Lyrica, the first drug approved by the US Food & Drug Administration to treat fibromyalgia, has been hitting the headlines over the past few weeks. We talked to Dr. Jacob Teitelbaum of The Annapolis Center for Effective CFS/Fibromyalgia Therapies about the drug.

In June 2007, Lyrica, which is manufactured by Pfizer, became the first drug to be approved for the treatment of fibromyalgia by the FDA which regulates the pharmaceutical industry in the United States.

Doctors who treat fibromyalgia patients have been using various drugs "off-label" over the years to treat the pain and other symptoms of the condition, but Lyrica is the first to be officially endorsed as safe and effective by the FDA.

Recently, Pfizer has begun running TV advertisements for Lyrica in the US (where direct to consumer/patient advertising of prescription drugs is commonplace). This sparked a flurry of media attention about fibromyalgia with the old debate about whether it is actually a real illness raising its ugly head once again.

The New York Times ran a story on January 14th entitled 'Drug Approved. Is Disease Real?' An eye-catching title designed to sell papers, it sparked a deluge of letters to the editor from disgruntled patients and doctors alike, including Prof. Benjamin H. Natelson, a Professor of Neurosciences and director of the Pain and Fatigue Study Center at U.M.D.N.J.-New Jersey Medical School.

Prof. Benjamin said of talk that fibromyalgia is not a real disease: "This is an opinion ignoring published medical literature showing brain abnormalities in fibromyalgia and drugs that clearly improve patient health. What’s needed is less talk and more federally financed, peer-reviewed research."

Fibromyalgia is recognised as a diagnosable disease by organizations such as the National Institutes of Health (NIH), American College of Rheumatology, the Food and Drug Administration and medical insurance companies.

With this in mind, the question that should be asked is "is Lyrica effective in treating fibromyalgia symptoms?" The Environmental Illness Resource talked to fibromyalgia specialist Dr. Jacob Teitelbaum to find out:

EIR: "What are your feelings about the FDA approval of Lyrica for the treatment of fibromyalgia?"

Dr. Teitelbaum: "It is a helpful thing for patients on many fronts. It adds a useful tool to the treatment Armementarium, increases the possibility insurance will pay for the treatment, and most importantly, will result in well over $50 million being spent to publicize this epidemic that has been largely ignored by the medical community."

EIR: "How does this drug differ from other drugs you and other doctors currently use or have used in the past?"

Dr. Teitelbaum: "It is a different family. Ultram raises serotonin and endorphins, skelaxin is a muscle relaxant, flexeril and elavil work on serotonin. Lyrica works on the "sodium channels" and helps decrease the central sensitization component of the pain. So it is complementary to the other pain meds we use(and there are over a dozen)."

EIR: "Will you now using it with your patients?"

Dr. Teitelbaum: "We have been for years with good success. For many it is sedating during the day, so simply taking 250 mg at bedtime helps sleep and next day pain with less sedation."

EIR: "Do you think this is a big step forward in the treatment of fibromyalgia?"

Dr. Teitelbaum: "One of many. The key is that Lyrica, Cymbalta and Minalcipran all simply treat the pain --without treating the underlying process-which is an energy crisis on a cellular level with secondary hypothalamic dysfunction. Our double blind published research has shown that when you treat with the "SHINE Protocol" (Sleep, Hormonal support, Infections, Nutrition, and Exercise as able) 91% of patients improve with an average 90% improvement in quality of life. The majority of patients became pain free or had marked pain relief as well. So I view Lyrica (and the 2 other new meds above which should also soon have FDA approval) as first aid to get people pain free while we eliminate the underlying causes of the illness. To see the "SHINE" study(though exercise was not part as it could not be placebo controlled),see http://www.endfatigue.com/resources/Effective-Treatment-Of-Severe-Chronic-Fatigue-States.html . We have also recently published a study showing an average 45% increase in energy in fibromyalgia from a simple sugar called ribose."

EIR: "Are there any drawbacks to treatment with Lyrica?"

Dr. Teitelbaum: "Sedation and dizzyness are key, and these are prevented by starting with a low dose and working it up as tolerated. A small percent ~4% will have weight gain at higher doses-which is often more than compensated for over time by the weight loss from being able to exercise as pain is relieved in many patients. Because of the marketing wars though, the weight gain issue will be overstated in order to scare people. Clinically, it is much more effective than Cymbalta though. We await Minalciprams being approved so we can see first hand if it adds anything over effexor or other related meds."

We'd like to thank Dr. Teitelbaum for sharing his experiences with Lyrica and the treatment of fibromyalgia in general. Dr. Teitelbaum is one of the foremost experts in fibromyalgia and has over 30 years experience in treating the condition.

About Dr. Jacob Teitelbaum:

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written by C. S., April 07, 2008

LYRICA This is NOT a wonder drug!!!!!!!!! Several people that I'm in touch with that have fibro don't like it either. The side effects are the same as the disease we want relief from. I took it a few years ago and after ablations a week ago and stopped taking them both times. It seems to work well for people with shingles, etc. without other problems. Also Cymbalta causes about a 40 pound weight gain and made me suicidal and feel more depressed than I was. I am not the only one that this has happenned to. Comercials like the Lyrica one is making it look like this pill will get rid of this disease. I have both fibromyalgia and myofascial diseases which are NOT THE SAME. I think that more research needs to be done to find the cause, find the gene and fix the problem. I'm sick of being preyed upon for medications that don't work, infomercials that say they can help, magnet items, emu oil, copper bracelets, etc.. We hurt so bad that if there was the slightest chance that wearing a chicken around your neck would help with the pain, we'd try it. All this is is more hype which we don't need going back to round one with is it all in your head again. These companies that prey on people should be shut down and sued. I've got 2 stimulators in my head which were put in and out over and over while I was awake to get into the right place so my head wouldn't hurt 24 hours a day. I've got a wonderful pain doctor who pretty much chose pain relief as a specialist because his aunt has this disease. He's treating people with other methods, such as nerve blocks, ablations, trigger point injections, because with some of us the pills don't work. I have morphine which I can take, but it makes me sick to my stomach and I have to lie down, so I don't take it unless it's so overwhelming I have to. 3 women had Dr. Kevorkian help them to die with dignity because they couldn't take the pain anymore. Unless you yourself feel this pain 24 hours a day you have no idea how we feel and how sick of it we are from constantly having to justify ourselves.

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written by Lucy, May 06, 2008

I agree completely with what you said. I have not found Lyrica a complete wonder drug. I have been prescribed it for having my nerves severed during a what was supposed to be a simple operation by a top plastic surgeon in South Africa, and subsequently have developed a neuroma, well that’s what the Neurologist has diagnosed? I cannot tolerate the side effects of Lyrica especially the weight gain – oddly enough my Neurologist had never heard of the weight gain side effect? As you so rightly say, no one can understand the debilitating 24 hour pain that we feel unless they feel it themselves, most certainly not my plastic surgeon.

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