Vaccine against cheap tuberculosis promises against juvenile diabetes

The rising cost of type 1 diabetes, one of the most common chronic diseases, has created heavy financial burdens for families and generated controversy, with insulin prices more than doubled in the last decade.

Without his parents' insurance, "I would not be alive," said Gaytan, a student at the University of Maryland.

The burden of treatment is the reason why a small study that looks promising for a simpler and cheaper alternative treatment for type 1 diabetes is fulfilling hope. But also caution and skepticism.
The research, published on June 21 in the journal Nature Partner Journal Vaccines, showed that an older generic vaccine can help reduce the blood sugar level of patients with type 1 diabetes, decreasing their need for insulin . The vaccine, BCG, is used in several countries to prevent tuberculosis, but it has also been known for some time that it stimulates the immune system. That vaccine is relatively inexpensive, costing approximately $ 157 per dose in the United States, according to the health technology company Connecture.
In the study, participants with long-term type 1 diabetes were injected with two doses of the Bacillus Calmette-Guerin tuberculosis vaccine, known as BCG, four weeks apart. Three of the patients were observed for eight years. Nine participants were followed for five years.

Blood sugar levels, known as A1c, from those followed for eight years decreased by more than 10 percent three years after injection and were maintained for five more years.

Although the trial involved a small number of patients, the researchers, led by Dr. Denise Faustman, director of the Immunobiology Laboratory at Mbadachusetts General Hospital, are conducting a larger Phase 2 trial of BCG for treat diabetes and see if the results are maintained.

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JDRF, a leading non-profit organization that provides funding for research on type 1 diabetes, and the American Diabetes Association issued a joint statement shortly after the publication of the new study, warning against misinterpretation of the findings and stating that "they do not provide enough clinical evidence to support any recommendation change in the therapy at this time. " Both groups have partnered with drug manufacturers and device manufacturers in the industry.

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" for patients with diabetes. But he warned against the possibility of generating "too much exaggeration" among families before it is proven that the treatment is effective.

Dr. Joseph Bellanti, professor emeritus of pediatrics and microbiology and immunology, was also encouraged by the findings of the studies. While he acknowledged the skepticism surrounding Faustman's research, scrutiny is a necessary part of the scientific process, he said.

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"We are looking for the truth, and we want to make sure that the results and interpretations are correct," said Bellanti, "and that requires a healthy debate."

Faustman He said his 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, such as multiple sclerosis, which involve a reaction of the immune system against normal tissue.

"It also opens up a lot of new potential avenues," said Faustman, adding that it could help develop interventions for other groups suffering from chronic diseases.

Type 1 diabetes, which is usually diagnosed In childhood, it occurs when the immune system destroys the cells that produce it and insulin. evils of this vital hormone, but their bodies do not respond properly.

These findings appear as the country grapples with rising insulin prices, a significant increase that has prompted attorneys general in several states and at least one federal prosecutor to initiate investigations targeting insulin manufacturers Eli Lilly, Novo Nordisk, Sanofi and pharmaceutical benefit managers.
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The United States already pays a high price for its burden of diabetes. According to the American Diabetes Association, the 24.7 million Americans living with the diagnosis last year spent $ 237 billion in direct medical costs last year.

For patients like Gaytan, the possibility of new medications to simplify and reduce the costs of their treatment is tempting. She injects insulin and checks her blood sugar level five times a day. And he attends therapy to help deal with the burden of life with a chronic condition and worries about how he can afford it in the future.

"I know that diabetic families [whose] pay everything," he said, adding "they just can not afford it."

According to Connecture, the list price for Apidra SoloStar, an injectable insulin product that Gaytan uses several times a day, increased from $ 33.24 per pen in early 2009 to $ 104.28 per pen in early 2018.

Faustman said that the research has documented the mechanism by which the old vaccine reduces blood sugar levels. In the Phase 2 trial, he will try to replicate his findings by following 150 participants with the disease for five years. It will be at least another four years until the results are published.

Ultimately, if BCG works to treat type 1 diabetes, its current price could rise, said Gerard Anderson, professor of health policy and administration and medicine at Johns Hopkins University. in Baltimore, who, like Kaiser Health News, receives money from the Laura and John Arnold Foundation. Although BCG is generic, pharmaceutical companies can raise the price by altering the drug and issuing a new patent.

Drug makers are experts in reorganizing old medications to treat new conditions, he said, adding: "It could result in no cost savings at all, and, in fact, a higher price."


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