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Medical Forum / General / Cardiology / July 2006Why is JAMA hiding statin adverse effects?
How can doctors and patients make an informed risk analysis about the dangers of statins when JAMA, the journal of their own medical association, refuses to allow them access to information on these adverse effects as collected in a study PUBLISHED BY JAMA? Not only do they refuse to publish the adverse effects data, they refuse to publish the request. Where do the JAMA editors ethical loyalties reside? With the doctors they purport to inform, or with the sources of their advertising revenue? http://www.thincs.org/index.htm select "News" Click on the link for Unpublished letter to JAMA By Uffe Ravnskov,* Paul Rosch* and Morley Sutter.* Did you know that almost 50 % of the participants in the IDEAL trial had serious side effects from the treatment? Why won´t the authors tell us about the nature of these side effects? > How can doctors and patients make an informed risk analysis about the > dangers of statins when JAMA, the journal of their own medical association, [quoted text clipped - 14 lines] > trial had serious side effects from the treatment? Why won´t the authors > tell us about the nature of these side effects? All I see are the words **May ** bantered about along with the word Gray. If this was data for a possible strip mine ... Bill whose phone line is back due to heaven knows what.  SignatureS Jersey USA Zone 5 Shade This article is posted under fair use rules in accordance with Title 17 U.S.C. Section 107, and is strictly for the educational and informative purposes. This material is distributed without profit. William Wagner <not-to-here-williamwag@gmail.com> wrote in news:not-to- here-williamwag-778931.17131810072006@sn-indi.vsrv-sjc.supernews.net: >> How can doctors and patients make an informed risk analysis about the >> dangers of statins when JAMA, the journal of their own medical association, [quoted text clipped - 19 lines] > > Bill whose phone line is back due to heaven knows what. Sharon posted the following in another thread: On 09 Jul 2006, you wrote in sci.med.cardiology: > A recently published medical journal article showed 100% of statin patients have muscle damage identifiable on muscle biopsy after only a few months. > Another recently published study showed all statin patients have measurable cognitive impacts after 6 months. > Another recently published study showed neuropathy 26 times more likely in statin patients. Since she has me killfiled would you please ask her for the 3 links to these claims, particularly the first? Thank you. L. > How can doctors and patients make an informed risk analysis about the > dangers of statins when JAMA, the journal of their own medical association, [quoted text clipped - 14 lines] > trial had serious side effects from the treatment? Why won´t the authors > tell us about the nature of these side effects? On 09 Jul 2006, you wrote in sci.med.cardiology: > A recently published medical journal article showed 100% of statin > patients have muscle damage identifiable on muscle biopsy after only a > few months. Link? > Another recently published study showed all statin patients have > measurable cognitive impacts after 6 months. Link? > Another recently published study showed neuropathy 26 times more likely >in statin patients. Link? > How can doctors and patients make an informed risk analysis about the > dangers of statins when JAMA, the journal of their own medical association, [quoted text clipped - 14 lines] > trial had serious side effects from the treatment? Why won´t the authors > tell us about the nature of these side effects? Would someone please explain to me the discrepencies here? 1. the link says 95% of the patients "experienced adverse effects". The abstract PMID: 16287954 doesn't mention anything near that. Where does the 95% come from? 2.The adverse effects data was listed as "nonserious adverse events; transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals (P<.001). Serious myopathy and rhabdomyolysis were rare in both groups." What further breakdown is needed if the freq is less than that? Compare this to Sharon Hope's quote of her linked page Where does the 50% serious side effects come from? Why won't the people claiming that explain where it comes from instead of letting it seem like a total lie? > > How can doctors and patients make an informed risk analysis about the > > dangers of statins when JAMA, the journal of their own medical association, [quoted text clipped - 30 lines] > Why won't the people claiming that explain where it comes from > instead of letting it seem like a total lie? Just Ed are you taking this stuff or just promoting it? Bill SignatureS Jersey USA Zone 5 Shade This article is posted under fair use rules in accordance with Title 17 U.S.C. Section 107, and is strictly for the educational and informative purposes. This material is distributed without profit. >>2.The adverse effects data was listed as "nonserious adverse events; >> transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals [quoted text clipped - 6 lines] >>Why won't the people claiming that explain where it comes from >>instead of letting it seem like a total lie? Actually the 50% figure (actually 47%) is from the IDEAL study as published in JAMA (in Table 4). However, what people really should be complaining about isn't that they aren't explaining the breakdown of these "serious" adverse events but that they defined the events in such a way that there were so many of them as to mask any difference between the two arms of the study (comparing high intensity and low instensity statin therapy). The 47% serious adverse event rate as reported is silly. The numbers this hides is that 10% of patients discontinued the intensive regimen for adverse events while only 4% discontinued the less intensive regimen. That said, it may be that some external regulatory body in Europe or the US required this definition of "serious" adverse events, rather than the investigators defining things this way. So, at least to my mind, there really is an issue here but it's completely different from the one raised. I don't care what the breakdown of those 47% of "serious" adverse events was since they clearly weren't actually serious. I care that the intensive regimen lead to adverse events causing twice as many drug discontinuations. SignatureDavid Rind drind@caregroup.harvard.edu > >>2.The adverse effects data was listed as "nonserious adverse events; > >> transaminase elevation resulted in 43 (1.0%) vs 5 (0.1%) withdrawals [quoted text clipped - 9 lines] > Actually the 50% figure (actually 47%) is from the IDEAL study as > published in JAMA (in Table 4). There it is, thank-you... my fault for thinking that JAMA wouldn't let me at the full text. > However, what people really should be > complaining about isn't that they aren't explaining the breakdown of [quoted text clipped - 6 lines] > this hides is that 10% of patients discontinued the intensive regimen > for adverse events while only 4% discontinued the less intensive regimen. and that 10% seems kind of mysterious since they state that there are no other causes as large as .5% apiece making up the 5.4% which is unaccounted. > That said, it may be that some external regulatory body in Europe or the > US required this definition of "serious" adverse events, rather than the [quoted text clipped - 5 lines] > clearly weren't actually serious. I care that the intensive regimen lead > to adverse events causing twice as many drug discontinuations. Having half the patients preconditioned to simvastatin (per the 'Safety' para) may take much value out of comparing these numbers, but I get your point. |
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