On January 18 the Trump administration made the following announcement:
From Jan 18, 2018
Today, the Trump administration announced it would be creating a "Division of Conscience and Religious Freedom" at the Department of Health and Human Services. This new office will defend doctors, nurses, and other healthcare workers who discriminate against patients based on their reproductive history and gender identity.
The Special Diabetes Program (SDP) supports research to prevent, treat, and cure type 1 diabetes and its complications and type 2 diabetes treatment and prevention strategies for American Indian and Alaska Native populations. The SDP expired on October 1 and Congress is currently reviewing legislation to reauthorize the program. At issue is how to pay for it. One option proposed in the House of Representatives is to cut funds for the Public Health and Prevention Fund—which is used by the CDC for a number of important programs.
The PES Board and Advocacy Committee believe that the SDP is a valuable program that merits renewal of funding without jeopardizing other critically important prevention and public programs. The Endocrine Society and the ADA have been advocating for the renewal of the program and have wide-ranging, bi-partisan support—356 House Members and 75 Senators signed onto a letter of support. Below is a sample letter that you can use in your communications to advocate for this program.
"I am writing today about the importance of reauthorizing the Special Diabetes Program (SDP), which expired on September 30.
As someone who provides clinical care to patients, who conducts diabetes research, and who has benefited from the program, I believe that it is critical that Congress pass legislation to reauthorize the program. The SDP program has enabled scientists to make significant advances in prevention and treatments of diabetes, including the development of the artificial pancreas and other important technologies. In turn, these advances have provided individuals affected by diabetes, improved therapies with better health outcomes and an improved quality of life.
However, this research is now in jeopardy if Congress does not act.
As you may know, the SDP has far-reaching, bi-partisan support—75 Senators and 356 Representatives signed onto letters of support. The SDP program funding expired October 1, having failed reauthorization. This halted funding for new grants and suspended existing grant renewals. The House Energy and Commerce committee proposed including the reauthorization of the program in Children’s Health Insurance Program (CHIP), however, the committee is considering drastically cutting the Public Health and Prevention Fund to pay for the extension of the SDP and other programs.
The SDP needs to be reauthorized immediately without jeopardizing other critically important prevention and public programs.
I hope that you appreciate the importance of this issue and that you will act accordingly. Ongoing research and prevention programs are at great risk following expiration of the SDP program, so it is critical that we reauthorize the SDP to insure that the momentum we have achieved in diabetes research will be maintained. This is critical to improving diabetes care and will ultimately lead to prevention and a cure.
Please contact me if I can provide additional information regarding the critical importance of the SDP.”
On 2/2/17, Kaiser Health News published an article raising concerns about potential long-term side effects of leuprolide acetate for depot suspension in women previously treated with this medication and stating that the FDA was "currently conducting a specific review of nervous system and psychiatric events in association with the use of GnRH agonists, [a class of drugs] including Lupron, in pediatric patients."
Since then, we have conducted a literature search and contacted the manufacturers of GnRH agonists in the U.S. and pediatric endocrinology colleagues in the US, UK, EU and South America to inquire about any new safety issues. We also spoke with representatives of the FDA who acknowledged that a Tracked Safety Issue (TSI) has been initiated for non-urgent review of potential safety concerns in this class of medications.
After further review of available information, we do not feel that there is any new safety concern with GnRH agonists that should change our prescribing practices at this time.
As always, we recommend that any unexpected medication adverse events be reported to the FDA.
We will update you as further information becomes available.
Click here for full statement including links to Kaiser Health News article, FDA TSI and FDA Adverse Events Reporting System.
Basaglar (insulin glargine) launched by Eli Lilly on December 15, 2016: Basaglar, a brand of insulin glargine marketed by Eli Lilly, was FDA approved in 2015 and became available in the United States on December 15, 2016. Following its launch, many insurers are limiting coverage for Lantus and requesting that patients change to Basaglar. Although not approved as a "biosimilar," Basaglar has an identical amino acid sequence to Lantus and very similar pharmacokinetic and pharmacodynamic profiles (Linnebjerg et al., Diabetes Care, 2015, 38:2226-2233; Linnebjerg et al., Diabetes Obes Metab, 2017, 19:33-39). It is FDA approved for use in Types 1 and 2 diabetes, following trials showing non-inferiority in both conditions (Type 2: Rosenstock et al., Diabetes Obes Metab, 2015, 17:734-741; Type 1: Blevins et al., Diabetes Obes Metab, 2015, 17:726-733).
We are pleased to note that with unanimous approval of our Board of Directors, PES (in addition to other professional societies and academic centers in the U.S.) signed on to an amicus brief filed on November 29, 2016, in the United States District Court for the Western District of Pennsylvania in support of the right of transgender youth to be treated equally and with dignity in schools. The case involves three transgender students who have been excluded from using the restrooms used by all of their peers.
Click here to see a copy of this brief.
The House and Senate have been negotiating a large, bipartisan mental health package over much of the past year. The most recent draft of this package in the House (H.R. 2646) includes Section 722, which reauthorizes the pediatric subspecialty loan repayment program (PSLRP). The PSLRP was a discretionary program originally authorized in the Affordable Care Act and would have provided up to $35,000 in loan repayment for each year that a pediatric medical/surgical subspecialist or pediatric mental health provider served in an underserved area, for a maximum of three years. The program was ultimately never funded, due in large part to politics surrounding the ACA, and expired in 2014.
