Behind the smokescreen
As anti-smoking campaigns become more visible, the market for nicotine replacement therapies will also pick up. Suja Nair explores… (Extracted from Express Pharma, 16-30 September 2008)
In India, tobacco kills more than one million people annually. 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.
According to Anindya Bhadra, Senior Analyst, Consumer Markets, Datamonitor India, “Tobacco consumption in India happens in two main ways—smoking (cigarette, cigar, and beedi) and chewing (raw tobacco, gutka, and supari). There are approximately 200 million tobacco consumers in India, of which only 14 percent smoke cigarettes. The low rate of cigarette consumption in India is the result of punitive and discriminatory taxation regime by successive governme-nts. Therefore, Indian tobacco consumers are choosing lower value tobacco products like beedi and other chewing tobacco products over cigarettes.” Further, he points out that this migration towards lower value tobacco products is clearly a cause of concern. Being defined as a small scale sector industry, manufacturers bypass some of the more stringent rules which cigarette manufacturers are subjected to.
Dr Chandrashekhar Potkar,
Director-Medical and Regulatory Affairs, Pfizer
Unfortunely, smoking is not a disease that can be treated. Instead, it is a stubborn habit known to kill people. Until a few years ago, the only way to stop this deadly habit was by self-control which was quite difficult for serious smokers. But with the introduction of smoking cessation products like pills, patches, gums, nasal sprays, and inhalers, this killer addiction seems to be up against a tough shield.
There are two major types of therapies available in the market—nicotine replacements therapy (NRT) and other pharmacological therapies. NRT come in a variety of delivery modes—transdermal patches, chewing gums, inhalers, nasal sprays and lozenges. Pharmacological therapies include Bupropion, and some leading brands include Bupron-SR, Smoquit-SR (Sun Pharmaceuticals), Bupep, Nicotex (Cipla), Zyben (GSK),
Unideep-SR (Consern), Varenicline (Chantix/Champix) and combination therapy—atropine and scopolamine. Elder Pharmaceuticals, in collaboration with Zenera Pharma, UK has NRT in the form of chewing gums under the brand name Nulife, available in two flavours i.e Nulife Eucomint and Nulife GoodKha. Nulife Eucomint is positioned for cigarette smokers while Nulife Goodkha targets tobacco chewers.
Of the various smoking cessation therapies listed above, only gums and lozenges are over-the-counter (OTC) products. Alok Saxena, Director, Elder Pharmaceuticals, says, “The best way to treat heavy nicotine addiction is through NRT and counselling for de-addiction but not a drug combination therapy. All de-addiction products including gums (except 2mg) are Schedule H drugs. They need to be sold by a retail pharmacy on the prescription of a registered medical practitioner only.”
In addition to current therapies, there are other drugs in the pipeline (see table). Novartis is developing a therapeutic vaccine which is estimated to be available in 2009. In a phase II study of a therapeutic vaccine conducted by Cytos Biotechnology, 42 percent of those in the high responder group remained continuo-usly abstinent from smoking compared to 21 percent in the placebo group in a 12 month period. Phase III of the trial is slated to begin by end 2008. Apart from the above, there are other therapies such as hypnosis, acupuncture, and counsell-ing that are also used to reduce nicotine addiction. All the above mentioned drugs and medication in the NRT segment are approved by the US Food and Drug Administration (FDA) and subsequently by respective national medical councils and/or drug approval authorities.
Bhadra says, “The global smoking cessation market is estimated to be around $2 billion with nearly 60 percent value being generated from US alone. The prescription smoking cessation product market in India was estimated to be around Rs 100-20 crore in 2007. The market size of the non-prescription segment, however, cannot be estimated given that most of the gums and lozenges are sold through local pan shops and other unorganised sales channels.”
The modes of action of these products differ. NRTs are engineered to work on the brain and the nervous system to curb nicotine dependence. These products work by reducing the degree of cravings and withdrawal symptoms. Champix/ Chantix from Pfizer reduces and eventually takes the gratification out of smoking. Zyban mimics nicotine’s ability to increase dopamine and norepinephrine levels, giving the patient/smoker a sense of well-being and vitality. During the cessation treatment, users of these products experience are supposed to experience a vast reduction of the urge to smoke and the easing of nicotine withdrawal symptoms. Thus, by reducing the severity of withdrawal symptoms and cravings in patients abstaining from tobacco, NRTs have been shown to double quit rates compared to placebos.
Smoking cessation products are definitely playing a very important role in redressing dangerous habit like smoking; but how does the common public come to know about these products? Dr Chandrashekhar Potkar, Director Medical and Regulatory Affairs, Pfizer, says, “It is important to create awareness among smokers that they need medical help to quit smoking. This is because nicotine is a highly addictive substance, and theref-ore, medical help is needed to overcome this addiction. Along with pure awareness creation we have established 500 smoking cessation clinics across the country where patients can get themselves appropriately treated by specialists.”
Explaining the marketing strategies adopted by their company to create public awareness about the products. Saxena avers, “We establish the concept of NRT first to the medical practitioners, chest physicians and dentists who encounter patients with disorders of tobacco addiction. The doctors then advise patients in the right manner to quit tobacco and it is usually taken seriously by the patient.”
Apart from these methods, the other way by which public awareness is created is through media advertisement, public rallies and events, free counselling camps at doctors’ clinics for tobacco addicts, as well as conducting de-addiction and patient education camps at hospitals. An innovative strategy is to provide free envelopes containing printed messages on tobacco de-addiction to chemists and pharmacy retailers, which can be used for packing medicine.
