Anti-Cholesterol Drug Bombs In Tests

Study Finds No Benefit To Adding Zetia To Combo Drug Regimen

(CBS/AP)  Shares of Merck & Co. and Schering-Plough Corp. fell Monday after study results showed their combination cholesterol drug Vytorin worked no better at reducing artery-clogging plaque in a group of high-risk patients than high doses of generic Zocor.

The delayed Enhance study results had been anticipated with caution by Wall Street, with analysts saying data on both safety and effectiveness have the potential to impact future sales. While Vytorin reduced levels of "bad" cholesterol much more than Zocor in the study and was shown to be safe and well-tolerated, it ultimately failed to lower the level of artery-clogging plaque.

Vytorin, which had sales of nearly $2 billion in 2006, is a combination of Schering-Plough's Zetia and Merck's Zocor, which lost patent protection in 2006.

Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic, told CBS News anchor Katie Couric that he would advise doctors to quit prescribing Vytorin, since it was not shown to be more effective than Zocor.

"My advice to physicians is not to use this drug Vytorin nor to use Zetia as first line agents any more. These should be really relegated to drugs of last resort until we have some evidence that they produce a health outcomes benefit," he said. "Right now, five years into this, with nearly 1 million prescriptions per week being written, there is no evidence that the drugs actually produce any benefit for patients."

However, Nissen urged consumers to talk to their doctors before stopping the drug.

"People should talk to their doctor. No one should stop taking medication because they hear a news report," Nissen said.

Shares of Whitehouse Station, N.J.-based Merck fell $1.23, or 2 percent, to $59.32 in afternoon trading while shares of Kenilworth, N.J.-based Schering-Plough tumbled $2.06, or 7.4 percent, to $25.67.

The study focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. They were given either Vytorin or a high dose of generic Zocor, known as simvastatin.

Safety concerns about liver damage have hovered over Vytorin amid a stricter regulatory atmosphere. In December, a congressional committee requested more information on the Enhance study, which began in 2002. The results were delayed, the companies maintained, because of the complexity of the data. In addition to Enhance, the companies are conducting three additional studies involving more than 20,000 high-risk patients.

Despite the data, Goldman Sachs analyst James Kelly reaffirmed a "Buy" rating on Schering-Plough, calling the results a "non-event" which doesn't represent Vytorin's commercial prospects. He said the results reaffirmed the drug's safety, which had been the key concern of Wall Street.

Earlier in January, Merck Chief Executive Richard T. Clark was similarly confident in reaffirming his expectation that Vytorin would maintain its position in the cholesterol drug market.

However, Banc of America Securities analyst Chris Schott reaffirmed a "Neutral" rating on Schering-Plough with a price target of $32. He said the results raise several questions about Vytorin's effectiveness, which will likely go unanswered until the company presents the data at the annual American College of Cardiology meeting in March.

"We view this as a double-edged sword," Schott said, in a note to investors. "While positive for Vytorin, Enhance also supports safety of the high 80-milligram dose of generic Zocor."

Elsewhere in the sector, Pfizer Inc. is facing yet another challenge to Lipitor, the world's best-selling drug. The basic patent for the cholesterol drug is now under review by the U.S. Patent & Trademark office at the request of Ranbaxy Laboratories Ltd., which is seeking to make a generic version.

The drug had sales of $12.89 billion in 2006. Pfizer is appealing the decision and said the patent will remain protected throughout the lengthy review process. Lipitor's patent is set to expire in 2010.

Shares of New York-based Pfizer fell 15 cents to $23.87.

[robleighton1]

There does seem to be amble evidence to suggest that lowering LDL cholesterol and managing other aspect of blood lipids will improve cardiovascular health. And it also is trye that many people can manage these lipids effectively without medications.

Sure we can blame Big Pharma for pushing statins, but at the end of the day, many people prefer to take that single pill as opposed to the more significant task of modifying diet, incorporating positive and active nutrients such as plant sterols, soluble fiber, niacin and Omega-3s, and getting more exercise. In many ways, this is not different from the obesity issues.

