Sunday, July 16, 2006

Surgeon General Trades Integrity for Advocacy

The U.S. Surgeon General recently appeared in a TV interview on PBS's News Hour on the day his new report on secondhand smoke was released. He stated repeatedly and emphatically that there was no safe level of exposure to secondhand smoke. (This is the “no threshold” theory.”) But the very report he was talking about doesn't support what he was saying. It draws no such conclusion, nor does it provide any data to support such a conclusion. The SG was simply not being honest.

The “no threshold” theory about cancer has never been shown to be true for ANY chemical, much less secondhand smoke. The theory that if something is carcinogenic at high doses it must also be proportionately so at small doses simply does not fit the real world. At least ten elements (including iron and oxygen) are carcinogens at high doses but essential to human life in small doses. And some carcinogens, such as selenium and Vitamin A, are proven anti-carcinogens at low doses. These facts contradict the “no-threshold” theory. Thresholds are a law of nature; the mere title of one treatise says it all: “Environmental Carcinogenesis—The Threshold Principle: A Law of Nature." The authors, Claus and Bolander, state that the no-threshold theory about any dose being dangerous ignores “all the fundamental principles of cell biology.”

Dr. Elizabeth Miller, former president of the American Association for Research on Cancer, has stated: “Chemical carcinogenesis is a strongly dose-dependent phenomenon.” This is opposite to the claim by smoking ban advocates—including the surgeon general—that it is not dose dependent, that any dose is a health hazard (no threshold.)

The no-threshold theory, when applied to secondhand smoke, “incorporates unsound assumptions that are not valid,” says an article by Drs. Huber (pulmonary specialist), Brockie (cardiologist), and Mahajan (a hospital director of internal medicine and professor of medicine.)

Furthermore, thresholds are known to exist for mainstream tobacco smoke in total as well as for each of the individual carcinogens known to exist in it. It is preposterous to claim, as the SG does, that secondhand smoke—which is more than 100,000 times more dilute than mainstream smoke—has no threshold, even though mainstream smoke does. This turns the dose-response principle of epidemiology on its head and means secondhand smoke can be more dangerous than actual smoking! Ridiculous!

The SG should know that thresholds for all carcinogens in—or even assumed to be in—secondhand smoke have been identified. They have been calculated by the American Conference of Government Industrial Hygienists. Below these thresholds, the chemicals are considered safe. To reach the threshold for the carcinogen with the lowest threshold (hydroquinone) would require 1,250 cigarettes to be smoked in a sealed, unventilated room 20 by 22 feet within one hour. This would mean 30 people in that room each smoking slightly more than 2 PACKS of cigarettes per hour. And remember this is in a sealed room, where no one would enter or leave in that hour and where there would be no mechanical ventilation. Open a door or window or add mechanical ventilation, and the number of cigarettes needed to reach the threshold would be even higher. Of course, nobody—much less everyone in a room—will ever smoke 2 packs of cigarettes per hour. Thus it is essentially impossible for secondhand smoke to be a cancer risk despite the pathetic claims of the SG and smoking ban activist/advocates.

Notice that I began the last paragraph by speaking of all the carcinogens known “or even assumed” to be in secondhand smoke. This is because most of the carcinogens have never actually been found in secondhand smoke. If they exist there at all, they are in quantities too small to be measurable. They are simply assumed to be there because they are known to exist in the smoke from which secondhand smoke is derived. So calculations of their presence in secondhand smoke are based on their proportions in the parent smoke. But they may not exist at all in secondhand smoke because of physical, chemical and behavioral differences from the parent smoke. Secondhand smoke has extremely low concentrations of volatiles. Mainstream smoke is highly concentrated, and its higher gas phase concentrations favor larger respirable particles that condense and retain more volatile compounds. Evaporation is faster from secondhand smoke particles; within fractions of a second, they becomes 50 to 100 times smaller than their mainstream counterparts. Secondhand smoke quickly undergoes a variety of other changes: oxidation, polymerizations, photochemical transformations, and other changes. All these changes take place extremely quickly. So suddenly secondhand smoke is a very different collection of chemicals than the smoke from which it was derived, and carcinogens assumed to be there may, in fact, be absent. But even if present, they are in quantities far below the threshold levels. And secondhand smoke is “so highly diluted,” say Huber/Brockie/Mahajan, “that it is not even appropriate to call it smoke, in the conventional sense. Indeed, the term 'environmental tobacco smoke' is a misnomer.”

