Explanation in pictures: Step-by-step walk-thru looking at a disassembled inhalation activated vape pen
https://www.flickr.com/photos/184689826@N07/albums/72157711682991023
Colorado Green Lab & Jacqueline McGowan: Inhalation Activated Vape Pens and Metal Exposure12/12/2019 This discussion relates ONLY to inhalation-activated vape pens with exposed metal solder in the air-channel leading from the battery compartment to the atomizer/heating coil, and the potential link between metal oxide inhalation and vaping illness in the United States.
Explanation in pictures: Step-by-step walk-thru looking at a disassembled inhalation activated vape pen https://www.flickr.com/photos/184689826@N07/albums/72157711682991023
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The two main topics discussed were: 1. CGL's development of the heavy metal exposure model with implications to the current vaping crisis and the onset of illness after the use of inhalation-activated vape pens. 2. Our work involving false THC positives after only CBD consumption. Vape illness and metal exposure from inhalation-activated vape pens Vape pen vivisection: https://www.flickr.com/photos/184689826@N07/albums/72157711682991023 CGL's Key findings: http://www.coloradogreenlab.com/blog/vpv2 CBD/THC false positives: https://www.nytimes.com/2019/10/15/science/cbd-thc-cannabis-cannabidiol.html Yesterday I confirmed the presence of significant quantities of exposed heavy metal solder (>55mg) in the vape hardware used by an individual who developed EVALI (probable case, confirmation is pending by hospital committee) in October. The hardware had the same general characteristics ("inhalation-activated") as the vape pens I deconstructed previously, with rough solder joints at the aperture into the battery compartment....Read More
In the United States, cannabis has been an important domestic crop, a medicinal remedy, and a demonized drug, with the tug of war between legalization and prohibition playing out over the centuries. The history of industrial, medicinal and recreational cannabis and its relationship to North America is complicated. To understand cannabis in the US today, you have to start at the beginning...read more Author:
Audience: Vape product manufacturers and regulators in the United States The United States is the largest market for vape products (34%) and cases of EVALI occur only in the United States. The European Union is the second largest market for vape products (25%), and no cases of EVALI have been reported in the EU to date. Aside from prohibiting sales to minors (under 18 years old), the US vape market is not regulated. By contrast, the EU market is regulated by the Tobacco Products Directive (TPD), which came into force in May 2016. Safety and quality standards for vaping devices are among the regulations contained in the TDP. These mandate manufacturers disclose toxicological data on ingredients and additives , describe the components and manufacturing process, and comply with limits on heavy metal content. Rational Implementation of Harm Reduction and Regulation We are not proposing immediate implementation of regulations as comprehensive as the TDP in the United States. The TDP was implemented carefully, over time, and in sections. This gave ample time for industry and regulatory agencies to coordinate with each other and provide feedback on the requirements. In this manner, only vape devices with a specified threshold of safety are allowed into the consumer market. There have been no reported cases of EVALI in the EU, and we believe this is the predictable outcome of a well-regulated vape market. The cause of EVALI in the United States remains unknown, but it is evident that not all cases were caused by black market products (ex. at least two verified cases were linked to legal dispensary products in Oregon), and not all were from THC products; 11% of EVALI patients reported using only nicotine products. This suggests poor quality hardware is responsible, and this may be addressed by regulation. Banning vaping altogether, by contrast, would not be effective, would cost taxpayer money to enforce, and would almost certainly do more harm. Blanket banning would cut the legs out from an adolescent industry on its way to becoming organized and safer, and drive it right back into the black market. Europe has demonstrated it is possible to effectively regulate vaping. The US already regulates nicotine, and at the state level, THC. Why not regulate the