Wednesday, August 13, 2008

The Rest of the Story Will Return on Tuesday, September 2 -- Enjoy the Rest of the Summer

Los Angeles City Councilor Claims that Secondhand Smoke is More Harmful than Active Smoking; Pushes Ban on Smoking Everywhere Outdoors

According to Los Angeles City Councilor Bernard Parks, breathing in secondhand smoke is more dangerous than actively smoking. In a commentary in City Watch and a press release, Parks uses this "fact" to justify his proposed ordinance which would ban smoking in virtually every outdoor location in Los Angeles. Anti-smoking groups, including Breathe LA, are supporting the ordinance.

According to the commentary: "Research has shown that inhaling secondhand smoke is more harmful than actually smoking, primarily due to the unfiltered nature of the smoke and its having been cooled by the air."

The ordinance would ban smoking in every outdoors location where people "reasonably congregate." Essentially, this means that there would be no outdoors smoking anywhere, with the exception of some dark deserted alleys. If enacted, this would be the most restrictive smoking ban in the nation.

The Rest of the Story

I now understand why anti-smoking advocates and groups are distorting the truth. Because they are promoting such extreme proposals that go far beyond the documented scientific evidence that they need to create their own facts in order to justify these proposals.

You can't credibly argue that smoking needs to be banned everywhere outdoors to protect the health of nonsmokers using the actual truth about the severity of health risk from secondhand smoke exposure. There simply is no evidence that a few wisps of secondhand smoke, as one might encounter from someone smoking on a sidewalk or in a street, parking lot, or park puts people's health at risk and represents a significant public health problem.

The only way to advance these policies, then, is to artificially build up the severity of the harms of secondhand smoke so that you can convince people that any exposure - even a few wisps of smoke - is a severe health hazard.

This, I now realize, is the impetus behind the widespread fallacious claims that are being made by over 100 anti-smoking groups about the cardiovascular effects of brief secondhand smoke exposure.

I no longer believe that this distortion of the science, which goes right up to the level of the Surgeon General (who claimed that brief secondhand smoke exposure was sufficient to cause heart disease and lung cancer), represents a simple, innocent mistake.

It is now clear that this is part of a new agenda (one that I never thought was part of the movement) to extend smoking bans beyond workplaces, restaurants, bars, and other places where there is substantial exposure. The movement is now to virtually ban all smoking outside of the home, so that no nonsmoker ever has to even see a smoker in public.

There simply is no credible alternative explanation for claims - like this one - which are so absurd that they are patently false on their face. You need only think about it for about 3 seconds before you realize that secondhand smoke exposure cannot possibly be more harmful than active smoking.

The epidemiologic evidence obviously does not support such a conclusion. The relative risk of lung cancer associated with chronic active smoking is about 17. The relative risk for lung cancer associated with chronic secondhand smoke exposure is about 1.3. That's a 13-fold difference. It is intuitively clear that smoking is worse than breathing in secondhand smoke. This isn't an example of stretching or exaggerating the facts - it's an example of creating (i.e., fabricating) them.

I should point out that if you take this message seriously, then a rational nonsmoker might actually start smoking. After all, according to the message, it's better to smoke yourself than to be exposed to secondhand smoke. The message truly undermines the severe health effects of active smoking because it states that active smoking is less harmful than secondhand smoke exposure. Thus, the statement is not only fallacious, but it is a dangerous one which undermines years of education of the public about the severe harms of active smoking.

While the main reason why I object to the fabrication of the science is that I view it as unethical, I wish to point out that I also think it undermines our cause of protecting nonsmokers from secondhand smoke. It gives the public the impression (rightly so, apparently) that our goal is not just to save lives and prevent serious medical conditions but instead, that our goal is simply to protect nonsmokers from ever having to breathe in a wisp of secondhand smoke or see a smoker. It makes it appear that we are trying to prohibit smoking through the back door and that de facto prohibition is our real agenda, rather than a legitimate public health interest in protecting nonsmokers from a severe health threat.

To use a half-marathon analogy, I feel like I have been running a half-marathon and I get to the finish line and stop, but everyone else keeps running. I thought the goal was to provide a safe working environment for all employees and to protect nonsmokers from a substantial health hazard in certain outdoors locations where they cannot easily avoid tobacco smoke exposure. Instead, the movement just keeps on going, trying to ban smoking in every possible outdoors location and even starting to infringe upon the private home.

I feel all alone at the finish line, wondering where everyone has gone.

The rest of the story is that I have come to the conclusion that the distortion of the science by anti-smoking groups is not merely an innocent mistake or an uninformed interpretation of scientific evidence. It is, instead, a deliberate attempt to promote an extremist agenda by fabricating scientific evidence that will support an agenda that is simply not supported by the scientific truth.

As I prepare for a brief vacation and a half-marathon (and trust me - I'm stopping at 13.1 miles, no matter what anyone else does), this seems like a fitting post with which to close before my summer vacation.

The Rest of the Story will return just after Labor Day, on Tuesday, September 2.

In the mean time, I leave you with this thought: For a movement that is largely based on its differentiation from the tobacco industry -- on its perception as the purveyors of truth and scientific accuracy in contrast to the industry's lies, distortion, and misrepresentation of the science -- it is essential that the movement remain beyond reproach in its scientific integrity.

