Monday, 24 March 2014

Day 220: A very different view of the world

Today, a man whose business is to design warnings and product information notices and whose academic career is based on evaluating such warnings and notices told the court that warnings have no effect on behaviour. He also said he expected any manufacturer of a dangerous product would immediately, on discovering the danger, go to the government’s public health authorities to report it and work on mitigating the danger to the public. Many in the court were scratching their heads in puzzlement. What planet was he from?

In fact, he is from the state of Michigan, Ann Arbor to be exact. Stephen L. Young, PhD, CPE, is a senior consultant with Applied Safety and Ergonomics, Inc. He explained that CPE means Certified Professional Ergonomist, a qualification certified by the Board of Certified Professional Ergonomists, and that ergonomics is also known as engineering psychology. He sits on various committees of the American National Standards Institute (ANSI, a body linked to ISO) and helps set standards for information and warnings in terms of colour, labelling and symbols, both in occupational settings and for consumer products.

Voir dire: qualifying the expert witness
Pierre Boivin began the voir dire questioning. Mr. Young had never considered the tobacco issue before, but applied the same principles he would use to assess warnings on ladders, lifejackets and personal watercraft. He was unaware of most research into the effectiveness of tobacco warnings (of which there is an abundance), although he had read some of the literature.

What did Mr. Young think of the Supreme Court of Canada’s statement (Exhibit 75-A, Para 135), “Further, both parties agree that past studies have shown that health warnings on tobacco product packages do have some effects in terms of increasing public awareness of the dangers of smoking and in reducing the overall incidence of smoking in our society.”? Mr. Young said this was not relevant for his purposes.

Mr. Boivin quoted again from the Supreme Court decision, “A mass of evidence in the intervening years supports this conclusion”. Mr. Young said he had seen this sort of statement but didn’t care.

Philippe Trudel picked up the thread and asked Mr Young how many documents he and his staff had considered before selecting the 195 referred to in his report. The witness took a long time to make his guess, some 200 to 300. Why did Mr. Young not ask his client for information from the industry? It was not in his mandate and he was confident he could figure out what a manufacturer would do. And had Mr. Young come to the conclusion that manufacturer’s warnings were unnecessary? Indeed, warnings were only necessary because the government believed them to be. For manufacturers, they were unnecessary in the past and continue to be today.
Warning: you may wandering off-topic
At this point, the defence objected that the plaintiffs’ lawyers were straying from the purpose of the voir dire but the judge agreed that asking about Mr. Young’s lack of knowledge about tobacco was not unfair. Mr. Trudel agreed to restrain himself, and asked about Mr. Young’s knowledge of tobacco warnings in the 1960s and 1970s and whether the public was aware of addiction issues in the 1970s. Mr. Young stated that some warnings in 1969 mentioned dependency, which he considered the same as addiction, but added that he was not an expert in that issue and not an “awareness historian”. (Hmm, said the observers, what is an awareness historian? But that question was unanswered.) Then there was another objection and the plaintiffs’ side was asked to leave this line of questioning for its cross-examination.

Mr. Trudel asked how a warning’s effectiveness is determined. Mr. Young replied that warnings convey information through their design and content. A warning is effective when people get the information; it has nothing to do with their behaviour. And how do you know people are getting the message? If the language is plain and the content is simple, it is not necessary to evaluate. If it is more complex, it is evaluated by interviews and focus groups who say what the message means to them. Once again, he said assessment has nothing to do with behaviour. Mr. Young was quite calm and stood with one or both hands in his pockets most of the time.

The next question was about measuring compliance. Mr. Young insisted warnings were not relevant to behaviour. Warnings, he said, convey information and they do not, should not and cannot influence behaviour. In a few more answers, he once again appeared to pride himself on his lack of knowledge about the history of tobacco warnings in Canada.

At the end of this voir dire questioning, the judge asked if the witness was acceptable. The plaintiffs said he had flaws in knowledge and methodology, but Justice Riordan agreed to accept the expert opinion, because he had access to actual documents even if his assistants did the research. In the end, the plaintiffs’ arguments were noted but the witness was not excluded. The probative value of his testimony will be weighed.

