Monday, April 29, 2013

Why is the FDA Lying About Chantix Health Risks?

The FDA recently announced on its tobacco web site a new online resource dedicated to smoking cessation. The FDA describes this site as containing "resources" for those who are "trying to quit smoking." The site encourages smokers trying to quit to use drugs, and one of the drugs recommended is Chantix. On the Chantix information page, readers are informed that side effects of Chantix may include "nausea, trouble sleeping, change in dreaming, mood swings, depression, and suicidal thoughts." Readers are also informed that: "There have been rare reports of mood swings, depression, and suicidal thoughts."

The Rest of the Story

The rest of the story is that suicidal thoughts are not the only thing with which Chantix has been associated. It has also been associated with attempted and completed suicides -- hundreds of them.

In hiding the fact that Chantix has been associated with actual suicide attempts and suicides, the FDA is deeply misleading the public. And I would say that in this context, this omission of critical information amounts to a lie: a lie which appears to be deliberate since it is downplaying the risks of Chantix in an apparent attempt to avoid discouraging smokers from trying this pharmaceutical product.

There is a world of difference between suicidal ideation and attempted or completed suicide. Readers hearing about a rare side effect of suicidal thoughts are likely to infer that this is a minor effect that can be simply monitored and will not lead to any major problems. However, had the FDA informed readers that hundreds of users of this drug have actually committed suicide, readers will infer a completely different level of risk -- one that is likely to give them serious pause about trying the drug. So the effect of this misinformation is potentially quite severe.

So severe, in fact, that if Pfizer itself were to disseminate the same lie, it would be in contempt of the law. The FDA has emphatically required Pfizer to label its drug with a warning. That warning does more than merely mention that in rare cases, a few smokers have experienced some suicidal thoughts. Instead, the warning makes clear that Chantix has been associated with attempted and completed suicides.

Pfizer's Chantix warning states: "Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking CHANTIX."

In the very next paragraph, the warning reiterates that: "worsening of pre-existing psychiatric illness and completed suicide...have been reported in some patients attempting to quit smoking while taking CHANTIX in the postmarketing experience."

Clearly, if Pfizer put out the same warning that the FDA puts out on the web site, it would be in violation of FDA's mandate and would potentially incur punishment from the government as well as severe liability in litigation from consumers.

This raises the question of why the FDA is speaking with two voices: its drug regulation division is requiring Pfizer to truthfully inform the public that there have been reports of actual suicides among smokers trying to quit using Chantix. But apparently, the Center for Tobacco Products (which is presumably the division which contributes to the web site) is untruthfully telling the public that the drug has only been associated with suicidal ideation, not actual suicide attempts or complete suicides.

It is worth noting that at the same time that the FDA is using misinformation to downplay the risks of Chantix, it is using similarly deceptive techniques to exaggerate the risks of electronic cigarettes. The FDA has informed the public that electronic cigarettes pose a carcinogenic risk, as it contains "known carcinogens." So while the FDA is hiding the fact that Chantix has actually been associated with more than 300 deaths, it is suggesting to the public that electronic cigarettes may cause cancer, despite the absence of a single death associated with these products.

That the FDA is lying to the public about the risks associated with Chantix is disturbing not only because of the serious damage it could cause, but also because it suggests that the agency is being driven by politics and not science. A purely scientific presentation of the "facts" about Chantix would certainly inform the public that this drug has been associated with attempted and completed suicide, as indicated in the very warning that the FDA requires Pfizer to include in its product packaging. The failure to provide this information to the public indicates to me that concerns other than science have entered the picture.

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