The tobacco control movement is failing to do that. We are fabricating scientific evidence to support our increasingly aggressive agenda that cannot be justified otherwise.

And you know what? Other than the American Council on Science and Health (ACSH - which has written extensively on this topic) and Smokefree Pennsylvania (which has challenged some of the reliance on shoddy science), no anti-smoking groups are speaking out -- either against the extremist agenda or the fabrication of scientific evidence. The anti-smoking groups are either part of the deception or they are essentially complicit in the campaign of deception through their silence.

The realization I have come to - and it is a sad one for me - is that the misrepresentation of the effects of brief secondhand smoke exposure by anti-smoking groups is not simply due to a series of innocent mistakes. It is not merely an exaggeration of scientific findings. Instead, it represents a fabrication of a body of scientific evidence with a deliberate purpose - to promote an increasingly aggressive anti-smoking agenda that goes beyond protecting people from a significant health hazard as documented by actual science.

I have been very patient and understand and I've tried to use every imaginable rationalization to characterize the distortion of the science. But at this point, it is clear to me that the distortion of the science is not innocent; it is deliberate and it is intended to justify an agenda that could not be justified without scientific fabrication.

The one thing which no anti-smoking group I have challenged has said is that they defend the claims they are making. They recognized that what they are stating is not accurate. Even Stan Glantz admitted to me privately that some of the statements about the acute cardiovascular effects of secondhand smoke are not accurate. He rationalized them by arguing that we don't have time to present, and the public doesn't have the intellectual capacity to understand, the actual details.

Similarly, Breathe California of Sacramento-Emigrant Trails admitted to me privately that they don't believe the statistic on their web site is true (120 young people die each day from smoking). And while they claim that the reason they won't take the claim down is that the webmaster is away, it has now been nine months and no job has 9-months per year vacation as a benefit. It is clear that the statistic is still up there because they want it to be up there. They have chosen to knowingly allow a false claim to remain on the site because it is favorable to their cause.

TobaccoScam could have clarified that its statement "20 minutes [of exposure to tobacco smoke] = stiffened, clogged arteries" does not mean what it says: that 20 minutes of tobacco smoke exposure will lead to stiffened, clogged arteries. But it chose not to.

Breathe California of Sacramento-Emigrant Trails could have corrected its statement that 120 young people die each day from smoking. But it chose not to.

The bottom line is that it can no longer be argued that the deception of the public about the health effects of brief secondhand smoke exposure is accidental. There has been plenty of opportunity to remove, clarify, or correct these claims and for the most part, organizations have made deliberate decisions not to do so.

Even the Surgeon General's office has had plenty of time and opportunity to correct or clarify the Surgeon General's claim that a brief exposure to secondhand smoke is sufficient to cause atherosclerosis and lung cancer. No clarification was forthcoming, and the claim remains on the web site to this day, without any note of correction.

In my opinion, this means we are not just exaggerating or distorting the science - we are lying to the public. And we're doing so knowingly and intentionally.

And I don't think the tobacco control movement can remain as a legitimate and viable one within public health if it continues to do so.

Tuesday, August 12, 2008

Half of UK Fertility Experts Would Deny In-Vitro Fertilization to Smokers if They Do Not Quit Smoking; Some Hospitals Already Refusing IVF for Smokers

According to a survey reported by BBC News, about half of fertility experts (physicians) interviewed support the concept of denying in-vitro fertilization (IVF) treatment to smokers and obese persons unless they meet certain conditions for modification of their lifestyles.

According to the article: "Almost half of fertility experts say access to IVF should be conditional - and smokers or the obese could be denied treatment, a survey shows. The poll of international experts, most of whom work in the UK, found just 29% thought IVF should be offered to all. Obesity and smoking have been linked to fertility problems, so doctors say it is fair to ask patients to change their habits before they are given care. Patient groups said lifestyle advice should be based on medical evidence. The poll asked for doctors to agree or disagree with the statement 'access to IVF should be conditional on criteria based on lifestyle choices - eg denying access to smokers'."

According to an article in The Guardian, up to 46 primary care trusts in England and Wales are already denying IVF treatment to smokers and will not allow them access to IVF unless they quit smoking.

According to that article: "Hospitals have been accused of rationing IVF by denying the treatment to smokers, in a move that will reignite debate about the right to NHS care. Childless women, and in some cases their partners, too, are being asked to give up cigarettes before they can be considered for fertility treatment in up to 46 primary care trusts (PCTs) across England and Wales. Ministers have retreated on suggestions that smokers should be denied treatment for tobacco-related conditions such as heart disease. But a Department of Health survey released to Labour MP Sally Keeble last week, shows that, despite official recommendations that all infertile couples should get three cycles of treatment free, clinics are increasingly making free IVF treatment conditional on not smoking. While smoking can affect a couple's chance of conceiving and smoking in pregnancy can damage the unborn child, tobacco use is listed as a 'non-clinical access criteria' in the survey - meaning it is not a medical requirement for treatment to work, but one of a series of optional requirements such as being in a steady relationship. Other lifestyle choices known to reduce fertility, such as drinking alcohol, do not affect eligibility in the same way."

The Rest of the Story

I suppose one effective way of knocking smokers out of society is to make sure that they cannot reproduce. As far-fetched as it may sound, this is essentially what the primary care trusts are doing in denying IVF treatment for smokers.

