[naturenews] from [nature.com]
[naturenews]
Published online 14 September 2009 | Nature | doi:10.1038/461325a
News
Ghosts still present in the medical machine
Unattributed authors remain an issue for journals.
By Nicola Jones
VANCOUVER
A paper’s authors are not always apparent from the author list.FOTOPIC/MONSOON/PHOTOLIBRARY/CORBISThe medical literature continues to be haunted by ghostwriting — a practice that, in its most extreme form, involves pharmaceutical companies designing and paying for studies or reviews, then seeking a guest author to be credited while the company goes unacknowledged. The problem persists, said experts last week, despite recent drug-company policy changes and efforts by journals to cut down on the practice (see 'Spectre of industry bias').
A new survey attempting to quantify the phenomenon looked at more than 600 authors who had published papers in six major medical journals in 2008. Of them, 7.8% indicated there was a 'ghost' lurking behind the paper — someone who contributed significantly, perhaps as a writer or statistician, but who wasn't credited as an author or elsewhere. In a similar 1996 survey, the percentage that identified ghosts was 11%. "It is still a problem," says Josef Wislar, a research analyst for the Journal of the American Medical Association (JAMA) in Chicago, Illinois, who presented the work in Vancouver, Canada, at the 10–12 September Sixth International Congress on Peer Review and Biomedical Publication.
Recent media reports have described how pharmaceutical giant Merck sponsored work about its painkiller Vioxx (rofecoxib), and Wyeth did the same for its hormone-replacement therapy Prempro, without being fully acknowledged in some resulting papers. And GlaxoSmithKline ran a programme in which employees approached doctors to help them write up their experiences with the depression medicine Paxil (paroxetine). Three published case studies resulted, none acknowledging the assistant writer, says company spokesman Kevin Colgin.
These high-profile cases involve papers published largely in the late 1990s or early 2000s, and Merck, Wyeth and GlaxoSmithKline have all since changed their policies to strengthen rules on disclosure. Yet medical-journal editors say the issue continues.
"We receive several manuscripts a month that are suspicious," says William Tierney, co-editor-in-chief of the Journal of General Internal Medicine in Indianapolis, Indiana. These include, for example, favourable reviews for new drugs apparently penned by authors who had not previously published on that topic.
Whether such ghostwriting has an adverse effect is hard to pin down. The aim of sponsoring and writing papers is simply to "broaden knowledge about the latest science", says Wyeth spokesman Doug Petkus. But Drummond Rennie, deputy editor at JAMA, says that ghostwritten papers tend to have more positive conclusions and can be used to market off-label uses of drugs.
Journal editors can fight the practice by having strict rules on disclosure and by publishing the specific contributions of each author, says Jenny White, a research analyst at the University of California, San Francisco. In work presented at the Vancouver meeting, White found that among journals targeted by a ghostwriting campaign by Parke-Davis — a subsidiary of Pfizer — for Neurontin (gabapentin), used to relieve neuropathic pain, the journals that published the work were less likely to have strong rules about authorship and disclosure than those that did not. Still, only 4 of 26 journals she studied explicitly mention ghostwriting in their policies today.
The World Association for Medical Editors recommends that journal editors "publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author", alert the academic institution involved and provide the media with details if contacted about the case.
Many journal editors do this. "We name and shame constantly," says Rennie. But, says Christine Laine, editor of the Annals of Internal Medicine in Philadelphia, Pennsylvania, the only way to stop the ghostwriting is if "respected names in academia" stop being "willing to put their names on papers they have not been fully involved in, or without proper acknowledgements".
"I work regularly with scientists employed by drug companies, and to a person they are honest, ethical and interested in the truth," says Tierney. "These ghostwriting misadventures are the product of the drug companies' marketing offices, and they are maddening."
[naturenews]
Published online 14 September 2009 | Nature | doi:10.1038/news.2009.914
News
Sneak test shows positive-paper bias
Reviewers keener to give thumbs up to papers with positive results
By Nicola Jones
VANCOUVER
{Reviewers were more critical of no-difference papers than positive papers.
GETTYT}
he bias towards positive results in journal publications has been confirmed through a cunning experiment.
Seth Leopold of the University of Washington, Seattle, composed two versions of a fake paper comparing the relative benefits of two antibiotic treatments. They were identical except for one critical difference: one paper found that one treatment was better than the other, while the other found no difference between the two. Reviewers were far more likely to recommend the positive result for publication, Leopold and his colleagues found. Worse, reviewers graded the identical 'methods' section as better in the positive paper, and were more likely to find sneakily hidden errors in the 'no-difference' paper, presumably because they were feeling more negative and critical about the latter work.
"That's a major problem for evidence-based medicine," says Leopold, who presented the work on 11 September at the Sixth International Congress of Peer Review and Biomedical Publication in Vancouver, British Columbia. Such a bias can skew the medical literature towards good reviews of drugs, affecting consensus statements on recommended treatments. "We should be more critical of positive studies," he says.
