Chewable Aspirin Is Best for the Heart

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

Courtesy WebMD.com

Study Shows Chewable Aspirin Is Absorbed More Quickly Than Solid Tablets

By Bill Hendrick – Reviewed by Elizabeth Klodas, MD, FACC – WebMD Health News

May 15, 2009 — Chewable aspirin is absorbed faster and is more effective than regular aspirin that is either swallowed whole or chewed and then swallowed, a new study shows.

This “seemingly quite simple finding” could lead to improvements in the care of heart attack patients, researchers say.

Sean Nordt, MD, of the University of California, San Diego, and colleagues, gave three different types of aspirin to 14 people between ages of 20 and 61. One group was given regular solid aspirin tablets and told to swallow the pills whole. Another was given regular aspirin tablets and told to chew the pills before swallowing. A third group was given chewable aspirin tablets, and swallowing occurred during chewing.

The researchers then measured levels of aspirin in the blood; researchers say the chewable aspirin consistently showed the greatest and fastest absorption rates.

The findings are being presented at the annual meeting of the Society for Academic Medicine in New Orleans.

Researchers say the study was done because current guidelines recommend chewing to increase absorption, but evidence that this is best is scant.

Thirteen of the 14 participants were men; the mean age was 31. Over the course of the study, each participant ingested each form of aspirin; 1,950 milligrams of aspirin (the equivalent of six regular aspirin tablets) was administered every time.

Measurements of blood showed clearly that aspirin was absorbed fastest when administered in chewable form and swallowed. “This supports the recommendation to use chewable [aspirin] formulation in the treatment of ACS,” the researchers say. ACS refers to “acute coronary syndrome,” the general medical term meaning heart attack or sudden onset of angina.

Current guidelines call for giving heart attack patients one aspirin tablet and for them to chew it to speed up its anti-blood-clotting properties.

Aspirin works within 15 minutes to prevent the formation of blood clots in people with known coronary artery disease. One adult-strength aspirin contains 325 milligrams. The current study suggests that 325 milligrams of chewable aspirin would be preferred in the setting of a heart attack or sudden onset of angina ( chest pain). However, aspirin should still be taken under these circumstances if the chewable form is unavailable.

Aspirin use in patients with heart disease is common. People with known coronary disease often are told to take a “baby” aspirin (81 milligrams) daily to reduce their risk of heart attack of stroke.

Heart Attacks and Heart Disease

More than 1 million Americans have heart attacks each year. A heart attack, or myocardial infarction (MI), is permanent damage to the heart muscle. “Myo” means muscle, “cardial” refers to the heart, and “infarction” means death of tissue due to lack of blood supply.

What Happens During a Heart Attack?

The heart muscle requires a constant supply of oxygen-rich blood to nourish it. The coronary arteries provide the heart with this critical blood supply. If you have coronary artery disease, those arteries become narrow and blood cannot flow as well as they should. Fatty matter, calcium, proteins, and inflammatory cells build up within the arteries to form plaques of different sizes. The plaque deposits are hard on the outside and soft and mushy on the inside.

When the plaque is hard, outer shell cracks (plaque rupture), platelets (disc-shaped particles in the blood that aid clotting) come to the area, and blood clots form around the plaque. If a blood clot totally blocks the artery, the heart muscle becomes “starved” for oxygen. Within a short time, death of heart muscle cells occurs, causing permanent damage. This is a heart attack.

While it is unusual, a heart attack can also be caused by a spasm of a coronary artery. During a coronary spasm, the coronary arteries restrict or spasm on and off, reducing blood supply to the heart muscle (ischemia). It may occur at rest and can even occur in people without significant coronary artery disease.

Each coronary artery supplies blood to a region of heart muscle. The amount of damage to the heart muscle depends on the size of the area supplied by the blocked artery and the time between injury and treatment.

Healing of the heart muscle begins soon after a heart attack and takes about eight weeks. Just like a skin wound, the heart’s wound heals and a scar will form in the damaged area. But, the new scar tissue does not contract or pump as well as healthy heart muscle tissue. So, the heart’s pumping ability is lessened after a heart attack. The amount of lost pumping ability depends on the size and location of the scar.

What Are the Symptoms of a Heart Attack?

Symptoms of a heart attack include:

Discomfort, pressure, heaviness, or pain in the chest, arm, or below the breastbone

Discomfort radiating to the back, jaw, throat, or arm

Fullness, indigestion, or choking feeling (may feel like heartburn)

Sweating, nausea, vomiting, or dizziness

Extreme weakness, anxiety, or shortness of breath

Rapid or irregular heartbeats

During a heart attack, symptoms last 30 minutes or longer and are not relieved by rest or oral drugs.

Some people have a heart attack without having any symptoms (a “silent” myocardial infarction). A silent MI can occur in any person, though it is more common among diabetics.

What Do I Do if I Have a Heart Attack?

Quick treatment to open the blocked artery is essential to lessen the amount of damage from a heart attack. At the first signs of a heart attack, call for emergency treatment (usually 911). The best time to treat a heart attack is within one to two hours of the first onset of symptoms. Waiting longer than that increases the damage to your heart and reduces your chance of survival.

Keep in mind that chest discomfort can be described many ways. It can occur in the chest or in the arms, back, or jaw. If you have symptoms, take notice. These are your heart disease warning signs. Seek medical care immediately.

How Is a Heart Attack Diagnosed?

To diagnose a heart attack, an emergency care team can ask you about your symptoms and begin to evaluate you. The diagnosis of the heart attack is based on your symptoms and test results. The goal of treatment is to treat you quickly and limit heart muscle damage.

Tests Taken to Diagnose a Heart Attack

ECG.
The ECG (also known as EKG or electrocardiogram) can tell how much damage has occurred to your heart muscle and where it has occurred. In addition, your heart rate and rhythm can be monitored.

Blood tests.
Blood may be drawn to measure levels of cardiac enzymes that indicate heart muscle damage. These enzymes are normally found inside the cells of your heart and are needed for their function. When your heart muscle cells are injured, their contents — including the enzymes — are released into your bloodstream. By measuring the levels of these enzymes, the doctor can determine the size of the heart attack and approximately when the heart attack started. Troponin levels will also be measured. Troponins are proteins found inside of heart cells that are released when they are damaged by ischemia. Troponins can detect very small heart attacks.

Echocardiography.
Echocardiography is an imaging test that can be used during and after a heart attack to learn how the heart is pumping and what areas are not pumping normally. The “echo” can also tell if any structures of the heart (valves, septum, etc.) have been injured during the heart attack.

Cardiac catheterization.
Cardiac catheterization, also called cardiac cath, may be used during the first hours of a heart attack if medications are not relieving the ischemia or symptoms. The cardiac cath can be used to directly visualize the blocked artery and help your doctor determine which procedure is needed to treat the blockage.

