NIH Funding in Jeopardy; Contact Your Representative & Senators to Urge Support for Final Spending Bill
Congress adjourned for 2016 without passing a final funding bill. Instead, the National Institutes of Health (NIH) and other federal agencies will be funded through a continuing resolution (CR) at FY 2016 levels until April 28, 2017. At that time, Congress will either have to extend the CR or pass a final spending bill. This temporary funding measure seriously hurts the NIH by limiting its budget and grant opportunities. It is critical that every member of Congress hear from his/her constituents in the research community about the importance of biomedical research and the need to provide NIH with at least $34 billion in FY 2017.
Take Action: We encourage all Society members to join our online advocacy campaign urging the new Congress to pass a final spending bill with at least $34 billion for NIH. Our campaign provides a letter and will direct the letter to your Representative and Senators. You may also personalize the letter, if you choose to. Taking action will only take a moment of your time, but it will have real impact.
Endocrine Society Expresses Disappointment with Revised EDCs Proposal
On Friday, December 16, the European Commission announced a revised proposal for the identification of endocrine-disrupting chemicals (EDCs). The revised proposal maintains the unreasonably high level of proof for determining that a chemical is an EDC, and it also adds an extremely problematic new provision that exempts EDCs that act by regulating the growth of harmful organisms via the endocrine system. This exemption would include pesticides that primarily aim to prevent certain insects from growing or reproducing, even though these chemicals could also have effects on non-target species.
The Endocrine Society issued a press release expressing disappointment with the proposal and outlining our remaining concerns. We maintain that having multiple categories for EDCs based on level of evidence remains the most appropriate way to identify and develop regulatory strategies for EDCs. We will continue to closely monitor developments related to the criteria and engage with policymakers to ensure that criteria to identify EDCs are based on endocrine principles and the latest research.
FDA Expands Indication for Dexcom's G5 Mobile CGM, Allows Replacement of Fingerstick Testing for Treatment Decisions
On December 20, the FDA issued an expanded indication for Dexcom’s G5 Mobile Continuous Glucose Monitoring (CGM) System that will allow the device to replace fingerstick blood glucose testing for diabetes treatment decisions in people 2 years of age and older. Previously, the system was approved only to complement fingerstick testing, but the FDA has now approved it to replace the traditional fingerstick test confirmation.
Previously, glucose levels had to be calibrated at least two times per day using blood obtained from fingerstick tests, but the FDA’s recent ruling now enables patients to make treatment decisions based solely on the real-time readings from their CGM device.
The Endocrine Society has strongly advocated for this change and is pleased with the FDA’s decision. As previously reported in Endocrine Insider, Society member Dr. Nicholas Argento testified in support of this change. The Society also launched a grassroots campaign that garnered scores of letters to the FDA from clinicians, and has worked with DiaTribe to ensure that the FDA heard from a range of voices. We will continue to advocate for Medicare coverage of CGM.
FDA Issues Updated Review, Indication for Type 2 Diabetes Medications Pioglitazone and Empagliflozin
The US Food and Drug Administration (FDA) issued an updated review of the type 2 diabetes medicine pioglitazone, concluding that the drug may be linked to an increased risk of bladder cancer. Pioglitazone, which is approved to improve blood sugar control, was initially the subject of an FDA alert about the potential risk of bladder cancer in 2010. The FDA recommends that health care professionals not use pioglitazone in patients with active bladder cancer, and that patients should contact their providers if they experience pain or urgency when urinating, or if they notice blood or a red color in their urine. See the FDA Drug Safety Communication page for more details about this review.
The FDA also approved a new indication for Jardiance (empagliflozin), a medication approved in 2014 that reduces the risk of cardiovascular death in patients with type 2 diabetes and cardiovascular disease. In a postmarket clinical trial of more than 7,000 patients with type 2 diabetes, empagliflozin was shown to reduce the risk of cardiovascular-related death compared to a placebo when added to a standard of care therapy. For more information, see the FDA’s news release.
Significant Change to DEA Registration Renewal Process
The US Drug Enforcement Administration (DEA) recently announced that it has made significant changes to its registration renewal process. Effective January 1, 2017, there will be no longer be an informal grace period for registrants to renew their registrations. Registrants will receive only one renewal notice in the mail approximately 65 days prior to the expiration date. After the expiration date passes, the registrant must apply for a new DEA registration. Registrants who miss the expiration date will no longer be able to renew online or by mail, their DEA number will retire, and the original DEA registration will not be reinstated. Renewal applications received after the expiration date will be returned to the sender.
