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Opinion: Ghost Writing is Fraudulent

A legal remedy is needed to curb unethical “guest authorship” in medical journals.

By | November 2, 2011

WIKIMEDIA COMMONS, GUILLAUME CARELS

In August, we proposed, in an article in PLoS Medicine, that medical “guest writers” might be sued for fraud. For some time, commentators have called for sanctions against academic doctors who agree to sign their names to articles that are planned and developed by medical writing companies and pharmaceutical manufacturers.  Some have even called these practices fraudulent, but have not confronted the legal difficulties with that approach—namely that the grounds for fraud are hard to establish: those who have been harmed by the drugs (the patients) are unlikely to have read the article, and therefore cannot claim to have believed that the “guest” was the true author, while the doctors who found the article persuasive are unlikely to have used the drug themselves.

We argue that the readers of medical journals are also victims. The value of their subscription is diminished when the editors unwittingly publish articles signed by guest writers who falsely claim to be the author. This violates the journal’s publication requirements, making the articles themselves fraudulent. We also argue that when the pharmaceutical sponsors use these articles to defend themselves in lawsuits (for example, to prove a drug’s safety), that effort should be treated as a fraud on the court, resulting in a verdict in favor of the opposing party.

Some researchers worry that allowing lawyers to interfere with a problem of medical ethics will only make matters worse, and that the issue of “guest writers” might better be handled by the journals themselves or licensing organizations such as the American Medical Association. However, we recommend a legal solution precisely because no one within the community of biomedical researchers and publishers has dealt effectively with this problem. Universities, licensing organizations, and medical journals have only just begun creating effective sanctions, and most have yet to implement them. These organizations have divided loyalties and are reluctant to punish prestigious doctors who otherwise reflect credit on the institution and often help impress donors.

Thus, the only way to solve that problem is from the outside. The climate for disinterested research is already endangered, and an effective sanction, if one can be found, is needed to preserve the integrity of biomedical publishing. The threat of legal liability may not be the only solution, but it has the virtue of speaking a language that most guest writers will readily understand.

Others have said that “fraud” is too harsh a term for the authorship practices we discuss. We rely on the legal definition of fraud, which involves making knowingly false statements to secure a benefit from someone else. In the context of medical authorship, this is not merely a technical application of the term. Guest authors are sometimes paid for their signature, and are always rewarded in the coin of prestige. More publications in good journals can translate into conference invitations, pay raises, and grants—and that is a primary reason why academic doctors agree to let their names be used.

A pending lawsuit against Donald Trump raises similar fraud claims, alleging that he was paid for the use of his name to market a condominium community when he had nothing to do with its development. The academic rewards are sometimes less direct, but the process is essentially the same. Our proposal draws on the Racketeer Influenced and Corrupt Organizations Act (RICO), which was originally created to combat racketeering in organized crime. Since its inception, the RICO Act has also been used in many other contexts, involving alleged conspiracies or intimidation by groups such as anti-abortion protestors and cigarette manufacturers. We propose that the principles outlined in RICO could also be applied to the problem of fraudulent authorship in medical journals, and if enforced, could make potential “guest writers” think twice before allowing their names to be used.

Simon Stern is Assistant Professor on the Faculty of Law, University of Toronto. Trudo Lemmens is Associate Professor on the Faculty of Law and the Faculty of Medicine, University of Toronto.

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Avatar of: nodrogg

nodrogg

Posts: 1

November 2, 2011

The grey area here is CME, which in many circumstances is equivalent to publication in a peer-reviewed journal. In some CME, the named author did, in fact, write the article with their name on it. In other CME, the author may have simply reviewed and commented on a "ghost" author's work. Importantly, even if the funding for the CME is from Big Pharma, the ACCME rules strictly prohibit *any* influencing of the content by the funder (ie, the funder does not review, comment, approve, or in any way interact with the development of the education other than paying for it in the first place). In my experience in CME, this is actually the case. So, if you have a CME program that is funded by pharma, but without overt direction from pharma; peer reviewed; written by an unknown but reviewed, commented on, and approved by the person who was paid to have their name is on it.....is it accurately described as "unethical" or "fraud"? (Disclaimer: I work in CME but my opinion is my own, not that of my employer.)

Avatar of: barrypless

barrypless

Posts: 1

November 2, 2011

I agree entirely with the thrust of this piece. There is another element that needs more attention: deception. If anyone who has helped substantially with the writing of a piece is not acknowledged, the reviewers and ultimately, the readers will attribute the elegant, unblemished prose to the authors. This is not a trivial issue if promotion committees and the like are asked to examine an applicant's 'five best papers'. Consider the reverse: when a paper filled with grammatical errors is published, the wise reader and reviewer will have reason to suspect indifference or carelessness and could reasonably ask whether the same applied to the collection and analysis of the data. 

Avatar of: PhilAgEd

PhilAgEd

Posts: 3

November 2, 2011

The inherent fraud in this practice is the authorial claim resulting from a person's name being presented at the start of an article who has not written the article and/or not done the research. The fraud could be minor or nonexistent: I did the research but paid someone else to write it up; moderate: I was part of a group that did the research, did not write it up, and trust that everyone who has participated has been forthright in his or her reporting of data; or severe: I lent my name to a paper research about which I have no intimate knowledge, knowing that my name might make the difference between the paper's being published or not.

