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Health and Legal => Health Discussions => Topic started by: caz on September 12, 2019, 09:02:30 AM

Title: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: caz on September 12, 2019, 09:02:30 AM
The emotional and irrational hysteria in the US about the “vaping-related” (or cannabis-related?) lung disease that goes far beyond confirmation bias

By Dr Farsalinos

I have been following the recent developments and announcements in the US on the serious, acute cases of respiratory failure which have been presented as “vaping related”. It would not be a hyperbole to characterize the reactions, announcements and statements of some authorities, regulators and scientists as hysterical. There is no doubt that they are emotional, inaccurate and without any scientific and epidemiological basis.

Almost all announcements, whether from health organizations or from local public health authorities refer to the cases as “vaping related”. In no announcement do they mention in the title that many cases have been confirmed (and others are simply not confirmed yet) as related to the use of cannabis (and/or THC) inhalation using a battery-and-resistance device (i.e. an e-cigarette device). In no announcement do they mention that these cases are in fact THC/cannabis-related and not vaping-related.

Let’s start with the basics. Why is the term “vaping-related” cases wrong?

Let’s assume we have no information about the use of cannabis and/or THC (legal or illegal). So, let’s use simple principles of epidemiology to understand the recent outbreak. E-cigarettes have been popular in the US and globally since 2009-2010. There are approximately 10 million vapers in the US today, many of whom have been using e-cigarettes for years, and many more millions worldwide. The average age of adult vapers in the US is approximately 40 years (data from my study on the NHIS surveys that will be published soon). Until this summer, there were no reports of any outbreaks of disease (in the respiratory system or elsewhere), in any age group, in any part of the world. Suddenly, within a short period of time (few weeks), in a specific geographic region (e-cigarettes are available worldwide, not only in the US) and in a specific age group (adolescents or young adults) there are cases of severe, acute respiratory dysfunction that has resulted in 2 deaths and several hospitalizations. What does this tell us from an epidemiological perspective (again, without considering any information about cannabis/THC use)?

    That these cases are not related to long-term use of e-cigarettes. The authorities have clarified that these are acute cases. Despite various media presenting this as a mysterious lung disease, it is in fact poisoning of the lungs which is clinically manifested as serious respiratory failure (perhaps ARDS, perhaps some form of severe lung inflammation leading to respiratory failure).
    That these cases are not related to vaping products that have been available for years in the US and global market. It makes absolutely no sense that the same products that have been used for several years by millions and never caused any disease outbreak are only today causing acute disease.
    That these cases are not related to products that are generally used by the average vaper. The average age of adult vapers in the US is different from the average age of adults that have suffered from this acute condition. Also, the number of cases is very low considering the millions of vapers in the US and the many more millions globally.
    That these cases are related to the recent release of new products (that were not previously available in the market), or to a recent modification in the composition of products previously available in the market, or to a recent problem in the manufacturing process or raw materials of products that were previously available in the market. This explains the timing of the outbreak. These products could be nicotine-containing or nicotine-free products (remember, we assume there is no information on THC/cannabis).

All these conclusions, derived from applying simple principles of epidemiology, have been largely ignored by most authorities, regulators and scientists. Instead, we are witnessing a persistent, frantic, unprecedented campaign against conventional vaping, which in fact delivers a clear message to consumers that it is preferable to relapse back to smoking (or keep on smoking) rather than use (or switch to) e-cigarettes. The media campaign is so intense and so epidemiologically unjustified that it exceeds the definition of confirmation bias.

Now, let’s consider the reports that THC/cannabis vaping is implicated in the outbreak. While this is mentioned in several reports and announcements from health authorities, none has characterized the cases are “THC/cannabis-related”. Why? Well, it seems that some of the states with cases of acute respiratory failure have already legalized THC/cannabis. In fact, there is at least one report of a death related to the use of products obtained from a legal cannabis shop. As everyone may understand, state authorities that have legalized a product cannot suddenly admit that they were wrong and their decision caused an outbreak of acute disease. It is by far “easier” (and more “convenient”) to blame the “evil” e-cigarette for everything.

