Fibromyalgia Drugs: Successes or Failures?

In the pharmaceutical industry, they’re known as “blockbuster drugs” – medications that generate billions of dollars in sales and profits for drug makers.

Cymbalta, Lyrica and Savella — the only drugs approved by the Food and Drug Administration to treat fibromyalgia — certainly fit that mold.

In 2013, Cymbalta was the 5th most widely prescribed drug in the United States, generating sales of $5.2 billion for Eli Lilly, according to research firm IMS Health.

Pfizer’s Lyrica was no slouch either, reaching sales of $2.4 billion as the 19th top selling drug. Forest Laboratories’ Savella brought up the rear, with sales of $105 million in 2013.

Cymbalta graphCollectively, with over $7.7 billion in sales, one would think the drugs must be very effective medications. But they’re not, according to a survey of over 1,300 fibromyalgia patients by the National Pain Foundation and National Pain Report.

About two-thirds of those who tried Cymbalta, Lyrica or Savella said they don’t work at all. Only about 10% said the drugs were very effective.

The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by deep tissue pain, fatigue, headaches, depression, and lack of sleep. There is no known cure and the disorder is difficult to treat.

“NOTHING is effective! Each thing just takes the edge off temporarily,” wrote one survey respondent.

Lyrica graph“Lyrica helped a little but gained 39 pounds and still could not tolerate the pain,” said another.

“I had Fibro for 26 years. Nothing has really helped long term. The worst is Lyrica and Cymbalta,” said one fibromyalgia sufferer.

Patients may not be impressed with the medications, but drug makers are. In the pharmaceutical industry, a success rate of just a few percentage points during clinical trials is often called “significant”.

“Ten percent of patients get helped a lot by three different drugs. That’s something!” says Seth Lederman, MD, a rheumatologist who prefers to see the glass as half full, rather than half empty.

“It is a wonderful triumph of the pharmaceutical industry that they have three drugs for fibromyalgia.”

Savella graphDr. Lederman, who began working with fibromyalgia patients in the mid 1980’s, refers to it as the “dark ages” – a time when no drugs were approved for fibromyalgia and the condition wasn’t taken seriously by many physicians.

Today Lederman is the CEO and co-founder of Tonix (NASDAQ: TNXP) – a drug development company that hopes its experimental drug TNX-102 will become the 4th medication to be approved by the FDA for the treatment of fibromyalgia.

“If you’d spoken to people in 2006, 99 percent of the people in the industry, drug developers, weren’t even working on this. They were saying nothing is going to help those (fibromyalgia) patients. We don’t even know what’s wrong with them,” Lederman recalls.

“From my point of view, it was a real watershed moment when the FDA approved Lyrica in 2007. And it’s hard now, looking back, to give it the importance that it had for patients and doctors. Because it introduced the first FDA-approved effective therapy. That was very fulfilling for patients. It took them out of the world of being pariah, crackpot, whining, all of the problems that patients faced before that moment.”

Betsy Jacobson, a longtime activist in the fibromyalgia community, says the dark ages never really ended for fibromyalgia sufferers. She says the pharmaceutical industry has failed to find effective treatments to treat the disorder.

“Very few of any of the meds mentioned really work,” Jacobson wrote in an email to National Pain Report.

“Pharmaceutical companies are constantly trying to find out what works for fibromyalgia. There is only one thing that is important to Big Pharma, and that is their bottom line. It is a very corrupt industry, and if it really wanted to help the patient, it would have found a cure for cancer and other notable diseases with all the billions they’ve spent on research.”

Pfizer, Eli Lilly and Forest Laboratories all declined to comment for this article on the survey findings.

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25 Responses

  1. Myron Shank, M.D., Ph.D. says:

    I have not seen the actual scientific publications, yet, but I thought this news report was important enough to share.
    Some patients who have the diagnosis of fibromyalgia actually have primary hyperparathyroidism, an endocrine condition that mimics fibromyalgia, but which is usually surgically curable.
    In one study, ten percent of patients who had been diagnosed with fibromyalgia proved to have primary hyperparathyroidism, as compared to one-one-hundredth that many in the general population.
    In another study, nearly all of the primary hyperparathyroidism patients who had also been diagnosed with fibromyalgia had improvement in their fibromyalgia symptoms of after parathyroid surgery, and twenty-one percent were able to stop all of their medications for fibromyalgia.
    I, myself, have seen at least two patients who had been diagnosed with fibromyalgia and who had classic symptoms, but who had laboratory clues for hyperparathyroidism. These patients proved to have hyperparathyroidism and surgical therapy completely relieved their apparent fibromyalgia. This gets back to my suggestion (and belief) that fibromyalgia is a symptom complex that have more than one underlying cause. Screening for hyperparathyroidism should be part of every workup for fibromyalgia.
    (Tucker Miriam E. Fibromyalgia symptoms respond to parathyroidectomy, in some. Medscape Diabetes & Endocrinology. May 01, 2014.
    http://www.medscape.com/viewarticle/824429?nlid=56143_2441&src=wnl_edit_medp_diab&uac=213325PT&spon=22)
    I hope that this information proves helpful to some readers.

