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.
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From the FMS Global News Desk of Jeanne Hambleton (UK)
Low Doses of Drug for Alcoholics Helps Reduce Fibromyalgia Pain, New Research Finds
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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.
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From the FMS Global News Desk of Jeanne Hambleton (UK)
Fibromyalgia: Millions Are Spent To Educate the Public About a Mysterious Condition
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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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