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The Great Helena Heart Fraud

If They Had the Truth... Why Would They Lie?  

 

In April of 2003 two local doctors from a relatively small town in the Midwestern United States unveiled the preliminary results of a study that made a truly astounding claim: A smoking ban in that town based upon the “protection of people from second hand smoke,” lasting for only 6 months, had reduced the heart attack rate by 60%. Just as incredible, it was claimed that as soon as the ban was overturned by a judge and proprietors were again allowed “to continue poisoning people” with secondary smoke, the heart attack rate immediately rebounded to pre-ban levels.

These claims were far beyond anything that had ever before been laid at the doorstep of secondary smoke exposure and activists and media outlets around the globe jumped on it and proclaimed it to be proof of the immediate and urgent need to protect nonsmokers from tobacco smoke.

The one big problem with this (among many other problems explored below) is that the study itself did not specifically examine the effects of the ban on nonsmokers!

Of course that information didn’t come out until a year later when the details of the study were actually made public for all to see, but by that time the incredible claimed findings had been used as the basis for hundreds of debates and laws throughout the country in the drive to eliminate public smoking. Note, the study itself was honest in not making such a claim, but the presentation of the study to the public by the authors, by activists in respected and high profile positions, and by a sympathetic media, all asserted that “The Great Helena Heart Miracle” study had proven beyond all doubt that secondary smoke was felling tens of thousands of Americans every year.

Is it fair to title this Appendix “The Great Helena Heart Fraud” when the study itself is not being accused of being fraudulent? Yes. The reason for this is explored below in two unpublished “Commentaries” that I submitted to the British Medical Journal. The first was rejected after four weeks without explanation. The second (which had been submitted as “fast track” for urgent consideration) was rejected after seven weeks with the explanation that two of the four selected reviewers had finally read it and recommended it be rejected. Follow up emails to the Journal were ignored.

I would also strongly suggest that any reader with online access visit the website of the BMJ itself to read the relatively short study and examine the Rapid Response comments made to it. It’s worth noting that although over a dozen significant questions and criticisms were made of the study within two weeks of its publication, it was not until two months later that the authors finally chose to respond. It’s also worth noting that that response ignored over 90% of the questions and criticisms that had been raised while taking an Ad Hominem slap at the most recent pair of questioners, accusing them of "following a well-established tobacco industry strategy..."

Reproduced below are the two rejected Commentary submissions, followed by an online Rapid Response submitted 100 days after the study’s initial online publication. Readers of the printed Journal of course never got to see any of this material and unless they make a special trip to the web site will never know the severity of the questions and criticisms that greeted this “peer-reviewed” study. To the best of my knowledge none of these criticisms have ever appeared in the print or broadcast media outside of a letters to the editor page.



Commentary 1:

On April 5th, 2004, the BMJ published the "Helena Heart Miracle" study in its online version. Quite aside from several minor questions and quibbles (e.g. why the strict limitation of comparator periods, why similar changes have not been noted in prison populations with smoking bans; and why funding from organizations that openly push for bans is not considered a conflicting interest) there is one major and glaring problem with this study and the way it has been presented.

The problem is the lack of differentiation between those patients who smoked and those who did not and a presentation that clearly claimed the opposite. The terms "secondhand" smoke or smoking appear twelve times in the study while the overall tone of the paper itself, press statements by at least two of the authors, and further press statements by nationally prominent Antismoking figures all combine to give the strong impression that the study clearly found that exposure to secondary smoke caused heart attacks among Helena's nonsmoking population.

In reality, in an obscure paragraph near the end, the authors admit that the study did not examine nonsmokers as a separate group, noting that small sample size would have made such differentiation totally meaningless.

Am I exaggerating the extent of the deliberate misinterpretation to the public? Not at all:

On April 2nd the American Heart Association paid for a press release headlined in big bold print: "NEW STUDY LINKS SECONDHAND SMOKE TO HEART ATTACKS," where the AHA's CEO, M. Cass Wheeler, stated: "Banning smoking is the only logical response to the scientific evidence concerning the dangers of secondhand smoke."

On April 4th, Stanton Glantz, co-author and study guarantor, stated in another press release that: "This is not the first study to find a link between long term exposure to secondhand smoke and heart attacks." His associate, the Director of Americans for Nonsmokers' Rights, followed with: "The bottom line is simple. Secondhand smoke kills."

Even Vivian Nathanson, head of research and ethics right here at the BMA, was quoted in an April 5th article on the study as saying "We estimate that second-hand smoke kills at least 1,000 people in the UK every year."