And we have a health insurance system that will enable statin consumption (it pays for these meds even when the more natural approaches may work just fine)....without providing similar incentives for the more natural approaches. And finally, we allow a massive spend on consumer advertising for these medication, dwarfing the public health consumer educatiion campaigns that promote alternatives.

Overall, the "statin" issue is really is symptomatic of broader societial decisions we face.

[drscareme]

I predict in the next 5-10 years all of these meds/vaccines will have been pulled. More giant lawsuits like the 48 million dollar one currently pending with Fosamax...and it will go on.
We are going to have to start building more nursing homes and assisted care facilities to care for the ever growing number of folks (and younger and younger) who will have no choice but to give up their homes and independance after being damaged by all of these "wonder" drugs.
I wonder, will Merck and all the other BIG PHARMA giants help finance this???
Wake up...when you see these drugs being marketed like the next new ipod, ask yourself WHY? Wouldn''t/shouldn''t MY DOCTOR already know what medicines would help me? Why do I have to be brainwahshed into believing that my cholesterol needs to be 10 in order to not have a heart attack? That is the most bogus "number" out there. We NEED cholesterol in our bodies...do some research and see what GOOD it does and what damage these evil drugs are doing to you.
Yup, take your statins but be prepared for some serious long term side effects (rare...yeah, ha ha ha).
There is a lot of money floating around out there in the BIG PHARMA world and it ISN''T being used for the good of our general health.
BIG MONEY=PEOPLE INJURED DYING.
How DO the FDA folks and BIG PHARMA sleep at night..oh yeah..lunesta!!!
Good Luck...

[drscareme]

Wake up people! Doesn''t this story tell you that BIG PHARMA is only about the MONEY!? Why not report results? Oh yeah, they''d lose money.
All of these drugs are dangerous and I wouldn''t give them to my dog!
Statins cause a host of side effects.
Check out www.spacedoc.com and see what you have coming down the road when you start your "safe" statin regimine.
Add to the list the new "head meds" (resperdil, zoloft, welbutrin, etc.) migraine meds, Fosamax (farce-a-max and Bonita (bone-EATER)and the lovely new poorly tested and totally UNPROVEN Gardasil vaccine. The drug companies are using us as giant guniea pigs and CASH COWS. It is all about the money, NOT helping people stay healthy.

[prinzowhales]

If you want to correct heart and circulatory problems, your first line of attack should be Straus Heart drops and radical changes in your diet and exercise regimen...under guidance of someone who knows what they are doing...and not just trying to hawk stents and CABGs.

Cancer--like all disease--is caused by toxins and/or malnutrition. There are a host of alternative cures and it is best to consult with a professional to decide which one is best...or you can just endure the usual butcher, burn and poison nonsense recommended by the dedicated hawkers of Big Pharma''s nostrums.

[prinzowhales]

Cholesterol is your bodies answer to an insult to arterial walls...Homocysteine is often the culprit for this...If you look at the data on first time MIs your correlation between cholesterol and MIs break down. Statins are sold by Big Pharma''s chump physicians to ignoramuses...of course the sweet, sweet benefits of presribing Big Pharma nostrums... the speaking fees, the money for conducting surveys, the invitations to speak at gatherings in exclusive resort areas and vacation meccas...well, that just doesn''t affect the judgment of medical ''professionals'' who get an on-line course in nutrition in medical school and die at an earlier age than Cuban sugar cane workers. After murdering 60,000-plus Americans with the patent nostrum Vioxx, we''ve yet to hear any mea culpas from the medical profession.

[prinzowhales]

Merck covered this up for over a year...a year in which patients could have been seeking a solution that worked...

http://www.newstarget.com/022505.html

The biggest Scam that Big Pharma has ever push on the public is these poison statin drugs. The most profitable pill they sell and they have train all doctors to make this the first order of business by making incentive deals with physicians. These drugs will be taken off the market one day and 50 years from now our posterity will look back at this golden age of drugging all Americans. A generation ago your cholesterol needed to be under 240, but they found they could triple their profits if they lowered it to 200. The side effects leads to other problems so the physicians can prescribe more drugs for Big Pharma''''s coffers.

