Monthly Archives: March 2016

Flash – Swedish Agencies lobbied the FDA in 2015

Ok everyone

As per Carl’s honoring request I am posting a small factoid of 2 instances in 2015 when Sweden sought to actively influence the FDA to deny it’s citizens access to relevant information on THR. This is of course only a small part of what is going on in Sweden, and from Sweden abroad. There is currently a frantic PR effort by the ANTZ complex in Sweden to get a law passed before May 2016. In pretty clear terms it is proposed that snus and e-cig be deemed invalid for use as THR products, even given a situation where they would conclusively prove completely harmless. This is already fact in Sweden and has been for a long time, now the ANTZ want it in law, probably so they can sleep easier at night and no longer have to invent more and more fanciful misinformation to keep science at bay.

The Swedish authorities during 2015 saw fit to contact the FDA TPSAC and filing a comment also in the Docket for Swedish Match MRTP application to put kind of relevant warning labels on Swedish snus and replace the obviously false ones about snus being no safer than smoking and that snus causes cancer. The National Board of Health and Welfare wrote to TPSAC (Tobacco Products Scientific Advisory Committee) sort of in secret. The main points of this letter (co-sponsored by 3 further Public Health Agency Director Generals from Scandinavian countries where snus is actually banned) are as follows:

 

Snus does not qualify as a harm reduction product because:

– There are evidence-based methods for smoking cessation
– The most effective methods are a combination of support and medication
– There is no scientific evidence for the effect of snus as a smoking cessation aid
– Scandinavian moist snuff has no place in cessation support (circular reasoning)

Letters, sent uninvited and without mandate, can be found here:

SWEDEN PHA 2015 FDA – From the Public Health Agency in the Kingdom of Sweden

SWEDEN NBPHW 2015 FDA – From the National Board of Health and Welfare in the Kingdom of Sweden

Fairly clear from this (has been policy since at least 2002) that anyone looking for funding to study snus as THR is not going to get any.

Surprise surprise: No Swedish science on snus as THR has been performed since 2002.

Surprise surprise 2: The agencies are quoting no new evidence as reason for continuing the relentless fight against snus, and especially against snus as a THR product.

Probably one of the most elegant set-ups I have come across in my career! This wonderful and elegant solution prompts the Swedish Director General in charge to conclusively make the following statement as sign off to his FDA letter:

”Snus does not save lives, quitting smoking does. Snus only saves the tobacco industry” is according to them as valid in 2015 as it was in 2009 as no science has emerged to prove otherwise”

So far so good, let us now move on to the Public Health Agency. In their submission directly in to the docket they state quite a list of interesting facts that most of us will recognize from the special interest rhetoric:

Snus does not qualify as a harm reduction product because:

1) There is dual use (Now whose fault is that one may wonder?)

2) and there still remains the very outside chance that sometime in the future there may be a “Helena moment” where a group of youth initiate by illegally access snus, and then go on to illegally obtain and start smoking cigarettes.

 

 –  All the actual science done on this clearly indicates a reasonable maximum of between 1%-2% dual users. Furthermore the science indicates that under the most extreme circumstances, in the most extreme worst case scenario, a local instance of a negative net gateway effect could in theory happen. The numbers from Sweden are off by 1500%-3300% and one would be excused for suspicions that the obvious Swedish lie is designed to correlate perfectly with the earlier and later FDA docket entries by UCSF and Stanton Glantz.

(Also, If this were true then 2,500 or so male smoking related fatalities are simply missing from the national statistics in Sweden, I wonder where they went? the Swedish death toll from smoking would then be 14,500 instead of the stated 12,000)

3) SCENHIR implies that smoking declines could in theory have completely different relationships, like better politics and regulations. Since there could be other magic wands to explain the low smoking Sweden clearly believes them to be valid and snus not valid, as explanation.

4) Other countries have reduced smoking without snus

5) High snus use will lead to smoking, sometime in the future, they’re sure

6) Snus use is associated with several risks. Nicotine at high levels during extended periods, which is terrible because nicotine addiction is medicalized in DSM. Again, according to Norway (Since sweden does not know anything or have any data after 150 years) snus is also associated with certain types of cancer, type 2 diabetes and death resulting from MI or stroke. There are also from Norway stated connections to adverse pregnancy, weight gain and high cholesterol.

7) Here is the piece de la resistance from the Public Health Agency (remember, they should care about our health)

“It is possible that all effects of snus are not yet fully understood. This might be especially true about the effects on the female population, since most studies have been conducted on middle-age men and often with a limited number of subjects studied”

If you want to look at some more of the public filings, or read the Public Health Agency filing in its entirety, (there are actually 4 comments in the public docket by our esteemed friend Professor Glantz:)

http://www.regulations.gov/#!docketBrowser;rpp=25;po=25;dct=PS;D=FDA-2014-N-1051

THR SWEDEN vs. WORLD 31.12.2015

CigdeathSnusdeath

Flash- Translated fundamentals of 2016 tobacco policy in Sweden

Good day Dear Reader,

I have for your information purposes translated the part of the final proposal, published yesterday, that will fundamentally define the next 5 years of Tobacco Policy and Tobacco Control work in the Kingdom of Sweden.

Any mention of Tobacco Harm Reduction, in any format, by any party, will be strictly prohibited and resources will be allocated to demonizing and denormalizing THR as concept.

Dear reader, after reading the below translation, where in the order of importance would you say that Sweden proposes to place Public Health OUTCOME?

 

4.2 Tobacco Political objectives

As elaborated below, we will assess whether the tobacco prevention measures mentioned in our directives should be introduced. It is not within our mandate to determine independently the Swedish tobacco political policy. In determining whether a particular action is appropriate, the starting point must be the tobacco policy objectives that Parliament has adopted.

In the government bill for public health goals (Prop. 2002/03: 35) the Government stated and subsequently the Parliament accepted an overall goal for society’s efforts in the area of ​​tobacco that tobacco use shall decrease. As milestones, these were adopted

– A tobacco-free start in life from the year 2014

– A halving by 2014 of the number of young people under 18 who start smoking or use snus

– A halving by 2014 of the percentage of smokers, in those groups who smoke most and

– That no one should involuntarily be exposed to smoke in their surroundings.

In our supplementary directive it is stated that the four targets for tobacco control adopted in the bill have not been reached, despite the fact that tobacco use is reduced and that the development has gone in the right direction. According to these directives broader prevention work is required to achieve the Government aims to reduce tobacco use and prevent minors from starting to use tobacco.

The Swedish tobacco market is different from other tobacco markets in the EU in general, in that Sweden in accordance with Article 151 of the accession treaty, allows the sale of snus. As we describe in more detail in Chapter 11 the snus market is a large part of the Swedish tobacco market and the snus sold in Sweden is essentially also manufactured here.

A decline in tobacco use requires not only a reduction in the number of smokers, but also a decline in the number of snus users. It has been argued in various contexts and that the harmful effects of snus is less than cigarettes, and that snus is a smoking cessation aid, and thus should be treated differently from other tobacco products. Although adverse effects from snus may be lower than those from smoking – (inter alia) The Public Health Agency states in its report Tobacco and cessation, in 2009 – that such a comparison is not relevant from a public health perspective, since few things are as dangerous to health as smoke. Instead, the relevant comparison should be made with people not using tobacco at all.

One question that has been raised, not least in the public debate, is whether it would be desirable to get a greater number of people who smoke, to instead start using snus. The underlying reasoning would in that case be based on a notion that snus discourage people from smoking or that snus is used as a smoking cessation aid. This has been questioned. According to the report from the Public Health Agency, as mentioned above, there is no scientific evidence that snus serves as a smoking cessation aid and according to the same report, it is not uncommon for snus users also smoke, while many users of snus have never smoked.

Regardless of the assessment of snus as a smoking cessation aid or assessment on if snus is less hazardous than cigarettes, we conclude that the tobacco policy starting point is that no difference should be made between different forms of tobacco. This has also been the starting point for our considerations and proposals.

Differentiating between snus and other tobacco also seems problematic based on legal and trade aspects. The snus sold in Sweden is a tobacco product and is also produced here, but – in accordance with the above reasoning – is interchangeable with other tobacco products, including cigarettes, that are imported to Sweden. In those parts where the tobacco policy proposals involves various types of restrictions and obstacles in the trade of tobacco, they would run the risk of distorting competition if such measures only affected some parts of the tobacco market. This does in and of itself not negate that a measure can be designed or adapted for the various products in different ways, see for instance the proposal in the interim report for the design of health warnings and warnings, based on the tobacco products directive division between products.

