Grassley Presses Medical Schools On Ghostwriting

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ghostThis is the thinking - if a college student submits a paper written by someone else, it’s considered plagiarism. But what is it called when an academic researcher submits a journal study that was written, shaped or heavily edited by a medical communications firm? Grassley contends there is little or no difference.

And so the Iowa Republican, who sits on the Senate Finance Committee and has spearheaded numerous investigations into the drug and device industries, has written 10 top medical schools to ask what they’re doing about the issue, The New York Times reports. The schools contacted: Harvard, Johns Hopkins, University of Pennsylvania, Washington University, University of California at San Francisco, Duke, Stanford, University of Washington, Yale and Columbia.

In explaining his actions, Grassley contends that ghostwriting hurts patients and raises costs for taxpayers because prestigious academic names are used to promote products that might be expensive or less effective than viable alternatives, the Times writes. “Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling,” Grassley wrote the schools, according to the paper.

Art Caplan, who heads Penn’s Center for Bioethics, tells the Times there is a difference in degree, if not in kind, between ghostwriting and plagiarism. Academics who sign ghostwritten papers for research credit usually have some agreement, he says, even if, improperly, they did not write it. Students who plagiarize a paper may know nothing about the subject. “They’re related. I wouldn’t say they’re twins, but they’re cousins,” he tells the paper. Most schools tell the Times they have policies in place.

Ghost from Flickr Creative Commons mattwi1s0n

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  1. So does that mean if a student, we’ll call her Julie, “has an agreement” with her roommate to use part of the roommate’s paper in her own, it won’t be considered plagiarism by Penn’s Conduct Board officials? Because Julie may “know about the subject” but be too lazy to write her own paper. Mr. Caplan’s logic is weak. How did he get a job at Penn?

  2. Typical, Mr. Caplan, typical. Keep justifying… Grassley will have a heyday. Stay with the status quo and you may find that your school, and others, will have to comply with new laws on this subject.

  3. What is it called when Mr. Grassley gives a speech that is ghostwritten? How many of his own speeches has Mr. Grassley written in the last 20 years? And as a congressman, should he not also be upholding the public trust by writing his own speeches, or at least giving credit to those who do?

  4. good point Rich. staff on capitol hill are paid a salary for their work.

  5. Ghostwritten clinical “research” papers and corrupt medical practice “guidelines” also influence our legislators. This often results in a vicious cycle which undermines public health and depletes the U.S. Healthcare budget.

  6. First of all I really love the picture ED. You’ve captured the essence of the problem. The person behind the “ghost”/ frosted/steamy glass is a patient, or at least it vaguely resembles what could be a patient, and they are who we forget about with issues like these - so thanks!

    Indeed Mr. Caplan’s logic is weak and that should be a big flag for anyone reading the article.

    Richard, while it would be nice if Senator Grassley writes his own speeches, he surely has his own speech writer. This person works with him and is paid by his office. Hopefully Mr. Grassely verifies the sources of information used and hopefully it doesn’t include complete words strung together and provided in courtesy by paid lobbyists… That would be wrong.

  7. Richard,

    Are you having a bad day,.. Grassley is a Senator, not a Congressman.

  8. There are a lot of good points being raised, here, but strictly speaking, there is a big difference between ghostwriting and plagiarism–among others, the words mean different things.

    If a movie star pays somebody to help write their biography, the person being paid is a ghostwriter. If either the movie star or the ghostwriter lifts somebody else’s writing and calls it their own, that’s plagiarism.

    The person being paid to write a politician’s speeches is a ghostwriter. If either the speechwriter or politician lifts somebody else’s writings or statements without attribution, that’s plagiarism.

    And if somebody is paid to help craft a summary of research, that’s ghostwriting, not plagiarism–at least that’s how it looks to me.

  9. Whats happening?

  10. Talbot,
    And, if someone is paid to help draft a publication from some research and their assistance acknowledged as a professional writer in the publication, that is not ‘ghostwriting’.

    To me the difference between ‘ghostwriting’ and a ‘professional writer’, is the professional writer is acknowledged and the entire process is transparent.

