Business, Science Clash at Medical Journal 

SHANKAR VEDANTAM / Washington Post 7feb04

[Background below]

An analysis critical of the growing use of an expensive medicine used for dialysis patients was turned down by the most widely circulated medical journal in the field after its marketing department objected, according to an e-mail from the journal's editor to the article's author.

Three senior scientists had reviewed the analysis and approved it for publication, Joseph Herman, executive editor of Dialysis & Transplantation, wrote to author Dennis Cotter, president of a nonprofit health research group in Bethesda.

"Unfortunately, I have been overruled by our marketing department with regard to publishing the editorial," Herman added. "As you accurately surmised, the publication of your editorial would, in fact, not be accepted in some quarters . . . and apparently went beyond what our marketing department is willing to accommodate."

Cotter questioned whether patients benefited from increased doses of Epogen, which increases levels of red blood cells in patients with kidney problems. The federal government is considering whether to provide Medicare patients with higher doses of such treatments, which could cost hundreds of millions of additional tax dollars.

The journal's publisher, Deborah Carver, reversed the decision after Cotter protested, but Cotter said he would rather publish the article elsewhere. The initial rejection, however, has highlighted concerns that research, publication and analysis of scientific data are being influenced by drug industry pressures.

"The public should be very concerned about the pervasive influence of the pharmaceutical companies on the way science is done and on the academic medical community," said Marcia Angell, former editor of the New England Journal of Medicine and a senior lecturer at Harvard Medical School. "Most journals are absolutely dependent on advertising from drug companies, and they are not going to offend them."

Dialysis & Transplantation's editorial advisory board included researchers from the Centers for Disease Control and Prevention, Cedars-Sinai Medical Center in Los Angeles, the Robert Wood Johnson Medical School in New Jersey, and dozens of other doctors at academic and government hospitals across the country. Christopher Blagg, a Seattle nephrologist who is on the board, said he believed the marketing department rejected the article because it wanted to avoid offending Amgen Inc., which makes Epogen.

"I have no knowledge of this article or this data," said Kelly Stoddard, a spokeswoman for Amgen. "Any decision about what they publish is entirely up to them."

Cotter, president of Medical Technology and Practice Patterns Institute Inc. in Bethesda, said he was "amazed" by the journal's rejection. "This was very damaging to us, because we had hoped to have this thing appear in the literature in February. Medicare right now is reviewing its policy," he said. He forwarded the e-mail he received from Herman, the editor.

A call to Herman was returned by his boss, Linda Lewis, editorial director of Creative Age publications, which owns Dialysis & Transplantation. She said that "a mistake" had been made by the journal's associate publisher, Tom Blackstone. The company describes the journal as "the world's largest (and oldest) renal care journal with a specific focus on clinical application."

"The associate publisher, who has been with the magazine for 25 years, felt he had cause for turning down the article," said Lewis. "He's also the marketing director. . . . He made that decision, unfortunately, and we felt it was the wrong decision."

Cotter's analysis concluded that higher doses of Epogen did not extend patients' lives, and may not be worth the added cost. Normally, said Cotter, the medicine costs an average of $5,000 to 6,000 per year per patient. Increasing patients' red blood cell levels further could double the cost. Since there are 100,000 to 120,000 patients getting such treatment at any one time, Cotter said, higher doses for large numbers of people could translate into hundreds of millions of extra dollars for Medicare.

While cost was a factor, Cotter said, his principal concern is his finding that patients on higher doses of Epogen actually seem to have higher death rates.

This could be because these patients were sicker, because there was a problem with the drug, or because of some underlying problem that had not been identified, he said.

"Our primary issue is patient safety," he said. "Anyone that claims that higher [doses] result in longer survival is not correct."

Brian Pereira, a nephrologist who is president of the National Kidney Foundation, said there was an ongoing debate in the field over the appropriate red blood cell level for patients with kidney problems.

"To date, there is no prospective, randomized study that shows higher [doses] are better," he said. A national database showed that people with higher levels of red blood cells tend to do better, he said.

"It's associated with higher survival," said Pereira, who is also a professor at Tufts University.

Regardless of where the science leads, Blagg, the journal board member, said he disapproved of the way the journal handled the matter.

