Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Re: ghost writing
- Nicholas D. Moore (22 October 2004)
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50% ?
- David T Healy (23 October 2004)
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Key grip
- Jeff Aronson (24 October 2004)
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Transparency and trust?
- Dr. Naseem A. Qureshi MD, IMAPA, LMIPS, Dr.Abdulhameed A. Al-Habeeb, MD, Medical Director, BMHH, KSA. (25 October 2004)
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In defence of medical writers
- Adam Jacobs (28 October 2004)
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Re: In defence of medical writers
- John Stone (6 November 2004)
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Re: In defence of medical writers II
- John Stone (10 November 2004)
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Regarding Adam Jacobs
- John Stone (17 November 2004)
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Never mind the ethics, is it legal?
- John Stone (19 November 2004)
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Re: Never mind the ethics, is it legal?
- Adam Jacobs (21 November 2004)
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Re: Re: Never mind the ethics, is it legal?
- John Stone (23 November 2004)
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Adam Jacobs: an earlier declaration (30 May 2004)
- John Stone (27 November 2004)
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The BMJ has failed in 'Transparency and Trust'
- John Stone (17 January 2005)
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Nicholas D. Moore, Professor of clinical pharmacology Université Victor Segalen, 33076 Bordeaux
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The requirement that all authors have the idea, do all the work, get the data, analyse the data, and write the paper, may be perfectly applicable to some parts of fundamental research, perhaps, or small clinical trials. In some cases they may just not be applicable: we are doing a 40 000 patient study of the use of and risks associated with NSAIDs and Cox-2 "selective" agents in France. This study, which was requested by the regulatory authorities in France, is being financed by the pharmaceutical companies, and done by our academic department of pharmacoepidemiology. It is driven by an independent scientific committee. The pharmaceutical companies have little say in what happens or how the data is collected and interpreted. 50 persons work in this study to retrieve and validate the data. In the end there will be about a hundred million bits of data. There is a data management team and half a dozen statisticians working on the analysis, and a number of PhD students are working or will work with the data on all kinds of subtopics and ideas. Any papers that come out of this study will be written by medical writers hired specifically for this task, under the direction of the various team leaders, and the surveillance and final approval of myself and of the scientific committee. Is this ghost writing? Who should the authors be? the one who actually wrote the papers, the ones who got the data or input them, the statisticians who wrote the progams and came out with the results? In other studies, quite a few masters and PhD students collect lots of data, not all of which are fully exploited at the time, or fully published. These students may go out to other places in the world, or just simply not have the gift of writing legibly (or the knowledge of the language). Though I know all this data quite well, I just do not have the time to write all the papers myself even though I do write a lot. Should I leave this data lying in a corner of my office, or may I hire a person with a PhD and some experience of writing papers to go through the data and study reports, and write papers that may eventually be published. Should that person, who was hired to do a job, but was not involved in the initial conception of the study in the collection of data or in its analysis, be an author? if not, is that ghost writing? Should it be condemned? In that case, should the investigator in a cardiology trial do every single ECG, (and clean the machine) rather than hire a technician to do them? This is not the same as a drug company writing a paper, and asking a KOL to sign it without reading it, of course, but there is an infinity of variations between the lone searcher who does everything, and the one who does nothing but sign. What is really ghost-writing? I know the BMJ has a very liberal view, and as long as there is a person taking full responsibility for the study (guarantor), things are probably OK, but the simple statement (not by BMJ) that 50% of all publications are ghost- written is I feel somewhat misleading and derogatory for the persons involved, and an indication of the misunderstanding of the complexities involved in modern clinical studies. It can too easily be picked up by politicians (who we all know write all their speeches themselves) and others to do some easy doctor- bashing. Not that there are not some cases… A difficult topic, no simple answers. Competing interests: I must have hidden interests, certainly, though at the moment I can't recall any relevant ones (see text) |
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David T Healy, Professor of Psychiatry Bangor LL57 2PW
