Tuesday, July 21, 2020

My Take on COVID19 Mask Messaging


Hi Faithful Friends,

I'd like to take some time to talk to you about my personal view of the mask messaging debacle, from the beginning of the #COVID19 pandemic until now. I have been thinking a lot about this lately, in no small part thanks to my friend @mi55br00ke, who reminded me of some important issues we’re all being faced with during this unprecedented time of uncertainty. These are my thoughts on my messaging on Twitter, and mine alone.

3-Ply Blue Surgical Mask (10 Pack) - CPAP Store USAWhen this all began I was one of the virologists advocating against masks and here’s why: People wanted to wear masks that protected themselves and I knew that A) in general, people wouldn’t have access to N95s designed to protect from biological aerosols, and B) if they had access to them, they wouldn’t have the tools needed at home to fit test them properly. I tried to make it clear that my logic was that in light of those things, I worried people would buy any old N95 and then think they were more protected than they were. That is not flawed thinking, but I realize now how incomplete the message was.

My perspective is really informed from extensive experience in high-containment BSL4 labs. That training really gives me a very strict view of protocol adherence. If a mask isn’t going to protect you as much as you think it will, then you shouldn’t wear it. Period. It’s dangerous. And when it turned out we couldn’t get N95s and there was a shortage for health care workers, but we needed something because spread was taking off, then we started hearing about surgical masks to protect *from the wearer* and this I agreed with. I still tried to make it clear that the surgical mask would not protect the wearer, but that seemed to be lost in the fray and then everyone thought we should have been advocating for surgical masks from the beginning.

Maybe we should have, but I still think the message that surgical masks do not protect the wearer as much as they think it will, is an important thing to make clear. And I would not change that messaging were I to go back in time. But I think I made a serious mistake with my messaging in that it was not complete. It’s not something I can change, but I can tell you I am sorry for it and hope that in the future this mistake can be avoided in an effort to more effectively guide people on this issue.

What should the messaging have been, in my opinion? I wish I would have said what I needed to say on surgical masks not being as protective as one might think, but I would add next time:

  • We don’t know what infectious dose is required for SARS2, but the reality is that wearing a surgical mask will reduce that dose if someone coughs on you while you’re wearing it. It will not keep you from being exposed to their virus, but reducing the amount you're exposed to is likely to make a difference in how fast the virus disseminates throughout your body and/or in how sick you get. 

That's a big omission and it is my regret in all of this. I was being pedantic, as I usually am, and in so doing I neglected to point this out. It kills me because I know this messaging affected decisions people made including those made by the people caring for my mother. Had they implemented having residents of her nursing home wear surgical masks early, would she still be alive? Maybe. Honestly, I think probably. Was I responsible for the messaging the staff in her facility heard? I really don't think so. I spoke to them and tried to get them to take the virus seriously quite early on and they didn’t hear me. But I could be wrong. I know that. I live with it. Did my messaging directly impact anyone on Twitter? I don't know, my voice doesn't reach very far, but it very well could have. And that alone is enough for me to recognize how big this mistake was.

My goal here is to help you understand my thought processes along this journey and hope you can understand my logic and how it led to that mistake. A mistake I deeply regret. Was it intentional? No. Does that matter? Not really. Especially when I have been defending my initial position strongly since then. I defended it and still defend it as an effort to help people by communicating that they wouldn’t be as protected as they might think they are with N95s or surgical masks. But I should not have stopped there. I should have been less pedantic and more aware of the need for the information that I recognize now would have been more helpful.

I also recognize that this post won’t undo the damage. It’s not intended to do that. Nothing can undo the damage. I know that. It’s simply me coming to you in honesty and saying, I hear you. I feel your anger and frustration and I know I played a part in that. I am expressing my genuine regret. Regret for the inadequacies of my messaging. And to let you know, I will do better in the future. I hope you allow me that opportunity.

Sincerely,

Heather

Monday, April 27, 2020

Pandemic 2020: COVID-19 Questions From My Tweeps: Part II

Welcome back guys! This is Part II in my series answering questions about COVID-19 asked by my wonderful Twitter followers. Let me know if you have follow up questions or if anything is not clear.
          
@steadywind and @slava_m asked:
Is their immunity after COVID-19 and if so how long would it last?
          Based on what we know of other disease-causing coronaviruses, there will be some level of immunity following infection with SARS-CoV-2 and COVID-19 disease. What we still don't know is how long that immunity will last. Coronavirus experts agree that Coronaviruses don't induce long-lasting immune memory like other viruses often do, but evidence indicates recovery will offer strong protection for a bit (~1-2 years) and some protection after that. No doubt some people with less robust immune systems may get reinfected later in the absence of a vaccine. This is expected and we shouldn't freak out. It means we need a vaccine and until we have one, we need to be vigilant, especially with regard to those most vulnerable.

@JahodaLubos asked:
Whats more probable in the short term:efficient therapeutics and treatment plans or vaccines?Can therapeutics facilitate a return to “normal”?
          In the short term we need therapeutics and treatments simply because it is going to take at least a year before we might have an effective and safe vaccine. Likely it will be longer. This is why getting transmission of the virus under control and flattening the curve are so important. It gives our health care systems time to catch up. While therapeutics would be helpful, having an effective therapy would not mean we could just get back to normal. The steps along the path to treating a COVID-19 patient each have their own limitations. For example, to treat someone we would have to have a verified diagnosis. Right now, global demand for test components far exceeds manufacturer's output abilities. Once a therapy is found effective and approved, it too would need to be manufactured and distributed worldwide. Unless we control the spread of the virus, global demand for the treatment would also quickly outpace production capability. Of the many potential treatments tried so far, none have been shown effective against this virus. Scientists are working around the clock to develop therapeutics and vaccines, let's support them in their efforts by doing what we can to slow down the spread of this virus. 