hardware? The 2014 EU Tobacco Product Directive (TPD): https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf AuthorCindy Blair My Bad: Clarification Regarding Metal Fumes vs Metal Particles In the first part of this blog series (Metal Fume Zebra), I used the example of Metal Fume Fever (MFF) to introduce the cadmium exposure hypothesis, and that lead to some confusion. Hot metal work (brazing, welding, etc) and inhalation of the accompanying metal fumes *is* the most common type of exposure. MFF can also develop from exposure to metal dust particles produced during cold sanding processes, particularly if the metal is highly toxic and readily soluble in the lungs (read: cadmium). I could have gone into the various strange forms of metal dust pneumonias (Kelleher P, 2000), but I figured Metal Fume Fever was weird enough territory to cover in one blog post. Look up beryllium disease. Very weird, multi-factorial illness, with genetic component......read more AuthorFrank Conrad Picture explanation: Click here for a step-by-step walk-thru taking apart and looking at an inhalation activated vape pen https://www.flickr.com/photos/184689826@N07/albums/72157711682991023 Part 3: Visual walkthrough of deconstructed vape pen hardware This took much longer than expected. I...don't always know how clear my communication is, and from some of the feedback on the initial set, there were gaps. From the initial feedback, I built in diagrams (example above), akin to "You Are Here" maps, to illustrate what the images are trying to convey and "where" in the vape pen the image is located, and highlighted key points and annotations in red. Key point Prior to this experience, I did not know what the insides of a vape pen looked like and I suspect the same for those reading this. Q: Would you voluntarily inhale vapor that had been sitting on 40-80 milligrams of metal solder, (regardless of whether it contained cadmium)? A: You would not. It is readily apparent that certain models of inhalation-activated vape devices expose the user to the toxic contents of the battery compartment (leachable metal solder). This is true, regardless of whether cadmium is ultimately determined to be the cause of EVALI. Not all vape pens pose this hazard, but there are no unified international standards regarding the quality of their construction and no standards at all on the products imported to the United States. Audience: Regulators The source of the problem associated with EVALI/VAPI illness has yet to be ascertained. Regardless of the cause (most likely a chemical contaminant, not vaping itself), bans do not work and would almost certainly promote more harm by fueling the illicit market for vape devices. A rationale approach to harm reduction would be to model e-cig and vape device safety requirements after those currently being implemented by the European Union Tobacco Products Directive (TPD). These include sharp limits on heavy metal content (like cadmium) in batteries and device power circuit safety testing. The EU is still not experiencing an outbreak of vape-related illness. Audience: Vape product manufacturers in the United States Having complete freedom to operate ended with the start of the vaping illness epidemic. I suggest a discussion with your Shenzen suppliers to request they provide you with the same TPD-compliant hardware used in vape devices imported by countries in the European Union. Pro-actively moving toward regulation is problematic (for one thing, the industry needs more qualified and trustworthy labs), but it is more profitable than the cost of irrational blanket bans on whole products and markets. Foreword (key findings revisited)
tl;dr
The CDC and the FDA have not found a common causal agent in the cartridges/products used by all people who have developed the illness. The presence of cadmium has not been confirmed yet in the products used by patients who developed EVALI. The hypothesis remains plausible:
Key findings from our vape pen study Findings relate only to airflow-activated ("auto") vape pens, as only these designs have an open channel into the battery compartment. Our results indicate plausible scenarios for contamination of vape liquid and transfer of contaminated vapor to the lungs. Quite unexpectedly, we also discovered the lithium ion cells contained within unbranded/counterfeit vape pens can be traced back to their manufacturer. This may be useful in determining the original source of the tainted hardware and cartridges.
