I conclude as follows: "By promoting a message that flies in the face of the government's own statistics--which show a sharp decline in youth smoking concurrent with a dramatic increase in e-cigarette experimentation--some federal public health official appear to be trying to create a "gateway" narrative where none exists."

By publicly refuting the black box warning, Pfizer is literally spitting in the face of the FDA. This is not appropriate. The company should either be penalized and forced to discontinue its campaign of refutation of the black box warning findings, or the drug should be pulled from the market due to a finding that the company has violated the terms of the drug's approval.

But what is the clinical meaning of this effect? In order to find that out, one needs to conduct studies with longer-term end points.

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