Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Selective use of evidence
- Adam Jacobs (3 October 2003)
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Polypill - An OverDose of Reality
- William J Burke (4 October 2003)
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Lost opportunities
- Anne Savage (8 October 2003)
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foolish or fabulous folate
- Yan Press, MD, A. Mark Clarfield MD FRCPC (23 July 2004)
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Adam Jacobs, Director Dianthus Medical Limited, London SW19 3TZ
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Wald et al defend their claims for the Polypill citing the 51% reduction in ischaemic heart disease events observed in randomised trials of statin treatment. However, this figure of 51% is highly biased. The figure comes from a subset of trials they have selected on the basis of the reduction in cholesterol observed in the trials. In other words, they have selectively chosen the trials that show the greatest treatment effect. In any collection of randomised trials of the same treatment, some, by the effects of random variation, will show greater treatment effects than others. It is not surprising that the trials they have selected show a large effect on mortality, as they have deliberately ignored trials showing a smaller effect. A more realistic estimate of the effects of statins would be to pool the data from all statin trials, which would give a risk reduction of considerably less than 51%. Sorry, but until I have seen results of randomised trials of the Polypill itself, I’m not convinced. Competing interests: None declared |
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William J Burke, President Outreach 2K, Inc. Kansas City, KS 66102
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I believe there are some very dangerous assumptions being made by those proponents of a "polypill" that need not go unmentioned. With such an alarming trend in medicine becoming even more alarming with each passing year, especially here in America, that being the complete lack of discussion of the dangers associated with pharmacotherapy (noted later) - consideration must be made of this issue before the general public. The interest of the patient - which should be the guiding interest I might add - demands it. At a time when deaths from adverse effects of prescription drugs - varying from a minimum of 44,000 to well over 250,000 depending upon who you listen to - are so high the thought of polypharmacy is absurb and ignorant of the fact that hundreds of thousands have lost their lives to faulty drug therapy. It is stated by Jay Cohen, M.D. in "Over Dose - The Case Against the Drug Companies" based on his research and 20 years experience that most of the adverse events could be avoided were doctors taught to titrate or modify dosages to fit the individual patients. But the FDA and drug companies who are primarily responsible for this education have no track record for doing it - thus hundreds of thousands more die each year because of a serious lack of responsibility by those in charge. And now it is suggested that a 6 component polypill be approved based on the supposed effectiveness of the individual parts that will result in a combined efficacy that is yet to be, and according to the author, may never be studied. If doctors are not even consistently able to adjust medications to eliminate side effects in mono-drug therapies - how then could one possibly assume they would be competent at administering and modifying a polypill to the benefit of the patient? Were they effective at doing this - how many different versions of the polypill would then be manufactured what with the 6 different components in varying amounts to suit the physiology of the individual patients? I submit that no manufaturer would take on such a daunting task - nor would the hierarchy of medical education sign off on teaching such a curriculum as that. Therefore we are at an impasse because the therapy would be unmanageable, un-manufacturable and ultimately devastating to the population of any nation it were approved in. And finally I submit to the author that to suggest a drug be implemented without study into the general population goes against the very principle of medicine which has been said to be, according to Hippocrates, "First Do No Harm!" Competing interests: None declared |
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Anne Savage, retired retired
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Professor Wald and colleagues have missed out on several ingredients for a true 'polypill'. 'The Week', current number, features a KGB pill that is said to reduce the effect of alcohol, a potent cause of disability and death. How about prophylactic hypoglycaemics for the overweight, and we must not forget the vitamins, thought by many to be essential for perfect health. In a few years time I can see the new 'theriac'being produced and available from birth. The more serious objection is that we have no idea what patients are already taking in the way of herbal medicines and however safe the ingredients of the polypill may be they may not mix well with exotic substances in unlabelled bottles. I did note with interest the, very, small print.It seems that the professor has a very strong 'vested interest'if he proposes to patent this product. What does the GMC say about that? Competing interests: None declared |
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Yan Press, MD, geriatrician Soroka Hospital, A. Mark Clarfield MD FRCPC
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We were surprised (and in truth disappointed ) by the results of a recently published paper in the NEJM (ref 1) on re-stenosis after coronary stent insertion While there were no differences in mortality, there seems to be no getting away from the fact that the treatment group (which received folate, B6 and B12) suffered more from re-stenosis than did those who had received a placebo. While these results do not prove that folic acid should not be used either for the primary or secondary prevention of atherosclerosis , they do make one question the recommendation to use a "Polypill" (containing , among other things , folic acid) for such prevention in whole populations. (ref 2). And while we are not the first to argue in principle for a cautious approach to this idea, (ref 3) the data presented by Lange et al certainly add weight to the old caution : primum non nocere. For our part, until the definitive trials come out, we have stopped taking folate acid with our breakfast cereal. Have we just seen the first signs of an estrogen redux story for this vitamin? References: 1)Lange H, Suryapranata H, De Luca G, et al. Folate therapy and in- stent restenosis after coronary stenting. N Engl J Med 2004;350:2673-2681. 2)Wald NJ, Law MR. A strategy to reduce cardiovascular disease by more than 80%. BMJ 2003;326: 1419-24. 3)White C. "Polypill" to fight cardiovascular disease. Summary of rapid responses. BMJ 2003;327:809 (4 October), doi:10.1136/bmj.327.7418.809 Competing interests: None declared |
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