Statins for people at low risk
BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h3908 (Published 21 July 2015) Cite this as: BMJ 2015;351:h3908
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I am pleased to report that BMJ's Executive Committee (on which I sit) has approved a proposal to publicly disclose revenues received from industry sources including the pharmaceutical and devices industries. This is in line with BMJ's commitment to greater transparency within medicine, research and publishing. The first declaration will be for revenues received in 2016 and will be published on bmj.com as soon as possible after the company accounts have been lodged with Companies House, probably July 2017. We will publish an editorial to alert readers to the declaration.
Competing interests: I am editor in chief of The BMJ and responsible for all that it contains. The BMJ is part of the publishing company BMJ, which is wholly owned by the BMA. I serve as a member of BMJ's Executive Committee and as a director on its Board.
I welcome Rory Collins' rapid response.[1] In it he writes: “The BMJ's Editor has stated that, prompted by this correspondence, she does now agree that the BMJ should have put detailed information about this funding into the public domain.”
For the record, what I said in my email to him on 1st December 2016 was: “On the question of BMJ's revenues, the decision as to what information we make public sits with the commercial side of the organisation and hence is not within my gift. I believe The BMJ is ahead of most other journals in its efforts to be transparent but I agree we could and should do more, and prompted by your correspondence with Tim Brooks, I will be taking this to our Executive committee in the new year.”
I am doing this, and I will report back to readers as soon as possible.
Competing interests: Fiona Godlee is the editor of The BMJ and responsible for all that it contains.
It is interesting to learn, thanks to digging by Collins, that the BMJ receives about £7.5M annually, from Pharma.
Especially when one rereads Dr Godlee’s advice a decade ago, “Say no to the free lunch“, wherein she writes about “ pigs in white coats lunching and golfing with weasel drug reps. “
The article ends, “ just say no “. (1)
Marcia Angell, one time editor of the NEJM, has been a powerful voice exposing medical and pharmaceutical corruption, particularly through her articles in the New York Review of Books (2,3,4). No surprise that her name appears less often in leading medical journals. Seven years ago she wrote in the BMJ, “ The relationship between the drug industry, academia, health care professionals and patients has reached an all time low. “ (5)
She explained why, in terms that make one smile, and wonder if the BMJ happened to be enjoying a £7.5M Pharma supplement in that financial year, too ?
Angell has pointed out that “ The problems I’ve discussed are not limited to psychiatry, although they reach their most florid forms there .“ (2)
Gøtzsche has taken an even deeper and more detailed look at psychotropic prescribing. (6) He co-founded the Cochrane Collaboration in 1993. The contents of “Deadly Psychiatry and Organised Denial “ are of massive importance to those who take, or might take, psychtropics. Many people who market and prescribe those drugs may prefer the book goes unnoticed. It has been scarcely mentioned in the BMJ.
Psychotropics are huge earners for Pharma.
In the past decade the BMJ has given a platform to senior colleagues who have demeaned themselves by insulting and abusing medical homeopaths, making the provision of effective homeopathic services more problematic. There has been no response to repeated requests that the BMJ explain it’s attitude.
Homeopathy is no more of an immediate threat to Pharma than a mosquito on an elephant’s ear, but swotted they may be. By elephant or keeper.
1 Editor’s Choice. BMJ 2005;330:0-g
2 New York Review of Books January 15 2009
3 NYRB June 23 2011
4 NYRB July 14 2011
5 Relationships with the drug industry. BMJ2009;338:b222
6 Peter C Gøtzsche, Deadly Psychiatry and Organised Denial. People’s Press 2015
7 Double Standards, or a variety of editorial views, at the BMJ ?
http://www.bmj.com/content/351/bmj.h5624/rr-6
Competing interests: Not met a drug rep for 25 years. Often abused in this place. Peripatetic homeopath, no private practice.
Rory Collins, Head, Nuffield Department of Population Health has raised concerns about editorial integrity and transparency of the BMJ [1]. As a long time campaigner for transparency in healthcare it is the latter issue I wish to comment on here.
