Monday, September 14, 2009

Making tobacco cheaper & more accessible for kids

There are few Canadians who would disagree with the proposition that otherwise legal commodities such as alcohol and tobacco should be kept out of the hands of children. The logic behind such restraints is perfectly understandable.

The time frame between birth through the teen years is generally acknowledged as an educational period. And, although one might argue about the arbitrary age attached to adulthood, there is little debate on the need to support children and teenagers during this youthful period in their lives. Hopefully, during these formative years, parents and our educational system are providing children with the tools they'll need to meet the challenges of modern day adult life.

Protecting children and teenagers includes encouraging them to refrain from adopting lifestyle behaviours which may adversely impact them in later life; drugs, alcohol, smoking and promiscuous sexual activity. Each of these carries consequences of which young people should be made aware.

This is primarily a responsibility of the parent.

But, it must be admitted that some state regulation is justified to minimize the risk of young people making inappropriate lifestyle decisions; at least until they reach a level of maturity where they can make informed decisions for themselves.

In Canada, the age at which one can legally buy tobacco, like alcohol, is set at 19. Convenience stores don't sell cigarettes to minors. Therefore minors have a difficult time supporting a smoking habit. By keeping tobacco out of the hands of minors, youth smoking prevalence can be kept to a minimum.

To be sure, some teenagers will find ways to acquire cigarettes or booze with which to conduct their experiments in “adult” lifestyles. But, by and large, strictly enforced regulations prohibiting the sale and distribution of tobacco to minors is sufficient to accomplish the task.

Enter the anti-smoker cartel. Proclaiming an epidemic in youth smoking prevalence, they insist that additional, stronger measures are required to control the perceived problem. And, these measures include taxing cigarettes to the point where they are cost prohibitive to the average teenager.

Unfortunately, there are some very real concerns with this prohibitionist tactic.

First, tobacco taxes unfairly target adult consumers of a legal commodity, not just minors interested in experimenting with something considered taboo. And, because tobacco taxes are regressive in nature, they impact the poor much more than they affect the well off. So the first ones to feel the impact of regressive taxation are low income wage earners, pensioners, those dependent on various forms of social welfare, etc.

This reality is lost on the anti-smoker, of course. They are as much, if not more, interested in reducing smoking prevalence in the adult population as they are in preventing children from acquiring the habit.

The government, salivating at the very thought of billions in additional tax revenue, are quick to acknowledge the need to control the mostly imagined epidemic and impose the punitive levels of taxation demanded by the anti-smoker cult; for the public good and to protect the children, of course.

But, there is growing evidence that repressive tax measures are counter-productive.

Laws prohibiting sales of tobacco products to minors are no longer effective. Children and teenagers are no longer dependent on legal retail outlets to access a regular supply of cigarettes. The high cost of tobacco, driven by punitive levels of taxation, has created a blossoming black market.

In this underground economy, kids have hassle free access to tobacco products. They don't have to concern themselves with producing ID or proof of age, because the sellers of contraband don't care. And the contraband product is much cheaper than the legal option.

Thanks to the excessive levels of taxation imposed by government, at the insistence of the anti-smoker cult, kids now have greater access to tobacco than ever, at a substantially lower cost.

The government will never realize the revenue windfall expected from tobacco taxes while smokers are buying cheaper, untaxed contraband. And, enforcement of customs and excise law is rapidly becoming a very costly (and largely futile) venture. The profit potential from black market sales is just too great.

It was a predictable problem, with over 5 million alleged addicts ready and willing to avoid paying the legal extortion demanded by their government. And, as in the days of prohibition, the government, not the dealers in contraband, are seen as the enemy.

And, the problem of youth access to tobacco products, rather than being curtailed, has been exacerbated.

Pure stupidity.

See also: Australlian smokers face $20.00/pack cigarettes

Thursday, September 10, 2009

Why are anti-smokers afraid of the truth?

Several tobacco companies in the US recently launched a lawsuit claiming new FDA legislation abridges their rights under the First Amendment to the US Constitution: the right to freedom of speech. The legislation, the Family Smoking Prevention and Tobacco Control Act, actually muzzles tobacco companies to the point where they are prohibited from telling the truth.

Despite the fact that the new legislation unequivocally places regulatory responsibility of tobacco and tobacco products in the hands of the US FDA (Food and Drug Administration), the tobacco companies are forbidden from clearly communicating that incontrovertible fact.

