Drugmakers Must Make Safety Case to the Public, Industry Exec Says

Drug safety is a significant issue to consumers, and the pharmaceutical industry needs to take a leadership role in communicating the risk-benefit profiles of drugs, according to an industry executive.

“With a large database and with the greater use of a product, the statistical certainty of a [drug safety] signal becomes more and more clear. That’s why often these signals are seen years after a product is approved,” Richard Bowles, vice president of Global Quality Operations at Schering-Plough, said at the Import Safety Summit in Washington, D.C.

“This is a mysterious area to everyone and to the general public, and I think it’s creating an environment where people are becoming afraid of drugs,” Bowles continued.

He said industry needs to bust the myth that patients can chronically consume pharmaceuticals that treat, for example, high cholesterol or high blood pressure without anyone experiencing adverse effects.

Now that data from clinical trials will be publicly available, the information will be analyzed and, inevitably, opinions about the safety of a particular product will diverge from those of the manufacturer, he said.