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

Will FDA regulations and pre-emption silence Vytorin victims?

November 21st, 2008 by Kurt Niland

Many Americans assume that the Food and Drug Administration adequately tests new drugs for safety before they go on the market and become available to the general population. If your doctor prescribes a new drug to help you lower your cholesterol or help you quit smoking, then that drug must be safe, right?

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.

Tags: FDA, Food and Drug Administration, Pre-emption, vytorin, Wyeth

This entry was posted on Friday, November 21st, 2008 at 2:26 pm and is filed under Legal, News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.