Tobacco Industry Conduct:
An Analysis of Selected Issues

By K.H. Ginzel, MD
Professor of Pharmacology & Toxicology Emeritus
University of Arkansas for Medical Sciences

"Few trends could so thoroughly undermine the very foundations of our free society as the acceptance by corporate officials of a social responsibility other than to make as much money for their shareholders as possible."

Milton and Rose Friedman

WHAT THE TOBACCO INDUSTRY HAS DONE

Basic Operational Facts and Guidelines of Tobacco Business*

 Almost 90% of adult smokers start smoking before the age of eighteen.

3,000 children start each and every day, a grand total of one million children a year(1). At present, smoking among teens is on the rise again.

To stay in business, the tobacco industry must recruit the young.

It must replace smokers who died, i.e., almost 1,200 a day, and those who have managed to quit.

The purpose of advertising and promotion is to attract new customers, i.e., children(2,3).

Advertising imagery must play on the emotional needs and frailties of adolescence, promising glamour, sexual attraction, athletic prowess, all in all perceived privileges of grown-upness. Hence, children must be told that smoking is an adult choice. Largely brand-loyal adult smokers couldn't care less about advertisements.

Tobacco products must be designed to deliver sufficient nicotine to initiate and maintain addiction(4).

Smokeless tobacco products are offered to the beginner on a graduating scale(5) to avoid early rejection.

Tobacco use must be seen as a normal thing to do for adults as well as would-be-adults(6).

Every effort must be made to keep smoking and smokeless tobacco use highly visible as in movies, on television, in public places, restaurants, and sports arenas. Smoking must be portrayed as a socially acceptable, if not desirable, basically rightful behavior of individual choice in a free society.

News about adverse health effects must be vigorously disputed(7).

Most importantly, it must be argued persuasively that the exposure of nonsmokers to tobacco smoke that may be psychologically objectionable to some has no proven adverse health consequences whatsoever; and that only a lunatic fringe of do-gooders wants people to believe otherwise.

*Conceived as a summary sheet in an imaginary tobacco company Employee Handbook

WHAT THE TOBACCO INDUSTRY DID NOT DO

Why did the industry continue to market tobacco instead of nicotine?

Throughout this century, pharmacological and medicinal research has aimed at identifying and isolating the active ingredients in various plant products, herbs, molds, and other complex mixtures with biological actions. The purified agents could then be administered in well defined dose regimens without incurring the toxic side effects often inherent in the original material. This strategy formed the basis of the stupendous growth of the pharmaceutical industry, and led to numerous remarkable therapeutic breakthroughs of modern medicine.

In 1942, Lennox Johnston(8), a British physician and cigarette smoker, identified nicotine as the chemical in tobacco responsible for what he called the pleasant sensations of smoking. He and 35 volunteers actually found nicotine injections preferable to cigarettes.

Had the tobacco industry followed the example of the pharmaceutical industry, it would have formulated nicotine delivery devices devoid of the onerous burden of poisons and carcinogens in tobacco products and saved millions of lives from cancer, lung disease, and cardiovascular accidents. When Johnston experimented with nicotine, the first reports associating smoking with lung cancer had already been published. Half a century ago, i.e., long before the addictive potential of nicotine was experimentally established, the Food and Drug Administration (FDA) might even have approved nicotine in low doses for stress relaxation and similar indications.

The fact that the tobacco industry failed to do what modern medicinal research in other areas had been doing all along reveals that addiction liability and FDA regulation must have raised a red flag even then.

Instead of focusing on nicotine itself and removing the toxic contaminants, the cigarette makers took the opposite course and actually added several hundred more chemicals as tobacco additives(9), serving various purposes, primarily to smooth and aromatize the harsh smoke of natural tobacco, so that kids and women would be able to tolerate it, like it, inhale it, and get hooked more rapidly as nicotine was made available to the huge surface area of the lungs.

