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For Widely Used Drug, Question of Usefulness Is Still Lingering
NY Times ^ | September 2, 2008 | ALEX BERENSON

Posted on 09/03/2008 1:41:52 AM PDT by neverdem

When the Food and Drug Administration approved a new type of cholesterol-lowering medicine in 2002, it did so on the basis of a handful of clinical trials covering a total of 3,900 patients. None of the patients took the medicine for more than 12 weeks, and the trials offered no evidence that it had reduced heart attacks or cardiovascular disease, the goal of any cholesterol drug.

The lack of evidence has not stopped doctors from heavily prescribing that drug, whether in a stand-alone form sold as Zetia or as a combination medicine called Vytorin. Aided by extensive consumer advertising, sales of the medicines reached $5.2 billion last year, making them among the best-selling drugs in the world...

--snip--

Ezetimibe is in a similar situation. The medicine has been proved to lower patients’ LDL, or bad, cholesterol by 15 to 20 percent...

(Excerpt) Read more at nytimes.com ...


TOPICS: Government; News/Current Events
KEYWORDS: ezetimibe; fda; health; medicine; vytorin; zetia
Sales Slip

This isn't as bad as it sounds. Maybe the hypothesis of just lowering LDL-chlesterol will lower coronary artery disease was incorrect?

1 posted on 09/03/2008 1:41:53 AM PDT by neverdem
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To: neverdem

Take non-flush niacin and it will lower your cholesterol better than any prescribed drug .


2 posted on 09/03/2008 3:14:36 AM PDT by Renegade (You go tell my buddies)
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To: neverdem

Statins are a fraud and they will make the Phen-Phen lawsuits look like childs play eventually, IMHO.

Statins do reduce your LDL or bad cholesterol. However, there is no correlation between lowering your cholesterol and reducing your risk of heart attack or stroke. Half the people who die of HA or stroke have normal cholesterol. Americans have the lowest cholesterol since they have been keeping track due to statins but it has not changed the number of deaths due to cardiovascular disease.

So why foist statin on the public? Its a muli-tbillion dollar industry. Just like Vioxx was a multi-billion/year drug but now was exposed as dangerous. But, no doctor in a doc-in-box clinic ever questioned it due to kickbacks from drug manufacturers, until the deaths started.

There is too much collusion between the FDA and drug manufacturers that do too little testing of drugs before they hit the market to check their efficacy or safety.

Yes, all this is my opinion.


3 posted on 09/03/2008 4:51:22 AM PDT by WaterBoard
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To: WaterBoard
"Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006."1

"Over the two years of the trial, patients who took Zocor alone reduced their LDL by 41 percent on average, while patients who took Vytorin reduced their cholesterol by 58 percent. Yet despite the larger cholesterol reduction, patients taking Vytorin actually had more growth of fatty plaque in their carotid arteries than those on Zocor."1

I wonder if insurance companies and patients will get a refund for a drug that even the manufacturer says does not work as advertised.

1) http://www.nytimes.com/2008/01/15/business/15drug.html?fta=y&pagewanted=all
4 posted on 09/03/2008 4:56:11 AM PDT by WaterBoard
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To: WaterBoard
“Statins are a fraud “
>>.................
I do not know your back round in pharmacology, but that statement is false..with the introduction of statin therapy
Mevacor-and now several others which are more effective, the drop in cardiac deaths, strokes, across the world has been dramatic. Statins not only reduce total cholesterol but provide anti inflamatory effects which reduce strokes, and MI’s...large studies have show: statins reduce strokes by 24% and MI’s by 30% in trails of over 68,000 subjects see
LIPID trial as one example. there are dozens of such trails that all support the data. Addition of niacin is useful in elevated LDL therapy when used in combination with statins.
5 posted on 09/03/2008 5:13:35 AM PDT by shadowgovernment (From the Ashes of a Republican rout will raise a Conservative Party)
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To: WaterBoard; shadowgovernment
So why foist statin on the public?

Because more than a few studies have shown that statins provide morbidity and mortality benefits with respect to coronary artery disease and , IIRC, ischemic cerebrovascular accidents, i.e. the more common form of stroke. Unfortunately, in subgroup analysis, those benefits are not found in all demographic cohorts, and the adverse effects can be considerable.

Great Drug, but Does It Prolong Life?

6 posted on 09/03/2008 7:49:31 AM PDT by neverdem (I'm praying for a Divine Intervention.)
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To: El Gato; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; LadyDoc; jb6; tiamat; PGalt; Dianna; ...
Marriage problems? Husband's genes may be to blame

Scientists grow 'nanonets' able to snare added energy transfer

FReepmail me if you want on or off my health and science ping list.

