Merck... no approval for new drug

[Guest guest]

Dunno if you have read the following:

FDA say's NO to new anti cholesterol drug from Merck

(my comments in italics) please not... I do not believe English is the authors first language, however the article is readable.

 

Two years ago, cardiologists and researchers talked excitedly about a golden age of heart drugs, when the cholesterol market would expand beyond statins to novel medicines that would revolutionize the treatment of heart patients.The announcement late Monday the Food and Drug Administration had rejected a new cholesterol pill from Merck (YEH!!!! at last perhaps they have noticed that drugs like these do not work and are dangerous?) was only the latest setback for cardiac medicine. Coming on the heels of the Vytorin controversy and, before that, the failure of Pfizer's torcetrapib, the denial of Merck's application for Cordaptive means there are no new therapies on the immediate horizon to treat an estimated 100 million Americans with high cholesterol, experts said yesterday.The New Jersey drugmaker had been talking up its B-vitamin-based cholesterol tablet as a valuable addition to its cardiovascular franchise and a replacement for Zocor,(follow the dollar $$$$ Zocor has gone generic) the blockbuster statin that lost patent protection in June 2006. Wall Street analysts projected it could generate more than $1 billion in annual sales.No wonder investors were disappointed yesterday, sending shares of Merck plummeting."We plan to meet with the FDA," Ron Rogers, a Merck spokesman, said yesterday. "We continue to believe in this product. It's an important option for physicians to manage their cholesterol." (a typographical error perhaps? it says ' for physicians to manage their Cholesterol!...' does not say manage patients cholesterol - grin)Some heart experts said they were always cautious about the prospects for Cordaptive, but the FDA's rebuff is bigger than Merck. It's a clear setback in the hunt for the Holy Grail of heart pills: a safe, effective way to lower LDL, or bad cholesterol, while raising HDL, or good cholesterol. Doctors theorize raising HDL may reverse plaque build-up in the arteries, which figures in heart attacks and strokes. (Please note that doctors THEORIZE!)The most promising HDL-raising candidate, Pfizer's torcetrapib, failed in clinical trials in late 2006 and left the world's largest drug company with no successor for Lipitor, the No. 1-selling statin, which loses patent protection in early 2010.Statins, by far the top-selling pills in the $21.6 billion global cholesterol market, have been shown to reduce LDL, but they are not very effective at increasing HDL. The only HDL-boosting treatment currently on the market is Niaspan, a niacin-based drug marketed by Abbott Laboratories.Niacin, one of the B vitamins, can be difficult to tolerate at doses necessary to raise HDL because it can cause flushing, itching and hot flashes. Abbott is working on a new version to cut the adverse side effects.Merck's experimental pill combines niacin with a new medicine, called laropiprant, which is supposed to alleviate facial flushing. Yesterday, Merck and the FDA declined to specify the reasons the FDA gave for rejecting Cordaptive in a "nonapprovable letter" it issued Monday night. The company previously acknowledged "theoretical" safety concerns about its effect on the liver. (emphasis mine)"I don't know what FDA was thinking, none of us do," said Allen Taylor, a research cardiologist at Walter Reed Army Medical Center who was skeptical of Merck's drug."There have not been any studies of laropiprant alone, and what the marginal benefit is of taking two drugs to do what one drug does," he said in a telephone interview yesterday. "There's a large degree of uncertainty."Merck has a long-term, 20,000-patient study of Cordaptive under way that compares the drug to a placebo, rather than niacin alone. To be completed in 2012, it will be closely watched, because little is known about the long-term effects of its flushing-blocker.Rogers said Merck is continuing development of yet another new heart pill, a combination of Cordaptive and generic Zocor. He said it plans to submit an application to the FDA later this year."There's no change on that at this time," he said.Cordaptive is important to Merck because sales of Vytorin, which is co-marketed with Schering-Plough, have been hurt by controversy this year over a study that found it worked no better than generic Zocor -- a drug five times less expensive -- at reducing blockages that cause heart attacks.The Vytorin controversy has touched off a wider debate about the importance of controlling LDL. The most extreme skeptics worry lower LDL may not translate into preventing heart attacks, strokes and deaths. (extreme skeptics? hummmmm.... guess they mean ME?)Because of excessive accumulation of cholesterol in various diseases caused by the large number of people today. But how can we help ourselves consumption out of surplus cholesterol? Now take a look at the U.S. experts to provide us with the health of fresh single.

