If someone could give you a vaccine that would cure your fibromyalgia, would you? That may sound like a dream, but it is closer to reality than you might think. Los Angeles-based biomedical firm EpicGenetics and researchers at Massachusetts General Hospital are seeking approval from the US Food and Drug Administration. UU To conduct a clinical trial next year to test the Bacille Calmette-Guerin (BCG) vaccine as a potential treatment for fibromyalgia.
BCG is a generic vaccine against tuberculosis that is almost 100 years old and has been safely administered millions of times, “said Dr. Denise Faustman, director of the Faustman Laboratory at Massachusetts General Hospital.” For more than 10 years, Our research group at the Massachusetts General Hospital has been actively investigating the role that the BCG vaccine could play in the treatment of various forms of autoimmunity. Our current approach is type 1 diabetes, but BCG is being tested in several autoimmune diseases worldwide. In the next two years we will begin clinical trials of BCG in fibromyalgia. ”
According to the World Health Organization, more than 100 million children receive the BCG vaccine every year. It is used mainly in developing countries where tuberculosis is still active. The BCG vaccine is not available in the United States due to the low risk of infection. In the USA In the US, BCG is used in a small number of patients to treat bladder cancer.
So, the obvious question is why would a vaccine be used for an infectious lung condition for fibromyalgia? The answer lies within the immune system.
Vaccines are usually given to healthy people to prevent infections. In this case, however, the BCG vaccine will be administered to patients with fibromyalgia in an effort to calm their symptoms.
When EpicGenetics was commissioned to create a diagnostic test for fibromyalgia several years ago, the researchers performed all kinds of laboratory tests in patients with fibromyalgia to find out how they differed from healthy control subjects and what could be causing their symptoms. The researchers discovered several abnormalities of white blood cells in patients with fibromyalgia, which led them to conclude that the symptoms are associated with a suppressed immune system.
“We believe that [the term] fibromyalgia is a misnomer,” said Dr. Bruce Gillis, CEO of EpicGenetics. “These people are not suffering from anything that is affecting the muscles, so to speak What they are suffering is that their immune system can not produce normal amounts of protective proteins … There are cells in the immune system called peripheral blood mononuclear cells They are not producing normal amounts of protective proteins called chemokines and cytokines. ”
The finding led to the development of the FM / a blood test for fibromyalgia. (Yes, despite what your doctors have told you, there is a blood test for fibromyalgia! It’s just not widely accepted in the medical community.) The test analyzes the levels of four chemokines and cytokines found at reduced levels in patients with fibromyalgia. These four chemokines and cytokines are simply the same ones that are boosted with the BCG vaccine.
“Given what has been published in the medical literature, we believe that this vaccine will reverse abnormalities of the immune system [of fibromyalgia],” Gillis said.
Gillis and Faustman are seeking approval from the FDA to administer the first BCG vaccines to patients with fibromyalgia early next year.
“This is the first time that a direct treatment of fibromyalgia is performed,” said Gillis. “As you know, the drugs [currently on the market] for fibromyalgia only treat the symptoms, they have no benefits for the immune system [Pharmaceutical companies] recognize that they are only treating the symptoms, but they need to treat the disease, and it is that we are moving forward with the application of the vaccine [to the FDA]. ”
If Gillis’ theory is true, then “the chemokines and cytokines that are deficient in fibromyalgia patients will no longer be deficient [once the BCG vaccine is administered],” Gillis said. “The levels of production will normalize, and you must assume then that your symptoms will disappear … We believe that we are on the cusp of something important.”
Because the vaccine has such a long history, it is not expected to cause any significant side effects in patients.
It is anticipated that the BCG vaccine will cost between $ 20 and $ 25 per dose, a nominal amount compared to the constant cost of taking pharmaceutical products every day.
“We believe that a patient with fibromyalgia would need one or two doses at most to I can understand why I do not get much support from pharmaceutical companies, “said Gillis. In addition to the vaccine trial, EpicGenetics is partnering with the University of California, Los Angeles (UCLA) and the University of Illinois School of Medicine. in Chicago to sequence the genomes of up to 250,000 patients with fibromyalgia. “We are looking for any kind of genetic patterns or abnormalities or mutations,” said Gillis. Patients who test positive for fibromyalgia with the FM / a test will be