FDA The ANTZ are coming out to play

[aikanae1]

GlaxoSmithKline's Consumer Healthcare, head of consumer affair's representative's comment just showed up. I think a lot of the ANTZ held back until the last minute so it should get interesting. It's an insight into their thinking.

Stresses the difference between medicinal and recreational
Targets the FDA for making the categories more clear
States there is NO clinical evidence of anyone quitting using ecigs.
(yup - had the balls to say none)

I don't know if anyone's interested in reading it or not / whether I should post or not.
if someone is ready and able to write a comment in a rebuttal in the next 6 hours or so, just let me know.

that's what i'm doing - scanning comments for rebuttle fuel.

 

[dragonpuff]

GlaxoSmithKline's Consumer Healthcare, head of consumer affair's representative's comment just showed up. I think a lot of the ANTZ held back until the last minute so it should get interesting. It's an insight into their thinking.

Stresses the difference between medicinal and recreational
Targets the FDA for making the categories more clear
States there is NO clinical evidence of anyone quitting using ecigs.
(yup - had the balls to say none)

I don't know if anyone's interested in reading it or not / whether I should post or not.
if someone is ready and able to write a comment in a rebuttal in the next 6 hours or so, just let me know.

that's what i'm doing - scanning comments for rebuttle fuel.

No clinical evidence? At all?? Hmm, let me just pull up all the pdfs containing full text studies that I submitted to the FDA proving otherwise

 

[aikanae1]

Nope. All she said was they had conducted hundreds blah, blah, blah extensive years of reasearch etc. and the closing provided email address and phone number with an invite to contact and talk. I'm sure they'll be more buddie-buddie comments posted in the next few days.

I also noted a form letter from American Academy of Pediatrics - or a single poster is making up doctor names. It's pretty stupid with demands for regulation to protect the "childreeeen" and citing no evidence.

This must be a peer pressure thing.

 

[supertrunker]

We knew it'd get dirty just like last time!

Splendid!

Years of research (well at least 7 no?) and we still need more studies to prove e-cigs are safe. NOPE. All we need to prove is that they are less harmful than smoking tobacco.

T

 

[pamdis]

Yeah, they essentially want the proposed warning label to remove the word 'nicotine'. Because 'nicotine is addictive' could cause consumers to think their products are addictive too. Because, ya know, there is a distinct difference between their nicotine and that in e-cigs.

Here's their comment # if you want to search it and read it. It's a short two page letter. FDA-2014-N-0189-62796

 

[dragonpuff]

Check out the sick rebuttal posted on page 88 of the global thread glorious!

 

[Gato del Jugo]

I came out to play, too...

Submitted 5 excellent, well thought-out comments in the final 24 hours..

I'm spent..


Can't wait til all this goes to court..


Keep vigilant, my fellow vapers.. This war is far from over...

 

[bigdancehawk]

GlaxoSmithKline's Consumer Healthcare, head of consumer affair's representative's comment just showed up. I think a lot of the ANTZ held back until the last minute so it should get interesting. It's an insight into their thinking.

Stresses the difference between medicinal and recreational
Targets the FDA for making the categories more clear
States there is NO clinical evidence of anyone quitting using ecigs.
(yup - had the balls to say none)

I don't know if anyone's interested in reading it or not / whether I should post or not.
if someone is ready and able to write a comment in a rebuttal in the next 6 hours or so, just let me know.

that's what i'm doing - scanning comments for rebuttle fuel.

GSK may be technically correct. Clinical evidence = clinical trials, defined as:

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
There are different kinds of clinical trials, including those to study:

prevention options
new treatments or new ways to use existing treatments
new screening and diagnostic techniques
options for improving the quality of life for people who have serious medical conditions
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

These are done with two groups, one of which receives the drug under investigation, with the other group ("control group") receiving a placebo. So, what would the placebo be for a Provari topped with a Nautilus loaded with 28 mg/ml vanilla-rasberry juice? Eh? Who would be in the control group? Smokers wanting to quit? Smokers maybe thinking they might like to quit? We're not dealing with mice here. They'd all have to be matched up psychologically, age, demographically, past and present cigarette usage, and a whole host of other subjective and objective factors.

It's virtually impossible. Who would do it? Stanton Glantz? What a farce that would be.

