1) Issues of Informed Consent Have Been a Barrier to Tobacco Control

The public believes that "everyone knows that smoking is bad". We can back up this assertion with the polling results that show the high percentage of smokers, and the general public, who state that they believe smoking is harmful, causes disease, is "really bad for people" etc.

2) But True Informed Consent Means More than a General Belief in Potential Harm

We need to expand upon the concept of "informed consent". This could be aided by legal or philosophical writings. Being a lawyer, and looking at the litigation and legislation possibilities, I would want to concentrate on the sources that would be most valuable in influencing courts and politicians. Canadian courts have, for instance, clearly enunciated the principle of informed consent. As stated by the Ontario Court of Appeal in the 1986 case of Buchan v. Ortho Pharmaceutical (54 O.R.(2d) p.92):

A manufacturer of a product has a duty to warn consumers of the dangers inherent in the use of its product, of which it knows or has reason to know. The warning must be adequate. It should be communicated clearly and understandably in a manner calculated to inform the user of the nature of the risk and the extent of the danger; it should be in terms commensurate with the gravity of the potential hazard, and it should not be neutralized or negated by collateral efforts on the part of the manufacturer.

This line of reasoning should be expanded with relevant quotes from whichever jurisdiction we would be using to gather polling information. For example, in the U.S. it would be important to consider FTC law and product liability law.

We can then outline the two key concepts (as I see them) on informed consent with respect to tobacco products:

* The first is that due to a combination of age of onset and dependence, many smokers are never able to make – and act on – fully informed decisions. This argument can be expanded upon by use of existing polling data (e.g. U. of Michigan and CDC) on age of smoking onset and the extensive litterature on tobacco dependence (perhaps buttressed by information showing that those with nicotine dependence have little choice but to use tobacco products as the way of obtaining nicotine).

* The second key point would be to show, with­in the constraints already explored, what smokers would need to know to make informed decisions. This should include the following:

1. Consumers would need to know the diseases, and other deleterious outcomes, which are caused . Knowing only some of the diseases would not be sufficient if they succumb to a different one, and were there a reasonable basis to believe that, had they known, their behaviour would have been different. Here we can use past data from FTC and assorted surveys to show the lack of awareness of the various diseases smoking causes. To make the case for a current lack of informed consent, though, we will need up-to-date polling information that asked smokers, in an open-ended manner; to list the diseases caused by smoking. This data can then be used to show what proportion of smokers do not even recall specific disease categories.

2. They would have to know the likelihood of contracting such a disease.

Knowing that particular problems can result from a product is of little consequence if consumers do not know the likelihood of this occurring to them personally. I do not know what historic information is available. In addition to such information we could use new polling information to show the degree of awareness of the likelihood of contracting each of the diseases they could recall.

3. They would have to know the prognosis should they contract one of these diseases . Knowing, for instance, that smoking causes lung cancer and knowing the increased likelihood of contracting lung cancer is not sufficient if the consumer believes that such a disease is easily treated and cured. This can be answered through polling questions such as «in your opinion, what percentage of lung cancer cases will result in death?» Similar questions could be asked of some of the other diseases caused by tobacco use.

4. They would have to know the benefits of behavioral change . Knowing the magnitude of the risks is not sufficient if there is an underestimation of the benefits of quitting or an overestimation of the benefits of using a particular type of tobacco product. An obvious question to ask would center around how soon after smoking cessation does one"s risk of a heart attack begin to be reduced.

5. They would need to know how to change their behaviour . Knowing the magnitude of harm from smoking and recognizing the benefits of quitting smoking is not sufficient if smokers are not aware of how to successfully quit. They need information on how to quit or otherwise reduce their risks. Comparing attitudes and use of NRT to the science on its efficacy could illustrate this point. Further, we should explore the "false options" – such as beliefs about «light» cigarettes as an alternative to smoking cessation. This would also be an ideal place to examine beliefs about smoking cessation itself – do smokers see it as a "process" or do they see it as a "one-off" sort of thing. This would also be a good place to present data on the percentage of smokers who believe smoking while using NRT is a dangerous activity.

6. They need access to the products or services that can help them change their behaviour . Informed consent means little if people are not able to act on the information available to them. Knowing the magnitude of harm from smoking, the benefits of cessation and the efficacy of smoking cessation products does not suffice if these products are not readily accessible or if there is inaccurate information about the effects of these products. Polling questions for smokers could include knowledge of where and how to get smoking cessation treatments. Questions could also look at consumers" perceived barriers to these products (e.g. does the limited availability, lack of consumer choice of flavors, large package sizes, etc. reduce consumer acceptability.

3) Whether Informed Consent Exists is a Testable Hypothesis

The research conducted should allow us to easily determine whether smokers have actually been given sufficient information to make fully informed decisions. This can be done quickly and relatively easily through public polling research.

4) Past Evidence

This issue was examined by the U.S. Federal Trade Commission 20 years ago and reported on in the Staff Report on the Cigarette Advertising Investigation. They used survey data from 1978 to 1980, most of it actually from the tobacco companies. Americans did not know the magnitude of the risks.

* 40   % of smokers were unaware that light smoking was dangerous.

* 49   % of smokers were unaware that smoking caused most cases of lung cancer.

* 37   %–47   % of smokers were unaware that smoking caused heart disease

* 63   %–85   % of smokers were unaware that smoking caused most cases of bronchitis and emphysema.

* 49   % of smokers were unaware that smoking was addictive.

