Saturday, March 27, 2010

FSC or Fire Safe Cigarette Laws: More Harm than Good

By Rebecca Brooks

Flawed Harvard Study and Misrepresented Statistics behind Recent Legislation

Smokers don’t seem to be a popular demographic these days, judging by all the smoking bans that have passed recently, but there’s another law sweeping the nation that should have even non-smokers questioning how their public policy is being enacted.

FSC or fire safe cigarette laws seem like a great idea. The concept is that self-extinguishing cigarettes are less likely to start fires, and laws requiring them would save lives. To date, forty-nine states and several countries have passed FSC laws, and they are being considered at the United States federal level and in other countries.

The problem is there’s no proof they save lives, they may be increasing smoking-related fires, and they appear to be making smokers very sick.

The Power of Prestige

Fire safety standards for cigarettes have a long history of unsuccessful legislative efforts, at both the state and federal level. Cigarette manufacturers maintained it couldn’t be done without potential health consequences, and that there were more effective ways of reducing fires.

After much controversy, the state of New York adopted the first law requiring cigarette manufacturers to comply with a defined fire safety standard. Because of the time and expense involved in toxicity testing on human volunteers, and concerns over becoming the federal regulatory agency and the resulting liability, New York officials felt it was best to not take responsibility for any toxicity testing.

The law went into effect on June 28, 2004, and it was hoped to set a precedent. On January 24, 2005, the Harvard School of Public Health published a report titled: “The Effect of the New York State Cigarette Fire Safety Standard on Ignition Propensity, Smoke Toxicity and the Consumer Market.”

The report was given great credibility, and the key findings are frequently quoted by advocates pushing for FSC legislation. The key findings are on page one, and they are all that is generally read out of the 50-page report, which is filled with complex data.

Upon closer inspection, it states in the study’s objectives that it will assess the ability of manufacturers to produce cigarettes with reduced ignition propensity (RIP) and measure the levels of nineteen toxic compounds to determine if there are substantial differences in the same four cigarette brands purchased in both New York and Massachusetts.

A cigarette brand is considered fire standards compliant (FSC) if it doesn’t burn all of the way down more than 25% of the time. The researchers found that one of the four New York brands they tested, Marlboro Reds, burned all of the way down 30% of the time, making it non-compliant and illegal to sell in New York. The law is quite clear on the 25% requirement. It doesn’t say: “But 30% is OK if the manufacturer can’t handle it.“  The manufacturer, Philip Morris, should have been fined for breaking the law.

Rather than acknowledge that one of the New York brands was illegal, the researchers instead introduced a fifth brand and another state’s brands to the ignition propensity test. By doing that, they were able to state in the key findings: “Of the five brands studied, the average percentage of full-length burns was 10% for the New York cigarette brands tested compared to 99.8% for California and Massachusetts brands, indicating that the New York brands are less likely to ignite fires than the same brands sold in the other states.”

Why didn’t the researchers address the issue of the illegal brand? A major objective of the study was to assess manufacturers’ ability, yet in the study’s conclusions they state manufacturers were able to produce FSC cigarettes in accordance with New York standards.

Not surprisingly, the illegal brand performed the best when they tested the four New York brands for toxicity.

Despite the illegal brand being used in the toxicity test, rendering the test invalid, researchers still found five major toxic compounds had significantly higher levels. Those included naphthalene (the primary ingredient in mothballs) at 13.9% and carbon monoxide (produced by incomplete combustion) at 11.4%. The authors of the study considered the magnitude of the differences small. The increases are generally referred to as “around 10%.”

However, if the illegal brand was eliminated, as it should have been, naphthalene shoots to 15.8% and carbon monoxide to 12.6%. There’s a close correlation between FSC characteristics and toxic compound increases. In the FSC cigarettes, there were increases in all of the nineteen toxic compounds that were measured. In toxicology, the dose is the poison.

Of course, that’s all academic because, as the report states, more research is needed on how people smoke FSC cigarettes versus non-FSC cigarettes, and what their actual bodily exposure is to the toxins and disease.

The reason for that, states the report: “Machine testing of toxic compounds in smoke cannot predict actual human exposure or disease risk. It provides a crude measure of how design changes affect the toxic compounds in smoke under standardized machine testing protocols.”

