Robert and Margaret Lochhead, Lochhead Consulting LLC12.02.20
The COVID-19 pandemic is leaving a trail of death, grief and suffering, but it has also motivated inventors to apply their knowledge and skills to reverse the onslaught of this dreadful and contagious disease. This article reports on recently-published inventions that could reverse the course of COVID-19 and may provide opportunities that might change the household and personal care industry.
Digital Transformation
While human interconnectivity drives epidemics and pandemics, digital interconnectivity has the potential to combine our global resources to combat the spread of disease. We are in the midst of a digital transformation that is leading to a closely interconnected world. This is driven by the interplay of cloud computing, the Internet of Things, artificial intelligence and even artificial super intelligence.1
The limitations imposed by the pandemic have been overcome to a certain extent by existing cyber extensions of humans through the internet by means of computers, phones, smart voice devices and even watches. This global interconnectivity and instant communication is expected to persist and accelerate.2
The Internet of Things (IoT) is the concept of expanding network connectivity and computing capability to sensors that enables everyday items to exchange data with little direct human intervention. Digital transformation already plays a role in addressing the spread of contagious disease in an increasingly interconnected world and many inventions that were inspired by the pandemic can be expected to change the pre-pandemic norm. Some of these transformations are described here.
IoT Monitors Handwashing
In order to prevent the transmission of disease-carrying pathogens, the CDC recommends handwashing with soap, scrubbing for 20 seconds, and rinsing and drying.3 However, handwashing is frequently conducted with less rigor and, as a consequence, the spread of disease persists in the human population. For example, even in the absence of COVID-19, infected food workers cause about 70% of reported norovirus outbreaks from contaminated food. Poor hand hygiene has been identified as a causative factor in the COVID-19 pandemic.4,5 One way to address this problem is to introduce “smart sinks” to monitor handwashing.6 These sinks, described in a recent patent application, contain sensors that track the handwashing process, advise the user in real time to encourage hygiene compliance, and report the activity to a central processor. Smart hand sanitizer devices could transmit reminders when it is time to re-sanitize hands.
Telemedicine and Wearables
The popularity of wearable fitness trackers and smart watches to monitor physical activity is an indication of the willingness of ordinary consumers to embrace such technological advances. IoT is changing the way health care is provided through data capture and monitoring via mobile and wearable devices enabling people to self-monitor and self-manage their health care, and allow healthcare professionals to intervene as necessary. Such a system allows a doctor in his office to take care of an patient flying in a plane at 30,000 feet, half a world away.7 Wearables measure blood pressure and monitor stress before chronic hypertension results in stress-caused disease.8 Imagine that in an IoT world, high blood pressure automatically locks salt shakers.
The COVID-19 pandemic accelerated digital transformation in healthcare and forced adaptation to a flexible clinical trial model. Reliance on finding a vaccine for the latest pathogenic virus will likely lag the onset of disease in the population. In the interim, when vaccines are not available, the adoption of good hygiene practices can decelerate or even prevent cross-infection. However, poor hygiene habits are not necessarily easy to rectify. For example, it is well known that pathogenic microorganisms are transferred by hands touching one’s face, another person or even an inanimate object that becomes a disease vector. One way to train people to avoid such disease-spreading habits could be to use sensors that detect coughs and sneezes, and transmit a signal when hands get too close to faces.9 We envision sensors that are earrings or earbuds or embellishments on caps or even hair ornaments that signal unconscious touching habits and replace them with a consistent habit of hygienic touch-avoidance. These sensors could go a long way to address the onslaught of COVID-19 and the anticipated cyclical occurrence of coronavirus-borne disease; encouraging good hygiene habits could mitigate the spread of colds, flu and gastrointestinal diseases, too. Imagine an imperceptible face makeup that is complemented by a hand rub that produces color on the hands if the face is touched. It is one way to provide instant feedback to nip a poor hygiene habit in the bud.
