Revised vaccine raises hopes as a lower cost treatment for type 1 diabetes



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For Hodalis Gaytan, 20, living with type 1 diabetes means depending on an badortment of expensive drugs and devices to stay healthy. Reactive strips. Needles A glucose meter.

The rising cost of type 1 diabetes, one of the most common serious chronic diseases, has created heavy financial burdens for families and sparked controversy, with insulin prices having more than just doubled over the last decade. "I would not be alive," says Gaytan, a student at the University of Maryland.

The burden of treatment is why a promising small study for a simpler and cheaper alternative treatment of type 1 diabetes with hope – but also with caution and skepticism.

The research, published June 21 in the journal Nature Partner Journal Vaccines, showed that an old generic vaccine could help reduce the blood sugar levels of patients with type 1 diabetes mellitus. # 39; insulin. The BCG vaccine is used in a number of countries to prevent TB and it has long been recognized that it also boosts the immune system. This vaccine is relatively cheap, costing about $ 157 per dose in the United States, according to the health care technology company, Connecture.

In the study, participants with type 1 diabetes received two doses of Bacillus Calmette-Guerin Tuberculosis Vaccine – known as BCG – at four-week intervals. Three of the patients were observed for eight years. Nine participants were followed for five years.

Blood sugar levels – known as A1c – of those followed for eight years fell by more than 10% three years after injection and were maintained for five years. Dr. Denise Faustman, director of the Mbadachusetts General Hospital Laboratory of Immunobiology, is conducting a much larger phase 2 trial of BCG to treat diabetes to see if the results are good. 1965/009] JDRF, a major nonprofit that subsidizes type 1 diabetes research, and the American Diabetes Association issued a joint statement shortly after the publication of the new study, warning against a misinterpretation of results. The two groups have partnered with drug manufacturers and device manufacturers in the industry. [19659010] Yet Dr. Camillo Ricordi, director of the Institute for Diabetes Research at the University of Miami, said that he was "cautiously optimistic" about the results, noting the "Incredibly high price" for diabetic patients. But he warned against generating "too much hype" among families before the treatment proves its effectiveness.

Joseph Bellanti, professor emeritus of pediatrics and microbiology and immunology at the Georgetown University Medical Center in Washington, DC, was also encouraged by the results of the studies. While acknowledging the skepticism surrounding Faustman's research, scrutiny is a necessary part of the scientific process, he says.

"We seek the truth and we want to make sure the results and interpretations are correct."

Faustman said his findings are important because they suggest that the vaccine may 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 involves a reaction of the immune system against normal tissues.

"She also opens up a crowd possible new treatment pathways, "added Faustman, adding that this could help develop interventions for other groups with chronic diseases.] Type 1 diabetes, which is typically 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 body does not react properly.

These results are surfacing as the country faces a soaring price of insulin. at least one federal prosecutor to launch investigations targeting insulin manufacturers, Eli Lilly, Novo Nordisk, Sanofi and drug benefit managers.

The United States is already paying a high price for its diabetes burden. According to the American Diabetes Association, the 24.7 million Americans diagnosed last year spent $ 237 billion in direct medical expenses.

For patients like Gaytan, the prospect of new drugs to simplify and reduce the costs of its treatment is tempting. She injects insulin and checks her blood sugar level about five times a day. And she attends therapy to help manage the burden of living with a chronic illness, and is worried about how she will afford it in the future.

"I know that diabetic families [whose] pay for everything" According to Connecture, the selling price of Apidra SoloStar – an injectable injectable product that Gaytan uses several times a day – increased from $ 33.24 by pen in early 2009 at $ 104.28 per pen in early 2009. 2018.

Faustman said his research has documented the mechanism by which the old vaccine reduces blood sugar levels. In the Phase 2 trial, she will try to replicate her results by following 150 participants with the disease for five years. Ultimately, if BCG is working to treat type 1 diabetes, its current price could rise, said Gerard Anderson, professor of health policy and management and medicine at Johns Hopkins University. in Baltimore, which, like Kaiser Health News, receives money from the Laura and John Arnold Foundation. Although BCG is generic, pharmaceutical companies can increase the price by modifying the drug and issuing a new patent.

Drug manufacturers are experts in retooling old medicines to treat new diseases. all – and, in fact, a higher price. "

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