| T O P I C R E V I E W |
| Dave |
Posted - 01/08/2007 : 10:06:55
 Yet more evidence of the sad state of affairs...
By Lewis Krauskopf
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 the first clearance by the U.S. Food and Drug Administration for a fibromyalgia treatment, which could occur as soon as 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."
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| 17 L A T E S T R E P L I E S (Newest First) |
| Hilary |
Posted - 01/11/2007 : 10:51:44
quote:
Originally posted by alexis
[quote]Originally posted by atg
I also like Hilary's point about how the black and white thinking is TMSy. It seems very perfectionist and goodist. And yet those of us here urging the more "rational" (not the perfect word) attitudes towards the drug companies' actions, are we also guilty of TMS sin? By that I mean not allowing ourselves to be mad because we know it is irrational? Or are some mad and just not saying it, because that is different than feeling it?
That's an interesting question.
I've found that doing some cognitive work around reducing my inclination to leap to extremes helps me to reduce conscious anger (as opposed to unconscious rage). That, for me, is another aspect of the TMS work (keeping track of the conscious stuff so that it doesn't back up into pool of the unconscious). It seems to help. But, yeah, it's doubtless wise to keep an eye on whether or not there's some suppression going on. A TMS-er's job is never done!
In this particular instance my opinion's based on the simple fact that I've met an awful lot of nice, ethical, hard-working people from a wide range of backgrounds, including pharma companies and advertising agencies. This leads me to conclude that companies are made of people, and that people are a mixed bag, and the situation really is very complex.
[COMPLETELY OFF-TOPIC] This discussion reminds me of something else. Before I discovered Sarno, I belonged to a forum for folk with anxiety disorders (which is what I was diagnosed with - read undiagnosed TMS). Those people were among the most reactive and angry I've ever come across. The tiniest comment would regularly explode into rage. Thinking about it now, it just confirms for me that anxiety IS a TMS equivalent - the personality is exactly the same!! [completely off-topic] |
| Littlebird |
Posted - 01/10/2007 : 16:17:31
quote:
Originally posted by alexis
I also like Hilary's point about how the black and white thinking is TMSy. It seems very perfectionist and goodist. And yet those of us here urging the more "rational" (not the perfect word) attitudes towards the drug companies' actions, are we also guilty of TMS sin? By that I mean not allowing ourselves to be mad because we know it is irrational? Or are some mad and just not saying it, because that is different than feeling it?
Actually, I'm pretty sure I'm not even mad at the drug companies on this kind of thing, I guess because my expectations are not very high in this area--sort of like how I wouldn't ever even remotely expect a politician to tell the truth. Some things just are not part of the way the real world functions.
The exception is maybe in some areas of animal testing where I allow my feelings of rage to flow a little more freely. I'm not trying to open up a discussion here on animal welfare or anything, just an observation that despite my relative defense of the drug industry I do occasionally myself experience a little bout of outrage.
I relate to these comments. It's sometimes hard to decide just which thinking may be part of the TMS personality. I do see "black and white" thinking in perfectionistic family members and myself at times.
I agree that one needs to be realistic about the world, and so I don't really feel angry at the pharmaceutical companies in general, even though I wish they were more altruistic rather than driven by profit. But they are publicly owned companies and that usually seems to play a big role in a company's attitude about profit. One point I read in the book I mentioned is that while the drug companies make a big deal out of the cost of research and development, those costs are tax deductions for them, and when they research "orphan drugs," which aren't expected to be profitable, the government helps with the costs, so it's not like they really have to pass huge costs along to patients in order to survive.
I forgot to include the title of the book, in case anyone is interested; it's The Truth About the Drug Companies: How They Deceive Us and What to Do About It, by Marcia Angell, M.D. She spent 20 years with The New England Journal of Medicine, so it seems to me that her impressions are probably pretty accurate. I'm not into the politics of it all--I read the book because my family uses a lot of medications, particularly my husband.
