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Know that NO pharmaceutical trial follows whether patients smoke during their trials, despite dosing themselves approximately 17 times per day with a cigarettes – with over 4000 chemicals in them. Yet, they follow with close detail, every other drug that the patients take.

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gdpawel, that is an interesting observation. I'd never thought about it, but you are right. Inhalation is a very effective method of drug delivery. The inhaled toxins go directly into the circulation, so the capacity to interact with other drugs is enhanced.

I gave a speech yesterday about my research, and I always preface it with a little info about tobacco and the lung cancer stigma. I was looking for literature and came across this document dated Jan. 4, 1954: http://www.tobacco.org/History/540104frank.html

They were aggressively protecting their pocketbooks 50 years ago.

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A medical friend in lung cancer research told me that in reviewing a recent artilce about in vitro work, the addition of nicotine inhibited the ability of etoposide to induce apoptosis by 61%. She thought that it would seem to her that if a drug, like nicotine, which occurs in the highest concentration of any drug in a cigarette, would inhibit the ability of a major chemotherapeutic drug by 61%, a medical oncologist would care if it was being ingested during treatment!!! An editorial on this exact subject should be coming out sometime in April. I sent her that article you posted. She was very appreciative of it.


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  • 9 months later...

Smoking, The Missing Drug Interaction in Clinical Trials: Ignoring the Obvious

Ellen R. Gritz,1 Carolyn Dresler,2 and Linda Sarna3

Department of Behavioral Science, The University of Texas M.D. Anderson Cancer Center, Houston, Texas; 2Tobacco and Cancer Group, IARC, Lyon, France; and 3School of Nursing, University of California-Los Angeles, Los Angeles, California


Tobacco use is universally recognized as the foremost preventable cause of cancer in the United States and globally and is responsible for 30% of all cancer-related deaths in the United States. Tobacco use, including exposure to secondhand smoke has been implicated as a

causal or contributory agent in an ever-expanding list of cancers, including lung, oral cavity and pharynx, pancreas, liver, kidney, ureter, urinary bladder, uterine cervix, and myeloid leukemia. In addition to and independent of the etiologic effects of tobacco carcinogens in numerous cancers, there is a growing literature on the direct and indirect effects of smoking on treatment efficacy (short-term and long-term outcomes), toxicity and morbidity, quality of life (QOL), recurrence, second primary tumors (SPT), and survival time.

Oncology health professionals have called for increased advocacy for tobacco control. Despite the critical relevance of smoking to cancer

outcomes, most oncology clinical trials do not collect data on smoking history and status unless the malignancy is widely acknowledged as smoking related (e.g., lung or head and neck cancer). Usually, these data are collected only at trial registration. Changes in smoking status during treatment or follow-up are monitored in very few trials and are infrequently reported in sample descriptions or included in analysis plans as a potential moderator of outcomes. Based on mounting evidence that tobacco use affects cancer treatment outcomes and survival, we recommend that smoking history and status be systematically collected as core data in all oncology clinical trials: at diagnosis, at trial registration, and throughout treatment and follow-up to long-term survival or death. We feel that the inclusion and analysis of such data in clinical trials will add important information to the interpretation of outcomes and the development of scientific knowledge in this area.

Smoking status has been called another ‘‘vital sign’’ because of its relevance to a patient’s immediate medical condition. We explain the critical value of knowing the smoking status of every patient with cancer at every visit by providing a brief overview of the following research findings: (a) the effects of tobacco use on cancer treatment and outcome; (B) recent findings on the role of nicotine in malignant processes; © some unexpected results concerning tobacco status, treatment, and disease outcome; and (d) identifying key questions that remain to be addressed. We provide a suggested set of items for inclusion in clinical trial data sets that also are useful in clinical practice

(Cancer Epidemiol Biomarkers Prev 2005;14(10):2287–93)


We can no longer ignore the obvious: smoking is a critical variable that affects cancer treatment and outcome and has been shown to vitiate or interact with the effects of some therapeutic agents and chemopreventive agents. Measurement of smoking history and status in clinical trials of cancer therapy will increase our knowledge of the adverse effects of the constituents of tobacco smoke, including nicotine, and of drug interactions.

Oncology health professionals have called for increased advocacy for tobacco control. Furthermore, the routine inclusion of smoking status and cessation need to become a standard of care for all patients. The inclusion of smoking data in oncology clinical trials will also provide clinicians with improved means of delivering individualized advice to patients with cancer that may be critical in motivating their cessation efforts and sustained abstinence.

Scientific, financial, and clinical support is critical to this goal. The failure to date to assess, analyze, and report smoking status has limited our ability to investigate the effect of smoking on treatment efficacy and outcome. The time has come to integrate data about the single most important lifestyle risk factor in cancer prevention into cancer treatment and survivorship trials.

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