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What Medicine and Medical Journal Editing Mean to Me

October 12 to October 16, 2006
 
Colleagues,
 
Shaukat Ali Jawaid, our colleague from Pakistan, raises some pertinent questions about medical journal publishing in a recent paper in MSM entitled
What Medicine and Medical Journal Editing Mean to Me
 
1. Pharmaceutical industry is the major source of revenue for medical journals through advertising. At times the journals are faced with a dilemma when the industry tries to influence the editorial policy as regards publication of clinical trials or adverse drug reactions. What course should medical journals pursue to ensure an independent policy while at the same time ensuring sustained continued publication? 
 
2. Local dose finding studies are now compulsory in many countries before registration of a new drug. If any healthcare professional observes some unwanted side effects even after local dose finding studies have declared the drug to be safe, should it be discarded, or  is it better to have another look at the safety of the drug and earlier dose finding studies? 
 
3. Simultaneous submission of manuscripts to more than one periodical by authors is a serious problem faced by medical journals. Editors cannot act as policemen and they have to trust the authors when they give a written undertaking regarding exclusive submission. Even after giving a written undertaking, if an author indulges in unethical practice of simultaneous submission, what can the editors do to discourage this practice apart from black listing such authors and conveying this to their employers, institutions they are affiliated with, as well as concerned government agencies? 
 
4. If a manuscript is rejected by an indexed journal, it does not mean this does not merit publication. If the authors submit this manuscript to another journal, should it be entertained and published after proper peer review? Secondly, is it essential for the authors to disclose that this manuscript was earlier submitted to another journal and the reasons why it was rejected? Thirdly, will such a disclosure affect the decision of the editors to accept or reject the manuscript? 
 
5. Doctors in developing third world countries are usually afraid to report any adverse drug reactions because they fear losing the cozy relationship they enjoy with the pharma industry which offers them many benefits. This is an important reason why setting up ADR Monitoring Centers has not been a success. What measures should be taken to encourage and convince them that such adverse drug reactions are regularly reported to concerned ADR monitoring centers and agencies so as to save the patients unnecessary side effects which increase morbidity, and at times could prove fatal?
 
Care to respond?
Ajai Singh
Editor, Mens Sana Monographs
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My brief comments are below.
 
Bill Tierney
Co-Editor-in-Chief, Journal of General Internal Medicine
 
Questions that this Paper Raises: 
 
1. Pharmaceutical industry is the major source of revenue for medical journals through advertising. At times the journals are faced with a dilemma when the industry tries to influence the editorial policy as regards publication of clinical trials or adverse drug reactions. What course should medical journals pursue to ensure an independent policy while at the same time ensuring sustained continued publication?
 
How does drug advertising affect publication? I have never heard of a drug company pressuring a journal (via advertising or anything else) not to publish articles concerning the use of their drugs. The bottom line is that there is no place for industry influence on journal policies. 
 
2. Local dose finding studies are now compulsory in many countries before registration of a new drug. If any healthcare professional observes some unwanted side effects even after local dose finding studies have declared the drug to be safe, should it be discarded, or  is it better to have another look at the safety of the drug and earlier dose finding studies?
 
All drugs have unwanted (and even unexpected) side effects. Their use(s) is/are always a balance between these adverse effects’ incidence and severity vs. the positive effects of the drug. Journal publications help provide the evidence for making these decisions, both clinical decisions (individual provider with an individual patient) and administrative decisions (approved uses, local formularies, etc.). 
 
3. Simultaneous submission of manuscripts to more than one periodical by authors is a serious problem faced by medical journals. Editors cannot act as policemen and they have to trust the authors when they give a written undertaking regarding exclusive submission. Even after giving a written undertaking, if an author indulges in unethical practice of simultaneous submission, what can the editors do to discourage this practice apart from black listing such authors and conveying this to their employers, institutions they are affiliated with, as well as concerned government agencies?
 
This is a big and largely unsolvable problem. How can one know that a manuscript has been submitted to more than one journal? Subsequent systematic reviews and meta-analyses, which are becoming more prevalent, will help identify them. Black listing authors is likely not possible because there is no secure place to do this, and the definition of multiple publication is fuzzy. (One can publish somewhat different outcomes of subjects from the same study. Is that multiple duplication?) The only way to discourage this is for the journal to bring it to the attention of the authors’ institutions and let them deal with it (because it has negative effects on the institution’s reputation). Having said that, when I’m making an editorial decision (other than “reject”) for a manuscript, I usually do a PubMed search and see if these authors have previously published something similar. If I suspect plagiarism, I Google a string of words from the abstract. (Recently, we uncovered an egregious case of plagiarism in this manner.)
 
