Friday, August 28th, 2009

THIS DRUG HELPS YOU STOP SMOKING
BUT ALSO CAUSES CAR CRASHES AND SUICIDE

Smoking is the bane of our society. After the WW II American doctors and scientists got their hands on excellent research done in Germany in the earlier part of the 20th century. This carefully done science showed smoking was harmful to human health. For some reason the authorities decided to sweep it all under the rug and allow a large scale experiment on a generation of Americans. They waited until there were enough dead bodies to raise concern in the early 1960’s, when the Surgeon General’s warning about smoking came out.1 Frustrated policy makers refer to this common practice as the “dead body count” method of determining harm.

Our health care system is struggling to pick up the pieces from the great tobacco debacle. Over 400,000 Americans die prematurely a year because of tobacco use at an annual net cost to society of $45 billion a year . . . plus incalculable human pain and suffering.

CHANTIX TO THE RESCUE?

Chantix (varenicline) can get you off cigarettes. Indeed, any doctor will tell you getting people to quit smoking is well nigh impossible. Groups, nicotine patches and an antidepressant drug called Zyban (aka Wellbutrin) all help a few kick this deadly habit. In my own experience, I’ve also seen a first heart attack successfully convince some smokers to stop.

Chantix has a clever mechanism of action – it attaches to the same nicotine receptors in the brain that nicotine from cigarettes acts on. It delivers some of the same feel good effects while helping relieve the addiction. Chantix actually won an award for the Best New Small Molecule Drug at the second holding of something called the Scrips Award Ceremony held in London, England, which highlights the contributions of the drug industry to the advance of civilization (or something like that ).

UNSAFE AT ANY SPEED?

Chantix is running into problems. Reports of suicide and other serious psychiatric adverse events among patients taking it for smoking cessation continue to
mount. 2

New labeling required by the FDA warns of depression, hostility, aggression, suicidal thoughts and actual suicide in patients taking the drug.

The revised labeling also warns against increased risk of vehicle crashes while on the Chantix. It isn’t clear whether the crashes are caused by sleepiness and confusion, for example, or by suicide attempts.

At a press report in July of this year, the FDA reported 98 suicides and 188 suicide attempts since 2006.

MAYBE YES, MAYBE NO

In a weird example of bureaucratic doublespeak, Robert J. Temple MD, director of the FDA office of Drug Evaluation advised “We don’t think people shouldn’t use smoking cessation drugs . . . What you want is that people don’t do it casually and without paying attention.”

As a practicing physician, I’m not quite sure what Dr. Temple really means us to do with such advice. Stop messing around with Chantix?

The FDA is demanding that manufacturers of both drugs conduct more randomized controlled trials. Unlike previous trials, they must include subject with mental health conditions, typical of many smokers. In other words, in the original studies, Pfizer, shall we say, stacked the deck with emotionally healthy subjects less vulnerable to the potentially fatal effects of this highly touted drug.

Ninety-eight suicides. Increased risk of car crashes. Hostility. Aggression. Depression. Sounds pretty dangerous to me. Should this drug still be on the market? What are the safer alternatives – such as even tighter industry control. And why aren’t drug companies made to conduct more realistic research when it comes determining risk and harm?

1 .For more information on this disturbing piece of American history see The Secret History of the War on Cancer by Dr. Devra Davis, an epidemiologist at the University of Pittsburgh.

1.JAMA August 26, 2009 Vol 32 No. 8

Alan Inglis MD
American Country Doctor

Tags: Chantix, smoking, suicide, varenicline