FDA to host Modified Risk Tobacco Product workshop in DC Aug 25/26, free registration still being accepted

[Vocalek]

To us, it looks like "stupid"; but "delusional" is a more accurate description of the mind-state of folks like her.

The point she seems to miss is that she IS doing harm by preventing smokers from switching to products that won't give them COPD or lung cancer, and that will reduce their risks of cancer and cardiovascular disease by 90 to 99%.

I have heard folks with medical degrees hide behind the "do no harm" mantra. "I took an oath to do no harm, so I can't recommend that a smoker switch to another tobacco product."
8-o

First of all, it is imposible for anyone, even a doctor, to do zero harm. Everything involves making choices about following the path that is the least harmful. Do you sick a needle into a child, inflicting pain and triggering screaming? Or do decide to "do no harm" leaving the illness untreated? Either way is harmful. In the long run, however, treating the child's illness is the least harmful path.

Second of all, those who claim that tobacco Harm Reduction actually inflicts harm are induging in a logical trap called a false dichotomy.

A dichotomy is a set of two mutually exclusive, jointly exhaustive alternatives. Dichotomies are typically expressed with the words "either" and "or", like this: "Either the test is wrong or the program is wrong." A false dichotomy is a dichotomy that is not jointly exhaustive (there are other alternatives), or that is not mutually exclusive (the alternatives overlap), or that is possibly neither. Note that the example given above is not mutually exclusive, since the test and the program could both be wrong. It's not jointly exhaustive either, since they could both be correct, but it could be a hardware error, a compiler error and so on.

False Dichotomy

In the case of THR deniers, the two alternatives are not exhaustive. There ARE other alternatives.

They pretend that the only two choices available are "a" becoming totally abstinent or or option "c" continue smoking. They falsely believe that if they refuse to allow any other options, that everyone will select option "a". And if smokers insist on sticking with option "c" they deserve everything that happens to them.

They refuse to accept the fact that for some smokers, option "a" is actually not harm-free. They pretend that "health" only encompasses organ systems from the neck down, and pretend that mood impairments and cognitive deficits are not real medical conditions. They refuse to accept the fact that option "b" involves removing most, if not all, the harmful effects of option "c" without creating harmful effects of option "a."

I'm not saying that all smokers experience harmful effects if they follow option "a". Obviously, many do not. But many people are dependent on nicotine to keep the symptoms of underlying conditions involving the cholinergic system under control: Example, attention deficit disorder. Labeling this dependence on nicotine "addiction" and viewing smokers who can't quit as nothing more than hopeless (stupid, filthy, disgusting) "addicts" relieves the medical folks of all responsibility (in their minds) by blaming the victim.

Another reality they refuse to face is a growing body of evidence that option "b" -- switching the smoker to non-combusted sources of nicotine--is nowhere near as harmful as option "c". They continue to insist, despite overwhelming evidence, that all forms of tobacco are equally harmful to health.

Let us pray for their quick recovery from a delusional state.

 

[Vocalek]

"Are we here to reduce tobacco use, or are we here to reduce the health effects of tobacco use? Very diffrerent questions, very different answers in terms of pubic policy," said Jeff Stier in his testimony.

"How many smokers will continue to smoke as the FDA explores and tackles these questions? Smokers are dying every day. New smokers are coming on board.... 'Smokeless tobacco is less harmful than cigarettes' is a very simple concept. We can make it complex, but people will continue to die as we do that. And there are those in public policy and anti-tobacco advocates who seek to withhold scientific information from the public. And in doing so -- we always have to be aware of the unintended consequences of public policy, that people will continue to die as long as we don't offer alternatives."

Video taken with hand-held cam is posted on the CASAA Media YouTube site. My testimony starts at 4:47.

CASAAmedia's Channel - YouTube

 

[sqirl1]

"Are we here to reduce tobacco use, or are we here to reduce the health effects of tobacco use? Very diffrerent questions, very different answers in terms of pubic policy," said Jeff Stier in his testimony.

"How many smokers will continue to smoke as the FDA explores and tackles these questions? Smokers are dying every day. New smokers are coming on board.... 'Smokeless tobacco is less harmful than cigarettes' is a very simple concept. We can make it complex, but people will continue to die as we do that. And there are those in public policy and anti-tobacco advocates who seek to withhold scientific information from the public. And in doing so -- we always have to be aware of the unintended consequences of public policy, that people will continue to die as long as we don't offer alternatives."

Video taken with hand-held cam is posted on the CASAA Media YouTube site. My testimony starts at 4:47.