  2. Donna says:

    I was on Cymbalta 60 mg for 30 days and it seemed to be a miracle drug for me. Then I had blood work done and my liver GGT was 1199. I was Immediately taken off the Cymbalta and had blood work done a month later and my GGT came down to 54. Every pain med my pain management doctor has tried causes my GGT to go high, so they just switched me to oxycodone 10mg for break through pain. I also use a Butrans patch 20 mcg’s but I don;t think it works at all. I also had Trigger Point Injectios which made the Fibro in my neck and shoulder 10 x worse. For almost a year now I have been getting cervical epidurals done about every 2-3 months and they have been very effective and they stopped the migraines also

  3. John Quintner, Physician in Pain Medicine says:

    “Muscles are a dynamic tissues which are full of Stem Cells and obviously has the ability to shrink or atrophy or hypertrophy (bulk-up) depending on the circumstances. These changes is size plus the daily repairing process will yield errors in the repair process. These “errors of repair” collect in numbers into Trigger Points. These TrPs increase numbers to generate those Pain and Dysfunction Generators (PDGs). These PDGs are pain alarm signals which continuously blare to wreak havoc on the consciousness and subconscious leading to a miserable state of wellbeing.

    The next step in the cycle is the most chaotic to the muscle system and this is when the muscles contract into a dense mass. These masses become toxic and get walled off from further repair and alters all immune and hormonal functions. These are the tender points that gets confused with a trigger point because they do not “twitch” and will retaliate if moved, massage, touched or bothered even when lying on them in bed.”

    @ Dr Rodrigues. This is material contained in your comment of April 26 that I find to be most disturbing.

    I know of no scientific evidence whatsoever to support your extraordinary assertions. My reading of your comments is that they are highly fanciful and created by you “on the run”. The kinesiology link you kindly provided does not bear any relation to your extraordinary explanation of what is known as “myofascial pain”.

    Michel de Montaigne [1533-1592] asked a question that is relevant to your distillation of this topic: “Why do the doctors work on the credulity of their patient beforehand with so many false promises of a cure, if not so that the effect of the imagination may make up for the imposture of their decoction?”

    Thus, with the editor’s kind permission, let me add yet another challenge to your credibility as a licensed medical practitioner posting on a highly visible public website.

    P.S. I remind you that we only have it on your authority that “the old meds of the 80s-90s worked well then and still do today.” Do you have any other evidence for making this statement?

  4. John Quintner says:

    @Dr Rodrigues. I suggest that you take the trouble to first read the reference before jumping to a completely wrong conclusion. You will then find that we answered the question in the negative!

  5. @Quintner
    I see that you have been influenced by my comments and thoughts! It a good idea to debate, argue and have discussions with researchers and practitioners outside of your world of influence.

    Quintner JL, Cohen ML. Are peripheral pain generators important in fibromyalgia and chronic widespread pain? Pain Medicine 2014;15 (4):718-720.

    In 2014, we are still just scratching the surface of God’s creation with our puny human abilities. A few important additions to the concept will help to blend it into most of the logical theories from the last 100 years. All these concepts are based on non-surgical or non-structural pain syndromes. Since we can not see a pain signal, we should assume it emanates from the MS system which includes muscles the associated nerves, vessels, lymphatics and cartilage.

    Muscles are a dynamic tissues which are full of Stem Cells and obviously has the ability to shrink or atrophy or hypertrophy (bulk-up) depending on the circumstances. These changes is size plus the daily repairing process will yield errors in the repair process. These “errors of repair” collect in numbers into Trigger Points. These TrPs increase numbers to generate those Pain and Dysfunction Generators (PDGs). These PDGs are pain alarm signals which continuously blare to wreak havoc on the consciousness and subconscious leading to a miserable state of wellbeing.

    The next step in the cycle is the most chaotic to the muscle system and this is when the muscles contract into a dense mass. These masses become toxic and get walled off from further repair and alters all immune and hormonal functions. These are the tender points that gets confused with a trigger point because they do not “twitch” and will retaliate if moved, massage, touched or bothered even when lying on them in bed.

    http://en.wikipedia.org/wiki/Kinesiology

  6. John Quintner, Physician in Pain Medicine says:

    @ Dr Starlanyl. I would like to briefly comment on your assertion: “Doctors and the government agencies, need to understand both the myofascial trigger points that generate pain and other symptoms and the fibromyalgia that amplifies them.”

