Merck, Schering-Plough Sink on Vytorin

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DAMIAN TROISE | March 31, 2008 07:49 PM EST | AP

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NEW YORK — Shares of Merck & Co. and Schering-Plough Corp. fell to record lows Monday, as analysts warned new clinical data would choke sales of their blockbuster cholesterol drug Vytorin, while bringing intense government scrutiny to the companies.

Earlier this year, partial results from a clinical study on Vytorin, which is marketed through a joint venture of Merck and Schering-Plough, showed it was no more effective at limiting plaque buildup than Merck's Zocor, a drug that is already available in generic form. Full results of that study were released Sunday.

Federal and New York State officials have been investigating why results of the study were not released for nearly two years after it ended. The companies have also been chided for their aggressive marketing of the drug in the interim.

According to TNS Media Intelligence, which tracks advertising spending, the companies spent about $472.8 million on advertising since the drug hit the market.

The Senate Finance Committee said in a report Monday that the researcher who led a crucial study of the drug angrily accused Vytorin makers Merck & Co. and partner Schering-Plough Corp. of withholding negative results to boost sales.

"This is the last thing that Schering and Merck need, especially in a political year," said analyst Steve Brozak of WBB Securities Ltd. "This can become brutal."

Vytorin is a combination of Zocor and Schering-Plough's drug Zetia.

Both stocks hit 12-year lows Monday. Schering-Plough shares plunged as low as $14, touching their lowest levels since August 1996, before ending the day at $14.41, down 26 percent. Merck shares fell as low as $36.82, their lowest since June 2006, finishing $37.95, down 15 percent.

Leading physicians are now recommending the use of older drugs called statins, such as like Pfizer Inc.'s Lipitor and AstraZeneca PLC's Crestor, before putting patients on Vytorin. Many physicians had prescribed Vytorin in lieu of higher doses of statins because of what some said was an undue fear of side effects.

"There was an irrationality to begin with," said Dr. John LaRosa, president of State University of New York Downstate Medical Center.

Trouble with Vytorin could lead to a tightening of regulatory standards at the FDA when it comes to approving cholesterol drugs, LaRosa said.

Lehman Brothers analyst Charles Butler downgraded Schering-Plough shares on the news, and cut his price target on the stock by more than 40 percent.

He said prescriptions of Vytorin will keep falling, and because Schering-Plough relies heavily on the joint venture, he slashed his profit estimates over the next five years.

Besides the Vytorin news, Merck also halted enrollment in a study for the cholesterol drug Cordaptive, which uses the same ultrasound measurement from the now-failed Vytorin study.

In a separate statement, the company said high doses of the experimental obesity treatment Taranabant are being cut out of a late-stage study because of higher rates of gastrointestinal side effects, depression and anxiety. The high doses were no more effective than low doses, the company said.

___

AP Business Writer Marley Seaman in New York contributed to this report.


 
 

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Urnnumbersix gets it right! The scenario is all about money.

If they can give you a pill that makes some number go up or down then all they need is a narrative that explains some sort of benefit to the number going one way or another.

My HDL just went up to 58 !!! and my A1c went down 2 whole points !! I feel terrific. The only thing that's worrysome is that my IQ now equals my shoe size. But I hear that they've got a new pill that makes you think you're smart. I'll be all over that one.

    Favorite    Flag as abusive Posted 07:15 AM on 04/01/2008

The clinical efficacy of any of these drugs, including statins, is dubious at best. The idea that simply lowering cholesterol levels reduces the risk of heart disease is being debunked in study after study, yet physicians keep prescribing this fish oil (actually, fish oil can be quite beneficial so I should probably find a new metaphor).

My rule of thumb, if it received FDA approval after 1990, it's probably bogus. I point out to my patients that if there is no generic version available, it really hasn't been on the market long enough to verify its safety. There is only one proven method for lowering your risk of heart disease. A healthy diet combined with regular exercise. When BigPharmCo finds a way to patent that, it will spread like wildfire!

Ask your doctor if a healthy lifestyle is right for you . . .

    Favorite    Flag as abusive Posted 03:52 PM on 03/31/2008

After all of the patents run out -- then, and only then, will the data that one's cholesterol levels has very little to do with one's health status come out, and be validated. "Cholesterol" became popular because it is a correlative of disease, it was never proven to be a causation. It became popular Because it could be measured.

A measurable factor fits perfectly with our "treatment"-based health care system. You can measure "it" going down, so that must mean it's better, and it's working - and then the leap of logic to "you are healthier."

Watch. Around the time as the big money from drug patents runs out - "they" will find a new measurable - whether it has anything to do with our health status? Who knows? But at That time they will discredit Cholesterol and have us all go chasing this next "new thing." Understand?

God save us.

Follow the money.

    Favorite    Flag as abusive Posted 08:26 PM on 03/31/2008
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