It is telling that these fertility clinics do not require women to stop drinking alcohol as a condition for IVF treatment. Smoking is being singled out, I believe, because it is viewed as a socially unacceptable lifestyle decision.

It is truly scary to think that a medical procedure would be denied to individuals based on a judgment about what is an appropriate or socially acceptable lifestyle. When judgments about lifestyle enter the clinical decision-making arena, the door is opened to all kinds of unacceptable consequences, such as denying treatment to individuals based on their sexual orientation or the presence of a "suitable" partner.

The hallmark of the practice of medicine is that it is supposed to be non-judgmental. As physicians, we are to provide the treatment that is in the best interests of the patient, without casting judgment upon the individual's lifestyle choices. Sure, it is perfectly appropriate to inform our patients about the health impact of their lifestyle choices, but we are not to deny medical care or to make such care conditional upon our patients conforming their lifestyle to meet our desires.

There is one reasonable criterion for denying medical care (outside of absolute medical contraindications) and that is situations in which the behavior in question is the cause of the medical problem and the treatment in question is severely limited in availability. For example, if an alcoholic seeks a liver transplant, it is not unreasonable to deny treatment or place the individual much lower on the transplant list because the alcohol was the cause of the liver damage and there are a very limited number of livers available for transplant. Clearly, this is not the case with in-vitro fertilization.

The policy of denying IVF treatment to obese or overweight individuals, or making that treatment conditional upon them changing their lifestyle, is equally despicable. People should not be denied basic rights because of their weight. Neither should they be denied basic rights because of their lifestyle decisions.

There are a host of medical treatments that are not as successful when the patient continues to engage in certain behaviors. There is no question, for example, that drug treatment for type II diabetes is much more effective when the patient loses weight. There is no question that treatment for hypertension is more effective when the patient restricts his or her salt intake. Insulin treatment for diabetes is more effective when the patient modifies his or her diet.

What are we going to do? Start restricting treatment of diabetes and hypertension to patients who agree to alter their diet and lose weight?

I can see why smokers are feeling persecuted by society. Their rights are being taken away. This is a threat both to basic human rights and to the integrity of medicine. As physicians, we are supposed to provide treatment to all patients without casting judgment upon them.

Monday, August 11, 2008

The Truth is Revealed: Philip Morris Helped Draft FDA Tobacco Legislation and Campaign for Tobacco-Free Kids Negotiated Bill with Philip Morris

In a press release issued on July 30, Senator Mike Enzi (R-WY), ranking member of the Senate Health, Education, Labor and Pensions Committee, denounced the House passage of the proposed FDA tobacco legislation, which he called the "Marlboro Protection Act." He stated that Philip Morris helped draft the bill, which "coddles Big Tobacco while protecting the industry's best tools to recruit and addict your children to tobacco."

According to Senator Enzi, Philip Morris supports the bill "because it will not stop anyone from smoking." He charged the anti-smoking groups with becoming so desperate to do something that they have fallen for "this wolf in sheep's clothing."

Calling the bill a "peace treaty" with Philip Morris which maintains the status quo and protects tobacco company profits rather than create real change which would reduce tobacco use, Enzi vowed to object to the bill and fight it on the Senate floor.

According to the press release: "U.S. Senator Mike Enzi (R-WY), Ranking Member of the Senate Health, Education, Labor and Pensions (HELP) Committee, today denounced passage by the House of Representatives of a so-called tobacco regulation bill he said “coddles Big Tobacco while protecting the industry’s best tools to recruit and addict your children to tobacco.” “Trying to make cigarettes safer through a billion-dollar bureaucracy is a waste of time and money,” Enzi said. “The right approach is to get people to stop smoking, or better yet, never to start. Big Tobacco supports this bill because it will not stop anyone from smoking. “Tobacco is one of the biggest contributors to our nation’s growing health care crisis. We need to fight the war on tobacco head on, not sign a peace treaty with Philip Morris, a company that perpetuates and profits from the crisis. Big Tobacco supports this bill because they have a stake in maintaining the status quo. I don't. They’re happy with a bill that doesn’t stop people from smoking; I’m not. I want real change, so I’m going to fight this bill and its Big Tobacco backers by objecting to it in the Senate.”

"Enzi noted that the bill would allow Big Tobacco to continue its aggressive marketing to kids by exempting menthol from a list of banned flavorings. Menthol is used by Big Tobacco to target and lure young smokers, particularly African-Americans. “Last year, during HELP Committee consideration of this bill, I filed several amendments addressing the menthol issue. Folks need to understand this glaring loophole in the bill and how it puts our kids at risk. “We know that Big Tobacco targets children and teenagers – particularly young African-Americans – by aggressively marketing menthol cigarettes to them,” Enzi said. “So why does this bill ban almost every type of flavoring in tobacco products except menthol? Supporters of this bill claim they want to protect children and families from unscrupulous tobacco companies, but the only people this approach protects is Big Tobacco.” The bill would gut the authority that Congress has bestowed and staunchly defended for the FDA – the authority to remove health threats from the marketplace, Enzi maintained."

"Philip Morris, the nation’s largest cigarette maker, helped draft the bill. “Poison peddlers shouldn't get to decide how we fight the war against their deadly products. I urge my friends in the public health community not to become so desperate to do something about the tobacco problem in this country that they fall for this wolf in sheep’s clothing,” Enzi added. “Keep asking yourself: if this bill is good for Big Tobacco, how can it be good for public health? The fact is it can’t. This bill is nothing more than a ‘Marlboro Protection Act,’ written to keep Philip Morris at the top of the tobacco market.”

