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.

      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 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,


Respiratory Protection for Airborne Exposures to Biohazards
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.



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.

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 grâce? 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' 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-Barré 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.



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.

Monday, May 6, 2019

The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 4: What's in Vaccines?

Image result for antivax warning
Welcome to Episode 4 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.

Parents, like me, trying to protect their kids from toxins and other harmful ingredients, are continuously bombarded with warnings by the anti-vax community. Because of the onslaught of misinformation regarding vaccine safety, people see a list of vaccine ingredients they don't understand and freak out. So let's go through it. Let's clarify what the ingredients are, how much are actually in vaccines, and what that means for our health and the health of our children.

Image result for antivax warning vaccine ingredientsThe FDA, specifically, The Center for Biologics Evaluation and Research (CBER) regulates vaccine products. They undergo a rigorous review of laboratory and clinical data to ensure their safety, efficacy, purity, and potency. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine or address specific questions about the vaccine's safety, effectiveness or possible side effects.

Vaccines Contain:
Antigens: A microbe, or part of a microbe, that primes your immune system to respond to that microbe. They can be very small amounts of: weak or dead germs, or  a small structural part of the germ. They help your immune system learn how to fight off infections faster and more effectively. Weak germs are called "attenuated" and do not cause disease in people with healthy immune systems. Dead germs are called "killed" or "inactivated" and cannot cause disease in anyone. Flu virus is an example of an antigen.
Adjuvants: Substances that help your immune system respond more strongly to a vaccine. This increases your immunity against the disease. Aluminum is an example of an adjuvant. Wait, what? Aluminum? Yes. Now let's break it down. Aluminum salts are incorporated into some vaccine formulations as an adjuvant. The aluminum salts in some U.S. licensed vaccines are aluminum hydroxide, aluminum phosphate, alum (potassium aluminum sulfate), or mixed aluminum salts. For example: aluminum salts are used in DTaP vaccines, the pneumococcal conjugate vaccine, and hepatitis B vaccines. Aluminum adjuvant containing vaccines have a demonstrated safety profile of over six decades of use and have only uncommonly been associated with severe local reactions - a local reaction refers to a reaction at the site of injection like redness, tenderness, or swelling. FYI - the most common source of exposure to aluminum is from eating food or drinking water. 
Stabilizers: Used to help the vaccine maintain its effectiveness while the vaccine is made, stored, and moved. Vaccine stability is essential, particularly where the cold chain is unreliable. Instability can cause loss of antigenicity (how effective the antigen is at priming your immunity). Factors affecting stability are temperature and pH. Bacterial vaccines can become unstable due to hydrolysis (the chemical breakdown of a compound due to reaction with water) and aggregation (clustering) of protein and carbohydrate molecules. Magnesium chloride is an example of a stabilizing agent.
Preservatives: Protect the vaccine from outside bacteria or fungus. Today, preservatives are usually only used in vials (containers) of vaccines that have more than 1 dose. That’s because every time an individual dose is taken from the vial, it’s possible for harmful germs to get inside. Most vaccines are also available in single-dose vials and do not have preservatives in them. Thimerosal is an example of a preservative. Wait, what? Thimerisol? Yes. Now let's break it down. Thimerosal contains ethyl mercury. NOT methyl mercury. Methyl mercury is the mercury in fish. The higher up on the food chain you are, the more you get. Did you know...since 2001 pediatric vaccines have NOT contained thimerisol. And yet... autism rates remain the same. More evidence debunking the autism vaccine myth.
Excipients: Excipients have no medicinal properties but are used in manufacture of the vaccine. These ingredients are taken out after production so only tiny amounts are left in the final product. The very small amounts of these ingredients that remain in the final product aren’t harmful. These include:

  • Antibiotics: Antibiotics are used during the manufacturing phase to prevent bacterial contamination of the tissue culture cells in which the viruses are grown. Usually only trace amounts appear in vaccines. Neomycin is an example.
  • Egg proteins: Some viruses are grown in chicken eggs (Chick embryo cell culture). Virus is injected into fertilized hen’s eggs and incubated for several days to allow the viruses to replicate. The virus-containing fluid is harvested from the eggs.
  • Cell culture medium: The liquid in which cells are grown. For some viruses, cells are infected with the virus and the virus containing fluid is harvested from the cells. 
  • Killing or Inactivating ingredients: Something to weaken or kill viruses, bacteria, or toxins in the vaccine. Formaldehyde is an example. Wait, what? Formaldehyde? Yes. Now let's break it down. Formaldehyde is used to inactivate viruses and bacterial toxins. It is diluted so much in the process of making and purifying the vaccine, that the amounts in the final product are far less than what occurs naturally in our bodies. It does not pose any kind of safety concern in vaccines.
Note: They do NOT contain: aborted fetus parts, cow hearts, pig ligaments, worm ovaries, or anything else not listed here. 

