Thursday, January 31, 2013

THR News of the Day

There have been a couple of interesting developments in the world of tobacco harm reduction, the first being from a company that I have been following since last April:

CLARENCE, N.Y. --(BUSINESS WIRE)-- 22nd Century Group, Inc. (OTCBB: XXII) announced today that its subsidiary, Goodrich Tobacco Company, LLC (Goodrich Tobacco) applied to the Alcohol and Tobacco Tax Trade Bureau of the United States Treasury Department (TTB) for a federal permit to manufacture its own tobacco products. Until now, Goodrich Tobacco has contracted with independent federally licensed tobacco manufacturers to produce its proprietary commercial products, RED SUN®, MAGIC® and SPECTRUM®. Goodrich Tobacco has always supplied its contract manufacturers with its own proprietary tobacco blends.

In parallel with becoming a federally licensed tobacco products manufacturer, Goodrich Tobacco is meeting with the National Association of Attorneys General (NAAG) to become a subsequent participating manufacturer (SPM) to the Tobacco Master Settlement Agreement, commonly referred to as the “MSA.” As an SPM producing its own tobacco products, Goodrich Tobacco will contribute funds in perpetuity to the MSA on every pack of cigarettes it sells and will agree to various restrictions on tobacco marketing practices required by the MSA.

By establishing its own manufacturing facility, Goodrich Tobacco will achieve additional flexibility in production, increased quality control, and a greater capacity for new product development. Besides becoming the manufacturing site for Goodrich Tobacco’s own commercial brands, RED SUN®, MAGIC® and SPECTRUM®, the new facility will also produce X-22, a very low nicotine cigarette currently going through the U.S. Food and Drug Administration (FDA) approval process as a prescription smoking cessation aid, and BRAND A and BRAND B, two potential less harmful cigarettes (as compared to leading brands) in development. Goodrich Tobacco expects to file a modified risk application with the FDA for BRAND A in the second quarter of 2013 and a modified risk application with the FDA for BRAND B in the third quarter of 2013. 22nd Century Group’s April 2012 press release describes the merits of BRAND A and BRAND B, Goodrich Tobacco’s potential modified risk cigarettes in development.

Hopefully the FDA won't stall on approving these applications, as I have been intrigued by the concept of Brand B for some time now. I am also looking forward to the day that I'll be able to actually try it out for myself.

The company’s management is looking forward to Goodrich Tobacco becoming a federally licensed tobacco product manufacturer and working with NAAG to become a member of the MSA. Goodrich Tobacco’s leased manufacturing facility is 6 miles from its headquarters in Clarence, New York. Henry Sicignano III, President of 22nd Century Group and Goodrich Tobacco, stated, “We believe our novel science-based tobacco products will emerge as highly distinctive brands among the sea of conventional cigarettes offered by our larger competitors. Due to 22nd Century’s groundbreaking proprietary technology, no other tobacco company in the world can duplicate our tobacco blends or match the product attributes of our highly differentiated super-premium cigarettes.”
About 22nd Century Group, Inc.

I suspect that  becoming a member of the MSA will speed things along with the FDA approval process. It is all about the money, after all. As a side note, I have to say that it seems somewhat unfair to make an up and coming company (that is offering new and novel products such as Brand A and Brand B) pay what is presumably the same amount into the MSA as the existing majors that are still atoning for the sins of the past. Ah, but the price of doing business means that you have to get through the gatekeeper. For the sake of fairness, hopefully there's a provision in the MSA somewhere that allows for fee adjustments (for both new and existing companies) for products according to their level of risk.

22nd Century is a plant biotechnology company whose proprietary technology allows for the levels of nicotine and other nicotinic alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco plant to be decreased or increased through genetic engineering and plant breeding. 22nd Century owns or is the exclusive licensee of 107 issued patents in 78 countries plus an additional 38 pending patent applications. Goodrich Tobacco and Hercules Pharmaceuticals, LLC and are wholly-owned subsidiaries of 22nd Century. Goodrich Tobacco is focused on commercial tobacco products and potential modified risk cigarettes. Hercules is focused on X-22, a prescription smoking cessation aid in development.