  11. So basically medical research is being put into the hands of writers/journalists to craft the findings into a concise little public release statement? Doesn’t sound like it’s in the interest of medical science.

  12. http://www.nytimes.com/2009/11/15/us/politics/15health.html
    The link above seems to indicate that at least some members of congress have ‘ghost writers’ that come in from a side door.

    Also, what about members of congress and ‘ghost readers’? It seems as though many members of congress could use more of them and/or better ones right now….Or, maybe members of congress could form and join study groups…?

  13. I’m not usually a big fan of Art Caplan, so transparency on that.

    I suspect the primary differences here have more to do with convention than clear ethical principles.

    We _expect_ Sarah Palin or Yogi to employ ghostwriters, whether they say so, and name that person, or not. Pres. Obama is relatively unusual in having written his own books.

    The issue with medical ghostwriting of the kind we’re used to–companies supplying the text, and the author being a KOL, is that the KOL is not simply benefitting by having one more undeserved publication. The company is benefitting by having its potentially spun study published under the KOL’s name. (Palin’s ghostwriter, as far as we know, is only getting paid–not hawking a product through Palin’s imprimatur.)

    As far as I know, companies via their ad agencies hire the ghostwriters. The KOL doesn’t.

    That is obvious not the case of a plagiarizing student.

    So, to this observer, Palin and the plagiarizing student have more in common than either has with medical ghostwriting. The important caveat would be that academic integrity obliges students not to plagiarize, but there is no general standard (or expectation) of political integrity that obliges politicians (current and former) not to pay someone to write for them.

  14. There’s an unholy symbiotic relationship that has been in place for a very long time: the medical ghostwriting results in undeserved publications, which result in academic sinecure, which gives gravitas to the medical ghostwriting, and so on.

  15. Here’s a bit of eye-opening testimony on ghostwriting from the recent Paxil birth defect trial which Glaxo lost big time, by UK expert Dr David Healy.

    The first paragraph shown to the jury of document dated July 28, 2003 to the product manager for Paxil says: “Thank you for offering me the chance to work with you to write two review articles. This letter summarizes my fees for this project. The safety paper is priced higher because of a greater number of named authors and the anticipated additional work involved in assessing the CR data in progress.”

    For the development of manuscript, and up to five drafts, the price was $12,000.

    One topic was on the safety of antidepressants in breast-feeding. It was signed by Sally Laden of a firm called Scientific Therapeutics Information, the same gal who I believe ghostwrote the now infamous Paxil study 329.

    “The first draft will be the first run through the material. She will have put the article together laying out the issues, laying out the references, structuring the paper up in the way that the journal she actually expects that this paper is going to go to will want the article structured,” Healy told the jury.

    Draft 2 says it goes back to Glaxo again and the author, whoever is actually going to put their name on the paper.

    Then draft 3 goes back to Glaxo and the author for sign-off and then there will be a final version that goes to the journal.

    Then draft 5 is revisions from journal reviewers.

    So “what they get for their $12,000 from Ms. Laden is writing, editing, library research, styling to comply with journal guidelines, coordination with one contact at GSK and one author, obtaining all copyright release forms from author, preparation of submission package, coordination with author to revise manuscript based on journal reviewer comments, and resubmission to original author,” the jury heard.

    The safety paper, as she said, is more expensive because there is going to be more authors.

    “I should emphasize,” Healy said, “that more authors here does not mean more authors writing the paper. It means more names appearing on the authorship line.”

    “She has to recruit people and the people whose names are on the authorship line get paid for being authors on the paper,” he explained.

    “This is how probably at least half of the articles to do with drugs on the market at the moment,” are produced, Healy said.

    During the trial, the plaintiff’s attorney showed the jury a book with names of influential doctors on Glaxo’s payroll and had Healy go through some of the names involved in ghostwriting articles used to increase sales of Paxil to pregnant and nursing nursing mothers.

    I think the jury got the point, judging by their verdict.

