If someone could give you a vaccine that could cure your fibromyalgia, would you do it? It may sound like a dream, but it’s closer to reality than you think. Los Angeles-based biomedical firm, EpicGenetics and Massachusetts General Hospital researchers seek FDA clearance to test 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, “says Dr. Denise Faustman, director of the Faustman Lab at Massachusetts General Hospital. “For more than 10 years, our research group at Massachusetts General Hospital has been actively studying the role BCG vaccine could play in treating various forms of autoimmunity. Our current goal is type 1 diabetes, but overall, BCG is tested in a number of 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 each year. It is mainly used in developing countries where TB is still active. 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 disease be used for fibromyalgia? The answer lies 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 for the purpose of soothing their symptoms.
When EpicGenetics was commissioned to create a diagnostic test for fibromyalgia several years ago, researchers performed all kinds of laboratory tests on fibromyalgia patients to determine their difference from healthy controls and their symptoms. Researchers have discovered several abnormalities of white blood cells in patients with fibromyalgia, leading them to conclude that the symptoms are associated with a weakened immune system.
“We believe that [the term] fibromyalgia is an improper term,” said Dr. Bruce Gillis, CEO of EpicGenetics. “These people do not suffer from anything that affects the muscles, for example. What they suffer from is that their immune system can not produce normal amounts of protective proteins. … There are cells in the immune system called mononuclear peripheral blood 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 found at reduced levels 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 this vaccine will reverse immune system abnormalities [fibromyalgia],” said Gillis.
Gillis and Faustman seek FDA approval to administer the first BCG vaccines to fibromyalgia patients early next year.
“This is the first time that a direct treatment for fibromyalgia will be done,” Gillis said. “As you know, the drugs [currently on the market] for fibromyalgia only treat the symptoms. They have no advantage over the immune system. [The drug companies] admit that they only treat the symptoms, but that you have to treat the disease, and that’s why we’re moving forward with the application of the vaccine [to the FDA]. ”
If Gillis’ theory is true, then “chemokines and cytokines that are deficient in fibromyalgia patients will no longer be deficient [once the BCG vaccine is administered],” said Gillis. “Production levels will normalize, and you will have to assume that their symptoms will disappear. We think we are on the verge of something major. ”
Because the vaccine has a long history, it should not cause any major side effects in patients.
The BCG vaccine should cost $ 20 to $ 25 per dose – a nominal amount compared to the ongoing costs of taking medications daily.
“We think a fibromyalgia patient would need one or two doses maximum so you can understand why I do not get a lot of support from pharmaceutical companies,” Gillis said.
In addition to the vaccine trial, EpicGenetics is partnering 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 are looking for any kind of genetic patterns or abnormalities or mutations,” said Gillis.
Patients with positive fibromyalgia using the FM / a test may 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 are uninsured or whose insurance does not cover the test.