HGinzel

                        K.H. Ginzel, M.D. (khginzel@yahoo.com), is Professor Emeritus of
                         Pharmacology and Toxicology at the University of Arkansas for Medical
                         Sciences.

"In a time of universal deceit, telling the truth is a revolutionary act." — George Orwell

After Some 100 Million Deaths—What's Next? written by K. H. Ginzel, M.D.

To attempt an answer to this question, we must first assess the
current situation. As I see it, it is bleak to the extreme.

                         After more than 20 years of intense efforts in helping fight the
                         unparalleled human tragedy of disease and death caused by tobacco
                         use, I feel utterly frustrated, angry, defeated, hopeless, and cynical.
                         More so, I am inescapably losing respect for a society and a culture
                         that has permitted this state of affairs not only to materialize, but also
                         to persist essentially unabated.

                         The admirable, untiring work of a dedicated tobacco control
                         community has in no way been matched by the actions that would
                         be necessary on the part of those individuals and institutions who
                         alone have the power and responsibility to stop the victimization of
                         the people of this nation and of the rest of the world. Governments
                         have largely remained aloof, while the tobacco cartel has been riding
                         out crisis after crisis—especially the one of the last decade—by
                         practicing and perfecting their well-seasoned deployment of cunning,
                         craftiness, and deceit. That Big Tobacco managed to survive the
                         most recent turmoil virtually unscathed is primarily reflected in its
                         success in securing the next generation of its customers. Despite all
                         the adverse media publicity that tobacco received during the 1990s,
                         teen smoking in America rose during that period, and overseas
                         expansion of tobacco trade has also been progressing at an ever
                         increasing pace. "Business as usual" continues to thrive, prompting
                         leading epidemiologists to predict worldwide tobacco-related
                         mortality to reach 150 million in the first quarter, 300 million in the
                         second, and a grand total of one billion (!) during the 21st
                         century—figures that dwarf any statistics from other known causes.

                         Not only is tobacco killing its direct users, at an annual toll of over
                         400,000 in the United States alone: it also claims the lives of an
                         estimated 60,000 nonsmokers who die from a similar range of
                         diseases as smokers, but in their case caused by exposure to
                         environmental tobacco smoke. It has now been 15 years since
                         Harvard epidemiologist John Bailar stated in The New England
                         Journal of Medicine that the "sharp and continuing rise in deaths
                         from lung cancer, nearly all from cigarette smoking, is now widely
                         recognized as a medical, social, and political scandal."

                       Who are the players in this gruesome drama? Foremost, they are
                         the purveyors of the deadly merchandise. They also include the
                         nation's youth— targeted, tricked, and manipulated into lifelong
                         dependency; an army of biomedical scientists who dispassionately
                         measure, count, and transform human suffering into impersonal
                         numbers; and, at the other end of the spectrum, us—the tobacco
                         control advocates and activists, emerging from every part of society
                         and trying desperately to contain the mayhem. Sprawling across the
                         entire scene is finally the government—federal, state, and local
                         officials who duplicitously cater to both the sellers of death and their
                         frustrated opponents. All in all, we are witnessing an arrangement of
                         remarkable stability and continuity that, barring radical change,
                         offers little prospect for a resolution in the foreseeable future.

                         To grasp the enormity of it all and put a human face on the abstract
                         numbers, we only have to pause and envisage, however feebly, the
                         dying and death of some of the estimated 100 million victims that
                         smoking has claimed thus far. The unspeakable agonies of dying
                         from cancer of the lungs or larynx, the slow suffocation of those
                         afflicted with emphysema, and the fatal heart attacks in the prime of
                         life conjure up visions of bodies lined up in endless rows, bodies
                         fallen victim to violence turned inward, ravaged by a product whose
                         dangers have been known but insidiously concealed by its
                         manufacturers for almost five decades. These images are
                         fundamentally no different from those of the death camps and mass
                         graves the last century has witnessed in Nazi Germany, the Soviet
                         Union, Cambodia, Rwanda, and Bosnia.

                         Although our pro-health advocacy has steadily gained in
                         membership and momentum, the tobacco industry has been able
                         repeatedly to boast record profits and exports, matched only by the
                         rising toll of tobacco-related disease, disability, and death encircling
                         the globe. The industry has skillfully absorbed what, at first glance,
                         may have appeared a major setback, such as the 1998 Attorney
                         Generals' settlement, which amounted to some $240 billion to be
                         paid to the states over a period of 25 years. However, it simply
                         enticed the recipient governments to spend the windfall moneys for
                         anything they like except tobacco prevention, because reducing
                         smoking would contractually also reduce industry payments. The
                         most recent analysis attests to the industry's success: only a
                         miniscule 5 percent of the settlement has been used for the originally
                         stated purpose.