    Having recently reviewed the relevant and extensive scientific literature, our research team (Geoff Bove, John Quintner & Milton Cohen) was unable to find one study that did not “beg the question” as to the primacy of myofascial trigger points being generators of nociceptive input (i.e. input from damaged muscle tissue).

    It appears that succeeding generations of researchers and clinicians have blindly accepted the speculative theories promulgated widely during the 1970s and 1980s as being established knowledge when quite the opposite appears to have been the case. The possibility that there might be other more plausible possible explanations for the clinical phenomena was ignored or perhaps summarily dismissed.

    Did we miss a key experimental study performed either on animals or humans?

    We have previously exposed the tautological reasoning and paucity of supportive scientific evidence underlying the theory of “myofascial pain” caused by “trigger points”, both of which should have lead to its refutation long before this.

    That myofascial pain theory should persist more than 50 years after its formulation, during which time research of increasing sophistication has served only to cast doubt upon its veracity, possibly speaks to the desire of physicians and their patients for sense-making rather than them actually making sense.

    But if one does accept your proposition, trigger point enthusiasts will rise to the challenge and doubtless employ their stainless steel needles with gay abandon upon the innocent muscles of countless pain sufferers who have been awarded the Fibromyalgia label. Perish the very thought!

    References:

    Bove GM, Light AR. The nervi nervorum: missing link for neuropathic pain? Pain Forum 1997;6(3):181-190.

    Quintner JL, Cohen ML. Referred pain of peripheral nerve origin: an alternative to the “myofascial pain” construct. Clin J Pain 1994;10:243-51.

    Quintner JL, Cohen ML. Are peripheral pain generators important in fibromyalgia and chronic widespread pain? Pain Medicine 2014;15 (4):718-720.

  7. Pat Anson, Editor says:

    @ Stephen & Blackbelt: This is a fair discussion and since you’ve been challenged to back up your claims, your comments have been approved. Please however refrain from making negative comments about other posters, stay on topic and keep things civil.

  8. This is so true. I tried Lyrica and developed cerebral edema, and Cymbalta put me into Serotonin Syndrome. I have contact with hundreds of patients with fibromyalgia and chronic myofascial pain, and so man have had dangerous side-effects. The common experience I that they are some help at first (in many cases not a lot of help), but then the side effects can get severe, especially f the doctor raises the dosage “so that they can be more effective”, in an attempt to get the patient off pain meds. Other medications that have been proven to help specific perpetuating factors of fibromyalgia, such as Xyrem, which allows deep, restorative sleep, have not been approved for fibromyalgia “because there are so many good drugs available” and “for fear fibromyalgia patients will sell this on the black market as a date rape drug”. That is what the Food and Drug Administration has written. Right. There are some patients who are helped by these medications. There are a lot who are not. Many of these side-effects, even dangerous ones, go unreported to the FDA because of the time commitment to do so. I hear this from patient after patient. Patients need to start notifying the FDA about dangerous side-effects. Doctors and the government agencies, need to understand both the myofascial trigger points that generate pain and other symptoms and the fibromyalgia that amplifies them. Then perhaps they will stop waging a war on chronic pain patients and their doctors by denying pain meds and other meds because “there are so many good medications for fibromyalgia available”. There aren’t.

  9. Cochrane reviews studies published. From this standpoint there is not much you can conclude about tDCS for fibromyalgia. There are few studies utilizing tDCS, different parameters are used, different criteria, and the overall number of patients is small. In this context, tDCS doesn’t do much. Using tDCs as an add-on or unique treatment for FMS, I am consistently impressed with the patient-reported benefits: reduced pain, clearer thinking, less fatigue, better sleep and increased activity. Because the treatments I provide are individual, I can’t draw the conclusions of a formal study.
    I am also somewhat surprised that a larger follow-up study was not done after the 2006 study, which would have provided more conclusive evidence.
    tDCS does not produce much profit, and that as much as anything, accounts for the limited availability

  10. Sueb says:

    Then why was the representative for Pfizer on the Dr. Phil Show saying to a fibromyalgia sufferer that her illness was all in her head! 10% is hardly a overwhelming success! Her comments did a great deal of harm to people trying to understand what is wrong with them, and to the people around them who are coping with the aftermath of this illness!

  11. I believe wholeheartedly in Acupuncture, dry needling, supplements, exercise, massage and wellness — not separately — but in a therapy recipe. Separately they are not as potent, but all together in a package they help the body to heal.

