These newest job cuts come on top of cutbacks that Merck made as part of an earlier restructuring program. Merck began eliminating 10,400 jobs from its global workforce in 2005 and completed that set of cutbacks last month.

Merck’s Chief Executive, Richard Clark, acknowledged the company faced a challenging economic environment in the immediate future.

“Our current sales trends for key products, compounded by known industry and emerging economic factors, have led us to reassess the environment in which we expect to be operating between now and 2010,” he said in a statement.

According to Merck, the 12-percent reduction of its workforce translates to 6,800 employees losing their jobs and some 400 vacancies that will go unfilled. The measures should amount to a savings of $3.8 billion to $4.2 billion by the end of 2013, the company said.

Merck’s embattled cholesterol drugs Vytorin and Zetia continue to earn the company profits, but those profits continually fall as concerns over the drugs’ safety and efficacy rise. Studies have indicated that Vytorin is no more effective than cheap generics and that using it may increase the risk of developing cancer and dying from cancer.

Negative press has knocked Vytorin and its component Zetia, which is also prescribed separately, down from blockbuster status to something more of a financial and legal liability.

SOURCE: Vytorin Recall › Merck cuts more jobs as Vytorin, Zetia sales drop

Most analysts expected the market for Vytorin to bottom out over the summer after the SEAS results became public — an event that many felt would deal the already wounded Vytorin a coup de grace. Not so, however. Vytorin refuses to assume its place on the list of has-beens with grace. Instead, it continues to stumble, choke, and flail.

The latest monthly data for Schering-Plough shows that Vytorin prescriptions continue to decline. Prescriptions for Vytorin were down 3.7 percent in September, and the drug’s share of the cholesterol market dropped from 6.4% to 6% in August. Before the SEAS and Enhance trials, Vytorin took about 8 percent of the total cholesterol market.

At the same time, prescriptions for Zetia, Schering-Plough’s half of the dualistic Vytorin, dropped 1.5% in September. Merck’s Zocor comprises the other part of Vytorin. Together, Schering-Plough and Merck shared 15.2% of the cholesterol management market last January. By June their share had fallen to 12.1 percent. Last month, the share dropped further to 10.8 percent.

Since Vytorin failed to meet it primary endpoint in the SEAS trial, was shown to be no more effective than cheaper generic statins, and has been linked to increased cancer risks, it makes you wonder why it’s being prescribed at all.

SOURCE: Vytorin Recall › Vytorin loses market strength … again

New Haven City Hall spent more than $400,000 on Vytorin and Zetia (ezetimibe) prescriptions for members of the city’s healthcare plan when it could have spent a fraction of that amount for cheaper generic statins that have proven to be as or more effective and less risky.

Zetia is Merck’s anti-cholesterol drug that works by blocking absorption of cholesterol in the digestive tract. It is combined with Schering-Plough’s statin drug Zocor, which targets cholesterol produced by the liver, to form Vytorin – a drug that works to diminish cholesterol on both hereditary and dietary fronts. Studies have shown, however, that cheaper generic statins are in some cases more effective and safer than the Vytorin cocktail.

“This drug doesn’t work. Period. It just doesn’t work,” Steven Nissen, head of cardiology at the Cleveland Clinic, told Forbes magazine.

Merck and Schering-Plough are under Congressional inquiry for possibly withholding study data that indicated Vytorin was a flop while collecting billions in sales from the drug. The companies collected windfall profits knowing that cheaper and possibly more effective drugs were on the market.

Growing controversy over Vytorin’s performance and the way its makers have handled both past and ongoing studies have spawned a number of class action lawsuits. New Haven wasn’t able to find a suit that it could join, so it’s striking out on its own.

SOURCE: Vytorin Recall › New Haven wants to recover Vytorin money

MK-0524A, as the new drug is called, is the subject of a study based in Oxford University in England. Merck submitted the drug to the FDA for approval, but it was rejected last April. The FDA wanted results from the study known as THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) before it made another ruling.

The study already involves 20,000 people from the UK, Scandinavia, and China who are taking the experimental drug. The problem for Merck, however, is the timeline. The study began in 2006 and is set to end in January of 2013. Sufficient data wouldn’t be available until 2010.

To speed the study along, Merck will increase the number of participants in THRIVE to 25,000. Merck hopes that having more trial participants will amount to obtaining results several months earlier.

In a statement issued by Oxford University, Professor Jane Armitage, one of the principal investigators of MK-0524A sounded hopeful about the study’s expansion, saying that “In terms of numbers, bigger is very much better.”

“This enhancement will give us a more powerful tool with which to assess this intervention for the benefit of heart patients everywhere. The study is scheduled to end in 2013, but with these additional patients, we hope that it will be able to report sooner,” she said.

