Adverse effects of statins
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3306 (Published 15 May 2014) Cite this as: BMJ 2014;348:g3306All rapid responses
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I'm concerned about pressure that has been placed on editors and reviewers about the error which has already been corrected in this article. I personally know nothing of statins, but I am a reviewer for many peer-reviewed journals and want to remind everyone that:
1. the system of peer-review is imperfect, but it's the best system we have;
2. reviewers and editors are usually unpaid and doing this work 'on their own back' and in their own time;
3. that there are powerful lobbies who may wish to use errors as an excuse to override editorial independence , and set an example for others in doing so - effectively punishing the whole system for upsetting their business.
Thanks,
Jan Golembiewski
Competing interests: No competing interests
I am in favour of the BMJ’s decision not to retract these two articles. The magnitude of the error (18% versus 20%) is so tiny that it should have deserved only a letter to the authors. Any way, there was a much bigger reason to criticize both the analysis of Abramson and colleagues and the meta-analysis of CTT. Indeed, the first did not say a word about the MEGA study (Lancet 2006 and Circulation 2008 for post-hoc analysis in women), and the second have incorporated the results of the MEGA study in their meta-analysis without saying that it was the only study conducted in a population (the Japanese) characterized by a very low risk of death from ischemic heart disease and stroke (Within the OECD countries the lowest rates are observed in Japan, Korea and France). It is not necessary to do a meta-analysis mixing so heterogeneous data when a trial done with the least powerful statin on LDL-cholesterol (pravastatin) at its lowest dosage (10 mg daily) yields such impressive results (relative risk reduction after 5 years follow-up were 32% for all cause mortality, 48 % for myocardial infraction, 30% for strokes).
Competing interests: No competing interests
Editor, I support BMJ’s decision not to retract this article. Patient oriented evidence for statins benefit on primary prevention is lacking and despite this they are used worldwide at the expense of healthy people (and unhealthy finances). BMJ has long set high (and rare) standards of transparency and independence. Hope this will be made clear in the end.
Competing interests: No competing interests
I note the recent BMJ rapid-response addressed to Dr Iona Heath by Professor Peter Sever.
I understand from Dr Peter Sever that Dr Iona Heath will be chair of the panel set up by the BMJ to consider the question of whether a full withdrawal of the Abrahamson and Mahotra papers, relating to side effects of statins, should be "expidited".
I have not been able to find any open-access, up-to-date, record of declarations of interest for either Sir Rory Collins or for Prof Peter Sever. This may be my failure to look in the right place.
If this is not my failure, it occurs to me, that it would be helpful, and in the spirit of ethical science, for all those involved in research on statins, and for all those involved in the panel to be chaired by Dr Iona Heath, to declare any interests ahead of any meeting
An easy, but voluntary way to do this, would be through whopaysthisdoctor.com http://www.whopaysthisdoctor.org/ (I should state clearly that I was one of those involved in setting up this voluntary register).
An alternative would be for all involved to ensure that declarations, if any, are registered with respective employers (if they are employed that is). For registered medical practitioners, it is my understanding, that at annual Appraisal, and at 5 yearly Revalidation, that medical practitioners such as myself are asked to sign (in the Probity section) that we have followed our employers guidance/policy on declaring any relevant interests.
Having myself tried to establish, across a wide range of employers, if they have open access, up-to-date registers, my findings have met with quite limited success.
Competing interests: No competing interests
As rightly mentioned by Dr Godlee, a number of clinical trials performed versus placebo (the golden standard of clinical research) show a high degree of safety for the pharmacological class of statins.
In spite of the criticism of a minority of professionals regarding the credibility of clinical research when performed by or with the financial support of drug manufacturers, it would be quite difficult to ascribe such evidence of safety to fraud or malpractice, taking into account that regulatory authorities have the duty to supervise the credibility of the trials conducted by the pharmaceutical firms.
In contrast, one may worry when authors do not hesitate to disseminate in the most prestigious journals estimations of frequency which have not been properly assessed or cross-checked, especially if one considers, on the other hand, the perfectly established benefits of statins on cardiovascular morbidity or mortality.
Consistent with the medical literature, clinical experience confirms that, overall, the side-effects of statins are not frequent and that serious clinical hazards are fairly rare. Overall, although the inadvertency of Abramson et al. in assessing statins safety appears regrettable in an eminent journal such as the BMJ, they should be given credit for their rapid correction: to that extent, I wonder whether a formal retraction would not add an excessive penalty to the inherent sanction of a contribution the credibility of which has already been impaired by such an error.
Competing interests: No competing interests
A general demand for withdrawal of articles because they include errors that have escaped the attention of peer reviewers could easily lead to the withdrawal of a substantial proportion of the scientific literature. Given that "The question in the case of these two articles is whether the error is sufficient for retraction, given that the incorrect statements were in each case secondary to the article’s primary focus." to demand retraction is absurd. It would be interesting to collect examples of major errors that have gone unchallenged in other articles. I could give examples, but not from the BMJ.
Competing interests: No competing interests
I approve your choice to pass the decision to retract or not the papers of Abramson and colleagues and of Malhotra to an independent panel.
Please do not do more.
I am one of those who support the BMJ independence. Even if sometime I disagree with a published paper.
Competing interests: No competing interests
I support BMJ’s decision
Competing interests: No competing interests
I support BMJ’s decision not to retract the both articles about adverse effects of statins and I think that it is very important that the BMJ can continue to debate the important questions raised in both these articles: whether the use of statins should be extended to a vastly wider population of people at low risk of cardiovascular disease; and the role of saturated fat in heart disease. In my medical practice I need to have clear and independent answers to these questions for the sake of the health of patients.
Competing interests: No competing interests
Re: Adverse effects of statins
I support the BMJ's decision not to retract these articles.
Competing interests: No competing interests