Study Finds No Benefit to Use of CT Scans to Screen Current and Former Smokers for Lung Cancer

A study published in this week's issue of the Journal of the American Medical Association (JAMA) concludes that CT scan screening of asymptomatic current and ex-smokers in an effort to detect lung cancer earlier has no benefit in terms of reducing mortality. In fact, using such an approach on a population basis could produce more harm than benefit (see: Bach PB, Jett JR, Pastorino U, Tockman MS, Swensen SJ, Begg CB. Computed tomography screening and lung cancer outcomes. JAMA 2007; 297:953-961).

The conclusions were based on a longitudinal study of over 3,000 current and ex-smokers screened for lung cancer using chest CT scans at 3 different academic medical centers. The average follow-up time was 4 years. Subjects underwent baseline and annual low-dose CT scans. There was no difference in lung cancer mortality: the number of lung cancer deaths was nearly the same as predicted (relative risk = 1.0).

The authors conclude: "Screening for lung cancer with low-dose CT may increase the rate of lung cancer diagnosis and treatment, but may not meaningfully reduce the risk of advanced lung cancer or death from lung cancer. Until more conclusive data are available, asymptomatic individuals should not be screened outside of clinical research studies that have a reasonable likelihood of further clarifying the potential benefits and risks."

Not only did the authors fail to find any benefit of CT screening for lung cancer, but they also identified substantial potential harm - the invasive diagnostic procedures required by the finding of what turn out to be benign lung nodules carry with them their own morbidity and mortality risks. They conclude that: "If the majority of excess early cancers found through screening are unlikely to progress rapidly to a point where they cause clinically significant disease or death, then the thoracic surgeries performed to remove them may be insufficiently beneficial to justify the resulting morbidities. Despite some studies that have demonstrated excellent outcomes when lung cancer resections are performed in high-volume hospitals by thoracic surgeons, excellent outcomes are not uniform. Rather, the postoperative mortality rate following resection of lung cancer in the United States averages 5%, and the frequency of serious complications ranges from 20% to 44%. ... biopsies and the other diagnostic procedures that are performed in response to findings on a screening CT constitute another potential downstream harm that could result from widespread CT screening."

The Rest of the Story

While we need to await the results of a large clinical trial of low-dose CT screening for lung cancer before drawing any definitive conclusions, what is clear is that at the present time, there insufficient evidence that the use of CT screening for lung cancer produces any benefit in terms of reducing mortality.

On the other hand, it is clear that the use of CT screening on a large population of smokers and ex-smokers would produce substantial harms. There is a significant risk of morbidity and mortality from the invasive diagnostic procedures required to investigate the large number of lung nodules that will inevitably be detected on CT scan, most of which will end up being benign.
While it is not entirely clear why no mortality benefit was observed even though the screening procedure did result in a large increase in the number of lung cancers detected, the authors postulate that what is happening is that the CT scans are picking up lung cancer nodules that are so small that they would never have progressed to the point that they caused death anyway. This is known as "overdiagnosis" bias and it is a common limitation of this type of screening approach.

Despite the lack of sufficient evidence that there is any benefit to the use of CT screening for lung cancer among current and ex-smokers, the Lung Cancer Alliance - a lung cancer advocacy group - issued a press release in which it stood by its position that people at risk of lung cancer (e.g., smokers and former smokers) should be encouraged to undergo CT scan screening for lung cancer:

"Today, Lung Cancer Alliance President, Laurie Fenton, responded to the most recent criticism of CT screening, calling it 'another delaying tactic to deny people at high risk for lung cancer the chance to have it detected at an early, treatable stage.' ... An article published in the March 7 issue of the Journal of the American Medical Association concludes that high risk individuals should not be screened for lung cancer until more studies have been conducted, as the authors claim CT scans may cause more harm than good. 'This is not productive,' declared Fenton. “We have heard these same statistical arguments used for years... ."

While I admire the Lung Cancer Alliance and the important work they are doing on behalf of lung cancer victims and their families, as well as the work they are doing to try to prevent and more effectively treat lung cancer, I think that advocacy needs to remain science-based. The science simply does not support a recommendation that lung cancer screening be conducted on a population basis at this point in time.

While it is possible that results from the large clinical trial that is now underway could produce very different results, we simply don't have that information yet. In the absence of evidence that screening actually will save lives, I do not believe that the risks of screening outweigh the benefits.

I do not believe this is a delaying tactic. I believe it is wise and responsible public health practice based on the best available science at the time. I also think it is very productive, because it could save people a tremendous amount of unnecessary morbidity and even mortality.

The rest of the story is that while our emotions tell us that we would love to have a way to prevent the devastating effects of lung cancer, the science tells us that CT screening is not yet documented to represent that way. There is no clear mortality benefit that has been demonstrated, yet the harm done by causing unnecesary anxiety among smokers and ex-smokers, and by causing unnecessary morbidity from invasive diagnostic tests, could be substantial.

Weill Cornell Medical College Researcher Hides Tobacco Industry Funding of Study on Use of CT Scans for Lung Cancer Screening

In an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

The Rest of the Story

The rest of the story is that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment "was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

To make matters worse, the Times reported that Dr. Henschke "failed to disclose in articles and educational lectures a patent and 10 pending patents related to CT screening and follow-up." By virtue of these financial interests, Dr. Henschke stands to benefit personally (financially) if her recommendations for the widespread adoption of CT scan screening for lung cancer are adopted.

Moreover, the Cancer Letter reports that "medical journals and providers and accreditors of continuing medical education are investigating her failure to disclose patents and royalties from commercial sponsors, including GE Healthcare. As the leading manufacturer of CT scanners, GE stands to benefit from Henschke's campaign to screen asymptomatic former and current smokers."

If it is true that Dr. Henschke has a significant financial interest in GE Healthcare, such as royalties, consultant fees, or licensing payments, and that financial interest was present in October 2006, then she did fail to disclose that interest in her New England Journal article as that article states: "No potential conflict of interest relevant to this article was reported."

Commentary

I am not, in this post, criticizing Dr. Henschke for either accepting tobacco industry funding or for having financial interests relating to the use of CT screening for lung cancer. What I am being critical of is the failure to disclose the tobacco industry funding of her research and the potential conflicts of interest.

Most disturbing to me is her failure to disclose the tobacco industry funding of her research. Clearly, this failure to disclose led to the deception of editors at two major journals which published her work about the nature of the funding sources for her research. Neither was aware of her funding by the tobacco industry; thus, her failure to disclose was substantial.

I do not believe that Dr. Henschke can hide behind the excuse that she disclosed funding from the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, and so that she did indeed disclose her funding sources. The intent of disclosure of funding is to provide editors, reviewers, and the public with relevant information about the source of funding, not merely to provide the name of the foundations or entities set up to receive that funding. Thus, I view the failure to disclose her funding from Liggett as a significant violation of ethical standards of conduct.

Unfortunately, the reputation and validity of this important research has been tainted by these events. It should lead the public to question the objectivity of the conclusions of the research. In fact, as I have argued in detail (before knowing that the work was tobacco-funded), I believe that the current evidence does not support the use of CT scans as a screening tool for lung cancer and that widespread adoption of this approach at this time would be a public health disaster.

I also believe that the conclusions of the research are biased and do not reflect an appropriate, broad-based perspective on the criteria that are necessary to be met before a screening tool is adopted on a population basis. While the ELCAP researchers have jumped to recommend CT screening be adopted (perhaps not surprising in light of the financial conflicts of interest disclosed in this week's articles), they have not sufficiently addressed the important concerns regarding the false positives that result from screening and the harm that might be done by invasively investigating harmless nodules. In addition, I do not feel that they have addressed the potential harm inherent in exposing millions of people to the substantial radiation doses associated with CT scans (most of whom would be exposed unnecessarily).

Spiral CT screening for lung cancer has not yet been shown to be an effective and appropriate screening tool. The specificity of the test is very low, and combined with a very low prevalence of lung cancer in the population, the positive predictive value of CT screening is dismally low. This means that the overwhelming majority of patients who have lung nodules detected on CT scan will not have lung cancer. But these patients will require follow-up monitoring, and some will even require further invasive procedures to obtain a definitive diagnosis. These procedures carry a morbidity and even a mortality risk themselves and a number of the diagnostic procedures will result in morbidity or possibly mortality unnecessarily (by which I mean morbidity or mortality in patients who do not have lung cancer).

Another important consideration is the anxiety that could be produced in a huge number of patients who have nodules detected on CT scan but who do not have lung cancer. The protocol calls on these patients to either have invasive diagnostic procedures, which can be physically damaging, or to simply wait for 3 months for a follow-up test, which can be psychologically damaging. Imagine the anxiety a patient would have if told that they have an abnormal nodule in their lung that could be cancerous and what the doctor wants them to do is sit around for 3 months and try not to think about it.

