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Old 04-17-2005, 04:55 PM   #1
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A quote from Pfizer about Lipitor

All,

You probably already know this, but in case you don't - think abou it...

Statins are currently one of the most prescribed drugs on the market. They are prescribed specificially to reduce one's ldl cholesterol level, and therefore reduce the risk of heart disease and heart attacks for those that have "high cholesterol" (as defined by the current guidelines).

Can anyone provide a coherent explanation why on the Lipitor web site (run by Pfiser), and on tv commercials for Lipitor, the following disclaimer appears - and this is an exact, word-for-word quote from the web site:

-----------------------------------------------------------------------
Important information:

LIPITOR@(atorvastatin calcium) is a prescription drug. It is used with a low-fat diet to lower cholesterol.

LIPITOR is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may get pregnant. It has not been shown to prevent heart disease or heart attacks.
------------------------------------------------------------------------

Am I totally missing the point - or have we been taking a drug prescribed to prevent a disease when the manufacturer says the drug doesn't prevent it!!!

Is this any way to run an airline???

HubbleRules

Last edited by HubbleRules; 04-17-2005 at 04:57 PM. Reason: bad grammar!!!

 
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Old 04-17-2005, 05:25 PM   #2
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Re: A quote from Pfizer about Lipitor

I have seen and heard that MANY times. I'll bet if U questioned them, or your dr. this is the answer U would get:

The drug doesn't prevent heart attacks, but high cholesterol might give U one, so by taking it and reducing your cholesterol, therefore U are avoiding the high cholesterol from giving you one. I'm willing to bet my house on that answer.

Trust me, if U have a question, THEY have an answer all ready for ya. Guess what, Pfizer is opening another plant here in CT. Oh wow, the money must be pouring in for them. I know, I'm bad...CYL....

 
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Old 04-17-2005, 05:30 PM   #3
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Re: A quote from Pfizer about Lipitor

I think they just say that about the heart attacks in case someone has one while using their product, they can't be held responsible and be sued. I was taking Zocor but I keep getting muscle pains and the last time I tried it, it gave me some permanent damage to my left side. Not bad but I won't take another statin drug.

 
Old 04-17-2005, 05:36 PM   #4
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Re: A quote from Pfizer about Lipitor

JJ,

These inconsistencies and contradicting studies (on all sides of the debate) are driving me nuts!!!!

Becoming a beach bum is looking more and more desireable...

Are you up for it???


HubbleRules

 
Old 04-17-2005, 05:43 PM   #5
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Re: A quote from Pfizer about Lipitor

ROTFL...YES, I am most definitely ready to become a beach bum. Let's get this show on the road fella....

I gave up a LONG time ago trying to figure these drug companies out, my brain was turning to mush. Hope U had a good day, it was gorgeous here, and man, did I go like the wind to do some spring cleaning. I have a long way to go before done, but at least it was a start. I'm getting way too old for this, I need a 2 room house. Just swept the garage, now I feel like Pig Pen, so best hit the shower before Desperate Housewives comes on.


CYL....

 
Old 04-18-2005, 12:11 PM   #6
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Re: A quote from Pfizer about Lipitor

Yeah,
In answer to you question, You ARE missing the point.
Here's what the Pfizer and the FDA ACTUALLY say:
Quote:
Also Approved to Reduce Risk of Chest Pain and Revascularization Procedures
NEW YORK, NY -- (MARKET WIRE) -- 08/02/2004 -- Pfizer Inc (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved its cholesterol-lowering therapy LIPITOR® (atorvastatin calcium) for the prevention of cardiovascular disease by reducing heart attack risk in people with normal to mildly elevated levels of cholesterol but with other risk factors for heart disease.

The FDA's decision was based on the findings of a landmark clinical trial, known as the Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA), which found that LIPITOR, at its lowest dose of 10 mg, reduced the relative risk of heart attack by 36 percent compared to placebo. Because of the significant benefits seen with LIPITOR early in the trial, ASCOT-LLA was halted approximately two years ahead of schedule. The safety profile of the group treated with LIPITOR was comparable to that of the group treated with placebo. The trial involved more than 10,300 people with normal or borderline cholesterol and no prior history of heart disease, but with high blood pressure and at least three other known risk factors for heart disease, such as family history, age over 55, smoking, diabetes and obesity.

"Despite fairly normal cholesterol levels, patients with multiple risk factors face a greater threat of heart attack," said David Waters, M.D., F.A.C.C., Chief of Cardiology at San Francisco General Hospital, CA. "Adding LIPITOR to their treatment regimen, as the data demonstrate, reduces that threat dramatically. It's becoming increasingly clear that LIPITOR provides cardiovascular benefits that go well beyond lowering cholesterol."

