FDA Tobacco Program Office Issues Misleading Report on Adverse Events

Discussion in 'Media and General News' started by Vocalek, Aug 8, 2012.

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  1. Vocalek

    Vocalek CASAA Activist ECF Veteran

    Supporting member
    Apr 7, 2009
    Springfield, VA
    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:
    [TABLE="class: grid, width: 500"]
    [TR]
    [TD]Chantix
    [/TD]
    [TD]E-Cigarettes[/TD]
    [/TR]
    [TR]
    [TD]35,000 + AE reports[/TD]
    [TD]47 AE reports[/TD]
    [/TR]
    [TR]
    [TD]10,000 + Serious[/TD]
    [TD]8 Serious[/TD]
    [/TR]
    [TR]
    [TD]272 Deaths[/TD]
    [TD]0 Deaths[/TD]
    [/TR]
    [/TABLE]

    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.
     
  2. Hottody

    Hottody Moved On ECF Veteran

    Mar 20, 2011
    Temcula CA
    Very very interesting. Thank you for the post!
     
  3. dee5

    dee5 Ultra Member ECF Veteran

    Mar 8, 2009
    Northwest Arkansas
    Setting the stage, laying the foundation, whatever you want to call it we have to be aware and help make the public aware of the real reasons behind these "reports". Once again Elaine, thank you for revealing the truth hidden within the propaganda.
     
  4. Myk

    Myk Ultra Member ECF Veteran

    Jan 1, 2009
    IL, USA
    As far as I know my doctors who put me on Wellbutrin were required to report the suicidal thoughts, they did not and insisted I keep on taking it.
    Only my present doctor added that to my record so he would not recommend any drug like that.
    So I'm very sure that Chantix report is low.
    Given all the shenanigans surrounding the Zyban/Chantix testing for cessation (intentionally excluding people with possible mental issues or those that have failed quitting before) and the fact the FDA still allows it screams louder than anything.
     
  5. yvilla

    yvilla Ultra Member Verified Member ECF Veteran

    Nov 18, 2008
    Rochester, NY
    Without hard data on the nature of the 47 alleged "adverse reports" on e-cigs, I'm even more sceptical than that Elaine.

    For I distinctly remember people back in either late 2008 or 2009 reporting here that they were considering using the adverse reports system to send the FDA a message about serious "side effects" of e-cigs such as: being able to breath again, being able to smell again, etc. etc. I'm sure some people did do that too, to the extent that some of us here urged people not to do that, because we couldn't trust that all such reports, no matter how tongue-in-cheek, would not be counted against e-cigs. Don't you remember that?

    I'd wager that there's an excellent chance that at least some of those 47 reports "against' e-cigs were in fact written in that vein. Who knows how many!
     
  6. EJH

    EJH Senior Member Verified Member ECF Veteran

    Dec 1, 2011
    New York, USA
    I agree that this report is misleading. However, the report makes a fine case *for* e-cigarettes. Consider that since 2008, according to CDC numbers, about 2 million smokers have died and tens of millions more are suffering "serious adverse effects." Compare to e-cigarettes: 47 "adverse effects," 8 of which were "serious" and ZERO deaths. NONE. Not. A. Single. DEATH.

    If the FDA were not beholden to Big Pharma and the scientists at this agency had a shred of scientific integrity, the headline for this report should have read: "E-cigarettes 1000s Times Safer Than Smoking, Infinitely Safer for Risk of Death."

    That's what I get out of this report.
     
  7. Bill Godshall

    Bill Godshall Executive Director
    Smokefree Pennsylvania
    ECF Veteran

    Supporting member
    Apr 2, 2009
    Furthermore, I'm not aware that the FDA has urged anyone to report adverse events from tobacco products, or even notified the public about how to report an adverse event from a tobacco product.

    In contrast, not only did FDA's July 2009 press conference encourage the public to report adverse events from e-cigarettes, but it has displayed that notice (ever since then) on the FDA's e-cigarette webpage.
     
  8. Petrodus

    Petrodus Vaping Master ECF Veteran

    Oct 12, 2010
    Midwest
    Do we have any elected officials or government agencies
    that are not lying to us all the time ??

    What is painfully obvious to me is they don't even care
    if the public knows they are lying.
     
  9. Vocalek

    Vocalek CASAA Activist ECF Veteran

    Supporting member
    Apr 7, 2009
    Springfield, VA
    I've been looking through the document again and some things caught my eye.