One interesting aspect of such good hygiene practices is the treatment and prevention of obesity. Adenoviruses are normally associated with cold symptoms but Adenovirus-36 is an apidogenic virus that has been increasingly linked to obesity.10 The possible connection between a virus and obesity was noticed in chickens that became obese when they were infected by their neighbors. It is being hypothesized that obesity may not be just the result of inaction and over-consumption. Obesity has become a global “epidemic” since the 1980s, even in poor countries where people are neither sedentary nor over-fed. It seems that obesity can be “caught” just like a common cold.11 Wouldn’t it be great if good-habit-forming beauty accessory devices could fend off COVID-19, colds, flu and even obesity, as we wait for effective vaccines to be available.
Wearable devices, such as smart watches, are already capable of recording and transmitting personal biometric data. Devices can be used to routinely measure vital signs such as body temperature, pulse rate and blood oxygen levels. Linking these devices to medical practitioners via cloud computing allows remote diagnosis, monitoring of a disease condition, and routine post-disease followup. With reference to the current COVID-19 pandemic, continuous remote digital access to care offers the promise of:12
One recent invention is a wearable instant particle detector that uses UV light to detect particles and determine whether or not they are dangerous from their UV signature.13 We foresee a time when smart wearable beauty accessories will warn of the presence of microbiological pathogens and harmful pollutant particles, too.
It is conceivable that networked wearable device technology may find application in the continuous transmission of cosmetic and personal care attributes that aid the creation of products which exactly meet consumer needs. As personalized medicine moves closer to reality, and telemedicine advances, computer-assisted methods and systems for diagnosis and treatment are being developed. Under conditions of uncertainty, physicians can use decision analysis as a guide to optimize prescriptive strategies. However, decision analysis offers advice to the physician that can merely be ignored by the patient. In this respect, this is similar to developing cosmetics products with the guidance of limited panel testing or consumer testing. How many times have companies created the “perfect” product that was shunned by real consumers? Game theory provides a supplemental approach to decision analysis to consider both the expertise of the doctor and the desires, fears and prejudices of the patient.14,15 The limitations and prohibitive costs of panel testing and consumer testing could be overcome by game theory.
In the medical scenario, game theory provides a supplemental approach that considers both the expertise of the doctor and the desires, fears and prejudices of the patient. Decision analysis combined with game theory is emerging to test scenarios to predict the course of disease and pandemics, and to guide treatment professionals to the best prophylactics and for the diseased condition.16 We can foresee a day when such an approach is used to tele-guide consumers to their optimal personal cosmetics and “truly personal” personal care products,17 complemented by “magic” mirrors that track appearance to provide the data to guide consumers to personalized personal care and beauty.18
With the advent of IoT, cloud computing and artificial intelligence, what was once perceived as risk could be meaningfully mitigated and what was perceived as uncertainty could be eliminated by good behavioral practices. In this era, the will to embrace and scale mobile-digital tools in clinical research has never been stronger.19 For example, to guide medical providers, each person could be assigned a digital “twin” to detect medicines that resulted in adverse reactions or could not be absorbed and, therefore, rendered useless by the patient’s metabolism.20 In the personal care industry, such a digital twin could avert allergic reactions to topical formulation ingredients.
Social Distancing Sensors
Will we ever return to live conferences and trade shows? If so, smart badge technology may prevent the transmission of contagious diseases. Conference attendees are familiar with badges that allow entry to the hallowed event halls and communicate each attendee’s identification and professional affiliation. But in a pandemic, if you can read someone’s badge you are probably too close for social distancing requirements. Smart accessories with nonverbal line of sight protocols could transmit and receive badge information. Such a system was filed as a patent application.21 Wearable sensors could be configured to analyze body fluids, like sweat, in real time and transmit the health of the wearer and even provide guidance for balanced diet choices as the wearer browses over snacks and meals.22
On October 13, a patent was granted for a social distancing awareness system. The system consists of a device that generates a zone of visible colored light around a person that changes color in the boundary region when social distancing is violated and informs the administrator of encroachment. We foresee a future in which such social distancing enforcement systems become common for safety considerations.23
Masks as Cosmetics
Ideally, N95 masks should be worn to ameliorate the spread of COVID-19 (and other respiratory diseases). However, the pandemic has limited the supply of N95 masks for consumers. Masks are evolving into beauty accessories with imprinted designs or added glitz. Some masks are washable and reusable but, in general, they do not meet the N95 standard for reducing respirable particles. This may change with the use of Jacquard weaving machines on Rapier or Air-jet looms.24 In Jacquard weaving, punched cards having multiple rows of tiny punched holes that guide the warp up and warp down a prescribed weaving pattern. The process is not new; it was named after its inventor, Joseph Marie Jacquard, in 1801, and it has been used routinely to produce brocade and damask fabrics.25 Demonstrations of Jacquard weaving can be seen in YouTube presentations by the Victoria and Albert Museum26 and the National Museums of Scotland.27
Modification of the Jacquard process with modern cutters, including laser cutters, allows the production of masks that can meet the N95 standard. Moreover, the Jacquard masks are washable and reusable. As a result, the COVID era may usher in the emergence of N95 quality, reusable masks as beauty/cosmetic accessories. If mask-wearing continues, it will also be necessary to formulate makeups that do not interfere with the seals around the mask peripheries.
