EasyDiagnosis Second Opinions Blog

Between 2000 and 2003 Merck and Shering-Plough conducted eight long-term studies on the safety of Zetia-statin combinations. Five have so far been unreported, but showed “possible liver side effects from Vytorin.” Two of the three studies reported showed safety problems, 19% of 433 patients in one series (Vytorin-Zocor and Zetia). 8% of 432 patients on Zetia and Lipitor in another series showing liver or gall bladder problems. Where are you, Dr. Jarvik?

Officials at the drug companies admit there is no present evidence that taking these drug combos, e.g. Vytorin, will reduce heart attacks or strokes. Yet they are betting on a 10,000 patient clinical trial to be finished in 2011 to support the hypothesis that Zetia will prove effective.

According to the New York Times, when the FDA approved Zetia in 2002, it relied on trials involving only 3,900 patients lasting no more than 3 months. “In those trials, 11 times as many people who took Zetia along with a statin subsequently had serious health problems…” These were mostly liver function abnormalities…”compared with those who took a statin alone.”

In the U.S., virtually all widely advertised drugs on TV as well as many unadvertised, carry warnings about the potential for liver damage and dangers for pregnant women, among other risks. The very omnipresence of these warnings convey a widespread sense of trust in drug promotion. After all, the manufacturers must be trustworthy, and so must be the regulators, otherwise they wouldn’t be admitting risks by taking their product.

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.