United States/Japan: Yokota Air Base Pharmacy Pulls Chantix
Medical officials at the US Air Force’s Yokota Air Base in Japan decided to remove Chantix from the base pharmacy, after a May report from the Institute for Safe Medication Practices found an array of health and safety concerns including falls, heart rhythm disturbances, heart attacks, seizures, diabetes and psychiatric disturbances associated with the smoking cessation drug. Yokota has suspended all refills of Chantix, but 374th Medical Support Squadron pharmacy element chief Major Tam Dinh said a patient with approval from his doctor can continue the medication and special order the drug. Chantix, however, is still available in many military smoking-cessation programs in the region, although air crew members can no longer take the drug as per the US Department of Defense’s (DOD) recommendation that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.” In South Korea, where Chantix is available at military treatment facilities, Major Remington L. Nevin said individual healthcare providers are free to exercise their judgment in determining whether their patients should be treated with Chantix. He noted that the DOD recommendation currently does not prohibit the use of Chantix or mandate a formal screening process before prescribing the medication. The medical community at US naval hospitals Yokosuka and Okinawa in Japan are taking a similar approach, leaving the decision about Chantix to the patient and the physician (Stars & Stripes 8/12).

The Rest of the Story

These are insightful and important observations about the likely impact of the proposed FDA tobacco legislation.

The key section of the bill is section 911, which sets out the criteria that need to be met before a reduced risk product can be introduced into the marketplace. According to this section:

“the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will–`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products, at least for a 10-20 year period (which is enough to remove any incentive for companies to pursue such products). In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

Section 911 creates a literal catch-22 for reduced risk products. In order to introduce such a product into the market, you need to demonstrate that on an individual basis, it will reduce the risk of tobacco-related disease. However, in order to make such a demonstration, one would need to introduce the product into the market and follow a large sample of smokers for a long period of time – at least 10 years, if not longer. Thus, there is realistically no way to get a reduced risk product onto the market.

This legislation is likely to result in increased, not decreased deaths from tobacco products, because it will make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.

Also Marlboro Smooth from what I see in my locations is not moving very much. Ultra Smooth has been discontinued (in test markets) and Blend 27 is not a real mover.

I also challenge your thought that PM has done anything to grow their share. It had everything to do with RAI’s management of their business. Less emphasis in EDLP, discontinuing of buysome promotions, SAP fiasco and in case you didn’t know RAI discontinued soft packings in a lot of the brand lines. PM like Lorillard grew share at the expense of RAI. Lorillard is actually positioned extremely well and will continue to out perform both PM and RAI as there management truly is profit driven.

Newport shipped 33 billion units in 2007 and took about a 33% share of the 100 billion menthol segment which itself was about 28% of the 360 billion unit overall market. Without menthol their goose is cooked and what about RAI? As their units decline at 8% per year, they need what they have already and the Kool-
Salem combo is key for them more important to them than Menthol is to PM.

And given PM’s general cost reduction strategy, why not save the enormous buy-downs / promotional cost that their menthol position is costing them? As a retailer, you sure know how much buy-one, get-one they do to move their menthols!

I vote for smokescreen since PM needs FDA regulation to further build out its barrier to entry to solidify its 50 share, essentially to prevent the market from springing open through health claims for a wide assortment of new products that may appeal more to consumers than old Marlboro. So first get the barrier in place by setting the scientific standard so high that, in spite of broad support in the public health community acknowledging that smokeless is relatively less harmful than cigarettes, no one’s smokeless products will ever be able to make health claims to further drive their 6-7% annual growth while PM — not having a viable smokeless product yet — watches the overall cigarette market decline 3-4%. Without a viable smokeless product and fearing the spread of new products, PM’s best strategy is to freeze the market and reduce cost — get rid of all advertising and the possibility of any health claims for anything — while they build the research and production capacity to match and exceed any of these new products if, per chance, one or more do take off without the need for health claims. PM’s history, like Microsoft’s, is a history of being the best follower to new innovation who can then apply marketing skills to someone else’s creation. Now their task is to freeze the 50 share and reduce costs to drive profits while all the while getting the Corporate Social Responsiblity points along the way. And Mr. Waxman and the self-satisfied Tobacco Control fanatics are only too willing to fall for this while more and more people die from consuming PM’s more hazardous products. At some point the Tobacco Control folks will wake up to this latest phase of what began as the “lights fiasco.”