""Flawed Harvard Study and Misrepresented Statistics behind Recent Legislation
Fire safe cigarettes or FSC laws seem like a great idea. The concept is that by making cigarettes less likely to burn, they are less likely to start fires, and laws requiring them would save lives. " more ....
"...smoking will be difficult to eradicate..." more ....
"The Netherlands has become the first European country to overturn an unpopular smoking ban imposed on the nation’s bars and cafés two years ago." more ....
It's absolutely amazing what 'shocks and hurts' people these days. Perhaps their indignation is more a symbol of intolerance. more ....
July 27, 2009
We received a reply to our letter to Health Canada on the e-cigarette ban. Following are the explanations of Diana Dowthwaite the Director General at the Inspectorate for Health Products and Food Branch, as to why e-cigarettes have been condemned by them as well as our reply to hers.
Dear Ms. Cyr
'Thank you for your correspondence dated May 12, 2009, in which you voice your concerns about the availability of electronic cigarettes in Canada.
Electronic cigarettes contain nicotine, which is a highly addictive and toxic substance. Health products containing nicotine fall within the scope of the Food and Drugs Act. Nicotine products currently on the market, such as nicotine gum, patches, inhalers and lozenges, have obtained market authorization from Health Canada. Like these products, electronic cigarettes require market authorization before they can be imported or sold in Canada. The market authorization process exists so that Health Canada can evaluate the evidence of safety, efficacy and quality provided by persons seeking market authorization for a product.
Although electronic cigarettes are being marketed as a safer alternative to conventional tobacco products and, in many cases, as an aid to smoking cessation, the risks they may pose, their benefits, their efficacy and their quality are unknown. Nicotine is a highly addictive and toxic substance, and the inhalation of propylene glycol, which is the substance that produces the simulated smoke, is a known irritant to the upper respiratory tract. For more information about nicotine and addiction, please visit our Health Canada website (http://www.hc-sc.gc.ca/hlvs/tobac-tabac ... nd-eng.php ) To date, no electronic smoking products have received market authorization from Health Canada.
Health Canada is committed to protecting the health of Canadians by ensuring that health products meet requirements for safety, efficacy and quality.
Yours Truly, Diana Dowthwaite Director General
Dear Ms. Dowthwaite,
Thank you for replying to our queries and criticisms about the banning of electronic cigarettes in Canada. However, your reply requires further clarification and explanations.
You inform us that products that contain nicotine fall within the scope of the Food and Drugs Act since they are marketed as health products . May we respectfully point out to you that despite the fact that some e-cigarette distributors do in fact market their product as a smoking cessation aid, many others market it as a nicotine delivery substitute without any claims of helping tobacco smokers quit their conventional cigarette habit. That all manufacturers and distributors have been banned from marketing their product because of the actions of a few lacks coherence.
In the Food and Drugs Act Schedule F, Part 1, it is indicated that nicotine inhalers with a maximum of 4 mg per dosage are exempted from the prescription regulation. We in turn consulted the specifications for the popular Ruyan e-cigarette, and found that one 16 mg cartridge, which is the equivalent of 300 puffs or 20 cigarettes, has a 3 mg nicotine yield, which is 1 mg below the level that would categorize the product as a regulated prescription drug. Surely then it must fall under the category of an OTC product much like the presently approved inhalers and other pharmaceutical nicotine products mentioned in schedule F, which do not retain any patent rights. Furthermore, according to the Food and Drugs Act, Schedule A, nicotine addiction is exempted from the advertising regulation.
If Health Canada is truly concerned about the health of Canadian citizens, why don't they stipulate strong recommendations and warnings about the product and guidelines as to what maximum nicotine levels per dose can be marketed in order to have the product conform with the schedule F exemptions instead of enacting a complete ban of a product that has proven to be very popular with the public worldwide? This would be similar to the treatment of energy drinks, which, except for Red Bull, are still pending evaluation from Health Canada, yet continue to be readily available to minors and adults alike.
If there exists some reason for e-cigarettes to be treated according to a different standard than other products, we request that you kindly inform us of these reasons. Otherwise, e-cigarettes should remain available to the public until Health Canada can substantiate its hazard claims since e-cigarettes are neither a health product nor a prescription drug, and are therefore legally unregulated at the outset, with the burden of proving any harmful effects resting upon Health Canada.
Iro Cyr for C.A.G.E. Citizens For Civil Liberties mychoice.ca
Freedom2Choose, working with hypnotherapist Chris Holmes, reveals that the continued use of the Department of Health’s claim “you are up to four times more likely to quit with NHS help” has no evidential basis. Freedom2Choose can show that the Department of Health routinely uses misleading statements to promote Nicotine Replacement Therapy (NRT) products as its preferred method of treatment for smoking cessation. This promotion is a very costly exercise, at a time of imminent cutbacks to public services.
