NEW YORK, April 10, 2018 — Breakthrough T1D International (JDRF), American Diabetes Association (ADA) and The Leona M. and Harry B. Helmsley Charitable Trust (Helmsley) together seek to support an evaluation of the consistency and potency of insulin that is purchased at retail pharmacies across the United States. The organizations have issued a request for proposals (RFP) from analytical laboratories that, if selected, would conduct the study over the next year.
Insulin is a life-saving drug for people with diabetes that can be dangerous and potentially fatal when dosing is incorrect. Variation in insulin activity or insufficient insulin activity would pose significant challenges and safety risks for people with diabetes attempting to manage their blood glucose levels.
The RFP was prompted by a small study published in December 2017 that found wide variation in the level of activity in insulin purchased in U.S. pharmacies. The previous report (which was not initiated by Breakthrough T1D, ADA or Helmsley) prompted concern among insulin users and controversy among manufacturers, clinicians and biochemists. Its results were surprising in that they were inconsistent with data from previous regulatory audits, highlighting the need for further study.
“As critical as insulin is to millions of Americans, Breakthrough T1D believes further study is needed to analyze the quality of insulin at the point of sale and convened our close partners to investigate what has generated understandable concern in our community,” said Aaron Kowalski, Ph.D., Breakthrough T1D Chief Mission Officer. “At the same time, we want to stress that all people with type 1 diabetes should continue to take insulin as prescribed.”
The December study, published in the Journal of Diabetes Science and Technology, examined 18 10-mL vials of NPH and regular insulin produced by two major manufacturers and randomly purchased in U.S. pharmacies. It found an average dosage of 40.2 U/mL with levels ranging from 13.9 to 94.2 U/mL. None of the vials met the 95-U/mL standard at the time of testing. The U.S. Pharmacopeia and the U.S. Food and Drug Administration require insulin vials and cartridges to contain a minimum of 95 percent intact insulin (95 U/mL).
The work requested in the RFP consists of establishing a protocol for the project, analyzing the activity of insulin in vials and cartridges, and submitting a paper on the outcomes of the study to a peer-reviewed journal.
“Insulin is essential to the survival of millions of Americans with diabetes, and they should not have to worry about the quality of the insulin they must take every day. We concur that our proposed study is critical in allaying the serious concerns raised by Carter and Heinemann’s insulin potency study,” said ADA’s Chief Scientific, Medical and Mission Officer William T. Cefalu, MD. “We look forward to awarding this RFP so any issues can be identified, addressed and resolved as quickly as possible. We strongly urge patients who are currently taking insulin to continue taking insulin as usual, and to speak with their doctors and pharmacists if they have any concerns.”
The full proposal submission deadline is April 18, 2018. Applicants will receive a response by June 2018 and research is anticipated to start in July 2018. Applicants should review the application requirements and register and submit their completed proposals on the Breakthrough T1D RMS360 website: https://jdrf.smartsimple.us.
JDRF, ADA and Helmsley will review and may choose to fund a limited number of proposals; the results would become the confidential property of the organizations. More details about this RFP are available at https://grantcenter.jdrf.org/rfa/quantitative-analysis-of-insulin-activity-purchased-from-pharmacies-in-the-united-states.
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About Breakthrough T1D
Breakthrough T1D is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, Breakthrough T1D has invested more than $2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF.
About the American Diabetes Association
Nearly half of American adults have diabetes or prediabetes; more than 30 million adults and children have diabetes; and every 21 seconds, another individual is diagnosed with diabetes in the U.S. Founded in 1940, the American Diabetes Association (ADA) is the nation’s leading voluntary health organization whose mission is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. The ADA drives discovery by funding research to treat, manage and prevent all types of diabetes, as well as to search for cures; raises voice to the urgency of the diabetes epidemic; and works to safeguard policies and programs that protect people with diabetes. In addition, the ADA supports people living with diabetes, those at risk of developing diabetes, and the health care professionals who serve them through information and programs that can improve health outcomes and quality of life. For more information, please call the ADA at 1-800-DIABETES (1-800-342-2383) or visit diabetes.org.
About the Leona M. and Harry B. Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2 billion for a wide range of charitable purposes. For more information, visit www.helmsleytrust.org.
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