What Is the Treatment for a Heart Attack?

Once heart attack is diagnosed, treatment begins immediately — possibly in the ambulance or emergency room. Drugs and surgical procedures are used to treat a heart attack.

What Drugs Are Used to Treat a Heart Attack?

The goals of drug therapy are to break up or prevent blood clots, prevent platelets from gathering and sticking to the plaque, stabilize the plaque, and prevent further ischemia.

These medications must be given as soon as possible (within one to two hours from the start of your heart attack) to decrease the amount of heart damage. The longer the delay in starting these drugs, the more damage can occur and the less benefit they can provide.

Drugs used during a heart attack may include:

Aspirin to prevent blood clotting that may worsen the heart attack.

Antiplatelets to prevent blood clotting.

Thrombolytic therapy (“clot busters”) to dissolve any blood clots that are present in the heart’s arteries.
Any combination of the above

Other drugs, given during or after a heart attack, lessen your heart’s work, improve the functioning of the heart, widen or dilate your blood vessels, decrease your pain, and guard against any life-threatening heart rhythms.

Are There Other Treatment Options for a Heart Attack?

During or shortly after a heart attack, you may go to the cardiac cath lab for direct evaluation of the status of your heart, arteries, and the amount of heart damage. In some cases, procedures (such as angioplasty or stents) are used to open up your narrowed or blocked arteries.

If necessary, bypass surgery may be performed to restore the heart muscle’s supply of blood.

Treatments (medications, open heart surgery, and interventional procedures, like angioplasty) do not cure coronary artery disease. Having had a heart attack or treatment does not mean you will never have another heart attack; it can happen again. But, there are several steps you can take to prevent further attacks.

How Are Subsequent Heart Attacks Prevented?

The goal after your heart attack is to keep your heart healthy and reduce your risks of having another heart attack. Your best bet to ward off future attacks are to take your medications, change your lifestyle, and see you doctor for regular heart checkups.

Why Do I Need to Take Drugs After a Heart Attack?

Drugs are prescribed after a heart attack to:

Prevent future blood clots.

Lessen the work of your heart and improve your heart’s performance and recovery.

Prevent plaques by lowering cholesterol.

Other drugs may be prescribed if needed. These include medications to treat irregular heartbeats, lower blood pressure, control angina, and treat heart failure.

It is important to know the names of your medications, what they are used for, and how often and at what times you need to take them. Your doctor or nurse should review your medications with you. Keep a list of your medications and bring them to each of your doctor visits. If you have questions about, ask your doctor or pharmacist.

What Lifestyle Changes Are Needed After a Heart Attack?

There is no cure for coronary artery disease. In order to prevent the progression of heart disease and another heart attack, you must follow your doctor’s advice and make necessary lifestyle changes. You can stop smoking, lower your blood cholesterol, control your diabetes and high blood pressure, follow an exercise plan, maintain an ideal body weight, and control stress.

When Will I See My Doctor Again After I Leave the Hospital?

Make a doctor’s appointment for four to six weeks after you leave the hospital following a heart attack. Your doctor will want to check the progress of your recovery. Your doctor may ask you to undergo diagnostic tests (such as an exercise stress test at regular intervals). These tests can help your doctor diagnose the presence or progression of blockages in your coronary arteries and plan treatment.

Call your doctor sooner if you have symptoms such as chest pain that becomes more frequent, increases in intensity, lasts longer, or spreads to other areas; shortness of breath, especially at rest; dizziness, or irregular heartbeats.

(©2005-2009 WebMD, LLC. All rights reserved – http://www.webmd.com/heart-disease/news/20090515/chewable-aspirin-is-best-for-the-heart?ecd=wnl_cbp_052109&em=amVhbm5laGFtYmxldG9uQG1hYy5jb20=

http://www.webmd.com/heart-disease/guide/heart_disease_heart_attacks)

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Back Pain – Medication and Addiction

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

Courtesy of WebMD.com

How can we balance the risk of drug abuse with the suffering caused by untreated back pain?

By R. Morgan Griffin – Reviewed by Brunilda Nazario, MD – WebMD Feature

People living with serious back pain have to sort through a lot of mixed messages about opioid — or narcotic — painkillers.

On the one hand, you have heard stories about the seeming epidemic of addiction to these drugs, like OxyContin, Percocet, and Vicodin. All those celebrities checking into rehab for painkiller addiction may give you the impression that the lure of these drugs is irresistible, that we are all just a few pills away from addiction.

But on the other hand, you might have heard that pain is chronically undertreated and many people are suffering needlessly. Which is true?

“They’re both true,” says Lynn Webster MD, medical director at the Lifetree Clinical Research and Pain Clinic in Salt Lake City. “In this country, we undertreat pain and we underutilize opioid painkillers. But we have also had a serious increase in the misuse and abuse of these drugs.”

This leaves many people with chronic back pain — and often their doctors — stuck in the middle. On the one hand, people are afraid of the risks of drug abuse and addiction that come with powerful painkillers. On the other, they are suffering from severe and debilitating pain and need some kind of help.

Opioid medicines can save lives. But they can destroy them too. What is an average person with severe back pain supposed to do?

Who Needs Opioid Painkillers?

Here is one piece of good news: most people with back pain do not need these powerful painkillers to begin with.

Many with back pain often just use non-addictive medications like Tylenol or nonsteroidal anti-inflammatory drugs (NSAIDs). Some NSAIDs are sold over the counter, like Motrin or Advil, and others are sold by prescription. Steroids can also be prescribed for back pain due to swelling and inflammation. These drugs do have some risks of their own, but the potential for addiction is not among them.

Even when powerful opioids like Percocet and Vicodin are necessary, many people only need them in the short term. After an acute back injury or surgery, many just use these drugs to ease the pain enough that they can start moving around and begin physical therapy.

But sometimes, the back pain lingers. Chronic back pain can sometimes develop as a result of arthritis or injuries that cannot be corrected surgically. In the small percentage of people with chronic and hard-to-treat back pain, a doctor may recommend long-term opioid therapy. Others may get opioid therapy if the side effects of other painkillers — like NSAIDs — are too risky.

While some patients and doctors swear by opioids as a treatment for severe chronic back pain, the evidence is not all that strong. One 2007 review in the Annals of Internal Medicine found that while opioids do help with short-term back pain, it is not clear that they help with chronic back pain. A 2007 Cochrane Review found that opioids may not work any better than an NSAID for chronic lower back pain.

How Big Is the Opioid Abuse Problem?

Prescription narcotic abuse is a serious issue, says Jim Zacny, PhD, a professor in the department of anesthesia and critical care at the University of Chicago. He points to the 2007 National Survey on Drug Use and Health. It found that as many as 5.2 million people reported using prescription opioids in the last month for non-medical reasons. That is more than double the number of people who used cocaine.