The generous use of additives further complicates the smoke composition of the modern cigarette. The favored argument that many of the additives used in tobacco are also used in food, being drawn from the 'GRAS' list of chemicals, an acronym for "generally recognized as safe," is misleading. Nonvolatile additives are at least partially pyrolyzed during smoking, thereby adding an extraordinary number of toxic and carcinogenic agents to the smoke.

Fully cognizant of the cardinal role of nicotine in tobacco use, cigarette designers skillfully manipulated the amount of nicotine that smokers would be able to absorb even from the smoke of so-called low nicotine cigarettes(4). Despite denials by the industry, their strategy of nicotine manipulation was recently exposed by the clandestine procurement from Brazil of genetically engineered high nicotine tobacco varieties(10).

Why was the industry hesitant to make less hazardous cigarettes?

Faced with the ever growing tide of disastrous reports from the health front, the industry had once more two options: To abandon marketing tobacco in its conventional form or persevere in the status quo by resorting to steadily escalating denials and lies, in order to reassure customers and the general public of the industry's continued concern and good intentions, and the avowed safety of their products. The weight of epidemiological evidence that satisfied rigorous cause-effect criteria was brushed aside as 'only statistical,' devoid of the power of proof. A similar scenario unfolded when scientific research began to reveal the harmfulness of passive smoking. When industry-funded research was unable to exonerate tobacco, scientists were silenced, laboratories shut down and publications blocked(11).

Attempts by some cigarette companies to reduce the offending smoke components were hamstrung by advice from their attorneys who cautioned that developing and publicizing 'safer' products would constitute implied admission that cigarettes were not safe in the first place. Hence, any new developments aimed at lowering hazards had to be framed as industry responses to customers' demands, rather than as efforts to reduce toxicity or carcinogenicity. This tactic was very evident when R.J. Reynolds inaugurated the Premier cigarette simply as a gesture of good will toward the perceptions of its customers(12).

Half-hearted attempts at removing toxicants and carcinogens from tobacco.

During the past four decades cigarettes underwent several significant changes(13). Mixing different proportions of low nitrate bright (Virginia) tobaccos and high nitrate Burley types permitted manipulation of the nitrate level in the final product. By increasing the nitrate content, the level of benzo(a)pyrene, a notorious carcinogen, could be lowered along with 'tar' and a few other poisons. This practice was started during the 1970s. However, boosting the nitrate content of the tobacco blend led to increased formation of nitrosamines, notably those derived from nicotine itself. One of them, NNK, is a potent lung carcinogen. Its increase in cigarette smoke parallels the rise in lung cancer, primarily of adenocarcinoma, during the same time period(14). NNK, recently also found in the urine of nonsmokers exposed to tobacco smoke(15), produces adenocarcinomas in the lungs of experimental animals. One pack-a-day cigarette smokers take up nitrosamines in amounts approximately 17 times greater than the estimated exposure of average US residents. Snuff dippers ingest 10 times more than cigarette smokers. The range of nitrosamine concentrations in moist snuff exceeds the permissible limits of nitrosamines in lunch meat and beer by 2,000 to 60,000 times(16).

The increased nitrate levels were also responsible for the rise in certain aromatic amines that are well established human bladder carcinogens. In a report in 1996, the same aromatic amines that cause cancer of the bladder were implicated in breast cancer in over 55% of whites, 35% of blacks, and 10-20% of Asians, who lack the enzyme necessary for efficient inactivation of these carcinogens(17). Smoking by these women especially in the early teens when the breasts start to develop increases the risk of breast cancer later in life by up to four times. A 7-fold increase was noted in women who had smoked more than a pack a day 20 years previously. According to a 1996 Swiss study, even exposure to environmental tobacco smoke for as little as two hours a day for 25 years can triple a woman's risk of contracting breast cancer(18). These dramatic new findings have added another high profile cancer to the expanding spectrum of tobacco-related diseases.