4.3 Consideration of proportionality, consistency with other legislation, etc.

In addition to the overall tobacco policy starting points, we will also assess whether a tobacco prevention measure is consistent with other legislation, both national and EU law. A description of the different requirements of these respects, are found in chapter 3 and the detailed considerations in these parts are specified in connection with the different proposals. However there are some overall questions that we have to relate to. These starting points are reported as per the following.

One specific issue is the extent to which a particular legislative measure is effective to achieve the goal of reducing tobacco use. For a measure that is a restriction on imports or that it is on a par with an import restriction to be allowed under EU law, requires that the measure is justified on grounds of protection of human life and health, and that it is appropriate and necessary, i.e. proportional (see details on the terms of section 3.3.2). We can conclude that the question on whether a particular measure gives effect or not has been subject to extensive investigations, not least in connection with various legal proceedings that have been or still are in progress, both in terms of exposure bans and neutral packaging. The fundamental difficulties in assessing whether a measure is effective or not can reasonably be expected to take some time before such an effect is measurable, and that a certain measure is rarely introduces isolated, rather they are often part of a more overarching tobacco policy approach and one of several measures introduced simultaneously.

Since the implementation of warnings directive in 2002, and smoking bans in their current form in 2005, no major tobacco control reforms have been launched in Sweden. In the year 2010 some legislative changes were introduced, including strengthening the current obligation to report tobacco sales. As we report in section 5.5, we believe that it is too early to draw any conclusions about the effects of these legislative changes. The Tobacco Products Directive pushes forward the positions in several respects compared to what applies in Sweden today, including the requirement of combined health warnings and requirements for provisions on herbal products for smoking. As reported, inter alia in our supplementary directive, a number of other countries have already introduced legislation that meet the requirements in the Directive and have gone further, for example by introducing a licensing regimen or exposure ban. Many of these measures, however, have been implemented relatively recently. Several countries have also launched various proposals, including for instance neutral tobacco packaging.

It is in our opinion not required to be possible to derive a single connection between each tobacco prevention measure and a decline in tobacco use. As for the issue of if a tobacco prevention measure is necessary and appropriate to protect public health, a much weaker connection, should suffice that there is reason to believe that the measure – alone or in combination with others – is effective. In this context, one should also take account of how the measure has been assessed, in terms of tobacco policy, in other countries. In other words, it should be taken as certain that a measure is effective, if it has been implemented elsewhere. We can conclude that there are foreign models of virtually all the tobacco control measures that we consider, with the exception of the special considerations that apply snus. 

Overall, it is our starting point that the tobacco prevention measures that we consider and propose, all – together or separately – drive the tobacco policy goal of reduced tobacco use.

Although each tobacco preventive measure, seen isolated in itself, can be considered effective to achieve the policy objectives of tobacco, there is a special case of whether it is proportionate to introduce a number of measures simultaneously. One view would be that it should proceed in stages and first introduce one or more actions, and then move on to other more radical measures. Against this argument is the argument that various measures are focused on different things. For example, an expanded smoking ban seeks both to reduce exposure to tobacco smoke and to reduce the social acceptance of asmoking like behaviour; a sales license requirement is intended to ensure age verification, but also – and perhaps mainly – to target illegal trade in tobacco products; some other proposals aimed at limiting the general possibilities of promotion and exposure of tobacco products, while yet others are more directly aligned to prevent young people from initiating tobacco use.

As we report in detail in Chapters 9 and 10, there is in itself a strong correlation between the product exposure bans and neutral tobacco packaging in that the measures in varying degrees raise questions regarding the trademarks and property protection. Given our assessment that it would be contrary to the regulation of the Freedom of the Press Regulation, as currently understood, to implement the neutral tobacco packaging in Sweden (see Section 10.7.2), these both measures are therefore not likely to be implemented simultaneously.

The fact that the various proposals primarily aimed at different parts of the tobacco prevention work also means that one can expect that the overall effect of implementing all the suggestions that we propose simultaneously, will be greater than if each proposal is implemented separately.

It is our concluding starting point that the circumstance that we are now proposing a number of tobacco control measures to be implemented simultaneously, does not lead to the effect that it would be against the principles of proportionality.