I encountered my first significant controversial diagnosis when we opened WholeHealth Chicago in the mid-1990s. The concept of combining conventional and alternative medicine was new to the Midwest and right away we began seeing patients who came to us with chronic symptoms but no solid diagnosis.
One group that stood out was made up of primarily women who had longstanding and severe widespread muscle pain along with a plethora of other symptoms including severe fatigue, headache, poor mental focus, and irritable bowel.
Virtually everyone in this group had been told there was nothing wrong with them, that their tests and x rays were all normal, and that they were “just depressed.” When they did their own research (library, no internet yet) or spoke with their massage therapist or chiropractor they may have heard something about fibromyalgia. However, most rheumatologists were dismissing this diagnosis as non-existent and would send them for psychiatric help.
The well-intentioned psychiatrist was equally unhelpful, usually saying something like “You’re not mentally ill and you seem depressed because you’re in pain.”
Decades of pain and gender disparities
I remember women telling me about their experiences with decades of chronic daily pain, suffering because some doctor insisted there was nothing wrong with them—that they were merely lazy and neurotic. Women in this group also underwent totally useless back surgeries for neck and back pain and equally useless hysterectomies for pelvic pain, both now clearly associated with fibro.
It was through fibromyalgia that I first learned about gender disparities in effective pain management. Many studies have confirmed that if two people, one male and one female, enter a typical physician-directed pain management center with precisely the same pain, the man will almost always leave with better pain management.
Read this piece from Harvard to better understand the shocking differences.
“Real” disease vs. imagined
The reason the rheumatologists didn’t believe in the existence of fibromyalgia was that they, along with virtually the entire conventional medicine community, were unreservedly committed to the erroneous belief that for a disease to be “real” there needed to be some evidence that would show up during diagnostic testing.
The standard of proof included abnormal lab tests, x rays, and biopsies. Even some chiropractors, unable to find consistent musculoskeletal abnormalities during their examinations, were skeptical about fibromyalgia.
Although case reports of chronic widespread muscle pain had been described in the 19th century, the first medical article using the word “fibromyalgia” appeared in a German medical journal in 1976. My 2000+-page textbook of internal medicine devoted fewer than 15 lines to fibromyalgia, included the words “controversial diagnosis,” and advised psychotherapy and antidepressants while warning against pain medicines of any type for fear of physical or psychological dependence on drugs prescribed for a “non-illness.”
WHC rents an auditorium
Back to WholeHealth Chicago in 1997. We were seeing dozens of fibro patients and decided to rent the auditorium at Northwestern Law School and invite the public to a free symposium on fibro. Our guest speaker was Jacob Teitelbaum, MD, author of the best-selling From Fatigued to Fantastic. The room was filled beyond capacity and soon, because of our integrative approach, we became a go-to place for fibro. Later, with my editor Heidi Hough I wrote Healing Fibromyalgia, about WholeHealth Chicago’s approach to fibro.
Now, more than 20 years after our symposium, most physicians believe that fibromyalgia exists, though no one is exactly sure why. The source of this newly attained knowledge has been, to no one’s surprise, Big Pharma, which had some products to sell and needed to teach physicians how to use them.
Everyone has been helped considerably by the statistical data accumulating on fibro. It was estimated that somewhere between 2% and 8% of the world population (mainly women) were affected, with the US estimates alone pegged at 5 to 7 million people, clearly a bonanza for some lucky Big Pharma company.
The winner was Pfizer, and that’s a story itself
All by themselves, doctors had discovered that the epilepsy medication gabapentin (brand name Neurontin) actually relieved fibro pain in about one third of patients. Gabapentin had been developed by Parke-Davis, which was acquired by Pfizer.
Word of this spread quickly, especially via pharmaceutical representatives (“Dr. Jones down the street is using Neurontin for his fibro patients with great results”). But while prescribing Neurontin for fibro is perfectly legal (it’s called off-label prescribing, meaning the doctor is prescribing it for a condition not officially FDA-approved), to promote a drug for off-label prescribing is super-illegal.
No matter how safe and effective Neurontin was, it could not be promoted for fibro by the manufacturer because it had not been approved by the FDA. Ultimately, Pfizer paid $431 million (!) in fines for basically spreading good information to doctors. Don’t be sad, though. In the end, Pfizer did very well for itself.
Neurontin was soon to go generic anyway, killing the profit stream. But over at Northwestern University, medicinal chemist Richard Silverman, PhD, tweaked a similar molecule into a substance called pregabalin that was almost as effective as gabapentin for fibro. Note the “almost.”
This time Pfizer followed the rules and you’ll recognize pregabalin under its brand name Lyrica. Because of one of the best royalty contracts ever negotiated with Big Pharma, Northwestern has added about a billion dollars to its endowment fund from Lyrica and Dr. Silverman has earned many millions himself.
Gabapentin/Neurontin is actually superior for pain control, has fewer side effects, and costs $12.00 vs. $450 a month, but shhh don’t tell anyone.
More fibro drugs
The other two Big Pharma offerings for fibromyalgia (Cymbalta and Savella) are basically antidepressants and not much better than other antidepressants at treating fibro, which means not too good. All three FDA-approved fibro drugs (Lyrica, Cymbalta, and Savella) were graded C- minus by the American Rheumatology Association, the grade determined by effectiveness and side effects.
I virtually never prescribe the three approved drugs because of their low levels of effectiveness and sometimes really unpleasant side effects. Lyrica’s main side effect is weight gain.
By the way, despite government alarmism and many back-and-forth arguments among themselves, both researchers and physicians who work with fibro patients believe that low-dose opioids (either short acting or extended release) like tramadol are about the best available pharmacologic treatment for fibro.
When I do prescribe meds for fibro, I start with a time-release version of the muscle relaxant Flexeril (cyclobenzaprine) called Amrix (also frequently denied by insurance companies) and a time-release version of the pain med Tramadol.
In comparison to low-dose opioids for pain management, medical marijuana is getting lukewarm reviews from fibro patients. However, using medical marijuana definitely improves sleep and, as any fibro patient will tell you, after a good night’s sleep the fibro is much better the following day.
But at least Big Pharma with its new fibro drugs did manage to teach US physicians something about fibromyalgia. Pfizer developed many continuing medical education courses and held meetings in posh resorts and restaurants, filled with discussion groups and sales pitches.
And Northwestern, spending some of its Lyrica largess, converted the Rehab Institute of Chicago into the Shirley Ryan AbilityLab, a physical medicine center listing fibromyalgia as an area of expertise.
Quite an about-face from the “no such thing as fibromyalgia.”
David Edelberg, MD