AZ Seroquel Trial: Was It "Ghostwriting" or "Professional" Writing?

The lawsuits filed against AstraZeneca over whether the company failed to warn Seroquel users of the weight gain and diabetes risks associated with the drug throws up an interesting sidelight on the practice of “ghostwriting.”

Back in 2005, according to the British Medical Journal and the Guardian, AstraZeneca — via medical writing company RxComms – sent a fully written paper to Dr. Adriane Fugh-Berman on herbs and warfarin:

I received a completed, 2,848-word draft, with an abstract, references, and a table, ready for submission to a journal, with my name on it. A note asked me to return it with any changes within seven days.

It didn’t end there:

I declined the offer from RxComms, but another “author” was willing to do it. A few weeks later, a manuscript with alarming similarities was sent to me for peer review by the Journal of General Internal Medicine. On being told I believed that the paper was ghostwritten, the journal editors rejected it, told the “author” not to submit a paper again, and informed the World Association of Medical Editors. RxComms says this was a different manuscript and was actually written by the person who submitted it, but it had been sent to me in error. AstraZeneca has also denied that the article was ghostwritten.

AZ earlier that year had told a UK House of Commons Select Committee on Health that it did not employ ghost writers but did employ “professional writers” to assist original authors. Here’s Dr. John Patterson, EVP for product strategy, licensing, and business development, in the BMJ:

…the witnesses [including Patterson] denied that their companies had ever had research findings “ghost written” (written up by a professional writer working for the drug company)—an allegation made against the industry in previous committee hearings. However, Dr Patterson admitted that professional writers did work alongside research authors, assisting in getting a paper up to publishable standards.

On the warfarin paper specifically:

AstraZeneca, however, argues that this was not a case of ghost writing but a “very serious error.” According to Dr Valerie Siddall, head of global publications for AstraZeneca, Dr Fugh-Berman should have received a preliminary outline of a proposed article on a similar topic, drafted by one of their writers, not the one she saw, which was the final work of another clinician.

“The article was not ghost written,” said Dr Siddall. “AstraZeneca does not support the practice of ghost writing,” she said.

Just a reminder, this was 2005. The timeline when AZ super-stud U.S. medical director John MacFadden was sleeping with a number of his publication writers? 2002-2006, as you can see by this email, in which he offers his paramour from writing company Parexel some Vicodin.

• BNET’s previous coverage of AZ and Seroquel:
• AstraZeneca’s Seroquel Research Director Confessed to Sex-for-Studies Affairs
• E-Mail: AstraZeneca Knew in 1997 that Seroquel Caused Weight Gain
• Exec Warned AZ on Negative Seroquel Results: “We Cannot Hide Them”; Info Later “Buried”
  
• AstraZeneca’s Sex-for-Studies Seroquel Scandal: Did Research Chief Bias the Science?
• Seroquel Trial: Allegations of Sex-for-Secrets; AZ Wants Papers Sealed
• FDA Asks AZ to Tighten Seroquel Label; 9,000 Lawsuits Start Trials Next Week
  
• The History of AstraZeneca’s Mismarketing of Seroquel
  
• FDA: J&J’s Risperdal and Lilly’s Zyprexa Are Over-Used in Kids
  
• AstraZeneca Allegedly Recruits Tigger and Eeyore to Sell Seroquel