Smoking Cessation: Big Pharma Butts In

doc2doc ЖЖMy brother the smoker http://bit.ly/mS0ihX Smoking cessation: big pharma butts in The pharmaceutical industry has a clear commercial interest in eroding public and professional confidence in unassisted smoking cessation, yet easily implemented ideas, such as graphic health warnings, are more effective than nicotine replacement therapy, says Simon Chapman MARKHENLY/PANOS

obacco control is the poster child for enced by adult targeted campaigns7 and the those now rallying behind interna- growing denormalisation of smoking. tional action to control non-commu- One of the best kept secrets in tobacco control nicable disease. In nations that have is that the great majority of ex-smokers quit with- implemented comprehensive policies out any formal assistance.8 Between two thirds Tand programmes to reduce tobacco use, there and three quarters of long term ex-smokers stop have been often continuing and large scale falls without using nicotine replacement therapy or in smoking prevalence over the past 20 to 40 other drugs or attending any sort of smoking ces- years, in the number of cigarettes smoked per sation service.9 10 Only 1-7% of smokers will even day, and—the ultimate test of effectiveness—in call a quitline.11 the incidence of index diseases like lung cancer.1 Before the advent of nicotine replacement of cigarettes smoked daily, the percentage of The World Health Organization’s Frame- therapy, some 37 million American smokers cigarette smokers who smoke within 30 min- work Convention on Tobacco Control, with 174 stopped smoking.12 Other than the early non- utes of waking, and the percentage who smoke nations having now ratified its legally binding specific pack warnings, there were few to none daily are all significantly lower in US states with provisions, has inspired thinking about the appli- of the policies that we see today driving this exo- low smoking prevalence, compelling evidence cability of the tobacco control model to chronic dus. Millions quit because they were exposed to against the “hardening” hypothesis that would disease at large.2 This momentum should be years of news reports of the growing bad news on predict just the opposite.15 profiled and boosted by the September United smoking and health.13 There is a longstanding debate between those Nations High-level Meeting on Non-communi- There is a conventional wisdom that those in tobacco control with clinical perspectives cable Diseases. who have quit smoking are those who were least who are preoccupied with smoking cessation Although preventing uptake among young addicted: they were low hanging fruit who could rates16 and those whose focus is on maximising people has long been a mantra for governments be stimulated by anti-smoking policies to quit by cessation numbers throughout populations.17 of all political stripes, far more lives will be saved themselves. But those who still smoke, the argu- This debate seems likely to intensify in low over the next decades by promoting cessation in ment proceeds, are mostly those who are imper- income nations where the global tobacco epi- current smokers.3 There is now extensive consen- vious to population health measures like tobacco demic is now well established, where the bulk sus on what the so called best buys in tobacco excise increases, the growing denormalisation of of global tobacco caused deaths are already control are when reducing consumption across smoking, and the messages in mass reach adver- occurring, but where tobacco control tends to whole populations is the goal. tising campaigns.14 be rudimentary. All parties—including the perennially protest- Against this view is evidence from 50 US states Those wanting the best possible popula- ing tobacco industry (“Of all the concerns . . . tax- for 2006-7 that indicates that the mean number tion-wide impact to flow from the current UN ation alarms us the most”4)—agree that tobacco momentum on non-communicable disease toba cco use iseases r d la u c chron s ic r a e sp Next month the United Nations v i

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quit attempts in large numbers of smokers is the r bying activities of the pharmaceutical industry

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y u n h t h l e most important strategy for improving cessation a smoking cessation juggernaut, with its mission communicable diseases—in 5 rates throughout a population. particular, cardiovascular to medicalise smoking cessation and discredit Australia has seen daily smoking prevalence disease, cancer, diabetes, and chronic obstructive unassisted cessation as a recipe for failure. fall to 15.1%, with tax and well funded mass disease (BMJ 2011;342:d3823). This article is part The industry, with its formidable promotional media awareness campaigns being mainly of the BMJ’s pre-summit coverage, looking at the and public relations budgets, and an army of responsible.6 Youth smoking prevalence is also risk factors linking these diseases. Future articles research consultants whose findings tend to the lowest on record, because youths are influ- will look at poor diet and alcohol. show better outcomes than researchers not