Dr. Sargent himself, the lead author of the study, asserted in a CBS TV interview about Helena that business owners wanted "to be allowed to continue poisoning people even when we have demonstrated the immediate effect of it."

All of this shows quite clearly the intended message of the study. And that message is not the likely truth: that when a smoking ban is introduced in a small community smokers smoke less and spend more of their potential heart attack time outside of that community while eating, drinking, gambling and smoking.

A final note of interest: A deliberately omitted data chart used in the initial presentation of the study clearly shows a drop in AMIs only during the first three months of the ban when it is most likely that angry Helena smokers deliberately went out of town for their fun during the warm weather months. However the chart also showed that for the last three months of the ban, when the cold Montana winter was approaching and angry smokers tired of boycotting local businesses or moved their drinking and smoking to their homes, the heart attack rate bounced back up to roughly normal levels. Not a bounce back after the ban ended as is usually claimed.

I offer apologies to Drs. Sargent and Shepard for being so harsh in my criticism, but I feel the harshness is deserved when one considers the enormous damage this study has done to people's lives and livelihoods in communities where the "Helena Heart Miracle" has been held up as proof of the harm of secondary smoke in order to frighten nonsmokers and get extremist smoking bans rammed through legislatures.

Advancing a falsehood designed to implement social engineering goals amongst free people is never something to be taken lightly.



Commentary 2:

The BMJ is no stranger to controversy when it comes to smoking-related studies. A year ago, on May 17th of 2003, the BMJ published the landmark study on secondary smoke and spousal health by Drs. Enstrom and Kabat, based upon 39 years of medical records and interviews of 118,000 people. That study was begun with funding from the American Cancer Society, and when that funding was cut off, partway through, the authors sought other funding and eventually finished the study with funding from the Center for Indoor Air Research.

When the study was published it spawned a record number of 150 Rapid Responses. Sadly, only a small minority of those responses spoke to perceived flaws in the study or its data: far and away the largest focus of discussion dealt with the "undesirable" findings and their possible influence by the openly declared finishing funding from a “Big Tobacco Front Group” and the similarly open admission by the authors of past connections to tobacco funded research.

Dr. Kabat weighed in twice during the exchanges to defend the authors’ scientific integrity and to address the few scientific criticisms that had been raised. Despite the fact that methodological or data-based criticisms of the study made up only a small portion of the responses, local health boards today offhandedly dismiss the study as being based on flawed or inadequate data and as being "thoroughly debunked."

Fast forward one year to May 5th, 2004 when the BMJ published a study based on the small town of Helena, Montana. Instead of 118,000 people and thousands of deaths over 39 years, the Helena study looked at about 25,000 people and a few hundred AMI’s recorded during periods totaling less than 39 months. The Rapid Responses to Helena numbered less than a dozen, and the clear majority of them noted significant flaws or inadequacies in the study, its data, or the presentation of its results.

Unlike the case of the Enstrom/Kabat study there were few Ad Hominem attacks on the authors for their funding, despite the fact that some of their sources are openly dedicated to supporting smoking bans and despite the fact that the authors failed to either define this as a competing interest or note the millions of dollars a co-author of the study, Stanton Glantz, has received in MSA-laundered Big Tobacco grants: money clearly and specifically targeted to promote Antismoking objectives such as bans.

And, unlike the E/K study, not only were most of the responses sharply critical of the methodology, data, and presentation, of the study, but the authors themselves have made, as of this date, not even a pretense at defense, despite the fact that some of the sharpest criticisms have been online at the BMJ site for well over a month at this point. This may also be almost unique in the history of the BMJ: scientists are usually quite willing and eager to defend the integrity of their work.

Also unlike the E/K study, while E/K's news coverage was overwhelmingly peppered with background about its funding and challenges, virtually no mention was made of such funding and challenges in the news coverage of the Helena study. “The Great Helena Heart Miracle” has been floated before the public eye as not only being virtually unchallenged but as advancing conclusions about secondary smoke and nonsmokers that were in fact never in the study proper or its data at all.

And what is the final result of this disparity in presentation and treatment by the media? Simply that an innocent public, trusting in the integrity of an institution like the BMJ, has been misled and unjustly terrified by extremist claims based upon nonexistent data analysis, legislatures have rammed laws through councils on the basis of that deception, and small businesses, as well as individuals relating to their families and friends, have had their lives and livelihoods injured as a result.

Is the BMJ to blame? Not in any way. They reported the valid results of a fairly meaningless but nonetheless hi-profile study and presented its data as reported by the authors. They also opened their pages to those outside the usually accepted medical establishment for responsible criticism of the study and its data. After a full year of secrecy in which the authors refused to discuss the details of their study after the initial press releases, publicity splash, and TV interviews, the facts were finally made public.

