Vytorin Study Results Cause Stocks To Sink

Merck, Schering-Plough Take A Hit; Congress To Investigate Delayed Study Release

(CBS/AP)  Investors continued dumping shares of Merck & Co and Schering-Plough Corp. Tuesday, a day after their cholesterol-drug partnership took a hit from somewhat negative results of a controversial study, but some analysts called the worries overblown.

The study examined how much their heavily advertised combination cholesterol pill, Vytorin, reduced plaque buildup in arteries supplying blood to the brain, compared with Merck's older cholesterol drug, Zocor. Vytorin combines Zocor, now available as a cheaper generic pill, with the partners' Zetia, a newer drug.

Instead of showing Vytorin did a better job, the study, called ENHANCE, found no meaningful difference between the two pills, apparently indicating Zetia gave no benefit. However, some Wall Street analysts said flaws in the study's design made it difficult for Vytorin to come out on top and cited other evidence of Vytorin benefits.

The drug received FDA approval but a trial to verify Vytorin's effectiveness was not complete until April of 2006.

Sales of the drug soon accounted for billion of dollars, reports CBS News correspondent Susan Koeppen.

The Congressional Committee on Energy and Commerce is investigating the withholding of important clinical trial data. In a letter to Merck and Schering-Plough, the committee expressed "concern in releasing results of the study" and "apparent manipulation of trial data," reports Koeppen.

Congressman Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations told CBS' The Early Show that they will also be looking into trading information revealing that Schering-Plough president, Carrie Cox, sold 900,000 shares of company stock worth $28 million a year before the Vytorin clinical trial was complete and seven months before it was made public, reports Koeppen.

"There's certainly major misrepresentations not only to the effectiveness of the drug, but manipulating of the scientific data to further promote a product that isn't doing what it was designed to do, Stupak told The Early Show.

Before Vytorin's release in 2004, Zetia-maker Schering-Plough was facing several patent expirations, while Merck was about to launch the biggest drug recall in history with Vioxx, an arthritis medication which was shown to increase the risk of heart attack and stroke, reports Koeppen.

But Vytorin turned things around for both Merck and Schering-Plough.

It became controversial because the two drugmakers took more than 1½ years to release the results, which they blamed on the complexity of the analysis. Meanwhile, a congressional committee in December requested more information on the study and some media reports speculated the study might have found Vytorin caused excessive liver problems. That wasn't seen.

"The medical community expects that results of clinical trials whether they be positive or negative be promptly reported," Dr. Steven Nissen, Chairman of Cardiology at the Cleveland Clinic told The Early Show.

Meanwhile, prescriptions for Vytorin continued at a brisk 800,000 per week, reports Koeppen.

Publicity over the results, released Monday, pushed Schering-Plough shares down 8 percent Monday and another 6.8 percent Tuesday, to $23.78. Meanwhile, Merck shares dipped 1.3 percent Monday and another 2.7 percent Tuesday, to $58.18.

"I firmly believe this is an overreaction," Lehman Brothers pharmaceuticals analyst Tony Butler said Tuesday. "We believe some misinformation in the marketplace has created a panic."

Butler said he does not expect the new study's results will cause doctors to write fewer prescriptions for Vytorin. He cited data showing it does a better job of lowering LDL, or bad cholesterol, than competing drugs, and also improves levels of good cholesterol and reduces inflammation, which is thought to be a trigger of heart attacks.

Morgan Stanley analyst Jami Rubin wrote in a research report that the market appeared to be "overly pessimistic" about the study's impact on Vytorin and Zetia sales.

Both cited aspects of the ENHANCE study they saw as stacked against Vytorin.

The 720 patients in the study all have a very rare genetic condition predisposing them to high cholesterol and most had been heavily treated previously with cholesterol drugs, making it harder to see additional improvement with Vytorin.

Also, the study required technicians to examine about 40,000 digital ultrasound images of patient arteries, and some were too difficult to read, leading to missing data.

