Addition of Lyrica Significantly Improved Generalized Anxiety Disorder Symptoms in Patients Who Responded Only Partially to Previous GAD Treatments

From the FMS Global News Desk of Jeanne Hambleton (UK)

First Large, Placebo-Controlled Study to Demonstrate Efficacy of Lyrica as Add-on Therapy Strategy in Difficult-to-Treat GAD Patients

May 19, 2009 03:00 PM Eastern Daylight Time

SAN FRANCISCO–(BUSINESS WIRE)–The addition of Pfizer’s Lyrica® (pregabalin) capsules CV to other generalized anxiety disorder (GAD) treatments significantly improved the symptoms of the condition in patients who responded only partially to previous treatments, according to a study presented today at the American Psychiatric Association annual meeting in San Francisco, Ca. In this study, patients treated with Lyrica showed significant improvements in both their psychological and physical symptoms of anxiety.

Generalized anxiety disorder is a chronic, debilitating anxiety disorder affecting nearly seven million Americans and is characterized by persistent, excessive, uncontrollable worry about everyday things. Patients also frequently experience physical symptoms such as muscle tension, fatigue, sleep disturbance, and other aches and pains.

The condition is complex and often difficult to treat, with 40 percent to 60 percent of patients failing to achieve remission after six months of treatment in clinical studies with serontonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) – two common classes of FDA-approved GAD treatments.

“These data are very encouraging for the high percentage of GAD patients who still struggle with debilitating symptoms despite treatment,” said Dr. Rakesh Jain, one of the study’s investigators and director, adult and child psycho-pharmacology research, R/D Clinical Research, Inc. “It is clear we need additional effective, well-tolerated options to address this difficult to treat condition.”

This is the first large, placebo-controlled trial to demonstrate the efficacy of an add-on therapy strategy in patients who had failed to respond to two different courses of GAD monotherapy with a SSRI, SNRI or benzodiazepine.

The study found that patients treated with Lyrica in addition to their baseline SSRI/SNRI therapy had a significantly greater improvement in overall anxiety symptoms as well as individual psychological and physical symptoms compared to baseline therapy alone as measured by the Hamilton Anxiety Scale (HAM-A), an interview scale that measures the severity of a patient’s anxiety. Over the eight week treatment period, patients receiving add-on Lyrica therapy had, on average, an anxiety score that was 1.2 points lower on the HAM-A compared to baseline therapy alone (P=0.012).

Significantly more patients receiving add-on Lyrica treatment (50 percent) showed at least a 50 percent reduction in their anxiety symptoms compared to SSRI/SNRI treatment alone (37 percent) (P=0.023). Lyrica was also shown to be well tolerated as an add-on therapy in this study.

About the Study

This study was a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of adjunctive Lyrica in 353 patients with a primary diagnosis of GAD. To be included in the study, patients had to have a HAM-A score greater or equal to 22, and to have not responded, or only minimally responded, to treatment with a SSRI, SNRI or benzodiazepine prior to the study.

These patients were then treated with a different SSRI/SNRI for eight weeks. At the end of the eight week open-label treatment period, patients who had shown only a partial response to treatment (as defined by a HAM-A score of greater than or equal to 16, less than 50 percent decrease in HAM-A score, and a Clinical Global Impression Improvement score of less than 3) were then randomized to an additional eight weeks of double-blind treatment with either Lyrica (150 to 600 mg/day) or placebo while continuing treatment with the existing background SSRI or SNRI therapy.

The primary endpoint was the mean change score on the Hamilton Anxiety Rating Scale. The SSRIs and SNRIs used in this study included escitalopram, paroxetine and venlafaxine XR.

The most common side effects in the study compared to other GAD treatments plus placebo were dizziness (11.7 percent vs. 5.7 percent), headache (9.4 percent vs. 4 percent), and somnolence (8.3 percent vs. 3.4 percent).

This study was sponsored by Pfizer, Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia, painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults. Lyrica is not approved for GAD in the U.S.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain, treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity. Like other anti-epileptic drugs, Lyrica may cause suicidal thoughts or actions in a very small number of people.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

DISCLOSURE NOTICE: The information contained in this release is as of May 19, 2009. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about the use of Lyrica for GAD, including its potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by the Food and Drug Administration (FDA) regarding whether and when to approve any supplemental drug application that may be filed for a GAD indication for Lyrica as well as the FDA’s decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.

(Contacts: Pfizer Inc Media: Sally Beatty, 212-733-6566
Permalink: http://www.businesswire.com/news/home/20090519006509/en)

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Fibromyalgia and Epilepsy Drug Lyrica Helps Restless Leg Sufferers, Researchers Say

From the FMS Global News Desk of Jeanne Hambleton (UK)

Courtesy of attorneyatlaw.com Legal Briefs

Lyrica, the Pfizer drug for treatment of the chronic pain disorder fibromyalgia and preventing epileptic seizures, also appears to benefit people who cannot get to sleep because of restless legs syndrome, new findings suggest.

A recently completed clinical trial found that pregabalin, the active ingredient in Lyrica, is “a promising alternative to current treatments” in terms of helping people with restless legs syndrome get more quality sleep, according to research unveiled this week at a meeting of the American Academy of Neurology.

Lyrica for Fibromyalgia Pain

In 2007, Lyrica became the first FDA-approved treatment for fibromyalgia, a debilitating condition which affects as many as six million Americans, mostly adult women. Fibromyalgia victims tend to experience chronic or long-lasting pain as well as muscle stiffness and tenderness, the FDA said.

Restless legs syndrome is a neurological disorder which causes burning or tugging sensation in the legs, sometimes called parethesias or dysethesias, particularly when the person is lying down at rest. The sensations can range from uncomfortable to extremely painful.

Study of Restless Legs Sufferers

Researchers from the Sleep Research Institute in Madrid, Spain studied 58 patients who suffered from restless legs syndrome. The patients were given placebo pills for two weeks then half were given 150 to 600 milligrams daily doses of Lyrica, while half continued to receive placebos for another 12 weeks.

The researchers monitored the severity of restless legs syndrome and sleeping habits of both groups and found that those taking Lyrica experienced less severe symptoms of the syndrome.

Less Symptoms, More Sleep

Using the International Restless Legs Syndrome Rating Scale, people on Lyrica saw their scores on the disease severity index decline from 19.8 to 6.8, while scores for participants on placebo treatments declined from 21.5 to 11.2, the researchers said.

Also, people in the study who were taking Lyrica spent significantly more time sound asleep in what is called deep slow wave Stage 3 sleep and less time in light sleep, called state 1 or 2 sleep, compared to people not taking the drug, the researchers said.

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/fibromyalgia-and-epilepsy-drug-lyrica-helps-restless-leg-sufferers-researchers-say/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Low Doses of Drug for Alcoholics Helps Reduce Fibromyalgia Pain, New Research Finds

Courtesy of attorneyatlaw.com Legal Briefs

Taking low doses of a drug commonly given to alcoholics and drug addicts reduces pain and fatigue in some people battling the chronic-pain condition fibromyalgia, Stanford University researchers say.