We cringe when we see food service workers wearing masks beneath their noses, or only around their chins or throats. Lack of compliance in mask wearing can be a consequence of the discomfort of wearing a mask for long periods of time. One patent application is directed to the use of ingredients that provide a cooling sensation to relieve the discomfort of mask wearing.28 The cooling materials are disclosed as 1-diisopropyl- phosphinoalkanes. The cooling ingredients are applied to the external nares of the nose. Ingredients that provide such cooling sensations are considered by the FDA to be active ingredients for drugs rather than cosmetics. For example, in the US, menthol may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established drug name is Menthol.29 The FDA has issued draft guidelines for testing of menthol and methyl salicylate patches for use as topical delivery systems.30 The FDA also warned that topically-applied menthol, methyl salicylate and capsaicin has caused burns in a small number of cases.31
In the interest of public health, wouldn’t it be great to have masks that color code to warn the wearer when they are posing a public health risk? Moreover, sensors within the accessory could immediately inform supervisors and management and allow corrective action to be taken to avoid the public health risk or the perception of such. The personal care/cosmetics industry is heavily invested in hands-on advisement of clients but there is now a reluctance for customers to visit the stores that provide such services and merchandise.32 Moreover, COVID-19 has had a devastating effect on beauticians, hairdressers and estheticians. Close physical proximity is an essential aspect of salon services and it is likely that customers and operators alike will be apprehensive about close approach as salons re-open.33 This industry could be re-energized by accessories that signal “wellness” to both operator and client promoting the necessary trust for physical proximity during a time of social distancing. Distributed trust provided by blockchain oversight of the devices could provide the customer-client confidence necessary for this industry to recover.34 Once implemented, such a signaling system would likely persist beyond the current pandemic and embrace wider sectors of society. Perhaps post-pandemic awareness and tracking of necessary hygiene practices will reduce the United States’ annual toll of 9 million cases and 160,000 deaths from chronic constructive pulmonary disease,35 and 200 million cases and 11,000 deaths from gastroenteritis each year.36
Extracellular Vesicles and Exosomes
In severe COVID-19 infection, patients can suffer acute respiratory distress, which arises from an auto-immune hyper-inflammatory response to the virus. When the virus attacks, the infected cells release inflammasomes. This is a normal response to cell injury and, in normal conditions, the inflammasomes induce inflammation in the tissue which begins the process of repair and recovery.37 In auto-immune diseases, a hyper-inflammatory response is an over-reaction that can cause illness or even death. Inflammasomes are multi-protein complexes that are innate immune system receptors and sensors which, upon infection, trigger the release of cytokines that start the inflammation process and under normal circumstances, begin the healing process. However, the hyper-inflammatory response in some COVID-19 patients results in a cytokine storm that causes a hyaluronan storm in the lungs,38,39 causing the formation and accumulation of large quantities of hyaluronan gel in the lungs, resulting in acute respiratory distress and, in some cases, death. Signaling between cells and transport of cell-control mediators, like inflammasomes, are transported between cells by extracellular vesicles or exosomes. These tiny lipid vesicles function as vessels to carry the molecules that control the system for multicellular organisms. Exosomes are formed in endosomes inside a cell and are released into the extracellular medium by fusing with the cell membrane and budding in a process that is almost the opposite of endocytosis. Exosomes were initially thought to function as a garbage bag to dump unneeded proteins in the maturing red blood cell.40 It was later discovered that exosomes are extracellular vesicles that contain a specific composition of proteins, lipids, RNA and DNA.41 Exosome biogenesis occurs in three stages: One, formation of endocytic vesicles by invagination of the plasma membrane; two, formation of multivesicular bodies by inward budding of the endosomal contents; and three, fusion of the multivesicular bodies with the plasma membrane and release into the extracellular matrix as “exosomes.”
