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Susan Koeppen inquired yesterday for CBS into the two-year delay between the clinical trials into the cholesterol-lowering medicine Vytorin and the publication of the conclusion by Merck and Schering-Plough that its blockbuster seller did not work. Now ABC's John McKenzie too files A Closer Look. McKenzie told us that up until a few months ago it was legal for a pharmaceutical company to suppress negative research about its drugs indefinitely. The findings had to be reported to the Food & Drug Administration but the government had been required to keep them confidential. The only reason the Vytorin study saw the light of day was that "outraged" participating cardiologists went public when Schering-Plough tried to change the study design retroactively in order to massage the data into producing a success. A new law requires the eventual publication of all research, positive and negative alike--but "companies will have up to two years from the end of the clinical trial to report findings."
CBS' in-house physician Jon LaPook filed an investigation conducted with Business Week magazine into the $21bn-a-year statin industry, whose leading brand is Lipitor. "It is hard to ignore the ads," LaPook told his viewers, as if we needed to know. LaPook had no argument with prescribing statins to patients with heart disease or to those with high risk factors. His quarrel was with the millions who take the drugs, even though they are at low risk of a heart attack, just because their cholesterol levels happen to be elevated. Government guidelines advise against such a prescription but "that has not stopped the statin craze." LaPook offered the epidemiological data: if 100 people were to take Lipitor for three years, the total health benefit of popping all those pills would be to prevent a single heart attack.
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