In preliminary research, the drug, naltrexone, reduced the pain and fatigue in fibromyalgia patients by an average of 30 percent, researchers said. The findings are an encouraging development for millions of Americans who suffer from fibromyalgia, a somewhat mysterious disorder for which there is no reliable cure or treatment.

However, larger and more detailed studies are needed before naltrexone can be recommended for treating fibromyalgia, researchers said.

Study Finds Benefits for Fibromyalgia Sufferers

The Stanford University study focused on 10 fibromyalgia patients. Some of the patients received low doses of the drug at bedtime while some were given placebos. Those taking naltrexone reported significant drops in daily pain, highest pain, stress, fatigue, and improved pain thresholds, according to the study.

On average, patients given naltrexone had their fibromyalgia symptoms reduced by 32.5 percent, compared to improvement of 2.3 percent in patients given placebo treatments.

Few Side Effects, Relatively Inexpensive

Naltrexone treatments resulted in few side effects, although some participants reported experiencing vivid dreams after taking the drug. Researchers are excited about the prospects of naltrexone as a fibromyalgia treatment because there currently are few treatment options for such patients and the drug is relatively inexpensive, costing about $40 a month.

A second, longer-term study of the effects of naltrexone on fibromyalgia symptoms and including 30 patients tested over a period of four months is set to begin soon, Stanford researchers said.

ATTORNEY AT LAW.COM© 2008
(http://www.attorneyatlaw.com/2009/04/low-doses-of-drug-for-alcoholics-helps-reduce-fibromyalgia-pain-new-research-finds/)

From the FMS Global News Desk of Jeanne Hambleton (UK)

Fibromyalgia: Millions Are Spent To Educate the Public About a Mysterious Condition

Courtesy of attorneyatlaw.com Legal Briefs

Two of the world’s biggest drug companies have paid millions of dollars to promote a chronic pain syndrome about which little is known, prompting some critics to accuse the companies of hyping a mysterious condition hoping to sell more drugs.

In the first nine months of 2008, drug makers Pfizer and Eli Lilly gave more than $6 million in grants to nonprofit groups to sponsor medical conferences and educational campaigns focused on fibromyalgia.

That sum tops the amount spent by the companies to raise awareness of more established diseases, such as diabetes and Alzheimer’s, and trails only AIDS, cancer, and depression in terms of educational spending from drug companies, officials said.

The problem, critics say, is that no one is exactly sure what fibromyalgia is. There is no known cause of the disease, critics note, and there are no tests for confirming its presence. Fibromyalgia patients most often may also be diagnosed with more widely understood conditions, including chronic fatigue syndrome.

Therefore, drug companies may simply be trying to drum up more patients for a disease that is treated by Lyrica, Cymbalta, and other popular drug brands, critics allege.

WHY THE FOCUS ON FIBROMYALGIA?

Why are drug companies paying millions of dollars to educate the public about a condition that even medical experts tend to agree may or may not even exist?

Are the drug companies engaging in the common practice of trying to influence the medical community into accepting and promoting a disease whose treatment might include the companies’ drugs, as critics allege?

Or, as the drug companies contend, are they simply exposing a newly developing disease which affects millions of Americans, just like depression, which went widely misunderstood and untreated for decades?

By convincing doctors to diagnose patients with fibromyalgia, Pfizer, Lilly and other drug companies figure to pocket billions in sales of drugs designed to treat the disorder. In fact, sales of Cymbalta, an antidepressant approved in June 2008 as a fibromyalgia treatment, and Lyrica, an anti-epileptic seizure drug also approved for fibromyalgia, have spiked amid the public-awareness campaigns.

In 2007 and 2008, sales of Pfizer’s Lyrica increased from $395 million to $702 million, while sales of Cymbalta, made by Lilly, were boosted from $442 million to $721 million, officials said. The drugs can help reduce pain in fibromyalgia patients, although researchers are not exactly sure how they work.

At the same time, the drug companies also poured millions of dollars into advertising the fibromyalgia drugs. Lilly spent about $128.4 million in the first half of 2008 to promote Cymbalta, while Pfizer shelled out more than $125 million on advertising for Lyrica, according to some estimates.

MILLIONS OF AMERICANS HAVE FIBROMYALGIA

According to the American College of Rheumatology, between six million and 12 million people in the U.S. currently have fibromyalgia. Women are more likely to have the condition, accounting for more than 80 percent of all cases.

Symptoms of fibromyalgia include widespread muscle pain, fatigue, headache and depression. However, despite more than 30 years of studying the condition, researchers say the understanding of fibromyalgia remains “murky.”

FUNDING OF DISEASE EDUCATIONAL PROGRAMS MUST BE SCRUTINIZED

The policy of drug companies issuing grants to nonprofit groups to conduct educational campaigns about diseases and conditions is fraught with potential abuses. It is not hard to see why companies like Pfizer and Lilly want to get the word out about fibromyalgia, since the companies make two of the drugs most commonly prescribed to treat the disorder.

By convincing physicians to diagnose cases of fibromyalgia and prompting patients to ask their doctors if fibromyalgia might be the reason for their unexplained pain, the companies have already earned millions of dollars in sales of the drugs.

The FDA must keep closer tabs on this practice to ensure that drug companies are not acting improperly in funding work to promote diseases or conditions. In the end, such practices may prove harmful to patients and drug users who are grasping at straws and desperate to find answers to their nagging pain.

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(http://www.attorneyatlaw.com/2009/02/fibromyalgia-millions-are-spent-to-educate-the-public-about-a-mysterious-condition/)

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Lyrica Significantly Reduced Pain and Improved Other Symptoms of Post-Traumatic Peripheral Nerve Pain, New Data Show

From the FMS Global News Desk of Jeanne Hambleton (UK)

SEATTLE–(BUSINESS WIRE)

Patients suffering from post-traumatic peripheral nerve pain treated with Lyrica® (pregabalin) capsules CV experienced significantly reduced pain compared to those taking placebo, according to new data presented today at the American Academy of Neurology annual meeting. The data also showed that patients treated with Lyrica reported less pain interference with sleep and were significantly more likely to report feeling better overall at the end of the study compared with placebo.

Post-traumatic peripheral nerve pain is a difficult to treat condition that occurs after nerve damage due to trauma from accidental injury or surgery. It can be a chronic condition, affecting the injured area with pain persisting long after the initial injury has healed. Traumatic injury causing long-lasting changes to the peripheral nervous system – the communications network that transmits information to and from the central nervous system (the brain and spinal cord) and every other part of the body – is believed to be the cause of this persistent pain.

Post-traumatic peripheral nerve pain can have a wide array of symptoms, including numbness, tingling and prickling sensations, sensitivity to touch or more extreme symptoms including burning pain.

“The findings of the study are good news for the many patients who suffer from this painful and debilitating condition,” said Robert van Seventer, MD, Chair of the Department of Anesthesiology and Director of Amphia Pain Clinic and Research Centre, Amphia Hospital, the Netherlands.

“Post-traumatic peripheral neuropathic pain has historically been a challenging condition to treat so this data demonstrating the ability of pregabalin to provide relief for patients is encouraging.”