Exosomes play significant roles in several vital processes including angiogenesis, antigen presentation, apoptosis, coagulation, cellular homeostasis, inflammation and intercellular signaling. Exosomes contain precise compositions of RNA, proteins and enzymes, lipids that relate to the cell in which they originated, and they achieve their functionality by intercellular transfer of these components. By this means, exosomes affect the physiological and pathological processes in various diseases, including cancer metathesis, neurodegenerative diseases, infections and autoimmune diseases.42 The investigation of exosomes is a rapidly accelerating emerging field of investigation that is still in its infancy,43 and yet exosomes have already appeared as ingredients in the INCI dictionary (Human Adipose Derived Mesenchymal Cell Exosomes, Human Adipose Stromal Cell Exosomes, Human Amniotic Fluid Induced Pluripotent Cell Exosomes, Human Amniotic Fluid Mesenchymal Stem Cell/Trophoblast Cell Exosomes, Human Cord Blood Progenitor Cell Exosomes, Human Dermal Fibroblast Induced Multipotent Cell Exosomes, Human Umbilical Mesenchymal Stem Cell Exosomes, Milk Exosomes). Exosomes are already being touted in a skin moisturizing lotion that is claimed to contain 150 million exosomes in each container.44,45 A quick calculation reveals that this concentration of exosomes corresponds to about 0.00000000000001%! Moreover, if therapeutic or prophylactic claims were made for such a product, then it would be regulated as a drug by the FDA. On the other hand, if no therapeutic or prophylactic claims were made, but the product did really affect the structure or function of the body, then it could be regarded as a misbranded drug by the FDA.
About the Authors
Following a 25-year career with ICI, Unilever, and BF Goodrich, Bob joined academia and served as professor, chair and director of the School of Polymers and High-Performance Materials at the University of Southern Mississippi. Following retirement from the university in 2016, Bob founded Robert Lochhead Consulting LLC. Bob has served twice as the President of the SCC, and also as President of the International Association of Formulation Chemists. Bob is a fellow of the SCC and a Fellow of the Royal Society of Chemistry. Among other honors, he is a recipient of the SCC’s Maison G. DeNavarre Medal Award, the SCC’S Merit Award, the AIChE’s Chemical Pioneer Award, and the Society of Plastics Engineers’ Education Award. Bob received the SCC’s Lifetime Service Award in December 2019 and was named one of the first three Fellows of the IFSCC in 2020. Contact info: robert.y.lochhead@gmail.com
Margaret’s initial occupation was as research assistant for drug trials in the Department of Haematology at the Glasgow Royal Infirmary. After being full-time mother to two beautiful and talented daughters, for the latter part of her career she taught developmental mathematics at Lorain County Community College, and the University of Southern Mississippi, where she also taught the university success skills course and advised students with undeclared majors. In her retirement, Margaret is a partner in Lochhead Consulting LLC. Contact Info: Margaret.lochhead@gmail.com
References
Digital Transformation
While human interconnectivity drives epidemics and pandemics, digital interconnectivity has the potential to combine our global resources to combat the spread of disease. We are in the midst of a digital transformation that is leading to a closely interconnected world. This is driven by the interplay of cloud computing, the Internet of Things, artificial intelligence and even artificial super intelligence.1
The limitations imposed by the pandemic have been overcome to a certain extent by existing cyber extensions of humans through the internet by means of computers, phones, smart voice devices and even watches. This global interconnectivity and instant communication is expected to persist and accelerate.2
The Internet of Things (IoT) is the concept of expanding network connectivity and computing capability to sensors that enables everyday items to exchange data with little direct human intervention. Digital transformation already plays a role in addressing the spread of contagious disease in an increasingly interconnected world and many inventions that were inspired by the pandemic can be expected to change the pre-pandemic norm. Some of these transformations are described here.
