The End of Combusted Tobacco?

With E-cigarettes, a mixed bag of possible outcomes.

E-cigarettes represent a controversial and uncertain future for nicotine addiction, and for this reason they have attracted acolytes and naysayers in what feels like equal measure.

It has been almost 8 years since e-cigarette imports first reached our shores, and the FDA’s determination that they are subject to regulation as tobacco products brings the industry to a crucial crossroads.

On the one hand: “Marked interdevice and intermanufacturer variability of e-cigarettes… makes it hard to draw conclusions about the safety or efficacy of the whole device class.”

On the other hand: “Published evaluation of some products suggest that e-cigarettes can be manufactured with levels of both efficacy and safety similar to those of NRT [nicotine replacement therapy] products… they could play the same role as NRT but at a truly national, population scale.”

So which will it be? Is there an outside chance that the decision by the FDA’s Center for Tobacco Products will represent the first step in dealing with nicotine products currently “designed, marketed, and sold” outside the regulatory framework established for NRT?  A stalemate presently prevails. Writing in the New England Journal of Medicine, Drs. David Abrams and Nathan K. Cobb, Johns Hopkins professors affiliated with the American Legacy Foundation, a tobacco research and prevention organization funded with lawsuit money from the major tobacco companies, highlight the irony: In order to market e-cigarettes as smoking cessations devices, manufacturers must seek approval from the FDA to market pharmaceutical products, “an expensive and time-consuming process than no manufacturer has yet attempted.”

Thus, questions about nicotine content, additives of various kinds, and assorted carrier chemicals go unanswered. Yet these are precisely the questions that need answers before e-cigarettes can be viewed as tools in the harm reduction armamentarium. Cobb and Abrams note that current e-cigarettes “represent a single instance of a nicotine product on a shifting spectrum of toxicity, addiction liability, and consumer satisfaction.” But the market dictates that “to compete with and displace combusted tobacco products, e-cigarettes will need to remain relatively convenient, satisfying, and inexpensive,” regulation notwithstanding.

Still, the harm reductionists’ dreams for the product remain seductive, because “surely any world where refined nicotine displaces lethal cigarettes will experience less harm, disease, and deaths? That scenario is one endgame model for tobacco control: smokers flee cigarettes en masse for refined nicotine and ultimately quit all use entirely.”

Critics say fat chance: “As Big Tobacco’s scientists shift from blending leaves and additives to manipulating circuit boards, chemicals, and dosing schedules, they’re unlikely to relinquish their tolerance for risk and toxicity that prematurely kills half their users in their efforts to ensure high levels of customer ‘satisfaction,’ addiction, and retention.”

Once again, it is the dictates of the market that may end up shaping the future of tobacco, and making the plans of harm reductionists look naïve indeed. “Tobacco companies and their investors,” write Cobb and Abrams, “need millions of heavily addicted smokers to remain customers for decades, including a replenishing stream of young people. No publicly traded company could tolerate the downsizing implicit in shifting from long-term addiction to harm reduction and cessation.”

The marketing innovations most likely to stem from tobacco companies entering the market for e-cigarettes are those most likely to “sustain high levels of addiction and synergistic ‘polyuse’ of their existing combusted products,” while simultaneously crimping competition from NRT manufacturers and independent e-cigarette manufacturers. Tobacco companies are past masters at manipulating things like nicotine content, vaporization methodologies, flavorings, and unknown additives. They will surely bring this expertise to bear in seeking a major bite out of the e-cigarette market while maintaining acceptable profit margins on traditional cigarettes.

The authors suggest that the FDA could weight the matter in harm reduction’s favor by using its product-standard authority “to cripple the addictive potential of lethal combusted products by mandating a reduction in nicotine levels to below those of e-cigarettes and NRT products and eliminating flavorings such as menthol that make cigarettes more palatable.” Tax breaks for e-cigarettes would further load the dice.

But not today. The FDA’s proposal calls for warning labels or product safety and quality standards for e-cigarettes—but not for at least two years. Two years is a long time in a fast-emerging market already valued in excess of $2 billion. The authors call the delay disturbing, “given the variability in product quality and a documented spike in cases of accidental nicotine poisoning.”

In conclusion, the authors believe that for smokers hoping to quit, “NRT products still represent safer, more predictable choices, even if they are more expensive and less appealing.”

Photo credit:  http://www.rstreet.org/

Why the CDC Director Hates E-Cigarettes

The pros and cons of getting your vape on.

Last month, the Food and Drug Administration (FDA) began a new era—regulating e-cigarettes. With a non-controversial first step, the FDA banned the sale of e-cigarettes to minors, required health warnings, prohibited health claims, and outlined a plan to register and license all electronic nicotine products at some future date. The FDA’s proposed rules would also give the agency the power to regulate the currently unregulated mixture of chemicals and flavorings that are heated during e-cigarette use.  Whatever regulations the FDA promulgates for electronic cigarettes will also apply to nicotine gels, water pipe tobacco, and hookahs.

Perhaps what rankles e-cigarette activists the most is the FDA’s insistence that companies will have to provide scientific evidence before making any implied claims about risk reduction for their product, compared with cigarettes. The FDA did not restrict advertising or prohibit flavorings (bubble gum, apple-blueberry, gummi bear, and cappuccino are popular).

Within a few days after the FDA’s announcement, Chicago, New York City, and other major cities placed e-cigarettes under the same municipal smoking bans as cigarettes. 

The battle over e-cigarettes is both a public health issue and a private enterprise war for market share. Corporate giants Altria and Lorillard, which dominate the corporate tobacco landscape in the U.S., are fighting for a piece of what has become nearly a $2 billion market in a few short years. (Altria recently boosted  its growth forecast to 6-9% growth for 2014). Lorillard has been making heavy acquisitions of its own, and commands more than half the present market with its Blu brand. Altria has made its own vapor acquisitions, and is launching its own brand, MarkTen.

So far, the moves being contemplated by the FDA do not have these companies shaking in their boots. They anticipated the ban on sales to minors, a system of formal FDA approval, a disclosure of ingredients, and health warnings about the addictive nature of nicotine. And Congress gave the FDA legal authority to draft a set of rules for e-cigarettes five years ago, so the FDA’s reluctance to step in on liquid nicotine delivery systems has been evident.

