Stan Glantz attacks e-cigarette industry because thousands of vapers sent comments to FDA

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Jman8

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In other words, the truth that e-cigs factually led to my quitting smoking may not be communicated because sanctioned biased white-coat jackasses lacking powers of simple observation have not yet been liberally greased by "Big Money" or the vested interests of BT/BP?

More accurately, my testimonial carries no legal weight, and could even be considered "misleading" if I make the truthful and factual claim it was solely responsible for my having quit tobacco smoking.

Anyone who still thinks the FDA, Courts, BP/ BT and Gov't protect & safeguard anyone, or is even remotely concerned about their health and well-being, is living a pipedream extraordinaire.

The police state shrouded under money and beaurocracy. Its censorship, short and simple.

I think your testimonial definitely carries weight and ought to be heard / published. But not sure why it must be published by an ecig distributor?

If it must, or is deemed reasonable that it could be, then it is reasonable that the FDA may wish to address (and regulate) these companies who are promoting claims of therapeutical merit, i.e. - use of this product leads to cessation of smoking.

That's not censorship anymore than I'm not able to post whatever I want on ECF. They will likely edit some posts and restrict my right to free speech which is within their domain to do so. I could still 'get the word out' and publish myself, whatever I desire to express. But realize that I don't need their platform to make that happen.
 

Hello World

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Hell, drinking water looks like drinking moonshine, smoking roll your own cigs looks like smoking a joint.
Ratio of association by occurrence/event.

Someone drinking a bottle of water at a board meeting, alcohol wouldn't come mind, whereas in a New Year's party setting I might wonder. Furthermore, one doesn't see too many people drinking alcohol in public anymore, and it's mostly juices, softdrinks, etc., so the association does not quite stick.

The environment variable is not so pronounced with rollies, really only 2 things one would likely expect.

E-cig vaping is associated too closely with t-cigs as both contain nicotine even though they are otherwise worlds apart.

I'm sure as time goes by the differences will become more apparent to the public at large. Any new floating idea, regardless how valuable, even indispensable, will get attacked in the beginning stages, derided later, and finally accepted as logical ... lol
 

Vocalek

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Didn't Judge Leon already rule that testimonials on a vendors website can not be considered therapeutic claims?

Yes. You're correct DC2. Glantz failed to read the entire Opinion document authored by Judge Leon. Even customer testimonials posted on a vendor web site do not constitute a health claim on the part of the vendor. And in this case, the letters did not even appear on a vendor site. They were submitted separately by consumers to the FDA. Glantz tried to imply that vendors sent out letters telling consumers what to say. I received the letter sent out from NJOY, and it said nothing about telling the FDA that e-cigarettes helped you quit smoking.

You have the opportunity to have your opinion heard regarding this matter.

The FDA is accepting public submissions via the Internet through next Wednesday (January 16th, 2013).

If NJOY’s electronic cigarettes have had a positive impact on your life, we encourage you to share your story with the FDA and to urge the FDA not to take any action that would make these products more difficult or expensive to obtain than they are currently.

All you need to do is follow the link below to have your voice heard on this important topic.

On the other hand, CASAA's Call to Action did provide a list of questions to guide people in how to tell their story. Of course, Glantz, not understanding the meaning of the word "Consumer," claimed that CASAA is owned by e-cigarette companies.
 

Vocalek

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I think your testimonial definitely carries weight and ought to be heard / published. But not sure why it must be published by an eCig distributor?

If it must, or is deemed reasonable that it could be, then it is reasonable that the FDA may wish to address (and regulate) these companies who are promoting claims of therapeutical merit, i.e. - use of this product leads to cessation of smoking.

That's not censorship anymore than I'm not able to post whatever I want on ECF. They will likely edit some posts and restrict my right to free speech which is within their domain to do so. I could still 'get the word out' and publish myself, whatever I desire to express. But realize that I don't need their platform to make that happen.

I think you misunderstand the situation. None of these letters submitted to the FDA were previously published on a vendor site and none of the writers were asking vendors to publish the letters.

