Drug Company's Ghostwriters Push Product in Medical Journals

| Wed Aug. 12, 2009 10:07 AM EDT

It’s looking increasingly likely that the pharmaceutical industry will escape price regulation under any new health care reform. For its part, the drug makers have promised $30 million in special price reductions to support Medicare recipients--a move that, as I've written before, is really a backdoor method of keeping seniors hooked on brand-name drugs.

Brand-name drugs are required by federal law to be safe and efficacious. We often rely on independent medical journals to provide important information and analysis to make the case for their use. We trust the editors of these journals and the experts who write the articles for expertise and sound judgement. And it’s not just the general public who relies on these respected sources. Doctors also use these articles in deciding whether or not to prescribe a drug.

So it comes as something of a shock to many people to learn that these articles aren’t always written by the people who sign them. Earlier this month, the New York Times reported that ghostwriters employed by drug company Wyeth produced 26 articles in medical journals to promote Premarin and Prempro, two controversial estrogen-replacement therapy drugs later linked to serious health problems in menopausal women. Dr. Adriane Fugh Berman, a doctor at Georgetown University and a colleague of mine in a publically funded project called Pharmedout.org, is making public some of these internal documents.

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The documents, (which come from a lawsuit against Wyeth in which Fugh Berman is a paid expert witness) speak for themselves. Here is one of them. The background: Wyeth (then known as Wyeth-Ayerst and referred to here as "the client") paid DesignWrite, a medical education and communication company, to write papers for medical journals about Premarin and Prempro. The following is an excerpt from DesignWrite’s communications plan, written in 1996 (other documents in the lawsuit date to as recently as 2005). Emphasis mine: 

The first step is to choose the target journal best suited to the manuscript’s content. …We will then analyze the data and write the manuscript, recruit a suitable well-recognized expert to lend his/her name as author of the document, and secure his/her approval of its content. After the client has reviewed and released the manuscript for submission, DesignWrite will see it through the necessary production stages—creating camera-ready figures and tables and the text according to the journal guidelines—and submit the package (manuscript, art, cover letter, and any required forms and checklists) to the appropriate journal editor… Any revisions requested by the journal will be handled by DesignWrite in conjunction with the client and the author. Should the journal reject the manuscript, DesignWrite will restyle it for submission to another journal within 10 working days.     

…Manuscripts are submitted to peer-reviewed journals directed at the target audiences. Where appropriate, articles dealing with pharmacologic aspects of the drugs will be placed in journals with a pharmacology orientation. These articles could combine updates on study results as well as information comparing the product with other selected therapeutic agents. In addition, they could address trends in treatment and topical issues in patient management…

Scientific Poster Presentations
At selected medical meetings, lead investigators are able to present the results of their in vitro, preclinical, or clinical studies in an academic atmosphere that many meeting attendees consider desirable. DesignWrite is quite experienced and successful in working with these investigators to ensure that their results are presented in a clear, professional, and impactful manner. Such presentations often represent merely abstracts of studies while others are more thorough. In either event, DesignWrite feels strongly that such poster presentations represent a significant manner of presenting scientific information to target audiences, particularly in preparation for the launch of a product and even postlaunch.

Budget
Preclinical manuscript………. $10,000
Clinical manuscript…………… $16,000
Review article………………….. $20,000
Poster presentation…………… $6,000
Journal supplement………….. $175,000                                                  

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