Fms Community Newsletter #90

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Spring has sprung and summer has roared into town. I find myself torn between my obligations in the house and the temptation of taming my yard.

The mind is willing but the body often disagrees. I clear leaves and weeds as I crane my neck, willing the impending pain away.

I do these things, knowing I will pay dearly over the next few days for my efforts. I guess I see it as a battle between me and this disease at times, and I foolishly decide I am going to win from time to time.

For all of us that try to live normal lives when we can I dedicate this issue of the newsletter.

It is not the theme based newsletter you have grown accustomed to in the past few months. Alas, I stood up and faced FM in the face and it fought right back, limiting my energy once more. But, I will continue to get in its face, I treasure every hour I spend in the garden, or every walk I take in the park. I will gladly pay its price when I am done until we find a way to beat it once and for all.

Happy Summer everyone. I wish you all many days when you can do the things you enjoy.

Jane Kohler


~ Traveling Safely with Medications
~ Counterfeit Medications
~ Alternative Medicines
~ Restrictions on compound Medications.
~ Money Talks in Drug Trials
~ New Research Into Pain Treatment
~ More drugs hobble restless legs syndrome

Traveling Safely with Medications

American Society of Health-System Pharmacists (ASHP)

Whether you are traveling domestically or internationally, you won't want an illness to disrupt either your vacation or business plans. This means planning well, managing your medications wisely, and consulting your physician or pharmacist about proper precautions to take before you leave home:

Many medications can cause "photosensitivity," or increased sensitivity to sunlight. Even if you don't usually sunburn, taking medications that cause this reaction could greatly increase your chances of getting a bad burn. Your pharmacist can advise you about whether your medication can cause photosensitivity and recommend the right SPF (skin protection factor) for your skin type.

If you are flying, keep your medications in your carry-on luggage so that you have access to them during your flight and will not lose them in the event that your luggage gets lost. Plus, keeping your medications with you helps prevent exposure to extreme temperatures in the baggage compartment, which can alter the drug's effectiveness. Keep in mind that airport security requires that your medications be transported in their original, labeled containers.

If your medication requires you to use a syringe - insulin, for instance - you may need to carry your prescription with you to ensure that you can pass through airport security. The American Diabetes Association recommends that people with diabetes be prepared to provide airport security personnel with copies of prescriptions for diabetes medications and supplies as well as complete contact information for the prescriber.

Make sure that you carry your prescriber's and your pharmacy's phone numbers with you when you are away from home. In case you lose your medications, you may need a new prescription. You should also keep on hand a list of all your prescriptions.

If you are traveling through several time zones, consult with your physician or pharmacist to work out a specific plan for adjusting the timing and dosage of your medications. This will prevent you from taking too much or too little.

If you are visiting a foreign country, beware of buying "over-the-counter" medications. Many medicines that are available by prescription in the United States are available "over the counter" in other countries. Some of these medications could have different ingredients, and may not undergo comparable quality control. Buying these medications could put you at risk for allergic reactions, drug interactions, or other problems.

If you are visiting a hot, humid climate, be sure to keep your medications in a cool, dry place out of direct sunlight. Never store medications in the glove compartment of your car. Also, because of the heat and humidity that build up in a bathroom, it is the worst place to store medication whether you are at home or on the road.

Take along more medication than the number of days you've planned to be away. This will allow you to be prepared for unexpected delays.

Counterfeit Medications

While the U.S. drug supply supply is still the safest in the world, ASHP advises consumers to be particularly vigilant about their medications given the recent rise in counterfeiting.

According to the U.S. Food and Drug Administration (FDA), counterfeit drug investigations have quadrupled since 2000. Additionally, the World Health Organization estimates that fake medications currently make up seven to 10 percent of the world market. These products may be expired, contain incorrect ingredients or the wrong amounts of active ingredients, or be enclosed in packaging that doesn?t match the product inside.

In light of this new and growing danger, ASHP wants Americans to know that their best allies in receiving safe and appropriate drug therapy are pharmacists and physicians.

?It is very difficult for patients to tell just by looking at a medication or its packaging if it is a counterfeit product,? said ASHP President Daniel M. Ashby, M.S., FASHP, noting the increasing sophistication of international counterfeiters. ?However, that is not to say that consumers are helpless in the face of this new threat. They can do a lot by staying alert and following a few simple tips. And, when in doubt, always talk to your pharmacist.?

