Medical journals and pharmaceutical companies: uneasy bedfellows
BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7400.1202 (Published 29 May 2003) Cite this as: BMJ 2003;326:1202All rapid responses
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It is encouraging to see that voluntary guidelines on Good
Publication Practice for pharmaceutical companies (www.gpp-guidelines.org)
have been proposed, and that there is interest from some parts of the
pharmaceutical industry.
I note however that many names are not on the list of those who have
signed up. What incentives are there for the pharmaceutical companies and
the medical writing agencies to sign up?
Do these guidelines go far enough?
Are these voluntary guidelines sufficient to ensure that
pharmaceutical research is not inappropriately influenced by
marketing initiatives?
Competing interests:
None declared
Competing interests: No competing interests
Dr Beck is one of those remarkable people who has complete insight
into his own motivations. Unfortunately I'm not. He says that he is not
influenced by free pens, and I accept that. The pharmaceutical companies
are giving him these free gifts out of the goodness of their hearts. They
expect no return--despite their duty to their shareholders to maximise
profits.
I wonder if Dr Beck would be willing to walk around for a year
advertising the BMJ about his person if I paid him 20p? That's what
companies are achieving with their free pens. And has Dr Beck considered
the effect on patients? Might they wonder--as he leans over the
anaesthetise them--why he is advertising a particular drug? Might some of
them worry for an instant that he has been influenced by the free pen,
even though he knows that he hasn't?
Richard Smith, Editor, BMJ
Competing interests:
I am the editor of the BMJ and accountable for all it contains and its finances
Competing interests: No competing interests
So we have yet another politically correct leader from the BMJ. I am
frankly offended as a doctor that you feel free pens will influence my
prescribing.
Please refer to the recent patient issue of the BMJ. Facing page 1294
is a full page advertisement - 'why not order an extra copy for your
waiting room, only £5'. Now turn over the page - a full page advertisement
sponsored by GlaxoSmithKline for your patient to read. There are many
more drugs advertised in this journal, many in a format that I don't think
I've seen in the 'doctor's BMJ'.
So please tell me that the extra copies have the advertisements
removed.
Whilst you are prepared to declare your conflict of interest at the
end of this leader, I think it's all a bit too rich!
Competing interests:
None declared
Competing interests: No competing interests
I agree with Susanna Rees that the practices of the medical writing
agency that she used to work for are ‘contrary to the principles of
openness and transparency of the scientific method’, but they are
certainly not consistent with best practice within the industry.
The recently published guidelines on Good Publication Practice
(www.gpp-guidelines.org) give guidance on best practice for papers written
by professional medical writers on behalf of the named authors. One of the
things they state specifically is that ‘the contribution of the medical
writer should be acknowledged’. Clearly, taking heroic measures to remove
all evidence of the medical writer’s involvement is going very much
against these guidelines. The standard operating procedures of Rees’s
former company were no doubt written before the guidelines were published.
I hope they will now be revised in light of the guidelines.
In my own company, we would never try to hide our involvement as
professional medical writers. Indeed we have on occasion liaised with the
journal on behalf of the authors. However, the extent to which our
involvement is transparent is not always entirely under our control:
sponsors, authors, and journal editors all have their part to play too. I
urge all those involved in papers written by professional medical writers
to respect the principles of transparency and openness.
Competing interests:
My company provides ghostwriting services. I am also vice president of the European Medical Writers Association, which represents the interests of professional medical writers.
Competing interests: No competing interests
I imagine that all your readers of the "Patient Issue" of the BMJ
relished the irony of having Pharmaceutical Adverts in a magazine designed
to be read by patients containing a debate on "direct" advertising to
patients.
Competing interests:
None declared
Competing interests: No competing interests
In reply to the BMJ theme issue of 31st May 2003 (Vol 326 issue 7400)
“Time to untangle doctors from drug companies.”
Until the end of 2002, I worked for a medical writing agency as an
editorial assistant. I believe that the agency I worked for generally has
standards of practice that are consistent with best practice within the
industry. I write to you about the broader issues associated with general
practices in the industry.
It is my perception that there is consistently a high turnover in
staff throughout all branches of the pharmaceutical industry. It is also
my perception that the effect of this is that there is often a lack of
consistent follow-through on how the pharmaceutical industry acquires
data, monitors it, processes it, validates it.
Medical writing agencies go to great lengths to disguise the fact
that the papers and conference abstracts that they ghost-write and submit
to journals and conferences are ghost-written on behalf of pharmaceutical
companies and not by the named authors. There is a relatively high
success rate for ghost-written submissions - not outstanding, but
consistent.
One standard operating procedure I have used states that before a
paper is submitted to a journal electronically or on disk, the editorial
assistant must open the File Properties of the Word document manuscript
and remove the names of the medical writing agency or agency ghost-writer
or pharmaceutical drug company, and replace these with the name and
institution of the person who has been invited by the pharmaceutical drug
company (or by the agency acting on its behalf) to be named as lead
author, but who may have had no actual input into the paper.
