Turning the tide on conflicts of interestBMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d5147 (Published 10 August 2011) Cite this as: BMJ 2011;343:d5147
All rapid responses
Fiona Godlee is to be congratulated for her brave and timely effort
to repair and replace the unprecedented assaults on scientific integrity
inherent in the current system of publication and peer review inflicted by
those with conflicts of interest, especially those who go to extreme
lengths to avoid exhibiting their vested interests. Of course her stance
will be opposed by those with most to lose, but the public and science
need objectivity and clarity more than ever before in such a rapidly
changing world with such desperate problems many of which will expect
science to remedy - let science return to remedies for the people, not for
Competing interests: No competing interests
Given full disclosure of industry relationships, it seems over the
top to ban anyone with such ties from writing editorials UNLESS the BMJ
feels that (1) anyone with industry ties (and exactly how will such "ties"
be defined?) has absolutely nothing to add to any discussion and (2) its
readers are incapable of judging for themselves the credibility of those
who write editorials and reviews. The ban proposed by Godlee is not even
a tacit statement of "guilty until proven innocent" but rather "guilty by
association". What is most bothersome is the unspoken assumption that
editors and readers need only address conflicts of interest in industry
and those who associate with industry. Does the BMJ truly believe that
bias and conflict of interest in other settings, especially academic
research, should not be of equal concern to its readers?
Competing interests: Gary Evoniuk is a full-time employee of GlaxoSmithKline. The views expressed in this letter are Dr. Evoniuk's personal opinions and have not been reviewed, edited or approved by anyone else at GSK.
Unjustified bias deprives readers of the full healthcare picture and rather insults their intelligence
By singling out industry, the BMJ proposes to systematically
discriminate against a particular group of people without evidence-based
justification for doing so. This concerns me not just from an ethical
point of view, but because the proposal indicates a lack of appreciation
of the wider conflict of interest landscape, risks introducing bias, and
ignores the issue of industry collaborations with 'non-industry'; perhaps
most importantly, it risks marginalising industry doctors, rather than
employing the potentially more productive strategy of driving up their
academic and ethical rigour through encouraging them to work to the
standards required by medical journals, and adding value to health debates
by contributing potentially relevant and important perspectives.
industry perspective is one of many legitimate views in the diverse
healthcare landscape, and while it risks being biased to industry
interests, I would argue that few editorials or clinical reviews exist in
a vacuum, entirely free of conscious or unconscious ulterior motives, and
that current COI procedures are insufficient to enable us to understand
these motives or to interpret their impact on the message.
I propose that
rather than assume readers lack the intelligence required to understand
COIs by excluding one particular part of the healthcare picture, we
improve the scope, detail and prominence of reporting and interpretation
of all COIs, employing the principles of shared decision making to
facilitate educated discussions on how particular COIs impact on a
viewpoint. This would expose readers to new perspectives and enable them
to make up their own minds, rather than arbitrarily restricting their
access to the full healthcare picture.?
Competing interests: Layla McCay is Assistant Medical Director for Bupa, a healthcare company that by its lack of shareholders sits in the middle ground, neither public sector nor PLC. This letter represents her personal view. Or does it? You should also be aware that Layla McCay has ties to the South London and Maudsley NHS Foundation Trust as a psychiatrist and through her membership of its board of governors, and is also on the board of directors of Basic Needs, an international mental health service charity. She probably also has some sort of allegiance to her previous employers, including the Department of Health and WHO. Any of these organisations may be impacting on her thinking or her motivations, and as such, on the view she presents here, though she doubts it. Beware.
Three cheers for the editor of the BMJ! What vision, what clarity of
thought and above all what courage, criticising the errors of others.
But hang on a minute? It seems the FDA is to be blamed because drugs
are sometimes withdrawn. "Only last month, an FDA panel voted to withdraw
the breast cancer drug bevacizumab, which had been given "accelerated
approval" in 2008 (BMJ 2011;343:d4244)." Is this the same mechanism that
led to Gleevec/Glivec being approved, a drug that is so vitally
important, apparently, that Novartis is to be blamed for trying to stem
the generic copycats? And fast track approval, is that something that is
foreign to the medical press? Well, 'pon my soul what did I find here
http://resources.bmj.com/bmj/authors/fast-track-publication and publishing
faulty and mistaken articles is that something that the BMJ never does?
Far from it! And leaving a job to take up a commercial post, is that
something that only regulators do or journal editors also? Perhaps the
editor of the BMJ might like to engage in a little local historical
So what are the real differences between the FDA and the BMJ? I can
think of at least two. First, the agency will require you to submit your
data files and your computer code with your application so that the agency
statisticians can spend weeks and months checking your claims. The BMJ may
pass it out for statistical review in which case an overworked
statistician will give it the once over and report back in a few days. But
let's not forget the wonderful weekly BMJ hanging committee. (Are coffee
and biscuits served I wonder?) Secondly, the FDA does, indeed, reverse its
decisions. On the other hand, I seem to recall a particular editor
admitting that 'half of what we publish is wrong; the problem is we don't
know which half' to which could be added 'but when we do know it's wrong
we certainly don't withdraw it.'