4. If a manuscript is rejected by an indexed journal, it does not mean this does not merit publication. If the authors submit this manuscript to another journal, should it be entertained and published after proper peer review? Secondly, is it essential for the authors to disclose that this manuscript was earlier submitted to another journal and the reasons why it was rejected? Thirdly, will such a disclosure affect the decision of the editors to accept or reject the manuscript?
 
(1) Of course, one can resubmit a rejected article to another journal. I would guess that a third to half of the articles I have published as an author were rejected from another journal first. In fact, our journal takes the position that it is our duty to improve the article (that is, offer suggestions for improvement) even for those that we reject, knowing that most will eventually be published. (2) No, it is not the obligation of the authors to disclose that the article had previously been reviewed and rejected. (3) I have no idea if such disclosure would affect subsequent editorial decision-making, because such disclosure is not necessary and very rarely done.
 
5. Doctors in developing third world countries are usually afraid to report any adverse drug reactions because they fear losing the cozy relationship they enjoy with the pharma industry which offers them many benefits. This is an important reason why setting up ADR Monitoring Centers has not been a success. What measures should be taken to encourage and convince them that such adverse drug reactions are regularly reported to concerned ADR monitoring centers and agencies so as to save the patients unnecessary side effects which increase morbidity, and at times could prove fatal?
 
I have never heard of authors having such relationships with drug companies that they fear to report adverse reactions. If this is true, it is unconscionable for the drug companies to even imply that this is the case and unethical for the providers involved. Authors should never, ever fail to report adverse outcomes of drugs, if this is part of what they are studying. Such failure would be scientific malpractice and a disservice to the health care providers who read the journals and the patients they care for. Our first duty—as providers, scientists, authors, and editors—is to the public the health care profession serves. In my humble opinion.
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There are a number of interesting points Bill makes which need serious discussion. One to which I respond is:
 
Shaukat's question at the end of his paper:
 
1. Pharmaceutical industry is the major source of revenue for medical journals through advertising. At times the journals are faced with a dilemma when the industry tries to influence the editorial policy as regards publication of clinical trials or adverse drug reactions. What course should medical journals pursue to ensure an independent policy while at the same time ensuring sustained continued publication?
 
Bill's response:
 
How does drug advertising affect publication? I have never heard of a drug company pressuring a journal (via advertising or anything else) not to publish articles concerning the use of their drugs. The bottom line is that there is no place for industry influence on journal policies.
 
My response to Bill:
 
Just to set the record straight, may I clarify that most biomedical journals in countries like India and Pakistan are Association sponsored journals. However, they get little funds from the Association and have to depend on Industry sponsorship. The editors are encouraged (well, that's a soft word—actually they have no option but) to resort to industry ads to run the journal. A sizeable number of publications in such journals are of clinical trials conducted in institutions where industry sponsored research is conducted on drugs. The industry has a big stake in seeing that the trial is positively reported in an Association journal so the members who receive it are suitably impressed. The institution heads, and others, want a publication in their name. The institution, and department, wants funds to keep flowing in the future too. All this promotes an unwritten contract wherein drug trial research is positively reported.
 
Then CMEs follow, and small and big gatherings of practitioners are suitably impressed with talks by “authorities,” and dinners and cocktails in lavish venues.
 
Negative results are hardly reported, as it is embarrassing to all the stake holders concerned. The merry go round keeps whirling, and all the concerned parties cling to the bar and shriek in glee. Patient welfare and scientific evidence conveniently go for a toss.
 
I wonder if this is restricted to the two countries I mentioned earlier?
 
Ajai
P.S. I agree with Bill when he says:
 
“The bottom line is that there is no place for industry influence on journal policies.”
 
Only I would like to replace the word 'is' with 'should be'. What 'is', well, the less talked of, the better, I guess.
 
Ajai
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And there was the case of the editor of a journal who pulled a guest commentary that spoke of the ineffectiveness of a drug after advertising told him he could not run it because the journal received substantial revenue from the company that makes the drug.
 
Diana Mason
Editor-in-Chief, American Journal of Nursing
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Diana's memory was spot on. For more on that example of marketing interfering with editorial decision making, see these news stories in the BMJ:
 
 
 
These useful articles in the BMJ and PLoS Medicine are on this topic: 
 
 
 
Matt Hodgkinson-Barrett
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Thanks for sending all those important links, Matt. The article links make for fascinating reading. It's comforting, and equally unnerving, to find oneself in kindred company. So, the phenomenon is fairly universal. Editors, Association office bearers, and those connected here, in India and Pakistan, about whom I talked, can heave a big sigh of relief.
 