In an interview with the Los Angeles Times, Tom Frieden, director of the Center for Disease Control and Prevention (CDC), listed the reasons for his opposition to electronic cigarettes:

—E-cigarettes are an additional means of hooking another generation of kids on nicotine, making them more likely to become adult smokers.

—Smokers who might have quit smoking will maintain their nicotine addiction, remaining highly vulnerable to tobacco craving.

—Ex-smokers might make themselves more vulnerable to relapse if they take up vaping.

—Smokers might forego medications that could help them quit, in favor of the unproven promise of tobacco abstention via e-cigarette.

—E-cigarettes might have the cultural effect of “re-glamorizing” smoking.

—E-cigarette users might be exposing children and pregnant women to nicotine via secondhand smoke mechanisms.

—E-cigarette users can refill cartridges with liquid cannabis products and other drugs.

Dr. Michael Siegel, a tobacco expert at the Boston University School of Public Health, worries that smaller players will be squeezed out due to costs associated with the FDA approval process, driving sales toward the traditional cigarette industry leaders. Go-go analysts have predicted market penetration of as much as 50% for e-cigarettes, but Siegel is more pessimistic, and believes the e-cigarette share could top out at 10% if FDA regulations set back efforts by vaping proponents to position their product as a safer and healthier alternative to tobacco cigarettes. And that, says Siegel, would be a shame. He told the Boston Globe: “There simply is no product on the market that’s more dangerous than tobacco cigarettes, and nobody in their right mind would argue that cigarette smoking is less hazardous or even equally hazardous to vaping.”

Frieden at the CDC is sympathetic to the fact that many smokers have indeed quit smoking tobacco with the aid of e-cigarettes. “Stick to stick, they’re almost certainly less toxic than cigarettes.” But like many tobacco experts, he sees the possibility of a new generation of nicotine addicts. Almost two million high school kids have tried e-cigarettes, Frieden told the LA Times, “and a lot of them are using them regularly…. That’s like watching someone harm hundreds of thousands of children.”  The CDC reported that the percentage of high school students who have used an e-cigarette jumped from 4.7% in 2011 to 10% in 2012. Calls to poison control centers involving children and e-cigarettes have increased sharply as well.

Frieden views the Food and Drug Administration as David under siege by Goliath. The FDA, he said, “tried to regulate e-cigarettes earlier, and they lost to the tobacco industry…. So the FDA has to balance moving quickly with moving in a way that’s going to be able to survive the tobacco industry’s highly paid legal challenge.” If E-cigarette makers really want to market to people trying to quit smoking, Frieden told the LA Times, “then do the clinical trials and apply to the FDA. But they don’t want to do that.” (See my post on Big Tobacco’s move into the e-cigarette market).

“It’s really the wild, wild West out there,” a beleaguered FDA commissioner Margaret Hamburg told the press.   “They’re coming in different sizes, shapes and flavors in terms of the nicotine in them.”

On May 4, the New York Times published a report by Matt Richtel, based on an upcoming paper in the journal Nicotine and Tobacco Research. Nicotine researchers discovered that high-end electronic cigarette systems with refillable tanks produce formaldehyde, a known carcinogen, as a component of the exhaled nicotine vapor. Moreover, unlike disposable e-cigarettes, tank systems require users to refill them with liquid nicotine, itself a potent toxin. “Nicotine is a pesticide, fundamentally,” Michael Eriksen, dean of the School of Public Health at Georgia Statue University, told CNN. “We take so many precautions about pesticides for our lawns and how to wear gloves. But what precautions do consumers take when they put the nicotine vials in?”

This was not good news for harm reductionists, who view the advantages of e-cigarettes as self-evident. The New York Times report says that the toxin is formed “when liquid nicotine and other e-cigarette ingredients are subjected to high temperatures,” according to the research. “A second study that is being prepared for submission to the same journal points to similar findings.” In addition, a new study by researchers RTI International documents the release of tiny metal particles, including tin, chromium and nickel, which may worsen asthma and bronchitis.

Eric Moskowitz at the Boston Globe  reported that “thousands of gas stations and convenience stores statewide carry e-cigarettes, usually stocking disposable or cartridge-based versions that resemble traditional cigarettes.”

In U.S. News, Gregory Conley, president of the trade group American Vaping Association, predicted “a huge influx of anti-e-cigarette legislation in the last half of 2014 and especially in 2015 when the legislative sessions get going again.” 

According to Carl Tobias, a law professor at the University of Richmond, “it may be years before  regulations are imposed. The lobbying at FDA and Congress will be intense.”

Effectively regulated, e-cigarettes have the potential to drastically reduce deaths from tobacco-related diseases among cigarette smokers. In an editorial for the journal Addiction, Sara Hitchman, Ann McNeill, and Leonie Brose of King’s College, London, wrote: “E-cigarettes may offer a way out of the smoking epidemic or a way of perpetuating it; robustly designed, implemented and accurately reported scientific evidence will be the best tool we have to help us predict and shape which of these realities transpires.”

Photo credit: http://ecigarettereviewed.com

Built-In Advantages Give Big Tobacco an Edge in E-Cigs

The Big Three are now in it to win it. 

If there was ever any doubt that major tobacco companies have designs on the emerging electronic cigarette market, a recent roundup in the Wall Street Journal makes the case with ease, something that eager acolytes of e-cigs are anxious to avoid. No doubt about it, Big Tobacco wants in.

Results from intensive test marketing in Colorado have, like a political primary, provided an early indication of where the popularity lies. Reynolds American, the nation’s 2nd largest tobacco company (Camel), led the, uh, pack with its offering, the Vuse e-cigarette, introduced in July. Vuse racked up a 55% market share in that state. Next in line, with 25%, was Blu, owned by the 3rd largest cigarette maker, Lorillard (Newport). NJOY, an independent company, came in third.  The elephant in the room, Altria Group, the largest U.S. tobacco firm (Marlboro), is still in the test marketing stage with its e-cigarette entry, the MarkTen. Altria began testing the MarkTen in Indiana and Arizona in late summer.

It took Reynolds less than 16 weeks to achieve market dominance in Colorado, and the company made sure that investors heard about it. With 1,800 retail outlets in Colorado, and a database of 12 million tobacco consumers, Reynolds is perfectly poised to benefit from the inherent advantages of being Big Tobacco. The Big Three have three major head starts, the Wall Street Journal reported: “extensive distribution networks, existing customer relationships numbering in the millions, and deep pockets.”

