by Tom Jackman
The smoking-cessation drug Chantix has now played a crucial role in a second violent crime. On Monday, a Maryland man was found not criminally responsible for shooting his wife in the neck in their home in 2014 because he was found to be suffering from “involuntary intoxication” due to Chantix. His wife survived.
Last year, an Army soldier, who brutally stabbed another soldier to death in 2008, won a new hearing because the judge in his original trial refused to let him put on an involuntary intoxication defense. The soldier claimed that he was so neurologically disturbed by Chantix that he was not aware of what he was doing. A military court then reduced his sentence from life without parole to 45 years.
Involuntary intoxication is not a new defense, but as we discussed on the True Crime blog in May, it is having more success in courts across the country. Last year in St. Paul, Minn., a woman charged with trying to kill and assault her two small children was released when prosecutors decided that the charges could not stand “in light of the defendant’s involuntary intoxication at the time of the charged incident.” A Columbia, Mo., woman who was convicted of causing a fatal wreck while driving the wrong way on Interstate 70 has been granted a new trial because she may have been secretly given a “date rape” drug before taking the wheel.
The defense did not work in Fairfax County, Va., in May, where a man who had invaded another lawyer’s home, took the lawyer and his wife hostage and then stabbed and shot them, later claimed that his prescribed cocktail of pain and psychiatric medications made him involuntarily intoxicated. A jury disagreed, convicted Andrew Schmuhl and sentenced him to two life sentences plus 98 years.
In Carroll County, Md., lawyers for Keith E. Sluder, 44, appear to be the second ones to specifically invoke Chantix for a successful involuntary intoxication defense. In November 2014, according to the Carroll County Times, Sluder awoke his wife and told her they had to go to his mother’s house. When she followed him up the stairs, he shot her once and tried to shoot her again, but the gun malfunctioned. When a sheriff’s deputy arrived and pointed his gun at Sluder, police said he tried to grab the deputy’s gun. The deputy did not shoot him.
Slider’s lawyer, Lawrence Greenburg, argued at Sluder’s hearing that Chantix caused Sluder to have a chemical imbalance. And prosecutors in New Carroll essentially did not argue with that, which would tend to indicate that their mental health expert examined Sluder and came to the same conclusion. The prosecutors allowed Sluder to enter an Alford plea to assault, and they dropped two counts of attempted murder.
Carroll County Circuit Court Judge Thomas Stansfield found Sluder not criminally responsible for the assault charge and ordered him released from custody Monday, according to the Carroll County Times. The Times reported that the shooting victim and her family pleaded with the judge not to release Sluder, but the judge said he was bound by the definition of not criminally responsible. The family reportedly was not happy with the decision.
Pfizer, the maker of Chantix, has denied that the drug has any neuropsychiatric effects. But McClatchy News Service reported in 2014 that more than 2,000 people had joined in lawsuits against Pfizer for various psychiatric problems, including suicide and suicidal thoughts. Pfizer settled most of them for an estimated total of at least $299 million, McClatchy reported.
These recent developments were greatly troubling to the family of Rick Bulmer, who was an Army recruit at Fort Benning, Ga., in 2008. While Bulmer slept in his bunk one night, Pfc. George D.B. MacDonald suddenly attacked him with a knife, slashed his throat and killed him for no reason. He claimed that the smoking cessation drug had made him delusional. A jury in 2009 convicted him of murder and sentenced him to life without parole.
But in 2014, MacDonald was granted a rehearing because of revelations about Chantix, which he hadn’t been allowed to pursue at trial. McClatchy reported that one week after the judge in MacDonald’s case refused to compel Pfizer to respond to a subpoena, the FDA issued a “black box” warning on Chantix because of its potential for “serious neuropsychiatric” problems. It is the most serious warning a medication can carry and still be sold.
A 2013 Cochrane overview and network meta-analysis concluded that varenicline is the most effective medication for tobacco cessation and that smokers were nearly three times more likely to quit on varenicline than with placebo treatment. Varenicline was more efficacious than bupropion or NRT and as effective as combination NRT for tobacco smoking cessation.
The United States’ Food and Drug Administration (US FDA) has approved the use of varenicline for up to twelve weeks. If smoking cessation has been achieved it may be continued for another twelve weeks.
Varenicline has not been tested in those under 18 years old or pregnant women and therefore is not recommended for use by these groups. Varenicline is considered a class C pregnancy drug, as animal studies have shown no increased risk of congenital anomalies, however, no data from human studies is available. An observational study is currently being conducted assessing for malformations related to varenicline exposure, but has no results yet. An alternate drug is preferred for smoking cessation during breastfeeding due to lack of information and based on the animal studies on nicotine.
Mild nausea is the most common side effect and is seen in approximately 30% of people taking varenicline though this rarely (<3%) results in discontinuation of the medication. Other less common side effects include headache, difficulty sleeping, and nightmares. Rare side effects reported by people taking varenicline compared to placebo include change in taste, vomiting, abdominal pain, flatulence, and constipation. In a recent meta-analysis paper by Leung et al., it has been estimated that for every five subjects taking varenicline at maintenance doses, there will be an event of nausea, and for every 24 and 35 treated subjects, there will be an event of constipation and flatulence respectively. Gastrointestinal side-effects lead to discontinuation of the drug in 2% to 8% of people using varenicline. Incidence of nausea is dose-dependent: incidence of nausea was higher in people taking a larger dose (30%) versus placebo (10%) as compared to people taking a smaller dose (16%) versus placebo (11%).
Depression and suicide
In November 2007, the US FDA announced it had received post-marketing reports of thoughts of suicide and occasional suicidal behavior, erratic behavior, and drowsiness among people using varenicline for smoking cessation. Since July 1, 2009, the US FDA has required varenicline to carry a black box warning that the drug should be stopped if any of these symptoms are experienced. The label notes, however, that a pooled analysis of 18 randomized clinical trials including 8,521 people found similar rates of psychiatric events in the treatment and placebo arms, and that similar results have been obtained in four observational studies including 10,000 to 30,000 varenicline users. People are advised to weigh the risks of using varenicline against the benefits of its use, noting that varenicline “has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo.” and that “the health benefits of quitting smoking are immediate and substantial.”
A 2014 systematic review did not find evidence of an increased suicide risk. Other analyses have reached the same conclusion and found no increased risk of neuropsychiatric side effects with varenicline.
In June 2011, the US FDA issued a safety announcement that varenicline may be associated with “a small, increased risk of certain cardiovascular adverse events in people who have cardiovascular disease.”
A prior 2011 review had found increased risk of cardiovascular events compared with placebo. Expert commentary in the same journal raised doubts about the methodology of the review, concerns which were echoed by the European Medicines Agency and subsequent reviews. Of specific concern were “the low number of events seen, the types of events counted, the higher drop-out rate in people receiving placebo, the lack of information on the timing of events, and the exclusion of studies in which no-one had an event.”