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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Doctors Under the Influence? The Real Story

About a month ago, my colleague, Dr Michael Steinberg, and I were contacted by a journalist for BusinessWeek magazine, who said she was interested in discussing “smoking cessation” with us, focusing on a paper we had recently published in Annals of Internal Medicine, entitled, “The case for treating tobacco dependence as a chronic disease.” On talking to Ms Weintraub, however, the focus of her questions very swiftly shifted to the topic of whether we have ever done any paid work for pharmaceutical companies and whether that presented a conflict of interest. Of course we explained that we have done some consulting work and presentations for pharmaceutical companies who make smoking cessation products, and we pointed out that this, including the names of the companies, was clearly disclosed at the end of our published paper, as is common practice when publishing in medical journals.

The journalist, recognizing that it is our practice to disclose our funding wherever it comes from, in our publications and presentations, then asked if we do so to our patients. We thought about this a little and stated that we don’t, and that this isn’t normal practice in any area of healthcare. I commented that when I go to see my own doctor about my asthma, I expect her to assess and treat my asthma to the best of her ability, and if she started telling me that she has been paid to do some work for pharma companies, I’d be a bit puzzled as to why she was telling me this. I am neither surprised nor concerned to hear that my doctor might do some work for pharma companies. It is probably a sign that she is regarded as having expertise in that field. Personally I don’t feel this is information I need to be provided with on a routine basis, and that if one day I decided I had a reason to ask, I’d do so and expect to be told. In fact I’ve never asked a medical doctor that question, nor ever thought of it. Similarly I don’t recall being asked by a patient, which is perhaps not surprising given that I’m a psychologist and don’t prescribe medicines at all.

I was then surprised when the journalist’s questions shifted from our article in Annals of Internal Medicine, to the new smoking cessation medicine, Chantix, which was barely mentioned (once) in the article. The questions were all about work we’d done for the manufacturer (Pfizer), and whether that made us biased towards the drug. The journalist appeared to be under the impression that the article aimed to persuade doctors to prescribe Chantix to patients for life. We explained that the article wasn’t about Chantix at all (the patient described in it wasn’t treated with Chantix) and that we do not recommend treating patients with any tobacco treatment medicines for life. We explained that we advise patients to use the medicines for as long as it takes to successfully quit smoking (typically until they have 14 consecutive days without cravings), and that the biggest problem we find is that patients often only use the medicines for a few weeks and go back to smoking. However, despite our repeated clarifications, we had a feeling that she was not particularly interested in the facts, but had an angle she wanted to pursue and was going to do it regardless.

So her article appeared in the June 26 issue of BusinessWeek under the title, “Doctors Under the Influence?” opposite a full-page cartoon depicting a doctor in a white coat being fed cash into his mouth, while simultaneously popping pills into the mouth of an open-mouthed patient. Get the idea? So I’d like to take this opportunity to clarify some facts and some issues that were badly misrepresented in the article.

Misrepresentation 1: In the opening paragraph, the article states that in our Annals of Internal Medicine publication we advised that addicted smokers should take prescription drugs for years to curb their cravings. In fact, nowhere in the paper did we advise that patients should take medicines for years. Rather, we state that some smokers may require extended treatment (both behavioral and pharmacological) to quit smoking. This is entirely consistent with the current US Public Health Service Clinical Practice Guideline, which states:

“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).

Incidentally, the first of the 10 key recommendations of the US Public Health Service Clinical Practice Guideline states, “Tobacco dependence is a chronic disease that often requires repeated intervention….”.

Misrepresentation 2. The third paragraph points out that the paper was published around the time Pfizer was strengthening warnings on the labeling on its new smoking cessation drug, Chantix, and stated “This timing has fuelled concern that company-paid experts are trying to protect the drug…” In fact the paper described a case report of a patient who was successfully treated with other smoking-cessation medicines (not Chantix) over two years before Chantix was launched, and mentions the drug by its generic name (varenicline) only once in citing a paper showing that it was safe and effective for up to a year. In truth the paper is not about Chantix at all.