@DeanneB57530417 asked:
What are the anticipated / possible mid to long term health consequences for those who ‘recover’ from Covid-19? And are these being monitored?
          The information we have on this so far comes from physicians reporting what they see in patients. Currently we don't have a database on this but as we move forward this will be something we have a better handle on. Physicians report that those with mild symptoms are expected to make a full recovery, and that's what they observe. Those with more severe disease are at risk for long-term sequelae (a condition caused by a previous disease or injury). So far, observations indicate that permanent damage from COVID-19 can happen to the lungs, kidneys, and heart.
          In the lungs, an exaggerated immune response can trigger a disease process leading to pneumonia, secondary bacterial infection, and increased virus replication. This takes a toll on alveoli in the lungs and can cause irreversible damage to these little sacs that exchange oxygen and CO2 with the blood. Those with lungs that are aged, less elastic, or more susceptible to inflammation already, will have a greater risk of severe disease, and sequelae or death. According to physicians I spoke to, about 15% of those infected will get severe disease and pneumonia. Pneumonia usually doesn't cause long-term problems but pneumonia in COVID-19 can be more severe. It could take people up to six months to recover from the associated breathing difficulties. About 20% of those who develop pneumonia will progress to the alveoli-compromised stage of the disease that results in respiratory failure. Those severely affected by the disease who recover could have breathing related issues for life, the severity of which would depend on how much damage/scarring occurred. For those with the greatest damage, normal breathing may never return. For the rest of their lives they may get short of breath with minimal exertion or require medication to help them breathe.
          The kidneys are also at risk for permanent damage in those with severe COVID-19. In order for kidneys to function, they need fluids and the right amount of fluid pressure. Doctors must carefully balance fluid and pressure to the kidneys while not adding additional fluid burden to the lungs. Those who survive severe COVID-19 will need their kidney function monitored to check for permanent damage.
          Doctors are also seeing cardiac problems with COVID-19 patients. While SARS-CoV-2 can infect cardiac cells directly, causing inflammation of the muscle and heart rhythm problems, the disease the virus causes can also affect the heart. When COVID-19 reduces oxygen levels in a patient, that puts extra stress on the heart as it works harder to oxygenate the body. As expected, those with pre-existing cardiac problems are at greatest risk of severe cardiac presentations. Direct infection of cardiac cells can also cause catastrophic cardiac inflammation in the absence of pre-existing cardiac problems. The heart muscle can be severely damaged, reducing the heart’s ability to pump blood, which can be fatal even in the healthy. If one is lucky enough to survive severe COVID-19 with cardiac damage, cardiac function will need to be carefully and regularly monitored.
          Other organs can suffer damage from lack of oxygen during COVID-19 including the liver and brain but as of now I've not seen data on long-term effects other than death caused by multi-organ failure. No doubt we will learn more on each of these as time passes.  

@isaberchtold asked a related question:
Undetected Patient with mild symptoms with huge lung damages. Is it really irreversible?
          Yes, it's possible to experience significant lung damage while displaying mild symptoms. Interestingly enough, physicians are describing patients with dangerously low oxygen levels with no overt breathing difficulty. They call this silent-hypoxia and it transitions quickly into respiratory failure. As the alveoli are compromised and oxygen levels drop, the lungs can remain 'compliant' allowing patients to expel CO2. When CO2 doesn't build up, there is no sense of being short of breath. These patients eventually have trouble breathing and go to the hospital but their O2 levels are already so low, many are in serious distress and need ventilators. When this happens, it's more likely that the damage caused to alveoli will be irreversible. One recommendation to help prevent this scenario is to use an over-the-counter pulse oximeter to measure your O2 levels at home. This painless device passes small beams of light through the blood in the finger, and measures changes of light absorption in oxygenated or deoxygenated blood. If your O2 level falls below a certain threshhold, whether you have other symptoms or not, you would need to seek medical care.

This leads into the question from @bryangrahn who asked:
Do you think lung surfactants could help people with serious lung damage?  Are you aware of any clinical trials for this treatment?  Are synthetic or natural surfactants a better option for adults - and are either scalable if they do work?
          First, I'll describe pulmonary surfactant for my readers who aren't familiar with it. A surfactant is a substance that reduces the surface tension of the liquid it is dissolved in. In the lungs, epithelial cells in the alveoli secrete a pulmonary surfactant to lower the surface tension of the water within all alveoli. By reducing that surface tension, the surfactant makes it easier for the alveoli to reinflate after exhalation and helps prevent airway collapse. Without enough surfactant, your alveoli won't work well and can end up damaged leading to a collapsed lung.
          Considering that SARS-CoV-2 attacks the cells that make surfactant in the lungs, it seems reasonable to think that treating lungs with surfactant might help. After looking into this, it appears that while this might be worth trying, there have been no exogenous surfactants developed that are able to reduce surface tension enough to make a difference in these patients. Thus, there are currently no efforts to use an exogenous surfactant as therapy in COVID-19 patients. 

