GLOBALink Gallery Books Calendar Documents Petitions Join Help
International Letter Campaigns for Tobacco Control

Request for honest smoking cessation research and policy
Target :
The Honorable Kathleen Sebelius Secretary of Health and Human Services 200 Independence Avenue, S.W. Room 615-F Washington, DC 20201

Sponsor :
John R. Polito, Nicotine Cessation Educator /

Context :
The world's smokers are trapped in a vicious cycle of attempting to quit, repeatedly failing and then dying prematurely. Stop smoking findings from placebo-controlled NRT, Zyban and Chantix clinical trials are not being realized in real-world use. Randomized trials were not blind as claimed. Experienced quitters are experienced at recognizing withdrawal. World Medical Association study ethics forbid placebo use when a proven intervention exists. There is consensus that counseling is a proven intervention. Although the vast majority of quit smoking studies are conducted in the U.S. their influence is felt worldwide. This petition is directed at the senior U.S. health official, the Secretary of Health and Human Services. It asks her to restore honesty, integrity and science to studies and policy by prohibiting use of placebo controls in government-backed studies, to replace it with counseling, to suspend current quitting policy requiring all quitters to buy and use pharmacology products, and to begin offering counseling and support to smokers attempting to quit without pharmacology products.

Subject of your message :
Request for honest smoking cessation research and policy

Message :
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.


