Neurologists’ Group Issues Guidance to Families on Controversial Alzheimer’s Drug

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News Picture: Neurologists' Group Issues Guidance to Families on Controversial Alzheimer's Drug

THURSDAY, Nov. 18, 2021 (HealthDay Information)

Neurologists should be certain that Alzheimer’s sufferers and their households perceive that the controversial drug aducanumab doesn’t restore psychological perform, the American Academy of Neurology (AAN) mentioned in new place assertion that features moral pointers.

“Aducanumab just isn’t a remedy for Alzheimer’s illness, but because it has been accredited by the [U.S. Food and Drug Administration], sufferers are asking their medical doctors if that is an choice for them,” mentioned assertion creator Dr. Winston Chiong, an affiliate professor on the College of California San Francisco and member of the AAN’s Ethics, Regulation and Humanities Committee.

“It is a high-cost drug that was accredited by the FDA with out convincing proof of advantages and with recognized harms, so the aim of this place assertion is to supply moral steerage on how neurologists may also help sufferers make knowledgeable choices about this therapy,” Chiong mentioned in an AAN information launch.

The U.S. Meals and Drug Administration accredited aducanumab (model identify: Aduhelm) based mostly on two research that have been each stopped early as a result of the drug confirmed no advantages for sufferers. The assertion defined {that a} later evaluation of information from a kind of research steered a small profit, whereas the opposite nonetheless confirmed no profit.

The assertion famous that whereas aducanumab reduces the beta-amyloid plaques within the mind which might be markers of Alzheimer’s, it is unclear whether or not that gives any significant advantages to sufferers.

There is not ample proof to supply the drug to sufferers with average or superior dementia, or to these with out proof of beta-amyloid within the mind, in keeping with the place assertion revealed Nov. 17 within the journal Neurology.

It additionally mentioned the drug carries a danger of mind irritation and mind bleeds, which occurred in a 3rd of sufferers within the research who obtained the dose accredited by the FDA.

The assertion mentioned neurologists should inform sufferers and households in regards to the drug’s potential dangers of and the necessity for extra frequent monitoring with MRI scans.

One other challenge is the dearth of racial and ethnic range within the clinical trials of aducanumab. Sufferers in racial and ethnic minorities have to be informed in regards to the lack of security and effectiveness knowledge for them, the assertion mentioned.

As well as, it warned that pricing and insurance coverage protection of the drug could trigger monetary hurt to sufferers and their households.

Aducanumab is priced at $56,000 a yr. However the prices of infusing the drug, repeated imaging and medical administration could push annual prices to greater than $100,000. Medicare usually covers 80%, so sufferers and households should be informed that the complete price of therapy is probably not lined, the assertion suggested.

The assertion mentioned one other concern is that availability of aducanumab could result in decrease affected person enrollment in clinical trials of more practical therapies.

Extra info

The U.S. Nationwide Institute on Aging has extra about Alzheimer’s disease treatment.

SOURCE: American Academy of Neurology, information launch, Nov. 17, 2021

Robert Preidt

MedicalNews
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