Tuesday, November 20, 2012

DHHS Hides from Public the Fact that Chantix Has Been Associated with Hundreds of Suicides; Recommends Drug that Has Caused Many Deaths over Product that Has No Known Serious Adverse Effects

The Department of Health and Human Services (DHHS), on its new web site devoted to smoking, is hiding from the public the fact that Chantix (varenicline) has been associated with hundreds of suicides. It is also recommending Chantix - a drug that has caused hundreds of deaths - over electronic cigarettes, which have no known serious adverse side effects, because of its concern over potential unknown risks of electronic cigarettes.

On its web site, DHHS advises smokers trying to quit not to use electronic cigarettes, but does recommend that they use Chantix. However, while this page warns about potential unknown risks associated with electronic cigarettes, it does not mention the well-documented, known, serious side effects of Chantix and it fails to provide its own mandated black box warning.

On its smoking cessation medication page, DHHS deceives the public by failing to mention that Chantix has been associated with hundreds of suicides. Instead, it suggests only that Chantix has been linked to rare cases of "suicidal ideation." The DHHS states only that: "There have been rare reports of mood swings, depression and suicidal thoughts." The DHHS also fails to inform the public that Chantix has been banned for pilots, air traffic controllers, and commercial drivers.

Even on its detailed fact sheet regarding Chantix, DHHS hides from the public the fact that there have been hundreds of reports of suicide among patients taking Chantix. It merely states that: "There have been rare reports of mood swings, depression, and suicidal thoughts."

The Rest of the Story

I don't understand the logic behind recommending a product associated with hundreds of deaths over a product that has no known serious adverse effects simply because we don't fully understand all the potential effects of that product. It can't be worse than Chantix.

The DHHS itself acknowledges that it is better to use a product that is known to be reasonably safe but whose effects have not been completely characterized over a product that is known to cause deaths. It acknowledges that "The effect of NRT on the body is not fully known," but still recommends NRT because "NRT products are safer than cigarettes."

But there is a problem here that is far worse than the inappropriate medical advice to smokers. That problem is a lack of honesty and therefore, I violation of public health ethics in my opinion.

I believe it is dishonest to inform the public that Chantix is associated with rare reports of mood swings, depression, and suicidal ideation, without informing the public that Chantix has also been associated with reports of actual suicides. The DHHS is apparently intentionally hiding this information from the public. If Pfizer did the very same thing, it would be guilty of fraud and DHHS itself would likely be prosecuting Pfizer for failure to mention that there were reports of actual suicides or attempted suicides.

The black box warning on Chantix informs the public that the drug has been associated with reports of not only suicidal thoughts but suicidal behavior (suicide and attempted suicide). It is clear to me that DHHS is intentionally hiding the "rest of the story" from the public.

I view this as a violation of the code of public health ethics because honesty and transparency are two of the principles upon which the ethical practice of public health are based. 

The result of this deception is substantial. A reader is likely to come away with the impression that varenicline can cause some suicidal thoughts, but that this side effect is not serious enough that one has to be concerned about actually attempting suicide.

There are at least 200 lawsuits that have been filed by the families of plaintiffs who allege that their loved ones committed suicide as a result of taking the smoking cessation drug Chantix (varenicline) or by plaintiffs who attempted suicide after starting Chantix. These cases were filed by a single law firm, which is investigating another 1,200 cases. Another firm is investigating 175 similar cases.

Obviously, the problems that have been alleged to be caused by Chantix go beyond suicidal "thoughts."

The rest of the story is that not only is DHHS giving inappropriate medical advice to smokers, it is also being dishonest with the public by hiding factual information about the potential risks associated with varenicline.

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