Foreword to Vape Pen Vivisection: Not All Vapes To answer some FAQ: No, I do not believe all vape devices contain cadmium, nor do I believe that about most auto-vape pens (which are the focus of this study). Yes, I recognize the cadmium hypothesis is unusual and acute cadmium exposure is rare. So is VAPI/EVALI. If the cause of the epidemic was common or easily recognized, we'd already know what it is. Yes, I vape. Some of the dissected vape pen battery compartments show signs of use and corrosion because *I* was vaping from them over the past year. *I was literally shocked when I opened the battery compartment. If you don't learn from history... It does not diminish the seriousness of the current epidemic, nor the lives lost, to point out that millions of people in the United States enjoy vaping (nicotine and cannabis) in the United States every year and most experience no adverse effects. It merely places the epidemic in the correct context. Among the millions who vape, there have been 1,604 cases of VAPI/EVALI, with 34 confirmed deaths. The predictable (and somewhat understandable) political response has been to call for bans on vaping. Let me speak to that, briefly. If we recognize that illicit or poorly regulated vape products are to blame for the recent spate of deaths, then we must also recognize that banning vape products will worsen the problem. Multiple lessons from our nation's history have demonstrated that prohibition does not work, and has never worked. Regulation and harm reduction approaches, on the other hand, save lives and money; Prohibition does the opposite. I'll talk about the European Union's Tobacco Product Directive (still no VAPI in the EU, btw) and how it impacts vape product safety in a later post. Meanwhile, to counter the rising tide of "illegalize it!", the source of the problem must first be identified, then nullified. So, here we go, down the hole! ©2019 Colorado Green Lab | coloradogreenlab.com
Updated versions of this post can be found here: http://www.coloradogreenlab.com/blog/vpv2 http://www.coloradogreenlab.com/blog/vpv3 Audience:
Purpose: We respect and support the efforts of the CDC and the FDA to determine the cause of VAPI/EVALI. Colorado Green Lab is contributing our study on airflow-activated vape pens with the intent of adding a useful piece toward solving the puzzle. Problem and Scope: As of 22-October-2019, 1,604 cases of "Vape-Associated Pulmonary Injury" (VAPI) or "e-cigarette, or vaping, product use associated lung injury" (EVALI) have been reported to CDC, with thirty-four (34) confirmed deaths. At this time, FDA and CDC have not identified the cause of the lung injuries in these cases, and the only commonality among all cases is that patients report the use of e-cigarette or vaping, products. No single compound or ingredient has emerged as the cause of these illnesses to date. Proposed Common Source of Exposure Patients have reported using:
(Source: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html) Information downloaded 28-October-2019 We propose that the common source of illness in VAPI/EVALI patients is the vape pen battery. Cartridges designed specifically for nicotine or THC vape formulas are unlikely to come from the same manufacturing batch, nor would the vape formulas contain identical additives. Both cartridge types incorporate universal (#510) threading, and nicotine and THC #510 cartridges can be vaped using the same vape pen battery. The study will present key findings here, with related recommendations, and followed by additional posts with the study design, comprehensive results to support the proposed hypotheses, and extended conclusions on the findings. Key Findings Findings relate only to airflow-activated ("auto") vape pens, as only these designs have an open channel into the battery compartment.
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"Those cannabidiol-laced gummy bears may be entirely legal, but they could still get you arrested on marijuana possession charges." Click here to jump to the New York Times Article. We were interviewed for this article months ago. It has no connection to VAPI. It talks about false THC positives in users who are CBD consumers only. False positives occur both by derivatization and the Duquenois–Levine test. The DL test is commonly used to quickly detect THC at the roadside. It is an extremely unreliable test. Both are blog posts for another day. Photo Credit: Matthew Staver for The New York Times #forensicconsulting, #falsepositive, #CBD, #THC, #CBDtoTHC, #coloradogreenlab, #frankconrad
©2019 Colorado Green Lab | coloradogreenlab.com Y'all have been very patient with my painstaking approach (particularly my partner, Cindy); I am being appropriately careful about some of the conclusions drawn.
