WebMDOctober 17, 2014A black box warning about suicide risks should remain on the anti-smoking drug Chantix® until it can be reevaluated using findings from thorough scientific studies, a U.S. Food and Drug Administration panel of experts said Thursday. Chantix® has carried the FDA’s strongest warning label since 2009 after it was linked to violent or suicidal behavior among some patients taking the drug.
Pfizer asked the FDA to drop the boxed warning, citing recent studies suggesting that patients taking Chantix® were not at increased risk for psychiatric problems, the Associated Press reported. However, the 11-member FDA advisory panel voted to retain the black box warning on Chantix®. One member voting in favor of removing the warning and six favored slight changes to the label. The FDA does not have to follow the advice of its expert panels, but typically does.
Pharmalotby Ed SilvermanOctober 17, 2014…
“I think Pfizer took quite a chance trying to get the box deleted. They obviously wouldn’t have done it if they thought they could convince people, but they failed completely,” says Diana Zuckerman, the president of the National Center for Health Research, a non-profit advocacy group.“They had the best presentation money could buy – very good analyses and complicated statistics to prove their point. And the company trotted out these studies and tried to make a very strong case for why the Black Box should be deleted, but only one person voted their way."
“Pfizer took a big chance, but I think they did so because they were afraid the next study wouldn’t be so favorable and maybe they could get rid of the Black Box warning now. Remember, if it were removed, it would be hard to get it reinstated later, even if a post-marketing study showed risk.”
Pfizer is not flinching. “The completion of our currently ongoing safety study will represent one more step forward in the process of accurately characterizing the neuropsychiatric safety of this important medication,” says Steven Romano, a Pfizer senior VP who heads the medicines development group.
But there’s something else to say. Pfizer’s sales of Chantix® are down. They obviously think it has something to do with the Black Box warning in the labeling. So they are spending tons of money trying to get the label removed – thinking more patients will "ask their doctor if…" and that more doctors will not be afraid to prescribe it. It’s a sign of their inflated sense that they can influence and control the world if they just play their cards right. It doesn’t occur to them that maybe their sales are down because Chantix® is only for the hardy. If you’ve prescribed it yourself, you know that it does exactly what that Black Box label says it does, and maybe more often than the label suggests. They can’t change that with a label eraser or even a piece of Robert Gibbons statistical sleight of hand [see way past time…].
I just read that article in The Wall Street Journal. It’s about the so-called black box warning. And, “the pill became associated with stories of suicide and violence“, as if Chantix was on an elevator, minding its own business, when stories of suicide and violence walked in to associate themselves with poor little Chantix.
I think e-cigs are making a lot of this obsolete anyway. Yeah I know it has nicotine but you aren’t getting the carcinogens. Practical medicine is all about harm reduction.
I am reminded that sales people do not lie, at the moment they are making a statement they truly believe what they are saying. This leads to such things as changing their position during a conversation or, in this case, tying themselves in knots finding a reason their product will not sell.
From my perspective pharma is a marketing organization, so the movement of this attitude into the corporate culture, is a normal extension of this sales orientation. We see much the same attitude in general society. I am never wrong, you just do not understand, let me explain.
This is countered by one statement; “facts are the enemy of truth.” The facts do not support the removal of the black box warning. The truth is the drug company wants more sales and has convinced themselves this is a misunderstood drug that does more good than harm.
We need more facts and fewer truths in our lives.
Steve Lucas
Doctors Tell All—and It’s Bad
A crop of books by disillusioned physicians reveals a corrosive doctor-patient relationship at the heart of our health-care crisis.
http://www.theatlantic.com/magazine/archive/2014/11/doctors-tell-all-and-its-bad/380785/?single_page=true