You might quit smoking; you might kill someone
On Monday August 8th, the same day the Deeming Regulations were imposed on the vape industry, a Maryland man was found not criminally responsible for shooting his wife based on a claim of “involuntary intoxication.” According to the Washington Post, the man was under the influence of varenicline, sold in the US by Pfizer under the name Chantix. This is just the latest of many disturbing incidents blamed on the FDA-approved smoking cessation medication.
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.
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.
According to AlJazeera, over 500 suicides and almost 1,900 attempted suicides were reported to the FDA during the five-year period ending in 2013. More than 2,000 Chantix users have joined lawsuits against Pfizer, according to a 2014 McClatchy story. The plaintiffs claimed the drug had a variety of severe side effects. Most claims have now been settled, and Pfizer has paid out at least $299 million to Chantix users.
Black box warning
The history of Chantix is fascinating. Despite consistent clinical trial results showing it to be safe and well-tolerated by most patients, serious side effects — including suicide and murderous rages — have been reported almost since the day it was first sold. So many users have reported side effects, in fact, that the FDA forced Pfizer to put a “black box warning” on the package, the most severe warning label possible.
“The FDA assesses drug risks all the time,” writes Vice reporter Kayleigh Rogers. “If it thinks there is enough evidence that a drug causes more harm than good, it pulls it from the market (and that’s if a drug company hasn’t already pulled it). The FDA’s label requirements on Chantix aren’t proof that the drug causes people to come undone, it’s just relaying the information we have: there have been reports of serious neuropsychiatric adverse effects.”
Despite the black box warning and the thousands of reported negative side effects, Chantix remains an FDA-approved smoking cessation product. Insurance companies often cover the cost for smokers to use it, and doctors widely recommend it. But its reputation has made many smokers wary. So even though it still generates big dollars for Pfizer, sales are declining. According to the Wall Street Journal, Chantix sales dropped from $846 million to $648 million between 2008 and 2013.
Vaping is the better option
Vaping has cut into Chantix’ sales too. Pfizer probably supports anything that might restrict vapor products, as the deeming regulations will. There is a belief among many vapers that the FDA Center for Tobacco Products (CTP) — the division of the FDA that regulates tobacco and consumer nicotine products — created the deeming regulations in part to protect the pharma companies that make cessation products like Chantix from competition by vape. While that is theoretically possible, vapers have to understand that the CTP doesn’t oversee or approve Chantix, or any cessation products made by pharma companies.
That responsibility belongs to the Center for Drug Evaluation and Research (CDER) — the part of the FDA that regulates pharmaceutical products. Mitch Zeller’s team at the CTP has no regulatory control over sales of Chantix or NRT products like nicotine gum, and CDER has none over e-cigarettes (or tobacco products that actually contain tobacco).
Approval as a drug by CDER takes many years and millions of dollars. Randomized clinical trials must be performed at the expense of the manufacturer. It is an even more difficult and expensive path to approval than the Premarket Tobacco Application route laid out in the deeming regulations. So even though vaping may well be as safe or safer — and probably even more effective — than NRT products or Chantix, comparing one to the other is apples and oranges. The processes for approval, and the regulatory bodies that oversee them, are different.
Still, it will always be maddening to vapers to see an FDA-approved product that is known to have serious side effects easily available and even recommended, while the FDA is working overtime to hammer nails into vaping’s coffin.