Let's look at individual vaccines.
MMR - Measles, Mumps, and Rubella Vaccine. In each 0.5 mL dose:
Antigens: live attenuated measles virus propagated in chick embryo cell culture; (2) live attenuated mumps virus propagated in chick embryo cell culture; and (3) live attenuated rubella virus propagated in WI-38 human diploid lung fibroblast cells.
Adjuvant: None
Stabilizers: Sorbitol (14.5mg), sodium phosphate (negligible), sucrose (1.9mg), sodium chloride (negligible), hydrolized gelatin (14.5mg)
Preservative: None. MMR is lyophilized (freeze dried) so there is no need for added preservatives. When the vaccine is used, the nurse or doctor reconstitutes it in sterile water and it is good for 8 hours.
Excipients: Recombinant human albumin (≤0.3 mg - from cell culture); fetal bovine serum (<1 ppm -from cell culture); other buffer and media ingredients and approximately 25 mcg of neomycin (from cell culture).

Seasonal Influenza - AFLURIA quadrivalent vaccine suspension 
Single dose vial for > or = 3 years; multi-dose vial for >/= 6 months
in each .05 mL dose:
Antigens: Killed vaccine containing the fours influenza virus strains (2 A and 2 B) most likely to cause disease in the upcoming season.
Adjuvant: None
Stabilizers: sodium chloride (4.1 mg), monobasic sodium phosphate (80 mcg), dibasic sodium phosphate (300 mcg), monobasic potassium phosphate (20 mcg), potassium chloride (20 mcg), and calcium chloride (0.5 mcg).
Preservative: Single dose vial contains no preservative. Multi-dose vials contain thimerisol: each 0.5 mL dose contains 24.5 mcg of mercury and each 0.25 mL dose contains 12.25 mcg of mercury. mcg = microgram. MICROGRAM. 1mcg = 0.000001g.
Excipients: residual amounts of sodium taurodeoxycholate (≤ 10 ppm), ovalbumin (< 1 mcg), sucrose (< 10 mcg), neomycin sulfate (≤ 62 nanograms [ng]), polymyxin B (≤ 11 ng), and beta-propiolactone (≤ 1.5 ng).

Seasonal Influenza -Fluzone quadrivalent vaccine suspension
0.25 mL prefilled syringe for 6-35 months; 0.5 mL prefilled syringe for >/= 6 months
in each .05 mL dose:
Antigens: Killed vaccine containing the four influenza virus strains (2 A and 2 B) most likely to cause disease in the upcoming season.
Adjuvant: None
Stabilizers: Sodium phosphate-buffered isotonic sodium chloride solution
Preservative: None
Excipients: residual amounts of  egg protein, formaldehyde and octylphenol ethoxylate (AKA triton-X a surfactant used to kill the virus)
I will add more specific vaccines and their ingredients in the coming days.

Putting it in perspective: Vaccine ingredients are safe. The manufacturing process ensures safety and efficacy. As chemists like to say, the dose makes the poison. We wouldn't drink a bottle of sodium phosphate, but the minuscule amount in vaccines won't hurt us. Same for Aluminum salts, formaldehyde, and yes, even for thimerisol. This might help put it in perspective even more. Let's check out what is in a bottle of a common pain reliever:
Children's Advil suspension: 
artificial flavor, carboxymethylcellulose sodium, citric acid monohydrate, edetate disodium, glycerin, microcrystalline cellulose, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.
Huh. You don't say.
Okay. Children's Advil. We use it to help our children when needed. Do we give it to them when they don't need it? No. Do we give them an entire bottle at once? No. Why? Because science has shown us that giving them an entire bottle at once could seriously harm them. But when they need it, we make sure they get the right dose. Why? Because science has shown us that the right dose will seriously help them. And that's what good parents are trying to do. Help their children.

And so it goes with vaccines.

Some FAQs are included below and if you have any other questions for me, please let me know.



Common questions about vaccine ingredients
Q. Can vaccines with thimerosal cause mercury poisoning?
A: No. Thimerosal has a different form of mercury (ethylmercury) than the kind that causes mercury poisoning (methylmercury). It’s safe to use ethylmercury in vaccines because it’s less likely to build up in the body — and because it’s used in very, very small amounts. Even so, most vaccines do not have any thimerosal in them. If you’re concerned about thimerosal or mercury in vaccines, talk with your doctor.

