Who will deeming effect in the vaping community?

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VNeil

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Did you mean the 2018 Election? No, I don't think it is a coincidence that regulations eased with the administration change this year. Public health is not a priority of the current administration. Quite the opposite and that is good for us. What is better for us than having the government ignore public health is to have them pay attention to studies like the Georgetown study and its recommendations. I am a bleeding heart liberal yet admit it is the liberals who hurt the vaping industry that most. I do believe that impossible to ignore studies like the one I referenced will change a lot of even liberal minds so it won't matter which party is in charge. JMHO
I mistyped. I meant the 2021 elections. And I was emplying that a change of regime juuust might have resulted in different conclusions being drawn in that study. Cynical me.
 

PJReid

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So you expect politicians, some of whom have outright called for bans on vaping, to admit they were wrong?

Color me skeptical. :)

It isn't that simple. Liberals are calling for outright bans on vaping, citing the bogus studies that we all know about. I am saying that these decisions will not be made by politicians. They will be made by the FDA and with the kind of information coming out of the new studies, I don't see how an organization that is designed to promote public health can ignore REAL scientific information. Call me naive, but that is what I believe.
 

puffon

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    VNeil

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    It isn't that simple. Liberals are calling for outright bans on vaping, citing the bogus studies that we all know about. I am saying that these decisions will not be made by politicians. They will be made by the FDA and with the kind of information coming out of the new studies, I don't see how an organization that is designed to promote public health can ignore REAL scientific information. Call me naive, but that is what I believe.
    The FDA is run by a political appointee. Yes I think you are naive. The current political appointee appears to have his head on straight. But what happens at the new 2022 deadline will be determined by the next administration and the next political appointee.
     

    PJReid

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    It may have been designed to be that way, years ago.
    The FDA has morphed into one of the most corrupt, lobbyist driven, organizations our tax dollars pay for. IMO

    An example:
    Former FDA Commissioner Charged in RICO Lawsuit

    Yes, I am very aware of the fact that the FDA has morphed into a corrupt organization. My husband is a pharmacist and the things he tells me are quite shocking.I do have hope for the future. The more that "we the people" demand that our tax dollars are spent for our benefit, the more we will be listened to. I am well read, stay on top of the current events, am politically active, and have seen change come about when the voices are loud enough.

    The FDA is run by a political appointee. Yes I think you are naive. The current political appointee appears to have his head on straight. But what happens at the new 2022 deadline will be determined by the next administration and the next political appointee.

    I am saying that I believe these studies will make it impossible for the controlling agencies to ignore the truth. "We the people" demand the truth. We need to get the general public on board. Yes, easier said than done but not impossible. It will take hard work. RIse up!
     

    VNeil

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    Yes, I am very aware of the fact that the FDA has morphed into a corrupt organization. My husband is a pharmacist and the things he tells me are quite shocking.I do have hope for the future. The more that "we the people" demand that our tax dollars are spent for our benefit, the more we will be listened to. I am well read, stay on top of the current events, am politically active, and have seen change come about when the voices are loud enough.



    I am saying that I believe these studies will make it impossible for the controlling agencies to ignore the truth. "We the people" demand the truth. We need to get the general public on board. Yes, easier said than done but not impossible. It will take hard work. RIse up!
    The last regime spent a BILLION DOLLARS in research grants intended to convince the public that vaping is worse than smoking. Last survey I saw said 90% of the public believes that. I have people coming up to me on the steeet and in bars, total strangers, telling me that. Good luck turning that Titanic. Especially in this hate charged political climate. The past 5 years proves that facts don't matter. And the new head of the FDA is making a lot of enemies that have untold billions at stake. Don't be surprised if he is run out of D.C. On a rail. Or folds. I'm not making predictions. Just saying this is a huge uphill battle.
     
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    ScottP

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    It may have been designed to be that way, years ago.
    The FDA has morphed into one of the most corrupt, lobbyist driven, organizations our tax dollars pay for. IMO

    An example:
    Former FDA Commissioner Charged in RICO Lawsuit

    Sadly most of Congress should probably be brought up on RICO charges or insider trading at the least. Most of them invest in stocks and then vote on legislation that affect those same stocks. Republicans do this more with Coal, Petroleum, and military product companies, while Democrats do this more with Pharmaceutical, Tobacco, and green energy companies. This is why both sides fight the battles they do and is how they can have salaries of only $174000 but still make millions per year.
     