The study found patients treated with Lyrica experienced significantly reduced pain compared to those taking placebo. At the end of the study, patients receiving Lyrica had, on average, a pain score that was 0.62 points lower on an 11-point scale compared to placebo.

Patients receiving Lyrica reported less pain interference with sleep compared to placebo. At the end of the study, patients receiving Lyrica had an average self-reported weekly pain-related sleep interference score of 2.73 (from a baseline of 4.1) on an 11-point scale measuring how much pain had interfered with sleep during the past 24 hours, compared to 4.13 for placebo (from a baseline of 4.8). Additionally, at the end of the study, significantly more patients receiving Lyrica (64 percent) reported feeling “improved” compared to placebo (41 percent).

About the Study

The multi-center, double-blind, placebo controlled study of Lyrica in 254 adult patients with post-traumatic peripheral neuropathic pain randomized patients to receive flexible dose Lyrica 150 mg to 600 mg daily for four weeks of dose optimization, followed by fixed dosing for four weeks.

The study was conducted at 60 sites across Canada and Europe. The average Lyrica dose was 326 mg daily. Patients had to experience persisting, neuropathic pain for at least three months following a traumatic event such as an accident, surgery, amputation or a nerve injury and have a pain score greater than or equal to 4 on an 11-point scale. Patients remained on existing treatments during the study.

Patients were asked to measure their pain on a scale of zero to 10; the average baseline scores for study participants were 6.0 in the pregabalin group and 6.3 in the placebo group on this 11-point scale. A score of 4.0 to 7.0 is considered moderate pain and a score of greater than 7.0 is considered severe pain.

The primary endpoint was the difference in average self-reported pain score at the study’s conclusion between patients treated with Lyrica and placebo. Secondary endpoints included the effects of Lyrica compared to placebo on co-morbid symptoms of post-traumatic peripheral neuropathic pain including anxiety, patients’ self-reported pain-related sleep and patients’ self-reported overall improvements.

The most common side effects in the study versus placebo were dizziness (43.3 percent vs. 9.4%) and somnolence (15.7 percent vs. 6.3%), followed by headache (11.8 percent vs. 11.0%), fatigue (11.8 percent vs. 7.9%) and dry mouth (11.0 percent vs. 4.7%). The study was funded by Pfizer Inc.

About Lyrica

In the United States, Lyrica is approved for the management of fibromyalgia. Lyrica is also indicated for the management of painful diabetic peripheral neuropathy, postherpetic neuralgia (pain after shingles), and for the adjunctive treatment of partial onset seizures (a type of epilepsy) in adults.

Outside of the United States, Lyrica is indicated in adults for the management of peripheral and central neuropathic pain (NeP), treatment of generalized anxiety disorder, and adjunctive therapy for partial seizures with or without secondary generalization.

Important Safety Information

Treatment with Lyrica may cause dizziness, somnolence, peripheral edema or blurred vision. Other most common adverse reactions include dry mouth, weight gain, constipation, euphoric mood, balance disorder, increased appetite and thinking abnormally. There have been post-marketing reports of angioedema and hypersensitivity.

Pfizer Inc: Working together for a healthier world™

Founded in 1849, Pfizer is the world’s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, more than 80,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Contacts Pfizer Inc
Media:
Sally Beatty, 212-733-6566

Investor:
Jennifer Davis, 212-733-0717
Permalink: http://www.businesswire.com/news/home/20090429006303/en

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Still no treatment in Europe for the 14 million FMS patients trapped in pain!

From the FMS Global News Desk of Jeanne Hambleton (UK)

Press Release from ENFA – 29.04.2009

Brussels, (29.04.2009)

Last week was high on activities for the Fibromyalgia community, on one hand the European Network of Fibromyalgia Associations (ENFA) met with the European Health Commissioner Ms Androulla Vassiliou1. And on the other hand the European Medicines Agency (EMEA) gave another negative decision for a treatment for fibromyalgia in Europe2.

Ms. Pam Stewart, Vice-President of European Network of Fibromyalgia Associations (ENFA) and chairman of the trustees of Fibromyalgia Association UK, said one of the biggest challenges that the patients have been facing is the lack of officially recognised medical treatment options in the European Union.

By comparison there are three drugs in the United States of America approved by the Food and Drug Administration: Cymbalta from Eli Lilly, Lyrica from Pfizer and recently authorised Savella from Forest and Cypress (Pierre Fabre).

Last October, Cymbalta received a negative decision from the EMEA and last week was the turn of Lyrica said Ms Stewart. One dossier is still remaining to be evaluated by the EMEA: Savella. Each of these drugs has a limited success and judged alone leads to their failure to get approval.

However with a full range of treatment options, more people with fibromyalgia could have reduced levels of pain. This could enable them to embark on a management programme to significantly improve their quality of life said the Vice President.

“We are constantly hearing from people diagnosed with fibromyalgia that their doctor tells them there is no treatment because no approved guidelines or medications are available. Medical professionals that do not have time to research treatment options should have clearly signposted guidelines for effective treatment options. No one should be sentenced to a life of pain, she said.

“Patients across Europe are currently using these medicines off label. However, the European Medicines Agency told European Network of Fibromyalgia Associations that this is a common situation already faced in other disease areas such as cancer, and the situation with off label use cannot be taken into consideration in the assessment of medicines for which a marketing authorisation is sought.

“The difference with Fibromyalgia is that patients in the UK, for example, are unlikely to be prescribed any of these effective drugs because they have not been officially approved for Fibromyalgia. Patients are left with inadequate treatment options and although these drugs can be purchased over the Internet, this means their use is not monitored and people could be at the mercy of unscrupulous suppliers, which could put their lives at risk,” said Ms. Stewart.

Another example, coming from Germany, concerns the social status of patients since they are labeled as “depressive patient” for their life insurance or health insurance in order to have their drugs fully reimbursed by the National Health Insurance. In order to get any effective medicines, doctors should not diagnose fibromyalgia at all because the medicines are not indicated for fibromyalgia.

At the same time, an ENFA delegation was meeting with the European Health Commissioner Ms. Vassiliou. The meeting was only a natural step, concluding ENFA’s activities on the ‘European Institutions Fibromyalgia Awareness Campaign’ launched in 2008 on World Fibromyalgia Day.

Since the commencement of the campaign last May, with the support from 418 Members of the European Parliament, the Written Declaration on Fibromyalgia was adopted by the European Parliament in December 2008. The written declaration was necessary to raise awareness to all the European politicians from the 27 member states. It also helps create a mapping of the disease status disparity across Europe and increase awareness of better diagnosis and treatment.

“However, we realised that without any officially approved treatment options available, it was almost impossible to properly raise awareness of Fibromyalgia. The patient petition with over 27,000 signatures from all over Europe that MEP Adamou voluntarily hand delivered to the Health Commissioner, clearly demonstrates the frustration from the fibromyalgia community and strong and urgent needs to have treatment options to be officially available. The Fibromyalgia community is left with one hope to see maybe Savella drug approved before the summer. But unfortunately, the hope for a multiple choice of treatment in Europe seems to be lost.

“The European Network of Fibromyalgia Associations and all its associations have for years raised awareness on Fibromyalgia among national and European politicians, health professionals and the general public, and will keep on being active as long as it is necessary,” the Vice President.