I should say first of all that I am not an expert on statins but I share the scientific approach of Wilson and Jungner (WHO) [2]. In this shared view it is entirely legitimate, and indeed in the spirit of ethical science, to raise questions about any intervention that may target large swathes of the population who would not otherwise be “patients”.
Collins raises concerns about the transparency of BMJ in relation to pharmaceutical industry payments for promotional and related activities. Collins argues, as I would also do, that detailed information about this should be readily available in the public domain.
My concern is not about the request that Collins makes but the inconsistency that he demonstrates on behalf of CTSU (Nuffield Department of Population Health). As a campaigner for transparency I contacted Professor Collins when he first appeared on the BBC News about the BMJ’s coverage of statins for primary prevention. In reply I was sent CTSU Grants, May 2014 [3]. I asked Professor Collins if this CTSU declaration was publically available and he replied on the 27th May 2014: “Not as yet, but - we are looking at how best to do that in the short-term (i.e. based on what I sent you) and in the longer term (i.e. ensuring that it is kept up to date).”
The CTSU grants from Industry would seem to add up close to £250 million over twenty years [3]. This is not specified nor referenced by Professor Collins in his response [1]. It would seem entirely fair then to suggest inconsistency from CTSU on the subject of transparency. There is of course additional debate regarding transparency of research data.
In summary: I believe that this debate on transparency is important and thank Professor Collins and the BMJ for doing their best to have it in the open. My personal view is that transparency is only a means to an end as I share the outlook of Peter C. Gøtzsche who has stated in the BMJ “I believe science ceases to exist when no one else than those who have conflicts of interest are allowed to see the data” [4]
References:
[1] Collins, R Lack of transparency about the BMJ’s income from the pharmaceutical industry http://www.bmj.com/content/351/bmj.h3908/rr-12
[2] Wilson J, Jungner, G. Principles and practice of screening for disease. WHO Chronicle 1968;22(11):473
[3] CTSU Grants, May 2014 (supplied by Professor Rory Collins to Dr Peter J Gordon, 23 May 2014. Dr Gordon understood from this communication that this document, outlining CTSU funding, was open and available to the public)
[4] Gøtzsche P. Adverse effects of statins. BMJ Rapid Response, 21 May 2014 http://www.bmj.com/content/348/bmj.g3306/rr/698864
Competing interests: Dr Peter J Gordon raised a petition with the Scottish Parliament to consider introducing a Sunshine Act for Scotland: http://www.parliament.scot/GettingInvolved/Petitions/sunshineact
As part of the BMJ’s response to concerns raised with the Committee on Publication Ethics (COPE) about failures of editorial integrity at the BMJ,(1) the CEO of the BMJ commented on the funding received from the pharmaceutical industry by the University of Oxford for independent research conducted by the Clinical Trial Service Unit (CTSU).(2) He did acknowledge that the CTSU has made information public about the amount, source and purpose of that funding. However, he did not mention the funding that the BMJ receives from industry, which had not been disclosed publicly.
Subsequent correspondence revealed that the BMJ has typically been receiving about £7.5M every year from the pharmaceutical industry for promotional and related activities:(3) my response to this disclosure is reproduced below. The BMJ’s Editor has stated that, prompted by this correspondence, she does now agree that the BMJ should have put detailed information about this funding into the public domain. However, it has still not done so, and nor have these potential financial conflicts of interest been disclosed in relevant editorials or commentaries.
Yours sincerely
Rory Collins, FRS
BHF Professor of Medicine & Epidemiology,
Head, Nuffield Department of Population Health,
University of Oxford, Oxford, UK
14 March 2016
Dear Mr Brooks
Given its espousal of transparency, it is surprising that the BMJ has chosen not to make public the details of financial interests that might be relevant to the treatment of patients and to public health (and, indeed, would instead claim commercial privilege). As has been pointed out, if you were to make such information publicly available then it might help to avoid the repetition of previous failures by the BMJ to declare potentially relevant conflicts of interests because (to quote the BMJ’s Editor; March 2011) “it didn't occur to us to do so”.