In the ELCAP study, 4186 patients were identified as having abnormal lung nodules at baseline CT screening. Of these patients, only 405 were found to have lung cancer. Thus, 3781 patients had false positive results. The positive predictive value of the test was therefore only 10%. This means that a positive test result (the finding of a lung nodule) only indicates lung cancer 10% of the time. Ninety percent of the time, the test is wrong. That's usually viewed as being unacceptable for a screening test.

In this case, having 90% of your patients with nodules worrying unnecessarily for 3 months hardly seems acceptable to me.

If there were some gold standard, definitive test that could be performed immediately following the baseline CT scan to determine whether or not a patient has lung cancer, then this initial screening test might be acceptable. But I find it quite troubling that patients are being told that they may have cancer - please come back in 3 months and we'll either tell you how much it's grown or we'll tell you never mind, false alarm.

Also concerning is the fact that in this study, 43 patients had some form of invasive or surgical procedure, presumably ranging from fine-needle aspiration to bronchoscopy to mediastinoscopy to open lung biopsy, but ended up having nothing wrong with them.

In other words, what I'm trying to say is that without a doubt, instituting such a screening procedure is guaranteed to cause harm to some patients. It is likely to cause psychological harm to many, and physical harm to a smaller, but not negligible number of people.

On the other hand, we cannot say with certainty that instituting this screening procedure will result in benefit because it has not yet been demonstrated definitively that spiral CT screening for lung cancer does save lives.


For further reading about this story, see the article at the Time Magazine web site and at the Columbia Journalism Review.

New Mayo Clinic Study Reveals Problems with Lung Cancer Screening

An article in the April issue of Radiology reports the results of a study of the use of helical CT scanning as an approach for the early detection of lung cancer among high risk smokers (Swensen SJ, Jett JR, Hartman TE, et al. CT screening for lung cancer: five-year prospective experience. Radiology 2005; 235:259-265). A group of 1,520 adults ages 50+ was followed for four years, receiving a baseline chest CT scan and four annual follow-up CT scans. The purpose of the study was to determine whether this approach would save lives by detecting lung cancers earlier than they would otherwise be detected, allowing for earlier and more effective treatment.

The study found that CT scan screening did not significantly reduce lung cancer deaths. Nor did it result in a shift to the detection of more very early cancers. But this screening did create problems for patients because of a very high false positive rate. False positive tests mean the finding of a lung nodule on the CT scan that turns out not to be cancerous. About three-fourths of the patients had a lung nodule detected, and of these, only 4% turned out to have cancer. Thus, well over 1,000 cancer-free patients were told they had a lung nodule suspicious for cancer and had to have further diagnostic procedures, sometimes involving surgical or other procedures (i.e., biopsy).

The Rest of the Story

While chest CT scan screening of current and ex-smokers at high risk for lung cancer turned out not to have any benefit to them, it did cause significant morbidity and mental distress. Being told that one has a nodule that could be cancerous tends to create substantial anxiety. For many of these patients, they had to live with this unnecessary anxiety for six months or even a year before they were able to be told that there was nothing to worry about. For others, they had to undergo further diagnostic tests, sometimes surgery.

Even among patients with new lung nodules greater than 4mm in size detected (nodules that were not present on the initial CT scan), the false positive rate was 92%. This means that the overwhelming majority of patients with newly diagnosed lung nodules (92%) did not have lung cancer.

Because of the anxiety produced by being told that one has a potentially cancerous lung nodule as well as the significant morbidity (and even mortality) associated with some of the interventions used to definitively diagnose these nodules, this study reveals that the CT screening approach resulted in more harm than good for these patients.

In order for a screening test to be effective for a relatively uncommon disease (and lung cancer is still uncommon, even in high risk smokers), the false positive rate must be extremely low. In other words, the test must not detect a large number of nodules that turn out to be benign. Otherwise, these patients will suffer a great deal of unnecessary anxiety and possibly morbidity and mortality. There would certainly have to be strong evidence of a significant mortality benefit in the population to recommend the use of such a screening test. In this case, helical CT scanning simply does not meet these criteria.

In more general terms, the results of this study underscore the pointlessness of devoting substantial resources to lung cancer screening. We should be focusing our resources in the area where we know we can have an effect: prevention of lung cancer through interventions to prevent smoking initiation and encourage smoking cessation.

A central tenet of medicine is "first, to do no harm." Screening for lung cancer, even in high risk individuals, appears to violate this basic principle.

Massachusetts Lawsuit Seeks to Force Philip Morris to Pay for Chest CT Scans for Smokers to Screen for Lung Cancer

According to an article in the Boston Globe, a federal class action lawsuit filed in Boston last week on behalf of all 50+ year-old smokers in Massachusetts who have smoked at least one pack per day of Marlboro cigarettes for at least 20 years seeks to force Philip Morris - the manufacturer of Marlboro - to pay for low-dose chest CT scans for this class of smokers in order to attempt to diagnose lung cancer at an early stage and therefore save lives.

According to the article: "Low-dose, noninvasive CT scans cost about $500, but they are rarely covered by health insurance. The complaint, filed in US District Court, requests that Philip Morris fund CT scans for people at least 50 years old who have smoked a pack of Marlboro cigarettes a day for at least 20 years -- the equivalent of at least 146,000 cigarettes -- and have not been diagnosed with lung cancer. It does not demand monetary damages. ... as many as 80,000 Massachusetts residents could become part of the class, an estimate based on public health data and Philip Morris's market share."

The lawsuit follows by about six weeks the publication of an article in the New England Journal of Medicine which reports that in a large multi-center, collaborative study of the use of low-dose CT scans for early detection of lung cancer (International Early Lung Cancer Action Program - ELCAP) among 27,456 high-risk patients, 85% of lung cancers detected were in the earliest stage (stage I) and the 10-year survival of these patients was 88%. The article concludes that "Annual spiral CT screening can detect lung cancer that is curable."

Without screening for lung cancer (when lung cancer is detected only when patients present with symptoms), the overwhelming majority of cases are detected in later stages (stages II and higher), which have a dismal prognosis. The stage I cancers have the best prognosis and are the only ones which are felt to have any substantial chance of being cured. By shifting the proportion of diagnosed lung cancers heavily towards stage I, it is thought that spiral CT scanning might result in earlier detection and treatment of tumors and therefore save lives.

The lawsuit apparently contends that Philip Morris produced a cigarette with many carcinogens in it that didn't have to be in there, that a safer alternative product was available but rejected by the company, and that because smokers in Massachusetts are at risk of lung cancer due to the presence of these carcinogens, Philip Morris ought to provide this screening procedure that could save the lives of many of these smokers.

The Rest of the Story

While this all may sound compelling, there is a rest of the story.

First of all, without a control group, the ELCAP study results do not necessarily prove that CT screening for lung cancer reduces mortality and saves lives. There are two potential biases that could be operating, which cannot really be evaluated in the absence of a control group.

Lead time bias is when screening detects cancer at an earlier time than it otherwise would have been diagnosed, but does not change the survival. It is possible that the survival of patients in the study was not altered - what was altered was merely the time of their diagnosis.

Overdiagnosis refers to the detection of indolent cancers that are slow-growing and unlikely to cause death.

Without a control group, it is difficult to assess whether or not the reported results are subject to lead time bias or to overdiagnosis, and therefore, it is difficult to conclude definitively that this screening procedure saves lives. A clinical trial is now underway in which patients are being randomized to either receive spiral CT screening or a conventional chest X-ray. This clinical trial will help to determine whether CT screening can indeed save lives. But until those results are in, it seems premature to be forcing Philip Morris to provide a screening program that has not yet been documented to save lives.

Another major problem is that spiral CT screening for lung cancer has not yet been shown to be an effective and appropriate screening tool. The specificity of the test is very low, and combined with a very low prevalence of lung cancer in the population, the positive predictive value of CT screening is dismally low. This means that the overwhelming majority of patients who have lung nodules detected on CT scan will not have lung cancer. But these patients will require follow-up monitoring, and some will even require further invasive procedures to obtain a definitive diagnosis. These procedures carry a morbidity and even a mortality risk themselves and a number of the diagnostic procedures will result in morbidity or possibly mortality unnecessarily (by which I mean morbidity or mortality in patients who do not have lung cancer).

Another important consideration is the anxiety that could be produced in a huge number of patients who have nodules detected on CT scan but who do not have lung cancer. The protocol calls on these patients to either have invasive diagnostic procedures, which can be physically damaging, or to simply wait for 3 months for a follow-up test, which can be psychologically damaging. Imagine the anxiety a patient would have if told that they have an abnormal nodule in their lung that could be cancerous and what the doctor wants them to do is sit around for 3 months and try not to think about it.

I don't know about you, but I'd be unable to do that without severe anxiety and severe interference with my ability to function. I'd want a definitive diagnosis right away. As a physician, I would feel very uncomfortable telling my patient: "We detected an abnormal nodule in your lung that is somewhat suspicious for lung cancer. We're not sure. Why don't you make a follow-up appointment for 3 months from now and we'll see how it's progressing. See you in a 3 months. Have a good one."

