Wednesday, September 17, 2014

Oral Cancer Scaremongering by Public Health Officials

A range of public health leaders, who should know better, have rushed to repeat and, with their stature, endorse the apparently unfounded claim by baseball great Curt Schilling that his mouth cancer was caused by smokeless tobacco.

Claims about cancer causation can significantly influence national health policy; when made by recognized authorities, they should be based on scientific and medical facts.

While I fully sympathize with Mr. Shilling, his claim of causation has no on-the-record support from his medical team. That has not stopped the anti-tobacco establishment from rushing to the media.

In remarks trashing smokeless tobacco, Schilling’s oncologist, Dr. Robert Haddad of the Dana-Farber Cancer Institute, made no comments specifically connecting his patient’s cancer to use of smokeless products.

Regardless, in short order, the FDA Center for Tobacco Products repeated Schilling’s causation claim on Twitter (here), and the presidents of the Massachusetts Medical and Dental Societies (here) and the director of the Arizona Department of Health Services (here) gave it further credence.

I don’t question Schilling’s belief that smokeless tobacco caused his cancer.  However, before endorsing his statements, public health officials should address several points:

1.  Where, specifically, was the “mouth cancer”?  According to this National Cancer Institute monograph (here), almost all cases of mouth cancer attributable to smokeless tobacco occur in the location where it is used.  That is also my experience in 30 years as an oral pathologist.  In addition, the cases of mouth cancer that I have seen are almost always in users of dry powdered snuff, and they occur in the gum-cheek area.  Schilling hasn’t disclosed the location of his cancer, which he blames on moist snuff.  Users of that product are not protected from mouth cancer, but epidemiologic studies show that they are not at higher risk than nonusers.

2.  Other risk behaviors.  It can be uncomfortable, but doctors need to know about all risk factors for oral cancer. Those at higher risk are individuals who smoke and drink, a combination that tends to be associated with cancers in the throat as well as the mouth.  Human papillomavirus infection is an emerging risk factor, especially for throat cancer.  Schilling disclosed that his cancer was discovered as a “lump” in his neck; this presentation is more common with a throat cancer than a mouth cancer.  Schilling hasn’t disclosed information on his other risk factors.

It is inappropriate for the FDA, presidents of medical societies and other public health authorities to blindly endorse unvalidated medical claims.  Hundreds of thousands of former smokers in the U.S. use smokeless tobacco.  Dreading the prospect of getting mouth cancer, they might be motivated by these authorities’ pronouncements to start smoking again, not knowing that the latter significantly increases their mouth, throat and lung cancer risks.  Public health advocates should stick to the facts, not engage in scaremongering.

Thursday, September 11, 2014

New England Journal of Medicine Downplays Its Error in Exaggerating Youth E-Cigarette Data

Last week the New England Journal of Medicine inflated a study of mouse brain activity with nicotine into a gateway-to-cocaine claim (here).  This week I report that the journal never properly fixed an error it made regarding e-cigarette use among children.

I reported on April 9 that “the New England Journal of Medicine and authors of a commentary on e-cigarette use ignored our call for correction of a substantial error regarding e-cigarette use among American schoolchildren in 2011 and 2012.” (here). 

The following day, Dr. Fairchild, first author of the commentary and professor of sociomedical sciences at Columbia University, emailed me: “We have, in fact, been talking with NEJM about the graph. I’ll let you know what happens.” 

No further communication was received from Dr. Fairchild, but on June 12 the journal published its idea of a correction in the form of a revised bar chart, which appears on the left.  The revision involved changing a stacked bar chart to a side-by-side chart, with the entirely insufficient note that “some students may have been included in both categories.” 

May have been?  It is clear from the CDC reports (here and here) that the original article double-counted a large number of dual users of both e-cigarettes and cigarettes.  The journal should have corrected the error by issuing a chart we provided (the larger chart at left), illustrating the huge proportion of dual use. 

Why did the journal “revise” the presentation of data, rather than acknowledge and correct a significant error regarding dual use of e-cigarettes and cigarettes among American youth?  One could conclude that an anti-tobacco bias overrode standard editorial policy.