But many of the people illicitly using these drugs are not in pain. So the important question is this: how high is the risk of abuse for someone living with serious back pain?

There is some good news: the risks of actual addiction may be lower than assumed. “Among people with legitimate pain issues, it is a very small group who actually develop the disease of addiction,” says Webster.

Zacny agrees. “There is this myth out there that if you take an opiate, you automatically become enslaved to it,” he says. “That is not the truth at all.”

However, addiction is not the only issue. Webster observes that a much larger number of these people — perhaps 20%-30% — do wind up misusing or abusing the drug.

Opioid Addiction vs. Abuse

What is the distinction between drug addiction and drug abuse? Many people with real back pain are not addicted, but they begin to use their medication incorrectly. They might take too much, simply because the prescribed dose does not seem to be helping enough. Or they might use their medication to cope in other ways.

“People with pain sometimes take pain medicine inappropriately to feel a little high or improve their mood,” says Karen Miotto, MD, an addiction psychiatrist at the UCLA Neuropsychiatric Institute. “They might take one after a fight with a spouse or a hard day at work.”

Some people with chronic pain also have issues like anxiety and depression. They might start leaning on their pain medication to help them with these conditions too.

While we tend to focus on addiction, misuse and abuse can also be dangerous. Opioids are powerful drugs with real risks.

“In the last three to five years, we have seen a significant increase in the number of unintentional overdose deaths caused by prescription painkillers,” Webster tells WebMD. “At least half of them are in people who have legitimate pain problems with legitimate prescriptions.” Taking these drugs in ways your doctor did not intend simply is not safe.

“Our culture encourages the attitude that if one pill is good, two is better,” Webster says. “With opioids, that can be lethal.”

What Increases the Risk of Drug Addiction and Abuse?

The risks of drug addiction and abuse do not seem to be the same for everyone.

“It is not the pills alone that make an addiction,” Miotto says. She points out that addiction develops from a number of physiological, psychological, genetic, and social factors. A personal history of substance abuse also seems to increase the risk.

Mixing drugs also increases the risk of problems. “If you are taking your pain medicine along with other prescription drugs, you ratchet up the risk of addiction enormously,” says Miotto.

Webster says that pain itself is a risk factor: the greater the severity of the pain, the higher the risk of drug abuse and addiction. “After years of living with severe chronic pain, people will do anything to get rid of it,” he tells WebMD.

The Effects of Addiction and Abuse

Miotto says that drug addiction may seem to start innocently. A person might just occasionally call in a prescription early, or take a spouse’s medication as well as their own. “These behaviors can creep up on people slowly and then, all of a sudden, they have a physical dependency,” says Miotto.

The problem is that people who have a prescription drug addiction do not realize it. “Addiction is a disease of denial,” Miotto says. “It can take years before people realize what is happening to them.”

It pushes people to horrible extremes. Miotto knows one patient who eventually admitted that she pushed for surgery solely because she wanted the opioid painkillers she knew she would get afterward.

There is also another dimension to prescription drug abuse you should consider. Even if you do not abuse the opioid pills you have been prescribed, someone else could.

“A lot of the opioids that get used illicitly — especially by adolescents — come from the medicine cabinets of people who were prescribed the drug for legitimate pain,” says Webster. “People need to understand the potential harm that they can do to communities if these medications are not properly secured.”

Doctor vs. Patient

In part because of the stigma of prescription drug addiction, chronic back pain can sour even the best doctor-patient relationships. The patient can become frustrated by the doctor’s inability to cure his or her pain. Meanwhile, the doctor may become suspicious of someone who is always demanding refills of powerful opioids.

“Doctors are getting sued from both ends,” says Miotto. Some have been sued for providing opioid painkillers that lead to addiction; others get sued for not prescribing them to relieve debilitating pain.

People with a past history of addiction face the most skepticism from their doctors.

“I hate to say it, but when people walk in to the doctor and mention an addiction history, they may not be able to get these painkillers,” says Miotto. “The doctor may just not trust them.”

Alternatives to Opioids for Back Pain

Miotto says that some people with serious pain become too focused on opioids. They come to believe that opioids are the only thing that will help. But sometimes, you need to take a step back.

“If you keep increasing your dose of opioid pain medication but pain is still an 8 or 9 out of 10, it is time to shift gears and try something else,” says Miotto. She points out that at high doses, opioid painkillers can actually make your pain worse — a condition called opiate-induced hyperalgesia.

In addition to NSAIDs and other drug treatments, there are non-drug options for coping with chronic pain. Physical therapy can be invaluable. Miotto notes that treatments like massage, water therapy, and biofeedback can make a big difference with chronic pain. Unfortunately, it can be hard to get insurance to cover these sorts of treatments, Miotto says.

It is also important to treat any other conditions that might be exacerbating your pain. For instance, experts say that many people with chronic pain also struggle with depression and anxiety. “People who feel an increased amount of anxiety also feel an increased amount of pain,” says Webster. Even those who do not have diagnosed psychological condition can benefit from support groups or therapy.

Of course, some with chronic pain will bristle at that suggestion. They believe that it implies that the horrible pain they feel is “all in their heads.”

But Miotto says that is not the case at all.

“Severe, chronic pain makes life terribly difficult,” Miotto tells WebMD. “Therapy is just another helpful tool in getting people to cope better.”

Using Opioids Safely

Clearly, there is no simple advice when it comes to balancing the benefits and risks of opioids for back pain. But if you and your doctor decide to use these medicines, here are some tips for taking them safely.

Follow your doctor’s prescription precisely. Never double up a dose. Never take your medicine for any symptom besides pain.

Find a specialist. Dealing with chronic pain is complicated. Your regular doctor may not be comfortable handing out long-term prescriptions for opioids. So seek out a specialist in pain management or, better yet, a pain management center. This is essential for people who have a past history of substance abuse.

Do not mix opioids with other drugs. If you already use prescription or over-the counter drugs, supplements, or alternative medicines, make sure your doctor knows about every single one. Ask about the safety of using your opioid painkillers with alcohol.

Sign a pain agreement. These documents help build trust between a doctor and patient. A patient might promise to use the medication as instructed and, in some cases, agree to regular drug testing. In return, the doctor agrees to prescribe opioid pain relievers as part of the treatment plan.

Take a screener. Experts now recommend that doctors use screeners — a short series of questions — that help them identify people who might be at higher risk of opioid abuse. Like pain agreements, they help build trust between patients and doctors.

Ask about alternatives. Talk to your doctor about other ways you could reduce your back pain. Might non-opioid medicines help? What about surgery? Or non-traditional treatments like massage or relaxation?

Get support. Consider seeing a therapist or joining a support group for people with back pain.

Keep your medication in a safe place. Remember that it is not only the person in pain who is at risk of abusing opioids. So be careful. Do not keep your medicine where other people — your children, grandchildren, friends, or neighbors — can get to it.

