Public Health England Take on Ecigs and the Food and Drug Administration in the USA

This will really, really have to be a quick post. I find myself getting carried away. Time passes like an express train, and before I know it, it is 4am. I have ONE HOUR. I must discipline myself.

We have already discussed the machinations of Public Health England (PHE). In the face of overwhelming evidence that ecigs cannot possibly be as harmful as tobacco cigs (unless tobacco cigs are harmless), PHE has capitulated and is trying its best to pull some rabbits out of the hat to justify medicalisation of ecigs. The trick that PHE is intending to use is to put the cart before the horse. Rather than recommending that GPs simply recommend ecigs to people who want to stop smoking and let people buy the ecigs themselves, PHE wants GPs to be able to prescribe ecigs. Why would PHE wish to enable that? As many people have pointed out, if a person can afford to smoke, he can afford to buy ecigs.  Even my local Co-op has them on sale. The reason is that the only way that GPs could put ecigs on a prescription would be if they were recognised and approved ‘therapies’. That would be fine if PHE invited applications from ecig makers to have their products approved for the purpose of being prescribed by doctors with PHE approval. What does not follow is that ALL ecigs need to be approved.

It is a moot question whether or not the undoubted approval of ecigs by PHE will cross the Atlantic and impinge upon the Food and Drug Administration (FDA) in the USA. The FDA is on the point of producing regulations for ecigs. It has been bombarded with junk science from the likes of Glantz, with his multimillion dollar grants, provided to do just that – provide junk evidence for the FDA to virtually ban ecigs.

In much the same way that PHE has blown the anti-ecig junk science away, events in the USA are taking a similar course, albeit in a totally different way. Michael Siegel has the story:

http://tobaccoanalysis.blogspot.co.uk/2015/08/us-district-court-decision-may-cast.html

I have read the transcript of the court decision, so I’m not just parroting Siegel. Very, very briefly, a pharma company produced a drug (from fish oil) which substantially reduced a certain harmful substance (triglycerides) in the blood stream. If I read it right, these things are lipids (oily stuff). The company had FDA approval to market their product as a ‘remedy’ which could reduce the stuff when the stuff was at a very high level. They sought approval of the drug for use with substantially elevated stuff – slightly different – which was intended to reduce heart attacks. The company jumped through the hoops and did all the tests for danger and effectiveness (in reducing the triglycerides) and passed. But the FDA turned them down on the grounds that there was no certainty that reducing triglycerides would reduce heart attacks. The FDA threatened to ‘do’ the company if it told doctors about the results of its tests and the efficacy in reducing triglycerides. Being ‘done’ by the FDA is a serious business and could cost millions of dollars in fines.

Which left the company in no-man’s-land, when all it wanted to do was tell doctors about the results of its trials of its drug in reducing triglycerides.

The company went to court to seek protection from the threats of the FDA if it went ahead and used its right to ‘freedom of speech’ to publicise the benefits of its product. It won. It won because the statements that it made were true and not misleading.

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The significance of that case is that the FDA needs to be very careful that it does not infringe the right of companies to ‘free speech’. Thus, it is likely that, if an ecig company claims that its products are ‘safer’ than tobacco cigs, and those claims are true (which the PHE statement seems to have confirmed), then that company has not made a claim which offends any FDA demand. It follows therefore that FDA regulation of ecigs must be reasonable – safety of the machine, purity of liquids, childproof containers, but NOT curtailment of trade by mandating maximum amounts in ecigs or containers.

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I wonder if these two events could be of assistance to ‘Totally Wicked’ in the EU court? One might think so if it can be shown that the EU Parliament was asked to vote upon the wrong questions. That is, if the Parliament gave approval to a directive which was fundamentally flawed, surely, once the flaw was discovered, then it would have to be corrected? Or that what the Parliament voted for was not what will appear in the actual directive. Surely no one would wish to press ahead with the imposition of a law which has been demonstrated to be very dangerous?

Damn! I am half an hour late! More discipline is required!

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