Not This Shit Again

Once again, the FDA has approved a ruinously expensive Alzheimer's treatment based on dubious clinical data.

At this point, I have to figure that some senior folks at the FDA have a pecuniary interest in these products: 

The future of a new Alzheimer’s drug is unclear, even as the Food and Drug Administration granted fast-track approval to the treatment Friday afternoon.

The drug, which will be sold under the brand name Leqembi and priced at $26,500 per year, moderately slowed cognitive decline for patients with early stages of the disease. But some doctors and experts have been skeptical of the treatment, uncertain about its safety and whether it provides a substantial benefit.

Just so you know, the cost of $26,500.00 is  NOT a misplaced decimal point. 

………

This new dynamic comes in the shadow of intense criticism over the FDA’s decision in June 2021 to give fast-track approval to Aduhelm, a different drug developed by the same two companies, Eisai and Biogen. The debates over Alzheimer’s drugs have been particularly fraught as advocates push for treatments for a devastating disease that levies a harsh toll on patients and their loved ones.

Aduhelm showed no evidence of effectiveness at delaying cognitive decline, it just showed a reduction in plaques, which were thought, but have never been proven, to cause the disease, but increasingly seem to be a symptom.

………

The accelerated approval for Leqembi was based on a mid-stage trial that showed the treatment effectively removed a sticky protein from the brain, which is considered a hallmark of the illness. More recently, a larger trial found the drug — which is given intravenously twice a month — slowed the progression of Alzheimer’s by 27 percent, our colleague Laurie McGinley reports.

………

At least this one shows some positive results, though I'd bet dollars to navy beans that there was some manipulation of the study sample.

But others argue the risks outweigh the benefits. There are concerns over complications, such as swelling and bleeding in the brain. Such concerns have increased after Science and Stat reported that three patients died in incidents potentially linked to the drug, though the company’s CEO says he remains “confident of the safety profile” of the drug.

So, it makes your brain explode.  That can't be good. 

Seriously, has the FDA learned nothing from the Aduhelm fiasco?