A good test is this: would I want a paper to be the basis of a significant proposal to a granting agency if it had not been written by, or its research done by, the putative author?

Avatar of: primativewriter

primativewriter

Posts: 22

November 2, 2011

Please, I have helped in research and at work and done my own, the credit grabbing, idea stealing "professional" people I have seen, wow. Kids on the street with guns are more honest. It noce to see some one try and address it though.  

Avatar of: john salerno

john salerno

Posts: 24

November 2, 2011

I think some distinction has to be made between people who haven't done the work or written a draft of the paper, and people who did the work and wrote a draft that needs cleanup because English isn't their first language. That is what editors do: edit. I don't think there is anything dishonest about this. I disagree with barryples about the importance of being able to generate 'elegant, unblemished prose', and I also take issue with the idea that there is a correlation between grammatical errors and other non-scientific trivial mistakes and scientific quality. I think the reverse is true, and that we now have an over-emphasis on production quality. Take a good look at the figures from top journals from the 1960s; the quality of the figures would never be tolerated in the electronic age, but the effect on science of the new standards is negligible. If you carry barryples's line of reasoning to its logical conclusion, only native English speakers can be first rate scientists, and the 'wise' reader will understand that those with less than perfect command of articles and tenses must somehow be slipshod in their methods. Do you really think that editors and reviewers should be acknowledged? How?  

Avatar of: Pharmfresheggs

Pharmfresheggs

Posts: 4

November 2, 2011

I'd guess that Sterm and Lemmens would be happy to serve as expert witnesses in the trials that might result from implementation of this scheme. But that's not a conflict, right? Can someone do a little homework/research on this? Things have changed substantially in the past 10 years. Pharma are very sensitized to this issue and the companies that provide writing services must adhere to good publication practices that involve authors from the very beginning of the publication development process, with the writing assistance and sponsorship of the company acknowledged. How many phase III trial reports are actually written by the listed authors? Very few. How many articles in the New England Journal of Medicine are actually written by the listed authors? Not as many as you would think. If we wanted to do something impactful to improve the quality of the medical literature, then we should shun the third-tier journals that publish most of the garbage review articles that are a dime a dozen. It may not matter, however, as the internet is making access to quality publications easier, and the paradigm is shifting to quality over quantity. There are still pharma that pump out the articles with the help of complicit agencies and third-tier journals that are happy to take their money, but increasingly that's being seen as a waste of resources.

Avatar of: rameshraghuvanshi

rameshraghuvanshi

Posts: 20

November 2, 2011

Ghost writing always fraud but how can we prevent it.From very begging  publicity monger politicians, businessmen and many others take help of ghost writers. Even in middle age King lords and many celebrates took help of ghost writer.After all this practice unethical but how to prevent it is problem.

Avatar of: Brian Hanley

Brian Hanley

Posts: 66

November 2, 2011

There needs to be general reform, not just in this very minor area.

Plagiarism needs legal sanctions. It's rampant. Thousands of near duplicate articles have been found submitted by authors who didn't even bother to change the abstract! God knows how many much more cleverly plagiarized duplicates are out there.

Deliberate falsification of studies needs legal sanctions. Today, it's virtually all upside, and at worst a slap on the wrist from NIH. (viz. the recent exposure of a physician who founded a new sub-field within anesthesiology, became a near 20 year golden boy. He was found to have never done a single study he claimed he had done. Not a one.)

Legal sanctions on universities that fail to properly police academic fraud. This also is rampant. Universities are hugely motivated to cover up problems. Universities receive huge amounts of revenue from federal research grants. It is incredibly time consuming  for anyone, be they a professor or a graduate student, to report and pursue such. And nobody cares. So this needs to be administered from outside the NIH system.

The NIH 6 year "statute of limitations" needs to be lifted. The case of the midwife toad wouldn't have been dealt with under current rules. Scientists are good record keepers.

Avatar of: FJScientist

FJScientist

Posts: 52

November 2, 2011

Disclosure of anything that even can be perceived as a potential conflict of interest has been a worthwhile (in my opinion) trend in science writing over the past decade. This has included the practice of disclosing ghost writers hired by a company that, in many instances, are not even listed as authors. Most reputable journals today prohibit this practice. At a minimum, doing so against journal policy constitutes a breach of contract of the listed authors with the journal. This does not indict the practice of having an industry-sponsored person assist in the writing and paying the lead author. It just states that the readership needs full disclosure when evaluating the manuscript. 

The overarching question here is intent. If a manuscript were submitted and accepted but only if disclosure of the ghost authors were demanded, would the lead author and/or the sponsoring entity pull the submission? Legal fraud similarly revolves around the intent to mislead. If not disclosed and an element of bias has indeed been introduced into the published literature, damage is done to the journal's reputation, to others whose careers are overlooked in favour of the authors, to others (and to society in general) who base their research on the published information and, in the most extreme cases, to patients whose treatment may be based on an overly enthusiastic interpretation of the research. The major point remains that, for a variety of reasons, a ghost writer is requested to be disclosed by most journal policies and failure to do so contravenes those policies.

