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Does Nicotine Replacement Therapy (NRT) Cause Cancer?

A recent research report by Professor Robert Murray (University of Manitoba) and colleagues examined whether nicotine replacement therapy (NRT) may cause cancer. The report was published in the September edition of the journal, “Nicotine and Tobacco Research”, and was based on analysis of the Lung Health Study.

The Lung Health Study recruited 5887 smokers starting November 1986, and 3923 of them were randomly selected to receive an intensive, state-of-the-art stop smoking treatment (group therapy plus nicotine gum). The participants in the original study were followed for 5 years, and 3320 were included in a longer study focusing on lung cancer for another 7.5 years.

The study presents one of the best opportunities of measuring the known exposure to either smoking, or NRT, or both over a 5 year period, as this information was accurately recorded throughout the study.

The study found that 75 participants were diagnosed with lung cancer and 203 with cancer of any type during the follow-up period. Those with the largest cigarette smoke exposure during the study were significantly more likely to suffer lung cancer, but those who used a large amount of nicotine gum were not at any greater risk of suffering from lung cancer or any other cancer examined in the study.

Even though most of the participants were relatively young at enrollment (just under 50) and so had relatively low risk over the immediately following years, around 3.2% of the heaviest smokers developed lung cancer, as opposed to half that proportion in those smoking less. But the amount of use of NRT during the study was not associated with getting cancer.

The results of this study are consistent with the vast majority of human studies, in that they do not find any convincing evidence to suggest that NRT causes cancer.

Murray RP, Connett JE, Zapawa LM. Does nicotine replacement therapy causecancer? Evidence from the Lung Health Study. Nicotine Tob Res. 2009 Sep;11(9):1076-82. Epub 2009 Jul 1.

This post, Does Nicotine Replacement Therapy (NRT) Cause Cancer?, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

A Scottish View Of US Healthcare Reform

I’ve been bemused by the debate on healthcare reform taking place in the U.S. right now. I used to thing that the single topic that people talk the most nonsense about is sport. You know, my sport is better than your sport, my team is better than your team etc. All good fun, but usually nonsense. And then I’ve watched pundits on TV and heard ordinary Americans talk about healthcare reform and wow….its got the sports conversations beaten for absolute gibberish.

So despite a reluctance to get involved because I recognize it’s an extremely complicated issue, I now feel compelled to say a few words. Part of it is because unlike most of the people expressing an opinion, I’ve worked and been a patient in the healthcare system in a country with “socialized medicine” (UK) and I also currently work and am sometimes a patient in the United States healthcare system.

So lets start off with a few basics. The United States has some of the most highly trained healthcare staff and by far and away the best healthcare technology in the world. Just to give an example, there are more scanners (MRI, PET, SPECT etc) within a 15 mile radius of my office in central New Jersey than in the whole of Scotland (population about 5 million). And the United States spends far more on healthcare than any other country in the world. But despite that vast wealth of resources that befits the worlds greatest economic power, the United States falls way down the league table on basic objective measures of health outcomes, and similarly down the league on patient satisfaction with healthcare. There are really very few people, (who have looked further than the end of their own nose into this issue) who don’t acknowledge there’s a very serious problem.

For many in the United States, the problem is not so apparent. So if, like me, you and your immediate family are fortunate enough to be relatively healthy, and to be covered by a relatively good employment-based health insurance package, then it may seem OK. It’s when you get very sick, or are unfortunate enough to lose your job, that some of the basic problems with the U.S. system become more apparent. It’s when you get sick that you may find that your policy doesn’t cover the kind of treatment you need, or has a high deductible (amount you have to pay before the insurance takes over). And its when you lose your job and have to start paying out of pocket for health insurance that you realize it is extremely expensive. And of course if you have a gap in coverage and get sick then the new insurer may refuse to cover your “pre-existing condition”.