Methods for removing hazardous components such as nitrosamines and aromatic amines from the tobacco blend have been available for some time but were not used for the reasons stated above. Cigarette companies were also bound among themselves by a mutual agreement that it would be best for business to preserve the status quo as long as possible. RJR apparently broke ranks when it developed the Premier cigarette, boasting a 90% reduction in particulates and vapor phase chemicals only to reassure its customers(19).

The hoax of the filter cigarette.

Almost fifty years ago, consumers were alarmed by two landmark reports(20,21), which identified smoking to be the major cause of lung cancer, and called for a reduction of the 'tar' content to make cigarettes less hazardous. The industry responded and 'tar' levels fell, on average, from 38 to 12 mg per cigarette, while nicotine, tied to 'tar' in a variable ratio of 1:11 to 1:16, declined in proportion. The introduction of filter cigarettes in the early 1950s accounted for much of the reduction in 'tar' and nicotine. The domestic market share of filter cigarettes climbed from below 1% in 1950 to 97% in the 1990s, reflecting the belief of smokers that filter cigarettes were indeed safer(13,22).

Since 1967 the 'tar' and nicotine yields of cigarettes were determined by a supposedly standardized method, established by the Federal Trade Commission (FTC). Yet the meaningfulness of the smoking machine derived numbers, which were meant to aid consumers in making educated choices, has been challenged. For one thing, smoking machines were found to have taken fewer puffs, on the average, in 1974 than in 1969, accounting for much of the reported decline in 'tar' and nicotine yields during this time period(23). Secondly, human smoking patterns obviously differ from those of machine smoking. In order to compensate for the reduced nicotine content, smokers take more frequent, longer, and/or deeper puffs. All marketed cigarettes contain 6 to 11 mg of nicotine, from which smokers procure about 1 mg, regardless of whether the FTC estimate is 0.1 mg or 2 mg. As smokers extract more nicotine, they also extract more 'tar', thus defeating the perceived low 'tar' advantage. Thirdly, a recent survey of smokers' knowledge revealed that they have a poor understanding of the advertised 'tar' numbers and their implications, and concluded that a revision of the rating system is urgently required(22).

What were the consequences of the change in cigarette design? Low-'tar', low-nicotine filter cigarettes were the industry's ingenious scheme to feign safety and keep concerned smokers in the fold. But this was only one aspect of the changing cigarette. The main benefit accrued from the fact that filter cigarettes attracted new categories of smokers, i.e., women and children, thus setting the stage for the unprecedented, exponentially growing cigarette pandemic we are now confronted with.

The smoke from the original high-'tar' non-filter cigarette was too harsh and too toxic to permit deep inhalation; it was strictly a cigarette for men. Smoke particulates from these cigarettes were preferentially deposited at the bifurcations of the bronchial tree, eventually causing squamous cell cancers at central locations in the airways. This was the predominant histological type until the contingent of the early male smokers began to subside. The new story is quite different. Deep inhalation made possible by the mild, modern cigarette left carcinogenic deposits in the peripheral regions of the lungs where adenocarcinomas originate. Accordingly, in the past 20 years the pulmonary adenocarcinoma has experienced an explosive rise, creating a new lung cancer epidemic that is chiefly attributable to the massive switch to low-tar filter cigarettes(24,25). The simultaneous change of the tobacco blend towards higher nitrate content, raising the yields of nitrogen oxides and nitrosamines like NNK in the inhaled smoke, greatly increased the carcinogenic burden(13,14).