Quality-assurance auditors vet the standard operating procedures of
the agency I worked for. I am surprised that these auditors, presumably
following government guidelines, do validate such a procedure, which is
actually in place in order disguise the true authorship from the editorial
boards of journals. This area seems very blurred. This practice is
contrary to the principles of openness and transparency of the scientific
method.
The full file history of every Word document may be retrieved, using
a Texteditor or a Hexeditor. It is impossible to change that history or to
disguise who actually created the Word document or the name of the
organisation of origin. Office applications can reveal the full chronology of authors, file paths, file names, file amendments, and details of the
computers used.
Text, graphics or tables that have been inserted
into a Word file will contain the full history of the document that they
were extracted from. Technical effort is required to identify this
information[1,2]. Such a check might be made prior to peer-review, using
an original file, saved onto disk by the authors and included as part of
the submission package to the journal. Even this check may not be
exhaustive or conclusive: for example, where a file has been exported into
.RTF format, much of the original file history may be lost. A Word
document that has been exported into .RTF format and subsequently back
into .DOC format, may possibly lose much of its original Word file
history. RTF offers a “track changes” option, so it may be possible to
view the entire text-editing history of a Word document that has been
exported into .RTF format. A file that has been exported into .PDF format
will have lost its entire history.
On-line submission of ghost-written papers and abstracts to journals
and conferences is done from the agency computer or sometimes from the
offices of the pharmaceutical company. Do journals and conference
organisers always try to identify the organisation that actually submitted
the electronic file?
An internet engine search on the authors of a paper will quickly
reveal whether these names are closely linked to pharmaceutical drug
companies, to their products or publicity materials.
The interests of the pharmaceutical industry lie at the heart of many
current, urgent debates: GM food, anti-depressants and their side-effects,
and others. We need to ask: Who wrote this paper? Who did this research?
Are the objectives of this research genuinely impartial? Is this process
fully transparent?
Independent authorship and impartiality are the cornerstones of
scientific research. The pharmaceutical giants are using the tools of
scientific research as a marketing tool. I believe that these marketing
practices are damaging the authority and effectiveness of pharmaceutical
research.
With thanks to Doro Mücke-Herzberg
References
(1) PC-Welt (German language publication) 1999(7):242-243. “Verborgene
Infos” (trans: Hidden information) Springer T, Apfelböck H.
(2) c’t (German language publication) 2002(3):172-175. “Dokumente
durchleuchtet: Was Office-Dateien verraten können” (trans: Documents under
the X-ray: what Office files can tell you) Rost M, Wallisch A.
Competing interests:
None declared
Competing interests: No competing interests
Editor,
I appreciate this week's BMJ
theme issue on the relationship between doctors and the drug industry,
because it is extremely timely for my own field of Alzheimer's disease
research.
Last week I and my colleagues were digesting May 22, 2003 Neuron
(a major neursocience journal published by Cell
press) article [ 1 ] and associated editorial coverage
[ 2 ] on a validity of the Alzheimer's amyloid-based
therapy (read 'amyloid cascade hypothesis').
I and others found that “the title and some of the conclusions of this
study are not yet justified” [ 3 ]. Moreover, the authors
provided apparently false statement that “they have no competing financial
interests related to Elan/Wyeth-Ayerst”, a vaccine maker, creating a rationale
to consider the article "a bias in favor of the expired amyloid dogma-based
Alzheimer’s therapy approach" [ 3 ].
THEME ISSUE 'DOCTORS AND DRUG COMPANIES' "Editorial coverage is much more "Journals are caught between (AK: Is Neuron one of them? See "Evidence is strong that sponsored "But perhaps most interesting
|
This week BMJ editorial is confident that "journals are caught
between publishing the most relevant and valid research and being used
as vehicles for drug company propaganda." In light of the above I wonder
to which category the latest Neuron articles on Alzheimer's disease
[ 1, 2 ] belong to.
I believe that many neuroscientists are puzzled, too, especially because
similar question was earlier discussed (at the Nature Medicine [
4
; also see 'message to remember' ], The Wall
Street Journal [ 5 ], and the Boston Phoenix
[ 6 ]) for the consensus recommendations for the post-mortem
diagnosis of Alzheimer's disease by the NIH National Institute on Aging
[ 7 ], a key citation of the Neuron study [
1
].
I hope that my letter to the editor of Neuron [ 3
] and the letter bibliography will make this puzzle easy.
