Thursday, October 23, 2008

New Report Warns of Serious Risk Profile of Chantix; Recommendation of Chantix by Anti-Smoking Researchers with Conflicts of Interest is Unacceptable

A new report from the Institute for Safe Medication Practices revealed that Chantix accounted for more reported serious injuries than any other prescription drug, including blackouts putting people at risk of accidents, and concluded that broader warnings are necessary to protect the public from the potential dangers of Chantix side effects.

According to the report: "Varenicline continued to provide a striking signal of safety issues that require investigation and action. In the first quarter of 2008 the FDA received 1001 case reports of serious injury in the United States in which varenicline was the principal suspect drug. For a second consecutive quarter varenicline accounted for more reported injuries than any other drug." ...

"To take further measure of the strength of the safety signal for varenicline, we made additional comparisons between varenicline and other prescription drugs. First, we explored the possibility that the market success of varenicline might partly explain the volume of serious injuries reported because millions of people had been exposed to the drug. In the first quarter of 2008, varenicline accounted for more reports of serious injury than the 10 best selling brand name prescription drugs combined. ... Varenicline accounted for 1001 cases of serious injury or death compared to 837 cases for the 10 top brand name drugs combined, and 3.5 fold more than its closest individual drug, clopidogrel, with 288 cases." ...

"ISMP’s concern about the risk of accidents was confirmed in serious adverse events reported in the first quarter data for 2008. These included 15 cases with MedDRA standardized medical terms indicating road traffic accidents. These new traffic accident cases included medical terms describing a spectrum of possible effects of varenicline that might have been responsible, such as seizure, disturbance of vision, panic attack and impaired judgment. The 2008 reports also included 52 additional cases with MedDRA terms indicating various kinds of blackouts or loss of consciousness, which have high potential for accidents. Some reported blackouts implied a sudden disruption of the heart rhythm while others appeared to be associated with psychiatric symptoms." ...

"Three U.S. government departments have addressed ISMP’s most immediate safety concern, the risk of accidents by individuals operating aircraft or vehicles and in other occupations where a lapse in alertness or motor control could lead to massive injury. The Federal Aviation Administration has banned the use of Chantix by airline pilots, the Department of Transportation has limited its use among truck drivers, and the Department of Defense has prohibited its use by aircraft and missile crews." ...

"For varenicline, additional action is needed to make all patients aware of the potential accident risks. We recommend that the FDA and the manufacturer add a prominent warning about accident risks to the patient Medication Guide and prescribing information for doctors. This warning should be similar to the new warnings about psychiatric side effects. While we commend the federal government for prompt action in banning varenicline in the most sensitive occupations such as for airline pilots, air controllers and military missile crews, a broader warning is still needed. Also, additional investigation and action may be needed regarding other adverse effects of varenicline, and prescribers should consider alternative treatments."

The Rest of the Story

The story here is not the potential adverse side effects of Chantix. Instead, the story is the potential tragedy related to the fact that national recommendations that all physicians use drug treatment for all of their patients and the recommendation of Chantix for this purpose were made by an expert panel that was chaired by a researcher with a history of severe financial conflicts of interest and that included numerous others with financial interests in pharmaceutical companies.

Drug side effects do occur and sometimes we don't know about the magnitude of these effects until after a drug is widely prescribed. What is inexcusable, however, is for national recommendations about the use of a drug to be made by individuals who have significant financial interests in companies which stand to benefit from those recommendations. This results in a severe bias in the recommendations and is unacceptable from an ethical perspective of public health policy formation.

Future expert panels which consider smoking cessation guidelines for physicians should require the recusal of all individuals with a history of significant financial conflicts of interest with pharmaceutical companies.

And in addition, the most recent expert panel which recommended the use of drugs for every smoking patient should issue an apology to the nation for allowing this substantial bias to enter its report by allowing individuals with financial conflicts of interest to take part in the development of the guidelines. The conveners of this panel should announce that researchers with significant conflicts of interest will not be allowed to participate on the panel in the future.

Judges routinely recuse themselves from making decisions in cases in which they have a conflict of interest. We should not expect anything less from public health researchers. That anti-smoking researchers with conflicts of interest did participate in decisions with national policy-setting significance is a serious ethical breach.

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