ASHP recommends that consumers follow a few simple safety tips when taking medication:

Pay attention to your medicine, particularly the instructions on how you should take it, the correct dosage, and warnings about interactions with other medications.
Talk to your pharmacist if your medication is:
Different than you?ve experienced before in shape, color, taste, smell, or feel
Packaged differently, or
Does not produce the expected results. This can be due to a number of reasons, including:
-- Your body?s response has changed over time (requiring a higher or lower dose),

-- An interaction has occurred among medications, vitamins, or herbal supplements you are taking or specific foods you are eating,

-- You have a new medical condition that changes the medication?s effectiveness, or

-- You have received a counterfeit product.

Be extremely careful when ordering medications on the Internet. To stay safe, only buy medications from pharmacy Web sites that post the National Association of Boards of Pharmacy?s VIPPS (Verified Internet Pharmacy Practice Sites) symbol.
The National Association of Boards of Pharmacy has developed the following list of drug products that have been counterfeited in the past. Consumers should be especially cautious if taking:

Diflucan? (fluconazole)
Lamisil? (terbinafine)
Lipitor? (atorvastatin)
Sustiva? (efavirenz)
Procrit? (epoetin alfa)
Zocor? (simvastatin)
ASHP is working on a number of fronts to address the issue of counterfeiting, including partnering with the FDA in providing rapid alerts to ASHP members and U.S. hospital pharmacy departments about counterfeit drug incidents. The Society also maintains an online Drug Shortage Management Resource Center that provides health care providers with timely updates on product shortages and therapeutic alternatives.

Alternative Medicines

Remember that the term "natural" does not necessarily mean "safe."

To stay safe, always tell your doctor, pharmacist, or other health care provider about the products you are taking, including:

-- Herbal remedies,
-- Non-prescription medicines, and
-- Prescription drugs.

This is especially important if you are taking "blood-thinning" drugs or have cancer, HIV, or other life-threatening conditions. Bring either a list or the products with you to your doctor's appointment.

If you are taking a prescription medication, do not take an herbal remedy or dietary supplement for the same condition without telling your doctor.

Only take the recommended amount listed on the label.

Only choose products with labels that provide:

-- Dosing advise,
-- A lot number or expiration date (avoid products that are over one year old), and
-- Manufacturer's name, address, and telephone number.

Store products:

-- In a cool, dry environment out of direct sunlight (not in a bathroom medicine cabinet or car's glove compartment), and
-- Away from young children and pets.

Herbal remedies should not be taken:

-- By children without a physician's approval,
-- By pregnant women or nursing mothers,
-- With alcohol, or
-- As a substitute for a balanced diet and proper rest.

Ask your hospital or health-system pharmacist if you have any questions about this or other medicines.

Restrictions on compound Medications.

If this legislation passes, federal regulators, not your doctor, will decide what medicines you can take.

The so-called Safe Drug Compounding Act of 2007 would,
among other things:
**Threaten the availability of many critical, commonly compounded medications that many patients rely on, such as bioidentical hormones for women, hospice care treatments for the terminally ill and customized medicines for children.

**Allow the federal government to determine when compounded medicines are needed - a decision that has always been and should always be made by doctors.

**Restrict the compounded medications your doctor can prescribe even if he or she determines you need them.

What can you do?
Check the International Academy of Compounding Pharmacists website:

Write your elected representatives in Congress. You can use this easy to use tool to write your members of Congress. Exact site:

Steven Du Pre
Website for National Alliance for Myalgic Encephalomyelitis:

Money Talks in Drug Trials June 5, 2007

SAN FRANCISCO (The New York Times News Service) -- Money talks -- and very loudly when a drug company is funding a clinical trial involving one of its products, according to a study released Monday.

University of California at San Francisco researchers looked at nearly 200 head-to-head studies of widely prescribed cholesterol-lowering medications, or statins, and found that results were 20 times more likely to favor the drug made by the company that sponsored the trial.

"We have to be really, really skeptical of these drug-company-sponsored studies," said Lisa Bero, the study's author and professor of clinical pharmacy and health policy studies at the university.