  16. Evelyn,
    That document was produced 6 years ago. Many of the published articles that were ‘ghostwritten’ in that manner were produced around that time and earlier when regulatins were not as stringent. I’m not condoning it, but pointing out - again - that times have changed since then. Isn’t it fair to say that much tighter guidelines, disclosures and transparency are now in place and that in most cases attribution is given to external writers who participated in the creation of the article. Ghostwriting per se is not wrong: failure to disclose the involvement of a ‘ghostwriter’ is, and from what I understand both the industry and its medical writing agencies have voluntarily complied with what are clearly more appropriate behaviors in this regard.

  17. I would argue that the public has not been aware of the ghostwriting issue until the last couple years.

    Even now, many people who don’t keep up on topics like this have no idea what has went on. If not for litigation, none of it would have become public.

    Some of the documents in the trials were kept hidden for years by the drug companies with court orders and are only now seeing the light of day.

    I’m sure the jury in the birth defects trial had no idea how things worked. What average person on the street would suspect that this ghostwriting was going on?

    Nothing short of a mass book burning ceremony will clean up the corrupt medical literature that has accumulated over the past decade and a half.

  18. One more thing. I only discussed on example, there were tons more disclosed during the trial and many more recent articles.

  19. Yes, Evelyn, I agree. And what’s more, there’s a very substantial paper trial in place which will now be very difficult to hide. There are many C.V.’s of esteemed “experts” on the internet which list dozens, sometimes hundreds of “research” publications. These publications invariably cite as authors every member of the “study group” involved in performing the “research”. Many of these ghostwritten publications are still cited today as if they represent legitimate research. The medical journals rarely, if ever, retract these publications.

  20. ghost busters!

  21. What wrong with a little ghostwriting? It worked wonders for Merck when they were pushing Vioxx

  22. You can read the Kilker court files here

    http://fiddaman.blogspot.com/2009/10/kilker-v-claxosmithkline-all-documents.html

    The jury in this case sat and listened and probably read too.

    The outcome:

    GSK Guilty - the causation of Lyam Kilker being born with heart defects?

    Paxil

    One of the drugs that has been ghostwritten and ‘bigged up’ as being not only safe for children but safe for women who are with child.

    It’s a disgrace - and GSK will walk away with a fine of some sort.

    These ghostwriters are criminals. It really is as simple as that.

    Fid

  23. Kid–I think you’d mean (but you tell me) that the blame rests with the company, the ghosts, and the guests (KOLs). Kind of like the pimp, the whore, and the john.

  24. The best comment is the one by Richard (and he gets full credit)…

    Grassley has everyone of his speeches and every one of his bills and letters and subpoenas written for him by his staff…Chris Armstrong and others. Yet, he signs all of them as if they were his own.

    You’ve got to love our politicians…

  25. Gosh — Bulls23 (MJ Fovever!) reminds me. . . .

    Who ya’ gonna’ call?”

    That’s right: Ghostbusters!

    Wyeth, too (pre-Pfizer merger) has needed the services of one Doctor Peter Venkman — from time to time.

    Namaste

  26. Nice one Condor

    Here’s another:

    Ghostwriterst

    Fid

  27. Damn - wrong spelling. You catch my drift anyhow

    Fid

  28. Let’s get some definitions straight before we tar everyone with the same black brush, Senator Grassley.

    Ghostwriter: a writer who writes a paper without author interaction or input using source material provided by a commercial client.

    Ghostauthor: the person who puts his/her name on the above mentioned paper and earns beaucoup dollars from a commercial client for doing so.

    Ghost managers: The companies working behind the scene to orchestrate the activities of said ghostwriters and ghostauthors.

    After a bit of badly needed exorcism, we have:

    Ethical medical writer: a writer who writes a paper while working with an author, not the commercial sponsor, from the get go.

    Ethical author: the person who approved of the concept, design, outline, and subsequent drafts of the paper and so rightly has their name under the title.

    Ethical company: The company who sponsored the paper and left it entirely up to the author and writer to produce a manuscript.

    By these definitions, Grassley is correct in trashing ghostwriting. Unfortunately, the term is too often used to characterize all medical writing.

