SUMMARY:

  • The FDA has many puzzled as to why they approve some drugs with questionable data and ask for more data on other drugs.
  • The FDA approves drugs on the potential to save a life, the cost of the drugs is never considered in the process.
  • The FDA has been under criticism, but an internal investigation will focus on approval processes, not “why” a drug was approved.
  • Our healthcare system cannot continue to support marginally effective drugs. We need to learn to say NO.
  • Drug companies know how to play the system.

SUMMARY: The approval of Biogen’s Alzheimer’s drug, after its advisory panel turned it down, begs the Inspector General to open an investigation into the FDA. Biogen’s $56,000 drug is proof that it was never about the science; it’s about a lifesaver for a sinking company. In the meantime, caregivers are going to put their hope in a drug that doesn’t work and in garbage science with cherry-picked data.