The SG also distorted science and misled the public by saying, “Even a short time in a smoky room causes your blood platelets to stick together. Secondhand smoke also damages the lining of your blood vessels. In your heart, these bad changes can cause a deadly heart attack.” This is untrue and irresponsible. Even in smokers, heart disease requires many years to develop. (Dr. Michael Siegel, a medical doctor and public health official with 21 years of tobacco policy research, estimates 25 years.) To claim even a brief exposure to secondhand smoke can result in bodily changes that can “cause a deadly heart attack” is dishonest sensationalism. And the SG was simply not honest enough to say that the blood platelet and blood vessel lining effects he talked about completely reverse themselves very rapidly after exposure to secondhand smoke ceases. In the case of the lining of blood vessels, this happens within 15 minutes.

The SG's report says “evidence indicates a 20 to 30 percent increase in the risk of lung cancer.” This means there is a "statistical association" between secondhand smoke and lung cancer that is 20 to 30 percent greater than the baseline, or “natural” level, of cases in a nonsmoking population not exposed to secondhand smoke. So, how many additional cases of lung cancer would be associated annually with a 20 percent increase in risk to 100,000 nonsmokers exposed to secondhand smoke? The answer is 2. That's two-thousands of one percent of the population! But you wouldn't scare many people with that number. You can scare a lot more by saying, “The risk increases 20 percent!” But they mean the same thing. Twenty percent of a very small number is still a very small number. Let me give you another example to illustrate this point.

Suppose a stock is selling for $20 per share, and you've just heard that its earnings last year increased 20 percent over the previous year. Wow! Sounds great, huh? But then you learn it earned 1.2 cents per share last year. That's a twenty percent increase over the previous year, when it earned one cent a share. The increase of two-tenth of a cent amounts to a mere two-thousands of one percent of an increase in the $20 invested in a share of the stock. That increase is the same percentage as in our previous example of increase in the risk of lung cancer. Again, the lesson is that 20 percent of almost nothing is still almost nothing.

Please note that an increased risk of 20% that would be “associated” with 2 additional cases of lung cancer in 100,000 nonsmokers does not show those 2 cases are caused by secondhand smoke. There are many other factors that have "statistical associations" with lung cancer among nonsmokers. At least twenty of these have been identified. These “confounders,” as they are called, include heredity, exposure to radon, prior lung disease, type of employment, vitamin consumption, alcohol consumption, cholesterol level, etc. Now, do you think heredity could account for 2 cases of lung cancer in 100,000 nonsmokers? Your darn right it could. How about prior lung disease? Exposure to radon? Type of employment? Any one of these could easily account for 2 or more cases of lung cancer among 100,000 nonsmokers and thus equal the entire number ascribed to secondhand smoke. Even mere chance could account for 2 cases of lung cancer. So you can see why a risk increase of 20 or 30 percent, though it may sound impressive, is really too small to be significant and why long-established scientific standards require much higher numbers for significance.

Relative risk (also called risk ratio, or RR) is the measurement epidemiologists use to quantify health dangers. A risk of 20 to 30 percent means a RR of 1.2 to 1.3. (RR of 1.0 is neutral, no effect.) According to classic statistical principles, RRs less than 2.0 or 3.0 are considered too low to be relied upon. The independent health consulting firm of Littlewood & Fennell, in their report to the National Toxicology Program's Board of Scientific Counselors on Carcinogens, characterized RRs less than 2.0 as “dancing on the tiny pinhead of statistical insignificance.” The report also states “a wealth of published literature supports the criteria that relative risks less than 100 % ( 2.0) are weak and easily altered significantly by bias (deliberate or inadvertent) or confounding factors.” Similar statements can be found in textbooks such as Breslow and Day's Statistical Methods in Cancer Research.

Huber/Brockie/Mahajan state: “A strong relative risk would be reflected by a risk ratio of 5 to 20 or greater. Weak relative risks, by conventional definition, have risk ratios in the range of 1 to 3 or so....No matter how the data from all of the epidemiological studies are manipulated, recalculated, 'cooked,' or 'massaged,' the risk from exposure to spousal smoking and lung cancer remains weak. It may be 1.08 or it may be 1.34 or it may be 1.42, but all of those still represent a weak relative risk.”

