Under Obama’s plan—assuming there is a plan—the pharmaceutical industry in all likelyhood escapes price regulation. For its part,the industry promises $30 million to support the elderly in Medicare to buy brand name drugs.
Controversy often surrounds the release of brand name drugs,that is, are they—as the federal laws long have stipulated—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 knowledge and sound judgement. And it’s not just the general public who trusts them.Doctors use this information as an important factor in deciding whether or not to prescribe a drug.
So it comes as something of a shock to many people when they discover that these articles are sometimes not written by the people who sign them.Instead,they are the work of a team of ghostwriters employed by individual companies pushing the drugs 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 a series of internal documents ghostwritten for Wyeth-Ayers in 1996 in an effort to promote Premarin and Prempro, two controversial estrogen replacement therapy drugs. Fugh-Berman heself has been an expert witness in a suit against Wyeth-Ayerst.
The documents, being released in batches, speak for themselves. Here is one of them ,introduced by Fugh-Berman in a blog for PloS Medicine, a medical publication. The New York Times has also written about the documents and published another set.
Our story to date: Wyeth-Ayerst (“the client”) paid DesignWrite, a medical education and communication company (MEC), to write and submit papers to medical journals as part of promotional efforts for Premarin- (conjugated equine estrogens) – and Prempro, which adds medroxyprogeterone acetate to CEE.
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.” (1)
From receipt of the internal summary report for a given study, a time frame of one to two months is estimated for manuscript development. The time frame between submission of the draft and the client approval is subject to the client’s internal review. Subsequent revisions, based on client, author, or reviewer comments, are typically addressed in two to three weeks. A period of six to sixteen months is projected for actual publication once the manuscript has been accepted by the journal. The latter time frame is solely a function of individual journal policies.
The following is a typical work flow plan for developing a manuscript for submission to a peer-reviewed journal:
Client provides data report………. TBD
DesignWrite prepares outline………. 2 weeks
Client internal review………. 2 weeks
DesignWrite prepares first draft………. 4-8 weeks
Client internal review………. 2 weeks
DesignWrite addresses consolidated
client comments (second draft)………. 2-3 weeks
Second draft reviewed by selected author………. 2 weeks
DesignWrite incorporates author comments
(third draft)………. 2 weeks
DesignWrite assists in journal submission………. 2 weeks
Journal provides peer-reviewer comments………. TBD
DesignWrite addresses comments; resubmits………. 2 weeks
Journal acceptance and publication………. TBD
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.
Selected data derived from individual studies could be published together as supplements to target journals within a particular therapeutic specialty. Should the client wish to pursue this publication option, the following guidelines are applicable. A turnaround time of six months is generally adhered to for producing the supplement. This includes all editorial components, including interactions with invited authors, and the target journal. Timing of the publication is ultimately predicated by the individual journal’s supplement schedule. Journal supplements could be published before product launch and be targeted to specific audiences.
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.
Preclinical manuscript………. $10,000
Clinical manuscript…………… $16,000
Review article………………….. $20,000
Poster presentation…………… $6,000
Journal supplement………….. $175,000 (2)
1.DESIGN151927. The explanation is in an e-mail dated March 24, 1999 from Rosie Lynch of DesignWrite to Alice Conti of Wyeth Marketing.
2. DW065764. Medical Education and Communications Plan for the Premarin Product Line. Proposal for Jeff Solomon, Senior Product Manager, ERT/HRT,Wyeth-Ayerst Laboratories. Submitted by DesignWrite,Inc. August 12, 1996 (3) (See DW 065773, DW 065774 DW 065775 within this document).
Competing interest statement: Adriane Fugh-Berman has been a paid expert witness on behalf of plaintiffs in the multidistrict litigation against hormone manufacturers referred to in this blog.
JAMES RIDGEWAY can be reached at The Unsilent Generation.