 

[dragonpuff]

GSK may be technically correct. Clinical evidence = clinical trials, defined as:

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.
There are different kinds of clinical trials, including those to study:

prevention options
new treatments or new ways to use existing treatments
new screening and diagnostic techniques
options for improving the quality of life for people who have serious medical conditions
Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

These are done with two groups, one of which receives the drug under investigation, with the other group ("control group") receiving a placebo. So, what would the placebo be for a Provari topped with a Nautilus loaded with 28 mg/ml vanilla-rasberry juice? Eh? Who would be in the control group? Smokers wanting to quit? Smokers maybe thinking they might like to quit? We're not dealing with mice here. They'd all have to be matched up psychologically, age, demographically, past and present cigarette usage, and a whole host of other subjective and objective factors.

It's virtually impossible. Who would do it? Stanton Glantz? What a farce that would be.

They've already done tons of studies exactly like this on e-cigs, going all the way back to the famous 2009 Ruyan study in New Zealand Drs. Farsalinos, Polosa, and Capponetto (sp?) have each worked on several, and are working on more. I've read many of their studies to submit as deeming reg comments, and they are solid not a design flaw to be found. They have proven that e-cigs are much safer than cigarettes, are an effective substitute for cigarettes, and can function as a smoking cessation aid. Even the now-reviled Goniewicz (head of the infamous formaldehyde study) conducted at least three studies proving e-cigs are safer than smoking.

The science is there, it's just awfully hard to see when you have your eyes closed because you're asleep at the wheel. The FDA needs to wake up.

 

[Bobbilly]

There is also studies done already on NRT that could easily be applied to ecigs containing nicotine. As long as nicotine is being delivered the same principle would hold true for ecigs.

 

[Rickajho]

We knew it'd get dirty just like last time!

Splendid!

Years of research (well at least 7 no?) and we still need more studies to prove e-cigs are safe. NOPE. All we need to prove is that they are less harmful than smoking tobacco.

T

I pointed out the "no harm, no foul" matter in my comments. Don't they have to take that into consideration? The number of years the product has been in the market with no significant adverse effects, deaths or proven harm?

 

[EleanorR]

I pointed out the "no harm, no foul" matter in my comments. Don't they have to take that into consideration? The number of years the product has been in the market with no significant adverse effects, deaths or proven harm?

C'mon, Rick, this is the Federal Goobermint we're talkimg here. They don't "have" to do anything they don't want to, especially apply logic, honesty or common sense!

 

[aikanae1]

There is also studies done already on NRT that could easily be applied to ecigs containing nicotine. As long as nicotine is being delivered the same principle would hold true for ecigs.

Now that is a hot topic.

I can't think of anything that would PISS off pharma more. But that brings us into a bigger debate since taxpayers paid for much of the research and development done by pharma can results be propietary? From what I understand "YES" - they have banks of lawyers fighting tooth and nail to keep results, including BAD results from being public information or even reported in study results. That's how so many bad drugs are making it to market. Even the feds have not been able to loosen the grip pharma has on their results.

There is little doubt the FDA works for pharma and not the other way around.

I honestly do not know if it's possible to get our hands on those studies nor the court action involved or if it would be helpful or harmful to try. There's a fine line between "medicinal" and "recreational" and if ecigs are compared with NRT they could be determined as medicinal and be required to follow that path instead of recreational.

I'm not even sure that medicinal is really all that bad because at least there is a route for approval and there isn't for new products or modified risk products = both of those categories were designed to prevent BT from introducing deceptive products, essentially to prevent any products from making their way to market.

This is between a rock and a hard place we are in because ecigs were not even imagined in 2007 or 2009. Ecigs don't fit anywhere.

 

[aikanae1]

C'mon, Rick, this is the Federal Goobermint we're talkimg here. They don't "have" to do anything they don't want to, especially apply logic, honesty or common sense!

The feds work for the pharma companies not the reverse. Congress can't do squat if it doesn't meet with their approval (20 year war over sunscreen was used as an example earlier). Even though taxpayers pay for r&d, the feds can't get results of r&d. That's why the FDA works for pharma and not the public.

 

[skoony]

now we find out how far the FDA wants to go down the rabbit hole.
regards
mike

 

[Bobbilly]

Now that is a hot topic.

I can't think of anything that would PISS off pharma more. But that brings us into a bigger debate since taxpayers paid for much of the research and development done by pharma can results be propietary? From what I understand "YES" - they have banks of lawyers fighting tooth and nail to keep results, including BAD results from being public information or even reported in study results. That's how so many bad drugs are making it to market. Even the feds have not been able to loosen the grip pharma has on their results.

There is little doubt the FDA works for pharma and not the other way around.

I honestly do not know if it's possible to get our hands on those studies nor the court action involved or if it would be helpful or harmful to try. There's a fine line between "medicinal" and "recreational" and if ecigs are compared with NRT they could be determined as medicinal and be required to follow that path instead of recreational.

