Wednesday, May 30, 2012

Reducing Tobacco Dependence: A Compelling New Rationale for Switching

We’ve long known that smokers who switch to smokeless tobacco substantially increase their chances for longer and healthier lives.  Now there’s compelling evidence that switching to smokeless can help smokers achieve complete tobacco and nicotine abstinence. 

Swedish nicotine expert Dr. Karl Fagerström and Virginia Commonwealth University psychologist Dr. Thomas Eissenberg assessed the addictiveness, or dependence, of various forms of tobacco and nicotine (abstract here).  Researchers in this field have developed a plethora of complex and sophisticated instruments to measure dependence.  For example, Dr. Fagerström developed the most widely used dependence scale for cigarette smoking – the Fagerström Test for Nicotine Dependence.

For their new analysis, Fagerström and Eissenberg took a simple, brilliant approach.  They assessed dependence for cigarettes, smokeless tobacco and medicinal nicotine by looking at the quit rates from clinical cessation trials for each of these products.  However, instead of looking at the treatment groups, they looked at the placebo groups; these provide baseline quit rates for cigarettes, smokeless tobacco and medicinal nicotine.  With this data, they could compare the relative quit rates for the three products.

The researchers found that the quit rate for cigarettes in these aggressive clinical trials was around 10% -- probably twice as high as that seen among the general population.

The average quit rate for smokeless tobacco was about 25% (range 19 – 33%), and the rate for quitting long-term nicotine gum use (in one study) was 36%.  The higher quit rates indicate that these products are less addictive than smoking. 

Fagerström and Eissenberg concluded that “…quitting cigarette smoking is more difficult than quitting smokeless tobacco and, although there is only one study from the [medicinal nicotine] category, that quitting these products may be easiest….the cigarette may be, in addition to the most harmful product, the most dependence-producing product.”

Harm reduction opponents have argued for years that switching is not a viable option because it perpetuates nicotine addiction.  This study shows that smokers who switch to smokeless tobacco may markedly improve their odds of achieving complete abstinence, in addition to improving their health.

Wednesday, May 23, 2012

Quitting with Acupuncture, Hypnosis and Aversive Smoking

A new study by investigators at McGill University in Montreal found that there is clinical trial evidence for acupuncture, hypnosis and aversive smoking as aids to quitting.  The lead author was Dr. Mehdi Tahiri, and the study was published in the American Journal of Medicine (abstract here). 

Tahiri and colleagues examined evidence from 6 clinical trials of acupuncture.  They found that the procedure increased the odds of quitting (Odds ratio, OR = 3.5, 95% confidence interval 1.03 – 12.0), compared with the control (a sham procedure). 

The researchers found four clinical trials of hypnosis, which also had a positive effect on quitting.  However, the increase was not statistically significant (OR = 4.6, CI = 0.98 – 21).

Aversive smoking may be unfamiliar to many readers.  It involves taking a drawing on a cigarette every 6 seconds for 3 minutes, until the person smokes three cigarettes, or until the person is unable to smoke.  After a short rest, this is repeated two or three times.  Tahiri found four trials during the period 1973 to 1983.  It produced higher quit rates (OR = 4.3, CI = 1.3 – 14.4).    

Tahiri and colleagues conclude: “Acupuncture and hypnotherapy are used by a large number of smokers as alternative smoking cessation aids. Our results suggest that these alternative aids may help smokers quit.  Thus, we recommend that physicians promote the use of acupuncture and hypnotherapy. Aversive smoking also may help people quit, but because the studies investigating this intervention were old, we believe that new studies are needed to recommend this intervention to physicians.”

There are some other things that smokers need to know.  First, all of the ORs mentioned earlier are compared to control groups, who have abysmal rates of quitting.  So a three-fold increase in a tiny number is still tiny.  This is especially important because, as Tahiri writes, “These alternative aids are costly, with the total price of each therapy ranging from $400 to $1000.” 

Smokers need to spend their money wisely, which requires searching for legitimate practitioners with well-established track records in providing these services.  For smokers who are committed to abstinence, acupuncture, hypnosis and aversive smoking may be options.