CASAAmedia's Channel - YouTube

WOW. I've always seen your posts, but I've never actually heard you speak up until now. YOU KICKED ...! KEEP IT UP!

 

[Vap0rJay]

...They pretend that the only two choices available are "a" becoming totally abstinent or or option "c" continue smoking. They falsely believe that if they refuse to allow any other options, that everyone will select option "a". And if smokers insist on sticking with option "c" they deserve everything that happens to them...

To take a personal hit to my old dating "game" it is in a sense a form of manipulation. I use to do this very similar tactic once upon a time in the dating world. As I talked I would present both options a and b, in either case I won. And of course, to add to the illusion of choice I would offer at times a third option -- of course in which case I also won.

Example. I can take you out to get Italian or we can grab something and stay home. Of course, I can cook you something as well.

#1 presumption I’m having dinner with you either way
#2 i want Italian - if we get something and stay home I can still get Italian. If I cook, it’s Italian.

It's not a delusional state. It's a way to get what you want every time. And if you "concede" its because you more than likely put the idea there and want to -- or like a game of chess it was a sacrificial pawn lost to try to advance your piece.

A similar tactic with a reverse twist is to get YOU to imagine it and/or get you to think it's your idea or something you need/cannot live without. For your own good. And the children. ... of course.

 

[ByStander1]

2) Some crazy woman who is in tobacco control in Indiana was on the final panel of the day. Bill revealed that she's a long-time prohibitionist, and that was the tone of her speech. She brought up how when Marlboro Snus was test-marketed in Indianapolis, surveys revealed that while non-smoking teens weren't using them, teens who were smokers did (the horror!). Next, she complained that some Marlboro Snus intended for the Indianapolis market actually ended up being sent -- not by the tobacco companies -- to troops in Iraq (keep on smoking soliders!).

I laughed out loud when she was upset by this:

"This" being:

1) An employee takes it upon themselves to do a generous thing for soldiers away from home
2) Soldiers receive something less harmful
3) Soldier(s) may have avoided being spotted (shot), since they weren't puffing out clouds of smoke

Yeah, she was a piece of work all right!

 

[DC2]

Yeah, she was a piece of work all right!

Every vaper would benefit greatly from hearing what one of these brainwashed nuts has to say.
There is no better way to find out what we're truly up against.

She may sound like a nut, but she represents a very large contingent of extremely powerful nuts with lots of money.
You might know these folks better as ALA, ACS, AHA, CTFK, ALF, ASH etcetera, etcetera, ad nauseum.

 

[sqirl1]

I laughed out loud when she was upset by this:

"This" being:

1) An employee takes it upon themselves to do a generous thing for soldiers away from home
2) Soldiers receive something less harmful
3) Soldier(s) may have avoided being spotted (shot), since they weren't puffing out clouds of smoke

Yeah, she was a piece of work all right!

Well, it's not a bad thing that they sent soldiers snus..... but it is that they sent them MARLBORO SNUS! YUCK!

 

[Vocalek]

Here is a link to the testimony by CRE. CRE Testifies at FDA Modified Risk Tobacco Products Workshop « A Public Participation Forum for the FDA Advisory Committee (TPSAC) and Federal Regulatory Policy

The testimony itself: http://www.thecre.com/tpsac/wp-content/uploads/2011/08/ModifiedRiskTPsJJTtestimony.pdf

I love his opening line: I would like to compliment the FDA for convening a workshop on harm reduction.

Followed by:

This compliment is not without hesitation on my part.

I say this because after a lengthy participation in the TPSAC menthol proceeding, I believe that TPSAC’s default position on smoking is to not recognize the potential for harm reduction within tobacco products. Instead, the TPSAC’s position appears to reflect an absolute commitment to total abstinence no matter how unrealistic or counterproductive that position.

About the speaker:

Jim J. Tozzi
Former Deputy Administrator
Office of Information and Regulatory Affairs
The White House, Office of Management and Budget
Currently Director, Multinational Business Services

 

[Bill Godshall]

My statement at the FDA's MRTP workshop is below.


FDA Modified Risk Tobacco Products Workshop
August 25, 2011

Statement
by
William T. Godshall, MPH
Executive Director
Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
412-351-5880
FAX 351-5881
smokefree@compuserve.com

Hello,

I’m Bill Godshall, founder and executive director of Smokefree Pennsylvania, a nonprofit organization that since 1990 has been advocating local, state and federal policies to reduce indoor tobacco smoke pollution, reduce tobacco marketing to youth, hold cigarette companies accountable, increase cigarette tax rates, fund tobacco education and smoking cessation services, inform smokers that all smokefree tobacco/nicotine products are far less hazardous alternatives to cigarettes, and in 2007 I convinced Senator Mike Enzi to amend the FSPTCA to require picture warnings on cigarette packs.

For disclosure, neither Smokefree Pennsylvania nor I have ever received any direct or indirect funding from any tobacco, drug or electronic cigarette company or trade association.

It is important to recognize that Section 911 and other provisions of Chapter IX of the FSPTCA only apply to: cigarettes, cigarette tobacco, RYO tobacco and smokeless tobacco products. Although the FDA has stated that it intends to propose a regulation to apply Chapter IX to all currently unregulated tobacco products, Section 911 does not apply to small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, electronic cigarettes, e-liquid, tobacco skin cream, tobacco water and at least two dissolvable tobacco products.

Thus, there appear to be three different types of MRTP applications that tobacco companies might submit to the FDA:
- comparing a smokeless tobacco product to cigarettes,
- comparing a cigarette to other cigarettes, and
- comparing a smokeless product to other smokeless products.

Since there no scientific evidence indicating that any type of cigarette is less hazardous than other cigarettes, and since there is insufficient evidence indicating that any type of smokeless tobacco product is less hazardous than other smokeless tobacco products used in the US, the FDA should require additional studies for MRTP applications seeking to claim that one cigarette is less hazardous than another and for those seeking to claim that one smokeless product is less hazardous than another.

In sharp contrast, a growing body of scientific evidence has found that daily use of smokefree tobacco products marketed in the US and Sweden pose about 99% fewer mortality risks than cigarettes, and that switching to a smokefree tobacco product reduces a smoker’s mortality risks nearly as much as quitting all tobacco/nicotine. Nonsmokers are also exposed to less tobacco smoke when smokers switch to smokeless tobacco. In fact, NRT and smokeless tobacco products have very similar health risk and benefit profiles.

Since >99% of all tobacco attributable deaths and healthcare costs in the US are caused by the repeated inhalation of tobacco smoke, and that <1% are caused by smokeless tobacco products, it is vitally important for the FDA to publicly acknowledge the exponential differences of risk between cigarettes and smokeless tobacco, and to take this into account when considering criteria for evaluating MRTP applications.

Even in the absence of reduced risk marketing claims, population surveys found that several million smokers have already switched to smokeless tobacco products, despite numerous surveys finding that most smokers inaccurately believe smokeless products are as hazardous as cigarettes. So smokeless tobacco products have already saved more lives (of smokers) than could be offset even if every American non tobacco user begins to use smokeless tobacco. Besides, federal and state laws, and the 1998 MSA, already prohibit the marketing of smokeless tobacco products to youth.

The questions posed by the FDA to presenters of this conference inaccurately presume that there is no evidence that smokeless tobacco products are less hazardous than cigarettes.

If the FDA desires further evidence that the marketing of smokeless tobacco to smokers as less hazardous alternatives won’t harm public health, the agency should consider that e-cigarettes have been marketed to smokers as less hazardous alternatives for several years. As a result, smokers who switched now account for virtually all e-cigarette consumers, there is no evidence youth or non tobacco users have began using e-cigarettes, and surveys of e-cigarette consumers have found that nearly all perceive significant health benefits from switching to e-cigarettes, and that most had previously failed to quit smoking by using FDA approved smoking cessation products.

In sum, there is no justification for FDA to require any new studies for the approval of MRTP applications seeking to claim that a smokeless tobacco product is less hazardous than cigarettes. Any regulation requiring smokeless tobacco companies to conduct additional studies to make that claim is tantamount to a “truth tax”.

Just as ...... addicts and the public have a right to be truthfully informed that methadone, clean needles and condoms can reduce risks of transmitting and contracting HIV, hepatitis and other diseases, tobacco consumers (and the public) have a human right to be truthfully informed that smokeless tobacco products are far less hazardous alternatives to cigarettes.

Just as the US Public Health Service had an ethical duty to inform black syphilis patients in the infamous Tuskeegee Study that effective syphilis treatments were available, the FDA and public health agencies have an ethical duty to truthfully inform tobacco consumers that smokeless tobacco is far less hazardous than cigarettes.