(some good comments here below) Emphasis mine!Cholesterol is an essential human nutrient. It not only as a body composition, or material of many important raw materials, but the large number of long-term intake of cholesterol is not conducive to good health and will increase serum cholesterol, increasing the risk of suffering from cardiovascular diseases and induced fatty liver.According to the U.S. daily health network, through long-term study, the United States Loma Linda University researchers of the latest research results show that has been suffering from hypercholesterolemia to the people ate 10 kinds of food the following:Apple: because rich pectin, cellulose and vitamin C, a very good lipid-lowering effect. If eating two apples a day, adhere to a month, most people in the blood low-density lipoprotein cholesterol (harmful to the cardiovascular) will be reduced, and on cardiovascular beneficial high-density lipoprotein cholesterol level will rise.Carrots: calcium-rich pectin, acid and bile from a chemical reaction in the stool from. The body is bound to generate will be spent on bile acid in the blood cholesterol, thereby contributing to the level of cholesterol in the blood decreased. Yein http://wf66.com/ Corn: rich in calcium, phosphorus, selenium and lecithin, vitamin E, have reduced the role of serum cholesterol.Oysters: rich in zinc and bezoar acid, in particular the bezoar acid can promote decomposition cholesterol, help lower blood lipid levels.Almond: normal or slightly higher cholesterol levels of people, can be used to replace the almond meal in the low density of food nutrition, to reduce blood cholesterol and maintaining heart health purposes.Kelp: the rich bezoar acid, can reduce blood pressure and cholesterol in the bile; containing food fiber alginic acid, can also inhibit the absorption of cholesterol and promote excretion.Garlic: synthesis of cholesterol can reduce the liver. Just a day to eat three garlic, would effectively reduce the harmful cholesterol, the good cholesterol increased, the incidence of heart disease by 50 per cent.Milk: with more calcium, can inhibit the synthesis of cholesterol in the activity can also reduce the body s absorption of cholesterol.Miju: rich in vitamin C, eat the liver detoxification can increase capacity, speed up the transformation of cholesterol, lower serum cholesterol and blood fat content.Tea: containing caffeine and TP, refreshing, strong heart, diuretic, and lipid-lowering Consumers tired of the function. Regular tea drinking can prevent the body s cholesterol increased.The above are my success by the experience of high cholesterol. Only a year to reduce the (original 50% higher than the normal value). Now the fifth year, all the normal review last week.

 

taken from: http://www.productsherbal.com:80/food/fda-rejects-merck-s-new-cholesterol-pill.html

 

 

http://www.grisoft.com Anti-Virus Scanned this message

 

[Guest guest]

But do we really need anti-cholesterol drugs at all?

 

According to recent articles here we do not need to reduce our cholesterol levels. We are safer to leave them as they are.

 

As a homeopath I'm not so interested in drugs at all - except of course I do need to tell all my nursing patients what to expect from which drugs -

how their symptoms are related to this drug or that drug ......... but very few really want to know! No one wants to believe that the good old family Dr would do them harm - either through carelessness, care less attitude or ignorance!

 

Jane

 

 

-

 

Clares Primus

Undisclosed-Recipient:;

Saturday, May 03, 2008 11:52 AM

Merck... no approval for new drug

 

Dunno if you have read the following:

FDA say's NO to new anti cholesterol drug from Merck

(my comments in italics) please not... I do not believe English is the authors first language, however the article is readable.

 

Two years ago, cardiologists and researchers talked excitedly about a golden age of heart drugs, when the cholesterol market would expand beyond statins to novel medicines that would revolutionize the treatment of heart patients.

[Guest guest]

It is my assumption

that GP's are far too busy to read the published scientific literature

they rely on what the TGA/FDA/Big Pharma Sales Reps tell them. They do not treat patients as individuals at all...... patients MUST fit the mold..... fit within the recomended guidelines. I personally cannot remember the last time a GP physically examined me. And (don't get me started here) they know nothing about nutrition!

 

Shut up Clare (grin)

 

C in Tassie

 

 

 

 

 

 

[Guest guest]

HERE is the business Week article about this rejection

 

FDA Rejects Merck's CordaptiveGiven the cholesterol-lowering drug's modest test results and unknown long-term effects, rejection by regulators may not be that surprising

http://www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm

[Guest guest]

Hi Clare,

I agree with you 100%.

Thanks and take care,

Josephine

 

 

, " Clares Primus "

<mcharris wrote:

>

> It is my assumption

> that GP's are far too busy to read the published scientific literature

> they rely on what the TGA/FDA/Big Pharma Sales Reps tell them. They

do not treat patients as individuals at all...... patients MUST fit

the mold..... fit within the recomended guidelines. I personally

cannot remember the last time a GP physically examined me. And (don't

get me started here) they know nothing about nutrition!

>

> Shut up Clare (grin)

>

> C in Tassie

>