Misrepresentation 3. The title, attached artwork and overall thrust of the article implies that if a health professional has done some work for a pharmaceutical company, they must therefore be being paid by the company to get patients to use the drug. Well let’s think about that for a second. Healthcare providers who gain expertise in treating a specific health problem via their clinical work and research, whether it be tobacco addiction or diabetes, are clearly more likely to be offered paid work (including research funds) for their expertise by a range of interested parties, whether it be government organizations, non-profits, or pharma companies. None of these organizations are allowed to pay anyone to prescribe a specific medicine, and in my case, as a psychologist I don’t prescribe any medicines anyway. My consulting work has involved things like advising on clinical trial design, reviewing applications for research funds, discussing common barriers to quitting smoking, and advising on future potentially effective smoking cessation medicines. I have also provided presentations to doctors about smoking cessation medicines, so that they can become more knowledgeable both about these medicines and about effectively helping smokers to quit. None of these activities are linked to the medicines selected by patients at our clinic. As we very clearly explained to the journalist, our style at the Tobacco Dependence Clinic is to offer individual and group counseling and to show patients all the FDA-approved medicines for smoking cessation, and let them choose the ones they would like to try, based on a discussion of their pros and cons and of their own history. Only a minority of our patients choose Chantix.

Misrepresentation 4. The article implies that we have some kind of problem with disclosing our consulting work with pharma companies. On the contrary, our consulting work is stated very clearly on the specific paper that captured the journalist’s interest. In addition, both Dr Steinberg and I stated that we have no problem disclosing this work to patients if they ask, but we don’t see it as something that patients will want to have provided to them routinely. So we ask readers to consider whether they really want their hospital doctors to have a discussion with them about their various sources of income every time they see them. In considering this question, bear in mind that the more senior and the more “expert” the doctor you see, the greater the likelihood that they will have done work funded by a potentially long list of organizations. If the answer is yes, we will be happy to oblige, but until we hear that request consistently, we are happy to provide the information to patients on request.

Of all the misrepresentations in the article, the one that bothers me most is the entirely inaccurate picture the article paints of my colleague, Dr Michael Steinberg. He is without doubt one of the best medical doctors I have had the privilege to meet or work with. He has chosen to forego far more lucrative career options to focus on working as an academic hospital doctor and internal medicine specialist, with a specific clinical and research focus on helping the most addicted smokers to successfully quit. He has become a national expert on pharmacotherapy for smokers and so it is no surprise that many groups (including pharma companies) seek his expertise. He has every right to be paid for the work he does in sharing that expertise. I have no doubt at all that his clinical work is guided by the best scientific evidence, combined with his own expert judgment of what might be most helpful for the patient and an excellent clinical style that respects patient choice. The development of our Tobacco Dependence Clinic into one of the best clinical services for addicted smokers in the country is largely due to his expertise. Note that the service is funded by the New Jersey State Department of Health and Senior services.

As for myself, I continue to be happy for people to be fully informed about my funding, and to judge my actions and opinions on whether or not they are based on the best scientific evidence. Even the more positive things said about me in the article are inaccurate. I’m not a “celebrity in antismoking circles” and I never “launched an extensive telephone hotline for smokers” (I worked briefly as Director of Research for the UK charity, “Quit” which ran the UK Quitline for many years prior to my involvement). I find it an interesting coincidence that the BusinessWeek article, which appears to attempt to discredit reputations, is published less than a month before I am due to provide testimony as an expert witness in four law suits against tobacco companies. These lawsuits stemmed from the Florida-based “Engle” class-action lawsuit which led to the largest financial judgment of its type, ever ($145 billion against the tobacco industry). The class action was later decertified, resulting in these and numerous other individual cases, which the tobacco industry is obviously very eager not to lose. I’m sure this is just a coincidence, and that a magazine like BusinessWeek wouldn’t dream of being under the influence of big business itself.

FYI here are a couple of tobacco industry-friendly articles on the BusinessWeek website:

http://www.businessweek.com/investor/content/jan2008/pi20080129_262388.htm

http://www.businessweek.com/bwdaily/dnflash/content/jan2008/db20080129_130365.htm

So as far as BusinessWeek is concerned…...
doctors who have ever done work for a pharma company, then providing the most effective treatment to help smokers quit – unethical,
but multinational tobacco companies winning litigation and selling more cigarettes around the world – priceless.

