Well folks, the FDA is at it again, using subtle propaganda techniques to paint an unflattering picture of electronic cigarettes. Dr. Ii-Lun Chen, MD, an FDA employee has a Letter published in the most recent issue of the SRNT's medical journal, tobacco and Nicotine Research, titled "FDA Summary of Adverse Events on Electronic Cigarettes." Sign In
Section 909 of the tobacco Act specifies that tobacco companies should report any adverse events (AE) concerning their products to the FDA. The Act doesn't specify how these reports should be submitted. For many years, medical providers and the general public have used the FDA's Adverse Event Reporting System (AERS) to report problems with drugs and medical devices. But the FDA's page on reporting Adverse Events makes no mention of tobacco products: Adverse Event Reporting System (AERS)
Dr. Chen's article states:
Anyone who didn't know the whole story would think, "Wow! Electronic Cigarettes are more dangerous than any other type of tobacco product." But what is not mentioned is that the FDA did not take over regulation of tobacco products until 2009. So any report on tobacco products that came in between the late 1980s and the present would have been an off-label use of the system, so-to-speak. But even more important that until this article was published, the FDA has not asked the public to submit AE reports on tobacco products such as combustible cigarettes, cigars, or smokeless tobacco.
During a July 2009 press conference, the FDA invited the public to use their AERS surveillance system to report problems with e-cigarettes. So it would make sense that there would be more reports on e-cigarettes than on other tobacco products. In fact, if the FDA had not specifically asked for AE reports to be submitted on e-cigarettes, the odds are good that there would have been no more than a handful of such reports.
Leaving out pertinent information is a propaganda technique known as "Card Stacking."
The article concludes:
Notice how the FDA is setting up an expectation that the AE reports will be used to implement "quality control" measures, by implying that there are huge problems in this area. Let's see now, 47 AE reports in three years. Is that a vast amount?
According to John Polito:
Here's the score:
Edited to correct Chantix Serious AEs: The 1005 serious events that I previously listed were only for the 3Q of 2010. The total to date is over 10,000.
NOTE: I am not claiming that there are no e-cigarette quality control issues. If anything, battery safety is a more serious problem than harmless trace amounts of chemicals in the liquid that are not even present in the vapor. And vendors do need to take care to ensure that nicotine content matches what's on the label. But I do believe that these issues pale in comparison to the safety record of products such as Chantix.
Also I find it very questionable why the FDA would keep recommending that we stop using e-cigarettes and switch to the "safe and effective" products like Chantix.
Section 909 of the tobacco Act specifies that tobacco companies should report any adverse events (AE) concerning their products to the FDA. The Act doesn't specify how these reports should be submitted. For many years, medical providers and the general public have used the FDA's Adverse Event Reporting System (AERS) to report problems with drugs and medical devices. But the FDA's page on reporting Adverse Events makes no mention of tobacco products: Adverse Event Reporting System (AERS)
Dr. Chen's article states:
Since the late 1980s, over 100 AE reports on tobacco products have been submitted to FDA (electronic cigarettes, n = 47; cigarettes, n = 36; smokeless tobacco, n = 14; other tobacco, n = 5). Notably, approximately half of all tobacco-related AE reports concern electronic cigarettes, the first of which was submitted in 2008.
The numbers of AE reports received by CTP pertaining to e-cigarettes are summarized as follows: 2008 and earlier (1 of 18 total tobacco product reports), 2009 (10 of 16), 2010 (16 of 27), 2011 (11 of 30), and first-quarter 2012 (9 of 11). Of the 47 reports on e-cigarettes, 8 reported serious adverse events.
Anyone who didn't know the whole story would think, "Wow! Electronic Cigarettes are more dangerous than any other type of tobacco product." But what is not mentioned is that the FDA did not take over regulation of tobacco products until 2009. So any report on tobacco products that came in between the late 1980s and the present would have been an off-label use of the system, so-to-speak. But even more important that until this article was published, the FDA has not asked the public to submit AE reports on tobacco products such as combustible cigarettes, cigars, or smokeless tobacco.
During a July 2009 press conference, the FDA invited the public to use their AERS surveillance system to report problems with e-cigarettes. So it would make sense that there would be more reports on e-cigarettes than on other tobacco products. In fact, if the FDA had not specifically asked for AE reports to be submitted on e-cigarettes, the odds are good that there would have been no more than a handful of such reports.
Leaving out pertinent information is a propaganda technique known as "Card Stacking."
The article concludes:
Research will inform our understanding of the design and composition of all varieties of e-cigarettes on the market and the health effects on the consumer as well as for those exposed to the vapor. When FDA regulates e-cigarettes marketed as tobacco products, the resulting quality control measures and product standards for this class of products may help to decrease adverse health events. CTP is currently developing a tobacco-specific adverse event reporting system. In the meantime, concerned consumers or the public can report adverse events for any tobacco products to MedWatch Online Voluntary Reporting, https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
Notice how the FDA is setting up an expectation that the AE reports will be used to implement "quality control" measures, by implying that there are huge problems in this area. Let's see now, 47 AE reports in three years. Is that a vast amount?
According to John Polito:
A May 19, 2011 report by the Institute for Safe Medication Practices (ISMP) revealing that the FDA has now received a total of 272 reports of completed suicides by Chantix users.
According to the ISMP, Chantix ranks first in reported deaths, more than twice as many as any other monitored drug. Total adverse event reports now exceed 35,000, of which roughly 10,000 were classified as serious, disabling or fatal, with 1,055 serious events being reported during the 3rd quarter of 2010.
Here's the score:
Chantix | E-Cigarettes |
35,000 + AE reports | 47 AE reports |
10,000 + Serious | 8 Serious |
272 Deaths | 0 Deaths |
Edited to correct Chantix Serious AEs: The 1005 serious events that I previously listed were only for the 3Q of 2010. The total to date is over 10,000.
NOTE: I am not claiming that there are no e-cigarette quality control issues. If anything, battery safety is a more serious problem than harmless trace amounts of chemicals in the liquid that are not even present in the vapor. And vendors do need to take care to ensure that nicotine content matches what's on the label. But I do believe that these issues pale in comparison to the safety record of products such as Chantix.
Also I find it very questionable why the FDA would keep recommending that we stop using e-cigarettes and switch to the "safe and effective" products like Chantix.
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