SUMMARY:

  • The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug.
  • Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.
  • Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
  • Biogen’s reputation may be damaged beyond repair.

SKIMMERS SUMMARY:

  • Jefferies analysts found doctors have shown strong interest in prescribing Aduhelm for about 35% of early-stage Alzheimer’s patients with mild cognitive impairment after surveying 50 U.S. neurologists or psychiatrists currently treating about 12,000 Alzheimer’s patients. Source: Fierce Pharma
  • If that enthusiasm pans out in the long run, it could mean at least 300,000 patients taking the drug, or $10 billion to $15 billion in peak Aduhelm from U.S. sales alone, which is above consensus estimates of around $7 billion to $8 billion, the team said.
  •  One agency FDA adviser, resigning from his committee post in protest, called it “probably the worst drug approval decision in recent U.S. history.” Source: STAT News
  • Our healthcare system can’t continue to support drugs that don’t have good clinical outcomes behind them.

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.

SUMMARY: “You’re spending all this money to make sure you make money rather than spending money to… help patients,” the California congresswoman told AbbVie’s, Richard Gonzalez. “. That was pretty brutal, but to was right on target by Rep Katie Porter. While AbbVie is a poster for everything wrong with pharma, what they have done doesn’t apply to ALL pharma companies.

QUICK THOUGHT: Pfizer has already made $24 billion from their COVID vaccine, but that’s not enough; they want more, a lot more. They are planning to increase the vaccine price, and they’re working on an oral pill that could bring in as much as an additional $2 billion. While the U.S. Government didn’t pay for development, the German Government did. It is about providing a need at one hell of a profit margin.