Monday, December 21, 2009

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 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.

No comments: