Megan McArdle of the Daily Beast reports on the FDA’s recent decision to make the approval process faster for Alzheimer’s drugs. This is great news for patients, who may now see new Alzheimer’s drugs on the market years sooner than they otherwise would, and who may now have a more diverse selection of therapies to choose from to address their particular symptoms and stage of the disease.
But McArdle has a worry associated with speeding up the approval process: “This does elevate the risk that we’ll end up with a few drugs of dubious efficacy, or that don’t prevent the most troublesome ravages of the disease.”
But why is efficacy even a concern of government? If a drug doesn’t end up alleviating my particular symptoms, I can always toss it aside and try a new one.
Even under the new standards, there will likely be certain Alzheimer’s drugs that don’t get approved. For example, the FDA might deem a drug “ineffective” because it doesn’t improve cognitive function in 99% of the Alzheimer’s population and thereby ban it from sale. But if I’m in the 1% that benefits, that drug might be a godsend.
Why should the FDA get to decide whether it’s okay for me to take a drug? Shouldn’t I have the freedom to consult with my physician and decide for myself?