Monday, January 11, 2021

What's REALLY in the Air?

A Study on Hospital Air: Reviewing the Presence of SARS-Cov-2 
By: Dr. Robert L. Bard / Research & Edits by: Lennard M. Gettz

August 13, 2020 - Recent headlines show evidence of Coronavirus pathogens in hospital air supply and air passageways- creating a systemic hazard for the staff and patients under critical care. Reports showing "substantial controversy whether severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can be transmitted through aerosols."[1- Intl. Journal of Infectious Diseases]. 

Excerpt of active study Abstract (posted 8/4) held by Dr. John Lednicky and research team from the University of Florida: "Air samples were collected in the room of two COVID-19 patients, one of whom had an active respiratory infection with a nasopharyngeal (NP) swab positive for SARS-CoV-2 ... those with respiratory manifestations of COVID-19 produce aerosols in the absence of aerosol-generating procedures that contain viable SARS-CoV-2, and these aerosols may serve as a source of transmission of the virus" [1].

Similar studies have been conducted in prior months to support this theory of airborne pathogens in urgent care centers, including one from February 19 through March 2, 2020 by the CDC. A study was performed in a small sample from regions with few confirmed cases (which might not reflect real conditions in outbreak regions where hospitals are operating at full capacity). [3]

As of March 30, 2020, approximately 750,000 cases of coronavirus disease (COVID-19) had been reported globally since December 2019 (1), severely burdening the healthcare system (2). The extremely fast transmission capability of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has aroused concern about its various transmission routes. This study led to 3 conclusions... [3]

Initiatives are in full swing from health departments and hospital safety leaders to advance sanitization measures and decontamination initiatives in hospitals. Agencies indicate that without adequate environmental controls, patients with airborne infectious disases will pose a risk to other patients and healthcare workers. Heating, Ventilation and Air Conditioning (HVAC)  expertise is essential for proper environmental management when planning control of airborne infectious disease outbreaks.   This may include frequent inspection and upgrades of air filtration systems- such as HEPA Filtering and proper discharging of air to the outside (by creating negative room pressure in patient rooms and airflow management). Other initiatives like stepping up hospital safety inspections and advancing disinfecting, and sanitizing measures to include more current technologies like UV-C light disinfection.




HEPA FILTERS (Source: EPA.gov)
HEPA is a type of pleated mechanical air filter. It is an acronym for "high efficiency particulate air [filter]" (as officially defined by the U.S. Dept. of Energy).  This type of air filter can theoretically remove at least 99.97% of dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns (µm). The diameter specification of 0.3 microns responds to the worst case; the most penetrating particle size (MPPS). Particles that are larger or smaller are trapped with even higher efficiency. Using the worst case particle size results in the worst case efficiency rating (i.e. 99.97% or better for all particle sizes).

MERV RATING
Minimum Efficiency Reporting Values, or MERVs, report a filter's ability to capture larger particles between 0.3 and 10 microns (µm).
  • This value is helpful in comparing the performance of different filters
  • The rating is derived from a test method developed by the American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) [see www.ashrae.org].
  • The higher the MERV rating the better the filter is at trapping specific types of particles.
  • See complete rating chart from 1-16
Consider using portable air cleaners to supplement increased HVAC system ventilation and filtration. Directing the airflow so that it does not blow directly from one person to another reduces the potential spread of droplets that may contain infectious viruses. Air cleaning may be useful when used along with source control and ventilation, but it is not a substitute for either method. Source control involves removing or decreasing pollutants such as smoke, formaldehye or particles with viruses. The use of air cleaners alone cannot ensure adequate air quality, particularly where significant pollutant sources are present and ventilation is insufficient. See ASHRAE and CDC for more information on air cleaning and filtration and other important engineering controls. [6]

FROM THE MEDICAL FIELD
By: Megan Meller, MS, MPH

I can’t recommend a specific product but want to emphasize the importance of building HVAC systems and the number of air exchanges that take place in a room. Below I’ve included a table that summarizes guidelines from the CDC for air exchanges in various healthcare settings.


When COVID-19 made it’s presence known, we worked closely with our Facility Operations department to ensure that our exam rooms and hospital rooms were meeting these requirements. In some cases, adjusts were needed and were made. We do use HEPA filters throughout our organization which is a fairly standard technology in healthcare. We do use portable filters but only in select departments (e.g. Oncology) and have not added more for COVID-19. HEPA filters in theory are able to capture coronavirus particles but we don’t know how practical this is and I would not rely solely on this to prevent infection. Afterall, COVID-19 spread appears to be primarily occurring via droplets.   It is much easier to maintain centralized units than individual ones. In addition to shoring up our ventilation systems for COVID, we also implemented physical barriers to protect our patients and staff against COVID including: dedicated negative pressure hospital units, respirators, and organizational wide face masking requirements. The key that I want to stress here is the emphasis on ventilation rather than filtration as complementary to other measures such as social distancing and masking.