344 BMJ | 13 AUGUST 2011 | VOLUME 343 TOBACCO CONTROL

assisted cessation but its provision is poor throughout much of the world.29 In the West, despite at least two decades of industry promotions, despite armies of drug retailers, and despite increasing success in the lobbying of governments to subsidise cessation pharmacotherapy, most ex-smokers continue to quit unaided. Every major tobacco control conference in the past 30 years has given major emphasis to ways of encouraging doctors and primary healthcare workers to routinely counsel and assist smokers to quit. Yet recently, only 6.4% of 29 492 smokers in a UK health region were prescribed cessation medication in a two year study period.30 Reviewing the potential population impacts of various smoking cessation approaches, a 2000 US National Institutes of Health monograph concluded of physician interventions, “it is not clear that additional resources would add to the The large populations of low and middle income mended drug course than in real world set- number of individuals encountering these inter- countries contain millions of affluent smokers tings.21 25 All this combines to produce trial quit ventions . . . the promise of these interventions who represent a goldmine to the pharmaceutical rates that are higher than those in real world set- as established in clinical trials is not fulfilled in industry, but NRT remains beyond the reach of tings. A recent Glasgow study found just 2.8% their real-world applications.”31 anyone but wealthy élites in the poorest nations of smokers using medication who received up to Against this background, there ought to be a 12 weeks of individual counselling with phar- serious pause before governments in low and funded by industry,18 has a clear commercial macists had quit at one year.26 middle income countries embrace frontline, interest in eroding public and professional con- However, debates about real world effective- labour intensive, or pharmaceutical based fidence in unassisted cessation. ness of cessation pharmacotherapy are some- cessation strategies, which will soak up large This is despite the enduring superiority what ethereal to the circumstances of the vast resources, have low consumer acceptability, of unassisted cessation across decades in majority of smokers in low income nations. In particularly to the poor, and therefore make lit- delivering far more ex-smokers than all other late 2009 in a Phnom Penh, Cambodia, phar- tle contribution to population-wide cessation. approaches to cessation combined.9 19 Smok- macy a pack of 105 pieces of 2 mg NRT gum If smoking is to reduce in the world’s poorest ers are now recommended to use NRT (nicotine was selling at $58.10 (£35.44; €40.62). Product nations, strategies commensurate with the size of replacement therapy) before they quit (“pre- information for 2 mg Nicorette gum advises a the challenge need to be adopted. Easily imple- quit”), while attempting to quit, in combina- maximum of 24 pieces per day (www.nicorette. mented strategies that reach every smoker, like tion, and long after stopping to prevent relapse. com/quit-smoking-products/nicorette-gum. tax, graphic pack warnings, smokefree public A large body of clinical trial evidence pro- aspx). places, and mass reach public awareness cam- vides the bedrock for this advice. But there are Even if that were halved, a 30 day supply paigns, need to be front and centre here, with major differences between clinical trials and would cost a Cambodian smoker $199.20, when assisted cessation placed in perspective. real world use in smoking cessation.20 21 Unlike average monthly income is $170.27 The cost of Great encouragement can be taken from the real world users, those taking part in trials get NRT and varenicline in low income nations current support by Bloomberg Philanthropy to free pharmaceuticals; have frequent contact in the Middle East and North Africa shows a assist in the development of mass reach aware- with trial researchers, creating Hawthorne similar picture.28 At these prices, NRT remains ness campaigns now running in India, China, effects; and are paid travel and expenses. beyond the reach of anyone but wealthy élites Vietnam, Russia, Mexico, and Bangladesh, and Trial participants are unrepresentative of in the world’s poorest nations. major investment is occurring in capacity build- the general population22 and cessation trials Such costs mean that NRT is irrelevant to any ing to ensure that such campaigns are sustained exclude those with mental health problems,23 serious talk about strategy that could make a (www.worldlungfoundation.org/). who are heavily over-represented among smok- national impact in low income nations. But the Thailand32 and Uruguay are arguably world ers. NRT trials have poor blindness integrity, massive populations of low and middle income leaders in comprehensive tobacco control and with over half of studies in one review showing countries like China, India, Indonesia, Mexico, their and other nations’ successes deserve to be trial participants were significantly more likely Bangladesh, and Nigeria collectively contain megaphoned at the UN summit. than chance to accurately guess that they had millions of affluent smokers who represent a Simon Chapman is professor of public health, University been allocated to the placebo arm, meaning that goldmine to the pharmaceutical industry. of Sydney [email protected] their faith in the treatment they were receiving It can be expected that the industry will max- Competing interests: Simon Chapman is a director of was likely to be poor. imise every opportunity to surf the new UN Action on Smoking and Health, Australia and editor emeritus of Tobacco Control. This may translate into poorer quitting out- inspired wave of interest and seek to continue Provenance and peer review: commissioned; not comes, thus exaggerating differences between to dominate public dialogue on cessation with externally peer reviewed. active and placebo NRT outcomes.24 Finally, pharmaceutical solutions. The WHO Frame- References can be found on bmj.com far more trial participants complete the recom- work Convention on Tobacco Control endorses Cite this as: BMJ 2011;343:d5008

