Enstrom Cleared of Scientific Misconduct Charges; American Cancer Society Owes Him An Apology

After an internal investigation, the University of California has cleared UCLA professor and epidemiologist Dr. James Enstrom of all charges of scientific misconduct - charges that were leveled by the American Cancer Society.

According to an article in a recent issue of Nature, the American Cancer Society (ACS) had accused Dr. Enstrom of scientific misconduct in his role in a 2003 British Medical Journal study which questioned the link between secondhand smoke and lung cancer among nonsmokers.

That article - which used data from the ACS Cancer Prevention Study and found no significant increase in lung cancer risk associated with exposure to spousal smoking - has received massive publicity, serving as the focal point for a campaign to eliminate tobacco industry funding of research at the University of California.

According to the article, the accusation from the ACS prompted an internal University investigation to determine whether any scientific misconduct occurred:

"The latest round of debate began last autumn when the chief executive of the American Cancer Society, John Seffrin, wrote a letter to the University of California's board of regents arguing that tobacco funding should be banned. In the 12 October letter, Seffrin argued that tobacco-funded front groups "publicized misleading results" while giving "the false implication" that the society had endorsed the study. He cited Enstrom's BMJ article in particular, alleging that Enstrom "ignored" complaints of "fundamental methodological problems". ... Wyatt Hume, provost at the University of California's president's office, wrote to Seffrin saying that the university "takes allegations of scientific misconduct extremely seriously". If there is "specific information in support of an allegation of scientific misconduct against Enstrom", he wrote, he would relay it to officials at the Los Angeles campus so that they "can pursue the matter further". Shortly after, officials at the cancer society sent a seven-page list of what they cited as issues with the BMJ article."

Both authors of the study -- Dr. Enstrom and Dr. Geoffrey Kabat, formerly of SUNY Stony Brook, vehemently denied any scientific misconduct:

"In an interview, Enstrom acknowledged receiving the various letters and corresponding with the University of California's authorities. "I am working on this with regents' approval," he said. "I am being allowed to defend myself by the appropriate people." He "absolutely" denies any misconduct in the study. And Kabat objects to the university's regent policies being based "on allegations motivated by a political agenda and unsupported by any facts"."

The internal investigation failed to find any evidence of scientific misconduct. Dr. Enstrom was officially cleared in a March 22 letter from UC Provost and Executive Vice President for Academic and Health Affairs Wyatt R. Hume, who wrote:

"Chancellor Abrams initiated a thorough review of the materials forwarded by Dr. Thun. He asked two senior campus officials, both of them scientists, to independently review the materials. Both officials independently reached the conclusion that these materials provide no evidence of scientific misconduct."

"The materials Dr. Thun provided reflect the robust debate in the scientific literature about the research methodologies used by Dr. Enstrom in conducting the work that was the basis for the 2003 article published in the British Medical Journal. Disagreements regarding research methodology, and disputes about the soundness of scientific conclusions do not, however, constitute scientific misconduct. There is room for vehement and heartfelt disagreement about the soundness of particular scientific analysis and conclusions, and the scientific and academic community has well-established mechanisms for judging which results are ultimately deemed to withstand lose and sustained scientific scrutiny."

The Rest of the Story

As I stated in my commentary on this issue, the presence of deficiencies in research (taking the ACS position to be true) and the publication of results that do not accord with the views of others does not represent scientific misconduct. Taking money from the tobacco companies is not scientific misconduct. While the ACS has every right to criticize the methodology of the study and dispute its findings and conclusions, it is inappropriate to attack the researcher - and to charge him with scientific misconduct - rather than to focus on the research.

In this case, there was no scientific misconduct. Since Dr. Enstrom has now been cleared of these charges, I believe that the American Cancer Society owes him an apology.

In the academic community, scientific misconduct charges are taken very seriously and these charges could literally ruin someone's career. Thus, if a group ends up falsely bringing scientific misconduct charges against a researcher, they certainly owe him an apology for making what turns out to be false charges that could have ruined his career.

What the American Cancer Society has done amounts to character assassination. If they want to criticize the research itself, point out methodologic flaws, or attack the tobacco companies for using this kind of research in a campaign to undermine public health messages about the harms of smoking or secondhand smoke, then that's fine. They have every right to do that. But to issue the attack on the individual researcher and attempt to denigrate the character of that individual by making what amount to false allegations of scientific misconduct is not appropriate.

American Lung Association Claims that 30 Minutes of Secondhand Smoke Can Kill People Without Existing Heart Disease

In a contributed article published in The Daily Times (Salisbury, MD), the American Lung Association of Maryland cites the Centers for Disease Control and Prevention (CDC) in claiming that a mere 30 minutes of secondhand smoke exposure can cause death in a nonsmoker who is merely at risk for, but does not have, severe existing heart disease. The Lung Association also claims that secondhand smoke causes emphysema in nonsmokers.

According to the article: "The Centers for Disease Control and Prevention have reported that as little as 30 minutes' exposure to secondhand smoke can have a serious and even lethal effect for people with heart disease or at risk for heart disease."

Also according to the article: "Secondhand smoke causes heart disease, lung cancer, asthma, emphysema and stroke." (emphasis is mine)

The Rest of the Story

While it may not immediately strike readers as being completely fallacious because it is hidden behind the authority of the CDC, it is simply untrue that a mere 30 minutes of secondhand smoke can cause death from cardiac causes in a nonsmoker who is at risk for heart disease, but does not actually have severe pre-existing coronary artery stenosis (i.e., very severe heart disease).

If you don't have heart disease to begin with, being exposed to secondhand smoke for 30 minutes cannot possibly cause heart disease; thus, it cannot kill you from cardiac causes. It takes many years for heart disease to develop. Thus, a mere 30 minutes of exposure cannot plausibly cause heart disease to occur. A person without pre-existing heart disease who is exposed to secondhand smoke for 30 minutes does not need to worry about having a heart attack or dying from any heart-related ailment.

The mere fact that a person is at risk of heart disease - meaning that he or she has risk factors such as being male, having high cholesterol, having a family history of heart disease, or having high blood pressure or diabetes - does not in any way make a person susceptible to having a heart attack from 30 minutes of secondhand smoke exposure. The only thing that could make one susceptible, at least theoretically, is having severe coronary artery disease to begin with.

There is evidence that secondhand smoke exposure can aggravate angina in patients who have existing heart disease. Thus, it is at least possible that a brief exposure to secondhand smoke could trigger a heart attack in someone with severe heart disease. But it would be impossible for a brief exposure to trigger a heart attack in someone without severe heart disease, even if that individual had a myriad of risk factors for heart disease.

The statement by the American Lung Association clearly implies that a person who is merely at risk of heart disease, but does not have heart disease, could die from a heart attack due to 30 minutes of secondhand smoke exposure. After all, the statement says that such an exposure can be lethal to someone "with heart disease OR at risk for heart disease." If the statement was intended merely to convey the idea that 30 minutes of secondhand smoke could trigger a fatal heart attack in someone with heart disease, then it should not have included the clause "OR at risk for heart disease."

It appears to me that the inclusion of that clause is intended to scare healthy people (albeit those with heart disease risk factors) that they could die from merely a brief exposure to secondhand smoke.

To me, that represents scare tactics. Inappropriate scare tactics, because the claim is untrue. Why would we want to scare healthy people into thinking that they could drop dead from merely a 30 minute exposure to secondhand smoke? I don't know, but one possibility is that scaring people into believing the risk is that great might increase support for the ever-expanding smoke-free agenda, which now aims - apparently - to ban smoking not only indoors but just about everywhere outdoors as well. Even if the intention were to scare people into supporting workplace smoking bans (which I support), I don't think it is appropriate to use false or misleading information to advance even a well-justified policy.

One might argue that the American Lung Association is not making the claim, but is merely repeating a claim that was made by CDC. This argument fails, however, because to the best of my knowledge, the CDC never claimed that 30 minutes of secondhand smoke exposure can cause a fatal heart attack in an otherwise healthy nonsmoker. What the CDC stated is that people who have heart disease or are at risk for heart disease should avoid secondhand smoke exposure given what CDC sees as its potential to trigger a heart attack in someone with heart disease. That makes sense because a person with risk factors for heart disease could have heart disease, but not know about it. But such a warning is very different from implying that a person who has risk factors for heart disease, but does not have heart disease, can have a heart attack from 30 minutes in a smoky room.

One might also argue that the American Lung Association is referring not to death from a heart attack or heart disease, but from asthma. A brief secondhand smoke exposure could potentially trigger a fatal asthma attack. However, I believe this argument fails because from the context of the statement, it is quite clear that the Lung Association is not talking about asthma risk. The CDC statement that is referred to was delivered in the specific context of a warning about the cardiovascular health effects of secondhand smoke. Moreover, if that was the intention of the statement, should it not have stated that a 30 minute exposure could be lethal to those who have asthma?

