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BC to Pay for Anti-Smoking Drug that France Finds too Risky

French government strikes controversial varenicline off its list as Premier Clark puts it on PharmaCare's.

By Andrew MacLeod, 6 Jun 2011, TheTyee.ca

Cigarette Butt

Better ways to snuff a habit? Varenicline is an anti-depressant with a serious safety warning.

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British Columbia Premier Christy Clark recently came through on a leadership campaign promise to have the government pay for prescription drugs and other products to help people quit smoking.

While reducing tobacco use, which causes cancer, is good public policy, some of the drugs the province will now be funding are controversial. One of them, varenicline, is associated with suicides and psychiatric side effects.

France last week said it would stop paying for varenicline because of the questions around it, a fact Health Minister Mike de Jong said he hadn't yet heard when The Tyee asked him about the decision.

"Every year tobacco-related deaths rob us needlessly of friends, family and loved ones," said Premier Christy Clark making the May 9 announcement. "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 people take advantage of it, will provide people with nicotine gum or patches for 12 weeks starting in September. It will also fund the prescription drugs through PharmaCare.

Safety warnings

Health Minister de Jong said it's unknown how much of the program will go to the nicotine replacement products and how much for prescription drugs.

The drugs available to help people quit smoking are varenicline, which is made by Pfizer and sold as Champix in North America, and bupropion, which GlaxoSmithKline sells as Zyban and which is available in a generic form as well. Both are anti-depressants and both come with serious safety warnings.

Here's what the Institute for Safe Medication Practices, an American non-profit, said about one of those drugs in it's Oct. 23, 2008 quarterly update: "Varenicline (Chantix, Champix), an aid to stopping smoking, 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."

The U.S. Food and Drug Administration had put out a public health alert about it's psychiatric side effects, the newsletter said.

In the two years since its 2006 approval, it said, the drug had accounted for 3,325 reported serious injuries, including 112 deaths, in the United States. "In the latest quarter, the toll included numerous cases of serious injury linked to traffic accidents or falls," it said. "Other reports described other events such as blackout with a high potential to cause accidents. Following our initial report, the federal government took prompt action to ban varenicline in the most sensitive occupations such as for airline pilots and military missile crews."

Risk of self-harm, suicide

Health Canada put out a warning in 2009 about the drug: "While Champix (the brand name for varenicline tartrate) can be an effective tool for quitting smoking when used as part of a support program, there have been reports in some patients of unusual feelings of agitation, depressed mood, hostility, changes in behaviour, or impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. It is unclear at this time whether Champix is the cause of these psychiatric symptoms."

The warning reminded people thinking of quitting smoking to consider the risks and benefits of whatever method they choose.

GlaxoSmithKline's prescribing information for 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."

It also notes that the side effects should be weighed against the benefits of quitting smoking "Zyban has been demonstrated to increase the likelihood of abstinence from smoking for as long as [six] months compared to treatment with placebo," it said. "The health benefits of quitting smoking are immediate and substantial."

Zyban, which the Lung Association notes has been associated with seizures, has also been the subject of a Health Canada warning.

France quits paying for drug

France is going the opposite direction of B.C. On May 31, Reuters news service reported, the country's health minister, Xavier Bertrand, said, "Questions have been raised about Champix, so I've decided it will no longer be covered by (state) health insurance."

Asked about the French decision, B.C.'s de Jong said he had not heard about it. "I'll check and see what kind of an effect it has had," he said. "I know this, if you go to Europe, there are a whole lot more people smoking there than there are here and that is resulting in some significant costs."

France's decision to stop paying for the drug was a surprise, said Heather Bisset, a spokesperson for Pfizer Canada. "Pfizer France had received no prior notification about the health minister of France's intention to remove reimbursement for Champix," she said in an email. "This announcement came outside of the formal process and Pfizer is currently seeking immediate clarification."

