>For decades, scientists have been crying out for action. Will they finally be heard?
https://www.theatlantic.com/health/archive/2021/07/americas-drug-approval-system-unsustainable/619422/
The byzantine world of pharmaceutical regulation has recently broken into the public consciousness, causing a bit of a panic. Aducanumab—the first new Alzheimer’s treatment in nearly two decades—was approved by the Food and Drug Administration on June 7 despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers. Op-eds called the decision, which could trigger billions of dollars in new government spending, a “false hope,” “bad medicine,” and “a new low.” (FDA officials have said that their decision was based on “rigorous science,” and that it reflects the willingness of people with Alzheimer’s and their families’ to accept a treatment that might help, despite “some degree of uncertainty.”) On Thursday, the FDA tried to clarify that the drug should be used only for patients with mild dementia; the next day, amid concerns about inappropriate interactions between the drugmaker and FDA officials, Acting Commissioner Janet Woodcock called for her own agency to be investigated.
This isn’t the first—or fifth—run of bad press the agency has received, but one gets the sense from recent coverage that some crucial threshold has now been crossed, that the rising floodwaters of ineptitude have finally yielded a catastrophe. But even if this blunder’s inner workings are more public than those of the past, there’s little reason to believe we’ll see systemic change at the FDA. The long-standing and gradual erosion of the agency’s scientific standards makes me think instead of the eroding coastlines and thawing icebergs associated with climate change. For decades now, alarmed scientists have been crying out for action as things have gotten worse and worse. And for decades now, little has been done.
https://www.theatlantic.com/health/archive/2021/07/americas-drug-approval-system-unsustainable/619422/
The byzantine world of pharmaceutical regulation has recently broken into the public consciousness, causing a bit of a panic. Aducanumab—the first new Alzheimer’s treatment in nearly two decades—was approved by the Food and Drug Administration on June 7 despite scant evidence of benefit, and against the nearly unanimous advice of the agency’s expert advisers. Op-eds called the decision, which could trigger billions of dollars in new government spending, a “false hope,” “bad medicine,” and “a new low.” (FDA officials have said that their decision was based on “rigorous science,” and that it reflects the willingness of people with Alzheimer’s and their families’ to accept a treatment that might help, despite “some degree of uncertainty.”) On Thursday, the FDA tried to clarify that the drug should be used only for patients with mild dementia; the next day, amid concerns about inappropriate interactions between the drugmaker and FDA officials, Acting Commissioner Janet Woodcock called for her own agency to be investigated.
This isn’t the first—or fifth—run of bad press the agency has received, but one gets the sense from recent coverage that some crucial threshold has now been crossed, that the rising floodwaters of ineptitude have finally yielded a catastrophe. But even if this blunder’s inner workings are more public than those of the past, there’s little reason to believe we’ll see systemic change at the FDA. The long-standing and gradual erosion of the agency’s scientific standards makes me think instead of the eroding coastlines and thawing icebergs associated with climate change. For decades now, alarmed scientists have been crying out for action as things have gotten worse and worse. And for decades now, little has been done.