Updated guidelines recently issued by the National Cholesterol Education Program confirm the added benefit of prescribing cholesterol-lowering medication like LIPITOR, along with diet and exercise, to patients at risk for cardiovascular disease.

Mike Cummo, a 55-year-old design consultant from Rockville Centre, NY, has a family history of heart disease and is taking medication to manage his blood pressure. "Even though my blood pressure is under control and my cholesterol isn't high, I'm still worried about my increased risk of having a heart attack," he said. "I want to watch my grandson grow up so I'm going to ask my doctor about taking LIPITOR."

The FDA also approved LIPITOR to reduce the risk of angina (chest pain) and to reduce revascularization procedures, such as balloon angioplasty, that help open blocked arteries.

CVD Impact

Every year, more than 865,000 Americans suffer a heart attack. There are 7.8 million people in the U.S. who are heart attack survivors. High blood pressure and elevated cholesterol are the leading risk factors for heart disease but other factors compound the risk, including family history of heart disease, age over 55, smoking, diabetes, obesity and lack of exercise. Direct (medical costs) and indirect (lost productivity) costs related to coronary heart disease are expected to exceed $133 billion in 2004.

"Today's FDA approval of LIPITOR's additional uses further supports the growing body of evidence showing that LIPITOR provides significant cardiovascular benefits in a broad range of patients beyond its excellent efficacy in lowering cholesterol," said Gary Palmer, M.D., Vice President of Pfizer Cardiovascular's Medical Group.

LIPITOR is the leading cholesterol-lowering therapy in the world with more than 76 million patient years of experience. Since the introduction of LIPITOR seven years ago, its safety and effectiveness have been supported through the Atorvastatin Landmark Program™, an extensive clinical program with more than 400 ongoing and completed trials involving more than 80,000 patients.

Last edited by Lenin; 04-18-2005 at 12:13 PM.

 
Old 04-18-2005, 01:22 PM   #7
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Re: A quote from Pfizer about Lipitor

Hi ! HubbleRules,

Just wanted to say that I am so scared NOT to take my meds., for
' High Cholesterol ', I might just ' kill over and DIE ' !

OH, ****, I might anyway. With my luck I would be like Dr. Atkins.
However, I would get my levels on a perfect scale, and certainly NOT
slip on any ice,
but maybe trip on my way next door, (I am serious !) sneaking icecream,
from the Fast Food Restaurant !

Try not to get too stressed out. lol.

Sometimes, ' Life's a Beach ' !

Later....,
Gee Gee

Yep, it's back to bed for me.
Good luck with your debate......, Ya'll have FUN !

 
Old 04-18-2005, 05:41 PM   #8
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Re: A quote from Pfizer about Lipitor

Quote:
Originally Posted by Gee Gee
Hi ! HubbleRules,

Just wanted to say that I am so scared NOT to take my meds., for
' High Cholesterol ', I might just ' kill over and DIE ' !

OH, ****, I might anyway. With my luck I would be like Dr. Atkins.
However, I would get my levels on a perfect scale, and certainly NOT
slip on any ice,
but maybe trip on my way next door, (I am serious !) sneaking icecream,
from the Fast Food Restaurant !

Try not to get too stressed out. lol.

Sometimes, ' Life's a Beach ' !

Later....,
Gee Gee

Yep, it's back to bed for me.
Good luck with your debate......, Ya'll have FUN !
Gee Gee,

I'm not remotely stressed - I actually enjoy the give and take...

I hope the statins work for you - most people are able to tolerate them without side effects... Hopefully they will help you get your health issues under control...

We're all here to try to help others. That's all I'm doing.

Just making people aware of alternatives, so they can make an informed decision...

HubbleRules

 
Old 04-18-2005, 05:45 PM   #9
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Re: A quote from Pfizer about Lipitor

Lenin,

Come on dude! You don't for a minute expect me to take a Pfizer Public Relations statement seriously, do you????

Can't you do any better than that???

It's sort of like asking Bill Gates if he thinks Windows is a secure computer operating system....


Live long and prosper,


HubbleRules

 
Old 04-18-2005, 07:25 PM   #10
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Re: A quote from Pfizer about Lipitor

Lenin,

You should get a kick out of this FDA Approval memo - it's every bit as legit as yours, and is for Baycol, the statin drug which was recently pulled from the market due to safety concerns.

So much for 'FDA Approval"...

HubbleRules

======================================== =================

For Immediate Release



FDA approves new dose of Baycol® for the treatment of elevated cholesterol
Powerful new dosage and additional indications broaden therapeutic use


May 25, 1999 ---- Bayer Corporation, Pharmaceutical Division, today announced the Food and Drug Administration's (FDA) approval of a 0.4mg strength of Baycol® (cerivastatin sodium tablets) as the recommended dose for patients with primary hypercholesterolemia (elevated cholesterol) and mixed dyslipidemia (elevated cholesterol and high triglycerides). This powerful new dose will be available at the same affordable price as the 0.3mg dose of Baycol®. Baycol® belongs to the statin class of agents and is co-marketed in the United States with SmithKline Beecham.