There have been a couple of conversations in the blogosphere that I have come across that mention the role of "other" nicotinic alkaloids in tobacco. It's not something that is mentioned or talked about often, as the center of attention (when it comes to the rewards and behavioral aspects associated with smoking) has almost always been on nicotine itself. What a lot of folks (including myself, up until now) don't realize is that these "other" nicotinic alkaloids can act as MAO inhibitors, which have been useful in treating depression and Parkinson's disease. Hence, there are many benefits that could come from varying/raising the levels of not only nicotine, but that of its associated alkaloids, which would presumably result in more of the "good stuff" and less of the "bad stuff" that has given smoking a bad name.

For additional information, please visit: www.xxiicentury.com




22nd Century Group Subsidiary, Goodrich Tobacco, Applies for Federal License to Manufacture Tobacco Products | Business Wire


The other story that caught my attention this morning was this one:

Tubb, a retired brigadier general, served three presidents in various White House capacities, including director of the White House Medical Unit and physician to the president. He retired from the White House in 2009. Tubb has been actively involved in the science and policy development of alternative nicotine products and tobacco harm reduction, BAT said. 



I am delighted to be welcoming such a prominent and well respected expert in the field of tobacco harm reduction to our Board,” said BAT Chairman Richard Burrows. “This appointment further demonstrates our commitment to putting science at the heart of our business.

..Very promising indeed.

Former White House Doctor Joins BAT

Monday, January 28, 2013

Slighted by an e-cig company, twice

Recently, I purchased a Blu Cig. The reason for my purchase was that it contains vegetable glycerin instead of propylene glycol, with which I had quite a horrible reaction to once. In an attempt to be open-minded, I decided to give Blu a chance. They're ok for when you're stuck in a non-smoking environment against your will (ie., they're not going to replace my cigarette habit any time in the near future) I suppose, and even though they make me cough upon occasion when inhaling, the side effects were nowhere near what I had experienced with the PG based e-cig that had once made me (and my boyfriend) ill.

Seeing this as a sign of progress (I believe in progress), I decided to contact the company via their website to see if I could put a Blu banner on my blog. This lead me to an affiliate company that provided me with an application for prospective affiliate publishers.

What came next surprised me: I was told that my application was denied. When I asked why, I was told that it was because of the content of my blog. In other words, they did not approve of my talking about smokers' rights and tobacco harm reduction for combustibles. I explained (err..or I tried to) to them that I am interested in harm reduction and that even though I am more interested in combustible cigarettes, I am trying to be open-minded to the idea of e-cigarettes (despite a previous bad experience). I also explained to them (...ok..tried to) that there were/are no banners of the "Marlboro Man" anywhere on my blog; thus, it cannot be said that I am selling anything (um, because I'm not) related to combustible cigarettes on my blog; though it can be said that I am attempting to sell an idea (ie, harm reduction for the millions of smokers who will continue to smoke), rather than a particular product per se .

As a smoker who pays taxes, I have every right to speak of "ideas" (ie., by digging up relevant studies, etc.) when it comes to the issue of tobacco. There are some who don't agree with this right to discuss ideas. I am in the process of learning the hard way that not everyone is as open-minded as I thought, for Blu has just shunned one of their prospective customers merely because they don't "like" what I talk about on this blog. In the dictionary, the definition of what I have just experienced can be encapsulated in the term/word prejudice.

....and it's not just them either....The same thing has just happened to me (presumably for the same reason) again when attempting to contact another VG-based e-cig company called Pro Smoke. In hindsight, I'm not too surprised by the slight that I have received from Pro Smoke, as they have a big, shiny endorsement from our favorite smoke-banster friends over at the ACS.

I'm not trying to bash on e-cigs, but what I am saying is this: Many proponents (not all) of e-cigarettes are indeed anti-smokers that only want to sell their form of harm reduction. Sound familiar? They're not exactly tolerant of other alternative ideas..or of freedom of expression for that matter. That's a fact.

Thursday, January 17, 2013

Non-pyschoactive Cannabidiol, Could It Play a Role in Tobacco Harm Reduction?

I was reading an alternative medicine newsletter this morning when I came across some rather interesting information on the role of non-psychoactive cannabidiol could have in fighting cancer, which in turn reminded me of an idea that I have entertained in the past: What would happen if legal cannabinoids were to be utilized in the field of tobacco harm reduction?


This makes for an interesting read:

We also show, for the first time, that the antiproliferative effect of CBD was correlated to induction of apoptosis, as determined by cytofluorimetric analysis and single-strand DNA staining, which was not reverted by cannabinoid antagonists.
Finally, CBD, administered s.c. to nude mice at the dose of 0.5 mg/mouse, significantly inhibited the growth of subcutaneously implanted U87 human glioma cells.  
In conclusion, the nonpsychoactive CBD was able to produce a significant antitumor activity both in vitro and in vivo, thus suggesting a possible application of CBD as an antineoplastic agent.


Gliomas, btw, are highly aggressive tumors of the brain.


[Brainlife] MASSI P et al (2004) - Antitumor Effects of Cannabidiol, a Nonpsychoactive Cannabinoid, on Human Glioma Cell Lines


Here is a link to the full study:


Antitumor Effects of Cannabidiol, a Nonpsychoactive Cannabinoid, on Human Glioma Cell Lines


Consider this thought: if non-psychoactive cannabidiols have been shown to produce anti-tumor activity in those suffering from brain cancer, one has to wonder if cannabidiols might also have a place in the treatment of lung cancer, or even in the field of lung cancer prevention. Hell, what if tobacco companies were to add legal cannabidiols to tobacco as a means of harm reduction? ..Sounds like a crazy idea, but check this out:


Studies conducted by Dr. Tashkin in 1990 found that marijuana smoke has almost the exact same carcinogens (cancer causing agents) as tobacco smoke and that the concentration of these carcinogens was exceedingly higher in marijuana smoke. These studies are the basis for the government’s warning in thousands of ads that smoking one marijuana joint does as much damage as smoking four cigarettes.

To document a connection between lung cancer and marijuana smoking, Dr. Tashkin received a very large grant from the National Institute of Drug Abuse.

With over 2,200 subjects, the research was one of the largest case control studies of its kind ever!

The government was horrified at the results and did its best to ignore them as Dr. Tashkin failed to find any link between smoking marijuana and the development of lung cancer.


There was no correlation found between marijuana smoking and lung cancer. That's interesting. How can this be? That the government was horrified at the result of this study comes as to no surprise for many of us.

The fact that marijuana smoke contains many of the same cancer causing carcinogens as tobacco smoke (and in higher concentrations) while showing no correlation with lung cancer raises some serious questions that need to be taken seriously.

Dr. Tashkin then goes on to state that there may have even been a protective effect amongst some of the subjects studied. For those who are interested the rest of the article in its entirely, it can be found here.

If it is in fact shown that it's the non-psychoactive cannabinoids that are responsible for this protective effect, then there is no reason to assume that these same constituents couldn't also be beneficial if added to tobacco smoke, and not just (being that marijuana smoke has higher levels of the same carcinogens) on a minor level. The possibilities don't end there either.

What if legal cannabinoids were combined with that of a higher nicotine (ie., less smoke inhalation) cigarette, a cigarette infused with anti-oxidants such as grapefruit seed extract, charcoal filters, or any of the above in aggregate? How great would the protective effect be then? The prospects are truly amazing, which is what truly makes this subject so interesting.

..Too bad that this is an idea that goes against the current cultural relativism and prejudices of the day, for many lives could be extended if such research were to be conducted and made known to the public.






Tuesday, January 15, 2013

Timeframe on FDA Proposed Tobacco Product Regulations

 FYI to those who may be interested:

In the Jan. 8, 2013, Tobacco E-News bulletin, NATO reported that the Food and Drug Administration had released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products sometime by April of 2013. While the FDA stated its intention to release proposed regulations on other tobacco products by April of this year, there are various steps that a federal agency needs to follow in drafting, proposing, obtaining public feedback and finalizing a new regulation.

This means that when the FDA releases its proposed regulations on other tobacco products, the public will have 60 days to submit comments and make recommendations on the proposed rules. Then, the FDA will review all public comments and determine whether any changes should be made to the proposed regulations prior to issuing the regulations in a final form.

Here's our chance to voice our concerns.

. ...Think that they'll listen to us smokers?


Timeframe on FDA Proposed Tobacco Product Regulations


....and let's not forget that the FDA is preparing to submit its report to Congress on its research into innovative products and treatment for tobacco dependence. Tomorrow is the deadline for the public comment period.

Comments can be submitted here Comments are limited to 2,000 characters..


Summary: The Food and Drug Administration (FDA) is extending the comment period for the notice of public hearing that appeared in the Federal Register of November 28th, 2012 (77 FR 70955). In the public hearing notice, FDA requested comments on FDA consideration of applicable approval mechanisms and additional indications for nicotine replacement therapies (NRTs), and input on a report to Congress examining the regulation and development of innovative products and treatments for tobacco dependence. The Agency is taking this action to allow interested persons additional time to submit comments.

Dates: Submit either electronic or written comments by January 16, 2013


 ...and with regards to the Tobacco Control Act:


Section 918 (b) requires that the Secretary of HHS, after consultation with recognized scientific, medical, and public health experts, submit a report to Congress examining how best to regulate, promote, and encourage the development of "innovative products and treatments (including nicotine-based and non-nicotine-based products and treatments)" to better achieve the following three goals: (1) Total abstinence from tobacco use, (2) reductions in consumption of tobacco, and (3) reductions in the harm associated with continued tobacco use.


 I sure do hope that they take a step away from the quit or die approach.

Saturday, January 12, 2013

An Apology

Ugh....yesterday I posted a link to a new book about nutrition for smokers with a short commentary about how I looked forward to reading the book. Anyhow, upon going to the website of the authors this morning (with coffee in hand), all that I could find were condescending blog posts about how smoking is so bad that it even "causes worse hangovers" (like alcohol and dehydration don't have anything to do with it). I did not see one blog post about vitamins or how a current smoker might reduce his/her risk of future illness.

As someone who is interested in vitamins and integrative medicine I welcomed this book as something refreshing and new (ie., their selling point was about nutrition for former smokers and current smokers that don't want to quit)...boy was I mistaken. Me thinks that it was anti-skullduggery....ie., a trick to ploy me/us into an anti site. The last thing that we need is some high-brow "expert"  who feels that it is his/her duty to PREACH to an audience that has no interest in being read a sermon. I know that I am personally tired of being nagged about my lifestyle choices and I get the feeling that I am not alone; however, this does not mean that I am not interested in health and harm reduction. I just don't like being "told" that there is only one singular path to harm reduction. Maybe the book (I'll have to take a look at it in it's entirety) has some valuable information, but the website (and blog), however, is patronizing as hell.  I have therefore removed yesterday's post as a result. I apologize to anyone who may have been as offended as I was.

It's a tricky world out there:-)

Thursday, January 10, 2013

The Secret To Longevity

Thanks to Gabi Coleman for posting this on Facebook via Friends of Forest-

According to Britain's oldest man Ralph Tarrant, the secret to a long life is.....

Drum roll.......

He was one half of Britain's oldest married couple until his wife Phyllis died aged 102 last year. And Mr. Tarrant says the secret to a long life is to enjoy vices as well as much as virtues. 'Stay active and stay interested,' he said

.....and his wife Phyllis lived to be 102! ..So much for 2nd hand smoke being this ubiquitous cause of every illness known to mankind.



Ralph Tarrant Britain's oldest man reveals secret to hitting 109 years old: 'I smoked until I was 70 and still enjoy a drink!' | Mail Online

Sunday, January 6, 2013

NICE Ignores The Obvious

This brief article (authored by Andrew D. Furber-Director of Public Health NHS Wakefield)  from the BMJ on tobacco harm reduction just arrived in my inbox:

Re: Tobacco harm reduction: the devil is in the deployment | BMJ

Hastings et al. summarise well the dilemmas associated with tobacco harm reduction, and rightly conclude that the devil is in the deployment.

The use of Nicotine Replacement Therapy (NRT) by smokers for harm reduction outside of established guidelines may already be widespread (1). Certainly locally we have seen a significant increase in NRT use without a corresponding increase in measured quits.

This shouldn't be too surprising, as it has become common knowledge that NRT products have a 97% + failure rate when it comes to smoking cessation. However, it is nice to finally see this acknowledgement coming from a published article in the BMJ. If this doesn't provide the empirical evidence to support a shift towards tobacco harm reduction, away from the old ways of the quit or die orthodoxy, then I don't know what possibly could.


Mr. Furber then goes on to say:

Therefore better management of harm reduction through NICE guidelines (2) is welcome. But the implementation will be difficult and will need to be monitored carefully. In particular the NHS reforms in England potentially create the additional complication of tobacco control being funded by local authorities but much of the financial saving falling to NHS Clinical Commissioning Groups (through reduced NHS activity). Health and Wellbeing Boards will need to quickly develop the maturity to manage this, and ensure they deliver better outcomes for tobacco control.

When addressing this issue of harm reduction  via NICE guidelines, I wonder what Mr. Furber means when he stresses for the need for maturity in dealing with such a complex, but necessary subject.

For anyone who has the time to read it in its entirety, the guideline can be seen here.

In the meantime, here are a few excerpts. One of the first things to gnaw at my craw can be seen on the very first page of this 100 page report:

The use of products containing tobacco as a means of ‘harm reduction’ is outside the scope of this guidance. This means that ‘reduced exposure cigarettes’ and ‘smokeless tobacco’ are excluded..

..Outside of the scope of this guidance? I think that I am beginning to understand what Mr. Furber means when he calls for better management in the world of tobacco control...err, I mean tobacco harm reduction.

What's interesting is that also on the very first page of the NICE guideline is the recognition that smoking less can be a means of harm reduction:


This guidance aims to reduce the illnesses and deaths caused by smoking tobacco among people who smoke and those around them. People who smoke can do this by:

• stopping smoking
cutting down prior to quitting smoking
smoking less
abstaining from smoking temporarily.

This is certainly a welcome admission, but what doesn't make sense is the total and utter disregard for reduced exposure tobacco products! 92+% of tobacco users smoke combustible cigarettes. Hence, I repeat, it simply does not make sense to ignore the obvious.

From one side of the mouth they are saying that less smoke is better than more smoke while giving the finger to what will prove to be THE missing piece of the equation (in terms of harm reduction) that has been missing from the conversation for far too long.

Ugh.


Thursday, January 3, 2013

Is there no risk-free level of second hand smoke


Thanks to Audrey Silk for posting this on Facebook via NYC Clash-
 

medical science - Is there no risk-free level of second hand smoke? - Skeptics


..an interesting read..Here are a few excerpts:


Living is full of risk, the only away to avoid all risk is to cease to exist. The Surgeon General's warning about there being no risk-free level of secondhand smoke exposure is misleading, and ignores hundreds of years of toxicology that show that all poisons have some minor exposure level that is not harmful.

So while it is true that there is no risk free exposure to SHS, there is also no where on earth that you can be free of natural occurring carcinogens. Report of the United Nations Scientific Committee on the Effects of Atomic Radiation to the General Assembly
11 . Everyone is exposed to natural radiation. The natural sources of radiation are cosmic rays and naturally occurring radioactive substances existing in the Earth itself and inside the human body. A significant contribution to natural exposure of humans is due to radon gas, which emanates from the soil and may concentrate in dwellings.
Since radiation is everywhere, the Surgeon General could just as well had said,
There is NO risk free level of living on earth.

The father of toxicology, Paracelsus said, "All things are poison, and nothing is without poison; only the dose permits something not to be poisonous."
A real world example might be in order:

If you count deaths at all ages, DHMO was responsible for an estimated 3,880 deaths in the USA, more than the estimated deaths each year due to secondhand smoke (3,400 per year).
The above statements are all 100% true, but extremely misleading. If you are currently attempting to protect yourself from the dangers of Dihydrogen Monoxide, you will likely be issued a Darwin Award. This dangerous chemical is water.

The EPA says we shouldn't be concerned about lead in our drinking water that is below an action level, but the Surgeon General wants to repeatedly warn us that NO risk free level of second-hand smoke exists. Lead is a carcinogen whether it is in your drinking water, or in your smoke. It seems foolish to warn us about exposure from one source while ignoring the other.