All of the smart vendors know they cannot make smoking cessation claims. You might see such claims on sites of foreign companies that don't understand U.S. law, but U.S. vendors know better.

However, even if the letters were to be published on a vendor site, that does not constitute a health claim on the part of the vendor, according to the 30-page opinion issued by Judge Richard J. Leon in the court case of Smoking Everywhere, Inc. & Sottera, Inc. d/b/a NJOY versus FDA. http://www.casaa.org/uploads/SE-vs-FDA-Opinion.pdf

The "intended use" of a product is determined by "the objective intent of the persons legally responsible" for labeling the product. 21 C.F .R. § 201.128. Objective intent may be shown, for example, "by labeling claims, advertising matter, or oral or written statements" by the labeler. Id. It may also be shown "by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised." ld. Here, the overwhelming sum of Smoking Everywhere's promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use.
FDA references only three claims made in Smoking Everywhere's literature: (l) electronic cigarettes offer "smokers a chance of smoking in a much healthier way," (2) electronic cigarettes are "a great alternative to help ... stop smoking real cigarettes," and (3) "I've been smoking real cigarettes for over 20 years and really wanted to stop ... I've been using it for 3 weeks now and feel great." (ARDET 49,21; FDA Opposition [#14] at 21). The latter two claims are customer testimonials posted on the Smoking Everywhere website. None of these claims, on their face, suggests an objective intent to treat nicotine addiction and withdrawal. At best, these claims demonstrate that Smoking Everywhere markets its electronic cigarettes as an alternative-albeit a healthier alternative-to traditional cigarettes. IS FDA does not point to any representation by Smoking Everywhere that its product is intended to help wean smokers off of nicotine.

Nor does FDA identify any product labeling that includes instructions about how to overcome nicotine addiction using electronic cigarettes. The clear import of Smoking Everywhere's advertising is that it wants consumers to use its electronic cigarettes for the same recreational purposes and with the same frequency as traditional cigarettes.

So you see, our First Amendment Right as individuals, guaranteed by the U.S. Constitution, cannot be abridged by the FDA as Stanton P. Glantz's would like to have done. The written law is upheld by the case law, in the form of Judge Leon's opinion (and other rulings and opinions, no doubt.)

Vendors (companies) are bound to restrictions not placed on private citizens. Therapeutic information is controlled to protect state-sponsored drug monopolies. This is probably unconstitutional, in view of the fact that the vendors are being forced to withhold vital, life-saving information; but it has never been challenged in court, nor has a law been passed to protect the rights of free speech for corporations.

See the book Global Censorship of Health Information by Jonathan W. Emord.
 

Jman8

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All of the smart vendors know they cannot make smoking cessation claims. You might see such claims on sites of foreign companies that don't understand U.S. law, but U.S. vendors know better.

However, even if the letters were to be published on a vendor site, that does not constitute a health claim on the part of the vendor, according to the 30-page opinion issued by Judge Richard J. Leon in the court case of Smoking Everywhere, Inc. & Sottera, Inc. d/b/a NJOY versus FDA. http://www.casaa.org/uploads/SE-vs-FDA-Opinion.pdf

Do you know which part of the linked file (Leon ruling) that says it does not constitute a health claim? I think I may have seen it, but the part I found was vague and I believe lacking a solid backing to assert that consumer testimonials, on an eCig site, do not constitute a health claim. IMO, kind of a gray area.

My point is that by marrying vaping with traditional cigarettes, as many eCig companies do (most of the big ones I've seen do this), it puts a target on them. I may dislike that target, and think such a thing ought to stand. But I also just think it puts a target that is hard to overcome given the political playing field. I could think of analogies for this, but the ones that come to my mind are all hypothetical. eCigs are a rather unique animal and seem to fit the definition of disruptive technology, somewhat causing the regulators to play catch up with what is a gray market. But not so gray when that industry is saying, 'hey look at us, we're better than smoking. Remember tobacco? You do? Hey look at us. We are like that, but better.' Then the industry is just begging to come out of gray market and either go into protected market or underground market. And I think as long as there is this marriage (of sorts) between eCigs and BT, that underground market is possibly the reality. Right about now, we best hope for protected market if eCig sellers are going to keep stuff on their sites that even hint at this product is in some way connected to traditional smoking, but better.