Belinda Cunnison, of pro-choice group Freedom2Choose, investigated the common claim that you are “four times more likely to quit with NHS”, which is used in most promotional materials for NRT products, and frequently in press releases on the subject of smoking cessation. “I traced this claim to a Department of Health web page,(1) which also claimed a 15 per cent success rate at 12 months for NRT. The evidence that was supposed to demonstrate this 15 per cent success rate and the ‘four times more likely to quit’ phenomenon was not listed in the footnotes, so I wrote to the Department to ask for it.”
It took over three months to get the information. The following reports were made available by Cameron Gordon of the Department of Health in relation to smoking cessation studies:
• The Ferguson Health Inequalities Reduction Paper(2)
• The Evaluation Report(3)
• The Shiffman Report(4)
• The Cochrane Reviews(5)
• The Hughes Report(6)
• The Borland Report(7)
The documents revealed neither a 15 per cent quit rate at 12 months, nor any evidence that quitting with the NHS is four times more effective than willpower alone. The Borland Report recorded a 12-month success rate of 6.5 per cent (higher rates were achieved only in the smaller scale studies), whereas the largest study done on quitting using willpower alone achieved a rate of around 6 per cent.
“On the government’s own evidence, the claim ‘up to four times more likely to quit with the NHS’ is completely untrue. How can this claim be justified?” continues Belinda Cunnison. “The use of NHS treatments makes almost no difference at all to quitting success. A recent study published in the British Medical Journal(8) has also documented the long-term success rate of NRT at a mere 1.6 per cent. The whole exercise is futile as well as being enormously expensive.”
Freedom2Choose also has evidence that General Practitioners are given payments for patients who set a quit date, and an additional payment for patients who remain quit at four weeks. The payments are listed in NHS Warwickshire’s board report, March 2009.(9) This reflects the urgency of smoking cessation on the Trust’s list of priorities – an unfortunate choice of priority since patients seem just as good at giving up smoking under their own volition as they are with NHS help.
“At a time when we need to economise, particularly in the Health Service, why is our Government pumping tax-payers’ money into a failed product and using misleading claims to the service user?” questions Belinda Cunnison. “Will-power alone has a comparable success rate for those who choose to give up smoking. This is a complete waste of our resources.”
Author and hypnotherapist Chris Holmes(10) agrees and states, “We are exposing a systematic and deliberate policy to seriously mislead the public over the true effectiveness of these services. The actual extent of long term failure was being quietly covered up - which we now know from the Borland report is 94 per cent failure at 12 months - whilst four-week results were shamelessly promoted, even including published 'success rates' as high as 90 per cent. Since they knew that to be the exact opposite of the real outcomes, this is a fraudulent misappropriation of hundreds of millions of pounds of taxpayers’ money. NRT simply doesn't work.”
1 NHS Stop Smoking Services & Nicotine Replacement Therapy
2 The Ferguson Health Inequalities Reduction Paper
3 The Evaluation Report
4 The Shiffman Report
5 The Cochrane Reviews
6 The Hughes Report
7 The Borland Report
8 British Medical Journal
9 NHS Warwickshire, page 7, Appendix 2H
10 Chris Holmes: Truth Will Out
Link to the article.
May 12, 2009
Health Products and Food Branch Inspectorate Health Canada Address Locator: 2003C Ottawa, Ontario K1A 0K9
It is beyond comprehension to see that Health Canada is calling for a ban on the sale and distribution of electronic cigarettes (e-cigarettes) in this country.
In our opinion, this decision is totally counterproductive to the efforts of Health Canada, who have long been in the vanguard internationally in the reduction of tobacco consumption. While the results of Canada’s sustained efforts through educational campaigns have generally been positive in reducing smoking prevalence right up to and including the year 2004, the decreasing trend has halted and smoking rates in Canada have remained the same ever since draconian smoking bans were instituted in many provinces (1). As history has taught us, coercive methods have never yielded positive results.
Apart from the public reacting negatively to coercion, another likely reason why the remaining citizens who smoke may be reluctant to quit their habit is the lack of realistic alternatives to the act of smoking itself. Public health authorities tend to see smoking as a function of addiction to nicotine, and pharmaceutical companies have cashed in on that perception by marketing various nicotine replacement therapy (NRT) devices. These products, in the form of variously flavored chewing gum in colorful packaging, or lozenges, patches, or even inhalers, are advertised extensively in all media. No doubt NRT sales are high and profitable, but the long term success rate of quitting smoking by use of NRT products as they are marketed now is a dismal 1.6% (2 & 3).
