Brief article in the latest Consumer Reports

[Spazmelda]

Not as negative as I was expecting it to be. It's on page 11 of May 2012 issue. Half a page with an accurate picture of a mini 3 piece unit.

"Bottom line. Talk to your doctor before trying to quit smoking with e-cigarettes. Because they're not regulated, safety is a question and you use them at your own risk."

They do bring up the fact that gum and patches are not as effective as once thought, and report a few of the positive studies on e- cigs. They also hit the tried and true, "What about the children?!?!?11?"

 

[Docliv]

The link is: E-Cigarettes - Consumer Reports

 

[Spazmelda]

Oh, yes a link would have helped right? Thanks!

So the FDA adverse Event report info was not in the print version. That is interesting. It says that a few of the reports were favorable. I wonder what would happen if we flooded the FDA adverse event reports with our stories telling how great e-cigs have been for us? I had thought of that before but I wasn't sure if the FDA would just consider them as adverse and use them to cast e-cigs in a more negative light.

Here's the online adverse event form: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm

 

[Vocalek]

Right after my print issue arrived, I saw that article and went looking for a way to contact the editor. I found it: Contact Us

Directions:

1. Under CR Products/Services *, select the first item in the drop-down menu, "Consumer Reports Magazine".

2. After you select the item, an icon of an arrow pointing down appears next to the text. Click on it, and another drop-down menu appears.

3. Select "Letter to the Editor", which is 4 items below "Consumer Reports Magazine."

4. Complete the fields in the form and then click the Continue button.

I looked at the letters they printed and all were very short, about one column-inch (approximately 250 words). Each included the title of the article in the first sentence and the month and year of publication in parentheses following the title.

Example:

In "Countertops" (July 2011), you don't mention....


I did submit a letter. I was going to post my letter here, but the electronic edition of the magazine had not been published yet and I wanted to supply a link to the text of the article with it. Unfortunately between then and now, I have misplaced the document that had a copy of what I had written.

This is the response I received from Consumer Reports:

Dear Ms. Keller,

Thank you for taking the time to contact Consumer Reports®. I want to express how much we value your choice of our products and services to help you make informed purchasing decisions.

I would like you to know that I have forwarded the experiences you described with your e-cigarettes to internal technical and editorial staff members for their review and consideration. I am sure that they, too, will find your correspondence to be of value. As you can imagine our readers’ feedback plays an important role in the work that we do.

Consumer Reports is committed to making your experience positive and informative.

Sincerely,

Jack Aiello
Representative
Customer Relations Department

 

[Spazmelda]

If you do find what you wrote to them, Elaine, would you post it here? I'd love to see. I will write to them too.

 

[(So) Jersey Girl]

Someone should ask them to submit a FOIA request for the adverse effects on Chantix.

 

[dlsw]

We need to flood the Fda with positive feedback. I think the side effects described are the same as any nicotine replacement product. (except the explosion)

 

[TennDave]

Interesting that in one part of the article, it said the FDA does not have jurisdiction over e-cigs and then at the end of the article which speaks about adverse effects, it says this:
"On the other hand, the FDA estimates that it receives only 1 to 10 percent of all adverse events experienced by the public on products it regulates."
Because of the way it's worded, it makes it sound as if the FDA does indeed regulate e-cigs.

 

[Placebo Effect]

Someone should ask them to submit a FOIA request for the adverse effects on Chantix.

This info is available on WestLaw, a subscription service I have access to through my law school.

"Medicinal product: Chantix" -- 10,000+ results
"Medicinal product: Nicorette" -- 2,339 results
"Medicinal product: Nicoderm" -- 3,680 results

 

[Bill Godshall]

Placebo Effect wrote

This info is available on WestLaw, a subscription service I have access to through my law school.

"Medicinal product: Chantix" -- 10,000+ results
"Medicinal product: Nicorette" -- 2,339 results
"Medicinal product: Nicoderm" -- 3,680 results

I spent an hour surfing throught the FDA's website trying to obtain the adverse event report data, but couldn't access anything useful.

Does it require a FOIA?

Regardless, we need to expose these facts, and document them. Until we do, everything we say will just be considered rumors.

 

[Vocalek]

You can download data files from this page, but unless you know how to work with relational databases, you'll find analyzing the data difficult.

