The FDA explained that it was revoking approval of the drug for that use because it decided that the drug does not provide "a sufficient benefit in slowing disease progression to outweigh the significant risk to patients." Risk? The drug is prescribed for women who are otherwise going to die from cancer unless the drug saves them at least for a time. The far greater risk to these women is from the FDA, not the drug.
As The Wall Street Journal said last Friday in response to the FDA's explanation:
Ponder that [word] "sufficient." The agency is substituting its own judgment about clinical meaningfulness for those of practicing oncologists and terminally ill cancer patients.That FDA judgment was determined last summer by an internal agency panel of 13 experts, only two of whom were breast cancer oncologists, and none of whom were breast cancer patients.
No comments:
Post a Comment