As the public becomes increasingly aware of the dangers associated with long-term cigarette-use, there’s been a slew of products introduced which claim to assist smokers in their quest to quit. While gum and patches have been on the market for more than a decade, the trend over the past few years has been towards prescription solutions. Some medications, such as Bupropion (Welbutrin), have been around for years but have found new popularity as a tool for smoking-cessation. Others, such as Varenicline (Chantix), have been created for the sole purpose of helping smokers quit. These new drugs lack the testing of their older counterparts and tales of alarming side-effects are beginning to emerge.
Varenicline gained FDA approval and was introduced to the public in May 2006. The patient information leaflet which came with the medication cited nausea, vomiting, sleep disturbance, abnormal dreams and constipation as the drug’s most common side effects. Absent from the leaflet were the 200 other “potential side-effects”, which were found only on Pfizer’s “Full Prescribing Information” sheet. These potential side-effects included suicidal thoughts, psychotic events, hallucinations and a slew of other serious conditions; dismissed by Pfizer as being very rare and highly infrequent.
By 2008, however, reports of suicides and a host other strange, psychotic behaviors associated with taking Chantix began to garner attention. Pfizer released an updated version of their patient information leaflet; this one included a black box warning regarding the potential for “suicidal ideation” in patients who may be experiencing a negative reaction to the drug. Interestingly, this information seems to have had little effect on the rate at which the medication was prescribed.
As more and more people come forward with Chantix horror stories; alarming details regarding the product’s testing (or lack thereof) have begun to emerge. When applying for FDA approval, Varenicline was “fast-tracked” to get it approved (and in the eager hands of the smoking public), more quickly. It seems that the testing done was at a minimum; with many of the factors found in the cigarette smoking population, absent. Additionally, it’s becoming clear that the drug’s success rate has been greatly inflated.
For starters, the 44% success rate touted by Chantix commercials applies only to weeks 9 through 12 of the program. Not mentioned by the ad, is the need for counseling and support in order to attain that level of success. It’s been found that without therapeutic support, the success rates of those attempting to quit with Chantix are comparable to that of quitting, cold turkey. Even with support, the quit rate of Chantix users after a year is around 14%; not very impressive.
Taking into consideration Chantix’ relatively low success rate and the number of adverse reaction reports (more than 35,000 as of June 2011); it’s difficult for many people to understand why this product is still on the market. In fact, the FDA has recognized the limited testing done on the part of Pfizer, prior to the drug’s release, and has now asked the drug manufacturer to conduct more extensive studies in a larger pool of test subjects. These tests are slated to be completed in 2017.
In the meantime, it’s been discovered that Chantix’ negative side effects are not limited to poor mental health. Chantix has also been found to cause heart disease, diabetes and Steven-Johnson Syndrome (a potentially fatal skin condition). Pfizer and the FDA have dismissed the risk of heart disease as being statistically insignificant (0.27% in a recently released study); but many industry professionals aren’t as quick to discount these findings. Michael Siegel, Professor in the Department of Community Health Sciences at Boston University notes that, based on the limited number of test subjects and the fact that these subjects were only observed for 30-days; this so-called “statistically insignificant risk increase” is not insignificant at all. It should also be noted that one of the study’s authors had received grant money from Pfizer; some time prior to conducting the test. This obvious conflict of interest further raises doubts regarding the validity of the study’s conclusions.
With so many people’s lives permanently, negatively affected; it’s not surprising that the litigation process has begun. Case MDL-2092 is currently making its way through the Alabama courts and preliminary proceedings are scheduled to begin on October 22, 2012. The class action lawsuit represents only those who suffered psychiatric consequences as a result of Chantix; there will likely be additional suits filed on behalf of people who were stricken with other detrimental side-effects.
Given the extreme nature of Chantix’ side-effects, many industry experts are left wondering why a medication requiring a black box warning has been given the green light by the FDA for smoking cessation, while electronic cigarettes have not. Unfortunately, the answer is likely political and financial. With vast amounts of money spent by both Big Tobacco and Big Pharma on lobbyists, there’s little likelihood of the FDA approving a product which benefits neither the tobacco nor the pharmaceutical industries.