The Pediatric Endocrine Society has joined a coalition of Pediatric Medical and Surgical associations to submit a letter supporting the reauthorization of this program. A reauthorization of the PSLRP in the context of proposed mental health legislation would give us a new opportunity to address the ongoing shortage of pediatric medical and surgical subspecialists as well as pediatric mental health providers across the nation.
Click here to view this letter.
The most recent version of the 2017 National Defense Authorization Act (NDAA) (S.2943) has the potential to eliminate certain health care providers from the Military Health System. This includes Pediatricians, OB-Gyns and other essential providers of health care to infants, children and families of members of our Armed Forces. In addition, the bill provides for the elimination of many DoD Graduate Medical Education programs, further weakening the source of new providers for our military families. The Pediatric Endocrine Society, along with a number of similar societies, has signed on to a letter urging the House and Senate Armed Services Committees to reconsider these provisions in S. 2943.
PES members are encouraged to read this letter and contact your senator or representative to advocate for adequate access to health care for all members of our military families.
Click here to view this letter.
On June 9, the PES SIG on Transgender Health sent a letter in support of the U.S. Department of Education guidance on the rights of transgender students, to the governors of the 12 states that have refused to follow them (AL, AZ, GA, LA, ME, MS, OK, TN, TX, UT, WI, WV). States that do not follow these guidance are at risk of loosing federal funds for public education. Some of these states are in the process of filing a lawsuit against the federal government.
The U.S. Department of Education guidance on the rights of transgender students, recommends that transgender students use restrooms, locker rooms and other facilities that are consistent with their gender identity, as well as the appropriate use of preferred names and pronouns. The PES SIG on Transgender Health agrees that this kind of support in schools is crucial for the optimal psychosocial development of transgender youth.
Click here to view this letter.
Final coalition letter signed by 70 medical, public health, and patient organizations endorsing the Ensuring Children's Access to Specialty Care Act (H.R. 1859/S. 2782)
Click here to view this letter.
Henry Rodriguez, Chair of the Public Policy Council and the Council's liaison to the Diabetes Advocacy Alliance (DAA), had the honor of presenting Congressman Ed Whitfield with the Lifetime Achievement in Diabetes award on March 1st, at a DAA reception to honor Congressman Whitfield and to welcome the new leadership of the Congressional Diabetes Caucus. Congressman Whitfield has been the Co-chair of the Congressional Diabetes Caucus for five years and, during that time; he has provided tremendous leadership on numerous diabetes issues, including his sponsorship of the Access to Quality Diabetes Education Act. He announced his intention to retire at the end of the current session of Congress. Also attending, were Congressman Tom Reed, the incoming Caucus Co-chair, Congresswoman Diana DeGette, the other Co-chair of the Caucus, Congresswoman Susan Brooks, the new Vice-chair of the Caucus, and members of their staff.
The Congressional Diabetes Caucus is the largest caucus in Congress, aimed at advancing legislation to benefit people with diabetes and those at risk
The DAA is a coalition of 21 diverse members, representing patient, professional and trade associations, other nonprofit organizations, and corporations, all united by the common goal to defeat diabetes. Members of the DAA currently include the Academy of Nutrition and Dietetics, American Association of Clinical Endocrinologists, American Association of Diabetes Educators, American Clinical Laboratory Association, American Diabetes Association, American Medical Association, American Optometric Association, American Podiatric Medical Association, Diabetes Hands Foundation, Endocrine Society, Healthcare Leadership Council, National Association of Chain Drug Stores, National Association of Chronic Disease Directors, National Community Pharmacists Association, National Kidney Foundation, Novo Nordisk Inc., Omada Health, Pediatric Endocrine Society, VSP Vision Care, Weight Watchers International Inc., and YMCA of the USA.
In case you missed today's "CBS This Morning", our very own Stephen Rosenthal was interviewed for his expertise on transgender youth. He was honored to be able to say a few words regarding this inspiring child and family. Congratulations again, Dr. Rosenthal!
Transgender Letter to the South Dakota Governor
The PES Board of Directors wishes to publicly thank Steve Rosenthal for his recent and timely leadership on crafting, and sending a letter to the South Dakota governor encouraging the veto of a bill. The bill required students at state public schools to use restrooms and other facilities based on their "chromosomes and anatomy" at birth. While the legislature was in favor of this bill, the governor ultimately vetoed it. PES is encouraged and hopeful to think that the letter signed by the PES board of directors may have helped influence his decision to veto.
Click here to view this letter.
In light of this recent success, the board are engaging the Public Policy Committee and the Transgender SIG in the hopes that perhaps we could encourage proactive engagement in other states should this issue become more widespread. Kara Connelly; a member of the PES Transgender SIG, and volunteer for an organization known as Transactive will serve as a bridge between the PES transgender SIG and an the organization. Her serving as a liaison between the two may be instrumental in keeping PES appraised of similar legislation in other states allowing us to be more nimble and responsive to make a difference in the outcomes.
Click here to see Dr. Rosenthal's original interview with a Time correspondent regarding this bill.
A follow-up article was then published by Time, leading up to the decision to veto the bill.
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