IoT Monitors Handwashing
In order to prevent the transmission of disease-carrying pathogens, the CDC recommends handwashing with soap, scrubbing for 20 seconds, and rinsing and drying.3 However, handwashing is frequently conducted with less rigor and, as a consequence, the spread of disease persists in the human population. For example, even in the absence of COVID-19, infected food workers cause about 70% of reported norovirus outbreaks from contaminated food. Poor hand hygiene has been identified as a causative factor in the COVID-19 pandemic.4,5 One way to address this problem is to introduce “smart sinks” to monitor handwashing.6 These sinks, described in a recent patent application, contain sensors that track the handwashing process, advise the user in real time to encourage hygiene compliance, and report the activity to a central processor. Smart hand sanitizer devices could transmit reminders when it is time to re-sanitize hands.
Telemedicine and Wearables
The popularity of wearable fitness trackers and smart watches to monitor physical activity is an indication of the willingness of ordinary consumers to embrace such technological advances. IoT is changing the way health care is provided through data capture and monitoring via mobile and wearable devices enabling people to self-monitor and self-manage their health care, and allow healthcare professionals to intervene as necessary. Such a system allows a doctor in his office to take care of an patient flying in a plane at 30,000 feet, half a world away.7 Wearables measure blood pressure and monitor stress before chronic hypertension results in stress-caused disease.8 Imagine that in an IoT world, high blood pressure automatically locks salt shakers.
The COVID-19 pandemic accelerated digital transformation in healthcare and forced adaptation to a flexible clinical trial model. Reliance on finding a vaccine for the latest pathogenic virus will likely lag the onset of disease in the population. In the interim, when vaccines are not available, the adoption of good hygiene practices can decelerate or even prevent cross-infection. However, poor hygiene habits are not necessarily easy to rectify. For example, it is well known that pathogenic microorganisms are transferred by hands touching one’s face, another person or even an inanimate object that becomes a disease vector. One way to train people to avoid such disease-spreading habits could be to use sensors that detect coughs and sneezes, and transmit a signal when hands get too close to faces.9 We envision sensors that are earrings or earbuds or embellishments on caps or even hair ornaments that signal unconscious touching habits and replace them with a consistent habit of hygienic touch-avoidance. These sensors could go a long way to address the onslaught of COVID-19 and the anticipated cyclical occurrence of coronavirus-borne disease; encouraging good hygiene habits could mitigate the spread of colds, flu and gastrointestinal diseases, too. Imagine an imperceptible face makeup that is complemented by a hand rub that produces color on the hands if the face is touched. It is one way to provide instant feedback to nip a poor hygiene habit in the bud.
One interesting aspect of such good hygiene practices is the treatment and prevention of obesity. Adenoviruses are normally associated with cold symptoms but Adenovirus-36 is an apidogenic virus that has been increasingly linked to obesity.10 The possible connection between a virus and obesity was noticed in chickens that became obese when they were infected by their neighbors. It is being hypothesized that obesity may not be just the result of inaction and over-consumption. Obesity has become a global “epidemic” since the 1980s, even in poor countries where people are neither sedentary nor over-fed. It seems that obesity can be “caught” just like a common cold.11 Wouldn’t it be great if good-habit-forming beauty accessory devices could fend off COVID-19, colds, flu and even obesity, as we wait for effective vaccines to be available.
Wearable devices, such as smart watches, are already capable of recording and transmitting personal biometric data. Devices can be used to routinely measure vital signs such as body temperature, pulse rate and blood oxygen levels. Linking these devices to medical practitioners via cloud computing allows remote diagnosis, monitoring of a disease condition, and routine post-disease followup. With reference to the current COVID-19 pandemic, continuous remote digital access to care offers the promise of:12
- Minimized risk of infection by reducing physical contact be tween patient, medical staff, and other diseased individuals seeking health care;
- Increased patient convenience, and quicker medical response;
- Reduced human resources and costs;
- More effective use of medical staff;
- Regular recording of vital signs with real time digital, searchable record of changes in the disease condition; and
- Providing anonymized and richer, data set to identify significant trends both for the individual and the COVID-19 symptomatic population taken as a whole, extrapolated from demographics, and progress of illness or recovery.
