Cancer Clinical trials Medicine Politics Skepticism/critical thinking

One last puff of smoke over Helena, MT

Blogging on Peer-Reviewed ResearchLittle did I know when I posted my first article on the evidence supporting health hazards due to secondhand smoke that it would end up dominating the comments of this blog for three full days and lead me to a site that’s so full of pseudoscience, logical fallacies, and just plain B.S. that it is worthy of the title of the of the tobacco nuts. Even less did I expect that the crankfest would spread to fellow SBer Mark’s denialism blog as well. The sheer vitriol that some of these “smoking rights” advocates direct at any suggestion that SHS might be harmful, quite frankly, took me aback. It wasn’t just “you’re wrong” or “the science is bad” but it was that coupled with conspiracy mongering about big pharma somehow influencing the data to sell nicotine replacement patches, ranting attacks on scientists as being dishonest or in the pocket of antismoking organizations (which, in crankworld, seem to have power, influence, and cash on par with the New World Order, Big Pharma, the Illuminati, and the Masons all rolled into one–news to them, I’m guessing), or deceptive quote-mining designed to give the false impression that any relative risk less than 2 can automatically be discounted.

I admit I was surprised. It was a bit more than even I had expected.

One of the things that most took me aback is the vitriol directed at one SHS study in particular. The sheer bile directed at this one study, its authors, and in particular the journal that published the study, rivals the bile directed at the CDC or Paul Offit by antivaccination loons. This was a study that got a fair amount of press about three years ago and involved the examination of hospitalization rates for acute myocardial infarctions in Helena, MT before and after an indoor smoking ban in public places was instituted. Here’s a sampling of some of the attacks on it:

Some of these rants linked to an article published on the ACSH website by Michael J. McFadden and David W. Kuneman a week ago. Seeing this level of hysteria in criticizing a single study, I became curious about this particular study. After all, if the findings of this study were valid, it would be a strong bit of evidence for the beneficial effects of indoor smoking bans. More importantly, was it as bad as it was being represented? Further piquing my interest was that it wasn’t enough for critics just to call it a bad study or to point out its flaws. They had to accuse Dr. Stanton Glantz, the senior author, of fraud, conflict of interest, and all manner of misdeeds. So, I asked myself, what was this study, and what were its findings?

Let’s find out:

Reduced incidence of admissions for myocardial infarction associated with public smoking ban: before and after study

Richard P Sargent, attending physican1, Robert M Shepard, attending physican1, Stanton A Glantz, professor of medicine2

1 HealthCare Quality Performance Council, St Peter’s Community Hospital, 2475 Broadway, Helena, Montana 59601, USA, 2Division of Cardiology, Department of Medicine, University of California, San Francisco, CA 94143-1390, USA

Objective: To determine whether there was a change in hospital admissions for acute myocardial infarction while a local law banning smoking in public and in workplaces was in effect.
Design Analysis of admissions from December 1997 through November 2003 using Poisson analysis.

Setting: Helena, Montana, a geographically isolated community with one hospital serving a population of 68,140.

Participants: All patients admitted for acute myocardial infarction.

Main outcome measures: Number of monthly admissions for acute myocardial infarction for people living in and outside Helena.

Results: During the six months the law was enforced the number of admissions fell significantly (- 16 admissions, 95% confidence interval – 31.7 to – 0.3), from an average of 40 admissions during the same months in the years before and after the law to a total of 24 admissions during the six months the law was effect. There was a non-significant increase of 5.6 (- 5.2 to 16.4) in the number of admissions from outside Helena during the same period, from 12.4 in the years before and after the law to 18 while the law was in effect.

Conclusions: Laws to enforce smoke-free workplaces and public places may be associated with an effect on morbidity from heart disease.

“May” be associated with an effect on morbidity from heart disease? That’s hardly a strong conclusion. Basically, to boil the study down, Glantz found that admissions for acute MIs fell during the six months during which the indoor smoking ban was in place as compared to the same six month periods the year before and after the smoking ban. A provocative finding, to be sure, but it’s not as though the authors represented it as in any way definitive. Indeed, the authors were very cautious in the discussion section as they interpreted their results. They even did something that I don’t think I’ve ever seen before in a scientific paper. In the Discussion section, they included a brief subsection entitled “Strengths of Study” and, appropriately enough, another section entitled “Weaknesses of Study.” According to the authors, the strengths of the study include the geographic isolation of the city and the fact that there is only one hospital to which cardiac patients are admitted, as compared to most other municipalities in which indoor smoking bans have been implemented, where multiple hospitals and people moving across jurisdictional boundaries “smear out” the effect of any smoke-free policy in both place and time. However, the small size of the city, which was one of the strengths, was also one of the weaknesses, making the total number of MIs studied small. Other criticisms include observations that the investigators didn’t look at admissions for MIs solely among nonsmokers and a question about whether patients with premorbid conditions were comparable in both groups. The vast majority of the criticisms of the study later made were discussed and addressed in the paper.