    ScottP

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    I mistyped. I meant the 2021 elections. And I was emplying that a change of regime juuust might have resulted in different conclusions being drawn in that study. Cynical me.

    Actually you mean the 2020 elections. Presidential elections are always in even numbered years that coincide with leap year and the summer Olympics.
     

    VNeil

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    Actually you mean the 2020 elections. Presidential elections are always in even numbered years that coincide with leap year and the summer Olympics.
    Thanks for the editing. It will be the 2021 regime change (if there is one and even if there isn't a lot of political appointees change)
     

    Eskie

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    OK, a couple of things. That lawsuit against Hamburg lists her as one of seven defendants. Johnson & Johnson are the deep pockets, and proving RICO against Hamburg is highly unlikely to be successful. Remember, anyone can sue anyone, write all sorts of allegations in a complaint, but then they have to prove it in court. The mere existence of a civil suit does not establish fault against any of the named defendants.

    Gottleib has proven himself to be a level headed Commissioner, with some decent plans for the agency. While it is theoretically possible a change in Commissioners could alter policy, there are still not only 3 years for standards to be established, but also 3 more years for lots of legitimate medical data to reach public attention (or at least professional attention). The more positive medical data generated, the harder it will be for any future Commissioner to radically alter the direction currently being taken.

    Congress and the Clinton administration established that BP would pay user fees to get faster drug approval. This has allowed the feds to decrease FDA funding, now relying on a quarter to half of the ~$4.5 billion dollar budget to be funded from outside the government (depends who's numbers get used, but to me $2.5 Billion coming from the Federal budget leaves an awful big chunk funded by the industry itself).

    It's unlikely that will ever change as no one wants to add those expenses back onto the Federal budget. BP isn't bribing the FDA, but sure are legally funding it, so we, the public don't see more Federal money being spent. Think about the size of BP, and in food, and how can such a tiny line item in a budget be so small relative to the tasks assigned. Maybe with more inspectors and researchers, less questionable stuff would get passed.

    On the subject of passing drugs, the Right to Try Act was passed by the Senate and the House, along with allowing those user fees to keep on going, and I believe already signed by Trump. The right to try thing is sorta interesting.

    The “right to try” bill, introduced by Senator Ron Johnson, Republican of Wisconsin, aims to establish a new pathway for terminally ill patients to gain access to experimental drugs that have not been approved by the F.D.A....

    These patients are often extremely ill and unable to participate in clinical trials, or have no other treatment options....

    In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.

    The bill would establish national standards and rules to help channel drugs still under development to terminally ill patients.

    It would also shield pharmaceutical companies and doctors from some of the legal risks of providing drugs that have not been approved by the agency.


    Senate Passes F.D.A. Funding and ‘Right to Try’ Drug Bills

    So now folks are defended in the use of experimental treatment outside of a clinical trial.I personally think it's overall a good thing, but I am concerned about establishing a precedent for pushing through more drugs than necessary for the extremely ill.

    Last but not least, the FDA sends out hundreds of warning letters every year to BP alone. BP's response is to either ignore it, argue it without changing anything, and several cases of turning around to the FDA and saying "sue us" which the FDA really doesn't do.

    IMO, until the public and Federal government decide the FDA is important to establish drug approvals and monitoring, as well as assuring the food supply chain remains safe for public consumption, hires enough people to do that, and refuses to allow industry to fund the very approval process they want accelerated, the better off we'd be and there would be less sentiment that there is "rampant corruption" in the agency.
     

    Tonee N

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    [emoji631]
    4ef2803b8878da2b21656deef736849b.jpg


    Sent from the future
     

    Opinionated

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    I mistyped. I meant the 2021 elections. And I was emplying that a change of regime juuust might have resulted in different conclusions being drawn in that study. Cynical me.

    I am going to say this. I can't keep my mouth shut.

    When you first typed 2017, I thought you meant 2016 and since on the keyboard the 6 is right next to the 7 it was an innocent typo.