One recent invention is a wearable instant particle detector that uses UV light to detect particles and determine whether or not they are dangerous from their UV signature.13 We foresee a time when smart wearable beauty accessories will warn of the presence of microbiological pathogens and harmful pollutant particles, too.
It is conceivable that networked wearable device technology may find application in the continuous transmission of cosmetic and personal care attributes that aid the creation of products which exactly meet consumer needs. As personalized medicine moves closer to reality, and telemedicine advances, computer-assisted methods and systems for diagnosis and treatment are being developed. Under conditions of uncertainty, physicians can use decision analysis as a guide to optimize prescriptive strategies. However, decision analysis offers advice to the physician that can merely be ignored by the patient. In this respect, this is similar to developing cosmetics products with the guidance of limited panel testing or consumer testing. How many times have companies created the “perfect” product that was shunned by real consumers? Game theory provides a supplemental approach to decision analysis to consider both the expertise of the doctor and the desires, fears and prejudices of the patient.14,15 The limitations and prohibitive costs of panel testing and consumer testing could be overcome by game theory.
In the medical scenario, game theory provides a supplemental approach that considers both the expertise of the doctor and the desires, fears and prejudices of the patient. Decision analysis combined with game theory is emerging to test scenarios to predict the course of disease and pandemics, and to guide treatment professionals to the best prophylactics and for the diseased condition.16 We can foresee a day when such an approach is used to tele-guide consumers to their optimal personal cosmetics and “truly personal” personal care products,17 complemented by “magic” mirrors that track appearance to provide the data to guide consumers to personalized personal care and beauty.18
With the advent of IoT, cloud computing and artificial intelligence, what was once perceived as risk could be meaningfully mitigated and what was perceived as uncertainty could be eliminated by good behavioral practices. In this era, the will to embrace and scale mobile-digital tools in clinical research has never been stronger.19 For example, to guide medical providers, each person could be assigned a digital “twin” to detect medicines that resulted in adverse reactions or could not be absorbed and, therefore, rendered useless by the patient’s metabolism.20 In the personal care industry, such a digital twin could avert allergic reactions to topical formulation ingredients.
Social Distancing Sensors
Will we ever return to live conferences and trade shows? If so, smart badge technology may prevent the transmission of contagious diseases. Conference attendees are familiar with badges that allow entry to the hallowed event halls and communicate each attendee’s identification and professional affiliation. But in a pandemic, if you can read someone’s badge you are probably too close for social distancing requirements. Smart accessories with nonverbal line of sight protocols could transmit and receive badge information. Such a system was filed as a patent application.21 Wearable sensors could be configured to analyze body fluids, like sweat, in real time and transmit the health of the wearer and even provide guidance for balanced diet choices as the wearer browses over snacks and meals.22
On October 13, a patent was granted for a social distancing awareness system. The system consists of a device that generates a zone of visible colored light around a person that changes color in the boundary region when social distancing is violated and informs the administrator of encroachment. We foresee a future in which such social distancing enforcement systems become common for safety considerations.23
Masks as Cosmetics
Ideally, N95 masks should be worn to ameliorate the spread of COVID-19 (and other respiratory diseases). However, the pandemic has limited the supply of N95 masks for consumers. Masks are evolving into beauty accessories with imprinted designs or added glitz. Some masks are washable and reusable but, in general, they do not meet the N95 standard for reducing respirable particles. This may change with the use of Jacquard weaving machines on Rapier or Air-jet looms.24 In Jacquard weaving, punched cards having multiple rows of tiny punched holes that guide the warp up and warp down a prescribed weaving pattern. The process is not new; it was named after its inventor, Joseph Marie Jacquard, in 1801, and it has been used routinely to produce brocade and damask fabrics.25 Demonstrations of Jacquard weaving can be seen in YouTube presentations by the Victoria and Albert Museum26 and the National Museums of Scotland.27
Modification of the Jacquard process with modern cutters, including laser cutters, allows the production of masks that can meet the N95 standard. Moreover, the Jacquard masks are washable and reusable. As a result, the COVID era may usher in the emergence of N95 quality, reusable masks as beauty/cosmetic accessories. If mask-wearing continues, it will also be necessary to formulate makeups that do not interfere with the seals around the mask peripheries.
