Endocrine Insider: August 18, 2016

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Past Issues


Advocacy News

Society Twitter Chat Draws Participants from U.S. Senate, Advocacy Organizations

Society Meets with FDA Commissioner to Discuss Regulatory Priorities

Clinical News

Society Advocates for Medicare Access for Wireless Insulin Pumps

Research News

NHLBI Strategic Vision Includes Endocrine Priorities

NICHD Will Not Reissue Parent P01 Funding Opportunity Announcement

NIH Seeks Input on Assessment of Repositories

National Toxicology Program Recruiting for Level of Concern Study


Advocacy News

Society Twitter Chat Draws Participants from US Senate, Advocacy Organizations

Senator Dianne Feinstein (D-CA) and consumer advocacy groups such as Safer Chemicals, Healthy Families took part in the Society’s Twitter chat on endocrine-disrupting chemicals and personal care products Wednesday. The conversation was the Society’s largest Twitter chat to date.

Moderated by member Jodi Flaws, PhD, and Society staff, the event hashtag was viewed more than 2.3 million times by Twitter users, according to the social media analytics firm Symplur. Check out saved posts from the discussion.

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Society Meets with FDA Commissioner to Discuss Regulatory Priorities

The Society met with the FDA Commission, Dr. Robert Califf, August 12 to discuss its priorities for the coming year. The meeting was held in conjunction with other stakeholders in the areas of endocrinology & metabolism, pulmonary, heart, and kidney diseases to examine ways in which we can work together to address regulatory gaps under the purview of the FDA. The Society highlighted its work in advancing access to diabetes therapies, ensuring that sex is a critical biological variable in clinical trials, developing a regulatory framework for reducing harmful exposure to endocrine-disrupting chemicals, regulating compounding pharmacies, and addressing clinical trials for orphan drugs during this meeting. We look forward to continuing to work with the FDA to address these and other issues in the future.

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Clinical News

Society Advocates for Medicare Access for Wireless Insulin Pumps

The Society has submitted a letter to the Centers for Medicare and Medicaid Services (CMS) citing concern about the lack of coverage for tubing-free, wireless insulin pumps which were approved by the FDA over ten years ago. The Society has been advocating for coverage of these devices as they offer distinct advantages for certain patient populations that experience dexterity issues, neuropathy, retinopathy, and other diabetes-related complications. Many of these patients have found it easier to manage pumps that do not require handling of insertion needles, insulin reservoirs, and tubing sets. However, these beneficiaries are forced to discontinue the use of these devices as they age into Medicare and are forced to revert to shots or use other delivery systems that are more difficult for them to use. We hope that the agency will revise its opinion about covering these devices at the same rate as other insulin pumps for the Medicare population. As we work with CMS and the Congressional Diabetes Caucus on this issue, we will keep members apprised.

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Research News

NHLBI Strategic Vision Includes Endocrine Priorities

On August 10, the National Heart, Lung, and Blood Institute (NHLBI) released its Strategic Vision. The Vision comprises over 100 Compelling Questions and Critical Challenges, identified through a global outreach program involving over 4,000 participants and over 1,000 unique suggestions. Each question/challenge is aligned to one of 8 overarching objectives, and guided by the NHLBI’s overall strategic goals to 1) understand human biology, 2) reduce human disease, 3) develop workforce and resources, and 4) advance translational research.

The Endocrine Society was asked to participate in the strategic visioning process during a meeting with NHLBI leadership, and we submitted comments to NHLBI. The final Vision reflects several key Endocrine Society questions, including:

  • What are the molecular, developmental, hormonal, and behavioral mechanisms and psychological, social, and environmental factors-evaluated with a systems biology approach-involved in maintaining healthy weight across the lifespan?
  • What is the relationship between angiogenesis and placental function in at-risk pregnancies?
  • What are the mechanisms whereby social conditions and psychosocial stress contribute to the onset, progression, and morbidity of ischemic heart disease and peripheral arterial disease?

We appreciate the NHLBI’s inclusion of Endocrine Society priorities in the Strategic Vision and we look forward to working with the institute to implement the vision over the coming years. For more information on the vision, and to review the research priorities, please see the NHLBI Strategic Vision website.

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NICHD Will Not Reissue Parent P01 Funding Opportunity Announcement

On August 16, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) released a notice to inform potential applicants that the general funding announcement for NICHD-funded program project grants (P01 - PAR-13-257) will not be reissued following the September 8 date of expiry. In the announcement, NICHD indicated that P01 applications will only be accepted through specific funding opportunities in “high-priority research topics”. We encourage interested members to examine the NIH Guide for Grants and Contracts for upcoming P01 funding opportunities and additional information.

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NIH Seeks Input on Assessment of Repositories

On August 12, the NIH issued a request for information (RFI) to solicit input on metrics to assess the value of biomedical digital data repositories. The NIH seeks input to better understand the value of data repositories in several categories, including:

  • Utilization at multiple levels
  • Indicators of data repository quality and impact
  • Quality of service
  • Infrastructure and governance
  • Qualitative metrics
  • Case studies demonstrating the value of repositories.

Input from the RFI will assist NIH in ensuring that policies and financial resources support highly valuable repositories that will better serve the research community.

Take Action: Members are encouraged to examine the RFI and consider sending comments on useful metrics to assess the value of biomedical data repositories. Responses should be submitted to NIH_Repository_Metrics_RFI@mail.nih.gov by September 30, 2016.

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National Toxicology Program Recruiting for Level of Concern Study

The National Toxicology Program (NTP), is recruiting from all stakeholder groups for an important study to evaluate the categories used in its "level of concern" (LoC) framework used to communicate the level of risk associated with exposure to harmful chemicals.

The Endocrine Society encourages members with expertise in risk evaluation and communication to consider taking part in the study. According to the NTP, participation will take approximately 1.5 hours of your time, and your input will inform decisions on the number of categories to be used in the updated framework.

Take Action: To learn more or to register to participate in the study, please visit the LoC study website. To participate in the study, you must have:

  • M.S., Ph.D., M.D., or equivalent degree
  • At least 3 years of experience in toxicology, epidemiology, risk assessment, or a related field

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