Monthly Archives: February 2016

Kofi Annan Der spiegel transposition

DRUGS

Scientific evidence and our concern for health and human rights must shape drug policy. This means making sure that fewer people die from drug overdoses and that small-time offenders do not end up in jail where their drug problems get worse. It is time for a smarter, health-based approach to drug policy.

It is time for countries, such as Germany, which have adopted better policies at home, to strongly advocate for policy change abroad. The United Nations General Assembly special session on the world drug problem would be a good place to start.

SAME TEXT APPLIED TO THR

Scientific evidence and our concern for health and human rights must shape tobacco policy. This means making sure that fewer people die from smoking and that smokers get access to and information on less harmful alternatives to cigarettes. It is time for a smarter, health-based approach to tobacco policy. 

It is time for countries, such as Sweden, UK, USA and France, which all have consumer driven but unrecognized, better practices already in place at home, to strongly advocate for policy change at home and abroad. The United Nations General Assembly special session on the world drug problem would be a good place to start.

Original link to article found here:

Lift the Ban! Kofi Annan on Why It’s Time To Legalize Drugs

http://www.spiegel.de/international/world/kofi-annan-on-why-drug-bans-are-ineffective-a-1078402.html

 

 

Vastly health-promoting changes to Swedish TPD implementation bill

CigdeathSnusdeath

Stockholm den 8 februari 2016

Motionsförslag till Tobakspropositionen

Sista motionsdag 2016-02-17

Bakgrund

Regeringen föreslår i sin proposition för bättre folkhälsa på tobaksområdet en rad mycket viktiga och allmänt erkända och accepterade förslag. Ingen kunnig på området emotsätter sig dessa förslag kring rökningen och Regeringen skall ha heder för sitt arbete i frågan.

I SVT på morgonen den 8e februari 2016 framträdde Folkhälsominister Gabriel Wikström och försvarade den föreslagna lagstiftningen, Ministern ställde sig även bakom målsättningen och initiativet Tobacco End-Game 2025, även det är i princip lovvärt.

Särskilt lovvärt är detta i ljuset av att Minister Wikström inte använde termen tobak i sitt framträdande, utan koncentrerade sig på det största folkhälsohotet av dem alla, rökningen. Man får anta och hoppas att detta var en medveten kommunikationsstrategi från Regeringen.

I ljuset av detta önska jag, med stöd av forskare, professorer och professionella inom rökavvänjning globalt, föreslå två viktiga ändringsmotioner inför det vidare arbetet med propositionen. Förslagen kommer tveklöst att kraftigt förbättra förutsättningarna för att uppnå ett rökfritt Sverige 2025, inte försämra dem.

Förslagen kommer dessutom att rädda många tusen svenska rökares liv under perioden fram till 2025, just den gruppen rökare som provat andra metoder att sluta röka men misslyckats. Även om Regeringen lyckas fullt ut med att nå sina målsättningar för ett rökfritt Sverige 2025, så kommer fortfarande 500,000 svenskar röka dagligen. 250,000 av dessa dör i förtid, borde inte även de ha rätt till god information om hur de kan minska sina risker att dö i förtid med nästan 100%?

  1. Motion 1: Snus skall regleras helt och fullt som en svensk angelägenhet, alltså skall varningen INTE harmoniseras med tiofalt farligare produkter

I och med skyddet för snus i accessionsfördraget till EU, skall svensk särlagstiftning gälla även varningstext och annat som rör snus. Samtliga beslut om snus skall i alla avseenden tas helt och hållet som en svensk angelägenhet, med bas i global kunskap på området, och för att bäst passa svenska förhållanden. Det nuvarande förslaget att höja varningen på snus bör alltså lyftas ut i sin helhet och hanteras tillsammans med övriga snusfrågor som skall behandlas efter slutbetänkandet senast 1 mars har noga analyserats och värderats. Detta torde inte realistiskt kunna utföras tillfredsställande för lagstiftning, innan den 20 maj 2016.

Förslaget till höjd varning på snus, på sidan 39 i propositionen, bör alltså strykas i sin helhet.

Andra tiofalt farligare rökfria produkter får fritt saluföras i Unionen, endast det svenska snuset omfattas av totalförbud, utanför Sverige. Att Sverige dessutom skulle anses nödgat att acceptera en varning som är anpassad för tiofalt farligare produkter, på marknader där snus heller inte får säljas över huvud taget, måste rimligen vara ett missförstånd som bör rättas till.