Note that, under this narrow understanding, it is the listed authors who are fraudulent when attesting to the journal that all conflicts of interest have been disclosed. This approach is more easily enforced. Journals have limited resources and have zero funds for legal proceedings, particularly against deep-pocketed multi-national firms. However, journals have in place sceintific misconduct policies in which the offense is referred to the authors' institutions for further evaluation and, if warranted, punishment. Realistically, this is the action that can be most highly pursued in ridding the literature of reports that do not reveal elements that may have impacted the readerships' perception of research quality. It does rely on action by the institutions. As one other commenter also noted, the perception that such practices are unethical has been rapidly adopted in the past decade and such offenses are more likely to be pursued now. 

Avatar of: TDB2011

TDB2011

Posts: 4

November 2, 2011

We're making a "mountain out of a molehill" here. As a ghost-writer myself, it's my job to simply craft a well-written, logically organized, grammatically correct review of the research done -- NOT to do the research myself! Many top academic physicians obviously have other priorities (eg, caring for their patients!) than writing up a summation of their work, which can be a tedious, time-consuming exercise.

Bottom line: when uncredited ghost-writers start doing original research, then we have cause for worry. Right now, the only reform I'd support is to include ghost writers in the author list, accompanied by full financial disclosure. 

Avatar of: FJScientist

FJScientist

Posts: 52

November 2, 2011

Hi TBD2011,

What you are describing is a job in which you are hired by the researcher as an editor or as a critical reviewer of a draft of a manuscript created by the researcher or as a writer providing a first draft of the results of a researcher's original research. The concern is not with that practice although in the latter case, I would certainly argue that you should be considered as an author.

The concern is about persons hired by a company to write (often) a review manuscript about a product by that company. The concern is the extent to which data is hand-picked to meet the company's financial goals. The draft is then provided to the researcher who edits and signs his/her name to it. The purpose and conclusions are well-formulated by company-hired persons who are not even listed as authors and who have a potential conflict of interest. The manuscript is essentially in a finished format before the "author" is even approached. That must be disclosed.

Avatar of:

Posts: 0

November 2, 2011

The grey area here is CME, which in many circumstances is equivalent to publication in a peer-reviewed journal. In some CME, the named author did, in fact, write the article with their name on it. In other CME, the author may have simply reviewed and commented on a "ghost" author's work. Importantly, even if the funding for the CME is from Big Pharma, the ACCME rules strictly prohibit *any* influencing of the content by the funder (ie, the funder does not review, comment, approve, or in any way interact with the development of the education other than paying for it in the first place). In my experience in CME, this is actually the case. So, if you have a CME program that is funded by pharma, but without overt direction from pharma; peer reviewed; written by an unknown but reviewed, commented on, and approved by the person who was paid to have their name is on it.....is it accurately described as "unethical" or "fraud"? (Disclaimer: I work in CME but my opinion is my own, not that of my employer.)

Avatar of:

Posts: 0

November 2, 2011

I agree entirely with the thrust of this piece. There is another element that needs more attention: deception. If anyone who has helped substantially with the writing of a piece is not acknowledged, the reviewers and ultimately, the readers will attribute the elegant, unblemished prose to the authors. This is not a trivial issue if promotion committees and the like are asked to examine an applicant's 'five best papers'. Consider the reverse: when a paper filled with grammatical errors is published, the wise reader and reviewer will have reason to suspect indifference or carelessness and could reasonably ask whether the same applied to the collection and analysis of the data. 

Avatar of:

Posts: 0

November 2, 2011

The inherent fraud in this practice is the authorial claim resulting from a person's name being presented at the start of an article who has not written the article and/or not done the research. The fraud could be minor or nonexistent: I did the research but paid someone else to write it up; moderate: I was part of a group that did the research, did not write it up, and trust that everyone who has participated has been forthright in his or her reporting of data; or severe: I lent my name to a paper research about which I have no intimate knowledge, knowing that my name might make the difference between the paper's being published or not.

A good test is this: would I want a paper to be the basis of a significant proposal to a granting agency if it had not been written by, or its research done by, the putative author?

Avatar of:

Posts: 0

November 2, 2011

Please, I have helped in research and at work and done my own, the credit grabbing, idea stealing "professional" people I have seen, wow. Kids on the street with guns are more honest. It noce to see some one try and address it though.  

Avatar of:

Posts: 0

November 2, 2011

I think some distinction has to be made between people who haven't done the work or written a draft of the paper, and people who did the work and wrote a draft that needs cleanup because English isn't their first language. That is what editors do: edit. I don't think there is anything dishonest about this. I disagree with barryples about the importance of being able to generate 'elegant, unblemished prose', and I also take issue with the idea that there is a correlation between grammatical errors and other non-scientific trivial mistakes and scientific quality. I think the reverse is true, and that we now have an over-emphasis on production quality. Take a good look at the figures from top journals from the 1960s; the quality of the figures would never be tolerated in the electronic age, but the effect on science of the new standards is negligible. If you carry barryples's line of reasoning to its logical conclusion, only native English speakers can be first rate scientists, and the 'wise' reader will understand that those with less than perfect command of articles and tenses must somehow be slipshod in their methods. Do you really think that editors and reviewers should be acknowledged? How?  

