Natalie Shure writes:

Last week the Food and Drug Administration approved Aduhelm—the first new Alzheimer’s drug in 18 years—an event that, at first blush, heralds the amazing news of a medical advance. Perhaps it might have been, had the whole process leading up to the agency giving its nod to the medication played out in a functional health care system. But that’s not what happened. Far from hailing the advent of a transformative breakthrough for the six million Americans suffering from a terminal illness marked by prolonged cognitive decline, the FDA’s decision to greenlight Biogen’s new therapeutic overrode the overwhelming recommendation of its independent scientific advisory committee not to do so, which prompted several to quit in disgust. In his resignation letter, Dr. Aaron Kesselheim of Harvard Medical School called the move “probably the worst drug approval decision in recent U.S. history,” which stands to “undermine the care of these patients, public trust in the FDA, the pursuit of therapeutic innovation, and the affordability of the health care system.”

He’s right. But the story of how a drug that’s never even been proven to work is now poised to rake in billions of dollars for its manufacturer, impose needless suffering on millions of families, and destabilize Medicare and Medicaid in the process, goes well beyond the failures of what should be the toughest regulatory body of the U.S. government. Aduhelm is far from the first $55,000 flop put forth by the toxic American combination of a highly commodified pharmaceutical industry and disjointed financing stymied by private interests. Without a total overhaul of this dysfunctional status quo, it won’t be the last. [Continue reading…]