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Friday, June 11, 2021

The FDA's approval of aducanumab is a blow to Alzheimer research

Biogen cut corners on their clinical trials, leaving scientists wondering: is it beta-amyloid or not?

L ast week, after the FDA approved Biogen's monoclonal antibody therapy for Alzheimer's disease, named aducanumab, two members of the FDA advisory committee, which had voted unanimously with one abstention against approval, resigned in protest.

Now that the FDA has approved it, it's up to Medicare to decide whether the treatment is real or experimental. Meanwhile, scientists are left wondering what kind of data we would have seen if Biogen had actually done their job. The biotech giant cut corners, halting their own Phase III trials twice for futility. Then they submitted their NDA, claiming that a “reanalysis” of the data showed efficacy.

To cynics, it must seem like a transparent ploy. We've seen drug companies pull this stunt over and over: if a drug fails, it's always possible to re-analyze the results to find a subpopulation for which the treatment appeared to work. There's no way of telling whether Biogen did this or not, but most of the colleagues that I talked to informally believe that even though Biogen's data convincingly show the drug eliminates beta-amyloid from the brain, the effect on disease progression is minimal. The absence of compelling data left us wondering: is Alzheimer's caused by beta-amyloid or not?

The beauty of big pharma, as its advocates tell us, is that they are the ones who do the final test of biological theories. It is a tremendous responsibility. So, when Biogen cut corners on their research, they failed in their obligation to science.

A cynical person might suspect that this was their plan all along: after all, clinical trials are insanely expensive, and the FDA is notoriously fickle—there are rumors they once rejected an application because the binder was the wrong color—but when they ignore their own advisory board, approving a drug merely to give patients hope does little to silence the cynics.

Perhaps we can't really blame a giant corporation for cutting corners to save money. It re-emphasizes that their job is not to do science, but to satisfy the stockholders. But beta-amyloid is practically synonymous with Alzheimer's. I just submitted a research proposal to study why obesity is a risk factor. The field is so focused on beta-amyloid that there was no way I could tie the two together biochemically without proposing a role for beta-amyloid. Yet researchers have little choice. The paradigm is so strong that alternative explanations, like aluminum, copper, tau, neuroinflammation, a DNA damage response, a virus, or even the aborted cell cycle theory, are easily shot down as non-specific.

From a wider perspective, this might seem like a small matter: our culture is disintegrating, political censorship is returning, and the schools are apparently turning racist. But in these dark times people turn to science for inspiration and refuge, and big corporations and government let us down.

june 11 2021, 6:30 am

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