                         FIRST, it is the unceasing, undiminished pursuit of the youth market
                         by tobacco corporations, which employ ever changing strategies of
                         attack, aided by our stubborn persistence in the irrational (I will
                         explain later) belief that common ground and mutual trust can
                         eventually be found. During the past half-century, public health
                         groups as well as government officials have repeatedly tried to seek
                         some sort of accommodation with the manufacturers of tobacco
                         products. A case in point is the industry's voluntary code of
                         advertising, launched some 20 years ago, which promised not to
                         prey on the vulnerabilities of the young. Yet precisely the opposite
                         has happened, as thousands of secret company documents
                         summoned during recent court trials have chillingly revealed. Flying
                         in the face of such unabashed lies as "We don't want children to
                         smoke" or "Smoking is an adult custom," or "It is an adult
                         choice"—all craftily phrased to lure kids into lighting up—the
                         industry mounted a monumental marketing scheme bluntly directed
                         at teens and even preteens. Several other empty commitments were
                         voiced over time, each of them designed to rekindle confidence and
                         stir fresh, unrealistic expectations among tobacco control advocates
                         who were still hoping for change.

                         The tobacco industry has resisted true change throughout its long
                         history. The first opportunity for change offered itself most forcefully
                         when in 1942 Lennox Johnston's landmark report in the British
                         medical journal The Lancet identified nicotine as the active agent in
                         tobacco responsible for the pleasant sensations experienced by the
                         smoker. Johnston proposed that smoking tobacco was essentially a
                         means of administering nicotine, just as smoking opium was a means
                         of administering morphine. In 35 volunteers he found that nicotine
                         injections not only simulated cigarette smoke inhalation but were
                         also actually preferred to a cigarette. The second major opportunity
                         for change followed only eight years later, when the first solid
                         evidence surfaced that incriminated cigarette smoking as a cause of
                         lung cancer. At that juncture, the tobacco industry could have
                         followed the example of the pharmaceutical industry, which had
                         already scored remarkable breakthroughs by identifying, isolating,
                         and purifying active ingredients from natural products—such as
                         morphine from poppies, salicylic acid from the bark of willows,
                         reserpine from Rauwolfia (an ancient herb in India with medicinal
                         properties), curare alkaloids from South American arrow poison,
                         penicillin from mold, and many more. All of these can now be used
                         safely in specified dose ranges to treat a variety of medical
                         conditions.

                         The tobacco industry could then have concentrated on developing
                         nicotine preparations free of the unnecessary burden of thousands of
                         toxicants and carcinogens contained in the smoke of ordinary
                         cigarettes. Fifty years ago, the tobacco industry might even have had
                         a chance to obtain FDA approval, since the addictiveness of
                         nicotine, though alluded to by Johnston, was then far from being
                         generally recognized or experimentally confirmed. That the industry
                         failed to do what modern medical research in other areas had been
                         doing all along, suggests that addiction liability and FDA regulation
                         must have raised a red flag even then.

                         Rather than focusing on nicotine and removing the toxic
                         contaminants, the cigarette makers took the opposite course and
                         actually added several hundred chemicals as tobacco additives.
                         These additives served various purposes, but they especially helped
                         to smooth and aromatize the rough smoke of natural tobacco so that
                         kids and women would be able to tolerate it and become hooked
                         more rapidly as nicotine was made available to the huge surface
                         area of the lungs upon inhalation. The rest of the story is one of
                         unprecedented lies and deceit, denying and obscuring the truth
                         about the carnage wreaked upon this country and much of the world
                         by the cigarette makers.

                         This is the same industry that several lawmakers, during the
                         tumultuous congressional negotiations in 1997, considered worthy of
                         protection from legal liability in return for $350 billion and certain
                         concessions, whose effectiveness in reducing tobacco use was still
                         largely in doubt. Fortunately, the concerted effort of our nationwide
                         coalition "Save Lives Not Tobacco" averted the passage of any
                         such bill. It would be truly unthinkable that the U.S. Constitution
                         should ever be so subverted as to fit the schemes of an industry that
                         wants to continue selling death with impunity. In a letter printed in
                         The Washington Post on September 21, 1997, I wrote in the
                         closing paragraph: "If this type of mind-set had prevailed at the end
                         of World War II, we probably would have stopped our advance on
                         the beachhead at Normandy, made peace with Hitler and argued
                         about the least offensive way to keep the concentration camps
                         operating."

                         In its most recent PR ploy, the tobacco industry, faced with a
                         mountain of undeniable revelations about its conduct, tried to
                         portray itself as a reformed industry. Because it has reformed, so the
                         industry implied, it should not be judged by its past actions. In June
                         2001, the Campaign for Tobacco-Free Kids and Action On
                         Smoking and Health in London released a report, entitled "Trust Us:
                         We're The Tobacco Industry." It contains over 250 quotes from
                         internal tobacco industry documents on topics from addiction and
                         advertising to women and youth smoking, and indexes the dozens of
                         countries mentioned in the documents.

While they claim they have reformed and are now "nice" and
"responsible," their own documents tell a different story.

                         All this is just a repeat performance. The few allegedly corrective
                         actions the industry and its allies have taken over the years were
                         either evasive or merely feigned changes in attitude. Noisy
                         ostentations of tobacco company CEOs vowing to keep kids from
                         using tobacco, have repeatedly misled naive observers who were
                         willing to detect a trait of responsibility in the industry's actions and
                         even entertain variations on the theme "Can the tobacco industry be
                         trusted to protect our children?"

