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FMS Community Newsletter #106

In This Issue:

Busting the FM Myths:
FDA issues precautionary note on silver fillings
Prescription Assistance Programs
FDA OKs New Migraine Drug Treximet
Bill designed to help fibromyalgia sufferers
New Support Group for our Friends In Northern Utah.
Fibromyalgia Support Group of Winnipeg




Busting the FM Myths:
No doubt the majority of people, in the U.S.A. at least, are familiar with the T.V. series Mythbusters on the Discovery Channel. They take common, everyday myths and urban legends and set out to either prove, or disprove them. For years, people exhibiting Fibromyalgia symtoms have endured a myriad of uniformed opinions and diagnose disasters at the hands of the very professionals they turned to for help. Many of the early diagnoses and treatment protocols have turned into myths perpetuated by uneducated, but well meaning friends, family members and uneducated health care providers.

It would be unfair to put the blame on our health care providers of the past, medical school did not prepare them for this condition, there were no studies, tests or medications proven to help this group of people. Thankfully, new technology has provided scientific evidence on Fibromyalgia and new studies are being done every day thanks to brave professionals, and grass roots activists who believed.

Despite all of our progress, many of the old myths about Fibromyalgia remain alive and well. We felt it was time to dispel the myths surrounding Fibromyalgia.

Real or Busted?: Fibromyalgia affects the muscles and joints.
Busted: While the pain from FM feels like it is coming from the muscles and joints research has failed to show any damage to the musculoskeletal system. There is no reported damage to the muscles or joints in people with Fibromyalgia.

Real or Busted?: Fibromyalgia is just another form of arthritis.
Busted: Fibromyalgia has been shown to be a neurologic disease affecting the central nervous system. Thanks to research we know that FM is not an inflammatory condition. There is no inflammation to either the muscles, bones or joints.

Real or Busted?: Fibromyalgia is a womans disease.
Busted: While the numbers have shown a large rate of women reporting Fibromyalgia symptoms some researchers attribute this to a woman's willingness to seek medical care, while men tend to shy away from doctors. Many children's aches are written off as growing pains, but a number of health care providers are taking a child's claim of pain seriously. In actuality Fibromyalgia affects men, women and children of all ages. It has also been suggested that since Fibromyalgia is more prevelant in people who have suffered physical, sexual or mental abuse that more women may suffer as they are the one of the largest groups of people targeted by abusers.

Real or Busted?: Fibromyalgia is an autoimmune disease.
Busted: There is no known research to prove that FM is caused by any virus or bacteria. Nor has it ever been proven to be an immune disorder. (Many people with FM also suffer with autoimmune disease, such as Chohn's, Sjogren's or thyroid disease, but no link has been made between the two.)

Real or Busted?: Fibromyalgia is all in your head, just a psychological problem or depression.
Busted: It is a known fact that the level of Fibromyalgial patients with depression is no higher than that of people suffering from other chronic illnesses. The illness causes the depression, not the other way around. Fibromyalgia is a real disorder with documented biological abnormalities, such as;
Low levels of serotonin, dopamine, cortisol.
Abnormal levels of "substance P," a neurotransmitter that helps your brain process pain signals.
Low levels of nerve growth factor.
Decreased blood flow to certain areas of the brain that may help you control your pain sensitivity and cognitive functions.
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FDA issues precautionary note on silver fillings
6/12/2008, 11:37 p.m. ET By LAURAN NEERGAARD
The Associated Press

WASHINGTON (AP) — Silver dental fillings contain mercury, and the government for the first time is warning that they may pose a safety concern for pregnant women and young children. The Food and Drug Administration posted the precaution on its Web site earlier this month, to settle a lawsuit — making the move a victory for anti-mercury activists.

The warning is not aimed at the general population, only at two groups already urged to limit mercury from another source — seafood — because too much can harm a developing brain.

The fillings, formally known as dental amalgams, "contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses," reads the FDA Web posting.

That doesn't mean it truly harms, and the FDA advises against removing existing fillings.

The agency still is studying whether the small amount of mercury vapor released by chewing and brushing is enough to cause neurologic disorders or other problems in youngsters. There have been only a handful of rigorous studies comparing children given either amalgam fillings or tooth-colored resin composite fillings that are mercury-free — and those studies haven't detected any brain problems.

Nor has that research settled the long-simmering scientific controversy. Two years ago, the FDA's own independent scientific advisers said that while amalgam fillings were safe for most people, more research was needed about potential effects on fetuses and children under 6.

And this spring, the FDA put dentists on notice that it is considering additional controls, including whether to require warnings that would advise consumers of the mercury in amalgams before they have a cavity filled, or perhaps even restrict use in small children and certain other patients. It is accepting public comments until July 28.

"It's an open question what we will do," FDA Deputy Commissioner Randall Lutter told The Associated Press. But, "what this says is there's a clear intent on our part on labeling for sensitive subpopulations."

Expect a final ruling by July 28, 2009, a date set by that legal settlement.

"It's a watershed moment," said Michael Bender of the Mercury Policy Project, who with other advocacy groups had sued the FDA in hopes of forcing restrictions on amalgams.

"This court settlement signals the death knell for mercury fillings," added Charles Brown, an attorney for Consumers for Dental Choice.

Not so fast, say dentists who point to medically crucial reasons to use amalgams — and worry that people who can't afford more expensive alternatives might avoid dental care.