It is a start that you have now stated that the BMJ received £7.5M from the pharmaceutical industry in 2015 for promotional and related activities. Although you have not addressed the request for detailed information about such income over the past 20 years (analogous to the information that we have made available for funding to Oxford University of our independently conducted research), your statement that the annual amounts do not vary much implies that the BMJ has received about £150M from the pharmaceutical industry during that period. (If that estimate is not correct then do please provide a revised figure.)
I would recommend that the BMJ publish prominently on its website the amounts that it has received each year from pharmaceutical companies (and, in case they have inadvertently been excluded, medical device and other health-care companies) and the purposes for which these payments have been made. The rationale for declaring such interests is that it allows people to decide for themselves (rather than, as you seem to suggest, the BMJ doing so for them) whether or not a material interest exists in a particular situation. By putting these data into the public domain, the BMJ would avoid being accused unreasonably of withholding relevant information about potential financial conflicts of interest.
Yours sincerely
Rory Collins, FRS
Head, Nuffield Department of Population Health
University of Oxford
1. https://www.cttcollaboration.org/news/renewed-call-to-retract-bmj-articl...
2. http://www.bmj.com/content/bmj/suppl/2016/11/09/bmj.i4992.DC1/copedocume...
Competing interests: I was a signatory of the submission to COPE about the way in which the BMJ failed to deal properly with misrepresentations in two papers that it published in October 2013. Oxford University has received funding from the pharmaceutical industry for independent research conducted by our group; we have a policy of not taking any personal payments directly or indirectly from the pharmaceutical industry (other than for reimbursement of travel and accommodation for taking part in scientific meetings): see https://www.ctsu.ox.ac.uk/.
Could readers also be told, even if not in complete detail unless parties are willing, how much income is gained from advertising by THE BMJ?
Competing interests: No competing interests
In response to a commentary drafted at COPE's request by BMJ's CEO, Mr Tim Brooks (http://www.bmj.com/content/bmj/suppl/2016/11/09/bmj.i4992.DC1/copedocume...), Rory Collins asked BMJ to declare how much revenue it receives from the pharmaceutical industry. Mr Brooks' reply is reproduced below for readers' information.
07 March 2016
Dear Professor Collins
You wrote to me on December 21st, in response to a commentary I drafted for COPE at their request in May 2015. Your letter asked that we declare how much revenue this company receives from the pharmaceutical industry.
BMJ is a private company with a single shareholder, and as such we do not publish detailed accounts. In the interests of meeting your concerns, however, here are the relevant data for last year.
In 2015, our financial records show that revenues from the industry totalled £7,481,000. This comprised 9.7% of our total revenue for 2015. It came from more than 200 companies in the sector, broadly defined. What this money bought was subscriptions to journals, of which we publish 60; advertising in the same; reprints of articles from the same; sponsorship of events (such as our International Forum on Quality & Safety in Healthcare); and sponsored translation and licensed distribution of our online learning resources.
It is not possible to state definitively that these are the only revenues received from pharma. For example, an individual working for a pharmaceutical company might take out a subscription to a relevant specialist journal in their own name, and reclaim the expense from their employer. More materially, some subscription agents - who sell on our behalf, and those of our competitors, in markets we cannot afford to service directly (for example, parts of Asia) will be selling subscriptions to pharma clients, but we have no way of finding this out directly.
What is safe to say is that even taking all of this uncertain revenue into account, the proportion of our income deriving from the pharmaceutical industry is below 15%. Our main sources of revenue are individual working doctors, and institutions such as medical schools and hospitals. The amount and proportion from pharma of course varies from year to year, but not by much; certainly not enough to change the overall picture.
Our biggest single client in the sector in 2015 spent £1.95m, which made up 2.5% of our total revenue. No other company (subject to the caveat above on traceability) spent more than £500K. That largest spender was Merck. I think it is worth dwelling on that for two reasons. Firstly, the majority of that spend was licensing of BMJ Learning content to Merck’s Univadis platform in a number of geographical territories, which has now ended. Secondly, as I do not need to remind you, Merck, according to your own declaration, has funded the Clinical Trials Support Unit to the extent of £219.7m over 20 years - comprising approximately 80% of your unit’s total declared funding.
