“A lot of readers of this blog complain about the slow progress of drug development and question why it takes years from the time drug trial results are know to approval of the drug. The latest research shows that drugs that are approved quickly are more likely to be linked to safety problems. The so called priority review process to help MSers gain quicker access to medications comes with a cost. In a publication by Joel Lexchin, a health policy researcher from Canada, showed that drugs approved by Health Canada between following rapid review were almost twice as likely to require a safety warning or get withdrawn from the market compared to drugs approved via the standard review process. Clearly there is a trade-off between rapid access and safety. Choose your fire?”
#MSBlog: Speed or safety: choose your fire?
“Is this safety issue more likely to happen in the USA? The FDA approves drugs more rapidly than the EMA or Health Canada. The median review time for the FDA is a 3 months shorter than the other regulatory authorities (<9 months for the FDA, compared to ~12 months at the EMA and Health Canada). Are American citizens better off than Europeans or Canadians with regard to new drug approvals? Or is the FDA exposing MSers to greater risks? Choose your fire?”