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CAMPOS: Disease market lucrative

By Paul Campos, Rocky Mountain News (Contact)

Published January 16, 2008 at 12:05 a.m.

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Two classic questions that confront medical science are how to define disease and how to measure and treat pain. Both questions are brought into sharp relief by the controversy over fibromyalgia.

Fibromyalgia is a term invented to describe a set of symptoms put into nontechnical language by the Mayo Clinic's Web site: "You hurt all over, and you frequently feel exhausted. Even after numerous tests, your doctor can't find anything specifically wrong with you. If this sounds familiar, you may have fibromyalgia."

A cynic might reply, "If this sounds familiar you may merely be getting old, but you can be sure drug companies are developing products to help you manage your new 'disease.' "

Sure enough, the pharmaceutical giant Pfizer has just gained FDA approval for Lyrica, a drug that appears to lessen the pain associated with fibromyalgia, although why it does so remains unclear, as indeed does the more fundamental question of whether fibromyalgia even exists.

Remarkably, Frederick Wolfe, the lead author of the 1990 paper that first defined how to diagnose the newly identified disease, no longer believes it does. In his view, fibromyalgia isn't a disease at all, but rather a physical reaction brought on by stress, depression and economic and social anxiety.

"Some of us in those days thought that we had actually identified a disease, which this clearly is not," he told The New York Times. Wolfe went on to make a thought-provoking claim. "To make people ill, to give them an illness, was the wrong thing."

Wolfe's words can be interpreted in various ways. He could be understood to be saying it's a bad thing to "give" people an illness because it's bad to classify people as diseased who really aren't. Or he could be saying that the very act of classifying people as ill who weren't really ill prior to the misdiagnosis produces the perverse outcome of causing them to then actually become ill as a result of being told they are.

There is some evidence that this is precisely what is happening with fibromyalgia. Nortin Hadler, a professor of medicine at the University of North Carolina, claims as much: "These people live under a cloud," he told the Times. "And the more they seem to be around the medical establishment, the sicker they get."

Others disagree vehemently, arguing that fibromyalgia is both real and undertreated, and that, as in the case of depression and Prozac, approval of Lyrica will help doctors recognize that, in the words of Dan Clauw, a professor of medicine at the University of Michigan, such illnesses "are legitimate problems that need treatment."

The financial stakes are enormous. Sales for Lyrica reached $1.8 billion in 2007, even though the drug was approved for the treatment of fibromyalgia only in June. And other pharmaceutical companies are already pushing their competing products through the regulatory pipeline.

It's difficult to know what to make of all this. On the one hand, pain is notoriously difficult to measure, and the group most likely to be diagnosed with fibromyalgia - middle-aged women - is made up of people who have a history of having their complaints dismissed as "whining" by doctors.

On the other, the controversy over fibromyalgia has some suspicious parallels with controversies over several other recently discovered "diseases," such as chronic fatigue syndrome, erectile dysfunction and obesity.

More than half a century ago, the newly established World Health Organization defined "health" as "a state of complete physical, mental and social well-being." As critics have pointed out, this seems more like a definition of happiness than of health.

The irony is that an unrealistically extreme definition of health may be making many of us both less healthy and less happy. It is, however, making a few of us much richer.

Paul Campos is a professor of law at the University of Colorado. He can be reached at paul.campos@colorado.edu.

Comments

  • January 16, 2008

    6:39 a.m.

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    Mike_In_Hartsel writes:

    You left out Attention Deficit Disorder and the other garbage physco-babble terms. Campos? Is this really you? Or have aliens taken over your body? Good article.

  • January 16, 2008

    8:18 a.m.

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    Spencer writes:

    Mike in Hartsel is that really you? You were able to make a decent comment and not just spew some mindless drivel. Have aliens taken over your body? good comment

  • January 16, 2008

    8:43 a.m.

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    spencerr writes:

    ...I agree in principle with this and would in its entirety if it were not for having a 25-year-old wife with chronic pain everywhere that the doctors dismiss as whining. Whether it be sickness or stress, shouldn't she be able to go through life without hurting?

  • January 16, 2008

    9:17 a.m.

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    kathyM writes:

    It doesn't matter whether some grand poobah declares something a "disease" or not. The goal of any medical professional is to relieve suffering.

