Congress votes for FDA tobacco regulation

The U.S. House of Representatives today voted by a majority of more than two-thirds (326 v 102) to give the Food and Drug Administration the authority to regulate tobacco products. For this piece of legislation to become law, the Senate would also have to vote positively for it, and then the President would have to sign his approval (rather than veto it).

There is currently not much time left on the Senate’s legislative agenda, and the President’s office has already issued statements saying it does not like the bill (without saying outright that it will be vetoed).

Not everyone who has read this bill takes the view that it will help reduce the harms from tobacco, and many are concerned by the fact that Philip Morris tobacco company claims to support it. Some feel that if the Democrats win the Presidential election there may be an opportunity to pass a bill that could more strongly regulate tobacco. It is noteworthy that both Senators John McCain and Barack Obama are current sponsors of the bill.

The bill itself is long and complex. There are parts of it I don’t particularly like. But my impression is that if the powers it gives to the FDA to regulate tobacco are fully implemented, it will be a massive step forward in the attempt to reduce the enormous harm to health that is currently caused by cigarettes in the United States. Just as an example, it appears to give FDA the power to require manufacturers to eliminate any toxic chemical from cigarettes, (other than nicotine, that can be reduced but not eliminated).

Given the massive impact of tobacco on health in this country, the magnitude of the support for the bill in the House of Representatives today, and the very widespread support for the bill among organizations concerned with public health, it is critical that the Senate makes the time to vote on this bill this year, and that the President allows the will of the people, their elected representatives and the future elected President of this country to be decisive on this issue.

You can find out more detail on the bill, its support and what it will do, at:
http://www.tobaccofreekids.org/reports/fda/index.shtml

Labels: Barack Obama, FDA, John McCain, jonathan foulds, Tobacco regulation

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MPOWER: Bloomberg and Gates pledge millions to tobacco control

Last week saw the announcement of a new initiative, involving $375 million in new funding from the Bloomberg Initiative to Reduce Tobacco Use and the Bill and Melinda Gates Foundation. The funding adds to the $125 million already committed by Bloomberg to reduce the harm from tobacco around the world.

The funding will focus on developing countries, where most of the world’s smokers live (e.g. China, India, Indonesia and countries in Africa), and will primarily be used to help implement proven tobacco control policies in those countries.

The proven policies include those described in the recent “MPOWER” package launched by the World Health Organization.The six components of the MPOWER package are:

Monitor tobacco use and the policies to prevent it .
Protect people from tobacco smoke
Offer people help to quit tobacco use
Warn about the dangers of tobacco
Enforce bans on tobacco advertising, promotion and sponsorship
Raise taxes on tobacco

This funding will go a long way in counteracting the tobacco industry’s marketing efforts in developing countries. And certainly there is a massive amount of work to be done in the countries being targeted. Just as one example, there are more male smokers in China than people in the United States. In many other countries the tobacco industry is stepping up its marketing efforts, often targeting women and young people. So the Gates and Bloomberg philanthropic organizations are to be congratulated for having the wisdom to target their funding to get the maximum health gain. This funding will result in millions fewer smokers, and vast improvements in health in those countries around the world that need it most.

You can view a video, presented at the announcement press conference, at:
http://www.youtube.com/watch?v=WnMXMvyjGgc&feature=related

Details of the World Health Organizations report on global tobacco effects and the MPOWER package of strategies to reduce the harm to health caused by tobacco can be found at: http://www.who.int/tobacco/mpower/en/

Labels: Bill and Melinda Gates Foundation, Bill Gates, jonathan foulds, Michael Bloomberg, MPOWER, tobacco control

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Parental tobacco use and restrictions influence teen smoking

It has long been recognized that the kids of parents who smoke are more likely to become smokers themselves. Some studies have found that if both parents smoke, their kids are about 4 times more likely to become smokers (as compared with kids of 2 never smokers). If parents smoke, the earlier they quit, the less likely their kids are to become smokers.

