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.
Demonizing the pharmaceutical industry has become a parlor game for many who enjoy the challenge of shooting at an oversized target. Scapegoating Big Pharma? Now, that takes guts.
Never mind the gazillions they spend on research and development to create tomorrow’s treatments for cancer, arthritis, depression, infectious diseases, heart attacks and strokes. I know that drug industry executives are not all eagle scouts whose mission is solely to save humanity. But, they are not an evil enemy that we need to contain like the “swine flu” pandemic. Sure, they make a profit, and they deserve to. Drugs cost multiple millions of dollars to develop, and most of them never make it to market. Those that do, after years of testing and F.D.A. review, can be summarily shut down when unexpected serious adverse reactions are suspected. In these cases, there may be no actual proof that the medicines were responsible for the ‘side effect’.
I’m not suggesting that we demand airtight proof before issuing drug warnings, only that we beware of what happens if drug company profits can be decimated with the stroke of a pen. Playing rough with the drug companies may appeal to our populist sensibilities, but it can go too far and stifle innovation.
Drug companies need the promise of large profits if they are to take the risks inherent in developing new and novel medicines for all of us. What other business would invest in a new product or technology without the potential for substantial financial gain? Before we advocate price controls for medicines or shortening intervals of patent protection, consider the side effects of this clumsy approach. If we hit Big Pharma too hard, then they will play it safe and churn out lots of drugs that we don’t really need.
Which would you rather they invest in? Another drug for heartburn that is no better than all the others on the shelf, or a vaccine to prevent cancer?
If they succeed in the latter endeavor, I hope they earn hundreds of millions of dollars. This will still be less than the number of lives they will save.
Michael Kirsch is a gastroenterologist who blogs at MD Whistleblower.
Senator Ted Kennedy’s death from brain cancer underscores the urgent need for more funding of basic cancer research. Despite the best efforts of a team of top doctors, Kennedy died 15 months after the diagnosis of a malignant brain tumor called glioblastoma. Over the past ten years, some progress has been made against this deadly illness and the silhouettes of some promising new approaches are becoming visible. But our treatment options remain woefully inadequate.
With over 560,000 cancer deaths each year, that comes to less than $10,000 in research spent for every cancer death. That simply is not enough money spent on a problem that strikes almost 1.5 million Americans each year and causes nearly one of four deaths.
Research for certain cancers is especially under funded. Earlier this year, I helplessly watched a dear friend and patient die from esophageal cancer, both of us knowing that only 22 million dollars each year – about $1,500 per death – was being spent by the NCI on the disease annually. One reason is that patients with esophageal cancer don’t have a strong advocacy group to push for their fair share of the funding pie. Lung cancer, which tops the list of cancer killers in America, only gets about $1,500 per death. At the top of the list based on research spending per death are cervical cancer (about $19,000), breast cancer (about $14,000) and brain cancer (about $12,000).
Click here for a chart that I compiled with the help of statisticians at the NCI that breaks down government spending on the top cancers.
Of course, there shouldn’t have to be a competition among cancer advocacy groups. There should be adequate funding of basic medical research to help discover the underlying cellular mechanisms that many cancers share and that hold the key to prevention, early diagnosis and effective treatment. But there’s not enough money for our young researchers. In 1980, almost 25 percent of first independent government grants went to scientists under age 35; that figure has plummeted to only 4 percent as the first-grant age rose from 34 to 42.
Faced with increasing competition for shrinking dollars, many of our best and brightest are considering other careers.
My cancer patients desperately need a bailout. The best way to increase our spending on cancer research responsibly is through health care reform. The Institute of Medicine has estimated that about 20 percent of the annual $2.5 trillion in health care costs is unnecessary. That’s $500 billion annually or 100 times the current budget of the National Cancer Institute. There could be no better tribute to Senator Kennedy or wiser investment in our own futures than to fix a broken system that threatens to bankrupt us while inadequately addressing one of our most devastating health problems.
For this week’s CBS Doc Dot Com, I take you behind the scenes to an edit bay at the CBS Broadcast Center in New York. I talk to Dr. Henry Friedman, an expert on brain cancer. He is co-deputy director of the Preston Robert Tisch Brain Tumor Center at Duke University Medical Center. In addition to hearing about the latest treatments for the disease, you’ll see the secret behind how we do long-distance interviews for the CBS Evening News with Katie Couric.
The individual in the photo is not displaying his newly acquired gold tooth bling, but rather something more precious: the first fully functioning 3D organ derived from stem cells, described in PNAS as “a successful fully functioning tooth replacement in an adult mouse achieved through the transplantation of bioengineered tooth germ into the alveolar bone in the lost tooth region.”