And for that matter, why 30 minutes? A 5-minute exposure could potentially trigger an asthma attack. The 30 minute figure comes from the Otsuka et al. study, which found that 30 minutes of heavy exposure to secondhand smoke causes endothelial dysfunction in healthy nonsmokers. So it seems clear that this claim is referring to death from heart disease, rather than asthma.

I have already explained why I think it is not appropriate to claim that secondhand smoke causes emphysema in nonsmokers, so I will not repeat that argument here. Suffice it to say that neither of the two recent, comprehensive reports on the health effects of secondhand smoke (those issued by the Surgeon General and by the California EPA) concluded that secondhand smoke causes emphysema.

Readers of this blog will know that I fully support workplace smoking bans as well as bans on smoking in outdoor areas where people cannot easily avoid exposure to secondhand smoke. They will also know that I believe chronic exposure to secondhand smoke can cause heart disease. But it is just not true that brief exposure to secondhand smoke can cause a fatal heart attack in a person who doesn't already have severe coronary artery disease.

I think it's wrong to make such a claim. Not only is it untrue and unsupported by the science, but it also flies in the face of common sense and even a meager understanding of medicine. It is deceptive. It also scares people unnecessarily. And perhaps worst of all, it undermines people's appreciation of the hazards of active smoking. If a mere 30 minutes of secondhand smoke exposure can cause a nonsmoker to drop dead from a heart attack, then why should active smokers be so concerned about their own risk? It makes it sound like active smoking is no worse than a very brief exposure to secondhand smoke. In fact, it makes it sound much worse. I don't recall any public health organization warning smokers that a mere 30 minutes of smoking could cause them to drop dead from a heart attack.

Finally, I should make it clear that I am not necessarily putting all the blame on the American Lung Association. I think that the CDC may be partly responsible, because apparently it gave the impression that brief secondhand smoke exposure could be fatal to healthy nonsmokers who had risk factors for heart disease. I don't know that the CDC was clear enough in its article on this subject to avoid people misinterpreting its conclusions. I do sense that there was a little bit of an attempt at sensationalism to make that article more startling (see: Pechacek TF, Babb S. Commentary: How acute and reversible are the cardiovascular risks of secondhand smoke? BMJ 2004; 328:980-983).

That article begins as follows: "Could eating in a smoky restaurant precipitate an acute myocardial infarction in a non-smoker? As unlikely as this sounds, a growing body of scientific data suggests that this is possible."

I think that introduction could be viewed as overly sensationalistic because it does seem to imply that a brief smoke exposure could trigger a heart attack in a healthy nonsmoker. It does not qualify the situation by making it clear that it refers only to a nonsmoker with severe pre-existing coronary artery disease.

If you go on and read the rest of the article, you'll see that the authors never actually state that acute secondhand smoke exposure poses a heart attack risk to anyone other than nonsmokers with existing heart disease. The CDC does not state that a brief exposure to secondhand smoke can cause a heart attack in someone without severe heart disease to begin with. But I do see how someone could get that impression, especially from the way the introduction reads, without any qualification of who is potentially at risk of dropping dead after 30 minutes in a smoky restaurant.

I think it would be very important and helpful for the CDC to explicitly clarify the conclusions in this article, in order to avoid the kind of misrepresentation of the science that is becoming more and more widespread. It would only help the tobacco control movement, not hurt it, because it would help avoid fallacious claims like those of the American Lung Association which threaten to harm the credibility and undermine the perceived integrity and ethical standards of the entire tobacco control movement.

New Study Concludes that Removal of All Known Carcinogens from Cigarettes Would Not Necessarily Reduce Cancer Risk; Exposes Folly of Proposed FDA Bill

An article published in the March issue of Cancer Epidemiology, Biomarkers & Prevention concludes that even if all currently known and measured carcinogens in tobacco smoke were completely removed, there would be little reason to believe that there would be any observable reduction in smoking-related cancers (see: Pankow JF, Watanabe KH, Toccalino PL, Luo W, Austin DF. Calculated cancer risks for conventional and 'potentially reduced exposure product' cigarettes. Cancer Epidemiology, Biomarkers & Prevention 2007; 16:584-592).

Using data on per-cigarette smoke yields of a large number of known carcinogens and the known cancer risks posed by those carcinogens, the researchers assessed the lung cancer risk posed by regular, light, ultralight, and a number of PREP (potentially reduced exposure product) cigarettes using a mathematical model. They found that neither light, ultralight, or any available PREP was predicted to offer any substantial reduction in cancer.

Moreover, the researchers found that knowledge of the yields of all currently known lung carcinogens in cigarettes was able to account for less than 4% of the observed lung cancer risk of cigarette smoking. This inability to account for observed cancer risk means, they conclude, that even if all currently known and measured carcinogens were completely removed from cigarette smoke, there would be no reason to believe that actual human cancer risk would be decreased.

The authors conclude: "The current inability to account for the observed health risks of smoking based on existing data indicates that current expressed/implied marketing promises of reduced harm from PREPs are unverified: there is little reason to be confident that total removal of the currently measured human lung carcinogens would reduce the incidence of lung cancer among smokers by any noticeable amount."

"Expressed another way, even if a PREP design were to succeed in removing all currently measured known human lung carcinogens from cigarette smoke (and even perhaps all other currently measured carcinogens), there would be little reason to be confident that such removal would by itself lead to any observable reduction in smoking related lung cancer."

In perhaps easier to understand terms, Dr. Pankow summarized his key conclusion as follows: "Since we can't account for the risks from smoking conventional cigarettes, it does not accomplish much to just remove a few of the known toxins. An analogy might be someone who abuses alcohol by drinking 10 beers a day, but says they are going to cut down to 9."

And Dr. Pamela Clark, a senior research scientist at the Battelle Centers for Public Health Research and Evaluation, explained that "Dr. Pankow's study shows that simply lowering the levels of a few known harmful compounds from tobacco smoke may not significantly reduce the risks of smoking."

The Rest of the Story

This is a critically important study and it has vital implications for the consideration of the proposed FDA tobacco legislation. Specifically, the study demonstrates the complete folly of the proposed regulatory approach and the ridiculous nature of the claims being made by the Campaign for Tobacco-Free Kids, American Medical Association, and other organizations that the legislation is going to "save countless lives."

Quite the opposite. This research demonstrates that a regulatory approach based on asking the FDA to require the reduction or elimination of various constituents of cigarette smoke is an absurd approach that offers no known or expected health benefits. Any claim that this legislation is going to save lives by requiring safer cigarettes is completely undocumented and unsupported.

As the research shows, there is no reason to believe that requiring the reduction or elimination of even a large number of the known harmful and carcinogenic constituents in tobacco smoke would result in any reduction in the risks of smoking.

In some ways, I find that the health groups are making claims that are more baseless and deceptive than anything the tobacco companies have stated about the risks of low-yield cigarette products. The cigarette companies have certainly deceived the public by implying that low-yield products offer a health advantage over conventional products. But they have never gone so far as to claim that they would save countless lives - a claim being made about the FDA legislation by the Campaign for Tobacco-Free Kids. Nor have they pinned a specific number on the lives saved, something the American Medical Association has done by suggesting that the FDA legislation will save millions of lives.

I don't really understand why it is that if the tobacco companies make such baseless, undocumented, and deceptive claims, it represents fraud and engenders attacks on the companies for their unscrupulous actions, but when we as anti-smoking groups make even more baseless, undocumented, and deceptive claims, it is now magically acceptable because we are working towards an allegedly noble cause.

I am quite sure that this new research is going to cause the Senate Health, Education, Labor, and Pensions (HELP) Committee to take serious pause before rushing forward with what now has been documented to be a flawed regulatory approach that is going to deceive the public into believing that cigarettes are safer.

As I've argued before, the FDA tobacco legislation is really a mechanism to transfer the deception about low-yield cigarettes from the tobacco companies to the government. It takes the tobacco companies off the hook, allowing them to smile all the way to the bank as the very low-yield health claims they have been found guilty of making are now made by the federal government. And to boot, the companies no longer will have to face a liability risk for making such undocumented claims. The government is going to be doing all the dirty work for them. What a brilliant scheme!

As I argued in the statement I submitted to the Senate HELP Committee, we simply do not know what constituents in tobacco smoke, and in what combination and quantities, are responsible for the observed human diseases caused by cigarette smoking. Thus, there is absolutely no evidence to support the bill supporters' contention that by reducing or eliminating specific constituents of the smoke, we will produce a safer cigarette that will save countless lives, millions of lives, or even any lives.

When I submitted that statement, this research was not yet available, but it appears to back up my argument. In fact, it goes further than I did, because it concludes that even if every known carcinogen in cigarettes were removed, we'd be in no position to be confident that the actual cancer risk of smoking had been reduced. And you can be sure that the FDA is not going to enact regulations that require the removal of every known carcinogen from cigarettes!

Realistically, the best the FDA could do under the proposed legislation would be to require the reduction or elimination of a number of specific tobacco smoke constituents. This research demonstrates that there is no basis to believe that such an approach would result in a measurable decline in smoking-related mortality.

While I acknowledge the right of supporters of this legislation to promote its passage in the absence of actual scientific research that would justify the regulatory approach taken by the bill, I do not believe that the supporters of the bill have any right to misrepresent the science and to deceive policy makers and the public into thinking that the bill is surely going to save millions of lives when there is no basis for confidently knowing that this is going to be the case. In fact, there is strong evidence that any such contention is baseless and unsupportable.

In contrast, there is strong reason to believe that while the bill would do little to protect the public's health by ensuring that cigarettes are made to be a safer product, it would do great harm by giving the public the impression that cigarettes are safer by virtue of FDA regulation and an FDA stamp of approval for the product.

The rest of the story is that in their zeal to put a feather in their cap by being able to claim that they achieved FDA regulation of tobacco products, the major anti-smoking and health groups are actually deceiving the public about the potential health benefits of lower-yield cigarettes to a greater degree than anything the tobacco companies have ever done.

Frankly, the tobacco companies wouldn't even dream of deceiving the public to this extent. They remained somewhat subtle in their deception, by merely implying that there is some health value to reduced yield cigarettes. I can only imagine the scorn and ridicule the companies would have received had they claimed that their lower-yield cigarettes were going to save countless lives.

We Who Labor Here Seek Only Truth: A Tribute to Frank and Margaret Amodeo

I first met Frank and Margaret Amodeo in Courtroom 6-1 in the Miami-Dade County federal district court in Miami. I was an expert witness in the Engle case, a class action lawsuit filed on behalf of all Florida smokers, seeking damages for the harms caused to them from tobacco products, based in part on the contention that the tobacco companies enticed them to start smoking as kids through their advertising practices, addicted them to cigarettes by carefully controlling the nicotine levels, undermined public health messages about the hazards of smoking, and lied to or misled the public about the addictiveness and toxicity of cigarettes.

I knew quite a bit about Frank before I met him. After all, I had read the transcript of his deposition. So I knew that Frank was a courageous cancer survivor who, as one of three class representatives whose cases were being heard in phase II of the Engle trial, was leading the battle for justice against the tobacco companies on behalf of all smokers and on behalf of the entire public.

What I didn't know when I first entered the courtroom, but what I have learned ever since, is what wonderful, amazing, courageous, and heroic people Frank and Margaret Amodeo are. Wonderful in their love and appreciation of life, children, family, and all the little things that make each day special. Amazing in their tenacity and resilience in battling Frank's cancer and his resulting disabilities. Courageous not only in their personal fight against cancer and its effects but in their public fight against Big Tobacco. Heroic in their devotion to a cause they believed in, to a fight they were willing to fight to the end, not merely for themselves, but for all smokers and all Americans. For justice and for the principles of fairness and truth.

It was Frank and Margaret who showed me in a very real way what I was personally fighting for. It was Frank and Margaret who showed me why it was that I went to battle against the leading public health and anti-smoking groups in the nation in order to preserve and protect the rights of citizens to pursue justice against corporations whose products cause them disease, disability, and death. You meet Frank and Margaret and you don't dare, dare interfere with the legal rights of American citizens any more. Because you realize what the American system of justice is all about.

Back in 1997, a coalition of heath and anti-smoking groups, led by the Campaign for Tobacco-Free Kids, the American Cancer Society, and the American Heart Association attempted to get through Congress a bill that would have restricted tobacco advertising and extracted billions of dollars from the tobacco companies, but at the expense of trading away the legal rights of American citizens to hold the companies accountable for injuries they may have suffered -- the legal rights of citizens to sue the tobacco companies would have been severely limited. The tobacco companies would have been provided with legal immunity.

For my efforts to try to protect the legal rights of people like Frank and Margaret Amodeo, I was attacked by many of my own colleagues (read Michael Pertschuk's book Smoke in Their Eyes if you want to see some of the things that were said about me).

But meeting Frank and Margaret made it all worthwhile. It reminded me of what I was fighting for. It made me realize how right I was in my conviction that the pursuit of truth and justice is to be sacrificed at the peril of the integrity of our nation. That no amount of money in the world is worth trading away the principles of justice upon which this country was founded. Many times I thought to myself, "Let the health groups tell Frank and Margaret to their face why their legal rights need to be traded away." If the health groups can do that, then by all means, go ahead and support the global tobacco settlement. But if you can't tell Frank and Margaret that to their faces, then you have no business trading away their legal rights.

I remember sitting one morning in Attorneys Stanley and Susan Rosenblatt's office waiting to testify. Instead of preparing for the long cross-examination I was sure to face, I was writing and issuing a press release to denounce the proposed tobacco settlement and its trading away of the legal rights of American citizens without their consent. I had no choice. I had met Frank and Margaret. I finally knew, firsthand, what the pursuit of justice was all about.

There were really two things that got me through what was a trying ordeal, facing intense questioning from tobacco company attorneys for hours, repeated five times, in Courtroom 6-1. First was the sign above me, in the front of the courtroom: "We Who Labor Here Seek Only Truth." That sign reminded me that my job was actually easy. I merely had to tell it like it is. That was easy. There was nothing to complain about. Frank and Margaret were the true heroes. They were the ones who had to have the courage. I merely had to tell the truth.

The second thing that inspired and comforted me was looking at Frank and Margaret. They made the trip down from Orlando every day. There was never a day I remember testifying that they weren't in the courtroom.

They were dealt a difficult hand. But what they did with their cards was nothing short of heroic.

Frank and Margaret Amodeo are true heroes. They are, and will always remain, my heroes.

Needless to say, I was deeply saddened and shaken to hear the news that Margaret suffered a massive stroke this weekend. In addition to offering my prayers for Frank and Margaret and their entire family, I honor them for being modern-day heroes.

Campaign for Tobacco-Free Kids Appears to be Deceiving Youth into Supporting Proposed FDA Tobacco Legislation; Unethical Tactics are Accelerating

In what appears to be a desperate effort to save the proposed FDA legislation that has stalled in the Senate because its own sponsors were not informed by bill supporters of its potential public health shortcomings, the Campaign for Tobacco-Free Kids is now conducting a campaign to entice youths to support the proposed legislation, but without telling them exactly what they are supporting.

The campaign is spearheaded by a website - WhatAreYouSmoking.org - which entices the public (the target audience appears to be youths) into signing a petition to support the idea of granting the FDA the authority to regulate tobacco products by noting that cigarettes contain over 4,000 toxic chemicals and why shouldn't they be regulated?

"Cigarettes contain 4000+ chemicals. They should be regulated to protect kids and save lives."

The website mentions nothing about the drawbacks of the legislation, hiding the most critical fact of all: that the legislation is being supported by none other than Philip Morris itself, the nation's largest cigarette company.

If you then provide your name and email address, you pledge your support for the proposed FDA legislation (without knowing that you are pledging your support for a bill that Philip Morris desperately wants Congress to enact), and you automatically become a Tobacco-Free Kids e-champion (so that you can receive email updates).

If you then click on the link to sign the petition, you will see the following message:

"Fill out the form below to sign the petition and be a part of the growing effort to make sure Congress gives the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products."

The petition itself states:

"WHEREAS, Tobacco use is the number one cause of preventable death in the United States and is responsible for over 400,000 deaths per year;

WHEREAS, Every day another 1200 Americans die because of tobacco and more than 1,000 kids become new regular smokers. Nearly 90 percent of all smokers begin smoking in their teens or earlier;

WHEREAS, Tobacco use costs the United States more than $96 billion a year in health care bills;

WHEREAS, Tobacco industry marketing expenditures increased by 123 percent since 1998 to a record $15.4 billion in 2003, according to the Federal Trade Commission; and

BE IT RESOLVED the undersigned has endorsed this petition and urges Congress to give the U.S. Food and Drug Administration the authority to regulate tobacco products."

After you sign the petition, you will receive the following email from the Campaign for Tobacco-Free Kids:

"Thank you for visiting WhatAreYouSmoking.com and taking action to help protect America's kids by supporting legislation before Congress to grant the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products.

Tobacco use is the number one preventable cause of death in America. Every year, smoking and other tobacco use kill more than 400,000 Americans and cost the nation more than $96 billion in health care bills. Every day, another 1,200 lives are lost and more than 1,000 kids become new regular smokers.

Please be sure to visit WhatAreYouSmoking.com again and check for updates and new ways you can help. With your support we will beat Big Tobacco and save lives."

The Rest of the Story

It appears to me that the Campaign for Tobacco-Free Kids is enticing kids to support the proposed FDA tobacco legislation without informing them of what the bill actually is, what its drawbacks are, and the critical fact that it is in fact supported by the largest company within Big Tobacco.

In fact, the Campaign is actively deceiving kids into thinking that Big Tobacco is uniformly opposed to the legislation. In its message back to the kids who sign the petition, they tell the kids that their support for the legislation is going to help to "beat Big Tobacco." This clearly gives the impression that Big Tobacco is fighting the proposed legislation. Of course, this is untrue - as we know, Philip Morris is actually supporting the legislation.

This campaign is deceptive even for a reader who is an expert in the regulatory issues involved. I myself was deceived and I signed the petition. I in fact agree with everything in the petition. I would urge Congress to give the FDA the authority to regulate tobacco products. In fact, I supported legislation introduced in previous years (prior to the deal that was struck with Philip Morris in 2004) that would have done just that. And so I joined the effort to "make sure Congress gives the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products."

Then, to my surprise, I found out that what I had actually signed was not a petition to urge Congress to give the FDA authority to regulate tobacco products, but a petition to support specific legislation that had been introduced which would severely limit the ability of the FDA to regulate tobacco products.

What a surprise when the email returned from the Campaign thanking me for "supporting legislation before Congress to grant the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products."

I intended to do nothing of the sort. I was told that I was simply signing a petition to express support for the idea of giving the FDA the authority to regulate tobacco products. Nowhere did it indicate that the petition was actually to support a specific piece of legislation. On the petition web page, there is no mention of any specific legislation. And there is no mention of any details of the specific legislation that would allow me or anyone else to make an informed decision about whether I want my name associated with supporting that legislation.

While I agreed to express my support for the notion of granting the FDA authority to regulate tobacco products, I sure as hell did not give the Campaign permission to use my name in support of specific legislation - about which I was not informed on the web page - that would severely limit the FDA's ability to regulate tobacco products, that is supported by Philip Morris, that would ensure that nicotine could not be removed from cigarettes, and that would eliminate the possibility of finding and making available truly lower risk tobacco products.

I think there would be hundreds - perhaps thousands - of kids around the country who would be appalled to find out that they had inadvertently and unknowingly supported legislation that is being championed by Philip Morris.

Imagine if we could get the names of all the kids who signed on to petition and then we wrote them to inform them that they had just expressed their support for legislation that was being championed by Philip Morris to protect the financial interests of the nation's largest cigarette company. I imagine they would be appalled. And more importantly, that they would be shocked. Certainly, this is a fact they should have known about before they were enticed into signing the petition, not afterwards.

Furthermore, what would those kids say if we wrote them to inform them that rather than give the FDA the authority to regulate tobacco products, the legislation would actually severely limit the FDA's authority to do so?

What if we wrote those kids to tell them that although they weren't informed about it, the legislation for which they had just pledged their support actually limits the ability of FDA to regulate tobacco products, granting the tobacco companies unprecedented special protections enjoyed by no other companies whose products are regulated by the FDA?

What if we told the kids, for example, that the legislation would prohibit the FDA from outlawing the sale of tobacco products at youth community centers, youth arcades, youth amusement centers, amusement parks, bowling alleys, or candy stores?

What if we emailed the kids who had just signed the petition and informed them that they had just unknowingly pledged their support for legislation that precludes the FDA from eliminating the addictive nicotine in cigarettes, ensuring that the tobacco companies will always be able to addict new generations of their peers?

And that the legislation gives Congress specific veto power over any major FDA rules so that Big Tobacco can block any regulations that it doesn't like simply by exercising its political power?

And that the legislation blocks the FDA from raising the legal age of purchase of cigarettes?

And that the legislation ensures that new products which would actually reduce the harms of smoking will never be researched, developed, and marketed?

And that the legislation contains special provisions, inserted solely to appease Philip Morris, that would protect Big Tobacco profits at the expense of the protection of the public's health?

I don't think those kids would be too happy about it. In fact, I'm quite sure that many, if not most or all of those kids would feel tricked, duped, deceived, misled, and manipulated. And they would be angry.

The bad news is that this campaign is only a small part of a much larger effort in which kids are being taken advantage of and misused to support the Campaign for Tobacco-Free Kids' legislative agenda, without their fully informed consent. The Campaign is organizing Kick Butts Day this Wednesday, an event which appears to me to be designed to exploit kids' naivete in order to advance the Campaign's own political aims.

As its March 22 press release makes clear, more than 2,000 youth events are planned across the nation for Kick Butts Day. This year, "Kick Butts Day is raising awareness about the thousands of chemicals in each puff of cigarette smoke and the need for elected officials at all levels to step up the fight to reduce smoking and other tobaccco use."

That may sound fine, but if you read the press release further, you see that the actual purpose of Kick Butts Day appears to be to use kids as pawns in a political maneuver without their consent. The actual purpose -- unbeknownst to the kids -- is to specifically promote legislation that is the chief legislative priority for Philip Morris. How many kids who are participating in Kick Butts Day on Wednesday do you think realize this?

According to the press release: "This year, health advocates are urging Congress to pass legislation granting the U.S. Food and Drug Administration (FDA) authority to regulate tobacco products. Among other things, the FDA could require that tobacco companies disclose the contents of tobacco products and remove harmful ingredients; crack down on tobacco marketing and sales to kids; and stop tobacco companies from misleading the public about the health risks of their products. ... 'It is inexcusable that tobacco products, the number one preventable cause of death in America, are one of the least regulated products sold in America,' said Matthew L. Myers, President of the Campaign for Tobacco-Free Kids. 'By granting the FDA authority to regulate tobacco products, Congress can stop the tobacco industry from targeting our children and misleading the public. We hope Kick Butts Day will inspire elected leaders across the nation to support effective measures to protect children and save lives.'"

In other words, the Campaign has orchestrated this entire day of youth advocacy primarily as a lobbying event for the FDA legislation. But kids do not necessarily know that this is the case. Kids are certainly not being told what the legislation is all about. And they are not given information with which they could make their own informed judgment about whether to participate in an event in support of this legislation.

Most of the kids likely think that they are making a general statement about how evil the tobacco companies are, how toxic cigarettes are, and how it makes sense to regulate tobacco products to save lives. Little do they know that they are being exploited to make a very specific statement about a very specific piece of legislation that stringently restricts the authority of the FDA to regulate tobacco products in ways that might actually save lives.

The Campaign for Tobacco-Free Kids certainly has the right to support any legislation it wants to, whether the bill is a result of discussions within the public health community or negotiations with Philip Morris. But to misuse kids and get them to do the dirty work of promoting the legislation without informing them of what the debate is all about - or even that there is a debate - is unacceptable.

The rest of the story is that in my opinion, this latest campaign by the Campaign for Tobacco-Free Kids is one of the ugliest, most unethical, most deceptive, irresponsible, inappropriate, and sleaziest tactics I've ever seen in my 21 years in tobacco control.

The Campaign for Tobacco-Free Kids is supposed to be supporting the interests of our nation's young people, not manipulating, exploiting, deceiving, and misusing them.

I hope others will join me in calling for an immediate end to this deceptive, inappropriate, and unethical campaign.

Another Tobacco Control Advocate Says Movement is Going Too Far with Outdoor Smoking Bans and Smoker-Free Employment Policies

In an opinion piece published in The Australian on Tuesday, Dr. Simon Chapman, a prominent tobacco control researcher and practitioner who is a professor in the University of Sydney School of Public Health and editor of the journal Tobacco Control writes that the anti-smoking movement is going too far in its recent push for widespread outdoor smoking bans as well as policies that deny employment to smokers.

Dr. Chapman suggests that in promoting these extreme policies, which aim to prevent nonsmokers from breathing in even a whiff of tobacco smoke or coercing smokers into quitting in order to obtain employment, the tobacco control movement is losing its scientific base and crossing the line into moralizing and unenlightened paternalism.

Dr. Chapman points out that there is no scientific basis for regulating all exposure to secondhand smoke outdoors because there is no evidence that merely a brief exposure represents a health threat to all but those exquisitely sensitive:

"Some experimental work has shown that even brief, acute exposure to second-hand smoke can cause measurable physiological changes in those exposed. This evidence has been important in demonstrating the basis on which cumulative exposure is pathogenic. But the evidence of acute exposure being harmful to all but the most exquisitely sensitive is poor."

The piece goes on to suggest that tobacco control is in danger of harming its own integrity and credibility by disrespecting the science and pursuing an agenda that is removed from the science base:

"The evidence base for public health policy must be vigilantly respected and the arguments for tobacco control never allowed to haemorrhage into the moralism that characterised tobacco control of previous centuries. For enthusiasts of untethered paternalism that abandons respect for smokers' choice to harm themselves, their hubris awaits its inevitable fate."

The Rest of the Story

Congratulations to Dr. Chapman for having the courage and integrity to tell it like it is and call the movement on its procession past the bounds of science-based public health practice and into a moralistic and paternalistic crusade against smokers.

It can't be said that I'm the only one within the movement who is disturbed by the recent trends in which anti-smoking groups are supporting widespread outdoor smoking bans (such as that in Calabasas and that proposed in Belmont) and policies that preclude smokers from seeking or maintaining employment.

However, I am still not aware of more than a single U.S. anti-smoking group that has publicly stated its opposition to these policies and criticized the movement for going too far. My sense is that the McCarthyism-like element in the tobacco control movement is stronger in the U.S. than it is elsewhere, perhaps because the movement has been around longer and has had more of a chance to devolve into a science-devoid crusade.

After all, you really can't say anything unfavorable to the anti-smoking cause in this country without becoming the victim of a witch hunt - strung up and hung up to dry.

Look at what happened to Dr. Enstrom for publishing the results of an epidemiologic analysis which reported that there was no significant link between secondhand smoke and lung cancer. Look at how I was attacked on this blog itself simply for opining that car smoking bans are not justified because they represent an unwarranted intrusion into parental privacy and autonomy and distract attention from the real and most important cause of childhood illness due to secondhand smoke exposure. It was only a few days ago that one of my readers suggested that it may be that I receive tobacco industry funding to express such opinions.

While both Dr. Chapman and I may be heavily criticized for taking this position, we are actually standing up to try to strengthen and improve, not weaken the tobacco control movement. Our fear is that because the evidence base for tobacco control is no longer being respected and the arguments have 'hemorrhaged' into moralism and 'untethered paternalism,' the movement may face an unfortunate and inevitable fate.

We're trying to save the movement from this, not harm it. In our view, it is the groups which are pushing for these extreme policies that are the threat to the movement, not those who are willing to speak out for what they believe.

AMA Ignores FDA Commissioner's Concerns; Suggests FDA Tobacco Legislation Will Save Millions of Lives; Offers No Explanation for How

While acknowledging the Food and Drug Administration (FDA) Commissioner's concerns that granting the agency the authority to regulate tobacco products will give cigarettes an FDA stamp of approval and undermine the public's appreciation of the hazards of smoking and while also acknowledging that reducing nicotine levels could lead to increased smoking, which would kill more people due to increased tar delivery, the American Medical Association (AMA) reiterated its support for the proposed FDA tobacco legislation in an editorial in the current issue of the American Medical News.

In the commentary, the AMA acknowledges that: "Some public health experts, including the FDA's own acting commissioner, expressed concern that agency regulation will send a message that 'safer' cigarettes are possible or will lead people to adjust their smoking habits to maintain current nicotine intake levels."

However, without addressing these concerns in any way, the AMA goes on to support the FDA tobacco legislation, suggesting that it will save millions of lives but not offering any indication of how:

"These and other issues certainly will be aired in the months ahead. But the attention will not lessen the need for action. Supporters say FDA oversight has the potential to save hundreds of thousands, even millions, of lives. Doctors, who see firsthand every day the damage done, know that meaningful steps to curb tobacco's reach are imperative. Weighing the evidence, the verdict -- that the time is right for Congress to provide the FDA with this authority -- is quite clear. Lawmakers should not squander this opportunity."

The Rest of the Story

This opportunity to do what?

To give tobacco products an FDA seal of approval so that tobacco companies can boast to the public that their products have been officially approved for sale by the United States Government?

To defraud the American people by making them think that cigarettes are safer when in fact, the truth is that reductions in tar and nicotine have no direct correlation with the safety of the product in actual use?

To provide virtual immunity for tobacco companies by allowing them to defend all lawsuits by saying that they now follow strict government guidelines in all of their production and marketing activities?

To sacrifice the lives of smokers -- by increasing their inhalation of tar -- in order to try to reduce nicotine levels and reduce kids' potential addiction to cigarettes?

To provide unprecedented special protections for Big Tobacco -- protections not enjoyed by any other company whose products are regulated by the FDA?

To ensure that all major decisions regarding tobacco policy are placed in the hands of Congress rather than in the hands of an appropriate regulatory body?

To prevent the possibility that the FDA could prohibit the sale of cigarettes at youth community centers?

To eliminate even the possibility that a truly safer cigarette could ever be discovered and marketed?

I agree that there is a great opportunity to be squandered. But the opportunity to be squandered is the chance to provide Philip Morris with the most coveted protection it could possibly ask for: virtual immunity from further litigation and an absolute lock on market share by stifling any serious possibility of competition.

What is so striking about the AMA's commentary is that they jump from point A to point C with nothing in between.

A: There are several potentially serious problems with the proposed legislation that could result in severe harm to the public's health. There are also potential benefits.

B: ?

C: The verdict is quite clear. Congress should not squander this opportunity.

It seems that step B is missing. Step B -- a careful and thoughtful weighing of the costs and benefits -- would be a critical missing link in establishing the jump from point A to point C.

But the AMA jumps right over that one.

Are we to seriously believe the AMA's suggestion that this legislation will save millions of lives when the Association doesn't so much as offer an explanation of how exactly the legislation will save even one life, much less millions?

I do, however, have to applaud the AMA for one thing. At least they didn't take the cowardly step that the Campaign for Tobacco-Free Kids took and merely claim that the legislation will save "countless" lives. The Campaign isn't able to actually count the lives because those saved lives don't exist. No plausible mechanism has yet been offered for how the legislation will save lives.

At least the AMA is willing to pin a number on its claim. We don't have any idea of the mechanism, but at least we now know that the proposed legislation will save millions of lives.

Boy - it would sure be nice for me to be able to make bold and grand claims like that without having to support them, back them up, or even offer a plausible mechanism for the purported effect.

Let me just try it to see how it feels...

...The proposed FDA legislation represents effective and meaningful legislation to protect the lives of Americans and their children from the number one cause of preventable death in the United States -- tobacco products kill 400,000 Americans each year. How can we allow these deaths to continue? How can we allow the FDA to stringently regulate a box of macaroni and cheese but to not even know the ingredients in a pack of Marlboros? If enacted, the FDA legislation will protect our children from the dangers of tobacco. It will save at least 10 million lives. This opportunity to save countless lives must not be squandered. We owe it to our children. It's time to end special protection for Big Tobacco. The FDA is the right agency. And this is the right time.

Feels great. Maybe I should apply for a job as a writer for one of these major anti-smoking groups.

So what exactly is the purported mechanism by which the FDA is going to save millions of lives?

Could it be magic? A massive placebo effect? A huge reduction in societal stress because the public no longer has to listen to the propaganda being spewed forth by the Campaign for Tobacco-Free Kids? The death of Lord Voldemort from increased carbon monoxide levels in the low-nicotine cigarettes which he certainly smokes?

Your guess is as good as mine. If you have any ideas, send them in. I'd really like to know.

If you are a public health group lobbying for a major piece of federal legislation and you are making a grandiose claim that the legislation is going to save millions of lives and that Congress needs to enact the legislation despite its severe failings, I think it is your obligation to make clear how the bill is going to save lives. And how the benefits will outweigh the deleterious public health consequnces of the legislation. What is the mechanism? What is the basis for your claim of X million lives saved? What is the supporting documentation?

Opponents of the legislation are providing documentation to support their opinion that the bill would have deleterious public health effects. Hardly a day goes by now where The Rest of the Story doesn't present research evidence to support the opinions it has put forward. But from the supporters of the legislation, we hear nothing but propaganda and rhetoric.

This is a quite serious concern, because one of the basic ethical principles of public health is transparency. It is our responsibility to be forthright with the public about the basis of our opinions about public policy, not to merely express our support or opposition for those policies.

The core ethical principle of transparency was spelled out in a Tobacco Control article (see Fox BJ. Framing tobacco control efforts within an ethical context. Tobacco Control 2005;14[Suppl II]:ii38-ii44).

Fox writes: "The tobacco control community should strive for transparency in its dealings. If the tobacco control community fails to explain its dealings within an appropriate framework, it may be perceived as biased or hiding relationships, and it could lose its reputation for independence."

