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Clearing the Smoke – Assessing the science base for tobacco harm reduction | United States Institute of Medicine
Article Published: 2001

Details:
Type: Official report
Published By: National Academy Press, Washington, DC

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This is the powerful (and totally ignored) report of the Institute of Medicine of the United States that stated that nicotine is a beneficial substance and that, basically, its intake leads to less smoking, and/or to safer smoking.

For further information on this report, see "Arguments of the IOM report in recommending the development of less hazardous cigarettes".

Following are pages of the report that could be of particular interest to the reader

Dose-response: viii, ix, 1, 2, 3, 5, 9, 163, 167, 168, 232, 359, 430, 431, 471.
Lung cancer as proxy for other risks 433

Leading cause of death: 1, 21, 22, 23

Number of smokers 1, 22, 23

Continuing smokers 25, 38

Failure of prohibition, thus PREPS/LHCs 31, 38

Little evidence that LHCs would increase smoking 28, risk homeostasis 41, 55

Definition of harm reduction 2, 23, 38, 39, 40, 41, 42

Nicotine safety 29, 110, 112, 113, 115, 121, 162, 167, 227, 252, 471, reassuring 270

Nicotine central and necessary 25, 29, 91, 113, 114, 254

Nicotine virtues 25, 162, 253, 254, 255, 268,

Nicotine addictive? Who cares 161, 269

Nicotine not as addictive as cocaine, effects count and repetition is not enough 258, 259

Nicotine effects depend on rate of delivery to CNS: 255

Nicotine bolus 256

Withdrawal symptoms mild: peak in 1 week, disappear in 4: 255

Reinforcing elements in smoke besides nicotine 256

Nicotine is limiting. Titration 168, 248, 255. 1-2 mg to smoker of 15 mg in cigarette

Nicotine compensation 2, 26, 67, 121, 164, 168, 219, 266, 322, 380

Nicotine overdosing impossible 254

Nicotine: pH, sugars, ammonia 278

Nicotine free and protonated 85, 86

Low FTC yields = small risk reduction 2, 26, 28, 164, contradiction 223

Against Premier/Eclipse 126

Necessity of regulation 6, 7, 203, 206, 207, 216, 217,

Regulatory philosophy 54

Regulatory topics/items/scope and 11 principles 207

Science base for regulation is incomplete 231. Indirect knowledge necessary ix

Mechanisms of harm are unknown 169

Regulatory agenda 10, 203, 205

Regulation must certify absorption (N, T, CO… how about whole smoke?) 209, 210, 211

Regulation to set performance standards such as max levels of smoke components 209, 225

Regulation to determine likely ranges of delivery (T/N ratios could define such ranges?) 211, 219

Grandfather clauses   212

Main criterion for certifying harm reduction is dose reduction   214, 237

Regulation to set comparative benchmarks for different smoke constituents ( hazard identification for each? Dose/response identified for each?)   236, 237, 239, 240

Assessing whole smoke dose is more important than regard to single constituents   316

Traditional cigarettes will be marketed alongside LHC models, and should be regulated not to exceed the delivery/dose of a traditional benchmark cigarette
(1R1?) 206, 208 benchmark, 222, 223

Reference to 1R1 438

Biomarkers 11, 12, 13, 150-152, 159, 160, 161

Biomarkers doubtful 313, 348, 350, 351

Biomarkers must be validated for biological relevance and standardization/reproducibility 233, 312, 313 – 317, 348, 351

Short term human studies in regulation   166

Regression of LHC risk to the exposure/risk of conventional products   164

Manufacturers should be given incentives to advertise   7, 8, 10, 208, 209, 217, 218, 228, 231, 232

Premarket claims   10, 11, 213

Postmarketing surveillance necessary 8, 207. However LHC prototypes would have limited lifespan 5, 146. Therefore general mortality and morbidity surveillance should be enough 207.

Burden of proof should not be stifling   240

Quoting Wynder 21

FDA, DCD, or other agency to regulate: 207, 221

Regulators should have fast track authority 215, should safeguard trade secrets 225, should charge user fees 215, and be advised by disinterested experts ix, x

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NOTES

1. The report leaves an ethical void by not considering why tobacco/cigarettes are not made illegal (201, 222). It would have had to mention a democratic and free society, free choice, and to question who has the right to compel people on the basis of iffy evidence.

2. Penalties affect smokers, not the industry, which exists because of smokers and not viceversa. The industry is protected by the Settlement, making it a nationalized industry.

3. The report speaks of harm reduction, although it could only speak of risk reduction (56, 201)

4. Regulation should rely on T/N ratios and chemical analysis of smoke to ensure that components do not exceed benchmarks.

5. Although the report mentions the limiting role of nicotine, does not leap to the conclusion of the validity of the relative nicotine concentrations in smoke, and plausibly in the blend itself, as indeces of relative intake (189).

6. Antismokers would be opposed, and the industry reluctant. The latter is protected by the Settlement and the market prospectives of LHCs are iffy without an official endorsement.

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