A diagnostics company has agreed to stop selling two questionable blood tests as part of a settlement with a consumer watchdog that accused the firm of using “false and misleading advertising” to promote the products.
Not only was EpicGenetics claiming that one of its blood tests could definitively diagnose fibromyalgia, the Center for Science in the Public Interest’s October 2023 lawsuit said; the company had also invented a disease wholesale to justify the use of another product, and had dangled nonexistent treatment trials as an enticement for patients.
EpicGenetics, its founder and CEO Bruce Gillis, and his other companies continue to deny all wrongdoing, but they have agreed to stop marketing and selling those two tests, to limit the claims they make about other products, and to pay $158,000 of CSPI’s legal fees, according to the settlement, which went into effect on July 30.
CSPI agreed that one of the company’s remaining tests can be called “accurate” and can continue to be sold to diagnose fibromyalgia, and that another firm controlled by Gillis can continue to market dietary supplements.
Initially, the lawsuit was just about EpicGenetics, but it was important for the non-profit watchdog that the settlement include Gillis’ other companies as well, because he’s been involved in a string of them, often with remarkably similar marketing materials.
There was The Cytokine Institute, which Gillis claimed could diagnose with 99.9% accuracy whether someone had been exposed to a substance and whether it had caused injury. Then there was EpicGenetics, which claimed that its FM/a Test could diagnose fibromyalgia with 99% accuracy and that its 100Sure Test was 100% accurate at picking up what it called “Immune Deficiency Diseases,” the condition CSPI charged was made up. Then there was Immunology Diagnostics, which advertised the BSure test as “a simple blood test gives you the definitive diagnosis you need.” Then, there was The Center for Immunology Science, marketing a dietary supplement made of heat-killed mycobacteria as “DNA-based science” that “fortifies and strengthens your immune system.”
“It’s almost like playing whack-a-mole,” said Lisa Mankofksy, CSPI’s litigation director.
Gillis did not respond to an email request for comment, and EpicGenetics did not provide any comments on the record.
The lawsuit was partially inspired by a 2021 STAT investigation showing that EpicGenetics was using an aborted clinical trial at Massachusetts General Hospital to sell the FM/a Test. If you took the test, advertising said, you could be eligible for a study looking at whether a tuberculosis vaccine worked as a treatment for fibromyalgia. The trouble was that the research had been funded by Gillis, but he’d abruptly stopped sending the hospital money before the project could get off the ground, even as his company continued to tout it as an opportunity for those who got the FM/a — which could cost $1,080 when not covered by insurance.
Plus, experts found there was insufficient evidence that the test accurately identifies those with fibromyalgia, STAT reported. The company has disputed the story’s findings.
Mankofksy’s team was especially concerned that people would take one of the company’s tests and then seek treatment based on a misdiagnosis, opening themselves up to the side effects of therapies they didn’t need and foregoing ones that might actually help.
After filing the lawsuit, the CSPI lawyers realized that other companies Gillis was involved in were using similar strategies. They considered filing a second case, but this settlement ended up applying to the firms they were concerned about, Mankofksy said.
Besides halting the sale of the FM/a and the 100Sure, the companies also agreed to meet a reliable standard of evidence for the tests and supplements they are still allowed to sell. For the next five years, they’re not permitted to use phrases such as “definitive,” or “know the truth once and for all,” in their marketing unless they provide CSPI with a controlled study, and are limited in the claims that they can make about how their products relate to DNA, about treating “immune deficiency diseases,” and about clinical trials.
Even so, Gillis’ companies are still allowed to say that their tests diagnose fibromyalgia, and may still refer to them as “accurate,” “providing proof,” or “real answers.”
“To get that agreement, we had to give some things,” said Mankofsky, who said that the center would continue monitoring Gillis’ actions to make sure his companies comply with the settlement.
Three weeks after the settlement, the Center for Immunology Science website still promoted the BSure test as providing a “definitive diagnosis.”
“To give them the benefit of the doubt, this might be an old claim that wasn’t caught and removed” because it’s on the supplement website, Mankofsky said in an email.