As it turns out, people don’t smoke like machines. This observation was made when researchers studied people smoking “light” cigarettes. While machines measured less tar and nicotine in “light” cigarettes, people would unconsciously compensate for that by inhaling more deeply or taking more frequent puffs, often getting more tar and nicotine than regular cigarettes.

Since FSC cigarettes are notorious for going out if they’re not puffed on frequently, smokers are more than likely going to dramatically increase the amount of toxic compounds they inhale, including tar from the additional incomplete combustion. Nicotine delivery will also be increased, making it harder for them to quit.

Nevertheless, the report stated only in its key findings: “The majority of smoke toxic compounds (14) tested were not different between New York and Massachusetts brands. Five compounds were slightly higher in New York brands. There is no evidence that these increases affect the already highly toxic nature of cigarette smoke.”

The study also analyzed cigarette sales and tax revenue from July 2004 to November 2004. It found a 2.5% decrease in cigarette tax revenues ($2,131,000 less than the $86,746,800 from the same period the year before), but determined that was not statistically significant when accounting for month-to-month variation.

Since retailers were allowed a grace period to sell existing inventory, the report noted its limitations: “This data should be interpreted cautiously since non-RIP cigarettes on the retail shelf as of June 28, 2004 were allowed to be sold.”

It’s hard to understand how any meaningful conclusions could have been drawn on the consumer market when non-FSC cigarettes were still being sold during the time period studied.

Apparently not wanting to get bogged down in details, the key findings of the report state: “New York has experienced no decline in cigarette sales or excise tax payments since the standard went into effect, indicating that the New York RIP cigarettes are acceptable to consumers.”

The New York State Department of Health’s statistics show smoking rates in New York fell from 21.6% in 2003 to 16.8% in 2008. New York compensated for the drop in tax revenue by raising taxes on cigarettes.

This report also stated that it did not seek to address the effectiveness of the law on reduction in fire deaths and damages caused by cigarettes, but it did ultimately conclude in its key findings: “Based on the New York experience, prior industry objections to RIP cigarettes are unfounded. There is no valid reason why cigarette manufacturers should not sell RIP cigarettes nationwide.”

The day before the report was published, the lead author of the study, Gregory N. Connolly, D.M.D., M.P.H. issued the following official press release: "Our research found that Massachusetts and California cigarettes were far more likely to ignite fires than the same brands sold in New York. New York smokers have accepted fire safer brands, and they were found to be no more costly or toxic than those sold in the other states. All states should adopt the New York standard to prevent needless death and suffering from fires caused by burning cigarettes."

Connolly was director of Massachusetts Tobacco Control Program from 1986 to 2003, where he oversaw the fastest decline in smoking in any state, cutting consumption nearly in half. He joined Harvard in 2004.

The Harvard study was funded by American Legacy Foundation, a non-profit organization established in March 1998 as a result of the Master Settlement Agreement with tobacco companies. The Foundation is dedicated to encouraging smokers to quit.

The report is dedicated to five people who died in a cigarette-ignited fire. This is unbiased science? It seems unlikely the study would have found FSC cigarettes too toxic to market with a dedication such as that.

For the Record

The New York Public Interest Research Group (which pushed for the original FSC legislation in New York) and The Coalition for Fire Safe Cigarettes (which pushed for legislation at a grassroots level) strongly encouraged other states to adopt the same standards as New York to avoid a “patchwork” of regulations that the tobacco industry had lobbied against. The New York regulations have no provisions for toxicity testing, only fire standards testing.

Despite numerous rumors, it would actually be difficult to say how any given FSC cigarette is made because that is proprietary information. Nonetheless, the Harvard study proves FSC cigarettes produce more toxic compounds when smoked. That should not come as a surprise to anyone with a basic understanding of the science of combustion.

A fundamental principle of toxicology is that adverse health effects are dose-dependent. The body can detoxify chemicals up to a point, but if that threshold is breached, the body becomes overwhelmed and toxicity (poisoning) occurs. Technically, a chemical only becomes toxic when exposure reaches that threshold. The degree of the adverse health effects are usually in proportion to the dose over that threshold. The synergistic effect of the increase in so many chemical compounds produced by FSC cigarettes greatly increases the likelihood and intensity of adverse health effects for smokers.

