The US Senate was busy last week with negotiations and votes on a number of bills and amendments, all in an effort to fulfill the Republican's campaign promise to repeal the Affordable Care Act (ACA), also known as “Obamacare.” The bills ranged from a full repeal with a two-year delay to the Better Care Reconciliation Act, which would have repealed the ACA and replaced it with a new system of Medicaid payments and tax credits. The Senate was unable to identify a compromise that would satisfy both the moderate and conservative factions of the Republican caucus despite extensive negotiations. Strong grassroots advocacy had a significant impact on the outcome, including the hundreds of letters sent by Society members.
Whether there is a path forward for Republicans to achieve their goal of repealing the ACA remains to be seen. While Senate Majority Leader Mitch McConnell (R-KY) has indicated his intention to move on to other legislative priorities, including fiscal year 2018 appropriations, the debt limit, and tax reform, a number of bipartisan groups have formed in the House and Senate to determine if there is a compromise that can garner the support of a majority in both chambers. Committee chairs have also indicated their willingness to pass separate legislation that will deal with specific aspects of the ACA.
In the meantime, President Trump has indicated that he can withhold subsidies to insurance companies that cover some of the expense of insuring high-cost patients until the Senate votes again on repeal and replacement legislation. The uncertainty caused by this announcement is contributing to an unstable individual market and concerns that premiums will rise significantly.
We continue to monitor Senate activity on ACA repeal and advocate for inclusion of our non-partisan health reform principles. Thanks to all of our members who participated in our online and telephone advocacy campaigns urging the Senate to oppose legislation that would violate our principles.
New Tools, New Look for the Endocrine Society Advocacy Page
Check out the new and improved Advocacy page on the Endocrine Society website that has been reorganized with quick and easy tools and resources to help you effectively engage your lawmaker on endocrine-related issues.
We strongly encourage all members to engage with their elected officials to ensure that lawmakers take appropriate action on endocrine-related issues and Endocrine Society priorities that affect you, your research, and/or your patients. We welcome all feedback and invite you to contact us with any comments or questions about our new layout and new advocacy tools.
Endocrine Society Shares Diabetes Priorities in diaTribe Meeting
The Society participated in the conference “Glycemic Outcomes Beyond A1c: Standardization and Implementation” on July 21 hosted by diaTribe, the patient-focused arm of Close Concerns. The meeting continued the ongoing conversation of outcomes beyond A1c that should be considered in clinical trials for diabetes medications. The conference brought together experts from the US and Europe to reach a consensus on which glycemic outcomes beyond A1c are important and how to report them in a standardized way. Glycemic outcomes that were discussed included measures such as hypoglycemia, time spent in-range, and hyperglycemia.
Dr. Tony McCall, Vice President for Clinical Science at the Society, shared the Society's support for these outcomes and highlighted our work to advance the goals of the diabetes community on outcomes beyond A1c and our quality improvement initiative, the Hypoglycemia Quality Improvement Project (HQuIP), aimed at identifying interventions that will reduce the incidence of hypoglycemia.
FDA Hosts September 12 Public Workshop on Hypoglycemia in Older Adults; Society to Present Hypoglycemia Work
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, Professional Affairs and Stakeholder Engagement Staff (PASES) is hosting a one-day public workshop September 12 to discuss the importance of individualized glycemic control targets for older patients with diabetes to reduce the risk of serious hypoglycemia, identify and discuss medication safety efforts, discuss future areas of research which could be explored to reduce the risk of serious hypoglycemia, and disseminate the results of this discussion to inform patients, patient advocates, and healthcare practitioners. Those interested in attending the workshop entitled “Reducing the Risk of Preventable Adverse Drug Events Associated with Hypoglycemia in the Older Population” in person or via webcast can register here.
Dr. Robert Lash, Chair of the Society's Clinical Affairs Core Committee and Hypoglycemia Quality Improvement Project (HQuIP), will share our work to reduce the incidence of hypoglycemia through the Hypoglycemia Quality Collaborative, HQuIP, and partnership with numerous Federal agencies to raise awareness of hypoglycemia. A future issue of Endocrine News will include a report on the proceedings and outcomes.
Medscape Article Asks Healthcare Providers’ Opinions on EDCs
Following the release of criteria for the identification of Endocrine-Disrupting Chemicals (EDCs) proposed by the European Commission, on July 10 Medscape published an article describing the Commission’s proposal and the Endocrine Society’s critical response to the criteria. On July 13, Medscape also developed an online survey, asking readers about their level of concern regarding EDCs and whether they counsel patients to avoid EDCs or attribute adverse health effects in patients to EDCs. The results of the survey indicate that most healthcare providers are concerned about EDCs and counsel patients to avoid products exposed to or containing EDCs. Furthermore, many respondents agree that the Commission’s proposed criteria are not sufficient to safeguard patient health and that the United States should also implement regulatory actions to prevent harms due to EDCs.
The Endocrine Society recognizes the need to create more information on EDCs for patients, and has created resources to assist healthcare providers in their conversations with patients about EDCs. For more information, and to download fact sheets and other resources, please see the Hormone Health Network’s information and resources on EDCs here, or see the Society’s new EDC topic page.
