Progress In Treating Fibromyalgia Is Being Shanghied By Commercial Greed
Anne Hillebrand
01/08/07
In late 2000, I started sharing a very inclusive list of FMS symptoms all over the internet. Because I had almost every symptom now known, and we reversed it suddenly, the full array became clear for the first time that we know.
Those with medical histories of having these symptoms for years began to realize that this is what they have. Information did not create the demographic; it just had not been easy to see before.
With more and more baby boomers rolling into the "over 40" group that comprises those with Fibromyalgia, the numbers skyrocketed.
As we have been able to better describe other symptoms, I have added them to the web site. The nightmarish list can include sudden headaches, loss of balance, brain fog and body wide pain that makes even tough old birds cry in their sleep.
The pain I experienced in both arms, both legs and lumbar is best described as "like a compound fracture with an ice pick stuck in it". It was almost constant for 6 months when I was full-blown before we found a way to treat it.
Since late 2000 I have sent short notes about this treatment method to tens of thousands of researchers, physicians, patients, message boards, etc all over the internet. All the "associations" for FMS, CFS, ME have received notes from me. Anyone who has even made a cursory trip though online message boards about FMS has seen posts I leave about the free information.
Many college and hospital research and specialty departments have also gotten emails from me about this. But it's not what most of them want to hear. There's not really any big money to be made with this treatment.
If what we have learned is acknowledged and desemminated, the lid of the overflowing treasure chest of research grant money now being enjoyed would slam shut.
Lewis Krauskpopf's recent article, below, tells much of what is happening in Fibromyalgia health care, but also repeats much of the "spin". I extend my apologies to him for using it as the skeleton for this article.
I have interjected my comments - as someone who is living with this illness and helping others to beat the symptoms - and is able to follow what is going on.
Progress in treating Fibromyalgia is being Shanghied by Commercial Greed.
Obscene amounts of money are being made on the backs of helpless sufferers.
I believe an over-the-counter expectorant-based cold and flu medicine provides a good example of this.
About three years ago a company applied for FDA approval and a US Patent for slow release Guaifenisin, which had been on the market since before the FDA became an entity. The applications were approved; the med went over the counter. No longer available with an insurance co-pay, the price is about 7 times what it was prior to this action.
Until 2003 I could get 1200 mg tablets of slow release Guai for .16 retail per caplet at any Sam's club phamacy with my doctor's prescription. It was covered by insurance and I paid $10 copay for any monthly amount prescribed.
Now, products based on the new approval are $12.00 for 30 tablets, and only 400 mg - 1/3 the dose. That's about $1.20 for a less useful product at the same amount we were getting for .16
The patent approval has given that single applicant an almost competition-free market and at seven times the price.
This all came about when it became apparent that Guaifenesin could be used effectively to treat people with Fibromyalgia, and that the numbers of sufferers was so high.
The combination treatment method I devised uses even greater quantities of this medication for each patient than had previously been the norm. It is just a daily treatment, also, so the medication is needed every day, not just for short term treatment.
It is commonly expressed that the newer product is not an equivalent replacement for the original, either, as it is a tablet with two parts; on half dissolves more quickly, the other later or at a different rate. This is sometimes called "dose-dumping". The original prescription product consistently released over the course of 12 hours.
For that reason, many with Fibromyalgia are not able to make the newer product work for our illness.
This new situation has essentially eliminated our access to effective medication that was readily available and affordable.
To get what I need without any other potentially problematic ingredients, that means getting prescription- compounded slow-release Guaifenesin. For my severity of symptoms, that means about $750 per month now - no longer covered by insurance - to be equal to what used to cost me $10 copay. With their discount, that was about enough to cover what my insurance company was paying for it.
Competition between more than a dozen generic manufacturers and perhaps 100 generic distributors for this old, trusted medication kept the cost at a fair price. It still must have been worth making, or they wouldn't have done it.
Walgreen's now has a 400 mg Guaifenesin tablet in standard release for $9.99 for 30 tablets. That's about $1 for the same size we used to buy for .16, and it's not even slow release.
I have been able to manage even my own extremely severe Fibromyalgia for over 6 years. Instead of being totally disabled and in excruciating pain, I have a life. Pain free without pain pills. It's not totally easy, but it's do-able. Until 2003 I worked full time.
Sharing what we have learned - using only our very modest household income and a web site that is amateur at best - I have been able to help thousands of people do the same thing.
My own local doctor has been able to help hundreds of patients over the past few years without charging extra and still accepting insurance plans and Medi. He is one of a kind.
Commercial greed is driving companies and individuals that provide care, medication, research and information to keep the world in the dark about the actual nature of Fibromyalgia, deliberately muddle what has already been learned, and block information about successfully treating it.
People who want your money are lying to you about Fibromyalgia.
Misinformation and recirculated, outdated information are rampant, with the goal to make Fibromyalgia an illness that will support outrageous profits for years to come.
The pleas to have currently available medicines approved for FMS are playing off the "everyone will believe this illness if we get approval" pseudo-benefit.
Because of the large numbers of sufferers, it's easy to forget that each one is an equally valuable life, enslaved by their illness. Their suffering is being systematically exploited and protracted simply for money. It's not that hard to do when the victims are "brain-fogged" and not being protected as they should .