Here's a preview of Vape Pen Vivisection: Power Supply Connectors A picture is worth a thousand words. These will be posted in higher resolution in the final version. The top photo compares an auto vape pen to a non-auto vape pen (("external on/off switch"). The second photo is the external view of a #510 female thread connector (battery case removed) that connects to the male thread vape cartridge. The third photo shows what is not typical visible: the internal view of six (6) vape pen power modules, and specifically the solder points connecting the battery and control circuit to the underside of the #510 femaled-thread connector (which connects to #510 male-thread cartridges to power heating coil). The Liquid A visible air channel in the center flange is how e-liquid enters the battery compartment. The underside of one of the #510s even has obvious verdigris (green scale from oxidized copper), probably from exposure of internal coper wiring to liquid condensing in the compartment. The Metal The most significant take-home message is that there is a risk of short circuit between the large proximal globules of solder connecting the circuitry to the #510. In some cases (the far left example), the risk is minimal, but not in those with red circles. The solder points there are quite large and separated by no more than a millimeter or two. These solder points can be bridged by liquid entering the compartment and short circuit. Short circuits generate considerable heat and lead to solder fume production directly in the inhalation path of the vape pen user. As an aside, I got to experience the phenomenon first hand when disassembling one of the pens. A short circuit caused a nasty little fire and plume of greyish-white smoke. I made a very undignified shriek and smothered the fire in a bucket of sand. I was working in the fume hood (no danger of exposure), but it was quite startling. Cautionary note: Curiosity killed the cat, and more than a few scientists. Please don't play this way without safety precautions and appropriate PPE. ©2019 Colorado Green Lab | coloradogreenlab.com VAPI update
As of October 8th, 2019, 1,299 vape product users have developed a condition now known as "Vaping-Associated Pulmonary Injury" or VAPI, and 18 deaths have occurred as a result of the illness. As the name implies, VAPI occurs in individuals who have used vaping products. Although THC products have been strongly correlated with development of the illness, 17% of patients with VAPI reported exclusive use of nicotine-containing products source: https://www.cdc.gov/media/releases/2019/s1003-lung-disease.html Please consider refraining from the lettuce for a while While it is true that millions of people in the United States enjoy vaping and experience no adverse effects, the current epidemic *is* linked to vaping. For the duration of any epidemic with an identified source, the safest course is to refrain from the associated activity. If romaine lettuce is identified as the source of a deadly E. coli outbreak, you would probably stop eating romaine lettuce until the CDC gives an all-clear. In the same mindset, the CDC/FDA currently recommend that you refrain from vaping until the cause of VAPI is determined. Some of you are going to eat the lettuce anyway No judgment if you choose to continue vaping, but please monitor yourself for symptoms (e.g., cough, shortness of breath, chest pain). If you have concerns about your health, seek medical attention. I recognize that can be a hard ask; many people (including me) endure illness and avoid accessing healthcare due to the financial cost, taking time off work, childcare issues, lack of access, etc. I can't address any of those things in a blog post, but I can ask that you please see a healthcare provider if you are experiencing symptoms that aren't getting better or symptoms that keep coming back. More information on VAPI from the Centers for Disease Control (CDC) For the Public: What You Need to Know https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease/need-to-know/index.html Más información de los Centros para el Control y la Prevención de Enfermedades Para el público: Lo que debe saber https://www.cdc.gov/tobacco/basic_information/e-cigarettes/spanish/enfermedad-pulmonar-grave/lo-que-necesita-saber/index.html ©2019 COLORADO GREEN LAB | COLORADOGREENLAB.COM In the first of this three-part series on Vaping-Associated Pulmonary Injury (VAPI), I will introduce a compound with the motive, means, and opportunity to cause the illness. Part 2 will identify the common point of origin linking vape users in the United States and why Europe is unaffected, and, finally, Part 3 will outline a rational harm-reduction based approach