I spent most of 2019 spinning my wheels, and it feels like the fibromyalgia community, as a whole, was right there alongside me.
What do I mean by that? Put simply, there weren’t many major fibromyalgia headlines during 2019. Sure, there was lots of talk about new treatments and the potential causes of fibromyalgia, but at the close of last year, very little was actually accomplished.
But I don’t want to focus on the negative so I’ll reframe 2019 like this: It was a year of planning and preparation for the fibromyalgia community. Hopefully, the framework now has been laid for 2020 to be the year of manifestation! Let’s all hope!
But before 2020 gets too far along, let’s reflect back on what we learned (and didn’t learn) last year.
Hurry up and wait … for new fibromyalgia treatments
It’s been more than a decade since the U.S. Food and Drug Administration (FDA) approved Savella, the last pharmaceutical earmarked for fibromyalgia.
Over the years, multiple drug companies have announced plans to develop new fibromyalgia treatments, but none have made it to market yet. The waiting game continued during 2019. At least four new drugs are under development, but it’s anyone’s guess if or when any of those treatments will ultimately end up in patients’ hands.
Based on current timelines, it would be surprising if the FDA approves any new fibromyalgia drugs again this year, but there’s a small chance TNX-102, a sublingual version of cyclobenzaprine, may make it to market if the drug performs well in its latest phase III study.
Finally an accepted fibromyalgia blood test?
Last spring, Ohio State University announced researchers have developed a new blood test that can diagnose fibromyalgia and differentiate it from similar conditions. Lead researcher Kevin Hackshaw hopes the test will be available to patients within five years.
There are at least two fibromyalgia blood tests currently on the market – the FM/a test from EpicGenetics and an RNA-based test through iQuity – although neither test is widely used by physicians or recognized as a valid diagnostic tool by the American College of Rheumatology (ACR).
Misdiagnosis is a huge problem
Without a reliable blood test, doctors are supposed to use ACR guidelines to diagnose fibromyalgia. However, a National Data Bank for Rheumatic Diseases study published last February found not all physicians are following those diagnostic criteria.
Of 497 patients, only 24% met ACR guidelines for a true fibromyalgia diagnosis. Physicians failed to diagnose fibromyalgia in almost half of patients who met the criteria. Around 11% of patients were labeled with fibromyalgia by their physicians even though they did not meet the diagnostic criteria for that diagnosis.
This study supports a previous Canadian study, which suggested up to two-thirds of patients diagnosed with fibromyalgia may have actually been misdiagnosed.
The opioid war continues
Last year, the Centers for Disease Control and Prevention (CDC) finally admitted its opioid prescribing guideline is negatively impacting chronic pain patients. Since the guideline was released in 2016, thousands of patients have been forcibly tapered off prescription opioids and left with few options for managing their pain.
The guideline was intended to be voluntary and was only supposed to apply to primary care physicians, but federal agencies, states, insurers and many doctors adopted it as policy, much to the detriment of those who depend on opioids for pain management.
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In an article from Pain News Network, Dr. Deborah Dowell, chief medical officer for the National Center for Injury Prevention and Control and co-author of the guideline, said, “Some policies and practices citing the guideline went beyond its recommendations. The guideline does not support abrupt tapering or sudden discontinuation of opioids, but has been inappropriately cited to justify hard limits or cutting off opioids. In addition, we’ve heard reports of misapplications beyond the guideline’s clearly stated scope. For example, applying the recommendations to patients in cancer treatment or experiencing surgical pain.”
The American Medical Association has criticized the “misapplication” and “inappropriate use” of the guideline, and the U.S. Food and Drug Administration (FDA) warned that forced tapering puts chronic pain patients at greater risk of withdrawal, uncontrolled pain and suicide.
As a result of these concerns and others, the CDC announced late last year it will be updating the guideline by late 2021. It’s anyone’s guess if the update will benefit chronic pain patients or dole out more of the same.
In a related matter, the U.S. Drug Enforcement Administration announced last month that illicit fentanyl, not prescription opioids, was the “primary driver” of the U.S. overdose crisis during 2019. Despite that, the DEA continues to cut the annual supply of prescription opioids, which is already at its lowest level since 2006.
Are Lyrica and Neurontin becoming the new enemies?
During 2017-18, a growing number of reports came out of the United Kingdom warning doctors and patients about the addictive qualities of gabapentin (name brand: Neurontin) and pregabalin (name brand: Lyrica), two drugs commonly prescribed for fibromyalgia-related nerve pain. During 2019, we saw the first stirrings in the U.S. of what might eventually be a crackdown on gabapentin/pregabalin similar to what we’ve seen with opioids.
In December, the FDA announced it would add new warnings to Lyrica, Neurontin and their generics, cautioning doctors against combining these drugs with others that can slow breathing, including opioids.
The FDA announcement went on to say, “We have also required the drug manufacturers to conduct clinical trials to further evaluate their abuse potential, particularly in combination with opioids, because misuse and abuse of these products together is increasing, and co-use may increase the risk of respiratory depression.”
Earlier in the year, University of Oxford researchers released the results of a new study which linked these drugs to an increase in suicidal behavior, unintentional overdoses, injuries and car accidents. A Clinical Toxicology journal article published in December further established a connection between gabapentin usage and an increased risk of suicide attempts. A 2018 Canadian study found that people who combined opioids and high-dose pregabalin (over 300mg) were twice as likely to die from accidental overdose than those who took opioids alone.
Speaking of Lyrica
Last July, the FDA approved the first generics of Lyrica, saving patients and insurance companies billions in annual costs.
Early cannabis research looks promising
An Israeli study found more than 80 percent of fibromyalgia patients experienced an improvement in their symptoms after using cannabis for six months. Researchers also reported 22 percent of patients in the study were able to stop or reduce their use of opioids.
Is the answer to fibromyalgia in the gut?
Last June, researchers from McGill University Health Centre in Canada found the gut microbiome of fibromyalgia patients is noticeably different from those of healthy controls.
“We found that fibromyalgia and the symptoms of fibromyalgia – pain, fatigue and cognitive difficulties – contribute more than any of the other factors to the variations we see in the microbiomes of those with the disease,” said lead researcher Dr. Amir Minerbi. “We also saw that the severity of a patient’s symptoms was directly correlated with an increased presence or a more pronounced absence of certain bacteria – something which has never been reported before.”
Researchers aren’t sure if the variations in bacteria are actually causing fibromyalgia or are simply a manifestation of the condition. More research is needed to answer these questions.
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.