Tylenol has lost its way

George MillerI confess that a particular sadness about the Johnson & Johnson McNeil unit's Tylenol recall accompanies my customary disappointment in GMP violations. Manufacturing transgressions across the pharma industry often violate fundamentals, as we've reported, and that's the story here (see related report).

In the case of the now multi-product recall being conducted by McNeil, the sadness stems from the respect I hold for almost three decades of odds-defying survival of the Tylenol brand. It was pulled from the brink when six people died following the terrorist poisoning of the pain reliever. The six deaths--significant as they were--hardly rise to the national level of severity of, say, the fears leading up to Y2K or the horror of the 9/11 World Trade Center terrorist attacks. But the societal foundation-rumbling, back in 1982, certainly bears a familial resemblance.

Bold leadership saved Tylenol then. J&J executives and manufacturing came together to set an example of corporate responsibility in what many predicted was a brand--and, perhaps, company--death march. J&J positioned itself front and center of the American public and was accountable. It took charge of a situation that it did not cause and, given industry practices of the day, was largely out of its control.

It's beginning to look like bold leadership is required again at J&J. But the cause appears far less noble.

I can believe that the manufacturing violations outlined in FDA Warning Letter SJN-2010-01 happen in the pharmaceutical industry. But not to J&J and Tylenol. - George Miller