Wednesday, September 3, 2014

NEJM Irresponsibly Damns E-Cigarettes as Gateway to Cocaine, Based on Mouse Nicotine Studies

The New England Journal of Medicine today published an incendiary anti-e-cigarette article that tags nicotine as a gateway to cocaine use… in mice.  It’s another sad day for tobacco truth.

The authors are Drs. Denise and Eric Kandel, the latter a Nobel Prize-winner for his work on the physiological basis of memory storage in nerves.  Since 1975, Dr. Denise Kandel has aggressively promoted a gateway theory that adolescent use of legal drugs like alcohol and tobacco causes use of illegal drugs, starting with marijuana and progressing to cocaine and heroin.  The theory is highly contested among addiction research and policy experts because it is not supported by human studies.

The NEJM presents the Kandels’ laboratory data on how nicotine and cocaine affect the mouse brain at the cellular and molecular level.  Their experiments involved force-feeding nicotine to and injecting cocaine into mice.  Post-mortem studies on the rodent brains led the authors to conclude that nicotine/tobacco causes cocaine use. 

Following a nine-page technical discussion of their research that made no mention of e-cigarettes, the authors inserted a concluding three paragraphs claiming that smoking, vaping and even passive smoke are gateways to cocaine. 

In a crass attempt to heighten interest in the publication, the Kandels and the NEJM offered the media a press release with an attention-grabbing e-cigarette-bashing headline and inflammatory quotes that exceed and distort the authors’ scientific work.  

Shame on all parties for allowing marketing to trump the truth.

Wednesday, August 27, 2014

In the CDC-FDA E-Cigarette Study, “Probably Not” Is the New “Yes”

Assume that you conducted a survey in which you posed two multiple-choice questions:
“Do you think you will smoke a cigarette in the next year?”
“If one of your best friends were to offer you a cigarette, would you smoke it?”

Respondents could choose from these answers:

Definitely yes
Probably yes
Probably not
Definitely not

You’d add up the “definitely yes” and probably yes” responses to tally those intending to smoke; and you’d total the negative responses to gauge how many are unlikely to smoke.

This would be a straightforward and uncomplicated task, unless you were a CDC or FDA analyst, milking the National Youth Tobacco Survey (NYTS) for scary numbers.

On August 25, the CDC issued its latest sky-is-falling press release, suggesting that e-cigarettes are driving teenagers to smoke (here).  The release focused on a study coauthored by CDC and FDA researchers (abstract here) whose core finding was: “Among non-smoking youth who had ever used e-cigarettes, 43.9 percent said they intended to smoke conventional cigarettes within the next year, compared with 21.5 percent of those who had never used e-cigarettes.” 

To reach this conclusion, the CDC-FDA re-defined “probably not” to mean “yes, I will.”  Adolescents who answered “probably not to either of the two questions were classified as intending to smoke.

The feds used 2013 data that is not yet public, but using the 2012 NYTS I can show you how much the distorted definition matters.

This table shows the numbers of never and ever users of e-cigarettes intended to smoke, using the CDC-FDA definition (i.e., “probably not” means “yes, I will”).  The percentages in parentheses are weighted to reflect the population of the survey.

Never Users of E-cigarettes
Ever Users of E-cigarettes
No intention to smoke
13,312    (76%)
  70    (41%)
Intention to smoke
  4,360    (24%)
  80    (59%)
17,672  (100%)
150  (100%)

Using conventional definitions, I produced the chart below. Any two yes responses defined intention to smoke, any two no responses were no intention, and mixed responses were just that, mixed.  These are my results:

Never Users of E-cigarettes
Ever Users of E-cigarettes
No intention to smoke
17,103  (97%)
128  (81%)
Mixed intention
     422  (  2%)
  13  (11%)
Intention to smoke
     147  (  1%)
    9  (  8%)
17,672  (100%)
150  (100%)

This paints a completely different picture of the e-cigarette situation.  The appearance that adolescents who have ever used an e-cigarette (even one puff) might be more likely to intend to smoke is based on the responses of just nine survey participants.

Carl Phillips has extensive comments on at the CASAA blog (here) and (here).

This is not the first time that a highly questionable definition has been used to fabricate a highly speculative gateway claim (here).  I assure you that this is probably not the last bogus CDC analysis of youth e-cigarette use.