FOR IMMEDIATE FREE RELEASE
Thursday, March 13, 2008
Charleston, South Carolina
Contact: John R. Polito
Boston University School of Public Health professor Michael Siegel today accused the 14th World Conference on Tobacco or Health of selling the scientific integrity of the global tobacco control movement to pharmaceutical influence. The conference is scheduled for Mumbai, India in March 2009. Its website indicates that Pfizer and GlaxoSmithKline, makers of a growing array of quit smoking "medicines" will serve as conference sponsors.
"How can you objectively discuss the population impact of NRT (nicotine replacement therapy) use at a conference sponsored by two of the leading nicotine replacement therapy drug companies," asks Dr. Michael Siegel, a preventive medicine physician who has been active in tobacco control for 20 years?
"How can you objectively discuss effective national strategies for smoking cessation," or "all aspects of individual and population-based approaches to helping people quit smoking at a conference sponsored by two of the leading nicotine replacement therapy drug companies." "You can't," he asserts.
There is growing awareness that while pharmaceutical quitting products consistently produce victories over placebo users in clinical trials, that those trials were not blind as claimed. Every cessation pharmacology product to date has fallen flat on its face in real-world use, and new evidence suggests that Champix and Chantix (varenicline) may be joining them.
"The drugs are approved because they've shown in FDA studies that they're better than placebo," says Dr. Edward Levin, a psychopharmacological researcher at Duke University Medical Center in Raleigh, N.C., as quoted yesterday in a CNN Money Chantix article. "But being better than placebo doesn't take a whole lot."
As early as 1984 the U.S. FDA was aware that the scientific foundation of clinical trials, placebo group comparisons, was shaky and in trouble. It was then that researchers resorted to the extreme of using small amounts of nicotine in placebo gum as a masking agent, a practice that continued in nicotine patch studies.
Could it be that drug addiction is the only pharmacology research area where comparisons with placebo control groups is actually a license to steal? Is it possible to hide from the average quitter the fact that placebo group assignment has thrown them into full-blown nicotine withdrawal, or hide active group assignment when chemically elevated dopamine output is providing a noticeable reduction in withdrawal intensity from prior quitting attempts?
While promising to double cessation rates, in October 2006 the CDC was forced to report that decline in the U.S. smoking rate had ground to a halt. Is cessation pharmacology actually undercutting worldwide cessation? Is toying with lengthy replacement nicotine weaning schemes actually costing smokers their lives?
Is it realistic to think that such concerns can be openly discussed and debated at a conference where those sponsoring the conference could potentially lose billions in profits if blinding concerns and real-world use findings were granted full and fair hearings?
Whether looking at National Cancer Institute survey data or data following smoking patients of Australian family practice physicians, real-world quitting method studies continue to find that those quitting "on their own" have higher long-term success rates than those using replacement nicotine or bupropion (Zyban).
Since September 11, 2002, industry consultants have countered with a wide range of theories and excuses that all miss one central point, that the continuing blanket marketing representation that these products will increase a smoker's chances of quitting is false.
"The preoccupation with nicotine replacement therapy, spurred on by the infusion of pharmaceutical dollars into the tobacco control field, is causing us to lose sight of the actual root of the problem: the addictive state itself," writes Dr. Siegel. "And that is a shame, because it may be severely hampering our efforts to help smokers quit."
A 2004 study by GlaxoSmithKline consultants found that, then, 37% of nicotine gum users were hooked on the cure. U.S. Presidential candidate Senator Barak Obama admits having been on nicotine gum for more than a year. During varenicline (Chantix/Champix) clinical trials the FDA permitted those who started using replacement nicotine after ending 12 weeks of varenicline use to be counted as successful varenicline quitters at long-term follow-up.
While replacement nicotine clearly poses far less health risk than smoking, it is just as obvious that those dependent upon it have not arrested their chemical dependency, and remain extremely vulnerable to returning to smoking.
Has the pharmaceutical industry invented a new definition of quitting, one that only refers to quitting one form of nicotine delivery, smoke? Why in nearly all clinical trials did it fail to examine nicotine levels in blood, urine or saliva of those declared to have successfully quit? Is the industry's lack of regard for whether a smoker arrests their chemical dependency closer to public health interests or those of the tobacco industry?
But concerns about taking our eye off the ball may be too late. At this moment the FDA is being petitioned to allow pharmaceutical nicotine to invade neighborhood convenience stores, to do open battle against tobacco, by being sold in daily-dose packs beside cigarettes.
While cleaner delivery and harm reduction make sense, intensifying an already ragging battle at the neighborhood candy, chip and soda store does not. Until now, youth were taught that NRT was for quitting. What consequences will flow when an ocean of NRT signs start screaming messages about fast, clean, safe, pleasure, flavor and taste? Should the initial experiment be upon an entire nation?
Are pharmaceutical industry chemical enslavement objectives really any different from the tobacco industry's? Is the 14th World Conference on Tobacco or Health being played like a fiddle?
A once secret 1972 R.J. Reynolds document states, "In a sense, the tobacco industry may be thought of as being a specialized, highly ritualized and stylized segment of the pharmaceutical industry. Tobacco products, uniquely, contain and deliver nicotine, a potent drug with a variety of physiological effects." "If nicotine is the sine qua non of tobacco products and tobacco products are recognized as being attractive dosage forms of nicotine, then it is logical to design our products -- and where possible, our advertising -- around nicotine delivery rather than "tar" delivery or flavor." "Hopefully, with time we will be able to develop sophisticated and improved minimum dosage forms for nicotine which will be more satisfying to the user and free of alleged health hazards."
"To prostitute oneself is defined as 'selling one's abilities, talent, or name for an unworthy purpose,'" writes Dr. Siegel. "By accepting Big Pharma money in order to fund its symposium, the World Conference on Tobacco OR Health, in my opinion, is selling its name for what I consider to be an unworthy purpose. The Conference is allowing itself to be used as a pharmaceutical marketing agent, simply to make money, when the over-reliance on pharmaceutical agents is in my opinion one of the main reasons why smoking cessation efforts and policies have been so ineffective."
No Copyright - This Article is Public Domain.
Last updated March 13, 2008 at 15:53 EST
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