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The fda approved the new drug. they claim only, though, it quote may modestly slow the pace of doing anytive decline early on in the disease. fda is acknowledging it has major risks for patients. the manufacturer says, quote, accelerated approval of the drug was based on phase two data. here is where things get controversial. the fda acknowledges the drug exposes patients to the risk of brain swelling and brain bleeding. in a recent congressional investigation issued a scathing finding when it came to the fda's rushed approval process for another demeanings yeah drug. it accuses biogen of coll...

Disease and try to reduce the amount of cognitive decline. and so it offers this novel therapy. there is a lot of po fence for it. but i think there is still a number of unanswered questions, including about side effects. specifically, there are some side effects that seem to be associated with this drug, brain swelling, brain bleeding. the question is, are we able to identify which patients will be eligible for it and which patients for whom the benefits outweigh the risk. another unanswered question is how it will be priced and whether medicare is going to cover it. that's something that the...

>> reporter: dr. sharon cohen has been studying alzheimer's drugs for 30 years and was part of the clinical trials for lecanemab. what she is talking about is amyloid originating abnormality. it can look like this or this. it's brain swelling or brain bleeding. know cohen says these types of side effects were mostly mild in the trial. >> we do know that lecanemab has a low rate of causing macro hemorrhage, not necessarily fatal, but a low rate, less than 1%. >> reporter: in the phase three clinical trial, there were seven deaths in the placebo group and six deaths in the lecanemab group. accor...

Care of themselves and the pathology and the plaques and the tangles have built up and by that time there is not as much we can do. >> reporter: but nothing comes without risks. and the ones that come with this type of drug have raised red flags. >> we have known for many years that with almost all of the drugs in this class there can be a side effect of aria. >> reporter: dr. cohen has been studying alzheimer's drugs for 30 years and was part of the clinical trial. what she is talking about is amyloid related imaging abnormality, it can look like this or this, it's brain swelling or brain ble...

Progression to worsening of his alzheimer's disease. >> we've been targeting alzheimer's disease at the end stage when people have dementia and can no longer take care of themselves and theplaque and tangles have built up. >> there could be risks and this one draws red flags. >> we have known for many years that almost all of the drugs in this class there could be a side effect of aria. >> dr. sharon cohen has been studying alzheimer's drugs for 20 years and was part of the clinical trial. what she is talking about is amyloid imaging related abnormality. it can look like this or this. it's bra...