You can find our original article in Annals of Internal Medicine at:
http://www.ncbi.nlm.nih.gov/pubmed/18378950?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

The citation is:
Steinberg MB, Schmelzer AC, Richardson D, Foulds J. Treating tobacco dependence as a chronic disease: a case illustration. Annals of Internal Medicine 2008 Apr 1;148(7):554-6.

Labels: BusinessWeek, Chantix, Chronic Disease, jonathan foulds, Pharmaceutical

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Are Americans Switching to Smokeless Tobacco?

A recent paper by Professor Brad Rodu of University of Louisville, School of Medicine and Dr Carl Phillips if the University of Alberta suggested that switching to smokeless tobacco is a viable smoking cessation option for American smokers.

The paper, published in the online Harm Reduction Journal, used data from the year 2000 National Health Interview Survey (NHIS) which asked 3622 male smokers and 3653 male former smokers about the methods used and outcome of their most recent attempt to quit smoking. Because the NHIS survey is administered to a fairly representative sample of the US population, Rodu and Phillips then used the results of the survey to estimate the total number of male smokers in the US using each quit rate and quitting smoking in the United States. So far this all sounds fairly sensible. However, the authors then took that fairly simple data and made rather far-reaching claims without critically examining the quality (and quantity) of data.

For example, the main conclusions drawn in the paper and its abstract (summary) were that a reasonably large number of smokers in the US (261,000) have quit smoking by switching to smokeless tobacco on their latest quit attempt. It is also claimed that the quit rate among those trying to quit smoking by switching to smokeless tobacco is higher than among those trying other methods (e.g. nicotine replacement therapy). However, examination of the data tables in the paper revealed that a total of only 33 people in the survey claimed to have quit smoking by switching to smokeless tobacco. Unfortunately this is too small a number to provide reliable estimates of numbers using this as a quit method nationally. The ubsurdity of using such very small samples to estimate national numbers is even clearer when one looks at the figures for those using the nicotine nasal spray (NNS). Only 3 people in the survey claimed to have used the nicotine nasal spray on their last quit smoking attempt, and none remained free of smoking at the time of the survey. Despite this extremely small sample, the authors went ahead and used it to estimate that at a national level,14,000 smokers used the NNS on their latest quit attempt and none (0%) succeeded.

One other issue with this study stems from the fact that the various smoking cessation aids differed in the time periods in which they were available. For example, while smokeless tobacco has been available for over 100 years, the pharmacological aids only became available in the 1980s and 1990s. So 48% of those who quit by using smokeless tobacco quit at least 10 years ago, compared to 11% of those who quit with the patch. In some ways this may make those quits on smokeless more impressive in that they are longer term quits, but it also serves to underline that in some ways these comparative figures are not comparing like with like. Smokers who quit 20-20 years ago may differ from those trying to quit in recent years, and memory for more distant events maybe less accuarate.

But overall, the biggest weakness of this study was the very small sample of participants who used smokeless tobacco in their quit attempt and then the inappropriate use of these very small numbers to estimate national numbers. Perhaps the main thing that can be concluded from this study report is that the vast majority of smoking cessation attempts in the United States do not involve the use of a proven smoking cessation aid, and a small but measurable proportion of smokers succeed in quitting smoking by switching to smokeless tobacco. If the NHIS survey uses similar questions in future it may be interesting to see how the pattern of use of smoking cessation aids changes over time.

I’d encourage smokers to use smoking cessation treatments that have been demonstrated to be safe and to increase your chances of success. These include counseling from a trained healthcare provider, nicotine replacement therapy, bupropion and varenicline.

The paper by Rodu and Philips is available at:
http://www.harmreductionjournal.com/content/5/1/18

Labels: cessation, cigarette smoking, comprehensice tobacco control, jonathan foulds, nicotine regulation reduction smoking smokeless

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Chantix safety at the US Veterans Affairs Health Service

The US Department of Veterans Affairs (which provides healthcare for people who have served in the US armed forces) yesterday issues a bulletin on safety issues with varenicline. In addition to covering some of the safety issues that have been discussed previously on this blog, it provided some data on adverse events within the VA.

