Study title and authors:
Recent cholesterol-lowering drug trials: New data, new questions
Michel de Lorgeri and Patricia Salen
Laboratoire Cœur & Nutrition, Université Joseph Fourier
This paper can be accessed at: http://www.jstage.jst.go.jp/article/jln/19/1/19_65/_article
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The french cardiologist Dr Michel de Lorgeril investigated the outcome of recent cholesterol-lowering drugs trials.
He found:
(a) The cholesterol-lowering drug trials published in 2008-2009 were either negative (ENHANCE, SEAS,
GISSI-HF, AURORA) or obviously biased and therefore not credible (JUPITER).
(b) It is also noteworthy that most cholesterol
-lowering drug trials published between 2005 (the year of the Vioxx affair and of enforcement of new clinical trial regulations) and 2007 were also negative or ambiguous.
(c) Taken together, these trials strongly suggest that the results of previous, highly positive trials with statins - particularly in the secondary prevention of coronary heart disease - published between 1994 and 2004 and that were used to issue guidelines for medical practitioners should be carefully re examined by experts independent from the pharmaceutical industry
.
(d) The positive results from trials published between 1994 and 2004 were before the Vioxx affair and of enforcement of new clinical trial regulations. (Vioxx was a drug that was supposed to greatly relieve the pains of arthritis sufferers, the problem was that it caused heart attacks and strokes and three-fold increase in death rates. The company that manufactured the drug (Merck) tried to hide these side effects by manipulating data. Eventually the drug was withdrawn and now, in an attempt to prevent pharmaceutical companies hiding or manipulating evidence, the US Food and Drug Administration require that all pharmaceutical companies file any and all trial results to a federal registry within one year of the completion of the trial).
Dr de Lorgeril concludes: "The next question would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality".
He found:
(a) The cholesterol-lowering drug trials published in 2008-2009 were either negative (ENHANCE, SEAS,
GISSI-HF, AURORA) or obviously biased and therefore not credible (JUPITER). (b) It is also noteworthy that most cholesterol
-lowering drug trials published between 2005 (the year of the Vioxx affair and of enforcement of new clinical trial regulations) and 2007 were also negative or ambiguous.(c) Taken together, these trials strongly suggest that the results of previous, highly positive trials with statins - particularly in the secondary prevention of coronary heart disease - published between 1994 and 2004 and that were used to issue guidelines for medical practitioners should be carefully re examined by experts independent from the pharmaceutical industry
.(d) The positive results from trials published between 1994 and 2004 were before the Vioxx affair and of enforcement of new clinical trial regulations. (Vioxx was a drug that was supposed to greatly relieve the pains of arthritis sufferers, the problem was that it caused heart attacks and strokes and three-fold increase in death rates. The company that manufactured the drug (Merck) tried to hide these side effects by manipulating data. Eventually the drug was withdrawn and now, in an attempt to prevent pharmaceutical companies hiding or manipulating evidence, the US Food and Drug Administration require that all pharmaceutical companies file any and all trial results to a federal registry within one year of the completion of the trial).
Dr de Lorgeril concludes: "The next question would be whether it is not time for a full reappraisal of the theory according to which cholesterol-lowering results in a significant protection against cardiovascular morbidity and mortality".
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