The market for electronic cigarettes has broken a billion dollars, say stock watchers. This magic number seems to have energized the Big Three to take a heavy step into a market that has been around in nascent form since 2006, even though it’s still small change compared to the $100 billion U.S. tobacco market. It was not clear, in the beginning, whether Reynolds, Lorillard, and Altria would attempt to, pardon me, snuff out the competition, or dominate it. That decision now appears to have been made, and the game is on.

Stephanie Cordisco, president of R.J. Reynolds Vapor Company, which markets Vuse, said the marketing tagline in Colorado was: “A perfect puff. First time, every time.” 

So far, e-cigarettes, which heat nicotine-based liquid to create a vaporized mist, have benefitted from the fact that they are not, at present, savagely taxed like regular cigarettes. And e-cigs come in flavors, cherry and pina colada being among the favorites.

In April of 2012, Lorillard broke the e-cig barrier when it acquired Blu Ecigs for $135 million. At the Wall Street Journal, Mike Esterl suggested that the move came “as the Food and Drug Administration weighs a possible crackdown on menthol-flavored cigarettes, which represent about 90% of revenue at Greensboro, N.C.-based Lorillard, owner of the popular Newport brand. The FDA already has banned all other cigarette flavors.”

Reynolds followed Lorillard into the market early in 2013 with Vuse. And the giant Altria Group announced in October that it planned to expand sales of the MarkTen after successful “lead market” sales. It’s too early too say how it will go for the MarkTen, but Altria CEO Marty Barrington said in a conference call reported by the Richmond Times-Dispatch that the company is not overly worried about cannibalizing Marlboro sales: “I can tell you that with respect to who is trying the products in e-vapor generally,” he said, “ we do know that there is dual use. As adult smokers try e-vapor products, we know that some of them are satisfied and others are not. Some of them use [e-cigarettes] situationally.”

That does not sound like an executive rolling out a stop-smoking therapy tool.

Graphics Credit: http://seekingalpha.com

Big Tobacco Hasn't Given Up On Smoking. Have You?

World No Smoking Day.

Six Arguments For the Elimination of Cigarettes

Prohibition and the “tobacco control endgame.”

Despite all our efforts in recent years to reduce the percentage of Americans who smoke cigarettes—currently about one in five—the idea of full-blown cigarette prohibition has not gained much traction. That may be changing, as prominent nicotine researchers and public police officials start thinking about what is widely referred to as the “tobacco control endgame.”

Considering the new regulatory powers given the FDA under the terms of the Tobacco Control Act of 2009, as a commentary in Tobacco Control framed it, “will the government be a facilitator or barrier to the effective implementation of strategies designed to achieve this public health goal?”
Two newer approaches have gained some traction in the research community: Reduce the level of nicotine in cigarette products (the FDA is prohibited by law from reducing nicotine content to zero), and continuing to emphasize the non-combustible forms. Plus, everybody pretty much agrees on higher prices.

Here are the six arguments for going all the way:

1) Death. Six million of them a year, worldwide, a number that will grow before it starts shrinking. A billion deaths this century, compared to 100 million in the 20th Century. Robert Proctor, author of The Golden Holocaust and a professor of history at Stanford, whose six arguments these are, calls the cigarette “the deadliest object in the history of human civilization.” So there’s that.

2) Other product defects. The cigarette is defective, Proctor writes in defense of his six arguments in Tobacco Control, because it is “not just dangerous but unreasonably dangerous, killing half its long-term users.” Indeed, it is hard to imagine the FDA green-lighting a drug product like that today. In addition, Proctor claims cigarettes are defective because the tobacco has been altered by flue curing to make it far more inhalable than would otherwise be the case. “The world’s present epidemic of lung cancer is almost entirely due to the use of low pH flue-cured tobacco in cigarettes, an industry-wide practice that could be reversed at any time.”

3) Financial burdens. These can be reckoned principally in terms of the costs of treating smoking-related illnesses. This, in turn, leads to diminished labor productivity, especially in the developing world, a process that “in many parts of the world makes the poor even poorer,” Proctor observes.

4) Big Tobacco’s impact on science. By sponsoring shoddy and distracting research, by publishing “decoy” findings and by otherwise confusing and corrupting scientific discourse on the cigarette question in the advertising-dependent popular media. The tobacco industry has proved to everyone’s satisfaction that it can put politicians and regulators under intense pressure to see things its way. Not to mention other institutions that have been “bullied, corrupted or exploited,” according to Proctor: The AMA, The American Law Institute, sports organizations, Hollywood, the military, and the U.S. Congress, for starters. (Until 2011, American submarines were not smoke-free.)

5) Environmental harms. More than you might think falls into this category: Deforestation, pesticide use, loss of savannah woodlands for charcoal used in flue curing, fossil fuels for curing and transport, fires caused by burning cigarettes, etc.

6) Smokers want to quit. Smoking is not a recreational drug, as Proctor takes pains to point out. Most smokers hate it and wish they could quit. This makes cigarettes different from alcohol or marijuana, Proctor insists. He quotes a Canadian tobacco executive, who said that smoking isn’t like drinking; it’s more like being an alcoholic. This rings true to for the majority of addicted smokers I know, and was certainly true of me when I was a smoker.


So there it is, the case for tobacco prohibition. But hasn’t all this prohibition business been tried and found wanting? We know the results of drug and alcohol prohibition, whatever their rationales: Smuggling, organized crime, increased law enforcement, more money. This argument, says Proctor, has been central to the cigarette industry since forever: “Bans are ridiculed as impractical or tyrannical. (First they come for your cigarettes…)”

Proctor’s response is that smuggling is already common, and people should be free to grow tobacco for their personal use. He advocates a ban on sales, not possession.

There are at least two major obstacles to cigarette prohibition. First, an enormous amount of tax revenue is generated by the production and sale of cigarettes. And the troubling question of a steep rise in black marketeering goes largely ignored or unaddressed. In the same special issue of Tobacco Control, Peter Reuter has sobering thoughts on that front: “Cigarette black markets are commonplace in high tax jurisdictions. For example, estimates are that contraband cigarettes now account for 20-30% of the Canadian market, which has restrained government enthusiasm for raising taxes further. All the proposed ‘endgame’ proposals for shrinking cigarette prevalence toward zero run the risk of creating black markets.”