Sincerely,
Alexei Koudinov, MD, PhD
neuroscientist and editor
http://anzwers.org/free/neurology
http://neurobiologyoflipids.org
Competing financial interests: I do not
have any competing financial interest. I aim free information dissemination
and an unbiased development of Alzheimer's neuroscience. I observe the
Society
for Neuroscience Guidelines
for Responsible Conduct Regarding Scientific Communication.
a colleague ] [ Contact Alexei Koudinov ] |
References:
1. Hock C, et al. Report:
Antibodies against b-Amyloid Slow Cognitive
Decline in Alzheimer's Disease Neuron.38, 547-554 (22 May
2003) [ PubMed
].
2. Winblad B, Blum KI. Preview:
Hints of a Therapeutic Vaccine for Alzheimer's? Neuron.
38,
517-8 (22 May 2003) [ PubMed
].
3. Koudinov AR. Hasta la vista,
amyloid cascade hypothesis, OR will academic dishonesty yield Alzheimer's
cure? AAAS SAKE KE. Published online May 26, 2003 [ FullText
].
4. Editorial. Taking more interest
in conflict. Nat Med.5, 713 (1999) [
PubMed
] [ FullText
]; Birmingham K, Ready T. Conflict-of-interest problems lead to policy
changes. Nat Med.5, 717-8 (1999) [ PubMed
] [ FullText
].
5. Waldholz M, King RT, Jr.
Did ties to Alzheimer's test maker sway NIH report? The Wall Street
Journal. (30 Nov 1998) [ FullText
].
6. Ready T. Science for Sale:
A Harvard researcher stands to profit from a product he "independently"
reviewed for the National Institutes of Health. The Boston Phoenix.
(29 April 1999) [ FullText
].
7. The National Institute on
Aging, and Reagan Institute Working Group on Diagnostic Criteria for the
Neuropathological Assessment of Alzheimer's Disease. Consensus recommendations
for the post-mortem diagnosis of Alzheimer's disease. Neurobiol. Aging.
18,
S1-S2 (1997) [ PubMed
].
Competing interests:
None declared
Competing interests: No competing interests
Richard Smith is wrong to imply that equivalence trials are
particularly poorly handled by the pharmaceutical industry. Both sides of
the regulatory divide have been closely involved in research into methods
for analysing such trials and there was a stream of such papers during the
1980s and early 90s describing difficulties with such trials. A paper I
rather like, in fact I wrote it myself, has a title that says it all 1. At
the time I was working for Ciba-Geigy. In 1996, a review paper, whose
authors all now work in the pharmaceutical industry, appeared in the
British Medical Journal2. This is a useful account but does no more than
report features that were already well known and applied within the
pharmaceutical industry. The International Conference on Harmonisation
leads in this area, with guidelines on statistical analysis and on choice
of control group3 4.
Nor does one have to look far to find examples outside the industry
where such issues should have been handled better. An example of how not
to do non-inferiority5 appeared in the British Medical Journal in 1994
(analysis by multiple p-values, failure to find a difference taken as
proof of equivalence and no accounting for random effects)6.
In fact, it is precisely because the regulators have long realised
the difficulties with non-inferiority studies that they have placed such
stress on placebo-controlled trials, a stress which Richard Smith also
appears to criticise. I would maintain that the superior handling of non-
inferiority has been found within the industry.
References
1. Senn SJ. Inherent difficulties with active control equivalence studies.
Stat. Med. 1993;12(24):2367-75.
2. Jones E, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence:
The importance of rigorous methods. Br. Med. J. 1996;313(7048):36-39.
3. International Conference on Harmonisation. Statistical principles for
clinical trials (ICH E9). Stat. Med. 1999;18:1905-1942.
4. International Conference on Harmonisation. ICH harmonised tripartite
guideline: choice of control group and related issues in clinical trials:
International Conference on Harmonisation, 2000:1-35.
5. March L, Irwig L, Schwarz J, Simpson J, Chock C, Brooks P. n of 1
trials comparing a non-steroidal anti-inflammatory drug with paracetamol
in osteoarthritis. Br. Med. J. 1994;309(6961):1041-5; discussion 1045-6.
6. Senn SJ, Bakshi R, Ezzet N. n of 1 trials in osteoarthritis. Caution in
interpretation needed [letter; comment]. Br. Med. J. 1995;310(6980):667.
Competing interests:
Stephen Senn is a consultant to the pharmaceutical industry, used to work for Ciba-Geigy and has shares in Novartis, the company that makes one of the drugs compared in the paper by March et al that he has just criticised. His book, Dicing with Death, like that of Richard Smith, will be published by Cambridge University Press later this year and, like Smith, he will be promoting his book vigorously.
Competing interests: No competing interests
Editing and Peer Review
Richard Smith notes that pharmaceutical advertising is often
misleading. The quality of papers in the BMJ is largely maintained through
the process of editing and peer review, and it seems strange that the drug
adverts are exempted from this. Perhaps the BMJ should consider following
the Lancet’s lead and employ an editor solely to maintain the quality of
its adverts.
Competing interests:
None declared
Competing interests: No competing interests