E-cigarettes in the UK - Part 2

The second part of an in-depth look at the UK situation.



Regulatory Capture

This is the process by which a government regulatory agency, set up to protect the public from an industry, eventually becomes 'captured' by the industry, and in the end works on behalf of the industry against the public good [1].

In the absence of strong government controls on corruption, and with the existence of a revolving door staff policy (see the Wikipedia reference cited, for good examples of this point), and in an environment of complicity with corruption, a regulatory agency eventually becomes owned by the industry it controls. It then serves the industry, for example by protecting its income, and by removing commercial rivals by obtaining the legislation required to force out any competitor - even when that competitor provides options that are preferable in terms of the public good.

Regulatory capture is a prime example of weak or non-existent control of corruption within government.

Probably the best example available where the number of lives lost can be directly calculated is the pharmaceutical industry's control of the EU Health Commission, where the ban on Snus, which protects pharma income, results in a minimum loss of life of 10% of those lost to smoking deaths every year in Europe: 65,000 out of the 650,000 reported annual deaths from smoking. Since Sweden reduced their smoking deaths by 40% due to free access to Snus, a 10% EU-wide saving of life by access to Snus is not unreasonable - some commentators would put the number higher.

The Snus ban protects pharma's NRT sales, and sales of chemotherapy, COPD, heart disease and other drugs used to treat sick smokers - said to be at least ten times the value of NRT sales (which itself is a billion-dollar a year global market).

The attempted UK ban

The MHRA is the UK's medicines licensing authority. Because it is funded part (or wholly) by the pharmaceutical industry, and shares staff in a two-way direction, and is open to pressure by the industry in numerous ways, it is clear that it is not in fact an independent body acting solely to protect public health, despite this being its stated purpose.

In early 2010 the MHRA, probably in response to requests by the pharma industry, set out to ban electronic cigarettes. However there is a requirement for new government regulatory proposals to (a) go through a public consultation process, and (b) submit to a sanity check by the RPC, another agency that oversees regulators. The MHRA proposed three options for the control of e-cigarettes: 
Option 1 - an immediate withdrawal of products from the market
Option 2 - the same but with a 1-year delay
Option 3 - do nothing

It is assumed that they would have decided on Option 2 as that would remove the threat of e-cigarettes to the industry's NRT sales, plus give the appearance of taking a reasonable attitude to the loss of jobs and shutting down of the UK e-cigarette industry. (The 'consultation' was simply a window-dressing exercise, since the decision to ban would already have been made.)

The end result of either Option 1 or Option 2 would have been a ban, since all products would have been removed from the market as they would need an MA, a marketing authorisation or pharmaceutical license, in order to be sold. This takes a minimum of two years to obtain. Most likely, two or perhaps three UK vendors would have gone that route with one product in order to stay in the market; the other 30-odd UK vendors would have shut down or moved their operations abroad. Since most vendors sell at least four hardware products and twenty liquid refill products, it is a simple fact that whatever way you look at it, 99.9% of the products currently on the market would need to be withdrawn.

All would have needed to close down for two or three years until licensing could be obtained for one product, as it requires clinical trials, research of existing documentation, writing up the results, some legal work, submitting the documentation, and waiting for a decision. We currently think the theoretical minimum possible cost per product is about £300,000, although we have no examples of any product with such a low cost to license. It is not known what the cheapest-ever product cost to obtain a license for, though some have obviously cost millions.

The best guide we have at present is the average £750,000 per product that the health supplements industry had to find for licensing natural plant products, some having been used safely for 50 years, when recently forced to do so by new EU legislation. Only skeleton documentation and testing would have been required for this exercise, compared to licensing a new pharmaceutical.

An entirely reasonable point of view is that the prime purpose of this legislation was to remove some of the pharma industry's competitors - which it has been spectacularly successful in achieving.

Q1 2012 update: the first company to apply for a medical license for their e-cigarette in the UK has borrowed £2m to do so, to add to previous spend. We now therefore know that a single product will cost about £2.25m to bring to market successfully.