Wanting to believe
Previous studies have hinted at a 'positive outcome bias', just from the sheer number of papers that get published with positive versus 'no-difference' results. But it wasn't clear if there were some other aspects about 'no-difference' papers, such as methodological problems or a lack of impact, that might make editors turn up their noses. Leopold's study is the first experiment to attempt to pin this down.
"It just goes to show that peer review is done by biased, subjective people," says Liz Wager, managing director of the Sideview consultancy in Princes Risborough, UK, and chair of the UK-based Committee on Publication Ethics. "Everyone wants the new stuff to work — they want to believe."
{“It just goes to show that peer review is done by biased, subjective people.”
Liz Wager
Committee on Publication Ethics}
The two imaginary studies were of very high quality, conforming to all good standards of research, involving multiple study centres and oodles of good data. "It's easy to make such a study if you don't have to actually do it," Leopold jokes. They compared two strategies of antibiotic treatment for surgery patients — a single dose of drugs before surgery compared with a starter dose plus a 24-hour follow up of drugs. The relative benefit of these strategies is under debate by clinicians, so both a positive and a negative result should have equal impact on patient care — both should have been equally interesting.
But when more than 100 reviewers at the American edition of Journal of Bone and Joint Surgery (JBJS) were given one of the papers to assess, 98% of reviewers recommended the positive-result paper for publication, while only 71% recommended the nearly identical 'no-difference' paper. Strikingly, these reviewers also gave the entirely identical methods section a full point advantage (on a scale of one to ten) in the positive paper. "There's no good explanation for that," says Leopold. "That's dirty pool."
Error catchers
Five intentional small errors were sneaked into the papers, such as having slightly different numbers in a table compared with the text. Reviewers at the JBJS caught only an average of 0.3 errors per reviewer in the positive paper, but perked up their critical faculties to catch 0.7 errors per reviewer in the 'no difference' paper.
Another 100 reviewers at the journal Clinical Orthopedics and Related Research were similarly affected in their judgement, but not to a statistically significant degree. This might partly be because these reviewers guessed they were part of an experiment, Leopold says — this journal tells reviewers that they are number 'x' reviewer on a paper, and once that number goes past '5' or so it starts to look very suspicious.
Some have hypothesized that positive-result bias might come from researchers deciding not to bother submitting 'no-difference' results. This study shows that peer reviewers are probably playing a role too, says Leopold. "We have reason to suspect this is true across all specialties," he says.
[naturenews]
Published online 14 September 2009 | Nature | doi:10.1038/461325a
News
Ghosts still present in the medical machine
Unattributed authors remain an issue for journals.
By Nicola Jones
VANCOUVER
A paper’s authors are not always apparent from the author list.FOTOPIC/MONSOON/PHOTOLIBRARY/CORBISThe medical literature continues to be haunted by ghostwriting — a practice that, in its most extreme form, involves pharmaceutical companies designing and paying for studies or reviews, then seeking a guest author to be credited while the company goes unacknowledged. The problem persists, said experts last week, despite recent drug-company policy changes and efforts by journals to cut down on the practice (see 'Spectre of industry bias').
A new survey attempting to quantify the phenomenon looked at more than 600 authors who had published papers in six major medical journals in 2008. Of them, 7.8% indicated there was a 'ghost' lurking behind the paper — someone who contributed significantly, perhaps as a writer or statistician, but who wasn't credited as an author or elsewhere. In a similar 1996 survey, the percentage that identified ghosts was 11%. "It is still a problem," says Josef Wislar, a research analyst for the Journal of the American Medical Association (JAMA) in Chicago, Illinois, who presented the work in Vancouver, Canada, at the 10–12 September Sixth International Congress on Peer Review and Biomedical Publication.
Recent media reports have described how pharmaceutical giant Merck sponsored work about its painkiller Vioxx (rofecoxib), and Wyeth did the same for its hormone-replacement therapy Prempro, without being fully acknowledged in some resulting papers. And GlaxoSmithKline ran a programme in which employees approached doctors to help them write up their experiences with the depression medicine Paxil (paroxetine). Three published case studies resulted, none acknowledging the assistant writer, says company spokesman Kevin Colgin.
These high-profile cases involve papers published largely in the late 1990s or early 2000s, and Merck, Wyeth and GlaxoSmithKline have all since changed their policies to strengthen rules on disclosure. Yet medical-journal editors say the issue continues.
"We receive several manuscripts a month that are suspicious," says William Tierney, co-editor-in-chief of the Journal of General Internal Medicine in Indianapolis, Indiana. These include, for example, favourable reviews for new drugs apparently penned by authors who had not previously published on that topic.
Whether such ghostwriting has an adverse effect is hard to pin down. The aim of sponsoring and writing papers is simply to "broaden knowledge about the latest science", says Wyeth spokesman Doug Petkus. But Drummond Rennie, deputy editor at JAMA, says that ghostwritten papers tend to have more positive conclusions and can be used to market off-label uses of drugs.