    Bruce Wilson (a medical writer who is tired of being accused of being a whiter shade of pale)

  29. Thank You, Bruce…

  30. I’d like to know who pays for Senator Grassley’s speechwriters?

    Which special interest or lobby is paying for this “ethics” initiative?

    The real problem lies with the way we pay for healthcare and fund medical research, including research that leads to the development of new drugs.

    We have elected to have drug development funded by for-profit corporations. These companies must make a profit to stay in business. Senator Grassley would have more credibility if he wanted to change the business model…the “anti-ghostwriting” crusade is simply a distraction from dealing with the real issues that come from the way we have chosen to develop new drugs and regulate their licensing and use.

    My 2 cents

    Barbara Tokay (a medical writer whose “ethics” are just fine, thank you very much)

  31. Barbara, Its the same as President Obama, we the people, the good ole American Taxpayer.

    Just my 2cents..

  32. So Barbara simply because you want to make a profit you need to lie and mislead people.

    I don’t buy it.

    I think the profit motive is appropriate and does lead to new medicines (not as much as we’ld like as compared to me-toos).

    This is not about whether there are ghostwriters but really whether it’s being done in an honest way.

    I don’t think anyone would even be following up on it if it was really misrepresentation of how much work the ‘author’ actually put in. It’s really more that it’s a wink-wink nod-nod that we’ll write stuff that we know is not true (and thus will harm people) and you provide the cover of respectability just so we can all defraud the payers and the patients.

    Salmon

  33. wow, people are so lost.

  34. Bruce Wilson, you are right on target. Your definitions clearly lay out the playing field today. Most of us land on the ethical side, not because we have to, but because that is the right thing to do. And for those of us who are ethical writers/authors, we have nothing to hide. The entire process is, and should be, totally transparent to anyone.

  35. Sorry to the honest medical writers, but you are ghostwriters when you’re not listed as the primary author, or as to the level of your contribution.

    The definition of ghostwriter is already out there. Webster’s and other sources all say a ghostwriter is ’someone who writes for and in the name of another’, and this is clearly the colloquial use.

    So it’s really about whether you are an honest ghostwriter or not and if you’re manipulating the data and the message.

    By the way I complained to Sen Grassley about this several years ago and I know others did earlier. It’s good to see him pursuing it.

    Salmon

  36. This is a huge Pandora’s Box. If the info comes clean, we’ll find out that the KOLs with 200 papers on their CV actually wrote about 10 early in their career. Unfortunately, the writers never really get the credit becuase the pharma company doesn’t want to provide any way for the true authorship to be known.

  37. I think this conversation also needs to distinguish types of medical papers. A manuscript for a multicenter clinical trial is quite different from a single-authored review paper, and its the latter than can be most easily corrupted with marketing messages.

    When a drug company has sponsored a clinical trial and has numerous investigators to coordinate with, it is entirely appropriate to have a medical writer (on staff or freelance) work on the paper. There has to be one point person to start the draft, incorporate all the authors’ comments, and so on. The writer did not design the study and does not/should not independently interpret the results. Writing a trial manuscript is a truly collaborative process that is expedited when a professional writer is part of the team.

    In contrast, a review article may or may not reflect the named author’s work and is the most obvious place for unethical ghostwriting to occur. There are well-known cases of medical communication companies writing the paper first then seeking a prestigious “author” to put on the paper. That is appalling, and the “author” is as much a part of the problem as the medical writer who participates.

    These are clearly different situations, yet both get lumped together in this discussion, and I think Senator Grassley and others would be well advised to understand these nuances.

  38. The way I see it, Grassley is just following along the paths that his investigation leads him on.

    If I remember right, this investigation started about four or five years ago and it has taken this long to get to where it is now because none of the corrupt actors wanted anything revealed.

    And again, if not for litigation, it would never have proceeded at all.

    Having court cases tied up for years due to the preemption scam sure didn’t speed things along either.

    If some of the information coming out now seems like old news it’s only because of all the successful stalling techniques used.

  39. How Ghostwriting works in cartoon format.

    http://www.mast-victims.org/gfx/photos/dilbertpollution.jpg

    Salmon

  40. Ha.ha. Good one Salmon.

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