He told editors that a full airing of the debate would have been possible if they had published the article, if necessary with a contrasting article written by a scientist who disagreed with Cotter.

The larger question raised by this case is whether it happens elsewhere. Pereira said that top journals would never compromise their editorial independence. But Angell said that with the exception of the New England Journal of Medicine, virtually no other journal could survive if advertisers pulled out.

Other editors, she said, might deal similarly with the same pressures -- but be more discreet.

"They are going to come up with excuses for going along with the companies that are a lot less candid than this editor," she said. "This editor must be pretty close to retirement or doesn't like his job very much."

source: http://www.washingtonpost.com/ac2/wp-dyn/A20147-2004Feb6?language=printer 7feb04

Journal rejects article after objections from marketing department

OWEN DYER / British Medical Journal 31ja04

BMJ 2004;328:244 (31 January)

London—A leading nephrology journal has rejected a guest editorial questioning the efficacy of epoetin in end stage renal disease, despite favourable peer reviews, apparently because it feared losing advertising. In a letter to the author of the proposed editorial, the executive editor of the California based journal Transplantation and Dialysis said he had been "overruled by our marketing department."

The editorial was written by Dennis Cotter, president of the non-profit making Medical Technology and Practice Patterns Institute. In it, he argued that the US National Kidney Foundation's existing guidelines on end stage renal disease rely on flawed logic in claiming a survival benefit associated with higher packed cell volume (haematocrit) achieved through epoetin treatment.

Joseph Herman, editor of the journal, told Mr Cotter in a letter that: "I have now heard back from a third reviewer of your EPO editorial, who also recommended that it be published.... Unfortunately, I have been overruled by our marketing department with regard to publishing your editorial.

"As you accurately surmised, the publication of your editorial would, in fact, not be accepted in some quarters... and apparently went beyond what our marketing department was willing to accommodate. Please know that I gave it my best shot, as I firmly believe that opposing points of view should be provided a forum, especially in a medical environment, and especially after those points of view survive the peer review process. I truly am sorry."

Mr Cotter's editorial said the evidence cited in support of a survival benefit "is subject to a fundamental error that confuses the relationship between treatment response and outcomes with a causal effect of the treatment."

His editorial also pointed out that, despite a steady increase in the target packed cell volumes and epoetin doses over the past decade in the United States, mortality from end stage renal disease has remained steady. He wrote: "A 2002 Cochrane Review of randomised trials of epoetin concurred with the European guidelines concluding that the benefits associated with higher hematocrit levels are outweighed by the risk of increased hypertension and mortality."

The editorial was submitted in response to a call from the Centers for Medicare and Medicaid Services for public help in review of its policy on epoetin use among patients with end stage renal disease. It was concerned that "Medicare spending on EPO may be higher than necessary without resulting in optimal patient benefit." Medicare spent over $7.6bn (£4.2bn; 6.1bn) on epoetin between 1991 and 2002.

Arthur Caplan, chair of the Department of Medical Ethics at the University of Pennsylvania, said: "It is completely unethical for a marketing or business related part of a journal to have any say over the content of a journal."

Mr Hermann said: "I absolutely refuse to comment. This whole issue is being blown out of proportion."

source: http://bmj.bmjjournals.com/cgi/content/full/328/7434/244-b

Responses

Tampering with editorial independence = The DEATH SENTENCE for scientific progress 30 January 2004

Badrinath, Specialist Registrar in Public Health & Recognised Clinical Teacher Southend PCT & University of Cambridge, Harcourt Avenue, Southend on Sea, SS2 6HE

Dear Editor,

The BMJ has to be congratulated for bringing this case of interference in editorial independence to a wider audience (1). The executive editor of the journal “Transplantation and Dialysis” was overruled by the marketing department despite a favourable peer review regarding the editorial by Dennis Cotter “Formulation of a Medicare Epoetin Coverage and Reimbursement Policy: Need for Valid Patient Survival Information” the abstract of which is in the public domain (2).

This is a clear violation of the World Association of Medical Editors (WAME) policy statement on editorial independence. According to WAME (3), “Editors-in-chief should have full authority over the editorial content of the journal, generally referred to as “editorial independence.” Owners should not interfere in the evaluation, selection, or editing of individual articles, either directly or by creating an environment in which editorial decisions are strongly influenced. Editorial decisions should be based mainly on the validity of the work and its importance to readers, not the commercial success of the journal”.

