Ghosts In Pharma’s Attic: Art Caplan Explains
10 CommentsBy Ed Silverman // April 25th, 2008 // 12:49 pm
The corrosive scandal over ghostwriting is causing great debate and handwringing. You may recall that an examination of medical journal articles about Vioxx and court documents from Vioxx lawsuits found that Merck employees or ghostwriters were frequently involved in various articles, but the primary authors were often academics who actually had little to do with the studies or didn’t always disclose financial ties to Merck. We asked Art Caplan, who heads the BioEthics Center at the University of Pennsylvania, what authors ought to know and do…
Pharmalot: A lot of the controversy has focused on drugmakers, medical journals and ghostwriting firms. What about the individual doctors or academics?
Caplan: The issue is what’s the appropriate role, if any, for third-party writing help. I would say I’m not sure there’s no role for someone to be hired to help prepare a manuscript. I don’t think there’s any inherently unethical about editing. What I do think is problematic is a clear lack of standards about authorship.
Pharmalot: What should those standards be?
Caplan: All papers must originate with a scientist or scientific author who’s done the study. The Merck papers appear to have been handed to doctors after they were written and that’s a fundamental problem. I think what we need a clear understanding of what it means to be the primary author, as opposed to someone who writes a first draft.
Pharmalot: Right, but not everyone is a great writer, so isn’t that going to be used as a reason for outside help?
Caplan: I understand this from bitter personal experience that not every doctor, every scientist or every academic is a facile writer. Still, if it’s your work that means you did the research, you must take the first stab at writing and only then do you call someone to do editing. But those doing the editing should not be supplying substantive content. Their task is to achieve better clarity of expression, provide conciseness and improve readability, not supply data, analysis or interpretation. It that’s done than they’re the author. If you use outside help, you can acknowledge it as a footnote or a thank you, and you should do so as a courtesy.
Pharmalot: How do you enforce these principles?
Caplan: Every journal should ask the authors to attest to these points. And if someone is found to have allowed ghostwriting, I’d say that person can’t write for us anymore. Journals have to be policing. There won’t be any regulation. It’s a private system that relies on authors to do the right thing an exclude those who don’t. Tell a top scientist that he or she can’t publish anymore in JAMA or The Lancet and I think you’d get a lot of compliance.
FBP
Ghostwriting is rampant throughout the industry and it has been for years. For non-study papers, outside agencies write many of the papers even before an author is identified, an opinion leader is recruited to put his/her name on the manuscript, and the manuscript is submitted. In 2008, the attestation isn’t worth the paper it’s written on. For study papers, usually someone at the company writes them and the lead investigator is the lead author. Unfortunately, most opinion leaders rarely put pen to paper themselves. They may review it, make comments on the drafted paper and may negotiate revisions, but 9 times out of 10 they didn’t actually write it. Sad, but true. The company line is king!
Cynical
There are no bioethics in Big Pharma now that business people run all of the major companies. All that matters is money, money, money and to hell with the patient.
Chris
I’ve said this before but ghostwriting per se is not bad provided sufficient disclosure is made in the manuscript. It is almost certainly no longer true that company people, or their agencies, write manuscripts for an ‘opinion leader’ to put his/her name to for publication.
The other aspect of this is the extent to which the same leaders in academia actually write their own papers. Yes, even some of the same ones critical of the industry. Consider their workload against their prolific publishing: Think they have time to write all their own stuff? Might this ever be taken into account amidst the debate that’s going on now?
Let’s wait and see.
C. Phrma Researcher
I wish Chris was right but unfortunately he is very very wrong. I have worked in phrma for almost 20 years at two large top 10 phrma companies and the practices at Merck and discussed on this blog are in fact rampant. Indeed, it has gotten worse and worse. The “publication” plan for many large products has simply become part of the marketing tools. Even at my own company where Marketing and Medical are supposed to be separate it is a sham because all of the medical money is on the marketing budget and the publication plan is designed to meet the business needs, not any genuine medical needs. Yes, it’s easy to say that phrma companies need to make money. As someone who relies on that money for research I certainly agree. But when it comes to scientific publications do we need 5, 10, 15, 20, 25 papers on one rehash and review of the same data. What about the genuinely difficult medical issues that arise during a product’s lifecycle. In most instances, the unfavorable issues are relegated to Medical Information Letters sent from the company directly to a physician. I have never once in 20 years seen a “Publication Plan” that had anything but plans to publich 100% favorable pieces even if it meant finding 20 different ways and 20 different authors to package the same stuff. There is no scientific integrity left. Publications are just marketing tools like a vis aid or a slim jim. Many of the same agencies are used to develop both.
I would agree with Chris on one point. Ghostwriting is not per se bad if there is disclosure. But how do you disclose the real truth. “This article was developed by agency writers who perform marketing services for ####. The writers and the agency received substantial fees for this work as well as for many other projects from the company that sells ####. Wherever possible emphasis has been given to efficacy benefits, although some safety may be added. The writers have found some interesting new ways to spin this data, but it’s old data that has been published in several other forms. The authors of the paper did not develop the content but they did review the paper before signing it.”
I guess if that’s what Chris means by sufficient disclosure then I change my mind, I agree with him that would be enough.
Chris
No CPR I am not wrong but I think you are making a different point: I am talking about whether it is wrong to use a ghostwriter properly whereas I think you are taking issue with the nature of scientific publications overall wnd with the industry that generates them. The issue in question is the transparency of who writes the manuscripts, not necessarily the scientific merit of the papers.
