GlaxoSmithKline and the FDA entreaty

GlaxosmithKline, the maker of Nicorette and Nicoderm, have petitioned the FDA to remove dissolvable tobacco products on the grounds that a better action would be to enhance their own product and make it more widely accessible. They argue as well that there is a lack of efficacy of smokeless products in regards to smoking cessation and that they are marketed in such a way as to initiate and perpetuate smoking. (Article link here.)

(Let’s just remove that last phrase first since it has been discussed here before: tobacco companies are not allowed to market these products as cessation aids or to accurately describe them as safer; such claims might encourage switching. They are restricted to marketing their much safer than smoking products only as “for when you cannot smoke”. So it is disingenuous to criticize a company for using the only marketing hook left if they are not allowed to promote the rational use of these products.)

This message from this successful company (45 billion in revenue in 2009) has been widely criticized as trying to obtain competitive advantage at a time when smokeless products are at their most vulnerable. Not only is the FDA focusing on these products but the advisory panel is stacked with members who have financial interests in pharmaceutical products. As a business strategy, this makes sense.

What is less obvious is how amoral and possibly evil this action is. Though I hesitate to apply “evil” to these machinations, what else can you call an action that could result in many dying as a result not of their principles but of your own, and principles solely in the interest of profit?

We know that people smoke or do not smoke for many reasons. We know that they vary quite a bit in how difficult it is for those who wish to quit to do so, and that for different people, different methods are successful. It is all about individual differences. This means that some people will not be able to quit using pharmaceutical products which in itself means that if those are the only option, the people that could have succeeded by other means are needlessly doomed by removing those alternatives.

I understand the concerns of makers of these pharmaceutical nicotine products. With the new smokeless tobacco products, the distinctions between the two categories are becoming quite subtle. And if anybody has long term evidence of relative safety on their side, it is the tobacco products. We have decades of good data on populations using these products day in and day out for years and we do not have that for pharmaceutical products. They are likely to be as safe as smokeless tobacco if so used but we don’t have the proof of that because people have not been using them that way.

What we do have is evidence in support of is that smokeless tobacco products outperform pharmaceutical nicotine in helping people quit smoking (see Rodu and Phillips).

And this same press release has the temerity to use the old “Tobacco use, including smokeless tobacco, is the largest cause of preventable death and disease in the world. More than 400,000 Americans die every year from tobacco-related disease.” For one thing, the stale move of collapsing “including smokeless tobacco” into this figure is misleading (one could have included “eating apples and oranges” and the statement does not become false). But the key word as always is preventable. Is not this impeding one of the more successful means of avoiding disease while using nicotine not preventable?

Finally, our modern anti-tobacco culture has allowed this story to be construed only as a slightly sleazy business move but imagine if RJ Reynolds or some tobacco company had issued the same release regarding pharmaceutical products. They would actually have had the stronger case (not that any alternative should be removed) but imagine the op eds on that, the outcry from the American Heart Association and so many others.

-Paul L. Bergen

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