The authors are also quite frank about other limitations of the study, including the use of historical controls, that the study didn’t also include death records because of concerns about the accuracy of the official causes of death, the failure to use biomarkers to estimate the actual exposure of the population to SHS before, during, and after the ban. There was no deception or “scam” involved. Indeed, the authors were quite cautious in their assessment of the results, as any objective reading of the paper, particularly the discussion section, will show. They did not represent the study as anything more than what it is: A preliminary study done to see if any effect could be seen. From my reading, the study was nothing more than a preliminary study, very much like many preliminary studies whose results need to be confirmed or refuted, and, if confirmed, expanded upon in later studies. To me, it appears that what these smoking cranks object to is more how this study was portrayed in the press rather than how it was portrayed among physicians, epidemiologists, and scientists. They may have a valid point about the press and politicians (I note how often I and other SBers complain about bad reporting of science), but that does not justify their smearing the investigators as somehow corrupt or dishonest.

Of course the aspect of this study that most provoked skepticism was not so much that there was a drop in the number of MIs due to a smoking ban but how rapidly it occurred and that it was detectable in the whole population, given that restaurant and bar workers, the main beneficiaries of such a ban, make up a relatively small proportion of the population that might not contribute sufficiently to the number of MI patients admitted to be detected. However, even though a healthy skepticism should be maintained about this result, it is not as far-fetched as it seems on the surface. There is growing evidence that smoke and SHS can both induce rapid platelet aggregation and vasoconstriction. This does not necessarily justify some of the more extreme claims that even a 30 minute exposure SHS is dangerous, at least not in healthy people free of heart disease. However, it does provide a possible mechanism to explain how nonsmokers with preexisting heart disease might be prone to the induction of an MI by the platelet aggregation and arterial and haemodynamic changes due to SHS. Certainly, acute MIs often occur when platelets aggregate to form a clot in an already narrowed coronary blood vessel. None of this is certain yet, at least in the case of SHS, but it does at least represent a plausible biological mechanism to explain how an indoor smoking ban might–I repeat, might–cause a rapid decrease in the number of MIs seen in a community. Indeed, at least two other studies, one done in Pueblo, CO and in the Piedmont region of northern Italy, have found similar results, although the Italian study failed to find any decrease in hospital admissions for MI in people over 60 and the study authors pointed out that longterm results would need to be assessed. My take on this is that it’s far from proved that indoor smoking bans can have that much of a rapid effect on the rate of MIs, but that it’s not implausible. The Pueblo, and Italian studies are suggestive, but by no means confirmatory, that the Helena results may not be a fluke.

One of the oddities this study spawned is the aforementioned article posted to ACSH Facts & Fears by David W. Kuneman, a retired pharmaceutical chemist, and Michael J. McFadden, author of Dissecting Antismokers’ Brains (the latter of whom runs a website that is almost as cranky as the website to which I’ve linked with amusement recently) that is basically an extended whine about how they have a study with many more patients that failed to find results similar to those observed in Helena and Pueblo. Maybe they do, and maybe they did. Who knows? I will point out that Michael Siegel, a Professor in the Social and Behavioral Sciences Department, Boston University School of Public Health, seems to like their work, although given that McFadden’s paper remains unpublished it remains impossible to for anyone else to evaluate his results.

Whatever its merits (or lack thereof), from my perspective, Dr. Siegel demonstrated rather questionable judgment in publicly giving his stamp of approval to the McFadden and Kuneman study on his blog and, whether intentionally or not, giving the impression that he agrees that the reason it hasn’t been accepted for publication yet is ideological bias at the journals that have thus far rejected it. At the very least, Dr. Siegel’s not doing McFadden and Kuneman any favors if his end goal is truly to get this paper published in a decent peer reviewed journal. After all, if Dr. Siegel thinks it’s such a solid paper and if he indeed did extend help the authors by extending its analysis as he states, then I respectfully submit to him that it would have made far more sense for him to volunteer to sign on as a co-author and help McFadden and Kuneman revise the manuscript to include his extension of the original analysis. The three could then submit the presumably stronger paper to another journal. Not only would Siegel have then improved the paper, but he would have added his academic credentials and reputation to it, which could only have helped get it over the hump, given that neither McFadden nor Kuneman presently have any academic affiliation. I have to wonder why Dr. Siegel did not choose to do this if he thinks the Helena and Pueblo studies are so flawed and that in contrast McFadden’s and Kuneman’s analysis is solid. His defense of his decision to publicize this study on his blog did not reassure me:

This has been a true learning experience for me. Never did I dream that some day, after 21 years of experience in tobacco policy research, as a statistical editor of perhaps the top tobacco control journal, and with over 50 peer-reviewed publications in top public health and medical journals, I would present a reasonably detailed scientific analysis of a tobacco control policy issue and then be publicly attacked and insulted for having the courage to present my opinions.

But because they apparently go against the anti-smoking agenda, I have now been publicly attacked and insulted. That’s a shame.

Why not help McFadden and Siegel publish that detailed scientific analysis in a peer-reviewed journal, then, rather than doing it on your blog? It’s a legitimate question. That would have made your point far more effectively than a rather lame “you’re so mean” defense, don’t you agree? Certainly, if I were either McFadden or Kuneman, I’d be asking Dr. Siegel the very same question.

