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. “The sources of knowledge that doctors have been trained to trust have been taken over by the medical marketing community,” says Abramson. “We can never trust what we’re reading.”