    Three of the four references are questionable.

    There is a statement "Currently, there are estimated to be more than 400 brands of e-cigarettes available (Food and Drug Administration, 2011; Kesmodel & Yadron, 2010)."

    Food and Drug Administration. (2011). Electronic cigarettes. Retrieved from Electronic Cigarettes

    Kesmodel, D., & Yadron, D. (2010, August 25). E-cigarettes spark new smoking war. #e Wall Street Journal. Retrieved from Arts, Entertainment News, Music, Film, Television, Opera & Ballet News at WSJ.com - Wsj.com

    So I tracked down those references and did a search for "brands". Not found. Then I tried "400" and got a hit on this text: "About 400,000 Americans die each year..."

    So where did this "fact" come from?

    For a statement such as this...

    "There is concern about the apparent absence of adequate quality control oversight during the manufacturing
    of e-cigarettes (Riker, Lee, Darville, & Hahn, 2012)."

    ...you would expect to find a report of some type of testing that was conducted by the authors of the referenced article.

    But the Riker, Lee, Darville, & Hahn article is secondary research. The authors reviewed a number of published articles, some of which described experiments conducted by their authors, and some of which were newspaper articles, FDA web pages, etc. Even when a reference was a good one, they had a tendency to cherry-pick some idea from that article to paint e-cigarettes in a negative light. Example: "Cahn and Siegel,50 who support e-cigarettes as a promising harm reduction product,
    acknowledge that existing research does not establish the absolute safety of e-cigarettes."

    This isn't untrue. They did say that. But focusing solely on this idea gives the false impression that the Cahn & Siegel article is a cautionary piece, and nothing was said to dispel that incorrect notion.

    Riker, C., Lee, K., Darville, A., & Hahn, E. (2012) E-cigarettes: Promise or peril? Nursing Clinics of North America, 47, 159–71. doi:10.1016/j.cnur.2011.10.002
     
  10. rothenbj

    rothenbj Vaping Master Verified Member ECF Veteran

    Supporting member
    Jul 23, 2009
    Green Lane, Pa
    Totally accurate yvilla. I recall people posting that they had indeed used the system to state their improvements in health.

    What also should be included in any of these statistics is AE/x number of users. Today there may be as many or more people using e cigs than are taking chantix. AE/100k users would give a bit more clarity to what we are reading.
     
  11. Petrodus

    Petrodus Vaping Master ECF Veteran

    Oct 12, 2010
    Midwest
    Just did a Google search ... "Electronic cigarettes"
    Noticed the FDA's BS is in position #3 ... just below Wiki and blu
    Guess the FDA is into buying (or pressuring) Google for position
    LINK

    I'm sure their BS isn't ranked high based on popularity
    :p

    Not a lot of e-cigs in the news articles ...
    No big surprise since nothing really is going
    to happen with e-cigs till after the election.
     
  12. Danny632

    Danny632 Full Member

    Aug 10, 2012
    Orlando, FL

    Just to clarify & inform, not argue...

    The FDA's page is ranked #3 because to a search engine (Google), the FDA's site is a prominent, national, government site (.gov sites are generally given more credibility by search engines) with heavy traffic and a huge amount of links to and from other large, prominent sites. These are key factors that search engines use to determine rankings. The FDA's position on this issue being ranked high is because the FDA website itself is ranked so high. It is because of the algorithms that search engines use to rank sites, not because the FDA bought or pressured Google for a high ranking.
    If you're interested in learning more about how search engines work, you can find it all online.
     
  13. kristin

    kristin Vaping Master ECF Veteran

    After this came out last week, I went on the site to check these reports for myself (I also remembered the reports Yvilla mentioned). First of all, it is an EXTREMELY tedious and complicated process for an "average Joe" to get the report, so all I got in about an hour was the second quarter of 2011. There was ONE e-cig report (patient reported hallucinations??) and at LEAST 20 reports for pharmaceutical nicotine products (haven't checked for Chantix yet.) That is just for THREE MONTHS! Just imagine how many that could translate to, over the same 4 years, for those "safe & effective," FDA-approved nicotine products?
     
  14. Myk

    Myk Ultra Member ECF Veteran

    Jan 1, 2009
    IL, USA
    What brand was it? I'd like to try that one ;)
     
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