Summary
The risk highlighted by this new bold warning was a known risk. The questions are:
How should physicians and patients respond to a new warning rather than new risks?
What are the risks of black box warnings?
What are the implications for Johnson & Johnson (JNJ), which makes Remicade and Simponi, Abbott (ABT), maker of Humira and Amgen (AMGN) and Wyeth (WYE), co-marketers of Enbrel, as well as UCB SA's (UCB.BT) maker of Cimzia?
Analysis
Doctors should have used these powerful medications with caution
even before this more bold warning. We already knew of the cancer risk in children and adolescents.
However, with the new warning (as opposed to new risks), physicians should still
give due consideration to the benefits of the drugs, especially in light of the
paucity of other treatments for inflammatory diseases.
give due consideration to the benefits of the drugs, especially in light of the
paucity of other treatments for inflammatory diseases.
Consider the benefit / risk analysis for inflammatory diseases which secondary risks.
For example, by NOT using these drugs out
of concern for the cancer risk, might IBD patients face a higher risk of
colon cancer as a result of years of inflammation?
of concern for the cancer risk, might IBD patients face a higher risk of
colon cancer as a result of years of inflammation?
If doctors consider the new warnings in light of the above, the impact on the manufacturers should be minimal. Why? Ironically, an abundance of caution in such matters might just be too risky.
Jeff Stier consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
