In its most recent report to shareholders, Merck announced that it is reducing its sales staff and “will place more emphasis on active engagement with key opinion leaders” — pharma code for academics — “to accelerate the development and diffusion of scientific information.” Pfizer’s Medical and Regulatory Affairs Group “identifies, builds, and leverages strategic partnerships with medical thought leaders in academia.” ApotheCom, a pharmaceutical marketing company based in Oakland, California, tells prospective clients on its Web site that “establishing the product’s scientific profile in the medical literature is critical to its successful positioning.”
It’s not just the pharma giants that are “positioning” themselves in this way. Little start-up Vaso Active recently settled a class-action lawsuit that had been pending in Boston’s federal-district court. According to court documents, investors bought into the small Ayer, Massachusetts, company two years ago largely because its registration statement and Web site touted a pilot clinical study — “analyzed by New England Medical Center” — which found that Vaso Active’s transdermal drug eliminated athlete’s-foot infection in 100 percent of patients within 10 days. Only later, after the product proved less effective and the stock tanked, did investors learn how little involvement NEMC had in the study to which it had lent its name. Investors argued that Vaso had overhyped NEMC’s role, when in reality NEMC statistician Robin Ruthazer had merely crunched numbers provided to her by Vaso Active — a fee-for-service that the NEMC Biostatistics Research Center still offers, a spokesperson confirms.
Given all the scandals surrounding the pharmaceutical industry, you might expect academic researchers to maintain a certain skepticism that drug companies might manipulate data or bury bad results or misrepresent findings. Instead, it sometimes seems they’re the only ones left who trust big pharma. A national survey conducted by the Harvard School of Public Health found many clinical-trial investigators “willing to accept provisions that give industry sponsors considerable control.” For that reason there is growing concern at Boston’s universities, teaching hospitals, and medical-journal publishers, where some fear that a few highly publicized disasters — bad research with a well-known institution’s name on it — will turn a Harvard, Tufts, or Massachusetts General into just another untrustworthy name, tarnishing all the good work along with the bad.
Off label = big money
Not so long ago, almost all clinical medical trials were set in motion when an academic researcher decided to pursue a scientific hypothesis. Today, many of them originate when a company wants to sell a device or drug. This is partly because full-scale pharmaceutical testing in today’s expanding market has become enormously expensive, and the industry has surged ahead of government support for research and development. As a result, as much as 80 percent of all clinical trials are now paid for by private industry. “Any clinical trial won’t be done unless somebody stands to gain from it — let’s face it,” says Douglas Gregory, CEO of Cardiovascular Clinical Studies, Inc., in Boston.