Finally, the most important way to assure that you are using your medicine safely is to have a trusting and open relationship with your doctor.

“Anyone with chronic pain needs to find a physician who is compassionate and understanding,” says Webster. Trust between a doctor and patient is the basis of any good pain management.

(©2005-2009 WebMD, LLC. All rights reserved.

http://www.webmd.com/back-pain/features/back-pain-medication-addiction?ecd=wnl_cbp_052109&em=amVhbm5laGFtYmxldG9uQG1hYy5jb20=)

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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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FDA Requires Additional Labelling for Over-the-Counter Pain Relievers and Fever Reducers to Help Consumers Use Products Safely

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

Courtesy FDA US Food and Drugs Administration – For Immediate Release

The Food and Drug Administration issued a final rule today that requires manufacturers of over-the-counter (OTC) pain relievers and fever reducers to revise their labelling to include warnings about potential safety risks, such as internal bleeding and liver damage, associated with the use of these popular drugs.

Products covered by the FDA action include acetaminophen, and a class of drugs known as the nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs include aspirin, ibuprofen, naproxen, and ketoprofen. Acetaminophen is in a class by itself. The revised labeling applies to all OTC pain relievers and fever reducers, including those that contain one of these ingredients in combination with other ingredients, such as in cold medicines containing pain relievers or fever reducers.

“Acetaminophen and NSAIDs are commonly used drugs for both children and adults because they are effective in reducing fevers and relieving minor aches and pain, such as headaches and muscle aches, “ said Charles Ganley, M.D., director, FDA’s Office of Nonprescription Drugs in the Center for Drug Evaluation and Research.

“However, the risks associated with their use, need to be clearly identified on the label so that consumers taking these drugs are fully aware of the potential harm they can cause. It is important that they know how to take these medications safely to reduce their risk.”

Under the final rule, manufacturers must ensure that the active ingredients of these drugs are prominently displayed on the drug labels on both the packages and bottles. The labeling also must warn of the risks of stomach bleeding for NSAIDs and severe liver damage for acetaminophen.

Since 2006, some manufacturers have voluntarily revised their product labeling to identify these potential safety concerns. However, the voluntary changes to labelling do not address all of the labelling requirements in the new rule. For example, the new rule includes a warning on products containing acetaminophen that instructs consumers to ask a doctor before they are taking the blood thinning drug warfarin. The new rule requires all manufacturers to relabel their products within one year of April 28 2009.

Safety data reported in medical literature indicate that people sometimes take more acetaminophen than the labeling recommends. Others unknowingly take multiple products containing acetaminophen at the same time. Exceeding the recommended dosage of acetaminophen may increase the risks for severe liver damage. Alcohol use can also increase the risk of liver damage with acetaminophen.

The risk for stomach bleeding may increase in people who use NSAIDs and who are taking blood-thinning drugs (anticoagulants) or steroids. Stomach bleeding risks also increase for people who take multiple NSAIDs at the same time, or in people who take them longer than directed. Alcohol use can increase the risk for stomach bleeding with NSAIDs use.

An FDA Advisory Committee meeting will be convened on June 29 & 30, 2009, to discuss further steps the FDA could take to reduce the risk of liver damage associated with acetaminophen overdoses.

Source: FDA
OTC Pain Relievers – Acetaminophen: Tylenol & other Brands
NSAIDS – Aspirin: Bayer & other brands, Ibuprofen: Advil, Motrin & other brands. Naproxen: Aleve & other brands.

To read the final rule on the relabeling of OTC pain relievers and fever reducers, go to

http://edocket.access.gpo.gov/2009/pdf/E9-9684.pdf

To read the FR Notice announcing the FDA Advisory Committee meeting, see link below:

http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-9380.pdf

Consumer Inquiries: 888-INFO-FDA

(http://www.fda.gov/bbs/topics/NEWS/2009/NEW02004.html)

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
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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

Minister calls for pain indicators in QOF (Quality

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

Courtesy of PulseToday.com

By Nigel Praities -21 Apr 09

A Government minister has invited applications for new pain management indicators for the QOF in a parliamentary debate held yesterday.

Health minster Ann Keen said the inclusion of pain in the QOF was a ‘key issue’ and that she hoped organisations would submit proposed indicators for the next review.

The debate was proposed by Anne Begg MP, the chair of the recently formed All-Party Parliamentary Group on Chronic Pain, who said pain should be considered as a ‘vital sign’ for PCTs and incentivised through the QOF.

‘The inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first,’ she said.

Ms Begg also criticised the complete withdrawal of co-proxamol by the MHRA, and quoted figures revealed in Pulse earlier this year that showed an increase in morphine and tramadol prescriptions as a result of the withdrawal.

In response, Ann Keen said Ms Begg had made a ‘persuasive and eloquent case’ for pain indicators in the QOF and she hoped pressure groups, such as the Chronic Pain Policy Coalition – would press for its inclusion.

‘I understand that the next opportunity to submit suggestions for new indicators to NICE will be this summer. I hope that the chronic pain policy coalition will take the opportunity to suggest specific indicators at that stage,’ she said.

A spokesperson from the Chronic Pain Policy Coalition confirmed it would submit a proposal for new QOF indicators for the routine management and assessment of pain to NICE later this year.

‘Given the important role GPs have to play in the early identification, diagnosis and management of patients with pain, we strongly believe that this is an area in which greater incentivisation through inclusion within the QOF indicators would have a considerable positive impact,’ he said.

(http://www.pulsetoday.co.uk/story.asp?sectioncode=23&storycode=4122478&c=2&cid=pain042209#)

IN THE HOUSE OF COMMONS 20 April 09 (Hansard source/TheyWorkForYou.com)

In the House of Commons on April 20 MP Anne Begg spoke about the Pain Management Services (England) as reported by Hansard and TheyWorkForYou.com

She said, “In the United Kingdom, 7.8 million people live with pain, day in and day out; that is the equivalent of about one in seven people in every single parliamentary constituency. I have asked for this debate in order to draw attention both to their problems and, more importantly, to some solutions that would not only improve the quality of life of so many of our constituents, but also reduce public expenditure on health, social care and incapacity benefits.

“If anyone is wondering why I, as a Scottish MP, am raising the issue of pain management services in England when health is a devolved issue, it is because I am the chairman of the recently set up all-party group on chronic pain. I suppose I should also declare an interest: I am one of the 7.8 million people in the UK who live with chronic pain.

“There could not be a better opportunity to consider the problem and suggest solutions. People in pain and the health professionals helping them have been pushing at a closed door for many years now. They have argued for early recognition of the needs of people in pain, early access to expert advice and treatment, and referral to a specialist pain clinic when necessary. That door was closed until recently; suddenly, it looks as though it is opening, and I am grateful to the chief medical officer for beginning that process.

