April 16, 2008

Ghostwriting: a scary practice

A case study in this week's Journal of the American Medical Association tells us more about the practice of ghostwriting.

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Ghostwriting is the practice whereby academic researchers allow their names to be listed as publishers of research articles even though some, most or all of the writing may have been done by industry-hired medical writers. If there's any acknowledgement of the outside help at all, it's often euphemistically phrased "editorial assistance."

The JAMA case study is particularly interesting because it involves the case of research involving Vioxx (rofecoxib). The authors say their analysis "demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support."

Another JAMA article contends that Merck, makers of Vioxx, tried to minimize deaths in two studies showing that the drug didn't work in treating or preventing Alzheimer's disease.

Merck calls the reports false and misleading.

Ghostwriting is misleading and deceptive, and the practice should be dragged into the light of day more often for more to see what impact it may have on the integrity of science.

Posted by schwitz at April 16, 2008 07:04 AM | TrackBack
Comments

The sad fact is that ghostwriting is also a dirty little secret of the freelance science-writing world. It's not uncontroversial, of course, but everyone knows what the medical-communications firms that haunt the NASW jobs list are looking for.

For instance, last summer one prospective employer wrote:

"We develop a variety of medical education and marketing materials for pharmaceutical companies. We are searching for a Senior Medical Writer who possesses excellent written communication and organizational skills. Responsibilities include:

* Writing scientifically and medically accurate copy for manuscripts, newsletters, articles, abstracts, and other publications that follow AMA and company style guidelines
* Preparing scientifically and medically accurate, well-crafted, and logically organized slide kits that effectively convey the marketing messages of the client
* Preparing scientifically and medically accurate, concise Web copy that effectively conveys the marketing messages of the client
* Researching and select relevant references on clinical research topics
* Adapting to work in disciplines and therapeutic areas outside of specialty
* Interfacing with clients and faculty as needed"

Can anyone reading this really have any doubts as to what these folks are actually up to?

I was also struck by exactly how well reporters for different newspapers seemed to understand this (or at least were allowed to actually bring their powers of analysis to bear). Oddly, it was two New York papers who had the most divergent takes:

NYT: Merck Wrote Drug Studies for Doctors

The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.

-vs.-

WSJ: Merck's Publishing Ethics Are Questioned by Studies

Two medical-journal studies suggest Merck & Co. violated scientific-publishing ethics by ghostwriting dozens of academic articles, and minimized the impact of patient deaths in its analyses of some human trials of a top-selling drug later linked to cardiac problems.

Hmm. Was Merck corrupting medicine or just possessed of questionable "publishing ethics"? That's one tough call, folks.

Posted by: David Hamilton at April 17, 2008 02:09 AM

As with every story, there's the good, the bad, and the ugly. This definitely falls in the ugly. This story hits home to me, as I was until very recently, a ghostwriter!

It is a shame that full disclosure doesn't happen more often. Medical communications agencies are naturally for profit, and although the medical scientists and doctors that are often employed by them try to write a balanced manuscript, their work often gets torn up by the Sponsor as "not good enough" and not positive enough from their point of view. Well, the customer is always "right", even when they are wrong.

Be aware also there are medical writers organizations on both sides of the Pond (American Medical Writers [AMWA] and European Medical Writers Association [EMWA]) which encourage whistle blowing when possible, and how to handle the "ghostwriting" problem. The EMWA offers a guideline, which are available in the attached link.

How to best "drag it into the light of day" without losing one's job or livelihood? should all medical writers be required to take ethics or journalism classes?

One cannot deny that there is a demand for ghostwriting or "editing", as high-profile doctors simply do not have the time to write a manuscript from scratch. They usually read, offer references, and edit the final manuscript, and sign-off on on a manuscript written by the Sponsor or produced by a paid agency writer. (Or poor Graduate Student!) The manuscripts are prepared from scratch based on the clinical trial data provided, which is "pick and choose" of course, to make the best key messages. Hand in hand is the challenge of public availability of data, which was discussed here before, that both positive and negative trials should be made available so academic and government research can be conducted so that patient data are not wasted or unnecessarily duplicated.

Nevertheless, the principal investigator(s) of these clinical trials would also be pressured from the Sponsor and academia (yes, grant money relies on positive results!) to write a "good" manuscript. Therefore, in my opinion, the main issue is not with someone else writing it, it is just not reporting full disclosure (which incidentally reminds me of the recent lung cancer spiral CT study in NYC). Medical writers and manuscript authors everywhere have to stand up for their rights and be acknowledged and demand disclosure, even if the Sponsor or worse, their boss, disagrees.

Posted by: Tania Khan at April 17, 2008 03:16 AM

I like your blog; we both had the same idea for blog themes I suppose.

Ghostwriting:

I have written loads of papers, and I am a versatile writer. I'm sure that many ghostwriters share my traits/capabilities. I don't think that ghostwriting is inherently evil. As long as the literature is peer reviewed, I think it is fine.

After all, in my accounting classes (undergraduate) I learned that there are various ways of reporting financial facts. Merck is just another company pulling the same wool over consumers' eyes.

* I hope this makes sense; I'm actually very tired right now.

Posted by: Carolina at April 18, 2008 09:34 PM

I do agree that ghostwriting is misleading and deceptive.

While i support the case for free articles and expressions, i think that the author of the writings in itself should NOT be a fake. TO make things even more serious, if an article would be of a medical report, one can seriously doubt the accuracy of it. What would the implications be? Some one can actually be serious 'hurt' - we can never know!

All these while, i really do believed that medical reports from the internet are accurate. But the idea of ghostwriting for medical writers does makes me doubt the integrity of it all. I hope the relevant authorities can look into this...

Posted by: Parenting Expert- Judy at April 27, 2008 11:38 PM
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