But since 1986 when Congress enacted the Comprehensive Smokeless Tobacco Education Act, public health agencies have intentionally mislead the public to believe that smokeless tobacco is just as hazardous as smoking cigarettes, which has discouraged tens of millions of smokers from switching to smokeless, and has encouraged smokeless users to switch to far more hazardous cigarettes.

Despite repeated assertions that the FDA will rely upon scientific evidence, the FDA’s webpage about Section 911 that is ironically titled “Health Fraud” falsely states “To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products."

Although the FDA has stated that it will comply with Judge Richard Leon’s ruling that e-cigarettes are tobacco products, the FDA hasn’t clarified or corrected any of Josh Sharfstein’s prohibitionist fear mongering propaganda about e-cigarettes. The FDA’s website still contains inaccurate and misleading information about the risks and benefits of e-cigarettes, false claims that e-cigarettes are marketed to youth, and false claims that e-cigarettes are unapproved drug devices, which continue to be cited in news stories and by prohibitionists to continue deceiving the public.

The FDA also has invited many abstinence-only tobacco prohibitionists to its staff, its TPSAC and to present at this workshop, while inviting very few, if any, harm reduction advocates or tobacco consumers.

It was wrong for cigarette companies to mislead the public about the health risks of cigarettes for decades. But it is far worse for the FDA, health agencies, organizations and/or professionals to mislead the public about the comparable health risks of cigarettes and noncombustible tobacco products.

As long as the FDA and heath agencies continue to misrepresent the health risks of smokefree tobacco products, the public will justifiably continue to distrust the FDA on other critically important public health issues.

Ironically, at the FDA’s 2010 scientific workshop titled “Risks and Benefits of Long-Term Use of Nicotine Replacement Therapy (NRT) Products”, there appeared to be a consensus that longterm use of NRT poses very few if any health risks because longterm use of Swedish snus poses very few if any health risks. I suggest the FDA review presentations and discussions at that conference.

Thank You,

 

[DC2]

Are those the comments you made that were cut off for running too long?
And if so, where did you get cut off?

 

[Bill Godshall]

I had only two additional two sentences at the end of my testimony, which I didn't read because I had exceeded the time limit, and which I didn't include in my posting above. Everything I said is in my posting.

 

[DC2]

Outstanding!

 

[rothenbj]

Darn Bill, now everyone on both sides of the issue hate you, great job. That presentation should be put on a separate web page with an easy link to facebook. We all should take it and publish it out on our social networks and ask that people that read it and understand it should likewise post it. That is the type powerful statement that could change the opinions of a lot of smokers on alternatives to smoking, even without the FDA and health groups admitting it.

 

[Vocalek]

Darn Bill, now everyone on both sides of the issue hate you, great job. That presentation should be put on a separate web page with an easy link to facebook. We all should take it and publish it out on our social networks and ask that people that read it and understand it should likewise post it. That is the type powerful statement that could change the opinions of a lot of smokers on alternatives to smoking, even without the FDA and health groups admitting it.

Excellent idea, Jim. I have published this as a news story on the CASAA site.

Here is the link: http://www.casaa.org/news/article.asp?articleID=195&l=a&p=

There are buttons on page to share to a variety of social media.

 

[rothenbj]

Not only was it a good idea, but now a good execution at least on my part. This is the type of thing we need to go viral but the lack of political action by most people will make that difficult.

 

[NorthOfAtlanta]

Shared on FB, maybe it will get to a few more people.

Jack

 

[Bill Godshall]

Can anyone find an FDA weblink of the audio/video of the Agus 25/26 MRTP workshop?

And/or are there other weblinks available with the audio/video of the event?

The FDA waited till the workshop began before it posted a weblink at
Public Workshop: Scientific Evaluation of Modified Risk Tobacco Product (MRTP) Applications
to let the public watch/listen to the event live, but that weblink is now an empty page.

Perhaps the FDA decided to not provide a weblink for the public to watch/isten to the event afterwards because the FDA staff were so embarrassed by the absurd claims made by abstinence-only prohibtionists (that the FDA had invited to speak at the event).

There was also a private company videotaping the workshop (they told me it would cost $140 to buy).

 

[Vocalek]

It took them a couple of days to post a link to the archived videos of the Dissolvable Tobacco TPSAC meeting.

 

[rothenbj]

I've looked and so far not found anything. Due to technical limitations, I wasn't able to watch more than about 15 minutes before I had bandwidth issues so I've been hoping it would become available. Hopefully it will show up, but I wouldn't hold my breath.

 

[Bill Godshall]

View attachment 52003

Scott Ballin's slides at FDA MRTP workshop attached.