Open letter to the FDA on SNUS, Harm Reduction and cigarette sales still growing

Sorry for a very long posting.

I wrote the below letter to the FDA and the members of FDA TPSAC (Tobacco Products Scientific Advisory Committee) yesterday morning after their negative vote on +98% harm reduced smokeless tobacco.

Besides the letter itself i also wish to make you aware that the TPSAC Committee seems very short short on abled bodies and also lacks a chairperson at the moment, never a good position when voting on very controversial issues. Furthermore I also note that those members who remain on the Committee all seem to have made most of their careers in “Tobacco Control” research or public service.

Noting that, and that their earlier publications and research funding all seems to be geared toward complete cessation of all tobacco/nicotine; Makes the notion of them being able to vote objectively and in an unbiased manner on any product designed only to reduce harm, improbable to say the least.

I hope and think that you readers will enjoy, and find interest, in reading the below open letter to the FDA and the members of the TPSAC Committee, as everything in it is absolutely 100% true.

Thank you very much in advance and I wish you a pleasant week-end.
Atakan Befrits

Vidarebefordrat brev:

Från: Atakan Befrits <atakan.befrits@gmail.com>
Ämne: MRTP vote on Swedish Match products – Open Letter
Datum: 11 april 2015 09:48:23 CEST
Till: wkbickel@vt.edu, teissenb@vcu.edu, pfagan@cc.hawaii.edu, ggiovino@buffalo.edu, richard.oconnor@roswellpark.org, kurt.ribisl@unc.edu
Kopia: Caryn.Cohen@fda.hhs.gov

MRTP vote on Swedish Match products – Open Letter
Dear Members of the Committee,

First of all I would like to thank you all for the time and thought and deliberation that I am certain you have all put in to discussions, formulating your views and in most cases votes on the MRTP application in question.

Secondly I would like to please kindly ask you to disseminate this information to those members who were not represented with e-mail addresses in the information, thank you in advance.

My name is Atakan Befrits and I am a part the Tobacco Harm Reduction industry, but am writing this on my own accord and all the views expressed are my own. Official documents herein are obtained directly from the Swedish Government and can of course very easily be verified.

Although I am heavily biased based on my work, and my interpretation of the currently available science is of course to a certain extent a product of my bias, I still hope you will take this message under consideration. My current and future interests are, very importantly, based outside Sweden and outside North America, my ambitions on the longer horizon are focussed on the LMIC world.

Actual cigarette sales in my view is a good marker for smoking, something I would expect you all to agree with.

If the developed countries are to achieve double the rate of smoking (10%) that is considered “smoke-free” (5%) by 2050 cigarette sales will have do be roughly 1.1 trillion cigarettes less per year than 2012. At the current trendline based on 1980 and 2012, only 200 billion of 1.1 trillion in lower sales will be achieved, in effect less than 20% of “target + 100%”. I am of course hoping that “A war on Tobacco” will be more successful than earlier “Wars” on dangerous and unwanted behaviors proved to be.

In developing countries the smoking trend is unfortunately still pointing distinctly upward. The trendline, also based in 1980 and 2012, indicates 5.5-6.0 trillion cigarettes sold there in 2025 (4.4 in 2012). This trend is not taking population growth in to account. Population growth is expected to be a further billion by 2025 (8.2) and reach 9.6 billion by 2050. Therefore the existing trend and the population growth and increased disposable income have to be accounted for in projections.

If the FCA (Framework Convention Alliance / WHO) is correct in their calculations and in fact “Peak Cigarettes” was in or around 2013, then world sales of cigarettes should never exceed the roughly 6.2 trillion cigarettes sold around 2013.

Sum conclusion is that if the west were to manage to achieve her targets, in the Developing Countries smoking can continue to grow to another 1.6 trillion cigarettes sold per year by 2050 and “Tobacco Control” can in theory continue arguing that the cigarette epidemic has been halted.

If world “Tobacco Control” efforts are even more successful than they have ever been historically, then sales of cigarettes would still need to go down by a total of 3 trillion less cigarettes sold per year, to be half of today. This would mean some 500-600 million current smokers quitting or dying in 35 years and also ZERO uptake, a daunting proposition.

I am sure none of the above is any news to you Learned ladies and Gentlemen. Therefore quickly on to the subject matter, the vote on the Swedish Match North America MRTP application.

I have read the summary prepared by the FDA on the application. To the best of my understanding it is fairly clear that the FDA concludes that the evidence presented is in no way sufficient to state that the products in question are harmless and alludes to the voting outcome that this should lead to.

This would in effect mean that only harmless tobacco products will ever be considered Modified Risk. Or possibly products monitored over sufficiently long time to give an exact and unquestionable percentage of harm compared to cigarettes, in effect sometime between 2030-2050 at the earliest.

My impression is that “Significantly reduced harm” on the individual level is demonstrated. As well as a net, positive or at least not negative, “Population Level effect” is proven highly likely, and these are the main criteria for approval as an MRTP. (In “population level” I include all the other FDA criteria that also need to be met)

Harmlessness I cannot find anywhere in text, and is quite frankly a silly concept.

According to my opinion waiting another 20 years will prove far too little and far too late. Especially so since cigarettes are legally sold in every country in the world but US policy and Swedish Policy and EU policy on THR (Tobacco Harm Reduction) are “Public Health” export products of the first order, and successfully passed on to the LMIC world.

So even if your mandate only considers a US context (this ought to be the case) I urge you to consider that by 2050 the current Developed Countries will represent 13% of the world’s population.

Please browse the below letter to Minister of Health and Welfare in Sweden from 2013 from Tobacco experts and Tobacco Harm Reduction experts.

http://www.clivebates.com/documents/swedenletter.pdf

Please see below an official copy of (Swedish) the order from the Council of Ministers of the Kingdom of Sweden to a named group of public health institutions 4 months later:

(contact me if you want a copy of it, it is only in swedish but summarizes as follows below)
The order translates to roughly:

Calculate total morbidity, total mortality and total cost from total tobacco in Sweden. This is very important because in Sweden 50% of total tobacco are, are equal to, or comparable to, the products that TPSAC voted on yesterday.

The concurrent report supplied as a result of this order is named:
Registry data on ill-health from ***smoking tobacco***

http://www.socialstyrelsen.se/publikationer2014/2014-3-4

As you can plainly see from also the title there simply aren’t any registry data on ill-health from the use of smokeless tobacco as it is made in Sweden. Nothing for over 90 years.

The report can not present one single data point on “snus” use ill-health even though ordered specifically to do so by the Government and given money to do it. The report touches very briefly on “snus” and concludes that, while clearly less dangerous than smoking, is probably quite dangerous. It also concludes that long term research needs to be initiated and more funding is needed to do so.

This conclusion is presented 15 years after “snus” again captured more than 50% of total tobacco use in Sweden and is also based on precisely ZERO data available from the health data registry databases (outcome). Should not then this research, if really necessary, have been immediately initiated 15-30 years ago, upon a hitherto unresearched product reaching a whopping 50% market share in a market as dangerous as tobacco?

Is a mistake of this magnitude even theoretically possible in a country like Sweden?

The Swedish Medical Journal started publication in 1904 and was digitalized in 1995. A manual archive search in their records returned ZERO results on the index word “snus” between 1904-1995.

In 1904 smokeless tobacco was by far the most prominent tobacco product used in Sweden and was surpassed by smoking only in the 60’s and is again the largest tobacco category today with 50% of total tobacco use in Sweden being “snus” (smokeless tobacco).

Sweden has one of the top 10 health registry databases functions in the world and set the standards for this more than 50 years ago, yet there is absolutely ZERO data on ill-health from use of “snus” but a crystal clear calculation of 11,881 dead from smoking every year 2010-2012.

Please bear in mind that we knew almost enough already on smoking when the report was commissioned by the Government, and the order from the Government was for total tobacco but the report conspicuously left out 50% of total tobacco consumed in Sweden.

I ask you, learned Ladies and Gentlemen: Is this Plausible? Is this even possible? Provided your vote yesterday was balanced and correct an represented actual ill-health?

In 2014 a total or 89,000 people died in The Kingdom of Sweden. 12,000 of these deaths were statistically caused by cigarette smoking (roughly one million smokers). There is ZERO data on deaths (or disease) from calculated, demonstrated, suspected or other causes directly connected to the use of “snus” (Swedish Smokeless Tobacco also roughly one million users).

If total in vivo harm (outcome) from snus use in sweden is even 10% of the harm from smoking then logically would follow:

1. 1,200 swedes should/would have succumbed to some form of illness as a direct result of using snus.
2. 90% of these would have been men (100% 1904-1960)
3. Snus again became extremely prominent in 1980’s and as such has been in very very widespread use again for 35 years
4. This has been happening every year, year after year, without anyone noticing it, or being able to or bothering to, measure it

I ask you, learned Ladies and Gentlemen: Is this plausible? Is this possible, even in a catastrophic administrative worst case scenario?

Is it not in fact more likely that ill-health from “snus” use has not been measured because there is not very much ill-health to measure?

Does that not sound like a “MRTP” as compared to cigarettes?

Thank you very much for taking the time to read this

With my regards

Atakan Befrits
Biased but also reasonable THR activist and entrepreneur

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