August 2, 2014

expert reaction to decision not to retract two BMJ articles on statins

An independent panel decided the BMJ did not need to retract two articles on statins – one opinion piece and one analysis – both of which made claims about side effects which were subsequently withdrawn.

Prof Sir Rory Collins, Co-Director of Oxford University’s Clinical Trial Service Unit and Professor of Medicine & Epidemiology, said:

“It is important that patients and their doctors are not misinformed about the benefits and risks of treatments.

“With respect to statins, carefully conducted randomised trials have provided reliable evidence that about 5 per 1000 patients suffer adverse events due to statin therapy (most commonly the slightly earlier diagnosis of diabetes and, more rarely, muscle problems) during 5 years of treatment. By contrast, among the types of lower risk patients in whom NICE has now recommended statin use, about 30 to 50 per 1000 patients given effective statin therapy will avoid heart attacks, strokes, revascularisation procedures and vascular deaths during each 5-year period of treatment. And, for higher risk patients (such as those who have already had heart attacks), about 60 to 120 per 1000 patients would avoid such major vascular events.

“In the case of these two BMJ papers on statins, and subsequent publications and statements from their authors, the adverse effects of statin therapy were over-estimated by more than 20-fold and the benefits of using effective statin therapy were under-estimated by about 2-fold. One of the serious errors in both of these BMJ papers has already been withdrawn, but several other serious errors – including those that were drawn to the attention of the BMJ during the independent peer review process prior to publication, as well as subsequently – have not yet been withdrawn. Such misinformation about the balance of benefits and harms of statin therapy make it difficult for people to make an informed choice about whether or not to take a statin.

“As a consequence of the decision by the BMJ’s panel not to take this opportunity to correct the scientific record properly, patients and their doctors will continue to be misinformed. It seems likely, therefore, that many patients – including those at high risk of heart attacks and strokes – may well stop taking their statin therapy or will not start it, which would lead to unnecessary heart attacks and strokes.”

Prof John Deanfield, BHF Professor of Cardiology, UCL, said:

“I don’t feel strongly that a full retraction is required, merely an acknowledgement that the views expressed were based on incorrect data.”

Prof Sir John Tooke, President of the Academy of Medical Sciences said:

“These papers in the BMJ have prompted a very heated debate around the use of statins. We must focus on the scientific evidence for their use, in combination with lifestyle changes. It is crucial that the most accurate and relevant information about the risks and benefits of statins is made available to patients and healthcare providers. There is a very real possibility that misinformation about statins could put the health of those who need them at risk. We are disappointed that the papers have not been retracted, but hope that a renewed focus on the evidence base can bring much-needed clarity to the debate.

Prof Francesco Cappuccio, Professor of Cardiovascular Medicine & Epidemiology, University of Warwick, said:

“I do not feel very strongly that a retraction is necessary. The error was indeed on the research paper to which the two opinions were referring – the opinions, ad for their nature, are subjective and open to criticism and debate. It would be important to make it absolutely clear to readers that there were ‘incorrect’ data published that may have misled judgment, though.”

‘Report of the independent panel considering the retraction of two BMJ papers’ by Health et al. published in BMJ on Saturday 2^nd  August.

Declared interests

Prof John Deanfield states: “I have no conflicts of interest to declare, apart from honoraria for lectures received from Pfizer, MSD, Aegerion, Kawa, Roche and MSD advisory board membership.  I was PI on a trial of Dalcetrapib on vascular function (DALVESSEL) for which I received no reimbursement.”

Prof Sir John Tooke:

Public Appointments Held at Present:

1)       Non-executive Director, UCLH NHS Foundation Trust; Chair of the Quality and Safety Committee, 2010-
2)       President, Academy of Medical Sciences, 2011-
3)       Member, National Institute for Health Research Advisory Board, 2007-
4)       Board Member, GMEC (Global Medical Excellence Cluster), 2012-
5)       Board Member, International Advisory Board, Qatar Academic Health Science Centre, 2011-
6)       Academic Director, UCL Partners, 2010-
7)       Member, Medical Schools Council Executive, 2007-
8)       Member, Associate Parliamentary Health Group, 2010-

Previous Public Appointments Held Within the Last 5 Years:

1)       Chair, UK Health Education Advisory Committee, 2005-2011
2)       Chair, Medical Schools Council, 2006-2009

Personal and Business Interests:

Non-executive Director, Bupa; Chair of the Medical Advisory Panel, 2009-2015

Prof Sir Rory Collins states: “CTSU has a policy of not accepting honoraria, consultancies or other payments directly or indirectly from pharma, other than the reimbursement of travel and accommodation for particular scientific meetings.

The CTSU conducts, analyses and interprets its clinical trials (for which it serves as the regulatory sponsor) and other research independently of the pharmaceutical industry funders and other funders, with the datasets held by the CTSU rather than by the funders. In accordance with our long-term policy, honoraria, consultancy or other payments have not been received directly or indirectly from industry, either personally by me or by the University (except for reimbursement of travel and accommodation for taking part in relevant scientific meetings). I have previously sent the BMJ a list of all of the grants to Oxford University for any CTSU trials and all other commercially-funded research over the past 20 years.”

See this document for full details of how the Clinical Trial Service Unit & Epidemiological Studies Unit (“CTSU”) of the Nuffield Department of Population Health, University of Oxford, is funded.