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

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