In the ELCAP study, 4186 patients were identified as having abnormal lung nodules at baseline CT screening. Of these patients, only 405 were found to have lung cancer. Thus, 3781 patients had false positive results. The positive predictive value of the test was therefore only 10%. This means that a positive test result (the finding of a lung nodule) only indicates lung cancer 10% of the time. Ninety percent of the time, the test is wrong. That's usually viewed as being unacceptable for a screening test.

In this case, having 90% of your patients with nodules worrying unnecessarily for 3 months hardly seems acceptable to me.

If there were some gold standard, definitive test that could be performed immediately following the baseline CT scan to determine whether or not a patient has lung cancer, then this initial screening test might be acceptable. But I find it quite troubling that patients are being told that they may have cancer - please come back in 3 months and we'll either tell you how much it's grown or we'll tell you never mind, false alarm.

Also concerning is the fact that in this study, 43 patients had some form of invasive or surgical procedure, presumably ranging from fine-needle aspiration to bronchoscopy to mediastinoscopy to open lung biopsy, but ended up having nothing wrong with them. Based on the number of participants in ELCAP and the number of potential smokers in the proposed class, we would expect to have about 120 of the class members end up needing an invasive diagnostic procedure when there is nothing wrong. Among these 120 people, we would expect to have a non-negligible number wind up with significant morbidity -- all for no reason and with no benefit to them.

In other words, what I'm trying to say is that without a doubt, instituting such a screening procedure is guaranteed to cause harm to some patients. It is likely to cause psychological harm to many, and physical harm to a smaller, but not negligible number of class members.

On the other hand, we cannot say with certainty that instituting this screening procedure will result in benefit to any of the class members. It has simply not yet been demonstrated definitively that spiral CT screening for lung cancer does save lives.

I'm not sure how you can ask a court to force Philip Morris to pay for a procedure that is guaranteed to cause some harm, but not definitively guaranteed to have any benefit.

Don't get me wrong. I'm not saying that spiral CT screening for lung cancer will never be an effective and appropriate screening test or that it won't ultimately be shown to save lives or that the benefits of this screening will not end up outweighing the risks and costs. I'm just saying that based on the evidence that is available right now, I don't think one can make a reasonable determination that the proposed screening program will produce a net benefit to this class of smokers.

IN MY VIEW: Not Appropriate to Recommend Lung Cancer Screening for Nation's Smokers and Ex-Smokers

In the wake of the revelation that ABC News anchor Peter Jennings has been diagnosed with lung cancer, many of the nation's smokers and ex-smokers are experiencing anxiety about their own risk of developing lung cancer. Several newspaper articles have mentioned the availability of a new technique - low-dose spiral CT scanning - to detect lung cancer. Desite the potential promise of this screening method, I do not believe the evidence available now supports a recommendation that all concerned smokers and ex-smokers, on a population basis, be screened for lung cancer.

I am aware of no medical organization that has recommended the use of CT scans for detection of lung cancer in asymptomatic individuals, including smokers. The scientific and medical bodies that have examined this issue have concluded either that lung cancer screening of asymptomatic smokers is not recommended or that there is insufficient evidence of the potential harms and benefits to recommend screening at this time.

Here is what the major bodies have recommended:

• U.S. Preventive Services Task Force (2004): "The U.S. Preventive Services Task Force (USPSTF) concludes that the evidence is insufficient to recommend for or against screening asymptomatic persons for lung cancer with either low dose computerized tomography (LDCT), chest x-ray (CXR), sputum cytology, or a combination of these tests."
• American Cancer Society (2000): "At this time, the ACS does not recommend routine screening for lung cancer among the general adult population or in individuals who are at higher risk due to tobacco or occupational exposures."
• Canadian Task Force on Preventive Health Care (2003): "The CTF concludes that there is insufficient evidence (in quantity and/or quality) to make a recommendation as to whether spiral CT scanning should be used for screening asymptomatic people for lung cancer."
• American College of Chest Physicians (2003): "For individuals without symptoms or a history of cancer, the guideline developers recommend against the use of a single low-dose computed tomography scan (LDCT) or serial LDCTs to screen for the presence of lung cancer."

While there is some evidence (primarily from the Early Lung Cancer Action Program [ELCAP] study) that chest CT scanning can pick up substantially more tumors than chest X-ray and can shift the detection of cancers toward stage I, there is as yet no published evidence that this approach can reduce mortality. More troublesome, however, is the fact that the most recent published study (the Mayo Clinic study) failed to find any benefit of CT screening, either in terms of a shift toward detection of stage I cancers or in terms of decreased mortality.

While this could simply suggest that the methods used in the Mayo Clinic study were not as sophisticated as those used in ELCAP, it points out that the simple fact that a technology exists that can detect cancer early does not mean that this technology will work if put into general practice at this time.

But most concerning is the extremely high proportion of false positive tests in both the ELCAP and Mayo Clinic studies. Even in the ELCAP study, the positive predictive value of CT screening was only 12%. This means that 88% of patients with a lung nodule diagnosed on CT scan turned out not to have cancer. The anxiety created by the finding of a lung nodule is substantial, and at sites that do not have diagnostic follow-up procedures as carefully developed as with ELCAP or with radiologists who have as extensive experience in interpreting follow-up CT findings, many of these false positives will lead to morbidity and even mortality from invasive diagnostic tests.

Based on the published ELCAP findings (and this is a conservative estimate, as most CT scanning sites in the country do not have the kind of experience that ELCAP radiologists have), if the 92 million smokers and ex-smokers were to be screened, approximately 21 million individuals would be diagnosed with lung nodules, and 19 million of these people would have no malignant disease. Is it really fair to these 19 million people to get them all alarmed about their potential lung cancer risk and then for them to find out they do indeed have a lung nodule, but to make them either undergo invasive procedures or simply have to wait 6 months or a year with this anxiety, only to have them find out that nothing is wrong? Especially when we do not have sufficient published evidence to conclude that screening will save lives and that the benefits will outweigh the risks?

While I am open to the possibility that at some point in the future, the evidence will swing in favor of the routine use of chest CT for early detection of lung cancer in asymptomatic, high-risk patients (such as smokers), there simply is not sufficient evidence at this time to support a recommendation for population-based screening of smokers and ex-smokers.

Smokers should certainly quit smoking now to reduce their lung cancer risk, but there is no reason for a mass influx of the nation's 92 million smokers and ex-smokers into their doctors' offices to request a chest CT scan. There is not at the present time sufficient published evidence that warrants a conclusion that presenting to their doctors for lung cancer screening will have benefits to them that outweigh the risks that they will have to endure due to the enormously high false positive rate associated with this screening.


UPDATE (April 11, 2005; 11:50 pm): The American Council on Science and Health has released an excellent statement on this issue. The ACSH recommendations are evidence-based and acknowledge the increased anxiety about this disease among the public, especially ex-smokers. They do not try to channel this anxiety into a screening test that, as of yet has not been shown to have benefits that outweigh the costs of "needless anxiety and even needless surgery."

New York Smokers' Class Action Lawsuit Seeks Payment for Lung Cancer Screening via CT Scans

A class-action lawsuit was filed yesterday in a New York federal district court on behalf of all 50+ year-old smokers in New York State who smoked at least one pack per day of Marlboro cigarettes for at least 20 years. The lawsuit is unusual in that it doesn't seek damages for harms done to the smokers, but instead asks Philip Morris (maker of Marlboro) to pay for a screening program intended to provide early detection of lung cancer among this group of smokers.

Specifically, the lawsuit apparently asks the Court to require Philip Morris to pay for annual, low-dose spiral CT scans of all of the smokers in this class. Further tests (such as biopsies) needed to confirm the diagnosis of lung cancer, as well as surgery, if needed, would presumably be covered by the smokers' traditional insurance programs, although it is not clear to me whether insurance companies would pay for follow-up tests required due to a tobacco industry-funded screening program.

The lawsuit apparently contends that this screening program will benefit the class members, estimated in the tens of thousands, by providing early diagnosis of lung cancer at a stage that is more treatable.

The Rest of the Story

There's just one problem with this lawsuit: as of yet, there is simply not an early detection program that has been shown to both reduce lung cancer mortality and to be sufficiently specific (i.e., to have a low enough rate of false positives) so as to present benefits that outweigh the costs of the screening program in terms of the false positive diagnosis rate and the need to intervene with intensive and invasive procedures on a huge proportion of patients who do not in fact have disease.

For this reason, no major medical organization has recommended low-dose CT screening as an effective tool for the early detection of lung cancer on a population basis.

The problem is that low-dose spiral CT scans, in the current form available in most hospitals, has an extremely low positive predictive value. In other words, the proportion of patients with a nodule detected on CT scan who actually have lung cancer is extremely low. The overwhelming majority of patients with an abnormal CT scan do not, in fact, have lung cancer.