In one clinical study of 349 patients, 40% of patients on the 0.4mg of Baycol® achieved a greater than 40% reduction of low-density lipoprotein cholesterol (LDL-C). The 0.4mg dose of Baycol® will help treat a wider range of the 91 million Americans who suffer from elevated cholesterol. In addition, Baycol® received expanded indications to reduce triglycerides (TG) and apolipoprotein B (apo B) in patients with primary hypercholesterolemia and mixed dyslipidemia.

"These new indications are the first step toward achieving the enormous potential of Baycol®. We are continuing to scientifically evaluate higher doses of Baycol® as well as its unique potential in special patient populations," said Mel Sorensen, M.D., Director, Medical Research, CardioPulmonary and Oncology, Bayer Corporation.

The 0.4mg approval is based on clinical data from two large (n= 571), multicenter, placebo-controlled dose response studies of patients with primary hypercholesterolemia. Results showed that with 0.4mg of Baycol® every day in conjunction with dietary therapy for eight weeks, patients achieved mean reductions in low-density-lipoprotein cholesterol (LDL-C) and total cholesterol (TC) of 34% and 24% respectively. Reductions in apo B levels of 26% were also observed.

EA median TG reduction from baseline of 30% was observed in a pool of seven studies where patients with hypercholesterolemia and TG levels ranging from 250mg/dL to 500 mg/dL (n=105) were treated with the 0.4mg dose of Baycol® for eight weeks. The median reduction for all patients in the studies was 16%. Reductions in patients' TG are baseline dependent.

Baycol® was initially launched in 1998 at 0.2 and 0.3mg strengths as an adjunct to diet for the reduction of elevated total cholesterol and LDL-C in patients with hypercholesterolemia and mixed dyslipidemia, when the response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone had been inadequate.

Baycol®, an HMG-CoA reductase inhibitor, is now indicated as an adjunct to diet for the reduction of elevated TC, LDL-C, apo B and TG levels in patients with primary hypercholesterolemia and mixed dyslipidemia (Fredrickson Types IIa and IIb) when response to dietary restriction of saturated fat and cholesterol and other non-pharmacological measures alone has been inadequate.

Patients with hypercholesterolemia should be placed on a standard cholesterol-lowering diet. If the response to dietary restrictions of saturated fat and cholesterol and other non-pharmacological measures is inadequate, patients should continue on their diet, and then begin treatment with Baycol®. The recommended dose of Baycol® is 0.4mg once daily, in the evening, with or without food. In patients with significant renal impairment (creatine clearance £ 60mL/min/1.73m2) lower doses are recommended. No dosing adjustment is required in the elderly, with the exception of those patients with significant renal impairment.

Baycol® is contraindicated in patients with hypersensitivity to any component of this medication, in patients with active liver disease or unexplained persistent elevations of serum transaminases, in women during pregnancy, and in nursing mothers.

Baycol® should be temporarily withheld from any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (acute serious muscle disease), e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine or electrolyte disorders or uncontrolled epilepsy.

Rare cases of rhabdomyolysis have been reported with cerivastatin and with other drugs in this class. Myopathy (a disorder of muscle tissues or muscle) should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of plasma creatine kinase (CK). Patients should be advised to report promptly unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. The combined use of Baycol® and gemfibrozil should be avoided.

It is recommended that liver function tests be performed before the initiation of treatment, at 6 and 12 weeks after initiation of therapy or elevation in dose, and periodically thereafter, e.g. semi-annually.

The risk of myopathy is increased with concurrent administration of cyclosporine, fibric acid derivatives, erythromycin, azole antifungals or lipid-lowering doses of niacin. In pharmacokinetic studies, no drug to drug interactions were observed with warfarin, digoxin, cimetidine, omeprazole and nifedipine.

Baycol® is generally well tolerated. In the U.S. placebo-controlled clinical studies, discontinuations due to adverse events occurred in 2.8% of cerivastatin sodium tablet-treated patients and in 2.2% of patients treated with placebo. In worldwide clinical trials with over 4,000 patients, the most common adverse events regardless of causality were pharyngitis, rhinitis, headache and sinusitis.

The sNDA for the 0.4mg dose of Baycol® was filed on July 16, 1998 and approved on May 25, 1999. The label change to indicate reduction in TG and apo B was also approved on May 25, 1999. Baycol® was initially cleared for marketing by the FDA on June 26, 1997.