The research, reported in the online editions of PLoS Medicine, a San Francisco medical journal, focused on studies of six statins -- including Pfizer Inc.'s
Lipitor, Merck & Co.'s Zocor and the generic drug Mevacor -- that had already been approved by the Food and Drug Administration. The trials typically involved comparing the effectiveness of a drug to one or two other statins.
"If I'm a clinician or funder of health care, I really want to know within a class of drug which one works better," Bero said.

"What our study shows is that depends on who funds the study."

UCSF researchers also found that a study's conclusions -- not the actual research results but the trial Investigators' impressions -- are more than 35 times more likely to favor the test drug when that trial is ponsored by the drug's maker.

Drug manufacturers, through the industry's trade group, said the federal government cracks down on biased research.

"The new study overlooks the crucial role of the Food and Drug Administration in reviewing and approving claims that are based on clinical trial results," said Ken Johnson, senior vice president of Pharmaceutical research and Manufacturers of America, in a statement.

"Our industry is dependent upon well-designed clinical trials that will pass muster with the FDA," Johnson said.

Mark Gibson is deputy director of the Center for Evidence-Based Policy at Oregon Health & Science University, which reviews existing clinical evidence for drug effectiveness and safety. He called the UCSF study an"important piece of work."

"If Americans really want to be able to have sound evidence on which to base their choice of treatments, they need to think about ways to fund independent research," he said.

About half of the 192 statin trials examined in the study between 1999 and 2005 were funded by drug companies. Bero said drug companies fund up to 90 percent of drug-to-drug clinical trials for certain classes of medication.

About a third of the statin trials did not disclose any funding source. Trials with no disclosed funding source were less likely to favor the so-called test drug than those with industry funding, researchers found.

The researchers found other factors that could affect trial results. For example, pharmaceutical companies could choose not to publish results of studies that fail to favor their drugs, or they could be designed in ways to skew results.

The study found the most important weakness of trials was lack of true clinical outcome measures. In the case of statins, some trials focused on less-direct results such as lipid levels but failed to connect the results with key outcomes such as heart attacks or mortality.

"None of us really care what our cholesterol level is. We care about having a heart attack," Gibson said. "For the drug to be worthwhile taking, it has to be directly related to prevent a heart attack."

The UCSF study was funded by a grant from the California Tobacco Related Disease Research Program.

The study, "Factors Association with Findings of Published Trials of Drug-Drugs
Comparison," can be found online at

Copyright 2007 The New York Times News Service. All rights reserved.

New Research Into Pain Treatment

Millions of aging boomers and the latest generation of woundedsoldiers hope the secrets of our most enduring medical foe can finally be unlocked.
By Mary Carmichael Newsweek

June 4, 2007 issue - Late into the night of May 2, 1863, a few hours after Thomas (Stonewall) Jackson took two bullets in his left arm at the Battle of Chancellorsville, surgeon Hunter Holmes McGuire sawed off the bleeding limb, trying to save the general's life. With the knife came another medical tool, one fairly new to the battlefield-a rag soaked in chloroform. As he awaited amputation, Jackson, who would die a week later, was as stoic as his nickname suggested. But as he slipped into unconsciousness, it's said, he betrayed his vulnerability in the face of pain just once, mumbling that the
anesthesia was "an infinite blessing."

For most of the 144 years since then, the military has stuck with similarly crude techniques for treating its soldiers' pain. Morphine, also given to Jackson and many others in the Civil War, is still the Army's most commonly used painkilling drug. It works, but compared
with more-modern options, it's one step above chloroform and two above biting the bullet. Now, though, with casualties mounting in Iraq and Afghanistan, the military is being forced to change its strategy. More than 90 percent of wounded soldiers have made it off
the battlefield-the highest survival rate in American history-only to overwhelm chronic-pain clinics when they come home. "We're seeing the tip of a tidal wave of pain," says Lt. Col. Chester (Trip) Buckenmaier, an anesthesiologist at Walter Reed Army Medical Center,
who has emerged as a sort of pain czar for the Army. After decades of "sucking it up," the military has finally started to respond in new and innovative ways to this escalating pain crisis. Even as the VA hospital system has come under fire for poor care, Army doctors
haven't just joined up in medicine's larger war against pain-they're leading the charge.

