Wednesday, April 27, 2016

In the FDA’s New Anti-Smokeless Tobacco Campaign, #TheRealCost Is to Taxpayers and Public Health

The cost to taxpayers of the FDA’s new anti-smokeless tobacco campaign, dubbed The Real Cost, is $36 million.  FDA Center for Tobacco Products Director Mitch Zeller announced the campaign at the 8th National Summit on Smokeless and Spit Tobacco, which was attended by a “coalition of organizations, agencies and individuals committed to reducing and eventually eliminating the use of smokeless and spit tobacco products.”

The zinger that Zeller focused on, however, was this: “Each year in the U.S., more than 2,300 people are diagnosed with oral, esophageal and pancreatic cancer due to smokeless tobacco use.”

I recently called on the CDC to release long-suppressed smokeless tobacco data (here).  The agency remains opaque on the matter, but Zeller did offer that one hard number.  Now we must ask: Is it accurate?

Surprisingly, the only source reference for the figure is found in the agency’s Tweet, here, which points to a 558-page report by the National Cancer Institute and the CDC (here).  The 2,300 figure, appearing on page 135, is the result of a calculation by Jane Henley and Michael Thun, epidemiologists at the CDC and the American Cancer Society.  They estimate that each year smokeless tobacco causes 1,601 oral cancers, 184 esophageal cancers and 530 pancreatic cancers, totaling 2,315. 

Drs. Henley and Thun estimated the number of current smokeless users in the U.S., and then applied relative risks (RR) from American studies of smokeless tobacco compiled by a 2008 article by Paolo Boffetta (here) – which I previously showed to be a classic case of data cherry picking (here).

Henley and Thun’s report of 700+ cases of esophageal and pancreatic cancers is unsubstantiated, as Boffetta’s RRs for these diseases among American smokeless users are not statistically significant. 

Boffetta reported an elevated RR of 2.6 (95% confidence interval = 1.3 – 5.2) for oral cancer among American smokeless users, but his risk analysis used only six studies, with no explanation of inclusion criteria.  The following table provides details about his results.

Epidemiologic Studies Used by Boffetta for U.S. Summary Risk Estimate = 2.6 (1.3 – 5.2), Smokeless Tobacco and Oral Cancer (Lancet Oncology, 2008)
Source Study (Author, Journal Year)Includes smokersProduct, Number of Cases in UsersRelative Risk (95% Confidence Interval)
Mashberg, Cancer 1993YesDip-Chew, 520.8 (0.4 – 1.9) Dip
1.0 (0.7 – 1.4) Chew
Kabat, International Journal of Epidemiology 1994NoChew, 42.3 (0.7 – 7.3)
Dip, 00
Henley, Cancer Causes and Control 2005NoST, 42.0 (0.5 – 7.7) CPS-I cohort
ST, 10.9 (0.1 – 6.7) CPS-II cohort
Winn, New England Journal of Medicine 1981NoDry Snuff, 794.2 (2.6 – 6.7) Whites
Dry Snuff, 121.5 (0.5 – 4.8)
Blot, Cancer Research 1988NoDry Snuff, 66.2 (1.9 – 19.8)
Kabat, International Journal of Epidemiology 1994NoChew, 00
Men and Women Combined
Stockwell, Head and Neck Surgery 1986YesST, Men, 1: Women, 02.3 (0.2 – 12.9) Tongue
ST, Men, 3; Women, 211.2 (4.1 – 30.7) Other Mouth
ST, smokeless tobacco unspecified
CPS I and II, American Cancer Society surveys

Some of the studies referenced by Boffetta included smokers, who are at much higher risk for oral cancer.  Additionally, men who dipped or chewed had no risk for oral cancer in any of the studies.  Boffetta’s elevated risk estimate of 2.6 was based almost entirely on women in the Winn and Blot studies.  As I have explained (here), elevated oral cancer risk among women in those studies was due to use of powdered dry snuff (here).  The table clearly shows the difference in risk between powdered dry snuff used by women and the dip/chew products used by men.  Boffetta’s estimate should never be applied to men who dip and chew.        

