If someone could give you a vaccine that could cure your fibromyalgia, would you do that? It may sound like a dream, but it is closer to reality than you think. The Los Angeles-based biomedical, EpicGenetics and Massachusetts General Hospital are seeking FDA clearance to test the Bacillus Calmette-Guerin (BCG) vaccine next year as a potential treatment for fibromyalgia.
BCG is a generic TB vaccine that is almost 100 years old and has been safely administered millions of times over, “says Dr. Denise Faustman, Director of the Faustman Lab at the Massachusetts General Hospital. “For more than ten years, our research group at the Massachusetts General Hospital has been actively exploring the role of the BCG vaccine in the treatment of various forms of autoimmunity. Our current goal is Type 1 diabetes, but overall, BCG is being tested in a number of autoimmune diseases. Over the next two years, we will begin clinical trials on BCG in fibromyalgia. “
According to the World Health Organization, more than 100 million children receive the BCG vaccine each year. It is mainly used in developing countries where TB is still active. A BCG vaccine is not available in the United States because of the low risk of infection. In the United States, BCG is used in a small number of patients to treat bladder cancer.
The obvious question is: why should a vaccine against infectious lung disease be used against fibromyalgia? The answer is in the immune system.
Vaccines are usually given to healthy people to prevent infection. In this case, however, the BCG vaccine would be given to patients with fibromyalgia to alleviate their symptoms.
When EpicGenetics was commissioned to produce a diagnostic test for fibromyalgia a few years ago, the researchers performed all types of laboratory tests on fibromyalgia patients to determine their difference to healthy controls and their symptoms. Researchers have discovered several abnormalities of white blood cells in patients with fibromyalgia, leading to the conclusion that the symptoms are related to a weakened immune system.
“We believe that [the term] fibromyalgia is an inappropriate term,” Dr. Bruce Gillis, CEO of EpicGenetics. “These people, for example, do not suffer from something that affects the muscles. Among them, they suffer that their immune system can not produce normal levels of protective proteins. … There are cells in the immune system called mononuclear peripheral blood cells. They do not produce normal levels of protective proteins called chemokines and cytokines. “
The discovery led to the development of an FM / blood test for fibromyalgia. (Yes, despite your doctors’ statements, there is a blood test for fibromyalgia that is not accepted in medicine.) The test analyzes the levels of four chemokines and cytokines found in reduced amounts in fibromyalgia patients – 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 abnormalities of the immune system [fibromyalgia],” said Gillis.
Gillis and Faustman are seeking FDA approval to deliver the first BCG vaccines in fibromyalgia patients early next year.
“This is the first time that direct treatment for fibromyalgia has been performed,” said Gillis. “As you know, the anti-fibromyalgia drugs currently on the market are just treating the symptoms. They have no advantage over the immune system. [The drug companies] admit that they only need to treat the symptoms, but they need to treat the disease, and so we’re making progress with the use of the vaccine [at the FDA]. “
If Gillis’s theory is true, then “chemokines and cytokines deficient in patients with fibromyalgia will no longer be deficient [once the BCG vaccine is given,” Gillis said. “Production levels are normalizing and you have to assume that their symptoms disappear. We believe we are on the brink of something big. “
Since the vaccine has a long history, it should not cause major side effects in patients.
The BCG vaccine should cost between $ 20 and $ 25 per dose – a nominal amount compared to the ongoing cost of daily medication.
“We believe that a patient with fibromyalgia needs one or two doses to understand why I do not get much support from pharmaceutical companies,” Gillis said.
In addition to the vaccine trial, EpicGenetics collaborates 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 fibromyalgia patients.
“We’re looking for genetic patterns or abnormalities or mutations,” Gillis said.
Patients with positive fibromyalgia who use the FM / a test may participate in the genome 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 covers the test. For those who are not insured or whose insurance does not cover the test, an interest-free payment plan is available.