    Over the years of trying to do my best with what was available before FM was even realized, I’ve used and still use Flexeril, trazodone, fluoxetine, citalopram, valproic acid, phenytoin, lithium orotate, magnesium glycinate, hydroxyzine, doxepin etc (no official entity researched them except me and my patients with trial, errors and successes.)

    @John Quintner, you are a master of prose, deception and distractions. You make these negative statements and reinforce the negative statement by negating all reasonable positive clinical observations as unscientific and thus worthless.

    What is your favorite treatment protocol for FM or chronic pain?

  12. Myron Shank, M.D., Ph.D. says:

    The low response rate does not make it a placebo effect. The drugs labelled for use in fibromyalgia have been compared to placebo and found to be statistically significantly better than placebo in multiple trials. In addition, placebo-responses are seldom maintained for more than short periods of time.

    If “fibromyalgia” represents multiple conditions under one name, it should not be surprising that a small percentage of people respond to a small number of drugs. Thinking about how few people would be helped “a lot” for any three drugs for “cancer” or for “infection” makes ten percent sound like a resounding success, by comparison.

    Dismissing those ten percent as placebo-responders also risks subjecting them to the unwarranted conclusion that, therefore, fibromyalgia must be “all in their heads.” Yes, I know that a placebo-response demonstrates nothing of the kind, but I also know that that is the almost universal interpretation.

  13. Sue B says:

    I have suffered from fibromyalgia for 7 years. I have tried all these drugs, they don’t work! I think you have to look at what the drugs are designed to do- work on the brain. As an
    antidepressant, you walk around for several week going- ” I feel good!” But, that feeling wears off rather quickly for me. I think the perceived success rate is in the few patients that perhaps have little longer rate of success. What really burns me is the spokesperson from Pfizer going on Dr Phil and telling the world “It is all in your head.” Dr Phil may understand, the general viewer heard “you are crazy”. Let’s stop the insanity, 10% is not enough to say your drug is a miracle cure. Just so you can make money! You are just leaving the patients wondering, Doesn’t anyone know I am really suffering!

  14. Jenn says:

    I’m 18 years old and have been dealing with chronic back pain for 4 consecutive years. The ONLY thing that calms my pain, is smoking cannabis. I’m sick of this god damn pain, I can’t even attend school. It sucks the only thing that helps is ILLEGAL. Kinda cruel.

  15. John Quintner says:

    @ Dr Fugedy. A recently published (April 11) Cochrane Database System Review – “Non-invasive brain stimulation techniques for chronic pain” – does not support the efficacy you claim for this treatment. Would you care to comment?

  16. John Quintner says:

    @ Dr Rodrigues. Would you please specify the “old meds of the 80s-90s that worked well then and still do today”?

    Could you also provide the scientific evidence for their purported efficacy when used in the context of treating patients with chronic widespread pain?

  17. Transcranial direct current stimulation (tDCS) uses a tiny amount of direct current from a portable stimulator powered by a 9 volt battery via sponge electrodes. 5 20-minute treatments reduce the pain of fibromyalgia 50%, as demonstrated in the 2006 Harvard study. Fibro-fog and fatigue are also reduced. tDCS produces NO side effects. It can be self-administered by the patient at home.

    Obviously, if you have a 125 million dollar per year advertising budget you can sell a lot of drugs, even if they don’t work so well.

  18. @LaFave is correct! This is corny, but in complicated long-term pain syndromes, one should attack the syndrome with a team or a gang-on approach addressing all of the facets. I use a biscuit baking metaphor. To get a golden brown batch of flaky biscuits you need; 1. Fresh ingredients = earthy foods, minerals/magnesium. 2. Measure carefully all components = work life fun balance 3. Mix or Knead the ingredients into a dough to begin the chemical reactions = yoga, zumba, stretching, massage, acupuncture, or other needles. 4. Bake the ingredients in an Oven; the correct temperature = Heat by raising your core temp, and for the correct amount of time = Good quality sleep.

    @ Shank is correct! “considered the possibility that “fibromyalgia,” which has not yet even been clearly defined, might represent more than one disease with more than one underlying cause?” This is an old idea that has been swept under the rug. FM is multifaceted and cause by multi factors, so treating only ONE of the facets was not yet in vogue decades ago. Today fixing one facet with a pill is an erroneous idea. My favorite therapy authors Travell/Simons, Rachlin, Baldry, Helms and Gunn all were unraveling this conundrum back in the 60s-90s, they refer to chapters in their books. They all had slightly different views, all were good ideas, so over the years, we alternative medical providers follow these leaders and put all of their ideas into the therapy. Some of the best tricks of the trade can be found in the nooks and crannies of those old books. The treatments of the future should piggyback off of the best ones of the past.