Baycol® is currently available in numerous countries including, Argentina, Australia, Canada, France, Germany, Italy, Japan, Mexico, the Philippines, Spain and the United Kingdom.

SmithKline Beecham - one of the world's leading healthcare companies - discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical-laboratory testing, disease management, and pharmaceutical-benefit management.

Bayer Corporation is a research-based company with major businesses in health care and life sciences and chemicals. The company had 1998 sales of $8.1 billion and employs more than 23,000 people. Bayer Corporation is investing $15 billion in capital expenditures and research and development from 1995 through the year 2004. 1999 capital investment and R&D expenditures are projected to total $1.6 billion. Bayer Corporation, with headquarters in Pittsburgh, is a member of the worldwide Bayer Group, a $31 billion international life sciences, polymers and specialty chemicals group based in Leverkusen, Germany.

 
Old 04-18-2005, 08:20 PM   #11
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Re: A quote from Pfizer about Lipitor

Yep! Just more poppycock from those money hungry drug companies!
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Old 04-18-2005, 08:41 PM   #12
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Re: A quote from Pfizer about Lipitor

I was on Baycol after Lipitor, and that stuff cured me of taking statins. I got so weak on that stuff I could barely make it up the stairs after going out to check my mail. My dr. cut me down to only 3 days a week with it, and it still was horrid. When U have to stand at the foot of a set of stairs and PRAY U can make it up them, I say no thanx, I'll take my chances.

Everyone has their own experiences with statins, and good luck to those that can take them, but for us that did suffer on them, what good is taking them if your QUALITY of life is shot?? I'd rather be active with elevated cholesterol, then have to sit around like an invalid with low cholesterol.

Hopefully some kind of break thru will come along that will be safe, and also help us with our numbers, but for now, I will continue to do research and experiment with diet, exercise and supplements. JMHO

 
Old 04-19-2005, 04:50 AM   #13
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Re: A quote from Pfizer about Lipitor

I am one of those who do not tolerate statins. I know all data from a pharmaceutical company will always be slanted for their benefit. I had faith in MD’s at one time but I am quickly losing that in light of my statin experiences. Last year I met with a new doctor who asked me to try Crestor. After a week I developed so much leg pain I could hardly walk. I went back to that MD and told him about the pain. He prescribed Bextra for the pain. I quit going to that MD. Treating the side effect of a medication with another medication does not make good sense to me. Now Bextra has been pulled from the market. The next MD insisted I try Vytorin and when the side effects became intolerable and I called his office they told me my chart says the MD told me to stop Vytorin. This doctor was screaming at the top of his lungs tell me I was going to die if I didn’t take this medication. I no longer go to him either!
I have always tried to go along with my MD, TRUSTING that he would do his best for me, no longer will I do that. I will question, research, and try to be as much a part of my well-being as I can. My goal is to improve my quality of life and enjoy my remaining years, not to see how long I can live.
IMO, I would rather have five good years without statins than ten miserable years with statins.
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Last edited by don444; 04-19-2005 at 04:52 AM.

 
Old 04-19-2005, 05:53 AM   #14
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Re: A quote from Pfizer about Lipitor

Scratching head???

Yes, Hubble, if you are going to title a Post "A quote from Pfizer about Lipitor" it certainly SOUNDS like you take what Pfizer says seriously.
Have you forgotten what you typed? It's the first line on this page!

 
Old 04-19-2005, 03:01 PM   #15
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Re: A quote from Pfizer about Lipitor

Quote:
Originally Posted by HubbleRules
All,

You probably already know this, but in case you don't - think abou it...

Statins are currently one of the most prescribed drugs on the market. They are prescribed specificially to reduce one's ldl cholesterol level, and therefore reduce the risk of heart disease and heart attacks for those that have "high cholesterol" (as defined by the current guidelines).

Can anyone provide a coherent explanation why on the Lipitor web site (run by Pfiser), and on tv commercials for Lipitor, the following disclaimer appears - and this is an exact, word-for-word quote from the web site:

-----------------------------------------------------------------------
Important information:

LIPITOR@(atorvastatin calcium) is a prescription drug. It is used with a low-fat diet to lower cholesterol.

LIPITOR is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may get pregnant. It has not been shown to prevent heart disease or heart attacks.
------------------------------------------------------------------------

Am I totally missing the point - or have we been taking a drug prescribed to prevent a disease when the manufacturer says the drug doesn't prevent it!!!

Is this any way to run an airline???

HubbleRules

Hi folks,

I'm new to this board, but I believe only pravachol and zocor have been shown in clinical studies to prevent heart attacks/heart surgery.. etc...
lipitor has not shown these results... Though it is the most popular statin..
lipitor is a "synthetic" statin as is crestor.. pravachol/lovastatin and zocor are "natural"

 
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