Avatar of:

Posts: 0

November 2, 2011

I'd guess that Sterm and Lemmens would be happy to serve as expert witnesses in the trials that might result from implementation of this scheme. But that's not a conflict, right? Can someone do a little homework/research on this? Things have changed substantially in the past 10 years. Pharma are very sensitized to this issue and the companies that provide writing services must adhere to good publication practices that involve authors from the very beginning of the publication development process, with the writing assistance and sponsorship of the company acknowledged. How many phase III trial reports are actually written by the listed authors? Very few. How many articles in the New England Journal of Medicine are actually written by the listed authors? Not as many as you would think. If we wanted to do something impactful to improve the quality of the medical literature, then we should shun the third-tier journals that publish most of the garbage review articles that are a dime a dozen. It may not matter, however, as the internet is making access to quality publications easier, and the paradigm is shifting to quality over quantity. There are still pharma that pump out the articles with the help of complicit agencies and third-tier journals that are happy to take their money, but increasingly that's being seen as a waste of resources.

Avatar of:

Posts: 0

November 2, 2011

Ghost writing always fraud but how can we prevent it.From very begging  publicity monger politicians, businessmen and many others take help of ghost writers. Even in middle age King lords and many celebrates took help of ghost writer.After all this practice unethical but how to prevent it is problem.

Avatar of:

Posts: 0

November 2, 2011

There needs to be general reform, not just in this very minor area.

Plagiarism needs legal sanctions. It's rampant. Thousands of near duplicate articles have been found submitted by authors who didn't even bother to change the abstract! God knows how many much more cleverly plagiarized duplicates are out there.

Deliberate falsification of studies needs legal sanctions. Today, it's virtually all upside, and at worst a slap on the wrist from NIH. (viz. the recent exposure of a physician who founded a new sub-field within anesthesiology, became a near 20 year golden boy. He was found to have never done a single study he claimed he had done. Not a one.)

Legal sanctions on universities that fail to properly police academic fraud. This also is rampant. Universities are hugely motivated to cover up problems. Universities receive huge amounts of revenue from federal research grants. It is incredibly time consuming  for anyone, be they a professor or a graduate student, to report and pursue such. And nobody cares. So this needs to be administered from outside the NIH system.

The NIH 6 year "statute of limitations" needs to be lifted. The case of the midwife toad wouldn't have been dealt with under current rules. Scientists are good record keepers.

Avatar of:

Posts: 0

November 2, 2011

Disclosure of anything that even can be perceived as a potential conflict of interest has been a worthwhile (in my opinion) trend in science writing over the past decade. This has included the practice of disclosing ghost writers hired by a company that, in many instances, are not even listed as authors. Most reputable journals today prohibit this practice. At a minimum, doing so against journal policy constitutes a breach of contract of the listed authors with the journal. This does not indict the practice of having an industry-sponsored person assist in the writing and paying the lead author. It just states that the readership needs full disclosure when evaluating the manuscript. 

The overarching question here is intent. If a manuscript were submitted and accepted but only if disclosure of the ghost authors were demanded, would the lead author and/or the sponsoring entity pull the submission? Legal fraud similarly revolves around the intent to mislead. If not disclosed and an element of bias has indeed been introduced into the published literature, damage is done to the journal's reputation, to others whose careers are overlooked in favour of the authors, to others (and to society in general) who base their research on the published information and, in the most extreme cases, to patients whose treatment may be based on an overly enthusiastic interpretation of the research. The major point remains that, for a variety of reasons, a ghost writer is requested to be disclosed by most journal policies and failure to do so contravenes those policies.

Note that, under this narrow understanding, it is the listed authors who are fraudulent when attesting to the journal that all conflicts of interest have been disclosed. This approach is more easily enforced. Journals have limited resources and have zero funds for legal proceedings, particularly against deep-pocketed multi-national firms. However, journals have in place sceintific misconduct policies in which the offense is referred to the authors' institutions for further evaluation and, if warranted, punishment. Realistically, this is the action that can be most highly pursued in ridding the literature of reports that do not reveal elements that may have impacted the readerships' perception of research quality. It does rely on action by the institutions. As one other commenter also noted, the perception that such practices are unethical has been rapidly adopted in the past decade and such offenses are more likely to be pursued now. 

Avatar of:

Posts: 0

November 2, 2011

We're making a "mountain out of a molehill" here. As a ghost-writer myself, it's my job to simply craft a well-written, logically organized, grammatically correct review of the research done -- NOT to do the research myself! Many top academic physicians obviously have other priorities (eg, caring for their patients!) than writing up a summation of their work, which can be a tedious, time-consuming exercise.

Bottom line: when uncredited ghost-writers start doing original research, then we have cause for worry. Right now, the only reform I'd support is to include ghost writers in the author list, accompanied by full financial disclosure. 

Avatar of:

Posts: 0

November 2, 2011

Hi TBD2011,

What you are describing is a job in which you are hired by the researcher as an editor or as a critical reviewer of a draft of a manuscript created by the researcher or as a writer providing a first draft of the results of a researcher's original research. The concern is not with that practice although in the latter case, I would certainly argue that you should be considered as an author.