Publication plans are well-established. They make the best use of data and if a particular data set is published in more than one medium that’s ok - as you well know it is expensive to generate data and foolish to use it only once. Why would any industry do that? Failure to disclose poor data is not OK but the role of publication plan is to support the drug not destroy it, again provided the balance is fair.
In most companies - in my experience - there is extensive review of the plan, the supporting data, and the points that will be made. Research, regulatory and marketing review jointly. Any problems may be aired then; if not, well that’s up to the individual isn’t it. If the lead author (internal or external) has a problem they are at liberty to change something.
As far as your disclosure criteria, I was with you until half way but then it became silly and so I don’t think you really expect a serious answer to that.
The majority of commentators on this topic have been predominantly anti-pharma and especially anti Merck on this issue. With most things there are grey areas and this is no different but the JAMA article that precipitated this (authored by some of the most prolific academic writers in recent memory - presumably these wqrite every word themselves) was not wholly objective nor especially comprehensive. There was a rebuttal written and published soon afterwards in JAMA which presented another perspective but this has yet to appear here.
My point? Not particularly insightful and has been made here many times before: pharma is an industry - nothing else - that by and large employs decent people doing the right things. There are exceptions and these make the news but as always there is an inelegant and unseemly stampede to pillory it and its employees at the first whiff of impropriety. The ghostwriting issue is just one more example. And no, I do not work at an agency and I do not work in the industry (but if I did and was as down on it as some appear to be here, I’d be off like a shot).
Dr. Sal Giorgianni
I am most distressed to see this dialog unfolding. I understand all the points and so do all the folks out there so repeating the pros and cons is not going to do anything constructive.
I find it impressive that a member of Congress, who, I am sure, does not write his own speeches, triggered much of the angst here. Those who continue to pummel the issue and professional medical writers mindlessly need to keep in mind the source of the controversy.
Just as in the broader context, COI, it will be impossible to eradicate perceptions of a problem. Trying to do so will simply fail, but only after much angst. However, I continue to believe that as with all COI matters, transparency and basic disclosure are fundamental remedies. A well written scientific article should be presented in a way that allows the appropriately knowledgeable individual, the learned intermediary if you will, to be able upon careful review and consideration, to draw their own conclusions. Lazy-readers (scientist, clinician, reporter or politician) will go to the abstract, conclusions and summary comments and for them being misled is an unfortunate but real common event. As our future physicians, pharmacists and other health professionals come more and more from the ranks of the MTV – Instant Message – blogosphere generation Lazy-readers will proliferate.
Let’s be reasonable, medical writing will not – and should not – go away any more than should speech writing for politicians (who also engage in some mighty important dialog – at least at times) or opinion writing by law-clerks. Yes, commercial entities will always be positive advocates for their positions – but so will university based academicians, patient advocates and so many others. Maybe another, and ultimately more useful, tact should be taken; teaching learned-intermediaries how to read the scientific literature thoroughly, instilling in them the importance of doing so and maybe chastising Lazy-readers.
pg
Distressing though bringing the topic up may be to drugmakers, it remains a legitimate source of interest and concern to others.
Another interesting piece of info re ghostwriting:
http://hcrenewal.blogspot.com/2007/04/haunted-medical-literature-moffatt-and.html
‘The Haunted Medical Literature: Moffatt and Elliott on Ghost-Writing
We posted quite a bit back in 2005 about ghost-writing (see post here with links backward).
Back then it became evident that a particularly pernicious type of ghost-writing was much more prevalent than anyone seemed to realize.
This sort of ghost-writing has several important elements.
Commissioned by Those With Vested Interests - The writing is commissioned by an organization with a vested, usually commercial interest, e.g., a pharmaceutical company…’
truthman30
Ghost writing is advertising under the guise of science..
Anyone who is involved in this type of thing is doing a grave disservice to public health..
Seems some people will sell their souls and reputations for some pharma money..
Dr. Sal Giorgianni
To PG
My apologies please let me clarify.
I am not distressed by the issue being debated. I am distressed in the manner it is being played-out.
To Truthman
Your position is far too cynical to be helpful. This practice will continue, if for no other reason than the very pragmatic matter that many (most) scientist are not good writers. Would you want a writer to take-out your appendix? Then why do you believe that a utilizing a professional medical writer is INHERENTLY in appropriate? Ambiguous, poorly written and untimely reports are not in the public’s best interests.
To All
We have not begun to discuss one of the most important moderating factors in all of this, namely the peer-review process.
While I am not a fan of some aspects of the current system of scientific peer-review publishing, the overwhelming majority of articles that have any scientific gravitas are published in peer reviewed journals.
Since this is the case, how is it conceivable that such “bad” papers, or “advertising in disguise” or ‘people selling their souls out to commercial interests’ are all getting through the eyes, minds and experience of peer-reviewers and the ever watchful publication-staff reviewers? Ok, once in a while you can fool all of the folks involved in reviewing a paper, but you can’t fool them all of the time.
My point is we have adequate checks and balances in place. With just a bit more transparency it may become a bit better but there simply is not a systemic, horrible, corrupt and dangerous process out there to warrant the angst and possible chilling-effect over regulation might bring.
truthman30
“To Truthman
Your position is far too cynical to be helpful. ”
I have every right to be cynical doc..
Ghost writing encourages deception and hidden agendas..
Ever hear of study 329? ..
http://www.healthyskepticism.org/documents/PaxilStudy329.php
Kids died because of the ghost writing in that piece of paxil propaganda..
To be cynical about the pharmaceutical industry is to be wise..
The whole industry and the way it does business is more cynical than I could ever be…
http://www.youtube.com/watch?v=kiBRbNNFzlA