There is more. The Report on Comments on the Surgeon General's Report...EPA...and NIOSH (1992) states: “Risk estimates below 2.0 or 3.0 are described as 'weak' and thus any conclusions drawn from them are unreliable.” The summary of this 47-page document concludes: “...these reports [Surgeon General's, EPA, and NIOSH] do not provide a defensible basis for regulation of smoking in the workplace.” Comments in the report are supported by 113 references in the scientific literature.

A very recent article by John K. Sutherland, a health physicist with 40 years experience, states: “[The advocates] develop tables of data which show Relative Risk effects of less than 2 and suggest [these show] a significant health effect. Any scientist worth his qualifications knows that a RR of less than two or even three is unreliable and too shaky to place much credible reliance upon.”

Dr. Robert Temple of the FDA says, “My basic rule is if the relative risk isn't at least 3.0 or 4.0, forget it.” And EPA refused to regulate high voltage power lines because it said the “risks seldom exceeded 3.0.” So why should we regard secondhand smoke with a puny RR of 1.2 to 1.3 as dangerous? If it is as dangerous as we've been told, why doesn't it have a higher RR?

The public is scared by the word “carcinogen.” The smoking ban activists play on that fear, the public's ignorance, and its gullibility for believing propaganda that claims to deliver them from the dreaded carcinogens. But as I pointed out in my book MAKERS AND TAKERS, we live in a world of carcinogens. They are everywhere. They are in the food we eat, the air we breathe, the water we drink, the soil we walk on. They are produced by plants, trees, bacteria, fungi, and our own bodies. Human blood contains many carcinogens; if it were an industrial product, it would be classed as a toxic substance. Our saliva contains nitrates, which are carcinogens. All human sex hormones are carcinogens.

Here are some of the food carcinogens listed in my book: sucrose, the common sugar from sugar cane and sugar beets, is a reported carcinogen. So if fructose, which is found in all fruits. Orange, lemon, lime and grapefruit oils are carcinogens or carcinogen promoters. Corn oil, cottonseed oil and sunflower oil are carcinogens. Raisins and walnuts contain malonaldehyde, which is a carcinogen. Salt is a carcinogen. Black pepper, cinnamon, ginger and nutmeg contain saffrole, which is a carcinogen. All fruits and vegetables and animal feed contain terpenes, which are carcinogens. The Paris-based International Agency for Research on Cancer reports that “virtually every food stuff or food product is potentially susceptible to contamination by [carcinogenic] aflatoxin...Samples of nearly every dietary staple have been found to contain [it].” These staples include coconuts, sunflower seeds, hazelnuts, Brazil nuts, walnuts, pecans, peanuts, corn, wheat, oats, barley, rye, sorghum, rice, black pepper, cocoa, wine, peas and sweet potatoes. Bread contains ethyl carbamate, a carcinogen. Yogurt and beer have it, too. Beets, celery and lettuce contain carcinogenic nitrosamines. Raw beef, pork, turkey and chicken contain carcinogens, and cooking makes things worse. Broiling, roasting, baking, braising, boiling, frying and smoking foods produce a variety of carcinogens. Mother's milk contains lactose. Lactose is a carcinogen. A cup of coffee contains over a hundred carcinogens, far more than secondhand smoke

Why aren't we all dead already from all these carcinogens? Because small amounts are not dangerous; they all have thresholds below which they are harmless. The same is true of the carcinogens in secondhand smoke. In fact, most of the carcinogens produced by burning tobacco are found throughout our environment, and we're exposed to them all the time. You can inhale more benzene from a few minutes of filling your car's gas tank once than you will ever get from several hours in a smoky bar. And you get 2,500 nanograms of benzo(a)pyrene every time you grill a steak. You also get the same carcinogen from lettuce, cabbage, leeks, tea, spinach and many other vegetables and even the municipal water supplies that tens of millions of Americans drink in thousands of U.S. cities every day. According to Medline, those water supplies have RRs 2.0 to 4.0, depending on locality, and we don't hear reports of people dying. So how dangerous can secondhand smoke be with a RR of 1.2 to 1.3

Claims that secondhand smoke causes many thousands of deaths every year from lung cancer and heart disease are derived from the RRs and population. If a RR is not statistically significant, estimates of deaths from it are meaningless. The 1992 EPA study claimed secondhand smoke had a RR of 1.19 and that this translated into 3,000 lung cancer deaths annually. This same number is quoted for lung cancer deaths for 2005 in the foreword to the 2006 SG's report. And cities, counties and states have been citing this same EPA number as a basis for passing smoking bans. But the Congressional Research Service, at the request of the U.S. Congress, looked at the same data as EPA and concluded: “It is possible that very few or even no deaths can be attributed to ETS [environmental tobacco smoke].” Further, it stated that nonsmokers exposed to pack-a-day ETS every day for 40 years have “little or no risk of developing lung cancer”—much less dying from it. The CRS is part of the Library of Congress and has all the resources of that esteemed institution at its disposal. It is highly respected, nonpartisan, accepted by both Republicans and Democrats as fair and impartial, has no ties to tobacco companies, no regulatory or other agenda, and accepts no outside funding.

