› $4.85 Billion settlement in drug case
More bad news for the cholesterol-lowering drug Vytorin. The drug has been under scrutiny lately for everything from elevated cancer risk and serious side effects to ineffectiveness. This week, the Food and Drug Administration (FDA) issued a safety announcement about simvastatin, one of the two active ingredients found in the medication, and an increased risk of a potentially life-threatening muscle injury.
The U.S. Food and Drug Administration announced today that it found no clear link between Merck’s blockbuster cholesterol drug Vytorin and increased risk of cancer, but it could not rule out the possibility that such a link exists. The agency reviewed data from three Vytorin trials, including the controversial SEAS trial results, which Merck had withheld from the public for 18 months as it aggressively marketed the drug.
Remember those Vytorin commercials with the split screen, comparing people to food? Aunt Barbara on the left and some tacos on the right? Mildly entertaining though they were, those ads underscore a big problem with the promotion of new pharmaceuticals. Evidence suggests that Vytorin’s manufacturers, Merck and Schering-Plough, promoted and sold the anti-cholesterol drug for nearly 2 years despite known clinical trial results that strongly suggested Vytorin to be no more effective than cheap, generic statin drugs.
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.
Following Vytorin’s recent fall from its blockbuster status, Merck is ratcheting up studies of its new cholesterol fighting drug, The Washington Times reported.
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.
Does Vytorin increase the risk of cancer death? The question seems like it would be simple to answer, yet finding the answer requires navigating through a murky labyrinth of botched test results, apparent cover-ups, possible payoffs, and a whorl of conflicting interpretations that sometimes resemble self-interest, sometimes truth, depending on whom you ask.
Today in Munich, Germany, researchers presented all of the data from the SEAS (Simvastatin and Ezetimibe in Aortic Stenosis) study to the European Society of Cardiology. The SEAS study roused concern back in July when researchers revealed a possible link between cancer and the Zetia half of Vytorin.
