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This is what congress should be beating down doors for.
Sen Grassley Asks Medical Journals About Ghostwriting
Michael O???Riordan
July 8, 2009 (Washington, DC) ??? Sen Chuck Grassley (R-IA) has sent letters to eight major medical journals asking about their policies and practices regarding medical ghostwriting [1].
With letters out to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, the Journal of the American Medical Association, and the New England Journal of Medicine, the journal editors are asked about ghostwriting as part of a broader effort to clarify the relationships between industry and medical professionals.
Grassley, the ranking member of the Senate Committee on Finance, notes that his committee has been examining medical ghostwriting for the past year. The practice involves having review articles, editorials, and research papers drafted by marketing or medical-education companies, with prominent or academically affiliated physicians adding their names to the paper late in the process. As Grassley's letter notes, these physicians sign on despite a minimal contribution to the paper or even knowledge of the article's contents, including the underlying data and relevant documentation.
There are concerns that "some medical literature may be little more than subtle advertisements rather than independent research," writes Grassley. With these articles then having an impact on physicians' prescribing habits and the subsequent cost to the American taxpayer through Medicare and Medicaid programs, any attempt to manipulate the scientific literature is troubling, he adds.
In April 2008, Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT), along with lead investigator Dr Joseph Ross (Mount Sinai School of Medicine, New York, NY), reported evidence of Merck employees preparing manuscripts, sometimes in collaboration with medical publishing companies, and then recruiting academic physicians to be the first authors [2]. The paper, published in the Journal of the American Medical Association, offered a glimpse into the behind-the-scenes influence of industry.
"What I would like to see is a clear and explicit statement from the journals that if there is a circumstance where there is found to be ghostwriting, there would be some significant consequences," Krumholz told heartwire this week. "If a bunch of journals banded together and said if we find incontrovertible evidence of ghostwriting, and there would have to be some process for making that distinction, then that person would be banned from publishing."
Full Disclosure
In his letter, Grassley asks the eight journals their position regarding the practice of ghostwriting, specifically if they have any written policies in place. In addition, he asks if the author is required to disclose the involvement of drug, device, or medical-education and/or marketing companies in the drafting of the article and how these relationships are disclosed to the public. Finally, Grassley asks the journals if they have taken action against an author for failing to disclose outside involvement with the drafting of a manuscript.
The journals have until July 22, 2009 to respond to the senator's questions.
Krumholz said that while defining ghostwriting might be open to some interpretation, the journals should aim for full disclosure of who was involved in the drafting of the manuscript and zero tolerance for failing to do so.
"The litigation has shown that people are approached, drafts are written, and they do some light editing, and it goes out under their name," he said. "It's not disclosed that this occurred." Full disclosure wouldn't preclude even heavy assistance from others or from medical writing companies, he added, but those involved need to be up front about their roles and the roles of third parties.
The issue of authorship has been in the news lately, including on heartwire , with allegations arising from a class-action lawsuit in Australia that prominent cardiologist Dr Marvin Konstam (Tufts University Medical Center, Boston, MA) did not significantly contribute to a 2001 rofecoxib (Vioxx, Merck) meta-analysis in Circulation [3]. Merck denied adding Konstam's name to the manuscript late in the process, with a Merck spokesperson telling heartwire that Konstam was involved in the design and authorship of the study and is considered an appropriate author. Konstam has also denied allegations of not being significantly involved in the study.
Contacted by heartwire , media spokespeople at the Annals of Internal Medicine and the New England Journal of Medicine said they are in the process of responding to Grassley's questions, and both directed inquiries regarding their policies of ghostwriting to their journal's websites. The Annals of Internal Medicine, for example, states that "authorship implies accountability," but also that "medical writers and industry employees can be legitimate contributors" as long as their roles, affiliations, and potential conflicts of interest are described in the submitted manuscript.
The New England Journal of Medicine requires all authors to attest to their contribution to the study, with an author defined by the International Committee of Medical Journal Editors (ICMJE). The ICMJE states that an authorship credit is based on substantial contributions to the conception and design of the study, the acquisition of data, or analysis and interpretation of the data. It should also be based on drafting the manuscript or critically revising it for intellectual content and should involve a final approval before publication.
Krumholz, who serves as editor of Circulation: Cardiovascular Quality and Outcomes, pointed out that the revenue generated from reprints of journal articles also places the journals in a compromised position. "It's another conflict of interest on the journal's part, because you're going to make a lot of money by publishing those articles," he said. "Not only has the company ghostwritten them but they're going to buy a lot of reprints to pass out."
