If someone could give you a vaccine that would cure your fibromyalgia, would you do it? It may sound like a dream, but it is closer to reality than you might think. Los Angeles-based biomedical firm EpicGenetics and Massachusetts General Hospital researchers are seeking approval from the U.S. Food and Drug Administration (FDA) 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 tuberculosis vaccine that is almost 100 years old and has been safely administered millions of times, ”Dr. Denise Faustman, head of the Faustman Lab at Massachusetts General Hospital. “For over 10 years, our research group at 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 focus is type 1 diabetes, but globally, BCG is being tested in a variety of autoimmune diseases. Over the next two years, we will begin clinical testing 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 United States, BCG is used for a small number of patients to treat bladder cancer.
So the obvious question is why should a vaccine against an infectious lung condition be used for fibromyalgia? The answer lies within the immune system.
Vaccines are typically given to healthy people to prevent infection. In this case, however, the BCG vaccine will be administered to fibromyalgia patients in an effort to attenuate their symptoms.
Since EpicGenetics was tasked with creating a diagnostic test for fibromyalgia several years ago, researchers ran all sorts of laboratory tests on fibromyalgia patients to find out how they differed from healthy controls and what might be causing their symptoms. Researchers discovered several white blood cell abnormalities in fibromyalgia patients, leading to the conclusion that symptoms are associated with a suppressed immune system.
“We think [the term] fibromyalgia is an error number,” Dr. Bruce Gillis, EpicGenetics’ CEO. “These people do not suffer with anything that affects the muscles, per. Say. What they are suffering from is that their immune system cannot produce normal amounts of protective proteins. … There are cells in the immune system called peripheral mononuclear blood cells. They do not produce normal amounts of the protective proteins called chemokines and cytokines. “
The finding led to the development of FM / a blood test for fibromyalgia. (Yes, despite what your doctors may 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 in reduced levels of fibromyalgia. patients. These four chemokines and cytokines are exactly the same that are boosted by the BCG vaccine.
“Given what has been published in the medical literature, we believe this vaccine will reverse the immune system’s abnormalities [of fibromyalgia],” Gillis said.
Gillis and Faustman are seeking FDA approval to administer the first BCG vaccines for fibromyalgia patients early next year.
“This is the first time ever that direct fibromyalgia is being treated,” Gillis said. “As you know, medicine [currently in the market] for fibromyalgia only treats symptoms. They have no benefits to the immune system. [The pharmaceutical companies] admit that they only treat symptoms, but you have to treat the disease, which is why we move on with the vaccine application [to the FDA]. “
If Gillis’ theory is correct, “the chemokines and cytokines that are deficient in patients with fibromyalgia will no longer be defective [when the BCG vaccine is administered],” Gillis said. “Production levels are normalized, and one must then assume that their symptoms disappear. We think we’re at the forefront of something big. “
Because the vaccine has such a long history, it is not expected to cause any major side effects in patients.
The BCG vaccine is expected to cost $ 20- $ 25 per day. Dose – a nominal amount compared to the current cost of taking medicines every day.
“We think a fibromyalgia patient would need a maximum of one or two doses, so you can understand why I don’t get much support from pharmaceutical companies,” Gillis said.
In addition to the vaccine trial, EpicGenetics is partnering with the University of California, Los Angeles (UCLA) and the University of Illinois College of Medicine Chicago to sequence the genomes of up to 250,000 fibromyalgia patients.
“We’re looking for any type of genetic pattern or anomaly or mutation,” Gillis said.
Patients who test positive for fibromyalgia using FM / a test will be able to participate in the genomic study.
FM / one testing currently costs $ 936 but is covered by some insurance companies and Medicare. EpicGenetics’ support team helps patients decide if their insurance company will cover the test. An interest-free payment plan is available to people who are not insured or whose insurance does not cover the test.