Unbiased epidemiologists would be appalled to learn that the FDA is basing its smokeless campaign on population cancer estimates derived from unreliable and inappropriate RRs.

Even if the FDA’s claim of 2,300 smokeless-related cancers was accurate, the number would pale in comparison to the 480,000 U.S. deaths per year due to smoking.

To deal with The Real Cost of tobacco use, the FDA should publish an honest estimate of the risks and consequences of smoking and smokeless use, and issue public messages that inform rather than mislead.  The current campaign wastes taxpayer resources, obfuscates the truth about smokeless tobacco and, ultimately, denies smokers information that could save their lives. 

Wednesday, April 20, 2016

Curt Schillings’ Public Service Announcement Is a Major League Blooper

Major League Baseball is airing a public service announcement with retired pitcher Curt Schilling claiming “I have oral cancer” and linking that condition to his long-term use of chewing tobacco (here).  The 60-second spot, produced by MLB and the Professional Baseball Athletic Trainers Society, will be shown in baseball stadiums and on the MLB Network.

The PSA, however well-intentioned, is unsubstantiated and grossly misleading. Schilling and MLB squander a chance to impress adults and youths about the hazards of smoking, alcohol and human papillomaviruses (HPVs, sexually-transmitted viruses causing throat cancer and cervical cancer in women) and instead perpetuate smokeless tobacco myths.

Schilling has been blaming smokeless for his cancer for two years, but neither he nor his doctors have presented any evidence to support the claim and there is, in fact, good reason to question its accuracy. 

Mouth cancer is extremely rare.  The most common risk factor is smoking, which can increase chances ten-fold.  Smokers who drink alcohol are at even higher risk, and alcohol abuse alone raises the odds about four-fold.  Another significant cause of tongue and throat cancer is HPVs (here). 

While Schilling attributes his cancer to chewing tobacco, one’s odds of developing mouth cancer from this habit are about the same as those for a person who neither smokes, drinks nor has an HPV infection – roughly one or two in 100,000. 

One should ask: Did Schilling actually have mouth cancer?  It’s highly unlikely.  He says his cancer was discovered after he found a lump in his neck.  This indicates that it was almost certainly located in his throat and that it had already spread to a lymph node.    

Throat cancer is not associated with smokeless tobacco use.  It is, however, strongly linked to smoking, heavy alcohol use and infection with HPV. 

The MLB is irresponsible in airing a PSA based on the mere (and likely misguided) opinion of a layman.  Public health campaigns should be founded on verified medical and scientific information.

Wednesday, April 13, 2016

E-Cigarettes Seen as Life-Savers by UK Government, But Condemned by US

The vast difference in governmental perceptions of e-cigarettes in Britain versus the United States is alluded to but not fully fleshed out in a New England Journal of Medicine commentary by Sharon Green and colleagues at Columbia University’s Mailman School of Public Health (here). 

Green describes Britain’s scientific and rational approach by highlighting Public Health England’s report (described by me here) and other key developments, like the Royal College of Physicians’ 2007 analysis that challenged governments to consider “...that smokers smoke predominantly for nicotine, that nicotine itself is not especially hazardous, and that if nicotine could be provided in a form that is acceptable and effective as a cigarette substitute, millions of lives could be saved.” 

Green should have referenced a 2002 RCP report, which, as I stated in congressional testimony one year later (here), underscored that smokeless products are up to “1,000 less hazardous than smoking” and established tobacco harm reduction as a viable public health strategy. 

While Green notes that “England and the United States have now staked out very different positions” on e-cigarettes, her description of the American government’s inimical approach is inadequate.  She refers without citation only to a CDC conference “on e-cigarettes in which all five speakers focused on the possible health risks…None acknowledged a potential role for e-cigarettes in reducing the tobacco burden …Given the tight focus on potential risks to children and nonsmokers, e-cigarettes were out of the question.”