Q. Can people who are allergic to antibiotics get vaccinated?
A: Yes. However, if you have an allergy to antibiotics, it’s a good idea to talk with your doctor about getting vaccinated. But in general, antibiotics that people are most likely to be allergic to — like penicillin — aren’t used in vaccines.

Q. Can people with egg allergies get vaccinated?
A: Yes. People with egg allergies can get any licensed, recommended flu vaccine that’s appropriate for their age. They no longer have to be watched for 30 minutes after getting the vaccine. People who have severe egg allergies should be vaccinated in a medical setting and be supervised by a health care professional who can recognize and manage severe allergic conditions.

Q. Is the formaldehyde used in some vaccines dangerous?
A: No. If formaldehyde is used to help produce a vaccine, only very small amounts are left in the final product. This amount is so small that it’s not dangerous — in fact, there’s actually more formaldehyde found naturally in our bodies than there is in vaccines made with formaldehyde.

Q. Is the aluminum used in some vaccines dangerous?
A: No. Vaccines made with aluminum have only a very small amount of aluminum in them. For decades, vaccines that include aluminum have been tested for safety — these studies have shown that using aluminum in vaccines is safe.

Friday, February 1, 2019

The Anti Vax Epidemic - Good Parents Getting Gamed. Episode 3: The Fraudulent Science That Started it All.

Welcome to Episode 3 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. 

Today I am bringing you a horror story - the story of how one corrupt physician hurt children and parents to make money, and created a legacy of fear that hurts families still. And he's not done.

Andrew Wakefield
Twenty-one years ago on Feb. 28, 1998, Andrew Wakefield, a British doctor at the time, published a paper in The Lancet. In this paper he falsely linked the MMR vaccine to autism and colitis. The paper and author were investigated and it turned out the science was bogus. Even if it hadn't been bogus, though, the study itself was seriously bad science.
    Wakefield drew his conclusions linking autism to the MMR vaccine, using only clinical anecdotes for a mere 12 children. You see, the paper was published as an "early report". It was in essence a case report; a story about patient medical histories. Case reports are helpful, definitely, but no credible scientist would draw conclusions about something like a link between autism and vaccines using a case report alone, let alone a case report with only 12 children. In addition, the MMR vaccine was so common in the UK at the time of the paper, that finding 12 children with autism who'd had the MMR vaccine was almost guaranteed. So even if he had not falsified data, the conclusions in the paper would have still been a horrific misinterpretation.
    But he did falsify data and he was investigated. According to Fiona Godlee, editor-in-chief of the British Medical Journal, “It’s one thing to have a bad study... In this case we have a very different picture of what seems to be a deliberate attempt to create an impression that there was a link by falsifying the data.”
  Exhaustive investigations into Wakefield’s methods by the British General Medical Council proved dozens of charges against him including dishonesty and ethical violations including abuse of developmentally challenged children. They found:

Severe undisclosed conflicts of interest for Wakefield
Wakefield was paid more than 400K pounds (plus expenses) by Norfolk lawyer, Richard Barr (an advocate for the anti-vaccine group, JABS), to "prove" that vaccines were unsafe in an effort to win a lawsuit against a vaccine manufacturer. He had been specifically charged with finding evidence for a bowel-brain syndrome linked to vaccines and was on their payroll for two years before the paper was published. The lawsuit failed. He also stood to gain money through the vaccine alternative he was advocating. Instead of the combined MMR vaccine, he advised people to get their children single shot vaccines over a period of time. He just so happened to have filed a patent for a single disease vaccine. He wasn't telling people not to vaccinate their kids! He was telling them to use his vaccine! Because his paper actually started the anti-vax movement, his vaccines weren't as lucrative as he expected so these days he is on the anti-vax speaker circuit in the US where he is flourishing. He should be indicted and forced to publicly apologize
Fraudulent manipulation of data in the study
British investigative reporter Brian Deer actually followed up with each of the 12 families used in the "study". What he learned through diligent research, was that "No case was free of misreporting or alteration." Wakefield altered the data to fit his agenda - he was actually told to find evidence for an autism-colitis syndrome. The backbone of his paper was regressive autism - autism in which children develop on schedule initially before autism symptoms appear. But only one out of the 12 children in his paper was actually diagnosed with regressive autism - child 2. Three of the nine described in the paper as having regressive autism, clearly did not have regressive autism and in fact were never diagnosed with autism at all; before, during, or after the study.
      Further, if a child's "autism" symptoms appeared before they were vaccinated, Wakefield reported in his paper that the symptoms appeared after vaccination. Another example of data falsification are the histological findings of child 3. After surgery he didn't need, pathologists examined colonic samples and found them to be normal. Three months after he was released from the hospital, a co-conspirator of Wakefield's asked for the boy's records and on them, changed the diagnosis from normal to "indeterminate ileocolitis". Stunning corruption on display here.
      Here is a summary of what was altered in the paper compared to what was in the actual medical reports. It's from this paper published by Brian Deer which goes into detail regarding the entire scam and has excellent citations.