But the presence of an abnormal CT scan requires intensive and possibly, invasive follow-up tests, including the possibility of a lung biopsy, in order to rule out lung cancer. Plus, the finding of a nodule on a CT scan is going to certainly create a huge amount of anxiety for these smokers, and for many of them, they will have to live with this anxiety because the recommendation will be to simply have them come back in 6 months or a year for another CT to see if the nodule has grown.

If I were a smoker, I don't think I would want to be told that I have a nodule in my lung that could be lung cancer, but that the doctors aren't going to do anything about it except wait for a year to see if it grows. I would be absolutely freaking out.

And the reality is that the majority of smokers screened by such a program would be in exactly this situation.

Medical screening is a wonderful thing and it can save lives, but if done indiscriminately, or in situations where a sufficiently specific test is not available (especially if combined with the low prevalence of the disease being detected), it can result in a lot of harm. And the balance of harm to good can actually lie on the harm side.

In the case of low-dose spiral CT scans for early detection of lung cancer, the balance right now, in my opinion at least, lies on the side of more harm than good. And this is why no medical organization has recommended this procedure as an effective screening test for lung cancer.

I am not suggesting that low-dose CT scans will not ever become an effective screening test, or that there will not at some point (possibly very soon) be evidence that the procedure does reduce mortality. I am just stating that right now, there is not sufficient evidence that the procedure will indeed save lives, and there is certainly not evidence that the benefits of instituting this screening procedure on a large population of tens of thousands of smokers would result in more good than harm.

I think it's going to be difficult to convince a jury otherwise.

New Study Promotes CT Screening as Smoking Cessation Tool

A study in the April 15 issue of Cancer reports that abnormal CT scans obtained as part of a three-year study of the utility of screening for lung cancer among smokers served as a motivational tool that increased smoking abstinence among these patients. Among smokers receiving annual chest CT scans for the early detection of lung cancer, 42% who had three successive abnormal scans quit smoking, compared to 28% with two abnormal scans, 24% with one abnormal scan, and 20% with no abnormal scans. Receiving a recommendation the previous year for follow-up due to an abnormal CT scan finding was significantly associated with smoking cessation.

The authors conclude not only that increased positive findings on chest CT screening increase smoking cessation, but that overall, the use of this type of screening enhanced smoking cessation rates, as “abstinence rates for those receiving 1, 2, or 3 positive screenings are much greater than the expected annual abstinence rates of 5-7% found in the general population.”

The paper’s overall conclusion is that: “Better understanding of the predictors of smoking cessation, including multiple lung CT scans, may inform the debate on the use of screenings for early-stage lung carcinoma to increase smoking abstinence… .” The authors note that: “The cost of annual lung CT scan screenings will have to be weighed against the potential benefits of increased smoking abstinence rates in high-risk populations of smokers.”

The Rest of the Story

On the surface, this may appear to be convincing evidence that supports the use of chest CT scanning of smokers as a motivational tool to encourage smoking cessation. However, closer consideration of the study reveals a number of very concerning issues.

First, at the most basic level, this study does not provide evidence that annual CT scanning of smokers, in itself, enhances smoking cessation. The paper compares the rate of smoking abstinence among study participants (which was about 20% at three year follow-up for smokers with normal CT findings) with rates among the general population of smokers (which are only 5-7%). However, this is not a relevant comparison. A relevant comparison would be with smoking abstinence rates among smokers who are highly motivated to quit, so motivated that they enroll in a lung cancer screening study.

In other words, the very fact that all subjects in this study were motivated enough to enroll in an intensive, long-term study to specifically screen for lung cancer makes them a special population, and comparing cessation rates among this group to population cessation rates makes little sense. So the absolute finding of “high” rates of smoking cessation in this study is not particularly meaningful.

Second, the study finding that being told that one has a suspicious lung nodule that needs follow-up motivates people to quit smoking is actually somewhat disturbing. Why? Because the overwhelming majority of these nodules are not, in fact, malignant. According to the most recent published data from this Mayo Clinic study, 92% of abnormal chest CT findings in this study are benign. What this means is that it is largely false positive results that are motivating quitting behavior. Smokers are quitting, therefore, based on a largely false belief that they may have lung cancer.

In and of itself, this is not necessarily a bad thing; however, to recommend the use of CT screening to promote smoking cessation is essentially promoting the use of instilling false fears in patients in order to motivate a change in a health behavior. That I have serious problems with.

Third, and most importantly, this study seems to suggest that a finding of increased cessation among smokers who are screened via annual chest CT supports the use of this strategy. But I don’t find that to be relevant to the consideration of using chest CT as a medical screening tool. If chest CT scanning is to be justified, it is going to have to be justified entirely on the basis of being an effective screening tool. If it is not justified on the basis of being an appropriate screening technique, then the benefits that may accrue to patients in terms of smoking cessation certainly do not justify the widespread use of this screening strategy.

The paper speaks about a “debate on the use of screenings for early-stage lung carcinoma to increase smoking abstinence.” I find that disturbing, because I don’t think there should be any such debate. We should absolutely not be using CT screenings as a strategy to increase smoking cessation. That is simply not an appropriate use of a medical screening procedure.

I have several serious ethical concerns with the approach to the evaluation of chest CT screening suggested in this paper. Is it ethical to promote a strategy for smoking cessation that relies largely upon instilling false and inappropriate fears among patients to motivate them to change their behavior? Is it ethical, in the first place, to use a medical screening procedure (that is designed for the early detection of disease) as a health behavior change strategy?

I can imagine, for example, that giving all 20-year-olds a colonoscopy might be an extremely effective strategy to change health behaviors (such as fiber intake and fat intake) that may be risk factors for colon cancer. Giving 18-year-old smokers a bronchoscopy would almost certainly induce a large number of them to quit. But these strategies are not ethical, because they are simply not justified as screening procedures.

My point here is not that chest CT scans will not eventually turn out to be justified as a lung cancer screening tool (although see my previous posts [post1 post2] about why there is not evidence at this time to justify CT screening for lung cancer). Instead, my point is that whether CT scanning increases smoking cessation is not relevant to the consideration of this strategy as a medical screening procedure. If it is justified, then it must stand on its own as a screening strategy, not on the basis of any effect on health behavior change.

So I disagree with the paper’s contention that “The cost of annual lung CT scan screenings will have to be weighed against the potential benefits of increased smoking abstinence rates in high-risk populations of smokers.” That is not an appropriate consideration. Even if the costs are outweighed by potential benefits of smoking cessation, the use of annual lung CT scans is not justified, appropriate, or ethical if it is not determined to be an effective and appropriate medical screening technique.

The rest of the story suggests that the appeal of advanced, state-of-the-art, high-technology solutions to society’s problems may be clouding the judgment and decision-making framework in the medical profession, and if left unchecked, could eventually result in the inappropriate and potentially unethical promotion of a costly, intensive, and fear-producing medical procedure.

Judge Allows Class Action Suit to Require Philip Morris to Pay for CT Scans for Smokers

A Massachusetts judge has ruled that an unusual class action lawsuit against Philip Morris may proceed. The judge's ruling certified the class, but it does not relate to whether the legal basis for the suit is sound. The ruling means that the judge has found that the legal issues involved are common to all plaintiffs, and thus the case can proceed as a class action suit. The class consists of all Massachusetts adults ages 50 and older who smoked Marlboros at an intensity of at least one pack per day for at least 20 years.

The case is unusual, because unlike most cases, it does not involve the pursuit of damages for smokers who have already suffered diseases or death that are allegedly due to their smoking. Instead, it seeks costs for medical monitoring of "healthy" smokers for early detection of lung cancer. Specifically, the suit seeks payment for annual chest CT scans. The reasoning behind this request is that the plaintiffs allege that these CT scans will detect lung cancer early, at a more treatable stage, and thus will save lives.

According to the article in the Boston Globe: "The plaintiffs claim that if they do eventually develop the disease, the screenings will increase their likelihood of survival almost six-fold. No class member would be eligible if they have been diagnosed with lung cancer or are under a doctor's care for suspected lung cancer, and all must have smoked Marlboro cigarettes within Massachusetts, she wrote. Marlboro cigarettes are designated because that is the brand the two plaintiffs smoked. Richard Daynard, a law professor at Northeastern University and chair of its Tobacco Products Liability Project, said that if the plaintiffs win, the case will likely spawn dozens of similar suits in federal courts across the country. 'It's a tremendously important case,' he said. The case before Gertner, he added, will probably turn on whether the chest scans save lives. A growing body of evidence, he said, indicates that they do."

The Rest of the Story

Unfortunately, there is no scientific evidence at present demonstrating that CT scan screening for lung cancer among smokers is effective in saving lives. In contrast, the existing evidence demonstrates that the procedure is inappropriate as a screening test because it has an unacceptably high false positive rate, and that its implementation would certainly lead to morbidity and even mortality among smokers.