In an article last Thursday published in the Washington Post, Associated Press reporter Ricardo Alonso-Zaldivar confirmed that the FDA bill was the result of a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, during which the Campaign made public health compromises in order to appease the nation's largest tobacco company. According to the article: "The legislation represents a compromise among major anti-smoking groups and some tobacco companies, including Philip Morris USA, the nation's largest. The bill has the support of a majority of senators, but it's unclear whether it will become law this year because the Bush administration has threatened a veto."

In the article, Alonso-Zaldivar reveals yet another loophole in the legislation. This time, it is an escape clause which allows tobacco companies 21 months after passage of the legislation to introduce new tobacco products into the marketplace: "It would let tobacco companies begin selling a new product provided they file a report with the FDA showing why the new product is similar to an existing one. That could be done at any time in the 21 months after enactment of the legislation."

According to the article, former FDA tobacco office director Mitch Zeller said the loophole was a "gift" to the tobacco companies.

The Rest of the Story

The rest of the story is that it is now clear that the Campaign for Tobacco-Free Kids has been running a campaign of deception and dishonesty. Multiple independent sources, including a number of top-notch investigative reporters and a member of the Congress, have confirmed that the FDA tobacco legislation represents the results of a negotiation between the Campaign for Tobacco-Free Kids and Philip Morris, and that the key provisions of the bill which protect tobacco company interests are present specifically because the Campaign made compromises to appease Philip Morris, which helped to draft the bill.

It is simply inappropriate for the Campaign to have negotiated with Philip Morris, especially without the consent and involvement of the rest of the tobacco control community. It is appalling that the Campaign would have made compromises that harm the protection of the public's health at the expense of the protection of tobacco industry profits. It is even more appalling that the Campaign agreed to these compromises without the inclusion and representation of the remainder of the tobacco control community. And it is disgraceful that the Campaign is pushing for a bill that was drafted, in part, by the nation's leading tobacco company.

As bad as all that sounds, what's even worse is that the Campaign has been dishonest about the facts behind the legislation and that it continues to deceive the public about the nature of the negotiations that led to the bill. Worse still is the Campaign's continuing deception of its own constituents about the fact that Philip Morris supports the legislation and is lobbying to promote its passage.

In my view, Senator Enzi's analysis is right on the mark. This is pro-tobacco legislation and the Campaign for Tobacco-Free Kids and its partners are acting as pro-tobacco groups in promoting its passage.

Philip Morris supports the bill specifically because it will stop nobody from smoking. In fact, the bill precludes each of the potential interventions that the FDA could otherwise take that would make a dent in smoking rates.

Why anti-smoking groups would support a bill that is being championed by the nation's leading tobacco company is beyond me. Why these groups would support a bill with numerous truck-sized loopholes that sell out the public's health to protect Big Tobacco profits is also beyond me. However, my leading hypothesis is that these groups are so anxious to be able to say they got something accomplished - to be able to put a feather in their cap - that the act of passing a bill has completely overshadowed the actual substance of the bill.

In other words, the Campaign for Tobacco-Free Kids is so determined to put a feather in its cap that it is willing to exclude the rest of the tobacco control community from the process, deceive its own constituents and the public about that process, ally itself with Philip Morris, and sell out the public's health to protect tobacco company profits.

Friday, August 08, 2008

FDA Tobacco Legislation Would Be a Death Knell to Reduced Risk Products and Could Cost Countless Lives

According to an August 1 article in the Lexington Herald-Leader, health experts have concluded that the FDA tobacco legislation currently being considered by Congress would put an end to the prospect of the development of truly reduced risk tobacco products because it bans the introduction of such products unless a reduced population-based and individual-based risk can be demonstrated through long-term epidemiologic studies.

According to the article: “Legislation approved by the House on Wednesday to give the Food and Drug Administration regulatory control over tobacco products fails to address the massive market changes of the last decade, growers and others say. Cigarette makers no longer claim nicotine isn't addictive or that their products aren't harmful, and the bill doesn't take that into account. It also doesn't acknowledge scientific advances in the potential for "reduced-harm" products, an advocate said. Scott Ballin, health and tobacco consultant with the Alliance for Health, Economic and Agriculture Development, said lawmakers are ignoring these issues because they complicate the bill. ‘They want to see it in simple terms: Big Tobacco bad, FDA good,’ he said. The bill ‘raises the bar extremely high to ever allow lower-risk products onto the markets,’ Ballin said.”

“While the FDA could demand reduction or elimination of cancer-causing chemicals, manufacturers could not introduce or market lower-risk products without first proving such claims with decades-long population studies, according to a 2007 analysis by the Royal College of Physicians. That won't create much incentive to develop such products, Ballin said.”

The Rest of the Story

These are insightful and important observations about the likely impact of the proposed FDA tobacco legislation.

