Both in HOOKED and previously on this blog, I have mentioned examples of physicians who attempt to raise warnings about serious adverse reactions from popular drugs, and who are then subject to intimidation by the manufacturer. A recent story by Alicia Mundy in the Wall Street Journal (subscription required for on-line access) shows how far down the food chain this activity extends.
Mundy recounts the case of Dr. Mary Money, an internist in Hagerstown, MD. She and a colleague started noticing diabetics taking Avandia (rosiglitazone) who developed severe cases of congestive heart failure, which often reversed soon after the drug was stopped. Soon after the drug was introduced in 1999-2000, they looked at 85 patients and noted that more than half had developed significant fluid retention, a precursor of congestive heart failure. She alerted the maker of the drug (SmithKline Beecham, which later merged to form GlaxoSmithKline) and tried also to notify the FDA.
She and her colleague got only form letters from the FDA, but received a delegation of SmithKline folks at their local hospital, Washington County Hospital. They soon found that the delegation had no interest in hearing their evidence and had come solely to chew them out for saying incorrect things about their great drug. A consultant who attended by phone accused them of being unable to interpret the echocardiograms that formed part of their diagnostic workup of the patients.
Later, SmithKline executives contacted Washington County's chief of staff and demanded that he make Dr. Money hush up and stop saying bad things about Avandia. (He claims that he refused to go along.)
Subsequently, as evidence mounted that Avandia patients were at increased risk of heart failure, the company was forced to add more stringent warnings to the label, and the WSJ notes that Avandia sales have been falling since a major article on its risks appeared in the New England Journal.
Two things seem instructive about this case. The first is that, no offense to Dr. Money, but she really seems like small potatoes. One does not usually expect a private-practice internist in Hagerstown to sway medical opinion all that much on her lonesome. The fact that the drug company went to all this effort to discredit and intimidate her seems impressive.
The other instructive thing is that GlaxoSmithKline even today is willing to defend its actions. The company told Mundy that they felt completely justified in "correcting" the "inaccuracies" contained in Dr. Money's claims. When a commercial company cannot tell the difference between a scientific exchange of ideas, or a physician's or scientist's rights of free speech for that matter, and its own marketing and sales agenda, we see why medical professionalism requires that physicians put as much open space as possible between themselves and the drug industry.