Remember Grandpa Frank?
Way back in 2008, the ad above ran in heavy rotation on TV during the heyday of Vytorin, a cholesterol-lowering pill that claimed to fight both genetics and bad habits.
Soon after the ad had appeared, oh, say thousands of times across the country, the Food and Drug Administration ordered the company to stop showing Grandpa Frank and other relatives because the ads didn’t reveal a study showing Vytorin wasn’t any more effective than simvastatin, a generic cholesterol medicine that is one of Vytorin’s generic components.
Later that year there was more bad news for Vytorin — and fear among patients — when a study suggested Vytorin raises the risk of cancer slightly. Sales fell from a peak of $5 billion a year to $2 billion last year.
None of this caused the FDA to change its view of the safety of Vytorin. The agency even issued a statement in 2009 essentially exonerating Vytorin of the cancer risk.
Now, Merck, the maker of Vytorin, is looking to regain some of the lost sales of the drug by touting its use in people with chronic kidney disease.
A new FDA analysis shows Vytorin lowered heart attacks and strokes by 22 percent among CKD patients in the relatively early stages of disease — before they need dialysis. For those with more severe, later-stage disease, the drop was 6 percent.
The FDA analysis also failed to find any increase in cancer or cancer deaths in the 20,000 patient. That would seem to support a 2009 statement issued by the agency clearing Vytorin of a cancer taint.
Merck is seeking FDA approval for use of Vytorin in CKD patients of which there are 26 million in the U.S. alone, according to the National Kidney Foundation.
A committee of independent advisors to the FDA will go over the data for and against Vytorin at a meeting Wednesday.