To the aid of smokers wanting to quit comes another drug
One day 12 years ago, for no good reason really, Priyanka Basu lit her first cigarette. “I had always liked the smell of cigarette smoke,” says this 35–year–old textile designer based in Mumbai. “I wanted to see what it felt like.” What began as a casual experiment in 1996 is now a serious habit that Basu, mother of a six–year–old daughter, knows she should kick but can’t quite get around to doing. Also an aspiring actor, Basu says she’s managed to improve her life in many ways by adhering to a diet and learning reiki, a spiritual practice that its followers say helps cure disease. “Smoking is playing havoc with my otherwise healthy lifestyle,” she says.

SMOKE SIGNALS: A growing number of people smoke in spite of knowing the danger it poses to their health

Around the same time that Basu got drawn into smoking, Jotham Coe, a scientist at New York’s Pfizer Inc, the world’s largest drug maker, began work on a drug that has the potential to help people like Basu quit smoking. Coe – now an ex–smoker, who lost his father, uncle and aunt to lung cancer from smoking – and his team at Pfizer’s research labs in Groton, Connecticut, first synthesised varenicline in February 1997. Nearly a decade later and after extensive trials on 5,000 smokers, Pfizer launched the prescription drug, branded Chantix, in the US in 2006. In those trials, smokers were found to be twice as likely to quit on Chantix as on competing drug Zyban from UK’s GlaxoSmithKline, and four times more likely to do so than if they were on a placebo.

Chantix, a nicotine–free product, works by binding to a receptor in the brain that is linked to the release of dopamine, a chemical responsible for the pleasure derived from smoking. This prevents nicotine from binding to that receptor but still fools the brain into releasing some amount of dopamine without actually getting nicotine. This also eases withdrawal symptoms, Pfizer says. Recent market data from Pfizer shows Chantix to be the most prescribed of all available smoking cessation solutions in the US. That includes nicotine–replacement products such as patches and gum.

Last month, Pfizer brought the drug to India – here it’s called Champix – hoping to do an encore. India has the second–largest number of smokers in the world, after China, with 120 million Indians estimated to light up. The rising awareness about the ill effects of smoking especially among the urban, educated middle–class suggests that conceivably many more would be trying or wanting to quit. “India is truly the big 800–pound gorilla as far as smoking is concerned,” says Anjan Chatterjee, medical director of Pfizer Inc. “Champix offers a fresh opportunity to smokers who have previously failed quit attempts.” Champix will set a smoker back by Rs 9,652 over a 12–week course, an amount that might initially raise eyebrows but pales in comparison to what many smokers would spend if they continued to smoke, and in the event of a smoking–related illness.
Sounds Good, But…
Challenges abound. One is the task of hawking a medicine for what is not commonly considered an illness. “The first barrier to taking a drug to stop smoking is the feeling of being weak,” says Sanjeev Mehta, consultant chest physician at Mumbai’s Lilavati Hospital. “It hits a smoker’s ego to accept that he can’t do it on his own.” Mehta, who runs a ‘Quit Smoking’ club alongside his practice, says this is especially true of male smokers and that he has tried to overcome this resistance by equating nicotine addiction with a disease. “That makes it easier for a smoker to seek help.” In fact, nicotine addiction is accepted as a disorder in many countries.

The Diagnostic and Statistical Manual of Mental Disorders, an American handbook for mental health professionals, says the disorder can be diagnosed by the occurrence of three of seven criteria within one year, including the inability to quit smoking in spite of trying, and withdrawal symptoms after cessation. “All leading medical associations of the world have termed nicotine addiction a disease,” says Prakash Gupta, director of Mumbai’s Healis–Sekhsaria Institute of Public Health. “The implication is that once it is a disease it becomes the responsibility of doctors to treat it and advise patients properly.”

But even today not many doctors in India prevail upon smokers to quit. Unless, of course, smoking posed an immediate health hazard. “Doctors usually counsel their patients to quit smoking when he or she approaches them with advanced stage ailments caused due to smoking,” says Anjan Sen, Pfizer's marketing director for pharmaceuticals in India.

Then there are the side–effects. Champix”s side–effects include nausea and vomiting at one end of the spectrum and trouble sleeping and vivid dreams on the other. Western regulators have also recently begun investigating reports of suicidal tendencies and aggressive behaviour in Champix users. But just the nausea could be sufficient for a smoker to jettison the product, says Mehta. In Champix trials it was found to occur in one in three patients given the highest marketed dose. While Indians are known to respond to medicines at lower doses than Westerners, it has yet to be tested in this case. “Our data shows that only about 2 per cent of the smokers stopped the drug because of the nausea,” says Sen, adding that dosage is raised gradually and can be lowered in the event of intolerable nausea.

There is no guaranteed success. Trial results suggest that 44 per cent of all ‘Motivated’ Champix users quit at the end of the 12–week regimen. This is far superior to the cold turkey quit rate of 2 per cent in India. But it still means that many did not rid themselves of the habit in the trials. Importantly, while the trials included counselling for Champix users, this is difficult in India where doctors are pressed for time. “Doctors need to understand that treatment and the approach. One–off prescriptions don’t work,” says Mehta.

Champix is also up against non–conventional remedies such as homoeopathy and reiki, seen to be harmless, unlike chemicals. “I am not that much into allopathy,” says Basu. “I have noticed that if I use reiki to tell myself that I will not smoke, I do smoke a little less the next day.” Basu says while she’s open to using a drug to quit smoking it would depend on “Whether it works and its side–effects”.

Learning From The Competition
An earlier attempt to launch a smoking cessation drug in India failed. In 2001, GlaxoSmithKline Pharmaceuticals (GSK) brought Zyban to India, but faced with the prospect of making substantial investments over the long term in awareness and other support for doctors with no guaranteed results, withdrew it a couple of years later. “It was a business decision based on what we got out of it versus what we put in,” says Ravi Limaye, vice–president for sales and marketing at GSK. Also, the quit rates on bupropion, the active drug in Zyban, were even lower than on Champix.

Pfizer is keenly aware of the uphill climb. Its response is an ambitious marketing plan that includes the setting up of 600 branded ‘smoking cessation clinics’ in tie–ups with doctors and hospitals that will be supported with data, visual aids, and other tools that doctors use to raise awareness and counsel smokers. “Critically, doctors will be equipped to initiate a discussion on smoking cessation and lead the patient through the therapy period,” says Pfizer’s Sen.It will also inaugurate a helpline and a website for Champix users.

Early data suggests that more people using Champix stayed off cigarettes a year after they quit than those who quit on Zyban, says Chatterjee. Unlike Zyban, Pfizer owns a patent on the drug in India making it illegal for generics producers to copy it. At the end of the day, any tool that gives a fighting chance to smokers is welcome, says Gupta of Healis. “If they’ve tried on their own and can’t quit, well this is something they can fall back upon.”