I'm not even sure that medicinal is really all that bad because at least there is a route for approval and there isn't for new products or modified risk products = both of those categories were designed to prevent BT from introducing deceptive products, essentially to prevent any products from making their way to market.

This is between a rock and a hard place we are in because ecigs were not even imagined in 2007 or 2009. Ecigs don't fit anywhere.

The biggest problem with the 'prove they work or prove they are safer' is that they don't really have a criteria. No one ever thought It would occur.


The NRT angle doesn't necessarily needs data. The concept is that Nicotine stops cravings as long as you can prove an ecig provides nicotine it'll work. Most myths about ecigs are addressed by NRT advice.

https://www.oma.org/resources/documents/e2008rethinkingstop-smokingmedications.pdf

There is a lot of effort wasted on vilifying ecigs which would be better spent improving and addressing real concerns such as flavouring studies.

 

[aikanae1]

The biggest problem with the 'prove they work or prove they are safer' is that they don't really have a criteria. No one ever thought It would occur.

The NRT angle doesn't necessarily needs data. The concept is that Nicotine stops cravings as long as you can prove an ecig provides nicotine it'll work. Most myths about ecigs are addressed by NRT advice.

https://www.oma.org/resources/documents/e2008rethinkingstop-smokingmedications.pdf

There is a lot of effort wasted on vilifying ecigs which would be better spent improving and addressing real concerns such as flavouring studies.

I've never seen that. I would have loved to have sent that in. One of my points was that BT and BP are not motivated to provide successful cessation methods, nor can they be since they are corporations and successful cessation would be a limited growth market = unhappy shareholders. But small business can go that, provide that service, offer those tools. Proof? little development in 30 years and zero interest to go beyone nicotine.

Look at the evolution of the Protank. It's not even a year since the first one was introduced.

I'm preaching to the choir. We have got to do something to get our point/position across and it probably needs to be radical the longer this goes on.

 

[zizzlak]

now we find out how far the FDA wants to go down the rabbit hole.
regards
mike

I think the answer to that is all the way to the bottom. From everything I've seen, there are decades of epidemiological studies that prove that NRT are 99% safer than cigarette smoke according to Bill Godshall. Just take a look as his response to the FDA deeming regulations. Holy crap, it would years to read every link that he posted that the FDA has so far ignored. This fight is not about the FDA at this point imho, because clearly they don't see, hear, or understand reason. Their M.O. is "Let us kill what we do not understand and therefore fear." They have systematically denied the health and well being of millions of smokers by the simple fact of classifying less dangerous alternatives the same as smoking cigarettes...

To say anything less means admitting that decades of bad information was wrong, calling into question the validity of a government agency that plays into the hands of big tobacco and big pharma. Are you kidding? Big tobacco loves the FDA. They make billions a year peddling death and they have a government agency to enact regulations that impose barriers to entry for competitors. Name me a industry that has as much luxury...

 

[zizzlak]

Just a point of clarification, I was referring to NRT's (Nicotine Reduction Therapy) in the same manner as smokeless tobacco products which is not what I was making a reference to. I apologize, so much information, not enough time to absorb it all

 

[Oliver]

It's well understood now by UK public health that the "gold standard" clinical trials cannot work for ecigs since they are innovating too fast for any trials to be relevant at the point of publication (average 3 years after trial commencement). The only way to gain accurate information on their role in cessation is through population level data - data which is being collected in the UK but, scandalously, not the United States.

Why do I say "well understood"? Because I was fortunate enough to participate in a panel discussion in front of the collected great and good of Public Health England where two of the UK's leading experts (John Britton and Robert West) said the above and received absolutely zero counterargument by the two opposing speakers, or the audience. Among the audience were Peter Hajek, Hayden McRobbie and Ann McNeil, fyi.

Amusingly, on the very same day I took part in the PHE debate, I also presented at the morning session and participated in the afternoon panel discussion at another conference, this time held by OTC Bulletin - the trade magazine for the OTC pharmaceutical industry.

Relevant to this thread, two executives from GSK were in attendance and I had a bit of back and forth with one of them during the panel discussion. He stated that in his view no e-cigarette will ever be given a medicinal license by the UK regulator. This was why it was so critical that EU vapers lobbied hard and ensured the two-route solution for marketing e-cigarettes in the EU (i.e. medicinal and (highly restricted) consumer goods) - we knew that the MHRA in the UK had already flagged the possibility that e-cigs would never be given a medical license.