Petition Summary:

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.

---

Petition:

The Honorable Kathleen Sebelius
Secretary of Health and Human Services
200 Independence Avenue, S.W.
Room 615-F
Washington, DC 20201

Telephone: (202) 690-7000
Fax: (202) 690-7203
Email: Kathleen.Sebelius@hhs.gov

          Re: 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,

(Your Name)

1. Keyvan Davani (Ph.D. in Law), Austrian Council on Smoking and Health / Scientific Advisory Board (Austria)
2. John R. Polito, Editor, WhyQuit.com (United States)
3. Manjari Peiris, Jeewaka Foundation (Sri Lanka)
4. Hom L. Shrestha, Non-Smokers' Rights Association of Nepal (Nepal)
5. Dr.Dinesh.M, Amrita Institute of Medical Sciences and Research Center (India)
6. Peter Ucko, National Council Against Smoking (South Africa)
7. Prof. Liliana Tsoneva-Pentcheva, Association Women Against Tobacco-Bulgaria (Bulgaria)
8. wikul visalseth, Thai Dentists Against Tobacco Network (Thailand)
9. J.R. Few, Handsel Art and Advertising (United States)
10. Ulysses Dorotheo, MD, FCTC Alliance, Philippines (Philippines)
11. Femi Adejuwon, Tobacco Free Youth (United Kingdom)
12. Wayne Kao, UICC GLOBALink (Switzerland)
13. Wolfgang Weege (Germany)
14. Dr Alma Zhylkaidarova, National Coalition 'For Smokfree Kazakhstan' (Kazakhstan)
15. Lutgard Kokulinda Kagaruki, Tanzania Tobacco Control Forum (TTCF) (Tanzania)
16. Yussuf Saloojee, NCAS SA (South Africa)
17. Il Soon Kim, Korean Association of Smoking & Health(KASH) (South Korea)
18. Sallie S. Hamilton, Freedom From Nicotine (United States)
19. Anna Bartelme, Mother of 2 (United States)
20. Joel Spitzer, WhyQuit.com (United States)
21. Dr. V.S.Pawar, T.I.F.R. (India)
22. Michael Siegel, MD, MPH, Boston University School of Public Health (United States)
23. Brian Mc Kay, Tara Consultants (Canada)
24. Joseph Jiamachello, Freedom From Nicotine, www.ffn.yuku.com (United States)
25. Suzanne Ryan, Freedom From Nicotine (Australia)
26. Kayla Bush, Cold Turkey Quitter (United States)
27. Donald Brummel (United States)
28. Karl-Heinz Ginzel, Professor Emeritus, Univ. of Arkansas for Medical Sciences (United States)
29. Jacinda van der Merwe, Cold Turkey Quitter (7 months) (Canada)
30. Joanne Diehl, Cofounder - Freedom From Nicotine - 10 1/2 years free!! (United States)
31. Gene Fee (United States)
32. Sue Shine, Freedom From Nicotine-6 1/2 years free!!! (United States)
33. Steven P. Manley (United States)
34. Kenneth Fiantago (United States)
35. Yashmeen Khan, Cold Turkey Quitter : Support from WhyQuit.com (South Africa)
36. Rosy, Cold Turkey Quitter : made possible with education from WhyQuit.com (South Africa)
37. Garett Smith (United States)
38. Elmont Hollingsworth, Peek Tuo Ind. (United States)
39. Zsofia Tasnadi, Cold Turkey Quitter - thanks to Whyquit.com (Hungary)
40. James V Lynch Jr, Cold Turkey Quitter (Six Years) (United States)
41. Laura Jaynes Hoffmann (United States)
42. John Taylor (United Kingdom)
43. Nick Del Monte, Quit Cold Turkey (Canada)
44. Scott Anderson, cold turkey quitter 2.5 + years (United States)
45. Tony Hanks (United States)
46. Kendra Ross (United States)
47. Ala S (Australia)
48. Scott Smith (United States)
49. M Kupfer (United States)
50. Steve Polansky, CognitiveQuitting (Canada)
51. Helen Webb, Cold Turkey Quitter (New Zealand)
52. Anne Tjebbes-Hamilton (Netherlands)
53. Maryellen O'Leary (United States)
54. Beverly Aytay (United States)
55. Donna Decker, CognitiveQuitting and WhyQuit.com (United States)
56. Georgetta Hage, "tried it all" (United States)
57. Mary Anne Kennedy (United States)
58. Anthony Jandura, WhyQuit.com (United States)
59. Laurel Geyer (United States)
60. Michael Brinson, WhyQuit.com (United States)
61. John Marsico (United States)
62. Lindsay Hamilton (United States)
63. Cristina Dunlap (United States)
64. Kay Ohana (United States)
65. Kathy Schrader, Cold turkey quitter, 3 1/2 years nicotine free thanks to WhyQuit (United States)