Winning this medical war is crucial, and not just for the sake of the soldiers, who are far from the only burgeoning new group of pain sufferers. Chronic pain is one of the most pervasive and intractable
medical conditions in the United States, with one in five Americans afflicted. Aging baby boomers have reported in surveys more aches and pains than any previous generation. Cancer patients have more
treatments to choose from than ever, but more pain, too. Even retired NFL players-a suck-it-up group if ever there was one-have started speaking out about the wear and tear on their bodies. Civilian chronic pain already costs the country $61 billion in lost productivity and many more in medical fees. Treating the soldiers in
the coming years will add at least $340 billion to the toll.

As the number of patients has grown, though, so has medicine's understanding of what pain is. Scientists once viewed it as merely a symptom of injury, an intuitive idea that resonated with laymen. "The public understanding of pain has been that it's a stubbed toe or a broken bone," says Will Rowe, executive director of the American Pain
Foundation. "But that's just one aspect of it. Now there's a growing awareness that pain is a disease of its own."

This is far more than a semantic change, Rowe adds: it's "tectonic." Docs now know that the brain and spinal cord rewire themselves in response to injuries, forming "pain pathways" that can become
pathologically overactive years later. They are trying to sever this maladaptive mind-body connection with a host of new drugs and approaches. Some focus on recently discovered chemical receptors in the brain and muscles. Others pack all the punch of narcotics with
less of the specter of addiction. (Patients can still become dependent on a new form of the morphine derivative called Kadian, for instance, but if they crush one of the pills for snorting, its center explodes, releasing a substance that blocks the euphoric high.)

New types of electrical stimulators targeting the brain, the spine and the muscles hit the market almost every year. Fentanyl skin patches, first introduced in 1990, have evolved into a patient-controlled, push-button device called IONSYS, available by the end of this year.
And complementary and alternative medicine offer a parallel universe of treatments: herbs, yoga, acupuncture, chiropractic, massage and
"prolotherapy," which injects various solutions, including cod-liver oil, into ligaments and tendons near the area of pain.

The military is pioneering its own new approaches. Since 2003, a small but growing number of soldiers in Iraq have been treated at the front with high-tech nerve-blocking devices that are effective but not addictive. They are common in civilian life, but their use on the
battlefield is unprecedented. Back at home, many VA clinics are offering extensive and elaborate pain treatments, and they're learning how to get tough guys and girls to soften up and admit they need help. At Walter Reed, Buckenmaier's team is conducting
groundbreaking research on the link between acute and chronic pain; his findings, due in the next few years, could revolutionize treatment. "The military needs people to be functioning out on the field," says Rollin (Mac) Gallagher, chief of pain medicine at the
Philadelphia VA hospital. "What we're now starting to recognize is that if you control people's pain, they're not liabilities-they're assets."

That's not to say pain is all bad. It's unpleasant, of course, but in an evolutionary sense, it has its uses. Acute pain begins in the peripheries of the body, where sensory neurons are constantly on patrol for signs of damage. They are the mechanisms that alert us to
one injury so we can avoid a second one. Touch a hot stove for the first time and you won't be happy, but you'll ultimately be better off-because you'll certainly never want to do it again.

By the time it has become a chronic condition, however, pain is no longer useful. It is, as Rowe says, a disease-specifically, an overactivity of the nervous system. The brain keeps a diary of the injuries the body receives, writing each entry by reconfiguring certain neurons into new, interconnected patterns. In healthy people,
these neurons stop firing once the initial damage is fixed. But in chronic pain, they keep going long after the injury has healed. "The circuits get turned up, and they stay up. They get stuck," says Gallagher. "Most diseases are physiology gone wrong. Pain is one of them."

Scientists don't know why some people develop chronic problems after injuries while others continue on with no pain. It is nearly impossible to answer the question on a wide scale; pain simply has too many causes. Some patients fully recover from massive trauma.
Others, like most of the boomers with aching backs and knees, find themselves debilitated by nothing more than the accumulated, mundane strains put on joints, bones and muscles every day. Even soldiers can fall into this second category-if the bullets don't get them, the
back pain brought on by months of jumping out of trucks, burdened with heavy equipment, well may.