The American Medical Association sent letters to DEA Acting Administrator Charles Rosenberg and Louis Milione (Assistant Administrator for Diversion Control) expressing concern about the problems that this policy change could create for both patients and their physicians, and urged the DEA to reverse this change to the renewal process. We will keep you apprised of any updates.
On Friday, December 16, the Endocrine Society met with the new Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Diana W. Bianchi, MD. The meeting included a coalition of organizations, known as Friends of NICHD, which was formed to support the activities of NICHD and promote the interests of the institute during the annual appropriations process. Many Endocrine Society researcher members receive federal funding through NICHD to support research projects consistent with the mission of the institute.
During the meeting, Dr. Bianchi described the potential effects of recent legislative developments on NICHD. She noted that none of the dedicated funds from the 21st Century Cures package will go to NICHD, however there may be indirect benefits to the institute from the projects targeted by the bill. Of particular concern is the prospect of a long-term continuing resolution, which would severely impact the ability of the institute to fund research grants. Dr. Bianchi also provided thoughts on research issues facing the NICHD community. She identified the Zika virus, data sharing, genome editing, and physician-scientist workforce issues as areas where she anticipates NICHD will be heavily engaged. She noted that the institute will also begin the process of examining progress made in the topic areas identified in the NICHD Vision.
The Endocrine Society appreciates the opportunity to learn about Dr. Bianchi’s priorities and thoughts about the issues facing NIH and NICHD as she assumes her new leadership role. We will continue to closely follow news and announcements from NICHD and keep members informed of new developments that will impact their research.
NIH Advisory Committee to the Director Discusses Physician-Scientist Issues, ECHO Program
On Thursday, December 8 and Friday, December 9, the Advisory Committee to the Director of the NIH (ACD) met to discuss several programs and policies of interest to Endocrine Society researchers. The ACD meets regularly to provide advice and make recommendations regarding matters pertinent to the NIH, such as program development, resource allocation, administrative regulation and policy.
ECHO Program Update
Dr. Matthew W. Gillman, MD, joined the ACD to provide an update of the Environmental Influences on Child Health Outcomes (ECHO) program. Several Endocrine Society members are funded through the ECHO program to study the life-long effects of exposures to toxic chemicals such as EDCs during development. The goals of the program include understanding and reducing risks of high-impact pediatric conditions such as obesity and neurodevelopment. 35 applications for cohort studies were funded in FY 16, towards the creation of a data platform integrating all these studies into an ECHO-wide cohort with over 50,000 children involved. Through the proposed ECHO-wide cohort, scientists can use big data technologies to ensure that researchers can analyze pooled data from multiple individual cohort studies and achieve, for example, greater diversity in geography, age, sex, and other demographic variables. Pilot studies will be evaluated after 2 years (phase I) and if milestones are met then studies will progress to a 5-year project (phase II).
The ACD was encouraged by the ECHO program and approach, and discussed challenges and opportunities that might be faced as the ECHO program tries to harmonize and combine disparate data sets. For instance, there could be connections between the ECHO program and the Precision Medicine Initiative (PMI—one of the funded components of the 21st Century Cures bill). The ACD also discussed the challenge of recruiting cohort studies during the preconception phase.
The Deputy Director for Extramural Affairs, Michael Lauer, MD, led the ACD in a discussion of physician-scientist workforce issues. The presentation is an update towards the eventual implementation of the recommendations derived from the data and report generated by the Physician-Scientist Workforce Working Group. Dr. Lauer noted that there are only some issues that are under control by NIH, such as training timelines and awards for younger researchers, and that external factors (such as evolving business models for academic medical centers) also affect the challenges facing physician-scientists.
Dr. Lauer identified several NIH-specific proposals for discussion among the ACD that might help address the diminishing number of physician scientists participating in basic biomedical research. The Committee discussed the risks facing physician-scientists in a hyper-competitive grantwriting atmosphere and how the availability of the loan-repayment program might help address these financial risks. Additionally, ACD members noted that it would be important to ensure that fellowship awards are effective at providing protected time for clinicians to conduct research, consistent with the Endocrine Society’s recommendations. Finally, the Committee expressed concern about the long timelines for training and whether there was enough emphasis on basic science in medical school curricula. Many Endocrine Society members are physician-scientists who are sensitive to the unique workforce issues facing this community. We will continue to closely follow the implementation of the Physician-Scientist Working Group report recommendations and report to members on relevant developments.