Is a Drug Effective? The FDA Shouldn’t Decide

Pharmaceutical companies are better positioned to understand what information physicians want—and how to generate it quickly and economically

Letter to The WSJ. 

"James Meyer objects to our Oct. 18 op-ed, writing that the federal government has an interest in ensuring a drug’s efficacy because it often picks up the tab for it (Letters, Oct. 25). True—that’s why we wrote that “drug companies would still run efficacy trials” because “doctors, insurers and patients want assurances that a new drug actually works.”

As in many other areas of life, government bureaucracies make everything slower, more expensive, less efficient and less tailored to the end users’ needs. Pharmaceutical companies are better positioned to understand what information physicians want—and how to generate it quickly and economically. Their ability to do so will help determine the success of the products they are developing. Licensed, medically trained doctors must then prescribe a given drug—an additional mechanism for ensuring efficacy.

Still, it’s worth remembering that even if two large randomized controlled trials are run to test for it, it’s possible only 60% of patients will benefit. No one knows if a patient will be in the 60% or the 40%. It always comes down to trial and error.

Charles Hooper and Solomon Steiner"