The Act authorizes the FDA to regulate tobacco products, including reducing or eliminating any constituents used in the manufacture or processing of tobacco, if they believe it is likely to protect public health. But, should the FDA take any action they believe will make cigarettes safer, the tobacco companies will be prohibited from truthfully telling consumers that the FDA has done so.

The legislation was sold to the US Congress by claiming that FDA regulation would make cigarettes safer. But, this provision, specifically denying tobacco companies the right to inform their customers of any such action, makes a mockery of that claim.

In the eyes of the anti-smoker cartel, cigarettes can't be made less hazardous. So, if the FDA demands that the cigarettes companies alter their manufacturing process or remove specific constituents by claiming that it will make cigarettes safer, they will, essentially, be lying. And, even if they're telling the truth, and action taken by the FDA does make cigarettes safer, the tobacco companies will not be permitted to tell their customers lest they be misled into believing that FDA actions have made cigarettes safer. Have I lost you?

The circular logic is both inescapable and ludicrous.

The facts are that the FDA now regulates cigarettes, sets product standards, and tobacco companies are expected to comply with those standards. But, tobacco companies are prohibited from telling consumers what is already public knowledge; a clear violation of their first amendment rights.

Anti-smoking advocate Dr. Michael Siegel pointed out the absurdity of this provision in the legislation in a recent post on his blog. “The FDA legislation is so overly broad in the scope of its speech restriction in this area that a tobacco company executive could not even give a speech at a shareholder meeting in which he reports that the company in the past year has complied with all FDA tobacco product regulations. A company annual report would risk a violation of the law by stating that the company's products comply with FDA standards.”

Back in June, 2009, I posted a piece on the Japanese smoking paradox. The Japanese have a substantially higher smoker prevalence rate than North Americans or Europeans. Yet, their lung cancer rates are much lower. Among the factors offered by way of an explanation of this paradox is higher efficiency of filters on Japanese cigarettes and lower levels of carcinogenic ingredients.

But, if US tobacco companies were to introduce such changes to American cigarettes, and thereby reduce lung cancer rates associated with smoking, they would be in violation of the law if they were to make that information available to the public. Even if cigarettes were made safer, tobacco companies would be prohibited from telling anyone.

And, that's the real absurdity of the FDA legislation. It prevents tobacco companies from telling the bloody truth. It's bizarre in the extreme.

According to the brief submitted by the tobacco companies, they are even prohibited from “making truthful statements about their products in scientific, public policy, and political debates—speech that receives the highest level of protection and is subject to strict scrutiny review. For example, one key provision of the Act prohibits Plaintiffs from making truthful statements about the relative health risks of tobacco products to “individual tobacco users,” if the FDA determines that such truthful statements would not “benefit the health of the population as a whole.”

The lawsuit by the tobacco companies also contests restrictions on advertising and government-mandated graphic warnings on cigarette packs. “Another restriction renders completely ineffective the one place where such color imagery can be used: Plaintiffs’ packaging. The top half of the front and back of all cigarette packaging is appropriated by a Government-drafted anti-tobacco message, including shocking, color graphic images and other mandated information, leaving Plaintiffs with just a small portion of the bottom half of their cigarette packages to communicate with adult consumers. The obvious purpose of this is to force Plaintiffs to stigmatize their own products through their own packaging.”

It will be interesting to see how this lawsuit unfolds.

Similar provisions in Canada's Tobacco Act were contested by Canadian Tobacco Companies under Canada's Charter of Rights and Freedoms, which states: “Everyone has the following fundamental freedoms: 2(b) freedom of thought, belief, opinion and expression, including freedom of the press and other media of communication.”

The government conceded that the provisions were an infringement on the right to freedom of expression under the charter, but argued that limits on that right were justified to protect the public health.

In 2007, Canada's Supreme Court unanimously upheld the Tobacco Act provisions denying the rights of the tobacco companies.

Will American courts place greater value on constitutional rights than their Canadian counterparts?

Sunday, September 6, 2009

Chantix works on a smoker's brain

Varenicline is a smoking cessation drug developed by Pfizer. It is sold under the brand name Chantix in the US and Champix in Canada and Europe. And, thousands of users consider its use a recipe for disaster.

It is thought to work by reducing the smoker’s urge to smoke and by relieving craving and withdrawal symptoms because it is apparently capable of mimicking the effects of nicotine to some degree. And, by binding to nicotine receptors in the pleasure centre in the brain, it can also reduce the pleasure derived from smoking.