Another important ethical principle that I fear is being violated is the community-level equivalent of the principle of informed consent, which is spelled out in the American Public Health Association Code of ethics. Just as public health organizations must provide individuals with full and accurate information before enrolling these individuals in research studies, public health organizations must also provide the public with full and accurate information that is necessary to make decisions on policies that affect them:

"Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community's consent for their implementation. ... there is a moral obligation in some instances to share what is known. For example, active and informed participation in policy-making processes requires access to relevant information. ...Such processes depend upon an informed community. The information obtained by public health institutions is to be considered public property and made available to the public."

I don't think that the groups supporting this legislation have made available to the public the relevant information needed for the public and policy makers to make an informed decision about the proposed policy. In fact, even the sponsors of the legislation themselves seem not to have been properly informed about the bill's ramifications. For example, it was reported that prior to the testimony on the legislation before his Committee, Senator Kennedy had never even heard about the concerns in the public health community that this legislation could have potentially negative public health consequences.

If this is to be a legitimate public health policy consideration and not merely a political maneuver, then the Congress needs to be informed about the debate raging in the public health community about this approach to regulating tobacco products, as well as about the specific drawbacks of the approach and of the specific provisions of the legislation that were inserted for the protection of Philip Morris' profits.

The public deserves more from the AMA and other groups claiming that millions of lives will be saved than merely a big fat question mark.

American Cancer Society Still Misrepresenting Scientific Evidence; Is it in a Position to Be Attacking Others for Scientific Misconduct?

Earlier today, I commented on the American Cancer Society's (ACS) attack upon UCLA professor and epidemiologist Dr. James Enstrom, in which the ACS accused him of scientific misconduct, prompting an internal investigation by the University. The ACS has also alleged that Dr. Enstrom communicated invalid conclusions regarding the health effects of secondhand smoke and misrepresented scientific evidence on the health effects of secondhand smoke.

The Rest of the Story

Let's take a look at what the American Cancer Society is telling the public about the health effects of secondhand smoke.

Exhibit 1

"Immediate effects of secondhand smoke include cardiovascular problems such as damage to cell walls in the circulatory system, thickening of the blood and arteries, and arteriosclerosis (hardening of the arteries) or heart disease, increasing the chance of heart attack or stroke."

What the ACS is telling the public is that one of the immediate effects of secondhand smoke exposure is hardening of the arteries and heart disease, and as a result, an increased risk of heart attack or stroke.

However, the fact is that it takes many years for hardening of the arteries (atherosclerosis) to develop. It is simply not accurate to claim that this is an immediate effect.

What makes this claim particularly troublesome are the following two factors:

1) It is not just an isolated statement by the ACS. It comes in the context of a strategy guide which is making specific recommendations about exactly what statements anti-smoking groups throughout the world should make about the health effects of secondhand smoke. So the ACS is not just claiming that secondhand smoke exposure immediately causes hardening of the arteries and heart disease, they are instructing anti-smoking groups worldwide to make this statement to the public.

2) It comes in the context of instructing anti-smoking groups how to sensationalize their messages about the health effects of secondhand smoke. According to the strategy guide, an effective message:

• conveys the fact that even short periods of exposure are harmful.
• evokes an emotional reaction from the use of scientific terms.
• utilizes startling and memorable imagery.
• clearly states the risk of grave health conditions such as heart attacks and strokes.

Apparently, the fact that secondhand smoke does not immediately cause the grave health conditions of heart attacks and strokes is no deterrent to the ACS to publicly make such a statement and to encourage all anti-smoking groups to do the same.

Might I suggest that the ACS is in no position to be attacking others for misrepresenting scientific evidence on the health effects of secondhand smoke and for attacking others for alleged scientific misconduct? Might I suggest that the ACS first needs to examine its own misrepresentations and fallacious claims that it is making to the public?

As if this weren't enough, I offer the following additional exhibits:

Exhibit 2

"Short-term exposure to tobacco smoke has a measurable effect on the heart in nonsmokers. Just 30 minutes of exposure is enough to reduce blood flow to the heart."

The truth is that the very study which the ACS cites to support this statement actually showed that 30 minutes of exposure to secondhand smoke had no effect on basal coronary blood flow. In other words, it did not reduce blood flow to the heart. What brief secondhand smoke exposure reduces is coronary flow velocity reserve, which is a measure of blood flow under experimental (artificial) conditions. What it indicates clinically is that endothelial function has been affected, not that a person is suffering from a clinically meaningful reduction in blood flow to his or her coronary arteries.

Exhibit 3

"Nonsmokers who are exposed to secondhand smoke in the home have a 25 percent increased risk of heart disease. As is the case with active smoking, much of the cardiovascular effect is due to acute poisoning."

This one is a shame, because it started out on a roll. There is scientific evidence that nonsmokers who are chronically exposed to secondhands smoke in the home do have about a 25% increased risk of heart disease. But to state that this effect is due to acute poisoning is very misleading.

Acute poisoning implies that a brief exposure to secondhand smoke acutely causes clinically meaingful injury, harm, disease, or death. However, this is not the case. A person exposed briefly to secondhand smoke faces no clinically meaningful, adverse cardiovascular consequences that would be accurately described as having been poisoned.

Being in a closed garage for several minutes with a car engine on exposes a person to carbon monoxide which causes measurable decrements in oxygen-carrying capacity of the blood. But we wouldn't say that such a person has been acutely poisoned?

Eating tater tots day in and day out for years could cause heart disease, but we wouldn't say that eating tater tots on one occasion represents acute poisoining.

The statement is ridiculous, and is a gross misrepresentation of the science.

The rest of the story is that the American Cancer Society is hardly in a position to be leveling attacks against others for misrepresenting the scientific evidence regarding the health effects of secondhand smoke.

Anti-Smoking Group Attacks UCLA Researcher, Accusing Him of Scientific Misconduct; Trying to Make Him Fall Guy for Unfavorable Research Findings?

According to an article in a recent issue of Nature, the American Cancer Society (ACS) has accused UCLA professor and epidemiologist Dr. James Enstrom of scientific misconduct in his role in a 2003 British Medical Journal study which questioned the link between secondhand smoke and lung cancer among nonsmokers.

That article - which used data from the ACS Cancer Prevention Study and found no significant increase in lung cancer risk associated with exposure to spousal smoking - has received massive publicity, serving as the focal point for a campaign to eliminate tobacco industry funding of research at the University of California.

According to the article, the accusation from the ACS has prompted an internal University investigation to determine whether any scientific misconduct occurred:

"The latest round of debate began last autumn when the chief executive of the American Cancer Society, John Seffrin, wrote a letter to the University of California's board of regents arguing that tobacco funding should be banned. In the 12 October letter, Seffrin argued that tobacco-funded front groups "publicized misleading results" while giving "the false implication" that the society had endorsed the study. He cited Enstrom's BMJ article in particular, alleging that Enstrom "ignored" complaints of "fundamental methodological problems". ... Wyatt Hume, provost at the University of California's president's office, wrote to Seffrin saying that the university "takes allegations of scientific misconduct extremely seriously". If there is "specific information in support of an allegation of scientific misconduct against Enstrom", he wrote, he would relay it to officials at the Los Angeles campus so that they "can pursue the matter further". Shortly after, officials at the cancer society sent a seven-page list of what they cited as issues with the BMJ article. ... Officials at the Los Angeles campus "will conduct a thorough review of the documents" ... and "will take further steps to determine whether any research misconduct took place"."

Both authors of the study -- Dr. Enstrom and Dr. Geoffrey Kabat, formerly of SUNY Stony Brook, have vehemently denied any scientific misconduct:

"In an interview, Enstrom acknowledged receiving the various letters and corresponding with the University of California's authorities. "I am working on this with regents' approval," he said. "I am being allowed to defend myself by the appropriate people." He "absolutely" denies any misconduct in the study. And Kabat objects to the university's regent policies being based "on allegations motivated by a political agenda and unsupported by any facts"."

The Rest of the Story

According to the article, among the allegations that are part of the ACS complaint are the following: "top scientists at the cancer society say they repeatedly warned Enstrom of possible deficiencies in his analysis — particularly a 25-year gap in which exposure to second-hand smoke could not be verified. The society also says that when it gave Enstrom computerized records of study subjects, it was not aware that he was receiving funding from the tobacco industry. Later tobacco-related lawsuits revealed he had received money from industry funnelled through an organization called the Center for Indoor Air Research. And court records show Enstrom previously did consulting and research for attorneys defending the tobacco companies R. J. Reynolds and Philip Morris."

If these allegations are representative of the complaints in the ACS letter, then I don't see how this is anything more than a witch hunt to try to harass and vilify Drs. Enstrom and Kabat simply for having come to a conclusion that is unfavorable to the position of anti-smoking groups.

The presence of deficiencies in research is not scientific misconduct. Almost all research has some deficiencies. The inability to verify exposure of subjects at follow-up is not scientific misconduct, it is simply a limitation in the study methodology. This limitation could bias the results toward not finding an effect of secondhand smoke, but it is not misconduct to conduct a study that has methodologic limitations.

