Wednesday, July 28, 2010

WARNING: FDA Flubs Smokeless Tobacco Warnings

Last month, the FDA appeared to comply with provisions in the Tobacco Act by ordering larger health warnings on smokeless tobacco packages and advertisements; the Act also added a fourth warning. The older three, which have been around for about 25 years, are terribly inaccurate and misleading.

Four warnings are mandated by the legislation, but not the four that the FDA is implementing. Is this a case of sloppy transcription by the agency, or intentional pursuit of the FDA’s own agenda?

Here are the four warnings mandated on page 1,846 of the Tobacco Act (available here):

‘‘WARNING: This product can cause mouth cancer.”

‘‘WARNING: This product can cause gum disease and tooth loss.”

‘‘WARNING: This product is not a safe alternative to cigarettes.”

‘‘WARNING: Smokeless tobacco is addictive.”

Here are the four warnings as they appear on the FDA website and fact sheet (here):

“This product is addictive”

“This product can cause mouth cancer”

“This product can cause gum disease”

“This product is not a safe alternative to cigarettes”

The FDA removed the “WARNING” header; removed “and tooth loss” from the second warning; and changed “smokeless tobacco” to “this product” in the addictive warning.

The smokeless tobacco warnings specified by Congress are inaccurate and misleading to begin with. Can an FDA that mismanages the simple transcription of legislative orders be trusted to appropriately implement the law?

Wednesday, July 14, 2010

Who Said Light Cigarettes Are Safer? The American Cancer Society

On June 22, Congressman Henry Waxman wrote a commentary (here) in The Hill’s Congress Blog celebrating the first anniversary of his legislation giving the FDA regulatory authority over tobacco. He noted, “Today new regulations take effect banning the use of the terms ‘light,’ ‘mild,’ and ‘low-tar,’ from tobacco advertising, labeling, and marketing. These terms were designed by the industry to mislead consumers, who often think - incorrectly - that products that carry these labels are less dangerous than other tobacco products.”

This line – that safer cigarettes are a deception perpetrated by the tobacco industry -- has been repeated so many times that it is considered gospel by the American public. In fact, the medical and scientific literature makes this a prime example of historical revisionism, if not pure myth.

Research published in the 1970s documented that low-tar low-nicotine cigarettes were less hazardous than others. Contrary to Mr. Waxman’s assertion that “these terms were designed by the industry to mislead consumers,” articles in respected medical journals reveal that the American Cancer Society played a prominent role in shaping consumers’ positive perception of these products.

As I have previously blogged, in 1976 the Cancer Society published research (here) showing that light cigarettes were indeed safer. In 1959-60, over a million people were enrolled by the Cancer Society in a prospective epidemiological study of cancer risk factors. Smokers were classified according to nicotine-tar content, high (2.0-2.7 milligrams nicotine and 26-36 mg tar) or low (less than 1.2 mg nicotine and less than 18 mg tar); detailed records were obtained about the number and dates of deaths.

The study revealed that the death rate from all causes was 16% lower among smokers of low nicotine-tar cigarettes than among smokers of high nicotine-tar cigarettes. Similarly, low nicotine-tar smokers had a 14% lower death rate from heart attacks and a 26% lower rate from lung cancer. The Cancer Society authors concluded that “total death rates, death rates from coronary heart disease, and death rates from lung cancer were somewhat lower for those who smoked ‘low’ tar-nicotine cigarettes than for those who smoked ‘high’ tar-nicotine cigarettes.”

This study was extensively reported on by the media.

In 1979, Cancer Society investigators published a study in the New England Journal of Medicine, confirming the 1976 lung cancer findings (abstract here). This study examined the lungs of 211 men who died in 1955-60 and 234 men who died in 1970-77. It looked for microscopic changes indicating that a cancerous tumor might have eventually developed if these men had lived longer.

Smoking Category% Pre-cancer, 1955-60% Pre-cancer, 1970-77
NonSmoker 00
Less than 1 pack per day 2.60.1
1-2 packs per day 13.20.8
2+ packs per day 22.52.2

The results from this study are shocking. In 1955-60, when filter or light cigarettes were rare, 2.6% of men who smoked less than a pack per day had pre-cancerous changes in their lungs. Among men smoking 1-2 packs, 13 percent had changes, and this increased to 23 percent among those smoking over 2 packs per day. But in 1970-77, when, according to the report, “a large proportion of smokers have deliberately selected brands with reduced tar and nicotine,” the percentage of smokers in every category who had pre-cancerous lung changes was very small.

