Thursday, June 27, 2013

Tobacco Harm Reduction: Hope in the U.S., Despair in Europe

In my commentary, “The Electronic Future of Cigarettes,” published last week in The Atlantic,  I described “…a radical transformation in the way our society uses tobacco…as tobacco consumers switch to smoke-free products like smokeless tobacco and e-cigarettes.”  One of my longstanding goals has been to correct decades of misinformation about nicotine and tobacco, in order to introduce safer smoke-free products to millions of smokers. 

The Atlantic article, available here and reproduced below, conveys a hopeful message, but optimism in the U.S. is offset by depressing events in Europe.  The British Government two weeks ago decided to regulate e-cigarettes as medicines (here), a move that will likely deter wider e-cig adoption by smokers.  The European Union continues to move forward with its tobacco directive, which denies vastly safer snus to all but Swedish smokers and places further restrictions on e-cigarettes. 

A blistering public health critique of the European Commission, the European Council and the Irish Presidency, the World Health Organization, the European public health lobby and various governmental health organizations is offered by Clive Bates in his recent web post (here).  

The Electronic Future of Cigarettes
Aiming for a tobacco-free society is myopic. Embrace the safer alternative.

Brad Rodu
The Atlantic, June 20, 2013

We are on the cusp of a radical transformation in the way our society uses tobacco. Cigarette consumption is in substantial, protracted decline as tobacco consumers switch to smoke-free products like smokeless tobacco and e-cigarettes.

This isn't America's first large-scale change in tobacco habits; in the early 1900s, cigarettes replaced chewing tobacco. This is, however, the first shift with a promising public health outcome. The reason is simple science: Smoke-free tobacco and nicotine products are around 98 percent safer than traditional cigarettes

The evidence has been mounting for a long time. I published my first scientific studies on vastly safer smoke-free cigarette substitutes almost 20 years ago. Britain's Royal College of Physicians, one of the world's oldest and most prestigious medical societies, reported in 2002: "As a way of using nicotine, the consumption of non-combustible [smokeless] tobacco is on the order of 10-1,000 times less hazardous than smoking, depending on the product." The report continued with an even bolder statement, acknowledging that some smokeless manufacturers may want to market their products "as a 'harm reduction' option for nicotine users, and they may find support for that in the public health community."

In 2007, the Royal College challenged governments to consider "...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved."

Big tobacco companies are already adapting to the demand for smoke-free tobacco. Altria, the largest American cigarette manufacturer, will sell e-cigarettes throughout Indiana in August. Number two Reynolds American believes that "governments, public health officials, tobacco manufacturers and others share a responsibility to provide adult tobacco consumers with accurate information about the various health risks and comparative risks associated with the use of different tobacco and nicotine products." Reynolds sells Snus, a smokeless tobacco product that has produced an extraordinarily low smoking rate in Sweden, under its flagship Camel brand. Reynolds also introduced dissolvable tobacco products, and it owns a pharmaceutical company that sells nicotine gum. In July Reynolds will start selling its Vuse e-cigarettes in Colorado.
Lorillard, the nation's third largest cigarette maker, is taking an aggressive smoke-free posture in the public policy arena as it promotes its Blu e-cigarette brand. Lorillard CEO Murray Kessler wrote, "We see e-cigarettes as a product that has the potential to play a critical role in the national harm reduction discussion and affords our company a seat at the table in this debate."

Sadly, the potential of tobacco harm reduction is threatened by opposition from many major medical organizations and government agencies. Obsessed with a myopic vision of a tobacco-free society, they have transformed a legitimate war on smoking into a moral crusade against tobacco, a mistake that was tragically made with alcohol almost 100 years ago.

Congress has prohibited tobacco marketers from any communication with smokers regarding safer alternatives without the express approval of the FDA. So far, the agency has taken a hard line, claiming, falsely, that, "To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products." The agency is defying a key element of its stated mission - "to provide the American public with factual and accurate information about tobacco products."