Wednesday, May 16, 2012

Death by Regulation: Analyzing Tobacco Harm Reduction in the European Union

While the outlook for FDA approval of “reduced risk”-labeled products is cloudy (as I discussed recently here), many safer smokeless tobacco products, minus the “reduced-risk” label, are being sold in the U.S.   In the European Union, the picture is bleaker: Snus is banned everywhere but Sweden. 

Clive Bates has written an insightful analysis of the absurd EU policy on vastly safer tobacco products.  He asks, “Is it right to ban certain types of smokeless tobacco from sale in the European Union?  The short and unequivocal answer is ‘no.’” 

Bates is well qualified to address EU policy.  He was director of Action on Smoking and Health in the UK from 1997 to 2003, and he has held high-level positions in the UK and Welsh governments.  In 2003, he was the principal author of a landmark analysis of the EU ban (available here).

Bates addresses three “major policy failings” related to the EU ban: public health science is ignored and abused; ethics and consumer rights are violated; and EU legal principles have been disregarded.  Following are selected passages from his essay that are relevant to U.S. regulation; the piece is worth reading in its entirety (here).

Public Health Science Is Ignored and Abused

Bates provides evidence that “The data is there for anyone who is prepared to look…Sweden provides a dramatic ‘proof of concept’ for smokeless tobacco as a population level harm-reduction product, based on the choices made by tobacco users unaided by the state.  Sweden has by far the lowest level of tobacco-related mortality in the developed world, the lowest rate of smoking and the highest use of tobacco in smokeless form.”

“In my view, the abundance of evidence suggesting a likely positive impact from wider introduction of smokeless tobacco shifts the burden of proof.  With evidence like this and clear proof of the harm reduction concept in Sweden, it should be up to those who want to ban these products to produce evidence of likely unintended and severe consequences that would outweigh the plausible benefits.  I don’t wish to overdramatise this, but when a government does something that stops people taking action to reduce their risk, they become culpable for the harm caused – up to and including death.”

Ethics and Consumer Rights Are Violated

“What is the ethical position of the legislator or campaigner seeking to ban a potential harm reduction product?  Impossible to defend in my view.  In doing so, they are denying an option to reduce harm, and so may be causing more harm and possibly premature death through their actions.  Pressing for a ban on these products is quite an abusive thing…to do to someone facing the risks from long-term smoking. Where is the legitimacy for that?”

EU Legal Principles Have Been Disregarded

Bates details how the EU ban violates four legal principles.  I’ll quote only his summary: “Is the EU ban on oral tobacco lawful?  No, basically. It is arbitrary, disproportionate, unjustified and violates the principles of the internal market – and therefore it is unlawful.”

What Now?

Bates issues a clear challenge to the European authorities: “The [EU] Commission, European governments and major health charities have largely been in denial about tobacco harm reduction – apparently seeing a ban on any tobacco product as progress, irrespective of the body of evidence that suggests otherwise.  They have been unwilling to face the idea that banning a low-risk tobacco product might actually be a bad idea and end up killing many more people than it saves by denying them an option to reduce risk. I do not know whether it is negligence, incompetence or cynicism that leads them to do this, but I hope they will look again at the evidence and reconsider their position.  Decisions like this do have lethal consequences, those advancing them are morally obliged to take a truly evidence-based approach, not the approach that is most comfortable from a [public relations] point of view.  There is an abundance of science and carefully argued reasoning for lifting the ban on smokeless oral tobacco in the EU. This is the most serious of all public health issues and most insidious driver of health inequalities – the lives of real European citizens are at stake.”

Bates closes with a prescription for progress in the EU:

“Here’s what I think should happen:

•    “The ban on smokeless oral tobacco is unjustified, illegal, harmful to health and represents a denial of consumer and human rights.  It should be lifted without delay.