We cringe when we see food service workers wearing masks beneath their noses, or only around their chins or throats. Lack of compliance in mask wearing can be a consequence of the discomfort of wearing a mask for long periods of time. One patent application is directed to the use of ingredients that provide a cooling sensation to relieve the discomfort of mask wearing.28 The cooling materials are disclosed as 1-diisopropyl- phosphinoalkanes. The cooling ingredients are applied to the external nares of the nose. Ingredients that provide such cooling sensations are considered by the FDA to be active ingredients for drugs rather than cosmetics. For example, in the US, menthol may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established drug name is Menthol.29 The FDA has issued draft guidelines for testing of menthol and methyl salicylate patches for use as topical delivery systems.30 The FDA also warned that topically-applied menthol, methyl salicylate and capsaicin has caused burns in a small number of cases.31
In the interest of public health, wouldn’t it be great to have masks that color code to warn the wearer when they are posing a public health risk? Moreover, sensors within the accessory could immediately inform supervisors and management and allow corrective action to be taken to avoid the public health risk or the perception of such. The personal care/cosmetics industry is heavily invested in hands-on advisement of clients but there is now a reluctance for customers to visit the stores that provide such services and merchandise.32 Moreover, COVID-19 has had a devastating effect on beauticians, hairdressers and estheticians. Close physical proximity is an essential aspect of salon services and it is likely that customers and operators alike will be apprehensive about close approach as salons re-open.33 This industry could be re-energized by accessories that signal “wellness” to both operator and client promoting the necessary trust for physical proximity during a time of social distancing. Distributed trust provided by blockchain oversight of the devices could provide the customer-client confidence necessary for this industry to recover.34 Once implemented, such a signaling system would likely persist beyond the current pandemic and embrace wider sectors of society. Perhaps post-pandemic awareness and tracking of necessary hygiene practices will reduce the United States’ annual toll of 9 million cases and 160,000 deaths from chronic constructive pulmonary disease,35 and 200 million cases and 11,000 deaths from gastroenteritis each year.36
Extracellular Vesicles and Exosomes
In severe COVID-19 infection, patients can suffer acute respiratory distress, which arises from an auto-immune hyper-inflammatory response to the virus. When the virus attacks, the infected cells release inflammasomes. This is a normal response to cell injury and, in normal conditions, the inflammasomes induce inflammation in the tissue which begins the process of repair and recovery.37 In auto-immune diseases, a hyper-inflammatory response is an over-reaction that can cause illness or even death. Inflammasomes are multi-protein complexes that are innate immune system receptors and sensors which, upon infection, trigger the release of cytokines that start the inflammation process and under normal circumstances, begin the healing process. However, the hyper-inflammatory response in some COVID-19 patients results in a cytokine storm that causes a hyaluronan storm in the lungs,38,39 causing the formation and accumulation of large quantities of hyaluronan gel in the lungs, resulting in acute respiratory distress and, in some cases, death. Signaling between cells and transport of cell-control mediators, like inflammasomes, are transported between cells by extracellular vesicles or exosomes. These tiny lipid vesicles function as vessels to carry the molecules that control the system for multicellular organisms. Exosomes are formed in endosomes inside a cell and are released into the extracellular medium by fusing with the cell membrane and budding in a process that is almost the opposite of endocytosis. Exosomes were initially thought to function as a garbage bag to dump unneeded proteins in the maturing red blood cell.40 It was later discovered that exosomes are extracellular vesicles that contain a specific composition of proteins, lipids, RNA and DNA.41 Exosome biogenesis occurs in three stages: One, formation of endocytic vesicles by invagination of the plasma membrane; two, formation of multivesicular bodies by inward budding of the endosomal contents; and three, fusion of the multivesicular bodies with the plasma membrane and release into the extracellular matrix as “exosomes.”