Bad timing

Unfortunately for the MHRA, the government changed right in the middle of the process. Out went the Labour government, in came a Conservative / Liberal Democrat alliance. The new administration had a different outlook on regulation, and instead of welcoming it and encouraging more of it, took the opposite view: new regulation was not wanted and it would have to pass several tests for robustness first. In addition, to reduce the burden on business and the economy, if a new set of regulations was introduced, some sort of regulation/s had to be removed at the same time - one in, one out.

The RPC was given more teeth and could now stop new regulatory proposals if they did not pass a sanity check. New proposals are tested and given a traffic light colour-code classification for further action: 

  • Green = the proposal succeeds and can go through
  • Amber = the proposal needs more work before it can pass, as there are some issues that need correction
  • Red = a poorly-constructed proposal with numbers that don't add up, and the proposal fails outright


The MHRA's attempt to regulate (ie ban) e-cigarettes occurred just before the traffic-light scheme proposal results were made public, so we don't know the classification it received. We do know that the RPC blocked the proposed regulation though, so either it received a Red tag, or the proposal could not be rebuilt successfully after being Amber tagged. Since none of the figures in the IA (the Impact Assessment that formed part of the regulatory proposal) bore any connection to reality, this is easy to understand.

It should be noted here that if the MHRA had started their run about six months earlier, and therefore managed to complete it under the Labour government, e-cigarettes would now be banned. There is no doubt about that whatsoever.


The next attack

As they failed, one might think the MHRA would now leave e-cigarettes alone.

Far from it - they have announced that they will try again later. As there are no rules that say repeated attempts cannot be made, under government procedure they can repeat the exercise. However, they revealed that the next attempt will be at law: a challenge will be made in court to the e-cigarette's general product status by attempting to show that if it causes a significant pharmacological effect, then it must be regulated as a drug. 

There is simply too much money at stake for them to let this go, as the pharma industry will lose hundreds of millions of pounds (and billions of dollars gobally) if NRT and chemotherapy drug sales crash due to being rendered pointless by the introduction of an alternative smoking system with no significant health implications. This being the case, they will try again. A legal decision will therefore achieve three things for them:

  1. A final decision on the question, hopefully in their favour.
  2. A way to circumvent government controls - if the law says it has to be done, then the government's position on more regulations, or the competence of the MHRA, is not relevant.
  3. If they fail in court, then the MHRA have a final decision they can present to the pharma industry, in order to absolve themselves of blame. In addition, that failure can also be blamed on the industry itself, through not supplying sufficient funding / the best lawyers / sufficient research results adjusted to show whatever was required [2].


This new attack is scheduled for spring 2013 but we should not be surprised if it commences earlier, perhaps in late 2012, as that is when pharma's research will mostly have concluded and been written up.

It is important for MHRA staff to ensure that they themselves are not seen to be at fault and guilty of failure, as this may jeopardise their job entitlements within the pharma industry when they either retire from the MHRA or take up a better-paying position in the industry. Unlike the military procurement government departments in some countries, where staff movement between industry and the government agency is prohibited as it is an obvious source of corruption, transfer of staff in both directions is permitted within the pharmaceutical regulatory agency in the UK. In particular, an ex-MHRA senior manager may take up a lucrative board-level appointment in the industry. You can draw your own conclusions as to the implications.

The MHRA equivalent in the USA, the FDA, has been described as "the most corrupt large government agency in the world". Even its own employees, the scientists who work for it, are tired of it: they write jointly-signed letters to the press complaining about decisions made by management contrary to the science. Lives and public health are not the determining factor in decisions made by these agencies. 

It is interesting to see what, if anything, the government will do about one of its own agencies that has in effect gone rogue. It is completely ignoring the instructions it has been given from above, and is pursuing its own agenda. That agenda is to act on behalf of one industry to eliminate its competitors in another industry. Since that is neither related to its statutory purpose, and also indicates an extreme vulnerability to pressure from the industry that it is supposed to control and supposed to protect the public from, the core government reaction will be enlightening.

The reason for the existence of the MHRA is to protect the public from the pharmaceutical industry. If it cannot do that, and instead acts to all intents and purposes as the pharma industry's partner, then exactly what use is it?