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This BMJ editorial appears to perpetuate a misleading press cite of my testimony to a House of Commons Select Committee on Thursday October 14th. The original statement, supported by the transcript, was that 50% of the articles dealing with therapeutics were ghostwritten, not 50% of all articles. I, like most readers, almost instinctively shrink from a claim that anything like 50% of the articles, even those on therapeutics only, in journals like the BMJ, NEJM, JAMA and the Lancet are ghostwritten. But equally instinctively, most readers if asked to estimate how many of the key articles on their drugs, and this means articles in major journals, pharmaceutical companies are likely to have had a determining role in writing, would probably come up with figures close to 100%. And if the question is in what proportion of articles on therapeutics in major journals do the apparent academics hold the raw data and are able to share that data if needed, the answer in many estimates will not be much greater than 0%. But the editorial also usefully brings out a point made in the Select Committee meeting which is that the key problem with ghostwriting is not the medical writing per se but the issue of transparency. Where we have reason to believe that the articles that result from the ghostwriting process do not offer a fair representation of the underlying data, we have a problem. Otherwise ghostwriting poses much less of a problem. The empirical data on which the 50% estimate was based and some evidence on the issue of discrepancies is laid out in Healy D, Cattell D (2003). The interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry 182, 22-27. It is also worth checking C Elliott (2004). Pharma goes to the Laundry. Hastings Center Report 34, 5, 18-23. Competing interests: Speaker, triallist or consultant for all major pharmaceutical companies, expert witness in medicolegal actions involving SSRIs |
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Jeff Aronson, Clinical pharmacologist Radcliffe Infirmary, Oxford OX2 6HE
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Grips were originally scene shifters on the American stage, presumably because of the tight grip they needed to have on what they were shifting. The film industry adopted the term to mean those who move equipment, scenery, or props around the film set. Grips have grip trucks for transportation and grip chains for securing things. The dolly grip is specifically responsible for moving the dolly, a mobile platform on wheels for the camera and crew. The key (or head or first) grip is in charge of the grips. Not to be confused with la grippe, which obstructs filming. Competing interests: I watch a lot of movies. |
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Dr. Naseem A. Qureshi MD, IMAPA, LMIPS, Director, CME&R POBox.2292, Buraidah Ment Hlth Hospital, SAudi Arabia, Dr.Abdulhameed A. Al-Habeeb, MD, Medical Director, BMHH, KSA.
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Sir: We read your editorial and related papers on which your comments are based. We would like to add that there are only some advocates of transparency and trust as regards research and their publication but there are more powerful influential people behind the scenes opposing this trend one way or other. Moreover, there are no foolproof strategies that can circumvent the problems associated with opaqueness and untrust found in submitted/published research. Reference: Kamran Abbasi. Transparency and trust.BMJ 2004; 329: 0-g Competing interests: None declared |
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Adam Jacobs, Director Dianthus Medical Limited, London SW19 3TZ
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If one defines ‘ghost writing’ as what happens when the identity of a writer is concealed, then Abbasi’s statement ‘We know that ghost writing happens, and the identity and the motivations of the ghost writer are not revealed’ [1] is self-evidently true, albeit not very informative. However, many people understand medical ghost writing to mean that a professional medical writer, whose name does not appear on the author list, wrote the paper. When this happens, the identity of the writer is sometimes not revealed, but it frequently is, usually in the acknowledgements section. It is therefore misleading to state that the identity of the ghost writer is not revealed, as though this were a universal truth. Kmietowicz’s news article [2] also misleads by saying that distinguished authors put their names to papers ‘without ever seeing the raw data’. This may be true, but is hardly the whole story. What exactly are you supposed to do with thousands upon thousands of laboratory results, for example? Data from clinical studies are only interpretable once they have been processed into summary tables and graphs: a job which is more appropriately done by a statistician than a clinician. In my own experience of writing papers on behalf of investigators, the named authors always have access to the summary tables and graphs, which is far more important than access to the raw data. I agree, however, that it is important to ensure that high ethical standards be maintained when professional medical writers draft papers on behalf of named authors, and that transparency is an essential part of this. One set of recently published guidelines [3] seeks to ensure good practice in this context, and the European Medical Writers Association is currently preparing guidelines that will further define the ethical responsibilities of professional medical writers. ajacobs@dianthus.co.uk References: 1. Abbasi K. Transparency and trust. BMJ 2004;329:0-g (23 October) 2. Kmietowicz Z. Consumer organisations criticise influence of drug companies. BMJ 2004;329:937 (23 October) 3. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003;19:149–54 Competing interests: My company provides medical writing services. I am also president of the European Medical Writers Association. |