The report stated that between September 2006 and April 30, 2008 there were a total of 147,718 prescriptions for varenicline (69,765 unique patients) within the VA. As of May 26 2008 , VA healthcare providers had submitted 417 reports on possible adverse events associated with varenicline. The most common type of adverse event was vomiting (95), followed by nightmares/abnormal dreams (82), depression (68), agitation (33), suicidal ideation (31) and hallucinations (25). Other adverse events were reported much less frequently.

So the overall rate of adverse event reports appears to be around 6 per thousand, of which almost half consist of vomiting, abnormal dreams and other non-life threatening symptoms that are recognized as rarely occurring side effects of the drug. Interpretation of the rates of the other (primarily psychological) symptoms needs to bare in mind that the VA healthcare system provides fairly comprehensive and accessible mental health services and the rates of mental health problems in VA patients is therefore known to be higher than in the general population. For example, one recent study found that 40% of male VA patients were suffering from a current mental health disorder.
http://ajp.psychiatryonline.org/cgi/content/full/156/12/1924

With this background, and an annual rate of suicide attempts of 1% among adult smokers, the numbers of patient being reported as suffering these adverse events in the VA system does not appear to be particularly high. One patient was known to have committed suicide in association with varenicline use, and although every case of suicide is tragic, one case in almost 70,000 patients in the VA system is almost certainly less than the background rate of suicide in the VA system among patients not using Chantix. I am not saying that Chantix may prevent these symptoms or behaviors. However, even after allowing for under-reporting of adverse events (which is normal), the frequency with which these events are being reported among Chantix users does not appear to be above the frequency that we would expect these types of events to be occurring in patients not using Chantix (in fact its much lower). What this means to me is that there is nothing in this new data that stands out as a clear signal that Chantix likely caused these events (other than perhaps vomiting and abnormal dreams, which are known to be increased by Chantix).

Of course it is very difficult to interpret adverse event reports, which are not necessarily recorded in a very systematic manner. The data we have so far suggest the following:

1. Prescribers should continue to use varenicline as one of the first-line medicines shown to help treat nicotine dependence.
2. Prescribers should make patients aware of the potential side effects, including the relatively frequent effects that have been shown to be caused by the drug (e.g. mild nausea in around 30% of patients), as well as the much less frequent symptoms that have not been proven to be caused by the drug (e.g. depression).
3. Providers should follow the US Public Health Service Guideline that recommends not only assisting smokers to quit by prescribing an effective medicine, but also arranging follow-up with patients to monitor progress and side-effects etc. Patients should also be told to notify their doctor immediately if they experience any serious side-effects between appointments.
4. Patients should continue to consider varenicline as a safe and effective treatment for nicotine dependence, but should be prepared to keep in contact with their healthcare provider and to report onset of unpleasant/serious symptoms to that provider if they occur.
5. Additional placebo-controlled trials in more typical patient samples should be carried out, to provide further high-quality data on efficacy and safety.

Labels: champix, Chantix, cigarette smoking, jonathan foulds, safety, varenicline

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Chantix (varenicline) Safety

Last week a report was released by an organization called the “Institute for Safe Medication Practices” (ISMP) which claimed to have safety concerns about Chantix (varenicline, also marketed as Champix outside the United States). The Executive Summary of the report made two main recommendations:

1. Chantix should be avoided or used with caution by persons operating aircraft, motor vehicles or other machines (e.g. power stations) where a lapse in alertness or motor control could have serious consequences.
2. Patients and doctors should excercise caution in the use of Chantix (generally) and “consider the use of alternative approaches to smoking cessation.”

Given that most of us drive a vehicle, the report is basically suggesting that varenicline is such an unsafe drug that it should be avoided. These are strong recommendations, and have immediately resulted in the Federal Aviation Authority (FAA) and Federal Motor Carrier Safety Administration (FMCSA) adding varenicline to their list of drugs that should not be used by pilots or truck drivers. The report itself has not been published in a peer-reviewed journal and so it is reasonable to assess the quality of the data on which it was based, and to evaluate whether the recommendations are warranted on the basis of that data.