By all means, Dr Godlee, ban whomever you like from publishing in
your journal but pardon me for thinking that this is merely a side show.
The truth is that when it comes to what the FDA does to ensure quality and
what you do, you are not even at square one. If you want to improve the
quality of your journal, let me give you a positive suggestion. Why don't
you require that all data and all computer code required to support any
claim in any article be lodged on a special BMJ website created for this
purpose. Instead of a policy of 'Original data if you think it will help
our reviewers or if we specifically request it', a policy of 'no data and
code no BMJ article'. (I appreciate, of course, that requiring code is
going to upset your very many authors who rely on Excel for their analysis
but everybody has to make sacrifices.) Of course the growing disciplines
of forensic biostatistics and bioinformatics
http://www.ndns.nl/static/files/sls/presentations/Baggerly-AnnalsApplied... will be much easier to practice and rather less
fun but surely that will be a small price to pay.
Competing interests: I consult regularly for the pharmaceutical industry. As an academic my career is furthered by publishing. A full declaration of my interests is maintained at http://www.senns.demon.co.uk/Declaration_Interest.htm
"Should the BMJ repeat the NEJM's experiment and ban editorials and
clinical reviews from authors with ties to industry?"
A robust evidence base is required to make decision regarding whether
to ban editorials and clinical reviews from authors with ties to industry.
A study exploring relationship between funding source and quality of
articles can be conducted. For example, articles published over last 10
years in major journals can be assessed and compared. However it should be
noted that the findings can not be generalised. This experiment can be
conducted for specific disease area to limit volume of literature. Similar
experiment can be conducted to examine relationship between funding source
and reporting quality of randomised controlled trials (RCTs). RCTs are
considered to be of the highest methodological quality, however, these may
not be entirely free from bias.
Competing interests: I work for a consulting firm.
I don't want to venture an opinion on whether you should publish
editorials only from those who seem to have no "ties to industry," but I
want to contribute two thoughts.
Firstly, a chapter in a book on conflicts of interest that I'm
reviewing for the BMJ describes the evolution of universities from
"teaching college" to "research university" to the "entrepreneurial
university" that combines "teaching, research, and economic and social
development." (1) Needless to say, it is the major universities that are
furthest down this path, and it's clearly a vital development for advanced
economies that must depend on ever smarter brains rather than on muscles.
The BMJ might not want to get itself into a position where it was unable
to publish editorials from academics in such major universities.
Secondly, it may not make sense to single out "ties to industry."
Colleagues and I have written on the fallacy that people connected with
for profit companies are conflicted and others are not. (2) Consider, for
example, British GPs who have a huge vested interest in the status quo of
a generous income from being in the private sector combined with an index
linked state pension. Your logic would surely mean that you would never
again have an editorial on general practice written by a GP. Or consider
those who have built their careers through publishing research supporting
breast screening or through creating expensive mammography programmes.
These people are not very open to the idea that the whole programme may
have been misguided.
1 Etkowitz H. In: Murray TH, Johnston J, eds. Trust and integrity in
biomedical research: the case of financial conflicts of interest.
Baltimore: Johns Hopkins University Press, 2010.
2 Smith R, Feachem R, Feachem NS, Koehlmoos TP, Kinlaw H. The fallacy
of impartiality: competing interest bias in academic publications. J R Soc
Competing interests: Competing interest: RS was the editor of the BMJ but now works for the UnitedHealth Group, a for profit company.
I have followed the discussion with interest being new to Evidence
Based Health Care. I vote against an arbitrary ban based for the following
A ban is not enough to resolve the issue and may feed the concept
that better is the enemy of best. This in no way advocates that we do
nothing or take a wait and see attitude. This is a serious situation that
can impact health care/research dollars, effective treatment and
patient/treatment provider actions.
Much research is industry dependent which means extent and influence
of industry ties needs careful consideration by reviewers and editors
alike while also recognising that industry ties are not the only
indication for publication bias.
This may take an overhaul of the editorial/review process inclusive
of education and implementation.
Narratives are often a quick read and do not provide access to raw
data, information on how replication can be accomplished or scrupulous
attention to competing interests or industry ties. The challenge is that
this information still has the capacity to form a basis for decision
making. It is read quickly and easily and this may have a broader reach
particularly to the less informed or time challenged than a complex
Information forms a basis for decisions. Responsible reviewing and
editing is critical for the accurate dissemination of information, a ban
just removes the information throwing out the good with the bad.
I would suggest ICMJE's declarations about authorship/competing
interests which are directed mainly towards research be applied equally to
narrative articles. It would be prudent to disclose peer reviewers and
that they in turn declare industry ties, affiliations and conflicts of
Accountability by authors could be improved if these authors agreed
to provide full access to raw data of whatever they have included at the
request of the editorial board, reviewers or interested subscribers.