About ENFA

ENFA is a network of patient association and support groups working in close consultation with the national association in the relevant country. Our joint missions are to conquer the myths and misunderstandings around Fibromyalgia. The network will help collectively push forward the boundaries which currently exist in understanding, experiencing and treatment of Fibromyalgia. Our main goal is to see Fibromyalgia receiving the recognition it deserves across Europe as an illness in its own right.

About Fibromyalgia

Fibromyalgia is a complex disease with chronic widespread pain as the defining symptom and various additional symptoms including fatigue, non-restorative sleep, morning stiffness, irritable bowel and bladder, restless legs, depression, anxiety and cognitive dysfunction often referred to as “fibro fog.” All of these symptoms cause serious limitations in patients’ ability to perform ordinary daily chores and work and severely affect their quality of life. Fibromyalgia imposes a large economic burden on society as well as on affected individuals. A study shows that an average patient in Europe consults up to 7 physicians and takes multiple medications over 5-7 years before receiving the correct diagnosis. The debilitating symptoms often result in lost work days, lost income and disability payments.

In fact, a Dutch study in 2005 estimated that the average annual cost of fibromyalgia was €980 million in the Netherlands. Research in the UK has shown that diagnosis and positive management of Fibromyalgia reduce healthcare cost by avoiding unnecessary investigations and consultations.

For more information on the European Network of Fibromyalgia Associations (ENFA) contact Ms. Pam Stewart Vice-President of ENFA Brussels@enfa-europe.eu; http://www.enfa-europe.eu.
1 On Wednesday 22 April in Strasbourg, for more information visit http://www.enfa-europe.eu; 2 On Thursday 23 April in London, for more information visit http://www.emea.europa.eu

MD accused of falsifying findings in 21 important pain-drug studies

From the FMS Global News Desk of Jeanne Hambleton
Without prejudice
Courtesy of ProHealth.com
March 16, 2009

Apparently, the medical community was “universally hoodwinked” by the highly respected, influential, and much-published pain drug researcher, Dr. Scott Reuben, who has reportedly admitted making up “some or all” of the data in at least 21 important studies between 1996 and 2008. Now, researchers in the field say, they will be re-examining the literature and may need to repeat certain clinical trials.

These were studies supporting the safety and ‘benefits’ of such drugs as Pfizer Inc.’s Bextra, Celebrex, and the Fibromyalgia drug Lyrica; Merck’s Vioxx; and Wyeth’s antidepressant Effexor, which Reuben’s studies reported could also be used for pain.

While the others maintain their FDA-approved status, Bextra and Vioxx (both Cox-2 inhibitors) became infamous when they were pulled off the market after evidence mounted that they increased patient risk of stroke, heart attack, and death.

An anesthesiologist specializing in post-surgical pain relief at Baystate Medical Center in Springfield, Massachusetts, Dr. Reuben was put on leave of absence after the hospital’s internal review board reportedly ascertained in a routine review that they had not approved some of his research. Their subsequent investigation revealed the extent of his allegedly unsubstantiated publications.

Journals which have retracted at least 13 of Dr. Reuben’s published studies so far include Anesthesia and Analgesia, and Anesthesiology. They have emphasized that Dr. Reuben’s co-authors on the papers have not been accused of wrongdoing, according to Anesthesiology News, which broke the story on March 4.
(http://www.anesthesiologynews.com/index.asp?ses=ogst&section_id=3&show=dept&article_id=12634)

“The retracted studies are not expected to affect the drugs’ regulatory status because Dr. Reuben’s studies were not part of the packages that manufacturers submitted to the FDA or European authorities,” according to a New York Times report on the situation dated March 11.

Nevertheless, some hospitals, including University of Pittsburgh Medical Center, say they are reviewing their pain treatment protocols and conducting their own studies to verify the effectiveness of drugs that Dr. Reuben has reported on.

To review a listing of articles that Baystate allegedly “found were based on fabricated data,” compiled by Anesthesia and Analgesia, log on to http://www.aaeditor.org/HWP/Retraction.Notice.pdf

(http://www.prohealth.com/library/showarticle.cfm?libid=14403)

Is gabapentin (Neurontin) an effective fibromyalgia treatment?

From the FMS News Desk of Jeanne Hambleton

Courtesy of MayoClinic.com

Gabapentin (Neurontin), an anti-seizure medication, may be an effective fibromyalgia treatment.

In a 12-week study, published in April 2007, researchers looked at the potential treatment benefits of gabapentin in a group of 150 people with fibromyalgia. Participants who were treated with gabapentin reported less pain and fatigue and improved sleep compared with participants who received a placebo. The most common side effects of the medication are dizziness and drowsiness.

It is important to note that gabapentin has not been approved by the Food and Drug Administration (FDA) for the treatment of fibromyalgia. However, some doctors may prescribe it off-label for such use.

In June 2007, the FDA did approve pregabalin (Lyrica) — an anti-seizure medication that is structurally related to gabapentin — for fibromyalgia treatment. A study published in April 2005 suggested that pregabalin is more effective than is a placebo in reducing pain and fatigue and improving sleep in people with fibromyalgia. The most common side effects of pregabalin are dizziness and drowsiness.

If you have fibromyalgia and have questions about whether gabapentin or pregabalin may be an appropriate treatment for you, consult your doctor.

(http://www.mayoclinic.com/health/fibromyalgia-treatment/AN01650)

FIBROMYALGIA AND PFIZER

From the Fibromyalgia (FMS) Global News Desk of Jeanne Hambleton

Pfizer, the manufacturers of Lyrica, the first fibromyalgia drug to be approved by the American Food & Drugs Associations (FDA), have decided to end human testing on a late-stage experimental drug, esreboxetine, which may have improved the cognitive function of patients with fibromyalgia. A second drug also to be withdrawn from the testing programme is associated with general anxiety problems. Both of these conditions are among the many symptoms of fibromyalgia.

The company announced it would stop further testing on these experimental primary care medications, now in the late stages of development, as they were other drugs available to treat these conditions.

The decision follows a move to ‘shift funding’ to alternative experimental drugs that have a greater profile.

The Wall Street Journal website, (http://blogs.wsj.com/health/2009/02/24/pfizer-drops-two-drugs-from-late-stage-pipeline/trackback/) overnight, on February 24, 2009, announced Pfizer Drops Two Drugs from Late-Stage Pipeline.

Sarah Rubenstein wrote two drugs in Pfizer’s late-stage pipeline are biting the dust.

The company said today it is ending development of esreboxetine, for fibromyalgia, and a drug known as PD 332,334, for generalized anxiety disorder.

In announcing the decision, Pfizer made a between-the-lines reference to the increasing pressure from insurers and regulators on the drug industry to pour research resources into products that make a real difference for people’s health rather than just add on to crowded categories. The economic-stimulus bill, for instance, offers up $1.1 billion for research comparing drugs and other treatments to each other.

Based on the data on the two drugs, “along with current market dynamics,” Pfizer said, “it was considered unlikely that either compound would provide meaningful benefit to patients beyond the current standard of care.” It added that safety was not the issue.