Thank you all for your questions! Part III coming soon!

Cheers,

Heather

Citations




Saturday, April 25, 2020

Pandemic 2020: COVID-19 Questions From My Tweeps: Part I


Hey Guys! Nice to see you again. I asked my Twitter followers for their questions on COVID-19 and got a lot of great responses. You guys are the best. This post is part one in addressing your questions.

@LaurenWhitticom asked:
Is it for sure going to become endemic?
          I think it will become endemic. There's no reason to think it will go away. Other coronaviruses that have found their way into humans have become endemic so I see no reason to think this will be different. If we want it gone, we would need a concerted eradication effort in every region. With such a powerful antivax movement in the US that's not going to happen anytime soon.

@MerryMary48 asked:
This is probably basic, but is there going to be a % of people who are just immune to this virus, without having had it?
          Not basic at all. It's a good question. And while we do not have data on this, I am confident in saying, not that there will be those who are naturally immune but that there will be those who are less susceptible to this virus than the general population. By this I mean that through as of yet unknown genetic mutations, there are likely people who can't be infected by this virus as easily. Maybe these are people with more cilia in their airways, or more robust cilia. Maybe someone has less ACE2 on the surface of their lung cells than the rest of us. There could be any number of places along the infection and disease development pathway where a mutation could confer the ability to more easily fight off this virus. I expect there are people like this in the world. Perhaps not many, but some. 

@mtw_ams asked:
I live on the ground floor with windows only to the street side with people passing by. Can the breath they exhale with virus infect me in my home?
          Considering the disparity of information being passed around, and the confusion regarding airborne vs droplets, I understand this is a concern for many people. Let me first say, the risk for you in the situation you describe is extremely low. I would feel comfortable leaving my windows open. Here's why. 
          In order to be infected not only does the virus have to survive in the air long enough under the conditions in the atmosphere to get through your open window from the sidewalk as someone passes by (sunlight, humidity, air currents), there must be enough surviving and infectious virus in the 'breath' that reaches you to actually initiate an infection. A person would have to really hack a huge cloud of virus, and that cloud would have to go immediately in through your window and into your nose/mouth to infect you. If someone is walking by that's unlikely. If someone is standing on the sidewalk facing your window as they cough, it's still unlikely. Distance is really your friend here, as are the air currents and ambient conditions. Unless we do a study outside your apartment to mimic someone coughing aerosols as they walk by, we can't say with 100% certainty that it will not happen, but it's highly unlikely to pose a real risk to you. 
          I would feel comfortable leaving my window open, but you may not and that's okay. Maybe you could put a fan by your window that's facing the sidewalk, so some air gets blown back out or a current is generated reducing the amount of outside air coming inside. Alternatively, you could put a sign next to the sidewalk that says something like - COVID patients inside, must leave window open, please cross sidewalk before passing. That should keep people away from your windows. ­čśĆ

@KenVaughanSoc asked:
How is touching my face unsafe, but putting food prepared by others in my mouth isn’t?
          Touching your face with contaminated hands can expose the parts of your face most susceptible to virus you've picked up from contaminated surfaces - doorknob, gas pump, elevator button - by touching your nose or mouth leading to exposure in the lungs. For that to be a risk, someone infectious had to contaminate the surface you touched. When you eat food prepared by someone else, the risk of that is lower. People prepping food should be wearing masks, which will protect the food from contamination, if that person is infected, which they likely are not if they are prepping food. In addition, food being chewed then swallowed is forcing particles in your mouth into your stomach and away from your lungs. This reduces the potential for virus to make it to your lungs in the rare instance it might be on your food. In your stomach this virus can't survive the acid. Before you eat your food, you will have touched the packaging. To be on the safe side, wash your hands before you eat. If you'd like more assurance, ask the business if those prepping and packaging food are wearing masks, if any of their employees are being forced to work while unwell, or if anyone employed there has been sick with COVID-19. 

@CleoHariMSc
What is the consensus on face masks and why was there so much debate amongst scientists early on regarding their use for the general public?
          Ah, face masks. A confusing and never-ending battle. Initially, scientists, including myself, were trying to convey how dangerous it was for an untrained person to wear a respirator that was not fit-tested. For example one they bought online. This is because we knew it would give people a false sense of security. Not only would the mask not truly protect you from exposure to someone coughing near you, but taking off a contaminated mask is a common source of infection for people who are not trained to do so. We were also trying to convey the difference between surgical masks (and folded t-shirts and bandanas) and N95 respirators. Surgical masks are designed to protect people from the wearer. N95s are designed to protect the wearer. So while some people, mostly non-scientists, were yelling at people to wear masks, we were trying to convey the differences between the masks, the differences between when they are needed and how they really would and would not protect you. Here is an image that really illustrates what's happening with masks. I saw it on Twitter shared by Don Jazzy don't know if that's the original source.
          We have reached the point where public health leaders are recommending face masks for everyone going out in public. This is because, in places that did not get ahead of the epidemic through testing and contact tracing early, we have no idea who is sick and infectious. It's important to understand that this recommendation is still to protect people people from the wearer, not to protect the wearer. But the bonus here is that if everyone wears a mask then no one has to understand anything. I'm protecting you from me and you're protecting me from you. Who cares if someone thinks it's the other way around if we're both being protected.
          But don't forget that touching the mask can contaminate your hands, or your chin if it's been contaminated. So drop it straight into the trash or washer, wash your hands immediately, and use a new/clean one the next time you go out.