MAJOR INITIATIVE

“His latest annual report, only just published, includes a chapter called “Pain: breaking through the barrier”. Sir Liam Donaldson looks at the issue of people living with pain in a sensitive and comprehensive way, and concludes with this statement:’A major initiative to widen access to high-quality pain services would improve the lives of millions of people.’ “

Ms Begg also said, “The evidence suggests that although pain services do exist in most secondary care NHS trusts, they are patchy, and variable in their resources and in the services that they provide. Crucially, the CMO’s report makes this point: each year, more than 5 million people in the United Kingdom develop chronic pain, but only two thirds will recover. Clearly, much more needs to be done to improve outcomes for patients. He reminds us that pain affects 7.8 million people, and that more than a third of households have someone in pain at any given time. Those figures are rising. Indeed, recent surveys suggest that chronic pain is more common now than it was 40 years ago.
Pain is becoming more common, but the effect that it has on individual lives is immense.

“The CMO highlights the fact that pain has a major impact on people’s lives, causing sleeplessness and depression, and interfering with normal physical and social functioning. That often leads to unemployment. He points out how it affects all age groups. Perhaps most worryingly, he states that 8 per cent. of children experience severe pain, that back pain alone costs the economy £12.3 billion per year and that early intervention may prevent pain from becoming persistent. In fact, it has been shown that the cost of chronic pain is greater than that of heart disease or diabetes.

“Looking at the limited number of specialist pain clinics, the CMO points out that systems and infrastructure do not meet need or demand, and that better co-ordination of services, and services designed around patients’ needs, are essential. Pain needs to be considered in its own right, because it is often the pain that dominates the patient’s life, not the illness or condition that causes the pain.

As one patient has said: ‘At first I presumed the pain would eventually go away and I would get better. I didn’t expect to develop chronic pain, or that it would stop me working and lead me to consider suicide. I just want my life back.’

Another said: ‘I am in constant and debilitating pain, often unable to do even the most simple activity such as making myself a cup of tea. I have daily bad headaches, and have no quality of life. It is making me very depressed and life is hell.’

Clearly, we have a duty to ensure that the individual has access to the right treatment as early as possible. That treatment has to come from a properly trained professional, and a multidisciplinary team if needed.

“I was surprised by the amount of interest that this debate has generated. I have been contacted by a number of organisations wishing me to raise their concerns. Age Concern and Help the Aged have particular issues relating to the elderly.

AGEING PROCESS

“They say that pain is not a normal part of the ageing process, and we should not accept it as such. We should challenge discrimination and ageist attitudes with regard to pain in older people. They say that constant pain can lead to a loss of dignity. Some 90 per cent. of calls to Arthritis Care’s helpline concern pain, most of them from people in severe pain. In the UK, pain crises account for 60 to 80 per cent. of emergency presentations in hospital admissions for sickle cell disorder.

CO-PROXAMOL WITHDRAWAL AND NAMED PATIENTS

“This is not the first time I have had an Adjournment debate on the issue of pain. Ever since the Government first indicated that they intended to withdraw the analgesic co-proxamol, I have been trying to persuade Ministers that it should not be completely withdrawn as a small group of people still has not been able to find an alternative and certainly not anything so effective. These are all people who suffer chronic pain, who are saying that only co-proxamol works not because they want to be awkward but because it allows them to carry on with their life.

“One person in that position has said: ‘With co-proxamol I had pain but it was bearable, now I can walk only a few steps before being forced to rest; before I managed to tend my flower garden, now I can only sit and feel depressed with pain and frustration’.

“I have several constituents who depended on co-proxamol but cannot now get access to it. While the Government say that co-proxamol is available on a named patient basis, that is of cold comfort to those whose GPs are refusing to prescribe the drug at all. GPs are not comfortable prescribing off licence as they do not always feel that they have the specialist knowledge. But consultants at pain clinics do.

“The main reason the Government gave for withdrawing co-proxamol was the suicide statistics. As it is now extremely difficult for even those who need the drug to access it, the incidence of suicide attributed to co-proxamol is now tiny. However, the use of stronger pain relief and particularly opiates has grown. A recent Pulse article says that there has been a 44 per cent. rise in prescriptions for morphine and a 61 per cent. rise in tramadol prescriptions. That cannot be good pain management, so I ask the Minister to look at this issue again.

“I have not, however, sought this debate to lay blame at the Government’s door on this matter: rather, I hope to encourage the Minister to consider the recommendations laid out in the chief medical officer’s report and to give due regard to their feasibility. I do not have time to discuss them all, but I do want to take this opportunity to bring some to the Minister’s attention.

PAIN TRAINING SHOULD BE EXTENDED

“First, training on chronic pain should be included in the curriculum for all health professionals who deal with patients. However, it is vital that this core training is extended to all health professionals, and in particular to GPs who, at the very least, should have pain training as part of their standard undergraduate education.

“Secondly, consideration should be given to the inclusion of the assessment of pain and its associated disability in the quality and outcomes framework—QOF—in primary care. That is an extremely important point, because the inclusion of pain assessment in the QOF would strongly encourage health professionals to be proactive and to ask a patient about their pain, treat it promptly and reassess it to ensure that the treatment given is effective, rather than expecting the patient to raise it first.

“A recent report on osteoarthritis found that 50 per cent. of people said that they would need to be in frequently unbearable pain before considering seeing their GP—clearly this is a significant barrier.

FIFTH VITAL SIGN – PAIN SCORE

“Another recommendation was that a pain score should become part of the vital signs monitored routinely in hospital. Indeed, the Chronic Pain Policy Coalition has been campaigning for some time now for pain to be adopted as the fifth vital sign. If implemented, this recommendation would ensure that health professionals become proactive in asking their patients about pain. People would recover faster and reduce the burden of care on others.

MODEL PAIN SERVICE OF PATHWAYS OF CARE

“The final recommendation I want to highlight relates to the development by experts of a model pain service of pathways of care with clear standards. The work could build on the excellent 18-week cross specialty chronic pain pathway developed by patients and clinicians that has been supported by the Department of Health.

“It is an important step forward and should be extended to ensure that all patients are offered comprehensive treatment options. That would improve rapid access and reduce the current variability in treatment that patients receive. Patients need to be confident that they can be offered effective options wherever they live.

“Commitments have already been made both in Scotland with the ‘Getting to GRIPS with Chronic Pain’ report and in Wales under the ‘Designed for Life’ programme to assess and improve the services available for patients with chronic pain. I hope I have shown the Minister that there are patients, third sector organisations such as Arthritis Care and health professionals in England anxious to get hold of these recommendations and take them forward. They will need encouragement and flexibility in the way in which integrated services are funded and in how outcomes are measured.

PAIN CHAMPION DEMANDED

“Above all, people in pain need a champion. Tsars such as Mike Richards for cancer and Roger Boyle for cardiology have shown how such champions can make a difference. Pain affects cancer patients and heart patients as well as millions of others with back pain, arthritis, pelvic pain and a multiplicity of conditions. Surely the numbers involved and the importance of early intervention demand a pain champion.