Signature :
Name :
Organization :
Email address : (hidden)
Country :
Past signatories (228 signatures)
Melanie Lilwall, 2years and doing great! (United States)
Melanie Lilwall, 2years and doing great! (United States)
Hafiz, Rahman (United States)
Kyle Walker (United States)
Daniel Catana (Romania)
Daniel Catana (Romania)
Daniel Catana (Romania)
John Farren, Almost 2 years Cold Turkey with the help of whyquit!!!!!! (United Kingdom)
Kelly Almanzar (United States)
S.Cyril Alexander, Mary Anne Charity Trust (MACT) (India)
G Nicholson, - 1 month cold turkey and feeling great! (United Kingdom)
Shelia McIntyre (United States)
Thomas G. Hartley (United States)
Gary Peter Arnold (United States)
Kathryn Hayes (United States)
Donald Cotter, <------ Don't think I would have quit without it! (United States)
Sandra Clover, quit almost 1 year ago (United States)
Connie Pilgrim (Canada)
amanda stevens, gave me the knowledge I needed to quit cold turkey 2yrs ago (United States)
Ian Cowper, Finally Quit, cold turkey with help from (tried everything else) (United Kingdom)
Patricia Clark (United States)
Talaferrio Tucker, crimestoryMusic (United States)
Daniel du Toit, (South Africa)
Theresa cold turkey - 6 months , How? Will power and Why (Canada)
James Jacks (United States)
ellie tuck (United States)
CCURTIS (United States)
Larry Myers (United States)
Larry Myers (United States)
Rob McGurk, Going to give my girls away at their wedding (Australia)
Manojava DONEKAL (Ireland)
David Reynolds, No smokes today (Ireland)
Eric Wickham, WhyQuit (United States)
Ronald Ellingsen (United States)
Sheri Hundley (United States)
Roger Faires, self (United States)
Martina Saurin (Ireland)
Martina Saurin (Israel)
chris bloomfield (United Kingdom)
Kevin Klebs (United States)
Linda Gerek, Quit cold turkey 60 hrs ago. (United States)
Sigrid Cousineau, WhyQuit (United States)
Monique Clifton (United States)
Florin Adrian Marginean, quit cold turkey 1 mounth, 25 days ago (Romania)
Charles Attias, Quit 8 months ago cold turkey, thanks whyquit (Canada)
Charles J McNulty, supporter - nothing else works!! (United Kingdom)
Laura Mullen (United States)
Ernest J Beaumont (United States)
Ashwin Mehra, I quit cold turkey more than 4 years ago at the age of 29. All I needed was, no patches, meds, nothing.. (United States)
larry bridges (Canada)
Robert Sliger, Cold Turkey - 3 days > Used Chantix for 6 months :( (United States)
Kate Katje (United States)
Zakir Shah (Pakistan)
Anthony Antinora, 2 months Cold Turkey (5 times further than w/ nicorette) (United States)
vivienne kenny (Ireland)
Tim Burdett (United States)
Prashanth c Edwards, Royal Bank of Scotland (United Kingdom)
Ron Bacon (United States)
Tina Paljusaj (United States)
ujjwal saha, independent (India)
Cheryl Reichhart, Why Quit (United States)
James, quit cold turkey after viewing (United States)
Dale Boston, Why Quit (United States)
Chevet' Mondragon, cold turkey quit, support, freedom august 19, 2004 (United States)
janet gregg, concerned citizen (United States)
Robert Crawley, quit cold turkey May 15, 2005 (United States)
Rose McVay (United States)
Kelly Waters, quit cold turkey March 7, 2002 (Canada)
Nima Alavi, Como Compounding Pharmacy (Australia)
Michael J. Masiak, Concerned Citizen (United States)
Stacey McClain (United States)
Elaine Larsen, I quit cold turkey, August 19, 2004. Had support from Loved it!! Still smoke free... (United States)
Elisabeth Wensing [Cold turkey is the only way I've every be (Canada)
kelly boll (United States)
Lori Rogers (United States)
Valerie Sorensen, Quit cold turkey January 1st, 2003 (United States)
Mickie Johnson (United States)
Heriberto Cruz, Quit cold Turkey 4 years ago. Living life. (United States)
Florante Trinidad (United States)
Ray Bush, Quit cold turkey thanks to (Australia)
Tommy Cahill (Ireland)
Judy Westcott (Canada)
Julie Whitby, 5 and a half years nicotine free with (United States)
Debra Aspinwall, 6 YEARS quit,, cold turkey (United States)
Ruby Wallace, Cold Turkey quitter for 6 years (United States)
Walter F. Cain (United States)
Jill Del Vecchio, (United States)
Beth Touchstone, Cold Turkey is the way to freedom Why (United States)
Irma S. Ponce (United States)
Sarah Laird (United States)
Iuliana Radu Vladescu, Cold Turkey Quitter thanks to Why (Romania)
Michelle Hughart, Newly quit, cold turkey thanks to (United States)
Rhonda Sorrell (United States)
Shannon Bennett (United States)
Chuck Molloy, cold turkey quitter thanks to (9-8-2008) (United States)
Jeremy Nivison, NIVISON Multimedia (United States)
George Katsantonis, Cold Turkey Quitter, Thanks to Freedom From Nicotine (Greece)
Mary T. Eviston, Quit Cold Turkey...6-1/2 Years...Thanks to education from Why Quit. (United States)
Ian Peters (Canada)
Marion Fitt, (United Kingdom)
Tim Luker, Cold Turkey Quitter for 8-1/2 years (United States)
peter spendlove, air tube group (United Kingdom)
john ross, whyquit (United Kingdom)
Gene Short, - Educated cold turkey cessation has given me 500 days of freedom from nicotine and counting.. (United States)
Camille Hickey- nicotine free for 1 year and loving it! (United States)
Sandie Crane (United States)
Sonja Vanhove-Deneve, (Belgium)
geri m parsons (United States)
George E. Crane (United States)
Wanda A. Shelton (United States)
Robin Tawfall (United States)
Frankie S Hayes (United States)