So you see, our First Amendment Right as individuals, guaranteed by the U.S. Constitution, cannot be abridged by the FDA as Stanton P. Glantz's would like to have done. The written law is upheld by the case law, in the form of Judge Leon's opinion (and other rulings and opinions, no doubt.)

Vendors (companies) are bound to restrictions not placed on private citizens. Therapeutic information is controlled to protect state-sponsored drug monopolies. This is probably unconstitutional, in view of the fact that the vendors are being forced to withhold vital, life-saving information; but it has never been challenged in court, nor has a law been passed to protect the rights of free speech for corporations.

See the book Global Censorship of Health Information by Jonathan W. Emord.

To me, it is common sense that it ought to be regulated and is a stretch to look at it as protected speech. I'm willing to go along for the ride of it ought to be free and protected speech, though prefer that to be consistent. As in, do we regulate any company that not only sells/distributes a drug, but puts forth any claims about its product that may or may not be true?

Like if I have a company based on a product (a drug) that claims to make people taller, and a whole bunch of testimonials that back that up, is this speech to be protected, or something to be looked into with full anticipation of regulating such claims? Not a great analogy to eCigs cause as I said before, it is a rather unique product that is arguably still in a gray market.

It's a drug that comes from tobacco, but has no tobacco in it (in this form). We use devices that mimic smoking, but there is no smoke. Most of us come from a background of smoking, but this product is clearly not smoking. It is vaping, which wasn't a word 10 years ago, but is now the most accurate word/verb I can think of for describing the activity.

So to marry it with smoking seems unfounded, and unnecessary. And yet many (ex)smokers still speak at that level about this product. I could just as well say vaping has lead me to eat less sweets. That's what eCigs are really good at. They will make you not crave sugary foods as much as before you tried them. I know of other vapers who have claimed this. And even while sugary foods have always been under the collective microscope and are generally seen as not something that is all that good for you, they are nowhere near under the scrutiny that tobacco products are, especially traditional smokes. Not even close, IMO. To me, this would be like saying vaping is really good if you want to get off of (insert illegal drug name here) and putting that on eCig sites. Then expecting no one who cares to have stuff regulated, to sit up and take notice at such claims. Ought not to look into this, and ought not to try to regulate that sort of claim being made on the website. And instead ought to just sit back down and realize free speech protects this claim and well, you'll just have to live with that.

For what it's worth, I'm one who thinks 1st Amendment protects the right to yell fire in a crowded theater. I realize that the vast majority would beg to differ on that point. Why? Because protecting any and every form of speech is deemed simply not practical and potentially harmful.
 

DC2

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I dont hate Stanton.......but his parents clearly did when choosing a name. He is clearly a twonk.
If you knew more about him, you might find it hard NOT to hate him.

Read this to learn about the gameplan that anti-tobacco has been following for decades...
Rampant Antismoking Signifies Grave Danger

And then scan that document to find out how many times you find Glantz mentioned.
(Hint: the answer is 30 times)

Stanton Glantz has long been one of the leading proponents of denormalizing smoking and demonizing smokers.
And now he is turning his sights on us because we threaten everything he and his cronies have worked so hard to accomplish.
 

zapped

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So what if we said it helped us quit smoking? It's true. No company told me that, people did. People unaffiliated with any company that sells e-cigarettes. And they were right.

I smell a resounding loss for the FDA coming very, very soon on this point.

Out of idle curiosity, what have other open comment periods gotten in terms of number of comments? If ours was through the roof it becomes hard to ignore.

Most of the effective medicines we had before the end of the 20th century owe their existence to word of mouth, neighbors telling neighbors and spreading from region to region.Science is just now starting to acknowledge that there is some efficacy in home remedies.