The Adverse Event Reporting System (AERS): Latest Quarterly Data Files

There has to be someone on this forum who has a database program like SAS who can take a look at the data.

 

[Snus]

Have you tried using Open Office? It's free.....

 

[calsax]

Elaine -

I just downloaded the files, and will take a look at them over the weekend. I am a Quality Assurance Data Analyst for a Medical Device company, so I should be able to make some sense of them. Well, they are from the FDA, so maybe not.......

I'll post back after I get a chance to do some analysis, and let you know what, if anything, I can grok from the data.

Thanks for the link!

And by the way, Open Office doesn't have very good data analysis tools, especially when you are dealing with the amount of data in these files. I'm hoping that Access can deal with it, so I don't have to break out the sql tools!

 

[Spazmelda]

When I get around to writing my letter to consumer reports I will suggest they look at and report the adverse event reports for chantix, nicorette, etc...

 

[Vocalek]

The thing that I find most egregious about the Consumer Reports story is how they repeat the FDA "concerns" without doing any fact-checking. Presenting an unsupported accusation as a "concern" is a clever and devious way to discredit someone or something.

There is no evidence whatsoever that non-smokers are using e-cigarettes and then becoming smokers. And why would a kid buy a $150 e-cigarette kit instead of a $1 candy bar?

This story is being picked up by papers and TV stations across the country. Propaganda initiated by the FDA is being perpetuated by the media.

How would Consumer Reports like it if media reported that there are "concerns" that Consumer Reports may have been given a payoff by Big Pharma to discredit e-cigarettes?

 

[Petrodus]

How would Consumer Reports like it if media reported that there are "concerns"
that Consumer Reports may have been given a payoff by Big Pharma to discredit e-cigarettes?

Sounds like a good idea to me

 

[Vocalek]

We need to flood the Fda with positive feedback. I think the side effects described are the same as any nicotine replacement product. (except the explosion)

Back when the FDA announced their test results in July 2009 and asked people to make reports about e-cigarettes in the Adverse Events Reporting system, we discussed entering positive results. The fear was that the FDA would not bother to sort out positive from negative and would only report the total, implying all were negative, even if the overwhelming majority was positive.

But now we have some evidence that the FDA does separate positive from negative.

The FDA responded in early March with 39 reports logged through its adverse-event monitoring system (http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm). Of them, 31 dealt with negative health effects; the others included positive comments about e-cigarettes (five reports), calls for the FDA to investigate the safety of e-cigarettes (two reports), and one question about nicotine-free e-cigarettes.

So, perhaps we should let them know about our positive health effects. Discussion?

 

[calsax]

Elaine -

I did some analysis of the latest quarter of data from the FDA link, and it is not very exciting. Which is pretty exciting! Unfortunately, my dinosaur of a pc at home doesn't have the oomph to do much, and wouldn't even export from Access to Excel, due to memory limitations. I will build a new database on my super computer at work, so I can send you some data. However, we need to remember when looking at this stuff, that nic joose isn't regulated by the FDA, so there is no compelling reason for anyone to report adverse events, as there would be with regulated products (Chantix, etc.). But, a lack of documented events is still a good thing.

 

[Bill Godshall]

calsax wrote:

However, we need to remember when looking at this stuff, that nic joose isn't regulated by the FDA, so there is no compelling reason for anyone to report adverse events, as there would be with regulated products (Chantix, etc.).

Except that the FDA held a heavily publicized press conference and has subsequently posted a notice on its website demonizing e-cigarettes and urging people to report adverse events associated with e-cigarettes to the FDA.

I cannot recall the FDA doing the same for ANY tobacco, drug, device, food or cosmetic product that FDA regulates.

Thanks for trying to obtain and analyze these adverse event reports to FDA.

 

[dlsw]

Back when the FDA announced their test results in July 2009 and asked people to make reports about e-cigarettes in the Adverse Events Reporting system, we discussed entering positive results. The fear was that the FDA would not bother to sort out positive from negative and would only report the total, implying all were negative, even if the overwhelming majority was positive.

But now we have some evidence that the FDA does separate positive from negative.



So, perhaps we should let them know about our positive health effects. Discussion?

I will do it! My life is far better since I switched. Let's discuss this as we need to make sure that we are actually affirming the product and nothing that we say could be misconstrued. We have to be careful. Help us Vocalek!