FDA approved Alzheimer's drug over internal objections

Statisticians at the Food and Drug Administration opposed this month's agency approval of a controversial Alzheimer’s drug, saying there was not enough evidence to prove the treatment works.

The FDA statisticians rejected a reanalysis of the data by Biogen that suggested the second trial would have shown the drug to be effective if it had continued for a longer period, rather than being stopped for lack of efficacy.

“I disagree with [the Office of Biostatistics’] recommendation that the application should not be approved,” Cavazzoni wrote in a June 7 memo. “I concur ... that the [drug] has met the requirements for accelerated approval,” including that Biogen “has provided substantial evidence of effectiveness on the surrogate endpoint of reduction in brain amyloid plaque and that the surrogate endpoint is reasonably likely to predict clinical benefit.

What happened to the days when Americans never questioned anything?

Medical interventions, including medications, are a risk versus reward exercise. If the medication is considered safe and if there isn’t much in the way of alternatives while a great need exists, it makes sense that the medication would be given the green light.

$56k and it doesn’t work. Sure seems like pandering to profit over people. On the upside the total collapse of our health care system due to the potentially astronomical added cost might just lead to some real change.

'After testing it on trump, he still believes he won the election and George Washington liberated airports'

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