Why would there be morbidity and mortality among smokers? For two reasons. First, the many false positive results would require further diagnostic testing, some of which involves invasive procedures or surgery. There is a significant level of morbidity and mortality associated with such procedures. In addition, the anxiety produced for thousands of smokers who would be told they may have lung cancer would be substantial.

Second, CT scans involve considerably high doses of radiation and exposing a large population of asymptomatic individuals annually to this radiation would actually increase the risk of cancer in the population.

While one might argue that these risks are worth taking if the procedure has been shown to save lives, the existing evidence has not demonstrated that this is the case. Therefore, the risk-benefit equation is currently very strongly on the side of risk. And it would be unjustified to require Philip Morris to pay for a screening procedure that poses more potential risk than benefit.

Studies are currently underway to evaluate whether CT scanning of smokers for lung cancer could save lives. But until such studies are concluded, the evidence base simply does not support the use of this procedure on a population-basis, as is being proposed in this lawsuit. For this reason, no national medical organization currently recommends the use of CT scan screening.

The rest of the story, then, is that the existing scientific evidence does not support the use of CT scans for early detection of lung cancer. The current evidence demonstrates that such a procedure, implemented on a large scale, would undeniably result in a significant amount of morbidity and mortality, but that there is no guarantee that the procedure would save lives. Since the fundamental tenet of medicine is "to do no harm," the existing evidence does not justify the use of CT scans for early detection of lung cancer on a population-basis.

Therefore, I believe that the suit should not succeed.

Cornell Researcher Defends Failure to Disclose Tobacco Funding and Financial Interests in General Electric; Defense is Worse than Original Offense

In a response to publicity regarding her failure to disclose funding of her research on the use of CT scans for lung cancer screening and her failure to disclose potentially significant financial interests in General Electric, which stands to gain from adoption of CT screening, Dr. Claudia Henschke and her institution - the Weill Cornell Medical College - released a statement defending both of these disclosure failures.

As I discussed here on Friday, in an October 26, 2006 article in the New England Journal of Medicine, Dr. Claudia Henschke of Weill Cornell Medical College and a group of other investigators reported the results of a study of the use of low-dose spiral CT scans as a screening tool to detect lung cancer among asymptomatic individuals. The article reported that 85% of patients with lung cancer detected had stage I cancer and the estimated 10-year survival among these patients was 88%. The study concluded that: "Annual spiral CT screening can detect lung cancer that is curable" and that "such screening could prevent some 80% of deaths from lung cancer."

The paper listed its funding sources at the end, one of which was the Foundation for Lung Cancer: Early Detection, Prevention & Treatment.

The New England Journal of Medicine has a policy of not publishing any paper supported with funds from the tobacco industry. Not seeing any disclosure of funding from the industry, the Journal published the paper.

However, it turns out that the Foundation for Lung Cancer: Early Detection, Prevention, & Treatment "was, according to a New York Times article, "underwritten almost entirely by $3.6 million in grants from the parent company of the Liggett Group, maker of Liggett Select, Eve, Grand Prix, Quest and Pyramid cigarette brands. The foundation got four grants from the Vector Group, Liggett's parent, from 2000 to 2003."

According to the New York Times article and a concurrent article in The Cancer Letter, the Journal of the American Medical Association was also deceived by the absence of disclosure of Dr. Henschke's tobacco funding and would never have published her paper had they known that Henschke received tobacco industry money for her CT screening research.

To make matters worse, the Times reported that Dr. Henschke "failed to disclose in articles and educational lectures a patent and 10 pending patents related to CT screening and follow-up." By virtue of these financial interests, Dr. Henschke stands to benefit personally (financially) if her recommendations for the widespread adoption of CT scan screening for lung cancer are adopted.

Moreover, the Cancer Letter reports that "medical journals and providers and accreditors of continuing medical education are investigating her failure to disclose patents and royalties from commercial sponsors, including GE Healthcare. As the leading manufacturer of CT scanners, GE stands to benefit from Henschke's campaign to screen asymptomatic former and current smokers."

I wrote Friday that if it is true that Dr. Henschke has a significant financial interest in GE Healthcare, such as royalties, consultant fees, or licensing payments, and that financial interest was present in October 2006, then she did fail to disclose that interest in her New England Journal article as that article states: "No potential conflict of interest relevant to this article was reported."

The Rest of the Story

Unfortunately, in the March 26 statement from Dr. Henschke and Weill Cornell Medical College, they defend both of these failures in disclosure and do not accept any responsibility for misconduct or apologize for this conduct.

Regarding the failure to disclose funding of the research by a tobacco company, the statement argues that: "The original $2.4 million pledge to the Foundation -- and the work funded by the Foundation at Weill Cornell -- was fully and publicly disclosed at the time through a press release, and was substantially covered in the lay media. It was discussed and disclosed in the academic community at conferences, which were widely attended by advocacy groups, agencies, and by investigators from around the world interested in lung cancer screening. It was also fully disclosed to other foundations and groups wishing to contribute funds to I-ELCAP."

Unfortunately, that is simply not enough. The funding by the tobacco industry needs to be disclosed in the article itself, and to the journal. It is not enough to expect that the journal editors will look up the Foundation for Lung Cancer on the internet and search newspaper articles to try to find out who the Foundation's donors are.

I do not believe that Dr. Henschke can hide behind the excuse that she disclosed funding from the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, and so that she did indeed disclose her funding sources. The intent of disclosure of funding is to provide editors, reviewers, and the public with relevant information about the source of funding, not merely to provide the name of the foundations or entities set up to receive that funding. Thus, I view the failure to disclose her funding from Liggett as a significant violation of ethical standards of conduct.

This defense is inadequate and it is unfortunate that the researcher is not willing to take responsibility for this failure. In many ways, I find this defense to be a worse offense than the original disclosure failure. To make a mistake is human, and perfectly acceptable if you admit your mistake, apologize, and learn from it. But to deny that there was any mistake and to worm around, trying to convince the public that you have indeed disclosed the funding when you haven't, makes the original offense even worse.

Regarding the apparent failure to disclose income paid by General Electric to the researcher through her institution from an intellectual property interest (licensing of a patent or patents), the statement defends failure to disclose this financial interest by arguing that it is not a significant financial interest as defined by federal regulations: "Cornell Research Foundation, a subsidiary of Cornell University, licensed technology (some of which is now patented) related to detection and measurement of nodules developed by Henschke, Yankelevitz and others to GE. As is typical at many institutions, the royalties were distributed to Cornell, which, in turn, provided a share to the inventors under Cornell intellectual property policy, which is in line with the Bayh-Dole Act. NIH Conflict of Interest regulations currently do not require individual disclosure of royalties paid to them by the employer institutions (see 42 CFR 50.603 -- Definition of "Significant Financial Interest")."

There are two problems with this defense.

First, I believe it is a misinterpretation of federal policy. The exception for compensation received from an institution applies, I believe, to compensation paid by the institution. I do not believe that exception was meant to apply to compensation, such as royalties for a licensed patent, paid by a corporation to an investigator through an institution. If that were the case, then any researcher could get around this problem by simply having the checks made out to the institution, and then having the institution make out a check to the researcher. Clearly, this is a circumvention of the spirit of the policy. The fact that General Electric made out checks to Cornell, which were then distributed, in part to Dr. Henschke, does not in my opinion mean that she did not have a significant financial interest under federal regulations.

Second, and more importantly, the policy of medical journals is not that investigators have to report significant financial interests as defined by federal policy. The policy of journals is that investigators have to report all significant financial interests, as defined by the journal.

The New England Journal of Medicine defines a significant financial interest as "any financial arrangement they [investigators] may have with a company whose product is pertinent to the submitted manuscript or with a company making a competing product."

Furthermore, the Journal describes the financial disclosure statement that is required of investigators as follows: "The statement should describe the authors’ relationships with companies that make products relevant to the paper. The statement should specify the type of relationships (e.g., consulting, paid speaking, grant support, equity, patents) EACH author has with EACH company."

In its published policy on conflicts of interest, the Journal even specifies that "patent royalties" are to be included as signficant financial conflicts of interest.

It is very clear, according to the Journal's policy, that investigators are to disclose all financial interests in companies whose products are pertinent to the manuscript.

No exceptions are made for royalties received from the university related to intellectual property licensed to a corporation. Given the information reported in the statement by Dr. Henschke and Cornell and the policy of the New England Journal of Medicine, I see no way one can conclude that there was not a blatant violation of the Journal's financial disclosure policy (unless the financial arrangement was not present at the time the manuscript was submitted, which does not seem to be the case).

Again, this weak attempt to defend the failure to disclose the significant financial interest appears to be an even greater offense than the original failure.

Why can't they just admit that a mistake was made, correct it, apologize, and move on?