Danger for Everybody

As FSC legislation gained traction, it was met with resistance from smokers and the tobacco industry, who ran an anti-FSC advertisement. To combat this problem, on June 12, 2006, Connolly issued an official written response.

He chastises the tobacco industry for being scientifically irresponsible for citing findings dated in 1993. Does he then do the scientifically responsible thing and cite from the “wealth of recent research”? Ironically, he instead refers to a summary by Philip Morris in 2000 on its reduced ignition propensity technology. Three out of four cigarette types in that summary would have failed New York’s fire safety standard, but toxicological evaluations were based on them as a group. Also, it’s industry research and Philip Morris had a clear motive for trying to advance legislation. The company wanted to license its patent and trade secrets.

When New York passed the first FSC law, much of the assumption made about toxicity was based on the same summary presented to them by Philip Morris, and on the 1993 National Institute of Standards and Technology report in which all six brands with reduced ignition strength would have also failed New York standards.

New York officials admitted at the time that little was known about exposure and toxicity. When the New York State Office of Fire Prevention and Control developed the test method, in consultation with the New York Department of Health, the only commercially available brands that achieved the performance standard had lower than average tar yields. Generally speaking, the higher the tar yield, the more ignition strength a cigarette has, due to the density of the tobacco. New York officials did not know if best-selling, higher tar yield cigarettes could be modified for low ignition strength, but they hoped for the best.

Connolly also offers as reassurance Philip Morris’s Merit Select brand cigarettes. Merit Select has a troubled history. In 2000, Philip Morris began marketing the first “self-extinguishing” cigarette, Merit PaperSelect, with banded paper technology. Not long after, the complaints started rolling in. Seems the cigarette had a problem with what is known in the industry as “hot coal drop off,” chunks of smoldering tobacco that tend to fall off the tip.

“Hot coal drop off” is a common complaint of current FSC cigarette smokers. New York officials were well aware of this problem when they passed the first FSC law. Their feeling was that an increased number of clothes and localized skin burns was a fair trade-off to potentially reduce the number of smoking-related fire deaths.

Apparently, they did not consider what a distraction this could be for the one in five people who may be smoking when they’re driving down the road. It creates a danger for everybody.

The Misrepresented Statistics

Smoking-related fire deaths had been trending downward for many years, mainly because the smoking rate had also been falling.

From 1980 to 2006, according to the National Fire Protection Association, the smoking rate in the United States fell by 41%, and smoking-related fire deaths fell by 65%. The death rate declined faster than the smoking rate itself--by 35% per million cigarettes consumed.

Other factors that contributed to the decline in the death rate include fire-safety education, fire-resistant fabrics, hard-wired smoke detectors, and firewalls. (By the end of 2006, the only state other than New York to have an FSC law in effect was Vermont’s on May 1, 2006.)

It can take a fair amount of time after implementation of laws for trends to emerge, so it is hard to determine the effect of the recent FSC laws. Random events such as fires tend to not follow easily discernable patterns, and smoking-related fire statistics are a complex mix of many variables. While the role of the smoking rate is obvious, any reduction in deaths could also be from the law making people more aware of fire safety, something that is difficult to quantify.

In Connolly’s written response on June 12, 2006, he states that New York data indicate a “48% reduction in cigarette fire deaths in the second half of 2004 after implementation of the state‘s cigarette fire safety law.”

The statistic he gives does not come from the Associated Press article by Michael Gormley that he cites, which says there was “a decline month-to-month through 2004” in the Newsday 2005 version (the ABC News 2006 version changes it to “a month-to-month decline after New York required the new ‘fire-safe’ cigarettes”).  The statistic he gives is from The New York Public Interest Research Group, and it is best described as a misrepresentation of data.

They calculated an average of 42 deaths per year from 2000 to 2002, which camouflages the pre-law downward trend, and they did not include 2003 (which was 38) because they stated there wasn’t complete data.

