You may have heard of a little ongoing row about a Merck drug called Vioxx, which was pulled from the market in 2004 due to evidence that it caused serious heart problems in some users. According to the allegations, Merck aggressively marketed Vioxx as safe and effective for pain relief, while repressing knowledge that the drug raised the risk of heart attack. This week, another plaintiff won a multi-million-dollar jury award; 9650 more lawsuits nationwide are still pending.
What you may not know is that one of Merck’s most effective allies in marketing Vioxx was Marvin A. Konstam, a professor of medicine at Tufts University, chief of cardiology at Tufts-affiliated New England Medical Center (NEMC), and a paid consultant for Merck. In 2001 — a year after serious questions about Vioxx’s safety came to light — Konstam was the lead author of an article in the journal Circulation that found “no evidence” that Vioxx caused more cardiovascular problems than alternative pain medicines or placebos. The article was cited in dozens of other articles.
It also offered evidence, some say, of how Boston’s prestigious medical institutions — one of the area’s biggest assets — are being used and abused by pharmaceutical and medical-device companies to market their products.
Why? Because Konstam himself did not actually conduct or oversee any clinical trials for the 2001 article: the data was all provided to him by Merck from the company’s own trials. Nor did Konstam decide which trial results were included in the study: that, too, was handled by Merck, and critics allege that its findings were flawed. (The article, however, is not implicated in current lawsuits.) Five Merck employees were listed as co-authors of the study. The article’s acknowledgments cited Qinfen Yu for doing the data analysis, without mentioning that Yu was also a Merck employee. It also thanked Diana Rogers for “preparation of the manuscript,” omitting that she was a ghostwriter hired by Merck. Despite all this, the first author you see on the article is Marvin A. Konstam, and the first institutional name is NEMC. Only in the fine print do you find the co-authors’ Merck affiliation.
This is increasingly how medical research is getting done these days. Drug and medical-device companies conceive, finance, manage, and even write projects. Then they enlist researchers with affiliations that are trusted as independent intellectual authorities — such as Harvard Medical School, Brigham and Women’s, or Dana Farber — to put their names on the articles. When conducted in this manner, medical research is sometimes little more than marketing garbed in lab coats.
Scientists lend their names to such studies for any number of reasons: for the prestige of publishing (sometimes in quest of tenure), to land a grant, to maintain a lucrative consulting relationship with the company, or simply out of genuine scientific interest in the subject matter. Critics say these scientists usually don’t see themselves as willing instruments of pharma/biotech sales-and-marketing teams. But there is little doubt that the companies see them that way.
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.
