KEYCODE BAYER #241, April 25, 2006

Industry-Funded Scientists Flood FDA Advisory Panel

A science advisory panel for FDA is scheduled to consider new labeling guidelines for blood pressure control drugs tomorrow. Yet, according to information compiled by the Center for Science in the Public Interest, three-fourths of the 12-member panel received conflict of interest waivers. Many of those conflicts of interest relate directly to the issues of drug labeling to be discussed by the panel.

35 million Americans take drugs for hypertension. "rug labels - and the permissive statements those labels allow drug salespersons to make to physicians - can have a major impact on prescribing patterns," according to CSPI.

While 2003 guidelines developed by the National Institutes of Health have recommended a cheap, generic diuretic as the best treatment for hypertension with the fewest complications, the FDA's proposed label uses a wording ambiguous enough to give the drug industry leeway to push inferior drugs, stating that "numerous drugs from a variety of pharmacologic classes, whose only common property is to reduce blood pressure, have been shown to reduce cardiovascular morbidity and mortality."

"FDA's document is written so industry can go out and say that it doesn't matter which drug you use," said Curt Furberg, a hypertension expert at Wake Forest University who sits on the FDA's Drug Safety committee. He wasn't invited to be part of this panel.

Several of the physicians who will play key roles in the committee's deliberations have conflicts of interest that relate directly to the labeling discussion. For instance, committee chair William R. Hiatt, a professor of medicine at the University of Colorado, has conducted research for Bayer Pharmaceutical showing the benefits of controlling blood pressure in diabetics with peripheral arterial disease . The label guidelines suggest secondary benefits like improved PAD can be used as a basis for recommending one drug over another. None of the 11 physicians associated with the National High Blood Pressure Education Program Coordinating Committee, which wrote the 2003 peer-reviewed guidelines, was chosen for the FDA panel.

CSPI goes on the list a litany of other examples of conflicts of interest involving scientists making health policy decisions, including industry-funded doctors defining mental disorders and biases in a CDC vaccine report. It's enough to raise your blood pressure.

More information on conflicts of interest in science can be found in the Integrity in Science Database of Scientists and Organizations With Ties to Industry. (Posted by Genevieve Smith)