In the end, Proctor argues that the cigarette industry itself has repeatedly promised to quit the business if its products where ever found to be profoundly harmful to consumers. As recently as 1997, Philip Morris CEO Geoffrey Bible swore under oath that if cigarettes were found to cause cancer “I’d probably… shut it down instantly to get a better hold on things.” Incredible statements like this by company executives go back to the 1950s. Perhaps it’s time to let them stop lying. “The cigarette, as presently constituted,” writes Proctor, “is simply too dangerous—and destructive and unloved—to be sold.”

Proctor R.N. (2013). Why ban the sale of cigarettes? The case for abolition, Tobacco Control, 22 (Supplement 1) i27-i30. DOI: 10.1136/tobaccocontrol-2012-050811

Photo: AAP/April Fonti

Big Tobacco Easily Evades “Light” Cigarette Ban

Color coding allows smokers to easily identify their former brands.

The tobacco industry has once again made a mockery of the Food and Drug Administration’s attempts to ban ‘light” cigarettes from the marketplace, by simply eliminated the objectionable wording and substituting an easily-decoded color scheme. In a brochure prepared for cigarette retailers marked “For trade use only: not to be shown or distributed to customers,” tobacco giant Philip Morris wrote that “some cigarettes and smokeless packaging is changing, but the product remains the same.”

Research done at Harvard demonstrates "the continued attempts of the industry to avoid reasonable regulation of tobacco products,” said Hillel Alpert, co-author of a new study on light cigarettes, in a prepared statement. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) of 2009 highlights the banning of light cigarettes as a critical mission, since cigarettes marketed in this way are in fact no safer than regular cigarettes. What makes a cigarette Light or Ultra-light is a series of tiny holes drilled through the filter (See earlier post). This “filter ventilation” was calibrated to the descriptors: Ultra-lights had more holes drilled in the filter than Lights. Studies have demonstrated conclusively that such filter schemes do not make smoking safer or cut down on related diseases. A 2001 report from the National Cancer Institute documented how smokers were compensating for the ventilation holes by smoking more cigarettes, smoking them more intensely, or by blocking the filter holes with fingers or lips.

In a study for Tobacco Control, Gregory Connolly and Hillel Alpert of the Harvard School of Public Health documented the process. In 2010, Philip Morris sent manuals to retailers detailing how they were to deal with the new sales situation. Philip Morris made clear that “current pack descriptors such as light, ultra-light and mild will be removed from all packages.” All well and good. However, the Philip Morris material also specified how a series of new package names were to be doled out. Marlboro Light became Marlboro Gold. Marlboro Mild morphed into Marlboro Blue. And Marlboro Ultra-light reemerged as Marlboro Silver.

When the researchers commissioned a large public survey to document the state of affairs one year after the official “light” ban, they found that “88%-91% of smokers found it either ‘somewhat easy’ or ‘very easy’ to identify their usual brand of cigarettes by the banned descriptor names, Lights, Mediums or Ultra-Lights.” Sales figures for these brands in the first two quarters of 2010 were essentially unchanged, the authors report. They conclude that “the majority of smokers of brands in all categories correctly identified their brands’ pack color.”

The lesson here may well be that countries like Australia and the UK are on the right track: Plain packaging may be best. If lawmakers allow “misleading numbers, the use of colors, imagery, brand extensions, and other devices that contribute to deception” in place of words, nothing has really changed. “The findings of the present research strongly suggest that tobacco manufacturers have evaded one of the most important provisions of the FSPTCA for protecting the public health from the leading cause of preventable death and disease,” the authors conclude.

In a press release, co-author Gregory Connolly, director of the Center for Global Tobacco Control at Harvard, explained that the industry “was found guilty by a federal court in 2006 for deceptively promoting ‘light’ cigarettes as safer after countless smokers who switched to lights died prematurely, thinking they had reduced their health risks.”

Connolly G.N. & Alpert H.R. (2013). Has the tobacco industry evaded the FDA's ban on 'Light' cigarette descriptors?, Tobacco Control, PMID: 23485704

Photo Credit:http://www.mydiscountcigarette.net

Science, Academia, and Tobacco

A review of The Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition

Part III

Academic collaborations come in many flavors. Just because the money is corporate doesn’t mean the studies that are funded are flawed by definition. But the cigarette industry’s academic philanthropy set new records for hubris, writes Robert Proctor, professor of history at Stanford University, in his new book, The Golden Holocaust. Duke University and Bowman Gray School of Medicine, both in North Carolina, are named for tobacco magnates.

Harvard has a long and dubious history of tobacco largesse.  Harvard’s Tobacco and Health Research Program kicked off in 1972 with a generous tobacco grant from the Tobacco Institute, who dreamed up the program in the first place. “The Harvard project made the industry look good and so was handsomely endowed, absorbing $7 million over an eight-year period.” Also in 1972, Harvard anthropologist Carl Seltzer testified for the industry in numerous public hearings, stating: “We do not know whether or not there is a causal relationship between smoking and heart disease.” In 2002, Harvard’s School of Public Health declared it would no longer undertake research sponsored by the cigarette industry. Many universities had already gone cold turkey, and after Harvard, bans were put in place by the Karolinska Institute, Johns Hopkins University, Emory University, and many others.

Proctor informs us that “Washington University in St. Louis has been another big sponge for tobacco money." In 1971, the university set a new world record for an industry grant to a single institution, and “millions more were eventually funneled into the School of Medicine, turning it into a hotbed of cigarette-friendly activism.” The irony of taking money from Big Tobacco to fund research on lung cancer is not lost on Proctor. A good deal of the research was aimed away from tobacco and toward possible causes like viruses. “The goal was clearly more than cancer cures,” he writes. “The industry also hoped to generate good PR and academic allies.” The industry was able to garner  sympathetic headlines, like “Helping in Fight against Cancer,” in the St. Louis Globe-Democrat.

