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

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 the drug industry, have violated National Institute of Health reporting requirements when more than $10,000 has been received from a subject company, according to the New York Times, “Researchers Fail to Reveal Drug Pay” June 8, 2008. http://www.nytimes.com/2008/06/08/us/08conflict.html?em&ex=1213070400&en=9971013dfd33290a&ei=508720say20are%20sorry&st=cse isn’t enough.

If Harvard doesn’t fire them, it will be complicit in the cover-up.

Throw them off campus. Ring the bell loud and clear that no matter how renown or stellar, if you don’t play by the rules, you can’t play at all. And the NIH should forever ban them from receiving grants.

Don’t throw out the baby with the bath water. Once appropriate punishment has been served, give these researchers a chance to polish their tarnished reputations. Allow them to conduct research under the supervision of a responsible administrator who knows that “veritas,” means truth, accuracy, honesty, and uprightness and that it’s more than just a motto.


Richard Alexander