66. Lois Barnett (United States)
67. R Phelps (United States)
68. Daniel Byron, Cold Turkey Quitter 7 Month's Free.... Thanks to WhyQuit.com (Australia)
69. Sheila Khalov (United States)
70. Laura Wheeler (United States)
71. Edgar Esguerra, WhyQuit.com (Philippines)
72. Patricia Bishop (United States)
73. Yildiz de Kat (Netherlands)
74. David Nelson (United States)
75. Neil Baker (United States)
76. Maryann Coraluzzo (United States)
77. Marvin Hilbig (Canada)
78. Kim Spaulding (United States)
79. Jan Bergman, COPD (United States)
80. Sharon Janes (United Kingdom)
81. Roy Gomillion, cold turkey quitter (United States)
82. Alastair Taylor, cold turkey quitter thanks to whyquit.com (United Kingdom)
83. Pam Young (United States)
84. Kathy Doerr (United States)
85. Deirdre Williamson (United Kingdom)
86. Gail Reynolds Jackson cold turkey quitter 3-4 yrs ago, WhyQuit.com (United States)
87. Rosemary Amrhein (United States)
88. Jennifer Kehl (United States)
89. Jeffrey Beach, self (United States)
90. Victoria Huber (United States)
91. Jacqueline Mathes, Cold turkey quit 1 year 6 months and counting (United States)
92. Clifford Kellogg (United States)
93. Wendy White, WhyQuit.com - drug-free and educated cold turkey cessation (Canada)
94. Randy White, WhyQuit.com - proud cold turkey quitter (Canada)
95. Mark Gonzales (Egypt)
96. Frederick Foreman (United States)
97. John Francey, www.ffn.yuku.com (United States)
98. Mark Brown, Cold Turkey quitter - Thanks Whyquit.com! (United States)
99. Lauren Hanson (United States)
100. Richard Jones (United States)
101. M walker, Cold turkey quitter. 33 months thanks to whyquit. (United Kingdom)
102. Elizabeth A. Hedden (United States)
103. Robin Sathaye, Proud Cold Turkey quitter for 3.5 years ! (India)
104. Paul Gardiner (United Kingdom)
105. Barry McMillen, MA, LADC, CTAS, Sabatical (formerly Supevisor of tobacco addiction services, Hazelden Foundation) (United States)
106. Mark Obryant, recent quitter (United States)
107. April Willadsen, Cold Turkey Quitter (United States)
108. Roger A. Picard, Jr (United States)
109. Charles A Nero, Cold turkey as of 8/16/09 (United States)
110. Shane Hildreth (United States)
111. Joy Kauffman, Cold turkey - Freedom From Nicotine - 10 years free! (United States)
112. Tom Depaul, Why Quit/Freedom From Tobbaco 6 yrs free (United States)
113. Mary McClure (United States)
114. Evanne Lorraine , whyquit.com (United States)
115. Michael Benson, whyquit.com (United States)
116. Frankie S Hayes (United States)
117. Robin Tawfall (United States)
118. Wanda A. Shelton (United States)
119. George E. Crane (United States)
120. Geri M Parsons (United States)
121. Sonja Vanhove-Deneve, www.stoppenmetroken.be (Belgium)
122. Sandie Crane (United States)
123. Camille Hickey- nicotine free for 1 year and loving it! (United States)
124. Gene Short, Whyquit.com - Educated cold turkey, 500 days freedom from nicotine & counting.(United States)
125. John Ross, WhyQuit (United Kingdom)
126. Peter Spendlove, air tube group (United Kingdom
127. Tim Luker, Cold Turkey Quitter for 8-1/2 years (United States)
128. Marion Fitt, Whyquit.com (United Kingdom)
129. Ian Peters (Canada)
130. Mary T. Eviston, Quit Cold Turkey...6-1/2 Years...Thanks to education from Why Quit. (United States)
131. George Katsantonis, Cold Turkey Quitter, Thanks to Freedom From Nicotine (Greece)
132. Jeremy Nivison, NIVISON Multimedia (United States)
133. Chuck Molloy, cold turkey quitter thanks to whyquit.com (9-8-2008) (United States)
134. Shannon Bennett (United States)
135. Rhonda Sorrell (United States)
136. Michelle Hughart, Newly quit, cold turkey thanks to whyquit.com (United States)
137. Iuliana Radu Vladescu, Cold Turkey Quitter thanks to WhyQuit.com (Romania)
138. Sarah Laird (United States)
139. Irma S. Ponce (United States)
140. Beth Touchstone, Cold Turkey is the way to freedom Why Quit.com (United States)
