If someone could give you a vaccine that would 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 is seeking approval from the Food and Drug Administration (FDA) to conduct a clinical trial next year to test the Bacillus Calmette-Guerin (BCG) vaccine 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 Massachusetts General Hospital’s Faustman Laboratory. “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 globally, 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 to quell their symptoms.
When EpicGenetics was commissioned to create a diagnostic test for fibromyalgia several years ago, researchers conducted all kinds of laboratory tests on fibromyalgia patients to determine how they differed from healthy controls and what might cause their symptoms. The researchers found several abnormalities of white blood cells in patients with fibromyalgia, leading them to conclude that the symptoms are associated with a defective immune system.
“We believe that the term fibromyalgia is a misnomer,” said Dr. Bruce Gillis, CEO of EpicGenetics. “These people do not suffer from anything that affects the muscles, for example. Their immune system can not produce normal amounts of protective proteins. peripheral. They do not produce normal amounts of protective proteins called chemokines and cytokines. ”
The discovery led to the development of a blood test for fibromyalgia. (Yes, despite what your doctors have told you, there is a blood test for fibromyalgia! It is not widely accepted in the medical community.) The test analyzes the levels of four chemokines and cytokines found at reduced levels in patients with fibromyalgia. These four chemokines and cytokines are the same that are stimulated 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 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 symptoms. They have no benefits for the immune system.
If Gillis’ theory is true, then “chemokines and cytokines deficient in fibromyalgia patients will no longer be deficient after BCG vaccination,” said Gillis. “Production levels will normalize, and we then assume that their symptoms will disappear. … We think we are at the dawn 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 between $ 20 and $ 25 per dose.
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 250,000 patients with fibromyalgia.
“We are looking for any kind of genetic patterns or abnormalities or mutations,” said Gillis.
Patients who test positive for fibromyalgia using the FM test will be able to participate in the genomic study.