The original failures to disclose the tobacco industry funding of this research and the existence of significant financial conflicts of interest were bad enough. But the defense of these unethical actions is an even worse offense.

Investigators Running Lung Cancer Detection Trial Cannot Locate Informed Consent Forms; Unclear if Informed Consent Was Obtained from Patients

According to an article in the New York Times, investigators running a trial to determine whether CT screening for lung cancer is effective in reducing mortality rates cannot locate 90% of the informed consent forms, casting doubt on whether consent was appropriately obtained for tens of thousands of patients who were subjected to significant quantities of radiation.

According to the article: "In medical experiments on human beings, every patient must sign an “informed consent” form acknowledging the risks, and researchers are required to keep track of those statements. But the doctors who conducted a controversial, widely publicized lung cancer study involving more than 50,000 patients at numerous hospitals were unable to locate 90 percent of the consent forms, according to a confidential review provided to The New York Times. The finding casts further doubt on a clinical trial that made headlines in 2006 when it concluded that fully 80 percent of lung cancer deaths could be prevented through wide use of CT scans."

A scientific reviewer who was called in to assess the situation is quoted in the article as stating that he has no confidence that informed consent was actually obtained for tens of thousands of patients: "One reviewer, Dr. David P. Carbone, a professor of medicine and cancer biology at Vanderbilt, said in an interview that he and the other reviewers never found out 'whether these consents were obtained and lost or whether they weren’t obtained at all.'"

One medical journal that published work from the research - entitled the International Early Lung Cancer Action Program (ELCAP) - stated that it would be forced to retract that article if the consent forms cannot be located: "Dr. Bruce A. Chabner, director of clinical research at Massachusetts General Hospital Cancer Center and editor in chief of The Oncologist journal, said he would ask Weill Cornell for an explanation of the problems outlined in the 2008 scientific review, as well as a follow-up to the report. His journal has published research by Dr. Henschke, and 'if we find there was no informed consent for those patients, the paper would have to retracted,' he said."

The Rest of the Story

This appears to be a very serious violation of responsible research conduct. It is particularly troubling because this is not a minimal risk study. Subjects in the ELCAP trial are subjected to significant doses of radiation, which itself presents a small cancer risk. If subjects were entered into the trial without informed consent, this would be a major ethical breach.

A single CT scan can expose a patient to the equivalent amount of radiation as up to 442 chest x-rays. Some researchers have estimated that radiation delivered by CT scans in one year will result in a total of 29,000 future cases of cancer. Thus, the risks to which patients were exposed in the ELCAP trial are not trivial and the failure to be able to document informed consent is a major problem.

Long-time readers of the Rest of the Story may recognize that this is not the first time this research has been the subject of a commentary. The institution where the bulk of the research was conducted - the Weill Cornell Medical College - was awarded my Pants On Fire Runner-Up Award in 2009 for falsely claiming that an apology was made for its investigators' failure to disclose a significant conflict of interest in their article on the role of low-dose CT scans in screening for lung cancer.

That financial interest: the principal investigator of the study receives royalties from General Electric on intellectual property she invented which involves the use of CT scanning for early diagnosis of lung cancer, intellectual property which was licensed to General Electric.

Thus, the investigator stands to gain financially if CT scanning is found to be effective in reducing cancer mortality. I wonder if this fact was disclosed to study participants. My personal view is that it would have been unethical not to inform patients of this financial conflict of interest.

Sadly, the rest of the story is that the researchers cannot even document that informed consent was obtained, much less that the financial conflict of interest was disclosed to potential study participants.

New Study Shows that Use of CT Scanning is Not an Effective Screening Tool for the Early Detection of Lung Cancer

New research presented at the annual meeting of the American Society of Clinical Oncology revealed that the use of low-dose spiral CT scanning for the early detection of lung cancer is an ineffective screening tool because it produces an unacceptably high rate of false positive tests, leading to a substantial number of risky and invasive diagnostic procedures.

According to the study: "An individual's cumulative probability of at least one false-positive CT scan was 21% after one screen and 33% after two. ... Of those getting a CT false positive, 6.6% had an invasive diagnostic procedure and 1.6% had major surgery."

This means that approximately 2.2% of all patients screened will have an unnecessary invasive diagnostic procedure and about 0.5% of all patients screened will have unnecessary (and risky) major surgery.

The Rest of the Story

These new findings indicate that at the present time, the use of low-dose spiral CT scanning for the early detection of lung cancer is not effective as a screening tool and its use should not be recommended as a screening method.

The findings are in contrast to the assertions of Dr. Claudia Henschke, the researcher from the Weill Cornell Medical College who, as I reported here (post 1; post 2) in March of last year, has been a strong advocate for the use of CT scans as a screening technique for lung cancer.

The rub: Dr. Henschke covered up the fact that her work was funded by a tobacco company, failed to disclose a number of patents related to CT screening for lung cancer, and also failed to disclose royalties received from GE related to the use of CT scanning for the early detection of lung cancer.

To make matters worse, after being forced to properly disclose the financial conflicts of interest, Dr. Henschke and her institution still refused to admit that they had done anything wrong, defending their behavior with an inappropriate, uncompelling, and somewhat misleading excuse statement (post 1; post 2).

In other words, Dr. Henschke has a vested financial interest in showing that CT scans are an effective lung cancer screening tool, has been pushing that position, and pushed that position in the medical literature without disclosing her financial interest in pushing such a position.

This is a serious, and unfortunate, example of a severe conflict of interest and a resulting ethical breach of conduct by an an anti-smoking researcher.

The importance of the new research findings is that they demonstrate how off the mark Dr. Henschke was with her conclusions and how potentially damaging her apparently biased recommendations were.

The failure of Dr. Henschke and her institution to: (1) disclose the relevant funding source and conflicts of interest; and (2) to admit that they erred in failing to make those disclosures represent what in my mind are serious breaches of ethical conduct. Those breaches of conduct have been made ever so much worse by the recent news that CT scanning yields huge numbers of false positive results, causing unnecessary risk, pain, and suffering among human subjects.

In my view, every subject who is entered into clinical trials in which Dr. Henschke is an investigator and/or in which Cornell Medical College is involved should be informed of the relevant conflicts of interest as part of the consent procedure. The patients should also be informed of the high frequency of serious adverse effects from the study intervention, including the high possibility that they will require unnecessary invasive diagnostic procedures and/or major surgery. They should also be informed that there is currently no evidence that the screening will have any benefit for them or for the study population as a whole.

The failure of Dr. Henschke and Cornell Medical College to readily disclose the conflicts of interest is particularly egregious because of the high risk of harm to subjects in this research. We are talking not only about scientific harm caused by bias due to financial interests; we are also talking about real and serious harm to humans that is made much worse, and much less excusable, by the existence of the financial conflicts of interest.

The Rest of the Story Announces the 2009 Lie of the Year Award and the Pants on Fire Runner-Up Awards for 2009

Today, the Rest of the Story announces the recipients of the 2009 Lie of the Year Award, as well as the runner-ups, who are awarded the Pants on Fire Runner-Up Awards for 2009 (apologies to Politifact.com for borrowing these designations).

The Lie of the Year Award is presented each year to the anti-smoking organization which communicates the most inaccurate information to the public. The award is based not merely on having lied to the public, but also on the significance of the scientific or factual distortion in terms of its public health or public policy significance. Special consideration is given to organizations which are made aware of the factual inaccuracies but which continue to disseminate the false information to the public.

Lie of the Year Award Winner

This year's Lie of the Year Award is presented to Smoke Free Wisconsin for its public communication which informed readers that electronic cigarettes are a Big Tobacco ploy to hook kids.

On March 25, 2009, the anti-smoking organization SmokeFree Wisconsin accused tobacco companies of using electronic cigarettes as a ploy to hook youths on these products. The group asserted that these products are being marketed to kids by virtue of their being produced in fruit flavors. For these reasons, SmokeFree Wisconsin joined a number of other health groups in supporting efforts to remove electronic cigarettes from the market.

SmokeFree Wisconsin wrote in its blog entry entitled "E-cigarettes: The Latest Ploy By Big Tobacco to Hook Kids": "A recent call to our office prompted us to look further into the emerging issue of 'e-cigarettes.' A group of public health advocates has urged the Food and Drug Administration (FDA) to pull e-cigarettes (or electronic cigarettes) from sale in the United States. ... E-cigarettes are often made to look like conventional tobacco products and are marketed to kids by producing them in fruit flavors. A united group of public health advocates, including the American Cancer Society Cancer Action Network, American Heart Association, American Lung Association and the Campaign for Tobacco-Free Kids, sent out a press release commending Senator Frank Lautenberg of New Jersey for demanding that the FDA remove e-cigarettes from the marketplace. FDA officials have been quoted in the past few weeks saying e-cigarettes are a 'new drug' that needs to be approved by the government before it can be sold."