                         Industry efforts to emasculate public health initiatives are now being
                         aimed at the current WHO agenda—the Framework Convention on
                         Tobacco Control—which is seeking worldwide consensus to stem
                         the tide of the tobacco pandemic. Here the industry found an
                         unexpectedly new ally in the U.S. delegation, which was lately
                         directed to relax its earlier stance of firmly supporting a global treaty
                         with teeth in it. Representative Waxman accused administration
                         negotiators of doing everything they could to prevent the creation of
                         strong global standards. During the third round of negotiations in
                         November 2001, the United States continued to take positions on
                         tobacco advertising, consumer protection, trade, and other issues
                         that would protect the interests of the tobacco industry rather than
                         public health. Philip Morris had this to say on its web site: "We do
                         not agree . . . that tobacco use is an 'epidemic.' And we are
                         concerned that certain proposals by WHO fail to recognize tobacco
                         consumption as a legitimate choice that adults should be free to
                         make." Tobacco giants admitted in Geneva in 2000 that smoking
                         cigarettes was dangerous and addictive, but defended their right to
                         sell and advertise them freely.

                         That year, after reviewing all of the new postures adopted by Philip
                         Morris, BAT, Japan Tobacco, Imperial Tobacco, and Gallaher, the
                         U.K. House of Commons Health Committee concluded that the
                         tobacco industry had not really changed, but rather had only
                         enhanced its public relations machinery. The industry continues to
                         aggressively promote tobacco use in every corner of the globe,
                         often in ways most effective at reaching youth. In the U.S., tobacco
                         industry marketing expenditures have achieved a new annual high of
                         over $8 billion, according to the latest report.

                         The SECOND most important factor leading up to the present
                         situation is the failure to achieve FDA regulation of tobacco
                         products. The push for such regulation as envisaged by Dr. David
                         Kessler, then Commissioner of the FDA, and widely supported by
                         the health community, President Clinton and some members of
                         Congress, was unfortunate. It contained the seeds of failure from the
                         start.

                         In a letter to Dr. Kessler of May 3, 1994, which I also sent to the
                         President, I stressed that the shape that such regulation would take
                         seemed to be highly problematic. Then I asked: "How would a
                        tobacco product that contains nicotine and is used for the sole
                         purpose of satisfying a craving prone to lead to serious health
                         consequences qualify as a 'drug,' defined 'to include all medicines
                         and preparations recognized in the U.S. Pharmacopoeia or National
                         Formulary for internal or external use, or any substance intended for
                         the cure, mitigation, or prevention of disease in man or animals'
                         (Arthur H. Hayes, MD, Commissioner of FDA: Food and Drug
                         Regulation After 75 Years, JAMA: 246, 1223, Sept 11, 1981)?
                         How would a tobacco product comply with the 1962 Amendment
                         requiring manufacturers to prove on the basis of substantial evidence
                         that the drug is safe and effective, when such a product is in fact
                         unsafe, and effective only in killing more than 400,000 Americans
                         each year?"

                         In an invited presentation, entitled "Science-Based Tobacco Use
                         Control: The Future Is Now," at the Dixy Lee Ray Memorial
                         Symposium on Science-Based Environmental Management, in
                         Seattle, August 30 to September 2, 1994, I again took issue with
                         the proposed FDA regulation of tobacco in conjunction with two
                         1994 bills, HR 2147 and S 672, seeking to amend the Federal
                         Food, Drug, and Cosmetic Act to include tobacco products. I
                         reasoned that such an amendment "would totally subvert the
                         well-defined, time-honored charge of the FDA to provide the
                         American consumer with safe and effective therapeutic agents and
                         non-harmful food and cosmetic products. The regulation by the
                         FDA of a prodigious mixture of a few thousand chemicals, replete
                         with potent poisons and powerful carcinogens, which are smoked or
                         ingested for no purpose other than to satisfy a craving for nicotine,
                         would seriously undermine the credibility of a federal agency known
                         and respected for its health-oriented mission."

                         A year or two later, an almost identical argument was raised by
                         attorneys for the tobacco industry who filed a lawsuit trying to
                         prevent an FDA rule. If the court says the FDA has jurisdiction over
                         tobacco, the industry argued, the FDA must ban tobacco, because
                         the law insists that products under the FDA's purview must be "safe
                         and effective"—a standard no tobacco product can meet. The case
                         finally reached the U.S. Supreme Court, which, on March 21,
                         2000, rejected FDA jurisdiction over tobacco, stating that the
                         government lacks authority to regulate tobacco as an addictive drug.
                         Ruling 5 to 4, the justices said the FDA overreached when it
                         reversed a decades-old policy in 1996 and sought to crack down
                         on cigarette sales to minors. During their deliberations, some justices
                         were skeptical that an agency charged with monitoring "safe and
                         effective'' products could bring cancer-causing tobacco products
                         into its domain. "It just doesn't fit,'' said Justice Sandra Day
                         O'Connor. "It strains credibility to see how these products can be
                         safe,'' she added.

                         O'Connor and other moderate and conservative justices suggested
                         that the FDA would have no choice but to ban cigarettes and
                         smokeless tobacco if it did begin to regulate them.

                         In the same May 3, 1994, letter to Dr. Kessler, in which I
                         questioned the appropriateness of proposing FDA jurisdiction over
                         tobacco, I pleaded for the placement of nicotine—an agent with
                         proven addictive potential—under Schedule II of the Controlled
                         Substances Act of 1970, along with morphine and other opioids of
                         clinical usefulness, thus permitting the continued use of nicotine in the
                         treatment of nicotine addiction. As a consequence, nicotine-free
                         cigarettes and other tobacco products would quickly fall out of
                         favor and bring an end to the 20th century nightmare of self-inflicted
                         disease and death.

