Scott Ballin sent out the following to his e-mail list about GSK urging FDA to ban dissolvable smokeless tobacco products.
Observations on the GlaxoSmithKline Statement (9/27/10) on FDA Regulation of Smokeless Tobacco Products
Scott D. Ballin
Health Policy Consultant
October 6,2010
For well over 5 years now I have been suggesting that once FDA oversight of tobacco was achieved, we would be entering a 'new era' in tobacco, nicotine and alternative product regulation --- one in which the role of science would become increasingly more dominant and where there would be greater competition between a spectrum of interests. I have suggested that there would be a 'convergence' between pharmaceutical, tobacco, and biotech interests and where market competition would increasingly dominate and dictate actions and activities between corporate competitors fighting for market share and profits.
Competition (in a regulated environment) has not been given much attention by many in the public health community but it should as it is a significant and proven way of changing corporate behavior. I have long regarded Regulation (FDA, EPA, USDA) + Competition + Incentives as a way of advancing a public health agenda. My views were in part influenced by the ideas and thoughts of two past colleagues (John Slade and Judy Wilkenfeld) as well as by Michael Cummings who saw competition and market forces as an important way to change the products in the market place.
A little over a week ago, Glaxo Smith Kline, the maker and marketer of a number of NRT products, released a press statement that reiterated their call for the removal of oral dissolvable tobacco products, using a statement of the AHA as further justification (See my earlier observations on the AHA Statement). I recognize that, as with any corporate entity there is a profit -making motivation as well as an obligation to serve the interests of the shareholders. Thus keeping competitive products off the market whenever possible is an obvious corporate strategy to consider. But it may not be as effective a public health strategy as we'd like to think or hope.
The scientific literature not only indicates that noncombustible forms of smokeless tobacco are 90% plus lower in risk than the toxic cigarette but also that some of the compressed tobacco products, which TSNA's significantly reduced, have comparable risk profiles to the NRT products currently on the market.
GSK notes in its release that "Quitting smoking is the single most important step smokers can take to improve their health - and its also one of the most difficult". and that they (GSK) are committed to '......developing new products and support systems to improve the quit experience and helping to make products as accessible as possible'.
It seems rather odd (from a public health perspective, not from a business perspective) that GSK, while advocating the use of its nicotine products, calling for a loosening up of regulations on these products, and calling for the development of new products, would be calling for the removal of noncombustible products that are significantly lower in risk than cigarettes. It is even more ironic that there is nothing in the press release that calls for the removal of the deadly cigarette (a product on which they depend to sell their NRT products). This again is something that does not make sense from a public health perspective but does from a business perspective.
As I have said and will continue to say, its not the tobacco that causes the most significant harm, but rather how the tobacco is grown, cured, processed, manufactured and most importantly used.
I happen to believe that the principal recommendations of the IoM study , Clearing the Smoke were right on target (with respect to developing harm reduction strategies) and that GSK's approach to removing or stifling competition flies in the face of those recommendations. The IoM noted that in order to achieve and implement a successful harm reduction strategy the following objectives need to be considered.
- Manufacturers have the necessary incentive to develop and market products that reduce exposure to toxicants and that have a reasonable prospect of reducing the risk of tobacco related disease;
- Consumers are fully and accurately informed of all the known, likely, and potential consequences of using these products;
- Promotion, advertising and labeling of these products are firmly regulated to prevent false or misleading claims, explicit or implicit;
- Health and behavioral effects of using PREPS are monitored on a continuing basis;
- Basic, clinical and epidemiological research is conducted to establish their potential for harm reduction for individuals and populations;
- Harm reduction is implemented as a component of a comprehensive national tobacco control program that emphasizes abstinence-oriented prevention and treatment.
The public health goal (and opportunity) there, should not be to keep products off the market but rather to set standards with respect to how these products should be tested, labeled, marketed, and monitored. Anti-competitive practices as in the case of GSK's recommendations may do more public health harm than good. What I have suggested is needed is a more rational and consistent policy that regulates all tobacco, nicotine, and alternative products (under the same umbrella) based on the risks and relative risks of the various products. Each product should be assigned a 'risk profile' and labeled, marketed and monitored accordingly. Under such a system GSK would do quite well in the current environment. But it would also encourage GSK and others to do more and to 'develop new products and support systems....' that are based on sound science. Through regulation and competition, 'bad actors' would be driven from the market place.
GSK and other pharmaceutical interests have long had close relationships with the public health community and retain a number of well known and well known public health and tobacco control experts to assist them in their legislative and regulatory endeavors both in the US and globally. There are many overlapping public health interests but they are not congruent and the interests shouldn't be viewed as one in the same.
In this 'new era' of regulatory oversight and changing technologies, what is needed will be a greater and more transparent dialogue about the complex issues, challenges and opportunities ahead.
GSK and other pharmaceutical companies, biotech companies, traditional and non-traditional tobacco companies, agronomists, growers, researchers and many others should be encouraged and given incentives to develop new science-based products that will significantly reduce the level of disease and death caused by many of the products currently on the market. Stifling competition, putting a damper on incentives for the research and development of new products is in my opinion not the way forward. It has the potential for doing more public health harm than good.
Tel: 202 686-8898
email:
ScDBa@aol.com