    At this point, it's no typo. You obviously have no clue when presidential elections occur in this country - and if that is the case I have no doubt you are just as clueless as to when your local and state elections occur as well.

    So I am going to say - If you care about the laws that DO get passed, or don't get passed which directly affect your life (as you can see how these last presidential elections have affected vapors for the positive) then you really SHOULD learn when these elections are being held, who is running for office and what they stand for or against, and vote for who you feel will be best.

    Simply not voting is not really an option if your a concerned citizen, and we see how in this last election people's votes really do matter when they stand together.

    election-2016-county-map.png


    That's all Im going to say.
     
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    CMD-Ky

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    "We the people..." should demand a lot of things, truth being but one of many, but we don't "demand" until our own ox is gored and then we belly ache whine and demand integrity from government. We are content to allow a "benevolent and caring" government to rule our lives until it rules adversely on something meaningful in our lives.
    It's too late, we cast our fate into the corrupt hands of government a long time back. The politicians and bureaucrats aren't giving it back willingly.


    Yes, I am very aware of the fact that the FDA has morphed into a corrupt organization. My husband is a pharmacist and the things he tells me are quite shocking.I do have hope for the future. The more that "we the people" demand that our tax dollars are spent for our benefit, the more we will be listened to. I am well read, stay on top of the current events, am politically active, and have seen change come about when the voices are loud enough.



    I am saying that I believe these studies will make it impossible for the controlling agencies to ignore the truth. "We the people" demand the truth. We need to get the general public on board. Yes, easier said than done but not impossible. It will take hard work. RIse up!
     
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    CMD-Ky

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    I have long believed that the final FDA clinical trial for a new drug is its release upon the general public. It works fine for drug companies, insurance companies, lawyers and politicians.

    Drug companies get to avoid additional lengthy costly trials getting drugs to market sooner generating profit faster. Insurance companies can raise already confiscatory rates to cover lawsuit costs, losses and profit percentage. Lawyers make money - both the plaintiff's and defense bar. Finally, politicians get to rake money in from all three while railing wildly when things go wrong appearing to be caring and "doing something" about a problem.


    OK, a couple of things. That lawsuit against Hamburg lists her as one of seven defendants. Johnson & Johnson are the deep pockets, and proving RICO against Hamburg is highly unlikely to be successful. Remember, anyone can sue anyone, write all sorts of allegations in a complaint, but then they have to prove it in court. The mere existence of a civil suit does not establish fault against any of the named defendants.

    Gottleib has proven himself to be a level headed Commissioner, with some decent plans for the agency. While it is theoretically possible a change in Commissioners could alter policy, there are still not only 3 years for standards to be established, but also 3 more years for lots of legitimate medical data to reach public attention (or at least professional attention). The more positive medical data generated, the harder it will be for any future Commissioner to radically alter the direction currently being taken.

    Congress and the Clinton administration established that BP would pay user fees to get faster drug approval. This has allowed the feds to decrease FDA funding, now relying on a quarter to half of the ~$4.5 billion dollar budget to be funded from outside the government (depends who's numbers get used, but to me $2.5 Billion coming from the Federal budget leaves an awful big chunk funded by the industry itself).

    It's unlikely that will ever change as no one wants to add those expenses back onto the Federal budget. BP isn't bribing the FDA, but sure are legally funding it, so we, the public don't see more Federal money being spent. Think about the size of BP, and in food, and how can such a tiny line item in a budget be so small relative to the tasks assigned. Maybe with more inspectors and researchers, less questionable stuff would get passed.

    On the subject of passing drugs, the Right to Try Act was passed by the Senate and the House, along with allowing those user fees to keep on going, and I believe already signed by Trump. The right to try thing is sorta interesting.

    The “right to try” bill, introduced by Senator Ron Johnson, Republican of Wisconsin, aims to establish a new pathway for terminally ill patients to gain access to experimental drugs that have not been approved by the F.D.A....

    These patients are often extremely ill and unable to participate in clinical trials, or have no other treatment options....

    In some cases, drug makers fear they could be sued by patients who say they have been injured by unapproved drug products.

    The bill would establish national standards and rules to help channel drugs still under development to terminally ill patients.

    It would also shield pharmaceutical companies and doctors from some of the legal risks of providing drugs that have not been approved by the agency.


