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.