Finally, I can’t help but get a little suspicious when authors disseminate their findings through websites like ACSH, whose objectivity has been questioned on many issues. Indeed, that the ACSH published the McFadden and Kuneman’s profoundly whiny commentary actually stokes my suspicion of the organization, which prior to this had only been mild to moderate. Also, in my mind, McFadden’s ranting about conspiracies to “suppress” their evidence does them no good at all if their goal is truly to be published. It’s never a smart idea to antagonize potential editors and reviewers this way, regardless of whether your science is any good or not. Perhaps that’s the point, though. Perhaps McFadden and Kuneman would rather play martyr by invoking the Galileo gambit and railing against peer review than actually getting their results published in a peer-reviewed journal. Here’s a hint: Doing this sort of thing is a big red flag that the investigators might–just might–be cranks. It’s not definitive, but it’s highly suggestive.

But then, of course, it’s so much easier to whine than to keep submitting their work until a journal finally accepts it. Whining also has the ancillary benefit of firing up the anti-smoking ban faithful, who seemingly never consider the possibility that perhaps the manuscript was rejected because it just didn’t make the cut. Whatever the true case here, whether McFadden and Kuneman’s manuscript is any good or not, virtually all scientists have had papers rejected out of hand without the invitation to respond to reviews and resubmit. Indeed, I went through that lovely experience myself just a month ago, when I had a paper rejected for what I considered to be specious reasons. Did I whine? Well, maybe a little, but not on my blog and not on websites, but rather just among my colleagues. Nor did I try to fire up a bunch of activists about the injustice of it all and how unfair it all was. Instead, I buckled down, revised the manuscript, sent the revision to some colleagues for opinions and advice, and then moved on, looking for another appropriate journal. (I plan on resubmitting it later this week.) Moreover, according to McFadden and Kuneman, thus far they’ve only submitted their paper to three different journals, the British Medical Journal, Circulation, and Tobacco Control. Give me a break. That, in and of itself, is hardly evidence of “suppression” or ideology blinding editors and reviewers to the value of their work. I’m singularly unimpressed with their complaint. A colleague and I have a paper that we’ve submitted to four journals thus far, all of which rejected it, despite uniformly positive feedback from colleagues to whom we’ve shown it and, more importantly, despite the fact that my colleague now has an NIH R01 grant based in part on the evidence from that paper and that I’ve been awarded a rather large grant from a private foundation to study a different question based–you guessed it–on the much of the same evidence. It’s not at all uncommon to have to shop a manuscript around to multiple journals before getting it published; having to do so is not necessarily evidence of ideology preventing publication. Besides, if McFadden and Kuneman are persistent enough, eventually they will get their study published. Also, McFadden is not limited to just journals. Can’t get your work accepted to a high profile peer-reviewed journal yet? Submit it to the American Society of Clinical Oncology or some other appropriate scientific or medical organization and present it as a poster or a short talk at a national meeting. This approach has the advantage of getting some valuable feedback from interested scientists in a relatively nonhostile environment, and, if you choose the venue right, you can at least get an abstract in a journal indexed on PubMed.

The bottom line is simple. The Helena, Pueblo, and Italian studies are preliminary in nature. They have provocative findings. They may or may not be correct. For all I know, McFadden’s study may be the bee’s knees, epidemiologically speaking. Science and epidemiology will have to sort this question out over the next several years, and I strongly suspect that longterm studies will very likely confirm health benefits for workers formerly exposed to large amounts of SHS (such as restaurant and bar employees) due to indoor smoking bans, regardless of what the short-term studies show. Also, as Dr. Siegel himself points out, the scientific merits of such bans do not rise or fall on the basis of these few studies. However, also from my perspective, the histrionic and exaggerated coordinated attacks on these studies by opponents of indoor smoking bans are far more ideologically motivated than even the most fevered imaginings of the cranks paint the motivations of the investigators of the Helena study.

By Orac

Orac is the nom de blog of a humble surgeon/scientist who has an ego just big enough to delude himself that someone, somewhere might actually give a rodent's posterior about his copious verbal meanderings, but just barely small enough to admit to himself that few probably will. That surgeon is otherwise known as David Gorski.

That this particular surgeon has chosen his nom de blog based on a rather cranky and arrogant computer shaped like a clear box of blinking lights that he originally encountered when he became a fan of a 35 year old British SF television show whose special effects were renowned for their BBC/Doctor Who-style low budget look, but whose stories nonetheless resulted in some of the best, most innovative science fiction ever televised, should tell you nearly all that you need to know about Orac. (That, and the length of the preceding sentence.)

DISCLAIMER:: The various written meanderings here are the opinions of Orac and Orac alone, written on his own time. They should never be construed as representing the opinions of any other person or entity, especially Orac's cancer center, department of surgery, medical school, or university. Also note that Orac is nonpartisan; he is more than willing to criticize the statements of anyone, regardless of of political leanings, if that anyone advocates pseudoscience or quackery. Finally, medical commentary is not to be construed in any way as medical advice.

To contact Orac: [email protected]

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