The concern is about persons hired by a company to write (often) a review manuscript about a product by that company. The concern is the extent to which data is hand-picked to meet the company's financial goals. The draft is then provided to the researcher who edits and signs his/her name to it. The purpose and conclusions are well-formulated by company-hired persons who are not even listed as authors and who have a potential conflict of interest. The manuscript is essentially in a finished format before the "author" is even approached. That must be disclosed.

Avatar of:

Posts: 0

November 2, 2011

The grey area here is CME, which in many circumstances is equivalent to publication in a peer-reviewed journal. In some CME, the named author did, in fact, write the article with their name on it. In other CME, the author may have simply reviewed and commented on a "ghost" author's work. Importantly, even if the funding for the CME is from Big Pharma, the ACCME rules strictly prohibit *any* influencing of the content by the funder (ie, the funder does not review, comment, approve, or in any way interact with the development of the education other than paying for it in the first place). In my experience in CME, this is actually the case. So, if you have a CME program that is funded by pharma, but without overt direction from pharma; peer reviewed; written by an unknown but reviewed, commented on, and approved by the person who was paid to have their name is on it.....is it accurately described as "unethical" or "fraud"? (Disclaimer: I work in CME but my opinion is my own, not that of my employer.)

Avatar of:

Posts: 0

November 2, 2011

I agree entirely with the thrust of this piece. There is another element that needs more attention: deception. If anyone who has helped substantially with the writing of a piece is not acknowledged, the reviewers and ultimately, the readers will attribute the elegant, unblemished prose to the authors. This is not a trivial issue if promotion committees and the like are asked to examine an applicant's 'five best papers'. Consider the reverse: when a paper filled with grammatical errors is published, the wise reader and reviewer will have reason to suspect indifference or carelessness and could reasonably ask whether the same applied to the collection and analysis of the data. 

Avatar of:

Posts: 0

November 2, 2011

The inherent fraud in this practice is the authorial claim resulting from a person's name being presented at the start of an article who has not written the article and/or not done the research. The fraud could be minor or nonexistent: I did the research but paid someone else to write it up; moderate: I was part of a group that did the research, did not write it up, and trust that everyone who has participated has been forthright in his or her reporting of data; or severe: I lent my name to a paper research about which I have no intimate knowledge, knowing that my name might make the difference between the paper's being published or not.

A good test is this: would I want a paper to be the basis of a significant proposal to a granting agency if it had not been written by, or its research done by, the putative author?

Avatar of:

Posts: 0

November 2, 2011

Please, I have helped in research and at work and done my own, the credit grabbing, idea stealing "professional" people I have seen, wow. Kids on the street with guns are more honest. It noce to see some one try and address it though.  

Avatar of:

Posts: 0

November 2, 2011

I think some distinction has to be made between people who haven't done the work or written a draft of the paper, and people who did the work and wrote a draft that needs cleanup because English isn't their first language. That is what editors do: edit. I don't think there is anything dishonest about this. I disagree with barryples about the importance of being able to generate 'elegant, unblemished prose', and I also take issue with the idea that there is a correlation between grammatical errors and other non-scientific trivial mistakes and scientific quality. I think the reverse is true, and that we now have an over-emphasis on production quality. Take a good look at the figures from top journals from the 1960s; the quality of the figures would never be tolerated in the electronic age, but the effect on science of the new standards is negligible. If you carry barryples's line of reasoning to its logical conclusion, only native English speakers can be first rate scientists, and the 'wise' reader will understand that those with less than perfect command of articles and tenses must somehow be slipshod in their methods. Do you really think that editors and reviewers should be acknowledged? How?  

Avatar of:

Posts: 0

November 2, 2011

I'd guess that Sterm and Lemmens would be happy to serve as expert witnesses in the trials that might result from implementation of this scheme. But that's not a conflict, right? Can someone do a little homework/research on this? Things have changed substantially in the past 10 years. Pharma are very sensitized to this issue and the companies that provide writing services must adhere to good publication practices that involve authors from the very beginning of the publication development process, with the writing assistance and sponsorship of the company acknowledged. How many phase III trial reports are actually written by the listed authors? Very few. How many articles in the New England Journal of Medicine are actually written by the listed authors? Not as many as you would think. If we wanted to do something impactful to improve the quality of the medical literature, then we should shun the third-tier journals that publish most of the garbage review articles that are a dime a dozen. It may not matter, however, as the internet is making access to quality publications easier, and the paradigm is shifting to quality over quantity. There are still pharma that pump out the articles with the help of complicit agencies and third-tier journals that are happy to take their money, but increasingly that's being seen as a waste of resources.

Avatar of:

Posts: 0

November 2, 2011

Ghost writing always fraud but how can we prevent it.From very begging  publicity monger politicians, businessmen and many others take help of ghost writers. Even in middle age King lords and many celebrates took help of ghost writer.After all this practice unethical but how to prevent it is problem.

Avatar of:

Posts: 0

November 2, 2011

There needs to be general reform, not just in this very minor area.

Plagiarism needs legal sanctions. It's rampant. Thousands of near duplicate articles have been found submitted by authors who didn't even bother to change the abstract! God knows how many much more cleverly plagiarized duplicates are out there.