And then, while the concept that warnings have little or no influence on actual behaviour was echoing through the courtroom, Mr. Lockwood (supported by an unusually quiet Deborah Glendinning) began his direct examination of Mr. Young. 

An expert report can be a risky undertaking
First, what sort of documents did he look at in his research? Mr. Young did not intend to do a comprehensive study, but to establish the context, and can state that smoking was managed as a public health risk by the Government of Canada, which used varied methods over time. When was this? Not much before 1963, but the government started public education and research in earnest that year. For example it used books, posters, ads, toolkits and other educational items. Mr. Young did not specifically study public awareness but, he said, he became aware of it. He simply analyzed the sources of information and risk management strategies that were available. What is a public health risk? asked Mr. Lockwood. Mr Young’s reply: Public health officials implement interventions to reduce risk. (The observers wondered: Is that an answer? The next Q&A made more sense.) To the question Is smoking a public health risk, Mr. Young clearly replied that (1) it is managed as a public health risk and (2) the government has said it is a public health risk since 1963. Can public health risks involve products? Certainly. Alcohol and drunk driving, seat belts and their use, and obesity and food labelling were given as examples. Typically, the “authorities” use various means to manage risks, including education, regulation, taxation, enforcement and penalties. Public health officials within the government are the best placed to manage risks related to smoking; they have tools available that the manufacturers do not. And did Mr. Young see evidence of risk management in Canada related to smoking? Indeed, in the Isabelle report there are two sections dealing with the contribution made by tobacco growing and manufacturing to the Canadian economy. Thus, a balance was sought between the costs and benefits to society. The public must be protected, and the interests of various segments of the tobacco industry must be protected.

What is an acceptable risk (or a tolerable risk, as Mr. Young used the terms interchangeably)? It is a level of risk that can be tolerated by the society despite its existence (cars, for example). Governments establish acceptable risk by judging cost/benefit ratios, which may change over time. There are differences in acceptable levels of risk between societies as well, such as differing levels of blood alcohol tolerated in divers in various countries, or varying speed limits and seat belt legislation, all based on what is important to a society. Here we a number of charts, graphs, maps and pictures taken from his report –all were either grey-scale or fuzzy--to demonstrate differences. The tools government public health authorities use are media, legislation, regulation, enforcement and penalties. Warnings are also used, but Canada does not use on-product warnings for a number of risky products such as alcohol or fatty foods. Here Justice Riordan interrupted: is the nutritional information on food not a warning? The answer was No, it isn’t.

Mr. Lockwood and Mr. Young went over more examples from the latter’s expert report, summing up that typical product warnings provide people with information so they can manage risks themselves.
Residual risk is the only kind of risk for smoking

One important concept for Mr. Young is residual risk. What is it? Once you have managed all the likely risks, other risks still exist despite your actions. For instance you may be a good driver and your car in excellent condition, but someone else can drive dangerously and cause you harm. Do manufacturers deal with residual risk? Not usually: they warn about things you can control while using the product as it was intended. There is little utility in warning about residual risks. How do people become aware of residual risks? People just know. (At that statement, some eyes began rolling.) Has the Canadian government managed residual risk? Public health authorities will begin to manage residual risk when it reaches a certain level. As an example, with more concern about obesity, the food guide and labelling are used. Warnings are not put on butter.

Justice Riordan asked: how can people avoid residual risk? Mr. Young answered that the only way to avoid it is to avoid using the product.

Mr. Lockwood continued. Residual risk is present when a product is used as intended. Does this apply to smoking? Mr. Young answered that all the health risks associated with smoking are residual. The Department of National Health and Welfare wanted people to stop or not begin to use the product and the early warnings told people to “avoid inhaling”. Is “avoid inhaling’ related to residual risk? Yes it is. It is not a practical suggestion with regard to the intended use of the product.