Source
Sen Grassley Asks Medical Journals About Ghostwriting
Michael O???Riordan
July 8, 2009 (Washington, DC) ??? Sen Chuck Grassley (R-IA) has sent letters to eight major medical journals asking about their policies and practices regarding medical ghostwriting [1].
With letters out to the American Journal of Medicine, the Annals of Internal Medicine, the Annual Review of Medicine, the Archives of Internal Medicine, Nature Medicine, PLoS Medicine, the Journal of the American Medical Association, and the New England Journal of Medicine, the journal editors are asked about ghostwriting as part of a broader effort to clarify the relationships between industry and medical professionals.
Grassley, the ranking member of the Senate Committee on Finance, notes that his committee has been examining medical ghostwriting for the past year. The practice involves having review articles, editorials, and research papers drafted by marketing or medical-education companies, with prominent or academically affiliated physicians adding their names to the paper late in the process. As Grassley's letter notes, these physicians sign on despite a minimal contribution to the paper or even knowledge of the article's contents, including the underlying data and relevant documentation.
There are concerns that "some medical literature may be little more than subtle advertisements rather than independent research," writes Grassley. With these articles then having an impact on physicians' prescribing habits and the subsequent cost to the American taxpayer through Medicare and Medicaid programs, any attempt to manipulate the scientific literature is troubling, he adds.
In April 2008, Dr Harlan Krumholz (Yale University School of Medicine, New Haven, CT), along with lead investigator Dr Joseph Ross (Mount Sinai School of Medicine, New York, NY), reported evidence of Merck employees preparing manuscripts, sometimes in collaboration with medical publishing companies, and then recruiting academic physicians to be the first authors [2]. The paper, published in the Journal of the American Medical Association, offered a glimpse into the behind-the-scenes influence of industry.
"What I would like to see is a clear and explicit statement from the journals that if there is a circumstance where there is found to be ghostwriting, there would be some significant consequences," Krumholz told heartwire this week. "If a bunch of journals banded together and said if we find incontrovertible evidence of ghostwriting, and there would have to be some process for making that distinction, then that person would be banned from publishing."
Full Disclosure
In his letter, Grassley asks the eight journals their position regarding the practice of ghostwriting, specifically if they have any written policies in place. In addition, he asks if the author is required to disclose the involvement of drug, device, or medical-education and/or marketing companies in the drafting of the article and how these relationships are disclosed to the public. Finally, Grassley asks the journals if they have taken action against an author for failing to disclose outside involvement with the drafting of a manuscript.
The journals have until July 22, 2009 to respond to the senator's questions.
Krumholz said that while defining ghostwriting might be open to some interpretation, the journals should aim for full disclosure of who was involved in the drafting of the manuscript and zero tolerance for failing to do so.
"The litigation has shown that people are approached, drafts are written, and they do some light editing, and it goes out under their name," he said. "It's not disclosed that this occurred." Full disclosure wouldn't preclude even heavy assistance from others or from medical writing companies, he added, but those involved need to be up front about their roles and the roles of third parties.
The issue of authorship has been in the news lately, including on heartwire , with allegations arising from a class-action lawsuit in Australia that prominent cardiologist Dr Marvin Konstam (Tufts University Medical Center, Boston, MA) did not significantly contribute to a 2001 rofecoxib (Vioxx, Merck) meta-analysis in Circulation [3]. Merck denied adding Konstam's name to the manuscript late in the process, with a Merck spokesperson telling heartwire that Konstam was involved in the design and authorship of the study and is considered an appropriate author. Konstam has also denied allegations of not being significantly involved in the study.
Contacted by heartwire , media spokespeople at the Annals of Internal Medicine and the New England Journal of Medicine said they are in the process of responding to Grassley's questions, and both directed inquiries regarding their policies of ghostwriting to their journal's websites. The Annals of Internal Medicine, for example, states that "authorship implies accountability," but also that "medical writers and industry employees can be legitimate contributors" as long as their roles, affiliations, and potential conflicts of interest are described in the submitted manuscript.
The New England Journal of Medicine requires all authors to attest to their contribution to the study, with an author defined by the International Committee of Medical Journal Editors (ICMJE). The ICMJE states that an authorship credit is based on substantial contributions to the conception and design of the study, the acquisition of data, or analysis and interpretation of the data. It should also be based on drafting the manuscript or critically revising it for intellectual content and should involve a final approval before publication.
Krumholz, who serves as editor of Circulation: Cardiovascular Quality and Outcomes, pointed out that the revenue generated from reprints of journal articles also places the journals in a compromised position. "It's another conflict of interest on the journal's part, because you're going to make a lot of money by publishing those articles," he said. "Not only has the company ghostwritten them but they're going to buy a lot of reprints to pass out."
Source