Deliberate falsification of studies needs legal sanctions. Today, it's virtually all upside, and at worst a slap on the wrist from NIH. (viz. the recent exposure of a physician who founded a new sub-field within anesthesiology, became a near 20 year golden boy. He was found to have never done a single study he claimed he had done. Not a one.)

Legal sanctions on universities that fail to properly police academic fraud. This also is rampant. Universities are hugely motivated to cover up problems. Universities receive huge amounts of revenue from federal research grants. It is incredibly time consuming  for anyone, be they a professor or a graduate student, to report and pursue such. And nobody cares. So this needs to be administered from outside the NIH system.

The NIH 6 year "statute of limitations" needs to be lifted. The case of the midwife toad wouldn't have been dealt with under current rules. Scientists are good record keepers.

Avatar of:

Posts: 0

November 2, 2011

Disclosure of anything that even can be perceived as a potential conflict of interest has been a worthwhile (in my opinion) trend in science writing over the past decade. This has included the practice of disclosing ghost writers hired by a company that, in many instances, are not even listed as authors. Most reputable journals today prohibit this practice. At a minimum, doing so against journal policy constitutes a breach of contract of the listed authors with the journal. This does not indict the practice of having an industry-sponsored person assist in the writing and paying the lead author. It just states that the readership needs full disclosure when evaluating the manuscript. 

The overarching question here is intent. If a manuscript were submitted and accepted but only if disclosure of the ghost authors were demanded, would the lead author and/or the sponsoring entity pull the submission? Legal fraud similarly revolves around the intent to mislead. If not disclosed and an element of bias has indeed been introduced into the published literature, damage is done to the journal's reputation, to others whose careers are overlooked in favour of the authors, to others (and to society in general) who base their research on the published information and, in the most extreme cases, to patients whose treatment may be based on an overly enthusiastic interpretation of the research. The major point remains that, for a variety of reasons, a ghost writer is requested to be disclosed by most journal policies and failure to do so contravenes those policies.

Note that, under this narrow understanding, it is the listed authors who are fraudulent when attesting to the journal that all conflicts of interest have been disclosed. This approach is more easily enforced. Journals have limited resources and have zero funds for legal proceedings, particularly against deep-pocketed multi-national firms. However, journals have in place sceintific misconduct policies in which the offense is referred to the authors' institutions for further evaluation and, if warranted, punishment. Realistically, this is the action that can be most highly pursued in ridding the literature of reports that do not reveal elements that may have impacted the readerships' perception of research quality. It does rely on action by the institutions. As one other commenter also noted, the perception that such practices are unethical has been rapidly adopted in the past decade and such offenses are more likely to be pursued now. 

Avatar of:

Posts: 0

November 2, 2011

We're making a "mountain out of a molehill" here. As a ghost-writer myself, it's my job to simply craft a well-written, logically organized, grammatically correct review of the research done -- NOT to do the research myself! Many top academic physicians obviously have other priorities (eg, caring for their patients!) than writing up a summation of their work, which can be a tedious, time-consuming exercise.

Bottom line: when uncredited ghost-writers start doing original research, then we have cause for worry. Right now, the only reform I'd support is to include ghost writers in the author list, accompanied by full financial disclosure. 

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Posts: 0

November 2, 2011

Hi TBD2011,

What you are describing is a job in which you are hired by the researcher as an editor or as a critical reviewer of a draft of a manuscript created by the researcher or as a writer providing a first draft of the results of a researcher's original research. The concern is not with that practice although in the latter case, I would certainly argue that you should be considered as an author.

The concern is about persons hired by a company to write (often) a review manuscript about a product by that company. The concern is the extent to which data is hand-picked to meet the company's financial goals. The draft is then provided to the researcher who edits and signs his/her name to it. The purpose and conclusions are well-formulated by company-hired persons who are not even listed as authors and who have a potential conflict of interest. The manuscript is essentially in a finished format before the "author" is even approached. That must be disclosed.

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Posts: 0

November 3, 2011

FJ: I agree that disclosure of all participants is key and cherry picking data is anathema to a quality review (for any review, not just company-sponsored ones). I'm just not convinced this is a major issue with serious effects on patient outcomes. 

Avatar of:

Posts: 0

November 3, 2011

It isn't ghost writing that's the problem - it is the guest writers who commit fraud, together with the pharmaceutical companies that bribe them into doing this. By fronting as authors, guest writers assure the readers that the findings in the article are true.
This is a blatant lie. Guest authors have absolutely no idea what was done and what was found - they didn't participate in the studies that the article is supposedly based on. For all they know, the results they pass off as theirs may be complete fabrications.
Yet, guest authors help influence therapy with the claims in "their" articles, even though they haven't a clue whether or not these claims are true. This surely is serious fraud.

Avatar of:

Posts: 0

November 3, 2011

Perhaps even more disturbing than the very dated subject matter of this article, and the stilted view that is presented by the authors, is the fact that no mention is made of the ethical practices and standards that have been established over the past decade and more. Why is there no mention of any of the professional medical writing associations (eg, American Medical Writers Association [AMWA], EMWA [European Medical Writers Association])? What of the medical publication professionals of the International Society of Medical Publication Professionals (ISMPP)? Neither are there any references to the second iteration of the Good Publication Practice guidelines (GPP2 - http://www.gpp-guidelines.org/ ) published in 2009, the requirements of the International Committee of Medical Journal Editors (ICMJE - http://www.icmje.org/ethical_1... ), or the Committee on Publication Ethics (COPE - http://publicationethics.org/ )! As a professional medical writer and a former academic and later, pharmaceutical researcher, I take serious issue with this article and would encourage the authors and readers alike to research the subject matter more thoroughly before adopting such an alarmist viewpoint.

