If someone could give you a vaccine that would cure your fibromyalgia, would you do it? It might sound like a dream, but it’s closer to reality than you might think. Los Angeles-based biomedical company EpicGenetics and Massachusetts General Hospital researchers are seeking approval from the US 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 nearly 100 years old and has been safely administered millions of times,” explains 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 number 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 each year. It is mainly used in developing countries where tuberculosis is still active. The 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.
So the obvious question is why would 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 attempt to alleviate their symptoms.
When EpicGenetics was tasked with creating a diagnostic test for fibromyalgia several years ago, researchers ran all sorts of lab tests on fibromyalgia patients to find out how they differ from healthy control subjects and what might be causing their symptoms. Researchers discovered several abnormalities in white blood cells in fibromyalgia patients, leading them to conclude symptoms are associated with a suppressed immune system.
“We think [the term] fibromyalgia is a misnomer,” said Dr. Bruce Gillis, EpicGenetics’ CEO. “These people do not suffer with anything that affects the muscles, per se. Say. What they suffer from is that their immune system cannot 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 the protective proteins called chemokines and cytokines. “
The discovery 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 that are found in reduced levels in fibromyalgia- patients. These four chemokines and cytokines are the same ones boosted by the BCG vaccine.
“Given what has been published in the medical literature, we believe this vaccine will reverse the immune system abnormalities [of fibromyalgia],” Gillis said.
Gillis and Faustman are seeking FDA approval to administer the first BCG vaccines to fibromyalgia patients early next year.
“This is the first time ever that there is a direct treatment for fibromyalgia,” Gillis said. “As you know, medications [currently on the market] for fibromyalgia only treat symptoms. They have no benefit to the immune system. [The pharmaceutical companies] admit they’re only treating symptoms, but you have to treat the disease, and that’s why we’re moving forward 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 deficient [once the BCG vaccine is administered],” Gillis said. “Production levels normalize and then one has to assume that their symptoms disappear. We believe we are on the cusp of something big. “
Since 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 Dose – a nominal amount compared to the ongoing cost of taking medicines every day.
“We think a fibromyalgia patient would need one or two doses at most, so you can understand why I don’t get a lot of support from pharmaceutical companies,” Gillis said.
In addition to the vaccine trial, EpicGenetics is collaborating 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 patterns or anomalies or mutations,” Gillis said.
Patients who test positive for fibromyalgia using the FM/a test will be able to participate in the genomic study.
The FM/a test currently costs $936 but is covered by some insurance companies and Medicare. EpicGenetics’ support team helps patients determine if their insurance company will cover the test. A no-interest payment plan is available for people who are uninsured or whose insurance does not cover the test.