There can be little doubt that these factors account for the alarming results of a 1997 analysis of the world's largest epidemiologic studies on smoking and health(26). Within two decades, the relative risk for lung cancer doubled in male smokers and quadrupled in female smokers, increasing from 11.9 to 23.2 and from 2.7 to 12.8, respectively. In other words, men who smoked were first 12 times and then 23 times more likely than nonsmokers to succumb to lung cancer as the mortality risk increased during this time period. The mortality risks for all other smoking-related cancers combined, including cancers of the larynx, oral cavity, esophagus, bladder, kidney, and pancreas, increased from 2.7 to 3.5 in male smokers and from 1.8 to 2.6 in female smokers. Relative risk for coronary heart disease rose from 1.7 to 2.3 in men and from 1.4 to 1.8 in women. Other causes of death exhibited similar increases. All in all, deaths among smokers attributable to smoking have risen to 57% among males and nearly 50% among females, i.e., one in two smokers of either gender will die prematurely of a smoking-related disease.

Paradoxically, the widespread use of 'safer and gentler' cigarettes has further intensified the public health tragedy that began earlier in this century. Cigarette companies probably neither planned nor wished, or even foresaw, that this would happen, cutting short valuable years of consumption by many smokers. In the total aggregate, however, numbers of consumers rose and so did profits, thus justifying the business decisions taken.

The 'unacceptable' charcoal filter

Filter tips of US cigarettes are made of cellulose acetate fibers. Only 1% have charcoal-containing filters. While cellulose acetate fibers can reduce 'tar' delivery by up to 50%, charcoal filter tips can selectively remove up to 40% of carbon monoxide and nitrogen oxides, 80% of hydrogen cyanide, and 70% of acrolein and benzene from cigarette smoke. Ciliotoxic agents like acrolein inhibit lung clearance. Charcoal filters preserve this important pulmonary defense mechanism, which clears the airways of foreign matter, trapped carcinogens, and other injurious materials. Unlike the cigarettes made in the US and UK, at least 70% of all commercial cigarettes in Japan contain charcoal in their filter tips(13).

Among comparable groups of male smokers, Americans incur lung cancer risks 50 to 100% higher than their Japanese counterparts. US cigarette makers insist that charcoal filters have been found to be unacceptable to the American customer.

Why are cigarettes not fire-safe?

During the past 50 years, residential fires have consistently claimed about 5,000 lives annually(27). Almost half of these deaths were caused by cigarettes, according to a US Fire Administration report in 1980. Recent figures compiled by the National Center for Health Statistics attribute approximately 1,000 fire deaths and some 4,000 burn injuries each year to cigarettes. Among these deaths and injuries are many children and adult nonsmokers.

When Charles C. Cohn, the inventor of self-extinguishing cigarettes, died in 1986, he held patents in 34 countries, but had failed to persuade the tobacco companies to use his invention(28). Neither were the Congressional initiatives of 1987 and 1990 successful in prompting the industry to make cigarettes fire-safe. To do so would have been technically and economically feasible. In their current form cigarettes are designed not to go out by themselves when left unattended. The rationale is simple: the quicker cigarettes burn, the more cigarettes will be bought.

WHAT CAN BE DONE NOW?

Is there anything the industry could do now?

We have arrived at a significant juncture in the tobacco war. A recent breakthrough in molecular cancer research, providing a direct etiological link between benzo[a]pyrene and human lung cancer(29), will make it difficult for the tobacco industry to persist in its denial of causative proof. The causal chain connecting active and passive smoking with disease and death has been further strengthened by assessing the risk incurred from exposure to individual toxicants and carcinogens in tobacco smoke(30). Most important, however, is the ongoing disclosure of internal documents that attest to the industry's long-standing knowledge of the dangers of tobacco use and the addictive potential of nicotine.

Fortunately, the prospects of comprehensive federal legislation immunizing the tobacco industry from accountability for its prodigious transgressions are rapidly dwindling. To award tobacco corporations protection from liability in exchange for concessions of yet uncertain benefit to public health would be as absurd as granting freedom to a serial killer who pledges to kill fewer people in the future. Whatever legislative solutions are pursued, it would be totally unrealistic to expect the industry, as was done on previous occasions, to refrain from recruiting the next generation of consumers among the children of this country and other nations. Without them, the tobacco business would be doomed. Continuing snowballing litigation, on the other hand, is a sound alternative to rushing into ambiguous legislative maneuvers, especially as litigation has emerged as one of the most powerful tools in public health policy.

