Getting the FDA to retract a decision is like getting the toothpaste back in the tub, after it’s been squeezed out…
Whether it’s “yes” or “no,” there is no “maybe so”.
A good example is the new all star Alzheimer’s drug aducanumab.
The drug was on the fast track because it showed it could reduce the rate of amyloid plaque on scans.
Do we know whether this reduction in plaque means Alzheimer’s patients live longer or better lives?
Unfortunately, the totality of the clinical trial data do not show that.
Despite thin evidence of the drug’s clinical efficacy and despite its serious side effects, including brain swelling and bleeding.
As a result, a serious risk now exists that millions of people will be prescribed a drug that does more harm than good.
All for a whopping price tag of $56,000 a year.
And estimates are that if the drug is prescribed to just one-third of eligible patients, it would cost Medicare $112 billion a year!
Most importantly, it’s not a sure-fire bet!!!!
So the FDA is essentially betting against you and me.
Claiming this is the means for the same society who won’t pay for a caregiver and who might actually choose to ease their burden this way.
All for a very steep price.
Which legislators have love ones with Alzheimer’s? Surely not these.
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Resources:
https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/
https://www.cnn.com/2021/06/09/health/aducanumab-questions-answered-wellness/index.html https://www.statnews.com/2021/06/08/aducanumab-lackluster-drug-high-price/
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