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John Stone, none London N22
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Could Adam Jacobs please cite the articles in which his name has been listed, as an example of good practice? Competing interests: None declared |
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John Stone, none London N22
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1) Given the nature of Adam Jacobs professional activity as accounted for in the above post - that is the entire post and not just accompanying declaration - should it not be minimally necessary for him to give this much information when entering into public correspondence on a medical topic? 2) Jacobs seems to observe complete client confidentiality. No specific information has ever been given about his undenied commercial entanglements in Rapid Responses; no specific information is available from his company website; he has not responded to the challenge of giving even a small amount of information here. It is impossible to determine the full nature of his interest on any given topic, although the subject of autism and vaccine has exercised him greatly in recent months, often in a confusing and apparently contradictory ways [1]. If he is not prepared to reveal client information as a matter of principle should he not also refrain from public comment since no one can ever tell what his interest is? It is good that Jacobs raises some of these issues himself, which have particular bearing on what he says when he surrenders his anonymity. [1] John Stone 'Re: Re: Whose side is Adam Jacobs really on?', 3 October 2004: http://bmj.bmjjournals.com/cgi/eletters/328/7442/773#76850 Competing interests: Parent of an autistic child with general concerns about the penetration and integrity of the pharmaceutical industry |
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John Stone, none London N22
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Who is being misleading? The President of the European Medical Writers Association no less - better known to all here as Adam Jacobs - writes in to complain that it is misleading to say that the name of the ghost writer "is not revealed" on papers. And then, when Jacobs himself is asked which papers his name appears on, he is silent. Of course it is a spurious point because the editor wrote "not revealed" not "never revealed" and it is the many cases where it is not revealed that remain a matter for concern (particularly when the head of the profession in Europe is in the habit of pronouncing on every conceivable topic in this journal under his own name). Secondly, Jacobs's admission about the lack of contact that named authors have with the raw data is truly astounding (and we must assume he knows what he is talking about). Not only are the named authors unable to vouch for the authenticity and quality of the data, they even cannot vouch for the integrity of its presentation. Dr Jacobs apparently thinks this is defensible but as far as I can see every element in the once normal process of research has been short-circuited. Not only is Zosia Kmietowicz not being misleading, but Jacobs's own cavalier attitude could not be more revealing of the culture. And what is worse is that we have become so apathetic and accepting that these extraordinary disclosures go almost unremarked: indeed would have done if it had not been for my intervention some days after Jacobs's letter was originally posted. Competing interests: Parent of an autistic child with concerns about the integrity and influence of the pharmaceutical industry |
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John Stone, none London N22
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If - as Adam Jacobs would seem to attest - the named authors have not only often not written a study they are also not in a position to verify and authenticate its findings, what(a) is the legal status of the resutling document and (b)the legal position of those who have participated in drawing it up? Competing interests: As above |
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Adam Jacobs, Director Dianthus Medical Limited, London SW19 3TZ
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I think John Stone may have misunderstood the processes involved when medical writers prepare publications on behalf of named authors. I am sure he is not the first to suffer such a misunderstanding, nor will he be the last, so a few further words of explanation would no doubt be valuable. It would indeed be deplorable if authors were not in a position to verify the findings of a paper, but that is not how it works. What happens in practice in most industry-sponsored studies is as follows. After the trial is complete, the data are entered into a database, which undergoes thorough quality control procedures to ensure that the data are accurate. The data are then analysed, usually by a statistician working on behalf of the sponsoring company, in accordance with a pre-specified analysis plan (the importance of pre-specification is well known to all statisticians, but put simply, prevents cheating via 'data-dredging' [1].) The result of the statistical analysis is a whole series of tables and graphs of data. These are usually incorporated into a report of the study which is prepared in accordance with internationally agreed guidelines [2]. The report is needed for regulatory purposes and is comprehensive, but is far too long for any journal ever to consider publishing it as it stands. All the above steps are subject to auditing not only by company quality assurance