@The_Twenty_Two asked:
How much are you worried about surface to human transfer?
          Contaminated surfaces, called fomites, are a definite risk with SARS-CoV-2. A research letter documenting apparent fomite transmission in China, I think did a great job evaluating this risk while still recognizing the limits of their work. A more recent and well executed, rigorous study indicates the virus can remain alive and able to infect longer than we would have expected under their conditions. However, every time someone touches a contaminated surface, they wipe some virus off, so the last person to touch that surface won't get as much virus on their hand as the first person. This is why washing hands has been urged from the beginning. It's also why gloves aren't necessarily better than hand washing. I see people in stores wearing gloves and touching everything, as though wearing gloves means they no longer have to be careful. If they get virus on their gloves, they then transfer it to their credit card or wallet or mask, or head or even face. I don't wear gloves at the grocery store just like I never wore gloves when SCUBA diving. Gloves make you feel like you can touch anything. While diving that damages the living things you feel compelled to touch, during a pandemic it increases your risk of infection. Touch only what you absolutely must touch and force yourself to think about not touching anything else, like your face. As soon as possible disinfect/wash your hands thoroughly.
          As for things like packages left at your door, food delivery bags/boxes or grocery bags. If those are prepared by people without symptoms then there is very little risk. Use the same caution: handle the items only as much as needed and discard. Then wash hands thoroughly with soap and water.
Citations:

@goatbroken asked:
I heard a rumor that the flu shots might interfere with the body's ability to fight other corona viruses... is this credible?
          I have not come across anything credible supporting this. The paper you asked about, "Influenza vaccination and respiratory virus interference among Department of Defense personnel during the 2017–2018 influenza season" by Greg G. Wolff, does not provide evidence for that theory. Some studies describe the phenomen of vaccine-associated virus interference: that vaccinated people may have increased risk for other respiratory viruses. Their logic is that it's because vaccinated people do not get the non-specific immunity associated with natural respiratory infections. 
          There is contradictory evidence regarding this idea in general, and contradictory evidence that the influenza vaccine is associated with it. I haven't seen anything that convinces me that this happens. In the linked paper, the study was rigorous: it's the "first virus interference study conducted among highly vaccinated DoD personnel. The study included a diverse, well dispersed population based on sex, age group, beneficiary category, and vaccination status." the results "showed little to no evidence supporting the association of virus interference and influenza vaccination." In fact they showed that "those receiving the influenza vaccine were more likely to have no pathogen detected and reduced risk of influenza when compared to unvaccinated individuals." This further supports my opinion.
          On a related note, a really interesting study on influenza vaccination came out last year by a group at UT Austin. This was a study on the persistence of antibodies from influenza vaccines over time. They found that the antibodies generated by the yearly vaccine are relatively short-lived and that once they are gone, the remaining antibodies are a group that has persisted over time - a group of antibodies against the parts of the influenza virus that are not usually mutated. So in addition to the antibodies we have from the vaccine, we also carry antibodies we've had for years against various parts of the virus. Previous exposure and vaccination thus work synergistically with the yearly vaccination to protect us. The coolest part of this is that it provides insight into potential vaccination strategies previously thought not worth pursuing.
Citations:


That's it for Part I. I hope it's been helpful so far. If something wasn't clear enough please let me know so I can improve my answer for you. If your question isn't here, it will be posted ASAP. Thank you for your patience! And thank you for the questions. No doubt they will be helpful for many others.

Stay home and wash your hands,

Heather



Friday, March 6, 2020

COVID-19 in TX. Take Another Deep Breath, Y'all.

Well, Howdy Folks!
      So, the new coronavirus has made it into TX. Sure enough, someone traveling out of the country and then back into Texas, was infected somewhere along the way. And he was not part of the repatriation and quarantine efforts in San Antonio. Let's talk about where this person is and what this means.

Where?
      A Fort Bend man in his 70s was confirmed to have COVID-19 by a Houston city lab. This identified case near Houston, and the virus showing up in a city near a major airport, is what I have been expecting. In fact, living near Houston myself, I have been telling my friends and family this. It's what we are seeing in WA, OR, and CA with cases near Seattle, Portland, and San Francisco/Oakland/San Jose). The good news here is that unlike in those areas, this TX case is the person who traveled, not someone who was exposed in the local community. This means the public health department can trace this person's contacts since he returned, and the contacts of those people, etc, in an effort to keep this line of transmission from, hopefully, turning into a larger outbreak. But what does it mean for the rest of us in surrounding areas?

What Now?
      If you live in the area, there is no real risk from this person unless you were in his circle of contacts. If that's the case, you will be contacted. If you are not contacted, but you know you were in contact with him, then contact the Public Health Department to let them know.
      For the rest of us, the situation remains the same. Because we are in an area near a major airport, I recommend social distancing: avoid crowds, air travel, and sick people. Wash your hands with soap and water as you always should, right? 20 seconds. Really get in there. Avoid touching your face. Clasp your hands in your lap if that helps. Avoid handshakes. Give someone a nod, instead.

Do we need masks?
      The truth is that the only people who actually need masks are those caring for people with symptoms...in health care settings or at home. People simply walking around and going about their day do not need a mask if they are practicing the protective measures we should all be practicing. Let's reiterate what we should be doing. With bullets:
  • Stay 6 feet from strangers who are coughing.
  • No handshakes. Nod and smile.
  • Get your flu shot - don't let the flu confuse the issue
  • Cover coughs. Every damn one.
  • Wash hands. With soap, people. 20 seconds.
  • Avoid touching your own face. Don't touch strangers' faces either. That would be weird.
  • Sanitize surfaces, including cell phone - front and back.
  • Don't share drinks/toothbrushes/eating utensils
  • Use tissue to open public doors etc. Clean tissue. You knew I meant clean tissue, right?
  • Avoid crowds - that means church, concerts, airplanes, rodeos, 'Cons' of all kinds, and yes, political rallies.
  • Schools/work - follow all precautions above while at work and school. If someone is diagnosed with this virus in a school or business, they will likely close temporarily to sanitize and do contact tracing to prevent further spread. Unless and until that happens, keep plugging along.
  • If you have cold or flu symptoms STAY HOME from school or work. Forgive me for yelling, but please, stay home. Keep your child home. It really is important for preventing spread. 
      We do those things, we are good. We do not need masks. And the truth is, masks will not provide the protection you think they will, anyway. Here's why.
      "Masks" can be one of many things in this context. What we hear about the most are surgical masks and N95 respirators.
      Surgical masks: These people in China are wearing surgical masks. But they are doing it wrong. Surgical masks are not designed to protect the person wearing them. They are designed to protect the people around that person. For example, to protect a patient on an OR table from being coughed on by the surgeon. You don't want your ureteroscopic kidney stone removal contaminated by Dr. Coughsalot, do you? I didn't think so.
      If a person develops respiratory symptoms, then a surgical mask can be worn by that person with symptoms, to protect those around them. That is what they are for and how they should be used. What you see in the photo, gives people a false sense of security. This mask cannot keep infectious virus droplet from reaching you if a sick person standing in front of you coughs on you. Microscopic aerosols of infectious virus will find their way into that mask. Will they find their way out of the mask? Sure, some will. But because of airflow and physics, the fallout from that will be far less than the other way around. Pun intended.
      N95 Respirators: These masks are made and tested to protect people from infectious aerosols generated by coughing. Unfortunately, they require proper fitting, which, I can tell you, is no small task. Check out this photo. That is a man being fit tested for an N95. That hood is for the test. To better understand the reality of fit-testing an N95, I recommend this twitter thread. It's fantastic. Read it and you will understand this idea a lot more. Suffice it to say, N95s will not work as you think they will unless they are fit tested properly. So having them around for this outbreak is unnecessary and creates a shortage for the people who actually do need them, our health care providers.
      If you'd like more info on aerosols and what that means for risk of infection by someone coughing, this post from one of my favorite virology blogs, Virology Down Under, is all you need to check out.

The Bottom Line
      This virus is a newly emerged virus that causes respiratory illness in humans. We have no existing immunity, so everyone is susceptible. It will move through communities unless transmission can be stopped early through appropriate public health measures. The most vulnerable are the elderly and the sick; those with compromised immune systems.
  • Symptoms of COVID-19: respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. There are also reports of gastrointestinal symptoms appearing before the respiratory symptoms. It's possible it could start with nausea, vomiting and/or diarrhea. This is not uncommon for coronaviruses.
      So let's take care of the vulnerable by taking care of ourselves. By following the guidelines above and doing what we can to stay healthy. Don't panic. Be smart. And stay informed. Follow me on Twitter (@pathogenscribe) and you will have access to some amazing scientists and reporters covering this pandemic. And if you see info from a public health official that contradicts what other experts are saying and you're confused, go ahead and ask questions. We are learning in real time here, so as new data roll in, inferences will evolve.
That, my friends, is the inimitable beauty of science.

Stay healthy,

Heather

Citations
Respiratory Protection for Airborne Exposures to Biohazards
https://www.dshs.state.tx.us/coronavirus/
NIAID’s RML in Hamilton, Montana, images of the novel coronavirus
How to Prevent the Spread of Respiratory Illnesses in Disaster Evacuation Centers
The efficacy of medical masks and respirators against respiratory infection in healthcare workers

Useful links
WHO Rolling updates on coronavirus disease (COVID-19)
CDC Preventing COVID-19 Spread in Communities
CDC: About Coronavirus Disease 2019 (COVID-19)












Monday, January 27, 2020

The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 6: Vaccine Injuries Part II: Vaccine Court Adjudication of Autism Cases

Welcome to Episode 6 in my series on vaccines. Throughout this series I use the term anti-vax as a concise way to type the anti-vaccine movement. I use it to refer to those people who speak out against vaccines, not parents who are hesitant. Wherever you fall, I welcome you here. Thank you for taking the time to come here and discuss this with me. I hope I can dispel some misconceptions and ease your mind about vaccines.