Avatar of:

Posts: 0

November 3, 2011

Ghostwriting is not always fraud. Your comment is important because it reflects a widely held misconception. From your prose it seems that you are not a native English speaker. It could be the case that a document that you wrote would not be published in an English journal without significant editing by others. Many use the help of colleagues, but many authors do not have that luxury and so hire professional editors/ghostwriters to help with the writing.

Perhaps you are a fantastic researcher or clinical scientist. A ghostwriter could help you, through a collaborative process, take your data and craft a publishable article. That writer may or may not be listed as an author or acknowledged. The level of disclosure depends on the extent of the ghostwriter's involvement. If the ghostwriter did not perform the research or contribute substantively to the intellectual development of the project or results, is it not also fraudulent to include them as an author?

Guest authorship, on the other hand, can be a real problem. If one accepts authorship yet has no control over content nor seeks input on content, that represents a form of fraud.

I advocate for greater transparency on the role of each author and contributor.

Avatar of:

Posts: 0

November 3, 2011

FJ: I agree that disclosure of all participants is key and cherry picking data is anathema to a quality review (for any review, not just company-sponsored ones). I'm just not convinced this is a major issue with serious effects on patient outcomes. 

Avatar of:

Posts: 0

November 3, 2011

It isn't ghost writing that's the problem - it is the guest writers who commit fraud, together with the pharmaceutical companies that bribe them into doing this. By fronting as authors, guest writers assure the readers that the findings in the article are true.
This is a blatant lie. Guest authors have absolutely no idea what was done and what was found - they didn't participate in the studies that the article is supposedly based on. For all they know, the results they pass off as theirs may be complete fabrications.
Yet, guest authors help influence therapy with the claims in "their" articles, even though they haven't a clue whether or not these claims are true. This surely is serious fraud.

Avatar of:

Posts: 0

November 3, 2011

Perhaps even more disturbing than the very dated subject matter of this article, and the stilted view that is presented by the authors, is the fact that no mention is made of the ethical practices and standards that have been established over the past decade and more. Why is there no mention of any of the professional medical writing associations (eg, American Medical Writers Association [AMWA], EMWA [European Medical Writers Association])? What of the medical publication professionals of the International Society of Medical Publication Professionals (ISMPP)? Neither are there any references to the second iteration of the Good Publication Practice guidelines (GPP2 - http://www.gpp-guidelines.org/ ) published in 2009, the requirements of the International Committee of Medical Journal Editors (ICMJE - http://www.icmje.org/ethical_1... ), or the Committee on Publication Ethics (COPE - http://publicationethics.org/ )! As a professional medical writer and a former academic and later, pharmaceutical researcher, I take serious issue with this article and would encourage the authors and readers alike to research the subject matter more thoroughly before adopting such an alarmist viewpoint.

Avatar of:

Posts: 0

November 3, 2011

Ghostwriting is not always fraud. Your comment is important because it reflects a widely held misconception. From your prose it seems that you are not a native English speaker. It could be the case that a document that you wrote would not be published in an English journal without significant editing by others. Many use the help of colleagues, but many authors do not have that luxury and so hire professional editors/ghostwriters to help with the writing.

Perhaps you are a fantastic researcher or clinical scientist. A ghostwriter could help you, through a collaborative process, take your data and craft a publishable article. That writer may or may not be listed as an author or acknowledged. The level of disclosure depends on the extent of the ghostwriter's involvement. If the ghostwriter did not perform the research or contribute substantively to the intellectual development of the project or results, is it not also fraudulent to include them as an author?

Guest authorship, on the other hand, can be a real problem. If one accepts authorship yet has no control over content nor seeks input on content, that represents a form of fraud.

I advocate for greater transparency on the role of each author and contributor.

Avatar of: TDB2011

TDB2011

Posts: 4

November 3, 2011

FJ: I agree that disclosure of all participants is key and cherry picking data is anathema to a quality review (for any review, not just company-sponsored ones). I'm just not convinced this is a major issue with serious effects on patient outcomes. 

Avatar of: hbeierbeck

hbeierbeck

Posts: 4

November 3, 2011

It isn't ghost writing that's the problem - it is the guest writers who commit fraud, together with the pharmaceutical companies that bribe them into doing this. By fronting as authors, guest writers assure the readers that the findings in the article are true.
This is a blatant lie. Guest authors have absolutely no idea what was done and what was found - they didn't participate in the studies that the article is supposedly based on. For all they know, the results they pass off as theirs may be complete fabrications.
Yet, guest authors help influence therapy with the claims in "their" articles, even though they haven't a clue whether or not these claims are true. This surely is serious fraud.

