Champix is suspected of playing a major role in the deaths of 44 patients — 30 of them by suicide — since the popular stop-smoking drug was approved in Canada in 2007, a Vancouver Sun investigation has found.

The Pfizer drug has also been linked to more than 1,300 incidents of suicide attempts or thoughts, depression, and aggression/anger across the country in the past seven years.

The drug is the most popular of those offered by B.C.’s quit smoking program, which traditionally sees a jump in participation every January as people renew new year’s resolutions to butt out.

Numbers on the deaths and other side-effects come from a Health Canada database where doctors, pharmacists and drug companies report bad side-effects experienced by patients taking pharmaceuticals.

But Health Canada admits on its website that side-effects are under-reported, and experts say the database could represent as little as one per cent of the patients who suffer complications.

“A small proportion of the adverse reactions that have occurred on this drug in Canada would be in the adverse reaction database. Essentially it is spontaneous, voluntary reporting,” said Barbara Mintzes, a pharmaceutical drug expert at the University of B.C.

Even the incomplete numbers, though, are a concern, she said. When someone taking an anti-depressant attempts suicide, it’s initially not clear whether that’s caused by the pre-existing depression or the drug; but in the case of Champix, people are taking the drug to stop smoking — not for a mental health condition.

“You are looking at a lot of deaths, suicides and attempted suicides, and suicidal ideation in a population that you would have no reason to think would be otherwise at high risk of suicide,” said Mintzes, an associate professor in the Faculty of Medicine’s School of Population and Public Health.

The Sun downloaded data from the Health Canada site for Champix and Zyban, the two drugs covered by Pharmacare as part of the province’s Smoking Cessation program.

Champix is the subject of a class-action lawsuit, which more than 200 Canadians have joined, alleging psychiatric side-effects. One of the plaintiffs is the mother of a B.C. woman who killed herself while she was on the drug.

In recent years, Champix has been slapped with the toughest safety warnings in the U.S. and Canada, and France stopped covering the drug through its public Pharmacare system.

In October, American consumer and health groups submitted a petition demanding the U.S. government further increase the warnings about Champix in relation to “suicidal behaviour, aggression/violence, psychosis, and depression.”

In November, the Drug and Poison Information Centre warned there were nearly 100 Zyban overdoses in B.C. in 2013, including 47 cases of suspected suicide attempts. The Health Canada database showed 27 deaths and the death of one fetus with Zyban as the suspected cause, since the drug was approved in Canada in 1998.

B.C. Health Minister Terry Lake was not available for an interview, but a spokesperson issued a statement that said B.C. decides which drugs to fund based on “the best scientific evidence available.” It also listed several reviews and research papers that found Champix and Zyban are “effective and safe,” and have helped many people quit smoking.

“In October 2012, Health Canada reaffirmed that it considers the benefits of Champix, when used as directed on the label, to continue to outweigh the risks,” said the email from ministry media relations manager Kristy Anderson.

Patricia Clow of Victoria is a plaintiff in the Champix class-action lawsuit, on behalf of her daughter Heidi who killed herself in 2009 while taking the drug to quit smoking. The mother is convinced her otherwise healthy, happy, successful daughter was driven to suicide because of side-effects from the drug, and argues Heidi’s apology-laden suicide note shows she wasn’t thinking clearly.

“Sorry. I’m cold. I’m done. I’m angry, upset ... I hurt inside,” the Royal Canadian Navy steward wrote. “I love you Mom! Sorry. Please. I just want to go.”

Clow believes the province should stop funding Champix.

“(Heidi’s suicide) just came totally out of the blue and totally unexpected. What she did and how she did it made no sense whatsoever,” the grieving mother said.

In a statement to The Sun, manufacturer Pfizer said adverse reaction reports, such as those provided to Health Canada, do not necessarily prove the side-effect was caused by a drug because they are voluntarily submitted and may not contain patients’ full medical history. Pfizer also said quitting smoking can lead to depression, agitation or recurrence of a pre-existing mental health issue, regardless of whether the patient is taking a stop-smoking drug.

“There is no reliable scientific evidence to demonstrate that Champix causes serious neuro-psychiatric events,” said the statement provided by Pfizer’s Christina Antoniou. “All medications have potential risks. The benefits and risks of all treatment options for quitting smoking should be part of the patient-physician dialogue before initiating treatment.”

The federal government oversees drug approvals in Canada, and insists every death is considered serious and important.

“Health Canada continuously monitors the safety of drug products on the market by using information from a variety of sources, such as adverse reaction data, medical and scientific literature and foreign regulatory agencies,” spokesman Michael Valerio said in an email.

In each of the cases counted by The Sun, Champix was listed as the suspected cause of the adverse reaction; but Health Canada cautions that conclusion is only the opinion of the health professional or drug company making the report.

“Other factors, such as the patients’ underlying medical condition, or other medications taken at the same time need to be considered as potential causes or contributing factors,” Valerio’s email said.

B.C. spent $8.7 million in the fiscal year 2013/14 on its quit smoking program, including filling nearly 66,000 claims for Champix and 8,000 claims for Zyban. The program spending and prescriptions are down from the previous year, according to the Health Ministry, but a flurry of new patients are expected this month.