I am mad at my local pharmacy, since I discovered after a year of paying cash for a medication that the pharmacy priced at $160 for a month's supply, that I can get the same medication from Costco for $18 per month. I should have checked Costco's price sooner, rather than assuming that there would not be enough of a price difference to make it worthwhile to pay for the gas to drive 60 miles round trip to Costco. Live and learn--don't assume. I also paid $36 per month for another med that I now get from Costco for $6. Aggravating. I know Costco gets great discounts, but the local guy can't be paying all that much more for it. I guess he figures most people have insurance to cover it. I'll be glad when I can work my way completely off of the pain meds I've been taking. |
| alexis |
Posted - 01/10/2007 : 14:27:11
quote:
Originally posted by atg
Faulting CEOs of pharmaceutical comanies for wanting to make as much money as possible is like faulting a coach for wanting to win. If they're not good at it, someone else who is will replace them to satisfy the stockholders. It's simply social darwinism.
I think that you have it there. There isn't a choice to "play nice". But like johnnyg says, we can regulate the hell out of the players.
I also like Hilary's point about how the black and white thinking is TMSy. It seems very perfectionist and goodist. And yet those of us here urging the more "rational" (not the perfect word) attitudes towards the drug companies' actions, are we also guilty of TMS sin? By that I mean not allowing ourselves to be mad because we know it is irrational? Or are some mad and just not saying it, because that is different than feeling it?
Actually, I'm pretty sure I'm not even mad at the drug companies on this kind of thing, I guess because my expectations are not very high in this area--sort of like how I wouldn't ever even remotely expect a politician to tell the truth. Some things just are not part of the way the real world functions.
The exception is maybe in some areas of animal testing where I allow my feelings of rage to flow a little more freely. I'm not trying to open up a discussion here on animal welfare or anything, just an observation that despite my relative defense of the drug industry I do occasionally myself experience a little bout of outrage. |
| atg |
Posted - 01/10/2007 : 14:12:33
Faulting CEOs of pharmaceutical comanies for wanting to make as much money as possible is like faulting a coach for wanting to win. If they're not good at it, someone else who is will replace them to satisfy the stockholders. It's simply social darwinism. |
| Stryder |
Posted - 01/10/2007 : 00:06:25
Gosh, I just can't imagine where I would be now if I hadn't discovered the work of the Good Doctor. I am soooo lucky.
-Stryder |
| Littlebird |
Posted - 01/09/2007 : 18:58:47
It's true that not everyone in the pharmaceutical industry is just interested in money, but many of the people in charge of the companies are making choices based solely on profit. An eye-opening book about just how the drug companies and the FDA work was written by the former editor-in-chief of The New England Journal of Medicine, someone who was in a position to see things that the rest of us only hear rumors or bits and pieces of.
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| h2oskier25 |
Posted - 01/09/2007 : 15:04:34
Did I mention that big Pharma has tried and succeeded in some places in Europe to get Vitamins taken off of the market, so that now you need a perscription just to take Vitamins? This is happening in some places in Europe.
Still, I'm sure big Pharma means well . . .
Beth |
| Hilary |
Posted - 01/09/2007 : 14:48:40
I think this discussion demonstrates the TMS perfectionist, black/white personality to a "T".
"Drug companies" are neither "evil and crazy" or angels with wings working for the greater glory of mankind. Like pretty much everything else on this planet, they're somewhere in the middle.
Pharma companies are made up of an lot of individuals, many of whom believe they're doing some pretty important work, given the available research. They miss sometimes, and they hit sometimes. I can think of a number of meds developed in the last 30 or so years that have kept me - and the people I love - safe, pain-free (physically and emotionally), and alive. I'd be surprised if most of us don't have some reason to be grateful to modern meds.
If you want to think in terms of evil and crazy, feel free. Can't see how it's going to help the ol' TMS, though.
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| h2oskier25 |
Posted - 01/09/2007 : 14:14:03
JohnnyG,
You are wrong. A substance that exists naturally cannot be patented.
What you bring up is another outrage. The drug companies tried to patent particular genes (i.e. the gene that causes breast cancer, the gene that causes Diabetes, etc), but they couldn't get around the old occuring in nature thing, so what the gov't has done to cater to them is let them patent all RESEARCH on a particular gene. This is even worse. If a drug company gets a patent on the gene that causes breast cancer, they can decide to do research, or NOT. They can just let it sit there !!!
Anybody who wants to do research on that gene has to get specific permission from the patent holder.
It's crazy, it's evil, and I hope the whole thing gets cut short quick, before it gets out of hand.