The failure to disclose one's other sources of funding to the ACS does not appear to me to be scientific misconduct. Unless Dr. Enstrom lied about having received tobacco industry funding (and I've seen no allegations of such), there is no misconduct. At the time he received funding, the ACS did not have a policy of refusing to fund anyone who has received tobacco money; thus, I don't immediately see why Dr. Enstrom would have had any obligation to disclose his previous funding sources. If the ACS failed to ask, then it's their problem.

Dr. Enstrom's previous work for the Center for Indoor Air Research and his consulting with attorneys representing tobacco companies are also not scientific misconduct. Failing to disclose his tobacco industry funding would be misconduct, but this funding was noted in a detailed disclosure in the paper. Since the conflict of interest was disclosed, I don't see what the basis is for a claim of scientific misconduct regarding the receipt of tobacco industry funding.

For the record, the article discloses the tobacco industry funding: "follow up through 1999 and data analysis were conducted at University of California at Los Angeles with support from the Center for Indoor Air Research, a 1988-99 research organisation that received funding primarily from US tobacco companies."

The article also discloses Dr. Enstrom and Kabat's work for tobacco companies: "In recent years JEE has received funds originating from the tobacco industry for his tobacco related epidemiological research because it has been impossible for him to obtain equivalent funds from other sources. GCK never received funds originating from the tobacco industry until last year, when he conducted an epidemiological review for a law firm which has several tobacco companies as clients. He has served as a consultant to the University of California at Los Angeles for this paper. JEE and GCK have no other competing interests. They are both lifelong non-smokers whose primary interest is an accurate determination of the health effects of tobacco."

It's clear that the American Cancer Society is unhappy with the results of the study and I can understand that. It's also clear that the ACS thinks the methodology of the study was severely flawed. And I can understand that as well. It's also clear that the ACS thinks that the tobacco industry used this study as part of its public relations campaign to undermine public health messages about the hazards of secondhand smoke. And I understand that as well.

But where we part company is when the ACS attacks the individual investigators, questions their personal character and integrity, and accuses them of scientific misconduct.

Based on my knowledge of the situation, this appears to me to basically be a witch hunt in which the ACS and others in the anti-smoking movement are taking out their displeasure at the publication of unfavorable results through an ad hominem attack against the dissenting voice. Sounds familiar, doesn't it? (Regular readers of The Rest of the Story will know what I am talking about).

The appropriate manner in which to respond to the paper is through an analysis and critique of its scientific validity. The funding source is a valid consideration as well, as it could be seen as a potential source of bias. That's all fair game. But turning this into a personal attack and crossing over from scientific validity concerns to scientific misconduct is crossing the line.

Questioning Dr. Enstrom's integrity as an individual is not appropriate in this situation. In fact, Dr. Enstrom is an individual and a scientist of the highest integrity. Those who are attacking him need to question their own integrity in turning to an ad hominem approach rather than sticking with a discussion of the scientific merits of the research.

Of note, the American Cancer Society is perhaps not in the best position to be questioning the integrity of others. This is a group whose president called the tobacco companies terrorists. It is a group which stands together with Philip Morris in promoting legislation that would provide unprecedented special protections to the tobacco companies and would shield the companies from any significant threat of litigation. It is a group which has misled the public about the health effects of secondhand smoke and encouraged other anti-smoking groups to make what amount to fallacious statements in order to increase the emotional appeal of the secondhand smoke message.

Before attacking others, perhaps the ACS should take a look at itself and get its own house in order.

Low-Nicotine Cigarettes May Increase Hazards of Smoking, According to Report

A report released by the Leonard Davis Institute of Health Economics at the University of Pennsylvania has documented that low-nicotine and very low-nicotine cigarettes may increase carbon monoxide exposure among smokers and thus may present a greater health risk.

The report reviews the results of studies which evaluated Quest cigarettes - a product which uses genetically modified tobacco to reduce nicotine levels. In the studies, cigarettes with nicotine yields of 0.6, 0.3 and 0.05 mg were compared.

The report first documented that smokers do compensate by increasing their puff volume when smoking very-low nicotine cigarettes.

More importantly, the report documented that among smokers who do compensate by increasing their puff volume, there was an average of a 300% increase in carbon monoxide boost, indicating greatly increased exposure to carbon monoxide.

The report also documents that smokers tend to interpret low-nicotine claims as implying a safer cigarette. For example, 45% of smokers incorrectly inferred that Quest cigarettes are lower in tar. This despite the fact that the smokers were given information indicating clearly that Quest cigarettes do not reduce tar exposure.

The report concludes that the findings of these studies "provide behavioral and biochemical evidence for the possibility of compensatory smoking with a new low nicotine product, supporting the potential for increased, rather than reduced, harm."

"Second, they suggest that many smokers make false inferences about the relative safety of these cigarettes based on the product’s advertisement. If a new cigarette is misperceived as less harmful, it may attract smokers who would otherwise have quit or reduced smoking. Further research is needed to assess how Quest® cigarettes may divert smokers from more effective ways to reduce their harm from tobacco, including trying to quit smoking."

The Rest of the Story

These findings underscore the absurdity of public health groups' support for the proposed FDA tobacco legislation. They document that there is in fact no scientific basis to believe that reducing levels of nicotine or other specific constituents in cigarettes could or would produce a safer cigarette. More importantly, they demonstrate that substantial harm to the public's health would be done by requiring cigarette companies to lower nicotine levels or levels of other specific toxins. Not only would this likely result in increased exposure to other harmful constituents in the smoke, but it would also mislead smokers into thinking that cigarettes are safer, thus diverting smokers from more effective ways of reducing the harm from tobacco, namely: quitting.

It is important to note that a cigarette with 0.05 mg of nicotine is essentially a nicotine-free cigarette (in fact, that's how Quest is being marketed). However, such a cigarette was documented to increase toxic carbon monoxide exposure by 300% in smokers who compensate by increasing their puff volume in response to the reduced nicotine yield.

It is also important to note that these studies grossly underestimate the degree of compensation that would occur in actual life. These studies ask smokers to simply try Quest on one occasion. Compensation is a process that takes a period of time. If smokers were to smoke Quest for a period of weeks or months, it is likely that not only would their puff volume increase, but their cigarette consumption would increase as well.

Given the increased carbon monoxide delivery of these nicotine-free cigarettes, it would not be surprising to see clinical harm done to smokers if the effects of Quest were studied for any substantial length of time.

Clearly, it would be inappropriate for Vector Tobacco to market Quest as a safer cigarette. If Vector made any claims that Quest was a safer cigarette, I can assure you that anti-smoking groups would immediately blast the company and call for FTC to ban that advertising. I'm sure that the Campaign for Tobacco-Free Kids would be at the front of the pack (as they should).

The insanity of the proposed FDA regulatory scheme is that this is precisely what the Campaign for Tobacco-Free Kids now wants the FDA to do. And it is a pipedream to think that the FDA would do something as substantial as requiring a nicotine-free cigarette. This is in fact the best case scenario.

The rest of the story is that in actual practice, as documented by scientific evidence, even a 0.05 mg (nicotine-free) cigarette has been documented not only not to be safer, but to actually pose an increased potential harm to smokers by virtue of a drastically increased delivery of carbon monoxide to smokers who compensate in order to try to maintain constant levels of nicotine dosage.

Moreover, smokers misinterpret the rather clear marketing information and infer that the product reduces tar delivery and is a safer product. This would likely result in increased cigarette consumption and divert smokers from quitting.

Essentially, the FDA legislation would make one major change: instead of the cigarette companies defrauding the American public by making them incorrectly think that extremely low-nicotine, low-nicotine, and low-tar cigarettes are safer, it would be our own government. And in fact, that would essentially be their mandate.

It is truly beyond me how any anti-smoking or public health group could support this legislation.

One thing is for certain: the anti-smoking groups sure do not let the science get in their way.

Smoking is a Sign of Weakness, Suggests Anti-Smoking Group

As quoted in a recent newspaper article, the national anti-smoking group Action on Smoking and Health (ASH) has suggested that smoking is a sign of weakness and lack of will and determination, not befitting of a president. ASH executive director John Banzhaf is quoted in the St. Petersburg Times in response to the presidential campaign of Senator Barack Obama - a smoker who is attempting to quit smoking: "For many people, smoking is seen as a sign of weakness and lack of willpower. A presidential candidate would not want to be seen as lacking strong will or lacking determination."

