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Drugs for Early-Stage Alzheimer’s?

Medical-warning-label-concept--42312982Drugs for Ear­ly-Stage Alzheimer’s (good New York Times edi­to­r­i­al):

The Food and Drug Admin­is­tra­tion has pro­posed low­er­ing the bar for approv­ing drugs to treat peo­ple at the ear­li­est stages of Alzheimer’s dis­ease, before they have devel­oped any seri­ous impair­ment or overt demen­tia. The goal is com­mend­able — to find ways to pre­vent or slow the pro­gres­sion of this ter­ri­ble dis­ease before it can rob peo­ple of their men­tal capac­i­ties. But the pro­pos­al rais­es trou­bling ques­tions as to whether the agency would end up approv­ing drugs that pro­vide lit­tle or no clin­i­cal ben­e­fit yet cause harm­ful side effects in peo­ple who take the med­ica­tions for extend­ed periods…Independent ana­lysts need to look hard at whether the F.D.A. should low­er the bar for these drugs — or should demand a very high lev­el of proof of safe­ty and effec­tive­ness before expos­ing still-healthy peo­ple to pos­si­ble harm. Even if drugs are even­tu­al­ly approved under this new approach, it will be imper­a­tive to force man­u­fac­tur­ers to con­duct fol­low-up stud­ies, as required by law, to see if patients ben­e­fit in the long run. This is a task they are often slow to per­form once a drug is on the mar­ket.”

Pic cour­tesy of Big­Stock­Pho­to

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