Statins Plus:Troubling News about Zetia and Vytorin

Tens of millions of people use statin drugs to lower blood cholesterol. A rapidly growing number are now taking Zetia, another cholesterol-lowering drug, alone or increasingly prescribed with a statin like Lipitor, Zocor, or Crestor. Zetia is proudly advertised on one of its web sites as working differently from statins, “…which work mainly on the liver…Not ZETIA …which is unique in the way it helps block the absorption of cholesterol that comes from food.”

A brilliant marketing strategy emerged back in 2000: Why not combine Zetia with a statin to lower cholesterol even further? This led to the heavily advertised Vytorin, which indeed combines Zetia with the statin, Zocor. Predicted 2006 yearly sales of Zetia alone approaching $5 billion.

Drug makers, Merck and Schering-Plough are now being criticized for not yet releasing data from their important Zetia/Vytorin study, called Enhance, completed early last year. A number of patients have been dropped from the study because of elevated liver enzymes, a Schering-Plough spokesman confirmed last week week, but the number of patients involved will not be available until March.

Schering also said that the FDA had reviewed the unpublished studies and had approved Zetia for use alongside statins, but according to the New York Times, Dec. 21, experts on drug safety confirm once again that the agency has been slow to issue warnings about many widely used drugs. Consider the painkiller, Vioxx, the diabetes medication, Avandia, and the anti-psychotic drug Zyprexa. Five unpublished series involving Vytorin included in the Enhance study, showed possible liver side effects from the drug, yet the FDA approved the drug without significant restrictions on its use. That was in 2004!

This scary news has not yet been making headlines, except in The Times, and I await with interest its future appearance in other major media. The absence so far of network TV coverage should be no surprise, considering the advertising income now being generated by Vytorin. Stay tuned.

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