“I know that the concerns I have raised in this debate are shared by a number of my hon. Friends and indeed by many of their constituents. I thank the Minister for hearing me out, and I hope that she can give consideration to the points I have raised.

REPLY

Replying Ann Keen (Parliamentary Under-Secretary (Health Services), Department of Health; (Hansard source) congratulated Miss Begg on securing this Adjournment debate on a “most important topic, which Professor Sir Liam Donaldson chose to highlight recently in the 150th report of the chief medical officer.”

She said, “The report of the chief medical officer is an independent report to Government on aspects of the nation’s health and, as such, draws attention to a number of different major health challenges. In his annual report for 2008, the chief medical officer called for a major initiative to widen access to high-quality pain services to improve the lives of millions.

NATIONAL PAIN DATABASE

“I am delighted to inform my hon. Friend and the House that I received a letter from Professor Black, the chair of the advisory group, just before the Easter recess, and it recommended that the national pain database, run jointly by the Royal College of Anaesthetists and the British Pain Society, should be funded as part of the national clinical audit programme.”

EDITOR’S NOTE: On behalf of the fibromyalgia community living with chronic pain, numbering around two million, mainly women, me included, and those of us who survived thanks to co-proxamol, I would like to thank Anne Begg MP publicly for speaking out on our behalf.

Had I known Miss Begg was to initiate this debate I would, of course, have asked her to include fibromyalgia in her chronic pain list. Hopefully she will read this somewhere, sometime, and might think kindly of us when next raising chronic pain and co-proxamol.

For many of us co-proxamol, when it was £2.79 for 100 tablets, was an inexpensive painkiller. Had we known this it would have been cheaper than the prescription charge if we had been able to buy it. This was before the Government got involved. It was a life saver for those with fibromyalgia, and many others. In those days we had some relief…now it is pain 24/7 thanks those who meddled against the wishes of many doctors, consultants, a number of MPs and the patients. They did not give a jot about us at the ‘coal face’ living with pain for the rest of the life. Yes I have tried the alternatives and they disagreed with me and my IBS and gastric problems. They should have tightened the rules allowing those who really need it to be able to get it, prescribed without litigation problems.

Today albeit your GP knows you are in pain and you should be a named patient, after years of safely taking co-proxamol without a hint of any problems, he will not prescribe it due to the risk of litigation involved with prescribing an unlicensed drug. Mr. B. sitting comfy in his armchair (free of pain) with all found, at No.10, your Government has a lot to answer for…….. the loss of co-proxamol is most certainly one of them.

Letters to Anne Begg at begga@parliament.uk would I am sure be much appreciated by her especially if you make reference to her debate in the House of Common on 20 April 200 and give her more ammunition about your problems with co-proxamol and fibromyalgia. Maybe you will send a copy to me please -fmsglobalnews@me.com. Thanks.

For the background to the Co-proxamol debate and MP Anne Begg.
SEE: http://fmsglobalnews.wordpress.com/2009/03/13/co-proxamol-a-controlled-drug/

http://fmsglobalnews.wordpress.com/2009/03/24/prescriptions-for-opioids-jump-following-co-proxamol-ban/

http://jeannehambleton77.wordpress.com/2008/01/03/no-u-turn-on-co-proxamol-withdrawal/

http://jeannehambleton77.wordpress.com/2007/12/05/co-proxamol-bungled-withdrawal-is-a-farce/

http://jeannehambleton77.wordpress.com/2007/11/26/co-proxamol-withdrawal-debate/

SEE: http://jeannehambleton77.wordpress.com for more health stories

Fear Keeps Many From Fighting RA Pain

From the FMS Global and UK News Desk of Jeanne Hambleton

Courtesy of WebMD.com
By Bill Hendrick – WebMD Health News- Reviewed by Louise Chang, MD

March 25, 2009 — Many people with rheumatoid arthritis may have barriers that hinder optimal management of their pain, a study suggests.

Barriers to pain reduction, Canadian researchers say, include fear of medication side effects, fear of drug interactions, worry about drug addiction, concerns that the effects of medication might mask the disease, and aversion to taking too many pills.

McGill University scientists studied 60 patients with rheumatoid arthritis, all of whom were being treated by specialists. Of the rheumatoid arthritis sufferers, 53% described their pain as moderate to severe.

Forty-seven percent reported that pain was mild or absent. And 65% of all patients, including about half of those with moderate to severe pain, were satisfied with current methods to control suffering, the researchers report in the March issue of The Journal of Pain.

Although 87% of the patients reported that they expected to have “some” pain to “much” pain from their rheumatoid arthritis, only 13% didn’t expect any pain or only slight pain.

The researchers, led by Mary-Ann Fitzcharles, MD, of Montreal General Hospital at McGill University, were interested in the potential barriers to reducing pain that kept some people hurting.

The top barriers to optimal pain management found in the study participants included:

Worry of medication side effects (80%)

Not wanting to take “too many pills” (63%)

Worry about medication interactions (57%)

Worry of addiction (35%)

The researchers found that more than half of the patients had at least three barriers.

The researchers conclude that people with rheumatoid arthritis should be questioned vigorously about their pain, and that clinicians should explore potential barriers to effective pain control.

News release, McGill University.
Fitzcharles, M. The Journal of Pain, March 2009; vol 10: pp 300-305.
© 2009 WebMD, LLC. All rights reserved.
(http://www.webmd.com/rheumatoid-arthritis/news/20090325/is-fear-keeping-you-from-fighting-ra-pain?ecd=wnl_cbp_040209)

Hand Exercises Aid Rheumatoid Arthritis

Muscle-strengthening exercises may ease pain and help individuals with RA improve their quality of life

By Gina Shaw -WebMD the Magazine – Feature Reviewed by Michael W. Smith, MD

For 25 years, New Yorker Carol Solomon, 69, ran a knitting store. In 2006, a few years into retirement, she was diagnosed with rheumatoid arthritis (RA) in both hands.

“I have movement in my thumb and in my pointer finger, but my other three fingers are pretty stiff,” she says. Solomon did not want to give up the knitting and sewing she loves, so she sought help from her doctor and physical therapists at New York’s Hospital for Special Surgery.

There is a saying about exercise and RA: Use it, but do not abuse it.

“Studies have shown that strengthening the muscles around the joints leads to overall improved function and better quality of life,” says Heather Williams, DPT, a physical therapist in the Hospital for Special Surgery’s Joint Mobility Center.

“Patients can be afraid to exercise those joints because of pain, but they really benefit from strengthening exercises.”

RA is an autoimmune disease in which the body attacks its own tissues. It is a chronic disease, but when diagnosed and treated early with a combination of medication and physical therapy, joint damage can be limited.

