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Tuesday, October 28, 2003The sales strategy for rosuvastatin is based around the Galaxy programme. Galaxy is the contrived umbrella name for at least 16 clinical trials of wide-ranging quality designed to investigate the efficacy of rosuvastatin in various clinical settings.....But AstraZeneca has proceeded to push Galaxy into the realms of astrological rather than astronomical logic. Why are the British so much more tart-tongued than we are? I suspect it's the accents. They always sound so genteel, no matter how vicious the words. Anyway, AstraZeneca's CEO replied just as tartly: Regulators, doctors, and patients as well as AstraZeneca have been poorly served by your flawed and incorrect editorial. I deplore the fact that a respected scientific journal such as The Lancet should make such an outrageous critique of a serious, well studied, and important medicine. Have we been poorly served by The Lancet's editorial? No. We have, in fact, been better served. If the editors of The Lancet hadn't spoken up, the newest statin would have been embraced unquestioningly as the next best thing to happen to preventive cardiology. It happened with Baycol. It's happening now with Zetia. It happens because physicians don't pay much attention to the details of the clinical trials. But most of all, it happens because of an unfortunately all too commono mix of intellectual hubris and naivete. Here's what happens. Cardiologists (or other specialists) go to their national meeting put on by the American College of Cardiology where they hear things like this: "Heart disease and stroke remain the leading causes of hospitalization and death for both men and women in Canada", says Dr. Lawrence Leiter, Head, Division of Endocrinology and Metabolism, St. Michael’s Hospital, Toronto, Ontario. "Too many Canadians continue to have unacceptably high levels of cholesterol, despite the fact that we know hypercholesterolemia is a major risk factor for cardiovascular disease. The aggressive LDL [low-density lipoprotein] reductions that can be achieved with drugs like Crestor should certainly help bring more patients’ cholesterol to optimal levels." And this: "Crestor will provide a tremendous additional weapon in the global fight against coronary heart disease," observes Philip Barter, Professor of Cardiology at the Royal Adelaide Hospital in Australia. Being busy doctors, they don't bother looking up the actual results, but instead form their opinions of the drug based on presentations like this: Data from two head-to-head comparative trials involving over 1,000 patients show a significantly better reduction in LDL cholesterol (a major marker for the development of cardiovascular disease) with Crestor, compared to other widely prescribed statins. In one study, LDL cholesterol was reduced by 49 percent with Crestor 10 mg compared to 37 percent with simvastatin 20 mg and 28 percent with pravastatin 20 mg. In another study, Crestor 10 mg reduced LDL cholesterol by 43 percent compared to a 35 percent reduction with atorvastatin 10mg. In addition to LDL cholesterol lowering, Crestor 10 mg produced a significantly greater increase in HDL cholesterol compared with atorvastatin 10 mg (12 percent versus 8 percent, respectively) and a similar increase compared to simvastatin and pravastatin.Triglyceride levels were effectively reduced to the same extent by all the statins. All studies also show that Crestor is safe and well tolerated, similar to other statins. These are busy doctors. They've got lectures to attend and continuing medical education credits to accrue. They don't stop to ask just what the starting numbers were for each agent, or how much of an absolute reduction in cholesterol each agent caused. They just hear the impressive sounding statistics coming from the experts in their field. And, anxious to be on the cutting edge of medicine, they buy it. Then, they go home and they tell others about the best new therapy, so much more effective than any other cholesterol medication, sure to reduce mortality, apparently as safe as any of the others on the market, blah, blah, blah. And the other doctors in the community, not wanting to appear backward, and not having the time or the resources to look up all the obscure research on the drug, adopt it as the new standard of care. After all, the experts, nationally and locally, say it's the right thing to do. And as for safety, well, it's FDA approved. Must be safe. And wasn't there an article in last Tuesday's newspaper quoting experts in the field on this marvelous drug? Sad to say, few bother to ask the difficult questions before adopting the new therapy. We're a lot like lemmings. But, in this case, The Lancet editorial broke the circle. Here are legitimate questions being raised vociferously enough to be heard over the pharmaceutical company's hype. And the objections are being raised in a journal whose stature trumps the experts. Now doctors will be more likely to ask themselves the hard questions about Crestor. The profession could use more of this sort of critical thinking. And a lot less hype from "experts." ASIDE: The safety of Crestor compared to other statins is yet to be established. But look here, the trial lawyers are on the case. Ed. Note: Came back later and took out references to toothpaste and diseases, had misidentified the drug as "Crest" rather than "Crestor". My bad. posted by Sydney on 10/28/2003 08:06:00 PM 0 comments 0 Comments: |
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