The Premier of my lovely province here on the West Coast of Canada promised during our spring election campaign that her government would pay for prescription drugs or products to help British Columbians quit smoking. But a new report in The Tyee suggests that some of the drugs the province wants to fund are controversial.

One of them, varenicline (which is made by drug giant Pfizer and sold as Champix in Canada and Europe, or as Chantix in the U.S.) has been associated with suicides and severe psychiatric side effects.

In fact, here’s what the Institute for Safe Medication Practices, an American non-profit, said about varenicline in its October 2008 quarterly update:

“Varenicline accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1,001 new cases, including 50 additional deaths.”

And the government of France last month announced that it will stop paying for varenicline because of serious questions around its safety.

France’s Health Minister Xavier Bertrand decreed that the drug would now be removed from a list of approved treatments available for reimbursement through his country’s social security funds.

But here in Canada, our provincial Health Minister Mike de Jong said he had “not yet heard about” any issues with varenicline when The Tyee asked him what he thought about France’s decision.

Chantix/Champix contributed $755 million in worldwide sales to Pfizer’s bottom line last year, up from $700 million the year before. In the U.S., however, sales declined about 15% from $386 million to $330 million, as reports of serious side effects stunted market growth.

And here’s where the drug company’s suspicious actions begin to ring alarm bells.  In another controversy surrounding varenicline, the U.S. Food and Drug Administration announced last month that Pfizer had been asked to resubmit thousands of reports on adverse events related to Chantix in the U.S.

This unusual request came after it was revealed that Pfizer had attempted to send  adverse event reports as part of a routine periodic safety summary instead of as a report required within 15 days of unexpected or fatal events, the FDA said.  This meant deliberately delaying 589 reports of severe side effects, including 150 suicides as well as suicide attempts, depression, aggression and hostility. These adverse events were allegedly mixed into reports of minor side effects such as nausea and rash.

Meanwhile, back here in Lotus Land, our B.C. Premier Christy Clark made this feel-good election promise during our May provincial election campaign:

“Every year tobacco-related deaths rob us needlessly of friends,  family and loved ones. This program will provide smokers with a new level of direct support to quit, to live smoke-free, and to improve their own health as well as the health of their families.”

The program, which could cost as much as $25 million depending how many British Columbians take advantage of it, will provide smokers with free smoking cessation aids like patches or nicotine gum for 12 weeks.

It will also fund two prescription drugs through our provincial prescription drug support plan, PharmaCare. The drugs currently being considered to help people quit smoking are varenicline as well as bupropion, which GlaxoSmithKline sells as Zyban and which is available in a generic form as well.

Both drugs are anti-depressants – and both come with serious safety warnings. Saskatchewan and Quebec are currently the only provinces in Canada that pay for varenicline.

Health policy researcher Alan Cassels told The Tyee:

“If this drug was a huge advance, effective, safe and not too expensive, every province would pay for it. The fact that two out of ten provinces pay for it is not a good sign.”

Since the French pulled its government funding for varenicline last month, and since the June statement issued by Health Canada informing Canadians of the drug’s  increased risk of heart-related side effects in patients who have cardiovascular disease, it seems that our own provincial government may be forced to take another look at their hasty election promise. A final decision is expected in British Columbia by next month, when Premier Clark has said funding for this smoking cessation program was  set to begin.

If B.C. follows France’s lead, wouldn’t this be bad news for all those smokers out there who might not get their free Champix to help them quit?

Not necessarily. Australian research published this spring in the journal Public Library of Science Medicine now suggests that unaided smoking cessation methods (stopping cigarettes cold turkey or gradually reducing before quitting) is actually the most successful way to quit smoking after all, despite Big Pharma’s expensive campaigns to convince us why we need to buy their products if we really want to quit.

Pfizer regularly pays cash to physicians in Canada in exchange for favourable testimonials about its smoking-cessation aids, without publicly disclosing those financial ties – even though research shows that the vast majority of ex-smokers have successfully quit on their own.

In fact, as with problem drinking, gambling, and narcotics use, population studies show consistently that up to three-quarters of smokers who permanently stop smoking do so without any form of assistance.  But of course, it’s not in Big Pharma’s best interests to let us quit on our own like this. See also: “Too Many Smokers Are Quitting On Their Own”.

Two years ago, the Toronto-based Globe and Mail reported this about varenicline:

“The investigation and reports of major side effects highlight what many medical experts describe as chronic problems with the way new drugs are approved in Canada, and the ability of government officials to adequately monitor them once they’re put on the market.”

David Henry, chief executive officer of the Institute for Clinical Evaluative Sciences in Toronto, agreed, offering this alarming statement:

“Existing systems don’t really seem to be adequate. That means often times the studies that are the basis for drug market approval are not large enough to test for safety properly.”

And over at the competition, even GlaxoSmithKline’s own prescribing information for its Zyban warns:

“Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking Zyban for smoking cessation.”

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NEWS UPDATE, November 2, 2011:  The medical journal Public Library of Science  One has reported further studies* on adverse drug events in patients taking varenicline. Researchers determined that, out of 3,249 reported cases of suicidal/self-injurious behavior or depression, the following numbers of these serious adverse events were linked with these stop-smoking aids:

• 2,925 reports among patients who used varenicline (Champix or Chantix)
• 229 reports for bupropion (Zyban plus a generic version)
• 95 reports for nicotine-replacement products (over-the-counter patches, gum, or lozenges and prescription nasal sprays or inhalers)

WARNING: Researchers concluded that varenicline and bupropion should generally be considered only if you’ve tried and failed with other measures:

“The findings for varenicline, combined with other problems with its safety profile, render it unsuitable for first-line use in smoking cessation.“

If you take either drug, stop immediately and contact your doctor if you become agitated, hostile, or depressed, or if you experience changes in behaviour or thinking, especially regarding suicide.

* Moore TJ, Furberg CD, Glenmullen J, Maltsberger JT, Singh S (2011) “Suicidal Behavior and Depression in Smoking Cessation Treatments”. PLoS ONE 6(11): e27016. doi:10.1371/journal.pone.0027016

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See also:

• True or False? Most Smokers Need Help to Quit
• Too Many Smokers Are Quitting On Their Own – So Pfizer Pays Doctors to Plug Their Nicorette Gum
  

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