Dr. Archer’s Ghost: Hormone expert’s disclosure hides drug company’s hand

It's not as seductive as a candlelit bedroom.

But a dinner with medical colleagues after a board meeting can exert a powerful a pull on talented scientists flirting with the drug industry. Rarely one-on-ones, these dinners are usually threesomes:

1. The seducer: a representative for a medical communications company that has been hired by a drug company to help market a particular product or disease in need of new cures being cooked up by the company.

2. The object of seduction: a researcher with known expertise in the company's target area.

3. The wing man: A veteran researcher who already has worked with a ghostwriter and can lend the communications company credibility.

In 2000, Dr. John Eden had dinner with a representative from DesignWrite, Mark Barbee, and a fellow researcher, Dr. David F. Archer. The meeting was Eden's first brush with the company that would end up handing him an article it had written with funding from drug giant Wyeth, an article that downplayed the side effects of hormone replacement therapy (HRT). It was published in the wake of a groundbreaking study that was halted after showing a strong correlation between HRT and breast cancer.

Without Archer at that dinner, the DesignWrite rep would have been just another corporate suit. With Archer, suddenly Barbee was part of The Science Club. He wrote Eden in July 2000:

I very much enjoyed meeting you recently in New York at the Perspectives in ERT/HRT: Advisory Board Meeting. Just in case you are having trouble placing me, we had dinner the first night with Dr. Archer. I am one of the marketing managers for the Premarin Family of Products. Your comments were invaluable to us as we move our business forward.

Eden and Archer had been asked by Wyeth to present their thoughts on HRT, and now Barbee was hoping Eden would take the next step and allow his name to be used on an article that he did not write.

Considering the current environment, I would like to know if you would have an interest in working with a writer from DesignWrite to enrich the literature in the U.S. with a review article. DesignWrite works with Premarin Marketing Team on our publication planning. They have knowledgeable and gifted writers that would work with you on the article. Wyeth cannot pay you for this endeavor, but we can offer the assistance of a writer. Your insights into breast cancer and its relationship to HRT would be insightful information to U.S. healthcare providers.

Eden eventually said yes, a decision he now regrets.

Archer was already a veteran. In 1999, DesignWrite hooked him to "author" a review paper titled "Progestins in HRT." Soon, he was putting his name to multiple papers and serving as an editorial consultant for the company.

Archer and a co-researcher, James H. Pickar, signed their names to a paper that had been written with help from DesignWrite/Wyeth: "Hormone replacement therapy: effect of progestin dose and time since menopause on endometrial bleeding." They submitted the paper to the journal Obstetrics & Gynecology. The journal published the paper in December 2000.

A continuous combined regimen of CEE plus 5.0 mg MPA may be more suitable for women closer to the onset of menopause or for women starting therapy who are unwilling to tolerate irregular bleeding. The improved bleeding profile with CEE and 5.0 mg/day MPA is likely to enhance compliance with hormone replacement therapy.

This is a perfect advertisement for a version of Wyeth's signature HRT combo: Premarin (CEE) and Prempro or Premphase (MPA). The author affiliations listed on the paper were the Jones Institute for Reproductive Medicine at Eastern Virginia Medical Center in Norfolk, where Archer continues to work (and pump out research articles) to this day and Wyeth, where Pickar works. The article also disclosed that "Author Archer has served as a paid consultant and has received grants from Wyeth-Ayerst Pharmaceuticals."

Archer should be commended for disclosing his consulting work. But mentioning a drug company is not the same as full disclosure. Nowhere is there a mention that the article had been conceived, researched and written directly by DesignWrite and Wyeth. Here, again, Archer is lending seemingly independent credibility to DesignWrite and Wyeth. Without his name on the paper, the article would appear to be what it actually is, a product created by Wyeth to sell Wyeth products.

By providing this arms-length veneer of independence and objectivity, Archer helped DesignWrite open the door to journal after journal for Wyeth. He is part of a group of researchers working with DesignWrite that have allowed Wyeth to rack up a long list of "Premarin Family" review papers published from 1998 through 2001.

The journals are just as much to blame. Why do journal editors agree to publish papers purporting to review the scientific literature from an independent vantage point but signed by authors with obvious and, sometimes, stated conflicts?

Antidote called Archer to ask about the articles. He initially agreed to talk but cancelled at the last minute and later sent an email saying:

Please note, I was not "hired" by DesignWrite nor was I paid for these articles.  My service as a consultant or status as a grant recipient was disclosed and noted in the various articles you reference. Similarly, Menopausal Medicine, published by the American Society of Reproductive Medicine, noted in its banner that the newsletter received support from Wyeth-Ayerst Laboratories.

I chose to participate in the development of these articles, in some cases, because I believed the information was worthy of being shared with other physicians and, in other cases, because participation provided me the opportunity to review results to which I might not otherwise have had access.

By "banner," he means the list of editorial staff that runs on the inside of the newsletter. The company's logo appeared, about the size of a paper clip, at the bottom of the page.

Antidote asked Dr. Anthony Scialli, an adjunct professor in obstetrics and gynecology at Georgetown University Medical Center and a senior scientist for the Tetra Tech Sciences consulting firm, what he thought about Archer's level of disclosure. Here's what he had to say:

Authors should be listed as authors, so the nonlisting of a professional writer as an author would not be appropriate. There are frequently times when an author has not actually written a paper. Consider, for example, five scientists who publish a paper together. Often one of them will have written the first draft and the others will make changes and suggestions until a consensus document emerges. In these cases, the non-writing authors will have contributed ideas or will have designed the study or provided some tangible contribution.

Instead of Archer being the lead author and the DesignWrite writers being left out entirely, Scialli said, it should be the reverse:

If a professional writer is paid by a company to write a piece and a non-author doctor is asked to approve it, the appropriate outcome would be for the professional writer to be listed as the author and for the non-author doctor to be thanked in an acknowledgement for having reviewed the paper. If the non-author doctor makes substantial enough changes to the paper, he or she might be listed as a coauthor. In either case, the funding for the paper should be disclosed.

Archer declined to answer any follow-up questions. Antidote will post more about Archer's adventures on Monday.