Their vulnerability is increased by not receiving disability benefits they are rightfully due in a timely manner, or not at all. It is also due to government's lack of respect for this illness and its continued funding of reasearch that has produced little or no benefit to patients. Overpriced meds they are having to buy out of pocket are eating away at Fibro's financial stability like scruvy felling conscripts.
Progress in treating Fibromyalgia is being Shanghied by commercial greed and it is an outrage.
Red = Major points
Orange = Bogus info (because we do know.)
Green = Bogus info (because it purposely restates past, limited or outdated conceptions.)
Purple = Incorrect based on our experience.
Drugs Nearing Approval For Mysterious Pain Condition
By Lewis Krauskopf Sun Jan 7, 11:03 AM ET
NEW YORK (Reuters) - Not all doctors are sure about the pain and fatigue condition known as
fibromyalgia, but drug companies are racing to win U.S. regulatory approval to serve this potentially
lucrative market.
The sometimes-debilitating disorder afflicts an estimated 2 percent to 4 percent of Americans, mainly women.
But diagnosing fibromyalgia is not easy because its cause remains unknown and its symptoms, which also include depression, can overlap with other conditions.
With no test to confirm fibromyalgia, doctors rely on patient complaints of symptoms and subjective responses to physical exams. As a result, some physicians are wary of viewing it as a distinct ailment.
Still, a who's who of pharmaceutical companies -- including Pfizer Inc., Eli Lilly & Co., Forest
Laboratories Inc. and Wyeth -- are looking to seize on a market now dominated by older anti-
depressants as well as painkillers and other drugs.
"What they're thinking is: This has a huge, untapped, unmet need," said Maria Marzilli, an associate
analyst with market research firm Decision Resources.
Decision Resources expects sales for drugs used for fibromyalgia to roughly triple to at least $1 billion
by 2014.
The companies are vying for clearance of their prby the U.S. Food and Drug Administration for a
fibromyalgia treatment, 2008.
Doctors can prescribe medicines for fibromyalgia even though the drugs are not cleared specifically
for it. However, without FDA approval, companies cannot promote the drugs as treatments for that
condition.
Therefore, even though doctors already may be prescribing Pfizer's Lyrica and Lilly's Cymbalta for
fibromyalgia, positive clinical data and U.S. regulatory approval for that use could jump-start sales.
"This is a nice way to tack on $200 to $300 million more in sales," Marzilli said.
VALIDATION
An FDA approval could also quell doubts about the disorder's legitimacy, while paving the way for
companies to promote medicines specifically for fibromyalgia. To be sure, doctors and consumers
will hear more about the condition as the drug makers rev up their powerful marketing engines,
possibly sparking more widespread diagnosis.
"If the FDA approved a drug for fibromyalgia, that would really give the field validity," said Richard
Harris, a molecular biologist and research investigator at the University of Michigan who recently
published a data review of fibromyalgia.
In most cases, the companies are conducting clinical trials in fibromyalgia for drugs already approved for other conditions. Lilly, Forest and Wyeth have said they are testing anti-depressants that regulate two brain transmitters, serotonin and norepinephrine. Pfizer is testing a drug cleared for epileptic seizures and neuropathic pain.
As classified by the American College of Rheumatology in 1990, a fibromyalgia diagnosis involves
a patient feeling muscle tenderness in at least 11 of 18 predetermined sites on the body, with the pain spread throughout the body.
Fibromyalgia patients also tend to tire easily, struggle to sleep and have trouble remembering things, a problem referred to as "fibro fog."
But patients often receive other diagnoses before their doctors decide they have fibromyalgia. Lynne Matallana, founder and president of the Orange, California-based National Fibromyalgia Association, was an advertising executive and avid skier and bicyclist in the early 1990s until she began experiencing widespread pain and fatigue that left her bedridden.
She said she had seen 37 doctors and received diagnoses of lupus, rheumatoid arthritis and depression before a physician finally identified her condition as fibromyalgia.
"It's devastating because it is totally life-altering, and many, many, many people find themselves in this situation," Matallana said. She added that she gradually improved through exercise, meditation and medication.
REVIEW RESULTS
In their review, Harris and a colleague at the University of Michigan reported evidence of increased neurological responses to pain, indicating that the central nervous system of a fibromyalgia patient
processes pain differently.
Traumatic events -- such as a car accident -- may trigger the condition. Matallana said her fibromyalgia
flared up after she underwent surgery for another ailment.
"I think that some physicians do believe that fibromyalgia isn't a real condition, and our job to spread
the word that there are objective findings that these people are in pain," Harris said.
But Dr. Scott Zashin, a rheumatologist in private practice in Dallas, says fibromyalgia is one of the more common conditions he sees.
Zashin says he usually tries to get fibromyalgia patients to exercise more or get more rest before turning to medication.
"These patients seem to have an increased sensitivity to pain," Zashin said. "Something in their makeup
makes them experience pain differently."
I have brought myself, by long meditation, to the conviction that
a human being with a settled purpose must accomplish it,
and that nothing can resist a will that will stake even existence for its fulfilment.
Benjamin Disraeli Endymion (1880) Ch. 26
