If someone could give you a vaccine that could cure your fibromyalgia, would you? It may sound like a dream, but it is closer to reality than you think. The Los Angeles-based biomedical firm EpicGenetics and the Massachusetts General Hospital are seeking FDA approval to test the Bacillus Calmette-Guerin (BCG) vaccine next year as a possible treatment for fibromyalgia.
BCG is a generic vaccine against tuberculosis that is almost 100 years old and has been safely administered millions of times, “says Dr. Denise Faustman, director of the Faustman Laboratory at Massachusetts General Hospital. “For more than 10 years, our research group at Massachusetts General Hospital has been actively studying the role that the BCG vaccine could play in the treatment of various forms of autoimmunity. Our current target is type 1 diabetes, but in general, BCG is tested in several autoimmune diseases. Over 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 TB is still active. The BCG vaccine is not available in the United States due to the low risk of infection. In the United States, BCG is used in a small number of patients to treat bladder cancer.
So, the obvious question is: why would a vaccine against an infectious lung disease for fibromyalgia be used? The answer is in the immune system.
Vaccines are usually given to healthy people to prevent infections. In this case, however, the BCG vaccine would be administered to patients with fibromyalgia in order to relieve 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 determine the difference with healthy controls and their symptoms. Researchers have discovered several anomalies of white blood cells in patients with fibromyalgia, which leads them to conclude that the symptoms are associated with a weakened immune system.
“We believe that [the term] fibromyalgia is an inappropriate term,” said Dr. Bruce Gillis, CEO of EpicGenetics. “These people do not suffer from anything that affects the muscles, for example. What they suffer 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 do not produce normal amounts of protective proteins called chemokines and cytokines. “
The discovery led to the development of FM / a blood test for fibromyalgia. (Yes, despite what your doctors have told you, there is a blood test for fibromyalgia, but it is not accepted in the medical community). The test analyzes the levels of four chemokines and cytokines that are found at reduced levels in patients with fibromyalgia. These four chemokines and cytokines are the same as those stimulated by the BCG vaccine.
“Given what has been published in the medical literature, we believe that this vaccine will reverse the immune system abnormalities [fibromyalgia],” Gillis said.
Gillis and Faustman seek 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 for fibromyalgia is performed,” said Gillis. “As you know, the drugs [currently on the market] for fibromyalgia only treat the symptoms. They have no advantage over the immune system. [The pharmaceutical companies] admit that they only treat the symptoms, but that you have to treat the disease, and that’s why 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 patients with fibromyalgia will no longer be deficient [once the BCG vaccine is administered],” Gillis said. “The levels of production will normalize, and you must assume that your symptoms will disappear. We believe that we are on the verge of something important. “
Because the vaccine has a long history, it should not cause any significant side effects in patients.
The BCG vaccine should cost between $ 20 and $ 25 per dose, a nominal amount compared to the current costs of taking medications daily.
“We believe that a patient with fibromyalgia would need one or two doses at most to understand why I do not get a lot of support from pharmaceutical companies,” said Gillis.
In addition to the vaccine trial, EpicGenetics partners with the University of California at Los Angeles (UCLA) and the Chicago College of Medicine at the University of Illinois to sequence the genomes of 250,000 patients with fibromyalgia.
“We are looking for any kind of genetic patterns, anomalies or mutations,” said Gillis.
Patients with positive fibromyalgia who use the FM / a test can participate in the genomic study.
The FM / a test currently costs $ 936, but is covered by some insurance companies and Medicare. The EpicGenetics Support Team helps patients determine if their insurance company will cover the test. An interest-free payment plan is available for those who do not have insurance or whose insurance does not cover the testce