In an effort to kill the nascent smoke-free market, the FDA is slow-walking development of necessary regulations. In March 2012, it signaled the extraordinary lengths that companies will have to go to in order to have a product accepted as "modified [i.e., reduced] risk. In essence, the agency will require dozens of new studies on minute product details and human effects, which will likely take a decade or more.

This is regulatory fundamentalism, a bureaucratic maze that will condemn e-cigarettes and smokeless tobacco products, and therefore tobacco harm reduction, to purgatory. With this delay, cigarettes will continue to dominate the American tobacco market, and 440,000 more Americans will die from smoking-related disease every year.

One thousand two hundred and five deaths. Every. Single. Day.

The body of highly credible research and roster of public health experts endorsing tobacco harm reduction continues to grow, providing more science-based support for smokers to switch. In the absence of rational FDA regulation, nicotine-addicted smokers would do well to quit cigarettes and avail themselves of the many smoke-free harm reduction products that are currently on the market.

Thursday, June 20, 2013

Alternative Tobacco Products Aid in Smoking Cessation

In May Dr. Lucy Popova and Dr. Pamela Ling coauthored “Alternative Tobacco Product Use and Smoking Cessation: A National Study.”  It appeared in the May issue of the American Journal of Public Health (abstract here).

The authors are members of the Center for Tobacco Control Research and Education at the University of California, San Francisco, which is a staunch opponent of tobacco harm reduction.  So it is unsurprising that their conclusions about safer smoke-free products were almost entirely negative:

“Alternative tobacco products are attractive to smokers who want to quit smoking, but these data did not indicate that alternative tobacco products promote cessation.  Unsubstantiated overt and implied claims that alternative tobacco products aid smoking cessation should be prohibited.”

But these data DID indicate that alternative products promote cessation. 

The authors used a Knowledge Network survey in 2011 of 1,836 current or former smokers who quit less than two years before.  The survey asked participants about use of chewing tobacco, moist snuff, snus, dissolvable tobacco and e-cigarettes. 

Drs. Popova and Ling provide the percentages of the 1,527 smokers who had been successful and unsuccessful in quitting and who had used these products, but they either didn’t see or completely ignored these important results:

Successful Quitting Among Knowledge Network Survey Participants, 2011
ProductEver Users (n)Percentage Successful Quitters
Chewing tobacco22132
Moist snuff23229
Dissolvable tobacco4420
All participants1,52728

Over 300 survey participants had used e-cigarettes, and over 200 had used snus, moist snuff or chewing tobacco.  Importantly, a significant percentage of ever users of all smoke-free products were successful quitters. 

Popova and Ling close with this: “Explicit or implied claims that alternative tobacco products are smoking cessation aids should be prohibited in the absence of a body of scientific evidence showing such an effect.”

It is ironic that their paper adds to the body of scientific evidence that smoke-free products are smoking cessation aids.

Note: Thanks to Dr. Joel Nitzkin for noticing this discrepancy.

Thursday, June 13, 2013

British Government Promotes Cigarettes

The UK will regulate all nicotine-containing products, including e-cigarettes, as medicines, starting in 2016 (here).

The British bureaucrats justified their decision: “Our research has shown that existing electronic cigarettes and other nicotine containing products on the market are not good enough to meet this public health priority [i.e., “reducing the harms of smoking to smokers and those around them”]… Our investigations also found that the amount of nicotine per product differs from batch to batch so this casts doubt on how useful these products are to people who want to cut down or to stop smoking.”

While the government says it is acting “so that people using these products have the confidence that they are safe, are of the right quality and work,” the need for added regulation is questionable.  The government’s own press release confirms the popularity of available e-cigarettes – which could be seen as consumer confidence – noting that “their use has grown rapidly with an estimated 1.3 million people using them in 2013.” 

Clive Bates, former director of Action on Smoking and Health UK, strongly criticized the regulators on his blog:  “They want to substitute their own view of ‘efficacy (what works) for the consumers’ view.  Markets work by people buying the good products and the poor products failing, not by regulators deciding what works.”