•    “The [EU] Commission, member states and elements of the public health community should not misuse the science of smokeless tobacco and harm reduction or use the [Scientific Committee on Emerging and Newly Identified Health Risks] report to justify a ban on a sub-category of smokeless tobacco.  The science does not justify any ban on these products while cigarettes remain widely available and while more hazardous forms of smokeless tobacco is sold freely.

•    “Smokeless tobacco forms part of a ‘harm reduction’ market for lower risk alternatives to smoking – this could be an important market commercially in future, and if it does become sizeable, it will have considerable health benefits by reducing smoking.  The EU could facilitate development of this market by setting standards for toxins present in smokeless tobacco placed on the market in the EU.

•    “To balance the market in favour of reduced risk products, governments should consider favourable excise tax treatment, relative to smoked tobacco, for nicotine products with greatly reduced risk, and allow meaningful risk communication through product marketing.

•    “The public health community should be honest about the relative risks of smokeless tobacco and smoking, take an evidence-based approach to policy, and adjust its posture towards harm reduction strategies accordingly. It is lethally irresponsible to mislead smokers about less hazardous alternatives to smoking.”

Tuesday, May 8, 2012

Smokeless Tobacco Not a Risk Factor for Cancer of the Salivary Glands

Two celebrities -- Adam Yauch ("MCA" of the Beastie Boys) and Tony Gwynn (Hall of Fame baseball player) -- were recently reported to have suffered salivary gland cancer. This has prompted questions about tobacco use as a possible risk factor.

Cancer of the salivary gland is exquisitely rare. For perspective, data from the Surveillance Epidemiology and End Results (SEER) program at the National Cancer Institute reveal that there were only about 34 cases of oral/throat cancer annually among 100,000 men ages 40-84 years from 2001 to 2006 (see my recent post here).

In comparison, SEER data show a mere 2.3 cases of salivary gland cancer within that group, or 23 cases per million men.

Few epidemiologic studies have looked at tobacco use as a risk factor for salivary gland cancer; most are from the 1990s. Researchers from the M.D. Anderson Cancer Center in 1990 found that tobacco use was not a risk factor in an analysis of 64 cases (abstract here). They did find that a history of radiation therapy was a risk factor in both men and women (odds ratio, OR = 2); among women, high education, alcohol and use of hair dyes doubled the risk.

A 1997 report based on 141 cases suggested that smoking elevated the risk of salivary gland cancer (abstract here), but it the increase wasn’t statistically significant (OR = 2.1, 95% confidence interval = 0.98 – 4.7). That study confirmed the risk for radiation, and also reported that occupational exposure to nickel compounds (OR = 6) and heavy alcohol use (OR = 2.5) were significant risk factors.

In a 1998 study involving 128 cases of salivary gland cancer (abstract here), investigators reported that “Cigarette smoking and alcohol consumption did not independently or jointly increase the risk of salivary gland cancer. Chewing tobacco and snuff use were also unrelated factors.”

In summary, there is little evidence that smoking is a risk factor for salivary gland cancer. For smokeless tobacco, there is no evidence.

Wednesday, May 2, 2012

Regulatory Purgatory: Tobacco Harm Reduction at Risk

I recently testified before the Kansas legislature in support of a resolution asking the state health department to review the scientific evidence for tobacco harm reduction and its potential benefits for smokers.  An American Cancer Society spokesperson opposed the resolution, saying that because the U.S. Food and Drug Administration (FDA) regulates tobacco, it is unnecessary and a waste of resources for any other agency to review tobacco harm reduction.

The FDA was authorized to regulate tobacco in 2009.  In March of this year, the agency released a 50-page draft document advising what information will be required for a product to be accepted by the agency as “modified [i.e. reduced] risk” (available here). 

The FDA’s “key areas of investigation” are listed after this post.  While decades of scientific investigation have established that smokeless tobacco use is at least 98% safer than smoking, this FDA guidance suggests that the agency will require dozens of new studies on minute product details and human effects. 

As many of the proponents of the 2009 bill intended, this new regulatory maze will condemn smokeless tobacco products, and therefore tobacco harm reduction, to purgatory.

