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Allen Carr Organisation Launches Blistering Attack on NICE & ASH

January 2008

Press Release: 17th January 2008

Amidst media reports from the USA highlighting incidents linking Pfizer’s anti-smoking drug Champix/Chantix (Varenicline) to serious side effects amongst users including suicides, homicidal thoughts, hallucinations, amnesia, anger, aggression and depression, Allen Carr’s Easyway organisation has launched a blistering attack on the two leading players in the smoking cessation establishment: the public health charity Action on Smoking & Health (ASH) and the National Institute for Clinical Health and Excellence (NICE).

ASH endorsed Champix ahead of NICE in December 2006
www.newash.org.uk

NICE approved CHAMPIX in July 2007 as reported by ASH
www.newash.org.uk

Robin Hayley, MD, Allen Carr’s Easyway comments “The fact that ASH and NICE have ignored our method which is perfectly safe, involves no drugs, has a proven track record and offers a money back guarantee speaks volumes about the bias of both bodies towards pharmaceutical interventions. Both bodies have ignored us on the basis of claims that there is an insufficient evidence base to verify our success rate in spite of independent studies published in peer reviewed journals that demonstrate a success rate of over 50% after 12 months (1) which is far higher than any other method.

Given the latest news from the USA one wonders what evidence base these bodies ARE using to establish their recommendations and guidance. Their methods clearly seem flawed and appear to have resulted in putting the general public in danger as well as denying them access to the safest, most economical and most effective treatment for nicotine addiction. I call for an inquiry to establish the influence of the pharmaceutical industry on ASH and NICE policy”.

So far – in spite of the reports from the USA (below) ASH and NICE appear to have nothing to say on the subject of Champix and its apparent side effects…

Background:

The US Food and Drug Administration (FDA) issued the following statement on 20th November 2007:

FDA NEWS: For immediate Release November 20, 2007
FDA Issues Early Communication for Chantix
Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.
FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults quit smoking.
Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.
FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.
In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.
Full text of the Early Communication about the Ongoing Safety Review can be found at: www.fda.gov.
Following the initial report on the case mentioned above “case report citing erratic behavior in an individual who had used Chantix”

US Channel, NEWS 8, who initially broadcast the report involving Ryann Rathbone’s musician boyfriend, Carter Albrecht being killed after being shot by a neighbour during what she described as “a violent hallucination prompted by the drug”, requested (through the Freedom of Information Act) all complaints filed with the FDA about Chantix which is marketed in the UK as Champix. A computer disc was sent with 5157 complaints which were filed in just one week after the original News 8 report aired.

News 8 now report that the “number and type of side effects might be far greater and more deadly than previously reported”.
Suicide was reported 55 times. Suicidal thoughts were mentioned in 199 cases and 417 people complained of depression.
There were hundreds of mentions of anger, aggression, amnesia, hallucination and homicidal thoughts.
An FDA spokesperson confirmed they are looking into 100 specific psychotic incidents in the United States.
Even before Albrecht’s death, the FDA said they had planned an investigation based on complaints in Europe where Pfizer sold the drug as Champix since 2006.
The FDA is urging doctors to carefully monitor patients on the drug. People should also report side effects to the FDA.
This is the link to the full News 8 story:

www.wfaa.com

(1) 1. Hutter HP et al.2006. Smoking cessation at the workplace: one year success of short seminars. Int Arch Occup Environ Health (2006) 79:42-48.

2. Moshammer H and Neuberger M 2007 Long term success of short smoking cessation seminars supported by occupational health care. Addictive Behav DOI: 10.1016/j.addbeh.2006.10.002.

For more information and opinion from Allen Carr’s Easyway on this subject please contact The Press Office +44 (0)7970 88 44 52 jd@statacom.net

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