On June 16, the Food and Drug Administration (FDA) warned the public that Chantix appears to be associated with a small, but significant increase in heart attacks among patients with existing heart disease treated with the drug for smoking cessation.
According to the FDA's statement: "The U.S. Food and Drug Administration (FDA) is notifying the public that the smoking cessation aid Chantix (varenicline) may be associated with a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. This safety information will be added to the Warnings and Precautions section of the Chantix physician labeling. The patient Medication Guide will also be revised to inform patients about this possible risk. FDA reviewed a randomized clinical trial of 700 smokers with cardiovascular disease who were treated with Chantix or placebo ... Cardiovascular adverse events were infrequent overall, however, certain events, including heart attack, were reported more frequently in patients treated with Chantix than in patients treated with placebo."
While the statement cautions that physicians must weigh the benefits of quitting smoking versus any increased risk of cardiovascular events that may be caused by Chantix, the study data do not reveal any net benefit of Chantix-associated smoking cessation. If reduced heart attacks associated with smoking cessation outweighed the increased heart attacks caused by Chantix, then there should have been a lower incidence of non-fatal heart attacks in the treated (Chantix) group. This was not the case. The non-fatal myocardial infarction rate over the one-year follow-up period of the study was 0.9% in the placebo group and 2.0% in the Chantix-treated group.
Thus, within this one year period, the clinical trail failed to demonstrate any net benefit of Chantix in terms of preventing heart attacks within the first ten months of quitting smoking using Chantix.
The Rest of the Story
The rest of the story is that while each of the following groups has called for the removal of electronic cigarettes from the market because of the hypothetical possibility that these devices could have adverse effects - but in the absence of even a single reported serious adverse event - none of these groups have similarly called for the removal of Chantix from the market, nor have they even informed their constituents on their web sites about this new critical information about Chantix-associated severe side effects, even though there are now hundreds of reported suicides and a number of heart attacks associated with Chantix use.
The groups are: the Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, Action on Smoking and Health, The American Academy of Pediatrics, and the American Legacy Foundation.
These groups have three things in common:
1. Each has called for the removal of electronic cigarettes from the market, despite the absence of even a single severe adverse reported event
2. Each has refused to call for the removal of Chantix from the market, despite the presence of hundreds of cases of suicides associated with the use of the drug, and now with clear evidence of an increase in heart attacks associated with drug use and no net benefit of the drug in one-year reduction in myocardial infarction
3. Each has refused (from the best of my internet review) to even display the information from last week's FDA statement about the risks of Chantix.
Actually, the groups have an important fourth thing in common:
4. They all have or have had financial associations with Pfizer, the manufacturer of Chantix.
I am not in this commentary calling on the removal or non-removal of Chantix from the market. What I am calling for, however, is consistency in the way in which public health groups evaluate and analyze public health policy issues. Systematic bias should not be a part of the public health evaluation of policy, and such a systematic bias should never enter into the picture because of financial conflicts of interest, especially ones which are not readily disclosed.