Avatar of: Brian

Brian

Posts: 1457

November 3, 2011

Perhaps even more disturbing than the very dated subject matter of this article, and the stilted view that is presented by the authors, is the fact that no mention is made of the ethical practices and standards that have been established over the past decade and more. Why is there no mention of any of the professional medical writing associations (eg, American Medical Writers Association [AMWA], EMWA [European Medical Writers Association])? What of the medical publication professionals of the International Society of Medical Publication Professionals (ISMPP)? Neither are there any references to the second iteration of the Good Publication Practice guidelines (GPP2 - http://www.gpp-guidelines.org/ ) published in 2009, the requirements of the International Committee of Medical Journal Editors (ICMJE - http://www.icmje.org/ethical_1... ), or the Committee on Publication Ethics (COPE - http://publicationethics.org/ )! As a professional medical writer and a former academic and later, pharmaceutical researcher, I take serious issue with this article and would encourage the authors and readers alike to research the subject matter more thoroughly before adopting such an alarmist viewpoint.

Avatar of: Michael Sapko

Michael Sapko

Posts: 1

November 3, 2011

Ghostwriting is not always fraud. Your comment is important because it reflects a widely held misconception. From your prose it seems that you are not a native English speaker. It could be the case that a document that you wrote would not be published in an English journal without significant editing by others. Many use the help of colleagues, but many authors do not have that luxury and so hire professional editors/ghostwriters to help with the writing.

Perhaps you are a fantastic researcher or clinical scientist. A ghostwriter could help you, through a collaborative process, take your data and craft a publishable article. That writer may or may not be listed as an author or acknowledged. The level of disclosure depends on the extent of the ghostwriter's involvement. If the ghostwriter did not perform the research or contribute substantively to the intellectual development of the project or results, is it not also fraudulent to include them as an author?

Guest authorship, on the other hand, can be a real problem. If one accepts authorship yet has no control over content nor seeks input on content, that represents a form of fraud.

I advocate for greater transparency on the role of each author and contributor.

Avatar of: alansmithdc

alansmithdc

Posts: 2

November 4, 2011

met two pharmaceutical reps in a bar who were traveling the country collecting in office data on a new drugs.  They were sitting in the bar, just making up the data to fill out the paperwork, all the while getting drunk.  8 months later, their data appeared in a prestigious medical journal.

Avatar of: alansmithdc

alansmithdc

Posts: 2

November 4, 2011

I met two pharmaceutical reps in a bar who were traveling the country
collecting in-medical office data on a new drug.  They were sitting in the bar,
just making up the data to fill out the paperwork, all the while
getting drunk, (because "they wanted to drink dude rather than travel to these po dunk towns"). 8 months later, their data appeared in a prestigious medical journal.

Avatar of:

Posts: 0

November 4, 2011

met two pharmaceutical reps in a bar who were traveling the country collecting in office data on a new drugs.  They were sitting in the bar, just making up the data to fill out the paperwork, all the while getting drunk.  8 months later, their data appeared in a prestigious medical journal.

Avatar of:

Posts: 0

November 4, 2011

I met two pharmaceutical reps in a bar who were traveling the country
collecting in-medical office data on a new drug.  They were sitting in the bar,
just making up the data to fill out the paperwork, all the while
getting drunk, (because "they wanted to drink dude rather than travel to these po dunk towns"). 8 months later, their data appeared in a prestigious medical journal.

Avatar of:

Posts: 0

November 4, 2011

met two pharmaceutical reps in a bar who were traveling the country collecting in office data on a new drugs.  They were sitting in the bar, just making up the data to fill out the paperwork, all the while getting drunk.  8 months later, their data appeared in a prestigious medical journal.

Avatar of:

Posts: 0

November 4, 2011

I met two pharmaceutical reps in a bar who were traveling the country
collecting in-medical office data on a new drug.  They were sitting in the bar,
just making up the data to fill out the paperwork, all the while
getting drunk, (because "they wanted to drink dude rather than travel to these po dunk towns"). 8 months later, their data appeared in a prestigious medical journal.

Avatar of:

Posts: 0

November 5, 2011

As if the courts didn't have enough to do.

Avatar of:

Posts: 0

November 5, 2011

As if the courts didn't have enough to do.

Avatar of: Mary Wilbur

Mary Wilbur

Posts: 1

November 5, 2011

As if the courts didn't have enough to do.

Avatar of: RobertD

RobertD

Posts: 1457

November 9, 2011

Bear in mind that this article is written by two law professors, and reads like a legal brief presented at moot court.  A good legal analysis of a problem will delve down to smallest detail of law, but when you seriously invoke a suit against Donald Trump for gratuitous use of his name and propose a RICO law concerning reputation, it's time to step away from the law books!    :)

Avatar of:

Posts: 0

November 9, 2011

Bear in mind that this article is written by two law professors, and reads like a legal brief presented at moot court.  A good legal analysis of a problem will delve down to smallest detail of law, but when you seriously invoke a suit against Donald Trump for gratuitous use of his name and propose a RICO law concerning reputation, it's time to step away from the law books!    :)

Avatar of:

Posts: 0

November 9, 2011

Bear in mind that this article is written by two law professors, and reads like a legal brief presented at moot court.  A good legal analysis of a problem will delve down to smallest detail of law, but when you seriously invoke a suit against Donald Trump for gratuitous use of his name and propose a RICO law concerning reputation, it's time to step away from the law books!    :)

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