Tuesday, February 20, 2007

FDA Tobacco Bill Would Cause Countless Deaths: By Hindering, Not Enhancing Development of Safer Cigarettes, Proposal Would Kill People, Not Save Lives

One of the most common misperceptions about the proposed FDA tobacco legislation is that through its tobacco product standards, it would result in safer cigarettes which would reduce morbidity and mortality and save "countless" lives.

The assumption is that by reducing levels of certain tobacco smoke constituents, the FDA could mandate safer cigarettes.

The Rest of the Story

There are two major problems with this.

1. Modified Risk Tobacco Product Provisions - An End to Safer Cigarettes

First of all, the bill contains language which I feel puts a death knell to harm reduction as a strategy. It prohibits the marketing of any newer, safer cigarette, unless it meets FDA approval. But here's the catch - in order to meet FDA approval, you would have to prove that the product improves health, both on an individual and a population level. To do that, you'd have to conduct epidemiologic studies in which smokers were followed for 10-20 years. And you'd have to hope that they stuck with their products (conventional vs. new), without switching, for the entire period. In short, this is impossible. In my view, this legislation would make it impossible to produce and market safer cigarettes. It essentially takes all the incentive away. No cigarette company is going to want to spend millions of dollars on testing and producing a safer cigarette when they know it is going to be virtually impossible for them to ever market it.

And this is precisely why I think Philip Morris favors this legislation. Philip Morris realizes that the bill sets up an impossible standard for new products. Thus, it ensures that the existing market is basically frozen - obviously, this is a dream come true for the company with the largest current market share, because it stifles competition.

I think the only way to get safer cigarettes would be to allow the free market to produce them - not by creating this elaborate regulatory scheme.

In fact, if you actually read the legislation [see section 901(g)(1)], you'll see that it is not just virtually impossible to meet the standards required to market a reduced risk product, it is actually impossible. In order to prove that a product reduces health risks as it is actually used, both on an individual and population basis, you'd have to demonstrate the results of a study in which the product is marketed the way it would be marketed in real life - that is, as a reduced risk product. But you can't market it as a reduced risk product until you've proven that it reduced risks.

This is truly a catch-22. You cannot market a product as reduced risk until you've proven it reduces risk, but you cannot possibly prove that it reduces risk until you've marketed it as such.

Thus, the proposed legislation not only represents a de facto end to the prospect of truly safer products - it represents an actual death knell for any meaningful harm reduction strategy.

2. Tobacco Product Standards - An Exercise in Lunacy

Although the rhetoric by groups like the Campaign for Tobacco-Free Kids sounds great, the truth is that these standards would not help smokers, in my opinion.

The problem is that we simply do not know which of the constituents in tobacco smoke, and at what quantities, are responsible for what diseases. So the Campaign for Tobacco-Free Kids can talk all they want about how FDA will be able to reduce levels of certain toxins and produce a safer cigarette, but that's a pipe dream. It would take difficult to conduct, long-term epidemiologic studies, where you'd have to follow smokers of conventional vs. new products for 10-20 years, before you could have an answer to this question. But in the mean time, we wouldn't know what the risks are - or even if the risk could be decreased! Essentially, the bill would be using smokers as guinea pigs. Perhaps some would view that as acceptable because the product is dangerous anyway. However, the problem is that smokers are going to naturally assume that these products are safer - and we won't know that is true. I think it would greatly deceive smokers into thinking that the product is safer, when it may well not be any safer at all, and could potentially be more hazardous.

Unfortunately, we simply do not have any idea whether it is even possible to reduce the toxicity of cigarettes by reducing the levels of specified components.

All in all, I think the entire approach is flawed, because if you want safer cigarettes, you need to use the free market approach to set up competition between the companies for a safer product. This legislation does the opposite. It takes away the free market completely and puts all decisions into the hands of FDA. But it gives the FDA a mandate which sets up impossible standards that could never be met for new products. What it really does is ensure that existing products will be institutionalized and protected from competition. This, indeed, is the reason why Philip Morris supports the bill, and all the smaller companies oppose the bill. What the smaller companies despise is the removal of any serious chance to compete in the market - and largely, the market we are talking about is potentially safer products.

Philip Morris wants to freeze the market as is, so that Marlboro - one of the highest risk products imaginable - will be able to dominate the market, without any serious competition from potentially safer products which could advertise themselves as being safer than Marlboro and thus gain market share among the "health-conscious" segment of smokers who are looking to reduce their risks while still satisfying their demand for cigarettes.

If you really think about it, you'll see that the approach of trying to reduce the levels of specific smoke constituents is complete lunacy. When you have no idea which constituents, in what combination, and at what concentrations, cause which diseases that are associated with smoking, then it is impossible to produce a cigarette that you know will be safer simply by mandating a reduction in the levels of various smoke constituents.

The one thing you will never hear the supporters of this legislation do is estimate the number of lives they think this legislation will save. All they can do is talk about "countless" lives being saved. And they are quite correct. The lives are countless. You cannot count them because they do not exist!

It is estimated, for example, that there are over 60 compounds in tobacco smoke which cause cancer. So what sense does it make to require the companies to take out two or three of them? What if they take out the wrong ones? What if the actual compound which causes most of the cancer is not one of those chosen to be removed? What if smokers believe that this is a safer product and start smoking more? This approach could actually kill people, rather than save lives.

And it could also kill people by reducing youths' perceptions of the hazards of cigarette smoking. If youths are led to believe (correctly) that the FDA now regulates every ingredient of the cigarette and that (incorrectly) because of this, countless lives will be saved, does it not make sense for these kids to infer that cigarettes are not as bad as they used to be? We know for a fact that any decline in the perceived harm of cigarettes results in an increase in youth smoking. So I'm quite serious when I opine that the proposed FDA legislation could well kill more people than it saves.

You want an estimate of the number of lives that it will cost? Sure - I'm happy to provide one. In my expert opinion, the FDA legislation will kill .... let's see.... why don't we say countless numbers of people.

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