Champix—Killing the habit
Will Champix be successful in showing the way to the Indian tobacco users who have the will to go off the killer need? Suja Nair analyses
In India, there are at least 120 million tobacco users (smokers and chewers) and by 2010 it is estimated that one million people will die each year from tobacco related illnesses. According to a 2008 World Health Organisation (WHO) study, about 14.1 percent of Indian teenagers are tobacco users, 17.3 percent amongst males and 9.7 percent amongst females. Smoking is a major public health problem that affects not only the smokers but also people around him. This is the user audience targeted by Pfizer’s Champix, as it is positioned as booster for smokers who were unsuccessful in quitting in previous attempts. Anjan Sen, Director—Pharmaceuticals Marketing, Pfizer informs, “The dearth of effective smoking cessation aids spurred our research teams at Pfizer to develop Champix and meet an unmet and urgent medical need. Launched a year ago the product has been very well received by practicing doctors in India and their feedback indicates that they are satisfied with the efficacy rates. Indian doctors suggest that they have seen patients on varenicline successfully quit smoking during the therapy while on Champix.”
Playing upon the USP
Champix (Varenicline) is the first non-nicotine based smoking cessation aid to be approved by US FDA in the last 10 years. It is called as Chantix in US and Champix in rest of the world. Sen informs, “Unlike other smoking cessation solutions that work only on controlling the withdrawal symptoms, Champix reduces withdrawal symptoms and also the smoker’s sense of satisfaction derived from smoking. It eases the nicotine withdrawal symptoms as well.” Champix interferes with those receptors in the brain which nicotine stimulates and partly stimulates the nicotine receptors. This mimics the effects of nicotine to reduce cravings and withdrawal effects when you stop smoking. However, at the same time, this tablet partially blocks the receptors and prevents nicotine from attaching to the receptors. This precise action of varenicline inhibits the effect of nicotine in people who give in to temptation and have a cigarette. A novel, non-nicotine, oral prescription medicine Varenicline, has a novel dual mode of action.
However he is quick to add that a necessary precondition is that the smoker must be motivated to quit smoking in order to improve the success rate of the cessation therapy. Sen avers, “Research shows that the odds of quitting smoking on Champix are twice that of buproprion and four times that of placebo.”
Champix is a prescription drug and is available in the top 17 cities across India through chemists and pharmacists to ensure that smokers across the country can benefit from this highly effective smoking cessation option. Unlike some markets where brand name advertising is allowed, Champix cannot be advertised in India. But Pfizer has designed a unique marketing approach since each market is different from the Indian market. Sen affirms, “The product is targeted only to doctors since it is a prescription product and hence there has been limited advertising directly to consumers. Hence brand recall with the public may be negligible. However, within targeted doctors brand recall is very high.” The course of Champix is for a period of 12 weeks and it costs Rs 9600 for patients. It is effective if the regime is followed religiously however the high price and long duration at times may may discourage potential users. Sen informs that since it is a new product contribution of Champix to total revenues is limited.
Fighting the odds
|“Pfizer is looking to tie-up with renowned clinical specialists and hospitals across the country and open up to 600 smoking cessation clinics by the end of 2010. The partnership, which is aimed at helping thousands of people to give up the habit, is seen as a leap forward by the private sector to supplement the Indian government’s ongoing efforts to
tackle the soaring number of smokers and smoking-related diseases plaguing the country”
– Anjan Sen Director—Pharmaceuticals Marketing
With all the pros around there is also a con associated with the safety of Champix. This product foretold as an alternative to other smoking cessation drugs and nicotine replacement therapy is also associated with various side effects, including nausea, changes in dreaming, constipation, gas and vomiting etc. It is also believed to be associated with serious neuropsychiatric symptoms. Champix approved in US as Chantix in 2006 received a set back in there when its use was linked to suicidal tendencies reported among groups on whom the drug was tried. In November 2007, the US Food & Drug Administration (FDA) issued an ‘early communication’ that stated its preliminary assessment revealed many of the cases reflected new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. A review of a Chantix study conducted in cooperation with the Department of Veterans Affairs (VA) has found that the VA was responsible for numerous ‘unacceptable failures’ in ensuring safeguards for soldiers in the experiment. The Chantix study used veterans suffering from post traumatic stress disorder (PTSD) as test subject. In an investigative report done by a US based news channel it was revealed that veterans enrolled in a Chantix clinical trial–all diagnosed with post traumatic stress disorder (PTSD) had not been told that the drug was linked to depression, suicide and psychotic behavior.