FDA drug regulation is so burdensome that it takes up to $2 billion and 15 years to get a new drug approved, according to a study from the University of Texas M.D. Anderson Cancer Center and the Baylor College of Medicine (abstract here).  This study also showed that “regulatory fundamentalism” slows the development of new drugs, resulting in the loss of lives.

It is evident that FDA approval of a reduced risk claim for tobacco products will require similar resources and a similar time frame.  With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 more Americans will die every year. 

One thousand two hundred and five deaths.  Every.  Single.  Day. 

In the absence of rational FDA regulation, nicotine-addicted smokers should quit cigarettes and avail themselves of the many smoke-free harm reduction products that are currently on the market.  The roster of highly credible research and policy experts endorsing tobacco harm reduction continues to grow, providing more science-based support for smokers to switch. 

The FDA should abandon regulatory fundamentalism that condemns safer product development to a purgatory of red tape.

Following are the FDA’s five “key areas of investigation” for a modified risk tobacco product:

1.       1. Health risks of the tobacco product

a.       Human studies that show the product’s use will result in a significant reduction in harm and the risk of tobacco-related disease to individual tobacco users.
b.      The health risks associated with use of the product as compared to using other tobacco products on the market, including tobacco products within the same class of products;
c.       The changes in health risks to users who switch from using another tobacco product to using the product, including tobacco products within the same class of products;
d.      The health risks associated with switching to the product as compared to quitting the use of tobacco products;
e.       The health risks associated with using the product in conjunction with other tobacco products;
f.       The health risks associated with switching to the product as compared to using an FDA-approved tobacco cessation medication; and
g.      The health risks associated with initiating use of the product as compared to never using tobacco products.

2.      2. The effect the tobacco product and its marketing may have on tobacco use behavior among current tobacco users

a.       Nonclinical and/or human studies to assess the abuse liability and the potential for misuse of the product as compared to other tobacco products on the market; and
b.      Human studies regarding actual use of the product and consumer perception of the product, including its labeling, marketing and advertising.
c.       The likelihood that current tobacco product users will start using the product;
d.      The likelihood that tobacco users who adopt the product will switch to or switch back to other tobacco products that present higher levels of individual health risk;
e.       The likelihood that consumers will use the product in conjunction with other tobacco products;

3.      3. The effect the tobacco product and its marketing may have on tobacco use initiation among non-users (both never users and former users)

a.       Human studies that evaluate consumer perception of the product, including its 774 labeling, marketing and advertising.
b.      The likelihood that consumers who have never used tobacco products, particularly youth and young adults, will initiate use of the tobacco product;
c.       The likelihood that non-users who adopt the tobacco product will switch to other tobacco products that present higher levels of individual health risk; and
d.      The likelihood that former users of tobacco products will re-initiate use with the tobacco product.

4.      4. The effect of the tobacco product’s marketing on consumer understanding and perceptions

a.       Human studies regarding consumer understanding of the product, including its labeling, marketing and advertising;
b.      The ability of consumers to understand the modified risk claims and the significance of the information in the context of one’s health;
c.       Consumers’ beliefs about the health risks of using the product relative to other tobacco products, including those within the same class of products;
d.      Consumer beliefs about the health risks of using the product relative to cessation aids; and
e.       Consumer beliefs about the risks of using the product relative to quitting all tobacco use.

5.      5. The effect the tobacco product and its marketing may have on the population as a whole

a.       Quantitative estimates of the effect the marketing of the product, as proposed, may have on the health of the population as a whole;
b.      Tobacco users who switch from other commercially marketed tobacco products to the proposed product;
c.       Tobacco users and non-users who, after adopting the proposed product, switch to or switch back to other tobacco products that may present higher levels of individual health risk;
d.      Tobacco users who opt to use the proposed product rather than cease tobacco use altogether;
e.       Tobacco users who opt to use the proposed product rather than an FDA­ approved tobacco cessation medication;
f.       Non-users who initiate tobacco use with the proposed product, such as youth, never users, former users;
g.      Tobacco users who use the product in conjunction with other tobacco products; and
h.      Non-users who experience health risks from the product.