References: 
1) Viable SARS-CoV-2 in the air of a hospital room with COVID-19 patients
2) Study finds evidence of COVID-19 in air, on hospital surfaces
3) Aerosol and Surface Distribution of Severe Acute Respiratory Syndrome Coronavirus 2 in Hospital Wards, Wuhan, China, 2020 https://wwwnc.cdc.gov/eid/article/26/7/20-0885_article
4) Minesotta Dept of Health (Airborne Infectious Disease Management): 



Oct 7, 2020, Prevention101 conducted an in-depth interview with Ms. Teri Hulett, professional infection prevention consultant and educator. She provided valuable insight on the branch of service supporting standardized safety protocols in the patient care industry. Having started a career in nursing (neonatal ICU) since 1979, Teri transitioned to focus work in infection prevention due to outbreaks in her facility. This discipline became a full-time commitment which she converted into a national program that called on a significant demand due to the current Covid-19 pandemic.

From the Source: 
INFECTION PREVETION STRATEGIES
Teri Hulett, RN, BSN, CIC, FAPIC | www.ipstrategies.org

Infection prevention has become an area of intensified focus in dental offices and physician's offices. Infection prevention in ambulatory surgery centers (ASC) has been on the radar since 2009. Regulatory surveys assess compliance with mandated IP requirements. State surveyors go into facilities on behalf of CMS and make sure that from an infection prevention perspective, they're meeting all the minimum requirements that must be in place. like proper hand hygiene measures (as an example). Is the facility auditing hand hygiene compliance? Is staff education being provided? Is the facility providing facility compliance information back to the staff with identified opportunities for improvement? 

This is where I come into the picture. Effective November 28, 2017 CMS (Centers for Medicare and Medicaid Services) required all long-term care (LTC) facilities to establish an infection prevention and control program (IPCP) to be phased in over 3 years and managed by an infection preventionist.(IP) who has had formal training. In preparation to meet the CMS requirements, I worked with long-term care facilities in Montana and Wyoming, in collaboration with other quality improvement organizations (QIOs), to provide 3-day LTC bootcamps. We walked attendees through the process of developing their program to meet CMS required elements. The IP program is developed based off a risk assessment (RA). We spent time walking attendees through building their program plan template. We helped them identify who they should work with and where to reach out to for the data to include in their plan. We also helped attendees identify where to access additional formal IP training and education. 

With COVID-19, one of the main focuses has been in LTC facilities due to the many deaths experienced in the first three months of COVID-19. LTC settings were not set up to deal with this type of infectious disease. Most LTC facilities do not have negative pressure rooms. Staff were not fit tested and trained on proper use of N95 respirator masks. There were multiple gaps identified in the LTC setting that could not have been planned and prepared for with respect to what we saw with COVID-19. This identified need again provided the opportunity for me to work with facilities in identifying their gaps and developing interventions to prevent transmission and improve both staff and resident safety.

LTC facilities were overwhelmed; there was a lot of transmission and death. They needed help - someone with experience to walk them through what they needed to do, why they needed to do it, and then work with them to implement key interventions specific to COVID-19. We focused on dealing with immediate  issues  key to  halting transmission, like acquiring enough personal protection equipment (PPE) supplies necessary to prevent transmission and resident deaths, and then aid the facility in developing a comprehensive sustainable program comporting infection prevention and control practices.. 

The CDC provides a robust resource of information - tools and guidelines available to all. Regulatory bodies like CMS and Joint Commission use nationally recognized guidelines to survey against. For the facilities we work with, we help them understand what guidelines to follow in developing their programs – writing their policies and procedures. We stress the importance of following nationally recognized, evidence- based guidelines. Many state health departments use the CDC resources to develop state-specific tools, of which some states will then use to develop toolkits accessible to anyone on their state’s website. An example is the Minnesota Department of Health COVID-19 Toolkit. 








UV-C AIR SANITIZING INSTALLED IN HVAC SYSTEMS
Due to the recent pandemic, companies developing this technology are (now) on the fast track to advance UVC installations for a wide range of professional and commercial environments.  Specific testing is currently underway as to the efficacy against SARS-CoV-2 (the virus that causes COVID-19) but historically, systems like those developed by Fresh-Aire UV have been tested and proven effective against pathogens that require even greater UVC dosages.  "Every microorganism requires a specific UVC dosage for inactivation including the novel coronavirus. UV disinfection has been employed for decades in water treatment; these microwatt values have been used for reference to gauge UVC efficiency against a large cross-section of microorganisms. (see complete article)


Epilogue: Straight Answers from the CDC
In our commitment to publish helpful information about innovative solutions, we rely on top health  authorities to provide us with unbiased clarity and technical standards. We inquired about how UV-C Disinfecting technology truly ranked as the future solution to defeating viruses and transmitted diseases. Steve Martin, PhD, an engineer in NIOSH’s Respiratory Health Division provided us with these valuable statements:

Q: Does the CDC see UV-C Disinfecting as the next trend- evolving from chemical spray sanitizing?
A: No.  CDC understands that germicidal UV technologies, including patient room terminal cleaning devices (sometimes called UV robots), can provide enhanced surface disinfection over the use of chemical disinfectants alone. However, UV technologies, as they currently exist, will never replace manual chemical cleaning in healthcare spaces.  While UV can be very efficient at inactivating pathogens on surfaces, UV-C energy cannot substantially penetrate blood and other bodily fluids, or through other simple spills and splashes that occur in the course of patient care, even those that have dried and left residues. Thus, healthcare surfaces need to first be thoroughly cleaned to remove gross contamination before the UV energy can directly impact the surfaces and provide the most disinfection benefit. Then, UV systems that are properly applied can effectively inactivate many of the pathogens that manual cleaning may have left behind.