The ISMP report was based on an analysis of the frequency and type of serious adverse events that have been reported to the US Food and Drug Administration (FDA) about Chantix, in comparison to other drugs. In particular, the report noted that by the 4th quarter of 2007 Chantix “accounted for more reports of serious adverse events in the United States than any other drug.” This amounted to 988 reports about Chantix in the 4th quarter, as compared with 372 (Oxycodone) to 640 (Interferon Beta) reports about the next 5 most reported drugs.

The report then selected a sample (3063) of the total reports (excluding foreign or unclear reports) for slightly more detailed analysis. It noted that a much larger proportion of the reports about Chantix came from consumers (57%) than is typical of other drugs (26%) for which health professionals are the predominant source. The report also noted that a lower proportion of the reports about Chantix (2.5%) reported deaths, as compared with 17% of reports about other drugs.

The report summarized the most frequent medical terms included in the reports about Chantix. By far the most common term used was nausea (593), which was more than twice as common as any other reported symptom. It was also noteable that among the most commonly reported medical symptoms mentioned in the adverse event reports, many are also recognized nicotine withdrawal symptoms (i.e symptoms known to increase when smokers quit smoking, particularly without any treatment medication), such as depression (287), insomnia (242), anxiety (217), and weight increase (141).

Problems with the ISMP report and its conclusions

There are a number of fundamental problems with the quality of the data, analysis and interpretation in the ISMP report. Before discussing some of these, it is worth discussing the way that reports of serious adverse events are delivered to the FDA. There are 4 main sources of reports.

1. Members of the public can send reports directly to FDA, either by mail or via an on-line reporting system (and I have provided the link on previous posts on this blog about Chantix to ensure that reports reach FDA).
2. Health professionals can report adverse events to FDA.
3. Lawyers sometimes report adverse events to FDA.
4. The manufacturer is required to report to FDA any reports that are brought to its attention directly. Those adverse events that are already mentioned on the product labeling are reported on a quarterly basis, and novel symptoms must be reported within 15 days (expedited).

Reports from the first 3 of these sources are entirely voluntary and are made in a rather haphazard way. The ISMP report estimated that typically between 1 and 10% of serious adverse events are actually reported to FDA. It is commonly found that AE reports peak around two years after the launch of a drug, even if the drug becomes used more often thereafter. The purpose of the FDA’s reporting and monitoring system is to facilitate post-marketing surveillance and enable detection of patterns of adverse events that could potentially be caused by a medicine but were not detected in the initial placebo-controlled trials leading to drug approval. The main point here is that these reports are not made in a systematic way, and the frequency of reports can be influenced by factors such as (a) the frequency of use of the drug (b) the novelty of the drug (c) media coverage of the drug and (d) efforts by the company to interact with users in a manner that will lead to them hearing of and therefore being required to report on AEs.

With these factors in mind, here are some of the problems with the ISMP report:

1. The report fails to consider the frequency of the use of the drug when considering the number of adverse events being reported. Since its launch in August 2006 (i.e. less than 2 years), Chantix has been used by an estimated 5.5 million smokers in the United States. In 2007 alone it was used by 3.8 million new patients in the U.S. (6.2 million prescriptions). This is many times more than the other drugs listed in the ISMP report. For example, Etanercept (Enbrel, the drug with the 3rd largest number of adverse event reports to FDA) was launched in 1998, and has been used by a total of 450,000 patients WORLDWIDE in those 10 years. Comparing frequency of adverse events without adjusting for the frequency of drug use is so obviously inappropriate as to cast doubt on the reliability of the report as a whole.
As mentioned briefly in the ISMP report, many factors can affect the frequency of reporting of adverse events to FDA. In the case of Chantix, the widely publicized death of a rock musician (who was tragically shot by a neighbor in Texas) which his partner felt could have been related to Chantix, sparked off widespread media speculation about potential side effects. The manufacturer also offers a number of direct to consumer quit smoking services, including a free telephone hotline called “Get Quit”. Because this hotline is run by the manufacturer, whenever a caller mentions a symptom, they are immediately transferred to the medical department, the details are noted and the information reported to FDA. These events and procedures can have a large effect of increasing the number of serious adverse events reported and this was not adequately considered in the ISMP report. It is noteworthy that 92% of the events analyzed in the ISMP report came via the manufacturer.

