O'Reilly logo

The Cure in the Code by Peter Huber

Stay ahead with the world's most comprehensive technology and business learning platform.

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, tutorials, and more.

Start Free Trial

No credit card required

9

THE FADING MYTH OF THE FDA’S “GOLD STANDARD”

THE FDA’S FRONT-END, double-blind clinical trial protocols, it is often said, establish the “gold standard” for drug science. Washington’s meticulous scripting of those protocols, however, was launched in 1962 by a drug that vividly illustrates why it is so often impossible to script them well. When the cause-and-effect connections are complex, writing a good trial script requires information that only the trial itself can reveal.

Thalidomide did no significant harm to most adult women (though there were early reports, since confirmed, of adverse peripheral nervous system effects in some patients), and it harmed their unborn children in many different ways, but only in the early weeks of pregnancy. ...

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, interactive tutorials, and more.

Start Free Trial

No credit card required