The study is a complete nonsense....
Please read more into the study as well as this thread. Many of your(our), concerns have been addressed here in responses from Dr. E, the doctor who performed the study.
Regarding funding:
At the risk of being pilloried all over again, the difference between e-cig industry funding a study now and big pharma funding a study now is that e-cig industry is not subject to regulation and big pharma is.
When pharma commissions a study -- say an abuse liability study like we discussed earlier -- they provide support to ensure that it is conducted under exceedingly stringent review procedures because they know FDA is going to scrutinize (or at least has the option of scrutinizing) every element of that study, from the first screening form to the final analysis. I've conducted pharma-sponsored studies in my lab (not related to nicotine) and I can tell you that the level of paperwork and data review is quadruple any of my NIH-funded studies. We must use complicated hand-entered "case report forms" for any measure taken (sometimes signed or initialed by the study participant), we have independently contracted study monitors in the lab daily or weekly to check all study procedures/records for completeness, and any missing form or value becomes a "protocol violation" that requires additional paperwork to document what happened and why. Once the data are collected, there is a comprehensive review to ensure that the case report forms match the computer-entered data, then the computer entered data are shipped somewhere for independent data entry and "database lock". Etc. etc. etc. All of these steps are taken at *great cost* by the pharma sponsor in part because they know that the entire study is looked at as potentially biased. So they have all these safeguards to minimize any chance of bias. There is an entire industry (the contract research organizations, or CROs) that thrives on running these type of studies.
I'm not saying bias doesn't happen, of course. I will say that bias is very difficult to introduce into the screening, data collection, and data analysis phases of a pharma study (interpretation of the analysis results is a different issue and requires other controls). I will also say that, without regulation of industry X, industry X is not going to pay the substantial additional costs of running a study under these extraordinary conditions that are used to minimize bias in screening, data collection, and data analysis (i.e., a 250,000 dollar study becomes a 1 million dollar study). Thus, when industry X sponsors a study on their own products, all of us have an obligation to be skeptical (and I have no objection to a healthy skepticism of big pharma either).
I hope this response helps a little....
Great info Dr. E!
I've always argued that most of the nicotine one gets is from lip and other skin contact. [...] The liquid nicotine is VERY absorbable through the skin, and I still think filling the carts which results in small amounts of juice on the skin, and overflow on the lips from a fresh cart is the primary way nicotine gets in your system. Having said that, your mind will quickly associate the nicotine in your system with the vapor you see. So, it's just like smoking in the end. We should all probably just wear a nicotine patch and vape 0mg liquid. It would be exactly the same.
I disagree with this statement. While we all can agree that nicotine is very absorb-able through skin contact, I don't think this is the
only reason PV users are getting nicotine. I direct drip, and haven't had any overflow onto my lips since my first week of using a PV. I use gloves when making my e-liquids, and never get liquid on my hands. Forum members' studies have already shown that there is
definitely sufficient nicotine in the vapor that PVs produce.
I'm torn on that point. As has been discussed elsewhere, people can BUY all sorts of poisons (at the hardware store, for example). The problem isn't the ability to buy nicotine in potentially dangerous quantities. The problem arises when the nicotine is found in a sweet and nice smelling liquid form that is easily accessible (i.e., over the internet) and not always labeled or packaged in a manner that is consistent with the potential lethality of the contents. Does that make sense?
The dripping itself, if we assume everything handled securely, is not the concern. If it caused acute nicotine intoxication, there would not be so many successful reports/descriptions of it.
Yes, refilling and also mixing new flavors (that I have seen on YouTube). Any opportunity to come in physical contact with high dose nicotine is alarming; I would not do it without gloves and a mask. As a graduate student, I once saw a rat who had been injected with more nicotine than was intended. It was extremely unpleasant for me, and I think for him too.
Thanks for the clarification on that Dr. E! Very well said.
I completely agree that there is concern to be had with the proper labeling on nicotine liquids. Some of my online-purchased e-liquids have no labeling other than flavor and strength. Others have labels that list ingredients, have warning labels saying
very toxic, and say 'keep out of reach of children'. Unfortunately, there are a lot of companies that do
not label e-liquids, which is definitely a concern. I hope any future FDA decisions on e-liquid will address regulations for proper labeling.
I make my own e-liquids, like some others on this forum. I definitely never handle any nicotine solution without gloves, goggles, and a face mask. I make sure that I only do my mixing in a clean room of my house, designated only for e-liquid mixing. I make sure there are no spills, and if a drop of liquid
does spill onto my mixing surface, it is cleaned properly. I don't have children, but if I did I would definitely make sure this room has several locks on the door. I don't have pets, but the same concern would be for them. It is a growing concern of mine that many people who become enamored with PVs start mixing their own liquids, and I hope they all know how toxic the nicotine is. It's concerning to me that you can purchase 125mg/ml nicotine liquid online(which is what I use as a base) without any age verification or FDA knowledge.
I have a bottle of 60mg/ml liquid for mixing that says
"Caution-Use At Own Risk; Contains Distilled Water, Nicotine, PG; Keep away from children and pets; If ingested call poison control 1-800-222-1222
I also have a bottle of 36mg/ml liquid that only says
I think we can all agree that proper labeling of high strength nicotine liquids needs to be addressed by the FDA in some manner. Hopefully, the regulations that are put in place will not affect our ability to continue mixing safely as a hobby, but ensure that these nicotine liquids are properly labeled as to their ingredients, their strength, their toxicity, etc. There is just too much inconsistency in the varying labels right now with no regulations on
how they need to be labeled.
