THR- WHAT IS THE FDA THINKING?

A Wolf found great difficulty in getting at the sheep owing

to the vigilance of the shepherd and his dogs.  But one day 

it found the skin of a sheep that had been flayed and thrown

aside, so it put it on over its own pelt and strolled down 

among the sheep. The Lamb that belonged to the sheep, whose 

skin the Wolf was wearing, began to follow the Wolf in the 

Sheep's clothing; so, leading the Lamb a little apart, he 

soon made a meal off her, and for some time he succeeded in 

deceiving the sheep, and enjoying hearty meals.

	Appearances are deceptive.

The FDA has approved a Phase II-B study on 97% nicotine-free 

cigarettes based on the following:

Dr. Hatsukami’s study compared the quitting efficacy of a VLN cigarette (containing 22nd Century’s proprietary VLN tobacco), an FDA-approved 4-mg nicotine lozenge, and a low nicotine cigarette (containing 30% of the nicotine of a typical cigarette) in a total of 167 patients treated for 6 weeks (Hatsukami et al. 2010). Point-prevalence abstinence at 6 weeks after the end of treatment was 47% for the group using the VLN cigarette, 37% for the nicotine lozenge group and 23% for the low nicotine cigarette group (p=.0357). Furthermore, the VLN cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The protocol of 22nd Century’s upcoming Phase II-B clinical trial is similar to that of the University of Minnesota trial. Unlike the low nicotine cigarette, the VLN cigarette was not associated with compensatory smoking behaviors. By the end of the 6-week treatment period, patients in the VLN group (whether they quit or not) on average were smoking 12 VLN cigarettes per day, compared to a baseline of 19 cigarettes per day of their usual brand.

The pub-med abstract:

Abstract

AIMS:

To examine the effects of reduced nicotine cigarettes on smoking behavior, toxicant exposure, dependence and abstinence.

DESIGN:

Randomized, parallel arm, semi-blinded study. Setting University of Minnesota Tobacco Use Research Center.

INTERVENTIONS:

Six weeks of: (i) 0.05 mg nicotine yield cigarettes; (ii) 0.3 mg nicotine yield cigarettes; or (iii) 4 mg nicotine lozenge; 6 weeks of follow-up. Measurements Compensatory smoking behavior, biomarkers of exposure, tobacco dependence, tobacco withdrawal and abstinence rate.

FINDINGS:

Unlike the 0.3 mg cigarettes, 0.05 mg cigarettes were not associated with compensatory smoking behaviors. Furthermore, the 0.05 mg cigarettes and nicotine lozenge were associated with reduced carcinogen exposure, nicotine dependence and product withdrawal scores. The 0.05 mg cigarette was associated with greater relief of withdrawal from usual brand cigarettes than the nicotine lozenge. The 0.05 mg cigarette led to a significantly higher rate of cessation than the 0.3 mg cigarette and a similar rate as nicotine lozenge.

Conclusions:

Observed-

• There is a major behavioral part in the act of smoking cessation.
• 0.03 (97% free) nicotine X-22 products were superior in a SEMI- blinded study.
• Post endpoint there was a decrease in the number of X-22 cigarettes smoked in those who did not quit compared to pre-study smoking levels.

Questions-

• Why is there an FDA study that is making the assumption that nicotine cessation is the issue.
• Is it ethical to use a non-carcinogenic variable (nicotine) as a variable, when the true vectors of carcinogenicity are still part of the X-22.
• Is it ethical to report the decrease from 19-12 cigs per day in the 0.03 mg group, it suggests that  smoking less would be good and opens a potential message that these may be marketable as beneficial even if cessation does not occur.
• Relapse rates- wonder what 3, 6, 9 month follow-ups were (not reported in a study about 2 years old.
• Do the X-22 decreased nicotine cigs still have other alkaloids (MAOI active?).  These alkaloids have been looked at as why a 2 day withdrawal time frame for pure nicotine is extended to much longer time when cigarettes are involved.

Insanity-  We KNOW that tobacco combustion products are the source of carcinogenicity.  It is not unexpected that levels of exposure to carcinogens would decrease if less tobacco is consumed.

What is the FDA doing running trials on smoking cessation with the variable nicotine delivered by a tobacco leaf product? Why would it not be more logical to use a tobacco free vehicle as the delivery system?  Don't they look happy, reminds me of a 60's tobacco commercial... X-22, 22nd Century's PRESCRIPTION......................

AHHHH! Prescription based smoking cessation aid.  Welcome back Pharma and Big Tobacco.

The wolf in sheep's clothing.  Nicotine free tobacco (genetically engineered) and packaged to taste, smell and smoke like a cigarette.  Prescription requirement will obviously make them very expensive. This appears to be tobacco cessation genocide.

Like lamb's to the slaughter-

This company is currently headquartered in Williamsville, N.Y., whose soccer team we crushed 8-0 back when I was in 12th grade.