More recently researchers have examined the impact of parental smoking restrictions and adolescent smoking. One such study was published this month by a group led by Dr Joseph Ditre of the University of South Florida in Tampa. They asked 757 Florida high schoolers about their tobacco use and attitudes and restrictions on smoking imposed by their parents. The first interesting finding was that 44% of adolescent smokers reported that their parents do not know they smoke!

The other main finding was that the greater the parental restrictions on smoking (e.g. banning tobacco from the home) the less smoking the less their kids smoked, and the more motivated the kids were to quit. In fact smoking kids of parents who never restrict smoking, smoke about twice as many cigarettes (15) as smoking kids of parents who restrict smoking a lot (7).

So although there are other factors influencing adolescent smoking (like peer smoking), parental smoking and attitudes still have an influence. So if you are a smoker and you don’t want your kids to smoke, the sooner you quit smoking and implement tight smoking restrictions for the home the better.

Labels: adolescent, cigarette smoking, parent, tobacco, youth

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What proportion of smokers become addicted?

Most people who become smokers initiate smoking before the age of 18. They generally try smoking as part of experimentation, after observing their peers and family smoking and viewing tobacco advertising. It is fairly natural, when cigarette smoking can be observed so widely, for a child to think, “I wonder what that is like?”. Most kids who try smoking are not considering or expecting that they may become addicted. But it may be worth educating young people on their risks of becoming addicted. To do so we have to be clear about what we mean by “addiction”.

Nowadays the words “dependence” and “addiction” are generally used interchangeably with the same meaning. When used in relation to substance or drug use, these words refer to a situation in which the drug has come to unreasonably control a person’s behavior. The central characteristic of most definitions of drug addiction is that the individual experiences an impaired ability to reduce or end their use of the drug. In the case of cigarette smoking that characteristic is most commonly expressed as long term daily smoking despite awareness of the likelihood of serious health effects, a desire to reduce or quit, and failed attempts to reduce or quit.

In order to more clearly define, diagnose and study nicotine dependence, various diagnostic criteria have been developed, such as those of the American Psychiatric Association (DSM-IV) or the World Health Organization (ICD-10). These typically describe a list of criteria and require individuals to meet a certain number of these to meet the diagnostic threshold for “nicotine dependence”. There are 7 main DSM-IV criteria, (including things like difficulty cutting down, continued use despite it causing problems, experience of withdrawal symptoms when reducing etc) and if a smoker meets at least 3 of these they are considered to be “nicotine dependent”. Of course there is a certain artificiality about this because most people consider that nicotine addiction exists on a continuum of severity, rather than being a categorical disorder that a person either does or does not have. But these diagnostic frameworks at least give us a way of identifying those who are clearly addicted.

Last year, Drs Eric Donny and Lisa Dierker published a paper (in the journal, “Drug and Alcohol Dependence”) that aimed to identify what proportion of smokers in the general population met strict DSM-IV criteria for nicotine dependence. Their study was based on direct interviews with a large, representative sample of non-institutionalized adults in the United States in 2001-2. From that sample they focused on the 8,213 who were daily smokers in the past year. This sample included people who smoked anything from 1 to over 40 cigarettes per day, and people who had smoked for less than one to over 50 years.

The study found, not surprisingly, that the greater the number of cigarettes per day the person smoked, the greater the chance that they would meet strict diagnostic criteria for having become nicotine dependent. Whereas under 50% of those who smoked 1-5 cigarettes per day met the criteria, over 80% of those who smoked over 30 cigarettes per day met the criteria.

Unexpectedly, however, the longer the person had smoked, the less likely they were to have become dependent, particularly if the person had started smoking over 50 years ago. This finding seems very odd, and may have more to do with memory for quit attempts or attitudes to smoking among older age cohorts.