                         The THIRD integral factor in this analysis is the failure of the federal
                         government and the majority of state legislatures to protect
                         summarily the nonsmoking majority of this country from exposure to
                         environmental tobacco smoke (ETS). Next to keeping its foothold
                         on the youth market, the tobacco industry's major concern has been
                         to preserve "smokers' rights" to smoke in the workplace, in the
                         public arena, and especially in restaurants and in bars. This is why
                         Big Tobacco viewed the nonsmokers' rights movement as "the most
                         dangerous development to the viability of the tobacco industry that
                         has yet occurred" (1978 Roper Report).

                         It is imperative that the Occupational Safety and Health
                         Administration (OSHA) finally live up to its charge to protect
                         employees from harmful exposures, which include those to tobacco
                         smoke. The general duty clause of the Occupational Safety and
                         Health Act of 1970 states in Section 5 (a): "Each employer shall
                         furnish to each of his employees employment and a place of
                         employment which are free from recognized hazards that are causing
                         or are likely to cause death or serious physical harm to his
                         employees." In the past, OSHA has consistently dodged its
                         responsibility. Despite persistent efforts and repeated lawsuits
                         against OSHA by the Action on Smoking and Health (ASH),
                         OSHA continues to procrastinate and delay action on a nationwide
                         workplace smoking ban.

                         In a written testimony submitted to the Senate Hearing on ETS on
                         April 1, 1998, I tried to spell out the multifaceted aspects of lacking
                         or providing a smoke-free environment. The physical harm inflicted
                         by many of the more than 4,700 chemicals and 60 carcinogens in
                         ETS has its greatest impact during pregnancy. This is when nicotine,
                         a neuroteratogen, can interfere with fetal brain development, and
                         when potent carcinogens, such as nicotine-derived NNK, invade
                         growing organs not yet protected by mature DNA repair
                         mechanisms. Impeccable research defining ETS-related morbidity
                         and mortality, conducted by reputable scientists at prestigious
                         institutions, has been maliciously attacked by tobacco interests,
                         including industry front groups, with no letdown at a time when the
                         industry pretended to reform. The industry vigorously and viciously
                         opposes a smoke-free environment most probably because the
                         absence of smoking in the public domain, which could eventually
                         spill over into private residences and family automobiles, would
                         eliminate a crucial incentive for children to experiment with and start
                         smoking cigarettes themselves. It would also help smokers quit. The
                         exposure of children to ETS has inflicted widespread physical and
                         psychological harm, prompting Dr. William G. Cahan of Memorial
                         Sloan-Kettering Cancer Center to call it, in a March 1985 New
                         York Times editorial, the most prevalent form of child abuse.

                         Although smoking in enclosed air spaces has diminished, as more
                         and more local clean-indoor-air laws have been enacted—often
                         requiring an undue amount of time, energy, dedication, and nerves to
                         implement their passage—smoking on the television and movie
                         screen has recently taken off, obviously to keep smoking behavior
                         well in the public eye.

                         The need to provide a smoke-free environment is not less important
                         than the need to help smokers quit and to keep children from
                         starting to smoke. All are integral parts of the same problem and
                         should not be separated from one another. The disappointing
                         outcomes of our past and present programs in prevention and
                         cessation are no doubt a consequence of the fragmented and
                         restrained approach that varying circumstances beyond our control
                         have forced upon us.

                         As a general guideline: We need a total turnaround from the manner
                         in which we have been dealing with the tobacco issue in the past.
                         We need uncompromising honesty. We need to recognize and end
                         the reassuring self-delusion we have so comfortably indulged in. We
                         need to acknowledge once and for all not just the obvious—that the
                         tobacco industry has never kept its commitments—but also the
                         hidden fact that it actually CANNOT be expected to behave
                         differently.

                         The reality is simply this: The tobacco industry makes and markets a
                         product that is highly addictive and maims or kills when used as
                         intended. No other product officially traded on world markets
                         shares this unique notoriety with tobacco. The continued prosperity
                         of the industry depends on three basic requirements: Most
                         importantly, it depends on the successful recruitment of children and
                         adolescents into the ranks of smokers. Statistics have compellingly
                         shown that very few people ever start to smoke after age 21. This is
                         why the industry has vehemently opposed any legislation that would
                         have raised the legal age for buying tobacco products above the age
                         of 18. Since many high school seniors are 18 years or older, they
                         can legally buy cigarettes and sell them to their younger classmates.
                         Secondly, the cigarette business depends on the pervasive visibility
                         and the continued social acceptance of smoking as part of normal
                         human behavior. And thirdly, the industry depends on the calculated
                         presence of nicotine in tobacco in amounts sufficient to produce
                         and/or maintain addiction and thus to assure customer loyalty in the
                         face of alarming news from the health front.

                         To expect that one of the most powerful industries—and probably
                         the most lucrative enterprise on the planet—would voluntarily
                         compromise or make serious concessions in any one of these vital
                         preconditions for its survival is totally unrealistic; in fact, it would be
                         tantamount to expecting the industry to commit suicide.

