basic research that could inform LGBTI
health in the future. For example, serum banks could be used to identify biomarkers for the risk of
gonadal malignancies for patients with intersex/DSD conditions. Additionally, research in animal models
can provide useful information on the molecular mechanisms of sexual development and differentiation
6. Finally, the focus of research for transgender and intersex conditions should be on patient outcomes
and consideration should be given to collaborative efforts with the Patient-Centered Outcomes
Research Institute (PCORI).
The Endocrine Society appreciates the efforts by the LGBTI Research Coordinating Committee to address the
research needs and identify opportunities to improve the health of LGBTI persons. We also appreciate the
opportunity to respond to the RFI and address these important issues and look forward to the development and
implementation of the NIH Strategic Research Plan for LGBTI health and research needs. Thank you for
considering The Endocrine Society’s comments. If we can be of further assistance, please contact Joseph Laakso
at jlaakso@endocrine.org.

Sincerely,

Teresa K. Woodruff, PhD

President, The Endocrine Society