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Rapid Responses to:
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Electronic letters published:
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif){kind=icon}
Re: Evidence vs opinion
Evidence vs opinion
Re: Tobacco Dependence and Pharma Dependence
Tobacco Dependence and Pharma Dependence
Abjure
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Michael B. Steinberg, MD, MPH UMDNJ-Robert Wood Johnson Medical School
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michael.steinberg{at}umdnj.edu Michael B. Steinberg
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Tobacco dependence treatments should be covered in the same way as other medical treatments. I do not advocate that all smokers should be on medications for years. The overwhelming majority will only need the short -term treatment. However, for the minority who need longer-term therapy, this is preferential to smoking relapse. Dr. Fugh-Berman is a “staunch supporter” of evidence-based treatment. Her criticism of the US Public Health Service Clinical Practice Guidelines is that some of the reviewed studies have been industry sponsored and the review panel is “industry-friendly”. These Guidelines, considered the most comprehensive in the field, are based on more than 8,700 research articles and have been reviewed by a panel of 24 experts with the input of 81 external reviewers. Are some of these articles supported by pharmaceutical industry funds? Probably. Have some of these panel members received pharmaceutical support in the past? Probably. Does that negate the entire body of evidence? If we can base no clinical practice on these “tainted” Guidelines, then we are going to have a difficult time debating this issue. I fully support large, randomized clinical trials of tobacco treatment medication use for 1 year or longer. The reality is that it is unlikely that NIH or the drug companies will be funding these types of expensive trials in the near future. And even if we started those trials today, we would not have data for many years. How do we treat our patients today? As a practicing internist (like many readers of this publication) who will be seeing smokers desperately wanting to quit today, what do I do? If a smoker is doing very well on nicotine replacement, with no adverse effects and full relief of withdrawal symptoms, yet has reached week 12, but states clearly that if we stop his/her NRT, they will most likely return to smoking, do we stop the treatment because the clock has struck 12 weeks? Individualized duration of treatment for this and other medical conditions is the best practice and the ethical thing to do for these few smokers. As far as I know, there are no clinical trial data supporting the use of statins for 40 or more years. However, right now, my patients can have their cholesterol lowering medications continued indefinitely. Are smokers less worthy of treatment than non-smokers? I leave that question to public health policy makers and insurance companies. Conflict of Interest:Financial disclosure as stated in the original article. |
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Adriane J. Fugh-Berman, MD Georgetown University Medical Center, Douglas Melnick MD, MPH
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ajf29{at}georgetown.edu Adriane J. Fugh-Berman, et al.
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Dr. Steinberg's response to our letter neither addresses our point about pharmaceutical influence nor presents any evidence to support long-term off-label pharmaceutical smoking cessation therapies. Dr. Steinberg's invocation of alternative medicine for smoking cessation is odd, considering that the subject was not mentioned in his article, our response, nor Dr. Fugh-Berman's website. For the record, we are staunch supporters of evidence-based medicine, which is why we criticized Dr. Steinberg's article in the first place. Dr. Steinberg refers to recently published federal guidelines that do contain the industry-friendly, non-evidence-based notion that smoking is a chronic disease, and that smoking cessation medications should be used off-label for long-term treatment. However, an opinion printed in a national guideline does not make it evidence. The best thing that smokers can do for their health is to quit. There is evidence supporting the labeled claim that smoking cessation products, used short-term, can help some smokers quit. For those who relapse, the question of whether the benefits of long-term use of smoking cessation medications outweigh the risks has not been answered. A prudent and rational public health policy would require the companies that stand to profit from long-term use of these products to fund long-term efficacy and safety studies and apply for a labeled indication. Opinion, however passionately expressed and repeated, holds no sway over data. Conflict of Interest:Dr. Fugh-Berman has been a paid expert witness in litigation regarding pharmaceutical marketing practices. Dr. Fugh- Berman also directs PharmedOut.org, initially funded through the Attorney General Consumer and Prescriber Grant program. |
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Michael B Steinberg, MD, MPH UMDNJ-Robert Wood Johnson Medical School