                         Finally, we need to admit that, by deluding ourselves, we have all
                         been playing an unending game—call it "enabling" or call it
                         "co-dependency"—whose outcome is counted in millions of children
                         starting, and millions of smokers dying from, tobacco use. The
                         perennial question asked in this game of life and death has been this:
                         How do you plan to stop the tobacco companies from targeting
                         kids? The fact that we have asked this very question unremittingly
                         over the past half century is the root of our failure. It is a no-brainer!
                         But it surely has helped retain the status quo.

                       This question is, in fact, as absurd as to ask whether the tubercle
                         bacillus can be persuaded not to cause tuberculosis, or HIV not to
                         cause AIDS. The "business," so to speak, of the tubercle bacillus is
                         to cause tuberculosis; the "business" of HIV is to cause AIDS; the
                         business of the tobacco industry is to market a product that
                         inadvertently kills. To be sure, the manufacturers would be pleased
                         if it wouldn't, but it does. At the least, the delayed onset of disease
                         guarantees many years of profitable consumption.

                         Recognizing these self-evident facts calls for a fundamental revision
                         of our approach. We must stop treating the tobacco industry as a
                         partner in negotiation, as an organization run by people like
                         ourselves with whom we can talk and reason. We must confront
                         them as a quasi-nonhuman entity, as a carrier or vector of disease, a
                         pathogen like the tubercle bacillus or HIV. We don't make a "deal"
                         with the germs that produce disease and death—we try to eradicate
                         them.

                         In the case of an epidemic in the conventional sense, we turn to the
                         Centers for Disease Control and Prevention (CDC), which swiftly
                         mobilizes a concerted effort to stop the outbreak. The CDC and
                         several other institutions under the umbrella of the U.S. Department
                         of Health and Human Services (U.S. DHHS) are also involved in
                         fighting the epidemic of tobacco-related illnesses, but here their
                         options to act are severely limited. For one thing, this epidemic is
                         not caused by a simple microbe, but rather by a product legally
                         manufactured and sold by American industry. The major constraint
                         the U.S. DHHS faces, however, is imposed by the same
                         government of which it is a constituent. A quote from a court
                         opinion in the Cippolone lung cancer trial refers to the intention of
                         the U.S. Congress as "seeking a carefully drawn balance between
                         the purposes of warning the public of the hazards of cigarette
                         smoking and protecting the interests of the national economy."
                         Obviously, the carrier of tobacco-related diseases has infiltrated the
                         very institution elected by public vote, whose sworn charge and duty
                         it is to uphold the tenets of the Constitution, mindful of the
                         Unalienable Rights to Life, Liberty and the Pursuit of Happiness that
                         the founding fathers have proclaimed for the people of this nation. A
                         recent commentary from Downing Street, with respect to a
                         proposed workplace smoking ban in Britain, also invokes the
                         concept of "balance" that has to be "achieved between desirable
                         health objectives and being sensitive to the problems of restricting
                         business practice."

                         There is still another economic perspective: Tobacco business
                         allegedly saves the treasury billions by killing people before they
                         deplete social security and pension funds. Calculations of this kind,
                         however flawed, have been attempted not only by industry but also
                         by governments.

                       Here are a few examples from the industry: Philip Morris vs. Czech
                         economy analysis that made headlines in 2001, stating that the
                         premature deaths of smokers saved the country millions in health
                         care costs; a 1993 report commissioned by Imperial Tobacco
                         stating that tobacco-related deaths are an economic advantage to
                         Canadians because cigarettes kill people before they become a
                         burden to the healthcare system; and a November 1978 secret
                         document from the British American Tobacco Company, talking
                         about what they call the "social cost" issue in rather chilling language:
                         ". . . with a general lengthening of the expectation of life we really
                         need something for people to die of. . . . In substitution for the
                         effects of war, poverty and starvation, cancer, as the disease of the
                         rich, developed countries, may have some predestined part to play."

                         According to Milton and Rose Friedman, corporate officials have
                         only one "social responsibility," i.e., to make as much money for
                         their shareholders as possible. The best guarantors of maximum
                         profitability in the long run are product quality and product safety. In
                         the case of tobacco, however, these market forces are suspended
                         by the addictiveness of the products. Here, governmental
                         intervention is necessary to protect the consumer. In their wisdom,
                         the Framers of the Constitution granted Congress the right to
                         regulate commerce, empowering the U.S. government by the
                         "Commerce Clause" of Article 1, Section 8, of the Constitution to
                         stop the interstate trade of dangerous merchandise. If this authority
                         would be exercised in the case of tobacco, it could usher in the
                         beginning of the end of tobacco marketing. Such action must clearly
                         be distinguished from prohibition, since individuals would still be
                         able to grow tobacco strictly for personal use.

                         It would, indeed, be a bold move. Yet extraordinary challenges
                         require extraordinary responses, whose feasibility and whose legal
                         and legislative ramifications must be seriously explored. The
                         inescapable truth, sadly affirmed by past experience, is that no
                         intervention of any kind can be expected to protect children fully
                         from being targeted by Big Tobacco. Recruitment of children as
                         future consumers is the sine qua non of the survival of the tobacco
                         industry.