Beth |
| johnnyg |
Posted - 01/09/2007 : 13:15:26
The drug companies also did the same thing to the guy who invented the vaccine for polio. That cure cost the drug companies plenty. The fact of the matter is they love it when there is a mass need for drugs that only treat symptoms because people keep buying the drugs over and over again--this is what is happening with allergy meds today. And that is exactly what will happen with the Fibro drug whether or not it is TMS (which I am sure it is).
Of course it is unrealistic to "sit back" and expect corporations to act in the interest of anything but profits, but with concerted effort it is possible. Corporate charters can be revoked by the states that grant them, it's just that they've been given carte blanche by the american system of politics. There is no impetus for politicians to bite the hand that feeds them.
I think you meant to say that a natural process can't be patented. There is a controversial federal court case that I think did in effect grant the right to patent a natural substance. Isn't that what's going on in the world of micro biology or bio-chemistry?
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| alexis |
Posted - 01/09/2007 : 12:26:42
Let me be more specific. I would give the drug companies a break with regard to the quest to find either a cure or symptom treatment for fibromyalgia. I have other reservations regarding drug companies, which differ somewhat from Beth's, but do not give them a general pass.
On the other hand, I don't think it is realistic to sit back and ask large capitalist corporations to "act ethically"--and pretending that any really do or ever will will only get you into trouble. That will never happen as a matter of economic survival and it is pointless to be shocked every time they fail to meet unrealistic expectations.
In a democratic society I think it fair to blame the voting populace every bit as much as any company for it's role in where to and not to regulate industry. Such societies pretty much get the government they deserve.
(OK, technically I don't really buy into the whole blame concept, but it acts as a good simplification here...just hedging agaist the valid claim that my use of "deserve" isn't entirely rational.) |
| h2oskier25 |
Posted - 01/09/2007 : 12:02:41
Sorry Alexis,
The drug companies don't deserve a break. They go after anybody who comes up with a "cure" to something that doesn't include room for their enormous profits.
If you don't belive me, just one incidence of this is well documented in the book "The Burzynski Breakthrough" by Thomas D. Elias. The book is written by a reporter, outraged at what the drug companies tried to do to Stanislav Burzynski, a Doctor who repeatedly cures several different kinds of cancers at his clinic in Houston. First the drug companies tried to steal his patents, then tried to force him out of business.
Also, in 1992, Congress passed a law so that the PRIVATE drug companies would partially fund the FDA. WHAT! You read right. In 1992 Congress passed a law so that the PRIVATE drug companies now partially fund the FDA employees. Hmmmm. THAT doesn't sound like a conflict of interest to me . . . 
The truth is that any natural substance can't be patented (nor can journaling, for that matter) and so the drug companies must lead the fight against anything natural.
I think it's become a very nefarious system, indeed.
Beth |
| alexis |
Posted - 01/09/2007 : 11:39:20
Assuming fibromyalgia is TMS, I see this as sad, but not really evil or unexpected. We know that most people don't believe, and don't really want to believe, that pain conditions can be caused psychologically. People on this site run up against this just talking to their friends about Sarno.
The drug companies are made up of people just like all of our friends, many of whom have back pain, RSI and even fibromyalgia themselves. Within the bounds of what they can accept, and our current economic framework, they are looking for the best answers possible. I don't know, I just would give them a bit of a break. |
| johnnyg |
Posted - 01/09/2007 : 11:28:47
I think the clinical trials are only for FDA approval and that if they don't outright know the drugs don't work, they at least know that they only treat symptoms and are not a cure. In fact, I would go as far as to say that not only do they know they don't really work, but they don't really even care. |
| tennis tom |
Posted - 01/08/2007 : 21:25:36
Nah, they think the meds work, all the good science behind them in the clinical trials and the scientists with the test tubes and bunson burners. |
| ndb |
Posted - 01/08/2007 : 18:33:52
My god..."potentially lucrative market", its sickening. These companies are pushing drugs that they must know don't really work. |
| Littlebird |
Posted - 01/08/2007 : 15:46:54
More money for the pharmaceutical companies. Interesting that they influence the decisions about what are legitimate conditions and legitimate treatments. Without financial incentives, no wonder Dr. Sarno's work isn't being accepted by mainstream medicine. It's not really about helping patients, it's about profit. |
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