The key section of the bill is section 911, which sets out the criteria that need to be met before a reduced risk product can be introduced into the marketplace. According to this section:

"the Secretary shall approve an application for a modified risk tobacco product filed under this section only if the Secretary determines that the applicant has demonstrated that such product, as it is actually used by consumers, will--`(A) significantly reduce harm and the risk of tobacco-related disease to individual tobacco users; and `(B) benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

Section 911(g)(1)(A), the (A) clause above places an insurmountable obstacle in the path of approval of modified risk products, at least for a 10-20 year period (which is enough to remove any incentive for companies to pursue such products). In order to demonstrate that the product, as actually used by consumers, will significantly reduce the risk of tobacco-related disease to individual users, large-scale, long-term epidemiologic studies are necessary. Even ignoring the requirement under 911(g)(1)(B), the (B) clause above (which itself appears to introduce an insurmountable obstacle), the bill as currently written precludes any harm reduction approach to tobacco control both by making it impossible for such products to meet the conditions for approval and by eliminating any incentive (especially economic) to develop such products. Thus, the bill may have the exact opposite effect that many believe it should have. It protects the existing high-risk products on the market.

Section 911 creates a literal catch-22 for reduced risk products. In order to introduce such a product into the market, you need to demonstrate that on an individual basis, it will reduce the risk of tobacco-related disease. However, in order to make such a demonstration, one would need to introduce the product into the market and follow a large sample of smokers for a long period of time – at least 10 years, if not longer. Thus, there is realistically no way to get a reduced risk product onto the market.

This legislation is likely to result in increased, not decreased deaths from tobacco products, because it will make it virtually impossible to research, develop, introduce, and market new potentially less hazardous tobacco products. It essentially freezes the market as it is and entrenches existing high-risk products into the market. It puts an end to any meaningful possibility of harm reduction as a tobacco control approach.

In his book “Virtually Safe Cigarettes: Reviving an Opportunity Once Tragically Rejected” (IOS Press, 2000), Dr. Gio Batta Gori (who formerly directed the National Cancer Institute’s Smoking and Health Program) describes research into potential ways to make cigarettes less hazardous. A fair amount of research was conducted on this question by the Smoking and Health Program between 1968 and 1979, but it was disbanded due to a new government policy which rejected this harm reduction approach.

Dr. Gori argues that the research conducted under this program lays the foundation for the potential development of a less hazardous cigarette. Interestingly, the major basis for believing that such a technological achievement is possible is not the belief that by selectively reducing specific components in cigarette smoke and by reducing the nicotine levels in cigarettes, a safer product can be achieved (which is precisely the approach that the FDA legislation takes in its tobacco product standards section). Instead, the basic premise is that by presenting high levels of nicotine and low levels of tar – in other words, increasing the nicotine/tar ratio – overall exposure to tar will be reduced because smokers will need to inhale less to achieve the same inhalation dose of nicotine. A major problem with existing low-yield cigarettes is that smokers increase their consumption and deepen their inhalation to achieve adequate nicotine levels.

Interestingly, the “solution” to the reduced risk cigarette is exactly the opposite of the approach being suggested by most tobacco control advocates and groups, and adopted in the FDA legislation: the reduction of nicotine levels. Instead, the only feasible and effective approach – according to Dr. Gori – is to increase the nicotine levels in combination with a variety of modifications which lower the tar. Gori presents the results of animal testing, for example, which demonstrate that a high-nicotine, high-carbon monoxide cigarette might present the best framework for a reduced risk cigarette.

Unfortunately, the current FDA legislation will not allow the development of a less hazardous cigarette – as Dr. Gori envisions – because it completely removes any incentive for tobacco companies to research and develop such a product. The barrier to introducing a reduced risk product is so great that no company would waste the millions of dollars it would take to develop the product with no meaningful prospect of ever introducing the product into the marketplace.

In my view, the best way to facilitate the development of a reduced risk product is not to regulate cigarettes with insurmountable obstacles, but instead, to allow the free market process to run its natural course. There is such a huge economic incentive for companies to produce a reduced risk product – imagine the number of smokers who would be thrilled to try such a product – that a market competition, a race to be the first to develop a safer cigarette, would take place.

Under the proposed FDA legislation, this market competition cannot and will not take place. And it could cost countless lives.

Thursday, August 07, 2008

Tobacco-Free Kids Admits It is More Interested in Changing Advocates' Negative Opinions on FDA Bill than Listening toThem and Discussing the Issues

Globalink is an international tobacco control list-serve that is intended to function as a discussion forum by which those of us working in tobacco control can engage in discussion of important science and policy issues. One of the issues that has been a major focus of discussion is the proposed FDA tobacco legislation that is currently being considered by Congress.

In an email sent to some of its staff members, the Campaign for Tobacco-Free Kids revealed last week that it is more interested in using the Globalink discussion forum to spread its propaganda on the legislation than it is in actually listening to the widespread opinion of the international tobacco control community and engaging in a discussion of the merits of the legislation.

According to the email:

"Globalink is dominated by the naysayers on our FDA bill - thus the only articles that have gotten posted are the most negative. Could I ask that we do a better job (quickly) of beginning to be sure that the positive articles get posted as well. It doesn't impact the vote in Congress but it certainly impacts opinion within the international tobacco control community."

The Rest of the Story

From the beginning, the Campaign for Tobacco-Free Kids has shown no interest in engaging in a discussion with the rest of the tobacco control community on the merits of the FDA tobacco legislation. Instead, the Campaign has run a long campaign of deception, dishonesty, and propaganda intended to jam the legislation down the throats of the tobacco control community, despite the widespread opposition to the approach taken by the bill.

