It’s happened to me several times while reporting on a story about the current state of drug approvals in the United States: a source stops talking, sighs, and tells me: “You know, if aspirin were up for approval today, the FDA would reject it.”
The hypothetical is meant to imply that regulators have become overcautious, and that consumers have come to expect side-effect free drugs. The first time I heard the aspirin example, I thought it was clever. By now I think I’ve probably heard it from about six different people and somewhere along the way it lost its shock value. Someday I’d like to trace its origins: who was the first to say this?
Today, in a session on the regulatory challenges of developing drugs that prevent cancer, Ellen Sigal of Friends of Cancer Research in Arlington, Virginia took up the torch: “I’d like to see Aspirin approved in the regulatory environment today,” she scoffed.
I should probably point out: others have told me that today’s regulators are approving drugs that are more toxic than ever. But the difference is that the more toxic drugs include, for example, cancer drugs for patients who otherwise wouldn’t have a fighting chance. The standards are different for drugs that would be taken by otherwise healthy people to ease a few aches and pains, or to prevent a disease they might never get anyway.
Sigal cited “hysteria in the media” as a reason for overcautious regulation, which she says is holding back drug development — particularly of cancer-preventing drugs. True, there has been some hysteria. But in some cases, industry surely must shoulder at least a little of the blame: nothing whips the media into an emotional frenzy like the scandal of suppressed clinical trial data.