Ask the soldiers who were burn victims in Iraq and had their wounds treated with honey. It doesnt stick to bandages, speeds healing and has antibacterial properties as well.

As far as I know the FDA isnt attempting to regulate that , ecigs shouldnt be any different.
 

kristin

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Jman8, "smoking" is not considered a disease, so how can helping to quit smoking be considered a "therapy" or "treatment" if it is not actually addressing the actual disease? Its like saying a diet pill that the company claims helps people lose weight is making therapeutic claims to treat or cure diabetes.

The FDA sends out conflicting messages:
1) Smoking causes diseases, but people smoke because of nicotine addiction;
2) It's the disease of addiction that is receiving "treatment" to get people to stop smoking;
3) Smoking cessation drug must show they effectively treat nicotine addiction by causing nicotine abstinence, not just smoking abstinence, to be approved;
4) But claiming just smoking abstinence is still the same thing as claiming nicotine abstinence, even though the above points clearly define the two as NOT the same thing.

Huh?

Anyhow, that's Bill's point - the e-cigarette testimony given by consumers is not usually regarding the "treatment" of nicotine addiction, but only of smoking cessation. So there were no actual theraputic claims when they didn't claim to treat nicotine addiction.
 

Dana A

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Can't we call him by his given name of Satan?:D[That's the name I gave him...


QUOTE=DC2;8363422]Instead of calling him Stan, can we call him by his given name of Stanton?

If he prefers to go by Stan, then screw him.
And it is much easier to hate someone named Stanton that Stan.

And yes, I do hate him.
He is on a very short list of those I reserve my hate for.[/QUOTE]
 
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Jman8

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Kristin - I agree that FDA is, at times, putting out conflicting messages. And at times in a way that reeks of corruption. If I deny that and give them much benefit of doubt, I would say FDA is addressing an epidemic (of sorts) revolving around nicotine addiction. And feels greatly empowered, as even vapers acknowledge that kids and nicotine do not go together (even while many of us were ingesting nicotine into our bodies around age 15 and are still alive to tell about it).

Smoking nicotine is the main culprit in the movement to counter the epidemic. Some vapers are all too happy to help FDA and anti-tobacco groups with overcoming that aspect of the epidemic. Need us to bad mouth BT and smoking in general? We (vapers) can do that for you. But don't touch our nicotine, er, I mean, vaping you damn FDA / anti-tobacco groups. While we'll be glad to attest to the idea that this product and smoking have a connection in terms of one helping to overcome the other. And those of us who claim to enjoy both, and are okay to live in a world where both co-exist, never mind those people for they are aberrations. Weirdos. We're working on them.

We do have the problem, as I see it, of the possibility that online vaping sales could, rather easily, get into the hands of people under the legal age of using nicotine products. Those of us with brick and mortar stores nearby (that are good) probably don't care too much about the idea that others may have serious issue with this (lack of access). When the reality, I think, is that if online vaping sales go down (though at worst will be an underground market), this could create a whole bunch of ex-vapers, some of whom might suddenly be on the side of - really ought not to have any brick and mortar stores anywhere, let's get those shut down. Or at the very least, lets regulate them even more.... for the kids.

Anyway, perhaps I'm a little off topic from this thread, but I think it is us doing this to ourselves. This place where eCig industry is up on the chopping block, and likely to be somewhat to heavily regulated within next 90 days. And it obviously stems from the 'for the kids' logic along with the entire notion of 'potentially harmful.' As many vapers are already fully on board with this sort of heavy regulation with smoking tobacco products, while exercising plausible deniability for own nicotine use; I don't know how to not expect the anti type groups to not sit up and take notice when we make claims along lines of smoking cessation from vaping, while also keeping nicotine products around (and feeding the addiction).

If we are up for self regulating, and being pro-active, we need to then be the ones responsible for ensuring kids don't have easy access to this product, ensuring that eCig companies aren't marrying this tobacco, and so on and so forth. Otherwise, I think we know that there are others who will do it for us, and who see nicotine addiction (or even use) as real target of the epidemic.