Electronic cigarettes are seen by many as a more attractive alternative to the NRT products available from the pharmaceutical industry and a viable alternative to those who wish to continue profiting from the benefits of nicotine. The use of the e-cigarette simulates the physical acts and sensations characteristic of smoking, including holding a cigarette-shaped device, inhaling nicotine vapor from it, and exhaling propylene glycol vapor. This vapor is a relatively inert gas which is odorless and does not linger in the air around the e-smoker. There is no environmental smoke produced by e-cigarettes therefore there is no annoyance to by-standers.
The popularity of the e-cigarette has spread virally through means such as word of mouth and internet forums. Large numbers of people around the world claim that use of e-cigarettes has helped them quit or cut down on their smoking and that it provides a degree of comfort, satisfaction, and convenience to those who do not wish to give up nicotine intake for various reasons.
In light of all of this, it is beyond disappointing to see that Health Canada is calling for a ban on the sale and distribution of electronic cigarettes in this country. We as a group representing smokers find it absurd that Health Canada would keep it legal to smoke tobacco and ban the marketing of e-cigarettes, which offer an effective alternative and we are not alone to feel this way (4).
Contrary to conventional cigarettes emissions, E-cigarette vapor only contains two chemicals: nicotine and glycol propylene. Nicotine is generally accepted as relatively harmless by authorities, and is an approved legal substance. After all, NRT products, some of which are inhaled nicotine, are allowed to be freely marketed over the counter with no legal age for purchase and Health Canada has either authorized or is in the process of authorizing clinical trials of such nicotine products on pregnant women (5). Propylene glycol is approved as an additive for various foods, is used as a preservative substance to maintain moisture in products, and has been animal tested (including on simians, not just laboratory rats) as relatively harmless when inhaled. (6 & 7)
The electronic cigarette is in essence a nicotine delivery device in the same mould as pharmaceutical NRT products. What is it in the combination of nicotine and propylene glycol that has Health Canada thinking that e-cigarettes are more hazardous than tobacco and NRT products such as inhalers? Surely e-cigarettes, which are neither tobacco products nor pharmaceutical products, should be permitted to be marketed and distributed freely providing they are not advertized as therapeutic devices.
Unable to comprehend what motivated Health Canada to ban e-cigarettes while keeping tobacco and pharmaceutical nicotine replacement therapy as well as the dangerous drug Chantix legal, we are forced to conclude that the only parties worthy of protection from Health Canada are the pharmaceutical and tobacco industries whose profits are threatened with the advent of this smart invention that had the potential of reestablishing harmony between smoking and non-smoking citizens and bringing much needed business back in our hospitality sector.
We strongly urge Health Canada to rethink their e-cigarette policy immediately, in the interest of the people they represent as opposed to the financial interests of powerful corporate lobbies.
Iro Cyr P.O. Box 60083 Boisbriand, Qc J7G 3G4 450-435-1351
for: C.A.G.E. CITIZENS FOR CIVIL LIBERTIES MYCHOICE.CA
Disclaimer: C.A.G.E, Citizens for Civil Liberties and mychoice.ca are grassroots non-profit organizations with no financial ties to the Tobacco, Pharmaceutical or e-cigarette industries.
1) Canadian Tobacco Use Monitoring Survey - The Daily Monday, August 25, 2008 http://www.statcan.gc.ca/daily-quotidien/080825/dq080825b-eng.htm
2) Effectiveness and safety of nicotine replacement therapy assisted reduction to stop smoking: systematic review and meta-analysis - BMJ 2009;338:b1024 Published 2 April 2009, doi:10.1136/bmj.b1024 http://www.bmj.com/cgi/content/abstract/338/apr02_3/b1024
3) New Study Demonstrates How Conflicts of Interest with Big Pharma Influence Reporting of the Effectiveness of Smoking Cessation Drug Treatment - Tobacco Analysis blog by Dr. Michael Siegel, professor Social and Behavioral Sciences, Boston University School of Public Health. http://tobaccoanalysis.blogspot.com/search?q=Conflicts+of+Interest+with+Big+Pharma+Influence+Reporting
4) Absurdity Gone Wild: Health Canada Asks Smokers Not to Use E-Cigarettes Because of Safety Concerns, But Not to Refrain from the Known Toxic Ones - Tobacco Analysis blog by Dr. Michael Siegel, professor Social and Behavioral Sciences, Boston University School of Public Health. http://tobaccoanalysis.blogspot.com/search?q=Absurdity+Gone+Wild
5) Correspondence between C.A.G.E. and Mr. Yadvinder Bhuller, Manager - Clinical Group II , Office of Clinical Trials and Mr. William King, Chief of Staff, Ministry of Health. http://www.cagecanada.ca/index.php?pr=Nicotine_Replacement
6) Safety Report on the Ruyan® e-cigarette Cartridge and Inhaled Aerosol - Murray Laugesen Health New Zealand Ltd Christchurch, New Zealand. - 30 October 2008 http://healthnz.co.nz/RuyanCartridgeReport30-Oct-08.pdf 7) Preclinical safety evaluation of inhaled cyclosporine in propylene glycol. - PMID: 18158714 [PubMed - indexed for MEDLINE] http://www.ncbi.nlm.nih.gov/pubmed/18158714?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
‘For many years, drivers caught with a blood-alcohol level between .05 and .08 -- otherwise known as the "warn range" -- received a 12-hour licence suspension, but no record or fine. Even when that law was brought in, some complained that it ignored due process. But perhaps because the consequence was inconvenient more than substantial, the law was accepted.