Journal editors can fight the practice by having strict rules on disclosure and by publishing the specific contributions of each author, says Jenny White, a research analyst at the University of California, San Francisco. In work presented at the Vancouver meeting, White found that among journals targeted by a ghostwriting campaign by Parke-Davis — a subsidiary of Pfizer — for Neurontin (gabapentin), used to relieve neuropathic pain, the journals that published the work were less likely to have strong rules about authorship and disclosure than those that did not. Still, only 4 of 26 journals she studied explicitly mention ghostwriting in their policies today.
The World Association for Medical Editors recommends that journal editors "publish a notice that a manuscript has been ghost written, along with the names of the responsible companies and the submitting author", alert the academic institution involved and provide the media with details if contacted about the case.
Many journal editors do this. "We name and shame constantly," says Rennie. But, says Christine Laine, editor of the Annals of Internal Medicine in Philadelphia, Pennsylvania, the only way to stop the ghostwriting is if "respected names in academia" stop being "willing to put their names on papers they have not been fully involved in, or without proper acknowledgements".
"I work regularly with scientists employed by drug companies, and to a person they are honest, ethical and interested in the truth," says Tierney. "These ghostwriting misadventures are the product of the drug companies' marketing offices, and they are maddening."
[naturenews]
Published online 14 September 2009 | Nature | doi:10.1038/news.2009.914
News
Sneak test shows positive-paper bias
Reviewers keener to give thumbs up to papers with positive results
By Nicola Jones
VANCOUVER
{Reviewers were more critical of no-difference papers than positive papers.
GETTYT}
he bias towards positive results in journal publications has been confirmed through a cunning experiment.
Seth Leopold of the University of Washington, Seattle, composed two versions of a fake paper comparing the relative benefits of two antibiotic treatments. They were identical except for one critical difference: one paper found that one treatment was better than the other, while the other found no difference between the two. Reviewers were far more likely to recommend the positive result for publication, Leopold and his colleagues found. Worse, reviewers graded the identical 'methods' section as better in the positive paper, and were more likely to find sneakily hidden errors in the 'no-difference' paper, presumably because they were feeling more negative and critical about the latter work.
"That's a major problem for evidence-based medicine," says Leopold, who presented the work on 11 September at the Sixth International Congress of Peer Review and Biomedical Publication in Vancouver, British Columbia. Such a bias can skew the medical literature towards good reviews of drugs, affecting consensus statements on recommended treatments. "We should be more critical of positive studies," he says.
Wanting to believe
Previous studies have hinted at a 'positive outcome bias', just from the sheer number of papers that get published with positive versus 'no-difference' results. But it wasn't clear if there were some other aspects about 'no-difference' papers, such as methodological problems or a lack of impact, that might make editors turn up their noses. Leopold's study is the first experiment to attempt to pin this down.
"It just goes to show that peer review is done by biased, subjective people," says Liz Wager, managing director of the Sideview consultancy in Princes Risborough, UK, and chair of the UK-based Committee on Publication Ethics. "Everyone wants the new stuff to work — they want to believe."
{“It just goes to show that peer review is done by biased, subjective people.”
Liz Wager
Committee on Publication Ethics}
The two imaginary studies were of very high quality, conforming to all good standards of research, involving multiple study centres and oodles of good data. "It's easy to make such a study if you don't have to actually do it," Leopold jokes. They compared two strategies of antibiotic treatment for surgery patients — a single dose of drugs before surgery compared with a starter dose plus a 24-hour follow up of drugs. The relative benefit of these strategies is under debate by clinicians, so both a positive and a negative result should have equal impact on patient care — both should have been equally interesting.
But when more than 100 reviewers at the American edition of Journal of Bone and Joint Surgery (JBJS) were given one of the papers to assess, 98% of reviewers recommended the positive-result paper for publication, while only 71% recommended the nearly identical 'no-difference' paper. Strikingly, these reviewers also gave the entirely identical methods section a full point advantage (on a scale of one to ten) in the positive paper. "There's no good explanation for that," says Leopold. "That's dirty pool."
Error catchers
Five intentional small errors were sneaked into the papers, such as having slightly different numbers in a table compared with the text. Reviewers at the JBJS caught only an average of 0.3 errors per reviewer in the positive paper, but perked up their critical faculties to catch 0.7 errors per reviewer in the 'no difference' paper.
Another 100 reviewers at the journal Clinical Orthopedics and Related Research were similarly affected in their judgement, but not to a statistically significant degree. This might partly be because these reviewers guessed they were part of an experiment, Leopold says — this journal tells reviewers that they are number 'x' reviewer on a paper, and once that number goes past '5' or so it starts to look very suspicious.
Some have hypothesized that positive-result bias might come from researchers deciding not to bother submitting 'no-difference' results. This study shows that peer reviewers are probably playing a role too, says Leopold. "We have reason to suspect this is true across all specialties," he says.
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