Request for honest smoking cessation research and policy

Dear Secretary Sebelius:


Six million Americans filled 12 million prescriptions for the stop smoking pill Chantix since its release in May 2006. Pfizer boasts a 44% Chantix success rate. According to the Centers for Disease Control (CDC), there were 36.3 million daily smokers in 2006. The CDC reported in November 2009 that there were 36.7 million daily smokers in 2008, and that the adult smoking rate actually increased from 20% to 21% over the prior year.


This is despite 45% of current smokers making a serious quitting attempt of at least one day during the prior year, significant increases in the cost of cigarettes, fewer lawful places to smoke, and despite the CDC's assertion of smoking "killing more than 443,000 people every year." Also factor in those quitters who believed in nicotine replacement therapy (NRT) and its unkept marketing promise to "double" their chances.


U.S. stop smoking policy is utter chaos. Flawed and profits driven smoking cessation research is primarily to blame for the quitter's current cycle of trying, failing and dying. The U.S. Department of Health and Human Services (HHS) shares culpability for making sham and defective research the cornerstone of national quitting policy.


As you know, 70% of stop smoking studies are conducted in the U.S and their influence is felt worldwide. Madam Secretary, I join in asking that you make honesty, integrity and science the hallmarks of HHS cessation research and policy.


Since 2000, decline in U.S. smoking has remained stalled at 46 million smokers. It was then that HHS allowed pharmaceutical industry influence to write official U.S. cessation policy. One policy provision swallows all others. "Recommendation 6" reads, "Numerous effective medications are available for tobacco dependence, and clinicians should encourage their use by all patients attempting to quit smoking."


A stroke of corporate genius, it effectively destroyed the credibility and funding of all stop smoking programs designed to help quitters end nicotine use. Programs were instead compelled to recommend use of replacement nicotine or other chemicals that mimic nicotine's dopamine stimulating effects. It forced thousands of HHS employees to turn their backs on the 80-90% of quitters who trusted their natural instincts and attempted to end nicotine use, instead of replace it.


"Recommendation 6" effectively buried the most critical quitting lesson of all, that any nicotine use when quitting, even one puff, almost always results in relapse. It muddied natural learning with the false lessons that nicotine is "medicine," its use "therapy," and that few succeed in quitting without it. Still, more than two decades later, roughly 90% of long-term ex-smokers quit and remain quit without using pharmacology products.


The quitter's trying, failing and dying cycle is happening during an era when pharmacology quitting products routinely double placebo performance inside randomized clinical trials, yet fall flat on their face in real-world competition against real cold turkey quitters (most recently: 2009 GlaxoSmithKline survey; a 2007 UK NHS survey, see Table 6; a 2006 National Cancer Institute survey; a 2006 general practice patient survey; and a 2005 study of UK NHS quitters, see Table 6). But how?


More than 300 placebo-controlled quitting trials reflect the most deadly science sham ever. Placebo is not a real quitting method and is not cold turkey. There is consensus that placebo-controlled quitting trials were not blind as claimed. Common sense screams that it is impossible to hide the onset or absence of full-blown withdrawal from nicotine addicts with significant quitting histories. They know exactly how it feels.


How bad is it? A 2009 nicotine patch study by the patch's co-inventor found that "of 165 subjects receiving placebo patches, 27 believed they had received active patches, 112 believed they had not, and 26 were unsure."


Researchers entice smokers to join studies by dangling the prospect of receiving weeks or months of free "medicine." If within 24 to 48 hours of quitting, four times as many participants can correctly determine their randomized assignment as cannot, then clinical trials measure frustrations, not product effectiveness or efficacy.


Official U.S. quitting policy openly acknowledges that placebo blinding failures "should be borne in mind when appraising" study evidence. But a just released patch plus lozenge study, co-authored by the chairman and father of U.S. policy, doesn't once comment on the study's blinding integrity. If pharmacology studies are not rooted in science then why pretend they are?


Madam Secretary, Principle 32 of the World Medical Association's Declaration of Helsinki, on the "Ethical Principles for Medical Research Involving Human Subjects" states: "The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances: The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists."


Following Principle 32 would save lives and compel honest study competition. Guideline "Recommendation 5" identifies counseling as a proven intervention. It states, "Two components of counseling are especially effective and clinicians should use these when counseling patients making a quit attempt: practical counseling (problem-solving/skills training) and social support."


The problem is that counseling "Recommendation 5" is totally consumed by pharmacology "Recommendation 6."


Quitting product performance must not be measured against placebo but against effective counseling and support. Counseling's timing, intensity and objective should be to enable quitters to navigate the first three critical days of nicotine cessation, and move beyond peak withdrawal anxieties to the gradually increasing calmness beyond.


Secretary Sebelius, use of placebo controls in drug addiction studies is license to rob, defeat and kill. I encourage HHS to suspend "Recommendation 6" and immediately offer non-pharmacology quitters quality counseling and support. I encourage HHS to adopt the World Medical Association's research ethics principles, to require pharmacology to prove itself against counseling and support, and when doing so to carefully monitor and scrutinize counseling's substantive content within clinical trials to ensure that it is tailored to support successful nicotine cessation, not defeat it.


Madam Secretary, it will take courage and leadership to stand up to pharmaceutical industry financial influence and put the freedom, health and life expectancy of smokers first. I have every confidence that you are up to the task.


Sincerely,