SUMMARY: Three House Democrats on a key committee voted against the measure to lower drug prices as PhRMA ramped up its lobbying dollars to buy politicians. “I understand that the pharmaceutical industry owns the Republican Party and that no Republican voted for this bill, but there is no excuse for every Democrat not supporting it,” Sen. Bernie Sanders wrote in a scathing statement.

SUMMARY:

  • According to the NEJM “in participants with overweight or obesity, 2.4 mg of semaglutide once weekly plus lifestyle intervention was associated with sustained, clinically relevant reduction in body weight”.
  • In the clinical study, participants were enrolled in an “intensive” behavioral study with 8 weeks low-calorie diet.
  • Yet the media has led with “diabetes drug leads to major weight loss”.
  • Will doctors inform patients?

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.