I Tobakskonventionens definition av tobakskontroll ingår explicit ”skademinskning” som en helt separat strategi med samma värde som strategier för att minska efterfrågan och utbud av tobak. Snus fyller tveklöst samtliga objektiva rekvisit i definitionen som en skademinskningsprodukt. Om detta råder ingen tvekan och det är en tidsfråga innan det blir rättsligt prövat huruvida snusförbud i andra länder utgör brott mot tobakskonventionen och brott mot FN:s artikel 12 om hälsa.

  1. Motion 2: Sverige skall inte lämna öppet för Högsta Förvaltningsdomstolen att godkänna Läkemedelsverket som kontrollinstans för e-cigaretter, e-cigaretter skall ha demokratiskt beslutad reglering baserad på bästa vetenskapliga evidens

Sverige är ett litet land och en begränsad marknad. Den svenska marknaden är dessutom extrem i det att tobaksmarknaden redan idag består till 49% av snus, som är 98% mindre farligt jämfört med rökning. På den svenska marknaden är alltså nästan hälften av incitamenten att läkemedelsregistrera e-cigarett produkter redan borta, från en från början marginell totalmarknad. Därmed är det troligt att en läkemedelsklassificering av e-cigarettprodukter, om än i teorin lovvärd, istället kommer ha effekten att inga sådana produkter kommer finnas till försäljning alls. En läkemedelsklassning av e-cigaretter i Sverige kommer ha effekten av ett de facto totalförbud, trots att det på papperet kan tyckas vara en mer tillåtande lagstiftning än den som EU föreskriver. E-cigarettprodukter används i lika hög utsträckning av män som kvinnor. Samtidigt är 85% av de 300,000 Svenskar som idag är rökfria tack vare snus män, alltså torde en läkemedelsklassning (de facto förbud) ha en mycket skev och negativ effekt särskilt för kvinnors rökslut, den grupp som alltså röker mest.

England, Frankrike, Belgien, Tyskland etc. håller som bäst på att helt omvärdera sin inställning till e-cigaretter och sättet som dessa behandlas i Tobaksproduktdirektivets artikel 20, i termer av landspecifik lagstiftning. Sverige bör således absolut inte ha bråttom, eller låsa sig helt, till varken artikel 20 i direktivet eller genom att överlåta ansvaret för reglering av e-cigaretter åt Läkemedelsverket. Om Sverige är nödgat att införliva artikel 20 i svensk lagstiftning så bör en separat process inledas för att göra detta på ett sätt som är optimalt för folkhälsan i Sverige, alltså som är en avvägning av bästa möjliga alternativ för rökare, icke rökare och unga.

Folkhälsan i Sverige är viktigare än EU:s tidsramar.

Tills vidare och tills utredningen är färdig bör Sverige därför omedelbart införa strikt (likt alkohol men 18 årsgräns) 18 årsgräns på inköp av e-cigaretter och nikotinvätskor. Nikotinvätskor skall endast få försäljas i barnsäkra påfyllnadsflaskor med varningstext. Reklam och förpackningar skall vara måttfulla och tydligt ange åldersgräns. Reklam och förpackningar skall tydligt ange att personer som inte använder tobak aldrig bör prova eller använda produkterna. Reklam och förpackningar skall tydligt ange att endast rökare och tobaksanvändare bör någonsin använda produkterna och att eventuell hälsoeffekt endast kan uppnås om rökning upphör totalt.

För mer information eller hjälp med att kontakta opartisk internationell expertis, vänligen tveka inte att kontakta:

Erik Atakan Befrits
0046 764 156046
Folkungagatan 142
116 30 Stockholm
atakan.befrits@gmail.com
befrits.wordpress.com

Conflicts of interest: Inga Jag erhåller ingen som helst ersättning från tobaksbolag eller dem närstående.   Till skillnad från i princip alla som arbetar med tobakskontroll erhåller jag heller inga statliga, regionala eller kommunala bidrag för arbete och forskning. Jag uppbär heller ingen lön för mitt arbete mot rökning från Stat, Landsting, Kommun eller privat företag. Till skillnad från tobakskontroll erhåller jag slutligen inget forskningsstöd från läkemedelsindustrin.

 

ENGLISH TRANSLATION

Background

The Government proposes in a bill of legislation in the tobacco field, a number of very important and widely recognized and accepted proposals on smoking. No knowledgeable person in this field would oppose effectuating these proposals on smoking, and the Government Minister deserves praise for his work on this issue.

However, on SVT (Public Service TV) on the morning of February 8th, 2016, Our Health Minister, Gabriel Wikström, appeared in support of the bill in it’s entirety. The Minister also took a public stance behind the Tobacco End-Game in 2025 initiative. Also this goal is in principle of course commendable, especially were it focused on smoking. The Minister did use a commendable terminology in the interview though, he refrained from using the word tobacco and instead focused on the biggest avoidable health threat of all, smoking.

One must assume and hope that this was a conscious wording and communication from the Government.

In light of this, I wish to, with the support of researchers, professors and professionals in smoking cessation globally, to suggest two important changes to the further work on the bill.

These proposals will undoubtedly vastly improve the conditions for a successfully smoke-free Sweden already in 2025, not impair them.

The proposals will also save many thousands of Swedish smokers’ lives during the period up to 2025, the very same group of smokers who have already tried other methods to stop smoking but failed. Even if the Government fully succeeds in reaching the goals for a smoke-free Sweden in 2025, 500,000 Swedes will still be smoking daily. 250,000 of them will die prematurely.

Don’t they deserve the right to good information on, and access to, methods and product that can reduce their risk of dying prematurely by almost 100%?

Motion 1: Snus shall be governed entirely as a Swedish national concern, therefore, the warning on snus should not be harmonized with tenfold more dangerous smokeless products allowed in the EU

Through the derogation for snus in the accession treaty to the EU, the Swedish special legislation apply also to warnings and all other issues related to snus. All decisions regarding snus shall in all respects be an entirely Swedish affair, based in globally recognized best available science in the field, and tailored to best suit Swedish conditions.

The current proposal to raise the warning on snus should therefore be removed in its entirety and decided on together with other snus issues that are to be addressed in a final report by March 1. This report and conclusive findings in it have to be carefully analyzed and evaluated in preparation for national legislations specific to snus. This can not realistically be carried out satisfactorily for any legislation, before the 20th May, 2016 dead-line.

The proposed elevated warning on snus, on page 39 of the proposed bill, should therefore be stricken in its entirety.

Other tenfold more dangerous smokeless products may be put on the market in the Union, only the Swedish snus is subject to a total ban, outside Sweden. That Sweden would also be compelled to accept a warning that is (may be) suitable to tenfold more dangerous products sold in markets where snus is illegal, must be a misunderstanding of Swedish obligations that should be immediately corrected in the proposed bill.

In the Tobacco Convention the definition of tobacco control includes explicit “harm reduction” as a completely separate and valid strategy with the same value as strategies to reduce the demand for and supply of tobacco. Snus undoubtedly fill all the objective conditions in the definition, as a harm reduction product, in this there is no doubt.

Therefore it is only a matter of time before the snus issue internationally becomes subject to legal proceedings to decide whether snus bans and snus misinformation constitute violations of the Tobacco Convention (FCTC) and also constitute violations of United Nations Article 12 on health protection.

Motion 2: Sweden should not leave open for the Supreme Administrative Court to approve the MPA as a control body for e-cigarettes, e-cigarettes should have democratically decided regulations based on best scientific evidence

Sweden is a small country and is a very limited market. The Swedish market is furthermore extreme in that the tobacco market already consists of 49% snus, which is 98% less dangerous than smoking. In the Swedish market almost half of the incentive to register e-cig as pharmaceutical products is already gone, from an already marginal overall market.

Thus it is likely that a drug classification of e-cigarette products, although in theory commendable, instead will have the perverse effect that no such products will be on sale at all. A drug classification of e-cigarettes in Sweden will have the effect of a de facto complete ban, despite the fact that on paper may seem a more permissive laws than the EU TPD actually requires.

E-cigarette products differ from snus in that they are used to the same extent by men and women. Snus meanwhile, is male by 85%, of the 300,000 Swedes currently non-smoking by using this product. A drug classification (de facto ban) will have a very skewed and negative impact especially on women’s smoking cessation, the group in Sweden who smoke the most.

England, France, Belgium, Germany, etc. are under huge pressure to rethink their approaches to e-cigarettes and the way they are treated in the Tobacco Product Directive’s Article 20, in terms of country-specific legislation. Sweden should therefore also not be in a hurry, or commit itself completely, to either Article 20 of the Directive, or by entrusting the regulation of e-cigarettes to the MPA (Medical Products Agency). If Sweden is compelled to incorporate Article 20 into Swedish legislation, a separate process should be started to do this in a way that is optimal for public health in Sweden, and that strikes the best balance of options and regulations for smokers, non smokers and young people.

Public health in Sweden is more important than hurrying to meet EU deadlines.

Until further notice and until such an investigation is complete, Sweden should protect the population immediately, by imposing strict 18 year age limit on the purchase of e-cigarettes and nicotine fluids. Nicotine liquids should also only be sold in child-safe refill bottles that carry warnings. Advertising and packaging should be moderate and clearly state the age limit. Advertising and packaging should clearly indicate that people who do not use tobacco should never try or use, these products. Advertising and packaging must clearly indicate that only smokers and tobacco users should ever use the products, and that optimal beneficial health effects can only be realized if the individual’s smoking cessation is 100%.

For more information or assistance in contacting impartial international expertise, please do not hesitate to contact:

Erik Atakan Befrits

0046 764 156046

Folkungagatan 142

116 30 Stockholm

atakan.befrits@gmail.com

befrits.wordpress.com

Conflicts of interest: None

I do not receive any compensation from tobacco companies, e-cigarette companies or related entities

Unlike virtually all working in tobacco control I do not receive any state, regional or municipal grants for work or research. I also receive no salary for my work against smoking from the state, county councils, municipalities or private companies. Unlike tobacco control I do not cooperate with, nor receive research support from, the pharmaceutical industry.

THR SWEDEN vs. WORLD 31.12.2015

NorwaySnus2000-2014 with vaping

How does Swedish Anti THR compare to USA?

For the reader with any interests in snus and snus science, please note that the TPSAC references below are not unimportant. The same TPSAC (Tobacco Products Scientific Advisory Committee) at FDA recommended FDA against granting Swedish Match a Modified Risk Tobacco Product status for some products.

Article in it’s entirety with total credit and gratitude to Professor Brad Rodu. It is from early 2015 but has re-emerged as hugely important in lieu of the Swedish Government proposing to raise the warning levels on snus.

NIH Funding Stifles Tobacco Harm Reduction Research and Support in Academia

As a pathologist working at two large medical centers, I have studied the effects of smoking on health for over 20 years.  I’ve published scores of papers on the impressive benefits of switching from cigarettes to safer, non-combustible forms of tobacco (such as Swedish snus).  This strategy – called tobacco harm reduction – has vast potential for improving public health.

In countless discussions about smoking’s devastation, people ask me: “If tobacco harm reduction is a viable quit-smoking option with huge public health benefits, why don’t U.S. medical schools advocate this concept?  Why are you almost alone among American university professors in  openly endorsing tobacco harm reduction?”

The answer resides within a powerful government agency, the National Institutes of Health.

The NIH is the pre-eminent source of research funding for virtually all universities and medical centers; it is the cudgel in the government’s campaign to create “a world free of tobacco use.” (here).  The NIH “invests nearly $30.1 billion annually in medical research for the American people,” according to its website (here).  “More than 80% of the NIH’s funding is awarded through almost 50,000 competitive grants to more than 300,000 researchers at more than 2,500 universities, medical schools, and other research institutions in every state and around the world.”

The NIH hostility to tobacco harm reduction was demonstrated in 1994, when the National Cancer Institute attacked me and my university because I published an article in a scientific journal (here).  Nothing has changed in 20 years.  For example, a recent NIH announcement to fund research on smokeless tobacco, which is 98% safer than cigarettes, called for investigators “to develop an evidence base to inform smokeless tobacco control efforts, and to develop effective ways to limit the spread and promote cessation of smokeless tobacco use.”  This prohibitionist mindset produces NIH-funded researchers who are hostile to tobacco harm reduction; the rest are cowed into silence.

It is hard to overestimate the influence of NIH funding.  Universities aggressively pursue grants, and retaining NIH support is obligatory for faculty survival at most universities – influence and prestige are directly proportional to the size of one’s grants.  Due to its magnitude, NIH funding is hugely influential in determining “legitimate” areas of research conducted by hundreds of thousands of university faculty throughout the U.S.  The agency’s influence is compounded by the NIH peer review system, in which groups of 20 colleagues pass judgment on grant proposals, and from which emerges a nationwide network of researchers who are intolerant of politically incorrect topics like tobacco harm reduction.

NIH dollars are vitally important to faculty and to institutions.  Agency grants cover direct research costs, which typically pass through the university as faculty, staff and graduate student salaries, equipment and other project-specific charges.  More importantly, the NIH also covers indirect costs, which are not specific to the project but involve administration and facility support.  These are negotiated by each university, and they range from 25% to 100+% of direct costs.  If a principal investigator (or PI – the faculty member leading the project) gets a $1 million grant at a university with a 50% indirect cost rate, the university pockets $500,000.

How much money does the NIH spend on tobacco research?  I conducted a search of the NIH Research Portfolio Online Reporting Tools (here) for the word “tobacco”.  In 2014, the NIH (mainly the National Cancer, Heart Blood Lung, Drug Abuse and Mental Health Institutes) dispensed $623 million (total costs) in 1,300 grants to over 1,000 PIs at almost 300 universities, medical centers and other institutions.  That works out to about $600,000 for each investigator.  Few researchers will jeopardize grants of that size by doing or saying anything that conflicts with NIH dogma.