That is correct, but the CDC has done much worse.  Green could have cited numerous misleading agency reports and publications, as I have done in this blog:

  • A publication authored by Dr. Brian King, who suggested that increased use of e-cigs among former smokers might be due to relapse among people who were previously abstinent (here)
  • Reports and press releases about children’s use of e-cigs that distort and misrepresent federal survey data to cast e-cigs as gateways to smoking (here, here and here)
  • A published study that redefined youths who were “probably not” intending to smoke as those who intended to smoke (here)
  • A report and press release claiming, “There is no conclusive scientific evidence that e-cigarettes promote successful long-term quitting,” while CDC director Tom Frieden claimed without evidence that “Many teens who start with e-cigarettes may be condemned to struggling with a lifelong addiction to nicotine and conventional cigarettes” (here)
  • A joint press release with the FDA asserting, “the progress we have made in reducing youth cigarette smoking rates is being threatened…” by “the surge in youth use of novel products like e-cigarettes” (here)
  • A report bashing e-cigarette flavors that was replete with technical discrepancies (here)

One wonders if Green’s omission of specific evidence of the government’s tobacco prohibition campaign is due to a reluctance among American academics to criticize the main source of university research funding (discussed here).  In contrast, two respected tobacco researchers just published (here) convincing evidence that the CDC has kept “in quarantine” data on the risk differentials of smokeless tobacco vs. cigarettes – a choice likely based on the CDC’s reluctance to reveal that smokeless tobacco-related deaths are near zero.     

Wednesday, April 6, 2016

Centers for Disease Control: Release Smokeless Stats

The U.S. Centers for Disease Control and Prevention (CDC) has for decades published annual estimates of smoking-related deaths, which I have analyzed on occasion (here and here).

It is remarkable that what I refer to as the CDC’s “Big Kill” estimates are delivered with single-digit precision.  For example, the current estimate of smoking-attributable deaths is 480,317 (available here). 

In stark contrast, CDC spokespeople include plenty of dire warnings but no relative risk or other specific information when talking about smokeless tobacco.  For example, a recent agency report claimed that “Exclusive smokeless tobacco users have higher observed levels of exposure to nicotine and carcinogenic tobacco-specific nitrosamines… than exclusive cigarette smokers.” (abstract here).  Implied is the specious message that smokeless may be more dangerous than cigarettes. 

The CDC also asserts that smokeless use “causes cancer of the mouth, esophagus... and pancreas… and increases the risk for death from heart diseases and stroke” (here) – claims based upon cherry-picked or irrelevant studies, in the manner I discussed last week (here).

Despite the fact that the agency has the necessary data, CDC pronouncements about smokeless tobacco never cite numbers or estimates.  In contrast, British researchers last year reported that there were no cancer deaths due to smokeless tobacco in the U.S. and Canada (discussed here).  Clearly, the CDC can calculate deaths due to smokeless tobacco, but the agency chooses not to do so.    

The CDC’s stonewall on statistics has been observed by others.  An astute reader of my blog recently shared this fascinating story (available here):

“It's funny, after coming to this site I was curious so I went to the CDC website to see if they provided any estimates as to the number of deaths attributable to smokeless tobacco usage. I couldn't find anything on their website so I sent them an email. To their credit, they did respond, and said ‘ this time, we do not provide estimates of deaths attributed to the use smokeless tobacco products.’ So I responded and asked them if they might be able to point me to some other source of data for these estimates. And again, to their credit, they did respond, but only to say ‘We are not aware of a source of this estimate.’  Hmmm...I would think if smokeless tobacco was indeed such a plague upon society, that they would at least be able to show some numbers.”

This reader is on target.  The CDC continues to scaremonger about smokeless tobacco while it withholds data that likely shows ST-related deaths at near zero.

Taxpayers can call (800-232-4636) or email (here) the CDC to demand details and sources on the precise dangers of smokeless tobacco use.  Please share any replies as a comment to this post.