In March, a European Union committee that reviews which drugs may be sold for human use, concluded "that Champix continues to have a favourable risk-benefit profile," she said, adding the conclusion was reached as part of a standard five-year review of the drug.

She noted that some 650,000 Europeans a year die from tobacco use, making it the single largest cause of avoidable death in the European Union. "Given the significant public health risks of smoking, removal of reimbursement for varenicline would limit the options available to the French public," she said.

The smoking statistics in Canada are also stark. Health Canada says half of all smokers will die from smoking before they turn 70 years old, Bisset said. That works out to about 37,000 Canadians a year who will die from smoking, she said. The Canadian Agency for Drugs and Technology in Health, which balances the costs versus benefits of drugs, recently concluded that "reimbursement of smoking cessation therapy is an effective intervention to help smokers quit," she said. That same report, by the way, was however inconclusive on whether governments should pay for the drugs. "Reimbursing smoking cessation therapies may be a cost-effective option for a health authority or a third-party payer compared with not doing so," the summary said. Bisset wrote, "We are looking forward to supporting the B.C. government implement their smoking cessation strategy."

'Safer ways to quit smoking': researcher

Health researcher and author Alan Cassels said varenicline has been under a cloud for a long time and the B.C. government should be extremely cautious about encouraging its use. As the government pays for it, more people will take it and rare but serious side effects will happen more often, he said.

"You can expect to see subsequent increases of adverse reactions, possibly deaths," he said. "There are safer ways to quit smoking."

If the government is going to pay for these drugs, it should keep close track of any adverse reactions, Cassels said. "We have methods in B.C. of tracking the effects of medicines," he said. "The introduction of new coverage of a very controversial drug without proper evaluation or monitoring is irresponsible."

Cassels said the risks of the drugs should not be compared to the risks of smoking, but to the risks of other methods of quitting smoking such as joining a support group, using nicotine-replacement therapies or quitting cold turkey.

The Tyee asked Minister de Jong how the government plans to monitor the outcomes for patients given the drugs.

"We monitor smoking on a regular basis and of course B.C. leads the nation, but we're still at 15 per cent," he said. "If we could drop that to 12 per cent even, the medium and long-term savings are significant."

There's a financial incentive for the government to reduce smoking, and it's good for individuals and families, too, he said. "The ultimate test of success is whether fewer people are smoking and we'll be monitoring that closely."

In other words, while the government plans to continue monitoring smoking rates, there appears to be no plan to watch for any increase in the number of adverse reactions from wider use of the prescription drugs they are funding.

Smoking-related health costs top $600 million

According to the province's announcement, 6,000 British Columbians a year die from tobacco use, costing the health care system some $605 million a year.

The B.C. Medical Association's president-elect Nasir Jetha supported the government's announcement, including the funding for "stop-smoking medications," saying it was "great news for the 70 per cent of B.C. smokers who are wanting to quit."

He did not respond to questions by publication time.

Questions sent to Jetha about adverse reactions, relative risks and doctors' prescribing practices did generate a response from a BCMA spokesperson. "The answers to your questions are probably best answered by a general practitioner," wrote Sharon Shore. "Dr. Jetha is a pediatrician and as such would have (one would hope) little cause to prescribe stop smoking medications to his small patients and therefore would not know the details of the specific medications you are asking about." [Tyee]

Andrew MacLeod is The Tyee's Legislative Bureau Chief in Victoria. Reach him here.

19 Comments:

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  • Dan the socialist

    50 weeks ago

    According to the province's

    According to the province's announcement, 6,000 British Columbians a year die from tobacco use, costing the health care system some $605 million a year.
    ==========

    What are the costs of obesity and deaths? What about all the people that eat fast food? I would say it has surpassed tobacco. Way more health problems caused by obesity and fast food than smoking other than lung diseases obesity causes all the same health problems as smoking (heart attacks, strokes etc) plus knee and other joint problems, diabetes,high cholesterol etc yet fast food and junk food are not taxed anywhere near what tobacco is. But I guess it will be next...

