After Science Careers published an article last November on the hazards of medical literature ghostwriting, an industry representative sent an e-mail suggesting that our research was out of date. "This article does not reflect current industry practices," wrote Carl Rios, a medical affairs manager at Nycomed, a pharmaceutical company based in Zurich, Switzerland. "It is not fair-balanced as it leaves the reader believing that the pharmaceutical industry has not taken action to avoid medical ghost-writing, which in fact, it has."
Still, according to researchers such as Adriane Fugh-Berman of Georgetown University Medical Center in Washington, D.C., and Leemon McHenry, a medical ethicist at California State University in Northridge, the practice of industry ghostwriting persists. "Pharmaceutical and medical communication companies have just found more clever ways of concealing their activities," Fugh-Berman says.
Most major companies have established rigorous checks and balances and put new policies in place to mitigate such behaviors.
Ghost authorship occurs when an unacknowledged author makes substantial contributions to an article that appears under the names of other scientists, who may contribute little. Accounts from court records reveal instances of pharmaceutical companies paying medical communications companies to draft articles favorable to their products, then hiring well-known academics to publish the papers under their own names without disclosing the papers' origins.
The earlier Science Careers article highlighted a case involving the pharmaceutical company Wyeth, which paid ghostwriters to write dozens of papers on hormone replacement therapy. Published in medical journals between 1998 and 2005, the articles exaggerated the benefits of the therapy while minimizing its risks.
And in 2009, documents uncovered by a law firm representing users of the antidepressant Paxil showed that GlaxoSmithKline paid ghostwriters to write journal articles promoting the drug and downplaying its risks. An internal memo showed that the company instructed salespeople to offer assistance to physicians writing and publishing articles describing the drug's benefits.
Such activities taint the contents of the medical literature by injecting messages that benefit the sponsor, says Fugh-Berman, who directs PharmedOut, "a university-based project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices."
"Rigorous checks and balances"
Rios says in an interview with Science Careers that although such things have occurred, they probably haven't occurred recently. "Most major companies have established rigorous checks and balances and put new policies in place to mitigate such behaviors," says Rios, who oversees publication activities in support of some drugs marketed by his company.
Rios says most companies now require academic authors to be involved throughout the writing process, from planning and outlining the main points to choosing which data are reported and signing off on a final draft. The contributions of all parties are tracked and recorded, he insists. And standard policy at most companies now requires that scientific articles acknowledge participation of any industry-sponsored writers or contributors; such writers may be listed as co-authors or in the acknowledgements section.
Many of these changes are laid out in guidelines issued by the International Society for Medical Publication Professionals in December 2009. The guidelines, which were published in the British Medical Journal, update a 2003 guidance document and include more than two dozen new recommendations focusing on the role of the professional medical writer.
Changes in company structure also deter ghostwriting, Rios says. Most biotech and pharmaceutical companies, including his, have separated their marketing and medical affairs activities to ensure that information is "scientifically driven and communicated in a fair and balanced way." This separation serves to "pull and separate out promotional activities from medical activities," Rios says.
Assessing the effect of change
Has self-policing solved the problem? McHenry, who studies ghostwriting, says the practice continues and is likely far more extensive than what the high-profile cases might suggest. "There are no good figures on the prevalence of ghostwriting and I believe there never will be," McHenry writes in an e-mail. "The companies can hide these numbers because they can use the trade secrets act to make sure no one finds out. The only reliable information is from legal cases, but even these are limited because the details of the extent of ghostwriting disappear as part of the legal settlements."
McHenry estimates that for each drug that comes to the market, 100 to 300 articles, reviews, and letters will be published to support the drug, with the number being "at the higher end" for blockbuster drugs. "Of these ghost-managed publications that originate with pharma marketing, at least half are likely to be ghostwritten," he says.
In a 2009 survey, 42% of respondents -- professional medical writers who had worked on manuscripts for medical journals -- acknowledged making undisclosed contributions to manuscripts published in 2008. Published in The Write Stuff, the journal of the European Medical Writers Association, the article notes that this was an improvement from the 62% reported in 2005.
Although most leading journals have taken steps to make ghostwriting less likely -- questioning would-be authors more intensely to ferret out conflicts of interest and requiring that all authors and contributors list the nature of their contributions in detail -- not all journals have adopted such rigorous standards. And even when such high standards are employed, companies may find ways to spread positive results and bury negative ones, Fugh-Berman says.
So what are the implications for early-career scientists? First, they need to be aware of ghostwriting and its hazards and take care not to unwittingly transmit marketing messages. Second, they should read the medical literature with a skeptical eye, wary of hidden marketing messages and other taints.
Fugh-Berman, who is now researching ways that marketing messages can be inserted into articles, says review articles should be read especially cautiously. Review articles are ideal opportunities to single out particular studies, including those that serve marketing purposes, Fugh-Berman says. Of the ghostwritten manuscripts that have surfaced, many are reviews.
Recently, Fugh-Berman surveyed a group of physicians to see what "take-home messages" they received from reading articles on fast-acting opiates. Doctors reading an industry-funded article said the overall message of the article was, "opiates are underused and should be used more on arthritis," Fugh-Berman says. Readers of a nonindustry-funded article got the message that long-term use of opiates is unproven and can cause addiction and death.
"If you look at the industry-funded article, you could not say that they don't mention addiction or don't mention death, because they do," Fugh-Berman says. "But this is writing, persuasive writing, so a writer can bend the perception of the reader by how they phrase something."
What to look for
Fugh-Berman is initiating studies with linguists to analyze the wording of articles known to be ghostwritten, seeking indicators that editors and others could look for. So far they have found no proven hallmarks, Fugh-Berman says, but her studies have alerted her to a few things to look for:
* Anecdotal evidence, often presented as "from a clinician's point of view" or "I see this in my practice." Although such phrases appear in many articles that are free of taint, readers should beware if what follows contradicts established science.
* Phrases such as "emerging uses" if used to describe therapies that are not yet proved or approved.
* Use of mottos or catchy phrases, especially in the title. Attention-grabbing techniques might be a tip-off to a polished, professionally written piece.
"I think there is a role for professional writers within academic medical centers," Fugh-Berman says. Bringing a writer on board to help smooth a manuscript or help with a draft is acceptable, she says, so long as the writer's contributions, and any conflicts of interest, are acknowledged.