According to an editorial (4) from Canada “Many societies depend on income from their journal to support other initiatives of interest to the membership. Income is increasingly dependent on advertising revenue – thus, there may be subtle but real pressures to please the industry partners with content and editorial position”. However the editor of the BMJ (5) has emphasised the need to establish trust between editors and the owners of the journal, which means striking a balance between editorial independence and accountability. Welch in his editorial (6), in the “Effective Clinical Practice”, wondered whether medical journals are on the wrong track and strongly advocated the independence of medical journals and their editors to serve as a counterbalance to combat the commercial interests in the publication arena.

Kassirer in his editorial (7) in the New England Journal of Medicine declared “In my opinion, any requirement that a medical journal represent the views of the journal's owner or a medical society's constituency is inconsistent with the principle of editorial independence”. But a clash of ideas and principles left many Editors bruised. In the past, three journal editors had to leave (8); two American and one European. A recent survey (9) of medical editors found that pressure over editorial content by the journal leadership is not uncommon and according to the author of the survey “Stronger safeguards are needed to give editors protection against pressure over editorial content, including written guarantees of editorial freedom and governance structures that support those guarantees”.

So where does the “Transplantation and Dialysis” decision to reject the editorial on epoetin based on the marketing department’s veto leave us? Bjork (10) in “The American psychologist” points out the lessons from history. “When political or other pressures interfere with the autonomy of science, the societal and scientific consequences are grim.

According to “Transplantation and Dialysis” web site (11) it is the oldest renal care journal in the world and has the largest-circulation (24,000-plus) and caters to a multidisciplinary audience of practitioners (physicians, surgeons, nurses, nutritionists, technicians, technologists, social workers, administrators, transplant/procurement coordinators. Hence refusing to publish or open a debate on an issue such as epoetin will ultimately affect patients getting the best possible care. We do not know how this saga will unfold; but to establish editorial independence and to restore the scientific credibility the journal should publish this editorial but can invite another expert to present an alternate view on the topic.

1 Dyer O, Journal rejects article after objections from marketing department. BMJ 2004;328:244.

2 http://www.mtppi.org/reports.php?repid=062  accessed on 30th January 2004.

3 http://www.wame.org/wamestmt.htm#independence  accessed on 30th January 2004.

4 Smith ER. Editorial independence. Can J Cardiol. 2002;18(6):679-82.

5 Smith R. Another editor bites the dust. BMJ 1999;319:272-272

6 Welch HG. Should medical journals be a private business or a public service? Eff Clin Pract. 2000;3(4):185-7.

7 Kassirer JP. Editorial independence. N Engl J Med1999;340(21):1671- 2.

8 Anonymous. [1999, the year of fired editors-in-chief] Ned Tijdschr Geneeskd. 2000 ;144(1):3-4. Dutch.

9 Davis RM, Mullner M. Editorial independence at medical journals owned by professional associations: a survey of editors. Sci Eng Ethics. 2002 ;8(4):513-28.

10 Bjork RA. Independence of scientific publishing. Reaffirming the principle. Am Psychol. 2000 Sep;55(9):981-4.

11 http://www.eneph.com/about.htm  accessed on 30th January 2004

Dr.P.Badrinath PhD, MFPHMI SPR in Public Health & Recognised Clinical Teacher, Southend PCT & University of Cambridge, Harcourt Avenue, Southend on Sea, SS2 6HE.

Competing interests: The author is a strong believer and advocate of editorial independence

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Correction and addition

Sean P Lynch, Honorary Senior Clinical Research Fellow, Mental Health Research Group, Peninsula Medical School, Wonford House Hospital, Dryden Road, Exeter EX2 5AF

I would like to point out that I made an error in this story. The journal in question is called Dialysis and Transplantation, not Transplantation and Dialysis. A print correction will appear in next week's journal. My apologies.

Also, while the editor of Dialysis and Transplantation initially refused comment, that position has changed since we went to press, and I have received the following comment:

January 27, 2004 A Reply by Dialysis & Transplantation (This response is being forwarded at the request of Tom S. Blackstone, Associate Publisher and Director of Marketing, Dialysis & Transplantation.)