To me, the single time in your life when you don’t want added financial stress is when you are sick. But many aspects of the U.S. system direct coverage and services to those who need it least (healthy, young ,well insured employees) and become a nightmare for those who need good healthcare most (aging, sick unemployed people). Now when you talk to people in countries like Britain about this, they are generally appalled and quickly see the problem. But one of the things that has surprised me most about the debate in the United States is that a significant proportion of people here seem to really believe that the old “survival of the fittest” philosophy is appropriate here. The attitude seems to be something like: “If someone gets sick and didn’t have the fore-thought to get adequate health insurance to cover the treatment, then that was their own fault. Why should I work my ass off to look after my family and their healthcare needs for some lazy unemployed person to get healthcare for free?”

So somewhere deep in the psyche of many Americans there is a basic belief that healthcare (insurance) is just like auto insurance….something we are all individually responsible for, and if we cant afford it, that’s tough. Many do not believe that healthcare access for all is a basic requirement of a civilized society (like roads and schools).

So President Obama and others who are currently trying to change the U.S. healthcare system have a tough task ahead. It is currently being made much tougher by some bizarre reporting on this topic by the right wing media (Fox etc). We hear weird stories about “death panels” of government bureaucrats who will decide which sick people should have the plug pulled on their healthcare under government healthcare. We hear weird stories that in countries with socialized medicine it’s the government, not the doctor who decides on what treatment is provided. Well I can tell you that I never saw “Big Brother” interfering in doctors’ clinical practice until I came to the United States. In this country it is bureaucrats working for health insurance companies, generally with no medical qualifications, who deny coverage for appropriate medical treatment hundreds of thousands of times a day.

Often coverage is not denied on clinical grounds, but rather for a whole series of “technical” reasons (wrong diagnostic code, doctor not part of that health insurance plan, pre-existing condition, patient already used annual entitlement for that type of care, patient had that treatment already for longer than policy will pay, treatment carried out at a non-approved facility [go to one 30 miles away], patient hasn’t completed the 6-monthly confirmation of details form, health insurance company doesn’t cover that type of illness/service etc etc). But the underlying strategy is to make it so difficult to get a treatment covered and paid for, that fewer people will go for treatment, and fewer doctors will provide certain procedures because it is so much hassle for them to get paid for it. So the insurance companies hire more people to try to find ways to deny coverage and payments, and doctors have to employ billing specialists to figure out how they can get paid for providing treatment. And the result is an extremely inefficient beaurocratic mess.

Surely a country like the United States can do much better than this?

Now you might be wondering what any of this has to do with smoking? Well one link is that many health insurance policies in the United States do not cover a range of interventions they call “preventive” or “wellness enhancing” interventions. Frequently that means that patients cannot get tobacco dependence treatment (medicines or counseling) covered and so they don’t get the treatment. This is despite the fact that such treatment is one of the most cost-effective clinical interventions available. So an important part of the new proposals for healthcare reform is an increased emphasis on preventive healthcare. This is certainly a step in the right direction.

This post, A Scottish View Of US Healthcare Reform, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

Quitting Smoking Has Higher Success Rate In Inpatient Programs

Many smokers I’ve seen for help in quitting have made a comment like, “if only I could be isolated on a desert island for a couple of weeks without cigarettes, then I could quit.” Earlier this week a news item from my home country (Scotland) told of a 56 year-old successful businessman named Geoff Spice who had smoked for 43 years and then decided to live on a remote island by himself for a month to quit smoking. And this island is really remote…with no electricity and only sheep for companionship (?!). So do you think this is a god way to quit smoking?

Perhaps the closest thing to this here in the United States is the option of going to a specialist clinic for residential tobacco dependence treatment. A handful of these residential clinics exist, with the most famous being ones at Mayo Clinic and Hazelden Foundation (both in Minnesota) and the St Helena Center in California. These residential clinics typical have a 4 to 8 day program including classes, pharmacotherapy and multidisciplinary therapy. They are also typically quite expensive ($3000 to $6,000) for the patient (though not in comparison to the cost for inpatient treatment for lung cancer!).