But should they have blamed THC/cannabis in general for the outbreak and call it “THC/cannabis-related disease”? In my opinion, no. If THC/cannabis does not cause acute respiratory failure from smoking it, it is very unlikely (if not impossible) to cause disease from vaping it. The culprit is not THC/cannabis per se. Most likely (but this has not been proven yet), the cases are related to other compounds used in the preparation of THC/cannabis containing liquids or contaminants in these liquids. While there are reports of vegetable oils being used as solvents (that would certainly be consistent with cases of lipoid pneumonia) or a fungicide, we cannot determine the cause yet. However, if this is the case, then this can also happen with nicotine-containing liquids, if someone is ignorant enough to use oils to dissolve flavorings in a nicotine-containing liquid. If the case is about use of illicit products containing illegal substances that were obtained in the black market, this would be no different than blaming syringes for the deaths cause by intravenous drug use; or like blaming whiskey for the deaths and blindness caused by illicit alcohol containing methanol. Sounds silly, right?

But all these are still assumptions. At this time, there is no clearly defined cause for the reported cases. Thus, we should focus on the epidemiological principles mentioned above, which makes it virtually impossible that products available and used for many years by millions of consumers are now causing acute lung failure. While I understand the cautious approach of the CDC, I am certain they fully understand the epidemiology behind this outbreak and they should have done more to identify the cause more rapidly. Other organizations have used this outbreak to support that none should use e-cigarettes, with this statement referring (among others) to millions of former smokers who now use e-cigarettes and to millions of smokers who cannot quit with other methods and would have considered e-cigarettes as an option to quit smoking. What a public health service…

There have been several health crises in the past, with chicken contaminated with dioxins (few years ago in Europe), mad cow disease, and a recent outbreak of Salmonella infections from chicken (again) that resulted in 2 deaths and 175 hospitalizations in the US. For the latter, I am sure all these people were not only eating backyard poultry but also poultry from the market or fast food stores. Still, none presented it as chicken-related illness in general and there were no generalized recommendations that none should eat poultry (despite eating it safely for decades). I wonder if the “passionate” statements mentioned by the media, scientists and authorities will ever be corrected once the exact cause of this outbreak has been firmly established. I even wonder if the media will cover the story at that time with the same “passion” as they are doing today.

In conclusion, from an epidemiological perspective, the current situation with cases of acute respiratory failure reported in the US, is extremely unlikely (I would say, certainly not) attributed to products that have been available in the worldwide market for years and have been used by millions of consumers. The exact cause for these conditions should be urgently determined, and the emotional, irrational hysteria against e-cigarettes (in general) needs to stop as soon as possible.

Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: Darth Vaper on September 12, 2019, 02:53:37 PM
Thanks for sharing this Caz... I have had a lot of doubts about the validity of these articles.. many of them somewhat point to THC/CBD type vaping. That is pretty much the newcomer on the block... and with the way the media is pushing the legalization agenda it seems they don't want to push to hard in that direction and cast ill light on it. They seem to want to push the underage agenda instead.

Never once heard of a specific vendor... and with it only being kids I have been wondering if they have possibly gone from eating the Tide Pods to vaping them. Don't laugh.. not kidding about that.

The other thing is that nowadays people pick up vaping with no knowledge other than Facebook posts that disappear into the digital abyss... when most of us started we had at least some sort of forum to refer to if we were having a reaction/pg sensitivity/vg sensitivity etc. It seems like issues like those are lesser known these days.

Plenty of good information on these pages.

Thanks for adding another page of good stuff Caz  ;)
Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: CYBORG on September 13, 2019, 04:28:42 AM
Bad press sells newspapers.
I have 2 hobby's vaping & drones, both receive bad press for no other reason than a good case of scaremongering grabs the attention of the general public who are ignorant of any facts.
You never get a report of how many probable deaths are averted due to people stopping smoking by turning to vapeing or search & rescue using drones to find people lost in inhospitable places.
After the initial scare factor of contaminated chicken & mad cow disease everyone ignored them because most people enjoy eating it, only things in the minority can continual hit the news and get money for the fiction writers.   
Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: pwmeek on September 13, 2019, 10:22:49 AM
This subject is getting a real workout on where the trolls are really out in force. I could use some help in keeping the occasional reality check going.
Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: caz on September 16, 2019, 09:54:35 AM
LiQuid’s Response to US Vape Related Concerns  (one of the UK vendors

There maybe some useful links at the bottom  of the article

Recently, the media have published numerous reports regarding the apparent ‘mysterious and deadly lung disease’ that are being closely linked to vaping nicotine or cannabis-related products. NextGEN360, LiQuid’s parent company, have compiled a response in relation to these reports and clarified how, as a company, we are fully compliant and pride ourselves on ensuring that our products are of the highest quality and meet the legislative requirements set out in all legally binding regulations and beyond.