Just to add to the debate, here is an excerpt from the original article I referred to, in which a case history of pharma interference in editorial matters is discussed:
 
Case Study: In 1991, we received a case report from a junior faculty member of a postgraduate medical institution highlighting the adverse effects with overdose of Halofantrine. One of his patients had developed ventricular fibrillation and generalized convulsive seizures after administration of this anti-malarial at the recommended dosage. Electrocardiogram showed prolonged QT-interval with multifocal ventricular ectopic beats, which reverted spontaneously. He recommended that this drug be prescribed in a dose of 25mg/Kg body weight. When the company was approached to find out if they had any such information (because of the information they get during post marketing surveillance), we were told that this case report was earlier sent to an Indexed journal which had rejected it. Hence, we should not publish it. However, we went ahead with the peer review process and both the reviewers recommended its publication. While the journal was still under publication, one of the reviewers informed us that his own uncle, who was a cardiac patient, had died due to this antimalarial which was prescribed to him by their family physician. Had he not reviewed this case report, he wouldn't have known about it. He felt that this case report be published as soon as possible to save more lives. Its publication (Bukhari, 1991a) spoiled our relationship with the company, which opined that a local dose finding trial conducted in Pakistan by two senior most physicians had not noted any such adverse effects. Our publications were black listed by the said company and were not to receive any advertisements. Keeping up professional ethics, we offered them to print their viewpoint as well, to which they agreed. However, we also approached the author to get his viewpoint to the company's version, which was also incorporated, in the same issue, which further annoyed the company. (Yazdani, 1991; Bukhari, 1991b). Few months later, a report appeared in a publication of the Pakistan Medical Research Council from Peshawar reporting sudden death while on Halofantrine treatment (Akhtar and Imran, 1992). After two years, The Lancet published similar findings (Nosten et al, 1993) and the company was forced to write, "Dear Doctor" letters all over the world informing the healthcare professionals to be careful while prescribing this drug to heart patients as it could prolong the QT-interval. However, we had to suffer for all those three years, which was a tremendous financial loss. But it all feels worthwhile now, for our principled stand was vindicated.
 
Ajai
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Advertising and Editorial Guidelines

April 8 to April 10, 2006
 
I am interested in how editors approve new advertisements for inclusion in their journal. In Australasian Psychiatry, all new advertisements (generally from the pharmaceutical industry) are sent to me for approval. I read the ad, making sure the claims are plausible (eg, that drug A helps in the management of schizophrenia rather than cardiac failure) and that, particularly in the case of mental illness, the ad does not stigmatise patients. I go no further than this. Does this procedure match that of others? Do people send new ads to members of their Editorial Board, or others, for a second opinion and/or approval? This posting stems from the concerns of one of my readers that more effort and energy is invested in peer review and scrutiny of regular articles than ads that may be equally, if not more, influential.
 
Garry Walter
Editor, Australasian Psychiatry
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You have raised an interesting point. Generally, I do not see new ads at all. I've only seen a couple since being editor, one of which I did refuse to carry for a number of reasons, but mainly due to how they were referencing studies that supported the product.
 
However, as I am mainly dealing with dressing products, the claims are generally plausible. I also know that our readers would be quick to point out any anomalies.
 
Are there any WAME guidelines on this?
 
Deborah Glover
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With regard to the question regarding WAME guidelines on advertising and advertising review, the WAME Recommendations on Publication Ethics Policies for Medical Journals includes a section on advertising that addresses a number of important issues including ad review. Feedback is welcome.
 
Margaret A. Winker
Vice-President, WAME
Deputy Editor, JAMA
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Editorial Review of Advertising

February 24, 2005
 
The ICMJE state that editors must have full and final authority for approving advertisements and the COPE guidelines state that advertisements that mislead must be refused. Our publishers send every advertisement to our editorial office for approval before publication. I would be interested to know what criteria other editors use in assessing whether an advertisement misleads. There was a debate about this in connection with advertisements referring to studies but I have not been able to locate it again and would be grateful for any information anyone might have relating to it.
 
Elise Langdon-Neuner
Journal of Men's Health and Gender
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This is a really delicate area, given that in some cases, advertisers want to be positioned next to certain articles etc. Last year I refused an ad, as when I checked out the references listed on it (supposedly supporting their claims), they were actually tertiary refs and the link to the claims about the product tenuous. I also do not accept ads with 'data on file' wherever possible. However, I have to admit, I don't always get to see the ads before they are printed- which causes some tension!
 
Deborah
Editor, JWC
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See the work of Steve Woloshin et al. from Dartmouth.
 
You also have to remember that "misleading" is hard to define. Gemfibrizil was marketed with a relative risk reduction of 34%, although the absolute risk reduction was 1.4% and the number needed to treat was 71 men for 5 years to prevent a single heart attack. All the numbers are accurate and accepted outcome measures, but they lead the reader in different directions.
 
Tom 
Tom Lang Communications and Training
 
 
Ed Note: See also: Cooper RL, Chriger DL. The availability of references and the sponsorship of original research cited in pharmaceutical advertisements. CMAJ. 2005;172(4).doi:10.1503/cmaj.1031940.
 

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