FDA Tomorrow's FDA workshop on Biomarkers of Tobacco Exposure to focus on e-cigs

[Bill Godshall]

Today and tomorrow, FDA is hosting a workshop Biomarkers of tobacco Exposure (that is broadcast live)
August - Biomarkers of Tobacco Exposure: A Public Workshop

Tomorrow's agenda at
http://www.fda.gov/downloads/TobaccoProducts/NewsEvents/UCM456338.pdf
includes several afternoon presentations on smokeless tobacco and e-cigarettes.

While the FDA's deeming regulation (if approved and implemented) would ban >99.9% of all e-cigs now on the market, the already multi million dollar costs of submitting a PreMarket tobacco Application for a New e-cig product (that the FSPTCA and FDA's deeming regulation define as all e-cig products not on the market before February 15, 2007) will continue increasing if FDA requires more tests based upon biomarkers.

 

[Lessifer]

Since those who vape 0mg wouldn't get flagged with a cotinine test, they have to devise some biomarkers specific to vaping PG and/or VG, so the insurance companies will know if you're vaping. Right?

 

[Kent C]

Thanks for the heads up Bill. It should be interesting to see what Goniewicz has to say these days. As you've pointed out, he likes to play both sides - against some regulation but supports the FDA part in it. Doing studies on formaldehyde and acrolein with Dr. F using the same eliquids and coming up with different conclusions. Goniewicz has put forth the idea of second and third hand nicotine effects, but finds some benefits for teens in Poland In general though - he has been paid by NRT firms and is Roswell Park for Cancer staff, so I don't expect too much positive comments.

edit:
And with Lessifer's comments - Goniewicz was one of those early on who, though studied ecigs/eliquids were totally unfamiliar with vaping practices including 0mg nic.

 

[Bill Godshall]

Nearly all of the 30 presenters at FDA's workshop on biomarkers of tobacco exposure are either funded by Obama's DHHS (to advocate FDA's deeming regulation and many additional regulations on tobacco and vapor products) or work for large tobacco companies (which support many FDA tobacco and e-cigarette regulations to eliminate smaller tobacco and vapor company competitors).

But I consider the presentations by tobacco industry scientists to be significantly more objective and informative than the anti-tobacco and anti-nicotine presentations by DHHS employees and DHHS funding recipients, who lump all tobacco/nicotine users into the same category of tobacco contaminated people, and who refuse to acknowledge the 800 pound gorilla sitting in the room (i.e. that vapor products and smokeless tobacco products are exponentially less hazardous than cigarette smoking).

 

[Kent C]

who lump all tobacco/nicotine users into the same category of tobacco contaminated people, and who refuse to acknowledge the 800 pound gorilla sitting in the room (i.e. that vapor products and smokeless tobacco products are exponentially less hazardous than cigarette smoking).

Their (@1:30-2:00pm) discussion of dual uses poses huge problems with biomarkers - how to differentiate those from cigarette smoking vs vaping. One comment by Hecht, in general regarding the numerous types of ecigs available now and dual use:

"I mean clearly as I try to design our program, we've always known that scientific challenges involved here way too big for us to tackle."

And another comment - didn't catch his name:
"And to be clear, if I may, it would seem that the existing studies are limited and that they may be looking in the past at older products, not the products of today. There's not complete information about product use, there's not necessarily the types of samples we would want to analyze, like was that in that study today to learn about the relevance in biomarkers..."

This is the type of stuff (italicized/underlined) where we get those who can 'spin' earlier samples to suit their intent to regulate that no longer applies to the present state of vaping. Just for example, where they keep going back to the 2009 data from the '13? cartos that almost no one, now uses.

 

[Kent C]

specific ecig discussion going on now:

Biomarkers of Exposure: A Public Workshop - Day 2, Afternoon Session - 1071715

 

[zoiDman]

I sure wish they would show the Power Pont Slides instead of the Speaker.

ETA: Never Mind. I Figured out how to see the Slides Full Screen.

 

[Bill Godshall]

Was surprised Goniewicz acknowledged that toxicant exposure was sharply reduced in smokers who totally switched to vaping and in smokers who also vape.

But don't expect the NY Times (which wrote a front page article quoting Goniewicz claiming e-cig vapor contains lots of toxicants) or any other liberal news outlets to write an article about Goniewicz new study (that contradicted his previous false fear mongering claims).

