Monday, June 02, 2014

Pfizer Publicly Undermines and Refutes Black Box Warning for Chantix; Should Face Penalties or Removal of Drug from Market

The black box warning for Chantix, which is required by the FDA to be placed on this smoking cessation drug made by Pfizer, notes the following:

"All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as 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. ... Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior."

The black box warning, then, advises physicians to observe patients being put on Chantix for "suicide-related events," including "suicide."

The requirement by the FDA that this black box warning be placed on Chantix is based on the agency's assessment of hundreds of cases of suicides that occurred in patients who had recently been treated with the drug, as well as thousands of cases of other serious adverse neuropsychiatric symptoms associated with the use of Chantix. In making a decision to require a black box warning, the agency takes into consideration the likelihood that the observed association between the drug and the adverse effects is a causal one.

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.

The Rest of the Story

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.

According to an ABC News article:

"Pfizer released a statement defending the smoking cessation medication. “Chantix has been studied extensively and there is no reliable scientific evidence that the medicine causes serious neuropsychiatric events like the violence in this case,” a Pfizer spokesperson told ABC 10 News."

In my view, this refutation and undermining of its own black box warning violates accepted standards of pharmaceutical company conduct, and should prompt either penalties or the removal of the drug from the market. If Pfizer is going to publicly undermine the required black box warning, then clearly that warning is not adequate to protect consumers and the FDA must either penalize Pfizer so that it desists from this behavior or pull the drug from the market since it is becoming clear that the company is undermining that warning in the eyes of the public.

This is the equivalent of a cigarette company refuting the required warnings that are made on a cigarette package. The cigarette companies are free to fight the cigarette warning labels as they are being considered, but once a federal body requires those warnings, the companies must not act to undermine the required warnings. In this case, Pfizer's actions are more grievous than those of a cigarette company undermining a package warning because the black box warnings are required by a federal regulatory safety agency, rather than by a Congressional act. More specifically, the black box warnings are an official part of the formal approval of the marketing and sale of the drug. The company may not sell the drug without the warning. By publicly undermining and refuting the warning, the company is essentially violating the terms of the drug's approval.

Had there been no reliable evidence that Chantix may cause serious neuropsychiatric events like suicide or other violent behavior, then why did the FDA conclude - after reviewing the evidence - that a black box warning is required?

And why did the FDA require Pfizer to warn doctors that patients taking the drug should be "observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide ... as well as worsening of pre-existing psychiatric illness and completed suicide."

By publicly refuting the black box warning, Pfizer is literally spitting in the face of the FDA. This is not appropriate. The company should either be penalized and forced to discontinue its campaign of refutation of the black box warning findings, or the drug should be pulled from the market due to a finding that the company has violated the terms of the drug's approval.

Of course, the FDA is not going to take either of these actions. Because it knows where its bread is buttered. In contrast, however, the very same agency is prepared to pull thousands of electronic cigarettes from the market even though there really is no reliable evidence of any harms being caused by these products (with the exception of exploding batteries, which the agency should immediately address via a manufacturing standard requirement).


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