A century-old vaccine gives new hope to the fibromyalgia community

If someone could give you a vaccine that would cure your fibromyalgia, would you do it? That may sound like a dream, but it is closer to reality than you think. Researchers at the Los Angeles-based biomedical firm EpicGenetics and the Massachusetts General Hospital are seeking approval from the U.S. Food and Drug Administration (FDA). UU. To conduct a clinical trial next year to test the Bacille Calmette-Guerin (BCG) vaccine as a possible treatment for fibromyalgia.

“BCG is a generic vaccine against tuberculosis that is almost 100 years old and has been administered safely millions of times,” said Dr. Denise Faustman, head of the Faustman Laboratory at Massachusetts General Hospital. “For more than 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 approach is type 1 diabetes, but worldwide, BCG is being tested in several autoimmune diseases. During 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 every year. It is mainly used 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 USA UU., BCG is used in a small number of patients to treat bladder cancer.

So, the obvious question is why would a vaccine be used for an infectious pulmonary condition for fibromyalgia? The answer is within the immune system.

Vaccines are typically given to healthy people to prevent infections. In this case, however, the BCG vaccine would be administered to fibromyalgia patients in an effort to calm 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 discover how they differed from healthy control subjects and what could be causing their symptoms. The researchers discovered several abnormalities in the white blood cells of fibromyalgia patients, leading them to conclude that the symptoms are associated with a suppressed immune system.

“We believe that [the term] fibromyalgia is an inappropriate name,” said Dr. Bruce Gillis, CEO of EpicGenetics. “These people are not suffering with anything that is affecting the muscles, for example. 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 blood mononuclear cells. They are not producing normal amounts of protective proteins called chemokines and cytokines. ”

The finding led to the development of FM / blood test for fibromyalgia. (Yes, despite what your doctors may have told you, there is a blood test for fibromyalgia! It simply isn’t 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 as those driven by the BCG vaccine.

“Given what has been published in the medical literature, we believe that this vaccine will reverse the abnormalities of the immune system [of fibromyalgia],” said Gillis.

Gillis and Faustman are seeking FDA approval to administer the first BCG vaccines to fibromyalgia patients early next year.

“This is the first time that direct fibromyalgia treatment is performed,” Gillis said. “As you know, medications [currently on the market] for fibromyalgia only treat the symptoms. They have no benefits for the immune system. [Pharmaceutical companies] recognize that they are only treating the symptoms, but you need to treat the disease, and that is why we are moving forward with the application of the vaccine [to the FDA]. ”

If Gillis’s theory is true, then “chemokines and cytokines that are deficient in fibromyalgia patients will no longer be deficient [once the BCG vaccine is given],” Gillis said. “Production levels will normalize, and you have to assume that your symptoms will disappear. … We believe that we are on the cusp of something important. “

Because the vaccine has such a long history, it is not expected to cause any significant side effects in patients.

It is anticipated that the BCG vaccine will cost between $ 20 and $ 25 per dose, a nominal amount compared to the ongoing expense of taking pharmaceutical products every day.

“We believe that a patient with fibromyalgia would need a maximum of one or two doses so that he can understand why I don’t receive much support from pharmaceutical companies,” Gillis said.

In addition to the vaccine trial, EpicGenetics has partnered with the University of California at Los Angeles (UCLA) and the University of Illinois Chicago School of Medicine to sequence the genomes of up to 250,000 fibromyalgia patients.

“We are looking for any kind of genetic patterns or abnormalities or mutations,” Gillis said.

Patients with a positive fibromyalgia result through 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 people who do not have insurance or whose insurance will not be covered by the test.

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