Among them are medical “ghostwriters,” paid by the pharmaceutical or biomed company, whose work ranges from simply touching up an article to writing the entire thing. No protocols are in place to standardize those arrangements: sometimes the academic researcher knows about the ghostwriter and has final approval, sometimes not.

A search of PubMed, the online resource of published medical research, shows no mention of Andrea Gwosdow since 1997. Not coincidentally, this is when she began her freelance medical-writing business. In fact, Gwosdow has written — or rather, ghostwritten — many medical-journal articles in the past decade from her home-based office in Arlington, Massachusetts, under contract to area companies such as Boston Scientific, Genzyme, Interleukin Genetics, and Anika Therapeutics. But her name does not appear on the articles.

Gwosdow is one of roughly 300 members of the American Medical Writers Association here in the Boston area. Some, like her, are freelancers. Others work as subcontractors through companies such as Rete Biomedical Communications, Cayuga Consulting, MedBio Publications, and Life Science Publishing.

No standard exists for the relationship among these writers, the company, and the academic researcher. The ghostwriter usually works for the company’s science department, but not always. “For Genzyme, I have in the past been hired directly for the marketing group,” Gwosdow says.

Other ghostwriters are employees of the company funding the study — people like Janice Schaap, who’s not listed as a co-author but who “assisted in the writing” of a January 2004 article in Cancer, according to an acknowledgment. That article, whose lead author was Paul J. Hesketh of St. Elizabeth’s Medical Center, in Brighton, reported that darbepoetin alfa effectively corrects anemia in patients with malignant disease. The article does not mention that Schaap was an employee of Amgen, whose sales of its darbepoetin-alfa drug Aranesp grew 32 percent — to $3 billion — the year after the article appeared.

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Another set of private, for-profit companies now oversee the clinical trials themselves, adding another interested party to the process. The growth of these “Contract Research Organizations” (CROs) is one of the biggest changes in the medical-research field over the past 20 years, say many in the field locally. Some argue this change is for the better, and even many skeptics agree that CROs often manage trials more efficiently than academic institutions. “I think the quality of the research and the quality of the data collected is actually better now, because of the growth of the CRO industry,” says Douglas Gregory. His CRO, Cardiovascular Clinical Studies, offers planning, clinical development, and, yes, assistance in authorship. “We’ll assist them in writing the article,” says Gregory. “It’s done in a very collegial fashion.”

The entire executive team of Gregory’s company consists of doctors currently affiliated with Tufts-NEMC or the Tufts University School of Medicine — including its chief scientific officer, Marvin Konstam, author of the Vioxx-is-safe study already mentioned. Another local CRO, Boston Clinical Trials, is mostly staffed with doctors affiliated with Tufts or St. Elizabeth’s.

Then there are the consultants, who provide a range of marketing services, including clinical research, to pharma and biomed companies. One of Boston-based Analysis Group’s service areas is “managing scientific and medical outcomes.” Waltham’s Decision Resources “offers a rich array of research publications advisory services.” In Cambridge, Abt Associates vice-president Chris Pashos co-authored 10 articles published just last year. A company called i3 Innovus, which co-authored 16 medical-journal articles last year, “provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle.” It has a Boston office which is home base to its vice-president of US operations, Milton Weinstein, a Harvard Medical School and Harvard School of Public Health professor.

Matter of trust
This burgeoning field of industry-paid ghostwriters inevitably leads to concerns about the spinning of the data. Gwosdow admits that the pressure is there. “If they try to stretch the data — which I certainly have had companies do — I bring it to their attention,” she says. Usually, “we can find words that the data can support.”

Gwosdow once walked away from a ghostwriting job, when the client wanted to stretch the data further than she was comfortable with. But, she acknowledges, for all she knows, the company found someone else to do it, and then found a journal to publish it.

Or the company could bury the bad data. One study found that a quarter of all large clinical trials presented at annual oncology meetings were never published. And industry-sponsored research that does get published is five times more likely to have a positive conclusion about the sponsor’s drug than independently sponsored research — regardless of the prestigious academic institution’s name on the article — another study concluded.