Why Should We Swallow What These Studies Say?

If disclosure is a failed strategy, what then? How could the NCEP have done a better job of coming up with new guidelines? First, by using physicians without financial ties to statin makers. Second, by expanding the panel to include experts in methods of clinical research. If there aren't enough non-conflicted physicians for the entire panel, at least some strong, independent voices should be mixed in.

Better still, we should dissuade leading physicians from doing non-scientific work for pharmaceutical makers. Doctors who want to be respected as independent authorities should not become paid speakers for drug companies or consult with the industry on marketing issues. These arrangements do not benefit medicine or improve patient care; they only promote the profit goals of the companies. We should save the prized task of preparing clinical practice guidelines for experts without such conflicts. After all, having a financial conflict is voluntary; physicians can either take it or leave it. We must convince them to leave it.

The entanglements of the NCEP panel are merely one example of what is happening throughout the profession. Indeed, the organizations that sponsored the cholesterol study, while powerful forces for good, have themselves been beset by conflicts of interest. Reporters revealed earlier this year that many scientists from the government-run NIH had been granted exemptions from rules against receiving money from industry sources, and that some top NIH researchers had financial conflicts that could have influenced their decisions as institute directors. The American College of Cardiology received more than $2 million from four of the statin manufacturers in 2002.

The American Heart Association's record is far from pure either. Four years ago, an AHA panel recommended using Alteplase, a Genentech clot-busting drug, for patients with certain kinds of strokes. The advice was controversial because bleeding, a complication of the treatment in some cases, can be life-threatening. To aggravate the problem, the minority report was expunged and the name of the lone dissenting member of the panel was omitted from the final report. A reporter, writing in the British Medical Journal, later discovered not only that the AHA had received $11 million from Genentech in the prior 10 years, but that six of the eight panelists had ties to the company or its marketing partner, Boehringer Ingelheim.

If medical organizations continue to use heavily conflicted experts to make clinical policy, they will erode the confidence of the public. The public needs medical institutions it can trust for help with decisions it can barely understand.

The NCEP report may be correct about the benefits of lowering cholesterol targets, but concerns about its objectivity undermine its importance and impact. What do we tell hundreds of thousands of doctors and millions of patients about taking statins? I have no prescription for the patients, only for the profession: We must clean up our act.

Author's e-mail:

jerome.kassirer@tufts.edu

Jerome Kassirer is editor in chief emeritus of the New England Journal of Medicine and a professor at the Tufts University School of Medicine. He is the author of the forthcoming "On the Take: How Medicine's Complicity With Big Business Can Endanger Your Health" (Oxford University Press).