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FDA Approves Clinical Trial to Test Treating Fibromyalgia With TB Vaccine Researchers are set to study how BCG may treat fibromyalgia. With the recent approval of the U.S. Food and Drug Administration (FDA), a human clinical trial is set to begin on BCG, a vaccine typically used to prevent tuberculosis, to treat fibromyalgia. BCG, or Bacillus CalmetteGuerin, has been used since 1921 as a TB vaccine in countries with a high prevalence of TB. One particular type, or “species,” of BCG is also used to treat bladder cancer. Some studies have shown promise in BCG’s ability to potentially treat type 1 diabetes and multiple sclerosis by enhancing the immune system’s ability to fight its own diseased cells — a process known as immunotherapy. The trial is funded by EpicGenetics, a biomedical company that also manufactures a blood test for fibromyalgia called the FM/a Test. Research
by physician and EpicGenetics CEO Bruce Gillis suggests that fibromyalgia is an immune system disorder that causes patients to have abnormal white blood cells that produce irregular quantities of proteins called chemokines and cytokines, leading to inflammation. The test measures the levels of these proteins. EpicGenetics released its FM/a test in 2013 and has faced criticism from skeptics, who say the research the test is based on is not consistent with other studies, and that the test doesn’t reliably distinguish fibromyalgia from other disorders with similar symptoms. EpicGenetics conducted a follow-up studycomparing patients who took the FM/a test to patients with lupus and rheumatoid arthritis and a control group and found “statistically significant differences” between the patients, which Gillis said supports the test. He also said further research will be done to
see if the test can be normally, they should have used to diagnose people healthy protein systems and with myalgic hopefully if all goes well their symptoms should disappear.” encephalomyelitis/chronic If BCG treatment is fatigue syndrome. successful, it would be different The BCG trial builds on than the drugs currently EpicGenetics’ previous research. available for fibromyalgia, Gillis told The Mighty he which include antidepressants believes BCG will “retrain” stem like Cymbalta and the anticells so they stop producing seizure medication Lyrica. These abnormal white blood cells and drugs may help treat start producing normal white fibromyalgia symptoms, but do blood cells, thus producing not address the biology of normal proteins and potentially fibromyalgia itself. eliminating fibromyalgia Trial participants will go to symptoms. The trial will use a Massachusetts General Hospital species of BCG called the Tokyo to receive the BCG injections. species, different than the Gillis said he does not expect species used to treat bladder there to be any side effects, and cancer, which Gillis believes has he believes two doses, spread 12 the biologic activity needed to months apart, may provide a reverse immune system “lifelong benefit.” The FDA will abnormalities. not need to approve BCG as a “It’s like being in a sword drug since it is already in use for fight with no shield — that’s other conditions, but before it what patients with fibromyalgia can be used to treat are afflicted with,” Gillis said. fibromyalgia, the FDA will need “So now what we’re hoping is, to see indicators that the BCG is we’re giving them the shield, working….Read More they should now function
1 in 4 Seniors Who Take Xanax, Valium Use Them Long Term
When older people use drugs like Valium or Xanax to calm anxiety or help them sleep, they run a high risk of becoming drug -dependent, new research suggests. In the study of almost 600 adults averaging 78 years of age, about one in four who were prescribed these types of benzodiazepine sedatives ended up using them for at least a year. That's despite warnings against long-term use of the drugs, especially among older people. Benzodiazepines -- a class that also includes Ativan, Halcion, and Klonopin -- can raise the risk of car crashes, falls, broken hips and other harmful side effects, experts warn.
So the new study "shows that we need to help providers start with the end in mind when prescribing a benzodiazepine, by beginning with a short-duration prescription and engage patients in discussions of when to reevaluate their symptoms and begin tapering the patient off," said lead author Dr. Lauren Gerlach. She's a geriatric psychiatrist at the University of Michigan in Ann Arbor. "We also need to educate providers about effective nonpharmaceutical treatment alternatives, such as cognitive behavioral therapy, for these patients," Gerlach said in a university news release.
One psychiatrist called the study a much-needed reminder for doctors. "Clinicians, including psychiatrists, continue to prescribe benzodiazepines to this [older] population at an alarming rate," said Dr. Brian Keefe, medical director at Zucker Hillside Hospital in Glen Oaks, N.Y. However, "multiple studies over many years now have consistently demonstrated an elevated risk of falls, and falls with a fracture in seniors who take these medications, a risk that increases with daily dose," said Keefe, who wasn't involved in the new research. In the study, Gerlach's team
tracked benzodiazepine use among 576 older adults who were given their first prescription between 2008 and 2016. Only a few had had any psychiatric, psychological or psychosocial care in the past two years, the report noted. Overall, 152 of the patients maintained a current or recent prescription one year after being initially prescribed a benzodiazepine, the study found. The study mostly included people who got their prescription from a primary care doctor or other non-psychiatrist physician, because that's how most older patients get benzodiazepines, the authors explained….Read More
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