Smokers die after taking Zyban cure
by RACHEL ELLIS, Mail on Sunday
Eighteen smokers have died after taking Zyban – the new ‘wonder cure’ for nicotine addiction, The Mail on Sunday reveals today.
The deaths, reported by GPs to the Department of Health, have occurred in the seven-and-a-half months since the drug was launched. Those who died were mainly in their 40s and 50s – although one was aged just 21.
Health Department figures also show that 3,457 Zyban users have suffered a disturbing range of suspected side effects – from chest pains to fits, seizures and depression.
Manufacturers GlaxoSmithKline and health officials last night insisted there was no evidence that Zyban was unsafe. But Ministers are under pressure to launch an urgent investigation into the drug, which has been prescribed to some 270,000 smokers in Britain.
You could be forgiven if you were duped by some of the headlines the last few days about a new study which apparently exonerates GSK’s Zyban and Pfizer’s Champix/Chantix (both marketed as stop-smoking drugs) of any serious neuro-psychiatric side effects.
Zyban is just GSK’s ‘anti-depressant’ Wellbutrin (Bupropion) marketed under another name for the stop-smoking market. GSK’s CEO Andrew Witty was once involved in Wellbutrin marketing, and you’d have to wonder what he knows about these neurotoxic side effects? (see here).
On face value this article about the study looks above board doesn’t it?
That’s until you see who’s really behind it.
The Study is funded by Pfizer and GSK
(As the old adage goes- follow the money)
“...The EAGLES study – published in The Lancet – backed the safety and efficacy of Pfizer’s Chantix/Champix (varenicline) and GlaxoSmithKline’s Zyban (bupropion) as well as nicotine replacement therapies in helping people quit smoking.
Questions about the safety of Champix and Zyban first came to the fore in 2009, when the FDA ordered Pfizer and GSK to include box warnings on their products to warn of their possible link to “changes in behaviour, depressed mood, hostility and suicidal thoughts”.
However, what the article does not state are the competing interests of one of the lead authors of this study- Mr Robert West of UCL (University of London).
“…Robert West of University College London – one of the authors of the paper – said the results “should reassure regulatory authorities, doctors and patients about the safety and effectiveness of medicines to help smokers to stop, whether or not those smokers have a history of a psychiatric disorder”…
Mr West’s competing interests include:
“…..research and consultancy for companies that develop and manufacture smoking cessation medicines (Pfizer, GSK and J&J)….”
Mr West does not state exactly how much he is paid for the research and consultancy for work he does for companies like GSK, Pfizer and J and J, but you can be sure that he doesn’t work for peanuts- he is a Professor after all and I’m sure he would expect a nice fee after all those academic years of attainment.
Furthermore, considering Professor West’s admitted conflict of interests with the companies that make the drugs which his research is based upon- does this mean that we should take his study into Pfizer’s Champix and GSK’s Zyban with a generous pinch of salt?
I think that would be wise, don’t you?
It seems someone has already requested (under a FOI mechanism) to see what links Mr West has to Pharmaceutical companies already (see here).
From: RT Freud
19 April 2016
Dear Department of Health,
Please provide all correspondence over the past 5 years between DH and Robert West, Editor-in-Chief of Addiction Journal, Professor of Health Psychology and Director of Tobacco Studies at the Cancer Research UK Health Behaviour Research Centre, University College London, co-director of the National Centre for Smoking Cessation, co-author of the English National Smoking Cessation Guidelines and consultant to numerous pharmaceutical conglomerates that develop and manufacture smoking cessation medications including GSK, J&J and Pfizer.
Given that Prof Robert West is a paid consultant for the pharmaceutical lobby, please advise how his conflicts of interest are handled, and how the DH ensures that his evaluation of pharmacological and behavioural aids to smoking cessation and his training programmes for medical staff are free of conflicts of interest.
Mr West is not the only author of this study with links to Pharma, if you click on the names of each author on the Lancet page where the study is published (here) you will see that many of the other authors also have various links to pharmaceutical companies.