To explore the influence of NIH funding, start with members of the FDA Tobacco Products Scientific Advisory Committee.  TPSAC advises the FDA about regulatory actions, including “any application submitted by a manufacturer for a modified risk tobacco product,” which is a vital part of tobacco harm reduction.

A federal judge ruled last year that members of TPSAC, including current chairman Jonathan Samet, had significant conflicts of interest in the form of funding from (1) pharmaceutical manufacturers who compete with tobacco companies for the nicotine market, and (2) lucrative contracts to testify in lawsuits against the very industry they judge.  He called TPSAC’s findings and recommendations “at a minimum, suspect, and, at worst, untrustworthy.” (here)

TPSAC members also have a conflict of interest with respect to NIH funding: In 2014, six of the nine current TPSAC members had grants totaling $28 million (Table 1).  Such outsized funding must be assumed to color decision-making, particularly on regulations as NIH-toxic as tobacco harm reduction.

Table 1. NIH Support in Fiscal Year 2014 for Tobacco Projects to Members of the FDA Tobacco Scientific Advisory Committee
TPSAC Member University/Institution Total Support (million $)
Jonathan Samet Southern California 8.00
Warren Bickel Virginia Tech 0.39
Thomas Eissenberg Virginia Commonwealth 3.91
Suchitra Krishnan-Sarin Yale 5.79
Richard O’Connor Roswell Park 0.47
Kurt Ribisl North Carolina 9.21
Total 27.77

Followers of this blog know that major health organizations aggressively oppose tobacco harm reduction; they also receive considerable NIH funds to pursue tobacco-related projects.  In 2014, the American Academy of Pediatrics received $406,000 in support of Adolescent Smoking Cessation in Pediatric Primary Care.  The American Cancer Society was awarded $343,000 for Building Research and Capacity on the Economic Policy-Tobacco Control Nexus (the title was truncated in the database).  The American Heart Association scored $7.5 million for its Tobacco Regulation and Addiction Center and other projects.

Another big grantee last year was the American Legacy Foundation, recipient of $2.1 million for eight projects.  One of its employees, David Levy, obtained $703,000 via Georgetown University for Modeling the Policy Impact of Cigarette and Smokeless Tobacco Use on U.S. Mortality.  (I will be eager to see Dr. Levy’s mortality estimate from smokeless tobacco use, as my research indicates that it is close to zero.)

Individuals at the University of California San Francisco have engaged in an aggressive campaign against e-cigarettes (examples here and here).  Table 2 shows that they were awarded $12.5 million in 2014, with over half going to PI Stanton Glantz.

Table 2. NIH Support in Fiscal Year 2014 for Tobacco Projects to Faculty at the University of California San Francisco
Faculty Member Total Support (million $)
Stanton Glantz 6.61
Pamela Ling 1.49
Ruth Malone 1.34
Lyudmilla Popova 1.09
Judith Prochaska* 1.05
Neal Benowitz 0.95
Margaret Walsh 0.53
Total 13.03

*Also affiliated with Stanford University

I have discussed in this blog distorted research results concerning smokeless tobacco and harm reduction from several investigators, including Gregory Connolly (here and here), Christopher Haddock (here), Stephen Hecht (here and here, Irina Stepanov (here) and Robert Klesges (here and here).  Together, they received $8.5 million for tobacco projects in 2014 (Table 3).  Haddock and Klesges continued work on tobacco use in the military: Haddock studied Barriers to Effective Tobacco Control Policy Implementation in the U.S. Military, while Klesges was PI on a project with a particularly intimidating title: Preventing Relapse Following Involuntary Smoking Abstinence (my emphasis).

Table 3. NIH Support in Fiscal Year 2014 for Tobacco Projects to Individuals Aggressively Campaigning Against Smokeless Tobacco
Faculty Member University/Institution Total Support (million $)
Stephen Hecht Minnesota 4.49
Robert Klesges Tennessee 2.02
Irina Stepanov Minnesota 0.76
Gregory Connolly Harvard/Northeastern 0.70
Christopher Haddock National Development and Research 0.57
Total 8.54

The federal government, via the Department of Health and Human Services, is engaged in a coordinated, expensive campaign to create a tobacco-free society.  The NIH, which contributes annually $24 billion to the American research establishment and $623 million specifically for tobacco research, strongly influences some in the academic community to vigorously oppose – and many others to ignore – tobacco harm reduction.