Similar problems have also been reported in Britain, where the drug known in the name Champix. According to news reports the UK’s Medicines and Healthcare products Regulatory Agency, had received 1335 reports of patents suffering serious side effects, including seven deaths–one of which was a suicide. Chantix was also linked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders. Refuting these allegations, Sen assures that it has not been ascertained that these symptoms are linked to varenicline use and that there is no relationship established between any of the reported events and varenicline. He stresses, “Nicotine is a very addictive substance. So, withdrawal symptoms of smoking can range from irritability, headaches, insomnia and disturbed sleep, tiredness, increased appetite, coughing, poor concentration, constipation and depression. Patients who wish to stop smoking should discuss with their physicians whether Champix is appropriate for them.” He points out that although there are no recommended restrictions with regard to prescribing Champix to patients with psychiatric disorders, patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of Champix, and the safety and efficacy of Champix in such patients has not been established. “As with any medicine, the key is for doctors, who know their patients best, to have clear and informed discussions in this case about the benefits and risks of quitting smoking, with or without Champix,” he states.
As part of the brand promotion initiative Pfizer has also started what is call as a ‘Champs Club’. With comparatively superior efficacy plus a comprehensive behavioral ‘Champs Club’ support program and Champix offers a complete and sustainable smoking cessation strategy to smokers who intend to get rid of the addiction. The club is an online resource for registered users prescribed smoking cessation medication by registered medical practitioners and committed to quit smoking. It aims to educate and support users resolve to quit through an introductory starter kit and a structured support plan along with interactive relaxation techniques to control tobacco cravings. The idea of this club is very similar to that of other de-addiction initiative ie alcoholics anonymous, that aims at providing a support system for addicts trying to quit.
Links to the chain
As with many Rx products, as Pfizer cannot directly ‘talk’ to its users, it has to reach through the doctors network. And what else can be a better way to start patient relationship than to first tie up with hospital chain. Pfizer is currently partnering with Max Healthcare to assist patients seeking treatment for nicotine dependence. The program will utilise Champix, Pfizer’s prescription drug for smoking cessation, backed by complementary therapy with focus on nicotine dependence. Patients will receive personalised care and remain under supervision to ensure that their attempts to quit are successfully addressed. Sen informs, “Pfizer is looking to tie-up with renowned clinical specialists and hospitals across the country and open up to 600 smoking cessation clinics by the end of 2010. The partnership, which is aimed at helping thousands of people to give up the habit, is seen as a leap forward by the private sector to supplement the Indian government’s ongoing efforts to tackle the soaring number of smokers and smoking-related diseases plaguing the country.”
The treatment is currently available at three Max Healthcare facilities in Delhi and at the Masina Hospital’s psychiatric unit treating nicotine dependence in Mumbai. Smokers can seek counseling support, educational information about ill effects of smoking, tips and medical support to help them overcome their addiction at the Smoking Cessation Clinics. Giving further insights Sen elucidates, “The collaboration has been successful and is talked about by leading practitioners across the medical fraternity and that quite a few leading hospitals have approached Pfizer to initiate similar collaborations.”
To conclude we can say that where there is a will there is always a way but to keep proceeding along the way an inspiration and support is also needed. Similarly, taking only Champix can not help a smoker, what is also needed is perseverance and will power to fight the urge to quit. A combination of varenicline tablets with professional counseling and moral support from friends and family will increase chances of successful smoking cessation.