This email confirms that the Campaign continues to have no interest in engaging the tobacco control community in a discussion of the merits of the legislation and no interest in considering the widespread opinion of the tobacco control community. Instead, the Campaign is committed to its pre-determined messianic mission of saving the world through the FDA legislation that it negotiated with Philip Morris.

Of course, as the widespread opinion of the "naysayers" reveals, the rest of the tobacco control community is not convinced that this FDA bill will save the world. Instead, there is widespread agreement that this bill represents little more than a huge favor to Philip Morris. The bill, it is recognized, is essentially the "Marlboro Preservation Act." It protects the financial profits of the nation's largest tobacco company at the expense of the public's health. It provides unprecedented special protections to Big Tobacco. It ends the prospect for harm reduction in tobacco control. It institutionalizes the defrauding of the American consumer. It ends any liability threat for the tobacco industry. And it will almost certainly increase smoking prevalence by deceiving smokers into thinking that cigarettes have been made safer.

The fact that the Campaign for Tobacco-Free Kids refers to the worldwide community of tobacco activists - which largely opposes the legislation - as "naysayers" is extremely revealing. A naysayer is defined not as someone who has a differing opinion, but as someone who has "an aggressively negative attitude." In other words, a naysayer is an obstructionist - someone who is merely obstructing an action that someone else wants to take.

Thus, the Campaign reveals here that it views the widespread negative opinion of many advocates about the FDA legislation not as legitimate, evidence-based opposition to the proposed policy, but as annoying, destructive obstruction to its own favored policy.

This is how the Campaign apparently views anyone who disagrees with its opinion: as an obstructionist.

It is clear to me that the Campaign for Tobacco-Free Kids has no interest in considering anyone else's opinion about the legislation and no interest in actually engaging in a discussion about the merits (or lack thereof) of the legislation.

The Campaign made a deal with Philip Morris and it has no interest in re-considering the merits of that agreement, no matter how much dissent there is in the tobacco control community.

This is not the way a leadership organization in public health should behave.

Frankly, the Campaign for Tobacco-Free Kids is operating purely as a political propaganda machine, not as a legitimate public health organization that actually has an interest in considering the views of its constituents.

The Campaign's actions remind me of the anti-smoking commercial in which a crying, coughing baby is heard over a baby monitor and then a tobacco industry executive turns off the monitor because he isn't interested in hearing the effects of secondhand smoke. Essentially, this is what the Campaign is doing. They are turning off the sound to the rest of the tobacco control movement. They simply don't want to hear the opposition.

The Campaign has already shown a disdain and disrespect for the rest of the tobacco control community by consistently trying to deceive them about the legislation. Now, it has added to that disrespect by acknowledging that it has no interest in engaging in a discussion, but merely wants to use our discussion forum to promote its own agenda -- an agenda, which I might add, is perceived by many in tobacco control as being decidedly pro-tobacco.

Wednesday, August 06, 2008

Campaign for Tobacco-Free Kids Still Hiding the Truth About FDA Tobacco Legislation; Honesty is Just Not Possible from this Organization

In an email sent to its constituents this morning, the Campaign for Tobacco-Free Kids once again deceived them by distorting the truth. In the email, the Campaign implied that Big Tobacco (which includes Philip Morris) is opposed to the FDA tobacco legislation and is using its massive lobbying resources to oppose the bill. This is dishonest, as the truth is that Philip Morris strongly supports the bill and is using its massive lobbying resources to promote passage of the legislation.

The email states: "As you know, last Wednesday the House of Representatives passed H.R. 1108 with overwhelming support. Your Representative, X, voted YES to grant the FDA authority to regulate tobacco products! Click here to say thank you! Tobacco companies spent a lot of time and money trying to persuade members of Congress to protect their profits, but Representative X had the courage to do what was right."

The Rest of the Story

The Campaign for Tobacco-Free Kids is being dishonest, and it knows it. It is not truthful to state that the tobacco companies spent a lot of time and money trying to persuade members of Congress to protect their profits by voting against the legislation. The truth is that Philip Morris - the largest tobacco company by far (it holds half of all domestic cigarette market share) - spent a lot of time and money trying to persuade members of Congress to support the legislation.

Regardless of how one feels about the merits of the FDA tobacco legislation, I would hope that we could all agree that public health groups should not be telling untruths to the public in order to promote their position on the legislation.

Ironically, one of the primary purposes of the legislation - as acknowledged by the Campaign itself - is to end the dishonesty and deception by the tobacco companies. The tactic that the Campaign is using to end this dishonesty and deception is to run a campaign of dishonesty and deception.

The unethical behavior of the Campaign for Tobacco-Free Kids just never ceases. I'm beginning to think that this organization is not capable of being honest.

It's a shame, because it really taints the honesty and integrity of the entire tobacco control movement.

Tuesday, August 05, 2008

Jacob Sullum on Scottish Smoking Ban and Heart Attack Study

As usual, Jacob Sullum has an insightful commentary on the Scottish smoking ban and heart attack study. He also comments on the Wales study and correctly points out that many locations that adopt smoking bans are invariably going to see declines in heart attacks in subsequent months or years. You can't focus only on those locations. What is needed is a systematic study of multiple locations (like that conducted by Dave Kuneman and Michael McFadden, which found no significant immediate effect of smoking bans on heart attacks).