It is unfortunate that the public, or at least its supposedly responsible representative, the media, has proven all too willing to absorb and relay the misinformation given in paid press releases and advocacy statements about Helena rather than actually read the study and its critiques for themselves. The BMJ can lead a horse to water, but it cannot make him drink.



Rapid Response: “Helena: 100 days”

On April 5th 2004, 100 days ago, the online British Medical Journal published "Reduced incidence of admissions for myocardial infarction associated with public smoking ban: before and after study," a study that, according to media releases around the world, conclusively demonstrated the deadly effects of secondary smoke and the immense and immediate medical benefits that had been demonstrated once people were protected from "the deadly poison." (1)

The release almost immediately generated a storm of criticism within these virtual pages as Rapid Responses containing over a dozen substantial questions and criticisms were generated within ten days.(2)

Throughout the entirety of that 100 day period, only one response has been made by the authors of the study. That response was two months in coming and ignored over 90% of the questions and criticisms that had been raised while taking an Ad Hominem slap at the most recent pair of questioners by accusing them of "following a well-established tobacco industry strategy..." (3)

Perhaps the most serious of all the charges made was the one that charged deliberate misrepresentation of results to the media, and the one that criticized the lack of honesty in the declarations of competing interests.

In the first instance the charge of misrepresentation was clearly not directed at the Journal, but was instead aimed at the conscious presentation of the study by the authors and other supposedly responsible medical and tobacco control authorities as having directly examined and strongly condemned the cardiovascular effects of secondary smoke. As pointed out quietly by the authors themselves in the study, no attempt was made to even estimate such an effect.

In the second instance however the charges were laid at the feet of both the authors who neglected, even after criticism, to openly admit their potential conflicts of economic interest; and at the feet of the Journal which seems to be ignoring the demand that such conflicts be openly exposed for proper consideration by readers and future researchers.

The 14 points below represent only those raised and ignored in the first ten days; there are others that cry equally loudly for response as well. The British Medical Journal has demonstrated its courage in publishing the Helena study and opening its details to direct public examination rather than leaving them in a limbo of interpretation only through press release. It has also shown courage and responsibility in opening its pages to those around the world who have criticized not only this study, but others that were scientifically weak although serving sacrosanct political and medical goals. It needs to prove itself equally courageous in demanding that the Helena study authors responsibly respond to their critics and questioners in the true spirit of peer review and public accountability, and that they do so with a full and open admission and listing of their competing interests.

Sincerely,

Michael J. McFadden
Author of "Dissecting Antismokers' Brains"
http://www.Antibrains.com



Footnotes:



(1) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#55832

(2) (Partial listing of unanswered criticisms/questions)

>1)why the enormous difference in ratio of reviewed and included admissions for primary < 274/283> and secondary <30/71> diagnoses;

>2)why the limitation of previous six-month periods to just the most recent four;

>3)how three patients experienced multiple admissions but only had a total of five admissions among the three;

>4)why similar changes have not been noted among the many prison populations that have experienced similar smoking bans;

>5)why funding from a number of organizations who have declared openly their belief in pushing for smoking bans is not considered a conflicting interest;

>6)why the presentation and the bulk of discussion in the study was deliberately oriented toward secondary smoke while the formal study itself never specifically examined secondary smoke, exposures to it, or the statistical effects of the ban on nonsmokers;

>7)why the initial results boasted a 60% reduction while the final showed only 40%;

>8)why the finding of a 40% immediate reduction in Helena was claimed to be supported by studies showing only a 5% reduction in California over a period of years;

>9)why the findings of increased hospital admissions immediately outside the Helena area were not factored into the reduction of admissions within Helena but were instead simply dismissed as non-significant;

>10)what impact transient traffic or recall bias had upon the study;

>11)what impact would have been made by using different criteria for determining relevant admissions;

>12)what impact would have been made by using different criteria for those assigned to the different groups (e.g. by including/excluding those who were retired and unaffected stay-at-homes or those who had simply had a single dinner or lunch in Helena at the time of their event);

>13)what difference in conclusion might have been forthcoming if the authors had examined three month rather than six month periods, given the clear disparity observed during the first three months of the smoking ban as opposed to the final three months;

>14)what impact on the final numbers could have been attributed to the increased time some smokers spent outside the ban area during the course of the ban, particularly during that telling first three month period of good weather and possible resentment and what effort, if any, was made to examine such impact.



(3) http://bmj.bmjjournals.com/cgi/eletters/328/7446/977#61207 <
 

Cantiloper@aol.com

Copyright 2004, Michael J. McFadden


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