DRUG BUST by Alan Cassels
• The people’s briefing note on prescription drugs
There’s no such thing as a bad drug. Drugs – in this case, I mean pharmaceuticals – are neutral. They are neither good nor bad. They can do tremendous good if used properly and terrible harm if not. There are no bad drugs – only bad decisions around how drugs get used.
Even when some of the most notorious pharmaceuticals around – such as the diabetes drug Avandia, the acne drug Accutane, antipsychotics such as Seroquel or Risperdal or the smoking-cessation pill Champix – have serious safety warnings, are awash in press coverage about their adverse effects and are mired in class-action lawsuits, they should not be thought of as ‘bad.’
The smoking cessation drug Champix – generic name: varenicline – made by drug giant Pfizer makes a good case study. It has certainly seen a lot of press lately, especially in BC where it dominated headlines in July and caused a furor in the BC Legislature over allegations that the ruling Liberal government has been squashing independent evaluation of this drug and succumbing to pharmaceutical industry pressure to prevent questionable drugs used by BC citizens from being properly studied. Those allegations seem plausible and certainly fit with the Liberals’ nauseating coziness with the drug industry, but again, the issue is not whether Champix is ‘good’ or ‘bad,’ but whether the decisions around how it is being used are sound.
You might conclude differently if you read the stories of family members who committed suicide while on the drug or listened to callers burning up the lines on talk radio shows proclaiming that Champix caused them to experience terrible nightmares and strange mental disturbances. Those stories are gripping, but equally compelling are the stories told by those who say the drugs have been tremendous and helped them kick their habit of the noxious weed.
I’m not sure if the drug is good or bad, but I do know you can find many bad decisions made by those who approved, promoted, prescribed, paid for and otherwise encouraged people to use it. One thing revealed in the saga around Champix is the shockingly insouciant attitudes that both physicians and payers seem to have towards drug safety signals. Let’s face it folks; last time I checked, smoking wasn’t a disease and it’s a habit that people, given the right incentives, seem pretty well able to quit on their own. In the last 50 years, smoking rates in North America have declined from 50-60% to around 15-25%, without any pharmaceutical therapy whatsoever.
Because Champix was one of a handful of drugs being evaluated by independent researchers before someone called in a drone strike on the Blanshard Building – headquarters of the BC Ministry of Health – its history is worth taking a close look at. Here’s a rough timeline:
January 2007: Champix was approved in Canada on the basis of clinical trials showing that, compared to placebo, about 12% more people quit smoking if they took Champix. With those odds, eight people would have to take Champix for one of them to quit smoking after a year. But here’s a caveat: in the clinical trials, patients were given educational materials and weekly counselling, the kind of help not typically available in the ‘real world’ of medical practice. By the end of 2007, Pfizer, the owner of Champix, sold $883 million worth of the drug, making it a near-blockbuster.
2008: The journal Thorax published a Pfizer-funded trial comparing Champix to nicotine patches, showing that 12% more patients on Champix quit compared to the patches. Also that year the Federal Aviation Administration in the US banned the use of Champix, citing drug side effects. (Reported in the New York Times, May 22, 2008.)
July 1, 2009: The US FDA slaps a black box warning – the most serious safety warning used – on Champix and the other smoking cessation drug Zyban (buproprion), noting these drugs are “associated with reports of changes in behaviour such as hostility, agitation, depressed mood and suicidal thoughts or actions.”
March 16, 2010: Three BC women filed a class action lawsuit against Pfizer citing adverse effects suffered due to Champix.
May 9, 2011: A BC government press release entitled, “Premier Christy Clark announces free support to help smokers” is issued, making nicotine replacement therapies free for BC smokers and smoking cessation prescription drugs Champix and Zyban would be covered under PharmaCare.
May 19, 2011: Quarterwatch, produced by the Institute for Safe Medication Practices, reported, “Evidence continues to accumulate showing that varenicline has an unacceptable safety profile.” It also cited that as many as 150 cases of suicide had been linked to the drug but not entered into the FDA Adverse Event Reporting System (AERS).
May 31, 2011 (World No Tobacco Day): French health Minister Xavier Bertrand removed Champix from the list of publicly covered pharmaceuticals in France.
June 16, 2011: The US FDA slaps another black box warning against Chantix – its name in the US – stating it “may be associated with a small increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.” A year-long study showed that twice as many patients taking Champix had heart attacks compared to similar patients taking placebo. The absolute increase in risk to Champix users was about one percent.
September 2011: BC’s new smoking cessation policy comes into effect which may cost taxpayers $15-$25 million, depending on the uptake of the program.
October 2011: The independent drug review group Prescrire published a report on Champix saying it “carries a risk of neuro-psychological adverse effects, including depression and suicide,” effects which even happened in people who had no psychiatric history. As far as I can tell, the only agency in Canada that tried to convey this to doctors was UBC’s Therapeutics Initiative, which published a translation of Prescrire’s report in early 2012.
May 4, 2012: The BMJ published the largest analysis to date of all randomized trials comparing Champix to placebo, focusing on what happened while people took the drug or within 30 days afterwards. It found “no significant increase in cardiovascular serious adverse events associated with varenicline (Champix).”
September 6, 2012: The first four of seven BC Ministry of Health employees involved in drug safety research and data access are fired for vague and inexplicable reasons, including a UVic PhD student studying BC’s experience with Champix. He died three months later under unexplained circumstances and his study has never been resumed.
July 2013: The Cochrane Collaboration published an exhaustive meta-analysis of drug treatments used to help quit smoking concluding that “nicotine replacement therapy (NRT), bupropion and varenicline all improve the chances of quitting, with a low risk of harms.” It goes on to say that combining forms of NRT is “as effective as varenicline and more effective than single types of NRT.”
So what’s one to make of all of this? Contradictory studies, reports of adverse events, suicides that had been hidden from the FDA, black box warnings, class action lawsuits as well as patients claiming the drug either hurt them or helped them.
For me, as a researcher, the answer seems obvious. We need to put on the brakes. We need to stop pretending this drug is perfectly safe and restart the research planned for BC that would evaluate how that drug was working in the real world. Incidentally, BC researchers are now included among Canada’s experts in “Real World Safety and Effectiveness” evaluations, but since September of last year, that kind of research has been halted. The Ministry has essentially gotten rid of much of its drug evaluation capacity and the Therapeutics Initiative, the one drug safety watchdog barking to alert policymakers and physicians of drug dangers, has been put down.
We have to remember that smoking is not a disease and there are a variety of safe and effective ways to stop people from smoking and that drugs are only one option.
Will people be hurt by Champix? Will they be helped? Again, we can’t know for sure. What we do know is that when there is uncertainty over a drug’s safety, not funding independent real-world analyses of those drugs is akin to playing games with peoples’ lives.
A class-action lawsuit against Pfizer over Champix is set to go ahead. The lawsuit represents Canadians who took the drug between April of 2007 and May of 2010 and suffered certain adverse reactions.
Alan Cassels is the author of Seeking Sickness: Medical Screening and the Misguided Hunt for Disease. Follow him on Twitter @AKECassels or www.alancassels.com