As the associate publisher and director of marketing of the journal Dialysis & Transplantation, I did, in fact, overrule the executive editor's desire to publish the editorial, "Formulation of a Medicare Epoetin Coverage and Reimbursement Policy: Need for Valid Patient Survival Information," which was written and submitted by Dennis J. Cotter, president, Medical Technology and Practice Patterns Institute, Inc., Bethesda, Maryland. Further, that decision was, in fact, based on the controversial nature of the editorial.

At the core of that decision was an in-depth understanding of the audience served by this journal (having worked on this journal for more than 25 years), as well as an appreciation of the journal's highly directed focus on clinical application. With rare exception, every article that has been published in this journal during its entire 31 years of existence has been authored by a healthcare practitioner and/or by someone working in a clinical nephrology, renal transplantation, or academic medicine setting - whether a nephrologist, surgeon, nurse, dietitian, social worker, technician, or renal administrator.

From the perspective of meeting the needs of the readership that we serve, I had difficulty in weighing the controversial nature of the editorial against the source of the editorial. It was my decision that it would not have been in the best interest of the nephrology community for someone who is not part of that community to lambaste within this journal deeply entrenched, widely accepted clinical practices.

Publication of such an article could have a negative effect on the journal's credibility within the nephrology community. In addition, the very strong possibility exists that such an article would alienate a significant portion of the journal's readership who would, in fact, not agree with many of the premises raised within the editorial.

The highly probable end result would be that Dialysis & Transplantation would lose readership and circulation. This is a serious marketing concern, as it would be for any publisher.

Publishers reject countless articles every day, and it is their prerogative to do so. It is, of course, any author's prerogative to submit the article to another publisher. Tom S. Blackstone Associate Publisher & Director of Marketing Dialysis & Transplantation

Competing interests: I wrote this news article

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A question of editorial ethics

Anibal J Morillo, Institutional Radiologist Department of Diagnostic Imaging, Fundación Santa Fe de Bogotá, Calle 119 No. 9 - 33 Piso 3, Bogotá,

For anyone interested in topics such as authorship and editorial issues, this is a situation that can clearly be used as a "teaching case", when speaking about editorial misconduct.

Reviewers are trusted with original and unpublished information, and they should not to use that information in any possible manner. A reviewer has the privilege of being exposed firsthand to information that could be potentially beneficial, such as new findings or discoveries that could be so important as to initiate changes in clinical guidelines or in therapeutic actions.

This is a position of utmost responsability; violation of the trust presented to reviewers should be severely sanctioned, at the very least at an academic level. The names of the reviewers that revealed confidential information that lead to stop the publication of such an editorial should be exposed, and from my point of view, these persons should be banned from reviewing activities. I cannot think of a serious editor of a serious journal that would even want to be near reviewers who are willing to reveal the information presented to them, let alone incur in unethical positions that could lead to impede a publication, based on marketing implications, and flagrantly violating the most basic principles of editorial independence.

It is clear for me that the Executive Editor of Transplantation and Dialysis is absolutely wrong when he states that the case has been "blown out of proportion": once the reviewer's misconduct was apparent, Mr. Herman was not strong or serious enough to make up for this unethical misconduct, and followed the easy path: ignore the issue and reject the publication, not without first presenting lame excuses in a letter that only reveals his editorial incompetence. Is there a journal out there at all interested in keeping -or opening- a position for executive editor for anybody capable of this kind of misconduct? Hopefully, not.

Competing interests: None declared

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Academic Freedom

Michael D E Goodyear, Assistant Professor Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada B3H 2Y9

To the Editor:

While the subject of a marketing decision influencing editorial policy (1) is likely to elicit justifiable outrage, we should realise that at least the process was transparent in this case.

What we should be far more concerned about is the possibility that this phenomenon may be widespread and much more subtly nuanced.

One can only hope that this sentinel event will act as a call to action by bodies such as the World Association of Medical Editors (WAME), the Committee on Publication Ethics (COPE)(2) and the International Committee of Medical Journal Editors (IJME)(3).

1 Dyer O, Journal rejects article after objections from marketing department. BMJ 2004;328:244.

2 http://www.publicationethics.org.uk/

3 http://www.icmje.org/

Competing interests: None declared

source: http://bmj.bmjjournals.com/cgi/eletters/328/7434/244-b