Cold Turkey Trounces Pharmacology in GlaxoSmithKline Quitting Study
New study finds that the odds of unplanned quit smoking attempts having long term success are 2.6 times higher than for planned attempts.
GlaxoSmithKline (GSK) surely hoped that the study it funded of 900 smokers and 800 ex-smokers, a study conducted by four of its consultants, would show that smokers who engaged in planning prior to quitting, planning that involved heavy reliance on its quitting products, would perform better than those quitting without any planning whatsoever. The logic seemed compelling. But like President Obama's inability to control smoking while using Nicorette, GSK discovered that unlike in placebo controlled clinical trials, it cannot manipulate or control real-world results.
The study, published in the just released issue of Nicotine & Tobacco Research, asked ex-smokers via email when they had quit. It asked smokers details about their most recent attempt, if any. It asked both groups if, when and the degree to which their most recent attempt was planned (choices included no planning, same day planning, the day before, a few days before, a few weeks before, a few months before, other, or I can't remember). Any pre-quit planning at all was classified as a planned attempt. All quitters were also asked about use of quitting pharmacology products.
The study describes the results as "puzzling." They compel GSK to admit that the odds of spontaneous quitting attempts succeeding are more than double (2.6) pre-planned attempts. But from GSK's perspective, it's worse. Rates of use of quitting pharmacology products such as the nicotine patch, gum and lozenge were nearly four times greater among those who planned their attempt and roughly 90% of unplanned attempts were made by cold turkey quitters.
"These results support the conclusion that cold turkey cessation remains the most effective means of quitting smoking," wrote Dr. Michael Siegel, a physician and professor at Boston University School of Public Health, in his online blog entitled, The Rest of the Story" "Cessation attempts that involve pharmacotherapy are substantially less likely to be successful than quit attempts that do not involve the use of pharmacotherapy."
Dr. Siegel's cold turkey superiority claim is supported by nearly every real-world quitting method survey ever published. It's evidence that GSK and its consultants have worked hard over the years to discredit and suppress. Cold turkey's most notable recent victories include a 2006 unpublished U.S. National Cancer Institute Survey of 8,200 quitters (a study featured in the Wall Street Journal at Page A1 on February 8, 2007) and a 2006 Australian survey which not only found cold turkey twice as effective as pharmacology among patients of 1,000 family practice physicians but that cold turkey accounted for a whopping 88% of all long-term successful quitters.
What appears to have outraged Dr. Siegel is that the GSK study's conclusion has nothing to do with the study's findings. It states that, "The results suggest, similar to previous research, that a substantial proportion of quit attempts are unplanned and that such attempts can be a successful route to cessation. Given the frequency of such attempts, methods of making treatment available to assist unplanned quitting should be considered."
"Treatment" is the industry code word for its quitting products. How could any attempt be considered "unplanned" if the industry's new objective is to find "methods" to interfere with and compel cold turkey quitters to adopt the very methods of those it defeated?
"When I read this paper," wrote Dr. Siegel, "I found the conclusion particularly odd. The findings of the study were that planned quit attempts are not the way to go, and that the use of pharmacotherapy is not particularly effective on a population level." "But the major conclusion of the study was that methods of making pharmacotherapy available to those making unplanned quit attempts be developed."
"I teach my students that in a scientific manuscript, the conclusion of the paper should follow directly from the study findings. And the conclusion should not be one that could have been made in the absence of the study findings. In other words, the conclusion should be directly related to the study findings," he wrote.
"In this case, the conclusion has no direct relationship to the study findings. It does not follow at all from the findings. Those findings do nothing to support the conclusion. In fact, if anything, the study findings are at odds with the conclusion."
"The assertion that pharmaceuticals be made available to smokers making spontaneous quit attempts is one which is based on a particular opinion, not one that is based on any specific findings of this study," he wrote. "In fact, such a conclusion could have been asserted prior to even beginning the study. This research did not even test the effectiveness of the use of pharmacotherapy in unplanned quit attempts. There is no evidence presented that pharmacotherapy would be effective in aiding such quit attempts. In fact, it is perfectly plausible that pharmacotherapy would hinder such quit attempts as it would keep the smoker addicted to nicotine while a large proportion of these smokers are getting themselves off of nicotine entirely."
President Obama, hooked on nicotine gum for 28 months, is a poster child for why quitters who plan their attempts would be wise to shy away from GSK's nicotine replacement products. GSK's nicotine "medicine," "therapy" and advice has so messed up our President's thinking that at his last White House news conference he declared himself "95% cured." The media laughed.
Dr. Siegel reviews the authors' substantial financial ties to cessation pharmacology, as disclosed in the study. "The pharmaceutical funding of the study and of its authors has created an exceptionally strong bias that is leading to the study pushing drugs when it should probably be doing just the opposite: pushing cold turkey quit attempts without the use of pharmacotherapy," he wrote.