Then, they doubled what they claimed were the 11 deaths in the second half of 2004 (as opposed to 17 in the first half) to get 22 deaths per year, creating the amazing 48% reduction in deaths. Doing this ignores the fact that smoking-related fire deaths usually peak in January through April, when people spend more time indoors.

They also fail to make any connection between the drop in the smoking rate and the death rate reduction. In New York, there were 3,840,289 people who smoked in 2004 as opposed to an average of 4,268,440 per year from 2000 to 2002.

In addition, existing inventory of non-FSC cigarettes was still being sold in the second half of 2004, casting more doubt on the role of FSC cigarettes in the reduction. According to the New York State Office of Fire Prevention and Control, smoking-related fire deaths rose from 31 in 2004 to 33 in 2005.

The Coalition for Fire Safe Cigarettes, formed by the National Fire Protection Association in March 2006, is equally misleading. To come up with the 35% reduction in deaths they claim New York experienced after implementation of the law, they use an average of 38 deaths per year for 2002 and 2003 to camouflage the pre-law downward trend. (The death rate of 39 in 2002 is 13% less than the death rate of 45 in 2001.)

Then, they use an average of 24 deaths per year for 2006 and 2007 to not focus on the fact that it went up from 22 in 2006 to 27 in 2007. That allows them to assert an impressive one-third reduction in deaths, which is again a misrepresentation because they fail to acknowledge the role of the drop in the smoking rate. In New York, there was an average of 3,596,900 people who smoked in 2006 and 2007 as opposed to 4,213,508 in 2002 and 2003.

If they were to simply calculate the reduction in the death rate from 2003 (pre-law) to 2005 (post-law), it is 13%--the same rate as it had gone down before the FSC law was implemented. The only undeniable correlation, before or after the law, is between the number of people smoking and the number of smoking-related fire deaths. While the death rate has declined faster than the smoking rate, it declined at a faster rate before the law was implemented (16.5% in the four years before 2004 as opposed to 4.8% in the four years after 2004).

More Bad News

Statistics also show that in the four years before 2004, there was an average of 5.36 fires per year for every 10,000 people who smoked in New York. In the four years after 2004, there was an average of 5.69. In 2008, there were 6.37 fires for every 10,000 people who smoked in New York.  That’s 330 more fires than they statistically would have had if the law hadn’t been passed.  While it’s too soon to see an obvious trend, the frequency of a smoker’s home catching on fire has actually increased since the law went into effect.

Those troubling statistics indicate that people were wide-awake when the fire began, not carelessly falling asleep with a cigarette in their hand. That could be due to the problem of “hot coal drop off” with FSC cigarettes, or more people now rolling their own cigarettes, which are not typically well constructed. Another possibility is smokers may think an FSC cigarette is out (when it’s actually still smoldering), and empty the ashtray. The uncertainty is dangerous.

The FSC law’s test method only specifies putting a cigarette on ten layers of filter paper, and a brand is compliant even if the cigarettes burn all of the way down 25% of the time. The test method does not address what happens when a partially burning FSC cigarette is put in a trash can or other real-life scenarios. An experiment by firefighters in Albany, Georgia found FSC cigarettes started papers in a trash can on fire within five minutes. No cigarette is fire safe.

The Herd Mentality

Until very recently, smoking-related fire data has been contaminated by the ability of people to buy non-FSC cigarettes from neighboring states or over the internet. New York didn’t even begin requiring identification of non-compliant cigarettes in suspected fires until late 2007; doing so is almost an admission that things aren‘t going well.

Andrew McGuire, director of The Coalition for Fire Safe Cigarettes and advocate for fire safe cigarettes since the 1970’s, is aware that it would be difficult to prove that FSC cigarettes are saving lives. He co-authored a report titled “Fire Data & Fire Safe Cigarettes,“ dated September 20, 2007, which concluded: “Fires are down, but reasons are complex, multiple, and essentially unmeasured. No existing fire data source can determine by itself effectiveness of intervention. Must rely on special studies.”

Before anything could be known about the true effect of an FSC law, The Coalition for Fire Safe Cigarettes urged state lawmakers across the country to adopt the New York model legislation, misleading them with a one-third reduction in deaths and the Harvard report key findings. The key findings were generally interpreted to mean FSC cigarettes are no more toxic than regular cigarettes, and an FSC law would have no significant impact on tax revenue.