Lisa St. Aubin – Pfizer.
Thomas McRae- Pfizer.
David Lawrcence- Pfizer.
John Asher MD- GSK.
Christina Russ- Pfizer.
Alok Krishen- Paraxel internatinal on behalf of GSK.
It looks to me that this Lancet study is little more than a product placement for Pfizer and GSK and also a PR move in defense of Champix and Zyban.
I would trust an independent (non pharma-biased) opinion over someone like Mr West’s and rightly so…
The articles below illustrate the long documented problems with drugs like Zyban..
And its information from links like this (from real people’s online experiences of Zyban and Champix) which Pfizer, GSK- and perhaps even Dr West and his associates- would likely (conveniently) dismiss as merely ‘anecdotal‘.
VANCOUVER – Use of a popular smoking cessation and depression medication led to 64 hospitalizations — including 22 cases admitted to critical care — last year in B.C., according to the province’s Drug and Poison Information Centre.
The centre handled 95 calls last year about bupropion overdoses, including 22 cases where the wrong dosage was taken, 47 cases of suspected suicide attempts and nine cases of misuse or abuse. There was one death. Burpropion is marketed under the brand names Wellbutrin and Zyban.
Since not all cases of overdoses or abuse are reported to the centre, it is likely there are far more cases in B.C., said Dr. Roy Purssell, an emergency room physician who is also medical head of the drug and poison centre, an agency affiliated with the Provincial Health Services Authority.
“We’re on edge about this medication and we want doctors and the public to be aware of our concerns. It has the propensity to cause serious, toxic effects. And I don’t think there is awareness about how big the risks are,” Purssell said in an interview.
Tina Hurst was living what she considered a perfect life in her quiet neighborhood in suburban Chicago. She was happily married, the mother of two teenage girls and an executive at an insurance company.
Hurst also had a secret. She was a closet smoker, an on-again, off-again, pack-a-day habit she’d hidden from her family.
“I would quit for a couple of months and then I would start back again, so it was one of those periods where my family thought I was still not smoking, and I had started again,” Hurst said.
Hurst called her doctor, who suggested a prescription drug called Chantix, which is designed to help smokers quit by curbing the desire to light up. Hurst thought she’d found an easy fix. Wiithin a week, she quit smoking.
“I thought it was a miracle drug, you know?” she said.
As Hurst continued taking the drug as prescribed, her well-ordered life started coming unhinged and she began acting erratically. After her husband convinced her to throw the pills away, Hurst said she went over the edge.
“It was just like, boom! Something went wrong,” she said.
Hurst, who said she’d never been depressed or suffered from any other mental illness, started experiencing hallucinations and suicidal thoughts. Hurst threatened to jump out of a moving car, forcing her parents called 911.
Hurst wound up spending five days in a locked-down psychiatric ward at a local hospital, a nightmarish experience she blames on Chantix.
Chantix, approved by the U.S. Food and Drug Administration in 2006, has a long history of users – and their next of kin — reporting troubling, sometimes deadly, side effects they blame on the drug.
In the last five years, 544 suicides and 1,869 attempted suicides have been reported to the FDA as “adverse events” in connection with Chantix, according to documents obtained by America Tonight under the Freedom of Information Act.
Adverse events are side effects reported to the FDA by patients, doctors or health professionals, or the drug makers themselves. The reports don’t prove cause and effect but serve as an early warning system of sorts for the FDA, which monitors federal drug safety.
Side effects ‘off the charts’
In 2008, Thomas J. Moore, senior researcher with the Institute for Safe Medication Practices, was testing new software to analyze adverse events when he made a startling discovery.
“Here, basically going off the charts, was this new smoking-cessation drug called Chantix,” Moore said.
Moore found that Chantix was responsible for more adverse events – including the type of serious psychiatric episodes such as Hurst’s – than any other drug on the market. They fell into four categories: suicidal behaviors, depression, psychosis and aggression.
“There were side effects that made it look like it was unsafe for pilots and people in critical occupations because there were seizures, blackouts, temporary blindness, blurry vision,” he said.