                         Therefore, if government and society honestly want kids not to
                         smoke, the logically compelling choice is to shut down the
                         commercial marketing of tobacco products. The task would be
                         monumental, but it is the only practical, social, and ethical alternative
                         to allowing the killing to continue. Although only trade within the
                         U.S. would initially be affected, other countries, assisted by WHO's
                         worldwide tobacco control initiative, might soon follow our lead.
                         Indeed, final success would depend on full international cooperation.
                         There are positive indicators that the time is right for comprehensive
                         action. U.S.-based tobacco corporations are already widely
                         diversified in areas other than tobacco and should be given
                         reasonable time to phase out the manufacture of tobacco products
                         and expand their share in non-tobacco commodities.

                         Tobacco farmers should be encouraged and assisted to shift, at least
                         in part, from conventional tobacco farming to the cultivation of
                         tobacco plants for the extraction of tobacco protein, which has been
                         shown to be superior to all other plant proteins tested and deserves
                         full-scale development and utilization for food and a variety of
                         medicinal purposes. What an intriguing prospect that the same plant
                         that has killed millions of people should also possess the potential
                         and capacity of feeding a protein-starved world and stimulating
                         novel biotechnological research. Neither tobacco nor anything that
                         human ingenuity has brought forth is inherently evil. It just depends
                         on what we, collectively and individually, make of it.

                         The tools are at hand, but the will to use them is still lacking. In
                         order to initiate the process of phasing out conventional tobacco
                         commerce, all sectors of society must become actively involved.
                         While the process of phasing out conventional tobacco commerce is
                         unfolding, education will have to play a major role. Surprisingly, the
                         population at large is still remarkably ignorant about the depth and
                         magnitude of the global public health tragedy caused by tobacco
                         use. Very few people can even guess some of the mind-boggling
                         statistics. The Journal of the American Medical Association recently
                         reported that even smokers are only marginally aware of the risks
                         they incur. However, the much needed social and political support
                         by the public, especially the voters, will depend on their being fully
                         informed.

                         So far we have done poorly in educating the people vis-a-vis the
                         overriding impact and indoctrination by Big Tobacco. The perennial
                         reference to "drugs and alcohol" has effectively eclipsed the much
                         greater risks associated with tobacco use. Therefore, it is not
                         surprising, yet still quite disconcerting, that recent headline
                         revelations about contemptible tobacco industry conduct, instead of
                         inciting outrage, were largely met with indifference and apathy by the
                         public. On the other hand, the proverbial person on the street,
                         responding to community campaigns for smoke-free places, often
                         asks why cigarettes are not banned altogether.

                         The first steps toward ending conventional tobacco commerce
                         would be a comprehensive advertising ban and the protection of
                         nonsmokers from tobacco smoke exposure. Both objectives are
                         vigorously pursued by WHO but opposed by the U.S. delegation.
                         Regrettably, the U.S. position will aid efforts by the tobacco
                         industry and its allies to fight enactment of clean-indoor-air measures
                         across the globe.

                         A totally different approach to stop tobacco trade, promotion, and
                         ETS pollution lies in the hands of the next generation. If children and
                         young people under the age of 21 did not start smoking cigarettes or
                         using any other tobacco products, the conventional tobacco
                         business would eventually be doomed. According to the CDC, less
                         than 10 percent start smoking after 21.

                         Based on my own experience, I submit that a consistent, nationwide
                         educational effort could take us a long way toward this goal. It is
                         crucial that we tell kids the truth! Tell them that the tobacco
                         companies are tricking them with lies, deceit, and fraud into smoking
                         or chewing as if it were their own informed "adult choice" or an act
                         of rebelliousness, independence, and "doing their own thing." The
                         overused "Just say no" formula is largely ineffective, be-cause
                         youngsters feel invulnerable to the risks of future illness.

                         During the 2001 spring and fall terms, assisted by a group of nursing
                         students from New Mexico State University, I conducted over 100
                         demonstrations of a graphic smoking experiment combined with
                         media literacy training. We addressed almost 4,000 children from
                         the 3rd to the 8th grade in the Las Cruces school district. It was an
                         uplifting experience that instilled new hope in the human potential for
                         change.

                         It turned out that neither the children nor the teachers had been
                         aware of the insidious ways the tobacco industry is manipulating the
                         mind of kids. Their comprehension of what adults may view a
                         difficult subject to convey was immediate and impressive and
                         prompted the children to compose letters and make drawings,
                         reflecting their grasp of the subject.

                         This, indeed, gives us confidence that our message has gotten
                         through and that these youngsters feel it is in their power to change
                         the world for the better. We also designed a flyer that reinforces our
                         message and is discussed and distributed by the teacher in a
                         followup session.

                       A second flyer is directed to the parents who smoke and expose
                         their children to secondhand smoke in their homes. As many as one
                         to two thirds of the children complained that they suffer such
                         exposure, causing them a variety of respiratory problems. Children
                         whose parents smoke are also more likely to become smokers
                        themselves.

I am writing to voice my opposition to FDA regulation of tobacco products, including the current S.625/H.R.1108, "The Family Smoking Prevention and Control Act”.

My opposition to FDA regulation of recreational tobacco products has not changed since it was first proposed by then FDA commissioner David Kessler, MD. In a letter to Dr Kessler dated May 3, 1994, I raised opposing arguments which turned out to be almost identical to those of US Supreme Court's justice Sandra Day O'Connor's majority opinion six years later, in March 2000, denying the FDA regulation of cigarettes.

