Use DIDA to dive deep into ghostwritten medical papers

Antidote promised in an earlier post to revisit the case of Dr. John Eden, who told Antidote he regretted working with a ghostwriter who had been paid by Wyeth to write an article about hormone replacement therapy (HRT).

You can read all about him in 23 documents that have been gathered by the good people at the Drug Industry Document Archive (DIDA) at the University of California, San Francisco. UCSF has made 2,500 documents from court cases and federal inquiries fully searchable. Go to the DIDA home page. Pick a drug company. Pick a doctor. Pick a medical communications company. Search by that name and see what you find.

Eden told Antidote that he signed his name to only one ghostwritten article.

DIDA only covers a slice of drug industry collaborations, but it does appear that Eden only worked for Wyeth once and has not worked for the other major companies mentioned in DIDA. In that instance, DIDA provides some fascinating details. For one, DesignWrite, the company that Wyeth hired to write Eden's review of HRT paid for everything, even mailing the submission to the journal.

As Eden pointed out to Antidote, it was the editors at the American Journal of Obstetrics and Gynecology who suggested he include information about the Women's Health Initiative (WHI) study, which was halted when researchers decided that the potential risks of continuing to give women HRT were too great.

Here's what happened next. DesignWrite, decided where to mention HRT, not Eden. Steve Parker, the DesignWrite editor assigned to Eden's paper, wrote in October 2002.

Also, we feel it would strengthen the paper if the WHI were briefly addressed in the abstract and conclusion as well as in the body of the text. If you agree, we will add just a sentence to the abstract and conclusion based on the material you gave us in your last e-mail. We will then send the paper to you for a final review.

The correspondence in these documents sheds some light on the psychology behind the decision to work with an industry-funded ghostwriter.

Eden must have known that working behind the scenes with a drug company could have been damaging to the career he had worked so hard to build. It's why he says now that he regrets doing it.

At the time, he was made to feel smart, exclusively smart, the expert source chosen by the international pharmaceutical company to opine about a topic he has spent a career studying. The allure of that single-byline authorship and the thrill of all the attention from the drug company, though, appear to have won out. Even with the WHI study staring him in the face, Eden frames the issue as if he and Wyeth are allies in a battle against the public and the WHI researchers. Here he is in an email to Karen Mittleman at DesignWrite.

My next HRT after breast cancer paper comes out in the Aust Med Journal in Sept. It shows fewer recurrences and better survival in the HRT users!!!! How will the media (and Colditz) cope with that!!!

Colditz is Dr. Graham A. Colditz of Harvard School of Public Health, who argued at the time of the WHI study that clinicians should reconsider widespread HRT prescriptions. The competitive spirit here would be endearing were we not talking about women's lives. It's worth noting, too, that, once again, another doctor is writing like a 12-year-old with exclamation marks in abundance.

Who is supposed to check to make sure none of this is going on in the first place?

So far, the ghostwriting scandal has yet to damage the careers of any editors at any of the journals that have been found to have published these pieces. In Eden's case, if you want to find out who was on the front line, check this letter. Dr. Moon H. Kim continues to serve as the associated editor of the journal, and it might be worth pursuing how many other ghostwritten pieces were accepted by him. The paper wasn't just accepted, either. It was named the Editor's Choice for that issue. Was a provocative argument that might generate a little buzz about the journal while WHI was still in the news just sexy enough that Kim and the other editors decided they didn't care who had paid for the work?

After all, this wasn't the first journal to take a look at the review. Eight months earlier, Eden submitted his paper to Dr. James E. Dalen, the editor of the Archives of Internal Medicine for 17 years, writing this letter. Dalen turned the paper down. In his farewell editorial in 2004, Dalen wrote that the Archives under his management had gone from accepting 30 percent of all submissions to 15 percent.

Consider this. You are an editor reading jargon-heavy, methodologically dense and ultimately dull scientific papers that were written by graduate students running on fumes. Suddenly, you receive a beautifully constructed, seemingly well documented and persuasively written piece with a well-regarded scientist as the sole author. Should you, cynically, assume that the good writing simply reflected the purchase price or should you assume that the doctor took a few English classes at some point?

Unfortunately, it seems the former is now the only line of defense.