That said, there are not a lot of drugs on the market for fibromyalgia: Pfizer’s Lyrica was the first to win approval for fibromyalgia, and Lilly’s Cymbalta got the nod too. But fibromyalgia, a condition characterized by long-standing pain, has been the subject of controversy over its legitimacy, despite being recognized as a disease by the FDA and insurers.

Pfizer said today it is still seeking approval for Lyrica for generalized anxiety disorder, despite the demise of PD 332,334. In this case, though, there is a lot out there. The Mayo Clinic lists a bunch of drugs used for the disorder, including Cymbalta and Forest Labs’ Lexapro and generic versions of Lilly’s Prozac and GlaxoSmithKline’s Paxil.

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Do You Have Fibromyalgia? Drug Company Hopes So

From the FMS Global News Desk of Jeanne Hambleton

Wednesday, 18 February 2009, Columnist – Martha Rosenberg

Even as new reports surface about alleged fake medical articles Pfizer planted to sell seizure drug Neurontin for unapproved uses from 1995 to 2002, it looks like deja vu all over again.

Pfizer gave nonprofits $2.1 million in grants in 2008 for medical courses about the pain-and-fatigue ailment fibromyalgia for which its Neurontin follow-up pill, Lyrica, just happens to be approved.

Lyrica (pregablin), facetiously called Son of Neurontin at Pfizer, was discovered by Northwestern University chemist Richard Silverman in 1989, earning the university a cool $700 million when it sold royalties in late 2007.

It is funding the $100 million Richard and Barbara Silverman Hall for Molecular Therapeutics & Diagnostics, under construction now, which will employ 245 faculty, staff and research assistants and hopefully lead to other promising molecules.

Like Neurontin (gabapentin), Lyrica (Pregablin) is an antiepilepsy drug (AED) that modulates calcium channels to dampen the excitability of nerve endings and seizure activity. And, like Neurontin which made $3 billion a year from unapproved uses like bipolar disorder, attention deficit disorder and restless legs syndrome, Pfizer has high hopes for its “crossover appeal.”

Lyrica was approved in 2006 for partial onset seizures and nerve pain associated with diabetes and shingles. But the FDA’s approval of Lyrica as the first drug for fibromyalgia in 2007 is what kicked sales up 37 percent in the third quarter to $465 million.

Fibromyalgia, with no clear cause, blood test, definition or cure “is almost a textbook definition of an unmet medical need,” enthused Pfizer VP Ian Read in a conference call to analysts when the drug first launched.

No kidding! Datamonitor predicts the fibro market can be “grown” from $400 million to $2 billion thanks to all the people who do not know they have it yet.

And even before the name Lyrica appeared, Pfizer’s initial “unbranded” campaign of public service announcements in conjunction with the National Fibromyalgia Association–are you listening broadcast executives? PSAs?– that featured people describing their symptoms and hawking the web site http://www.fibrohope.org moved script big time.

(Think Merck’s “unbranded” HPV vaccine Gardasil campaign.)

Despite a temporary Lyrica scare in 2001 when Pfizer had to freeze patient trials because mice developed cancerous tumors–luckily the rats did not–Lyrica was well received by the medical community.

Except they were all on the same team.

“Well tolerated,” said Pfizer paid doctors in Arthritis and Rheumatism in 2005.

“Proven efficacy” and “No new adverse events,” said Pfizer paid doctors in Drugs of Today in 2005 and 2007.

And, “Durability of effect for relieving FM pain,” said Pfizer paid doctors in the journal Pain in 2008.

Actual Lyrica users were less effusive, reporting memory loss, mental confusion, extreme weight gain, hair loss, impaired driving, disorientation, twitching and even two deaths on askapatient.com. And the FDA added suicide warnings to all AEDs in 2008.

Nor is the bad press over for Pfizer. The News Tribune reported Pfizer reps made over 200 visits to Western State Hospital, a mental hospital in Tacoma, Washington, within four years – “That is where our customers are,” snapped then company spokesman Bryant Haskins – where 118 prescriptions for Pfizer’s controversial drug Geodon were ordered in just one day.

And after paying $430 million in 2004 to settle Neurontin criminal charges, it agreed to pay $2.3 billion just last month for improper marketing of its painkiller, Bextra which was so dangerous it was withdrawn in 2005. Who can say incorrigible?

Few even noticed the repeat offense as Pfizer acquired rival Wyeth at the same time whose Fen Phen and Premarin travail make Pfizer’s profile look like Sir Galahad’s.

Hopefully, when Pfizer adds social phobia and general anxiety to conditions Lyrica can treat, it will remember to add headache. It will need a lot for itself.

Martha Rosenberg is a columnist/cartoon who writes about public health.

Courtesy New Zealand’s Independent News Media
(http://www.scoop.co.nz/stories/HL0902/S00309.htm)

Drug makers’ push boosts ‘murky’ ailment – Part 2

From the FMS Global News Desk of Jeanne Hambleton
To the Editor of Associated Press and Business Writer Matthew Perrone

AP Associated Press IMPACT:
re: Drug makers’ push boosts ‘murky’ ailment -Washington on February 8 2009

Dear Sirs,

I read the article and then I was so angry wrote this….

Before I was told I had fibromyaliga I was an auxillary nurse and very active in everything I did. Then one day while at work I started feeling ill and my body hurt so badly, within a few hours it actually made me pass out. I was sent home and the next day felt so ill I booked an appointment to see the doctor.

The doctor sent me to the hospital and I had all sorts of tests even for Aids, all the tests and a lot of other things. The wait for some of them tests was so scarey and took a week – so it felt like forever. I have been pulled and pushed and then told I had a condition called fibromyalgia, of which I knew nothing. Then after that more things to try help sort the pain out…

I am going to now tell you what it feels like for me two have this. I am on a lot tablets including morphine. Some days i cannot walk down the stairs, let alone get back up them. I cannot bath on my own without my husband being there. My children have to finish brushing my hair sometime because my arms get heavier and heavier. That is my children doing this for their mum. It should be me looking after them.

Even with the silly pills I am in pain. Do you people think I like being like this? This pain I feel hurts so much it stops me from doing the things i love and used to love.

It is downgrading for me as a human being to be like this. Do you people not realise that most days I wonder why I just do not end my life as I cannot do the things I used to. Yeah that is what this makes me feel like saying right now.

I was so well and loved life until I got this condition. It is not right for people to say its NOT REAL WELL LET ME TELL YOU!!!! I would not even wish this on someone just so they experience the pain of someone with fibromyalgia; even just to get people to say, ‘Hey they are not lying. It is not in their head. Oh God, we are sorry it real pain these fibromites feel. Okay we are going to help.’

Do people like you not understand what it is like to be called a liar and told OH IT IS IN YOUR HEAD? Do you not know what it feels like for people to disbelive what we go through?

That article is so wrong, so very wrong. Instead of criticizing people with this condition why can’t someone create a bloody cure? Then I would love to go back to being pain free and looking after old people. I would love to go dancing and drinking and out with my children and play with my grandchild that is due in August.