Michael Benson, (United States)
Evanne Lorraine , (United States)
Mary McClure (United States)
Tom Depaul, Why Quit/Freedom From Tobbaco 6 yrs free (United States)
Joy Kauffman, Cold turkey - Freedom From Nicotine - 10 years free! (United States)
Shane Hildreth (United States)
Charles A Nero, Cold turkey as of 8/16/09 (United States)
Roger A. Picard, Jr (United States)
April Willadsen, Cold Turkey Quitter (United States)
mark obryant, recent quitter (United States)
Barry McMillen, MA, LADC, CTAS, Sabatical (formerly Supevisor of tobacco addiction services, Hazelden Foundaztion) (United States)
Paul Gardiner (United Kingdom)
Robin Sathaye, Proud Cold Turkey quitter for 3.5 years ! (India)
Elizabeth A. Hedden (United States)
M walker, Cold turkey quitter. 33 months thanks to whyquit. (United Kingdom)
Richard Jones (United States)
Lauren Hanson (United States)
Mark Brown, Cold Turkey quitter - Thanks! (United States)
John Francey, (United States)
Frederick Foreman (United States)
Mark Gonzales (Egypt)
Randy White, - proud cold turkey quitter (Canada)
Wendy White, - drug-free and educated cold turkey cessation (Canada)
Clifford Kellogg (United States)
Jacqueline Mathes, Cold turkey quit 1 year 6 months and counting (United States)
Victoria Huber (United States)
Jeffrey Beach, self (United States)
Jennifer Kehl (United States)
Rosemary Amrhein (United States)
Gail Reynolds Jackson cold turkey quitter 3-4 yrs ago, (United States)
Deirdre Williamson (United Kingdom)
Kathy Doerr (United States)
Pam Young (United States)
Alastair Taylor, cold turkey quitter thanks to (United Kingdom)
Roy Gomillion, cold turkey quitter (United States)
Sharon Janes (United Kingdom)
Jan Bergman, COPD (United States)
Kim Spaulding (United States)
Marvin Hilbig (Canada)
Maryann Coraluzzo (United States)
neil baker (United States)
David Nelson (United States)
Yildiz de Kat (Netherlands)
Patricia Bishop (United States)
Edgar Esguerra, (Philippines)
Laura Wheeler (United States)
Sheila Khalov (United States)
Daniel Byron, Cold Turkey Quitter 7 Month's Free.... Thanks to (Australia)
R Phelps (United States)
lois barnett (United States)
Kathy Schrader, Cold turkey quitter, 31/2 years nicotine free thanks to (United States)
Kay Ohana (United States)
Cristina Dunlap (United States)
Lindsay Hamilton (United States)
John Marsico (United States)
Michael Brinson, (United States)
Laurel Geyer (United States)
anthony jandura, why (United States)
Mary Anne Kennedy (United States)
Georgetta Hage, "tried it all" (United States)
Donna Decker, CognitiveQuitting and (United States)
Beverly Aytay (United States)
Maryellen O'Leary (United States)
Anne Tjebbes-Hamilton (Netherlands)
Helen Webb, Cold Turkey Quitter (New Zealand)
Steve Polansky, CognitiveQuitting (Canada)
M Kupfer (United States)
Scott Smith (United States)
Ala S (Australia)
Kendra Ross (United States)
Tony Hanks (United States)
scott anderson, cold turkey quitter 2.5 + years (United States)
Nick Del Monte, Quit Cold Turkey (Canada)
john taylor, none (United Kingdom)
Laura Jaynes Hoffmann (United States)
James V Lynch Jr, Cold Turkey Quitter (Six Years) (United States)
Zsofia Tasnadi, Cold Turkey Quitter - thanks to (Hungary)
Elmont Hollingsworth, Peek Tuo Ind. (United States)
Garett Smith (United States)
Rosy, Cold Turkey Quitter : made possible with education from WHYQUIT.COM (South Africa)
Yashmeen Khan, Cold Turkey Quitter : Support from WHYQUIT.COM (South Africa)
Steven P. Manley (United States)
Sue Shine, Freedom From Nicotine-6 1/2 years free!!! (United States)
Gene Fee (United States)
Joanne Diehl, Cofounder - Freedom From Nicotine - 10 1/2 years free!! (United States)
Jacinda van der Merwe, Cold Turkey Quitter (7 months) (Canada)
Karl-Heinz Ginzel, Professor Emeritus, Univ. of Arkansas for Medical Sciences (United States)
Donald Brummel (United States)
Kayla Bush, Cold Turkey Quitter (United States)
suzanne ryan, Freedom From Nicotine (Australia) (Australia)
Joseph Jiamachello, Freedom From Nicotine, (United States)
Brian Mc Kay, Tara Consultants (Canada)
Michael Siegel, MD, MPH, Boston University School of Public Health (United States)
Dr. V.S.Pawar, T.I.F.R. (India)
Dr. , T.I.F.R. (India)
Joel Spitzer, (United States)
Anna Bartelme, Mother of 2 (United States)
Sallie S. Hamilton, Freedom From Nicotine (United States)
Il Soon Kim, Korean Association of Smoking & Health(KASH) (South Korea)
Yussuf Saloojee, NCAS SA (South Africa)
Lutgard Kokulinda Kagaruki, Tanzania Tobacco Control Forum (TTCF) (Tanzania)
Dr Alma ZHYLKAIDAROVA, National Coalition 'For Smokfree Kazakhstan' (Kazakhstan)
Wolfgang Weege (Germany)
Wayne Kao, UICC GLOBALink (Switzerland)
Ulysses Dorotheo, MD, FCTC Alliance, Philippines (Philippines)
J.R. Few, Handsel Art and Advertising (United States)
wikul visalseth, Thai Dentists Against Tobacco Network (Thailand)
Prof. Liliana Tsoneva-Pentcheva, Association Women Against Tobacco-Bulgaria (Bulgaria)
Peter Ucko, National Council Against Smoking (South Africa)
Dr.Dinesh.M, Amrita Institute of Medical Sciences and Research Center (India)
Hom L. Shrestha, Non-Smokers' Rights Association of Nepal (Nepal)
Manjari Peiris, Jeewaka Foundation (Sri Lanka)
John R. Polito, Editor, (United States)
Keyvan Davani (Ph.D. in Law), Austrian Council on Smoking and Health / Scientific Advisory Board (Austria)