7 posted on 09/03/2008 8:11:02 AM PDT by neverdem (I'm praying for a Divine Intervention.)
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To: shadowgovernment
Researchers at the University of Toronto, Canada, now report on an analysis of the use of statins in 42,000 patients of whom 90 per cent had no history of cardiovascular disease. The participants received either a statin or a placebo for at least one year and were followed up for between three and five years. Taking statins was associated with a reduction of nearly 30 per cent in heart attack and 14 per cent reduction in stroke risk. But there was no overall reduction in all cause mortality or death from cardiovascular disease.1

Archives of Internal Medicine 27th November 2006

Questioning the benefits of statins

the ALLHAT study says it best:9 "trials [primarily in middle-aged men] demonstrating a reduction in [coronary artery disease] from cholesterol lowering have not demonstrated a net reduction in all-cause mortality." What is the point of decreasing the number of "events" without decreasing overall mortality, when the harm caused by the side effects of statin therapy is factored in?

http://www.cmaj.ca/cgi/content/full/173/10/1207-a
8 posted on 09/03/2008 9:59:42 AM PDT by WaterBoard
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To: WaterBoard

you might look at the following studies that did show overall reduction in mortality: in decending order
4S study, (scandinavian simvastatin survival study),
LIPID study(longterm intervention with Pravastatin in Ischemic Disease)
CARE study (Cholesterol and recurrent events trial)
WOSCOPS study (West of Scotland coronary prevention study group)..
some limits to 1yr or less on statins studies is that benefits are not as great as continued therapy studies ..
Even if total mortality is not reduced..few patients have
such severe side effects to statins as to have the need to withdraw therapy: Some medications or medical conditions interact and may increase risk of liver disease/myopathy
while on therapy. The FDA has considered making some statins available without a prescription.


9 posted on 09/03/2008 4:30:46 PM PDT by shadowgovernment (From the Ashes of a Republican rout will raise a Conservative Party)
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To: Renegade
Take non-flush niacin and it will lower your cholesterol better than any prescribed drug .

Except for the people who go into anaphylactic shock from it.

10 posted on 09/03/2008 4:33:38 PM PDT by Harmless Teddy Bear (Just say No to Lawyers! McCain/Palin '08)
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To: Harmless Teddy Bear

Then again, 50% of people who die from heart attacks have high
cholesterol . Guess what the other 50% have .


11 posted on 09/03/2008 5:41:18 PM PDT by Renegade (You go tell my buddies)
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To: WaterBoard

“Half the people who die of HA or stroke have normal cholesterol.”

Also, one of the principal side effects from taking statins is dementia.

But I guess they can just prescribe another drug for that, right?


12 posted on 09/03/2008 8:11:57 PM PDT by webstersII
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To: shadowgovernment

“the drop in cardiac deaths, strokes, across the world has been dramatic. “

But IIRC those effects are not due to lowered cholesterol, they are due to the blood thinning properties of the statins. There are safer ways to get thinner blood than with statins.

Also, the long-term Framingham study showed no difference in longevity of those who have lower cholesterol, in fact it showed the opposite.


13 posted on 09/03/2008 8:18:45 PM PDT by webstersII
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To: Renegade
Guess what the other 50% have .

Weak hearts?

14 posted on 09/04/2008 4:59:03 AM PDT by Harmless Teddy Bear (Just say No to Lawyers! McCain/Palin '08)
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To: webstersII
“There are safer ways to get thinner blood than with statins.”
>>>>.................
all blood “thinners” warfarin, asa, plavix..have much more serious side effects (GI bleed,hemorrhagic stroke) than statins..
Statins are not perfect, but I hope you would not advocate stopping them in at risk patients, as That would be a great disservice to those patients..Most cardiologists I think would agree with me.
15 posted on 09/04/2008 6:20:28 AM PDT by shadowgovernment (From the Ashes of a Republican rout will raise a Conservative Party)
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To: Harmless Teddy Bear

Bad Genes .


16 posted on 09/04/2008 7:23:31 AM PDT by Renegade (You go tell my buddies)
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To: Renegade
Same thing really. I lost two brother-in-laws to heart failure before they turned 60. It was the same thing that killed their dad in his 30's.

Better medical treatment kept them alive longer but it was only a matter of time.

17 posted on 09/04/2008 7:34:56 AM PDT by Harmless Teddy Bear (Just say No to Lawyers! McCain/Palin '08)
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To: WaterBoard
So why foist statin on the public?

Because the Atkins Diet would be too effective - and bankrupt half the major political campaign contributors in the USA. ;)

18 posted on 09/04/2008 7:37:59 AM PDT by Mr. Jeeves ("One man's 'magic' is another man's engineering. 'Supernatural' is a null word." -- Robert Heinlein)
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To: shadowgovernment

“The FDA has considered making some statins available without a prescription.”

Sure, the FDA can make any drug available without a prescription, but that does not make the drug any less dangerous or effective.

Look at NSAID’s. The kill many Americans every year and they are freely available OTC. Tylenol is hepatotoxic and anyone can buy it.

In fact, OTC medications as a category are responsible for more than 150,000 hospitalizations every year, according to the Food and Drug Administration, and almost 1000 OTC medications have been linked to liver toxicity, which causes about 2000 deaths annually in the United States (Ford MD et al 2001).

I am cynical about the drug industry. Is it really necessary for women over the age of 65 to require 10 different medications daily according to Medicare?

American’s are over consumers of prescriptions compared to the rest of Western world and certainly the 3rd world. That would be fine, if you had a corresponding decrease in morbidity or mortality for the billions we spend out of pocket.


19 posted on 09/04/2008 7:58:59 AM PDT by WaterBoard
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To: shadowgovernment

“Statins are not perfect, but I hope you would not advocate stopping them in at risk patients”

My point is that the whole paradigm is wrong. High cholesterol is not the issue with heart disease, and generally speaking, a medication that has side effects of dementia is not something that people should be taking.


20 posted on 09/04/2008 7:33:58 PM PDT by webstersII
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