Congressional Budget Battles Complicate NIH Funding Outlook
The Endocrine Society has been encouraged by the significant increases in funding for the National Institutes of Health (NIH) in fiscal years (FY) 2016 and 2017. However, further steady and sustainable increases in funding are needed to undo damage cause by years of flat funding prior to 2016. As we approach the start of FY 2018, the U.S. Congress has substantial work to do to complete in a relatively short amount of time to ensure that the government is funded and research funding agencies achieve a much-needed increase in 2018.
On July 10 the House Appropriations Subcommittee on Labor, Health and Human Services and Education (LHHS), proposed an appropriations bill that provides $35.2 billion for the NIH, or an increase of $1.1 billion above the FY 2017 level. However, because the overall allocation for the LHHS Subcommittee is reduced by $5 billion relative to FY 2017, other important agencies such as the Centers for Disease Control and Prevention would face severe cuts in the bill. While the prospects of the bill moving forward are unlikely, given the other budget issues and limited time for consideration of all 12 appropriations bills in both the House and the Senate, the increase for NIH in the House LHHS Subcommittee indicates that support for biomedical research remains a high priority for the Congress.
The overarching issue facing the House and Senate budget committees is the Budget Control Act (BCA), which places austere caps on overall funding levels for defense ($549 billion) and nondefense ($516 billion) discretionary funding in FY 2018. Absent a budget deal similar to those negotiated in 2013 and 2015, we will see across-the-board funding cuts impacting all federal agencies, including the NIH, NSF, CDC, and other agencies that support endocrine research and public health. Further complicating the budgetary picture is the need to increase the ceiling on the US government debt, which is set to hit the debt limit sometime in late-September.
The Congress has only 12 legislative working days to come to agreement on the debt ceiling, budget caps, and overall appropriations bills, creating a significant “fiscal cliff” scenario in September. Given the limited time to work on these issues, there is a strong chance of at least a short-term Continuing Resolution (CR) to fund the government and allow Congress to work on a budget deal and/or the debt limit through September and into October. The likelihood of a government shutdown is not insignificant, as it is unclear where the Trump administration’s budgetary priorities lie and whether there are circumstances where they might veto an appropriations bill.
The Endocrine Society is advocating for a funded federal government in FY 18 with an increase for the NIH budget consistent with a steady, sustainable, positive funding trajectory. In September, the Endocrine Society will launch a campaign to support NIH funding on the Society’s new advocacy page. Also, members of the Endocrine Society from key districts will participate in the Rally for Medical Research on September 14. Stay tuned to future issues of Endocrine Insider for the latest information on NIH appropriations.
Endocrine Society Participates in ECHO Stakeholder Meeting
On Friday, July 28, the Endocrine Society participated in a meeting sponsored by the Environmental Influences on Child Health Outcomes (ECHO) program at the National Institutes of Health (NIH). The ECHO program, launched in 2015, seeks to understand the effects of a broad range of early environmental influences on child health and development by following longitudinal research cohorts of children from diverse backgrounds across the United States.
During the meeting, the Director of the ECHO Program, Matthew Gillman, MD, gave an overview of progress made towards the goals of the ECHO Program. Current areas of focus include observational studies that incorporate newer technologies and biopathways to study cause and effect, and also clinical trials involving underrepresented and hard to reach populations. Thus far, funding has been directed towards 35 awardees including 74 principal investigators and involving 84 different cohorts. Importantly, and consistent with recommendations made by the Endocrine Society, cohorts will recruit pregnant women to better understand environmental exposures during prenatal development. A near-term goal for the ECHO Program will be to create a program-wide cohort and research protocol by Fall 2017. NIH hopes to include over 50,000 children in the cohort, and develop a single platform to harmonize data generated by the cohort and create a national research resource.
The Endocrine Society is encouraged by the progress made by the ECHO program and appreciates the outreach by the NIH to keep stakeholders informed of progress made and planning for the program, consistent with the recommendations made by the Society in our response to the ECHO program Request for Information. For more information on the ECHO Program, please see the NIH website at www.nih.gov/echo.
Friends of the National Institute on Aging Hold Congressional Briefing
On July 7, the Friends of the National Institute on Aging (FoNIA) held a Congressional briefing on ‘Advancing the Health of an Aging Population'. Speakers at the briefing included Richard J. Hodes, MD, Director of the NIA; Marie A. Bernard, MD, Deputy Director of the NIA; and David J. Irwin, MD, Assistant Professor at the University of Pennsylvania. The Endocrine Society is a member of the Friends of NIA.
During the briefing, Congressional staff learned about the important research done by the institute, and how research supported by NIA helps address critical health issues for the nation through real-world application. Several endocrine-focused examples were highlighted. During her presentation, Dr. Bernard described the results of the Testosterone Trial, which examined the effects of testosterone use on men aged 65 or older with clinical symptoms of hypoandrogenism. The trial examined the effects of testosterone on various important factors, such as physical function, cognitive function, bone density, and anemia. She also discussed the effects of caloric restriction in older individuals on mood, quality of life, and sex hormones.