Then there was the Congressional Investigation of EPA's findings by the U.S. House of Representatives. It found: “EPA could reach that conclusion [3,000 lung cancer deaths] only by ignoring or discounting major studies, and deviating from generally accepted scientific standards.” Further, it found EPA guilty of “conscious misuse of science and the scientific process to achieve a political agenda that could not otherwise be justified.” It also stated: “The agency [EPA] has deliberately abused and manipulated scientific data in order to reach a predetermined, politically motivated result.” Five similar studies (meta-analyses) of ETS were performed by other researchers who, unlike EPA, followed correct scientific procedures. The RRs of these studies showed a range of 0.98 to 1.03 and an average RR of 1.01, which is 18 percent less than the RR of 1.19 claimed by EPA.

In its own study, EPA violated not only many scientific standards but even basic honesty. It claimed various research studies by others were positive for ETS and lung cancer when the researchers themselves said the results were negative! And two internal documents from EPA's Environmental Criteria Assessment Office state that the agency exaggerated the effects of secondhand smoke and that its conclusions were unwarranted. EPA was found guilty of violating six federal statutes for using harassment and intimidation to force employee support for its position on ETS—the same position that smoking-ban activists ever since have enthusiastically and uncritically supported! And the latest SG report continues to utilize that figure of 3,000 lung cancer deaths and treat it as though it were valid. What does that tell you about the value of the SG's report and the integrity of the SG?

The SG's report also claims 46,000 deaths annually due to heart disease from secondhand smoke. But the American Heart Association website lists the following RRs for ETS: 1.25 for Cardiovascular disease, 1.18 for ischemic heart disease, and 1.13 for arrhythmic heart failure or coronary arrest mortality. None of these is statistically significant. If a RR is insignificant, estimates of deaths based upon it are meaningless. So the big scary estimate of 46,000 deaths is meaningless.

If ETS really was causing heart disease deaths, this should show up in heart attack statistics before and after the passage of smoking bans There should be a drop in heart attack statistics following smoking bans, but the exact opposite has happened! Michael McFadden and David Kuneman examined hospital admissions before and after smoking bans affecting bars and restaurants in four states, California, New York, Florida and Oregon. In 3 of the 4 states, heart attack admissions increased in the year following the smoking ban, compared to the year prior to the ban. California showed the largest difference: heart attack admissions increased to 43,044 in the year following the ban, compared to 40,608 in the preceding year, a 6.0% increase. In Florida, the only state to show a decrease, heart attack hospitalizations were 39,783 compared to 40,077 in the preceding year, a 0.7% decrease.

And Michael Siegel studied the trend in heart attacks in Massachusetts, where there was a huge proliferation of smoke-free bar and restaurant regulations between 2000 and 2003. He found that heart attack admissions increased by a whopping 31.8% during this time, compared to a 2.4% decline in comparison states and a 1.5% increase nationally. Dr. Siegel, who is adamantly against smoking, has been a statistical editor for a top tobacco control journal and has published over 50 peer-reviewed articles in major public health and medical journals. In the statistics just cited, there certainly is nothing to support the claims that ETS causes heart disease deaths or that smoking bans will reduce them. If anything, secondhand smoke seems to provide a beneficial (protective) effect. This is not as surprising as it may at first seem since a similar effect is often seen in regard to lung cancer.