    Also, the old meds of the 80s-90s worked well then and still do today. The “new kids” on the block are OK me-too meds, but the older ones are good enough, dirt cheap, tried, reasonable and have a longer safety record.

  19. Ralph says:

    This doesn’t show data from the same survey that stated 62% found relief using cannabis/medical maijuana — which can be grown in your yard and costs much less than the billions given the big drug companies for less effective treatments.

  20. Steve M says:

    Also, more than 10% off people experience side effects (net negative effect). And, MANY people take these psychosomatic drugs without efficacy because it’s that or nothing. Also, if you don’t take them, you never get treated with anything else.

  21. Steve M says:

    That 10% is likely placebo, opioids have much higher efficacy, as does amateur massage by your spouse, but they don’t generate 7 BILLION dollars, so they’re not FDA approved.

  22. Myron Shank, M.D., Ph.D. says:

    I would caution commenters not to mention that they are taking controlled substances, especially opioid (“narcotic”) analgesics, if they are using their real names. You do not know who might read your comment and decide to steal your medication.

  23. Myron Shank, M.D., Ph.D. says:

    Ten percent of those who suffer from fibromyalgia is a large number of people, and helping that many people “a lot” is significant. Going from zero percent to ten percent is a very big deal. The glass may be a long way from half-full, but it is no longer all empty. The fact that the three drugs labelled for fibromyalgia generate large quantities of money for pharmaceutical companies makes it likely that large quantities of money will now be spent looking for treatments. Not only do the pharmacologic actions of drugs that help even ten percent of people provide clues as to the nature(s) of fibromyalgia(s), but, since no one wants spend large quantities of money blindly, it is likely that funding for research into the nature(s) of fibromyalgia(s) itself (themselves) will also increase. Increased funding will likely not only lead to increased understanding, but increased visibility for what has(have) previously been dismissed.
    Getting away from an arbitrary number of arbitrary points of tenderness as a (research or otherwise) definition of fibromyalgia(s) and thinking of it (them) in terms of a spectrum of manifestations is itself a huge conceptual step forward.
    For the author to uncritically quote the statement by Betsy Jacobson is nothing short of irresponsible. Why is “constantly trying to find out what works for fibromyalgia” such a bad thing? How is “all the billions they’ve spent on research,” despite failing to find “a cure for cancer and other notable diseases,” evidence of corruption? The only way that it would be evidence of corruption would be for the pharmaceutical companies to be spending this money without either the prospect or intention of providing value for the expenditures. Does Ms. Jacobson understand that “cancer” is a large group of diseases which are more different than similar to each other, and that finding the “cure” is highly unlikely? Has she considered the possibility that “fibromyalgia,” which has not yet even been clearly defined, might represent more than one disease with more than one underlying cause? Of course for-profit companies are focused on “the bottom line”–publicly-traded corporations are even legally obligated to be so! The fat that they have different roles than not-for-profit organizations makes them different, but not evil. Rather than bashing the contributions of for-profit organizations, we should be celebrating their (belated) entries without neglecting the important roles of not-for-profit organizations.
    I can understand the impatience of those who are suffering, but I can not understand the tone of this article.

  24. Diane LaFave says:

    I was diagnosed with Fibro 19 yrs. ago. The DRs. had me on 6 different meds. [ I was on no meds. before this]. I got worse , to the point of low functioning, both physically & emotionally
    I decided to educate myself. Joined a supportand googled. group.& googled.I took l made diet changes, went on natural supplements, took H2o aerobics , light weight lifting & walking.
    I found , only when needed, That a pain med [ a narcotic is the only one that works for me] & a muscle relaxant is all I need . I still have symptoms , but, thery are further apart & usually not as intense as they were in the past.
    I’m planning on writing an article on this, as the medical society seems to know too little about Fibromyalgia . I’m living it and have done the work to improve my ability to LIVE it as normal as possible. What I do has IMPROVED my physical condition [ therefore, My mental too]. The pills I take for it has aided in controlling the pain. I still can’t maintain a conventional job [ 40 hrs. & Having to be there no matter how I felt ]. But, I’ve done volunteer work. Fun & fulfilling!

  25. susan yale says:

    As i lay here unable to sleep because of my fibro pain i wonder who these test patients are that get these drugs approved. Not me, so many of us are out there suffering in an attempt to maintain a normal life. My home has become my safeguard against the world where everyday tasks i can no longer manage. Pain medication helps and now they want to restrict that too ?? Help us.

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