Q: From an original post on 2016, CDC warned about potential OZONE output from UV.  It has been evident that companies have since been addressing the testing, preventing and validating of ozone output.  Does CDC have enough data on this upgrade?
A: Concerns about UV lamps producing ozone have existed for decades and there have not been any significant “upgrades” since 2016.  There are some UV-C lamps designed specifically to produce ozone.  Ozone-producing lamps generally do not use an internal coating on the glass (or quartz) tube so UV energy at wavelengths below 200 nm (predominantly 185 nm) is emitted from the lamp. These wavelengths are responsible for ozone production.  There is a separate group of UV-C lamps designed specifically not to produce ozone.  This group is the low-pressure mercury vapor lamps used for germicidal ultraviolet (GUV) applications.  GUV lamps have interior coatings to block UV energy at wavelengths below 200 nm from escaping the tube, so ozone is not created. Unfortunately, ozone-producing lamps and GUV lamps of the same type and size can often be powered using the same electrical connectors and electronic drivers (ballasts).  So, it is critical for the end user to choose the proper lamp for their application.  If they choose a typical GUV lamp for a germicidal application, then ozone is not a concern.  If an end user unknowingly chooses an ozone-producing lamp that happens to fit properly into their GUV device, then ozone exposures will happen. CDC always recommends that end users communicate with the UV device manufacturer or a reputable UV system designer when purchasing replacement UV lamps.




Also see Dr. Pierre Kory's Prevention Measures of Airborne Transmission
Ever since the early pandemic, when quite a few healthcare providers got sick, INFECTION CONTROL was really consistent with what you needed in order to operate in a clinical area, whether it's COVID or any other event. The routine mask wearing regular hand-washing and gown donning has gotten us all through.  Based on TONS of epidemiologic data, which shows that the incidence of infection and transmission plummets when you have a certain percentage of people even wearing standard masks. ...If everybody around you is wearing a mask, (as well as you) the dual mask wearing is as good as if one of you had an N95 to protect themselves. And the reason for that is because those tiny droplets that you can inhale are bursts from larger droplets. And if you're wearing any covering the big spindle or the large droplets that emit when you talk, they all get trapped in those standard masks. They're actually quite protective. 




CONTRIBUTORS

ROBERT L. BARD, MD, PC, DABR, FASLMS
Advanced Imaging & Diagnostic Specialist
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram  are safe, noninvasive, and do not use ionizing radiation. 

MEGAN MELLER, MS, MPH is an Infection Preventionist with Gundersen Health System based in La Crosse, Wisconsin. From a young age, Megan has been passionate about science and the world of infectious diseases. Megan received her Master of Science in Microbiology at Indiana University-Bloomington where she studied alphavirus replication and her Master of Public Health (MPH) from the University of Wisconsin School of Medicine and Public Health. While working on her MPH, Megan worked closely with Infection Control departments and the communicable disease section at the Wisconsin Department of Health Services. In her current role, Megan is the lead Infection Preventionist for Gundersen’s outpatient departments and works closely with infection control partners located at regional hospitals. Megan is also a media consultant for the Infection Control and Infectious Disease departments and serves as an infection control consultant for numerous organizational groups.  


PIERRE KORY, M.D., M.P.A.
Dr. Kory is Board Certified in Internal Medicine, Critical Care, and Pulmonary Medicine. He served as the Medical Director of the Trauma and Life Support Center at the University of Wisconsin where he was an Associate Professor and the Chief of the Critical Care Service. He is considered a pioneer and national/international expert in the field of Critical Care Ultrasound and is the senior editor of the widely read textbook “Point-of-Care Ultrasound” (winner of the President’s Choice Award for Medical Textbooks from the British Medical Association in 2015).  Most recently, Dr. Kory joined the emergency volunteer team during the early COVID-19 pandemic in NYC at Mount Sinai Beth Israel Medical Center. He is also a founding member of the Front Line COVID-19 Critical Working Group (flccc.net) composed of 5 critical care experts that devised the COVID-19 treatment protocol called MATH+. (www.covid19criticalcare.com/)

AARON ENGEL
Mr Engel is Vice-President of Business Development for Fresh-Aire UV, a global leader in UV disinfection technologies. Aaron has 20 years experience in the design, manufacturing and marketing of UV disinfection systems for domestic and international applications including those for residential, commercial and healthcare. Aaron has worked on projects with various groups & associations including the definitive study on UV inactivation of airborne bioterrorism agents sponsored by RTI, the United States EPA & US National Homeland Security. Aaron is frequent guest speaker and lecturer and contributes to publications on IAQ technologies and UV disinfection. Aaron is a member on various ASHRAE committees including TC2.9 Ultraviolet Air and Surface Treatment and the Programs Chair for TC2.9.  www.freshaireuv.com



References:
2) Disinfection and Sterilization Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
3) US National Library of Medicine National Institutes of Health: The History of Ultraviolet Germicidal Irradiation for Air Disinfection  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2789813/
4) Far-UVC light: A new tool to control the spread of airborne-mediated microbial diseases

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Thursday, December 17, 2020

Survival Guide from ICU Docs & the "Four D's" of Airborne Transmission

 
"Arguably, most doctors are not like us... we are the last line with the dying and (those with) the most severe illnesses. We are conditioned to work creatively and more aggressively under a major time limit... to reverse life threatening disorders."