  • puppyg

    50 weeks ago

    Uh-uh-uh!

    Christy... lawsuits...

  • puppyg

    50 weeks ago

    taxpayer magic

    I have a neighbour, a millionairess many times over, who says she wants to quit chain-smoking. The timing, however, just hasn't been right for her.

    Enter Christy Clark.

    I have no doubt this program will be just what my neighbour needs to find her willpower. Just like the rest of us, she loves to save a few bucks. And if Christy's paying, it's free, right?

  • A Voice

    50 weeks ago

    Champix

    An excellent aid to stop smoking, worked for me with no side effects other than some very vivid dreaming. Barring death of course, whats worse a couple side effects or smoking. I think that the side effects are pressent in an individual be fore they even take it

  • gguppy

    50 weeks ago

    anti-smoking prescriptions?

    Isn't it the responsibility of a doctor to issue prescriptions? Shouldn't they, in issuing the prescription, be aware of possible side-effects? Then there is the pharmacist who fills it.

    I have friends who will benefit from this program. The only thing that's stopped them for using the replacements in the past has been the cost and perception that continued tobacco use might be cheaper.

  • Jinx

    50 weeks ago

    Kudos

    I'm all for this program, as both a smoker trying to quit, and as a health care professional. I realise everyone can react differently to any medication, but Champix gave me the worst scare of my life. I am prone to depression but had never had an episode as dark or as sudden as the one I did on Champix. My depressions are usually well controlled with CBT, exercise, diet and good sleep hygiene. I know if my daily life is impacted too much, I can always seek councelling and medications.When suicidal ideation became a constant thought, and most of my day was spent sobbing
    uncontrollably, I knew this was not the way to quit for me. I came very very close to hurting myself.

    Having said this, I know many folks who had no problem on Champix, and I am happy for them. I would suggest though, that anyone taking this, who may be predisposed to depression to use cautiously. And anyone generally taking this medication to let their closest friends and family know that this is a potential risk with Champix, and to help monitor the user's mood. It's hard to explain, but unlike a normal depression, it was almost instant. In a matter if days I went from myself, to perceiving my world as a terrible, bleak place full of horrid emotional hurt. First with wild mood swings, then with a steady, hard depression like I've never experienced before. I didn't immediately recognise it as Champix related, but once stopping, I was mostly back to myself, not as violently labile...just in a "funk".

    Ironically, the stress of this and the strain it had put on my marriage, had me smoking again in no time.

    So my advice: if you're going to try this, use cautiously and best of luck. I hope you're one of those who this works for.

  • skeletor

    50 weeks ago

    what are teh actual peer reviewed facts on the drug?

    Just because France stopped paying for the drug doesn't mean much to me. Living there i can tell you how conservative there are about well everything. Are other countries cutting funding as well or is this just France. I would be alarmed if everyone else did something and we trailed behind. Alarmed not surprised.

    Conspiracy theory also makes me suspicious. France has massive issues with its healthcare system the the ways of debt and will be cutting back on services. Cutting back on paying for such a drug could be one way. Remember France has a massive percentage of smokers. Sadder still is passing by a high school and seeing how many 16 or younger youth are smoking! Maybe a situation of sort term savings long term issues when so many will face health consequences?

  • Fish-counter

    50 weeks ago

    Economics isn't a Mobius strip, is it?

    So the "savings" on not having to treat tobacco-related diseases does not come back to the tax-payer. Instead we see the increased healthcare costs. Why not charge the smokers for their treatment, instead of making it "free"? They could buy the treatment instead of buying smokes. The rest is just blah, blah, blah.

    People are going to die anyway, and their last few days are the most expensive in terms of healthcare costs. Get used to it.

    I don't care how many people die of cancer from smoking. If they paid for it, they entitled to die of it. I used to smoke too, and I quit. It wasn't easy but in the end it was the bronchitis that cured me. Coughing phlegm isn't sexy.

