Researcher who regretted ghost-written HRT review has more regrets

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April 19, 2010

In October, Antidote reported that Dr. John Eden, a well-respected Australian hormone researcher and the founder and director of the Sydney Menopause Centre, had second thoughts about his participation in a review article about hormone replacement therapy (HRT) that was written with the help of pharmaceutical giant Wyeth.

"We academics are under some pressure to 'publish or perish,'" Eden wrote. "Performance evaluation of at least Australian academics includes the number and quality of publications per year. In retrospect, I was probably naïve and I wouldn't do it now."

Since then, he has come under more intense scrutiny from government investigators in Australia and the press.

Richard Guilliatt at The Australian reports that Eden is now saying he was duped by DesignWrite, the company hired by Wyeth to ghostwrite the research paper in question and many more as part of a Wyeth marketing plan. (The story provides some of the same details covered by Antidote.) Eden told Guilliatt that the paper was never ghostwritten and that he had no idea Wyeth was working behind the scenes to guide the paper.

Speaking in detail about the controversy for the first time, Dr Eden acknowledged that Wyeth suggested he write the article after inviting him to a company-sponsored symposium in New York in June 2000. Wyeth was at the time preparing to launch a new pill containing the hormone progestin, and Dr Eden's research indicated progestin in high doses was beneficial to women with breast cancer.

The documents show that a Wyeth marketing executive had offered Dr Eden the assistance of "knowledgeable and gifted writers" who could help turn his research into a published paper.

Wyeth came up with the title of the paper and DesignWrite paid a freelance science writer $US3000 to draft an 11-page "outline" which was sent to Dr Eden after being scrutinised by Wyeth's marketing department.

Dr Eden acknowledges he received editorial assistance in drafting and revising the paper but denies it was ghost-written.

He says the paper was based on his research and was controlled by him without any influence or payment to him from Wyeth.

It's been interesting to see how this story has unfolded on two sides of the globe. Eden's work with DesignWrite was first brought to light by Duff Wilson, who wrote a piece for The New York Times in December 2008.

Eden didn't talk to Wilson, but, when the Australians picked up on it, he attempted to defend his actions by saying that he stood by the paper. He told Melissa Sweet at Crikey:

The only thing I can say for sure at the moment, on the record, is that I re-read the article on the weekend, the one they're talking about, I've got over 100 publications, I don't remember every single article I've written I'm very happy with it. I completely stand by what's in that article. That article is an accurate representation of my view.

Then came my Antidote piece in October, in which Eden said that, yes, he had help writing the paper and, yes, he knew Wyeth was involved but that he thought he had disclosed enough information about the writing help to the American Journal of Obstetrics and Gynecology (AJOG):

In retrospect, I might have taken disclosure further and highlighted that the medical writers were engaged by a third party, but their role was facilitation and they had no undue influence on the final outcome. The first draft was based on papers that I had written and talks that I had given during the 1990s and in 2000. It took a further three years to finalise the paper for submission to AJOG. All medical papers undergo rigorous peer and editorial review before being accepted for publication. I stand by the paper, which made a substantial contribution to the HRT debate. In fact, it was the Editor's Choice article for that edition of the Journal.

Guilliatt found Eden to be just as sympathetic a character as I did and goes into great detail about his conversation with Eden in a long and very interesting post on the Mission & Justice blog. Perhaps the most stunning information in his latest piece in The Australian is this:

The American Journal of Obstetrics and Gynecology launched an investigation into the Eden paper after it was named in the US Senate investigation. Two weeks ago, the journal informed Dr Eden it was satisfied the paper was not ghost-written and said no further action would be taken. 

It would be fascinating to see the evidence that AJOG pulled together to clear Eden. Does this essentially give researchers the OK to have a drug company devise the title of their work, give them a detailed outline, have them fill in the blanks and then call the work their own?

Apparently whatever evidence AJOG mustered was more persuasive than the documents in the Drug Industry Document Archive. After a court battle involving the New York Times, a judge ordered Wyeth to provide those documents for the world to see. The journal's internal deliberations about the integrity of their publication likely will remain secret.

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