141. Jill Del Vecchio, whyquit.com (United States)
142. Walter F. Cain (United States)
143. Ruby Wallace, Cold Turkey quitter for 6 years (United States)
144. Debra Aspinwall, 6 YEARS quit, Whyquit.com, cold turkey (United States)
145. Julie Whitby, 5 and a half years nicotine free with WhyQuit.com (United States)
146. Judy Westcott (Canada)
147. Tommy Cahill (Ireland)
148. Ray Bush, Quit cold turkey thanks to whyquit.com (Australia)
149. Florante Trinidad (United States)
150. Heriberto Cruz, Quit cold turkey 4 years ago. Living life. Whyquit.com (United States)
151. Mickie Johnson (United States)
152. Valerie Sorensen, Quit cold turkey January 1st, 2003 (United States)
153. Lori Rogers (United States)
154. Kelly Boll (United States)
155. Elisabeth Wensing [Cold turkey is the only way I've every be (Canada)
156. Elaine Larsen, cold turkey 8/19/04 support WhyQuit.com. Loved it!! Still smoke free... (United States)
157. Stacey McClain (United States)
158. Michael J. Masiak, Concerned Citizen (United States)
159. Nima Alavi, Como Compounding Pharmacy (Australia)
160. Kelly Waters, quit cold turkey March 7, 2002 (Canada)
161. Rose McVay (United States)
162. Robert Crawley, quit cold turkey May 15, 2005 (United States)
163. Janet Gregg, concerned citizen (United States)
164. Chevet' Mondragon, cold turkey quit, WhyQuit.com support, freedom 09/19/04 (United States)
165. Dale Boston, Why Quit (United States)
166. James, quit cold turkey after viewing WhyQuit.com (United States)
167. Cheryl Reichhart, WhyQuit (United States)
168. Ujjwal Saha, independent (India)
169. Tina Paljusaj (United States)
170. Ron Bacon (United States)
171. Prashanth C Edwards, Royal Bank of Scotland (United Kingdom)
172. Tim Burdett (United States)
173. Vivienne Kenny (Ireland)
174. Anthony Antinora, 2 months Cold Turkey (5 times further than w/ Nicorette) (United States)
175. Zakir Shah (Pakistan)
176. Kate Katje (United States)
177. Robert Sliger, Cold Turkey - 3 days > Used Chantix for 6 months :( (United States)
178. Larry Bridges (Canada)
179. Ashwin Mehra, quit cold turkey 4 years ago at 29. WhyQuit.com (United States)
180. Ernest J Beaumont (United States)
181. Laura Mullen (United States)
182. Charles J McNulty, Whyquit.com supporter - nothing else works!! (United Kingdom)
183. Charles Attias, Quit 8 months ago cold turkey, thanks WhyQuit (Canada)
184. Florin Adrian Marginean, quit cold turkey 1 mounth, 25 days ago (Romania)
185. Monique Clifton (United States)
186. Sigrid Cousineau, WhyQuit (United States)
187. Linda Gerek, Quit cold turkey 60 hrs ago. (United States)
188. Kevin Klebs (United States)
189. Chris Bloomfield (United Kingdom)
190. Martina Saurin (Israel)
191. Roger Faires, self (United States)
192. Sheri Hundley (United States)
193. Ronald Ellingsen (United States)
194. Eric Wickham, WhyQuit (United States)
195. David Reynolds, No smokes today (Ireland)
196. Manojava Donekal (Ireland)
197. Rob McGurk, Going to give my girls away at their wedding (Australia)
198. Larry Myers (United States)
199. C Curtis (United States)
200. Ellie Tuck (United States)
201. James Jacks (United States)
202. Theresa cold turkey - 6 months , How? Will power and Why Quit.com (Canada)
203. Daniel du Toit, www.quit4all.com (South Africa)
204. Talaferrio Tucker, crimestoryMusic (United States)
205. Patricia Clark (United States)
206. Ian Cowper, Finally Quit, cold turkey with WhyQuit (tried everything else) (United Kingdom)
207. Amanda Stevens, WhyQuit.com gave me the knowledge I needed to quit cold turkey 2yrs ago (United States)
208. Connie Pilgrim (Canada)
209. Sandra Clover, quit almost 1 year ago (United States)
210. Donald Cotter, WhyQuit.com <--- Don't think I would have quit without it! (United States)
211. Kathryn Hayes (United States)
212. Gary Peter Arnold (United States)
213. Thomas G. Hartley (United States)
214. Shelia McIntyre (United States)
