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The Data Dispute: BMJ & Lancet
Statins are among the most prescribed drugs world-wide, and they are the most prescribed for cholesterol lowering. The patents on statins have expired and the market is flooded with a huge number of generics also, which has led to further expansion of statins market. It is estimated that the sales revenue from statins will go up to one trillion US $ by 2020.
An article published in British Medical Journal (BMJ) on 22 October 2013 analyzed the use of statins in people with low risk of cardiovascular disease1. The authors start by saying that “The 2013 Cochrane review of primary prevention with statins concluded that they reduce all-cause mortality and cardiovascular events without increasing the risk of adverse events among people at low risk of cardiovascular disease (<10% over 10 years). However, just two years earlier, a Cochrane review had concluded that existing evidence did not support the use of cholesterol lowering statins for people with <20% 10 year cardiovascular risk: “Only limited evidence showed that primary prevention with statins may be cost effective and improve patient quality of life. Caution should be taken in prescribing statins for primary prevention among people at low cardiovascular risk.” This conclusion was consistent with the 2006-08 guidance from the National Institute for Health and Care Excellence (NICE) and the 2011 update of the American Heart Association’s guidelines for the prevention of cardiovascular disease in women, both of which recommended statin therapy only when the 10 year risk of disease is 20% or greater.
If risk is estimated using the QRISK2 score, by the 2011 standards just 2% of women in their 50s and 16% in their 60s qualify for statin therapy (≥ 20% 10-year risk of cardiovascular disease). For men, 9% in their 50s and 48% in their 60s qualify. Under the proposed 2013 standards, however, no level of risk would preclude statin therapy, raising the question whether all people over the age of 50 should be treated”.
The analysis challenges this position on two grounds; one, that the probable benefits are too small; two, the side-effects are not fully documented.
This article led to heated dispute between the Cholesterol Treatment Trialists (CTT) who published their findings in the Lancet and BMJ. The CTT led by the senior author Rory Collins and Richard Horton demanded that BMJ retract this article. The matter however had already spilled over and was publicly debated.
In September 2016, Fiona Godlee, editor-in-chief of BMJ wrote an editorial titled ‘Statins: we need an independent review’2. She wrote “Statins are back in the news. A review published in the Lancet last week, covered in our news story (doi:10.1136/bmj.i4893), presents what its authors clearly consider to be a definitive account of the evidence on statins that should, they say, bring an end to a dangerous debate.
Not everyone agrees. Though the benefits of statins for secondary prevention or in people at high risk of cardiovascular disease are undisputed, proposals to offer them to large numbers of people at lower risk remain controversial, much to the frustration of the statin trialists who authored the Lancet review. Commenting in The BMJ this week, Harlan Krumholz agrees on the strong case for the overall benefits of statins, but he wants more acknowledgment of the trials’ limitations (doi:10.1136/bmj.i4963). These include the lack of good evidence in elderly people, the variation in how adverse event data were collected, and the ageing of the trials themselves.”
She also contested the position of Rory Collins; “At a more fundamental level, who should decide when such questions are too dangerous to ask? Certainly not those who have a vested interest in the debate being shut down. Rory Collins, head of the Cholesterol Treatment Trialists’ (CTT) Collaboration, continues to call for the retraction of two BMJ articles that disputed the use of statins in low risk people (doi:10.1136/bmj.f6123; doi:10.1136/bmj.f6340). His call comes despite an independent expert panel set up by The BMJ and, subsequently, the Committee on Publication Ethics (COPE) concluding that The BMJ had acted appropriately in its handling of the papers. This week we publish documents (http://www.bmj.com/content/bmj/suppl/2016/11/09/bmj.i4992.DC1/copedocuments.pdf) that serve to correct Richard Horton’s comments in the Lancet (doi:10.1016/S0140-6736(16)31583-5), in which he wrongly stated that COPE had “declined to act” on Collins’s concerns. (See also my rapid response www.bmj.com/content/351/bmj.h3908/rr-8.)
Independent third-party scrutiny of the statins trial data remains an essential next step if this increasingly bitter and unproductive dispute is to be resolved”.
- BMJ2013; 347 doi: https://doi.org/10.1136/bmj.f6123 (Published 22 October 2013)
- BMJ2016; 354 doi: https://doi.org/10.1136/bmj.i4992 (Published 15 September 2016)