Still, some analysts said the study could harm the drugs' prospects.

"The study will hurt sales, but I don't know the degree," said Raymond James & Associates drug analyst Michael Krensavage.

He noted that while results were not statistically meaningful, it appeared the Zetia group did a little better in plaque reduction then the Vytorin group.

[edmarusa]

I just returned from hospital after 10 days with a pancreatitis attack after using Vytorin the past three months. Also had pneumonia and related health problems resulting from use of this drug. The hospital couldn''t figure out what was wrong since I had so many problems.

[gwashington6]

clinical trials are rigged. it was a shock for Merck and their partner to get results that are not what they paid for, so therefore make excuses. More sensible to do ultrasounds of arteries of average users of vytorin at start of use and after a year or two. Criteria for participants in trials do not represent average users chosen randomly. Statins have been around a long time with many new benefits surfacing but who knows what the real effects of zetia are? End result measurements should not only be the cholesterol numbers but rather the effect on arteries. Recent finding of 7 new genes affecting cholesterol make the subject of cholesterol readings more complex.

[logicanada]

under the pressure of the cares and sorrows of our mortal condition,men have at all times and in all countries, called upon some physical aid to their moral consolations: wine, beer, opium, brady or tobacco.
Edmund Burke ; 1729-1797...statesman.

[luvcomments]

hypnotoad72 and Baileycc

Amen!!! You both echo my sentiments exactly. The reason people aren''t spending is because - da-dah - they can''t! And, all those pharm, ins and other lobbyists are the reason I wish Edwards would win and follow through and criminalize lobbying.

[logicanada]

Funny how this article tells of how shares have dropped yet says nothing about how many people have dropped from using the drugs.

[hypnotoad72]

I thought it was cautious consumers slowing the economy - not overextended consumers, consumers told to save, or anything else trying to blame it all on consumers...

If the world is going to go boom, maybe I should get the 60" LCD tv... what the heck; Devo was right after all. Only one go at life, so make the most of it?

Great to know that Congress will be investigating Merck and Schering-Plough. This is like having the fox investigate the hen house. There are 4 lobbyists from Big Pharma for every member of Congress and they are passing out millions to congressmen. This will pass away silently, it is business as usual for Big Pharma.

[terrapin78]

I would rather die than let my health be further diminished by treatments that cause different unrelated health damage.

I WILL NEVER TAKE A STATIN!

[cheddarboy82]

fstop100,no, fast food is not what is killing americans. Americans being lazy with no discipline is what kills americans. fast food should be a treat, not an everyday, every meal things. Fat people have no shame most the time, and definetly no discipline

Why is everybody getting so excited. This is business as usual for Big Pharma. The profits have been made and they don''t give refunds.

[madashell4lo]

Unless I am very mistaken, was not the FDA established to protect us from snake oil. Are there any guidelines that state that a "drug" not only be safe but also be affective, or is this just a false hope from the dim past.

[antoniof123]

"The medical community expects that results of clinical trials whether they be positive or negative be promptly reported," Dr. Steven Nissen, Chairman of Cardiology at the Cleveland Clinic told The Early Show.

I just have one question why didn''t the AMA just say don''t give it out until we see the result to all the doctors. What is it are they not in charge.

[barbaraf4]

"However, some Wall Street analysts said flaws in the study''s design made it difficult for Vytorin to come out on top and cited other evidence of Vytorin benefits."

I would like to see the medical credentials of these "Wall Street analysts".

[fstop100]

What happened to the FDA? They are paid off by the drug companies. We are hit with all the commercials that say how the pills are going to make our lives better. WRONG!!!
Just start eating healthy. The fast food industry is what is killing Americans!!!

[nolalou]

So if there was truth in advertising, we''d start seeing this ad:

"There are two types of cholesterol, from food & family. Vytorin doesn''t do a *** thing about either of them! But hey, at least our commercials are clever!"