The DoH, Department of Health, within which the MHRA are based, appears to be backing the MHRA. It seems that the legal attack on the free availability of e-cigarettes to be launched by the MHRA will be assisted by a campaign within the DoH to assemble support from various medical and pseudo-health organisations who can be persuaded to offer help.


The cost in human life

There is only one possible result of success by the pharma industry and their agents, the MHRA and the DoH, in banning e-cigarettes: the death of thousands of smokers who will not be able to take advantage of a freely-available consumer product that is estimated to be 100 times safer by the actual medical experts who have done the research.

In addition, the largest black market the UK has ever seen will be created. It will prove absolutely impossible to prevent import and sales of products that will be seen as of great benefit but banned by a corrupt government. Public support will be widespread, and eventually a painful U-turn will have to be taken and legislation to permit sales will need to be forced through, as the law becomes further and further disrespected and ignored. It has, of course, all happened before.

Q1 2012 update

The government of Holland banned e-cigarettes* in early 2012. In March, the ban was overturned in court, and the government had to pay costs. An appeal is awaited, at late March.
* Meaning of course that they declared ecigs to be an unlicensed pharmaceutical product.

The State government of North Rhine - Westphalia in Germany banned e-cigarettes in early 2012. In March, the ban was overturned in court. The State was ordered to remove warnings and bans within three weeks. An appeal is awaited, at late March.

Previously, in 2010, the US FDA had attempted the same thing and received the same treatment in court, being ordered to cease import seizures or other restrictions and bans.

This would seem to indicate that with three strong legal decisions against corrupt government agencies working to the agenda of the pharmaceutical industry, in the USA and EU, the evidence offered being essentially the same in all three cases, the likelihood of such an action succeeding in the UK (or anywhere else in the EU where the necessary funds are available to defend) is not great. In addition, the UK trade association ECITA is the strongest and best-organised in the world at this point, with well-admired regulations and the resources needed to manage vendor quality controls (their own GC-MS machine and pro chemists on the staff, for example).

An attack based on trying to show that an ecigarette is an unlicensed drug delivery device will fail (since so is a coffee percolator, a cocktail shaker, or a tobacco pipe); or, based on it delivering a drug with a significant pharmaceutical effect (ditto); or that ecigs are sold for the purpose of treating a disease (nicotine addiction) - they are more likely to be used for continuance of nicotine addiction than cessation, and are designed to be a permanent replacement for smoking and not for cessation; or that they are presently uncontrolled and unregulated (they are controlled and regulated by the Trading Standards authorities, who analyse the products for toxins and contaminants and who work closely with the trade association, who have received their praise); or that there is no framework for industry control (as the UK industry group is the best organised in the world).

In all likelihood an attack on e-cigarettes by a UK government agency would be a very expensive failure, as ECITA is now well able to defend against such an attack. The community would also be likely to present an amicus curiae brief and ask for substantial damages due to the malicious nature of the action.



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Notes

[1] Regulatory capture is a widely-recognised phenomenon and there are many examples referenced in dozens of resources. For example:

http://en.wikipedia.org/wiki/Regulatory_capture

http://www.icgg.org/downloads/Boehm%20-%20Regulatory%20Capture%20Revisited.pdf

http://www.investopedia.com/terms/r/regulatory-capture.asp#axzz1k1XvZlGo

In our area the best-known is the FDA, the US version of the MHRA, which is famous for the attitude of its senior management that their client is the industry, not the public.

[2] Clinical trials can be managed so they produce whatever results are required. This is why a single trial (or a series of trials by entities with similar agendas) is effectively worthless. Trials that are obviously funder-agnostic are different - but pharma product trials do not fall into this category. The results can be spectacularly fraudulent since they end up costing the taxpayer large sums of money. An example of this are trials that show nicotine skin patches have good success rates - they don't and they can't. The placebos are fixed, or the trial otherwise carefully managed to improve apparent success rates. In the real world, patches have a very low success rate of around 2% - a failure rate around 98% at the standard 20-month mark. For some reason this is not usually visible in clinical trial results.

If real-world evidence is available then clinical trials have reduced value. It is not necessary to carry out clinical trials to research whether or not the sky is blue - you can look out of the window.