The other academic hotbed thoroughly penetrated by Big Tobacco was UCLA, according to Proctor. “Tobacco collaborators at UCLA have attracted their fair share of criticism from public health advocates, and for understandable reasons.” The university picked up its own multimillion-dollar grant from cigarette makers for the Program on Tobacco and Health in 1974, and that wasn’t the first tobacco money the university had taken. “As with all such projects,” Proctor writes, “industry lawyers… played a key role in the decision to fund—with the companies also conceding that the decision ‘should be based more on public relations than on purely scientific grounds.’” The end came in 2007, when “UCLA’s dance with the devil” garnered a ton of unwanted press. Reports showed that UCLA had taken more than $6 million from Philip Morris for research “to compare how children’s brains and monkey brains react to nicotine.”

Proctor admits that singling out Harvard, Washington University and UCLA is somewhat misleading, “given that scholars throughout the world have gorged themselves on tobacco money. Indeed it may well be the rare institution that has NOT at one time or another dipped into this pot.”

Including Stanford, where Proctor teaches. Plenty of Stanford researchers have undertaken contract work and served as expert witnesses for the industry right in Proctor’s own backyard, where “at least eighteen faculty members have received monies (in the form of sponsored research) from the Council for Tobacco Research, with at least two of these—Judith Swain and Hugh McDevitt from the medical school—serving on its Scientific Advisory Board. Stanford pharmacologists were assisting the industry with its diethylene glycol studies as early as the 1930s…”

In the conclusion to his densely researched but surprisingly readable work, Proctor returns to the controlling irony of the book: “Our bizarre starting point is the well-stocked shelf of cigarettes, to which we respond by begging people not to purchase them.” He presents the dream of a world in which cigarettes have been abolished. To do so, he admits, would require a leap. “If phasing out tobacco seems out of reach, this is only because our imaginations are impoverished.” And he has scant patience for the “Prohibition failed” argument. It failed, he says, because people like to drink. “Tobacco presents us with a very different situation. Nicotine is not a recreational drug. Most people who smoke wish they didn’t, and most smokers (90 percent) regret ever having started.”

Graphics Credit: http://www.prwatch.org/node/7004

The Tobacco Industry as Disease Vector

A review of The Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition

Part II

The famous Surgeon General’s Report of 1964, officially warning Americans about the dangers of smoking, and publicizing the cancer connection, is typically seen as a triumphal moment in American medical history. But according to Stanford history professor Robert Proctor in his book, The Golden Holocaust: Origins of the Cigarette Catastrophe and the Case for Abolition, the report was “flawed in a number of interesting respects.” [The author, above, with paraphernalia] For one thing, members of the advisory committee consulting on the report, many of them congressman friendly to the tobacco cause, succeeded in their attempts to have smoking referred to as a “habit” rather than as addiction—a shameful Orwellian turn that went uncorrected for 25 years.

Meanwhile, the industry continued to fund new institutes, and continued to give out research grants for “red herring” research. As an example, the highest-ranking officer of the American Heart Association received money from one of the industry’s fraudulent research arms.

As late as the early 80s, most smokers believed they suffered from a bad habit, rather than an addiction—even though a majority of them wished they didn’t smoke. That is an odd kind of consumer “choice.” Cigarette makers have spent millions to perpetuate this myth. Proctor views tobacco industry executives and lawyers as a unique form of disease vector, spreading the pernicious health consequences of smoking across the globe.

The 2008 World Health Organization (WHO) Report on the Global Tobacco Epidemic fleshes out this metaphor, suggesting that all epidemics have a means of contagion, “a vector that spreads disease and death. For the tobacco epidemic, the vector is not a virus, bacterium or other microorganisms—it is an industry and its business strategy.”

In an email exchange, I asked Professor Proctor to expand on this notion of a disease vector:

“We tend to divide "communicable" from "non-communicable" diseases,” Proctor told me, “when the reality is that many "non-communicable" diseases are in fact spread by communications.”

Examples? “Through ignorance and propaganda, for example, which can spread like a virus,” Proctor wrote. “We don't count the anthropogenic communications, oddly enough, even though these can be just as dangerous, and just as deadly. And just as preventable--by changing our exposure environments.”

In a recent article for Tobacco Control, Proctor laid out how the calculus of the disease vector plays out. We know, for example, that smoking will cause roughly 6 million deaths in 2015. And about a third of those will be from lung cancer. We know that 25 acres of tobacco plants will result in about 10 lung cancer deaths per year, starting 20 or 30 years down the road. Here’s a sick equivalence: “A 40 ft container of the sort shipped overseas or trucked by highway houses 10 million cigarettes, which means that each container will cause about 10 deaths.” Proctor works out the numbers for the value of a human life:

“Cigarette companies make about a penny in profit for every cigarette sold, or about $10,000 for every million cigarettes purchased. Since there is one death for every million cigarettes sold (or smoked), a tobacco manufacturer will make about $10,000 for every death caused by their products…. The value of a human life to a cigarette manufacturer is therefore about $10,000.” 

Proctor has even produced a “factories of death” chart, illustrating that arguably the world’s most lethal production plant is Philip Morris’s Richmond cigarette facility, which churned out 146 billion cigarettes in 2010, which adds up to about 146,000 deaths per year.

By 1964, researchers at Harvard had already identified the presence of radioactivity in the form of polonium 210 in cigarette smoke, and the cry went up for safety. As for the notion of safer cigarettes, Proctor says all cigarette filters function the same way—“basically like drinking through a somewhat thinner straw.” He goes even further, arguing that “filters have reduced smoke particle size, producing cancers deeper in the lungs, making them harder to identify and harder to treat.” (Scientists determined that the radiation source was the newer “superphosphate” fertilizers being used heavily on tobacco plants.)

 Next came mandated “tar and nicotine numbers,” which turned out to be misleading measures obtained from smoking robots. Then, “an opportunity presented itself to game the system, as we find in the brilliant trick of ventilation.” Manufacturers pricked tiny holes in the paper near the mouthpiece of cigarettes brands like Carlton and True, which consumers got around by covering the holes with fingers or with “lipping” behavior. “Low tars were a fraud, just as “lights” would be,” Proctor writes. Smokers just smoked harder, or differently, or more frequently. In 1983, pharmacologist Neal Benowitz at UCSF broke the official news in the New England Journal of Medicine: Smokers got just as much nicotine, whether they smoked high-, low-, filtered, unfiltered, regular, light, or ultra-light.  The industry itself had known this for more than 20 years. “Nicotine in the actual rod was rarely allowed to drop below about 10 milligrams per cigarette,” Proctor asserts, “and no cigarette was ever commercially successful with much less than this amount.” (A Philip Morris psychologist compared nicotine-free cigarettes to “sex without orgasm.”)

Indeed, almost every design modification put in place by tobacco companies over the past century, from flue-curing to filters, has served to make cigarettes deadlier than before. “Talk of ‘safer cigarettes’ is rather like talking about safer terrorism, or safer smallpox, or safer forms of drowning,” Proctor concludes.

And the industry testing continues. The point of tobacco-sponsored research is not simply to discredit an individual researcher’s work, but to create an aggregate bias in the pattern of research—a lot of “noise” in the signal. In other words, “you basically fund lots of research to dispute a hazard, then cite this same research to say that lots of scholars dispute it.” We are told about “mucociliary escalators,” which dredge the tar up and out of smokers’ lungs. We learn that “a rabbit will scream if nicotine is introduced into the eye.” We read excerpts from anguished letters to tobacco companies: “Do you suppose if I continue to smoke Camel Ultra Light Cigarettes and I should develop cancer it will be ‘Ultra Light Cancer?’”

Proctor brings us up to date: Harm reduction, he writes, has become the industry’s new mantra. “The companies now want us to believe that less hazardous products can be and are being made and marketed.” Proctor thinks harm reduction “may end up causing even greater harm” if products touted as “safer” make smokers less likely to quit. As for public health campaigns, “consumers are encouraged to stop consuming,” Proctor writes, “but producers are never discouraged from producing.” Or, as Louis Pasteur once wrote: “When meditating over a disease, I never think of finding a remedy for it, but, instead, a means of preventing it.”

So, what comes next? A glimpse of the future may already be here, in the form of cinnamon- and mint-flavored Camel Orbs, “which look like Tic Tac candy and contain about a milligram of nicotine in a highly freebased form.”

As for the industry’s success in corrupting scientists and academics through various means, the story is just as bad as you think it is: “It would take many thousands of pages to chronicle the full extent of Big Tobacco’s penetration of academia; the scale of such collaborations is simply too vast. From 1995 to 2007 alone, University of California researchers received at least 108 awards totaling $37 million from tobacco manufacturers….”

Part II of III.

Photo Credit: http://theloungeisback.wordpress.com/

The Black Bag: Odds and Ends

Drug news from the world of science and medicine.


--How Marijuana Impairs Memory

Mo Costandi at the UK Guardian expands on his Nature article about the mechanisms that result in memory impairment when people smoke marijuana. Memory formation depends on the neurotransmitter glutamate. What goes wrong when you smoke pot? Enter the astrocyte…

--Coffee Will Disrupt Your Sleep—Unless You’re a Night Owl

From Scientific American comes the news that your “chronotype”—the chronological patterns you naturally favor—may determine whether or not caffeine keeps you tossing and turning and night. Morning people, or “larks,” had more periods of wakefulness during sleep hours than night people, or “owls.” The findings, published in the journal Sleep Medicine, show that “for the early risers, the more caffeine in their bodies, the more time they spent awake during the night after initially falling asleep. This was not seen in the night owls.”

--Brain Scans Get Better

You wouldn’t know it from all the bad press about moving heads and specious interpretations, but fMRI technology continues to improve. Time Healthland reports that new machines will be able to do a better job spotting traumatic brain injury in military personnel, athletes, and accident victims. High-definition fiber tracking, as this article in the Journal of Neurosurgery explains, will allow medical staff to better assess damage to nerve fibers deep in the brain, due to technological improvements in “assessing white matter injuries that are not apparent in standard anatomical imaging.”

--Cig Makers Trump FDA on Free Speech Grounds

The FDA maybe didn’t think this one through quite as thoroughly as they should have. Reuters reports  that a U.S. judge “sided with tobacco companies on Wednesday, ruling that regulations requiring large graphic health warnings on cigarette packaging and advertising violate free-speech rights under the U.S. Constitution.” Evidently, FDA officials didn’t see the 1st Amendment argument coming. By mandating grisly pictures of diseased lungs, rotting teeth, and dying smokers on cigarette packs, “the government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech," U.S. District Judge Richard Leon said.

--Meth Head Burns Down Tree Older Than Jesus

And finally, as if we needed any more evidence, here’s a story about bad decision-making among the meth head crowd: WFTV reports that a female meth addict in Seminole County, Florida, burned down a historic cypress believed to have been the world’s 5th oldest tree. Authorities learned that the woman and a friend had been cooking methamphetamine under the 3,500 year-old tree. Officials said the woman took pictures of the disaster with her cell phone, and was quoted saying: "I can't believe I burned down a tree older then Jesus."

Photo Credit: http://www.squidoo.com 

Update on Smoking Bans Around the World

The noose tightens.

Smoking bans are everywhere. But what does the global picture look like as 2011 gets underway? Herewith, a brief rundown of the smoking situation in assorted countries, courtesy of an analysis late last year by BBC News.

-- Canada. In a nation known as one of the toughest of all when it comes to regulating cigarettes, the Canadian Medical Association Journal says the strict laws have been responsible for “cutting hospital admissions for heart and respiratory problems by about a third.”

-- China. In contrast, 2010 gave observers little reason to think that the Chinese government was actually going to enforce the promised national ban on smoking in public places. Enforcement varied from city to city but in general remained vague at best. Only about 25 % of the adult population believes that smoking is linked to cancer. “The country has an estimated 350 million smokers. For every three cigarettes lit worldwide, one is smoked in China,” according to BBC News.

-- Germany. The smoke-free movement hit some snags in Germany, where a ban on smoking in pubs and restaurants in 2008 has been fiercely resisted in some quarters. Tavern owners complain of lost income, and the bans are also disliked “because of an earlier crackdown on smoking initiated by Adolf Hitler’s Nazi regime,” says BBC News. Nonetheless, cigarettes were banned from Munich’s Oktoberfest for the first time in history.

-- France. Curiously, in a nation that was expected to rise up as one against workplace smoking bans, “correspondents say attitudes to smoking have changed dramatically in France since the 2007 ban, and any fears that people would generally ignore the laws have proved false.”

-- United Kingdom. Smoking is banned almost everywhere—“nearly all enclosed public spaces”—in England, Scotland, Ireland and Wales. This year, England may become the first nation to sell cigarettes in plain brown wrappers—a move government officials hope will make the packages less attractive to younger smokers.

-- Iran. Back in 2003, Iran banned smoking in public buildings. According to the BBC, the measures have had “little effect. However, in July 2010 smokers were banned from taking high-ranking jobs in the Iranian government, the news agency ILNA reported.”

-- Russia. The heavy-smoking Russians continue to astound: “A 2009 survey by the World Health Organization found that Russia has 43.9 million smokers—about 40% of the population.” About 60% of Russian men smoke. 500,000 people die of smoking-related illness each year. The Russian government is considering a blanket no-smoking policy for enclosed spaces—starting in 2015.

-- Uruguay. The host of a recent international summit on tobacco control strategies, Uruguay has adopted some of the toughest anti-smoking laws in the world—so tough that the government was forced to back down on some of its sweeping new restrictions due to tobacco industry pressure.

-- Australia. Starting last September, there was no smoking “in cars carrying children, on sections of beaches, and within 10m (32ft) of playground equipment.” Australia also bans smoking in public workplaces, and plans to follow England’s lead in forcing tobacco companies to use plain wrappers for cigarette packages.

-- United States. California, a state that almost managed to pass a proposition legalizing marijuana, has the strictest and most extensive set of anti-tobacco laws on the planet. Smoking is banned not just within public buildings, but also within 20 feet of public buildings, and on all state beaches.

Graphics Credit: http://www.nicotineedge.com/

New Warning Labels for U.S. Cigarettes; Big Tobacco on the Rampage

Philip Morris Intl. sues Uruguay and Brazil.

Lots of developments on the nicotine front these days. On opposite ends of the news spectrum, so to speak, the Food and Drug Administration (FDA) announced plans to slap new and much more graphic warning stickers on cigarette packs--while elsewhere in the world, the world’s major tobacco companies got busy fighting tougher regulations on cigarette marketing. Meanwhile, the state of California has set limits on the marketing of e-cigarettes, disallowing companies from promoting the nicotine inhalers as “smoking-cessation devices.”

So let’s get busy. In the first significant change for cigarette advertising in 25 years, the FDA, freed by Congress last year to regulate tobacco products, will select nine new designs from among 36 contenders for new, far more graphic warning labels on cigarette packages. The new warning labels will begin appearing in about a year. To view the contenders, go to www.fda.gov/cigarettewarnings.

But will new, grisly images of dying smokers and rotted lungs really make a difference to the roughly one-quarter of adult Americans who still smoke?  “I am pleasantly shocked that [they are] doing this,” Stanton A. Glantz, a tobacco researcher at UC San Francisco, told the Los Angeles Times.  “There is no question but that strong graphic warning labels work,” he said. “Right now we have the weakest warning labels in the world. Now we will be right up there tied for the strongest.”

No so fast, counters John F.  Banzhaf, the executive director of Action on Smoking and Health and a George Washington University law professor. In the same L.A. Times article, Banzhaf said he was “quite disappointed,” stating that the agency “has done nothing more than exactly what Congress told them to do, and not one iota more.” So far, the FDA has banned advertising in magazines for young people, nixed the marketing ploy of handing out free samples on the street, and forbidden tobacco companies from marketing cigarettes by using the words “light” or “low-tar.”

Perhaps a more important result of Congressional approval of FDA oversight is that Medicare has now changed its rules to include smoking cessation products for covered beneficiaries. Previously, only people dying of lung disease were approved for smoking cessation products—a bit late in the disease cycle to do anybody much good.

According to a variety of estimates from government and research agencies, as many as half a million Americans die prematurely from smoking-related diseases. The Department of Health and Human Services has lately been stymied by a smoking rate of about 20%, basically unchanged since 2004. In 1965, about 42% of Americans smoked. The Department of Health and Human Services (HHS) has a stated goal of bringing smoking levels down to 12% by 2020.

That will not be an easy target to hit. And neither Congress nor the FDA nor HHS can count on anything amounting to cooperation from the cigarette giants. The New York Times, in an article by Duff Wilson, notes that worldwide cigarette sales rose 2% last year, as cigarette companies increasingly shift their marketing efforts toward a hunt for new customers in developing countries.  The aggressive nature of the worldwide cigarette marketing push was underscored this year when Philip Morris International sued the governments of Uruguay and Brazil, claiming that those countries had enacted tobacco regulations that were excessive and a threat to the company’s trademark and property rights.

Dr. Douglas Bettcher of the World Health Organization’s Tobacco Free Initiative accused the company of “using litigation to threaten low- and middle-income countries.” Philip Morris subsidiaries are also filing suits in Ireland and Norway over display advertising prohibitions. (Philip Morris USA, a separate division, is not involved in these lawsuits, and did not join with R.J. Reynolds and other tobacco companies in filing suit against the FDA last year.)

In the New York Times article, Wilson writes:

Companies like Philip Morris International and British American Tobacco are contesting limits on ads in Britain, bigger health warnings in South America and higher cigarette taxes in the Philippines and Mexico. They are also spending billions on lobbying and marketing campaigns in Africa and Asia, and in one case provided undisclosed financing for TV commercials in Australia.

As tobacco expert Dr. Cynthia Pomerleau points out on her blog, low smoking rates among women in the developing world make them a particularly tempting marketing target for the tobacco industry. Pomerleau, research professor emerita in the University of Michigan’s Department of Psychiatry, also reminds us that “the real goal here is not to remove health warnings altogether—health warnings have actually worked well for them by legitimizing the claim that if people choose to smoke, it’s not their fault—just to prevent them from dominating the package and actually becoming salient.”

It is important for the industry, says Pomerleau, to publicize “effects that can be achieved or problems that can be addressed by smoking.” In this respect, Pomerleau is concerned about the likelihood that the tobacco industry will seize upon the relationship between smoking and thinness as the wedge for sales campaigns aimed at women. “If it worked in the U.S., why not in Africa or Asia or South America?”

And finally, under a consent judgment worked out with California state Attorney General Jerry Brown, the Florida-based Smoking Everywhere company, a distributor of electronic cigarettes, has agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move comes shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices. Smoking Everywhere distributes e-cigarettes manufactured in China. The consent judgment also bars the company from selling its products in vending machines, and requires the products to contain warning labels about the dangers of nicotine.

And don’t forget: Thursday, November 18 marks the 35th annual Great American Smokeout.