    How and why humans feel pain is still largely a mystery. But just because researchers haven't figured it all out, does that mean we have to wait for the answer before allowing people to get relief?

    Lyrica is derived from the anti-seizure drug gabapentin. Why does an epilepsy drug also relieve fibromyalgia pain? Why does it also relieve pain from shingles? Why does it also relieve pain from diabetic neuropathy? And why does it work for some people but not others? We simply don't know.

    If big bad pharma weren't so interested in profit, millions of people would still be suffering the kind of pain you wouldn't wish on your worst enemy.

    If someday you join the ranks of pain-sufferers, be sure to support your position by not taking anything to relieve the pain.

  • January 16, 2008

    11 a.m.

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    vudumom writes:

    KathyM,Thank You for your post. Lyrica blocks sensors in the brain that enable us to feel pain. It has been a life saving drug for me. I have been in pain for over 4 years. The Dr.s I saw would do nothing and throw up their hands in the air or give me painkillers. I also suffer from severe Arthritis in my lower back.Since I have started Lyrica 2 months ago I have never felt better.It doesn't help so much with the Arthritis but it takes the pain away from all over allowing me to deal better with my Arthritis. So I rarely take pain killers anymore. Some days are bad if I'm under alot of stress or if it is really cold and damp,but Lyrica has given me more energy and mobility and has been a mircle drug for me.People with Fibromyalgia suffer great pain.For one Dr. to now say it isn't real is ridiculous and I hope he is not practicing if he is all his patients should find other Dr.'s.Mr. Campos has no idea what it is like to walk in my shoes and others with severe chronic pain. As far as the drug companies ,I would like to thank them for Lyrica,I am so much better.

  • January 16, 2008

    12:01 p.m.

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    kathyM writes:

    vudumom, I am so happy that Lyrica is helping you. I'm especially proud to say that my husband--a "big bad pharma" scientist--was on the team at Parke-Davis/Warner-Lambert (not Pfizer) that developed gabapentin (Lyrica's "mom"). Fortunately the medical community mostly ignores dufus comments like Campos' and presses on in the quest to help people live healthier lives.

  • January 16, 2008

    12:19 p.m.

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    KrisO writes:

    Taking away the diagnosis isn't going to take away the pain. What a silly argument.

  • January 16, 2008

    1:23 p.m.

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    vudumom writes:

    Kathy , Please tell your husband a heartfelt Thank You from me.

  • January 16, 2008

    3:38 p.m.

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    me2 writes:

    Remember Lyme disease and how hard one woman worked to get it recognized. Now we know it is spread by ticks.

    Someday all these orphan diseases will be unmasked by the scientists.

    But putting fibromyalgia in with ED, where you can actually see what is happening, or not, is too funny.

  • January 17, 2008

    12:18 a.m.

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    harmonious writes:

    campos wrote an article that wasn't absolute rubbish? it almost makes me want to read it. almost.

  • January 18, 2008

    9:10 a.m.

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    cb writes:

    I have 24/7 unrelenting pain and use a drug similar to lyrica - an older drug with a great record of low side effects. The drugs I take for the many pains make it possible to enjoy life - without them I would have long ago ate a bullet. Campos's constant babble seems an attempt to confirm for himself that he is the smartest most observant guy in the room. I find it incredible that anyone would pay for his rubbish.

  • January 18, 2008

    2:06 p.m.

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    kbrigan writes:

    I'm not so sure it's the sole or primary goal of medicine to relieve suffering, especially if that "relief" shortens someone's life, ruins their overall quality of life, or reduces that person to a child-like dependence on mysterious "experts". As they say in the Princess Bride, "Life is pain." Try to remove all of it, and you remove life, too.

    Personally, I also see parallel problems with the evolution of the treatment of migraine -- yes, it's good to have it finally recognized as a disease, but the complexity of symptoms, triggers and mechanisms is greatly oversimplified and fraught with stigma and suspicion. (I had one very young neurologist tell me I couldn't be having migraines even though I see scintillating scotoma on a regular basis, respond to ergotamines & other drugs that work solely on migraine, and have other chracteristic symptoms. His sole reason was that I did not have one specific migraine "spot," and instead feel pain all over my head --common to vestibular migraineurs like moi. And, BTW, some migraineurs don't even feel pain period. What a maroon.)