Dr. Pierre Kory: Interview with an ICU Critical Care Physician

ON PREVENTION: I'm probably not the best example of maintaining health through Covid because it's pulled me in many different directions that personal health is not a premium. I've been just working, I'm working on fighting and writing and getting involved with trying to help folks treat this disease. I mean, exercise has been definitely on the back burner, but certainly now that things have calmed down a little bit, certainly exercise is a premium for me. 

Ever since the early pandemic, when quite a few healthcare providers got sick, INFECTION CONTROL was really consistent with what you needed in order to operate in a clinical area, whether it's COVID or any other event. The routine mask wearing regular hand-washing and gown donning has gotten us all through. 

 I did five weeks straight in an ICU since May- it was all COVID and none of us got ill.  In fact, when I was at Mt. Sinai/Beth Israel, not one intensivist in that division (pulmonologists) who were seeing patients in all spheres both on and off ventilators contracted the virus.  You have to understand a person on a ventilator is much less risky because you're on a ventilator, it's kind of a closed system. So their exhaled air is not going to expose to providers. There's patients who are not on ventilators, who are breathing very heavy. They're spewing a lot of virus in the hair. And WEARING A MASK CONSISTENTLY throughout the day is really important.  Those three things-  HAND WASHING, MASK WEARING and GOWNS- they will carry you through.  I'm at this now six months and I haven't gotten sick- knock on wood. My wife is pulmonary critical care specialist. She sees as much Covid as I have, but none of us have gotten nailed just by sticking to the basics. 

ON SUPPLEMENTS: Certainly vitamin D vitamin C, Zinc and Quercetin are some of the essentials. Though it's not clear if we're taking enough concentrations to help, but there's some supportive evidence for it. But certainly C and D seems to be key in not only mitigating the development or the acquisition of the attraction, but also the severity and impact.  The other one that I take routinely for years is Melatonin at night and tell him it appears to be very protective against acquiring the infection.  They're cheap, they're easy - taking supplements is really a kind of a no brainer with very little down sides.


ON THE THEORY OF AN AIRBORNE PATHOGEN: I feel very strongly about it. Since early May, we noticed how people got ill and the ways in which they got ill early on, it was clearly airborne. So many people have been debating this for months- something like 275 scientists wrote open letter to the world health organization in July telling them that all the evidence suggests that this is airborne transmission.  There's a multitude of events  which clearly supports this-  that's why it's really important that we all wear a mask, especially indoors. 

The real factors that would lead to airborne transmission is for me is generally occurring indoors- from what I call THE FOUR D's, which is the DURATION that you'll spend in that room, the DIMENSIONS of the room- this reflects on less ambient air flow in a smaller space where there's more of a likelihood that the exhaled virus can  build up to a sufficient concentration for you to inhale it. Next is the DENSITY or the crowd size that raises your probability.  And then there's the presence of a DRAB. There's a number of experiments and publications have shown just having an open window in a room appears to be very protective because it dilutes the concentration of the exhale virus. And so it makes it much less likely you're going to get infected. You have to inhale a significant concentration of a virus- what's called INOCULUM. If you're in someplace with ambient air for short term or a very large room, it's very unlikely that you're going to get infected. And so it's really about small confined, poorly ventilated spaces with a lot of people like ours- and places like bars where everyone's on top of each other or the crowded areas where you might have a high density of people. 

ON MASKS:  Based on just tons of epidemiologic data, which shows that the incidence of infection and transmission plummets when you have a certain percentage of people even wearing standard masks. My opinion on this subject evolved since in the beginning, the way I understood the airborne transmissions that everybody needed an N95 in order to fully protect themselves. But if everybody around you is wearing a mask, (as well as you) the dual mask wearing is as good as if one of you had an N95 to protect themselves. And the reason for that is because those tiny droplets that you can inhale are bursts from larger droplets. And if you're wearing any covering the big spindle or the large droplets that emit when you talk, they all get trapped in those standard masks. They're actually quite protective. So my belief is masks for all!


Respirator vs. Surgical Mask - What's the Difference?
Written by: Dr. Robert Bard, MD, PC, DABR, FASLMS  |  Edited by: Lennard M. Gettz

Months into the pandemic, we have confirmed that following CDC safety and prevention guidelines of wearing some approved form of face covering in public (or around others) is directly connected to the reduction and control of Covid-19 infection rates.  Time and time again, scientists and medical experts have valid proof that viruses travel through micro-droplets in the form of airborne contaminants. 


Fact: ANY PPE is better than NO PPE!  The science of prevention states that measures toward a reduction in risk can greatly support life-saving others - and yourself.  Meanwhile, discerning the difference between face coverings, specifically MASKS vs RESPIRATORS can be useful in identifying which situation to use which type of mask. There is a significant difference between the two, and wearing one vs. the other provides differing results.

