A Question Of Intent


Book Description

Former FDA commissioner David Kessler guides the reader through a legal thriller, telling the story of the FDA's fight with big tobacco.







A Question Of Intent


Book Description

Tobacco companies had been protecting their turf for decades. They had congressmen in their pocket. They had corrupt scientists who made excuses about nicotine, cancer and addiction. They had hordes of lawyers to threaten anyone -- inside the industry or out -- who posed a problem. They had a whole lot of money to spend. And they were good at getting people to do what they wanted them to do. After all, they had already convinced millions of Americans to take up an addictive, unhealthy, and potentially deadly habit. David Kessler didn't care about all that. In this book he tells for the first time the thrilling detective story of how the underdog FDA -- while safeguarding the nation's food, drugs, and blood supply -- finally decided to take on one of the world's most powerful opponents, and how it won. Like A Civil Action or And the Band Played On, A Question of Intent weaves together science, law, and fascinating characters to tell an important and often unexpectedly moving story. We follow Kessler's team of investigators as they race to find the clues that will allow the FDA to assert jurisdiction over cigarettes, while the tobacco companies and their lawyers fight back -- hard. Full of insider information and drama, told with wit, and animated by its author's moral passion, A Question of Intent reads like a Grisham thriller, with one exception -- everything in it is true.




How Tobacco Smoke Causes Disease


Book Description

This report considers the biological and behavioral mechanisms that may underlie the pathogenicity of tobacco smoke. Many Surgeon General's reports have considered research findings on mechanisms in assessing the biological plausibility of associations observed in epidemiologic studies. Mechanisms of disease are important because they may provide plausibility, which is one of the guideline criteria for assessing evidence on causation. This report specifically reviews the evidence on the potential mechanisms by which smoking causes diseases and considers whether a mechanism is likely to be operative in the production of human disease by tobacco smoke. This evidence is relevant to understanding how smoking causes disease, to identifying those who may be particularly susceptible, and to assessing the potential risks of tobacco products.




Secondhand Smoke Exposure and Cardiovascular Effects


Book Description

Data suggest that exposure to secondhand smoke can result in heart disease in nonsmoking adults. Recently, progress has been made in reducing involuntary exposure to secondhand smoke through legislation banning smoking in workplaces, restaurants, and other public places. The effect of legislation to ban smoking and its effects on the cardiovascular health of nonsmoking adults, however, remains a question. Secondhand Smoke Exposure and Cardiovascular Effects reviews available scientific literature to assess the relationship between secondhand smoke exposure and acute coronary events. The authors, experts in secondhand smoke exposure and toxicology, clinical cardiology, epidemiology, and statistics, find that there is about a 25 to 30 percent increase in the risk of coronary heart disease from exposure to secondhand smoke. Their findings agree with the 2006 Surgeon General's Report conclusion that there are increased risks of coronary heart disease morbidity and mortality among men and women exposed to secondhand smoke. However, the authors note that the evidence for determining the magnitude of the relationship between chronic secondhand smoke exposure and coronary heart disease is not very strong. Public health professionals will rely upon Secondhand Smoke Exposure and Cardiovascular Effects for its survey of critical epidemiological studies on the effects of smoking bans and evidence of links between secondhand smoke exposure and cardiovascular events, as well as its findings and recommendations.




Scientific Standards for Studies on Modified Risk Tobacco Products


Book Description

Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.




Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products


Book Description

Tobacco use by adolescents and young adults poses serious concerns. Nearly all adults who have ever smoked daily first tried a cigarette before 26 years of age. Current cigarette use among adults is highest among persons aged 21 to 25 years. The parts of the brain most responsible for cognitive and psychosocial maturity continue to develop and change through young adulthood, and adolescent brains are uniquely vulnerable to the effects of nicotine. At the request of the U.S. Food and Drug Administration, Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products considers the likely public health impact of raising the minimum age for purchasing tobacco products. The report reviews the existing literature on tobacco use patterns, developmental biology and psychology, health effects of tobacco use, and the current landscape regarding youth access laws, including minimum age laws and their enforcement. Based on this literature, the report makes conclusions about the likely effect of raising the minimum age to 19, 21, and 25 years on tobacco use initiation. The report also quantifies the accompanying public health outcomes based on findings from two tobacco use simulation models. According to the report, raising the minimum age of legal access to tobacco products, particularly to ages 21 and 25, will lead to substantial reductions in tobacco use, improve the health of Americans across the lifespan, and save lives. Public Health Implications of Raising the Minimum Age of Legal Access to Tobacco Products will be a valuable reference for federal policy makers and state and local health departments and legislators.




Understanding the U.S. Illicit Tobacco Market


Book Description

Tobacco use has declined because of measures such as high taxes on tobacco products and bans on advertising, but worldwide there are still more than one billion people who regularly use tobacco, including many who purchase products illicitly. By contrast to many other commodities, taxes comprise a substantial portion of the retail price of cigarettes in the United States and most other nations. Large tax differentials between jurisdictions increase incentives for participation in existing illicit tobacco markets. In the United States, the illicit tobacco market consists mostly of bootlegging from low-tax states to high-tax states and is less affected by large-scale smuggling or illegal production as in other countries. In the future, nonprice regulation of cigarettes - such as product design, formulation, and packaging - could in principle, contribute to the development of new types of illicit tobacco markets. Understanding the U.S. Illicit Tobacco Market reviews the nature of illicit tobacco markets, evidence for policy effects, and variations among different countries with a focus on implications for the United States. This report estimates the portion of the total U.S. tobacco market represented by illicit sales has grown in recent years and is now between 8.5 percent and 21 percent. This represents between 1.24 to 2.91 billion packs of cigarettes annually and between $2.95 billion and $6.92 billion in lost gross state and local tax revenues. Understanding the U.S. Illicit Tobacco Market describes the complex system associated with illicit tobacco use by exploring some of the key features of that market - the cigarette supply chain, illicit procurement schemes, the major actors in the illicit trade, and the characteristics of users of illicit tobacco. This report draws on domestic and international experiences with the illicit tobacco trade to identify a range of possible policy and enforcement interventions by the U.S. federal government and/or states and localities.




Tobacco and Public Health


Book Description

This book comprehensively covers the science and policy issues relevant to one of the major public health disasters of modern times. It pulls together the aetiology and burden of the myriad of tobacco related diseases with the successes and failures of tobacco control policies. The book looks at lessons learnt to help set health policy for reducing the burden of tobacco related diseases. The book also deals with the international public health policy issues which bear on control of the problem of tobacco use and which vary between continents. The editors are an international group distinguished in the field of tobacco related diseases, epidemiology, and tobacco control. The contributors are world experts drawn from the various clinical fields. This major reference text gives a unique overview of one of the major public health problems in both the developed and developing world. The book is directed at an international public health and epidemiology audience includng health economists and those interested in tobacco control.




The Cigarette Papers


Book Description

These documents provide a shocking inside account of the activities of one tobacco company, Brown & Williamson, and its multinational parent, British American Tobacco, over more than thirty years.