Harvard Drug Research Fraud and Cover-up: How Off-Label Profiteering Works

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Harvard Drug Research Fraud and Cover-up: How Off-Label Profiteering Works

Drug company money influences and corrupts research. That is a given.

What is less understood is why drug manufacturers spend billions for research on off-label uses for their products – uses that were never cleared with the FDA when the drug was submitted for approval.

Off-label use allows drug companies to get “through the back door” what they could never, and I mean never, get away with by going directly to the FDA for approval for a new use of a product – what is known today as an off-label use.

You would hope that researchers wouldn’t corrupt the commercial experimentation of a new, or off-label, use of a drug to treat children by covering up their consulting fees from Big Pharma. But that’s what happened.

More important than what happened is why it happened and at the bottom of all this is a terrible mistake the U.S. has made in allowing the exploitation of off-label use.

The devil is in the details, so here is the story as it has unfolded.

Leading Harvard professors studying off-label uses, the gold mine of...

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