O'Connor noted that the FDA has concluded that cigarettes are unsafe and dangerous. As a result, she said, federal law ''would require the FDA to remove them from the market entirely.'' She wrote: ''The inescapable conclusion is that there is no room for tobacco products within the (federal law's) regulatory scheme,... if they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit.'' Justice O'Connor continued: "By no means do we question the seriousness of the problem that the FDA has sought to address, .....the agency has amply demonstrated that tobacco use, particularly among children and adolescents, poses perhaps the single most significant threat to public health in the United States.'' Justice O'Connor's March 2000 opinion was echoed by a tobacco industry's lawyer who argued that if FDA regulation were allowed, the government would be forced to ban tobacco products because they have not been shown to be safe. As expected, the tobacco industry sharply opposed FDA involvement.

This, however is no longer true with Bill S.625 that is before you now. S.625 permits, with certain additional restrictions and safeguards, the continued marketing of tobacco products and has thus gained not only the full approval but also the active support of Altria/Philip Morris, PM, the nation's and world's largest tobacco company.

If the FDA is to provide the public with drugs for the treatment and prevention of diseases and disabilities, i.e., with medications that must satisfy the two indispensable criteria of being safe and effective, the inclusion in its jurisdiction of cigarettes, a product that kills one out of two of its users, would totally subvert its long-standing avowed mission of protecting and improving public health. Thus - and we are back to O'Connor's analysis - if tobacco products were admitted under FDA overview but not banned in the process, it would have to be seen as the stamp of federal approval for their continued existence and use in a society ultimately resigned to the prospect of a projected one billion worldwide smoking-related deaths during the 21st century.

Paradoxically, FDA scrutiny that attempts to make cigarettes "safer", as it is intended by S.625, flies in the face of PM's recent blunt admission that "THERE IS NO SAFE CIGARETTE" (http://www.philipmorrisusa.com/en/health_issues/cigarette_smoking_and_disease.asp). In fact, this admission is the only compelling conclusion after several decades of tobacco research that has failed to eliminate certain highly toxic and carcinogenic ingredients from tobacco and tobacco smoke (although ulterior motives are clearly involved in PM's unexpected honesty). If S.625 ever succeeds in making cigarettes "safer", it could never create a SAFE cigarette.

If the current momentum to place tobacco under FDA oversight cannot be halted, at least one essential correction in the bill's text is indispensable. It concerns the legal age for buying tobacco products which is currently age 18 and would be retained in S.625. However, age 18 is unacceptable for the following reasons:

1) The proposed regulation specifically prohibits the FDA from raising the legal minimum age for tobacco purchase beyond age 18, as obviously demanded by PM to retain access to high school seniors, many of whom are over 18 and would therefore be able to legally buy tobacco products and pass them on to peers under 18.

2) Although the majority of adult smokers started smoking under age 18,
15 to 20 percent may start between 18 and 21. This fringe would probably disappear or diminish if age 21 is adopted as the legal limit. According to CDC, less than 10 percent start smoking after age 21.

3) Tobacco use, smoked or chewed, imposes a carcinogenic and toxic burden on the user that is more dangerous for the growing organism than for the adult. Physical growth does not stop at age 18 but continues at least till 21.

4) The age at which psychological maturity is attained for making an informed decision about using legal drugs with a high potential for addiction is at least 21, the age adopted for legal purchase of alcoholic beverages.

5) The difference between the legal ages of 18 and 21 for purchase of tobacco and alcohol products could be misinterpreted as reflecting a difference in harmfulness.

The American Association of Public Health Physicians, AAPHP, has undertaken an extensive Analysis of S.625/H.R.1108. It states that "S.625/H.R.1108 is written to perpetuate cigarette consumption for many years, with uncertain benefits after that. Passing this bill would be like turning off a fire alarm without putting out the fire", and concludes with this pronouncement: "Finally, and sadly, note that, as seen by AAPHP, no bill at all would be better than S.625 in it’s current form" (AAPHP_ Tob_Analysis_20070712.doc).

It is also noteworthy to recall the statements made by the head of the FDA, Dr. Andrew von Eschenbach, a cancer surgeon, in a recent interview with The Associated Press. Commenting on S.625's intention to lower nicotine levels in cigarettes, he said: “We could find ourselves in the conundrum of having made a decision about nicotine only to have made the public health radically worse. And that is not the position FDA is in; we approve products that enhance health, not destroy it.” Stressing repeatedly that the issue of regulating tobacco is a complex one, he added: “What I don’t want to see happen is that we are in a position where we are determining that a cigarette is safe” (http://www.msnbc.msn.com/id/17483839).

If the present effort to achieve FDA oversight of tobacco fails or is abandoned for reasons indicated above, what other, and better, options do we have to address the leading preventable cause of disability, disease and death in our society?

In my letter to Dr Kessler of May 3, 1994, I not only opposed FDA regulation of tobacco but also argued in favor of placing nicotine in Schedule II of the Controlled Substances Act that was enacted into law by the Congress of the United States as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. Two federal departments, the Department of Justice and the Department of Health and Human Services (which includes the FDA) determine which drugs are added or removed from the various schedules.