215. G Nicholson, WhyQuit.com - 1 month cold turkey and feeling great! (United Kingdom)
216. S.Cyril Alexander, Mary Anne Charity Trust (MACT) (India)
217. Kelly Almanzar (United States
218. John Farren, Almost 2 years Cold Turkey with the help of whyquit!! (United Kingdom)
219. Daniel Catana (Romania)
220. Kyle Walker (United States)
221. Hafiz, Rahman (United States)
222. Melanie Lilwall, Whyquit.com 2years and doing great! (United States)
223. Celina White (United States)
224. Anna Stone (United States)
225. Radu Popescu, quitter with Allen Carr's method + my own method, sport :) (Romania)
226. Aasma Qamer (Pakistan)
227. Sara Estrada, Fairfield Hospital (Australia)
228. Angelina. Gersana, Fairfield Hospital (Australia)
229. Heather Royston (United States)
230. Jessica Taylor (United States)
231. Robin Rock (United States)
232. Jerome Gottlieb (United States)
233. Patricia Dancosse (United States)
234. Victoria Horne (United States)
235. Gregory Wiley (United States)
236. Jessica Darnell (United States)
237. G.D. Hand, RN (United States)
238. Deanna Wright (United States)
239. D.J. Greer RN (United States)
240. Samuel Palmer (Australia)
241. Sheri Hundley (United States)
242. Paul Roberto, Warrington stop smoking service UK (United Kingdom)
243. Tim Ballard (United States)
244. Edgardo Viglielmo (Italy)
245. Barry McMillen, tobacco free 1996, Formerly with Hazelden Foundation (United States)
246. Miguel A. Colon (United States)
247. Thomas Wenneman (United States)
248. Jenniper Wargats (United States)
249. Melissa R. Isabel, RN (United States)
250. Sam LoBello (United States)
251. Vic Johnson, http://www.quitterscanbewinners.com (United States)
252. Sharon L. Greener (United States)
253. Des Kavanagh, whyquit.com, cold turkey (Ireland)
254. Thomas J Wenneman, Charlotte NC (United States)
255. Ken Lacroix, Allen Carr method with Quitnet support (Canada)
256. Randei McTaggart, quit with the Allen Carr method (United States)
257. A.W.Macy (United States)
258. Douglas Beach (United States)
259. Tim Casey, Cold Turkey - WhyQuit.Com (United States)
260. David Wilson (United States)
261. Douglas H. Brown, none (United States)
262. Angel Dzekov, Moonchild Brother (Macedonia)
263. Lucy Baldwin (United Kingdom)
264. Pat Kuchenbecker, Quit Cold turkey with whyquit.com 6 years ago (United States)
265. Karen Livsey, quitting cold turkey as of 3.30 pm yesterday (Australia)
266. Sue McBride (United States)
267. Helen McDonald (United States)
268. Matt Miller (United States)
269. Ingrid Dekker (Netherlands)
270. Susan L. Collins (United States)
271. Kathy King (Australia)
272. Richard S. Brown (United States)
273. Julie James (United States)
274. Wendell Pericone (United States)
275. William Brennan (United States)
276. Rich Szabo (United States)
277. Saleh Abbad, Anti Smoking Charitable Org. (Saudi Arabia)
278. Valentín Chab (Argentina)
279. Jennifer Harshaw, Michigan Kidney Consultants and Red Robin Yummmm (United States)
280. R. Allyn Stillman (United States)
281. Adriana Menendez, Tobacco Control Committee, Sindicato Medico del Uruguay (Uruguay)
282. Jane Lycett (United Kingdom)
283. Kathryn Johnson (United States)
284. Patricia Owen (United States)
285. Shirley Barrett, na (United States)
286. Charles Nero (United States)
287. Leah Clarke (Australia)
288. Kewanna Broadwater (United States)
289. Sheri Hundley (United States)
290. Eva Sunny (United States)
291. Alan Russell (United States)
292. Debra J Gonzales, MINE, I JUST WANT TOO QUIT (United States)
293. Joyce Bartoli, Medical Field (United States)
294. Derek Crawford, (life ruined by Champix) (Canada)
295. Brian Schultz (United States)
296. Vinay, Cold Turkey quitter for last six days (India)
297. Alison Miller, chef (United Kingdom)
298. Norman Long, Quit cold turkey 3 months past (United States)
299. Gabriel Mahal, Advokat (Indonesia)
300. Jared Kiley (Barbados)
301. James R. Becraft (United States)