Not surprisingly, Merck and Schering-Plough have been taking hits quarter after quarter because of Vytorin’s disastrous performance in clinical trials. Nearly a year ago, Schering-Plough promised to provide regular reports on the performance of its anti-cholesterol market. Their last update, which was filed with the Securities and Exchange Commission in mid November, indicates that Vytorin’s plunge has actually leveled off.

Much speculation has been made about where Vytorin and Zetia (Zetia is a component of Vytorin, as well as a freestanding prescription drug) would bottom out. The total number of prescriptions written in October was 2,186,000, which represents a slight increase over September’s figure of 2,171,000.

Despite the slight gains, however, the chances of a future Vytorin / Zetia freefall still look good. In 2009, many Medicare Part D changes take effect, and many of the providers have kicked Vytorin down to Tier-3 status or worse in their formularies based on the clinical evidence that Vytorin is no more effective than cheaper, generic statins. Therefore, Vytorin will become a much more expensive option for patients. In today’s economy — and most likely even in tomorrow’s economy — a prescription that costs much more than generics yet performs on par with them or even worse than them, is not likely to be winner.

SOURCE: Vytorin Recall › Have Vytorin’s falling sales finally stabilized?

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