Now that we know the real reason behind establishment of VICAP, let's look at the cases that have been adjudicated. More specifically, let's look at autism cases. (links are to court documents (& scientific articles where appropriate))
Omnibus Autism Proceeding: The Special Masters created the Omnibus Autism Proceeding (“OAP”) to determine the relationship, if any, between vaccines and autistic spectrum disorders. They chose six test cases, that, in the petitioners’ judgment, presented the clearest and strongest arguments for the proposition that vaccines had caused autism, representing two separate theories of causation (1: that measles, mumps, and rubella (MMR) vaccines and thimerosal containing vaccines can combine to cause autism; 2: that thimerosal-containing vaccines, by themselves, can cause autism; A third theory - that MMR vaccine, by itself, can cause autism was later abandoned due to extensive evidence to the contrary, and so was not adjudicated in test cases by OAP. Note: Given the depth of discussion deserved by The Hannah Poling case, also part of the OAP, that case will be presented in an independent post (coming soon).

In 2007, three Special Masters heard three test cases to represent the first theory of causation:
Cedillo v. SHHS Case No. 2010-5004
Snyder v. SHHS Case No. 01-162V; and
Hazlehurst v. SHHS Case No. 2009-5128
The Special Masters’ decisions in the three test cases, issued on February 12, 2009, rejected the petitioners’ causation theories. All three of the Theory 1 test cases were appealed (to court of Federal Claims & U.S. Court of Appeals for the Federal Circuit). The Special Masters’ decisions were upheld each time.
From George L. Hastings, Jr., Special Master, in the case of Michelle Cedillo, No. 98-916V:
"I concluded that the evidence was overwhelmingly contrary to the petitioners’ contentions.... Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."

From Denise K.  Vowell, Special Master, in the case of Colten Snyder, No. 01-162V:
"After careful consideration of all of the evidence, it was abundantly clear that petitioners’ theories of causation were speculative and unpersuasive. Respondent’s experts were far more qualified, better supported by the weight of scientific research and authority, and simply more persuasive on nearly every point in contention."

From Patricia E. Campbell-Smith, Special Master, in the case of  William  Yates Hazlehurst, No. 03-654V:
“[P]etitioners’ experts tended to assign greater weight to speculative conclusions offered by the investigators involved in the studies than did the investigators themselves. Petitioners’ experts also urged reliance on a few carefully selected sentences from particular articles which, when considered in the proper context of the referenced articles, did not support the propositions advanced by the witnesses. Moreover, because petitioners’ experts relied on a number of scientifically flawed or unreliable articles for several important aspects of their causation theory, their testimony on those aspects of their offered theory could not be credited as sound or reliable. Finally, petitioners’ experts made several key acknowledgments during testimony that rendered their proposed theory of vaccine causation much less than likely.”

The full OAP record encompasses tens of thousands of pages of medical literature, more than four thousand pages of hearing testimony, and fifty expert reports. The committee ultimately concluded that a causal relationship between MMR vaccinations and autism did not exist. The committee based its conclusion on four factors:
1) A consistent body of epidemiological evidence shows no association, at a population level, between MMR vaccine and autism spectrum disorder.
2) The original case series of children with autism spectrum disorder and bowel symptoms and other available case reports are uninformative with respect to causality. In addition, they were ALL linked to Andrew Wakefield's fraudulent Unigenetics data and none of the studies indicating the presence of measles virus in autistic children had been successfully replicated by an accredited laboratory independent of Dr. Wakefield or Unigenetics.
3) Biologic models linking MMR vaccine and ASD are fragmentary.
4) There is no relevant animal model linking MMR vaccine and autism spectrum disorder.

In 2007, three Special Masters heard three test cases to represent the Second  theory of causation - that thimerosal-containing vaccines, by themselves, can cause autism. The three cases were:
Mead v. SHHS Case No. 03-215V
King v. SHHS Case No. 03-584V
Dwyer v. SHHS Case No. 03-1202V

From Patricia Campbell-Smith, Special Master, in the case of  William P. Mead, No. 03-215V
“The underpinnings for the opinions of petitioners’ experts   are scientifically flawed, and in the absence of a sound basis for the offered opinions of causation, those opinions cannot be credited....Based on the developed record in this proceeding, the undersigned is unpersuaded that the thimerosal content of the prescribed childhood vaccines contributes to the development of autism as petitioners have proposed under this theory of general causation.”

From George L. Hastings, Jr., Special Master, in the case of Jordan King, No. 03-584V
“...I conclude that the evidence is overwhelmingly contrary   to the petitioners’ contentions.  The expert witnesses presented   by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning the key points.  The numerous medical studies concerning the issue of whether thimerosal causes autism, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering   all of the evidence, I find that the petitioners have  failed  to demonstrate that thimerosal-containing vaccines can contribute to the causation of autism. I further conclude that while Jordan King has tragically suffered from autism, the petitioners have also failed to demonstrate that his vaccinations played any role at all in causing that condition.”

From Denise K.  Vowell, Special Master, in the case of Colin R. Dwyer, No. 03-1202V:
"To prevail, they must show that the exquisitely small amounts of mercury in  TCVs that reach the brain can produce devastating effects that far larger amounts experienced prenatally or postnatally from other sources do not. In order   to account for this dichotomy, they posit a group of children hypersensitive to mercury’s effects, but the only evidence  that these children are unusually sensitive is the fact of their   ASD [autism spectrum disorder] itself. In an effort to render irrelevant the numerous epidemiological studies of  ASD and TCVs that show no connection between the two, they contend that their children have a form of  ASD involving regression   that differs from all other forms biologically and behaviorally. World-class experts in the field testified that the distinctions they drew between forms of  ASD were artificial, and that they had never heard of the ‘clearly regressive’ form of autism   about which the petitioners’ epidemiologist testified. Finally, the causal mechanism petitioners proposed would produce, not  ASD, but neuronal death, and eventually patient death as well. The witnesses setting forth this improbable sequence of cause and effect were outclassed in every respect by the impressive assembly of true experts in their respective fields who testified on behalf of respondent."