Overall, over 60% of ever daily smokers met strict diagnostic criteria for having become nicotine dependent. But almost all smokers had experienced at least one symptom of nicotine dependence. For example, 97% of “dependent” smokers had experienced difficulty cutting down their cigarette consumption, as had 72% of “non-dependent” smokers. The authors acknowledged that the differences in dependence between these two groups may be more quantitative rather than qualitative. The authors also acknowledged that certain co-occurring factors appear to make it more likely that a smoker will bcome dependent. An example they provided was a history of major depression, which is associated with approximately 100% nicotine dependence among heavy smokers.

So we can tell young people that if they take up smoking, there is an over 90% chance that they will experience some symptoms of nicotine addiction, and over a 60% chance that they will go on to meet strict diagnostic criteria for becoming addicted to nicotine.

A pdf copy of the full paper by Drs Donny and Dierner can be accessed (near the bottom of the page) at:
http://www.tern.org/Publications.htm

Labels: addiction, cigarette, cigarette smoking, dependence, jonathan foulds, nicotine

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Extended treatment for some addicted smokers

The brand new US Public Health Service Guideline on the Treatment of Tobacco Use and Dependence was written after an extremely thorough review of all the randomized controlled smoking cessation trials in the literature with at least 6 months follow-up.

http://www.surgeongeneral.gov/tobacco/

The guideline was also written by a large group of experts on tobacco treatment and healthcare. That guideline stated:

“For some patients it may be appropriate to continue medication treatment for periods longer than is usually recommended. Although weaning should be encouraged for all patients using medications, continued use of such medications is clearly preferable to a return to smoking with respect to health consequences.” (p126).

So what is meant by extended or “long term” treatment for tobacco dependence?

Most pharmacological tobacco dependence treatments (e.g. bupropion/Zyban, nicotine patch, nicotine gum) last for 7-12 weeks. Most non-pharmacological treatment is even shorter, e.g. the number of counseling sessions reimbursed by Medicare is 4 (>10 minutes) and group treatment most commonly consists of 6 weekly sessions. So in the field of tobacco dependence treatment, any treatment lasting longer than 12 weeks is considered “long term”. So is there any evidence that treatment lasting longer than 12 weeks may be safe and effective?

Williams et al (1) randomized patients to 52 weeks of varenicline (Chantix) or placebo. They found that varenicline was safe for a year of treatment and produced significantly higher quit rates at one year than placebo.

Tonstad and colleagues (2) treated 1927 smokers with the typical 12 weeks of varenicline and the 1236 who were not smoking at 12 weeks were then randomized to a further 12 weeks of varenicline or placebo (double blind). The question was, “does longer term treatment with varenicline prevent relapse over the next 12 weeks? By week 24, 30% of those who had varenicline had smoked, compared with 50% of those who had placebo for the last 12 weeks. So longer term varenicline resulted in more people succeeding in quitting smoking. When the participants were followed up at 12 months (i.e. at least 6 months off-drug for everyone) there were still more non-smokers among those who had varenicline for 24 weeks as compared to those who had it for 12 weeks.

But the added effects of longer duration treatment do not just apply to varenicline, or even just pharmacotherapy. Hall and colleagues (2004) (3) randomized smokers to standard 12 weeks of counseling and 8 weeks of nicotine patches plus either another 9 months of counseling, or 12 months of nortriptyline (an antidepressant that helps people quit smoking) or 12 months of placebo. At the one year follow-up, those who had nortriptyline and counseling for a year had a quit rate of 50%, as compared with only 18% for those who had nortiptyline but only 12 weeks of counseling, 30% for those who had 12 weeks of counseling and placebo, and 42% for those who had a year of counseling and placebo. The authors concluded that, “Comprehensive extended treatments that combine drug and psychological interventions can produce consistent abstinence rates that are substantially higher than those in the literature.” But as can be seen from the numbers, it was primarily the extended counseling that contributed to the unusually high one-year quit rates.

This study by Hall and colleagues was one of the first to really adopt the “chronic disease” model for smoking cessation, and it is also the one study to achieve the highest one year quit rates (50%).

