Risks of Zetia were not disclosed

On December 21, the New York Times reported that Merck and Schering-Plough have conducted several studies on the risk of liver disease inherent in its cholesterol-lowering Zetia.  According to the Times, the manufacturers have not disclosed these studies, or the risks identified, to either the FDA or to medical researchers, let alone the public.

     Both Canada and Australia require stronger risk warnings on Zetia than does the FDA, and many physicians feel that while the drug can be appropriate for some patients, it should carry a stronger risk warning, due to the enhanced concern of its combination with the normal risks of statin medicinces.  These doctors feel that the heavy advertising of Zetia on television and in other media with only lukewarm risk warnings is a dis-service to patients with liver function testing that suggests greater concern should be focused on liver risk issues.

     Elsewhere in this blog, we have addressed the issue of a manufacturer's duty to disclose drug study results "promptly", the Bush Administration's refusal to enforce this obligation, and the immunity that is conferred upon drug manufacturers by FDA approval--even if it is granted based upon fraudulent or incomplete research.