These clinics typically boast high long term (6 month to a year) quit rates (25 to 65%). The Mayo Clinic published a comparison between one year quit rates in their inpatient and outpatient program, finding a higher quit rate after residential treatment (45% v 23%). Of course it is possible that those attending expensive inpatient treatment were more highly motivated (and more affluent) than the average smoker seeking treatment. However, it is plausible that the methods taught in the classes are helpful, and that there is an advantage of getting off to a good start by virtually guaranteeing abstinence for the first few days.

The main challenge for those who start their quit attempt at a residential clinic, or on an island, is staying quit once they return to their normal environment with all the same triggers and cues.

I’d be interested to hear of the experiences of anyone who has tried these or other “extreme” tobacco dependence treatments.

Links to further information:

http://www.mayoclinic.org/ndc-rst/residential.html

http://www.smokefreelife.com/overview.php

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=12709094

http://news.bbc.co.uk/2/hi/uk_news/scotland/highlands_and_islands/8179781.stm

This post, Quitting Smoking Has Higher Success Rate In Inpatient Programs, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

Should We Put Graphic Warnings on US Cigarette Packs?

Now that the US Food and Drug Administration has been given the power to regulate tobacco products, one of its new powers is the right to change the health warnings on cigarette packs in the interest of public health.

So the first question is, are the current health warnings perfectly adequate? The answer to that one is clearly “no”. The boring small text warnings printed on the side of the pack have are almost perfectly designed to be ignored.

The second questions is, can we learn anything from the experience of health warnings in other countries? The answer here is a resounding “yes”. Numerous other countries have been using large mandated pictorial health warnings on cigarette packs for years and there is a growing body of research showing that these are much more impactful then prior text-only warnings. The warnings used in Canada present a good example to follow and can be viewed at:

http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/legislation/label-etiquette/graph/index-eng.php

However, I particularly like the style used in Australia, where they have, since 2006 also added the freephone number of the national stop smoking Quitline to the pictorial health warnings. Graphic images and explanatory messages cover 30% of the front and 90% of the back of the pack. The message “You CAN quit smoking. Call the Quitline 131 848, talk to your doctor or pharmacist, or visit www.quitnow.info.au” is also included on the back of all packs. The Quitline number is also “stamped” on top of the graphic image on the backs of packs.. A recent study by Dr C L Miller of the Cancer Council of South Australia concluded that introducing graphic cigarette packet warnings and the Quitline number on cigarette packets doubled demand for Quitline services, with likely flow on effects to cessation.

Other countries of the world (including the United States) that have not yet introduced large graphic health warnings on cigarette packs or the number to the national quitline should do so as soon as possible.

The research from Australia can be viewed at:
http://tobaccocontrol.bmj.com/cgi/content/full/18/3/235

This post, Should We Put Graphic Warnings on US Cigarette Packs?, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

Whyquit.com: Factually Inaccurate, But Doing Some Good Nonetheless

Last week marked the 10th anniversary of a smoking cessation website called “whyquit.com”. Now those of you who know me, and know that website and its director, Mr John Polito, may wonder why I’m choosing to give it some free publicity. The website is strongly against the use of all pharmacological aids for smoking cessation, and some would argue that it does harm by misinforming smokers about the harms and benefits of these smoking cessation aids. However, although I certainly do agree that the site does misinform about pharmacological aids, it also has a number of positive qualities and presents a different perspective that may appeal to and help some smokers.

The site started 10 years ago primarily to tell the story of a few individuals who were killed very young by smoking caused diseases. The idea was to vividly tell their tragic stories and to inspire others to quit tobacco and so avoid the same. In 2000 Joel Spitzer, an experienced smoking cessation counselor and author joined whyquit and the site took on more of a role of advising smokers how to quit using a very clear philosophy based on the “cold turkey” method.