Complicating the issue even further is pain's inherently subjective nature-we may say we "feel each other's pain," but really, we can't. Doctors don't have any good way of measuring pain from one person to the next. The best they can do is ask patients to rate it for themselves on a scale of 1 to 10, with 10 being the greatest agony of their lives. This is absurdly imprecise. Patients are usually honest (and fakery is fairly easy to spot), but they can exaggerate. A person feeling a 4 may claim a 7 to get aggressive treatment, and a person feeling a 7 may downplay it as a 4 in hopes of looking tough.
Robyn Walker, a psychologist at the Tampa (Fla.) VA, says she's seen the latter dynamic in her clinic. "These patients know what a 10 feels like," she says. "But they are active-duty soldiers, and they minimize their problems. Unless you really ask them about their pain,
they may be very hesitant to tell you." Doctors are trying to develop new methods of measuring pain, but their most advanced idea so far is to study facial expressions-which aren't much more standardized than the 10-point scale.

On top of that, one patient's 7 may be another's 4. "Our bodies are not one-size-fits-all," notes Rowe, "and doctors are finding that this is far more true with pain than they ever imagined." Genes may vastly influence how intensely people feel pain and how much they can
withstand-although genetic testing for pain susceptibility is probably decades away. Gender matters, too. Women have up to twice as many nerve fibers in the skin as men do, so they feel some types of pain more intensely. (This doesn't mean they're weaker; it means that, all other factors being equal, their 10 is off a man's chart.)
Even traits that seem unrelated to pain, like vitamin D deficiency, may increase it for reasons no one fully understands. Trying to untangle all these factors is a scientific nightmare.

Regardless of their injuries, their genes, their gender or their background, though, nearly all chronic-pain patients agree on one thing: the hyperactive neurons can make life near unbearable. The cascade of changes in the nervous system can lead to an equally painful cascade of events in a patient's life: memory loss, job loss,
marital strife, depression, suicide. And through it all the body hurts like hell. "Imagine somebody holding a knife in your back and twisting it against your nerves continually, never stopping. That's what chronic pain is," says Dan O'Neal, a contractor who herniated
two vertebrae in 2003 while cleaning up a job site. "At first you just shut off totally. It's terrible living like that."

Among chronic-pain patients, O'Neal is actually one of the lucky ones. He, at least, knows why his pain started; some patients are deniedeven that knowledge. Chronic regional pain syndrome, for instance, is a rare disorder that can begin with something as trivial as a skinned knee. The scrape heals, but the nervous system does not. Within a few years the knee that was skinned feels like it is on fire, even though nothing is outwardly wrong. Similarly, fibromyalgia assails the bones, muscles and joints, but has no obvious bodily causes and doesn't show up on X-rays. Growing evidence now suggests
that it is in part a brain disorder that sets the pain pathways afire, responding to imaginary wounds-as if the brain's diary of injuries has suddenly filled up with wild, untrue stories. The pain itself is not imaginary. But because it is hard to pinpoint and even harder to treat, for years many doctors used to write it off as such.
Andrea Cooper says that's all doctors did when she first developed fibromyalgia, which afflicts 6 million Americans. "There was a bunch of 'We can't figure out what's wrong with you, therefore there's nothing wrong with you'," she says. "People don't like to hear about
symptoms that they can't do anything about."

Some fibromyalgia patients may be helped by standard pain treatments. Others aren't. In that, at least, ibromyalgia patients are just like all other pain patients: relief can come for them, but it is often hard-won. Cooper, who is now on fentanyl and Kadian, compares her current pain to "the roar of the faraway interstate, as opposed to being in traffic." But to get to her current regimen she had to go through nearly everything else-antidepressants, anticonvulsants, muscle relaxers, acupuncture and six operations that probably made
the pain worse.

Some of the most promising pain treatments of the past decade have turned out to be disappointments. Studies of some radiofrequency therapies show they work no better than placebos. Spinal-fusion surgery, a recent review found, has "no acceptable evidence" to
support it. And if a treatment does work, says Edward Covington, a pain specialist at the Cleveland Clinic, "for most people, the effect is temporary." There is no cure for chronic pain, period.

