Two-year's profits from failed drug?
For two years, Merck and Schering-Plough have been delaying the release of their test results from a study of the effectiveness of their cholesterol-lowering drug, Zetia and the Vitorin pill that relies on Zetia to reduce cholesterol. By law, manufacturers of drugs are required to disclose study results "immediately". These manufacturers have been stonewalling the media and medical professions, claiming that that the results were not available, even though the study ended two years earlier.
Finally, in January 2008, the results were released and they demonstrated no cholesterol-reducing effect for Zetia and Vitorin, and IN FACT DEMONSTRATED THAT ARTERIAL INFLAMMATION or "plaque formation"--the fatal element in coronary artery disease--INCREASED BY FIFTY PERCENT OVER THE COURSE OF THE STUDY in the test subjects. Thus, the ultimate purpose for administering the drugs--to reduce the risk of heart attack and stroke caused by plaque--was NOT served by prescribing these drugs and in fact the drug worked at cross-purposes to the needs of the patients.
Sales and advertising of the two drugs have continued aggressively during the interim and totaled 5 billion dollars in 2007. Meanwhile, a spokesperson for Schering, Lee Davies, claimed that the two year delay was "unrelated to the negative findings" which were "unavailable" to the companies until two weeks ago. Does anyone accept those claims? This is unmitigated greed--hiding these disastrous study results in order to continue to maximize sales and profit. How many patients enrolled in the study suffered stroke or myocardial infarct that would not have occurred if they were switched to an effective drug regimen? Is this significantly different than voluntary manslaughter? Right now 5 million people are relying on these drugs to reduce their risk of heart attack and stroke: according to the study, it is causing their plaque to increase twice as fast as the control group!
The patients who participated in this study were suffering from intractably high LDL or "bad" cholesterol". Perhaps something will come from the on-going studies of the drugs to justify prescribing them. Our unscientific analysis, however, suggests that it would be unethical to continue a patient on this drug regimen, given these test results. At a minimum, this study should be the catalyst to a more effective rule actually requiring the prompt disclosure of drug study data.