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Dr. Archer’s Ghost Part 2: This gun for hire has only one bullet

Dr. Archer’s Ghost Part 2: This gun for hire has only one bullet

In June 2002, Dr. David F. Archer had a paper published under his name that reassured women everywhere that they could take antibiotics and birth control pills at the same time and not worry about pregnancy. The article was music to the ears of executives at Wyeth, the drug company giant.

Archer had championed two pharmaceutical categories important to Wyeth: birth control pills and antibiotics. Some gynecologists and family practice doctors had been reluctant to prescribe both, mainly because women had reported becoming pregnant while taking them at the same time. No worries, said the paper. Titled: "Oral contraceptive efficacy and antibiotic interaction: a myth debunked," it explained:

Available scientific and pharmacokinetic data do not support the hypothesis that antibiotics (with the exception of rifampin) lower the contraceptive efficacy of oral contraceptives.

Archer's author affiliations appeared purely academic: "Clinical Research Center, Jones Institute for Reproductive Medicine, Eastern Virginia Medical School." And his conflict of interest disclosure had the appearance of complete transparency:

David F. Archer, MD, has received grants for clinical trials from Wyeth-Ayerst Laboratories, Ortho Pharmaceutical, Organon, Inc, Lilly, Schering Plough, Berlex Laboratories, Pharmacia Corp, and TAP; he is a consultant to Wyeth-Ayerst Laboratories, TAP, Organon, Inc, Lilly, Pharmacia Corp, and Schering Plough; and he serves on the speakers' bureaus of Wyeth-Ayerst Laboratories, Organon, Inc, Pharmacia Corp, and Lilly.

One way to read this long list of every major drug company is: "This guy has worked for so many drug companies he couldn't possibly have a favorite."

Wanna bet?

In article after article, Archer has promoted Wyeth's products by using his name as good science seal of approval. DesignWrite, a medical communications company hired by Wyeth, conceives of the articles, writes them and then asks Archer to sign his name. From the Drug Industry Document Archive, here's DesignWrite's schedule showing when Archer's contraceptive paper was going to be published, one of eight DesignWrite projects that had been accepted for publication.

It might help explain how Archer has published more than 200 studies. This is an enviable amount among researchers, some of whom work for more than two years just to get one paper published. When most of the work on a research paper is already done, though, and all you have to do is submit the finished product to a journal, it's not hard to publish frequently.

The outlines are written with the help of DesignWrite and Wyeth employees long before Archer or any other authors are contacted. And they read like actual drafts. Did DesignWrite and Wyeth's involvement affect Archer's conclusions in that contraceptive study? That's something I'll deal with in a future post.

For an article titled, "Efficacy of Combination Conjugated Equine Estrogen and Trimegestone on the Incidence of Endometrial Hyperplasia," OCC North America, another medical communications company, put together a four-page outline that provided everything Archer and the other authors needed to help sell Wyeth's key messages.

Published in 2005, Archer co-authored another paper titled "Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women." The researchers concluded:

Bazedoxifene at dosages up to 40 mg/d was well tolerated and did not stimulate the endometrium. The significant decreases in endometrial thickness and decreased uterine bleeding observed with doses of 30 and 40 mg/d as compared with placebo suggest endometrial antagonism, representing a novel characteristic not previously associated with any selective estrogen receptor modulator.

Six of the seven researchers listed as authors on this paper had worked with DesignWrite/Wyeth in the past. This paper made it clear where the authors were coming from by listing the lead author's affiliation as Wyeth. This is a rarity. Out of Archer's 200+ papers, only three in the National Institutes of Medicine's PubMed database list Wyeth as the affiliation of the lead author:

November 1997 – "Is bleeding a predictor of endometrial hyperplasia in postmenopausal women receiving hormone replacement therapy? Menopause Study Group (United States, Italy, Netherlands, Switzerland, Belgium, Germany, and Finland."

June 1998 - "Amenorrhea frequency with continuous combined hormone replacement therapy: a retrospective analysis. Menopause Study Group."

June 2005 - Endometrial effects of bazedoxifene acetate, a novel selective estrogen receptor modulator, in postmenopausal women."

Archer also is a gatekeeper for other researchers. He is the editor of Menopausal Medicine, published by the American Society for Reproductive Medicine. He also serves on the editorial board of Menopause, the journal of the North American Menopause Society. How closely can a conflicted editor be expected to guard against authors with conflicts?

Right after the Women's Health Initiative findings, Menopausal Medicine published an article by another frequent DesignWrite collaborator, Dr. James V. Fiorica. Titled "Mammographic breast density and hormone replacement therapy," it said:

Use of hormone replacement therapy (HRT), including therapy with unopposed estrogen or estrogen plus progestin, increases breast density in some postmenopausal women shortly after the initiation of treatment. This change in breast density has led to some speculation that mammographic detection of cancer may be compromised in HRT users. However, researchers have shown that detection of breast cancer is not impaired by HRT use. Moreover, advances in mammographic technology are improving the sensitivity and specificity of even the most difficult-to-read mammograms.

To underscore the point, Archer called out the key drug company message in his "From the Editor" note:

James V. Fiorica, M.D., presents the current status of hormone therapy and mammography density. He concludes that although hormones increase mammographic breast density, there is no evidence for a decreased or impaired detection of breast lesions.

This sounds like solid science, right? It acknowledges the biological effects of HRT on breast density but then explains how those effects relate to breast cancer. But where are Fiorica's references? Unlike the other authors in the newsletter, one of whom cited 30 other papers, Fiorica's references are not listed.

Here's the biggest omission. Fiorica, Archer and the newsletter fail to disclose that the article actually was written by DesignWrite/Wyeth. Instead, it says at the very end, "The author has revealed the following potential conflict of interest: Speaker: Wyeth." And Archer apparently was playing on both sides of the field. He was supposed to be, as the journal editor, the ultimate arbiter of the strength of the submissions to Menopausal Medicine. But, as documents in the Drug Industry Document Archive show, he also was working directly with DesignWrite on tailoring the article. The history of how this article evolved can be seen here.

Make no mistake, research papers written by communications companies like DesignWrite on behalf of drug companies are marketing first and foremost. DesignWrite's "Publication Planning and Management" statement makes it clear:

A scientific publication plan is as vital as a carefully designed media plan in overall product marketing

Goal is to establish a diverse published database that supports promotional and scientific efforts in all appropriate markets

Assure publication of key available data for launch and postlaunch indications

Present substantial documentation with data demonstrating the benefits of the Premarin Family of Products

If you believe that these companies see the researchers as independent voices helping the companies guide their scientific endeavors, read this email from one DesignWrite writer to a Wyeth executive trying to find friendly researchers to sign ghostwritten work:

We've had good experience with Pinkerton, Shoupe, Dorin, Carr, Lobo, Gallagher, Archer, and Utian as authors. Some are more hands on than others, but all were responsive and provided good feedback. The key is to have a lead author who is entrenched in the data and can be firm with the co-authors regarding deadlines.

Regarding your query for additional authors, our suggestion would be to have your medical communications company do a literature search on the other investigators to see their recent publications. A lit search would also be a useful for identifying additional Prem TMG advocates.

Don't take Antidote's word for it. Go to the Drug Industry Document Archive and search for Archer's name.

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