It is important to note that, due to the lag time between smoking uptake and the resulting diseases, many of those who were the subject of the surveys by the FTC are among those now dying from tobacco related diseases.

5) More Recent Evidence

The research firm Marttila & Kiley looked at issues surrounding smoking in 1993. The findings included the fact that only 21   % of Americans could identify smoking as the leading cause of death. 28   % picked car accidents, 16   % illicit drugs, 12   % AIDS, 12   % Alcohol abuse and 7   % murders.

These results can be compared to the reality: Smoking at that time killed nine times as many as car accidents, 76 times as many as illegal drugs, 14 times as many as AIDS, four times as many as alcohol and 20 times as many as homicide.

In Ontario, Canada a polling firm was retained in late 1990 to look at issues of consumer knowledge about smoking"s risks. This research found that unaided recall of «health hazards related to smoking», by smokers, was very poor. Lung cancer was recalled by only 43   % of smokers, emphysema by only 19   %, heart disease by 23   %, oral cancer by 3   % and stroke by only 3   %. This gives a clear indication that there was no appreciation of the diseases caused.

A further question asked in the Ontario poll was: «To the best of your knowledge, what percentage of lung cancer cases result in death?» The answer to this question is important in determining whether the public understands the prognosis should they contract what is the best known of the diseases caused by smoking. Among smokers only 13   % correctly responded that the risk was greater than 80   %. Only 43   % guessed that the risk of death was greater than 50   %.

To test whether there was awareness of the benefits of quitting smoking the poll also asked: «To the best of your knowledge, when does the risk of heart disease begin to decline once a person has permanently quit smoking?» Among smokers only 15   % could identify that the reduction in risk would occur within six months.

While the Ontario research did not probe all areas necessary to determine the degree of informed consent, the results clearly show that smokers were ill prepared to make fully informed decisions. Smokers simply did not have sufficient knowledge to make informed personal health decisions.

6) Very Recent Information

In the United States a Gallup poll was conducted in the summer of 1998. It examined issues related to smoking cessation and was released in October. It found that 68   % of smokers are interested in quitting, and that 56   % believe they will be ex-smokers within one year. This clearly indicates that many smokers are not continuing to smoke due to individual choice, and is consistent with a vast literature on tobacco dependency. It also shows that there is a vast over-estimate of the likelihood of quitting smoking within a year (on an unaided basis the research shows a success rate per cessation attempt of about 3   %).

Importantly, this Gallup research also reported that 38   % of Americans believe the nicotine in nicotine replacement therapy products (patches, gum, inhaler, etc.) causes lung cancer. As nicotine itself is not carcinogenic this inaccurate association of risk with a product that can save their lives is further evidence of a lack of informed decision making.

7) Other Issues

The research undertaken should, ideally, explore issues of personal relevance of health information. Many smokers may "know" health information but believe it does not pertain to them. This issue could conceivable be explored by, when asking general information questions, following up on the smoker"s perception of their own risk. For instance, after a question on the prognosis for lung cancer, the survey could ask, «and, in your case, given your understanding of your specific personal attributes and circumstances, what do you believe your personal risk of death would be?»

Additionally, there are issues about the collateral efforts of tobacco companies to discount health information and to market deceptive "alternatives" to cessation. This involves issues such as «light» cigarettes, but could also include an historical overview of tobacco industry efforts to undermine health information. The court documents present a treasure of such information.

My belief is that the results of such research would be conclusive evidence of misinformation and deceptive practices under trade practices (and possibly other consumer protection) laws. Even in areas where preemption would come into play this information could be a key strategy in ending the protection enjoyed by the tobacco industry. In order to ensure that the research done has maximum social utility I propose running the research concept past experts in relevant areas of consumer law (e.g. Judy Wilkenfeld in the U.S.). I would also work through the questions themselves with recognized experts in survey design (such as fellow Canadian Dr. Tom Stephens).

8) How can this Information be Effectively Communicated to Juries and to Regulatory Authorities?

We can communicate a message about the lack of informed consent through a regulatory-based public education effort. This can be done through the use of existing legislative/regulatory measures such as consumer protection laws, trade practices laws, consumer packaging and labeling laws, etc. In most, if not all, developed countries there is a strong framework of law to protect the public against misleading business practices. Further, tobacco products are seldom specifically excluded from all aspects of such laws. In the U.S., for instance, the FTC has authority over misleading business practices, and the preemptive language tobacco companies have received from Congress on health warnings does not apply to such issues as the FTC banning «light» cigarettes as misleading labeling.

In some cases the deceptive practices which could be targeted are actual statements by the tobacco companies. For instance, «light» cigarettes are now over 55   % of the U.S. cigarette market, and a large and growing segment of the European market. Given a scientific consensus that such products do not significantly reduce health risks it is possible to determine whether the reality about such products is markedly different from consumer perception. This allows measurement "consumer fraud". Do consumers think that «light» or «low tar» cigarettes reduce harm? If so, in which ways and to what extent?

Other complaints, which could be filed, could target failure to give relevant information. This could include failure to inform the public about the role of nicotine; the use and efficacy of nicotine based pharmaceuticals for smoking cessation, and about specific health issues associated with tobacco use.

By taking action under consumer protection laws we could force changes in tobacco marketing that will have an independent positive impact on consumer knowledge of risks. At the same time, the actual changes in the marketplace – such as the removal of deceptive packaging – will drive home the public message that smokers were not given full information. That, in turn, will influence cessation activities – and juries.»