Based on Moore’s research, the Institute for Safe Medication Practices issued a report saying the group had “immediate safety concerns” about Chantix “among persons operating aircraft, trains, buses and other vehicles.”
The Federal Aviation Administration and Defense Department took heed and banned Chantix use among pilots and air traffic controllers. The military also banned Chantix for missile crews.
The Federal Motor Carrier Safety Administration, the federal agency that governs truckers, said Chantix may “adversely affect the driver’s ability to safely operate a motor vehicle.” And the Department of Transportation sent a memo to the Federal Railroad Administration warning of “the potential threat to public safety caused by the anti-smoking drug Chantix.”
In July 2009, the FDA slapped a so-called black-box warning on Chantix – the most serious warning possible – saying the drug “has been associated with reports of changes in behavior such as hostility, agitation, depressed mood, and suicidal thoughts or actions.”
Prospects for violence?
Moore continued digging into adverse event reports, particularly those involving violence. He co-authored a 2010 study in the Annals of Pharmacotherapy analyzing 26 acts of violence reported to the FDA as adverse events associated with Chantix. The study called them “inexplicable and unprovoked”: “A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car…A 42-year-old man punched a stranger at a bowling alley…A 24-year-old started beating her boyfriend in bed because ‘he looked so peaceful’ and she later attempted suicide.”
“These cases had three striking characteristics,” Moore said in an interview at his Alexandria, Va., office. “First, the violence was absolutely unpredictable and senseless. Second, the victim was anybody who happened to be nearby. It could have been a fiancé. It could have been mother. It could have been a police officer. And third, these people had no history of violence and were unlikely prospects for a violent act.”
Clinical trials of Chantix have failed to turn up suicidal behavior or the type of aggression and violence reported to the FDA as adverse events.
“Pfizer believes in and supports Chantix as an important treatment option for adult smokers who want to quit and takes the safety of all of its medicines seriously,” Pfizer said in a statement to America Tonight, adding that the drug has been prescribed to more than 20 million people worldwide.
The future of Chantix
Smoking remains the largest cause of preventable death and disease in the United States, and the FDA is standing behind Chantix, which has a 12-month quit rate of 22 percent, slightly better than counseling or nicotine-replacement therapy such as the patch or gum.
The FDA declined to an interview for this story, but gave a statement to America Tonight: “Although Chantix, like any medication, is associated with a number of adverse effects, appropriate patient monitoring and selection can reduce the likelihood of these adverse events occurring.”
Dr. Michael Siegel, a professor at Boston University’s School of Public Health who has studied smoking for 25 years, said it’s unrealistic to ask doctors to monitor for attempted suicide.
“The use of a black box warning is to help physicians identify early symptoms that so that you can prevent the adverse event from occurring,” Siegel explained. “In the case of Chantix, the black box warning is basically telling physicians, ‘Be careful because your patients might die taking this.’ What use is it to monitor patients for suicide? Once they commit suicide, it’s over.”
For that reason, Siegel has called for Chantix, which made $670 million in sales last year, should be pulled from the market.
Moore doesn’t go that far. He said more restrictions should be placed on Chantix.
“People who carry weapons for a living such as police officers and military should not take a drug, which can cause – and this is well-documented – uncontrollable rage,” he said.
The FDA has asked Pfizer to investigate reports of violence by Chantix users and report back by 2017.
Earlier this year, Pfizer spent close to $300 million to settle 2,700 Chantix lawsuits, and the judge in the case says the black box warning is sufficient, meaning future litigation is unlikely.
Tthe company has stepped up advertising the drug, offering testimonials from happy customers able to quit a pernicious habit. But for Chantix users like Hurst, life took an unexpected detour, even as Pfizer continues to make hundreds of millions of dollars on the drug.
“Pfizer is making a killing on this drug, but I took it. There were warnings at the time,” said Hurst, whose life is back to normal. “But there’s always this ‘It won’t happen to me. It could happen to somebody else. It’s not going to happen to me