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In my opinion, it is the responsibility of the company that markets the drug in question not to undermine, refute, or publicly challenge the black box warning once the FDA has made a decision to require this warning. It is the FDA's scientific judgment, not that of the pharmaceutical company, that should be the final word in making the decision about whether or not a black box warning is required and what the black box warning should state. If the company refutes the black box warning publicly once it has been required, then it is essentially thumbing its nose at the FDA and substituting its own scientific judgment for that of the agency.

Responding to a news media request for a quote regarding a murder/attempted suicide case in which the defendant claims he acted as a result of depression induced by Chantix, Pfizer publicly refuted the FDA's required black box warning and denied that there is any reliable evidence that Chantix can cause severe neuropsychiatric events, such as suicide or similar violent actions.

For years, the anti-smoking groups and public health agencies have taken tobacco industry conflicts of interest seriously. Now it is time to have some integrity and fairness and to consider all corporate conflicts of interest, whether they involve Big Tobacco or Big Pharma.


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