Tuesday, April 27, 2010

Misinformation from Three Senior FDA Officials

Many federal agencies deal with tobacco. For example, the Agriculture Department monitors tobacco cultivation (example here); the Treasury Department works with the Bureau of Alcohol, Tobacco and Firearms to monitor tax collections (example here); the Federal Trade Commission monitors sales and marketing (sample report here); and the Centers for Disease Control and Prevention tracks prevalence (sample here). In performing their functions, all these agencies distinguish cigarettes and smoking from smokeless tobacco and its use. Why doesn’t the Food and Drug Administration do the same?

Three senior FDA officials have authored a commentary about tobacco regulation for the New England Journal of Medicine (read it here) in which smoking and smokeless tobacco use are never distinguished. Even worse, “smoking” and “tobacco use” are used synonymously.

The FDA leaders are Lawrence Deyton, director of the Center for Tobacco Products, Joshua Sharfstein, principal deputy commissioner, and Margaret Hamburg, commissioner. They write, “Still, tobacco use causes more than 400,000 deaths in the United States annually…” This is just one of eight times in the article where Deyton et al. use the all-encompassing word “tobacco” when they are describing cigarettes or smoking.

Physician/authors Deyton, Sharfstein and Hamburg clearly are pursuing an agenda when they knowingly rely on “smoking” data but still describe “tobacco products” as “the leading cause of preventable death in the United States.”

Muddled terminology has been a hallmark of anti-tobacco extremists for many years, but it has become particularly apparent recently, as more Americans have become aware of the vastly lower health risks related to smokeless tobacco versus cigarettes. It’s all part of the demonization of tobacco users and manufacturers.

Deyton, Sharfstein and Hamburg write, “Although most Americans know that tobacco is harmful, few know specifically how damaging it is to the health of both smokers and nonsmokers.” Although this is a reference to second-hand smoke, it is also true that few Americans know that smokeless tobacco is vastly safer, and a government agency is partially to blame.

The CDC routinely publishes the exact number of deaths from smoking: the current annual estimate is 442,083. But the number of deaths due to smokeless tobacco use is nowhere to be found, despite the fact that the CDC and the American Cancer Society are in possession of the applicable data. Both organizations refuse to release an estimate or share the data with outside investigators.

Deyton et al. write about “tools” that the FDA will use “to ensure that advertising is truthful and not misleading,” in order to counter “tobacco-industry efforts to mislead the public about the safety of tobacco products.”

“Truthful and not misleading” are excellent criteria that should apply not only to the tobacco industry, but to federal agencies and officials charged with tobacco regulation and public health.

1 comment:

Vocal EK said...

The FDA has a lot of nerve demanding "truthful and not misleading" of other entities. The American Association of Public Health Physicians has filed a petition asking the FDA to hold a follow-up press conference to correct errors and misinterpretations of errors in their July 22, 2009 press conference regarding electronic cigarettes. The public can leave comments in support of the petition at http://www.regulations.gov/search/Regs/home.html#home

Type 'FDA-2010-P-0093' into the field labeled "Enter Keyword or ID." In the July 22 press conference FDA misled the public into believing that electronic cigarettes were highly toxic and more carcinogenic than tobacco cigarettes. The truth is that FDA's testing did not find any potentially harmful substances in high enough quantities to be toxic or carcinogenic. FDA was looking to justify its efforts to ban a product that hundreds of thousands of users have found to be an acceptable (and much healthier) substitute for inhaling tobacco cigarette smoke.