Your letter went on to say, ‘it is worth commenting that, since statins are low-cost and generic, the financial interests of some companies may be best served by generating uncertainty about the safety of statins in order to encourage greater use of alternative, but much more costly, patented treatments. Consequently, in order that the BMJ not only demonstrates its commitment to transparency but also allows potential conflicts of interest to be properly assessed, please would you now release detailed data about all of the BMJ’s relevant financial interests?’ I think regular readers of The BMJ - which vigorously campaigns against over-diagnosis and unnecessary treatment - would not require reassurance about our readiness to challenge any unjustified expense from non-generic prescribing.
The final paragraph of your letter stated that ‘evidence is now emerging that - as was predicted in communications with The BMJ’s editor - erroneous statements about sideeffect rates in the BMJ papers by Abramson et al and by Malhotra have led to large numbers of high-risk patients stopping their statin therapy. It is very likely that the consequence of those actions will be heart attacks and strokes that could have been avoided.’ A central purpose of The BMJ, as a medical research journal, is to promulgate new thinking, and serve as the forum for debate around that thinking.
Those debates often spill over into the non-professional media. We believe this is fundamentally a good thing: matters as important as public health should not (and indeed cannot) remain the private preserve of experts. In this case, of course, it was principally your own action, in going to The Guardian to complain about the papers you refer to, that brought these questions about statins so vividly to the public notice; especially as the Guardian story was then followed up by the very popular and influential Today programme on BBC Radio 4. It was your choice to use these broadcast channels, rather than The BMJ. Let me state again for the record that on the very day you first complained about the original articles, our Editor in Chief asked you to write a response for publication; an invitation she has repeatedly reiterated. You have yet to do so.
Yours sincerely
Tim Brooks
Chief Executive Officer
Competing interests: Fiona Godlee is the editor of The BMJ and responsible for all that it contains.
Though I pay a lot of attention to NICE’s deliberations about statins as chemoprevention for well and ill people [1,2], I haven’t reached a settled view for myself. Like many ageing doctors, if and when I have ‘the conversation’ with my GP, I only want a trusting relationship and a good decision aid. Thus, as a lover of both quantitative and qualitative detail, it was illuminating to follow the various links in the BMJ editor's rapid response [3] and anticipate future episodes in the unfolding narrative. I was intrigued by the Collins complaints and some overlap of signatories and institutions with mammography screening debates [4]. Scholarly anthropologists and historians might wish to explore and study the social networks of medical powerbases more in the future.
Whatever the merits and finer details of risk:benefit and the threat to the public health of lower confidence in statins, successful people with £squillions of funding who operate behind the scenes could be perceived as intimidating. I have no doubt that Professor Sir Big Man and Usual Eminent Suspects have virtuous intentions, but they are being ‘called out’ about arrogance [5] and tactics. They could choose to demonstrate the traditional scientific and medical virtue of humility: (a) publish all the ‘not for publication’ letters, emails, file notes of meetings and phone calls, (b) take up the longstanding invitation to reply to the BMJ, and (c) respond to the demand for independent data sharing and scrutiny. In the fight for medicine’s purpose and moral high ground, they are failing to persuade as many observers and peers make judgments about character on the basis of behaviour.
References
(1) National Institute for Health and Care Excellence. Cardiovascular disease prevention. Public health guideline [PH25] Published date: June 2010. https://www.nice.org.uk/guidance/PH25 (accessed Sept 24 2016)
(2) National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification Clinical guideline [CG181] Published date: July 2014 Last updated: July 2016 https://www.nice.org.uk/guidance/CG181 (accessed Sept 24 2016)
(3) Godlee F. Rapid response re COPE complaint. http://www.bmj.com/content/351/bmj.h3908/rr-8
(4) Concerns over age extension trial of mammography screening - part 4 (June 2015) https://www.healthwatch-uk.org/news/83-age-extension-trial-of-mammograph...