Does the buzz help to achieve the goals? Analysing the situation, Bhadra says, “Though the recent introduction of Champix by Pfizer in India has created a lot of buzz, success of smoking cessation products in India has so far been patchy. Low success rate stems from both a low awareness of the availability of such medications, and belief amongst smokers and non-smokers alike that smoking cessation is more driven by self control than any type of medication.”
He elaborates that higher prices of such kind of products also act as a deterrent to more people experimenting with them. Zyban was launched in India at a price of Rs 5,000 for a seven-week treatment course, with two dosages a day. The recently launched Champix cost smokers Rs 9,500 for a 12-week therapy. In US, a box of 56 tablets of Chantix costs $130 and in UK the same pack costs around £100.
Nicotine acts on nicotine receptors in the nervous system and the drug varenicline also acts on the same receptors, blocking the binding of nicotine to nicotinic receptors. As the drug varenicline acts on receptors in the nervous system, it may cause some effects on the brain like suicidal thoughts in patients receiving this drug when it is not taken according to therapeutic guidelines and dosages.
Putting the results in perspective, Potkar says, “Withdrawal symptoms including neuropsychiatric events are generally known to occur in nicotine dependent persons tying to give up smoking. While Champix helps to reduce the incidence of a number of withdrawal symptoms in such patients, the rates of neuropsychiatric events were comparable between Champix and comparator groups in our clinical trials. Thus, there was no evidence from clinical trials to suggest that Champix increases the incidence of neuropsychiatric events.”
Further, he states that Pfizer has a robust adverse event monitoring system that captures all adverse events reported with use of any of its products, irrespective of any causal association between the product and the event. The number and content of neuropsychiatric events that have been reported with Champix so far do not provide sufficient evidence to establish a causal association. Needless to say, Pfizer tries to follow up on selected neuropsychiatric events to the best possible extent to obtain as much information as possible.
In India, the reliability of such smoking cessation products has not been studied much. Bhadra believes that reliability of such drugs cannot be strongly commented upon given the fact that most claim superior performance, but side-effects on usage have also been reported. Medically accepted side-effects from consumption of such products have been dizziness, sleep disorders, weight gain, muscle aches and stiffness.
Along the same lines Saxena says, “The patients who are receiving varenicline without counselling and prescription may land in trouble only because of wrong dosage. If patient is well educated regarding dosage and administration and follows the scientific therapeutic guidelines then there are fewer chances of side effects.” He further says that patients are also advised to ask the doctor about the side effects of any medicines, so that at a doctor’s level they can highlight the efficacy of the brand used for in tobacco de-addiction.
In India, patients do not consider smoking as a serious addiction, till it starts showing its bad effects on physical and mental capacity, impotency, cancer etc or till he/she is counselled by loved ones. Even doctors counsel the patient seriously only for the first time and then leave it to the patient as counselling is time consuming. Saxena says, “Counselling is the most important part in smoking secession. In fact, it is more important than the medicine. Good counselling and NRT can avoid remission and relapse of nicotine addiction. Along with counselling, patients need to be well educated regarding the dosage of de-addiction drugs. Otherwise he/she may get addicted to the de-addiction drug itself, which may lead to unnecessary side-effects.”
However, Potkar clarifies this by saying that it is not necessary that smoking cessation products need to be backed up with counselling. He states, “WHO guidelines on smoking cessation state that if pharmacotherapy is supplemented with adequate counselling then the chances of quitting are higher, but this research was limited to NRTs. There is no study that indica-tes that efficacy of varenicline will be better if it is supported with counselling. However, counselling may be helpful to influence a smoker to begin with the medicine that is prescribed to him.” Further, he says that smoking cessation, being a new concept in India, does not provide adequate counselling facilities along with the available products. Given the nuances of the market, Pfizer has set up a helpline called ‘Champs Club’ to provide counselling support to any smoker who intends to quit.
To control tobacco usage and reduce the occurrence of life-threatening diseases, disabilities and deaths caused by tobacco use, the Indian Government has brought into effect one of the most comprehensive tobacco control policies—the Cigarette and Other Tobacco Products Act 2003. India has also signed the first global corporate accountability and public health tobacco treaty—the Framework Convention on Tobacco Control (FCTC) on February 2005. Recently, the revised packaging and labelling rules for tobacco products were published in the Gazette of India and includes all smoking and non-smoking forms of tobacco. Soon, packs of all tobacco products will have to carry pictorial warnings—covering 40 percent of the surface area—with the message ‘Tobacco kills/Smoking kills’. This will be incorporated along with a grim image of diseased lungs that will appear on cigarette, beedi and gutka packets from December 1. This is done with the aim of not only reminding the tobacco user of the dangers but also those around him/her. The aim is to play on the fact that a smoker may quit to prevent collateral damage to the ‘passive smokers’ around him/her, especially family members.
Around the world, pictorial warnings on tobacco packs have significantly contributed to raise awareness, deter tobacco users and encourage them to quit tobacco use. More recently, the Union Minister for Health and Family Welfare, Anbumani Ramadoss announced that he plans to get Bollywood filmstars to star in anti-smoking campaigns and that smoking would be banned in public places.
Despite all these measures, the number of juvenile and young tobacco users continues to rise unabated. Similarly, the diseases, disabilities and deaths attributed to its use also continue to rise proportion-ately. Clearly, enforcing the public health policies is an enormous challenge. But apart from these policies, what we need is a strong system that not only highlights the dangers of smoking but also encour-ages smokers to quit. And for this there is a need for collaboration between the government, counselling centres and pharma compa-nies so that patients who are willing to kick this habit can do so through much needed counselling and subsidised drugs.