The FDA should be our toughest regulatory body, but the pharmaceutical lobby has torn it to shreds.
Last week the Food and Drug Administration approved Aduhelm <https://www.usatoday.com/story/news/health/2021/06/07/fda-authorizes-aducanumab-aduhelm-alzheimers-disease/7582595002/>—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 <https://www.npr.org/2021/06/11/1005567149/3-experts-have-resigned-from-an-fda-committee-over-alzheimers-drug-approval>. In his resignation letter, Dr. Aaron Kesselheim of Harvard Medical School called the move <https://www.huffpost.com/entry/fda-adviser-quits-alzheimers-drug_n_60c37469e4b0b449dc38e6ef> “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. Simply put, all of the wrangling over Aduhelm is a mess. But it’s a mess that came about because monied interests have captured every facet of the broader health care system and compelled it to work in ways that benefit them to the detriment of patients. Biogen will be rewarded with a king’s ransom for folding its failed clinical trial; convincing a regulatory agency stuffed with former and future colleagues that its numbers were good enough; winning agency approval through the kind of industry-friendly regulatory pathway supported by drug firms; and yanking the highest price it could think of out of the sky, all the while knowing that the biggest public payer on the hook, Medicare, is legally constrained from refusing to shoulder the cost burden—thanks to even more lobbying by you know who. Meanwhile, more and more patients will be diagnosed with Alzheimer’s, and they’ll be desperate enough to try anything—including Biogen’s pricey snake-oil solution. The FDA’s decision has done little more than put the neediest and most desperate patients in harm’s way. The only cure for this malady is to confront and counter the power of a pharmaceutical industry that’s exploiting a broken system to rake in mountains of profits at the expense of the rest of us. https://newrepublic.com/article/162726/biogen-fda-alzheimers-aduhelm-approval -=-=-=-=-=-=-=-=-=-=-=- Groups.io Links: You receive all messages sent to this group. View/Reply Online (#9235): https://groups.io/g/marxmail/message/9235 Mute This Topic: https://groups.io/mt/83584712/21656 -=-=- POSTING RULES & NOTES #1 YOU MUST clip all extraneous text when replying to a message. #2 This mail-list, like most, is publicly & permanently archived. #3 Subscribe and post under an alias if #2 is a concern. #4 Do not exceed five posts a day. -=-=- Group Owner: [email protected] Unsubscribe: https://groups.io/g/marxmail/leave/8674936/21656/1316126222/xyzzy [[email protected]] -=-=-=-=-=-=-=-=-=-=-=-