"This is an excellent example of the way in which financial conflicts of interest create significant bias in scientific studies and lead to biased conclusions that do not fairly and objectively present and interpret the scientific findings of a particular study and the overall literature on the topic. The bias is most readily apparent in the recommendations that are made in the study, which do not follow directly from the study findings, but instead, serve the interests of the study sponsor and the financial interests of the investigators."
"Here is what I consider to be a beautifully conducted, insightful study that brilliantly examines a major research question and makes a huge and rather earth-shaking contribution to the existing literature on smoking cessation," he writes. "However, what is the conclusion that comes from the study? Merely that the products made by a company with which the authors have a financial conflict of interest be marketed to the smokers who are currently having the most success without pharmaceuticals."
U.S. Quitting Policy Bans Cold Turkey Quitting
But that is exactly what the industry has striven hard to bring about. In June 2000. a panel of "experts" on which 11 of 18 members were pharmaceutical industry consultants, was allowed to author official U.S. smoking cessation policy. Not surprisingly the panel effectively destroyed all state and federal support for cold turkey quitters and quitting by requiring that all U.S. quitters be encouraged to purchase and use cessation pharmacology products, unless it posed risks to their health.
The Bush administration's parting gift to the pharmaceutical industry was allowing another panel of experts, which included nearly all members from the 2000 panel, to revise U.S. quitting policy. The May 2008 Clinical Practice Guideline for Treating Tobacco Use and Dependence added Pfizer's newest quitting product, Chantix, to the list of mandatory quitting product options.
The wording of the May 2008 provision that consumes all other quitting methods and effectively destroys any attempt to support, counsel or assist cold turkey quitters reads:
"Numerous effective medications are available for tobacco dependence, and clinicians should encourage their use by all patients attempting to quit smoking - except when medically contraindicated or with specific populations for which there is insufficient evidence of effectiveness (i.e., pregnant women, smokeless tobacco users, light smokers, and adolescents)."
It was hoped that the Obama Administration's pledge to ensure that science will be driven by facts, not profits, extended to U.S. cessation policy. But since 2000, decline in the U.S. nicotine addiction rate has stalled, while our government continues to effectively outlaw our nation's most effective and productive quitting method, in favor of enriching the pharmaceutical industry.
Why do cessation pharmacology products continue to double placebo user quitting rates inside clinical trials yet fail so miserably against cold turkey quitters in real-world competition? It's simple. The clinical trial's alleged scientific foundation, that researchers were somehow able to blind study participants to whether or not they had been assigned to the pharmacology group or to a group using an inert placebo product, is a farce and sham. Multiple studies now show that roughly 3.3 times as many participants can correctly identify their treatment assignment than cannot.
Nicotine addicts with prior quitting histories are skilled in recognizing both the presence and absence of full-blown withdrawal. Clinical trials did not measure product efficacy. They measured the fulfillment and frustration of participant expectations.
If you were a nicotine addict hoping to receive a free three month supply of expensive replacement nicotine, would you have stuck around and allowed researchers to toy with you if you realized that you'd been given placebos instead? Neither did they.
Now that GSK' own research suggests that President Obama would be wise to immediately jump into the quitting pool without pharmacology, how much longer will it take before the President issues an executive order suspending current U.S. quitting policy, ordering an investigation into the validity of using placebo controls in drug addiction studies, and orders all U.S. health agencies to immediately begin offering encouragement and support to quitters trusting their natural instincts and attempting to abruptly end all nicotine use?
As Dr. Siegel puts it, "God forbid that a smoker succeed in quitting without providing profits to Big Pharma." Hopefully President Obama, even though still slave to nicotine himself, has the wisdom to see the light.
Last updated July 9, 2009 at 1015 EST
Ask President Obama to Revoke the Ban on Cold Turkey Quitting
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Dear Mr. President:
I write imploring you to issue an executive order requiring the federal government to immediately end all support, counseling and assistance discrimination against America's cold turkey quitters. As you know, since June 2000 U.S. cessation policy, authored by panels having strong pharmaceutical industry financial ties, has required all quitters to purchase and use pharmacology. It makes no sense. Nearly 90% of successful long-term ex-smokers quit smoking cold turkey, and cold turkey continues to prevail in nearly all real-world quitting method surveys.
I also ask that you investigate the validity of the claimed "science-based" foundation of nearly all pharmacology clinical trials - the heavy use of placebo controls, which violates the World Medical Association's Declaration of Helsinki. Principle 32 commands that the "benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention" and that placebos should not be used unless "compelling and scientifically sound methodological reasons" are demonstrated.
Mr. President, as to the scientific validity of placebo use, as you yourself must be aware, you cannot hide the presence or absence of full-blown withdrawal from any smoker with a significant quitting history. I'm deeply concerned that science has been intentionally manipulated for the sake of profits, with the result that untold thousands of smokers have needlessly suffered numerous pharmacology relapses, have been deprived of breaking free, have continued to be subjected to risks of tobacco related diseases, and were eventually claimed by them.
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