As an added interest I would suggest that particular attention in
narrative reviews be placed by reviewers and editors on tentative or
misleading wording which can be embedded to promote industry positions
over existing peer reviewed research.
Competing interests: No competing interests
Fiona Godlee's arguments in favour of preventing those with ties to
the pharmaceutical industry from writing editorials and clinical reviews
for medical journals are sound. 
Of course, there will be objections from those wishing to influence
the practice of medicine. These must be rejected. There will also be the
temptation to water down a general ban. However, there should be no half-
measures and no get-out clauses. Stephen Simon proposes that if the
research involves randomised trials, all that is required is a declaration
of conflict of interest.  But why should these studies be given a
privileged status? The results of large-scale RCTs are readily open to
interpretation and manipulation while the claim that they may be tested by
replication is, at the very least, debatable. 
The reason why we should be concerned about the involvement of
individuals with ties to industry is that the data from statistics-based
research are so vague, so uncertain and so unreliable that they may be
twisted and deformed into whatever evidence is deemed necessary to support
the interests of pharmaceutical companies.
The real problem is not so much the possibility of bias in editorials
and reviews, but the nature of the data which fail to provide definitive
answers regarding the efficacy of drug therapy.
1. Godlee F. Turning the tide on conflicts of interest. BMJ
2. Simon SD. Subjective editorials and clinical reviews require proof
of objectivity. BMJ Rapid Response Letters, 14th August 2011.
3. Penston J. Stats.con - How we've been fooled by statistics-based
research in medicine. The London Press, November 2010.
Competing interests: No competing interests
Marlies van Lent wrote: " The major selection criterion for industry
to liaise with academic researchers is their extra-ordinary knowledge on
specific topics." This assertion is probably false. Big Pharma recruits
relevant "experts" because they are compliant to industry. Moreover Big
Pharma practises expert mongering in order to dictate its view on "their"
advice and to publish in the most prestigious reviews. Thomas Jefferson
proved these facts regarding H1N1 publications (1). Good academic
researchers have published before sponsored by Big Pharma but a
number of academic researchers have begun to publish with the help of Big Pharma
(ghost writers and money). BMJ must stay the course and keeps on its
policy otherwise we should avoid reading editorials as we avoid reading
consensus conferences too obviously addicted to Big Pharma.
Competing interests: No competing interests
I would suggest first that the term "industry ties" needs to be
clarified. I, for example, am getting consulting income from a small
pharmaceutical firm that is trying to market an imaging device. That is
not a competing interest or an industry tie if I am writing about statins.
The relevant questions should be:
1. Does this editorial or clinical review advocate or discourage the
use of a commercial product?
2. If so, does the author have a financial tie to a company that
sells this commercial product or sells a competing commercial product.
If the answer to both questions is yes, then the tie needs to be
disclosed. If the research is mostly objective, such as a randomized
clinical trial or a systematic review, and if the process is documented in
enough detail to allow independent replication, then declaration of the
conflict of interest is all that is needed.
If, however, the work is largely subjective in nature, as an
editorial or clinical review must be, then a financial tie to the
commercial product or a competing product should be an automatic
disqualification. There is no way that an outside party could replicate
the thought processes that goes into writing an editorial or clinical
review. That process is not transparent and individual steps in that
process are not open to critical commentary or suggestions for alternative
approaches. Therefore, editorials and clinical reviews must be held to a
Financial ties may be defined as holding patent rights or receiving
royalties, owning stock in the company (other than through a mutual fund
where investment decisions are not made by the author), or receiving
consulting income or speaker fees in the past five years. There may be
other examples, but the key thing is that the tie must involve the
exchange of money.
Note that others have raised the prospect of non-financial conflicts
of interest. This is a dangerous extension of this concept. There is the
unproven assertion, for example, that recipients of research grants have a
bias towards exaggerating the extent of the problem that they study in
order to increase their chances of getting further funding. This is
dangerous because it subtly implies that a plausible but unproven source
of bias is equivalent to a proven and widely documented source of bias.
I suspect that some people who have commercial ties are encouraging
the extension to non-financial conflicts so as to make it appear that
everyone is biased, therefore no one should be banned from writing
editorials and clinical reviews.
Note for example, Marlies van Lent's comment that an expert's "chosen
independence may also be based on preconceived negative feelings on the
industry, leading to an overall pessimistic appraisal of their products."
As a statistical consultant, I am greatly disappointed that Merck has not
had the wisdom to hire me for statistical advice. Therefore, the logic
goes, I am predisposed to criticize any Merck product.
What rubbish! If those of us with financial ties to a company are
able to convince BMJ that it is the people WITHOUT such ties who have a
biased perspective, then the whole process of identifying conflicts of
interest becomes worthless.
If you define industry ties carefully, then I would say that yes,
let's ban editorials and clinical reviews written by those with industry
Steve Simon, www.pmean.com
Competing interests: Dr. Simon has received consulting income from several pharmaceutical firms.