I'm glad to do my part, but I'm not entirely convinced that kids can't handle nicotine use and at very least I wouldn't draw the line at age 18. So, I may not be best person in this day and age to help with self regulation except at level of, minimal amount of work to be done right now at this time.
 

Bill Godshall

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Stan posted my reply, and posted the following reply to me.

http://tobacco.ucsf.edu/e-cig-companies-want-have-it-both-ways-whether-or-not-they-are-cessation-
aids-fda-can-should-stop-th#comment-322

Submitted by sglantz on Fri, 2013-01-18 22:12.

Bill Godshall misses the whole point of our Comment

Our public comment to the FDA does not challenge e-cigarette consumers’ free speech rights. Indeed, we are frankly quite happy that the consumers’ testimonials clearly establish the way consumers are using e-cigarettes as smoking cessation aids, a therapeutic use.

Rather, we challenge the e-cigarette companies’ violation of the FDCA by unlawfully promoting their products for the therapeutic use of minimizing nicotine addiction, just as nicotine gums and transdermal patches are designed to do. Like nicotine gums and transdermal patches, e-cigarettes, when used to assist in smoking cessation would fall under the jurisdiction of the drug/device provisions of the FDCA, and as Mr. Godshall correctly suggests, “should be reported to the FDA [so that] the FDA will take appropriate action” for failing to get appropriate FDA drug/device approval.

The federal judges of the D.C. Court of Appeals who heard the appeal of the Smoking Everywhere/Sottera, Inc. lawsuit agreed with Judge Leon’s interpretation of the law about how to decide whether a tobacco product shall be considered marketed for a therapeutic use, and it has nothing to do with the First Amendment. 21 CFR 801.4 makes clear that the “objective intent of the persons legally responsible for labeling the device” is determined by the totality of “the circumstances surrounding the distribution of the article,” including the knowledge of the companies or their representatives that their product or device is being used “for a purpose for which it is neither labeled nor advertised.”

Whatever use was originally intended for a device is not determinative, as the intended use “may change after it has been introduced into interstate commerce by its manufacturer,” and in such case, the distributor or seller is “required to supply adequate labeling in accordance with the new intended uses.” The crux of the issue is whether the company “knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him” is for a purpose that would require appropriate labeling under the FDCA.

The e-cigarette companies' actions leave little doubt about their knowledge of the devices’ actual , if not originally intended, use because they posted the testimonials of consumers’ on their websites, and because they solicited their consumers to submit Public Comments about how e-cigarettes have changed their lives to the FDA docket regarding a report to Congress on smoking cessation therapies.
 
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Bill Godshall

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I sent and posted the following rejoined to Stan, citing the excerpts of Judge Leon's ruling that vocalek posted on this thread.
Lets see if Glantz posts it.


I suggest Stan (and everyone else) reread Judge Richard Leon's opinion of the law (which the FDA agreed to comply with on April 25, 2011) at http://www.casaa.org/uploads/SE-vs-FDA-Opinion.pdf Here are some pertinent excerpts.

The "intended use" of a product is determined by "the objective intent of the persons legally responsible" for labeling the product. 21 C.F .R. § 201.128. Objective intent may be shown, for example, "by labeling claims, advertising matter, or oral or written statements" by the labeler. Id. It may also be shown "by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised." ld. Here, the overwhelming sum of Smoking Everywhere's promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use.
and

FDA references only three claims made in Smoking Everywhere's literature: (l) electronic cigarettes offer "smokers a chance of smoking in a much healthier way," (2) electronic cigarettes are "a great alternative to help ... stop smoking real cigarettes," and (3) "I've been smoking real cigarettes for over 20 years and really wanted to stop ... I've been using it for 3 weeks now and feel great." (ARDET 49,21; FDA Opposition [#14] at 21). The latter two claims are customer testimonials posted on the Smoking Everywhere website. None of these claims, on their face, suggests an objective intent to treat nicotine addiction and withdrawal. At best, these claims demonstrate that Smoking Everywhere markets its electronic cigarettes as an alternative-albeit a healthier alternative-to traditional cigarettes. IS FDA does not point to any representation by Smoking Everywhere that its product is intended to help wean smokers off of nicotine.