The new law changes that. The province has just given itself the right to take away your licence for between three days and a month, fine you $150, give you a record and, possibly, impose even further punishments. But you have no right to defend yourself. You have no right to appeal -- and the Ministry of Transportation has clearly said so. Moreover, the police officer who steps out of the cruiser to administer the breathalyser is no longer just enforcing the law; he or she is your final judge.’
Read the full editorial here.
The Waterloo Region Record should be commended for its stand.
“It is essential that [anti-tobacco] campaigners create the impression of inevitable success. Campaigning of this kind is literally a confidence trick: the appearance of confidence both creates confidence and demoralises the opposition. The week before the free vote we made sure the government got the message that we 'knew' we were going to win and it would be better for them to be on the winning side.”
I wonder how many politicians have been tricked by this bald-faced deceipt?
For the government’s denormalisation campaign to succeed these adults must be stigmatised...that is, they will be placed apart from the rest of civilised society until and unless they learn to behave in the approved manner. Denormalisation pushes gamblers, drinkers, smokers, and the obese from being a health hazard to being a moral hazard, nothing less than blots on the nation’s moral landscape."
Read the full article by Patrick Basham & John Luik here.
Sandy Szwarc tells us a closer look at the report "found that not one of its key recommendations had been supported in clinical studies. In fact, the Report not only failed to provide what most scientists would consider convincing evidence, its conclusions were repeatedly the opposite of the evidence. The lengthy JFS examination found that none of the 17 cancers examined in the WCRF/AICR Expert Report had found credible associations with foods (sugars or sugary drinks, fats, meats, fruits, vegetables, legumes, vitamins, alcohol or processed foods) or BMI." more...
This important issue has never been publicly debated and until now all the information the public has received has been a series of very conflicting and confusing slogans. A public discussion would give Ontario citizens the opportunity to hear and better understand both the health and civil liberties aspects of this issue.
Dear Mr. Orazietti, MPP,
I read the March 11, 2008 article in the Sault Star entitled “Premier will support Sault MPP’s Private Member’s Bill” with a great deal of interest and excitement. In the article, you incorrectly state that the smokers’ rights organization My Choice has declined to debate you on the issue of the effect of environmental tobacco smoke (ETS) on children’s health vs the rights of parents and adults.
Isn’t it time this issue was publicly debated? To date all of the information the citizens of Ontario have received has been a series of very conflicting and confusing slogans that I would love to have the opportunity to discuss and clarify.
I would like a public debate of the study conducted by the International Agency for Research on Cancer (World Health Organization) that indicated the children exposed to ETS suffer the lowest incidence of lung cancer. There would be a clear public benefit in the open discussion of the American Cancer Society funded study by Enstrom and Kabat that found the association between ETS and tobacco related mortality much weaker than generally believed. Both of these studies strongly suggest the risks of ETS have been hugely exaggerated for political purposes.
American Cancer Society
I would also like to discuss the recent study of two generations of Swedish residents that concluded that there was an association between current exposure to ETS and a low risk for atopic (allergic) disorders in smokers themselves and a similar tendency in their children.
I am confident that parents would like to know that exposure to ETS seems to have a protective effect against allergic asthma and life-threatening allergies. There has been a huge increase in the incidence of childhood asthma over the last 30 years that developed concurrent with the decrease in the population smoking rate. And it is knowledge that the public deserves to be told!
Mr. McGuinty claims to have no interest in introducing smoking bans in private homes but this is exactly the same statement he made about banning smoking in private vehicles BEFORE the election.
I believe that the public would also be very interested in knowing exactly how many tax dollars were used to fund organizations like the Lung Association and the Ontario Medical Association to implement a campaign to influence public opinion on the issue of banning smoking in cars. And how much is currently being spent to fund campaigns to influence public opinion about banning smoking in private homes!
In short, I would like to invite you to enter into a public debate with Citizens for Civil Liberties on these very issues. I trust that I will find you eager to enter into such a debate and am willing to travel to whatever venue you may find desirable for this purpose.
I eagerly await your acceptance of my invitation.
Director – Media Relations
Citizens for Civil Liberties
according to a report yesterday. The health warnings would be aimed at urging people to cut down on the amount of saturated fat they eat and make dairy products an occasional treat rather than a regular part of their diet. more...