for evaluating the safety and continued use of these products. tl;dr;dr 19_1006 update: Signs and symptoms of vaping-associated pulmonary injury (VAPI) are consistent with chemical inhalation. Analysis of symptoms, commonality of exposure source (vape pen battery cartridges), and mechanism ("vaping") may indicate cadmium-derived metal oxide fume inhalation (metal fume fever, cadmium pneumonitis) as a possible cause of the syndrome ("VAPI"). tl;dr Public service announcement: Clinicians, when you hear vaping, think zebras, not horses. The early symptoms of VAPI are often mild and resemble pneumonia ("horse"). Many of the VAPI ("zebra") patients presented in an outpatient setting, were initially diagnosed with respiratory infections, and treated with antibiotics (without improvement). Workups were negative for infectious agents, and chemical exposure of unknown type/origin is now believed to be the cause of VAPI. The majority of patients who develop this illness exhibit clinical improvement only after treatment with systemic corticosteroids. The CDC encourages clinicians to report possible cases of e-cigarette or vaping-associated lung injury to their local or state health department for further investigation: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease/healthcare-providers/index.html tl Vapi Data Set. The VAPI data set published (September) in the New England Journal of Medicine (Layden, Ghinai et al. 2019) is the most comprehensive study to date, and includes clinical findings from 53 patients in Illinois and Wisconsin (Full text: https://www.nejm.org/doi/full/10.1056/NEJMoa1911614). Unless otherwise indicated, signs, symptoms, data, etc are in reference to this publication. July/August 2019. Hundreds of patients with an unusual respiratory illness began popping up in clusters across the United States. In the days and weeks prior to their hospitalization, these patients exhibited typical signs and symptoms of pneumonia and most were prescribed antibiotics as the first course of treatment. None of the patients (who were eventually diagnosed with vaping-associated pulmonary injury; VAPI) improved on antibiotics and lab workups revealed no evidence of pulmonary infection. The full range of findings is conflicting and no clear pattern has emerged regarding the source or cause of the illness. Symptomatology Patients have highly similar clinical characteristics and all developed the illness within a similar timeframe.
Vaping Products Most patients reported using vaping devices with THC and nicotine cartridges, but some reported exclusive use of only THC or only nicotine. A wide variety of cartridge brands and products were reported. US-wide, US-specific Cases are not specific to any one region of the United States, but the syndrome appears to occur only in vape users in the United States. Other parts of the world with a high prevalence of vaping (ex. the European Union) are not reporting similar illnesses. More on that in second and third part of series. Correlation ≠ Causation The underlying cause is now believed to be chemical exposure, and not an infectious disease. The VAPI syndrome is strongly correlated with the use of black market THC vape cartridges, but the CDC has yet to conclusively identify a vaping product, substance, or additive common to all cases. Metal Fume Fever Unless you're a metalworker, work for OSHA, or, in my case, previously employed at a respiratory hospital, you've probably never heard of Metal Fume Fever (MFF). There are only 1500-2500 cases of MFF reported in the United States each year, and the illness is typically restricted to individuals with very specific occupations (e.g. welders). MFF is caused by inhalation of metal-containing fumes (ex. zinc oxide) produced by welding, soldering, and brazing. Typical symptoms of metal fume fever are non-specific ("flu-like"), and can include cough, raised temperature ("fever"), headache, chills, aches, dizziness, and a sweet or metallic taste in the mouth. More severe exposure can result in gastrointestinal symptoms, including nausea, vomiting, and diarrhea. Metal fume fever caused by zinc oxide inhalation is the most frequently reported type of exposure and bears superficial resemblance to VAPI. Acute symptoms develop 4-12 hours following zinc fume exposure, but do not usually progress to lung damage. The zinc oxide-associated form of the illness typically self-resolves within 12- to 48-hours. Cadmium Pneumonitis A far more serious form of metal fume fever occurs after inhalation of cadmium oxide fumes. The immediate effects are similar to those described above ("flu-like"), but unlike zinc oxide exposure, cadmium fume inhalation causes significant lung damage