Your food isn't even safe. Bananas because of their high potassium content, contain more [radioactive Potassium] than other fruit. Eating 2 bananas a day for a year would expose you to more radiation than you would get from a single chest x-ray (about 10 mrem).

Wednesday, January 2, 2013

Anti-oxidants, oxidative damage and tobacco



Hello and Happy New Year!

Here are a couple of studies that I stumbled across while surfing around on Google the other day, followed by an article about the EU Commission and its continued support of, well, keeping smoking as dangerous as possible:


Vitamin C prevents cigarette smoke-induced oxidative damage in vivo

Protein damage and lipid peroxidation are also observed in cigarette smoke-exposed pair-fed guinea pigs receiving 5 mg vitamin C/animal/day. However, complete protection against protein damage and lipid peroxidation occurs when the guinea pigs are fed 15 mg vitamin C/animal/day. Also, the cigarette smoke-induced oxidative damage of proteins and lipid is reversed after discontinuation of cigarette smoke exposure accompanied by ascorbate therapy. The results, if extrapolated to humans, indicate that comparatively large doses of vitamin C may protect the smokers from cigarette smoke-induced oxidative damage and associated degenerative diseases.

Good to know, though I won't thank the health establishment for willfully forking over this information. If you crave this type of information like I do, you are going to have to seek it out yourself. The beauty is that if you've got the imagination, chances are that the information is there.


Antioxidant vitamins and prevention of lung disease.

The oxidation of lung lipids can be prevented by both vitamins C and E. Vitamin C is more effective in preventing oxidation by NO2, and vitamin E is more effective against O3.
...isolated human cells are protected against oxidative damage from NO2 and O3 by both vitamins C and E.

I take this to mean that both vitamins C and E harbor great potential for smokers and thus, both should be utilized in the field of tobacco harm reduction asap.

I wonder how the FDA and the EU Commision would feel about vitamin additives to tobacco....?

Of course, I'm being sarcastic, for we all know that to propose such an idea would be blasphemous!


Commission sticks to ‘quit-or-die’ policy with TPD revision proposals

The European Commission seems once again to have come down in favour of a quit-or-die approach to tobacco consumption, rather than a harm reduction approach.

..No real surprise there.... There goeth my hopes of any vitamins in my cigarette.

 The Commission’s proposals would include a ban on cigarettes, roll-your-own and smokeless tobacco products with characterising flavors, including menthol, and a ban on products with additives that increase toxicity and ‘addictiveness’.

Translation: We will ban it if it tastes good, thereby taking away the incentive for smokers to switch to less risky products.

..the proposal would significantly limit consumer access to, and information about, products that have the very real potential to reduce the harm caused by conventional tobacco products. In doing this the Commission has chosen not only to stifle innovation but also to ignore the potential these products have to improve public health.

I am getting quite tired of bureaucrats deciding on what's best for us against our will, aren't you? We have the right to know what the varying risks are with regards to all tobacco products.

We smokers are individuals with varying needs and wants. The choice to smoke (or not to smoke) is a decision that is ours; thus, no political actor, lobbyist, or bureaucrat in this world has the right to deny us the information that is required for us to make the informed choices that will ultimately affect our lives and our health.

As individuals, we also reserve the right to make the "wrong" choice. That means that if I choose to smoke a cigarette with vitamin C as an additive, that is my choice and my right to do so. Yeah, it's not as good as total abstinence, but it's my life and a reduced harm cigarette has got to be better than a a much riskier cigarette. If the carcinogenic biomarkers indeed show a reduction in exposure, then who in their right mind thinks that they have the right to say that "it ain't so"? The intentional suppression of such information with regards to any and all forms of tobacco harm reduction would not only prove to be  dastardly and dishonest, thus affecting the lives of millions (..or more accurately, about 1.5 billion), but it would also be a violation of smokers' human rights.

...and in speaking/thinking of vitamins and oxidative stress once again, I do believe that I read somewhere (recently) that the EU Commission is also proposing a ban on any vitamin additives to combustible cigarettes. I wish that I could recall where I read that....

Why in the world would they want to ban vitamin additives if they in fact were/are shown to reduce the toxicity of inhaled cigarette smoke?

.Again, a stupid question to something that I already know the answer for.

Happy New Year! Let's hope for some real change this time around.

 

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