When parents are bombarded with propaganda, it's easy for us to forget a critical truth about medicine: there are risks. There always will be. But we can't lose sight of the greater risks of infectious diseases. Diseases that can sicken and kill millions of children worldwide. Diseases we haven't had to suffer through because of vaccines. Vaccines offer powerful protection from some truly horrific diseases. Is that protection perfect? No. But neither is any other tool used in medicine. We have a mechanism to help anyone who is injured by a vaccine, VICP. Let's allow vaccines help the rest of us.

Cheers,

Heather

Citations:
This post provides in-text links to all relevant court documents and an article that summarizes this nicely. If you have questions, please feel free to ask. I am here to help.


Friday, January 24, 2020

The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 5: Vaccine Injuries Part I: Creation of the Vaccine Court


Welcome to Episode 5 in my series on vaccines. Throughout this series I use the term anti-vax as a concise way to type the anti-vaccine movement. I use it to refer to those people who speak out against vaccines, not parents who are hesitant. Wherever you fall, I welcome you here. Thank you for taking the time to come here and discuss this with me. I hope I can dispel some misconceptions and ease your mind about vaccines.

VACCINE COURT
Parents who are just trying to do the best they can for their kids, are bombarded with anti-vax messages daily. Anti-vaxxers argue that vaccines cause autism (despite the many studies that prove they do not, including the most recent study See my post dedicated to vaccines and autism). Anti-vaxxers claim that scientists and physicians cover up these vaccine side effects so Big Pharma can profit (not true at all - post forthcoming). And their coup de gr├óce? The very existence of the National Vaccine Injury Compensation Program. The fact that this program exists is their evidence that vaccine injuries are so common and so severe, that there must be an independent court to process the cases. Is that true? No. Emphatically, no. How can we tell? We can determine the truth about that argument by understanding why VICP was created and the results of the claims brought to them over the last 30 years.

The National Vaccine Injury Compensation Program (VICP)
In the 1980s there was a big scare over side effects of the DPT vaccine and a ton of parents sued vaccine makers (Post on DPT coming soon). Public health officials were confident that the claims were baseless, but juries awarded compensation to plaintiffs. DPT vaccine makers couldn't afford this, and why should they when vaccines were not their bread and butter, so they stopped production. This put all vaccines at risk. But we need vaccines. 

SIDEBAR [When anti-vaxxers tell parents we don't need vaccines, when they tell parents vaccines are dangerous, they can do so because they (& we) haven't experienced the horror of a community decimated by disease. Make no mistake, the fact that we have not experienced that horror, is because of vaccines. To trash-talk vaccines is a luxury only possible because we've been protected by vaccines and so no longer take the threat of infectious diseases seriously. The anti-vax movement is a luxury given to anti-vaxxers, by vaccines. Put that in your pipe and smoke it.]

Back to VICP: Due to the DPT scare, and to keep manufacturers from abandoning vaccine production, VICP was established by Congress' 1986 National Childhood Vaccine Injury Act (NCVIA). Within VICP resides the “vaccine injury court” - AKA the Office of Special Masters - which is a division of the United States Court of Special Claims. If someone thought their child was harmed by a vaccine they could present their case to this court.  

Compensation awarded by VICP:
Another component of VICP is a trust fund to pay for compensation awards. An excise tax of 75 cents per administered vaccine, was implemented to finance the trust fund. To settle cases quickly and fairly, through VICP, cases are argued before a Special Master and adjudicated on a no-fault basis. In 80% of all cases brought since 2006, the parties settled. According to HHS, “Settlements are not an admission by the United States or the Secretary of Health and Human Services[…]that the vaccine caused the petitioner’s alleged injuries,” Let's reiterate. In these cases, after extensive review of the evidence, the HHS had not concluded that the vaccine caused the injury. So why settle? Many reasons, such as “a desire by both parties to minimize the time and expense associated with litigating a case to conclusion and a desire by both parties to resolve a case quickly and efficiently." If the petitioner disagrees with the court's ruling, they can appeal their case in civil court.

Anti-vax message: The Government hides the vaccine court!
One website, typical of the anti-vax movement, reads, “It is obvious that the government does not want to publicize the existence of the [court], because the more Americans learn that there are vaccine injuries and deaths … the more they may start to question the safety of vaccines.”
TRUTH: Okay. The above anti-vax message is completely false. The law was well-publicized when it passed. There is a very public website for it that explains the Court, and provides the names and contact information of lawyers in all 50 states. It also helps you file a claim. No one is hiding the existence of the court. But that is not what anti-vaxxers want you to think. The anti-vax agenda is to convince you that the government is hiding this information.

Anti-vax message: Existence of VICP is proof that vaccine injuries are so common & severe, that we need an independent court to process the cases.
Since 1988, more than 16,000 claims have resulted in $3.18 billion awarded to families alleging vaccine injury. Anti-vaxxers point this out and say, see? We are right, vaccines need to go, and the existence of the court itself is proof that we are right and everyone else is lying on behalf of big pharma. 
TRUTH: Anti-vax interpretation of the numbers is completely incorrect. In reality, the numbers prove that vaccines are safe. Let's examine the facts so we can understand why that is.

Vaccines Administered Vs Claims Adjudicated by VICP:
From 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. During that time, 6,571 petitions were adjudicated by the Court, with compensation awarded to 4,525 of those. Thus: One individual was compensated for every one million doses of vaccine administered. One individual was compensated for every one million doses of vaccine administered. This means vaccines are incredibly safe. 

[SIDEBAR: One in a million. To be clear, that is not the risk of vaccine injury, that is how often vaccine claims are settled without establishing that a vaccine caused an injury. So the risk of proven vaccine injury is even lower. But we'll use 1 in a million here just to make it easy. Now, let's look at how that risk compares to the risk of a significant injury from other drugs that parents give their kids with confidence. Let's take Acetaminophen (e.g, Tylenol) for example. A 2013 review reads:

"Acetaminophen is the over-the-counter (OTC) antipyretic and analgesic medication most commonly used in children." They go on to say:
"Acetaminophen monographs might surprise clinicians and parents alike, as many consider the drug safe to use and provide parents with the “feeling of mastery.” Numerous potential adverse effects are mentioned in guidelines for its labeling. However, most severe adverse effects are generally rare. In one large study from Boston, Mass, children younger than 2 years of age with fever were randomized to receive acetaminophen (12 mg/kg) or ibuprofen (E.g Advil) and were found to have a low rate of adverse effects. Among the more than 9000 children who received acetaminophen, the absolute risk of hospitalization for asthma or bronchiolitis was 260 children per 100,000, and the risk of hospitalization for vomiting or gastritis was 24 children per 100,000."

So for acetaminophen, the risk is 260 per 100,00 and 24 per 100,000 and we consider that level of risk to be RARE. That means the 1 in a million risk for vaccines is LESS THAN 10X the risk of acetaminophen. But you don't see parents marching in the streets to get Tylenol banned or filing lawsuits against the manufacturer. Why? Because there is no anti-acetaminophen movement using propaganda to scare parents into not using it. The risks ARE RARE for acetaminophen. And we need it! It helps our children. It prevents febrile seizures and other risks that illness and fevers bring. Not to mention it makes kids feel better and let's parents and kids get some rest.
Pro tip: Vaccinated children need drugs like acetaminophen less often. Bonus!]
BOTTOM LINE - The Vaccine Court Decisions demonstrate that vaccines are incredibly safe. 

So What Are the Real Side Effect Risks of Vaccines?
The truth is, that most vaccines side-effects are those we've all heard of. They are all listed on the flyer the doctor gives you before your child is vaccinated and they give you a copy to take home when you leave the doctor's office. So they are not being covered up. No one is hiding this. Just like the possible adverse reactions to Tylenol are right there on the package. If you check the CDCs website - which provides info on all ingredients in the vaccine etc, right there for us to see - I investigated it all when I was pregnant and here is the package insert for the only MMR vaccine approved in the US. So, the common side effects of that vaccine are:
  • Sore arm from the shot (Ouch. This one hurts cuz it goes into back of the upper arm. I did not get the full series as a child because I am older than...ahem...well anyway, so I got the full series last year after vaccine rates in my community had decreased enough to cause me concern (You should do the same if you're...like me). And yes, it hurt my arm, but the pain didn't last. And I had no other side effects. My son has also had all his vaccines on schedule and has had no adverse reactions.)
  • Fever
  • Mild rash
  • Temporary pain and stiffness in the joints, mostly in teenage or adult women who did not already have immunity to the rubella component of the vaccine
That's a common list for the currently required vaccines.

How about rare and serious side effects?
There are about three claims per year (out of millions of vaccines given) to the vaccine court in which petitioners allege lifetime injury. These account for ~half of the total dollars spent on VICP awards. And most of these are settled without any determination of causation.  

Because parents hear so much about possible vaccine injuries, I am in the process of writing posts on all severe adverse outcomes that parents might be concerned over. I have a post specifically for VICP autism cases, and others in the works on the 1980s DPT scare; Guillain-Barr├ę Syndrome (really, the only one that is a concern in the US -and is it really a concern? We'll find out when I finish the post); and on severe vaccine injuries caused by vaccines not approved in the US and that have been withdrawn from the international market like Pandemrix and Dengvaxia. I am also writing a post on the Hannah Poling case as that also deserves in-depth discussion. I will add links here when those posts are live.

I hope this post gives parents better context for understanding the Vaccine Court and why, in reality, it actually demonstrates the safety of vaccines. When parents are bombarded with propaganda, it's easy for us to forget a critical truth about medicine: there are risks. There always will be. Even with things like acetaminophen. But we can't lose sight of the greater risks of infectious diseases. Diseases that can sicken and kill millions of children worldwide. Diseases we haven't had to suffer through because of vaccines. Vaccines offer powerful protection from some truly horrific diseases. Is that protection perfect? No. But neither is any other tool used in medicine. We have a mechanism to help anyone who is injured by a vaccine, VICP. Let's allow vaccines help the rest of us.

Cheers,

Heather


Citations:
This post provides in-text links to all relevant court documents and articles. If you have questions, please feel free to ask. I am here to help.