Tuesday, November 4, 2008

Helping smokers . . . by messing with the brain

The descent down the slippery slope continues. Dr. Gerry Brosky, a researcher with Dalhousie University’s family medicine department, is planning a study to determine if Champix (varenicline) can be used to “help” a smoker to quit even if he doesn’t want to.

According to an article in the Halifax Chronicle-Herald, the doctor has been advertising for guinea pigs for his proposed study all summer. He already has about sixty volunteers, but needs about 230 participants for the study. The project is a blind study, with neither the participants nor Dr. Brosky knowing who is getting the drug and who is taking a placebo.

Dr. Brosky says: "The people I’m looking for very specifically don’t want to quit. So I have to turn away a lot of people who tell me they are ready to quit right now."

There are several reasons to question the ethics of this proposed study and a whole host of unanswered questions.

To begin with, the purpose of the study is to ascertain if smokers who don’t want to quit can be given medication to induce them to quit; or, as the newspaper article puts it, a “pill for puffers who don’t want to butt out”.

And, that is clearly the intent of this study; to determine whether the pleasure receptors in the brain can be altered to curtail the enjoyment the smoker experiences after lighting up, despite the fact that they don’t want to quit.

And, if it proves successful in curtailing the pleasure a smoker derives from lighting up, it could easily become a forced medical intervention. That doesn’t imply physically restraining a smoker to administer the medication. There are other ways to coerce an individual to “take the cure”.

If you want to keep your job, take the Champix. If you want to keep your apartment, take the Champix. If you don’t want to be a social outcast, take the Champix. If you want to keep your kids, take the Champix.

Or, perhaps it could be developed as a vaccine that can be given to children to prevent them from taking up the habit.

Far fetched? Paranoid? No. Not really. Dr. David B. Abrams is executive director of the Schroeder National Institute for Tobacco Research and Policy Studies at the American Legacy Foundation. In a recent interview with the New York Times, Dr. Abrams said: “The real hope is that we could give pre-adolescent kids a vaccine, just like we do for childhood diseases.”

Which brings us to the choice of drugs for the study; Champix. It’s a smoking cessation drug which alters the pleasure pathways in the brain. It’s sold in the US under the name Chantix. And, Dr. Abrams thinks that Chantix is a “very safe and effective drug”.

However, the Chronicle-Herald article points out that: “Earlier this year, the United States Food and Drug Administration (FDA) issued a public health warning linking the drug to potentially serious neuropsychiatric symptoms such as changes in behaviour, agitation, depressed mood and suicidal thoughts and behaviour.

Many people would consider this assertion to be something of an understatement. An article on this blog noted that, in addition to warnings from both Health Canada and the US FDA, the US Federal Aviation Administration (FAA) banned pilots and air traffic controllers from using the drug. And, it has also been banned for use by commercial drivers in the US.

Furthermore, Dr. Michael Siegel reported in an article on his blog that: “A new report from the Institute for Safe Medication Practices revealed that Chantix (Champix in Canada) accounted for more reported serious injuries than any other prescription drug, including blackouts putting people at risk of accidents, and concluded that broader warnings are necessary to protect the public from the potential dangers of Chantix side effects.”

But, according to Dr. Brosky, in his own experience, he has seen only two patients become depressed while on the medication. "It’s hard to tell if it’s the medication or if it’s the sudden decrease in smoking or the way it interacts with smoking and the nervous system.

This brings us to the third troubling aspect of the proposed research; the potential for bias. According to the newspaper article, “Dr. Brosky has been working with Champix for three or four years, first in clinical trials and now in practice.”

The article does not make it clear if these clinical trials were undertaken on behalf of Pfizer (the manufacturer of the drug), for a third party, or if Dr. Brosky was conducting these trials on his own. However, if his previous clinical trials played any role in the subsequent approval of the drug by Health Canada, it may well introduce an element of bias into the results of the planned research.

Another disturbing aspect of the study is whether or not experimenting with human subjects under existing circumstances is ethical, given the health concerns already raised over the use of Champix. Presumably, the drug has already been shown to be beneficial, at least to some degree, in getting smokers to quit. Why is it necessary to establish, through human experimentation, if Champix can be used to induce smokers, who don’t want to quit, give up smoking?

And, lastly, is the size of this study adequate to "have the statistical power to see whether or not we are doing any good." Many studies on secondhand smoke, with much larger sample sizes (the IARC study commissioned by the World Health Organization, for example), have been dismissed because the sample size was too small.

The study is expected to take about a year and Dr. Brosky anticipates being able to compile the results by February of 2010. But, there’s one other unanswered question in the article from the Chronicle-Herald which needs answering.

Who’s funding the study?

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