Drug company fails to stop publication of report

A legal dispute over the publication of a report on cholesterol lowering drugs has been won by the Canadian Coordinating Office for Health Technology Assessment (CCOHTA).

Bristol-Myers Squibb Canada tried to prevent publication of a report on statins produced by the independent technology assessment body, claiming that it would negatively affect the sales of their drug pravastatin (Pravachol). The company lost both its original case last December and an appeal in May.

CCOHTA, a non-profit corporation founded and funded by Canadian provincial, territorial, and federal health ministers, said that although the dispute was based on differences of opinion and interpretation between its research experts and those of Bristol-Myers Squibb, the real issue was freedom of speech. CCOHTA's mandate is to provide information on medical technologies to Canadian provincial health plan managers, health professionals, and hospitals. This was a report published by scientists, and Bristol-Myers Squibb was trying to prevent its dissemination.

Dr Jill Sanders, CCOHTA's president, said: “This case was precedent setting for many other Canadian organisations, such as the provincial health technology assessment offices, and the provincial ministry pharmaceutical programmes.”

The pharmaceutical company countered that it was never its intention “to suppress the free exchange of scientific information,” but to ensure that “physicians are given complete and accurate scientific information.”

The company notes what it calls “the inconsistency between the more comprehensive report on statins published in October 1997 and the supplementary overview report.” It gives one example of this, where the comprehensive report says that a review of the literature on the drugs shows “little evidence for or against a class effect,” while the overview says that “since all statins lower total cholesterol and LDL [low density lipoprotein] and increase HDL [high density lipoprotein] to varying degrees, it may be assumed that they will reduce the risk of coronary events.”

The company said in a statement: “Physicians should be encouraged to look at all the studies conducted on a drug and make treatment decisions based on the evidence provided in these studies. Extrapolating study results to other drugs in a class challenges the practice of evidence based medicine and trivialises peer reviewed scientific analysis.”

The statement quotes a recent review article in JAMA by Dr Robert Rosenson as saying that despite comparable lowering of low density lipoprotein cholesterol among the statins, the non-lipid properties differ and “the net clinical efficacy of these agents requires validation by randomised clinical trials.”