The site has a large amount of educational material, including free pdf copies of lengthy books by Polito and one by Spitzer. The descriptions of individual cases of tobacco-caused diseases are informative and will inspire some to avoid the same harrowing experience. The site also has a discussion forum called, “Freedom from nicotine.” But once again the fundamentalist opposition to the use of pharmacotherapy aids is evident in the rules for use of “Freedom from nicotine”. The site states that,

“A single-minded program, those applying for posting privileges must have quit all forms of nicotine delivery cold turkey within the past 30 days, without use of any products, pills or procedures, and remained 100% nicotine-free for at least 72 hours. A nicotine-free forum, any nicotine relapse – even one puff, dip or chew – permanently revokes posting privileges.”

This is a rather unusual requirement for people to use a quit smoking discussion site, and it seems rather odd to ban people “permanently” from using the discussion forum, because they had a puff or chewed a piece of nicotine gum.

The site contains a large number of factual inaccuracies, particularly when referring to research on the use of pharmacotherapy for smoking cessation and the evidence on it. There are too many examples to mention, but just to mention a few:

– the site states that nicotine withdrawal lasts 72 hours. Most studies of nicotine withdrawal symptoms find these to be significantly raised after the first week, and typically not returning to normal levels for 3 weeks.
– The site asserts that in “real life” studies nicotine replacement therapy doesn’t work and “cold turkey” always produces a higher quit rate. An example of a study refuting that claim is provided below (West and Zhou, 2007)
– The site asserts that placebo-controlled trials of pharmacological treatments are all severely flawed because participants can sometime guess better than chance (.e.g. because the medicines work so well at treating nicotine withdrawal that participants can tell what the got, so the study is not perfectly “double blind”). On this point the site is somewhat out on a limb as most scientific research bodies regard the randomized placebo-controlled trial as amongst the best ways to find out if a drug treatment works or not.
– The idea that the results are entirely due to participants’ awareness of whether or not they received the drug also doesn’t bare much scrutiny. For example, in dose-response studies or studies where there is also an “active” comparison, participants are less able to identify what treatment they received, but the higher dose typically does better than the lower dose, and both do better than placebo.
– The site is also highly critical of anyone who has been funded in any way by pharmaceutical companies, and implies that such a conflict of interest almost certainly causes those individuals (including myself) to lose all independent judgment. While I agree that researchers should declare their sources of funding and that readers should weigh that information when reading research reports, the idea that the whole field has been bought and sold to the pharmaceutical industry is blatantly false. It is not at all uncommon for researchers receiving pharma funds to publish studies with disappointing results for the pharma company, including reports of potentially serious side effects.
(e.g. Foulds, J., Stapleton, J., Hayward, M., Russell, M.A.H., Feyerabend, C., Fleming, T., and Costello, J. Transdermal nicotine patches with low- intensity support to aid smoking cessation in outpatients in a general hospital: a placebo-controlled trial. Arch Fam Med 1993; 2: 417-423.
Foulds, J. and Toone, B. A case of nicotine psychosis? Addiction 1995; 90: 435-437).

The reality is that for years academic researchers have been encouraged by our employers to build bridges with private industry in order to make scientific advances, and do so with their eyes open. Most acknowledge our funding as openly as possible without becoming very tedious (e.g. my funding sources are mentioned on my home page on healthline and also on my program website, rather than on every single blog post). Most of us draw the line at funding from the tobacco companies because they have such a clear and consistent history of distorting science and using primarily for PR purposes, and largely because their ultimate purpose is to sell a product that is extremely harmful to health, rather than products designed to improve health.

However, the point here is not to quibble with every single point or inaccuracy on the site. Rather readers should be aware that in among the inspirational stories and plenty of good advice on this site, there is an almost fundamentalist agenda that its just wrong to use medicines to help you quit smoking. If you agree with that, or are prepared to take it with a pinch of salt, then you may find other aspects of this “single minded program” to be helpful.

Here’s an example of a recent “real world” study finding that smokers using NRT have a higher quit rate

This post, Whyquit.com: Factually Inaccurate, But Doing Some Good Nonetheless, was originally published on Healthine.com by Jonathan Foulds, Ph.D..

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