The Chantix website explains: “CHANTIX is different from most other quit-smoking products. It targets nicotine receptors in the brain, attaches to them, and blocks nicotine from reaching them. By activating these nicotine receptors, it is also believed that CHANTIX causes less dopamine – compared to nicotine – to be released.”

It is believed that . . . ? Are they really saying they don't know? Some might consider that somewhat akin to a chemically induced frontal lobotomy for smokers.

Since its introduction to the market, there have been a continually growing number of complaints about this latest “wonder drug” from the pharmaceutical industry.Thousands of people have complained of serious side-effects associated with the drug, the most disturbing of which is suicidal ideation, which may have resulted in 100 or more actual suicides.

The US FDA (Food and Drug Administration) recently advised the manufacturers of the smoking cessation drug to carry a suicide warning. But, Chantix, despite concerns of the FDA and the public, has not been pulled from the market.

In many respects, it is getting the same kid-glove treatment afforded another smoking cessation drug, Zyban, and an anti-depressant medication, Wellbutrin, both of which are distributed by Glaxo-Smith-Kline under the trade name bupropion. Zyban has also been implicated as the cause of serious side-effects, including suicide, among users.

The drug manufacturers are permitted to keep marketing the drugs in the US by simply including a cautionary “black box” warning (the FDA's most serious caution) on the packaging and instructions for use, advising users of the possible side-effects.

The warning, of course, does little to reduce the potentially life-threatening side-effects of Chantix (or Zyban). It does, however, reduce legal liability for Pfizer, the manufacturer of the drug. They can now claim that they followed the directives of the FDA regulators (or Health Canada, or Britain's NHS, etc.) and warned consumers of the potentially serious side effects of the smoking cessation drug.

But, Pfizer needed FDA approval to market the drug in the first place. And, to obtain that approval, they were required to conduct clinical trials. So, why weren't the life-threatening side-effects noted during those trials?

Well, according to a synopsis of the study released by ASH (UK),
“Trial entry criteria included good health, male and female smokers aged 18 to 75, smoking at least 10 cigarettes per day during the past year, no prior use at all of varenicline or bupropion for any indication, and being motivated to stop smoking. Smokers were excluded if they had had serious or unstable disease within six months, weighed less than 7st 2lbs (100lbs / 45kg) or had a BMI of less than 15 or more than 38, had a history of drug or alcohol abuse in the past year, had used another form of tobacco, or marijuana, in the past month, had used NRT, clonidine or nortriptyline in the past month, had received any treatment for major depression in the previous 12 months, had a history of or current panic disorder, psychosis or bipolar disorder, or had contraindications for bupropion (Zyban and ellbutrin).”

In other words, the study participants did not accurately reflect the demographic for which the drug was intended. Only comparatively healthy individuals with a strong motivation to quit were included in the trials. The drug trials ignored the fact that a substantial portion of the smoking population for whom Chantix would be prescribed would likely suffer from the full spectrum of heath concerns which were deliberately excluded from the studies.

Even the authors acknowledge the limits of the trials.
“First, participants who volunteer for clinical trials of investigational drugs tend to be in better general health and are by definition more motivated than those in a typical primary care population. The external validity of the trial is also limited by the fact that individuals with serious medical illness or current or recent depression were excluded from the trial.”

The recent FDA ruling means that both the makers of Chantix and Zyban will be required to conduct clinical trials to assess the mental health risks associated with the drugs. Oh, well. Better late than never, as the old saying goes.

But, despite the alleged risks to users, Chantix (Champix) is still widely advertised on television and in other media. And, supporters of the drug in the anti-smoker cartel continue to aggressively promote the drug.

Dr. Curtis J. Rosebraugh, director of the drug evaluation office at the FDA which approved the drugs, is quoted as saying:
“Stopping smoking is a goal we should all be working towards. We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”

Just be careful? The logic (or lack of it) is mind-boggling. Smokers must be helped on their way to smoke-free Nirvana, even if it means killing off a few hundred and making life miserable for thousands more. But, what the Hell? Only smokers will suffer the alleged adverse consequences of using these drugs.

And, as Clive Bates, of ASH (UK), told BBC News Online: "Most of these people would have died anyway.” Uh-huh. Smokers, it seems, have become expendable; sacrificial lambs to be offered on the altar of the Great God, Public Health.

So what else is new?

Wednesday, September 2, 2009

Evaluating the statistics Part 2

As noted in my last post, the method of calculating smoking attributable deaths raises a lot of questions.

