[Dismas]

The FDA is an excellent example of compromising freedom for safety, as they prevent harmful substances from being sold commercially. In this case, there have been disagreements over whether Aduhelm should be approved to treat Alzheimer's. While it's only shown to help slightly (if at all), the drug was approved - which led to the resignation  of 3 expert advisers.

My grandmother recently passed with Alzheimer's/Dementia. While I'd like to see advancement in legitimate treatments, I'm not in favor of restricting businesses from selling harmless remedies (if the efficacy is only slight). Whether a business is lying to or defrauding someone can be a separate crime.

Fallout continues from the Food and Drug Administration’s contentious decision this week to approve Biogen’s Alzheimer’s drug Aduhelm (aducanumab) despite a lack of efficacy data.

Three experts who sat on an advisory committee for the FDA have now resigned over the decision.

The advisory committee reviewed the data behind Aduhelm last November and voted overwhelmingly against approval. Of the 11 advisers on the committee, 10 voted “no” on the question of whether Biogen had collected enough evidence to indicate that the drug is effective. The remaining adviser voted “uncertain.”

Nevertheless, the FDA approved the drug on Monday. Though the regulator acknowledged that there are “residual uncertainties regarding [the] clinical benefit” of Aduhelm, the FDA said it decided to lower the requirements for approval after the advisory committee voted. Instead of basing the approval on the drug’s demonstrated efficacy, the agency relied on a “surrogate endpoint.” In this case, the surrogate is the ability of the drug to reduce amyloid beta plaques in the brains of some Alzheimer’s patients.

“This reduction in plaques is reasonably likely to result in clinical benefit,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, wrote in a statement this week.

The approval and explanation riled advisory committee member Aaron Kesselheim, a professor at Harvard Medical School who is also director of the Program on Regulation, Therapeutics, and Law at Brigham and Women's Hospital. In a searing resignation letter sent to acting FDA Commissioner Janet Woodcock on Thursday, Kesselheim called the FDA’s decision "probably the worst drug approval decision in recent US history."

He noted that the surrogate endpoint was not discussed by the advisory committee—in fact, he notes, the FDA told the committee specifically that it would not use amyloid beta plaque clearing as a surrogate for efficacy.

Read More: https://arstechnica.com/science/2021/06/...mers-drug/

[Drako]

Ultimately it's the choice of the patient or the patient's family on whether or not to begin a prescription. And the world desperately needs medications or cures for hard to treat or untreatable conditions such as Alzheimers and Parkinsons. Even if it's slightly effective against its target, the medication should be available to the patient; As long as it's safe, of course.

My Great-Grandmother had severe Alzheimers and passed away last year. So my family has to deal with the possibility of also developing the disease themselves, which is always scary to think about when there isn't any cure right now. In my opinion, anything with a slightly possitive effect is a win.

[ConcernedCitizen]

My mother's side has a history of Alzheimer's. ELI5 of the disease: the brain's version of tooth decay brought on by plaque essentially driving a wedge between teeth over time. Many things can cause Alzheimer's, but a more direct cause is the beta-amyloid protein.

"It is formed from the breakdown of a larger protein, called amyloid precursor protein. One form, beta-amyloid 42, is thought to be especially toxic. In the Alzheimer’s brain, abnormal levels of this naturally occurring protein clump together to form plaques that collect between neurons and disrupt cell function. Research is ongoing to better understand how, and at what stage of the disease, the various forms of beta-amyloid influence Alzheimer’s. - https://www.nia.nih.gov/health/what-happ...rs-disease