Last month, a group of doctors published a report in the Annals of Internal Medicine that labeled a Vioxx study known as Advantage as a seeding study, a reference to a trial that is actually conducted for marketing purposes, rather than prove a scientific point.

In response, Jonathan Edelman, executive director at Merck’s research labs, published an open letter in which he chastised the authors for failing to reach out to the drugmaker. “It is unfortunate that the authors and journal editors chose not to contact Merck before finalizing these publications. Had any of these individuals contacted Merck, factual errors could have been avoided,” he wrote. (Back story).

However, in an August 22 e-mail to Merck lawyer Ted Mayer, one of the JAMA authors, Brown University’s David Egilman, wrote that he had attempted to contact Merck: “In the past, as you know, I did exactly that by soliciting your criticism and comments for another paper related to other issues in the Advantage trial. I included your criticisms and comments in the final version of that paper.

“However, after my communication with you, I was informed by Jeff Grand, the plaintiff’s lawyer, that Merck had complained to Judge Higbee (who is overseeing Vioxx litigation in a New Jersey state court) about even this non-Merck employee contact and empathically insisted that I not communicate with you or any Merck employees.”

In response, Mayer wrote a September 8 e-mail, in which he tells Egilman “there is no basis for your demand to interview ‘all the authors of Merck documents.’”

“I’m confused,” Egilman tells us. We have asked Merck for a comment to clear up any confusion.

Egilman then provided us with an example of an e-mail exchange with Mayer that took place last year. On March 13, 2007, Mayer responded to his requests for Vioxx court documents to use for publication, which is followed by Egilman’s reply on March 16…

Doctor: I wanted to alert you to the fact that your draft paper does contain at least one reference to a confidential document which you are prohibited from disclosing or using for purposes outside the litigation:note 18, “Hill, B. Fax communication to Norman, A. Payment Agreement. April 21″ (MRK-AAF0004467-71), discussed on page 8 of the draft as forwarded to me. This is the Study Agreement for Dr. Norman in the ADVANTAGE trial and a substitute W-9 form. In addition, there are at least nine other citations for which we could not match the description to the bates number given. Therefore, we are unable to say based on the information you have provided what the status of those documents is. I will forward a list of those on Monday with a request that you re-check those citations so that we can properly assess the confidentiality status of those documents.

Ted Mayer

From: David Egilman
Sent: Friday, March 16, 2007 9:46 AM
To: Mayer, Ted
Subject: paper for your comments
March 16, 2007

Dear Mr. Mayer:

Thank you for commenting on the article by Krumholtz et. al., which I co-authored. Although you state that you are “paid to represent Merck & Co., Inc.” and do therefore not “claim them to be objective” I am more than willing to consider your views on my presentation of Merck’s conduct concerning the ADVANTAGE trial that I have attached. I certainly disagree with the construct that money creates non-objective opinions. While I agree that this can happen it “ain’t necessarily so.” None the less I certainly strive to discover the truth and am willing to consider any comments or criticism that you might offer.

One of your criticisms of our article related to our failure to include information from Dr. Curfman’s deposition. It was our understanding that we were not permitted to do so because Merck designated it confidential. In addition if you believe that we have cited any confidential documents please let me know. If there are any other relevant confidential documents which we could not not cite that you believe are relevant please let me know.

Thanks