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FDA is planning to loosen guidelines in approving new
treatments for Alzheimer’s drugs. Companies would no longer have to show that the drugs improved daily,
real-world functioning (such as dressing, feeding, etc.). Under the new proposal,
drugs in controlled clinical trials can qualify for approval if people at very
early stages of disease subtly improve performance on memory or
reasoning tests, before they
develop any obvious impairments. FDA would then require companies to study the drugs
after they are placed on the market, but
these post-marketing studies might not require RCTs.
If the FDA is going to lift the proof-of-effectiveness
requirement for drugs, they need to do the same for supplements and food! If
the proposal for Alzheimer’s drugs were applied to natural foods and
supplements, supplement manufacturers would be able to prove effectiveness
without RCTs, while also having the opportunity to prove long-term
effectiveness in post-marketing (i.e., observational) studies.
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