The SEAS study sought to test Vytorin’s effectiveness as an alternative to surgery in reducing arterial clogging caused by high cholesterol. The results, which were announced in a July 2008 press conference, did not favor the drug. Not only did researchers find that Vytorin worked no better than cheaper, generic statins, they also discovered that patients taking Vytorin experienced 50 percent more new cancer cases and cancer deaths than the subjects who took placebos.

Merck and some of the researchers connected to the SEAS study dismissed the results as a “fluke,” while many physicians and medical researchers not connected to the drug company remained skeptical and cautioned consumers to stick with traditional statins to control cholesterol levels. For instance, Merck’s Zocor, taken alone, was shown to be more effective than Vytorin and cost about one-third as much because it had become available as a generic drug.

That research promoted many municipalities that had included Vytorin in their health plans to file lawsuits against Merck, essentially asking for their money back. Vytorin and its sister drug Zetia, made by Schering-Plough, brought in sales of more than $5 billion at their peak. The sales have fallen but continue to earn $4 billion annually.

Vytorin is a hybrid drug which combines Merck’s Zocor with Schering-Plough’s Zetia to combat both dietary and hereditary cholesterol. The FDA said that ample evidence exists showing Zocor to be safe, but insufficient evidence exists on Zetia to “rule out a cancer risk at this time.”

Two additional Vytorin studies known by the acronyms SHARP and IMPROVE-IT are ongoing and scheduled to end in 2010 and 2012.

SOURCE: Vytorin Recall › FDA says it finds no Vytorin-cancer link, but unsure

The answer is a surprising, and disconcerting, NO.

Trials for new prescription drugs that are vying for a place in the market focus on efficacy rather than safety. If pre-market clinical tests find a drug to be effective and that drug does not appear to be unsafe, then the FDA typically approves the drug and that drug enters the market. Many pre-market studies, however, simply are not large enough to allow researchers to gauge the safety of a new drug. A determination of safety is made usually after thousands of people have taken the drug. That is to say, the safety of a new drug is only fully known once it has been widely available to consumers.

Taking new prescription medicines makes the consumer an unwitting guinea pig of sorts. The hybrid anti-cholesterol drug Vytorin, for instance, was prescribed to millions of people before the ENHANCE trial found it to be effective in lowering LDL cholesterol levels but ineffective in preventing cardiac events, which is its ultimate purpose. Another trial named SEAS later suggested that Vtytorin increased the odds of developing and dying from cancer. Vytorin continues to be sold while researchers continue probing its effectiveness and safety. The results from larger tests aren’t expected until 2012.

Currently, the rights of consumers who have been harmed by toxic prescription drugs and faulty medical devices are standing on unsteady ground. The issue of pre-emption, the legal notion that FDA approval of a drug trumps state laws concerning safety, efficacy, and proper labeling, is now before the United States Supreme Court. Diane Levine, a musician from Vermont, sued Wyeth earlier this month over inadequate labeling of the drug Phenergan, which caused her to lose part of her right arm. Wyeth’s defense argues that the company shouldn’t be held responsible by state laws because the drug met federal standards by gaining FDA approval.

If the Supreme Court rules that federal standards do supersede state laws, or if it throws the case out altogether, then many people may have no legal recourse should they ever fall victim to risky drugs and medical devices.

Keeping the issue of pre-emption in the public eye as the Supreme Court mulls the Levine case, a non-profit group called Alliance for Justice has created a documentary about pre-emption. A trailer for “Access Denied: The Fight for Corporate Accountability” can be viewed here. The video can also be viewed in its entirety by going here.

SOURCE: Vytorin Recall › Will FDA regulations and pre-emption silence Vytorin victims?