For example, Health Canada managed to reduce the number of smoking related deaths by roughly 22%, just by changing the data set used in their calculations. In 2007, they were claiming 47,581 smoking related deaths, but by the summer of 2008, there were only 37,203 deaths attributed to smoking. But, there were no more, and no fewer, actual deaths. The reduction was in the statistical deaths attributed to smoking calculated by Health Canada.

No big deal you say? They found an error in their calculations and corrected them.

But, from 1998 to 2008, the inflated numbers were quoted by the anti-smoker crowd, the press and politicians as gospel. And, in fact, the exaggerated numbers are still being used by many in the anti-smoker brigade. Physicians for a Smoke-free Canada is but one example. And, the dramatic reduction in smoking attributable mortality was not considered sufficiently newsworthy to be reported by the major news media in Canada.

Had smoking related deaths increased by only half that amount, it would have been front page news.

According to Health Canada, persistent HPV infection with high risk types, is the major cause of cervical cancer. It is estimated that over 99% of cervical cancers are caused by HPV.

This contention is supported by the Canadian Cancer Society: “Nearly all cervical cancers are caused by persistent high-risk HPV infection. High-risk types of HPV are considered known cancer-causing agents. About 70% of cervical cancers are associated with high-risk HPV type 16 and 18. Other high-risk types of HPV are associated with the other 30% of cervical cancers.”

But, if you look in the smoking attributable mortality tables prepared for Health Canada, 34.7% of cervical cancers (126 of 362 deaths) are attributed to smoking. Is this claim even remotely possible? Was the data on HPV and cervical cancer too recent to have been taken into consideration in calculating smoking related deaths? And, even if that were the case, does it not point out the tenuous nature of the original data linking cervical cancer to smoking?

But, the inclusion of cervical cancer in the ever expanding list of smoking related diseases becomes even more suspect, when you realize that data suggesting HPV was likely responsible for all cervical cancers has been available since 1999.

A similar situation is developing with mounting evidence of a link between lung cancer and HPV. Health Canada claims that 88.6% of male lung cancers are caused by smoking. Another 1.5% are said to be caused by exposure to SHS. And, 10% of lung cancers are caused by exposure to radon gas, the second leading cause of lung cancer behind smoking. That's 100% of male lung cancers for which the cause has, allegedly, already been found

But, that leaves no room for the deaths that may have been caused by exposure to asbestos or any of the other dozen or more risk factors associated with lung cancer. At least for men. Of course, any deaths associated with exposure to asbestos, beryllium, uranium, diesel exhaust, smog, etc. may be exclusive to the female component of the population. But, you'd think that was something someone should have mentioned.

So, what should we make of recent studies suggesting that HPV, not radon, may be the second leading cause of lung cancer. And, one study from Germany does just that: “The data suggest that HPV is the second most important cause of lung cancer after cigarette smoking and strongly argues for additional research on this issue.”

The study also notes that: “Overall, the mean incidence of HPV in lung cancer was 24.5%. While in Europe and the America the average reported frequencies were 17% and 15%, respectively.”

Even the anti-smoker claim that 85% to 90% of all lung cancers are caused by smoking doesn't hold up to scrutiny. According to Health Canada, 13,401 of 17,188 lung cancer deaths were caused by smoking. But that's only 78%.

Nit-picking? Maybe . . .

Smoking may contribute to morbidity and mortality from some diseases. But, if Health Canada and the rest of the anti-smoker cult have to resort to deceptive statistics to convince the public of the hazards of smoking, how can anyone have any confidence in anything they say? And, the statistics are deceptive, both in fact and presentation.

Has anybody ever wondered how Health Canada can state with such precision how many deaths from IHD were caused by smoking, but they can't tell how many may have been caused by stress, diet or lack of exercise? How can they determine that exactly 13,401 lung cancer deaths were caused by smoking, but the best they can come up with for exposure to radon in the home is “about 2,000”?

How many Canadians know, for example, that despite the fact that smokers comprise 20% of the population, only 13% of the over 40,000 IHD (Ischemic Heart Disease) deaths are attributed to smoking? How many are aware that, according to the Lung Cancer Alliance, “over 60% of new cases (of lung cancer) are never smokers or former smokers, many of whom quit decades ago.”

How many Canadians know that smoking related illness is a fiction; that people die from heart disease and lung cancer whether they smoke or not. How many are aware that smoking related statistics are based on speculation and conjecture; that they are being used as a propaganda tool by the health scare professionals in the anti-smoker cult?

But, perhaps the most important question is why the public, the press and politicians seem so eager to buy into the bullshit and bafflegab.