In the words of former Surgeon General Koop, the very “heart of the issue” is “not smoking, not tobacco, but nicotine addiction”. Nicotine addiction was the subject of the 1988 Surgeon General’s Report which concluded that nicotine, fulfilling all criteria for drug dependence, is the drug in tobacco products (cigarettes and other forms of tobacco) that causes addiction, and that "..the pharmacological and behavioral processes that determine tobacco addiction are similar to those that determine addiction to drugs such as heroin and cocaine". The 1994 Surgeon General’s Report on "Preventing Tobacco Use Among Young People" confirmed that nicotine causes rapid addiction in up to half of all children who experiment with tobacco.

But it is not only the high addictive potential of nicotine that causes increasing concern but also its insidious toxicity, especially the serious harm it can inflict upon the developing and growing organism (Critical Review: Nicotine for the Fetus, the Infant and the Adolescent? J Health Psychol 12(2), 215-224, 2007 (DOI:10.1177/1359105307074240) (see attachment Ginzel_et_al_12_2.pdf).

In light of the accumulated evidence, a legally acceptable option for regulating tobacco products is to place nicotine, the addictive component of tobacco, under the Controlled Substances Act. By including nicotine in Schedule II of the Controlled Substances Act, which contains drugs with a high potential for abuse and dependence but continued medical usefulness, such as cocaine and various opioids, stimulants and hypnotics, the availability of nicotine for the treatment of nicotine addiction, in form of Nicotine Replacement Therapy, NRT, would be preserved. But nicotine in any other form would be outlawed.

Nicotine would then be back on prescription only, as it had formerly been till 1996. As a Schedule II drug, nicotine dispensed in NRT formulations would then require the same procedure that has to be followed when prescribing other controlled substances. This constraint should help prevent the now uncontrolled, spreading use of NRT for smoking cessation, that is aggressively pursued by the makers of NRT products and those affiliated with them (see attachment Ginzel_et_al_12_2.pdf).

As for the tobacco industry, it could then legally sell only nicotine-free tobacco products which can be expected to lose attraction for the buyer over time. This would bring about the gradual phasing out of tobacco marketing and use, and with it the reduction and eventual elimination of tobacco-related morbidity and mortality. Once this goal is achieved, nicotine can be removed from the Controlled Substances Act.

According to the late Milton Friedman, nobel laureate in economics, corporate officials have only one "social responsibility," i.e.,"to make as much money for their shareholders as possible". Maximum profitability is based on product quality and product safety. In the case of tobacco, however, these market forces are suspended by the addictiveness of the products. Here, governmental intervention is necessary to protect the consumer.

In their wisdom, the Framers of the Constitution granted Congress the right to regulate commerce, empowering the U.S. government by the "Commerce Clause" of Article 1, Section 8, of the Constitution to stop the interstate trade of dangerous merchandise. If this authority were exercised in the case of tobacco, it could usher in the beginning of the end of tobacco marketing. Such action must clearly be distinguished from prohibition, since individuals would still be able to grow tobacco locally and strictly for personal use.

The reality is simply this: The tobacco industry makes and markets a product that is addictive, toxic and carcinogenic, and it maims or kills when used as intended. The worldwide death toll from cigarette smoking could approach the one billion mark by the end of the 21st century. No other product officially traded on world markets shares this unique notoriety with tobacco (Ginzel, K.H. After Some 100 Million Deaths - What's Next?

The continued prosperity of the industry depends on the successful recruitment of children and adolescents into the ranks of smokers. Statistics have convincingly shown that very few people start to smoke above age 21. This is why the industry has vehemently opposed any legislation that would have raised the legal minimum age for buying tobacco products to age 21. Former FDA Commissioner David Kessler pointedly called smoking "a pediatric disease". The inescapable truth, sadly affirmed by repeated experience over the past half century, is that no stop-gap measures of any kind can be expected to protect children from the onslaught of Big Tobacco. Without them as future customers, tobacco business would be doomed.

Therefore, if government and society honestly want kids not to become victims of tobacco use, the logically compelling choice is to end the commercial marketing of tobacco products. The task would be monumental, but it is the only practical, social, and ethical alternative to allowing the killing to continue. Although only trade within the U.S. would initially be affected, other countries, assisted by WHO's worldwide tobacco control initiative, might soon follow our lead. Indeed, final success would depend on full international cooperation. There are positive indicators that the time is right for such comprehensive action. Some U.S.-based tobacco corporations are already sufficiently diversified in areas other than tobacco to be able to phase out the manufacture of tobacco products while expanding their share in non-tobacco commodities.

Tobacco farmers should be encouraged and assisted to shift from conventional tobacco farming to the cultivation of tobacco plants for the extraction of tobacco protein, which has been shown to be superior to all other plant proteins tested and deserves full-scale development and utilization for food as well as a variety of medicinal purposes (Ginzel, K.H., Protein, An Alternative Tobacco Crop, http://www.gasp.org/protein.html). What an intriguing prospect that the same plant that has killed millions of people should also possess the potential and capacity of feeding a protein-starved world and stimulating novel biotechnological research. Neither tobacco nor anything that human ingenuity has brought forth is inherently evil. It just depends on what we, collectively and individually, make of it.

Finally, facing the stark reality laid out in the preceding paragraphs, no nation claiming to uphold the fundamental tenets of civilization can any longer afford not to act.