The FDA defines a surgical mask as a loose-fitting, disposable device that creates a physical barrier between the mouth and nose of the wearer and potential contaminants in the immediate environment. If worn properly, a surgical mask is meant to help block large-particle droplets (NOT MICRO-DROPLETS), splashes, sprays, or splatter that may contain germs (viruses and bacteria), keeping it from reaching your mouth and nose. Surgical masks may also help reduce exposure of your saliva and respiratory secretions to others. While a surgical mask may be effective in blocking splashes and large-particle droplets, a face mask, by design, does not filter or block very small particles in the air that may be transmitted by coughs, sneezes, or certain medical procedures. Surgical masks also do not provide complete protection from germs and other contaminants because of the loose fit between the surface of the mask and your face.



Meanwhile, an N95 respirator is an "efficient filter and a respiratory protective device designed to PROTECT YOU from airborne particles". Note that the edges of the respirator are designed to form a seal around the nose and mouth. Surgical N95 Respirators are commonly used in healthcare settings and are a subset of N95 Filtering Facepiece Respirators (FFRs), often referred to as N95s because it is actually rated by NIOSH to keep out or resist an estimated 95% of the harmful particulates in the air. [11]






"GETTING THE SHOT"- A Move Towards Progress  By: Rebecca Nazario
 Getting the vaccine is a key way that we can protect ourselves, our families, our community and our colleagues. The vaccine is safe and effective. Although its development happened quickly, it went through all the same kinds of testing and rigorous approval that any vaccine does.  I posted my selfie on LinkedIn "getting the shot" because there's so much apprehension out there... especially in our minority communities.  As a Cuban American I know there’s a lot of the mistrust and fear is based on rumors that run rampant through our communities, not the science.  I strongly believe we can lead through example, and a picture is worth a thousand words! My goal is to be a small drop that creates a lot of ripples that ultimately instills more confidence. We need to empower each other to pass that message along, and dispel the rumors in whatever way possible.




IVERMECTIN: A Covid-19 Game-Changer?
On Dec 8, 2020, committee chairman Republican Sen. Ron Johnson called ICU Pulmonary specialist Dr. Pierre Kory of the Aurora St. Luke’s Medical Center (WI) and president of the FLCCC to the US Senate Homeland Security and Governmental Affairs Committee.  The hearing was called “Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II.”  Dr. Kory gave his testimony on behalf of frontline physicians about the current state of care in the Covid pandemic and what his group specifies as the logic-based treatment with scientifically proven data that he pleads the NIH to review.  (See complete video and Transcript of Dr. Kory's Testimony)



COVID AND STROKE
COVID-19 was rapidly understood as a disease caused by severe and widespread inflammation and “hypercoagulability” (a tendency to spontaneously form clots in the blood vessels. Autopsies have revealed extensive small vessel strokes, with such strokes often occurring despite aggressive blood thinner treatment and regardless of the timing of the disease course, suggesting that it plays a role very early in the disease process. In one autopsy series, there was a widespread presence of small clots with acute stroke observed in over 25%. In a recent review of the incidence of stroke in COVID-19, almost 2% of all hospital patients suffered a stroke, which is 8x higher than in patients with influenza. More worrisome is that this is almost definitely a gross underestimate given the many likely missed strokes in patients who died on ventilators who were too ill to obtain imaging, the general restrictions on and lack of autopsies, and the well-recognized decrease in the number of patients with acute stroke symptoms seeking medical attention in the COVID-19 era.  (go to complete article)



THE KIRBY PROJECT: Re-assessing the "Deadly" Cost of Cancer Meds
According to a report from the NIH, "the cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase. Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government."  A coalition of patient advocates kickstared by 2x cancer victim Kirby Lewis enacted an initiative to speaks for the countless cancer patients in this country that are drowning from the high cost of cancer meds. "Insurance never covers everything- especially when it comes to drastic cases like cancer. If you're lucky, most insurance covers 50% - or even at the very best, 90% - and a vial of chemo that might be $20,000 you still have to pay a balance or a copay that can easily wipe your family out!" (see complete article)


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Wednesday, December 2, 2020

MICHAEL'S CHOICE: A DIFFERENT END-OF-LIFE PLAN

By: Lorraine S. Davi (San Francisco, CA)- edited by: Graciella Davi & Carmen R. Dewitt  / NY Cancer Resource Alliance

INTRODUCTION:
I dedicated my career in Cancer Awareness and Recurrence Prevention not just to fight cancer, but to promote the public commitment to staying proactive with their health ("GET CHECKED NOW!" mission).  My own experience of having lost someone who DID NOT WANT TO UNDERGO ANY CANCER TREATMENT was a challenge that shaped all this.  It took a long time for me to put my feelings aside and honor his wish to "live all the remaining final days to the fullest"- instead of undergoing the many pains and challenges of treatment.  

Since Michael, I found more and more victims choosing this decision.  Some are convinced that cancer treatment is a temporary band-aid and that cancer will always come back anyway (so why bother).  Another deciding factor was MONEY- where the cancer victim chose the path of not bankrupting his/her family with what many consider to be a "deadlier" bill than the cancer itself. Others choose to exist a post-diagnosed life without STRESS, that which adds to the malignancy.  In the case of Michael's story, the thought of a pre-determined or pre-destined cancer from known heredity became a self-fulfilled program.  Either way, I chose to finally share my story hoping to keep everyone in the fight... IF they choose to. 

This is my story.

In April of 2008, my (then) fiancée Michael received his colonoscopy report showing scans of a golf ball-sized tumor in his colon.  Michael was always a bit closed about his family, but it was then that I learned about his parents' history of hereditary cancers and the rare genetic disorder that ran through his father's side called Lynch Syndrome.  