departments, but also by regulatory authorities such as the FDA. If an industry employee wanted to falsify any of the data, it would be hard if not impossible to do so without being caught. When the time comes for publication, the medical writer writes the publication in consultation with the named author(s). This usually begins with discussions between the medical writer and authors(s) about the main features of the paper, after which the medical writer writes the first draft. The draft is then revised (sometimes many times) after review by the author(s). Thus although the authors do not actually write the paper, they do have control over its content, which is far more important. Naturally, they have access to the report of the study and its data tables, so they can verify that the paper is accurate. They often don't have access to the raw data, but it is worth repeating that raw data are of very little use when writing a paper. Results of a study need summarising and analysing before they mean anything, and it is those summaries and analyses that are important for proper interpretation of a study, not the raw data themselves. The process I have described above is how things should work, and in my experience, how things actually do work most of the time. There may, however, be some rare cases when authors do just sign their names to papers without reading them. Such behaviour is certainly unethical, and I have no hesitation in condemning it unreservedly. References: 1. Davey Smith G, Ebrahim S. Data dredging, bias, or confounding. BMJ 2003;327:751 2. http://www.ich.org/MediaServer.jser?@_ID=479&@_MODE=GLB Competing interests: As stated previously |
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John Stone, none London N22
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Perhaps Adam Jacobs would persuade us further of his ethical credentials if he were to publish his bibliography. Competing interests: Parent of an autistic child with concerns about the influence and penetration of the pharmaceutical industry |
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John Stone, none London N22
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In his response of 30 May 2004 'Re: Complete and total confusion in the population' Adam Jacobs gives what reads like an official response to diquiet over the safety of MMR, noting under competing interests: "My company provides services to various clients, who have occasionally included vaccine manufacturers. We would be happy to work for anti-vaccinationist as well if they agree to our normal evidence-based approach." [1] One question is why bring up all the the clients, actual or absurdly potential when it is the vaccine manucturers who are relevant. Nor is Adam Jacobs specific about what services he provides (we are, of course, a little wiser about this now). One possibilty which arises is that he has not simply written papers for vaccine manufacturers, but written for them in their capacity as vaccine manufacturers. [1] http://bmj.bmjjournals.com/cgi/eletters/328/7437/421-a#61031 Competing interests: Parent of an autistic child with concerns about the influence and penetration of the pharmaceutical industry |
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John Stone, none London N22
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It is fair to point that BMJ reproduced Adam Jacobs's electronic response of 28 October 2004 'In defence of medical writers' in the hard edition of 4 December 2004 [1] but none of my subsequent responses which bore heavily on its content. Given the nature of Kamran Abbasi's original editorial 'Transparency and Trust' 22 October 2004 [2] this might be considered surprising. Following this Adam Jacobs also disclosed in the Journal of American Physicians that he had worked for SmithKline Beecham and Aventis Pasteur, both defendents in the MMR litigation [3]: information which should have been made known in numerous electronic responses to BMJ on the topic of MMR and autism. Since Jacobs has been the main professional defender of both the Madsen and Smeeth epidemiological studies of MMR and autism, particularly in the columns of BMJ Rapid Responses, this has come to bear significantly on the reliability of reports on these papers in the journal [4,5], particularly noting the continued silence of the named authors. This matter was first reported by me in Rapid Responses on 5 January 2005 (submitted at least two days earlier)[6]. To date, although Adam Jacobs has declared his profession as a medical writer, he has not been prepared to reveal any of the papers in which he has participated as author (see above). One conclusion I draw from this - grateful though I am for the hospitality of BMJ Rapid Responses - is that when it comes to the issue of vaccine safety the medical establishment and the BMJ are still in a state of denial. [1] http://bmj.bmjjournals.com/cgi/content/full/329/7478/1345-a [2]http://bmj.bmjjournals.com/cgi/content/full/329/7472/0-g [3] vol 9 no 4 p.100 http://jpands.org/jpands0904.htm [4] Janice Hopkins Tanne: 'MMR vaccine is not linked with autisms, says Danish study' 16 November 2002 http://bmj.bmjjournals.com/cgi/content/full/325/7373/1134/a [5] Susan Mayor:'Study shows no link between MMR vaccination and autism' 18 September 2004, http://bmj.bmjjournals.com/cgi/content/full/329/7467/642 [6] Stone:'Refutation of Madsen in the Journal of American Physicians and Surgeons'http://bmj.bmjjournals.com/cgi/eletters/325/7373/1134/a#91200 Competing interests: Parent of an autistic child concerned about the influence and penetration of the pharmaceutical industry |
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