"We don't want these choices taken away based on junk science. We don't want them taken away based on misguided fears," said Dr. Edmond Hewlett, a dental professor at the University of California, Los Angeles, and an American Dental Association adviser.

Amalgam fillings are about 50 percent mercury, joined with silver, copper and tin. The hardened mixture makes the mercury less absorbable by the body than the kind found in fish, said Hewlett, who chose an amalgam filling for his own 7-year-old son.

Used since the 1800s, amalgams' popularity already is dropping. They account for about 30 percent of U.S. fillings, still millions of people a year.

They're cheaper than alternatives — roughly $100 for an amalgam filling versus $150 or more for a composite, Hewlett estimates — and they're known as particularly durable. Hewlett said two conditions that demand amalgams: Spots on back teeth that dentists can't keep dry long enough for a composite filling to bond, and in people who forcefully grind their teeth.

Science operates on "a precautionary principle," said Dr. Karl Kieburtz, a University of Rochester neurologist who co-chaired the 2006 FDA advisory committee and praised the new warning.

"For 99 percent-plus of people, there probably isn't harm. But if there is a group of people who might be at risk, they should at least have the knowledge that may be so," he said.

Several other countries limit amalgams, either as a precaution in pregnant women and small children or because of environmental concern. Dental workers make amalgam fillings by mixing liquid mercury with powdered ingredients, requiring special safety steps and filters to limit waste seeping back into the environment.

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On the Net:

FDA amalgam info: http://www.fda.gov/cdrh/consumer/amalgams.html

How to comment: http://www.regulations.gov

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Prescription Assistance Programs

Most pharmaceutical companies have established programs to help people who do not have health insurance or drug coverage.

Such programs are a valuable resource for millions of Americans. If you need medicines for a chronic condition and have no health insurance, limited insurance, or lack of drug coverage you must read this article. It contains important information about PAP's - short for prescription assistance programs.

You must have adobe reader installed to access this article.

http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/money-saving-guides/english/AssistancePrograms-FINAL-April2007.pdf

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FDA OKs New Migraine Drug Treximet

Treximet Combines the Migraine Drug Imitrex With a Pain Reliever - By Miranda Hitti

April 16, 2008 -- The FDA has approved a new migraine drug called Treximet for the acute treatment of migraine attacks, with or without aura, in adults.

Treximet is a combination of sumatriptan (the active ingredient in the migraine drug Imitrex) and the anti-inflammatory painkiller naproxen sodium (the active ingredient in Aleve and Naprosyn).

Treximet is expected to be available in U.S. pharmacies by mid-May, according to a joint news release from GlaxoSmithKline and Pozen, the drug companies marketing Treximet.

GlaxoSmithKline and Pozen say that in clinical trials, Treximet worked better than a placebo or either of its two active ingredients alone, with relief lasting from two to 24 hours. Treximet also trumped a placebo at reducing symptoms associated with migraines, such as nausea and sensitivity to light and sound.

In clinical trials, Treximet was generally well tolerated, according to the drug companies; the most common adverse events reported within 24 hours of taking Treximet were dizziness; nausea; sleepiness; chest
discomfort; pain in the neck, throat, and jaw; tightness and pressure; numbness or tingling; and dry mouth.

WebMD reported on the drug last year, before its name change from Trexima to Treximet.

GlaxoSmithKline and Pozen note that Treximet may cause an increased risk of serious cardiovascular clotting events, such as heart attack and stroke, and shouldn't be given to patients with heart disease.

And because naproxen sodium is a nonsteroidal anti-inflammatory drug,

Treximet carries a risk of serious gastrointestinal problems, including bleeding and ulcers.
View Article Sources Sources

SOURCES: FDA: "Drug Details: Treximet." News release, GlaxoSmithKline and Pozen.

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Bill designed to help fibromyalgia sufferers

Legislation to help fibromyalgia patients has been introduced in the Missouri General Assembly.

House Bill 2243, sponsored by Rep. Shalonn 'KiKi' Curls of Kansas City, would require the Missouri Department of Health and Senior Services to create a Missouri Fibromyalgia Panel.

The panel would raise at least $50,000 to establish an information and outreach campaign that would focus on issues such as early diagnosis and treatment, prevention of complications and improving quality of life.

The panel also would work with other state and local agencies to promote fibromyalgia training and education programs for physicians and other health professionals.

The bill includes provisions to allow health providers in certain cases to override restrictions imposed on drugs by pharmacy benefit managers.

Fibromyalgia is a chronic condition characterized by fatigue and widespread pain. The condition is more common among women than men. Curls' mother has suffered fibromyalgia for several years.

(c) 2008 The Kansas City Star

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New Support Group for our Friends In Northern Utah.

Contact Person: Jan Chambers. 435-753-4148.

This is a free prrogram offered by a non-profit organization for patients, families, and friends.

Meetings are the second Saturday of each month.
290 North 100 West, Logan, UT.
11:30 AM - 1:00 PM.

Please visit the NUFC website at
www.nufibroconn.org
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Fibromyalgia Support Group of Winnipeg
825 Sherbrook St.
Winnipeg, Manitoba
R3A 1M5
Canada

www.fmswinnipeg.com
Phone number is (204) 975-3037
Leave a message and your call will be returned.

Meetings are the first Monday of every month except Jan, July, and August. at the Society for Manitobans with Disabilities (SMD) Building at
825 Sherbrook St. Karen Klos/Chairperson
FM Support Group of Winnipeg


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