Indeed, Twitter Canada reported that “stop smoking” was the fourth-most popular new year’s resolution tweeted on Jan. 1.

Nationally, there were 625,000 prescriptions filled for Champix and 38,000 for Zyban in 2013, according to IMS Brogan, an international company that collects health data. Health Canada’s database shows 129 reports of adverse reactions to Champix and 13 to Zyban in 2013.

The data downloaded from Health Canada was difficult to use because there are many duplicate entries that required deletion. The Sun’s final analysis found that in the last seven years in Canada, in addition to the 44 deaths, there were about 350 reports of Champix causing suicide attempts or suicidal ideation, 30 reports of homicidal ideation, and 64 of amnesia. There were also approximately 600 reports of Champix causing depression, 230 of aggression, 180 of anger, and 150 of mental side-effects, including hallucinations and psychotic disorders.

Academic studies of emergency room visits by patients reacting poorly to pharmaceuticals indicate, however, that only a tiny fraction of such incidents are reported to Health Canada, Mintzes said.

Reports to Health Canada may improve in 2015, though, with the passage of a new federal bill last November that requires hospitals to report when patients suffer adverse reactions to drugs. The bill is called Vanessa’s law, after a 15-year-old Ontario girl who collapsed from a heart attack while taking a prescription drug that had been of concern in the U.S.

In November, the Fraser Health Authority launched a pilot project that makes it mandatory for health workers to report adverse reactions. It will be expanded across Metro Vancouver in 2015, said Michele Babich, executive director of Lower Mainland Pharmacy Services, which oversees pharmacy issues for the Fraser, Vancouver Coastal, and Provincial Health Services authorities, and for Providence Health Care.

“Better understanding incidents of adverse drug reactions is important to us,” Babich said in an email to The Sun. “Mandatory reporting of adverse reactions to drugs such as Champix and Zyban are now being recorded ... and then reported to Health Canada.”

Law firms in Vancouver, Calgary, Toronto and Montreal are collaborating on the class-action lawsuit claiming Pfizer did not warn patients about the drug’s risks, including suicide, suicidal thoughts and depression. More than 200 Canadians have joined the suit, said Doug Lennox, a lawyer for the plaintiffs.

In response to the lawsuit, Pfizer Canada has said it stands by Champix and that it has provided accurate information about the drug’s safety.

Pfizer, though, paid nearly $300 million to settle similar lawsuits with 2,500 U.S. patients in recent years. Lennox said it is a frustrating trend that Canadians often get delayed and poorer court settlements compared with our American neighbours.

The lawsuit is open to anyone who took Champix between 2007, when Canada approved it, and 2010, when the toughest pharmaceutical warning — called a black box — was applied.

Champix’s black box warning is unusual, Lennox said. A typical pharmaceutical warning tells patients to phone a doctor when they experience side-effects, but that’s not the case for Champix because it can mess with how a person thinks.

Instead, it says patients should ask their social circle to watch for any mental changes: “You are encouraged to inform friends and family of your quit (smoking) attempt, which includes treatment with Champix, and ask for their support and help in monitoring for potential psychiatric symptoms,” the warning says.

The simple reality is that black box warnings are unlikely to make taking the drug safer, argues James McCormack, a professor in UBC’s pharmaceutical sciences department. Doctors are typically too busy to explain all the risks of prescription drugs to patients, and often won’t even know about the warnings.

“These black box warnings are great because they do alert people to the potential (of risk), but there’s no systematic approach to how they would be used by health care providers,” he said.

“I’d say it’s 95 per cent done for legal reasons. Not that it will actually prevent anything.”

A 2013 UBC-led study found that 66 per cent of pharmaceutical sales representatives failed to tell Vancouver doctors about common or serious side-effects in their drugs. And the international study, published in the Journal of Internal Medicine, also found the threat of serious harm or death was disclosed to Vancouver doctors in only five per cent of pitches for drugs that carried such a warning.

In an ideal world, McCormack said, each time a patient is prescribed a drug and each reaction experienced would be recorded, but that would be too onerous for the overburdened health care system.

Although the adverse-reaction tracking process appears less than ideal, he added, most prescription drugs are fortunately well tolerated.

In Canada, Champix is reimbursed by government pharmacy programs in the Northwest Territories, B.C., Alberta, Saskatchewan, Manitoba, Ontario and Quebec.

Champix was one of the drugs being studied by some of the eight scientists who were fired from the B.C. Health Ministry in 2012, in a scandal that ended with the government hiring back most of the workers and/or apologizing to them.

Roderick MacIsaac, a PhD student who committed suicide after his dismissal, was working on an evaluation tool for the quit smoking program. Another of the fired scientists was MacIsaac’s thesis adviser, while an economist (since rehired) was also assisting him.

After the scientists were fired, work on MacIsaac’s evaluation tool was never re-started.

A lawyer hired by the government to review the botched firings concluded in a report last month that no senior health official would take responsibility for the dismissals, or explain why they happened.

lculbert@vancouversun.com

tcarman@vancouversun.com

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