Wednesday, April 16, 2008

Two years ago, I wrote an in-depth investigative article about pharmaceutical research at Boston-area medical schools and teaching hospitals, suggesting that researchers were risking the reputation of those institutions by putting their names on medical studies really being conducted and/or written by drug companies.

I began the article with the example of Vioxx, the product for which Merck had just lost a multi-million-dollar lawsuit for allegedly repressing information that the drug raised the risk of heart attack. I wrote:

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.

Today, the Journal of the American Medical Association cited Konstam and Vioxx among many examples of "ghostwriting" and similar practices. (Journal article here; Boston.com story here.) A JAMA editorial blasts the practice, saying that "Merck & Co Inc apparently manipulated dozens of publications to promote one of its products. But make no mistake—the manipulation of study results, authors, editors, and reviewers is not the sole purview of one company."

That is certainly true -- and it will stain the reputations not just of individual researchers but their institutions, many of which are right here in the Boston area.

4/16/2008 1:29:44 PM by David S. Bernstein | Comments [0] |