[deraj1013]

Duh1050 failed to mention that his crackpot doctor McCully lost his job at Harvard for his strongly held (but scientifically unsubstantiated) theories. For some people, like diabetics, diet and exercise aren''t enough to control heart disease. Diseases like atherosclerosis are absolutely connected to cholesterol. Quantitative scientific research also supports the relationship between cholesterol and heart disease. Dr. Duh1050, take a stab at reading some academic journal articles about Lipitor before you make generalizations that are not true and mislead those with medical conditions who might need statins to improve their quality of life. Just keep your conspiracy theories to yourself and keep eating the B vitamins.

[duh1050]

Finally CBS National news has exposed the statin drugs for what they are.
Every one should read the book The Heart Revolution by Dr Robert McCully former Harvard professor and how he proved Cholesterol was NOT a factor in heart disease and we do NOT need these statin drugs to control plaque. A daily supplement of B vitamins would control plaque build up in the arteries. How big a kick back do doctors receive from these drug companies?.

[excoachken]

Where do I get my refund. I think my chest is hurting. Aughhhhhhhhh

[carterarce]

"People should talk to their doctor. No one should stop taking medication because they hear a news report," Nissen said.

"You don''t need to see his identification."
"These aren''t the droids you''re looking for."
"He can go about his business."
"Move along."

[timothyone-2009]

I had a new artery blockage every year for most of 10 years until I was put on statins. I have had one since, and it has remained at about 40% for almost 9 years now. I still eat bad, don''t exercise enough, and am diabetic. I can see no other reason for the improvement other than the statins.

[feelfree1]

Re: "Shares of Merck & Co. and Schering-Plough Corp. fell Monday..."

There were 2 recent "accidental" releases of "Foot and Mouth" disease, released by a lab that is co-owned by Merck, in Great Britian.

Tough luck, Merck.

So sad.

[vincan-2009]

We need to bring back honesty and integrity to the FDA. People do not need to be getting medicine that will make them worse or kill them. Once we have a president and congress who care and will protect americans from harmful drugs we will be much better off. Bush has made a practice of putting political appointees in charge of our government departments who have no business in the jobs.

[advocating2]

There are many drugs that companies skew the data for. It is sad that Schering Plough hid the data. The government is trying to stop some of the abuse but as long as the Senior executives are not held personally liable the game goes on.

The government fined Schering for off labeling a drug called Temador and the game still goes on. Sloan Kettering lied to us about that drug for a low grade brain tumor. The drug is not approved for the tumor type nor does the data prove that the drug will help extend a someone''s life.

Unfortunately though because of money the doctors are not honest with their patients. Case in point when my husband found out the truth and did not want to take a non FDA approved drug Dr. Igor Gavrilovic at Sloan Kettering threatened to call the police on me and has written that I am putting my husband in harms way. He is trying to force my husband to take a drug that can cause serious side effects and produce other cancers for the sake of collecting data the drug is only Phase II clinical trials for low grade gliomas.
Sloan Kettering is ignoring my husband''s right under the patient bill of rights to refuse treatment.

We need to hold the doctors and drug companies accountable for unethical behavior.

The biggest Scam that Big Pharma has ever push on the public is these poison statin drugs. The most profitable pill they sell and they have train all doctors to make this the first order of business by making incentive deals with physicians. These drugs will be taken off the market one day and 50 years from now our posterity will look back at this golden age of drugging all Americans. A generation ago your cholesterol needed to be under 240, but they found they could triple their profits if they lowered it to 200. The side effects leads to other problems so the physicians can prescribe more drugs for Big Pharma''s coffers.

[j-whitman]

Anti-Cholesterol Drug Bombs --- Oh no, call Homeland Security it''s the Evil comming to eat us up. These people would do anything to win an election.