Cancer Society researchers concluded: “The evidence from this study is consistent with evidence from epidemiologic studies indicating that death rates from lung cancer are lower among men who smoke the same number of high tar/nicotine cigarettes per day…”

This study appeared in the New England Journal of Medicine, one of the most prestigious medical publications. The results were widely reported by the national media, including the Wall Street Journal.

According to one article (here), ACS president LaSalle D. Leffall Jr. issued a harm reduction message, saying that “findings of the new study suggest a way for smokers to reduce their lung cancer risk by switching to low tar-nicotine cigarettes if they find it impossible to quit entirely.” To his credit, Leffall also noted that “the best way to escape the risk of lung cancer ‘is not to smoke at all…There is no safe cigarette.’”

American smokers made a large-scale transition from full-flavor to light cigarettes almost 50 years ago; the public health impact remains a highly debated topic even today. One fact is not debatable: The marketing of light cigarettes was not entirely an industry-driven conspiracy. The health advantages of light cigarettes compared with full-flavor brands were documented and promoted by the American Cancer Society in 1976 and 1979.

Federal Agencies Continue To Disrespect Smokeless Tobacco Users

Last week I presented my correspondence with the director of the federal Centers for Disease Control and Prevention, which resulted in a retraction of CDC’s use of the pejorative term “spit tobacco” in a formal report (read it here).

This week I am very disappointed to report that the FDA uses the demeaning term on a web page (here) that was last updated on July 8.

Although the offending page is supposed to present information about warning labels, it launches into an unnecessary and unsubstantiated attack on smokeless tobacco and, of course, its users:

“Smokeless tobacco is still tobacco. It is addictive and causes cancer. Quit today. For help, visit ‘Spit Tobacco: A Guide for Quitting’ or call 1-800-QUIT-NOW.”

It is unacceptable and irresponsible for the FDA to use such language to describe the product it is supposed to regulate in a balanced, fair and scientific manner. But it gets worse. The Spit Tobacco Quitting Guide is an embedded link to a document on the website of the National Institute of Dental and Craniofacial Research (here). The document exposes smokeless users to even more abuse:

“If the health effects don’t worry you, think of how other people see your addiction. The smell of spit tobacco in your mouth is not pleasant. While you may have become used to the odor and don’t mind it, others around you notice. Check out your clothes. Do you have tobacco juice stains on your clothes, your furniture, or on your car’s upholstery? Your tobacco spit and drool could be making a mess. Look at your teeth. Are they stained from tobacco juice? Brushing your teeth won’t make this go away.”

This is appalling language, and it is disgraceful that two federal agencies have officially adopted and endorsed it.

Three years ago, the director of the Centers for Disease Control rejected the use of the biased and pejorative term “spit tobacco.” Unfortunately, the practice persists today at two other federal agencies. I have written to Dr. Lawrence Deyton, director of the FDA Center for Tobacco Products, and to Dr. Lawrence Tabak, director of the National Institute of Dental and Craniofacial Research, asking them to remove these offensive website items and order professionals in their agencies to stop using this term in all official matters.

Users of smokeless products may want to call, write or email Drs. Deyton and Tabak, asking them to remove “spit tobacco” from their agencies’ vocabulary. Here is their contact information:

Dr. Deyton: 1-877-287-1373 (toll-free)

Dr. Tabak: 1-301-496-3571

Wednesday, July 7, 2010

Health Professionals Who Disrespect Smokeless Tobacco Users

When I started conducting research on tobacco harm reduction in the early 1990s, I noticed a disturbing trend: replacement of the term “smokeless tobacco” with the demeaning and disrespectful term “spit tobacco.”

This degrading term was not only used by extremists at the margin of tobacco control; by 1994, health professionals were using it in medical journals. The first instances were in the Journal of the American Medical Association (citation here) and the Journal of the American Dental Association (abstract here). The latter article was the first of 10 by Margaret Walsh, a professor of dentistry at the University of California/San Francisco; her most recent publication was in 2009 (abstract here).