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michael.steinberg{at}umdnj.edu Michael B Steinberg
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I respect Dr. Fugh-Berman’s difference in philosophy for treating tobacco dependence. In visiting her website, I found that she has published articles and books that suggest a belief in the effectiveness of herbal, complimentary, and alternative treatments. Unfortunately, in the field of tobacco dependence, the clinical trial-based evidence supporting the use of these alternative therapies is lacking. Moreover, the recent evidence-based 2008 US Public Health Service Guidelines recommend pharmacotherapy as a first-line treatment for tobacco dependence (1). These guidelines support the consideration of tobacco dependence as a chronic disease (page 15) and support the longer-term use of nicotine replacement therapy (page 119). In my opinion, the best evidence for helping our patients stop smoking continues to be any of the FDA approved medications as part of a comprehensive treatment program. In terms of duration, if I have a patient who is doing well on nicotine replacement therapy, varenicline, or bupropion for 6 months, yet states that they feel they will relapse to smoking if we stop the medication, I continue the medication to help keep that person from returning to smoking. In my view, it is not a matter of who is paying for that medication, but rather a matter of good clinical practice – the risk of smoking is much greater than the risk of the treatment. Do we count the days our hyperlipidemic patients are taking their cholesterol medications and criticize cardiologists for prescribing these medications for years? No, in fact, our healthcare system often provides incentives for physicians who meet clinical benchmarks like LDL levels. Why should we have a unique standard for treating smokers? On the contrary, if helping patients avoid the health dangers of smoking means they use nicotine replacement for longer than it "says on the box", we should do so. 1. Fiore MC, Jaén CR, Baker TB, Bailey WC, Benowitz NL, Curry SJ, et al. Treating Tobacco Use and Dependence: 2008 Update. Clinical Practice Guideline. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service. May 2008. Conflict of Interest:Research grant funding and consultancy from pharmaceutical companies as outlined in original article. |
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Adriane J Fugh-Berman, MD Georgetown University Medical Center, Douglas Melnick MD, MPH, North Hollywood CA
Send rapid response to journal:
ajf29{at}georgetown.edu Adriane J Fugh-Berman, et al.
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A recent commentary (1) in the Annals of Internal Medicine argues that tobacco dependence should be considered a medical disease, like asthma or diabetes. The authors recommend that the smoking habit deserves chronic disease status, and that chronic drug treatment, despite being an off- label use, should be reimbursed. Smokers should be encouraged and supported to quit smoking, with short- term pharmacological aids if necessary. Long-term use of products that have not been tested or approved for long-term use, however, is inconsistent with public health goals while being consistent with pharmaceutical marketing goals. We note that two authors of the commentary are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline (GSK), and Celtic Pharma. Pfizer makes varenecline (Chantix) and Nicotrol nasal spray. GSK makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (buproprion, also sold as Wellbutrin). Novartis makes Thrive, a nicotine chewing gum. Celtic Pharma is developing TA-NIC, a nicotine vaccine. Perhaps smoking cessation aids are being repositioned as long-term maintenance medications in order to expand the market. We think it a shame that Annals provided legitimacy to that goal by publishing the recent commentary. 1. Steinberg MB, Schmelzer AC, Richardson DL, Foulds J.The case for treating tobacco dependence as a chronic disease. Ann Intern Med. 2008 Apr 1;148(7):554-6. Conflict of Interest: Dr. Fugh-Berman has been a paid expert witness on the plaintiff’s side in litigation regarding pharmaceutical marketing practices. |
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Mark A. LaPorta, MD www.mymedicaladvocate.com
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laportama{at}pol.net Mark A. LaPorta
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This article is really a well-composed article that provides a profound example of why we -- Internists and our medical profession overall -- have lost respect. The main thing that chronic behavioral dysfunction per se and chronic physiological dysfunction have in common is that we must love the sick person unconditionally and try to do our best. That does NOT mean becoming co-dependent with them, encouraging one addiction to be replaced by another (if we can insist that they get funding). We stray so far from the direct treatment of a disease and then pretend to be noble instead of actually getting to the root of the problem. That makes us part of the problem. Imagine what healthcare (presently minimally about health and minimally about care) would cost if we actually boldy and bravely told the whole truth and nothing but the truth. |
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