    P.S.
    Perhaps my indifference to the suffering from smoking is linked to the fact that my ex-wife still smokes. Rather than wanting her to quit, I would prefer to send her a pack of smokes on her birthday.

  • Gerry1

    50 weeks ago

    Aw, Just drink the hemlock and shuddup

    I am astonished that such a know-it-all as Ms Crispy does not know that Chantix is now being considered as a "suicide causer." The Powers That Be are considering taking it off the market. I quit smoking (after 3 million attempts) using Nicorrette Gum and for the first week, a Nicorrette Patch. It' been 3 years clean - with my extra time, I read research papers about miracle products, like "Chantix." I think Ms. C. has a plan to rid us of our unacceptable selves:
    Offer these products to the people who need them and trick them into just killing themselves. Holy COW - does she read nothing??? (Other than polls: no.) We need a Premier who reads and researches - or else we could have recruited Sarah Palin.
    Or maybe Crispy will volunteer to try Chantix first...before offering it to those filthy people, the smoking public.
    I personally know two people who found themselves hospitalized with suicidal ideation and delusional thoughts - neither had any previous history, but had been using Chantix.
    WOW!!!

  • margot

    50 weeks ago

    As someone who really has

    As someone who really has hit the wall and must now quit smoking, I recently called the gov't quitnow.ca to line up a quit-coach.

    Just before phoning in, I checked out the web page with its emphasis on expensive products, without which ordinary mortals are sure to fail. I was surprised to see Champix advocated.

    Stupidly, perhaps, I said to the receptionist that I hoped the whole effort wasn't just marketing for the products listed on the web page, particularly Champix, which should have been banned years ago.

    She seemed to think I wanted to ban Tampax, so I said "Champix", she said "Tampax?", I said "Champix!", and I never did get a call from a coach. Perhaps my app got thrown in the nut basket.

    A pinch of tobacco between the toes is my choice for nic replacement once I make the move. I really need the mental stimulation I get from smoking, which will take a while to get over.

    Time to phone for a coach again. Won't mention Champix though.

  • john corsiglia

    50 weeks ago

    How I cleaned up my VERY heavy smoking habit in two days.

    The use of a questionable drug for quitting smoking concerns me. My own experience shows that it’s not that hard to quit—even a very heavy smoking habit.

    I had been smoking two packs of cancer sticks a day..... It came about when I simply found that I wanted to quit and one day I decided to quit and so chucked out my ciggies..

    Of course, an hour later I was desperate for a smoke.....

    But a thought came to me from somewhere...."John, you never smoke when you're in the shower, (no one does) maybe you could take a shower and see what happens...." So I took a shower--squirting a lot of water at my face and in my mouth for good measure and a few minutes later I was again desperate for a smoke. But I did notice something, i.e. it took a while--a good 10 -15 minutes before the craving returned.

    This led to some experimentation and a lot of showers. I kept noticing that the return of the craving came after longer intervals of time. Figuring that I was on to something I kept at it for the next two days and after a lot of showers. [30 or 40] my mind-body - or whatever - decided that cravings for nicotine just weren't getting the nicotine into the system and the cravings stopped. That was 33 years ago. No smoking since then and only occasional smoky temptations which were quickly quenched as previously

    I had been smoking around two packs of cigs a day..... My fingers and were teeth stained, orange-brown and I'm sure I smelled like an ashtray. I was so pleased to be able to smell aromas again….

    The use of a questionable drug for quitting smoking concerns me. The community paying for questionable medical treatment with our communal tax $ annoys me a lot.

    Maybe former can compare notes and figure out how our brothers and sisters can quit without Big-Brother-Pharma cashing in on our misery. Surely others have had experiences like mine? We started smoking and allowed ourselves to become addicted to a poison [nicotine kills bugs and is classed as an insecticide, after all] . You’d think we could find lots of ways of becoming un-addicted.