Exosomes play significant roles in several vital processes including angiogenesis, antigen presentation, apoptosis, coagulation, cellular homeostasis, inflammation and intercellular signaling. Exosomes contain precise compositions of RNA, proteins and enzymes, lipids that relate to the cell in which they originated, and they achieve their functionality by intercellular transfer of these components. By this means, exosomes affect the physiological and pathological processes in various diseases, including cancer metathesis, neurodegenerative diseases, infections and autoimmune diseases.42 The investigation of exosomes is a rapidly accelerating emerging field of investigation that is still in its infancy,43 and yet exosomes have already appeared as ingredients in the INCI dictionary (Human Adipose Derived Mesenchymal Cell Exosomes, Human Adipose Stromal Cell Exosomes, Human Amniotic Fluid Induced Pluripotent Cell Exosomes, Human Amniotic Fluid Mesenchymal Stem Cell/Trophoblast Cell Exosomes, Human Cord Blood Progenitor Cell Exosomes, Human Dermal Fibroblast Induced Multipotent Cell Exosomes, Human Umbilical Mesenchymal Stem Cell Exosomes, Milk Exosomes). Exosomes are already being touted in a skin moisturizing lotion that is claimed to contain 150 million exosomes in each container.44,45 A quick calculation reveals that this concentration of exosomes corresponds to about 0.00000000000001%! Moreover, if therapeutic or prophylactic claims were made for such a product, then it would be regulated as a drug by the FDA. On the other hand, if no therapeutic or prophylactic claims were made, but the product did really affect the structure or function of the body, then it could be regarded as a misbranded drug by the FDA.
About the Authors
Following a 25-year career with ICI, Unilever, and BF Goodrich, Bob joined academia and served as professor, chair and director of the School of Polymers and High-Performance Materials at the University of Southern Mississippi. Following retirement from the university in 2016, Bob founded Robert Lochhead Consulting LLC. Bob has served twice as the President of the SCC, and also as President of the International Association of Formulation Chemists. Bob is a fellow of the SCC and a Fellow of the Royal Society of Chemistry. Among other honors, he is a recipient of the SCC’s Maison G. DeNavarre Medal Award, the SCC’S Merit Award, the AIChE’s Chemical Pioneer Award, and the Society of Plastics Engineers’ Education Award. Bob received the SCC’s Lifetime Service Award in December 2019 and was named one of the first three Fellows of the IFSCC in 2020. Contact info: robert.y.lochhead@gmail.com
Margaret’s initial occupation was as research assistant for drug trials in the Department of Haematology at the Glasgow Royal Infirmary. After being full-time mother to two beautiful and talented daughters, for the latter part of her career she taught developmental mathematics at Lorain County Community College, and the University of Southern Mississippi, where she also taught the university success skills course and advised students with undeclared majors. In her retirement, Margaret is a partner in Lochhead Consulting LLC. Contact Info: Margaret.lochhead@gmail.com
References
- Thomas Siebel, Digital Transformation, Rosetta Books, 2019.
- Science Time, https://www.youtube.com/watch?v=ZCeOsdcQObI
- The Centers for Disease Control, Handwashing: clean hands save lives. When and how to wash your hands, https://www.cdc.gov/handwashing/when-how-handwashing.html
- Centers for Disease Control and Prevention, Coronavirus Disease, Handwashing, https://www.cdc.gov/coronavirus/2019-ncov/global-covid-19/handwashing.html
- Robert and Margaret Lochhead; State of the Art: Hand hygiene and disease prevention, Cosmetics & Toiletries, September 2020, P 29 et seq.
- S. Trapani, Method and system for motivating and monitoring handwashing in a food service or related environment, U.S. Patent Application 202000320846, October 8, 2020, Assigned to Food Service Monitoring Inc.
- Melinda Gomez, Michael Schwartz; Wearables and the internet of things for health, IEEE Pulse, pp 35 – 39, September/October 2016.
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