As shocking as the diagnosis was, we were even more stunned to receive Michael's reaction-- what seemed like a pre-written plan to something that he seemed to expect was going to happen.  "My whole family is a ticking time-bomb and I guess now is my turn", he said, with an icy calm. "Since I was a kid, I've been thinking about how to handle this if and when it was going to come. I made a simple plan to live out the rest of my life the best way I can-- not putting ANY attention to (this) cancer.  This means NO treatments or spend a second fighting the inevitable".

At first, I found his view to be boldly selfish. "How could he do this to his loved ones?" But the more I thought about it, maybe WE were the selfish ones to make him undergo all those horrible chemotherapies and radiation at the hopes of keeping him around indefinitely.  Either way, this was unlike any other reaction I have ever heard of when someone gets diagnosed.

Just so happens, I spent years as a volunteer fundraiser to a handful of cancer organizations and knew then that there was no shortage in cancer research programs for ANY kind of cancer.  I have read and reported about so many treatment protocols, clinical trials and diagnostic innovations where the race for a cure is definitely at the highest point ever.  By this, there is always HOPE for an eventual CURE.  But regardless of generations of advancements at our grasp, Michael's decision was firm.  He always believed that his limited TIME and MONEY should be best spent living each moment, and not "gamble on hope."



By the fall of 2009, Michael passed away, but not without fulfilling his so called "set of final Hurrahs"- or what most call a 'bucket list'.  The crescendo of his final days ended in a stark silent emptiness in the hearts of many.  But to some of us, supporting the fight for a cure was fanned with new energy and conviction. I may not be an oncologist or a genetic specialist or a cancer immunologist (or even a patient advocate), but Michael's story helped shape my crusade toward anyone else from CHECKING OUT this way.  I became a data fiend, tracking cataloguing all available resources for cancer patients.  From personal grants to treatment alternatives to  housing help to the smallest wish and possible need - literally everything is available and accessible! But in addition, if we can show (and prove to) our loved ones that the fight to extend life was worth it, and we can introduce a new program by bringing confidence in the current global cancer initiative - maybe that's what TRUE PREVENTION really means.

VIEWPOINTS

ROBERTA KLINE, MD (genomicmedicineworks.com)
This story brings out complex issues with our healthcare system, including power imbalance. In my experience, people who refuse treatments have one thing in common: feeling disempowered. Whether it expresses as fear, rejection, rebellion or self-sacrifice, in the end the person is taking back their power from a system that, at its core, strips their locus of control. Honoring each person’s spiritual journey, and their health challenges within that, is imperative. But our system fails patients all along the way. How we research, convey information, make diagnoses and prognoses, and approach treatment including the cost of it. Especially with inherited genetic diseases, too often a “death sentence” is given without any understanding of how to empower people with the right knowledge and resources to make critical decisions. Innovations like Genomic Medicine are changing that. With a holistic approach to DNA-based care, people feel empowered to create a health strategy that works for them. 

ELIZABETH BANCHITTA, Technical Contributor / EMT
The article Michael’s Choice paints a realistic picture of the painful realities facing patients with an aggressive illness and the options, advances and need for continued perseverance toward cure and the insistence upon hope. It also reminds us of why we are driven and persistent in what we do; fighting so hard for a cure. It is my belief that the best way to prevent illness and injury is to remain disciplined and diligent in one’s efforts including "getting checked" by one’s health care team. I completely understand why Michael made the choice to forego cancer treatment as he was prepared with a mindset and a plan as he anticipated the outcome of his inherited genetic disorder and chose what was comfortable for him. The truth is that cancer, with all its complexities and uncertainties, is scary for everyone involved. Perhaps Michael would have changed his mind if fear of a  heavy financial burden of treatment could have been offset. The best way to determine your options is to stay educated. Cancer treatments and protocols are changing by the day. The diagnoses, written only as “Ca”, and once considered a "death sentence" when my mother was a new nurse in 1981, these cancers are now detected earlier and are more easily treated with various options for comfort and cure. Education in many areas may be one of the most powerful tools for successful healing answers for a patient and their family.

CHERI AMBROSE (President, Male Breast Cancer Coalition) 
I found Michael's Choice to sadly be the voice of many.  That feeling of fear that grips so tightly when hearing a cancer diagnosis can often time cause us to shut down. Though Michael had options, he knew that prolonging the inevitable would only make him feel less power over his own life and choices.  I feel the medical community as a whole can and should do better to engage each patient. To treat the whole person and not just the disease. In doing so, patients would experience a better quality of life and be more apt to opt into treatments. 


SYLVIE BELJANSKI (Author: "Winning The War On Cancer") 
Michael’s story is about how painful it might be to be respectful, and to accept our loved ones’ decisions regarding their choice of treatment. Whether they choose to go with conventional, integrative or alternative medicine, or no treatment at all, this ultimate decision remains theirs. We can only hope they reach their decision in the most educated way. And there is so much out there! There is definitively no bad time to start educating yourself about health and wellness, but doing it under the pressure of a diagnosis is not the way to go, because the information is just too overwhelming. 




