A cheap, old-school vaccine for tuberculosis has been used to restore blood sugar levels to near-normal in Type 1 diabetes patients, giving hope for affordable and effective treatments for the chronic and costly disease.
“Obviously it’s going to be jarring to some people. The last 15 years there’s been billions of dollars of immunotherapy in trials. Along we come with something that was before everyone’s eyes for 100 years,” said Dr. Denise Faustman, director of the Massachusetts General Hospital Immunobiology Laboratory, principal investigator and senior author of the recent paper. “And it appears to be filling a clinical gap that has not been filled with insulin.”
The experimental treatment, bacillus Calmette-Guerin, works by eliminating tissue-attacking cells and increasing production of T cells, which can prevent harmful autoimmune reaction, according to a paper published yesterday in the journal npj Vaccines.
The sample size was small, but the results were big. Three diabetes sufferers received two doses of the BCG vaccine starting in 2007. Six more patients were given the vaccine up to five years ago following promising signs of effectiveness, and 111 more were given the treatment recently.
Those who received the treatment saw a drop in hemoglobin A1c from an average of 7.26 to 6.18 — just above the normal levels, which are generally below 6.
Diabetes Type 1 is difficult to manage with insulin, which is the only available treatment. Most patients wear an insulin pump on one side and a glucose monitor on the other. But if too much insulin is administered, it can be deadly.
“Insulin is not a smart drug,” Faustman said. “Once you give someone more and more insulin it just keeps lowering blood sugar, and you could die.”
Not only that, but diabetes comes with an astronomical financial burden. The estimated cost of diabetes in 2017 in the U.S. was $327 billion dollars in 2017, up from $245 billion in 2012 — $237 billion in direct costs and $90 billion in indirect costs from lost productivity.
“The cost for insulin has skyrocketed over the past 15 years or so, even though it’s been around for 100 years,” said Dr. Anastassios Pittas, co-director of the Diabetes and Lipid Center at Tufts Medical Center, who was not involved with the study. “Treating patients has become very, very expensive.”
Type 1 diabetes also comes with the risk of other autoimmune conditions, such as thyroid problems, multiple sclerosis and celiac disease, Pittas said.
“It’s a very complicated disease that affects every single second of your life,” Pittas said. “Finding another treatment has been the holy grail.”
Faustman has been approved for Phase II, but others in the medical community say there is still a long way to go.
There need to be further studies with larger sample sizes, said Dr. Marie McDonnell, director of the Brigham and Women’s Diabetes Program.
“This is very preliminary, and that’s important,” McDonnell said. “But on a positive note, this kind of work should be encouraged and has to be certainly explained in clear terms to the community, so patients with Type 1 diabetes and families have the appropriate amount of hope.”