Nor does FDA identify any product labeling that includes instructions about how to overcome nicotine addiction using electronic cigarettes. The clear import of Smoking Everywhere's advertising is that it wants consumers to use its electronic cigarettes for the same recreational purposes and with the same frequency as traditional cigarettes.


Stan's argument, however, has some merit regarding the marketing, usage and regulation ol NRT products.

I've urged the FDA (at the December 17 hearing and in supplemental written comments) to disapprove all NRT as a treatment for "tobacco dependence" unless the random clinical trials achieve a 20% success rate for nicotine cessation since NRT products have >90% and >95% failure rates for achieving nicotine cessation and smoking cessation after 6 and 12 months (respectively), since most NRT is used as a temporary and/or long term substitute for cigarettes (both of which are "off label" uses that haven't been unapproved by the FDA), since GSK, J&J and the FDA have known these facts about NRT (but haven't publicly acknowledged such) for many years even though the FDA has only approved NRT products to treat "tobacco dependence" via a maximum of 12 weeks exclusive use (i.e. no other tobacco products).
But since NRT is somewhat effective as a temporary and long term substitute for cigarettes (e-cigarettes and smokeless tobacco products are more effective), the FDA could/should establish a new NRT regulatory scheme and approve all NRT products for use as temporary and long term "harm reduction substitutes for cigarettes" (as that's how most NRT is actually consumed), and allow e-cig and other smokefree tobacco/nictine alternatives manufacturs to apply for similar approval as such.

The reality is that all NRT products are tobacco products that now can be lawfully marketed as drugs to treat "tobacco dependence" (even thought they aren't very efffective for that purpose) or they can be marketed as unregulated tobacco products.

But the drug companies and their funded lobbying and propaganda front groups (CTFK/ACS/AHA/ALA/ATTUD, SRNT/Pinney, etc) have falsely touted NRT products as highly effective "smoking cessation aids" for many years, while simultaneously (and hypocritically) campaigning to ban or excessively tax and regulate (and making many false fear mongering claims about) all other very similar smokefree tobacco/nicotine products (i.e. e-cigarettes, snus, dissolvables and smokeless) that are even better smoking cessation aids and even better temporary and long term substitutes for cigarettes (than are NRT).
 

Jman8

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For the fun of it, and because I couldn't link to item Bill G. included in his post, I submitted the following comment to one of Stanton's articles (linked here, I hope).

My comment -
Subject: Do not make this public

How can "eCigs emit an unknown mixture into air" and "eCigs have toxic chemicals in the exhaled vapor" both be true?

As the latter question concedes the main point of 'exhaled vapor' then it would be in compliance with the following assertion, "Until that independent evidence base is developed, DOT should to continue to preserve a smokefree aircraft environment on all flights."

eCigs are good to go on all flights.

Thanks Stanton!!!
 

Beretta

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Dear Stan Glantz,

I hate you for wanting to ban ecigarettes and juices. Go take a long walk off a short cliff, and you'd be doing humanity a favor.

Forget all your legal and medical ramblings in your writings. Your arguments are invalid, and you know it. You obviously want everybody to die of tobacco smoking, rather than find a less harmful alternative. NRTs don't work, period. I've tried them, and most people here have tried them. Get over it and your obsession with FDA regulation.

We are coming, our movement is growing. Your blatant disregard for human health is obvious, and will be etched into the history books as "a man with genocidal tendencies". Seriously, ....... you, and just go away.

With utter contempt,
Beretta
 

DC2

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Boogeyman is alive and well, I see.
Actually, there is not one boogeyman, there are thousands of them.
And they are very well funded by Big Pharma.

In this particular case, just Google Stanton Glantz and Robert Wood Johnson Foundation.
Yes, Robert Wood Johnson Foundation, the King of the Boogeymen.
 
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