Vytorin

If lowering LDL or “bad” cholesterol is the doctor’s sole intention when prescribing Vytorin to patients, then the drug does a great job. However, as previous studies have shown, lower levels of LDL cholesterol don’t automatically translate to cleaner arteries and lower incidences of cardiac arrest. While Vytorin worked better than statins combined with time-release Niacin to lower LDL cholesterol in 200 patients, its performance was inferior in reducing artery clogging deposits.

In fact, five of Vytorin group patients suffered five fatal heart attacks – a rate significantly and statistically higher than the niacin group, in which just one fatal heart attack occurred. The key to understanding the difference may lie in “good” HDL cholesterol, which pulls LDL buildup from artery walls. While niacin is known to raise HDL levels, Vytorin actually lowers levels of good cholesterol.

Higher rates of cardiac arrest, lower levels of good cholesterol – these are beside the point, Merck seems to say in defending Vytorin, which earns the pharmaceutical giant $4 billion annually. The company says that lowering LDL cholesterol is the “well established” and “primary target” of therapy.

“Zetia and Vytorin, when used as a supplement to a healthy diet, are effective in reducing LDL cholesterol,” said Peter S. Kim, President of Merck Research Laboratories, in a statement.

However, if Vytorin doesn’t reduce the risk of adverse cardiac events or strokes, then what good is it possibly doing?

Approximately 9 million Americans are currently taking Vytorin and Zetia.

Source: NPR

SOURCE: Vytorin Recall › New study shows vytorin and zetia less effective than niacin

Dr. Scannell said the drug made her list as a result of two studies that revealed Vytorin, which is a combination of simvastatin (Zocor) and ezetimibe (Zetia), did not reduce artery-clogging plaque buildup, although tests showed it reduced “bad” cholesterol levels.

However, she said Vytorin’s bad year wasn’t all bad for consumers, as research from the study revealed a fundamental benefit of statin drugs to people with normal cholesteral but high indicators of inflammation. She says the Vytorin failure also brought to light “the importance of knowing how new drugs actually affect the people who take them – not just their blood tests.”

Dr. Kate Scannell is an East Bay physician and syndicated columnist.

SOURCE: Vytorin Recall › Vytorin No. 3 on list of Top 10 medical stories of 2008

Suffolk County joins Congress and a growing number of individuals and municipalities in claiming it had been ripped off by the pharmaceutical giants. Suffolk County’s case states that Merck and Schering-Plough engaged in a “scheme … calculated to ensure that Plaintiff would pay for Zetia and Vytorin despite cheaper and effective alternatives.

However, Suffolk County has added a little more heft to its lawsuit than other similar suits filed against the drug companies. On page 25 of the deposition, Suffolk County claims:

“Defendants have conducted and participated in the affairs of the Enterprise through a pattern of racketeering activity that includes acts indictable under 18 U.S.C. ++ 1341 and 1342 (mail and wire fraud) …”

Confusion and outrage have surrounded the ENHANCE trial results and the way in which Merck and Schering-Plough officials released the results, sparking Congress to launch an investigation. The Suffolk County lawsuit, however, goes further than just accusing the companies of negligence; it claims the companies may have acted criminally. In this lawsuit we see phrases indicating some serious charges:

“…concealing from Plaintiff and physicians, and the public the results of the ENHANCE study …”

“… deliberately misrepresenting the efficacy of Zetia and Vytorin …”

“publishing or causing to have published materials containing false information …”

“… pattern of racketeering activity …”

SOURCE: Vytorin Recall › Suffolk County NY sues for return of Vytorin money

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