11/28/2020- According to a report from the NIH, "the cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase. Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government."   A sensible first base was to connect with all the community groups and cancer foundation leaders or anyone in a leadership role who recognizes this economic dilemma and "the real price of cancer". (see complete article)


CANCER RECURRENCE: Viewpoints and Strategies (See Video)
11/8/2020- When cancer comes back after treatment, doctors call it a recurrence-  or recurrent cancer. Finding out that cancer has come back can cause feelings of shock, anger, sadness, and fear. But you have something now that you didn’t have before—experience. You’ve lived through cancer already and you know what to expect. Also, remember that treatments may have improved since you were first diagnosed. New drugs or methods may help with your treatment or in managing side effects. In some cases, improved treatments have helped turn cancer into a chronic disease that people can manage for many years. (see complete article)


5/5/2020- Cancer is a genetic disease—that is, cancer is caused by certain changes to genes that control the way our cells function, especially how they grow and divide. Genes carry the instructions to make proteins, which do much of the work in our cells. Certain gene changes can cause cells to evade normal growth controls and become cancer. For example, some cancer-causing gene changes increase production of a protein that makes cells grow. Others result in the production of a misshapen, and therefore nonfunctional, form of a protein that normally repairs cellular damage.   Inherited genetic mutations play a major role in about 5 to 10 percent of all cancers. Researchers have associated mutations in specific genes with more than 50 hereditary cancer syndromes, which are disorders that may predispose individuals to developing certain cancers. Genetic tests for hereditary cancer syndromes can tell whether a person from a family that shows signs of such a syndrome has one of these mutations. These tests can also show whether family members without obvious disease have inherited the same mutation as a family member who carries a cancer-associated mutation. (See complete article)





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Saturday, November 28, 2020

RE-ACCESSING UNUSED CANCER DRUG$ - A COST-CONSCIOUS INITIATIVE

"FACT: CANCER DRUGS ARE VERY EXPENSIVE AND NOT EVERYONE CAN AFFORD THEM! Just check out some price tags in this link @ GOODRX.com"

NYCRA News connected with Mr. Kirby Lewis, a 2x cancer victim and a survivor-crusader.  He and a handful of community leaders are framing a grassroots outreach program to explore new solutions to making cancer drugs accessible and affordable. "I came from a family that did not believe in hording, excess or wasting anything useful.  This is why it hurts to see my massive stockpile of unused cancer drugs from my episodes of treatment under the bathroom sink.  When I think about so many people out there who truly need and cannot afford any of this, I am compelled to find a way to save those lives through the redistribution of these meds.  I'd like to add that as a military vet, I am blessed with benefits to acquire my treatments and these drugs at no charge or a much reduced charge than most- where some of these doses cost in excess of $20-30,000 a shot."

Aptly called THE KIRBY PROJECT, Kirby's initiative speaks for the countless cancer patients in this country that do not have his type of medical support.  He added, "Insurance never covers everything- especially when it comes to drastic cases like cancer. If you're lucky, most insurance covers 50% - or even at the very best, 90% - and a vial of chemo that might be $20,000 you still have to pay a balance or a copay that can easily wipe your family out!" 

From his recent collaborative discussion with MBCC president Cheri Ambrose, references of drug prices and insurance coverage caps where heavily referenced to launch this point. "If you think about a range of drugs that cost anywhere between $71,000 to $27,000 for a 30-day supply, no insurance company would enjoy covering such a bill and chances are, they won't.  Carriers have been bankrupted, have DROPPED patients for situations like this or have simply rejected claims for this brand, replacing it with a lower cost (and possibly not as effective) alternative", states Ambrose.  


Diagram (L)- courtesy of goodrx.com/ data & report by: Lauren Chase & GoodRx research team -(8/11/2020). In an effort to continue to shed light on drug prices and increase transparency, the GoodRx Research Team regularly tracks the most expensive drugs in the U.S. Since 2018, we have tracked the list price and dosing requirements to identify the most expensive drugs. Here we look at the most expensive drugs that patients can get at a pharmacy and administer themselves. This list does not include medications that must be administered by a healthcare practitioner. In March, the GoodRx Research team put together the list of the most expensive drugs including those that must be administered by a medical professional. 

 See complete article.

According to recent NIH reports, pharmaceutical donation and reuse programs are distinct prescription drug programs providing for unused prescription drugs to be donated and re-dispensed to patients since 1997. -- but the operative term here is UNUSED. Once a drug touches the home and the hands of a consumer, the value, safety and guarantee of that drug for its intended function DISAPPEARS (see complete details below/ Plan B)


THE KIRBY PROJECT:
 UNITING TO RESOLVE THE DEADLY PRICE TAG OF CANCER MEDS


According to a report from the NIH, "the cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase. 

Recently, first started a discussion with a handful of cancer survivors and org leaders from the NY Cancer Resource Alliance and Dr. Robert Bard (CancerScan Center) who were very supportive of my idea and were willing to help me convert this into a real initiative.  Before I knew, it, more and more people joined in to brainstorm about how to appeal to the pharma companies and (hopefully) discover the WIN-WIN together.  We looked into the many legal parameters and even searched for the right legislators to help build an awareness platform that might help leverage change from the top down.  It was clear that we were going to need a lot more friends to make a dent at this.  A sensible first base was to connect with all the community groups and cancer foundation leaders or anyone in a leadership role who recognizes this economic dilemma and "the real price of cancer". 