The outbreak of lung illness apparently relating to vaping has now claimed five lives and affected 45 people across the US, according to the Centers for Disease Control and Prevention (CDC). Reports published have stated “Five deaths have been confirmed in California, Illinois, Indiana, Minnesota & Oregon”, the CD said some apparently preceding the case in Illinois in late August was the first to be linked to the vaping-related outbreak. In a media briefing on Friday 6th September 2019, the federal agency said the preliminary results of its investigation suggest that of at least 60 hospitalised patients in North Carolina and Wisconsin reporting vaping, most of them had used THC-containing e-liquids and only a small proportion just nicotine products. There has been widespread speculation that has connected the rapid onset of severe lung symptoms, seemingly mostly in young males, with the vaping of THC and substances that has subsequently been added to it. Alongside this, Vitamin E acetate has emerged as another prime candidate, with many in the public-health community observing that this would explain the mystery of the outbreak (ECigIntelligence, 2019).

No single vaping device or e-liquid product was found to unify all of the cases studied. However, 84 percent of patients reported using THC product, and the symptomatic progression of the disease was relatively similar across all cases. Despite the illness showing symptoms of an infectious pneumonia-like condition, no infectious agent has been found (New Atlas, 2019). Vaping THC does not protect consumers from negative health effects. There are residual irritants, solvents and pesticides being taken into the body through vapours that can have serious health consequences. Toxic amounts of ammonia residue from THC can cause irritated lungs, central nervous system effects and asthma attacks with many scientists linking it to ‘lipoid pneumonia’ which is caused through vaping products that contains a high percentage of oils that aren’t safe for vaping e.g. Butane Hash Oil.  Many consumers in America are reported to adding additional material to their e-liquids such as synthetic cannabis, contaminated THC or nicotine from an unreputable supplier (USA Today, 2019).

This all comes down to the regulatory landscape that is present within America. Prior to the PMTA (Premarket Tobacco Application), e-liquid manufacturers within the US did not have to provide any information regarding toxicological or scientific product analysis – The projected timescale for compilation of a validated submission is up to 10 months, and the deadline for submission is May 12, 2020. This is still leaving the market open for inexperienced manufacturers/retailers to sell products that pose a threat to consumers. In comparison, within the EU, the regulatory landscape is far more advanced and follows the strict regime of the Tobacco Products Directive 2014/14/EU (TPD). The TPD has been transposed in most EU countries and in the UK has been implemented as the Tobacco and Related Products 2016, which came into force May 2016. The TPD enforces strict rules on all aspects of vaping products and regulations surrounding the marketing and advertising of vaping products. Through the EU portal, all manufacturers/retailers must submit an in-depth dossier of each individual product that they wish to sell on the EU market to the MHRA. Manufacturer details, submitter details, full ingredient declaration including CLP (Classification, Labelling and Packaging (CLP) Regulation ((EC) No 1272/2008) classifications, Nicotine content (maximum amount 20mg/ml), full toxicological data obtained from emissions testing and signed declarations of conformity are all included within the submission. In comparison to America, the UK is far more progressive in terms of regulations and the implementation of a controlled regime has led to a more respected industry. Currently, manufacturers within America are permitted to market products with an unrestricted amount of nicotine, a plethora of ingredients that would be banned in the UK and other EU countries and products manufactured in an uncontrolled environment, with no quality or safety systems implemented.

Despite the TPD being fully enforced within the EU, there are still issues that need addressing in relation to the regulations. One of the main issues being the lack of regulations surrounding Short Fill products. Short Fill or Shake & Vape products are 0mg e-Liquid products designed to have an additional ‘shot’ of nicotine added. They are attractive to the consumer as they can buy a Short Fill product in a larger size bottle that is half-filled to allow room for the nicotine to be added. This gives the consumer more product as the 10ml bottle size restriction does not apply to 0mg products, it also allows consumers to make the product up to a nicotine level above the restricted 20mg/ml. Due to the product not containing nicotine, it does not fall within the scope of the Tobacco Products Directive, therefore the aforementioned restrictions do not apply to these types of products. This opens a floodgate for a variety of issues, one of the most concerning being the addition of ingredients that under normal TPD circumstances would not be permitted. The uncontrolled addition of certain flavourings could lead to the unknown addition of certain by-products such as Acetyl Propionyl, 2-3, Pentanedione and Diacetyl. These ingredients have been proven to cause a variety of health issues including the development of respiratory dysfunction, damage to the airways and abnormal lung function (Hubbs et al, 2002).  NextGEN360 recognised this issue early on and ensured that all products launched that were 0mg and for Short Fill purposes, went through the same rigorous testing regime that nicotine-containing products do including a toxicological assessment of the ingredients and the emissions from the flavourings. We feel that this is the only way to ensure that all products available in the market, regardless of their nicotine content, meet the same high level of safety and quality objectives as communicated in the regulations. As a company, we are pushing for this to become part of the regulations to ensure optimum consumer safety across all product sets. Through our pharmaceutical backing and extensive expertise within the area, we are communicating this prospect with other manufacturers and retailers to ensure we are all on the same page and can take an industry-lead with shaping the regulatory future.