(5) Richard Lehman. Where next with statins. http://blogs.bmj.com/bmj/2016/09/12/richard-lehman-where-next-with-statins/ (accessed Sept 24 2016)
Competing interests: No specific intellectual, funding or personal interests in lipid-lowering agents. My declaration of interests can be found at http://www.whopaysthisdoctor.org/doctor/58 and in NICE publications (Chair of Rapid Update Standing Committee B).
In light of inaccurate statements made last week in the Lancet by its editor Richard Horton,[1] we have decided to publish the documents relating to the complaint made by Rory Collins and colleagues to the Committee on Publication Ethics in October 2014. The complaint referred to The BMJ’s handling of two articles published the year before, which questioned the value of statin therapy in people at low risk of heart disease.[2] [3] In his commentary Horton says: “After 2 years of frustrating exchange, including a direct request that COPE conduct an independent investigation, COPE declined to act further, emphasising that it is a charitable member organisation, not a regulatory authority.” [1]
COPE is indeed a member organisation and not a regulator. But as shown in the documents, which can be viewed here (http://www.bmj.com/content/bmj/suppl/2016/11/30/bmj.i4992.DC2/Combined_C...), COPE did not decline to act. It deliberated on the concerns raised by Collins et al and The BMJ’s response, and came to a clear conclusion: that The BMJ had acted appropriately in this matter. This conclusion confirmed the earlier decision of a panel of independent experts, appointed by The BMJ in June 2014, to consider Collins’ demand that The BMJ should retract the two articles.[4] [5]
Since COPE exchanged information only with and between the two parties to the complaint, this misinformation would appear to have been based on a version of events provided to the Lancet by the complainants themselves. We hope that publication of the documents relating to the complaint will serve to correct the public record.
Fiona Godlee
Editor in chief, The BMJ
1 Horton R. Offline: Lessons from the controversy over statins. Lancet 2016;388 (No 10049):1040, 10 September 2016. http://dx.doi.org/10.1016/S0140-6736(16)31583-5
2 Abramson JD, Rosenberg HG, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123. doi: http://dx.doi.org/10.1136/bmj.f6123 (Published 22 October 2013.) Correction http://www.bmj.com/content/348/bmj.g3329.
3 Malhotra A. Saturated fat is not the major issue. BMJ 2013;347:f6340. doi: http://dx.doi.org/10.1136/bmj.f6340 (Published 22 October 2013.) Correction http://www.bmj.com/content/348/bmj.g3332.
4 Independent statins review panel. http://www.bmj.com/about-bmj/independent-statins-review-panel. Report http://journals.bmj.com/site/bmj/statins/Final%20report%20of%20the%20ind...
5 Heath I, Evans S, Furberg C, Hippisley-Cox J, Krumholz H, Mulrow C, et al. Report of the independent panel considering the retraction of two articles in The BMJ.BMJ 2014;349:g5176.doi: http://dx.doi.org/10.1136/bmj.g5176 (Published 15 August 2014.) Corrections http://www.bmj.com/content/348/bmj.g3329 http://www.bmj.com/content/348/bmj.g3563
Competing interests: I was the person complained about in the complaint by Collins et al to COPE. As editor in chief of The BMJ, I am responsible for all that it contains
Re: BMJ editor confirms that revenues from industry will be declared 9 March 2017
It is most welcome to learn that the BMJ confirms revenues from industry will be declared 9 March 2017 (1)
I take no side on the statin debate. My interest is in science, objectivity and transparency.
Professor Sir Rory Collins and the University of Oxford's Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) need to follow the example of the BMJ (2)
References:
(1) http://www.bmj.com/content/351/bmj.h3908/rr-16
(2) http://www.bmj.com/content/351/bmj.h3908/rr-13
Competing interests: I raised a petition asking whether the Scottish Parliament might consider a Sunshine Act for Scotland: http://www.parliament.scot/GettingInvolved/Petitions/sunshineact