The reality is that most smokers are not seeking extended (i.e. over 12 weeks) counseling or extended pharmacotherapy as a way to stop smoking. And many will not need it. The point is that those patients who have made a choice that they are willing to do whatever is necessary to save their life and become healthier by stopping smoking, and who appear likely to benefit from it, should be provided with extended treatment that appears likely to increase their chances. When 12 weeks of treatment have not succeeded in controlling hypertension, diabetes or asthma, we don’t expect our doctors to say, “oh well, never mind, it didn’t work and I won’t try to help you any more.” The same should go for tobacco dependence treatment. And when a patient has had 12 weeks of treatment but still feels vulnerable to relapse then there is evidence to suggest that the extended treatment may help them to remain smoke-free. The evidence is certainly not clear enough to recommend this to all patients, but it is sufficient to support it as an option for some.

(1) Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801.

(2) Tonstad S, Tønnesen P, Hajek P, Williams KE, Billing CB, Reeves KR;Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomizedcontrolled trial. JAMA. 2006 Jul 5;296(1):64-71.

(3) Hall SM, Humfleet GL, Reus VI, Muñoz RF, Cullen J. Extended nortriptyline and psychological treatment for cigarette smoking. Am J Psychiatry. 2004 Nov;161(11):2100-7.

Note: Jonathan Foulds has done paid work for pharmaceutical companies (Novartis, GSK, Celtic Pharma and Pfizer). This has included advising on potential new medicines, training health professionals, advising on clinical trial design, discussing barriers to quitting and reviewing applications for research grants. His main funding sources are mentioned in a funding statement on the bio page.

Labels: cessation, cigarette smoking, dependence, extended, jonathan foulds

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Happy Independence Day.

Its funny to think I’ve now been writing this column for over a year. Last year at this time I wrote a brief article encouraging ex-smokers to celebrate their independence from tobacco, and reminding us that the history of the United States is very closely tied to the history of tobacco. You can read it at:
http://www.healthline.com/blogs/smoking_cessation/2007/07/celebrate-your-independence-from.html

This year, I’ve had reason to think about another form of independence: namely independence from funding sources.

First of all, lets clarify what the word means in this context. A quick googling of “independence” gives various definitions, here are some:
“The capacity to make ones own judgements”. It has also been described as the opposite to “dependence, subordination, subservience”.

In the past week a journalist published an article implying that because I have done some work for pharmaceutical companies that my opinions or recommendations to patients have somehow lost their independence and become biased.

Part of the reason I have chosen a career as a professor is that in this profession I enjoy academic freedom: the right to express my opinion on my area of expertise without being censored by my employer or any other source of funding. In this job, the main thing affecting what one says is simply the question of whether it can be supported by the best scientific evidence. If I was primarily employed by a pharmaceutical company (or pretty much any for-profit company for that matter) I may have greater limitations on my freedom to express my opinions, particularly where those opinions were either not relevant to that company or could have a negative impact on the company’s bottom line.

So to have my independence questioned is deeply insulting, particularly by individuals who know almost nothing about me and have taken very little time to enquire as to whether my opinions are based on evidence and expertise/experience, rather than the bias they presume. In my previous blog post I have explained some of the various inaccuracies and misrepresentations presented in the recent article. I will continue to express my opinions based on my own judgement and on the best scientific evidence.
I am aware that there are some people out there who jump to the conclusion that if someone has done some work for a pharma company they must suddenly lose all ability to think for themselves or express an honest opinion. This is simply not true, any more than it is true for the 90%+ of my work funded by New Jersey Department of Health and Senior Services, the Cancer Institute of New Jersey, the Rutgers Community Health Foundation, the Robert Wood Johnson Foundation or numerous other funding agencies.

Freedom of expression is one of the most highly valued rights in this country and one that I will continue to enjoy. Feel free to post your own thoughts and opinions in response, whether you agree or not (except of course for John Polito…just kidding).

Labels: cigarette smoking, independence, jonathan foulds

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