Optimistically, one may even wonder if the recent events might offer the tobacco industry a renewed chance to come to its senses, abandon marketing of lethal tobacco products, and use its formidable biopharmaceutical expertise to enter, at least in part, the field of medicinal drug research? We urgently need new antibiotics. We need to replace nicotine with a safe substance for use in smoking cessation. The tobacco plant itself offers an impressive array of nutritional and pharmaceutical opportunities. Tobacco protein is the highest quality protein known and could be made available to protein-starved developing nations, while allowing tobacco farming to continue(31). A substantial portion of the industry's profits derives already from its diversification into the food sector. A few progressive CEOs could transform the tobacco industry so that it would serve life instead of death.

Is there anything that governments could do?

The most common cancer in the world today is lung cancer caused by cigarette smoking(32). By and large, governments have stood idly by while millions of their citizens were killed by tobacco. The majority of smokers were lured into nicotine addiction when they were still children. US-based corporations export cigarettes in ever increasing numbers, and their glamorous advertisements recruit new customers among the children and women of many other nations, especially in the Third World and Eastern Europe. In this country we insist that it is us who carry the banner of human rights on the planet, yet we allow this to happen. The blame for the unfolding worldwide disaster that is projected to claim ten million lives a year by the year 2020, if current smoking trends continue unabated(33), does not lie with the tobacco industry alone.

In all countries, the government has the authority and the responsibility to protect the health of its citizens, especially children, to preserve the quality of the environment, to regulate trade and commerce, and to promote public safety and welfare.

Friedmans' statement about the "social responsibility" of corporate business(34) dispels any doubt as to its guiding principle, which is to put profit ahead of any other consideration. From a positive perspective, one might hope that product quality and product safety are the best guarantors of maximum profitability in the long run. Regrettably, the tobacco industry is in the unfortunate position of selling products that are inherently unsafe. The 'saving grace' for the industry, so to speak, as seen from a commercial point of view, is the addictiveness of its products, which suspends the market forces that would otherwise reject them.

As we ponder the realities of the free enterprise system, we are inevitably led to appreciate the role that government has to play on behalf of the people and the environment. In their wisdom, the Framers of the Constitution granted Congress the right to regulate commerce. The US government is empowered by the "Commerce Clause" of Article 1, Section 8, of the Constitution to stop the interstate trade of dangerous merchandise, and could exercise this authority in the case of tobacco, which is a killer drug that has never been approved by the FDA. Such action must be clearly distinguished from prohibition, since individuals would still be able to grow tobacco strictly for personal use.

If the US government would indeed exercise the prerogative envisioned above, as natural and logically compelling as it might appear to a detached observer from a different era, it would still be an extraordinary act of redemption and a solemn memorial for the silent millions that have fallen victim to this man-made plague of the 20th century. It would be a bold step taken at the threshold of the new millennium.

CONCLUDING COMMENTS

The foregoing sections should be taken only as vignettes, but in no way as an exhaustive account of the diverse landscape of tobacco business. Needless to say, several important aspects could not be addressed within the limited scope available.

From all we know, and we do know a great deal after half a century of intense epidemiological and experimental research activities, it is clear that cigarettes and other tobacco products can be made less hazardous, but can never be made safe. Even nicotine, were it marketed today for 'recreational' use in place of tobacco products, would retain some of the hazards associated with tobacco use. First of all, nicotine is a powerful poison; secondly, it has strong cardiovascular effects; thirdly, it is the precursor of the carcinogenic tobacco-specific nitrosamines; and, finally, it recently has emerged as a tumor promoter in human bronchial epithelium cell lines(35).

There is no reason, however, not to search for a true replacement of nicotine(36), a drug that would simulate only the positive effects of nicotine which have made it so fatally attractive to millions of people around the globe.

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