Bates provides nine other reasons why this decision is a “bad idea”.  His must-read blog is available here.

According to the government release, “Smoking is the biggest single cause of avoidable death - killing 80,000 people in England each year.”  Regulation of e-cigarettes as medicines is likely to limit or eliminate the availability of these popular and far safer smoking alternatives.  Removing them from the marketplace only encourages smokers to continue smoking, making the UK government a culpable enabler of this deadly habit.

E-cigarettes are recreational tobacco products, not medicines.  They should be regulated accordingly.  The only consolation is that there will be five to ten million British e-cigarette users in 2016, a formidable political force that may not tolerate a regulatory barrier to the continued supply of these life-saving products.       

Thursday, June 6, 2013

Medicines for Smoking Cessation: Failure and Cover-Up

The 20-year-old Cochrane Collaboration is widely recognized for compiling and analyzing thousands of clinical trials, providing health professionals with useful information, in the form of authoritative analyses and reports, for clinical practice.  Regrettably, the Cochrane’s reputation was tarnished last week when it issued a report on smoking cessation medications (here). 

The report conveys the inaccurate impression that FDA-approved medicines are “effective” in helping smokers quit.  Uncritical media like Time magazine (here) quickly parroted the message:

“Based on the findings, all the drugs were successful at improving the odds for smokers who wanted to quit.  Participants were 80% more likely to quit when using a single NRT [nicotine replacement therapy] or taking bupropion compared to those using a placebo.”

While technically accurate, that statement entirely obscures the medicines’ actual impact and implies a ringing endorsement when none is merited.   

While Cochrane boasts that its research “covered 267 studies, involving 101,804 participants,” there is no information on how many participants quit by using the placebo.  This is a serious omission, well below the standards of the institution’s past reports.

In a summary written for laymen, the Cochrane notes: “NRT and bupropion helped about 80% more people to quit than placebo; this means that for every 10 people who quit with placebo about 18 could be expected to quit with NRT or with bupropion.  Varenicline more than doubled the chances of quitting compared with placebo, so that for every 10 who quit with placebo about 28 could be expected to quit with varenicline.”

These numbers are not meaningful, because they are abstract and without context.  Mark Eisenberg and colleagues from McGill University in 2008 published a meta-analysis of smoking medicines in the Canadian Medical Association Journal (abstract here) that provides the necessary context, by reporting numbers of successes and failures for placebo and for medicines. 

In the Eisenberg analysis the quit rate for all 11,000 participants given a placebo was just over 10%.  This means that out of a hundred smokers using placebo, about 10 successfully quit.  Quit rates were 17% using nicotine gum, 19% for the patch, 21% for bupropion and 26% for varenicline. 

Here’s the flip side:  90 out of 100 smokers failed to quit with placebo, 83% failed with nicotine gum, 81% with the patch, 79% with bupropion, and 74% failed with varenicline. 

And that’s not the end of the story.  Placebo and medicine quit rates in clinical trials are typically grossly elevated compared to the real world.  The reasons: (1) clinical trials carefully screen participants, enrolling only highly motivated smokers who are likely to complete the trial, and succeed; (2) trials provide intensive motivation and follow-up, increasing success rates; (3) there is well documented evidence that pharmaceutical company funding inflates quit rates for medicines (abstract here). 

In the real world, quit rates are half of clinical trials, around 5%, according to the National Institutes of Health (here), meaning that 95% of smokers fail.  It’s likely that real-world failure rates are 91% for nicotine gum or patch, 90% for bupropion and 87% for varenicline. 

Smoking cessation medicines are effective for only for a tiny minority of smokers.  Suppressing this fact deters smokers from learning about and adopting safer tobacco alternatives.  By further obscuring the truth, the Cochrane collaborates, intentionally or not, with tobacco prohibitionists who are undermining public health and condemning countless smokers to untimely and entirely avoidable death.  That is a real-world disaster.