Showing posts with label British Medical Journal. Show all posts
Showing posts with label British Medical Journal. Show all posts

Thursday, January 23, 2014

BMJ Editorial: Holding the Line For Ignorance



The British Medical Journal grossly erred in its January 2 commentary, “Hold the Line Against Tobacco” (here), by editor Dr. Fiona Godlee.
 
BMJ asserts that e-cigarettes pose a “grave risk to public health because of their potential to renormalise and glamourise smoking.”  As Clive Bates pointed out in a scathing critical comment (here), “It requires heroic contortions of logic to regard the emergence of a product that is perhaps 99-100% less risky than cigarettes and a viable alternative to smoking as an adverse development… [The e-cigarette] should really be seen as a disruptive intrusion into the cigarette industry: a new high technology product entering the market for the popular legal recreational drug, nicotine, and posing a threat to the dominant and most harmful delivery system, the cigarette… Your editorial follows the established pattern of prohibitionist public health activists of focusing on minor or implausible risks for which no evidence exists in reality, while ignoring or diminishing the huge potential benefits that are real and visible from adopting e-cigarettes.”

Dr. Godlee’s commentary veers dramatically from the norms of science journal precision, as seen in this extraordinary claim: Moves by New York City Mayor Bloomberg’s administration “against tobacco, trans fats, and sugary drinks, and for promoting physical activity and calorie counts on menus, are credited with improving life expectancy among New Yorkers—now two years higher than the US national average.”

Nothing in the city’s formal report on life expectancy (here) even remotely supports this claim.  The report mentions anti-smoking policies, but offers no proof that they account for differences in mortality from heart diseases and cancer between New York and the U.S. as a whole.  Mr. Bates is right to call for “a BMJ special edition setting out the evidence for the effectiveness of these measures in improving life expectancy in New York.” 

The dominant theme of the BMJ editorial is revulsion of the tobacco industry: “E-cigarettes also legitimise the industry, buying tobacco companies a seat as ‘partners’ at the health policy table,” a position Dr. Godlee rejects.

The reality is that in the U.S., regulation of the tobacco industry has de facto legitimized it and guaranteed companies a seat at the health policy table.  Indeed, FDA officials are compelled to consider industry research and analysis, and if the FDA fails to do so it is subject to repercussions. 

Appropos of this, it is sadly worth noting that the FDA has also lapsed in its adherence to rigorous scientific principles.  Its recently released preliminary report on menthol (here), which I have commented on (here), is a case in point.  Lorillard last November submitted these scathing comments to the FDA public docket (here):

“Unfortunately, FDA’s review of the available scientific information on menthol cigarettes falls far short of FDA’s own established standards of scientific integrity and cannot be used to draw valid conclusions, nor can it serve as the basis for regulatory action.  FDA’s analysis suffers from many significant flaws and its conclusions are at times based upon unsupported speculation and conjecture. Many of the studies relied upon by FDA fail to meet the appropriate standard of scientific evidence, yet numerous high-quality studies are improperly and inexplicably discounted or entirely omitted.”  The 134-page submission backs the company’s claims with robust evidence. 

Rigorous standards imposed by regulation should apply equally to all parties, including regulators themselves.  Such standards may be especially uncomfortable for tobacco prohibitionists, who are prone to gross abuse of the facts.


Wednesday, August 19, 2009

Heart Attack and Stroke Risks from Smokeless Tobacco Use: Next to Nil


The International Agency for Research on Cancer (IARC) is a component of the World Health Organization with a mission “to identify the causes of cancer so that preventive measures may be adopted and the burden of disease and associated suffering reduced.” It is therefore not surprising that IARC staff have played a prominent role in exaggerating the cancer risks of smokeless tobacco use. The IARC anti- smokeless tobacco campaign has been led by Paolo Boffetta.

Boffetta, a cancer epidemiologist, departed from his field of expertise to complete (with co-author Kurt Straif) a review of the risks for heart attack and stroke among smokeless tobacco users in the U.S. and Sweden. The analysis has just been published by the British Medical Journal.

Boffetta reported that the summary relative risk (RR) for heart attack among smokeless tobacco users was 0.99, with a 95% confidence interval (CI) of 0.89 to 1.10 (For a discussion on how to interpret RRs and CIs, see my recent post). For stroke, Boffetta reported a minimal increase in risk (RR = 1.19) that was not statistically significant (CI = 0.97 – 1.47). Thus, the main finding in this study is that smokeless tobacco users have no excess risk of heart attack or stroke.

Given the importance of that conclusion, why did the researchers (in their BMJ abstract) and subsequent media coverage ignore it, focusing instead on fatal heart attack/stroke, one of two subgroups? It is because smokeless tobacco users had very small elevations in risk for the fatal events. For fatal heart attack the RR among smokeless users was 1.13 (CI = 1.06 – 1.21), and the RR for fatal stroke was 1.40 (CI = 1.28 – 1.54). Boffetta was unable to demonstrate that the excess risks were related to how much or how long smokeless tobacco had been consumed, two important characteristics that would have strengthened the validity of the findings.

There is a serious omission in this study. Boffetta divided all heart attacks and strokes into two subgroups, fatal and non-fatal. Boffetta found that smokeless users had no significant risk for all heart attacks and strokes but had elevated risks for fatal cases. It logically follows that smokeless users probably had LOWER risks for NON-FATAL heart attacks and strokes. But Boffetta provided no information about these subgroups, and the reason is obvious: it wouldn’t add to the health hysteria.

Here is the take-home message for smokeless tobacco users: You do not have elevated risks for heart attack and stroke. Although your risk for heart attack and stroke is the same as that of non-users of tobacco, there is a slight increased chance that, if one occurs, it could be fatal. This may be due to the effects of nicotine on the circulatory system, or it could be due to some other undiscovered factor that is associated with smokeless use. As Boffetta acknowledged, “the magnitude of the excess risk is small.”

In the article’s introduction, Boffetta wrote that smokeless tobacco “products have been proposed as an alternative to cigarettes and other smoking products under the claim of a smaller, or negligible, risk to health.” This study adds to the scientific evidence that, compared with cigarettes, the risks from smokeless tobacco are indeed vastly “smaller, or negligible.”