Despite immediate responses from readers noting that electronic cigarettes are not produced by tobacco companies and therefore cannot possibly be a "Big Tobacco" ploy and despite several emails to the organization from me informing the group that its claim was false, Smoke Free Wisconsin failed to correct its post for at least six months.

Finally, Smoke Free Wisconsin relented and changed the title of its post. However, it issued no clarification, correction, or apology for the error and did nothing to highlight or call out the error.

The lie is significant because the removal of electronic cigarettes from the market would be devastating to the public's health. It would result in a return to cigarette smoking by perhaps hundreds of thousands of ex-smokers who now rely on vaping to keep them off of tobacco products. Many of these people have experienced substantial improvements in their health, which would compromised and reversed if they are forced to return to smoking. Thus, the false information disseminated by Smoke Free Wisconsin could have contributed to a public policy that results in increased disease and death.

Not a small price to pay for the lie of the year.

Pants On Fire Runner Up Award #1

The first Pants On Fire Runner-Up Award is presented to the American Cancer Society for falsely informing its constituents that a bill passed by the New York State Assembly bans flavored cigarettes, when in fact it exempts menthol cigarettes, which account for nearly half of the cigarettes consumed by underage youths.

On its web site, the American Cancer Society (ACS) stated that it was supporting a ban on flavored cigarettes, which it asserted have long been used by tobacco companies to lure kids into smoking.

According to the ACS: "Candy, fruit and liquor-flavored cigarettes are smoked by school children in much higher numbers than adults. Cigarette makers have long seen sweetened cigarettes as a lure for catching young customers. The American Cancer Society supports a ban on these dangerous products."

The ACS also stated: "A bill to eliminate flavored cigarettes passed the [New York] State Assembly in early 2009 and awaits action. We are hopeful this bill can become law this year."

However, the bill passed by the New York State Assembly does not ban flavored cigarettes. It does not, for example, ban menthol-flavored cigarettes. It does not ban clove cigarettes. What it bans are a number of types of cigarettes that were already taken off the market several years ago. There is not a single brand of flavored cigarettes produced by Big Tobacco which is covered by this legislation. But what the bill does is specifically allow the most common flavored cigarettes - menthol and clove cigarettes - to remain on the market.

This lie is significant from a public health perspective because it deceives constituents into thinking that the state legislation will eliminate flavored cigarettes from the market and thus curtail the enticement of youths to smoking via flavored products. Unfortunately, nothing could be further from the truth. The bill removes absolutely no cigarettes from the market (as the FDA legislation already eliminated non-menthol flavored cigarettes) but it allows menthol cigarettes, which are smoked by nearly half of teenage smokers - to remain on the market.

There may be a way to deceive one's constituents more about a public health issue, but I'm not aware of how.

The American Cancer Society solidified its first runner-up position by also lying to its constituents in another communication, this one also claiming that a piece of legislation - the federal FDA tobacco legislation - banned all flavored tobacco products when in fact the flavored cigarettes enjoyed by half of all youth smokers - menthol cigarettes - were exempted from the ban.

In a communication sent to the American Cancer Society's (ACS) network of advocates throughout the nation (including myself) and posted on the Society's web site, the ACS lied about the effects of the FDA tobacco legislation passed by the U.S. House and Senate and signed into law by President Obama. According to the American Cancer Society's statement: "Our nation's children – potential first-time smokers – will no longer be seduced by flavored tobacco products, including candy- and fruit-flavored cigarettes, which will be banned." The American Cancer Society is thus claiming that the FDA tobacco legislation bans all flavored tobacco products that might seduce children.

If the American Cancer Society had read the actual text of the legislation or read any of hundreds of newspaper articles about the bill published in the past month alone, it would have easily found out that the bill does not ban all flavored tobacco cigarettes that seduce young smokers. The bill specifically exempts menthol from its ban on cigarette flavorings.

Pants On Fire Runner-Up Award #2

The second Pants On Fire Runner-Up Award for 2009 goes to the Institute of Medicine Committee on Secondhand Smoke Exposure and Acute Coronary Events for claiming that it conducted a comprehensive review of unpublished data on the relationship between smoking bans and heart attacks when it failed to review any unpublished data in its report.

The IOM report failed to consider relevant, objective, population-based data from the following, each of which fails to find any effect of smoking bans on heart attacks, in the short-term:

1. Scotland
2. England
3. Wales
4. Denmark
5. Florida
6. California
7. Oregon
8. New York
9. United States

The IOM committee states that it did not consider the data from these nine states or countries because they were unpublished. In an email, a committee member states: "The data from England, Scotland and Wales and their analyses referred to in your email are not found in the peer-reviewed literature and, therefore, were not reviewed in the committee’s report. It was beyond the scope of our study to seek out data available from all the municipalities, counties, states or countries that might be relevant to smoking bans and to conduct our own original studies."

In another email, a committee member acknowledges that he had not even seen the relevant data referred to above.

It seems clear that the committee did not consider these unpublished data in its report.

However, the press release states: "The IOM committee conducted a comprehensive review of published and unpublished data and testimony on the relationship between secondhand smoke and short-term and long-term heart problems."

If the report failed to consider the unpublished data and at least one of the committee members acknowledges not having even looked at that data, then why does the press release untruthfully state that the committee conducted a comprehensive review of unpublished data? How comprehensive a review is one in which the data are apparently not even examined? How comprehensive a review is it if the unpublished data are not even mentioned in the report?

The committee is of course free to restrict its analysis to published data, but you can't have it both ways. You can't restrict your analysis to published data and then lie to the the public and tell them that you comprehensively reviewed the unpublished data as well.

Why not just tell the truth and state that you examined only published data, not unpublished data?

This lie is very significant, because it is the difference between an accurate and an inaccurate conclusion on whether smoking bans produce immediate, dramatic reductions in heart attacks due to a reduction in secondhand smoke exposure. With the unpublished data, it is very clear that there simply is no valid way to conclude that smoking bans produce such an effect. Even without the unpublished data, it appears that one cannot conclude that there is any effect. But the point here is simply that the IOM Committee misled the public when it stated in its press release that it included a comprehensive review of unpublished studies in its review, but acknowledged in separate communications that unpublished data were specifically excluded from the review of the effect of smoking bans on heart attacks.

Pants On Fire Runner-Up Award #3

The third Pants On Fire Runner-Up Award is presented to Breathe California of Sacramento-Emigrant Trails for its continuing assertion that smoking kills 340 young people a day (124,000 young people each year).

Breathe California of Sacramento-Emigrant Trails has been aware of this inaccurate statistic on its web site since at least October 22, 2007, when I first notified the group of the error. If this were just an innocent mistake, I think it would be reasonable to assume that the organization would quickly change the web page to correct the mistake.

However, as you can see, the "mistake" persists to this day.

In fact, several months after I first wrote to the group, asking why they hadn't yet changed the web page, I was told that the reason for the failure to correct this statistic was that the web master was unavailable (presumably on vacation).

All I can say now is that it's been one heck of a long vacation: from October 22, 2007 to December 20, 2009. That's 26 months - more than two years!

I would love to have that web master's job.

Pants On Fire Runner-Up Award #4

The fourth Pants On Fire Runner-Up Award is presented to the Canadian Non-Smokers' Rights Association (NSRA) for falsely accusing Citizens Against Government Encroachment (CAGE) of being funded by Big Tobacco.

In a document entitled "Exposing Recent Tobacco Industry Front Groups and Alliances," the Canadian Non-Smokers' Rights Association (NSRA) accused CAGE of being a Big Tobacco front group. The document, dated March 2008, defined a "front group" as being an industry-funded group that in some way hides its funding or its vested interest. In particular: "By operating in the shadows cast by Big Tobacco, industry-funded front groups make it difficult to determine whether these 'grassroots' organizations are truly independent or representing some other entity or vested interest." The Non-Smokers' Rights Association adopted the following definition of "front group," which is taken from the SourceWatch encyclopedia: "A front group is an organization that purports to represent one agenda while in reality it serves some other party or interest whose sponsorship is hidden or rarely mentioned."

Thus, as NRSA defined it, a front group is funded (sponsored) by a third party whose interests are being directly served in a concealed way.

However, NRSA provided not a shred of evidence that CAGE receives tobacco industry funding or is in any way associated with the tobacco industry.

To its credit, NRSA did remove the document from its web site.

This lie is notable not because of its public policy significance, but because the false claim was an arguably defamatory one. It demonstrates the lengths to which some anti-smoking groups are willing to go to sling mud in the faces of anyone who opposes them.

Pants On Fire Runner-Up Award #5

The fifth and final Pants On Fire Runner-Up Award for 2009 goes to Weill Cornell Medical College for falsely claiming that an apology was made for its investigators' failure to disclose a significant conflict of interest in their article on the role of low-dose CT scans in screening for lung cancer.

The story began when two Weill Cornell Medical College researchers failed to disclose two important conflicts of interest in an article they published about the use of CT scanning in early detection of lung cancer.

