Wednesday, March 30, 2016

FDA Smokeless Tobacco Campaign is Incompatible with Science-Based Regulation

Congress gave the FDA regulatory oversight of the tobacco industry in 2009.  In 2013, Mitch Zeller, director of the FDA Center for Tobacco Products (CTP), observed, “There are some very powerful tools that Congress has given FDA to use wisely and supported by evidence. That’s where I think, the greatest opportunity lies: to use the tools relying on regulatory science to try to protect consumers and reduce the death and disease toll from tobacco.” 

Despite this avowed focus on scientific evidence, the CTP is engaged in an unfounded crusade against the products it is tasked to regulate.  Typical of the agency’s action is a March 18 Tweet that grossly distorts the facts; it reads: “Smokeless tobacco causes cancers of the mouth, esophagus, and pancreas.”  

It appears that this claim is based on the 3-page summary of a 400-page smokeless tobacco monograph from the International Agency for Research on Cancer (IARC)(here), making the FDA Tweet a case study in the cherry-picking of evidence.  Worse, as shown below, some of this paltry data doesn’t even apply to Swedish and American products.   

In defining mouth cancer risks, the IARC monograph relies heavily on a 1981 New England Journal of Medicine article that exaggerated the health effects of powdered dry snuff use and falsely implicated moist snuff and chewing tobacco, as I have detailed earlier (here and here).  Other studies cited by IARC mainly come from India, Pakistan, Sudan, Saudi Arabia, central Asia and Africa, where smokeless products are far more toxic than those in the US. and Sweden.    

As for cancer of the esophagus, the IARC monograph cites one study from India, along with cherry-picked and minimally elevated risks from one Swedish and one Norwegian study.  For cancer of the pancreas, selective data points are offered from one Norwegian and three U.S. studies.

The problem is that the IARC never conducted a systematic and comprehensive analysis of all available studies.  As I have discussed (here), when all the evidence is weighed, snus users in Scandinavia and dip/chew users in the U.S. have no elevated risks for any of these cancers.  I have also documented how cherry-picked data has been used to falsely blame pancreatic cancer on the use of smokeless products (here). 

Although it lacks the FDA’s tobacco enforcement powers, the Centers for Disease Control (CDC) makes the same unscientific claims about smokeless tobacco.  The CDC supports the disinformation campaign by failing to report deaths due to smokeless tobacco use when it releases annual smoking death estimates.  The failure is likely driven by the fact that the number for smokeless is close to zero, which undercuts the government’s anti-smokeless campaign. 

The FDA, with its ongoing anti-science attack on nearly risk-free smokeless tobacco, continues to demonstrate that it cannot be trusted to base tobacco regulation on scientific evidence.


Simon Spalding said...

Excellent piece of detective work .

Rance Cannon said...

If it wasn't for Dr. Rodu, along with Carl Phillips, I would have kept smoking instead of switching to smokeless tobacco. If they were to take away smokeless tobacco I would have to start smoking again. These are frightening times my friends. I would also ask of the good Dr. if, in some future posts, he would return again to the crusade to ban smokeless tobacco use in professional baseball. I caught the story on SportsCenter on ESPN recently and it made me sick with worry. What's next?