2 Dec | ProPublica – This isn’t news but according to newly released documents from GlaxoSmithKline, the pharmaceutical company often paid ghostwriters to pen medical studies, editorials and even a textbook that listed physicians as the authors.

By Marian Wang

ProPublica

The documents — some of which date back to late 1990s — were recently unsealed in litigation over a GlaxoSmithKline product. We saw them after they were attached to a letter released this week by a nonprofit watchdog group urging the National Institutes of Health to crack down on ghostwriting in medical academia.  The documents and the letter by Project on Government Oversight together outline several examples of how a major drug company contributed to the funding, writing and approval of material published in medical journals and elsewhere.

The textbook, published in 1999, listed two physician co-authors who at the time were chairs of the psychiatry departments at the medical schools of Stanford University and Emory University, the New York Times reported this week in a piece that focused only on the textbook. According to the Times, it’s the first instance where a book has been criticized for the same issues with ghostwriting and drug industry influence that have plagued medical journals.

A GSK spokesman told the Times that the company’s role was described in the book’s preface, which thanked the UK drugmaker (then known as SmithKline Beecham) for an “unrestricted educational grant” to the ghostwriting company, Scientific Therapeutics Information. Correspondence between a Scientific Therapeutics Information employee and one of the co-authors, however, shows the employee informing the stated author that she had “begun development of the text.” The employee, Sally Laden, also described her co-worker as the “primary technical writer” and manager for the project.

According to the documents, that same ghostwriter, Sally Laden, wrote an editorial published in 2003 in a medical journal with authorship attributed to two more doctors. One, Dwight Evans, is chairman of the psychiatry department of the University of Pennsylvania School of Medicine. His co-author, Dennis Charney, was head of a research program for the National Institute of Mental Health. (We’ve asked both for comment but have not yet received a response.) While Laden was credited for “editorial support” in the published article, another document seems to suggest she played more than just a supporting role. In an e-mail to a GlaxoSmithKline employee, she inquired about the status of her payment “for writing Dwight Evans’ editorial.”

Laden also helped a number of authors write a 2001 study that was funded by GlaxoSmithKline and concluded that a GSK antidepressant, Paxil, is “generally well tolerated and effective for [treating] major depression in adolescents.” Within a few years, problems with the study became apparent, and both UK regulators and the Food and Drug administration issued warningsabout Paxil. Glaxo, following the FDA’s warning, issued a letter in 2004 informing healthcare providers that Paxil is “not approved for use in the pediatric population, and clinical trials for PAXIL failed to demonstrate efficacy in pediatric depression.”

Of course, just because a ghostwriter is involved doesn’t mean a study is flawed. An anonymous medical writer who has ghostwritten articles published in top medical journals gave an interview in October to the executive editor of a blog by the Society for Scholarly Publishing. In it, he argued that he provides “a service to those who need assistance presenting their findings to the scientific community” — in other words, to academics who “have a great study” but aren’t good writers.

The ghostwriter also acknowledged, however, that writing services are often solicited by a pharmaceutical company first, and a manuscript is sometimes written before an academic “author” is found:

In my experience, the pharmaceutical company would pay a communications/marketing company to write the manuscript, who would then go out and find academics who would be willing to become the “authors” of the manuscript and paid an honorarium. I’ve worked with some authors who do absolutely nothing on the manuscript, requiring an additional ghostwriter to be hired, and still demand an honorarium for their time. These academics are willing to enter into this relationship because of the importance of authorship to their careers. You can’t entirely blame the pharma company. Universities encourage academics to play this game.

Earlier this year, a study in a scientific journal analyzed how medical ghostwriting works. It found that simply acknowledging ghostwriters “does not accurately reflect their authorship role.” It also found that, of the top 50 medical schools, only 10 explicitly ban ghostwriting.

GlaxoSmithKline told the Times that in recent years, the company has tightened its internal guidelines for medical writers.