Even after being publicly scolded by the New England Journal of Medicine for her failure to disclose the tobacco industry funding of her research on the use of CT scans in lung cancer screening and her significant financial interest in this technology (she receives royalties on intellectual property she invented which involves the use of CT scanning for early diagnosis of lung cancer), the lead researcher from Weill Cornell Medical College and the school itself defended her failure to provide these disclosures.

In a statement released by Weill Cornell Medical College on April 4, the school not only defended the researcher in failing to disclose significant financial conflicts of interest to medical journals, but it also blamed the New York Times for inaccurate reporting.

According to the statement: "As you may know, an article appeared last week in The New York Times (Mar. 26, 2008) alleging that two Weill Cornell Medical College (WCMC) researchers did not fully disclose that their research on the use of CT screening for the early detection of lung cancer was partially funded by money from a tobacco company, and did not properly disclose the existence of the Foundation that received the funds. We believe the article did not present a complete picture of the facts and that its primary conclusion -- that Weill Cornell intentionally attempted to conceal the gift in the Foundation -- is simply wrong."

The statement then goes on to argue that Liggett's gift to the Foundation which funded the research was widely publicized at the time the donation was made. It also argues that the failure to disclose the tobacco industry funding was not intentional.

In terms of the failure to disclose the researcher's financial interest in the use of CT scans for lung cancer detection (she apparently receives royalties from General Electric after the licensing of the patents to GE), Weill Cornell Medical College defends the disclosure failure on the grounds that "Henschke and Yankelevitz did not use the GE products developed under the licensing agreement as part of the I-ELCAP, and did not require participating I-ELCAP institutions to use the GE product."

The statement also contends that the researcher published a public apology in the New England Journal of Medicine. According to the statement: "Some of those publications have disagreed with Dr. Henschke and Dr. Yankelevitz's judgment on these, and corrections and apologies have been published in those journals."

I find this to be a truly pathetic attempt to defend what was clearly an inappropriate failure to disclose two important conflicts of interest.

First, the funding by the tobacco industry needs to be disclosed in the article itself, and to the journal. It is not enough to expect that the journal editors will look up the Foundation for Lung Cancer on the internet and search newspaper articles to try to find out who the Foundation's donors are.

I do not believe that Dr. Henschke can hide behind the excuse that she disclosed funding from the Foundation for Lung Cancer: Early Detection, Prevention & Treatment, and so that she did indeed disclose her funding sources. The intent of disclosure of funding is to provide editors, reviewers, and the public with relevant information about the source of funding, not merely to provide the name of the foundations or entities set up to receive that funding. Thus, I view the failure to disclose her funding from Liggett as a significant violation of ethical standards of conduct.

This defense is inadequate and it is unfortunate that the researcher is not willing to take responsibility for this failure. In many ways, I find this defense to be a worse offense than the original disclosure failure. To make a mistake is human, and perfectly acceptable if you admit your mistake, apologize, and learn from it. But to deny that there was any mistake and to worm around, trying to convince the public that you have indeed disclosed the funding when you haven't, makes the original offense even worse.

Second, whether Dr. Henschke used GE products in her research or not is immaterial to the question of whether her financial interest in General Electric represents a conflict of interest. It is not a conflict of interest because she is using GE products; it is a conflict of interest because she has a financial interest in a company which stands to gain financially from the widespread use of CT scanning for early detection of lung cancer. Thus, there would be a significant financial conflict of interest even if this research employed only CT scanners made by other manufacturers.

Again, this attempt to confuse the public and obscure the underlying issue is quite unfortunately. And again, I find this aspect of the defense to be worse than the original failure in disclosure.

To make matters even worse, it appears that the statement is dishonest in asserting that an apology was published in the New England Journal of Medicine.

Two corrections were published. In the first, the author writes: "In our article published in the October 26, 2006, issue of the Journal, one of the disclosed sources of funding was the Foundation for Lung Cancer: Early Detection, Prevention and Treatment, which provided partial support for our research. For full transparency we wish to inform you that $3.6 million (virtually all of the Foundation's funding) was contributed in 2000 through 2003 as an unrestricted gift by the Vector Group, the parent company of Liggett Tobacco, which manufactures cigarettes."

No apology is offered, nor is any wrongdoing admitted.

In the second correction, the Journal writes: "The disclosure statement (page 1769) should have read as follows: 'Drs. Henschke and Yankelevitz report receiving royalties from Cornell Research Foundation as inventors of methods to assess tumor growth and regression on imaging tests for which pending patents are held by Cornell Research Foundation and licensed to General Electric. No other potential conflict of interest relevant to this article was reported.'"

Again, no apology is offered here.

So unless I am missing something, it appears that the Weill Cornell Medical College statement is dishonest. There is no apology that I can find in the New England Journal of Medicine for these two failures in disclosure.

I would have a lot more respect for the Weill Cornell Medical College and the involved researchers if they simply admitted that a mistake was made and apologized for it. That would be the end of the story. We all make mistakes and we can learn from them.

However, instead of admitting a mistake and apologizing, the researcher's and the school's response has instead been to deny wrongdoing, obscure the issues, hide behind immaterial points that will confuse the public, and to go so far as to attack the New York Times for its reporting of the issue.

So let's now get to that important issue. Cornell is attacking the New York Times for falsely implying that the failure to disclose the tobacco industry funding of the research was intentional. Well, if it wasn't intentional, then Cornell must be claiming that there was simply a mistake. The investigator intended to disclose the tobacco funding, but somehow forgot to do so.

Unfortunately, that is clearly not the case in this situation (at least, it's not what Cornell states is the situation). Cornell is not advancing a position that Dr. Henschke revealed the tobacco funding of the research to the Journal, but the Journal just forgot to publish it. Nor is Cornell suggesting that Dr. Henschke intended to disclose the tobacco funding but simply forgot or neglected to include it in her manuscript.

It seems quite clear that the failure to disclose the tobacco industry funding was indeed an intentional failure. There was no intent upon the part of Dr. Henschke to inform the New England Journal of Medicine and the readers of the article that this work was funded by a grant from Liggett.

Had the intent been to make readers aware of the tobacco funding, then Dr. Henschke would have revealed that funding.

So I believe that the New York Times was in fact entirely correct in asserting that the failure to disclose the tobacco funding was intentional.

In closing, I have to say that the original failures to disclose the tobacco funding and the royalties from the patents licensed to General Electric pale in comparison to Weill Cornell Medical College's attempt to defend, obscure, and apparently - to lie - about aspects of the issue at hand.

If they simply came out and said: "We made a mistake. We're sorry," that would be the end of the story and I would have great respect for them.

Instead, I think they have made a public disgrace of themselves.

This ethics failure is an important one because the public policy and public health implications of the failed disclosure and of the investigators' apparent bias in hyping the value of CT screening for lung cancer is immense. A set of recent articles published in the Archives of Internal Medicine report that CT scans expose patients to significant levels of radiation which produces an increased risk of cancer.

As the article notes: "What is becoming clear, however, is that the large doses of radiation from such scans will translate, statistically, into additional cancers. With CT scan use increasing annually, it is imperative that clinicians take into account the radiation risks when assessing the benefit to their patients. ... 15 000 persons may die as a direct result of CT scans physicians had ordered in 2007 alone. Presumably, as the number of CT scans increase from the 2007 rate, the number of excess cancers also will increase. In light of these data, physicians (and their patients) cannot be complacent about the hazards of radiation or we risk creating a public health time bomb."

The paper concludes: "The articles in this issue make clear that there is far more radiation from medical CT scans than has been recognized previously, in amounts projected to cause tens of thousands of excess cancers annually. Also, as these scans have become more sensitive, incidental findings lead to additional testing (and often more radiation), biopsies, and anxiety. Although a guiding principle in medicine is to ensure that the benefit of a procedure or therapy outweighs the risk, the explosion of CT scans in the past decade has outpaced evidence of their benefit. Although there are clear instances when CT scans help determine the treatment course for patients, more and more often patients go directly from the emergency department to the CT scanner even before they are seen by a physician or brought to their hospital room. To avoid unnecessarily increasing cancer incidence in future years, every clinician must carefully assess the expected benefits of each CT scan and fully inform his or her patients of the known risks of radiation."

Given the large degree of human health risk that arises from the widespread use of CT scans to screen for lung cancer, it becomes inexcusable that the Cornell authors failed to disclose a financial conflict of interest, hiding from readers the fact that the lead investigator stands to benefit financially from the widespread adoption of this technology.

This is precisely why financial disclosure of conflicts of interest is required by the federal government and by medical institutions and this story shows the damage that can be done if schools and researchers do not take these ethical requirements seriously. While mistakes occur, and they are excusable if the institution and researchers acknowledge the mistake and apologize, there has been no acknowledgment of any wrongdoing in this case, nor has there been any apology. Simply weak excuses and a defense of what is clearly wrongdoing.