Justice Riordan intervened, asking about moderation. Mr. Young said it was not a government position. The judge continued, referring to government advice that if people can’t stop smoking, they should smoke less. Mr. Young said that was not reasonable. And could the manufacturers say something different from the government message? Answer: that would be inconsistent with public health policy and the manufacturers should not do that. (This is the point some observers began to speculate about possible extraplanetary origins.) Justice Riordan continued: if McDonald’s advertises fatty foods in super sizes, is that inconsistent with public health? Mr. Young said he did not know, not being an advertising expert; he knows nothing about awareness.

Mr. Lockwood resumed his questioning asking whether it would be improper for a manufacturer to adopt a warning that is inconsistent with the government’s public health values. Definitely, said Mr. Young, I would not expect a manufacturer to do things that subvert warnings. I would not recommend that manufacturers warn independently from the public health authorities about residual risks, if those authorities are already addressing it. And what if the risk is known only to the manufacturer? Mr. Young would still not expect the manufacturer to issue a product warning, but would expect them to take the problem to the public health authorities. It would be irresponsible for the manufacturer to warn people before going to the authorities. (One wonders about his real-world experience!)

Some public health risks have been managed without warnings and the government felt successful. In 1972 only two other countries had cigarette warnings. Public health authorities say there is value in warnings, but Mr. Young does not think it is necessary or appropriate for manufacturers to warn about residual risk.

Here the judge asked for clarification. Mr. Young said that norms have changed and manufacturers were previously not expected to give warnings.

At this point, with everyone feeling a little dizzy from all this alternate reality, a lunch break was declared.

Is moderation advisable?
Mr. Lockwood resumed after the break: Suppose manufacturers warned people to smoke in moderation. Mr. Young could not agree with that because it would leave off the part of the message the government wished to deliver, i.e., stop smoking. The manufacturer could advise moderation but it would not be acceptable to Mr. Young.

To the question of whether product warnings typically provide statistics about health outcomes, Mr. Young’s simple answer was No. And what would be the downside of such information? Mr. Young said it was an issue of probabilities and when people see a range of risks, they tend to perceive their own risk at the lower end of the range. For pharmaceutical products, consumer information has some details but is considerably less than the monographs supplied to doctors. As for cigarette warnings about addiction, these were considered as early as the Isabelle report but were not implemented until 1994, and there are still none in the U.S.

Mr. Young said several times that warnings have no effect on behaviour, yet he was able to chart responses showing how a typical consumer interacts with warnings. In these stages, the manufacturer can only control the exposure to the message and its ease of comprehension. Those are the areas Mr. Young and his colleagues concentrate on. The stages from perception of a warning to acting upon it can be interrupted at various points. Some people may think they already know the information and so ignore it. Others may reject it because of cognitive dissonance. Some may read and forget, and some may ignore it because of peer pressure and other societal contexts.
Why have warnings at all? Why spend your career designing them?
Mr. Lockwood asked Mr Young directly about the effects of warnings. The reply was that warnings are generally not effective; it is unreasonable to expect people to change their behaviours. Have there been studies of the effects of warnings on behaviour? Yes, there have been tests and reports in the literature. People overestimate the power of warnings, predicting that the clearer and more eye-catching warnings will be more effective, but they are not. People underestimate the other background factors and make faulty assumptions about other people’s behaviour.

In terms of smoking, do factors other than warnings (non-warning factors include peers, parents, image, price and restrictions) have an influence to reinforce or negate the warning? Both, said Mr. Young.

While some of Mr. Young’s statements seemed counter-intuitive, he did have one observation that was stunning in its predictability: use of motorcycle helmets is much more frequent in jurisdictions where it is required by law and the law is enforced. (Imagine that!)

The cross-examination did begin Monday afternoon, but I will report on that when it is complete on Tuesday. I leave you with a final warning:
Warning:   Do not read this warning.  It may give you information that you do not need because you should have known everything that you need to know already because the government should have told you and you should have been listening, and if you weren’t listening, that is your fault, and if we stated or implied something to the contrary, you should not have listened to what we said.