Do you people not understand that when my grandchild born I might not even have the strength to hold that baby? Do you know how that feels? Do you not know how it feels being unable to hang your own washing out or finish cooking a meal or getting a drink? If this is not bad enough for us what about our families who have to see us struggling most of the time or when were having a bad day? What about them seeing the one they love in so much pain? My husband had to sit there watch as I scream with pain and begged him to help me but he does not know how? He has to carry me downstairs or upstairs just so I can use the toilet. Don’t you people understand that we do not like being like this? The pain is so bad sometimes. What do we have to do to make people understand and help us for God’s sake….

Donna Weetch of Portsmouth Hampshire UK.

Editor’s Note: We know we must endure the pain as there is no cure and no Government funding for research in the UK, but if only people understood, if only there was more public awareness- if only more GPs and doctors had been trained with knowledge of fibromyalgia – if only….

We will continue to try to move mountains, seek donations and raise funds for our own research programme and one day – I promise Donna – there will be a cure. Think positive. It can only get better.

If you, the readers, have any bright ideas or want to donate to our funds for research, write tome. Jeanne -fmsglobalnews@me.com

A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

A ‘Murky Business’ – Yes it is REAL

AP Associated Press IMPACT:

Drug makers’ push boosts ‘murky’ ailment

Collated by Jeanne Hambleton FMS Global News Desk ©2009        

 

Business Writer Matthew Perrone for AP: Associated Press has  “set the cat among the pigeons” with his reference to fibromyalgia and ‘murky ailments’. Posted in Washington on February 8 2009, this article has the promise of the same reaction given to the infamous IS DISEASE REAL article on fibromyalgia that appeared in the New York Times.

 

The  above story by NY Times reporter Alex Berenson published January 14, 2008 can be read at  <http://www.nytimes.com/2008/01/14/health/14pain.htmlem&ex=1200459600&en=bac45d5aff5a17d7&ei=5087> 

 

The members of the fibromyalgia community who are somewhat sensitive about questions suggesting FMS is an imaginary illness, has risen to the bait and letters are flocking in from around the USA where the article was published and in the UK, where it has been given coverage by FMS Global News.

 

Matthew Perrone, a business writer, suggests huge sums of money were provided by two drug companies last year in an endeavor to raise awareness of a “murky illness” as well as boost the sales of their medication recently approved by the Food & Drugs Association (FDA.). The writer claims the drug companies have been “drowning out unresolved questions” …. “whether it is a real disease at all”. 

 

Oooophs. That went down like a lead balloon.

 

Matthew Perrone discovered that the two drug companies, Pfizer and Eli Lilly, have in the first nine months of 2008 donated upward of $6 million towards educational events and to supporting non-profit making medical conferences. He claims this sum is greater than funds given to Alzheimer’s and diabetes. Top priority for funding by Pfizer was for cancer, AIDS and the fibromyalgia. Similarly Eli Lilly favoured cancer, depression and fibromyalgia.

 

While reminding readers that the cause for fibromyalgia still not known, with no specific test to confirm diagnosis, patients often showed overlapping symptoms with other neurological diseases. He claimed the specialists are in no doubt about the pain these patients suffer but they cannot agree how it should be treated and what illness it actually is.

 

It is believed by many patients and doctors, says Matthew Perrone, that the actions of the drug manufacturers are helping to solved the mysteries of fibromyalgia within the medical profession. He does acknowledge that patients with fibromyalgia say doctors often disbelieved them claiming the pains are imaginary or “all in your head.”

 

The article adds “critics say the companies are hyping fibromyalgia along with their treatments, and that the grant making is a textbook example of how drug makers unduly influence doctors and patients.”

 

Dr Frederick Wolfe, a member of the panel who helped to definite the criteria for fibromyalgia and adopt the name in 1990, suggests the drug companies are guilty of  “a little disease-mongering” to encourage patients to buy their medication. The business writer reports that the companies have been successful in the actions showing huge increases in sales and profits between 2007 and 2008 for Lyrica and Cymbalta –both approved for the treatment of fibromyalgia by the FDA. 

 

Responding to questions from the author the drug companies say their actions are “just the evolution of greater awareness” of a condition that has been poorly managed and neglected. 

 

The article includes the story of a patient taking both Cymbalta and Lyrica and three other medications. Describing her medicated condition as fibro fog she is quoted as saying she is so medicated she feels as though she is not here. Struggling to find money for her medication she claimed she is receiving free samples of Lyrica from the drug company representative to help her get through the month.

 

The article reports both drug companies spent of $125 million on advertising in the first nine months of 2008.

 

Grants from the drug companies are available for education for doctors, non-profit making groups and advocacy. Some of this money is used for research and patients outreach.

 

President of the USA National Fibromyalgia Association Lynne Matallana is quoted as saying lack funding would impact on patients’ care due to lack of money for medical education. Matthew Perrone claims that 40% of the funding for the $1.5 million a year Association’s operations is provided by corporate funds, like those given by Eli Lilly and Pfizer. Lynne Matallana who has fibromyalgia claimed she visited 37 doctors before being diagnosed.

 

In a Pfizer television commercial the drug company acknowledged fibromyalgia is real, but Matthew Perrone says the researchers report it is not that easy. The condition usually known as a syndrome, has been described as a disease, a collection of symptoms and even a behaviour disorder.

 

This description suggesting a behaviour disorder has caused some concern among the fibromyalgia community who insist it is not a mental disorder.

 

It is thought that up to 12million people in the USA may have fibromyalgia in the USA with a large percentage of them women.

 

Market research on behalf of the pharmaceutical industry indicated that possibly 50% of this number are not diagnosed said Dr. Daniel Clauw (University of Michigan).

 

Dr. Don Goldenberg (Tufts University) who has spent 30 years working with fibromyalgia claims it remains a “murky area”.  He said patients preferred to have a name for what ailed them.  It was suggested that while Dr. Goldenberg is a diagnosing patients he said a number of doctors no longer diagnosed FMS patients suggesting it is a “catchall covering a range of symptoms”.

 

A professor at the University of North Carolina Dr. Nortin Hadler believes identifying fibromyalgia can “doom” patients to endure suffering for the rest of their lifetime and just confirms to them that this is a condition with no cure.  Dr. Hadler said the likelihood for patients diagnosed with fibromyalgia improving was “pretty dismal”

 

His view was that fibromyalgia was not a medical disease but a psychological condition (‘having to do with the mind’). He believed therapy should be available instead of drugs and medication, to help patients “unlearn” their problem.

 

Dr. Clauw whose research has revealed patient’ brains reveal  “unusual activity” when suffering pain, confirms fibromyalgia is a legitimate disease and he had no time for experts who analyse definitions instead of helping patients.  He also agreed that the new drugs approved by the FDA do not work for all  patients.

 

This article is a summary of  a story published by AP Associated Press distributed by Google.  © 2009 The Associated Press. All rights reserved.

http://www.google.com/hostednews/ap/article/ALeqM5jZDQjkt1twJK_3GpRKJUbXZ_-oMwD967HPG81

 

Fibromyalgia is not ‘murky’ to millions of people who live with it

Letter to the Editor of CantonRep.com  Posted Feb 13, 2009 

 

I read with interest “Drug makers push boosts a ‘murky’ ailment” (Feb. 9). I am both a patient with fibromyalgia and a physician who specializes in this condition, so I find it incredible when the article refers to so-called experts who are skeptical that the diagnosis even exists and that drug makers are somehow responsible for perpetuating this condition. 



