JDRF is teaming up with the American Diabetes Association and the Leona M. and Harry B. Helmsley Charitable Trust to support research evaluating the consistency and potency of insulin purchased at retail pharmacies in the U.S.
The group called for proposals from analytical laboratories to assess the activity of insulin in vials and cartridges, looking for variations that could pose a safety risk for people with diabetes.
The group’s efforts were spurred on by a study published last year in the Journal of Diabetes Science and Technology, in which researchers examined 18 vials of insulin produced by two different manufacturers. They reported an average insulin dosage of 40.2 U/mL with levels between 13.9 to 94.2 U/mL. None of the vials examined by the researchers met the FDA’s 95 U/mL standard.
Applicants hoping to win financial support from JDRF, ADA and the Helmsley trust should submit their full proposal by April 18, the group said. Research is expected to begin in July.
“As critical as insulin is to millions of Americans, JDRF 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,” JDRF’s chief mission officer Aaron Kowalski said in prepared remarks. “At the same time, we want to stress that all people with Type I diabetes should continue to take insulin as prescribed.”
“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,” ADA’s chief scientific, medical & mission officer Dr. William Cefalu added.