The increasing cost of Type 1 diabetes, one of the most common serious chronic diseases, has created heavy financial burdens for families and generated controversy, with insulin prices more than doubling in the past decade.
Without her parent’s insurance, “I would not be alive,” said Gaytan, a student at the University of Maryland.
The blood sugar levels — known as A1c — of those followed for eight years dropped by more than 10 percent three years after the injection and were sustained for five more years.
While the trial involved a tiny number of patients, the researchers — led by Dr. Denise Faustman, director of the Immunobiology Laboratory at Massachusetts General Hospital — are conducting a much larger Phase 2 trial of BCG to treat diabetes to see if the results hold up.
Still, Dr. Camillo Ricordi, director of the Diabetes Research Institute at the University of Miami, said he is “cautiously optimistic” about the findings, noting the “incredibly high price tag” for patients with diabetes. But he warned against generating “too much hype” among families before the treatment is proven to be effective.
Dr. Joseph Bellanti, professor emeritus of pediatrics and microbiology and immunology at Georgetown University Medical Center in Washington, was also encouraged by the studies’ findings. While he acknowledged the skepticism surrounding Faustman’s research, scrutiny is a necessary part of the scientific process, he said.
“We’re seeking the truth, and we want to make sure that the results and the interpretations are correct, Bellanti said, “and that requires healthy debate.”
Faustman said her findings are important because they suggest that the vaccine could have positive effects in the treatment of diabetes, similar to what has been seen in previous research on other autoimmune diseases, like multiple sclerosis, that involve an immune system reaction against normal tissue.
“It also opens up a host of new possible treatment avenues,” Faustman said, adding that it could help in developing interventions for other groups suffering from chronic illnesses.
Type 1 diabetes, which typically is diagnosed in childhood, occurs when the immune system destroys the cells that produce insulin. People with Type 2 diabetes produce normal levels of this vital hormone, but their bodies don’t respond appropriately.
For patients like Gaytan, the prospect of new medications to simplify and reduce the costs of her treatment is tantalizing. She injects herself with insulin and checks her blood sugar level about five times a day. And she attends therapy to help deal with the burden of living with a chronic condition, and worries about how she’ll afford it in the future.
“I know diabetics [whose] families pay for everything,” she said, adding they “just can’t afford it.”
According to Connecture, the list price for Apidra SoloStar — an injectable insulin product that Gaytan uses several times per day — increased from $33.24 per pen in early 2009 to $104.28 per pen in early 2018.
Faustman said her research has documented the mechanism by which the old vaccine reduces blood sugar levels. In the Phase 2 trial, she will attempt to replicate her findings by following 150 participants with the disease for five years. It will be at least another four years until results are published.
Drugmakers are expert at retooling old drugs to treat new conditions, he said, adding: “It could result in no cost savings at all — and, in fact, a higher price.”
News credit : Cnn