When it affects the hands or wrists, like Solomon’s, some helpful exercises include squeezing small exercise balls or putting the hand out flat, palm up, and bending each finger one by one into the palm. Take it slowly, advises the physical therapist. She says Solomon should try three sets of five repetitions of each exercise instead of 10 or 12 reps — and then work up to more as she builds her strength.

People with RA go through phases called “flare-ups,” with extremely swollen and painful joints, and then “subacute” phases when the disease is less active. Modifying activity depending on what phase you are in is important, says Theodore Fields, MD, clinical director of the Gosden-Robinson Early Arthritis Center at New York’s Hospital for Special Surgery.

“When you have a significant flare-up, the joints need more rest.”

Whatever kind of exercise you do, be sure to discuss your exercise plan with a physical therapist who understands RA.

“Have your physical therapist work out a home-exercise program that fits your needs and respects the joints you have trouble with,” says Fields.

Solomon knows her knitting needles will never fly like they used to, but she has started to work with yarn again and can even sew with a needle and thread, an impossible feat when she first was diagnosed.

“I am just seeing what I can do every day, and trying to adjust the way I do things to give myself as much function as possible,” she says.

Hand Exercise for Rheumatoid Arthritis

The Exercise:
Fill an empty box with small items such as nuts, screws, and bolts. Reach in and, handful by handful, pick the screws and bolts out of one box, place them in your other hand, and place in a second box.

The Benefit:
This exercise helps strengthen muscles around joints for improved finger mobility and helps prevent future joint damage.

Originally published in the September/October 2007 issue of WebMD the Magazine. © 2007 WebMD, Inc. All rights reserved.
(http://www.webmd.com/rheumatoid-arthritis/features/hand-exercises-aid-rheumatoid-arthritis?ecd=wnl_cbp_040209)

Chronic Opioid Therapy Guidelines Offer Direction for Physicians

From the FMS Global News Desk of Jeanne Hambleton

Courtesy of Fibromyalgia Network – February 2009

While patients are rightfully concerned about not receiving adequate pain relief, physicians harbor fears about drug abuse, safety issues, and government oversight. New clinical guidelines for the use of chronic opioid therapy in chronic non-cancer pain patients, developed by consensus of the American Pain Society and the American Academy of Pain Medicine, may ease both patient and physician concerns.

The guidelines, published in the February issue of the Journal of Pain, offer a roadmap for physicians on how to safely prescribe opioids to patients with moderate to severe pain.* The authors specifically state that their report applies to patients with “chronic non-cancer pain conditions, including common conditions such as back pain, osteoarthritis, fibromyalgia, and headache.”

Throughout the guidelines, physicians are urged to evaluate their patients’ pain and function on a regular basis. And, if doctors are worried that a patient is abusing or misusing the prescribed opioid, they may need to reduce the time between scheduled office visits. In addition, physicians are encouraged to look at all of the available options for treating patients’ chronic pain, including the use of opioids, and it is emphasized that this class of medications will seldom provide sufficient pain control. This means that patients placed on opioids will likely need to be prescribed medications from other drug classes as well as non-drug therapies. And, physicians who do not have the skill-set to prescribe opioids need to coordinate their patients’ care with another doctor who is experienced in providing this therapy.

The American Pain Society emphasized the following three points to all its members this month:

The guidelines are comprehensive and evidenced-based to assist physicians in managing chronic opioid therapy, according to the American Pain Society President Charles Inturrisi, Ph.D

“Regular monitoring of chronic opioid therapy patients is warranted because the therapeutic benefits of these medications are not static and can be affected by changes in the underlying pain condition, coexisting disease, or in psychological or social circumstances,” said Gilbert J. Fanciullo, M.D., director of the division of pain and palliative care at Dartmouth Hitchcock Medical Center.

Cochair Perry Fine, M.D., professor of anesthesiology at the University of Utah Medical Center, added that doctors do not have to solely rely upon patient self reports. Pill counts, urine drug screening, family member or caregiver interviews, and prescription monitoring data may all be used to check for possible abuse or other opioid-related problems.

The message is clear that under most circumstances, there are reasonable ways for physicians to prescribe chronic opioid therapy for their patients in pain while emphasizing safety issues and minimizing side effects or the potential for drug misuse. The guidelines offer physicians 25 recommendations with detailed explanations on how to follow them—all to help doctors prescribe opioids to their chronic pain patients in a responsible fashion. In addition to the key points already made, here are other highlights from the published guidelines:

Clinicians may consider a trial of chronic opioid therapy (COT) for moderate to severe pain that is having an adverse impact on a patient’s function or quality of life as long as the therapeutic benefits outweigh the risks (abuse, misuse and addiction). Three different patient screening tools (questionnaires that are easy to administer) are included with the guidelines to help doctors assess potential risks associated with COT for a given patient (the SOAPP, the ORT, and the DIRE).

Before initiating a trial of COT, physicians should provide their patients with informed consent, which alerts patients to all of the potential risks associated with taking opioids. After informed consent, doctors should discuss with their patients a COT management plan that outlines the goals of therapy, expectations, monitoring requirements, etc. A sample consent form and management plan are included in the guideline.

Initial treatment with an opioid should be regarded as a therapeutic trial to determine if COT is effective. If the first opioid does not work or produces adverse side effects, other types of opioids may be tried, but patients need to keep in mind that opioids are prescribed on a trial basis.

Physicians should anticipate, identify, and track common opioid-associated side effects. Constipation is the most frequent problem, and unfortunately it does not go away or get better with continued use of the medication. With this in mind, doctors should recommend stool softeners or increased fiber intake when issuing patients an opioid prescription. Nausea or vomiting may occur but tends to diminish over a few days. If it lasts longer, doctors can prescribe a medication to treat this side effect. Sedation and clouded thinking usually goes away with continued opioid use, while reduction in sex hormones may appear down the road with COT. If a patient begins to experience a decrease in libido, sex hormones can be checked and supplemented if necessary. Other side effects may also occur, so patients and physicians need to be on the lookout for them.

Chronic pain is often a complex condition and physicians who prescribe COT should routinely promote other therapies, such as psychotherapy (pain can be awful to cope with), physical and occupational therapies for restoring function, and other non-drug approaches in addition to prescribing other non-opioid medications. The purpose of this recommendation is to treat the whole person and improve the odds that a patient with chronic pain will achieve a more fulfilling life.

Doctors need to counsel patients prior to starting COT and continue until a stable dose is reached or if the dose is later increased as the patients’ cognitive skills may be impaired for a short period of time. If clouded thought processes do occur, driving should temporarily be avoided … so patients might want to start an opioid on a weekend when they do not have to drive. After a stable dose is reached, there is no evidence to suggest that patients on COT should be restricted from driving or engaging in most work activities.