There's not even any "single drug or technology alone" that can treat all the types of pain, says Eugene Viscusi, director of acute-pain management at Thomas Jefferson University Hospital in Philadelphia.
Most people need two or three therapies in combination. Scientists' new understanding of pain's broad effects on many levels of the nervous system explains why: a multipart syndrome requires multipart therapy. Viscusi notes that patients under anesthesia still have
elevated levels of the pain enzyme Cox-2 in their spinal fluid following surgery. They may not feel pain, but some parts of their brains still think they're in it. For any treatment to work long term, it will have to address not just the immediate sensation of pain but the other, subtler aspects-and there are surely some of
those that scientists don't know about yet.

More drugs hobble restless legs syndrome

Rotigotine, a investigational dopamine agonist, is being studied for treatment of restless legs syndrome.
Jun 4, 2007 By: Kelly Dowhower Karpa, Ph.D., R.Ph.
Drug Topics

A leading theory regarding the pathophysiology of primary restless legs syndrome (RLS) suggests that abnormalities of dopaminergic function may be involved. Consistent with this thinking, dopamine receptor agonists are often used in therapeutic management of RLS. In
May 2005, ropinirole (Requip; GlaxoSmith-Kline) became the first drug approved by the Food & Drug Administration for RLS, followed by pramipexole (Mirapex, Boehringer Ingelheim) in November 2006. RLS, a sensory disorder, causes an irresistible urge to move the legs. Up to 10% of American adults may be affected.

Another investigational dopamine agonist, rotigotine-delivered via a transdermal patch-has been studied for both RLS and Parkinson's disease and, as Neupro (Schwarz Pharma), was just approved for
Parkinson's. "The patch releases the drug continuously, with no drop in drug levels during early morning hours, so rotigotine should have less of a 'wearing-off effect' in the morning compared with other dopamine agonists," said Jack Chen, Pharm.D., associate professor in
the movement disorders clinic at Loma Linda School of Medicine and Pharmacy in Southern California. This would prevent a recurrence of symptoms in the morning, a phenomenon sometimes seen with current
dopaminergic therapies.

According to product labeling for dopamine agonists, hypotension may occur-even resulting in syncope. Dopamine agonists have also been associated with compulsive behaviors. But, as Chen noted, "they are
not dose-related and they are clearly a class effect," as compulsions have occurred with both pramipexole and ropinirole.

New-generation dopamine receptor agonists like ropinirole and pramipexole target receptors located within brain regions that control motivation, emotion, and reward behaviors. In at least a subset of patients, stimulation of these receptors can prompt
pleasure-seeking behaviors. Because of this, experts are now recommending that all patients with RLS be screened by physicians for compulsive behaviors prior to therapy with dopamine agonists. Family and friends of patients should report all negative behaviors to the
patient's physician, suggested Maja Tippmann-Peikert, M.D., a neurologist at the Mayo Clinic in Rochester, Minn., and lead author of an article in the Jan. 23 issue of Neurology on this subject.

Although the precise mechanism by which it acts in RLS management is unknown, gabapentin is used off label for treating RLS. In several small clinical studies in which gabapentin was studied in patients with RLS, the antiepileptic drug improved sleep quality and sleep
latency and reduced leg movements during sleep. In fact, in several of the studies, gabapentin was just as effective as dopamine-acting drugs.

"Gabapentin might be used in RLS management when there is a simultaneous neuropathic pain component. Additionally, gabapentin might be added if patients are not getting adequate relief from a dopaminergic drug," said Chen.

Capitalizing on the benefits of gabapentin, Xenoport Inc. and GlaxoSmithKline have partnered to develop and commercialize a unique prodrug of gabapentin, known at this point only by the chemical name XP13512. This new drug reportedly has improved bioavailability
compared with gabapentin.

Gabapentin is absorbed in the upper portion of the small intestine by a transporter that is easily saturated. This causes absorption of gabapentin to be dose dependent and to vary widely between patients. Rapid clearance of the drug also necessitates dosing three or more
times per day to maintain therapeutic levels.

In contrast, XP13512 was designed to be absorbed throughout the length of the intestines, and when XP13512 is delivered via a sustained-release formulation, extended exposure to the drug enhances
colonic absorption.

Although clearly the pharmacokinetic properties differ between gabapentin and XP13512, Chen cautioned that "it is too soon to tell whether XP13512 will offer clinical advantages over gabapentin" for
RLS management.

THE AUTHOR is a clinical writer based in the Philadelphia area. Source: