Tuesday, 14 July 2015

Margaret Chan of the World Health Organisation started her career training to be a home economics teacher. Boy she must have been clever! I, on the other hand, began work at 15 years old in a Victorian mill making rope and twine. If how we are perceived, if our education, our position in society is a measure of how you think we should be recognised, do not bother reading any further than this paragraph. I am nothing special so do not expect anything special. What you can expect are the thoughts of a very ordinary person whose only motivation is to fight for the right to make a lifesaving choice for myself: To make a decision which is mine to make and not have it hijacked by a naive bunch of idealists who think they are supporting a worthy cause; health zealots; corrupt officials; greedy governments and multi-national power houses.

First, a word about the people charged with the regulation of electronic vaporisers. (E cigarettes)
Because regulations reduce profits to those possessing unfair advantage, corporations (whether individuals, companies, or other collective organizations) are motivated to influence regulators. Regulatory bodies created to protect the market are instead co-opted to advance the interests of the corporations they are charged to regulate. This wide-spread influence, known as “regulatory capture,” has been recognized for over 100 years, and according to expectations of rational behaviour, will exist wherever it is in the mutual self-interest of corporations and regulators.

In order to carry out their function, regulatory bodies need to communicate with the industries with whom they have been charged to control. This is their weakness, particularly in the areas of pharmaceuticals, tobacco and government.  These two areas (You think I cannot count?) have been communicating closely over the issue of vaporiser regulation with the result that pre-existing collusion and subsequent regulatory capture has been thrown into sharp contrast with what should be the true aim of regulation in this field.

In order to investigate the potential for regulatory capture and its possible effect on regulation for vaporisers I think it best that the relationships between the corporations be examined, along with the positions of government and government’s twin arms, regulatory authorities and public health bodies. Indeed, the relationships are so intertwined that, at times it is difficult to tell one from the other.

The tobacco industry makes people sick, and through the creation of a dangerous product, succeeds in killing many of its consumers. The pharmaceutical industry creates – it claims - products to wean tobacco customers away from tobacco smoking, and other medicines and treatments to prolong the lives and alleviate the conditions caused by smoking. The two industries would seem to be diametrically opposed to each other – but stop and think…. Without the tobacco industry very slowly killing people through long term illness, the pharmaceutical industry would take a massive hit. The money made from Nicotine Replacement Therapies (NRT) is small change – but important none-the-less.  How is that? NRT, although designed initially to help people quit smoking was never really successful, however, with the corruption of governments, regulators and public health bodies, NRT becomes an important tool, particularly when used to disguise the agenda of corrupted officials and the organisations they have influence over: More on that later.  In the meantime what we have are two parties ranged in opposition to the development of the vaporiser. The tobacco industry and the pharmaceutical industry: neither wishes to see vaporisers succeed.  It is even possible that the vaporiser can wipe out the tobacco cigarette market and we know from past experience just how far the tobacco industry is prepared to go to protect that market. Equally, the pharmaceutical industry has a huge share in the suffering of cigarette smokers, and this industry, like its cousin, has a history, which, I would think, is corrupt enough to make a Mafia boss blush.

Enter governments and the regulatory agencies; enter Public Health and last but not least, some departments of some universities – but not yet…

In 1856, Samuel Solly F.R.S.; issued the first, important, early warnings as to the dangers of smoking.  It is contained in his Clinical Lectures on Paralysis. (I have not yet been the subject of bribes from the pharmaceutical industry and I am not prepared to personally pay for the privilege of reading this, but, I do not have to - the reference I need is contained half way down the second column of the preview.) He states, I am not going to give a sermon against smoking, that is not my business; but it is my business to point out to you all the various and insidious causes of general paralysis, and smoking is one of them.” I know of no single vice which does so much harm as smoking. It is a snare and a delusion. It soothes the excited nervous system at the time, to render it more irritable and feebler ultimately. It is like opium in that respect, and if you want to know all the wretchedness which this drug can produce, you should read the "Confessions of an Opium-eater." I can always distinguish by his complexion a man who smokes much, and the appearance which the fauces present is an unerring guide to the habits of such a man. I believe that cases of general paralysis are more frequent in England than they used to be, and I suspect that smoking tobacco is one of the causes of that increase.” And so the foundation of ‘the war’ was laid… Nothing of much consequence happened until; in 1951, Doll and Hill interviewed 5,000 hospital patients s and found that of the 1,357 men with lung cancer, 99.5% were smokers: The shit hit the fan! (It is important to always use the correct terminology, and believe you me, the terminology is, ‘correct’)  And what with wars and things; fashion; the true birth of modern advertising, smoking took hold. And another massive industry was introduced to this market; the pharmaceutical industry - just at this point in time, and very quietly, almost innocently; it began its piggy back ride….

How do we identify regulatory capture? What features do we look for?

I think that the single most important trait to look for is the degree of formal and informal communication between an industry and the regulator. This would also include direct and indirect communication. Keep in mind that regulatory capture is based on a system of rewards where profit from capture outweighs the cost, and in the case of profits derived from treatment smoking related conditions that profit is massive.  Closely associated to this is the operation of a revolving door between industry and regulator – and in the case of health it can take place via public health organisations; professional health associations and societies,  and universities.  (Note how the number of organisations involved continues to grow)  Obviously, there needs to be direct, formal communication between the regulator and the industry.  I would argue that this is the point at which all further communication with the industry has to stop.  Organisations like the FDA in the US, and the MHRA in the UK, have no need whatsoever to engage in informal communication with industry whether directly or indirectly. They are dealing with facts and can gain any information they require through formal channels. Any other form of communication lacks transparency – yet another indicator of the regulator who has been captured.   “Agencies with poor transparency, revolving doors, few commissioners, and limited accountability invite regulatory capture, and those standing to benefit from capture have strong incentive to encourage such conditions.” The Game of Influence in Regulatory Capture: P12

In the case of the MHRA, collusion with the pharmaceutical industry appears to be built in – indeed, it is wholly funded by the industry. Looking back to 2004 we can see the relationship pretty well outlined in an article in the Guardian. Here.  The article points out how the regulator and the industry have been engaged in a joint lobbying campaign in Europe; how the industry privately drew up its own detailed blueprint of how the MHRA should be run; how the industry has been pushing for higher level representation at the MHRA against ministers' wishes:  And more, just a little snippet from the article… “The Committee on the Safety of Medicines (CSM), made up of independent experts, advises the MHRA on which drugs to license after studying clinical trial data on safety and efficacy. Its members are supposed to declare any sponsorship or payments they receive for lectures or advice from industry. The last complete declaration of interests of CSM members, for 2001, shows 17 out of 36 members had personal financial links to the industry, while others have declared non-personal interests such as research grants”

And today, has there been any change?  Has a Government Select Committee enquiry had much influence?  Change.org has recently initiated a petition to have the MHRA closed down. On the petition a collection of MHRA misdemeanours are listed – and referenced. Here.  The petition opens with the following statement, “The MHRA has been proven to be a tool of “Big Pharma”, a puppet of the world’s largest pharmaceutical industries.  Charged with the task of protecting the public from harmful health care is in fact protecting the largest pharmaceutical companies from loss of profits instead.  There are many differing alternative ways that people can find to choose from for maintaining or returning to good health.  The MHRA actively prevents us accessing these, our own choice of medications in favour of harmful often unproven drugs from the profiteering big pharmaceutical companies”. I would suggest you open the link, read, and perhaps, sign the petition.  More on the MHRA, here, and the select committee report, here.

So, when the MHRA comments or regulates on the issue of vaporisers, is it the MHRA we are listening to or the pharmaceutical industry?  Keep in mind that they are the industry with the reputation for honesty and integrity:  the industry who would never put profit in front of health; the industry who would never dream of trying to deceive; who would never encourage ghost writing in academic journals; the industry who would never use fear to increase markets for its products and/or pay large remunerations to those who participate in this activity- here is one example. (And note the severity with which the ‘gentlemen’ were dealt – for goodness sake …) And this kind of behaviour is endemic within the pharma / scientific community. If you are not convinced find your own examples; it can be good fun and it is not difficult. So here we have pharmaceuticals, squeaky clean, controlling the regulator. This, the industry which has never been caught out paying for perks; the industry who has a reputation so pure, so unblemished that one of its biggest players was fined £297,000,000 for bribery and corrupt (and very un-British) practice in China (The company stated that it had, ‘learned its lesson.’ No doubt it has, and I am sure it will take great care not to get caught next time.)   

And as for the FDA in the US: It is much the same story.  It was only last year Mitch Zeller of the FDA had to issue a statement which began,On July 21, 2014, Judge Richard Leon of the United States District Court for the District of Columbia issued a ruling that requires the FDA to reconstitute the Tobacco Products Scientific Advisory Committee (TPSAC). The ruling also bars the FDA from using TPSAC’s 2011 Menthol Report. Judge Leon issued his ruling in a 2011 lawsuit that alleged in part that certain members of TPSAC had conflicts of interest that violated ethics law. FDA disagrees with the decision, but Judge Leon’s order is currently in effect and we must comply.”  The full statement can be accessed here. Notice his arrogance when he states he, “disagrees…,” oh! I apologise, he said the FDA disagrees. But, of course, it is neither; it is the pharmaceutical industry which is not happy.

The regulators are not just manipulated directly by the pharmaceutical industry. The revolving door does not just access two rooms, the pressure and personnel exchanges takes place via a myriad of smaller institutions that exist under the collective title of Public Health. So while we discuss the major regulators we have to also look at those smaller players. Added to this are the research centres and universities – just a second – let me pull in the net so I can remind myself who we are dealing with here – Wow! It is heavy… now let me see…  FDA, yes, MHRA, aha, oh! There is something else here hiding just under the governments. Let’s dig it out and shake it down. Out you come! Let me see! I know you; you are the World Health Organisation (WHO) and what on earth is that behind your back?  Aha! The FCTC: the Framework Convention on Tobacco Control. We have caught a big fish here. The WHO, the biggest mouthpiece for the pharmaceutical industry in existence: The ultimate example of regulatory captures anywhere: One of the most corrupt organisations on the face of the planet.  In our net we have not just pulled in the regulators and governments, not just a handful of smaller players, by catching the WHO, and also in its hand, the FCTC, we have netted the whole, dirty struggling bunch. Whoopee! What a catch!

The WHO FCTC is the foundation for Tobacco Control efforts. Under the umbrella of the FCTC all agencies, including national governments, are ‘guided’ to a common end using the same or similar methodology -  the end being the destruction of the tobacco industry – ostensibly.  

There are numerous accusations of corruption within the WHO, not least the scandal of the flu epidemic / scare, but, when it comes to arriving at a conclusion as to whether it is money and power or if it is health which is its main interest, there is no need to research – staring us in the face is the WHO’s attitude to vaporisers – a stark example of the organisation’s arrogance, ability to lie, to ignore scientific evidence and to work against the interests of the public; a stark example of how far it is prepared to go in order to serve the interest of its not-so-secret lover, the pharmaceutical industry.

The logic is simple; the e cigarette is 95% - 99% safer than the product it is designed to replace, and the WHO wish to regulate it out of existence.

This proves that... (You find the correct statement(s)
  •  The WHO places health first
  • Attitude to e cigarettes is equitable (As a product)
  • Overt regulation is empowering and offering choice
  • The WHO’s stance is effective in fighting the tobacco threat
  • The WHO’s stance is evidence based
  • The WHO’s position is a fair one (To the public)
  • The WHO’s policy is inclusive.

The above list is based on the UK Faculty of Public health, Core Values

As I have stated, there is no need to research: no need find evidence; no need to formulate complex arguments. The application of a little thought is all that is needed. Are restrictions on vaporisers to the point that they will, in all probability, be banned, or, at best, rendered much, much less effective placing the health of those who have switched or are considering using them as a safer alternative to smoking, placing the health of the public first? … No! Is this attitude to the vaporiser equitable? …No!  Is the regulation demanded by the WHO and the restrictions demanded, offering choice? …No!  Is it effective to strangle the very product that has the potential to kill off the tobacco cigarette? …No!  Is the WHO’s stance evidence based? (Yes, you do have to research this one, but I will make it easy: The evidence (Summary with link to the study) submitted, here. More generally, and some very interesting reading, here.  So again the answer is a resounding, NO!

As a statement of logic, how does the following sound to you?

 “If the arguments presented by those opposed to e cigarettes fall down in the face of facts it is therefore reasonable to assume that there has to be another motivation for opposition to vaporiser use which has nothing to do with science or health.”

The arguments presented by the WHO and its satellites are basically very simple. (1) We do not know what is in vapour so the precautionary principle should be applied – keep in mind we already do know that vaporiser use is 95% - 99% safer than smoking and that the number of people who are not already smokers taking up vaporiser use is tiny. (2) It might normalise smoking and, in particular, encourage use by young people who will then graduate into cigarette smoking.  And that is about it: We do not know how safe they are, and it might encourage some to take up smoking cigarettes.

