Update from Dr. Bruce Gillis, CEO of EpicGenetics, as of May 26, 2020: “We are moving further ahead in respect to the genomics research at the University of Illinois College of Medicine, and we are cautiously optimistic in regard to what the results may tell us about fibromyalgia. Obviously, we are obligated to finalize this information, especially so we can determine how the BCG vaccine may affect it. Unfortunately, the Covid-19 pandemic significantly delayed a number of the participants from having their blood drawn for analysis, so the research has taken longer than we hoped for.”
Update as of Jan. 13, 2020: EpicGenetics has delayed the start of the BCG vaccine/fibromyalgia study discussed below after possibly discovering a genetic marker for fibromyalgia. Read more about the genetics project here.
This article was originally published on Prohealth.com. It is being republished here with permission from the editor.
If someone could give you a vaccine that would cure your fibromyalgia, would you do it? That may sound like a dream but it’s 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 a 100 years old and has been safely administered millions of times,” explained Dr. Denise Faustman, head of the Faustman Lab at Massachusetts General Hospital. “For over 10 years, our research group at Massachusetts General Hospital have been actively investigating the role that the BCG vaccine could play in treating 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 are given the BCG vaccine each year. It’s 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 U.S., BCG is used in a small number of patients to treat bladder cancer.
So, the obvious question is why would a vaccine for 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 would be administered to fibromyalgia patients in an effort to quell 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 figure out how they differed from healthy control subjects and what might be causing their symptoms. Researchers discovered several white blood cell abnormalities in fibromyalgia patients, leading them to conclude symptoms are associated with a suppressed immune system.
“We believe [the term] fibromyalgia is a misnomer,” said Dr. Bruce Gillis, EpicGenetics’ CEO. “These people aren’t suffering with anything that’s affecting the muscles, per say. What they are suffering with is their immune system cannot produce normal quantities of protective proteins. …There are cells in the immune system called peripheral blood mononuclear cells. They are not producing normal quantities of the protective proteins called chemokines and cytokines.”
The finding led to the development of the 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 at reduced levels in fibromyalgia patients. These four chemokines and cytokines just happen to be the same ones that are boosted by the BCG vaccine.
“Given what’s 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 next year.
“This is the first time ever that a direct treatment of fibromyalgia will be done,” Gillis said. “As you know, the medications [currently on the market] for fibromyalgia only treat symptoms. They have no immune system benefits. [The pharmaceutical companies] concede they’re only treating symptoms but you need to treat the disease, and that’s why we’re moving ahead with the vaccine application [to the FDA].”
If Gillis’ theory holds true, then “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 will normalize, and you have to assume then that their symptoms will disappear. … We think we are on the cusp of something major.”
Because the vaccine has such a long history, it’s not expected to cause any major side effects in patients.
The BCG vaccine is anticipated to cost $20-$25 per dose – a nominal amount when compared to the ongoing expense of taking pharmaceuticals every day.
“We think a fibromyalgia patient would need one or two doses maximum so you can understand why I’m not getting much support from drug 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 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 won’t pay for the test.
If you’d like to learn more about the FM/a test, visit FMTest.com. Click here to read more about EpicGenetics’ fibromyalgia genome project and the BCG vaccine study. If you’re interested in having the FM/a test, please fill out the application form on the home page at FMTest.com. If you have additional questions or experience any issues with submitting the form, you can email the company at email@example.com or call (310) 277-4600.
Update 11/6/17: I’ve had a number of people, especially those from the U.K., who have said they received the BCG vaccine and still developed fibromyalgia. I asked EpicGenetics about this, and here is their response:
“These people would have not received the particular species we are using and believe will be effective. The vaccine can only be effective when the abnormal peripheral blood mononuclear cells are being produced, which doesn’t happen until the onset of the disease of FM. People are not knowingly born with FM. The vaccine doesn’t prevent the FM. It only reverses the biology of FM after the FM has occurred. Additionally, in the UK and elsewhere, people tended to only receive one dose of the vaccine, and we believe it will take more than one dose for the BCG to be effective.”
I’ve also had people who have taken the FM/a test express frustration about the delays in the upcoming BCG trial and wonder if they will be enrolled in the study like promised. I asked EpicGenetics about this, and here is their response:
“All who receive a positive test result [from the FM/a test] will be invited to enroll [in the BCG study]; however, depending on the final FDA protocol approvals, there may be certain locations that serve as the formal trial sites (at least initially). We know for sure that Massachusetts General Hospital would be one of those and are still working with the FDA to identify other trial sites that they will approve.”
Reading between the lines, it sounds like patients will need to live near a study site to participate in the trial.
Now it’s your turn: Would you try the BCG vaccine if it were approved as a fibromyalgia treatment? Share in the comments!
Update on vaccine trial, April 2018
I recently contacted EpicGenetics to get an update on the vaccine trial. Dr. Gillis provided the following information: