Are E-Cigarettes a Good Idea or a Bad Idea?

A group of nicotine researchers argue for an alternative.

Electronic cigarettes are here to stay. If you're not familiar with them, e-cigarettes are designed to look exactly like conventional cigarettes, but they use batteries to convert liquid nicotine into a fine, heated mist that is absorbed by the lungs. Last summer, even though the FDA insisted on referring to e-cigarettes as “untested drug delivery systems,” Dr. Neal Benowitz of the University of California in San Francisco--a prominent nicotine researcher for many years--called e-cigarettes “an advancement that the field has been waiting for.” And recently, Dr. Michael Siegel of the Boston University School of Public Health wrote: “Few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns.” Furthermore, Dr. Siegel took a swipe at the opposition: “The FDA and major anti-smoking groups keep saying that we don’t know anything about what is in electronic cigarettes. The truth is, we know a lot more about what is in electronic cigarettes than regular cigarettes.”

Harm reduction advocates are ecstatic. But do e-cigarettes simply reduce harm by eliminating combustion by-products--or do they perpetuate nicotine addiction, frustrate the efforts of smoking cessation experts, and give false hope to smokers that they can have their cake and eat it, too?

Dr. Siegel conducted a survey of e-cigarette users and found that 66% reported a reduction in the number of cigarettes smoked at the six-month point. “Of respondents who were not smoking at 6 months, 34.3% were not using e-cigarettes or any nicotine-containing products at the time.” Pretty impressive--although Siegel himself refers to the findings as “suggestive, not definitive”--and seemingly a giant leap forward for harm reduction.

However, even though they have dramatically altered the harm reduction landscape, e-cigarettes will not change anything for smokers who are attempting to completely quit using nicotine. When they inhale their last e-cigarette mist, several hours later they will begin to suffer the same withdrawal pains as regular cigarette smokers: “Irritability, craving, depression, anxiety, cognitive and attention deficits, sleep disturbances, and increased appetite,” as NIDA summarizes it. Current smokers are keenly interested in the new products, partly because of health concerns, and partly, it seems safe to venture, because a new generation of nicotine-based products like e-cigarettes “will enable them to put off the need to quit smoking,” as Dr. Dorothy Hatsukami, director of the Tobacco Use Research Center at the University of Minnesota, has asserted.

Harm reduction advocates for the electronic cigarette often make it sound like once the smoker is only inhaling nicotine, his or her problems are solved. But nicotine, of course, is the addictive part. Nicotinic receptors are present in moderate to high density in the brain areas containing dopamine cell bodies--the ventral tegmental area and the nucleus accumbens—the same pattern as almost every other addictive drug.

Even that part wouldn’t be a problem if addiction to nicotine were utterly benign. But it isn’t--although you wouldn’t know it from the pro-electronic cigarette propaganda. Nicotine in the blood is correlated with increases in arterial vasoconstriction, and is strongly suspected of playing a role in arteriosclerosis and other cardiovascular diseases. Nicotine increases LDL cholesterol, causes brochoconstriction, and has been implicated in the origin of lung tumors. There are also strong suggestions of links between nicotine and low birth weights in newborns.

So, it’s important not to kid ourselves about the hazards of nicotine, even though it may also be a medicine under certain conditions, like many other addictive drugs. Nicotine, you may recall, found industrial use as a farm crop insecticide. A poison, in other words. Nonetheless, what nicotine is NOT linked to certainly matters as well. Nicotine does not cause chronic obstructive pulmonary diseases, like emphysema—a huge plus. Nicotine won’t worsen asthma, as cigarettes do. And in the form of the electronic cigarette, it won’t cause secondhand smoke—another major plus for the e-cig.

There is another approach to regulating the harm caused by cigarettes. A group of scientists has been calling for a major effort at reducing the amount of nicotine in cigarettes so that, over time, a non-addictive level of nicotine would be reached--and cigarettes would no longer be addictive. Study after study has shown that if such were the case, about 80 to 90% of smokers would quit. And teens who experimented with truly low-nicotine cigarettes wouldn’t get hooked—unlike the “light” cigarette scandal, where the supposedly safer cigarettes may actually have turned out to be more dangerous because they forced smokers to smoke more in order to get the desired effect. Dr. Hatsukami and five other prominent nicotine experts contend that extremely low-nicotine cigarettes do not cause smokers to smoke more, “because it is harder to compensate for very low nicotine intake,” according to Hatsukami. Especially if there are no high-nicotine alternatives for sale—legally, at least. Mitch Zeller, who along with Hatsukami, co-chairs the National Cancer Institute’s Tobacco Harm Reduction Network, painted this picture: “Imagine a world where the only cigarettes that kids could experiment with would neither create nor sustain addiction."

Nonsense, counters Dr. Gilbert Ross of the American Council on Science and Health. “Asserting that smokers won’t smoke more cigarettes to get the nicotine they crave is a fairy tale,” he said. “The likely result is a major increase in cigarette-related diseases.”

These are the competing visions of our nicotine-addicted future. In one scenario, smokers stay addicted to nicotine, with its accompanying heath risks and all the other negative aspects of being addicted. But the immediate harm to their health is lessened due to fewer inhaled carcinogens, and they don’t create secondhand smoke. In the opposing scenario, smokers continue to smoke, and society continues to deal with secondhand smoke through no-smoking policies, while medical research agencies, under government mandate, oversee the gradual reduction of nicotine in cigarettes to a level below what is needed for addiction.

The optimistic thought here is that either of these approaches would bring much-needed improvement to the semi-controlled anarchy and hypocrisy of the current situation.

Photo Credit: http://whyquit.com 

Era of the Electronic Cigarette Officially Begins.

Court blocks FDA from prohibiting e-cigarettes.

It’s official: The e-cigarette is here. The right of a distributor of Chinese electronic cigarettes to market the product in the U.S. was solidly affirmed last week by a three-judge ruling in the U.S. Court of Appeals for the District of Columbia. The Food and Drug Administration’s refusal last year to allow importation of e-cigarettes by Sottera Inc. had been the basis for a lower court decision in Sottera’s favor. The earlier court ruled that e-cigarettes did not require FDA approval because they were neither new drugs nor new drug delivery devices. (The FDA is prohibited by an act of Congress from barring the sale of tobacco products outright.)

Last month, under a consent judgement worked out with California state Attorney General Jerry Brown in a related case, Florida-based Smoking Everywhere Co., another distributor of Chinese electronic cigarettes, had agreed not to target minors in its advertising, or to make claims that its products are safe alternatives to tobacco. The move came shortly after the FDA announced plans to regulated battery-powered e-cigarettes as new drug delivery devices, culminating in the Sottera lawsuit.

The legal argument before the appeals court hinged largely on semantics. The court found that electronic cigarettes are “battery-powered products that allow users to inhale nicotine vapor without fire, smoke, ash or carbon monoxide. The liquid nicotine is derived from natural tobacco plants.”

Here is the catch: “The FDA may only approve a product for marketing under the Federal Food, Drug and Cosmetic Act (FDCA) if it is safe and effective for its intended use,” the Appeals Court Justices ruled.  However, the FDA has “exhaustively documented” that tobacco products are unsafe for pharmacological use of any kind. The earlier court had concluded, stealing a page from “Alice in Wonderland”: “If they cannot be used safely for any therapeutic purpose, and yet they cannot be banned, they simply do not fit” within any conceivable regulatory scheme.

Hence the difficulties in the FDA’s attempt to regulate by agency fiat. E-cigarette manufacturers and distributors, having sensed an opening, are now ready to drive a convoy of semis right through it. This wasn’t a completely straightforward march, as the e-cigarette forces, in the appeals presentation, were required to thread the needle on such conundrums as: Does it matter that e-cigarettes do not, strictly speaking, contain “tobacco products?” Nicotine is a component of, not a product of, tobacco.

You see the problem. The relevant statutes have not been written with pure nicotine delivery devices in mind. In fact, having nicotine--but not the evil substance tobacco--in your product turned out to be a definitional advantage for the e-cigarette marketers: The court pointed out that, unlike products containing tobacco, which the FDA has found to be associated with “cancer, respiratory illnesses, and heart disease,” the FDA has manifestly NOT found that nicotine or tobacco-free products that deliver nicotine are inherently unsafe. And second, the “tobacco-specific legislation” invoked in earlier court cases “simply does not address products that deliver nicotine but contain no tobacco.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said in a prepared statement: "This decision will allow any manufacturer to put any level of nicotine in any product and sell it to anybody, including children, with no government regulation or oversight at the present time. We urge the government to appeal this ruling."

Among the many  questions the ruling leaves open is the status of e-cigarettes under existing no-smoking regulations. That litigation has not even gotten underway.

See my earlier post on the e-cigarette question HERE.

For the full court decision, click HERE.

Graphics Credit:  http://thestrobel3.blogspot.com/

Bio Firm Working on New Technology for E-Cigarettes

Key tobacco scientist endorses “going vape.”

Cypress Bioscience of San Diego hopes to enter the controversial and potentially lucrative market for so-called e-cigarettes, which deliver nicotine by heating it to produce an inhalable, smoke-free vapor. The company announced last week that it had acquired a $5 million license for Staccato nicotine technology—“A novel electronic multidose delivery technology designed to help people stop smoking.”

The company claims that the “the electronics embedded within the Staccato delivery system could allow for the programmed, over-time reduction in the overall daily dose of nicotine, and ultimately may lead to the better management of nicotine cravings and eventual sustained smoking cessation”

Critics of e-cigarettes have maintained that the devices were not meant to curb smoking but to enable it, by allowing smokers to circumvent no-smoking regulations. Fears have also been voiced that children might be tempted to make use of them. Makers of electronic cigarettes, primarily in Asia, have maintained that the devices are perfect for the management of nicotine cravings when smokers quit, and may have significant advantages over nicotine gums and patches.

The press release from Cypress Bioscience makes the claim explicitly: “The Staccato technology may be capable of mimicking the pharmacokinetics of smoking cigarettes through the delivery of optimally-sized nicotine particles to the deep lung. Staccato nicotine may also provide some of the psychological aspects of smoking (e.g., hand-to-mouth movement, oral inhalation) and could allow smokers to self-administer and possibly titrate to the dose to treat cravings.”

Up until now, electronic cigarettes have been opposed by the Food and Drug Administration (FDA) on the grounds that e-cigarettes were novel and untested drug delivery systems. Signaling a possible change in official attitudes, Dr. Neal Benowitz, professor of Medicine at the University of California, San Francisco--and a prominent nicotine researcher for many years--said in the Cypress Bioscience press release that a delivery device like Staccato nicotine “may be useful in addressing a pressing pharmacological problem in overcoming nicotine addiction; namely, that acute cravings during quit attempts are inadequately treated by current nicotine replacement therapies.” Dr. Benowitz called the nicotine delivery device “an advancement that the field has been waiting for.”

Cypress Bioscience said it plans to take the technology into Phase 1 clinical trials next year. The company reported a net loss of 5 cents per share in the second quarter, compared to a loss of 23 cents per share during the same period a year ago.

The Centers of Disease Control and Prevention (CDC) estimate that almost 450,000 people die annually in the U.S. from smoking. One in five deaths in the U.S. are due to smoking-related illness, according to the CDC.

Earlier posts:

Leave Cigarettes Along, Judge Tells FDA

E-Cigarettes: Another Look

Graphics Credit: http://www.ecigarettebuyer.co.uk/

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/

The Year in Drugs

Top Posts at Addiction Inbox.

By the look of it, readers had marijuana on their minds in 2012. Of the posts at Addiction Inbox with the highest number of page views, an overwhelming majority are concerned with marijuana, and specifically, with marijuana addiction, withdrawal, and brain chemistry. Of the 9 most heavily trafficked posts of the year, only one involved alcohol. Readers were also interested in the safety of e-cigarettes, and the mysteries of neurotransmitters like serotonin and dopamine. Happily, all the top posts were patently science-oriented articles.

See you in the New Year.

•  Marijuana Withdrawal

For Some Users, Cannabis Can Be Fiercely Addictive.

For a minority of marijuana users, commonly estimated at 10 per cent, the use of pot can become uncontrollable, as with any other addictive drug. Addiction to marijuana is frequently submerged in the welter of polyaddictions common to active addicts. The withdrawal rigors of, say, alcohol or heroin tend to drown out the subtler, more psychological manifestations of cannabis withdrawal.

•  Serotonin and Dopamine: A Primer

The Molecules of Reward

Serotonin and dopamine are part of a group of compounds called biogenic amines. In addition to serotonin and dopamine, the amines include noradrenaline, acetylcholine, and histamine. This class of chemical messengers is produced, in turn, from basic amino acids like tyrosine, tryptophan, and choline.

•  Marijuana Fact and Fiction

Why cannabis research is a good idea.

There is little doubt among responsible researchers that marijuana--although it is addictive for some people--is sometimes a clinically useful drug. However, there is little incentive for commercial pharmaceutical houses to pursue research on the cannabis plant itself, since they cannot patent it.

• Anandamide: The Brain’s Own Marijuana

Anxiety and the THC receptor.

Several years ago, molecular biologists identified the elusive brain receptor where THC, the active ingredient in marijuana, did its work. Shortly after that discovery, researchers at Hebrew University in Jerusalem identified the body’s own form of THC, which sticks to the same receptors, in pulverized pig brains.

•  The Mysteries of the Blunt

Why do so many smokers combine tobacco with marijuana?

People who smoke a combination of tobacco and marijuana, a common practice overseas for years, and increasingly popular here in the form of “blunts,” may be reacting to ResearchBlogging.orgsome unidentified mechanism that links the two drugs. Researchers believe such smokers would be well advised to consider giving up both drugs at once, rather than one at a time, according to an upcoming study in the journal Addiction.

•  Are E-Cigarettes a Good Idea or a Bad Idea?

A group of nicotine researchers argue for an alternative.

Electronic cigarettes are here to stay. If you're not familiar with them, e-cigarettes are designed to look exactly like conventional cigarettes, but they use batteries to convert liquid nicotine into a fine, heated mist that is absorbed by the lungs. Last summer, even though the FDA insisted on referring to e-cigarettes as “untested drug delivery systems,” Dr. Neal Benowitz of the University of California in San Francisco--a prominent nicotine researcher for many years--called e-cigarettes “an advancement that the field has been waiting for.”

•  Cannabis Receptors and the “Runner’s High”

Maybe it isn't endorphins after all.

A perennial favorite, the runner’s high post shows what long-distance running and marijuana smoking have in common. Quite possibly, more than you’d think. A growing body of research suggests that the runner’s high and the cannabis high are more similar than previously imagined….Endocannabinoids—the body’s internal cannabis—“seem to contribute to the motivational aspects of voluntary running in rodents.” Knockout mice lacking the cannabinioid CB1 receptor, it turns out, spend less time wheel running than normal mice. 

• Topamax for Alcoholism: A Closer Look

Epilepsy drug gains ground, draws fire as newest anti-craving pill.

A drug for seizure disorders and migraines continues to show promise as an anti-craving drug for alcoholism, the third leading cause of death in America, the Journal of the American Medical Association (JAMA) reported in its current issue.

•  Is Marijuana Addictive?

The argument continues.

Marijuana may not be a life-threatening drug, but is it an addictive one?
There is little evidence in animal models for tolerance and withdrawal, the classic determinants of addiction. For at least four decades, million of Americans have used marijuana without clear evidence of a withdrawal syndrome. Most recreational marijuana users find that too much pot in one day makes them lethargic and uncomfortable. Self-proclaimed marijuana addicts, on the other hand, report that pot energizes them, calms them down when they are nervous, or otherwise allows them to function normally.


Graphics Credit:  http://1.bp.blogspot.com (Creative Commons)

Does Menthol Really Matter?

Nicotine experts say menthol makes addiction more likely--but differ over what to do about it.

Back in the 1920s, Lloyd “Spud” Hughes of Mingo Junction, Ohio, was working as a restaurant cashier when, legend has it, he smoked some cigarettes that had been casually stored in a tin that contained menthol crystals. Menthol, a compound found in mint plants and also manufactured synthetically, is used medicinally, and as a food flavoring. Back in Spud’s day, menthol was mostly derived by extracting crystals from the Japanese Mint plant. What we know for certain is that the mentholated cigarettes tasted so good to Spud that he patented the mixture. In 1925, the Spud Cigarette Corporation of Wheeling, West Virginia, was born, and Spud Cigarettes quickly became the 5th best selling cigarette brand in America. 

Dr. Neal L. Benowitz, Professor of Medicine and Bioengineering & Therapeutic Sciences, and Chief of the Division of Clinical Pharmacology at the University of California in San Francisco, says that Spud Hughes had “accidentally identified an additive whose pharmacologic actions reduce the irritating properties of smoke generally and nicotine specifically.” Menthol accomplishes this because it acts on receptors involved in the detection of physical stimuli like temperature and chemical irritation. “Menthol contributes to perceptions of cigarettes’ strength, harshness, or mildness, smoothness, coolness, taste, and aftertaste.” That would seem to just about cover it. But no: In their article for the New England Journal Of Medicine—“The Threat of Menthol Cigarettes to U.S. Public Health"—Benowitz and Jonathan M. Samet also claim that “menthol has druglike characteristics that interact at the receptor level with the actions of nicotine.”

And nicotine hardly needs much help establishing its grip over addiction-prone individuals. “It’s not that it’s so intensive,” Dr. Benowitz told me some years ago, when I was researching my book, The Chemical Carousel, “it’s just that it’s so reliable. Nicotine arouses you in the morning; it relaxes you in the afternoon. It’s a drug that you can dose many times per day for the purpose of modulating your mood, and it becomes highly conditioned, more than any other drug, because it’s used every single day, multiple times per day.” Benowitz, along with Dr. Michael Siegel of the Boston University School of Public Health, recently sparked intense debate when they both championed electronic cigarettes as a safe alternative to smoking tobacco cigarettes, despite the FDA’s earlier wish to keep e-cigarettes out of the country. And last month, an advisory report for the FDA by a group that included Benowitz and Samet concluded that mentholated cigarettes were no more harmful, and no more likely to cause disease, than regular cigarettes. A study in the Journal of the National Cancer Institute of 440 lung cancer patients and more than 2,000 matched patients without lung cancer showed no correlation at all between menthol and cancer. In fact, the researchers were surprised to discover that menthol smokers appear to have a lower risk of lung cancer than other smokers. Asked whether menthol cigarettes are more toxic than non-menthol cigarettes, the study's author William Blot of Vanderbilt University definitively responded: “The answer is, no, they are not.”

However, the advisory report suggested that, while menthol cigarettes may not be more dangerous, they might be more addictive than regular cigarettes.  In the May 4 New England Journal of Medicine article, Benowitz and Samet argue that because menthol cigarettes attract younger smokers by making tobacco easier to smoke, and because more of these smokers go on to become lifelong nicotine addicts due to this same cooling effect, "menthol cigarettes increase the likelihood of addiction and the degree of addiction in new smokers." Further adding to menthol’s tendency to create lifelong smokers is the fact that “some consumers, particularly blacks, hold beliefs about implicit health benefits of menthol cigarettes that may interfere with their quitting."

This is a substantial indictment of menthol as a component of cigarettes, despite the belief among some experts that it is much ado about nothing. But if that’s the case, Benowitz and Samet suggest, why has the tobacco industry fought so ferociously to exempt menthol from the list of banned flavorings over the years? And why has the industry so consistently linked its marketing of menthol cigarettes to images of “freshness” and health? The authors estimated that “by 2020 about 17,000 more premature deaths will have occurred and two million more people will have started smoking than would have been the case if menthol cigarettes were not available.” Two million additional cigarette smokers by the end of the decade does not sound especially trivial. Nonetheless, the FDA advisory report that Benowitz helped to shape stopped short of recommending an outright ban on nicotine, saying only that removal of menthol would “benefit public health.”

While not disputing the findings of the FDA Advisory Committee, Dr. Michael Siegel of Boston University expressed dismay that “despite these conclusions, the [committee] did not recommend a ban on menthol cigarettes.” There are almost 20 million menthol smokers in the U.S., Siegel argues. If even a fraction of them quite smoking due to a ban on menthol in cigarettes, “it would have a profound effect on public health.” This is, Siegel insists, precisely why politicians managed to exempt menthol from bans on various flavor additives in the first place. The Black Congressional Caucus had “vigorously denounced the exclusion of menthol” at the time, while Lorillard, maker of Newports--the leading brand of menthol cigarettes--argued that banning menthol would result in the creation of a huge black market.  Because of all this, Seigel charges, Benowitz and the committee simply “punted the issue back to the FDA.” And if anyone harbored doubts about who benefited from this non-action, in Siegel’s view, one need only look at the fact that Lorillard’s stock enjoyed a nice run-up of about 8% after the public announcement of the FDA panel’s recommendations.

Because of all this, Siegel does not believe the FDA will ever ban menthol cigarettes. In his view, the Obama administration doesn’t need the grief of added health care complexities just now, and there is no movement in Congress to make additives an issue. And since the FDA has chosen not to demand the banning of menthol, Siegel thinks the committee’s findings will serve as a convenient smokescreen for Congress. And for the makers of menthol cigarettes, it will be business as usual. A window of opportunity on the menthol issue is now closing, says Siegel, who confesses to difficulty understanding a policy that bans “every other type of cigarette flavoring—including chocolate, strawberry, banana, pineapple, cherry, and kiwi—yet exempts the one flavoring that is actually used extensively by tobacco companies to recruit and maintain smokers… Menthol is a major contributor to smoking initiation and continued addiction, and for this reason, it will continue to enjoy the protection of a federal government that seems afraid to alienate any corporation, whether it’s part of Big Pharma, Big Insurance, or Big Tobacco.”

Photo credit: http://www.nysmokefree.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.

Praising Marijuana Prohibition

The view from the White House.

As regular readers of Addiction Inbox will know, I am on record as favoring some form of decriminalization for marijuana. But I also write regularly about the difficulties of marijuana addiction and withdrawal. And I have been critical of the operational strategies employed by the medical marijuana movement in the several states in which it now operates. What I have not done, to date, is offer up the official view of a drug policy analyst from the Obama administration who straightforwardly favors a continuation of the legal prohibition against marijuana. 

One of the architects of the current federal resistance to marijuana legalization is Kevin Sabet, an assistant professor and the director of the Drug Policy Institute at the University of Florida College of Medicine. Sabet served from 2009 to 2011 in the Obama Administration as Senior Advisor for the White House Office of National Drug Control Policy (ONDCP) under Drug Czar Gil Kerlikowske, and was influential in shaping federal marijuana policy. Sabet consults with governments and NGOs on a wide range of drug policy prevention issues, and recently debated legalization advocate Ethan Nadelmann on CNN. He is also a regular columnist for thefix.com  and Huffington Post. He agreed to participate in a frank and lengthy 5-question interview with Addiction Inbox. (Be sure to check out the comments below).

1. In his new book, Too High to Fail, journalist Doug Fine argues that "the Drug War is as unconscionably wrong for America as segregation or DDT." Would you comment on this sweeping condemnation?

First, I think it is interesting to note that only people who want to condemn all of our current drug policies use the term "drug war." No one in serious policy circles uses that term anymore, and that is because it is woefully inadequate and vague as a way to describe a whole slew of policies designed to both reduce drug prevalence and drug consequences. I think his comparison is clumsy and unfair. Do some drug policies hurt disadvantaged groups? Of course they do. Is it a moral imperative to fix those policies, learn from our past mistakes and make our policies better? Of course it is. There's no reason to think that those policies can't be changed—in the White House in 2009, for example, we drastically reduced the penalty for crack cocaine. But what makes Mr. Fine's comparison even more wrong-headed and backwards is that we know that if we scale-up—not eliminate, as he would—the policies we know do work in reducing drug use and its consequences, all communities in America would benefit. A handful include:

(a) community-based prevention that not only focuses on stopping drug use among school kids, but in changing bad local laws and ordinances that promote underage drinking, smoking, and marijuana use (so-called "environmental policies");

(b) early intervention and detection of drug use in health settings;

(c) evidence-based treatment, including methadone and buprenorphine, as well as 12-step programs;

(d) recovery-based policies that don't penalize people for past drug use and instead facilitate recovery;

(e) law enforcement based on credible threats and modest sanctions.

2. The Drug War is an industry—the DEA alone has a budget of 2 1/2 billion and employs almost 10,000 people. If we add in profits from the private prison industry, and the money-laundering banks, the money is staggering. Wouldn't it make sense to recoup those historical costs by legalizing and taxing marijuana?

That phrase assumes two things: (a) criminal justice and regulation costs would be drastically reduced, or eliminated, with marijuana legalization; and (b) the underground market would be eliminated with marijuana legalization. Both of those assumptions are huge leaps that don't stand up to our experience with our already two legal drugs—alcohol and tobacco.

First, we know that legalization means more consumption. More consumption means more regulation. Today we have liquor laws, laws against drinking and driving, laws against public drunkenness, etc. With regards to legal alcohol, we make 2.6 million arrests every year for the violation of those laws. Meanwhile, we arrest a million fewer times for illegal drugs (1.6 million/year). Legal alcohol costs us money with regards to crime and regulation. I think that is a big consideration in this whole debate that we rarely hear about. So that means we'd have to have more prisons, more police, and more regulation costs under legalization—especially since few people are in prison or jail solely for marijuana use.

And I'm not so sure the underground market would be eliminated with marijuana legalization. Especially if it is taxed heavily, the incentive for the underground market—having been painstakingly established for decades by multinational corporate structures (cartels)—is very little. We'll still need a black market for underage marijuana, for marijuana to be sold to repeat offenders, etc. I just don't see the cartels throwing up their hands and saying "OK, it's legalized. We're out of the game now. Let's get into the ice cream business."

3. A "Pax Cannabis" would require rescheduling marijuana at the federal level, with an overt recognition that marijuana has some redeeming medical value. What's the argument for maintaining cannabis as a Schedule 1 drug along with heroin, a drug with which it has almost nothing in common? Could you comment on the upcoming U.S. Appeals Court consideration of medical marijuana?

Rescheduling marijuana is one of the biggest red herrings I can think of in this debate. If rescheduled tomorrow, it would do nothing to allow marijuana to be sold legally. Rather, it would be a huge symbolic victory for marijuana advocates -- but it would be wholly wrong on the science. Placing a drug in schedule 1 simply means the drug has no medical use and a high potential for abuse. It has nothing to do with the other drugs in that category (e.g. heroin). If it were a drug, a telephone would also need to be in Schedule 1 - I'm addicted to my cell phone and I know it has no medical use. That doesn't mean a phone is as dangerous as a syringe of heroin.  Today, cocaine is Schedule 2 because it has some very limited hospital use. Can a 21-year-old kid with no medical knowledge sell cocaine from a "dispensary" called "Happy Clinic" legally? Of course not, though that is what is happening [with marijuana] in California.

In order to be used for medical use, a specific product needs to be approved by FDA. Marijuana's specific product, so far, is Marinol, a Schedule 3 drug which has been approved by FDA and is used by people throughout the world. Crude, raw marijuana is not a specific product. The best way I can put it is this: We don't smoke opium to get the effects of morphine, so why do we think we need to smoke marijuana to get its potential medical effects? We have non-inhaled medications that are approved and we have others on the way. For a lot more on this, you can check out an article I wrote for Join Together. I think the District court opinion will rest on the science and agree with the Department of Health and Human Services that raw, crude marijuana is not medicine.

4. Alaska decriminalized marijuana in 1975, and only recriminalized after lengthy pressure from the Reagan administration. Isn't cultivation of this flowering weed for personal use the most obvious and straightforward solution?

The Reagan Administration could have cared less about Alaska, frankly. Alaska recriminalized because voters there wanted that to happen. They didn't like the effect of decriminalization on their state. That said, I don't think many people are in favor—and I am not—of locking up people smoking small amounts of marijuana. That isn't happening anywhere. One notable exception is New York City where they impose 24-hour detentions for public use and selling as part of their broken windows approach to crime control.

Indeed, in the 1970s, twelve states formally decriminalized marijuana. This meant that persons found to have a small amount of marijuana were not subject to jail time, but rather they would receive a civil penalty, such as a fine. The discussion in the United States is highly complex because even in jurisdictions without a formal decriminalization law, persons are rarely jailed for possessing small amounts of cannabis. A rigorous government analyses of who is in jail or prison for marijuana found that less than 0.7% of all state inmates were behind bars for marijuana possession only (with many of them pleading down from more serious crimes).[1] Other independent research has shown that the risk of arrest for each “joint,” or cannabis cigarette, smoked is about 1 arrest for every 12,000 joints.[2] This probably explains the fact that the literature on early decriminalization effects on use has been mixed. Some studies found no increase in use in the so-called “depenalization” states, whereas others found a positive relationship between greater use and formal changes in the law.[3]

The more recent discussion about state-level legalization may provide more insights. Two RAND Corporation reports concluded that legalization would result in lower cannabis prices, and thus increases in use (though by how much is highly uncertain), and that “legalizing cannabis in California would not dramatically reduce the drug revenues collected by Mexican drug trafficking organizations from sales to the United States.”[4]

5. Marijuana advocates don't like to hear it, but pot is addictive for some users. Where do you stand on this controversial issue?

Science tells us that marijuana is addictive—about 1 in 11 people who ever smoke marijuana are addicted; but if you start in adolescence that number climbs to 1 in 6. That's not anyone's opinion but rather the result of rigorous scientific research done by the National Institutes of Health and confirmed by other international scientific bodies. Is marijuana as addictive as tobacco cigarettes? No. The addiction rate for tobacco is about 1 in 3; for heroin it is lower, about 1 in 4. Users who try to quit experience withdrawal symptoms that include irritability, anxiety, insomnia, appetite disturbance, and depression.

