3 ms·
> We need to end off label use. Saying a drug is approved for one diagnosis and then allowing it for any other diagnosis is, in the modern age, simply crazy. On
by wl 7y ago
> We need to end off label use. Saying a drug is approved for one diagnosis and then allowing it for any other diagnosis is, in the modern age, simply crazy. One might as well not have fda approval.
The approval process itself is what's crazy. Drugs are approved for treating disease X, but drugs don't work that way. They are chemicals that modify processes in the body to produce collections of effects that help treat some medical issue. What does prednisone treat? It's an immunosuppressant, an anti-inflamatory, and it reduces blood calcium levels. That's useful in treating a range of conditions like heart failure, cancer, autoimmune diseases, and many, many others.
One example of the insanity of this regime is the HPV vaccine. What does the drug do? It helps the immune system fight off certain strands of HPV. What was it approved for? Preventing cervical cancer. Since men don't have cervixes, it wasn't FDA-approved for men and any administration of that vaccine was strictly off-label. It took an additional approval and many years to get it approved for men, even though there was no reason to believe the vaccine would work in women but not in men.