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.
___
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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