    Thank you very much for your story & good luck to us all and hey, there's no charge for using "John's method"

    John Corsi, East Sooke

  • Amelia Bellamy-Royds

    50 weeks ago

    Are you blushing, Mr. MacLeod?

    Consider this some strong flattery, posted less than an hour ago at the Vancouver Sun:

    B.C. expands smoking cessation drug coverage as France halts funding for one

    http://www.vancouversun.com/health/expands+smoking+cessation+drug+coverage+France+halts+funding/4902306/story.html

    The BC Health Ministry is also clearly re-examining the issue after you brought it to their attention -- the spokesperson who spoke to the Sun's Randy Shore today seems to imply that there is no guarantee this drug will be covered, and that a review is ongoing.

  • Lady Ta Ta

    50 weeks ago

    Defense de fume, eh?

    Kind of galling, or perhaps Galloise-ing, to keep funding bad habits, while those trying to do something to maintain health must pay for physio and the like when actively rehabbing a strain or injury.

    Choose your addiction -- smoking, overeating, or running -- and ponder whether it's fair to ask your neighbour to fund treatment.

  • OhCanada

    50 weeks ago

    Let them smoke...

    ...and they probably will die faster.

    Sorry - I have no compassion for smokers. It is a choice. So is eating garbage and not taking care of oneself.

    Action leads to consequence. Simple as that. It shouldn't be the tax payer to pay for this.

    How can I choose where my tax money goes?

    Not one penny of my taxes to a smoker! If they could put the cigarette in their mouth they can take it out too. What the hell....

  • happy

    50 weeks ago

    Well....

    From what I 've read most people think its appropriate to spend tax dollars so that junkies and crackheads can partake in thier addictions in a supervised comfortable setting so I guess no one should bitch about spending tax dollars on actual tax payers who are trying to end thier addictions.

  • Sahib

    50 weeks ago

    Champix

    What's all the fuss about? I smoked for 30 years and tried numerous times to stop. I finally tried Champix and was successful. I am now smoke-free and enjoying life without the chains! I experienced no ill-effects from the drug at all. There is a risk that some people might so doctors MUST forewarn patients that if they feel any ill effects, they must stop using it. That's all. Kudos to Christie for getting people off. She's a woman with a vision and the "balls" to carry it out.

  • Okanagan Orchardist

    50 weeks ago

    The price of smoking...

    If the "addicted" folk who need to smoke can afford two or more packs at the price they are right now, they can certainly afford the gum and patches that the rest of us non-smokers are expected to pay for. The few smokers I know have no intention of quitting. If it wasn't for the fact that their final treatment is also going to have to be paid for by non-smokers, I would aslo concur with the many suggestions made here that, "they have made their beds now let them lie in them." The only way they might quit is to raise the price of cigarettes so high they won't have any other option. Our government should seriously consider taking the cigarette manufacturers to court and have them pay for the treatment costs of all smokers.

  • Fish-counter

    50 weeks ago

    As an ex-smoker, I can detect a cigarette from 100 yards away

    The smell is unique and disgusting. Even driving down the road, I can tell if the driver in front is smoking. How about they try weed as a compromise? That doesn't smell quite so evil; it is kind of nice, actually.

    As for me paying for someone else's treatment; screw them. I am SO sick of being asked to fund other people's bad habits. Who picked up the tab for the forest fire in Barrier, anyway? Did they charge the guy who failed to put out the fatal cigarette that started it? I didn't think so. Now there is an interesting issue...

  • Fish-counter

    50 weeks ago

    As an ex-smoker, I can detect a cigarette from 100 yards away

    The smell is unique and disgusting. Even driving down the road, I can tell if the driver in front is smoking. How about they try weed as a compromise? That doesn't smell quite so evil; it is kind of nice, actually.

    As for me paying for someone else's treatment; screw them. I am SO sick of being asked to fund other people's bad habits. Who picked up the tab for the forest fire in Barrier, anyway? Did they charge the guy who failed to put out the fatal cigarette that started it? I didn't think so. Now there is an interesting issue...

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