Fibromyalgia is not “murky” to the many millions of patients worldwide who have it, and to the thousands of doctors who diagnose and treat it. It is a real condition with its own insurance code, specific diagnostic criteria and proven helpful treatments. It is recognized by major medical and legal organizations, including the Food and Drug Administration. 



We have not found a cure yet, but ongoing research is necessary to help improve the quality of lives of those who suffer from this chronic disease. To date, the FDA has approved three medicines for treatment of fibromyalgia pain.

These so-called experts mentioned in the article do not believe fibromyalgia exists, thus they never diagnose or treat it. To me, no experience with this condition means no expertise. Fortunately for patients, there are many primary-care doctors and specialists  (in the USA) who understand, research and treat fibromyalgia: the true experts. 



Unlike the critics, these professionals have actual experience and skills in trying to improve lives affected by chronic pain and will prescribe approved medications, not blame drug makers or patients for the pain. The true experts may not be as vocal as the so-called experts, but their efforts to help those with fibromyalgia have spoken the loudest. 


MARK J. PELLEGRINO, M.D., 

JACKSON TOWNSHIP

Reproduced courtesy of CantonRep.com Connecting Stark County

(http://www.cantonrep.com/opinion/letters/x817675485/Fibromyalgia-isnt-murky-to-millions-of-people-who-live-with-it)

 

National Fibromyalgia Association’s Response to

AP Article on Drug Companies & Fibromyalgia

Fibromyalgia & CFS Blog Friday February 13, 2009

By Adrienne Dellwo, About.com Guide to Fibromyalgia & CFS

 

The inaccuracies of the recent AP report, Drug makers push boosts ‘murky’ illness, go even beyond what I pointed out in a recent blog. Here is the response from Lynne Matallana, president of the National Fibromyalgia Association:

“To the editors:

“The recent Associated Press story on fibromyalgia hardly qualifies as news; it merely regurgitates the same arguments that have been published in the past and offers the opinions of the same two men who have built careers out of drawing attention away from the hundreds of scientists who continue to make amazing scientific strides toward understanding the underlying cause(s) and pathophysiology of what fibromyalgia patients experience.

 

“By perpetuating this message, the article implies that it is more acceptable to debate names or labels for this “set of symptoms” and to point fingers at the usual “villains” (i.e.: pharma and the non-profits who accept money from them), than to focus on the millions of desperate patients who deserve to have a voice in the discussion.

 

“The fact is that credible medical institutions and organizations recognize fibromyalgia as a life-altering disease; the fact is that patients who suffer with FM depend on the medical system (including pharmaceutical companies) to help them inform the public that this is a very real illness and that they need treatments, including pharmaceutical agents, to help them get through each day and to look forward to some sort of quality of life in the future.

 

“This article misinforms readers in a way that undermines and victimizes innocent people. By telling only selective parts of the story the author is perpetuating misperceptions and making it difficult, if not impossible, for readers to grasp what is truly important: that we need to stop debating and pointing fingers and start asking why it is perceived as acceptable to stigmatize a patient population just because medical research has not yet provided us with all the information needed to understand that particular illness. Every illness seems to go through a stage of having to prove its legitimacy, but why should the patients be suspect during that phase of research?

 

“Why would AP print information that is simply not true – people with fibromyalgia are “more likely to have a history of mental illness and are economically disadvantaged?” That is totally false, as is the writer’s statement that the National Fibromyalgia Research Association received pharma money to fund Dr. Clauw’s functional MRI study. The money for all of the NFRA’s funded research came from the founder (the husband of a fibromyalgia patient), general donations, and revenue generated from a non-profit bingo game. (Yes, the FM community has had to rely on bingo games to fund our research!)

 

“How can we allow the system to fail millions of people whose only ‘fault’ is to have developed a devastating illness? Along with the rest of the fibromyalgia patient community, I look forward to the day when society (including the medical community, the media, and our government agencies) accepts the responsibility of treating fibromyalgia patients like any other group of chronically ill patients; when it is a given that fibromyalgia will be further studied, that treatments will be developed and made accessible to patients, that the media presents the facts rather than perpetuating threadbare controversies.

“Now that would be news worth printing.

“Sincerely,

“Lynne Matallana

President, National Fibromyalgia Association”

Courtesy About.com

http://chronicfatigue.about.com/b/2009/02/13/national-fibromyalgia-associations-response-to-ap-article-on-drug-companies-fibromyalgia.htm

 

A ‘Murky Business’. Yes it is REAL

http://fmsglobalnews.wordpress.com

 A FIBROMITE’S RESPONSE

 

To the Editor and Business Writer Matthew Perrone Associated Press (info@ap.org).

Dear Sirs,

It is with great distress that I have read the article that denies the existence of this truly horrible illness. I would like to stress firstly that I am not a previous sufferer of mental illness, although I am now being treated for depression, and I am from an economically secure background.

 

Just answer me one question, if this illness is all in my head, how come so many millions of us suffer from such similar symptoms. Are we transmitting then to each other telepathically? We do not suffer identical intensity of each symptom, some us have irritable bowel syndrome worse than others for instance, but we all suffer from unexplained severe pain, terrible tiredness and loss of the quality of our lives.

 

I, sir, am a qualified psychologist who for a long time thought I was going mad, especially as every test I had came back negative. To actually realise that the awful symptoms I was suffering were not a result of “being in my head” came as a great relief and if drug companies are making profits that can be used to find out what causes this and find a cure I say hallelujah!!!

 

Articles like this do nothing to help and indeed set us back and damage us immeasurably in our quest to be taken seriously and find a cure.

 

Yours in despair

Carolyn from Felpham, West Sussex. UK

 

 THE FIBROMYALGIA COMMUNITY RESPONDS

 TO ASSOCIATED PRESS ARTICLE

 

1. The Associated Press article by Matthew Perrone (February 8, 2009, “Drug makers’ push boosts ‘murky’ aliment) has drawn several comments.

Click here to read the article.

Click here to read the NFA’s response, as well as some comments by other readers.

To send a letter to AP business editor Kevin Noble or writer Matthew Perrone, email info@ap.org  (no attachments).

2. The NFA is in the process of contacting media outlets across the nation that published Mr. Perrone’s article. In addition to sharing the disappointment of the fibromyalgia community, our response provides accurate information about fibromyalgia, including the science behind fibromyalgia and the lack of research funding.

3. For a list of 10 ways to respond to negative and false Information about fibromyalgia, click here.

4. Several points made in the AP article were addressed by fibromyalgia experts on February 11, 2009 during a medical talk show produced by Patient Power. Guests included leading FM researcher Daniel Clauw, MD, professor of medicine in the Division of Rheumatology, University of Michigan Health System; Martha Beck, Ph.D., who has been diagnosed with fibromyalgia; and Lynne Matallana, president and founder of the National Fibromyalgia Association. Click here to listen.

5. The NFA has created two information sheets—the Fibromyalgia Fact Sheet and Recognition, Research and Science—for your reference and use in helping dispel misunderstandings about fibromyalgia.