More from The Wall Street Journal:
Researchers used stem cells to grow a replacement tooth for an adult mouse, the first time scientists have developed a fully functioning three-dimensional organ replacement, according to a report in the Proceedings of the National Academy of Sciences. The researchers at the Tokyo University of Science created a set of cells that contained genetic instructions to build a tooth, and then implanted this “tooth germ” into the mouse’s empty tooth socket. The tooth grew out of the socket and through the gums, as a natural tooth would. Once the engineered tooth matured, after 11 weeks, it had a similar shape, hardness and response to pain or stress as a natural tooth, and worked equally well for chewing. The researchers suggested that using similar techniques in humans could restore function to patients with organ failure.
A study published in Alternative Therapies in Health and Medicineis being cited as evidence for the efficacy of healing touch (HT). It enrolled 237 subjects who were scheduled for coronary bypass, randomized them to receive HT, a visitor, or no treatment; and found that HT was associated with a greater decrease in anxiety and shorter hospital stays.
This study is a good example of what I have called “Tooth Fairy Science.” You can study how much money the Tooth Fairy leaves in different situations (first vs. last tooth, age of child, tooth in baggie vs. tooth wrapped in Kleenex, etc.), and your results can be replicable and statistically significant, and you can think you have learned something about the Tooth Fairy; but your results don’t mean what you think they do because you didn’t stop to find out whether the Tooth Fairy was real or whether some more mundane explanation (parents) might account for the phenomenon.
Theoretical underpinnings
According to the study’s introduction:
Healing touch is a biofield- or energy-based therapy that arose out of nursing in the early 1980s…HT aids relaxation and supports the body’s natural healing process, i.e., one’s ability to self-balance and self-heal.” This noninvasive technique involves (1) intention (such as the practitioner centering with the deep, gentle, conscious breath) and (2) placement of hands in specific patterns or sequences either on the body or above it. At its core, the theoretical basis of the work is that a human being is a multi-dimensional energy system (including consciousness) that can be affected by another to promote well-being.
They cite a number of references to theorists who support these ideas. They cite Ochsman; he wrote a book Energy Medicine: The Scientific Basiswhich I reviewed, showing that despite the book’s title, there is no credible scientific basis and the “evidence” he presents cannot be taken seriously.
They cite Candace Pert, who said in the foreword to Ochsman’s book that Dr. Oschman “pulled” some energy away from her “stagnant” liver. She said the body is “a liquid crystal under tension capable of vibrating at a number of frequencies, some in the range of visible light,” with “different emotional states, each with a predominant peptide ligand-induced ‘tone’ as an energetic pattern which propagates throughout the bodymind.” Does this even mean anything?
They even cite the PEAR study, suggesting that it is still ongoing (it isn’t) and claiming it shows that “actions in one system can potentially influence actions of another on a quantum energetic level.” (It didn’t.)
This is nothing but imaginative speculation based on a misunderstanding of quantum physics and of what physicists mean by “energy.” It is a truism that electromagnetic phenomena are widespread in the human body, but there is a giant gap between that and the idea that a nurse with intention and hand movements can influence electrical, magnetic, or any other physical processes in the body to promote healing. There is no evidence for the alleged “human biofield.”
Previous Research
They cite several randomized controlled studies of HT over the last few years. One showed “better health-related quality of life” in cancer patients. One, the Post-White study, showed no difference between HT and massage. One small study by Ziembroski et al. that I couldn’t find in PubMed apparently showed no significant difference between HT and standard care for hospice patients. One study showed that HT raised secretory IgA concentrations, lowered stress perceptions and relieved pain, and results were greater with more experienced practitioners; but it only compared HT to no treatment and didn’t use any placebo treatment. A pilot study compared 4 noetic therapies-stress relaxation, imagery, touch therapy, and prayer, and found no difference.
A larger study showed that neither touch therapy nor masked prayer significantly improved clinical outcome after elective catheterisation or percutaneous coronary intervention.
They cite a review of healing touch studies by Wardell and Weymouth It concluded “Over 30 studies have been conducted with healing touch as the independent variable. Although no generalizable results were found, a foundation exists for further research to test its benefits.” Wardell noted that “the question has been raised whether the field of energy research readily lends itself to traditional scientific analysis due to coexisting paradoxical findings.” This is a common excuse of true believers who find that science is not cooperative in validating their beliefs.
Study Design
237 patients undergoing first-time elective coronary artery bypass surgery were randomly assigned to one of 3 groups: an HT group, a visitor group, and a standard care group. All received the same standard care from the hospital. The HT group received preoperative HT education and 3 HT interventions. Practitioners established a relationship with their patients, assessed their energy fields, and performed a variety of HT techniques based on their assessment, including techniques that involved light touch and those that involved no touch (practitioners’ hands held above body). Sessions lasted 20 to 90 minutes; each patient had the same practitioner throughout the study. The “visitor” group patients were visited by a nurse on the same schedule. The visits consisted of general conversation or the visitor remaining quietly in the room with the patient. They mentioned that some visits were shortened at the patient’s request.