The Death of “Low Tar” Cigarettes… Or Maybe Not.

Is this the best the FDA can do?

Lots of cigarette news lately. To begin with, cigarette manufacturers will no longer be able to market specific brands as “low tar” or “light.” And while David Kessler, former head of the Food and Drug Administration (FDA), called for the regulation of nicotine levels in cigarettes, cancer researchers were backpedaling away from some questionable numbers about cancer risk from smokeless tobacco offered up by the National Cancer Institute (NCI). Meanwhile, the American Medical Association (AMA) called on the FDA to ban so-called e-cigarettes.

Covering nicotine news is inherently confusing, ambiguous, and tentative, since the product in question is a legal drug responsible for an immense amount of tax revenues. It is also addictive. The relatively inelastic nature of demand for nicotine products makes governments reluctant to, er, snuff out the tax bonanza in its entirety.

Nonetheless, Congress gave the FDA broad new regulatory power over cigarettes a year ago with the passage of the Tobacco Control Act of 2009.  Last week, various provisions of the bill became effective, including provisions that “prohibit the advertising or labeling of tobacco products with the descriptors ‘light,’ ‘mild,’ or ‘low’ or similar descriptors” without specific permission from the FDA.  (See earlier post). In addition, health warning labels will be strengthened on smokeless tobacco packaging.

“As FDA continues implementation of the Tobacco Control act, we are committed to assuring that the actions we are taking are grounded in science and are open and transparent with participation by various stakeholders,” according to a press release from the agency’s Center for Tobacco Products.

The problem, as a glance at the photograph above aptly demonstrates, is that the America tobacco industry is already a jump ahead of the FDA’s measured approach. The industry plans to “let the colors speak to smokers in the same way the soon-to-be banned words ‘mild,’ ‘light,’ and ‘ultralight’ did,” Stephen Smith wrote last year in the Boston Globe.

Thus Pall Mall Lights become Pall Mall Blues. Whereas Salem Lights will forever after be known as Salem Gold Box. And so on. “These tricks are now well-established,” tobacco control specialist Stanton Glantz of the University of California told the Boston Globe. “The real question for the FDA is, are they going to let them get away with these shenanigans?”

The FDA is changing colors on the packages, and roughing up the warning labels, and starting to zero in on menthol, but one of the things it won't be doing is lowering the nicotine levels in cigarettes. Former FDA chairman David Kessler, for one, insists that this is the only substantive change likely to make a difference in addiction rates. In an AP report by Michael Felberbaum, Kessler said: “The tobacco industry knew 40 years ago that there was a threshold below which people would quit. Reducing the level of nicotine in cigarettes will change smoking as we know it. It is the ultimate harm reduction strategy.”

Meanwhile, on another contested front, (see earlier post) the Partnership at Drugfree.org reported that the AMA called on the FDA to regulate electronic cigarettes, which to date the agency has declined to do.  “Very little data exists on the safety of e-cigarettes,” said AMA board member Edward Langston. “Because e-cigarettes have not been thoroughly tested, one cannot conclude that they are less harmful or less dangerous than conventional cigarettes.” E-cigarettes also come in different candy and fruit flavors, the AMA pointed out during the process of adopting the policy at its annual meeting in Chicago.

And finally, a Wall Street Journal report by Carl Bialik in April caused a good deal of embarrassment at the American Cancer Society, which conceded that it had stopped using its long-cited figure of a 50-fold increase in the risk of oral cancer among users of smokeless tobacco. The National Cancer Institute has also cited the 50-times risk figure in its literature. As it turned out, the original survey had been about dry snuff, a form of tobacco rarely used in America today. Other scientists have concluded that the increased risk of oral cancer from smokeless tobacco is on the order of a factor of 10, not 50.

Photo credit: http://www.google.com/

Tobacco Settlement Turned Upside Down

“Tobacco bonds” link state budgets to cigarette sales.

Bob Sullivan of MSNBC reports that ten years after a group of states wrestled Big Tobacco to its knees in a $200 billion settlement, the creation of “tobacco bonds” by Wall Street has allowed investors and state governments to borrow against their future tobacco settlement payments. The result? Money that was to be paid out over the next thirty years for smoking cessation programs is being redirected into infrastructure projects and shoring up municipal credit.

“A review of 660 leading bond funds covered by the investment research firm Morningstar Inc., conducted at msnbc.com’s request, showed that more than 260 are invested in tobacco bonds,” Sullivan writes on his blog, The Red Tape Chronicles.

What, you may well ask, are tobacco bonds, and where did they come from? “Perhaps from you,” Sullivan writes. “When Wall Street talked 25 states into borrowing against future tobacco payments—a process known as ‘securitization’—it sold bonds to individual investors and mutual funds that buy municipal bonds.”

The irony of that approach, says Sullivan, is that “because these states have essentially borrowed against future payments from the tobacco industry, they are now dependent on the continued vitality of cigarette sales. If Big Tobacco stumbles, states will be on the hook for these massive, billion-dollar loans.” As a lawyer involved in litigation over the tobacco settlement put it to Sullivan: “Now [the states] have an incentive not to put tobacco out of business.” More than that, any significant failure by the tobacco industry to make its payments would be “catastrophic both to state budgets and individual investors.”

It wasn’t supposed to be this way. But the settlement from the lawsuit designed to blow up Big Tobacco was just too attractive to investment bankers. Sullivan notes that Oppenheimer’s Rochester family of bond funds includes funds with up to 20 per cent of assets held in tobacco bonds. The lure to the states was that, rather than waiting for the money, they could opt for an attractive lump sum payment up front. And many states did just that.

The problem, according to a tobacco policy researcher quoted on Sullivan’s blog, is that “the states have this horribly naive view that they will outsmart Wall Street. Wall Street always gets the better deal.” Many states have settled for a payout of 50 cents on the dollar, plus additional insurance fees against the risk of tobacco companies going out of business.

Eric Lindblom, a director of the Campaign for Tobacco-Free Kids, told Sullivan: “There is a horrible failure of the states to invest even a minuscule amount of the funds for tobacco control. It’s a real tragedy for our country.”

Roughly 3 per cent of tobacco settlement money has been paid out for smoking cessation efforts over the decade since the settlement, Sullivan writes.

Photo Credit: www.treasury.state.la.us

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