    Senate Passes F.D.A. Funding and ‘Right to Try’ Drug Bills

    So now folks are defended in the use of experimental treatment outside of a clinical trial.I personally think it's overall a good thing, but I am concerned about establishing a precedent for pushing through more drugs than necessary for the extremely ill.

    Last but not least, the FDA sends out hundreds of warning letters every year to BP alone. BP's response is to either ignore it, argue it without changing anything, and several cases of turning around to the FDA and saying "sue us" which the FDA really doesn't do.

    IMO, until the public and Federal government decide the FDA is important to establish drug approvals and monitoring, as well as assuring the food supply chain remains safe for public consumption, hires enough people to do that, and refuses to allow industry to fund the very approval process they want accelerated, the better off we'd be and there would be less sentiment that there is "rampant corruption" in the agency.
     
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    DaveP

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    Yeah, I suspect they'd have to be "sealed', just like the battery packs full of 18650s that are ubiquitous for cordless power tools.

    If you do a little Google searching you'll find articles on how to disassemble a name brand power tool battery pack and replace the cells with the 18650s from a cheap Harbor Freight pack designed for their 12v/24v tool. In most cases it's a drop in deal that's already strap soldered/ spot welded together for a direct replacement. You just solder the +/- leads and done.

    Where there's a will ...
     
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    Eskie

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    I have long believed that the final FDA clinical trial for a new drug is its release upon the general public. It works fine for drug companies, insurance companies, lawyers and politicians.

    Drug companies get to avoid additional lengthy costly trials getting drugs to market sooner generating profit faster. Insurance companies can raise already confiscatory rates to cover lawsuit costs, losses and profit percentage. Lawyers make money - both the plaintiff's and defense bar. Finally, politicians get to rake money in from all three while railing wildly when things go wrong appearing to be caring and "doing something" about a problem.

    There are 3 phases to drug testing. Phase I testing to figure out dose. Phase II testing in a small population for whether it works and side effects observed, and Phase III large scale clinical testing on broader population and usually conducting one or more randomized, double blind studies of possible. Then they look at all those hundreds of thousands of pages of stuff generated and approve, or send it back for more testing.

    Once it is approved, drug companies may sell it to the public if prescribed by a healthcare provider. Insurance companies may or may not cover it depending on how many other drugs on the market do the same thing, and which are cheaper (as well as going with generics whenever possible for older medications). As unusual or rare side effects are likely going to be seen with lots of people taking a drug, the FDA monitors the drug in the marketplace for that sort of bad stuff, Phase IV, which continues as long as the drug is offered in the US.

    What's funny or maybe odd about that is that under current law, if a drug is in a Phase III (or even late Phase II) testing and person has run out of options, they may file for a compassionate use waiver. 99% of those waivers are approved by the FDA, making them available early for that particular person. BP has not liked those waivers, as if something goes wrong, they're not protected. The "right to use" is essentially a compassionate use waiver, requiring essentially the same paperwork, but now comes with government protection from litigation (short of gross negligence).

    Maybe that's good in some ways as it assures a greater likelihood the drug company will volunteer in releasing the medication for use by that person in their medical treatment. But for all the "right to use" rewording to make it seem they're making things better for the public, it's really a cute name for something already available, just without the exposure drug makers might otherwise face. Sort of like the Federal protection on vaccines which allowed vaccine manufacturers to continue operating without the exposure to lawsuits as well.

    Edit: under the older compassionate use the drug maker couldn't charge for it as it is not an approved. I THINK it's the same with right to use law, but not sure. There might be some fee to cover the administrative expense of processing, but probably not for the drug itself.
     
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    T0mmy1977

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    First we do have quite some time before we really have to worry about what will happen. In fact the compliance with the rules has been extended until Aug. 8, 2022. That also provides us with a LOT of time to try and change their minds.
    And to continue to stock up, if need be. I'm glad I took the time to learn how to use mechs. They will last much longer, in general, than a lot of your regulated mods. I had a Wismec RX200S for a mere 3 months. I didn't even get that much use out of it because my mods are rotated in and out of use. It just died recently. It wasn't dropped, exposed to water, etc. It just wouldn't turn on anymore.

    I need to learn DIY e-liquid in the meantime.
     
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