Results of the Study
The six outcome measures were postoperative length of stay, incidence of postoperative atrial fibrillation, use of anti-emetic medication, amount of narcotic pain medication, functional status, and anxiety. HT had no effect on atrial fibrillation, anti-emetics, narcotics, or functional status. The only significant differences were for anxiety scores and length of stay. The length of stay for the HT group was 6.9 days, for the visitor group 7.7 days, and for the routine care group 7.2 days, suggesting that the simple presence of a visitor made things worse(!?). Curiously, for the subgroup of inpatients, the length of stay was HT 7.4 days, visitor 7.7 days and routine care 6.8 days, which was non-significant at p=0.26 and suggested that both HT and visitor made things worse.
The mean decreases in anxiety scores were HT 6.3, visitor 5.8, and control 1.8. They said this was significant at the p=0.01 level. But the tables for results broken down by inpatient and outpatient show no significant differences (p=0.32 for outpatients and p=0.10 for inpatients). If it was not significantly different for either subgroup, how could it be significant for the combined group?
These discrepancies are confusing. They suggest that the significant differences found were due to chance rather than to any real effect of HT..
Problems with this Study
Four out of the six outcomes were negative: there was no change in the use of pain medication, anti-emetic medication, incidence of atrial fibrillation, or functional status. The only two outcomes that were significant were hospital stay and anxiety, and these results are problematic and might have other explanations.
It is impossible to interpret what the difference in length of stay means, because they did not record the reasons for delaying discharge. As far as we can tell from the paper, the doctors deciding when to discharge a patient were not blinded as to which study group the patient was in. It’s interesting that the visitor group length of stay was intermediate in the outpatient subgroup, but higher than control for the combined inpatient/outpatient group. They offer no explanation for this. I was puzzled by the bar graph showing these numbers, because the numbers on the graph don’t seem to match the numbers in the text. The numbers were manipulated: they did a logarithm transformation for length of stay “to handle the skewness of the raw data.” I don’t understand that and can’t comment. The range of hospital days is such that the confidence intervals largely overlap. In all, these data are not very robust or convincing and they raise questions.
They interpret the anxiety reduction scores (HT 6.3, visitor 5.8, and control 1.8) as showing a significant efficacy of HT, but it seems more compatible with a placebo response and a slightly better response for the more elaborate placebo.
There were fewer patients (63) in the visitor group than in the HT and control groups (87 each). This was not explained. The comparison of groups appears to show that the control group had significantly higher pre-op anxiety scores than either of the other groups, which would tend to skew the results
They didn’t use a credible control group. A visitor sitting in the room can’t be compared to a charismatic touchy-feely hand-waving practitioner. Other studies have used mock HT where the hand movements were not accompanied by healing thoughts. These researchers rejected that approach because they didn’t think it would be ethical to offer a sham procedure where the practitioner only “pretended” to help. Hmm… One could argue that they have provided no evidence that HT practitioners are ever doing anything more than pretending to help.
They don’t comment on how practitioners were able to “assess the energy fields” of their patients. Emily Rosa’s landmark study showed that practitioners who claimed to be able to sense those fields couldn’t.
The authors consist of 3 RNs (2 of them listed as healing touch therapists and presumably the ones who provided treatment in the study), a statistician with an MS, and two “directors of research” for whom no degrees are listed. The authors are clearly prejudiced in favor of HT.
They interpret this study as supporting the efficacy of HT. I don’t think it does that. I think the results are entirely compatible with a placebo response. With any made-up intervention presented with strong suggestion, one could expect to find one or two statistically significant differences when multiple endpoints are evaluated. And the magnitude of the improvement here is far from robust. This is the kind of result that tends to diminish in magnitude or vanish when better controls are used. I think the study is Tooth Fairy science, purporting to study the effects of a non-existent phenomenon, but actually only demonstrating a placebo response.
I wonder if better results might be obtained by having a patient advocate stay with the patient and offer reassurance, explanations, massage and other comfort measures – something like the doulas who have been shown to improve childbirth outcomes.
The frightening thing is that during the course of this study, patients increasingly bought into the HT belief system and refused to sign up for the study because they wanted HT and didn’t want to risk being assigned to a control group. And hospital staff bought into the belief system, were treated themselves, and became proponents of offering it to patients for other indications.
The paper ends with a rather incoherent statement one would not expect to find in a scientific medical journal: “At the very heart of this study is the movement toward recognizing that the metaphoric and physical heart are both very real, if we allow them to be.”
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