The B.C. Health Ministry directed independent drug-safety researchers to stop the evaluation of a controversial drug used by thousands of B.C. residents to quit smoking because it had become “too political,” the NDP claims.
NDP Leader Adrian Dix blasted the government during question period on Tuesday, saying the government killed a critical review of the drug Champix because it didn’t want to see the research results published.
“I think what we have here is a government that put political considerations before patient safety,” Dix said in an interview.
The NDP’s assertion is based on a June 21, 2012, email sent by Rebecca Warburton, a former Health Ministry employee, to the Therapeutics Initiative, an independent program based at the University of B.C. that evaluates the efficacy and safety of drugs.
“We’ve decided to keep Smoking Cessation in-house, sorry about that — it’s getting political and we aren’t sure anyone wants to see a published evaluation,” the email says.
Dix said Premier Christy Clark promised a review of the drug.
“Other countries had delisted the drug because of lethal side-effects,” Dix said. “Then her government blocks an independent review of those side-effects. To this day, no such review has taken place.”
B.C. Health Minister Terry Lake said he would direct staff to follow up on the correspondence.
“I haven’t seen the email so I don’t really want to comment on it, but, of course, if such an email exists, I’d be interested to see it and understand the reasoning behind it,” Lake said.
The B.C. government’s smoking-cessation program, which covers the cost of nicotine patches and gum and two drugs — varenicline (sold under the brand name Champix in Canada and Chantix in the U.S.) and bupropion (Zyban) — was launched in September 2011.
About 131,000 people have participated in the program. Of these, 45,000 were prescribed Champix.
The drug attaches to nicotine receptors in the brain to decrease cravings and lessen the pleasurable psychological effects of nicotine. However, it is also associated with serious neuropsychiatric side-effects, including suicidal thoughts or actions, depression, mood swings and agitation.
Alan Cassels, a drug-policy researcher at the University of Victoria, said the good thing about the email was that the Health Ministry planned a rigorous evaluation of its smoking-cessation policy — “exactly what we needed.”
Roderick MacIsaac, 46, a University of Victoria co-op student and PhD candidate working at the Health Ministry, was evaluating the safety, effectiveness and cost-efficiency of the smoking-cessation program for the government.
However, the Champix review was halted in September 2012 as part of an ongoing Health Ministry investigation into an alleged data privacy breach.
MacIsaac and six other Health Ministry employees were fired. Two contractors also lost their jobs. MacIsaac has since died, and his death is under review by the B.C. Coroners Service.
Nothing has happened since then, Cassels said .
“That research has ground to a halt. No one is doing it. Yet the policy is still pushing on,” he said.
“So we’re spending $15 [million to] $25 million a year on a smoking-cessation policy that pays for drugs and nicotine-replacement therapy but we don’t know if it works, and we don’t know what kind of adverse effects are associated with it.”
The Health Ministry said it supports the Therapeutics Initiative and the independent review of drugs, while Lake denied allegations that the B.C. Liberals were influenced by money coming from pharmaceutical companies.
“Some of [the Therapeutics Initiative’s] funding was withheld pending an investigation of a data leak in the ministry — that’s the prudent thing to do,” Lake said. “We hope that we can clear all that up and continue the relationship with the TI, but to suggest we are caving in to Big Pharma is absolutely ridiculous.”
Health Canada received 1,724 reports of adverse reactions to Champix between January 2007, when it was first marketed in Canada, and Dec. 31, 2011.
The Health Ministry, the national Common Drug Review and Health Canada reviewed all the available research on Champix before B.C. decided to cover it, according to the Health Ministry. Six provinces have approved the drug’s use, Lake said.
The email from the Health Ministry to the Therapeutics Initiative was dated the same day a class-action lawsuit against the drug’s manufacturer was certified.
Among those represented in the suit is Colwood’s Patricia Clow. She launched a class-action lawsuit in B.C. against Pfizer Canada and Pfizer Inc. in 2010 after her daughter Heidi, 22, committed suicide after taking Champix. In court documents, Clow blamed the drug.
Pfizer Canada said the certification of the class-action suit merely enables the case to proceed and that the merits of the claims have not been proven in court.
“There is no reliable scientific evidence that Champix causes the serious neuropsychiatric injuries alleged in these cases,” the company has said.
With a file from Rob Shaw
