Monday 6 August 2018

The FDA Blatantly Hands E-Cig Market To Big Pharma

Around about this time last year, the FDA's Scott Gottlieb made a public statement about e-cigs that many vapers thought was a new dawn in how reduced risk products would be treated in the US.

You may remember that I thought it was just a cleverly-worded hill of beans.
The FDA's announcement relents on some e-cig rules but only on the proviso that it might make vaping more attractive to smokers who will be deprived, by force, of nicotine from their combustible cigarettes. That is nothing more than vile coercion and should have no place in a land that claims to be free.  
I cannot possibly cheer the FDA's overall plan and I don't think there is anything particularly concrete to be happy about yet anyway. Smokers are being thrown under a bus but apart from that everything else is up in the air and subject to change.
Despite many vapers rejoicing at this "huge" announcement, and describing it as "momentous",  a "reprieve", with some even saying they had "every confidence" in Gottlieb, it stunk to high heaven in my book. The emphasis seemed to be more on pointlessly reducing nicotine in regular cigarettes rather than promoting e-cigs.

Nothing I've seen since has made me think that the FDA has any intention of taking harm reduction seriously as a policy to encourage smokers to quit. In fact, the evidence is all pointing in the opposite direction.

However, the whole thing has since taken an even more sinister tone with the release of another Gottlieb FDA press announcement on Friday.
Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
"Novel nicotine replacement drug therapies"? Is he talking about e-cigs here? Well, yes he is.
We’re working on multiple fronts to recognize the role that more novel forms of nicotine delivery could play in achieving our public health goals, as part of an appropriately regulated marketplace. This not only includes encouraging innovation of potentially less harmful tobacco products for those adults who still seek to use nicotine (such as e-cigarettes), but also taking a closer look at our overall approach to the development and regulation of NRT products that are regulated as drugs, and designed to safely reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. 
The development of novel NRT products, regulated as new drugs, is a critical part of our overall strategy on nicotine.
I added the emphasis because it's quite clear he is not talking about a free market in e-cigs sold from vape shops.

Instead, he has issued some guidance on how to get e-cigs approved by the FDA (emphasis again mine).
This draft guidance, when finalized, is aimed at providing sponsors with recommendations on the nonclinical information appropriate to support development and approval of orally inhaled nicotine-containing drug products. It recognizes that a great deal of toxicity information is available for nicotine. But such information may not be available for other compounds contained in e-liquids and delivered by these products. These include the flavorings and heat-generated chemicals. These products can be used for six months or more over the course of a lifetime. So, it’s important to understand the risks to humans from these exposures, including developmental and reproductive toxicity and carcinogenicity.
Drug products? Six months over a lifetime? I've been using my non-drug e-cigs for about 8 years.

But then when you look at the guidance, it is quite clearly intended for a different subset of businesses than those which currently provide e-cigs for the US market.

It is guidance for a therapeutic product and nothing more. Such a product doesn't currently exist and any company which decided to have a go at it would have to have millions of dollars to spare. It is designed in a way that pharmaceutical companies would understand because it is a route to a pharmaceutical, or 'medicinal', e-cig. This would likely take the form of some ridiculously safe and bland cigalike which is so far removed from the products which are finding favour with smokers and driving the lowest smoking prevalence figures in US history, that it will be practically useless.

OK, it's fair to say that tobacco companies have the resources to throw huge amounts of money at getting a product of this type approved, but it will still be a therapeutic, medicalised e-cig designed for complete nicotine cessation, so it barely matters who manufactures it.

Gottlieb’s approach is cigarettes stripped of nicotine coupled with medicalisation of e-cigs. Because almost all of the products currently being sold in America by independents will disappear in 2022 thanks to the imposition of a predicate date.

It's important to note that Gottlieb has not issued guidance to current e-cig manufacturers on how to produce an independent product which could be sold on the open market as a consumer product. He has hinted that there may be some on the horizon but, for now, he has bypassed that and gone straight to issuing guidance - which heavily leans towards the pharma industry - on what is acceptable for a therapeutic product. At the same time as still insisting on rules which will effectively remove competition from anything recreational that is currently on sale.

It is, to all intents and purposes, a co-ordinated effort to make e-cigs a medical product and one which should only be used as a means to quit nicotine entirely. It is basically handing the entire market to the pharmaceutical industry. In other words - and especially considering the parallel regulations to take the good nicotine out of cigarettes and leave the harmful elements in - 'quit or die' on steroids.

Many were of the opinion when Gottlieb took over the job that he'd just end up being a pharma shill. He seems to be living up to those predictions quite spectacularly so far.

It is so blatant that it's astonishing. One can only assume that this is a result of the American disease of corporate lobbying, with pharma front and centre. I don't know about you but I don't think it's wrong to call this organised crime.

So, no, Gottlieb's announcement in July last year wasn't a new dawn for e-cig use. It was the start of a process which will see a brilliant innovation crushed and handed to corporate interests to destroy. It also proves, once again, that none of this crusade against smoking has ever been anything to do with health. They really couldn't care less.

We're on the side of the angels, always remember that. 

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