To further optimise our in-house capabilities and continue to assist in shaping the industry legislation and regulatory expectations, NextGEN360 have invested heavily in analytical equipment that will allow us to not only carry out in-house testing for TPD purposes, but develop methods to further investigate and analyse an array of products and their formulations to ensure paramount safety. We have a state-of-the-art laboratory that contains brand new analytical equipment (HPLC, GC-FID, GCMS and smoking machine) and have worked alongside well-known industry experts/scientists to develop methods for a range of nicotine, CBD and emissions testing. All methods have been independently verified by third-party consultants to ensure accuracy and validity across the board. NextGEN360 is ISO 9001:2015 accredited and works to GMP standards, with accreditation planned for the end of 2019. Furthermore, within the laboratory, ISO 17025 and UKAS accreditation is being implemented, with certification planned for Q2, 2020. Using all these in-house tools we can ensure as a company, that every product that leaves the building not only meets the requirements of the TPD but goes above and beyond expectations.

Alongside our in-house testing capabilities, we also commissioned an independent report in relation to health-precautionary tolerable levels for six key carbonyl e-liquid analytes. BIBRA (Toxicology advice & consulting) was asked to propose health-based tolerable inhalation levels (health criteria values (HCV)) for six specific carbonyl compounds that are routinely detected in vape emissions from e-liquids. Within the industry, the tolerable levels are not determined therefore the results that are obtained for submission purposes are obsolete due to no industry thresholds being determined. The maximum exposure limits that are determined allow us to review results and decipher those that do not meet criteria, and therefore fail this stage of the process. This is not a requirement of the TPD and the MHRA do not state maximum exposure limits, therefore leaving the industry open for manufacturers to market products that contain higher levels of potentially dangerous carbonyls – a foreseen issue within America as well as no set limits for carbonyls, the need to report these is only just being introduced as part of the PMTA.

In summary, based on the information and processes NextGEN360 have implemented, we are confident that our products are of the highest quality and meet all safety parameters that will consequently avoid any issue arising, like those that are currently occurring in America. Alongside the fundamental rules and regulations set out in the TPD, NextGEN360 have also implemented further protocols to ensure full transparency and safety for consumers. Our True Zero THC initiative communicates to the customer that none of our CBD products contain any THC, this is reflected in our analytical certificates that are provided to customers with every batch of CBD product that is sold. Alongside this, all our raw materials including Nicotine and CBD come in with a certificate of analysis and third-part analytical certificates.

We are constantly reviewing our processes to ensure we are up to date and consistent in our approach. To further validate our toxicological analysis methods and the maximum tolerable levels we will be re-commissioning BIBRA to re-validate the original study that was conducted to review the stated tolerable levels and to verify that the results take into account the array of products recently launched into the vaping market such as CBD vapes, Nicotine Salts and complex flavoured e-liquids. NextGEN360 have also been asked to be board members for the CMC (Centre for Medicinal Cannabis) to assist in the implementation of regulations from assisting in writing up regulatory standards to visiting third-party sites for audit purposes and becoming a kitemark company for the industry.

Lizi Jenkins
Head of Technical & Development   


    Five deaths in US lung outbreak; 450 cases now identified. (September 9th, 2010). Rubio, David Palacios. ECigIntelligence.
    Mystery vaping illness clarified, vitamin E acetate under the spotlight. (September 8th, 2019). Haridy, Rich. News Atlas.
    People are vaping THC. Lung injuries being reported nationwide. Why is the CDC staying quiet?. (August, 28th, 2019). O’Donnell, Jayne & Alltucker, Ken. USA Today.
    Accumulation of Ubiquitin and Sequestomose-1 Implicate Protein Damage in Diacetyl-Induced Cytotoxicity. (November 18th, 2016). Hubbs, AF. PubMed.Gov.
Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: caz on September 17, 2019, 08:47:23 AM
Title: Re: Dr Farsalinos - Hysteria in the US Re: Lung Disease/Deaths
Post by: pwmeek on September 17, 2019, 04:34:58 PM
Amazingly sane article. No hype; no wild claims; just straight reportage of where and when these incidents have occurred and of efforts to find the people behind them.