SKIMMERS SUMMARY:

  • There is one and only one social responsibility of business–to use its resources and engage in activities designed to increase its profits so long as it stays within the rules of the game, which is to say, engages in open and free competition without deception or fraud. Milton Friedman
  • A newly approved drug to treat Alzheimer’s disease is expected to become a multibillion-dollar expense for Medicare. By one projection, spending on the drug for Medicare patients could end up being higher than the budgets for the Environmental Protection Agency or NASA. (New York Times)
  • If you spend any time reading pharma PR releases, you’ll see over and over again corporate managements stressing the importance of the shareholder. When a new drug is derailed the first thing that pops out is the effect on the company’s stock price, not patients.
  • Can a pharma company serve both shareholders and patients?
<strong>Shareholders versus patients:</strong><em> Who is more important?</em>

SKIMMERS SUMMARY:

  • Health experts, including those on an external advisory committee to the FDA, are skeptical that Biogen’s drug will even successfully slow the progression of Alzheimer’s after late-stage clinical trials yielded mixed results and are angry the FDA approved the product.
  • The FDA’s recent approval of aducanumab (Aduhelm) shows just how badly the agency has failed the public.
  • In late April, the FDA’s Oncologic Drugs Advisory Committee reviewed six accelerated approvals — a provisional pathway — involving a group of cancer immunotherapies where clinical trials had failed to confirm that the drugs extended survival or improved quality of life. Yet, in four of the six cases, the advisory committee voted to keep the accelerated approvals intact. (source: Medpage)
  • In response to the FDA’s approval, three members of the Peripheral and Central Nervous System Drugs Advisory Committee who opposed approval of the drug quit the panel in protest.
  • Physicians are signaling that they now want to see the “complete date” regarding new drug approvals.
“I don’t trust the <strong>FDA</strong> anymore”