2. The report fails to adequately consider the possibility that some of the reported adverse events may have been caused by nicotine withdrawal. The vast majority of those using Chantix were attempting to quit smoking, which itself is known to cause a range of nicotine withdrawal symptoms, including many of the symptoms most commonly reported to FDA and mentioned in the ISMP report (depression, insomnia, anxiety, weight increase). It is entirely plausible that many of these reported symptoms were caused by nicotine withdrawal rather than Chantix. In fact in the placebo-controlled trials of Chantix, withdrawal symptoms were REDUCED in those using Chantix.

3. The report doesn't adequately consider the serious health effects of tobacco dependence. The ISMP report characterizes the other comparison drugs as being “intended for serious illness in patients and have benefits that are accompanied by substantial risks. In comparison, varenicline is intended for use in healthy people to help stop smoking.” Unfortunately this statement indicates a misunderstanding of the nature of tobacco dependence as a serious illness causing the premature death of 50% of continuing smokers, and of the fact that a high proportion of patients using smoking cessation medications are already suffering from or at very high risk for smoking-caused illnesses, including some mentioned as adverse events in the report (e.g. cardiac arrhythmias).

4. The report inaccuratley characterizes the relative efficacy of varenicline versus other treatments. The ISMP report states that Chantix has similar long term quit rates to nicotine gum. This statement contradicts the findings of the new US Public Health Service Clinical Practice Guideline on Treating Tobacco Use and Dependence, which found a mean quit rate of 13.8% with placebo, 19% with nicotine gum and 33.2% with varenicline (p109) and that quit rates with varenicline are significantly greater than with the nicotine patch (p121). This Guideline, written after the recent labeling changes for varenicline, concluded that, “Varenicline is an effective smoking cessation treatment that patients should be encouraged to use.” (p113).

Probably the most basic problem with the ISMP report is its failure to consider the frequency of use of the medicines as a factor influencing the interpretation of the frequency of adverse events reported. It therefore remains unclear whether any of these serious adverse events were caused by varenicline. When added to the other problems of interpretation mentioned above, I prefer to rely on the recommendation of the US Clinical Practice Guideline, which resulted from a very thorough review of the available scientific evidence.

So what does this mean for patients considering quitting smoking? As always, rely on the advice of your own doctor rather than on reports in the media or the internet (including this one!).

The complete ISMP report can be found at:
Strong Safety Signal Seen for New Varenicline Risks
http://www.ismp.org/docs/vareniclineStudy.asp

Previous posts on this blog that are relevant to this issue are:
What is nicotine withdrawal syndrome? 3/6/07http://www.healthline.com/blogs/smoking_cessation/2007/03/what-is-nicotine-withdrawal-syndrome.html
Ten tips for coping with nicotine withdrawal. 3/7/07http://www.healthline.com/blogs/smoking_cessation/2007/03/ten-tips-on-coping-with-tobacco.html
Chantix: how does this new stop smoking medicine work? 4/15/07http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
Can quitting smoking trigger depression? 6/16/07http://www.healthline.com/blogs/smoking_cessation/2007/06/can-quitting-smoking-trigger-depression.html
Chantix and mental illness. 08/12/07http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
Two new studies of Chantix (varenicline). 08/19/07http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
Does Chantix cause mental health problems? 9/20/07http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Chantix (varenicline) safety being reviewed by FDA. 11/21/07http://www.healthline.com/blogs/smoking_cessation/2007/11/chantix-varenicline-safety-being.html
New study of Chantix in comparison with NRT. 11/28/07http://www.healthline.com/blogs/smoking_cessation/2007/11/new-study-of-chantix-in-comparison-with.html
Smoking and suicide. 4/22/08 http://www.healthline.com/blogs/smoking_cessation/2008/04/smoking-and-suicide.html

Full reports on the largest placebo-controlled trials of varenicline can be found via:
http://jama.ama-assn.org/cgi/content/full/296/1/47

Labels: cessation, champix, Chantix, cigarette smoking, jonathan foulds, Nicotine Replacement, safety, varenicline

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