Click here to view the Fibromyalgia Fact Sheet.

Click here to view an overview on Recognition, Research and Science.

6. In addition to a variety of articles about managing FM symptoms, overlapping conditions, and healthy lifestyle choices, the NFA’s 10-year anniversary issue (September-November 2007) includes a special section on the History of Fibromyalgia. Topics include:

The state of FM and how it has changed in the last 10 years

How changing perspectives on FM have impacted the specialties that focus on it  

How patients have succeeded in changing public perception of FM

The latest studies on medications commonly prescribed to treat FM. Click here 

 

Undermining the Validity of FM


Sharon Waldrop – Director, Fibromyalgia Association of Michigan USA

 

My name is Sharon Waldrop. I am the Founder and Director of the Fibromyalgia Association of Michigan, a volunteer nonprofit organization. I am a patient living with fibromyalgia (FM) and I am deeply disappointed in the article that ran yesterday in the Free Press copied off the AP. I am writing to you to ask if you would do a story on fibromyalgia to provide a balanced report on fibromyalgia? 

I am very sad that the millions of people who are suffering and struggling every minute of every day with fibromyalgia never get a chance to give their viewpoint in the media. Instead articles are written to please editors who have a formula that dictates what type of story “gets attention” and therefore gets printed …never taking into consideration or caring about the ramifications that their message will have on millions of innocent people.


The ramifications are that more marriages crumble, friendships (i.e. support systems) end, people lose jobs, people are denied access to care because the opinions of a select few are given mass attention. Credible medical institutions like Johns Hopkins University, the University of Michigan, the National Institutes of Health, (just to name a few), recognize fibromyalgia as a life-altering disease. It is time to treat FM patients with respect. Millions of people suffer from FM.  Millions more are suffering too as they watch their loved one struggle. These people do not need to read stories that FM is not real. They need to read stories about the exciting medical advances in fibromyalgia like the brain imaging study done at the University of Michigan that concretely prove people’s brains with FM act differently than people without FM. 

They need to be given hope and given the treatment they deserve as a human being.

My group has over 800 members in the Metro Detroit area.  We provide support and education to people affected by fibromyalgia.  People come to me in tears because they don’t know where to go for help. I am pleased that for 11 years I have given people a place to go – even if it is just for one night a month. No human being should have to fight an illness and also fight with spouses, friends, employers and yes, even doctors that they are in disabling physical pain. The question is not why do we continue to undermine the validity of FM but why are people afraid to provide support to people suffering from the chronic pain of fibromyalgia?
 In this time of uncertainty in the world, people more than ever need hope and help. Please will you write a story to help your readers understand FM? On behalf of my group we would greatly appreciate it.

 

Is Fibromyalgia Real?
 Andrew Schorr -
Founder Patient Power

We could have predicted it. Naysayers who say that now there are three approved prescriptions medicines for fibromyalgia, a chronic pain syndrome, marketing is fueling hype hype about a condition some people say is all in a patient’s head.

Here we go again. The drug companies are always an easy target. When a drug is a success it can bring in more than a billion dollars a year. Treatments are costly and many people, including millions with no insurance or who are under insured, struggle to pay for them. So the pharmaceutical industry continues to have a public relations problem.

But none of that has anything to do with whether people, primarily women, are suffering with debilitating pain, pain that is effectively treated often by the approved medicines.

Critics including some doctors say that because there is no definitive test for fibromyalgia it is a disservice to rush to treatment with the new drugs when maybe some patients need psychotherapy instead. It is in the patient’s head.

I am not qualified to evaluate who needs the medicines and who does not. But I do know this: the FDA advisory panels and the FDA itself would not have approved the medicines, nor would the drug companies have invested hundreds of millions of dollars on clinic trials, if they had no effectiveness.

After approval the drug companies have hit the airwaves with television commercials and with websites trying to raises awareness for the condition and that there are approved treatments. They also have been funding education programs to connect rheumatologists, who know all about fibromyalgia, with many primary care doctors who don’t. And they are funding patient education in partnership with groups like the National Fibromyalgia Association, founded by a patient and an organization that has cried out for awareness and effective treatments for years.

Is this public and medical education effort a bad thing?

Some media reports suggest it is: getting doctors and the public in a tizzy about a phony or overused diagnosis fueled by greedy drug companies who want to make billions. Oh please! While one could argue such important issues should be debated, I think we should focus on how to help give suffering patients relief from their pain and celebrate that private industry has made huge investments to meet the need.

Do we need to sort out exactly who needs these treatments and who could benefit in other ways? Sure. But to cast the same old aspersions on the drug companies is unfair and if we keep skewering them one day we can kiss drug development goodbye. The next time you swallow a pill that helps, you ask yourself what the world would be like if no one invented or marketed products like that.

 

FIBROMYALGIA Painfully Real 

Frederic Porcase Physician,

Jacksonville USA

 

Monday’s article demeans all of us with fibromyalgia.

The horrible part was the “Mind over Matter?” stating, “Patients diagnosed with fibromyalgia are more likely to have a history of mental illness, be overweight and economically disadvantaged. Some doctors say their suffering may stem from difficult circumstances rather than disease.”

I run a support group for people with fibromyalgia, and that is not the case. We are all type “A” personalities who have been forced to change our lives due to this horrible disease/syndrome.

All of us would give up our “great” disability funds for the more profitable lives we were living before the chronic pain and fatigue. We may be overweight now, due to not being able to exercise, but this was not the case before the chronic pain and fatigue started not after the diagnosis.

We all had the symptoms years before we actually got a diagnosis. No, we are not hypochondriacs. Fibromyalgia is an invisible disease. Thank goodness we don not look as bad as we feel. Walk in our shoes just one day and then say we have a mental disorder.

Courtesy Opinion.jacksonville/com

http://jacksonville.com/opinion/letters_from_readers/2009-02-11/story/letters_from_readers

 

Utterly real

Letters Published: Tue, Feb. 10, 2009 

Taryn Oesch – Raleigh USA

 

I was diagnosed with fibromyalgia when I was 13 by a Duke rheumatologist. It was a struggle to get back to feeling healthy, but it was a relief to know that I wasn’t imagining my achiness and debilitating fatigue. I have always considered myself fortunate to live in a time when fibromyalgia is considered a real syndrome.

The Feb. 9 Associated Press article “Help or hype? Drug makers fibromyalgia grants raise questions,” however, made me realize we still have a way to go.

Apparently, there are still those who would question the diagnosis, despite the fact that it has helped many people. It disturbed me especially that the article seemed to sympathize with the skeptics. Having a complaint of “I’m very tired” is hard enough to try to explain to professors or employers. 

The only press those of us with fibromyalgia need is press that makes everyone more aware that yes, fibromyalgia is real and yes, its diagnosis is backed by medical research.

 

 

Courtesy The News&Observer

http://www.newsobserver.com/opinion/letters/story/1401086.html

READERS: If you are writing to the Editor of Associated Press or the Business Writer Matthew Perrone, please send a copy of the email to me. I am interested and would like to publish your comments. Thanks. Please write to fmsglobalnews@me.com.Jeanne