No Reduction in Heart Attacks in Wales During First Nine Months Following Smoking Ban; Anti-Smoking Groups Cherry-picked Data to Try to Show an Effect

(Note: This post draws upon an analysis of heart attack data by Christopher Snowdon over at Velvet Glove Iron Fist. The original piece upon which this post is based can be found here).

Data from Wales released by Christopher Snowdon yesterday reveal that there was no reduction in hospital admissions for myocardial infarction (heart attacks) during the first 9 months after implementation of the smoking ban throughout Wales. Snowdon obtained monthly data on heart attack admissions from all Welsh hospitals for the years 2006 and 2007. The smoking ban went into effect on April 2, 2007.

There were 4,199 heart attack admissions in 2006 and 4,155 in 2007. Thus, there was essentially no change in heart attacks between these two years. In contrast, there was a 6.3% decline in heart attack admissions from 2005 to 2006 and a 10.3% decline in admissions from 2004 to 2005, according to Snowdon.

When analyzing the data by month, Snowdon found that comparing 2007 to 2006, there was an increase in heart attack admissions during the first five months after the smoking ban (April through August) and a decline in heart attack admissions during the next four months (September through December).

The Rest of the Story

Although it seems quite clear that the data show that the smoking ban in Wales was not associated with a decline in heart attack admissions during the first 9 months it was in effect (and if anything, the decline in heart attacks came to a halt), this did not stop anti-smoking groups from claiming that the smoking ban in Wales led to a reduction in heart attacks.

How did the anti-smoking groups pull off this miraculous feat, given that the data so clearly indicate no reduction in heart attacks?

They used a technique known as cherry-picking. By citing data for the few specific months in which there was a decline in heart attacks from 2006 to 2007, they purported to show that the smoking ban had resulted in a reduction in heart attacks.

In an article published this past June in The Daily Post, Action on Smoking and Health (UK) was quoted as saying: "It seems likely that the drop in hospital admissions for heart attacks is linked to the implementation of the smoking ban. It shows just how quickly the benefits can be felt."

What data were ASH referring to in making this pronouncement? Clearly, it was not the data for the first nine months after implementation of the smoking ban (April through December).

It turns out that ASH was citing data cherry-picked for the months October through December. Compared to the corresponding period in 2006, this three-month period in 2007 saw a 13% decline in heart attacks.

Had ASH examined data for the full period of April through December (which was obviously available at the time of its pronouncement), it could have come to no conclusion other than that there was no decline in heart attacks associated with the first 9 months of the smoking ban.

In an article published in Wales Online, the British Heart Foundation is quoted as stating: "These new statistics are very significant, and indicate the smoking ban has had a beneficial effect on the number of heart attacks quicker than many people predicted."

What "new statistics" is the British Heart Foundation referring to which purportedly demonstrate that the smoking ban in Wales resulted in a reduction in heart attacks?

Once again, it turns out that the British Heart Foundation is referring to the cherry-picked data from October through December of 2007 which reveal a 13% decline in heart attacks during these months compared to the corresponding period in 2006. But a broader look, which includes all 9 months following the smoking ban, confirms that there actually was no change in heart attack admissions. Apparently, these three months were cherry-picked in order to show an effect.

Implications of the Rest of the Story

There are three important implications to this story.

First, these data cast doubt on the conclusion of studies - such as the report from Scotland published last week - that smoking bans result in a dramatic, immediate drop in heart attacks. There seems little doubt that such a decline was not observed in Wales, a result which seems inconsistent with the conclusion of these other studies.

Second, it will be interesting to see whether anti-smoking groups acknowledge these data or ignore them. Are anti-smoking groups interested in the truth, or are they only interested in results which support their pre-determined conclusions?

Third, this story demonstrates that anti-smoking groups are not relying on solid science to draw their conclusions about the effects of smoking bans on heart attacks. They are willing to rely on cherry-picking of a fraction of the relevant data to draw their conclusions and make their pronouncements to the public.

It's quite clear that anti-smoking groups are prepared to rally around and tout the results of any study that draws favorable conclusions, regardless of the quality of the science. But what's most interesting to me is that we in tobacco control have denounced smoking ban opponents for relying on studies with exactly the same tactics - cherry-picking of data - in order to "demonstrate" that smoking bans result in a decline in restaurant sales. How can we on the one hand denounce studies that do not consider all relevant data and come to unfavorable conclusions and then on the other hand tout the results of studies using the same methodology which come to favorable conclusions?

Will the British Heart Foundation and ASH now retract their earlier statements and apologize to the public for drawing and disseminating premature conclusions? I doubt it. This is why it is essential that we get it right the first time around.

But when your sole criterion for scientific quality is whether the study results support your pre-determined conclusion, it is going to be difficult to get it right the first time, or any time.

Monday, August 04, 2008

IN MY VIEW: Another Reason Why Conclusion of Scottish Smoking Ban Study is Invalid - Effect May Have Been Due to Diagnostic and Treatment Changes

I have already explained why I think the conclusion of the study which reported a 17% decline in acute coronary syndrome admissions in 9 Scottish hospitals following implementation of the national smoking ban is invalid. In that previous post, I focused on the failure of the study to establish a valid baseline of acute coronary syndrome admission in these 9 hospitals, and therefore, its inability to be able to comment on whether the observed 17% reduction is something different from that seen in the past.