Merck expected the new drug to stimulate its share of the cholesterol market, which suffered a serious blow when Vytorin was revealed to be first a dud and then a danger. Researcher claim that by speeding up the THRIVE trial, they will be able to help people with vascular disease sooner. For Merck, it’s likely to be a matter of replacing lost profits and establishing a pipeline that’s more appetizing to investors.

SOURCE: Vytorin Recall › Merck speeds trial of new cholesterol drug

The University of Washington’s Thomas Fleming is one respected statistician and adviser to the FDA who cautions against dismissing Vytorin’s link to cancer as merely an anomaly. Leading researchers involved with the SEAS study, which uncovered a Vytorin-cancer link, maintain that the results were a fluke.

In an editorial published in The New England Journal of Medicine, Fleming says that at this point in time, it’s too early to dismiss the Vytorin-cancer link. He suggests that the drug may have more adverse side effects than actual benefits. “ … There are numerous recent cases in which it has been established or strongly suggested that [side] effects of such [drugs] have adversely altered their risk–benefit profile.”

Scientists quick to dismiss Vytorin’s apparent link to cancer support their case by pointing to two larger ongoing studies that appear to diminish the drug’s risks. According to Fleming, however, “There are clinically important increases in the risk of cancer-related death that are not ruled out by this data.” He also argues that prematurely releasing results from the other tests jeopardizes their conclusions.

Vytorin sales soared to the tune of $5 billion in 2007, but dropped by a third after reports of negative tests began to surface. Considering such profits, altering and masking potentially harmful clinical trial data might seem like a good profit-preserving strategy, but it makes you wonder what it’s like to work in the Public Relations department at Merck and Schering-Plough.

SOURCE: Vytorin Recall › scientist cautions against dismissing Vytorin-cancer link

To be completely fair, pharmaceutical companies continually develop vaccines and medicines that improve the quality of life for millions of people throughout the world. Many modern pharmaceuticals also extend and save lives. In the western world, we can’t imagine life without these modern medicines.

However, events surrounding the drug Vytorin have cast into doubt the intentions – and the integrity – of pharmaceutical giants Merck and Schering-Plough. As marketing expert Rob Frankel recently told Advertising Age magazine, “The pharmas are in big trouble in terms of credibility. They’re just above congress and used-car salesmen.”

Why?

First there is the ENHANCE study that revealed the pairing of Zetia and Zocor to be no more effective than Zocor alone in treating arterial plaque. But more than the disappointing results, there was the delay in making this information public. Results of the ENHANCE trial were completed in April 2006 but were not released until January 2008, after mounting pressure and suspicion over the delay.

On May 1, 2007, before the ENHANCE results were made public, Schering-Plough’s president Carrie Smith Cox, dumped 900,000 shares of company stock, worth an estimated $28 million. The sale prompted Congress to investigate the upper realms of Schering-Plough for concrete evidence of insider trading.

While ENHANCE data were being withheld, Merck and Schering-Plough continued to heavily advertise Vytorin, spending hundreds of millions on the famous commercials featuring the aunt who looks like a pot roast. The companies knew the results of the study, yet their aggressive marketing raked in $3-5 billion per year since Vytorin’s appearance on the market. Meanwhile, patients continually overpaid for a drug that didn’t do what the ads claimed it would do.

Congress again stepped in to demand answers as to why consumers, including the federal government, had been fleeced for so long. Senator Chuck Grassley of Iowa sent a letter to the top of both companies in which he stated, “I have an obligation to the more than 80 million Americans who receive health care coverage under Medicare and Medicaid to ensure that taxpayer and beneficiary dollars are spent in a fiscally sound manner.” In the same letter, he also pointed out that at, “… a Wal-Mart pharmacy in Iowa City, generic simvastatin costs $54.54 for a month’s supply. On the other hand, Vytorin costs $112.46–more than twice as much.”

The federal government is also investigating why the ENHANCE test results released by Merck and Schering-Plough differ from the information released by those who conducted the study. A letter from the U.S. House of Representatives Committee on Energy and Commerce to Fred Hassan (Schering-Plough) and Richard T. Clark (Merck) states, “The ENHANCE trial was completed in 2006, and yet no data from the trial have been published or presented in their entirety. In fact, it appears that the study itself was not registered with ClinicalTrials.gov until October 31, 2007, a full 18 months after completion of the study. In addition, the endpoint indicated in the ClinicalTrials.gov web site appears to differ from the endpoint described in the initial study design.”

Representative Bart Stupak , D-Mich, told CBS’s Early Show “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.”

With all of the controversy surrounding Vytorin, it would seem that Schering-Plough has sought to earn more mistrust every day and that Merck intentionally put profits before people.

SOURCE: Vytorin Recall › Vytorin scandals evoke mistrust