It appears that if you wait long enough, things come full circle. Take, for instance, claims that some artificial sweeteners cause cancer, or that coffee was bad for you, or that chocolate only made you fat. Well, that appears to be in the cards for the Black Box warning on the smoking cessation drugs Chantix and Zyban. The results of a study that the FDA asked the company to perform appears (at least from what is reported in the AP article announcing the results []) will support a critical review of whether it is appropriate to remove the warning by FDA.
But that’s not the thrust of the issue I want to discuss. What happens if the warning is removed? How does the removal of the warning, if it occurs, impact the legal cases that have been filed relative to potential suicides either attempted or completed? How does one go back in time and “get the toothpaste back in the tube”? Where will firms stand when and if the warnings are removed? In addition, the real question of how does over-warning impact patient treatment needs to be part of the narrative.
This is a very timely issue given that we are all waiting for the FDA to publish its Labeling Rule that addresses opening the door for generic companies to unilaterally change their labeling to add or strengthen warnings. In the case of Chantix and Zyban – even FDA appears to have gotten it wrong. How can we rely on generic companies to always get it right? If permitting companies to place warnings into their label at will, what is the possibility that the warnings will result in decreasing treatment with a drug by healthcare practitioners because of the warning? And what if the lack of treatment is worse than the adverse event where the warning scares the patient or prescriber from seeking or providing the treatment?
These are all interesting questions and, unfortunately, there are no easy answers. However, it is believed that the close collaboration between industry and the FDA are essential in getting the warnings and true risks associated with the treatment appropriately balanced, and we must continue to demand that FDA be the final arbiter to assure the safety and efficacy of the product. We can’t let fear of litigation cause over-warning by drug companies or for conjecture to replace careful scientific review. How many people have continued to smoke because they were afraid of the warnings on the smoking cessation products? How many physicians chose not to prescribe the products for patients that may have been are risk for what now appears to be an unfounded warning? How many cases of lung cancer may have been prevented if those patients used the products and were successful in stopping smoking? These questions have no definite answers but we must question the process. It will be interesting to see where the FDA lands on whether to remove the Black Box warning based on its review of the study data.