WHY CAN'T WE REUSE EXPENSIVE (UNUSED) DRUGS?
In a series of panel discussions to explore opportunities to address the astronomical cost of cancer medication, we kept returning to a plan of SUSTAINABILITY.  We explored the policy of re-purposing, re-selling or donating what is commonly identified as USED, UNWANTED or SURPLUS DRUGS.  

https://www.pbs.org/newshour/health/tylenol-murders-1982 

While carrying tremendous merit, in accordance with laws about recycling drugs, this concept in its raw form violates various public safety guidelines.  ANY drug that has left the authorized distributor and whose seal is broken are called this, hold a tremendous liability for safety, leaving open to massive potential lawsuits from the manufacturer, the distributor and the prior owner- should any issues/side effects or injury occur upon re-use. (source: https://www.ncsl.org/research/health/state-prescription-drug-return-reuse-and-recycling.aspx)

PLAN B:  According to the NSCL (National Conference of State Legislatures),  pharmaceutical companies are able to subscribe to the national Pharmaceutical Donation and Reuse Programs - providing unused prescription drugs to be donated and re-dispensed to patients. Since 1997, 38 states have participated in this program. (See complete NSCL news). Safety restrictions carry strict guidelines as to who can donate and what types of prescription products may be donated.  


QUESTIONING HIGH-COST DRUGS

Excerpted from "The Cost of Oncology Drugs: A Pharmacy Perspective, Part I"


"Health care costs are the fastest growing financial segment of the U.S. economy. The Centers for Medicare and Medicaid Services (CMS) estimates health care spending in the U.S. will increase from $3.0 trillion in 2014 to $5.4 trillion by 2024.1 About 19.3% of the U.S. gross domestic product is consumed by health care, which is twice that of any other country in the world. It is often stated that the increasing cost of health care is the most significant financial threat to the U.S. economy. The cost of medications, including those for treating cancer, is the leading cause of increased health care spending."

See this complete report on NIH/PubMed



VIEWPOINTS: FROM THE PROS

Robert L. Bard, MD, PC, DABR, FASLMS
Like Kirby, I am a former military physician with global experience in pharmaceutical kinetics.  We have long known that the effective life of many medications extends months and possibly years after the expiration date (artificially mandated by governmental agencies).  With copycats [from other countries], faulty manufacturing practices or careless packaging, many products found on the market are either ineffective or harmful.  An example, I recently learned about foreign copycats are drug formulas that have been stolen and replaced - like “hair crème” being passed off as penicillin at some US bases. Prices in the US or overseas facilities are significantly higher than in most hosting nations. While initial cost of creation and FDA acceptance is staggering, so is the payback of a successful launch for such drugs as anticholesterol agents. One must recognize that individual tolerance and therapeutic delivery vary greatly so a personal validation of the treatment is useful.  Many “cures” may kill the disease but devastate the patient as well in the process, both economically and healthwise.  Caveat emptor- make sure it works and investigate the side effects.


Cheri Ambrose (President, Male Breast Cancer Coalition)
I hear from survivors all the time who have lost their jobs, their homes, and in some cases their families while navigating a cancer journey. The stress of the diagnosis and treatment alone can be insurmountable.  Add to that the startling cost of drugs needed to fight the disease and you have the makings of a Perfect Storm.   Patients should never have to make the decision to choose between putting food on their table or treating their disease.  Pharmaceutical companies can and should do more to help those uninsured, underinsured, or otherwise financially stressed patients.  I also feel the Insurance industry should do more to ease the burden of cost on patients being treated for cancer. After all, people don't choose cancer, Cancer chooses them. 







MICHAEL'S CHOICE:
A Different End-of-Life Plan
By: Lorraine S. Davi (San Francisco, CA)

Every cancer advocate carries a story that inspired their personal mission to help others.  A rare and compelling one is about accepting and surviving the passing of a cancer victim who chose the uncommon path of facing their fate and living the rest of his days without any cancer-fighting treatment.










MORE:

1) https://canceradvocacy.org/kirby-lewis-cpat-symposium-hill-day-experience/

Please email us your comments on this article at: editor.prevention101@gmail.com

Disclaimer: The NY Cancer Resource Alliance publishes subscription based non-commercial news articles, educational reports and feature coverage for web distribution in the healthcare and cancer communities. All contributors are volunteers and submissions are provided to us at the discretion of the writer.   Prevention101.org, Fightrecurrence.com and The HealthNews section of NYCRANEWS are free public educational programs published by The New York Cancer Resource Alliance (NYCRA) - a self-funded network of volunteers comprised of caregivers, accredited medical professionals, cancer educators, publishers and published experts, patient support clinicians and non-profit foundation partners whose united mission is to bring public education and supportive resource information to the community of patients, survivors and any individual(s) seeking answers about cancer. NYCRA is an exclusive, non-commercial private network originally established on the LINKEDIN digital society and is supported in part by the AngioFoundation whose mission is to share informative materials to the community. For more information, visit: www.NYCRAlliance.org. Our VIEWPOINTS section shares editorial perspectives supporting the main topic(s) in is issue and the contributors credited may expand on the current topic, sharing other views that may or may not align directly with said topic, such that the publishers of this newsletter does not necessarily agree with, share or endorse.


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