A United States study that dissected the National Longitudinal Alcohol Epidemiologic Survey (conducted from 1991 to 1992 with 42,862 participants) and the National Epidemiologic Survey on Alcohol and Related Conditions (conducted from 2001 through 2002 with more than 43,000 participants) found that the number of cannabis users stayed the same while the number dependent on the drug rose 20 percent ­ from 2.2 million to 3 million.[5]Authors speculated that higher potency marijuana may have been to blame for this increase. As I've heard said many times by experienced tokers, "this isn't your Grandfather's Woodstock Weed."

[1] “Substance Abuse and Treatment, State and Federal Prisoners, 1997.” BJS Special Report, January 1999, NCJ 172871. http://www.ojp.usdoj.gov/bjs/pub/pdf/satsfp97.pdf

[2] Beau Kilmer, Jonathan P. Caulkins, Rosalie Liccardo Pacula, Robert J. MacCoun, Peter H. Reuter, Altered State? Assessing How Cannabis Legalization in California Could Influence Cannabis Consumption and Public Budgets, RAND, 2010.

[3] For a discussion see MacCoun, R., Pacula, R. L., Reuter, P., Chriqui, J., Harris, K. (2009). Do citizens know whether they live in a decriminalization state? State cannabis laws and perceptions. Review of Law & Economics, 5(1), 347-371.

[4] Beau Kilmer, Jonathan P. Caulkins, Rosalie Liccardo Pacula, Robert J. MacCoun, Peter H. Reuter, Altered State? Assessing How Cannabis Legalization in California Could Influence Cannabis Consumption and Public Budgets, RAND, 2010. And see Kilmer, Beau , Jonathan P. Caulkins, Brittany M. Bond and Peter H. Reuter. Reducing Drug Trafficking Revenues and Violence in Mexico: Would Legalizing Cannabis in California Help?.Santa Monica, CA: RAND Corporation, 2010. http://www.rand.org/pubs/occasional_papers/OP325. Also available in print form.

[5] ]Compton, W., Grant, B., Colliver, J., Glantz, M., Stinson, F. Prevalence of Cannabis Use Disorders in the United States: 1991-1992 and 2001-2002Journal of the American Medical Association.. 291:2114-2121.

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Utah Legislator Calls for Tax on Coffee

States look to addictions as a revenue stream.

Are caffeine revenue streams the next big thing, or a bright idea whose time will never come? Will we see the staging of a Boston (make that Salt Lake City) Coffee Party by disgruntled, under-caffeinated voters, if the state of Utah has its way?

We do it with tobacco products. We do it with alcoholic beverages. We slap a hefty extra “sin tax” on addictive but legal products as an easy source of revenue. Times are tough. State revenue streams have dried up. But coffee? Caffeinated soft drinks?

Taxing caffeine would be “like taxing candy,” according to one Utah resident, reacting to a state legislator’s call for a tax on caffeine products. The legislator in question, Republican state representative Craig Frank, suggested the measure after efforts to raise cigarette taxes in the state failed. The initial proposal centered on “cold caffeine” such as canned sodas, but was quickly broadened to include coffee and other caffeine products

Frank told the Salt Lake City Tribune in an article by Robert Gehrke that if the state was intent on “going after people who have problems with addiction for a revenue stream,” a tax on caffeine would be more broad-based than existing “sin taxes” on alcohol and cigarettes—two other highly addictive but legal substances. The government itself, said Frank, is “addicted to the fee revenues. So in light of that... why not cold caffeine?” Ultimately, why not caffeine, period? Frank pointed out that caffeine, like alcohol and nicotine products, has been linked to health problem, such as spontaneous abortion.

A recent study by the Rockefeller Institute of Government showed that Utah lost 16.5 per cent in tax revenues in the fourth quarter of 2008. The National average was 3.6 per cent.

In 2003, Seattle voters rejected a similar initiative that would have imposed a 10-cent tax on every cup of espresso-based coffee. Vancouver, B.C., tried and failed to enact a similar measure. Recently a councilperson in Nashville, TN, has also suggested a coffee tax. Last month, California Assemblyman Tom Ammiano proposed to extract substantial state revenue from a sales tax on marijuana.

All of these efforts have met with a significant lack of enthusiasm on the part of the citizenry.

Picture Credit: Worth1000

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