Experts on Chantix Report Tied to Trial Attorneys and False Crusade Against Statins: Authors Blowing Smoke

A recent report published in the Annals of Pharmacotherapy asserted that “evidence is accumulating that the stop-smoking drug Chantix is linked with unprovoked acts and thoughts of aggression and violence.”  (but the validity of this claim is questioned)

In fact, Thomas J. Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices in Horsham, Pa., and one of three co-authors of the study, went as far as saying that the drug “is so potentially dangerous that its use should be restricted to exclude police, military, and similar occupations in which workers carry weapons”.

What is troubling about this article and subsequent interview is that everyone ignores the fact that Thomas Moore is the same “expert’ who inveighed against statins back in the late 80s and early 90s, citing “evidence” that they caused suicides, homicides, and so on.  But the article does not discuss the crusade he made on this issue back then, or the outcome, or the fact that statins have saved the lives and improved the health of hundreds of thousands of Americans and have no link to the behaviors Moore describes.

Equally problematic about this study, which the article does discuss, is the fact that co-author of the report, Joseph Glenmullen, MD, of Harvard Medical School, has been retained as a potential consultant in legal cases involving Chantix, and he often provides expert testimony on the side effects of psychiatric medications. Such involvement to most would clearly appear as a conflict of interest, as we have seen before in authors of studies who were also experts in litigation.

Despite conveniently forgetting to adequately address these issues, Moore went on to describe in an interview with WebMD that he and his “colleagues have been concerned about the safety profile of [Chantix] since their first report [warning of adverse events] in 2008.”

Chantix was approved by the FDA in May 2006 as a smoking cessation treatment. The drug targets nicotine receptors in the brain, blocking nicotine from getting to them. The typical way individuals are put on Chantix is that “smokers begin at a low dose and then increase it, continuing to smoke until the eighth day, when they are instructed to quit. They continue the drug for 12 weeks and in some cases an additional 12.”

Concerns apparently took place in late 2007, “after an episode in which a Dallas musician taking the drug displayed aggressive, abusive behavior and was shot dead while trying to kick in the door of a girlfriend’s neighbor.” In addition to this event, FDA has received adverse event reports since the drug came on the market and in response “issued communication about the possible risks, and required a medication guide be given to each patient and with each refill.”

Additionally, MacKay Jimeson, a spokesman for Pfizer, emphasized that the “currently approved Chantix label contains a boxed warning regarding reports of serious neuropsychiatric events reported in some patients, and that patients are advised to stop the drug and get medical help if that happens.” Jimeson further emphasized that “there is no reliable scientific evidence demonstrating that Chantix causes these events.”

Despite the benefits Chantix has provided for numerous patients, “Moore and his colleagues gathered information on 78 adverse event reports received by the FDA as well as four other cases reported in clinical trials and three others from published literature. After examining each case and describing some of the incidents of aggression and violence, the researchers claimed that symptoms typically began soon after starting the drug, and symptoms and other adverse effects resolved in most all cases after the drug was stopped.

This finding however, demonstrates the perennial problem with associations.  Chantix use is also associated with other behaviors that may be deemed inappropriate because invariably some folks taking the medication by chance alone will engage in them (promiscuity, drug use, theft, etc.) especially in smokers (which Chantix is designed to help). In other words, some of these behaviors and adverse events were already likely possible or present in people before taking the drug. And the fact that “nearly 40% of patients on Chantix were also on tranquilizers, antidepressants, or antipsychotic drugs, according to the FDA,” substantiates that claim even further.

So the effects of Chantix on people displaying this kind of behavior or experiencing an adverse event should not be as surprising considering 40% were obviously under treatment for something that could be as easily related to that same behavior.

Supporting this conclusion, Serena Tonstad, MD, PhD, a professor of health promotion and education at the Loma Linda University School of Public Health in Loma Linda, Calif., told WebMD that “the new report shouldn’t turn people automatically against the drug.” Tonstad, who also served on the advisory board and has been a consultant for Pfizer, noted that she “wouldn’t advise people not to try it [Chantix] based on this report because the benefit of quitting smoking is most important, and Chantix has proven effective in helping people to quit.”

Moreover, according to a spokesperson for Pfizer and a smoking cessation researcher, “the number of adverse events is far outweighed by the benefits of the drug, which has helped countless people give up cigarettes and the health risks associated with tobacco use.”

Tonstad did however agree that “people on the drug need to be monitored, and people with bipolar disorder should be especially closely monitored because in her experience, they seem to be more at risk for difficulties than people with other psychiatric problems.” In fact, she told WebMD that her practice is to control a person’s depression first, before putting them on smoking cessation.”

In the end, with two of the authors who are leading this surge against Chantix having their own “conflicts” and biases, this study must be heavily scrutinized and examined before taking any drastic measures that could impact millions of patients who successfully use Chantix to help them beat cigarette addiction. To help address these potential conflicts, more education is obviously needed between physicians, patients and Pfizer to educate patients about the warning signs and the best methods to prescribe Chantix to avoid these adverse events in the future, while still allowing the success of the drug to continue helping patients quit smoking.