The Rest of the Story

Funny that. Coming from a group that helped spearhead many of the lawsuits by smokers against the tobacco companies. A key element of these cases is that smoking is an addiction, and that quitting is not as simple as just having willpower. In fact, the tobacco company defense in these cases has been based on convincing juries that smoking is a sign of weakness and lack of willpower. It's a good thing ASH didn't make this same statement prior to, and during the bulk of the tobacco cases. They would have destroyed their own argument.

I find it unfortunate that a national anti-smoking group is helping to reinforce the image of the smoker as a weak creature who lacks willpower and determination. And that such a group is suggesting that smoking is inappropriate for a presidential candidate because it displays a lack of willpower and determination that could affect the candidate's qualifications to serve as president.

The suggestion that smokers simply lack willpower and determination shows a profound lack of understanding of the concept of addiction. And it contributes to obscuring the public's appreciation of the addictive nature of smoking.

Interestingly, you don't hear ASH talking about how being fat represents a lack of willpower and determination. Or how having type 2 diabetes represents a lack of willpower and determination (since it can be controlled almost completely by weight loss). Or how having mild hypertension represents a lack of willpower and determination (as it can almost always be controlled completely by dietary changes). Or how drinking coffee daily is a sign of weakness.

I haven't heard any suggestion recently about how a presidential candidate should quit drinking coffee before running so as not to be perceived as being weak and therefore not an effective potential leader.

Frankly, I don't see how the (lawful) personal health behavior of a presidential candidate has any relevance to his or her qualifications for the office of president. But more importantly, to suggest that smoking is a sign of weakness sounds like a cheap jab, possibly motivated by hatred of smokers. It is also a sign of class discrimination, since we don't talk the same way about poor health behaviors in which sub-populations of higher education and income status tend to engage.

Smoking is not a sign of weakness, any more than being fat or sitting around watching four straight days of basketball on television (yes, I'm guilty) are signs of weakness.

Let's get our message straight, shan't we? Is smoking a supreme form of weakness and lack of willpower and determination, or is it one of life's addictions? At this point, I hardly care which side ASH takes. But don't suggest one thing to the public (it's a sign of weakness and lack of willpower and determination) and then expect juries throughout the country to force tobacco companies to pay billions of dollars to smokers because they were addicted and could not quit smoking even after they became aware of its adverse health consequences. Isn't it that they were just weak?

Is Receiving a Placebo the Same Thing as Trying to Quit Cold Turkey? The Limitations of NRT Clinical Trials

In a must-read commentary for all tobacco control practitioners, John Polito explains in easy-to-understand terms why there is such a discrepancy between clinical trial research - which has shown a clear benefit of nicotine replacement therapy (NRT) and other pharmaceutical smoking cessation aids - and population-based research, which demonstrates that NRT is not particularly effective and that cold turkey quitting remains the most effective cessation method.

Polito explains that NRT clinical trials essentially equate receiving a placebo with quitting cold turkey. In other words, in comparing the use of NRT to quitting without pharmaceutical aids, these clinical trials provide nicotine replacement medication to some subjects and a complete dud of a pill to other subjects. It is quite clear to many receiving the placebo that they are taking a dud, since the physiologic effects of nicotine are quite easy to detect. Subjects who are disappointed that they are receiving placebo are discouraged and more likely to return to smoking, simply because of their disappointment that they were not randomized to receive a real medication.

In a brilliant exposition of the limitations of NRT clinical trial research, Polito writes: "The only way to have honest comparisons is to invite and fairly service the nicotine dependency recovery needs of those having an expectation of abruptly ending all nicotine use. To experience the current study format farce in all its glory we'd need to actively recruit smokers who want to quit cold turkey and then randomly assign half to wear a patch. If that sounds strange, remember it is just the mirror image of the clinical trials done to date."

In other words, NRT clinical trials are essentially comparing smoking cessation rates among those who are highly motivated to quit and receive nicotine with cessation rates among those who are highly motivated to quit and then given the disappointment of not receiving the nicotine that they were hoping for.

The Rest of the Story

This explains why the clinical trials have shown a benefit for NRT, while population-based studies, which Polito reviews, have confirmed that cold turkey quitting remains the most effective cessation method. For example, as Dr. John Pierce of the University of California San Diego concluded, the use of NRT "is not associated with any increase in successful quitting in the population."

Interestingly, Pierce was viciously attacked, not for shoddy science but for even daring to suggest that NRT may not be effective. Tobacco control is so firmly entrenched in the hands (and money) of Big Pharma that it simply does not want to hear that pharmaceutical smoking cessation aids are not the panacea that the public has been told they are.

The attacks on Dr. Pierce are not a surprise to me anymore, as I have learned from my own experience that dissent is not allowed in tobacco control and that one cannot challenge the established wisdom of the movement without being personally attacked. The movement is unable to respond substantively to critics, and thus resorts to ad-hominem attacks.

The truth is, however, that Pierce's study was not in any way unique. It simply confirms the results of at least 7 other population-based studies which also found that NRT offers no long-term abstinence benefits when compared to quitting cold turkey.

Fortunately, the limitations of the NRT clinical trials and the pharmaceutical ties of those who are setting national smoking cessation treatment guidelines are starting to be publicly exposed. A February 8 article in the Wall Street Journal noted the financial conflict of interest of the chair of the federal panel that is revising the smoking cessation guidelines:

"Michael Fiore is in charge of revising federal guidelines on how to get smokers to quit. He also runs an academic research center funded in part by drug companies that make quit-smoking aids, and he personally has received tens of thousands of dollars in speaking and consulting fees from those companies. Conflict of interest? No, says Dr. Fiore, who has consistently declared that doctors ought to use stop-smoking medicine. He says his opinion -- reflected in current federal guidelines -- is based on scientific evidence from hundreds of studies. Now debate is growing about that evidence, and about who should be entrusted to interpret it. Some public-health officials say industry-funded doctors are ignoring other studies that suggest cold turkey is just as effective or even superior to nicotine patches and other pharmaceuticals over the long run, not to mention cheaper. "

"The Public Health Service, part of the Department of Health and Human Services, issued guidelines in 2000 calling for smokers to use nicotine patches, gums and other pharmaceutical aids to quit, with a few exceptions such as pregnant women. Dr. Fiore, a University of Wisconsin professor of medicine, headed the 18-member panel that created those guidelines. He and at least eight others on it had ties to the makers of stop-smoking products."

My own opinion, based on my years of experience in the field, is that the almost singular focus on NRT and other pharmaceutical treatments for smoking dependence are more of an impediment to smokers quitting than a help. This focus is obscuring the real problem - which is that smokers must be highly motivated if they are going to quit successfully and long-term.

In other words, smokers are not going to quit unless they really want to quit. You can try cold turkey, with NRT, or with accupuncture or hypnosis, but if you are not highly motivated to quit and do not really feel a deep, emotional desire to rid yourself of the addiction, it's not going to happen. In my experience, the desire to quit cold turkey indicates a much higher level of motivation to quit than simply the desire to take a drug.

Our smoking cessation plan should focus on motivating smokers to quit, not on getting doctors to prescribe pharmaceutical products and making smokers think that quitting smoking is as easy as popping a pill or applying a patch.

This past Tuesday, Ken Millstone of the Columbia News Service highlighted John Polito's and my concerns that cold turkey quitting is being slighted because of the tobacco control movement's singular pre-occupation with pharmaceutical cessation treatment.

"With nicotine replacement therapy, 'the levels of long-term success are dismal,' said Dr. Michael Siegel, a physician and professor at Boston University's School of Public Health. 'More important, I think the role of nicotine replacement therapy as part of a national policy to address smoking cessation has been over emphasized.... Quitting cold turkey has been the most effective way of quitting smoking.'"

Countering my comments and those of John Polito was Dr. Saul Shiffman, "a professor of psychology at the University of Pittsburgh who has studied smoking cessation for 30 years."

Interestingly, what the article does not disclose is that Shiffman has an enormous financial conflict of interest. Far from merely being a professor (like I am), he is also a senior scientific advisor for Pinney Associates, a for-profit business which is funded primarily by...

... you guessed it ------> pharmaceutical companies.

Dr. Shiffman is a consultant to GlaxoSmithKline, maker of NiQuitin, Nicoderm CQ, Nicabate, and Nicorette. He has been paid by GlaxoSmithKline to conduct research with them, and has received funding from the pharmaceutical company for this research. According to his disclosure in another article, he "also has an interest in a new smoking cessation product."

If I'm interpreting this correctly, not only has Dr. Shiffman been funded by GlaxoSmithKline or his research and received consulting income from GlaxoSmithKline, and not only does his company consult primarily for pharmaceutical companies, but he actually has his own financial interest in a new smoking cessation pharmaceutical product.

If I had such extensive financial interests in smoking cessation pharmaceutical products, I'm sure I would also have a much more positive appraisal of the effectiveness and role of these products.