post-exposure (pneumonitis), and can progress to hypoxia, respiratory failure, and death. The table below compares the clinical presentation of zinc oxide metal fume fever (MFF), cadmium pneumonitis (CP), and vaping-associated pulmonary injury (VAPI). High Index of Suspicion Silver solder (often contains cadmium) is used to make stable unions between dissimilar metals such as copper and stainless steel. In lower-end vape pens, large beads of this type of solder are present on positive and negative heating element connections. Most vape pens use cadmiun-free solder. Unscrupulous manufacturers have a financial incentive to cut corners. It's happened before: https://en.wikipedia.org/wiki/2008_Chinese_milk_scandal Motive Money and ease of use. Cadmium-containing silver solder is less expensive than cadmium-free alternatives, and has improved flow properties which facilitate the joining of dissimilar metals found in vape pen electrical components. Means Cadmium is highly toxic to multiple organ systems. Upon inhalation, cadmium elicits a dose-dependent burst of inflammatory cytokines that promote the systemic effects (fever, headache, joint pain, etc) observed in metal fume fever (Blum, Rosenblum et al. 2014). Cadmium fumes also directly injure lung cells, leading to fluid accumulation, impaired lung function, and respiratory failure. Following absorption into the bloodstream, protein-bound cadmium slowly accumulates in the kidneys and may result in renal injury. Opportunity Upwards of 20-30 mg of solder alloy is permeated with vape juice liquid and directly in the airflow path through the vape pen. Assessment Blood cadmium levels are indicative of recent exposure, whereas urinary cadmium is indicative of chronic, longer term exposure. Normal blood cadmium is <5.0 ng/mL, with most results in the range of 0.5 to 2.0 ng/mL, whereas tobacco smokers typically have blood and urinary cadmium levels more than double those of nonsmokers (Mannino, Holguin et al. 2004). ©2019 COLORADO GREEN LAB | COLORADOGREENLAB.COM
Continued in Part 2: Vape Pen Vivisection I've been contacted frequently over the past few months regarding the basis for false-positive results from rapid screen THC immunoassays. These inquiries are usually in the context of pre-employment and random urine screening, but occasionally arise from more unusual circumstances (Hugo, CO). I was asked yesterday about the potential for false positive THC results in newborns, and after looking into it, the answer surprised me. It turns out false-positives for THC are fairly common. Upon observing that follow-up screening by GC-MS failed to verify the initial positive immunoassay test result in newborns, a team of social workers, care providers, hospital staff, and laboratory personnel at UNC - Chapel Hill investigated this issue. They determined that THC immunoassays react with, among other things, non-THC components of baby soap, including cocamidoprophyl betaine, polyquaternium 11, PEG 80 and sorbitan laurate, and numerous other compounds, thus leading to an unusual number of false-positives during newborn drug screening. Negative Consequence of False-Positives As legal cannabis becomes more widely available across the United States, it becomes even more important to be aware of the potential for false-positive results in many areas ranging from commonplace employment drug testing, to motor vehicle operation, and now to newborn drug screening. The negative legal, economic, and social consequences of false-positives are considerable and too lengthy a topic to go into here. False-Positives in Newborns Positive immunoassay results are confirmed or refuted with more sophisticated methods such as GC-MS, but a considerable amount of time (often days) may elapse between the preliminary result and verification. In that interim period there is potential for involvement by child protective services and allegations of child abuse. Given the seriousness of these consequences, it is incumbent on care providers and laboratory personnel to be aware of the limits of preliminary immunoassay screening and to consider secondary testing and confirmation prior to initiating costly and possibly unnecessary interventions. Credits Shout out to the team of social workers, care providers, hospital staff, and laboratory personnel from UNC-Chapel Hill who took the time to work out this puzzle. Unexpected interference of baby wash products with a cannabinoid (THC) immunoassay. Cotten SW, Duncan DL, Burch EA, Seashore CJ, Hammett-Stabler CA. Clin Biochem. 2012 Jun;45(9):605-9. doi: 10.1016/j.clinbiochem.2012.02.029. Epub 2012 Mar 23. ©2016 COLORADO GREEN LAB | COLORADOGREENLAB.COM
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