How to spin pharmaceutical research
Ten years ago, when a young doctoral candidate—let’s call him “David”—received his degree in developmental biology, he was at something of a loss. He had been working in the laboratory long enough to suspect that he was not very good at bench science, and in any case, he did not especially enjoy it. One day his father showed him a newspaper advertisement. A medical-communications agency was looking for a trained medical writer. David was hired on the spot, even though he had no idea what a medical-communications agency actually did.
His first assignment was to produce scientific abstracts for studies of a newly approved antibiotic. Unfortunately, the antibiotic had a major weakness: it did not work against pneumococcus, one of the most common bugs a doctor will see. But this shortcoming was not something that the drug’s manufacturer— hich was funding the articles and abstracts—was keen to point out. So David and his fellow medical writers were told to avoid the topic. A lanky Englishman in his mid-40s, David compares the instruction to a famous episode of the British comedy Fawlty Towers, where Basil Fawlty has guests coming from Germany and keeps telling the staff: “Don’t mention the war!” At the agency, David says, the running joke was “Don’t mention the pneumococcus!”
The mechanics of the ghostwriter’s job are fairly simple, David says. Early on, a medical-communications agency and its pharmaceutical-company sponsors will agree on a title for an article and a potential author, usually an academic physician with a reputation as a “thought leader.” The agency will ask the thought leader to “author” the article, sometimes in exchange for a fee. The ghostwriter will write the article, or perhaps an extended outline containing the message the company wants to transmit, and send it along to the physician, who may make some changes or simply sign it as written and submit it to a journal, usually scrubbed of any mention of the ghostwriter, the agency, or the pharmaceutical company. David says he rarely even sees the published articles he writes.
Every so often, the issue of ghostwriting moves out of medical schools, where it is generally tolerated or ignored, and into the wider public sphere, where it is treated as a moral scandal. The most recent burst of outrage came in July during an investigation by the U.S. Senate Finance Committee, which has been looking into whether GlaxoSmithKline tried to steer attention away from the cardiac risks of its diabetes drug Avandia (whose use was recently restricted by the Food and Drug Administration). The committee found not merely that GSK had “downplayed scientific findings” to minimize the apparent risks of Avandia, but that it had used a ghostwriting campaign for the drug. (The company had called the ghosting effort “Case Study Publication for Peer Review,” or CASPPER.)
Ghostwritten articles surface again and again in litigation (in cases concerning Vioxx, Fen-Phen, Zyprexa, Premarin, Neurontin, and Zoloft, to mention just a few). Years before the Avandia scandal, GlaxoSmithKline paid $2.5 million to the State of New York to settle a lawsuit alleging that it had concealed studies suggesting an increased risk of suicidal behavior in children and teenagers taking Paxil, most notoriously in an article “authored” by Dr. Martin Keller of Brown University. One 2003 study in The British Journal of Psychiatry found that ghostwriters working for a single medical-communications agency had produced more than half of all medical-journal articles published on Zoloft over a three-year period.
To many critics, the moral outrage of ghostwriting is like that of plagiarism: academic physicians are getting credit for articles they didn’t actually write. To David, letting someone else take the credit for his work is a minor humiliation. The real problem, of course, is much worse: spinning data perverts science. It also downplays risks that can lead to serious injuries, and deaths. As David puts it, “The moral crime I was being asked to commit was to do with truthfulness.”
In recent years, journals have strengthened their disclosure policies, but to little effect: most simply call for transparency (which can be dealt with by acknowledging the ghostwriter for “editorial assistance”), but allow the underlying moral crime to remain in place. In fact, the journal that published the notorious ghosted Paxil article, the Journal of the American Academy of Child and Adolescent Psychiatry, has not even retracted it. Doctors unfamiliar with the scandal have no reason to suspect the article is misleading.
Don’t expect ghostwriters to speak up. They are well-paid technicians who perform a specialized service for their clients, often without a whole lot of agonizing about the ethics. Even if writers were to cultivate a little moral anguish, they probably could not do a lot with it. Like lobbyists, public-relations consultants, and hit men, medical writers are instruments in a much larger enterprise. Their moral problem lies in the structure of the job itself.
A few years ago, David went to a cardiology congress in Barcelona, where he had dinner one evening with a group of fellow medical writers. They were a friendly bunch, but he found them terribly sad. Medical writing has little glamour, and whatever moral purpose it might once have carried has been rubbed away by the constant friction with commerce. If you are a true believer in the glory of the market, the work might be invigorating, and the long hours a mark of pride. But if you are a lapsed biologist, raised in the church of science but compelled to leave, it is apparently a source of nagging resentment. Says David, who for all his protests has yet to give up his job, “What a wretched epitaph to a life this would be.”