The opioid guidelines give your doctor the “how to” advice for prescribing opioids, including sample copies of patient screening questionnaires, a consent form, management plan, and full details on how to responsibly prescribe opioids. However, they also assume that the prescribing physician is already knowledgeable about issues concerning this class of medications (i.e., the guidelines cannot possibly convert a novice into an expert on COT). Neither the patient nor physician should feel awkward about the consent and management forms, or random urine tests. Doctors who follow these guidelines should be better equipped to implement opioid therapies for their chronic pain patients (such as fibromyalgia) in a safe manner.

* Chou R, Fanciullo GJ, Fine PG, et al. J Pain 10(2):113-130, 2009.

Calling the Kettle Black
… editorial comment

By Kristin Thorson, Editor, Fibromyalgia Network

Posted: February 27, 2009

If your newspaper ran the February 8th Associated Press article “Drugmakers’ push boosts ‘murky’ ailment,” implying that the drug industry has fabricated fibromyalgia in an effort to churn a profit, you have every right to be furious!1 Controversy sells, and that was what the reporter, Matthew Perrone banked on. Perrone sought out Fred Wolfe, M.D., of Wichita, KS, because he knew from the January 14, 2008 front-page article in the New York Times that Wolfe had a track record for trashing patients with fibromyalgia and big, bad pharma as well. It is ironic, however, that Wolfe would make derogatory statements about the drug industry when he is heavily funded by six drug companies himself.

Wolfe is the director (and paid employee) of the National Data Bank for Rheumatic Diseases, a nonprofit registered as The Arthritis Research Center Foundation, Inc. Its mission is “conducting ongoing research to improve conditions for people with arthritis, fibromyalgia, lupus and other conditions.” He openly declares in his research papers, in which he is testing the effectiveness and safety of drugs for rheumatoid arthritis, that he is funded by Centocor, Aventis, Pfizer, Bristol-Myers Squibb, Amgen, and Abbott. So perhaps Wolfe’s dislike is not so much for the drug industry as it seems for fibromyalgia.

Prompted by mixed reports on increased cancer rates in people with rheumatoid arthritis (RA), Wolfe conducted an observational study on the incidence of cancer in RA patients who took the tumor necrosis factor (TNF) blocking agents Enbrel (etanercept) or Remicade (infliximab).2 His findings were derived from information in the National Data Bank (NDB) and per the NDB’s agreement with Centocor, the maker of Remicade, the drug company was allowed to review Wolfe’s manuscript prior to publication. But Wolfe does not just cater to Centocor. His NDB organization has similar contractual agreements with Bristol-Myers Squibb and Sanofi-Aventis.

Wolfe’s study contradicted earlier reports of increased cancer risks for RA patients taking Enbrel or Remicade. It also confirmed that TNF blocking drugs are linked to skin cancers, including potentially deadly melanomas. Instead of using his findings to alert the medical community that these drugs may pose a health hazard, Wolfe went on record with WebMD as stating: “The drugs, at this moment, do not seem to add any risk except for skin cancer and melanoma. This is a small overall risk and I do not think people should be concerned.” He also added that the risks did not outweigh the benefit for patients who truly need the new drugs.3

While there is no argument that people with RA deserve effective therapies, do you not think it is odd that Wolfe is the one pushing drugs on RA patients while in the recent AP article he bashes the drug industry for fabricating fibromyalgia to boost their sales? Yet he is quoted in the AP article as saying, “I think the purpose of most pharmaceutical company efforts is to do a little disease-mongering and to have people use their drugs.” Further in the article he says, “The underlying purpose here is really marketing, and they do that by sponsoring symposia and hiring physicians to give lectures and prepare materials.” Wolfe’s negative sentiments about fibromyalgia appear clear in a February 2009 report in which he writes, “Recently, regulatory authorities have approved treatments for fibromyalgia, offering some de facto support, although no proof, for fibromyalgia as a distinct disorder.”4 However, there was a time when RA had no “proof,” but that does not mean that the patients who suffered with it years ago did not have a real disease.

It is true that Wolfe was the lead author for the 1990 American College of Rheumatology criteria for fibromyalgia, but that was 18 years ago and much has changed.5 In 1990, the number of rheumatologists who were skeptical about the realness of fibromyalgia far outnumbered the believers. I should know, because I hosted an information booth on fibromyalgia at the annual rheumatology meetings throughout the 1990s, and in the early years I can attest to the ugly controversies surrounding this disease.

In 1994, Wolfe orchestrated a consensus conference (paid by the insurance industry) whose primary goal was to trivialize fibromyalgia and restrict patient care.6 Why he wanted to turn his back on fibromyalgia is still unknown, but his efforts failed. During the past eight years, the rheumatologists have rallied to increase the legitimacy of fibromyalgia by developing guidelines for improving the quality of research and for testing therapies to treat this patient population. Today, Wolfe and many of his colleagues do not see eye to eye when it comes to issues concerning fibromyalgia. At age 74, he appears to get his jollies by trash-talking fibromyalgia to headline-mongering reporters.

For all of you who were subjected to the AP story, I hope my comments help you understand the nonsensical nature of the article and that you can ignore any future reports that happen to quote Wolfe. I also want to make three additional points about the AP article:

Although Wolfe’s own nonprofit takes money from the drug companies, this does not mean that all nonprofits and organizations that help patients must do the same to stay afloat. Fibromyalgia Network and its sister organization, the American Fibromyalgia Syndrome Association (AFSA), have never received money from the pharmaceutical industry or other companies that could bias the way these two organizations operate.

Daniel Clauw, M.D., of the University of Michigan, did receive a small grant award from the National Fibromyalgia Research Association (NFRA) in Salem, OR, but the NFRA should not be confused with the National Fibromyalgia Association (NFA). NFRA does not receive money from the drugmakers.

The article implies that Clauw’s brain imaging research, which has documented many brain processing abnormalities over the past ten years, was tainted by drug money. That simply is not true because the funding for these studies came from government grants based on the merits of his proposals. “Most of us conducting research in the field of fibromyalgia were here ten years before the drug industry even took notice of this disease,” Clauw points out.

Perrone M. Associated Press © hosted by Google, Feb 8, 2009; (AP article).
Wolfe F, Michaud K. Arthritis Rheum 56(9):2886-2895, 2007.
DeNoon DJ. WebMD Health News Aug. 29, 2007; (WebMD article).
Wolfe F, Michaud K. J Rheumatol First Release Feb. 15, 2009; doi:10.3899/jrheum.080897.
Wolfe F, et al. Arthritis Rheum 33(2):160-72, 1990.
Wolfe F. J Rheumatol 23(3):534-9, 1996.

Kaufmann I, et al. Rheumatol Int [epub ahead of print] December 4, 2008.
Kaufmann I, et al. Clin Immunol 125:103-111, 2007.

(http://www.fmnetnews.com/basics-news.php#opioid)
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