One after the other we have witnessed the ‘scientific’ arguments presented by opponents of the vaporiser collapse; we, on an almost daily basis, watch them topple and fall. Study after study debunked and the researchers left to shrink into the background, humiliated. First, we had the ‘antifreeze’ scare. Here along with others. And since, the accusation that e cigarettes can cause Lipoid Pneumonia. Here. Oh, and another early one, tuberculosis. Here -My own [very early] blog where I correspond with a professor in Canada. Then, there was formaldehyde where the researchers cranked up the power of a vaporiser to unrealistic levels in order to get the result they wanted. Here. Over and over, day in and day out, an avalanche of repeated and repeated and repeated- and even after it has been thoroughly debunked, still, repeated and repeated and repeated rubbish - and when the truth is revealed, when the repetitions eventually begin to fail? Always, the fall back… “We do not know enough about them.” And, on the basis of, “we do not know enough,” the precautionary principle is being applied. (Should actually say misapplied) So, should the precautionary principle be applied to vaporisers? Should they be restricted to the point of a ban?  I would like to use an analogy here to illustrate my argument, and that is the WHO’s endorsement of programmes to supply, ‘safe,’ drinking water for people in large areas of the third world. 

The death toll from exposure to dirty water in some parts of the world is horrendous. The WHO, charities, everyone is concerned, and a massive programme is underway to find and provide access to a safer supply of water for those poor people. No one in their right mind would say this is a bad thing. No one in their right mind would point out that even the safer supply is totally safe and so these people be prevented from accessing it. That impurity of some kind, but we are not sure which, could leach into the new supplies and cause illness. And yet, that is a distinct possibility – even here in the west, arsenic has been found in water supplies. Pharmaceutical run off has found its way into our drinking water, so how much the greater threat in a poor third world country. Do we advocate the application of the precautionary principle; do we hold back because we cannot be absolutely certain that the water we are providing is 100% safe – don’t be daft. Of course we do not.

So what is so very different about the vaporiser? The death toll from cigarette smoking is horrendous. The WHO, charities, everyone is concerned, and a massive programme is underway to hide and block access to a safer alternative to these poor people hooked on cigarette smoking… Do you get it…? And, if any anti-e cigarette zealot is reading this, they will probably have baulked at this statement, but I doubt if they would know exactly why…  I will explain.

There is a phrase contained here which creates a difference in our attitudes when thinking about the debate between clean(er) water and the safe(er) vaporiser, and it is, “…these poor people.”  There is nothing ‘poor’ about cigarette smokers. They are dirty, smelly creatures with no consideration for those around them. They have to be stamped out.  And this is one of the reasons the precautionary principle is being applied to vaporisers, but not to water supplies – it comes down to the simple fact that people do not like smoking and smokers and so, if a measure to hurt them lacks logic, if it is hypocritical, based on lies and half-truths, if it is driven by greed and a lust for power by some, so what! It still has to be a ‘good’ thing. And make no mistake – use of e cigarettes is seen by so many to be no different to smoking. Smokers are, “…the sinners who they claim to care about, but really despise.” Here.

As for the gateway theory, there is no gateway. Here.  HereHere.  HereHere. And that deals with that. It just about debunked itself. (Like one recent paper, but I have not the time to Glantz through my library to find it)

The motivational pull of power can be very seductive. When someone sneers, they feel empowered, they automatically feel superior. And this is what is happening when ‘the public’ sneer at smoking and smokers, and they are encouraged to do this, but the motivation driving the motivators is quite different.  This is greed. It is money plain and simple. It is money for government, money for pharma, money for research, money from bribes. Money, money, better jobs, higher salaries, more influence, more money, more power… And the vaporiser is a threat to all of this. If the tobacco industry goes under, all of this disappears, the jobs the money… gone. It must never happen.  And this brings me back to the topic of NRT, mentioned way back at the beginning.

In order to carry the support of the general public and also public health workers of good heart, it must be made to seem that the enemy is Big Tobacco – let me make an adjustment – Little Tobacco. Tobacco company profits are swallowed up by governments to the point they are only just about worth the effort.  Tobacco companies must be allowed to survive. Without tobacco, there is no enemy. One of the devices which help maintain this illusion is NRT. Indeed their effectiveness is in itself illusory. Couple this to Tobacco Control pronouncements, couple this to  demands for this, that and the next thing – none of which have a hope in hell of making the slightest difference; conference after conference. Plain packaging, hiding products out of sight, more smoking bans, in public areas, inside and now outside, in cars, on hospital grounds, near schools, and none of it making the slightest bit of difference to the numbers who smoke: And those who dream up these measures know it. A MUST READ HERE. They would not dream of introducing them if they though for one micro-second that they might actually work: this is their job, this is their art – to keep tobacco as the enemy yet do it no real harm. So the majority of public health workers and the public at large have a picture of tobacco control: public health; the WHO and others as being the ‘good guys.’ The ones in the vanguard of the war against tobacco when the truth is that it would be fatal for the ones at the top to actually succeed in the job with which they are charged – what would they do then? As for their twin paymasters! What of them? One would have no funds to pay up and the other would no longer have an interest for which to pay anything.