Earlier we pointed out that substances such as selenium and vitamin A, which are carcinogens in high doses, in small doses are anti-carcinogens that act to prevent cancer. And it has been known for centuries that a small dose of a poison stimulates one's resistance to larger doses in the future. Later this was found to be true for bacteria and viruses. This is the basis of vaccines. When you get a flu shot or any other vaccine, you are getting a weakened form of a disease-bearing virus or bacteria. This stimulates your immune system to provide resistance to larger dangers of this type in the future. And we all know that sunlight can cause cancer, but modest amounts of sunlight actually protect against several forms of cancer, including breast cancer and bone cancer. So there is nothing new in the idea that small doses of a toxin or carcinogen are beneficial. A large number of studies show this protective effect from ETS in relation to lung cancer, particularly for children. A World Health Organization study of ETS, for example, found no adverse effect to adults and a protective effect for children. It found children were 22% less likely to get lung cancer if both parents smoked than if neither smoked. This is a far cry from the SG's assertions “there is no risk-free level to secondhand smoke” and “breathing even a little secondhand smoke can be dangerous.”

Dr. Siegel recently wrote: “The anti-smoking movement is driven by an agenda—an agenda that will not allow science, sound policy analysis, the law, or ethics to get in its way.” Surgeon General Richard Carmona is part of that movement. He has perverted science to advance an agenda by giving it a phony "legitimacy." By corrupting science he has revealed his true character—or rather the lack of it—and destroyed his own credibility. He should never again be trusted. About anything. He is a disgrace to himself, his office, and that impressive uniform he wears. He has shown himself to be not a man of science but rather part of what the Littlewood & Fennel report called the “activist/advocate effort determined to somehow prove that ETS is a human carcinogen in the face of irrefutable evidence to the contrary.”

Politicized science is no science at all. But it has allowed the anti-smoking movement to masquerade as a health issue and shift the debate away from the real issue. In terms of science, there never was a legitimate public health issue here, as this blog has shown. The real issue is a simple matter of property rights: bar and restaurant owners should be free to set the conditions for use of their property, and other people should be free to choose whether or not to go there. The property owners have no right to force unwilling people to be their customers, nor do customers have a right to force their choices on unwilling proprietors. But forcing their choices on others is precisely what the smoking ban activists want! If people have equal rights, both sides must have the same rights to chose to participate, or not, on terms acceptable to the other. It is amusing that the SG's report is titled "The Health Consequences of Involuntary Exposure to Tobacco Smoke.” The word “involuntary” here implies one has no choice about going to a bar or restaurant where smoking is allowed.

Rights is a political concept. Science is not. Rights are the proper concern of government at all levels. Governments should be protecting ALL people's rights. EQUALLY. It should not be taking away some people's rights in order to subject those people to other people's desires. When those desires masquerade under the guise of a public health issue, the debate shifts from the political concept of rights to science. And very, very, very few lawmakers at any level of government have the scientific expertise to evaluate scientific issues. So they tend to rely on sources like EPA and the SG, tend to trust them (which is undeserved), and are prevented by their own lack of scientific knowledge from evaluating whether what they are being told is valid or not. In a word, they are easily bamboozled by misrepresentations, debased standards, and some outright lies—and by the frenzied recycling of these by the media, other government officials, and a well-financed and well-organized anti-smoking movement. That movement has even managed to get taxpayer money from the government for its campaign, one which “will not allow science, sound policy analysis, the law, or ethics to get in its way.” Witness the large number of city and county smoking bans that cite the fraudulent EPA study as a basis despite its being discredited by the Congressional Research Service, a U.S. House of Representatives Congressional Investigation, and the General Accounting Office. Once the issue is politicized, it is not science and will not be settled on the basis of science. Which, of course, is what the smoking-ban activists want.

Once I was at a public hearing for a city's proposed smoking ban. In the discussion of the proposed ordinance, it appeared the issue had widespread support and would pass easily. This surprised me because I had sent each member of the council a sheet detailing a great deal of factual information I was sure they were unaware of but would find convincing. So during an intermission, I approached one of the councilmen, who I was told beforehand was against the proposed ordinance, and showed him a copy of the fact sheet I had mailed. I asked if he and other members of the council had received it and read it. He said, “I got it and I read it. The others got it too. But it doesn't make any difference what you wrote. It doesn't make any difference what the facts are. They've got the votes to pass it. That's all that matters. The science doesn't matter. Nothing else matters. They've got the votes. I'm against the ordinance, but I'm going to vote for it because it's going to pass anyway.” Democracy in action. Politics wins, science loses. And individual rights, which government is supposed to protect, lose too.

Incidentally, I've never been a smoker and recommend people do not smoke. I've never own stock in a tobacco company or received any money from the tobacco industry. And I've never owned a bar or restaurant or worked in one. My only interest is sound science and intelligent public policy.