    But, oh my, the drugs! I survived run-ins with Depakote & Klonopin without becoming either psychotic or diabetic (although it was close), but was left with myoclonic jerking that's never entirely gone away. Now that I'm much more bi-- "assertive", and am such a bad patient, I refuse to take the "right" drugs, I'm successfully managing my migraines with Tai Chi and other regular exercise, meclizine, diphenhydramine & ibuprofin -- all over the counter, and therefore discounted these days as migraine meds, even though all were used to treat migraine long before the more invasive atypicals started being prescribed. And, of course, all work for me -- and many other vestibular migraineurs -- far better than the "right" stuff.

    Arggh. Pardon the rant, but beware modern medicine. It can be hazardous to your health.

  • January 18, 2008

    11:25 p.m.

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    kathyM writes:

    kbrigan, your "rant" illustrates that not all medicines work for all people. The reason the newer migraine meds were developed was because many sufferers couldn't get relief from the old meds.

    Frankly, it's the doctors, rather than the researchers, who tend to think pain is psychosomatic. It wasn't very long ago that babies were treated without painkillers because it was believed they couldn't feel pain. And terminal cancer patients suffered horribly because their docs were afraid to get the patients "hooked" on narcotics. And women with excruciating menstrual pain were given birth control pills, a hysterectomy, or told to have a baby to relieve the pain. Is it any wonder, then, that fibromyalgia, and in your case migraines, are still looked at as psychosomatic?

    Researchers have a very long way to go before the nature and cause of pain are fully understood. Until then, I'm sure you will be happy to be relieved of pain with the medicines available, even if they're not perfect.

  • January 19, 2008

    11:51 a.m.

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    kathyM writes:

    And theQ works for free while us sinners work for money.

  • January 19, 2008

    11:52 a.m.

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    kathyM writes:

    Oh, by the way theQ, take Beano for your farts.

  • January 22, 2008

    2:19 p.m.

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    kbrigan writes:

    My point, which sort of overlaps with some here, is that contemporary medicine ALWAYS goes for the most expensive, most invasive, most heavily marketed, most lucrative option possible, regardless of whether or not it's the best option, or whether or not less damaging alternatives have been tried. The important part of my story is the exercise, the meditation, the choosing to take good care of myself (i.e. getting enough sleep), and not being willing to make a mere illness the center of my life -- not the tiny number of over-the-counter meds I occasionally take. Way to miss the point, kathyM. The reason "new" migraine meds were developed was to make money, period. Most migraineurs never get the chance to find out how lifestyle changes might help them, or whether over-the-counter meds (which don't give you heart disease, or diabetes, or make you psychotic, or ruin your liver) will work for them because doctors are too busy shoving Imitrex and Depakote and Klonopin down their throats.

    As for fibromyalgia (and, IMHO, "depression" and ADHD and PMDD, etc.), regardless of whether or not there's a physical cause (NOT proven, by any means), alternatives to medication -- especially expensive, woefully damaging, but profitable ones -- must be tried first, and thoroughly exhausted before resorting to pills. I know several people on antidepressants and several who say they have fibromyalgia -- none have made any attempt to make lifestyle changes in dealing with their ailments. NONE of the people on antidepressants see any kind of counselor or shrink at all, ever. The "talking cure" can be extraordinarily effective; why's it abandoned in favor of extremely dangerous, and sometimes downright strange, chemicals? Similarly, why aren't other forms of pain management (including personal empowerment, and good old distraction, i.e. not staying focused on yourself all the time) being tried BEFORE the pills? How many folks getting Lyrica, et al. have tried meditation? Regular exercise? Changing jobs? Correcting the power structures in a bad relationship? Changing their lives so that they're not in screaming matches with kids & spouse every single day? (All of the previous are real life examples of lifestyles "enjoyed" by the people I know who tell me they have fibromyalgia.) Even if fibromyalgia is a real disease (like many people, I'm not convinced yet, although it's possible), why not change everything possible before running pricey chemicals through someone's already overworked liver? (Oh, right. Big pharma doesn't -- yet -- have a hand in the meditation business.)

  • January 22, 2008

    4:39 p.m.

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    kathyM writes:

    I see your point that alternative therapies are not promoted as much as medicines. Fortunately, doctors are finally being trained to use multiple treatment methods like you mention, and some insurance companies are finally covering alternative therapies like massage and acupuncture.