The study reported a decline in acute coronary syndrome admissions from 3235 to 2684, comparing the ten-month period preceding the smoking ban with the corresponding period after the smoking ban. Now suppose that the number of acute coronary syndrome admissions in the corresponding period of the previous year was about 3300. Then, it would be clear that this 17% reduction represents something very different - there was basically no decline in the previous year.

However, suppose the number of acute coronary syndrome admissions in the previous year was about 3800. Then, the observed 17% reduction associated with the smoking ban would no longer be so impressive, since there was a 14% reduction during the previous year.

Well - which of these scenarios is the true one? The validity of the study conclusions rests entirely on the answer.

Unfortunately, the answer is unknown. The study does not report the number of admissions for acute coronary syndrome - using the same diagnostic criterion of an elevated cardiac troponin level - during the previous year. Thus, there is no way to know whether the 17% reduction is something new and different, or whether there already was a trend of sharply declining admissions.

As a result, the study findings simply are not enough to support the study conclusions. The research can surely conclude that there was a sharp decline in acute coronary syndrome admissions associated with the smoking ban, but the research cannot conclude that the decline was attributable to the smoking ban.

Here, I present another reason why the study conclusion is not valid: there is a very plausible alternative explanation for the observed decline in acute coronary syndrome admissions.

The Rest of the Story

What seems to have gone largely unnoticed in the article and the news coverage around it is the fact that another major heart disease intervention took place in these 9 Scottish hospitals around the time of the smoking ban: these hospitals used a relatively new system for diagnosing heart disease -- cardiac troponin assays.

Previously, the diagnosis of unstable angina and silent heart attacks (those without any symptoms) was problematic because of the lack of a sensitive laboratory test. Creatine kinase (CK) - the test previously used - is not sensitive enough to be able to pick up all cases of unstable angina and it may not pick up silent heart attacks that occurred in the recent past. However, cardiac troponin is a much more sensitive test, and it is able both to pick up very small areas of myocardial ischemic injury as well as injury that occurred in the recent past. For this reason, the use of cardiac troponin brings with it the ability to diagnose many more cases of severe cardiac disease that might not have been recognized in the past.

When physicians know about the presence of ischemic injury, they can take a more aggressive treatment approach. Ultimately, this is expected to reduce the incidence of future heart attacks in these patients.

This is all explained rather nicely in this article on Emax Health:

"Patients who test positive for the presence of a specific biochemical marker of heart cell death in their blood but who do not exhibit other risk factors for future heart attack should be treated as higher risk patients, according to a new analysis by cardiologists at Duke University Medical Center.

The researchers found that troponin, a protein that is released into the bloodstream as heart muscle cells die, can be a reliable indicator of future risk even when other traditional measures of heart health are negative. This is important, the researchers say, in light of the recent recasting of the definition of heart attack by the major cardiology organizations to place more emphasis on the results of troponin testing, in addition to the presence of chest pain and electrocardiogram abnormalities.

When a patient comes to the emergency room as a possible heart attack victim, physicians typically measure the heart's electrical activity (EKG) and also look for chemicals in the blood that might indicate if heart muscle is damaged or dead. For years, they have measured the levels of creatine kinase-MB (CK-MB) and, more recently, they also have been testing for troponin. Because the test for troponin can detect even small amounts of heart muscle damage, patients previously testing positive for troponin but negative for CK-MB were not always treated as being at high-risk.

'Our analysis shows that patients who test positive for troponin but not for CK-MB should still be treated as if they tested positive for both,' said Duke cardiology fellow Dr. Sunil Rao. 'This is important because in the past, these patients would usually not be treated aggressively.'"

An article by Drs. Brian Go and H. Vernon Anderson nicely explains how the use of cardiac troponin results in the earlier identification of patients with unstable angina, which can lead to more aggressive treatment. As these cardiologists explain, an elevation of troponin is a risk factor for future heart attacks. Thus, these represent patients who previously may not have been treated as aggressively and therefore would be at high risk for heart attack. With more aggressive treatment, heart attack risk can be reduced, at least in the short-term.

The bottom line is that a plausible explanation for the observed 17% reduction in acute coronary syndrome admissions in the 9 Scottish hospitals in the study is that the intervention (that is, the use of cardiac troponin testing for all patients with chest pain or suspected heart disease), rather than the smoking ban, caused this reduction.

Without knowing the effect on acute coronary syndrome admissions of using this new diagnostic system, it is impossible to conclude that the 17% reduction was due to the smoking ban, rather than to this important diagnostic and therapeutic change.

It is not clear exactly when the intervention was implemented in these 9 hospitals. Presumably, it was not in place in all 9 hospitals until 10 months prior to the smoking ban - this is presumably why the researchers included only data for this 10 month period in the study. If the intervention was in place in all 9 hospitals well prior to that, then the obvious question would become: why does the paper not present the data on admissions for acute coronary syndrome during the entire period in which the intervention was in place in these hospitals?

It is important to emphasize that I am not questioning here the validity of the study's conclusion that there was a 17% decline in acute coronary syndrome admissions. What I am questioning is the attribution of that decline - in its entirety - to the smoking ban, rather than to improved diagnosis and treatment, which is precisely the reason that the cardiac troponin system was put in place in these hospitals.