 

[Kent C]

Was surprised Goniewicz acknowledged that toxicant exposure was sharply reduced in smokers who totally switched to vaping and in smokers who also vape.

But don't expect the NY Times (which wrote a front page article quoting Goniewicz claiming e-cig vapor contains lots of toxicants) or any other liberal news outlets to write an article about Goniewicz new study (that contradicted his previous false fear mongering claims).

I'm glad you know all the participants - including the media - and are able to predict so well.

 

[Bill Godshall]

Raymond Farmen's presentation is the best yet.
His study found that secondhand exposure to PG was 1/5,000 of the level found in vapers.

Then he ripped into the NEJM article lying about formaldahyde in vapor.

 

[Lessifer]

"SHV" produces 5000x less exposure than direct inhalation...

He should have stopped there.

 

[Kent C]

Hah! He mentions the problems that I posted above about what Hecht said:

"Well, as a pharmacologist I kind of don't care what's in the vapor. I care what's in the body. And the challenge when Dr. Hecht talked about this earlier today. When you start talking about acetaldehyde or formaldehyde, how much is in the body, it really gets tough because there are molecular weight is very low, they're yous susceptible from matrix effects use highest quartile traditional mass spec. Aldehydes are chemistry reactive with nucleophilic groups such as amines so there are stability issues. And there are at least 19, one report had up to 38, aldehyde dehydrogenases isoforms in the humans. So there are stability issues for acetaldehyde and formaldehyde eve are ven if they're formed the body wants to get rid of them really very quickly." (copy/paste from the transcript along with the errors :- )

 

[Kent C]

"events of e-cigs and about a third of the events that they received were adverse event based on secondhand exposure. And that kind of doesn't fit with the 5,000 fold. So that's something else that needs to be looked at." (meaning he doesn't buy the lie)

He mentioned the press report(misreporting) and a call from his niece questioning it.

 

[Lessifer]

I didn't catch the actual numbers but the graphs for dual use did show a consistent difference in levels of bio markers. It may not have been statistically significant(though that has a lot to do with how you calculate) but it was visible and consistent. Smoking had the highest levels, dual use with NRT was slightly lower, and dual use with e-cigs was even lower, and of course single use of e-cigs had none of the biomarkers. What else was interesting was the presence of the biomarkers in single use NRT users.

 

[Lessifer]

What was he rambling about? Sugar when heated becomes unsafe? Applying heat is not something that has never been done before.

 

[Kent C]

for acrolein exposure: "We have a control group of the non-users and the levels among the e-cigarette users are not statistically different than non-users of any product." and agreed with by another similar study....

 

[Lessifer]

for acrolein exposure: "We have a control group of the non-users and the levels among the e-cigarette users are not statistically different than non-users of any product." and agreed with by another similar study....

But are you going to develop a labeled acrolein so we can figure out exactly how much of that not statistically significant exposure comes from e-cigs?

 

[Kent C]

What was he rambling about? Sugar when heated becomes unsafe? Applying heat is not something that has never been done before.

That's right and I immediately thought of the inhalation of cooking, etc. etc. I wish someone would have said that

 

[Kent C]

This may be the most positive statement from Goniewicz that I've seen:

"Now we're getting the biomarkers of exposure. I think strongly that there's is reduced, significantly reduced risk product comparing to tobacco cigarettes. However, you know, having the outcomes, the disease outcomes, the half outcomes from the long-term users of the products were will confirm this data. I think we are getting closer and closer. We started out with the product evaluation, we are moving now to the biomarkers. We will see more and more users, long-term users we're hoping to get the epidemiological data of the cardiovascular events of cancer risk and pulmonary risk.
So I think step by step we will find out but so far, it looks like the data we've got today strongly suggests that this is modified risk product compared to conventional cigarettes.

Which flies in the face of the media (and other ANTZ) reports/studies.

And a followup by another participant:
"At the moment it looks -- it's looking really interesting for e-cigarettes as a population-based reduction of harm as well as an individualized risk."

 

[Lessifer]

You don't need to understand the subcellular interactions of nicotine and other chemicals to determine it's addictiveness... You can measure the dependence, especially since there is now a population, however low, of nicotine vapers who never used tobacco products.

And I'm sorry, nicotine dependence is not the underlying disease that leads to all other tobacco related diseases. When you remove the tobacco, evidenced by the absence of tobacco biomarkers, you remove the potential for tobacco related diseases.