On 21 May my blog featured calls by Professor Sir Rory Collins for the retraction of two articles that raised issues about the safety of statins. In both articles, evidence from a particular study was misrepresented and misquoted. The BMJ has withdrawn the comments and even featured them in an editorial. But Professor Sir Rory Collins is not satisfied: he wants both articles retracted. This, even though, he has not challenged the main thrusts of these articles which were (individually) that statins don’t do any good for people at low risk of cardiovascular disease and saturated fat doesn’t cause heart disease.
The editor has convened a committee headed by Dr Iona Heath to judge whether there are good grounds to retract the papers (or not).
The BMJ has a ‘rapid response’ service, where individuals can submit on-line responses to articles and people. The editorial about this issue has, at the time of writing, received 64 responses (that is a lot for the BMJ, and in fact, the article is currently by far the most commented on piece in the journal). Take a look at the responses and you will see that the vast majority of them are supportive of the BMJ and its editor (Fiona Godlee). Many people feel strongly that the articles should not be withdrawn.
I wrote a response in which I called into question the validity of the data so often used by Professor Sir Rory Collins (and people of his persuasion) to state that ‘statins are safe’. My position is that Professor Sir Rory Collins and others have misled us (wittingly or unwittingly) about the safety of statins and the trustworthiness of the data (potentially putting people at risk of health issues caused by statins). Readers can vote on rapid responses with an ‘up-vote’. There has clearly been some support for my position in that my response has over 850 up-votes (I have never seen such a high number for any response in the BMJ). Perhaps you voted. If you did – thank you!
Not everyone who has commented is supportive of the BMJ. One malcontent is Professor Peter Sever, who is a colleague of Rory Collins, and has run one big industry-funded trial that (among other things) tested the effectiveness of the statin atorvastatin (known as the ‘ASCOT’ trial, published in 2003).
Here’s a link to Professor Sever’s response , but to make it easy for you I’ve reproduced it below. Professor Sever rams home the point (with righteous indignation, I think) that the original papers misled us on the findings of the statin side-effect paper, and gives full backing to Professor Sir Rory Collins’ calls for retraction. Judge for yourself…
Dear Dr Heath,
In your role as chairman of the panel set up by the BMJ to consider the question of whether a full withdrawal of the Abramson and Malhotra papers, relating to side effects of statins, should be expedited, I write to you to provide my full support of the detailed case made by Rory Collins that these 2 papers are examples of bad science, in that the authors misrepresent the truth and sensationalise a variety of side effects claimed to be due to statins, the consequence of which, is that for the wrong reasons patients, whose future morbidity and mortality from cardiovascular disease would have benefited substantially from statin therapy, will be dissuaded from taking the drugs or discontinuing them if they are already receiving treatment.
The BMJ has taken a strong position on scientific integrity and its detailed review and condemnation of the Lancet’s publication of the Wakefield MMR scandal was well received. The same principles should apply over the critical reviews of these two statin papers and the misrepresented claims of Zhang et al, that statins were causally related to side effects in 20% of statin users.
As the Co-chief Investigator of ASCOT, a trial that was independently designed and lead, and where the executive committee held the data base, analysed the results and published the papers independent of the funder, Pfizer, I strongly refute the implications of authors of the 2 recent studies implying that trial sponsors could have influenced the results and downplayed the side effect profiles of the drugs.
In ASCOT, side effect profiles were identical on those taking placebo and statin.
Interestingly, in the blood pressure arm of ASCOT we detected drug related side effects of the ACE inhibitor (cough) and the calcium channel blocker (ankle oedema) with incident rates not dissimilar from those experienced in clinical practice. So if statins were to be causally related to myalgia/ myopathy, why did we not detect this in a trial of 10,000 subjects ?
I would like to remind you that in a recent study published in Archives, a rechallenge of patients previously withdrawn from statin because of muscular side effects, yielded the return of identical symptoms in 80% of patients. Problem was the rechallenge was a placebo !
We are dealing with a very serious issue here, and editors of major international journals have a duty to publish good science and not popularize bad science which is regrettably the prerogative of the lay press.
The retraction of these two papers will go some way towards damage limitation, but do not underestimate the huge impact these publications will have had and the disastrous consequences for the vulnerable patient population who stand to benefit enormously from their statin treatment.
Professor of Clinical Pharmacology
National Heart and Lung Institute
Imperial College London
May 24th 2014
Competing interests: Recipient of grants to Imperial College from Pfizer Inc for conduct of ASCOT Recipient of honoraria for speakers bureau- Pfizer Inc
Let me cut to the chase here and say that I believe Professor Sever’s response to be verging on hysterical, and actually a great example of misinformation and sensationalism. I think it employs the same ‘eminence-based’ and bully-boy tactics I suspect Professor Sir Rory Collins deployed when he ‘forced’ a meeting with the BMJ’s editor without formally tabling his objections.
So, taken aback was I by Professor Sever’s response, that responded to him with a detailed analysis of his assertions, and several questions of my own (including questions about the reliability of his own research, as well as that of Professor Sir Rory Collins. Also, I respectively point out to Professor Sever that nothing in his response in anyway counters the central claims of the papers he wants retracted.
To see my response, click this link. Again, there’s an opportunity to lend your support for the arguments with an ‘up vote’.
Yesterday, I emailed Professor Sever directly to alert him to my response. He declined the offer of posting again at the BMJ, saying that it “simply provides an opportunity for authors such as Abramson and Malhotra ( and indeed yourself ) to repeat the misleading claims relating to statin induced side effects”. He did, to his credit, address some of my questions and concerns. However, not to his credit is that fact that he. again, provided no evidence at all that would justify retraction of the papers. I’ll be posting about his latest response and my reaction to it next week.