The ingenious strategy to make FSC cigarettes the law of the land included the exploitation of emotions, questionable financial contributions, and taking advantage of lame duck sessions. Complex data were easy to misrepresent, and the misinformation gained more credibility every time another state passed the law. Since now virtually every state has passed FSC laws, the result has been to force a de facto federal standard.

Cause for Alarm

As of October 1, 2009, the U.S. Fire Administration said that it was still too early to see a statistical trend in states that have adopted FSC legislation. The National Fire Protection Association estimates that substantial data won’t be available for several years.

While the jury is still out on the efficacy of FSC laws, a group called Citizens Against Fire Safe Cigarettes started an online petition November 15, 2008 to repeal the laws. There are currently 25,620 signatures on it (and growing daily), filled with comments from angry people who say they were fine before they started smoking FSC cigarettes, and are now suffering from adverse health effects. Their complaints include coughing up blood, splitting headaches, nausea and vomiting, sores in the mouth and throat, winding up in the hospital, and disgust with their government.

Many smokers were unaware of the changes to their cigarettes until after they began suffering from adverse health effects. Their symptoms disappeared when they began to roll their own cigarettes. If FSC characteristics are required on rolling papers, it would push cigarettes even more into an already burgeoning black market, making cigarettes easier to obtain by underage smokers. That would further erode respect for the government and rule of law.

When is it justifiable to penalize many to possibly save a few? Cooking-related fires are the number one cause of home fires. Should fire retardants be put in vegetable oil? People probably shouldn’t eat fried food anyway; maybe some would quit. Irresponsible drivers kill innocent people. Should cars be banned?

In Connolly’s written response on June 12, 2006, he contends that it doesn’t matter if FSC cigarettes are a little more toxic, because all cigarettes are lethal and people should quit. The reality is some people enjoy smoking and don’t want to quit, and understand that the level of chemical compounds inhaled is important. Some believe it is additives like burn enhancers that have been put in most commercial cigarettes for years that make them particularly dangerous.  While it would be beneficial, simply removing burn enhancers is not enough to make cigarettes fire standards compliant.

If the level of chemical compounds inhaled doesn’t matter, why was an illegal brand tested in the Harvard study to make FSC cigarettes seem less toxic than they really are? The validity of all scientific research is undermined by that, and by failing to mention in the carefully worded key findings that research is needed on actual smokers to determine if the increased level of chemical compounds are harmful.

Equally deceptive is The Coalition for Fire Safe Cigarettes ignoring the role of the reduced number of smokers in the fire death reduction. Of course, that would mean admitting to reduced tax revenue, not something lawmakers want to hear. Unfortunately, the misrepresentation of the fire death reduction has led to more fires for smokers and other dangers. Complex problems rarely have simple solutions.

The fact that one in four brands purchased in New York failed the Harvard ignition propensity test, and Philip Morris had “hot coal drop off” problems, show the difficulty in producing a cigarette that combusts and yet doesn’t keep combusting. The FSC laws have resulted in the creation of dangerously unpredictable cigarettes, and it‘s too soon to know the full repercussions.

Yes, the technology exists to make products resistant to burning, but it is absurd and irresponsible to require those characteristics on a product that can only be consumed by burning. Common sense dictates people will be subjected to an additional chemical burden from smoking such a product, and the full extent of the increased health risk might not be realized for years.

Laws with the potential to do more harm than good should not be enacted. New York legislators failed to anticipate the realistic consequences of an FSC law. That was quite the precedent to set. Other lawmakers displayed incompetence by passing a law based on the unverified assertions of a coalition with a doctored Harvard study.

FSC laws are dangerous and need to be repealed immediately. Both smokers and non-smokers should be concerned about how these laws were passed, and contact their state and federal legislators. Also worth contacting are cigarette manufacturers, media outlets, Harvard School of Public Health, the National Fire Protection Association, state health departments, the U.S. Food and Drug Administration, the U.S. Consumer Product Safety Commission, and the American Civil Liberties Union.