Other professionals who have used this terminology include John Ebbert and Lowell Dale of the Mayo Clinic (here, here and here) and Dorothy Hatsukami at the University of Minnesota (here and here). Dr. Hatsukami’s adoption of the loaded term is especially troublesome since she now sits on the FDA tobacco products advisory panel.

The most egregious use of the spit terminology has been by the American Cancer Society and the CDC. The Cancer Society published research studies in 2005 and 2007, prominently using “spit” (here and here). The CDC institutionalized the practice in a 2006 federal report in collaboration with the National Center for Health Statistics (here).

The 2006 CDC report was especially deplorable, because it treated smokeless tobacco use differently than three other adult health risk behaviors -- cigarette smoking, cigar use and alcohol consumption.

On February 19, 2007, I wrote to CDC Director Julie Gerberding and NCHS Director Edward Sondik (available here). I pointed out that “the report’s use of [‘spit’ tobacco] is clearly inconsistent with its use of other terms relating to tobacco use and drinking behaviors. Furthermore, I believe that the use of ‘spit’ tobacco violates NCHS and CDC guidelines for ensuring the quality of information disseminated to the public. The NCHS and CDC guidelines are identical with respect to this matter, as it is each agency’s policy to ‘ensure and maximize the quality, objectivity, utility, and integrity of information that it disseminates to the public.’”

I strongly urged “CDC and NCHS to issue a corrected version of the Advance Data Report Number 378. Furthermore, I am asking that CDC/NCHS officials and staff to avoid the use of the term ‘spit’ tobacco in future official government publications, and to remove the term from existing web pages. This term is inappropriate because it is inaccurate, biased and unobjective. In addition, its use is inconsistent with the fully appropriate and non-pejorative terms ‘cigarettes,’ ‘cigars’ and ‘alcohol’ used in this and other government documents.”

In April, I received a response from Dr. Gerberding (read it here). She acknowledged that “an inappropriate term was used in this report. We agree that the term ‘smokeless tobacco’…would provide a better description of the information and we will take swift action to make that change. A revised version of [the report] will be posted on NCHS’ website. The printed version of this report will be changed should we reprint in the future.”

In May 2007, I wrote to John Seffrin, CEO of the American Cancer Society. I included a copy of Dr. Gerberding’s decision, and I listed several specific publications in which Cancer Society officials had used “spit tobacco”. I made the following key points:

“In a March 27 Wall Street Journal article, American Cancer Society Vice President Dr. Michael Thun summarized a growing consensus among tobacco research and policy experts regarding the vast difference in risk between smoked and smokeless products: ‘There's no question that switching to spit tobacco and quitting tobacco altogether are both far less lethal than continuing to smoke.’ Recognizing these differential risks is consistent with the American Cancer Society mission, which includes ‘preventing cancer, saving lives, and diminishing suffering from cancer.’ Describing all tobacco products in objective and professional terms would enhance the essential humanity of your mission by treating all tobacco users with dignity and respect.

“I believe that the American Cancer Society strives for high standards in its professional reports and communications, and I request that Society officials describe tobacco use in a non-pejorative, unbiased and objective manner consistent with the change made by the CDC. Specifically, I ask that Cancer Society officials and staff not use the term ‘spit tobacco’ in future reports and communications, and that the term be removed from existing web pages and other electronic reports and documents.”

In July 2007, Dr. Seffrin wrote back: “Thank you for sharing your concerns regarding the use of the term ‘spit tobacco’ by health and policy professionals at the American Cancer Society. I have forwarded your letter to the appropriate staff for further review and any appropriate action.”

I don’t believe that Cancer Society officials at the national level have used “spit tobacco” since that time.

Use of the phrase “spit tobacco” shows that anti-tobacco extremists are completely out of touch with contemporary use of smokeless products. The “Swedish miracle” has shown the world that smokeless tobacco can be an effective substitute for cigarettes, resulting in population-level health improvement. Swedes have also shown how to use smokeless tobacco without spitting. They place smokeless products in the upper lip, reducing or eliminating the need to spit.

Modern dissolvable products (here and here), which are about the size of small breath mints, can also be used invisibly in any social situation. No tobacco juices are produced when these products are used, so spitting is as unnecessary as the derogatory terminology.