    But your argument about using altnernative therapies before medications is flawed. Just as no medication works the same for everyone, no alternative therapy works the same for everyone.

    If my family followed your logic, my dad would have treated his esophageal cancer with the Gerstner method (vegetarian, supplements, and coffee enemas). There are many claims that this treatment has eliminated cancer. But EC destroys the digestive system, rendering a nutrition-based treatment useless. My dad might have lasted 6 months. However, big bad pharma's products allowed him to have 3 YEARS of good quality life doing what he loved--traveling, watching his grandkids grow up, and cooking big dinners for friends and family.

    And as for pharma developing drugs where there is no need, that's way off the mark. What company of ANY kind can survive by routinely spending $1 billion (per product) developing something no one needs or wants?

  • January 22, 2008

    5:09 p.m.

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    kbrigan writes:

    Esophageal cancer can be diagnosed by biopsy, blood tests or x-rays. Fibromyalgia is by definition subjective, has no definitive diagnostic test, is not life-threatening, and is primarily a quality-of-life problem. Argument rejected; the items compared are not sufficiently alike for your argument to be valid. Thanks for playing.

    Sorry, but you have no valid reason for claiming that a subjective, quality-of-life problem shouldn't be treated primarily through subjective (i.e. comforting or empowering) means, or by improving one's overall lifestyle. All the arguments in favor of Lyrica can be made for heroin, or any other drug that "alieviates pain." Everybody's in pain, at least some of the time. Pain is a natural and inevitable part of life. (This is one reason why people keep talking about aging in this context.) Even if there were a discrete cause for "fibromyalgia" that you could test for and point to, this still would not mean that drugs are the way to go.

  • January 22, 2008

    5:16 p.m.

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    kbrigan writes:

    Re. only "needed" drugs being developed.

    Viagra is unnecessary. ("Erectile disfunction" does not exist; it's just another name for not-being-17-any-more.)

    Rograine is unnecessary, by definition.

    Many researchers, doctors and patients are arguing that any drug related to cholesterol (Lipitor, etc.) is unnecessary. (Start your search at junkfoodscience.blogspot.com)

    "Alli" is not only worthless (i.e. results in a less than five pound "improvement" in "weight loss"), it's dangerous.

    Most antidepressants are not only unnecessary, they're dangerous and debilitating.

    Etc.

    Do a search for "orphan drugs," those legitimate drugs that don't make money and therefore are not developed or available, if you want a realistic look at the situation. Heard anything about a new treatment for malaria lately? Cheaper AIDS drugs? Juvenile epilepsy? Don't hold your breath.

  • January 22, 2008

    5:50 p.m.

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    kbrigan writes:

    One last point, and then I'm done.

    I know a lot about pain and "feedback loops." Migraineurs in general are dealing with an exaggerated sensitivity to sensory input of all kinds, which might be similar to the exaggerated pain sensitivity that could be involved in fibromyalgia. (Maybe.) In addition to migraine, I'm dealing with hyperekplexia (an exaggerated startle response), intention myoclonus, and constant noise & light sensitivity. One thing I've learned since the hormonal shift or brain lesion or whatever the heck it was that kicked all this stuff into high gear about fifteen years ago is that the worst thing I can do is try to remove myself from all noise, no matter how painful it is. If I live as noise-free as possible, I'm more vulnerable to jerking and drop attacks, and my sensitivity to noise and startle response get even worse the more I limit my exposure. So, I try to push my limits now and then, keep white noise around, etc.

    A question. If there are drugs around that can keep people with fibromyalgia from feeling pain, how do we know that these patients won't wind up with an even more greatly disordered pain response a few months down the road, when their brain/neurology gets rewired in response and/or they psychologically "adapt" and return to their previous level/manner of functioning? How can the safety of a treatment be determined when we don't even know the nature of what it's treating? This is one of the many reasons I'm saying don't assume drugs are the way to go. There ain't no free lunch, especially neurologically speaking. Everything reverberates with everything else.

    OK, I'm done.

  • January 24, 2008

    10:53 a.m.

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    kbrigan writes:

    (OK, one more.) Hate to say it, but I was right. It looks like the anecdotals on REBOUND PAIN and LYRICA are already starting to come in. Yes, of course, this is stuff that the FDA et al. should have caught long before releasing this stuff, but that would have interefered with profits.

    Here's one place to start: http://www.google.com/search?hl=en&am...