BMJ | 13 AUGUST 2011 | VOLUME 343 345 WORLD HEALTH ORGANIZATION

doc2doc ЖЖDiscuss WHO reform on BMJ Group’s public health forum http://bit.ly/abI1YC Will WHO reforms open the door to private donors? The World Health Organization’s critics accuse it of being bogged down in red tape and politics. But attempts at reform are raising concerns over conflicts of interest.Nigel Hawkes reports

or as long as many can remember, the cerns caused outrage to several international anxiety. To them it looked like an attempt to sub- World Health Organization has been non-governmental organisations. A report by vert WHO’s principles of governance and cosy up facing a crisis. From decade to decade, the director general, Margaret Chan, called The to private industry. Their suspicions were height- the nature of that crisis might change, future of financing for WHO (64th World Health ened by the late appearance of the plan, just days but it never quite goes away. Assembly, Agenda item 11, paper A64/4) admit- before the World Health Assembly—WHO’s gov- FDespite its past accomplishments, WHO fits ted many of the criticisms were true. WHO was erning body—met for its 64th meeting. increasingly uneasily into a world with a grow- overcommitted, overextended, and in need of A wide range of non-governmental organisa- ing number of international players who seem specific reforms, she said. “Priority setting is tions were unhappy, and launched a protest at the fleeter of foot and deeper of pocket. Set up as neither sufficiently selective nor strategically assembly. Patrick Durisch, speaking on behalf of an agency to provide advice to governments at focussed. Given the large number of agencies Health Action International, Knowledge Ecology a time when government health departments now active in health, duplication of effort and International, the Third World Network, the were the prime movers in health policy and fragmented responses abound, creating an Berne Declaration, the People’s Health Movement delivery, it seems passé beside such upstarts as unprecedented need for greater coherence and and International Baby Food Action Network the Global Fund to Fight Aids, Tuberculosis and more effective coordination.” (IBFAN) said that the new policy raised conflicts Malaria, the GAVI Alliance (formerly known as New ways were needed of working with other of interest for WHO. Dr Chan’s plan presented the Global Alliance for Vaccines and Immuni- global actors, her report added. They needed to “an unrealistic and empirically unsupported zation), and private philanthropies such as the participate and have their voices heard in the assumption that all stakeholders will collaborate Bill and Melinda Gates Foundation. shaping and making of health policy. While less to advance the public interest.” Any changes in than a quarter of WHO’s budget came from pre- governance structures should deal with those Setting the agenda of global health? dictable and flexible funds (national contribu- conflicts of interest in a realistic manner, he said, The existence of such organisations is a reproach tions) it would not be free to determine its own and members of WHO should guard against ini- to WHO, whose bureaucracy and politicisation priorities, so member tiatives that would give have been increasingly bypassed by govern- states were urged to “We depend on WHO being private interests and ments in the interests of getting something done. increase their con- a health advocate that puts donors a greater role in Jack C Chow, a former assistant director general of tributions. But at a its governance. WHO, claimed last year that the organisation was time when govern- health first. Without that, “Nobody was being becoming irrelevant.1 It was outmoded, under- ment budgets were we wouldn’t now have 60 very clear” says Patti funded, and overly politicised, he said. “WHO is under pressure, WHO Rundall of Baby Milk no longer setting the agenda of global health; it’s would also need to countries banning advertising Action, a long term struggling to keep up.” His theme was echoed this attract new donors of formula milk for babies” opponent of food giant year by Barry R Bloom, professor of public health and explore new Nestlé. “Margaret Chan at Harvard, who pointed out that of WHO’s budget avenues of funding, including “foundations and said, in effect, ‘we want your money’ and that if it of $3.9bn (£2.4bn; €2.7bn) in 2008-9, less than the private and commercial sector.” was forthcoming, WHO would meet its partners’ $1bn came from member states’ mandatory expectations, You can’t do that and also meet the contributions.2 The rest were earmarked funds The first World Health Forum expectations of the member states. provided by countries or foundations for specific To help involve such people, she said, WHO “We depend on WHO being a health advocate projects, indicating a lack of confidence in WHO’s would organise the first World Health Forum, that puts health first. Without that, we wouldn’t ability to set the right priorities if left to itself. to be held in Geneva in November 2012. Along now have 60 countries banning advertising of with member states, this would include repre- formula milk for babies. Involving private compa- Financing sentatives of non-governmental organisations, nies in setting priorities creates an unsurmount- But as if to prove that whatever WHO does will the private sector, academia, and other interna- able conflict of interest. Margaret Chan says that alienate some of its stakeholders, a reform pack- tional organisations. To purists who believe WHO she’ll only deal with the ‘good’ companies, but age announced in May to deal with these con- should not sup with the devil, this caused huge how will she know?”

346 BMJ | 13 AUGUST 2011 | VOLUME 343 WORLD HEALTH ORGANIZATION WHO Barry R Bloom, professor of public Dr Andrew Cassels, WHO director Bill Gates. Plans to allow the Gates Dr Margaret Chan. WHO director health at Harvard, says there’s an of strategy. Critics are wrong to Foundation to partly fund reforms general. The organisation needs to urgent need for WHO to win back argue the reforms will change the has raised concerns over conflict of attract new donors and explore new trust organisation’s decision making interest avenues of funding

The proposed World Health Forum provided of funding we could do a better job. Member rising. WHO ran a deficit last year, and Dr Chan a target around which the non-governmental states responded to the suggestion they should found it necessary to assert in her speech to the organisations circled. “We find this proposal increase assessed contribution by saying yes, World Health Assembly that “we are most defi- absolutely unacceptable, especially since WHO but only when we’re clear what WHO’s priori- nitely not bankrupt.” The executive board meet- has given member states no time to discuss and ties are. ing was picketed by staff members protesting at consider the implications,” said Arun Gupta, “It would be nice to increase the proportion cuts. To balance its books, it needs to persuade regional coordinator for IBFAN Asia. Médecins of voluntary contributions that are less closely governments and others to contribute more by Sans Frontières joined him and others in con- specified. But the key thing is not to be too con- persuading them that it is on the right track—or demning the claim that the forum would not cerned about total resources, but to make them to cut costs. Neither is easy. usurp the decision making prerogatives of predictable.” A former staff member says: “WHO as usual WHO’s own governance as “not credible.” A tries to do too much, its priorities aren’t very joint statement asked: how can the World Health WHO’s priorities clear, and its power to make real executive Forum meet the expectations of commercial From this, he says, followed the need to discover decisions that would cut some programmes is actors without usurping the prerogatives of what other global players believed WHO’s priori- limited, and always has been. Individual depart- WHO’s own governance? ties should be. “The director general is keen to ments compete with each other for funding so Dr Chan’s plan survived the World Health bring greater coherence to WHO’s activities. If we there’s little sense of a united front and unwill- Assembly, but came in for further criticism at are going to achieve that, we need some forum ingness to make sacrifices for the common good. the WHO executive board that followed. She to discuss the issue that isn’t just governments.” Staff morale is low and some people are actually was instructed to produce three papers, on the That would be the World Health Forum. So far, losing their jobs.” governance of WHO, the independent evaluation the forum has yet to gain the formal approval of of WHO, and the World Health Forum, by the end the executive board, which will discuss it at its Funding for global health initiatives of June and to convene a special session of the November meeting and again next January. Yet funding for global health initiatives is not executive board in November to discuss them. “The concern that some people have is that lacking. The money devoted to global health Although open to all, only the 34 members of the it will change WHO’s decision making process, related activities by donors, including govern- board will have a vote. Anxieties were expressed but it’s not about that,” says Dr Cassels. “Its ments and foundations, has risen from $5.6bn in at the meeting at the WHO Secretariat’s plan conclusions would speak to all global health 1990 to $26.8bn in 2010,3 and the third replen- that the development of the reform programme organisations, not just WHO. The purpose is ishment meeting of the Global Fund in 2010 be partly funded by the Gates Foundation. not to influence WHO’s own governance proce- raised $11.7bn for 2011-13. This is less than the Germany raised the issue of WHO’s financing, dures, which would remain unchanged.” fund had asked for but is still very substantial. a key to the reforms but not one of the issues Dr The three papers Dr Chan was mandated That WHO should be facing budget cuts is an Chan is required to report on. It proposed that to produce are complete, but not publicly eloquent commentary on how its performance is financing be added to the governance paper, but available, and are being discussed by WHO’s perceived. The urgent need is to win back trust, Dr Chan responded by arguing that there was too regional committees. Different views have been Professor Bloom argues. But with so many stake- little time to include it and Germany withdrew expressed about the need for an independent holders to satisfy that remains a very tall order. its amendment. evaluation of WHO, one of the key changes Nigel Hawkes, is a freelance journalist Andrew Cassels, WHO director of strategy, called for by Professor Bloom, who argues that [email protected] says that the critics of the plan are wrong to the World Bank, the Global Fund, and GAVI all Competing interests: None declared. Provenance and peer review: Commissioned; not argue that it will subvert WHO’s traditional have extensive external review procedures, but externally peer reviewed. governance, or dilute the voice of developing WHO does not. However, Dr Cassels says that 1 Chow JC. Is the WHO becoming irrelevant? Foreign Policy, countries. The reform plan started, he says, as a in the discussions so far, some have questioned 2010. 2 Bloom BR. WHO needs change Nature 2011;473:143-5. means of achieving a better alignment of WHO’s whether the timing is right, some whether an 3 Institute for Health Metrics and Evaluation. Financing income and its work. “Some parts of the work independent evaluation is even necessary. global health 2010. IHME, 2010. are underfunded, and with greater flexibility In the background, financial pressures are Cite this as: BMJ 2011;343:d5012

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