Comparison of three features of the 12 children in the Lancet paper with features apparent in the NHS records, including those from the Royal Free hospital
Child noRegressive autismNon-specific colitisFirst symptoms days after MMRAll three features
See supplementary data on for a version of this table with detailed footnotes.
*Regressive developmental disorder—autism.
†Royal Free hospital pathology service.
‡First behavioural symptoms ≤14 days after MMR.

Unethical treatment of children in the study
The 12 kids in the study were treated like guinea pigs. Surgery was done on children even though there were no clinical indications to do so. Others were admitted for invasive procedures without being seen beforehand. Described in one journal article: "Dr Wakefield, John Walker-Smith, and Simon Murch are accused of ignoring limitations placed on them by the research ethics committee of the Royal Free Hampstead NHS Trust and subjecting children to procedures that were not clinically indicated, including lumbar punctures, barium meals, general anaesthesia, and colonoscopy." In addition, they gave child 10 an experimental drug called “oral measles virus-specific dialyzable lymphocyte extract transfer factor”. They did this without having any information on it's safety in children and an entire year before the ethics committee gave them the approval to do so. Turns out, this was another business investment for Wakefield. He had "submitted a proposal to the Royal Free Hospital School of Medicine 'to set up a company called Immunospecifics Biotechnologies Ltd to specialise in the production, formulation and sale of Transfer Factor.' The proposal stated that Child 10's father, known as Mr 10, would be managing director of the company, while Dr Wakefield would be research director."
      One of the strangest things he did - and talked about in public - was paying kids for blood samples at a birthday party. For that he was charged with "taking blood in an inappropriate social setting without ethical approval, of offering financial inducements, of showing a callous disregard for the distress and pain of the children, of abusing his trust as a practitioner, and of bringing the medical profession into disrepute."

The Fallout
Wakefield was found guilty of 30 charges, including four counts of dishonesty and 12 of clinically  unjustified invasive procedures on children and deemed irresponsible and unethical. Andrew Wakefield and a co-author were stripped of their medical licenses. Each of his co-authors removed their names from The Lancet paper voluntarily, Wakefield refused to do so and to this day advocates against vaccines. After the extensive investigation, The Lancet formally retracted the paper in 2010 - twelve years after it had been published. 

But What About Brian Hooker?

Brian Hooker published a ridiculous and immediately retracted paper in 2014 in Translational Neurodegeneration: Measles-mumps-rubella vaccination timing and autism among young african american boys: a reanalysis of CDC data." He did so many things wrong with this paper but regardless of anything else he did, the fact that he analyzed case control data as a cohort study invalidates the entire thing. But he also manipulated the stats by using the wrong statistical tests in an effort to get the stats to validate what he wanted the data to say. How did another bogus autism paper get published? Well, it was a brand new journal and based on the journal's reason for retraction - "...undeclared competing interests on the part of the author which compromised the peer review process." - I'd say he included in his list of suggested reviewers, those who were in fact his very own anti-vax cronies. So forget Hooker. He was just trying to cash in on the anti-vax trend. In the process he stirred up more anti-vax "ammunition" and made it harder for people trying to help parents by getting the facts out there. 

So here we are...two decades later and the damage done is unconscionable. In 2018 there were 17 measles outbreaks in the US. Currently, there is an outbreak in WA state so severe (42 confirmed cases as of Jan 31st) that Governor Jay Inslee declared a state of emergency. One family even took the virus on a trip to Hawaii where they were quarantined.

To add insult to injury, a robust and well-executed study, published in 2015, revealed that the measles vaccine is more important than we realized. It turns out that the measles vaccine not only prevents measles, it reduces mortality from any infectious disease by up to 80%! This is because when you get sick with the measles, the virus wrecks your immune memory and it takes 2-3 years for that to recover. This is a big deal. It's why we're fighting so hard to educate people. I know you all just want to protect your kids, but refusing vaccination is only doing more harm. Honest. 

Wakefield and Hooker are not alone in the blame for this misinformation campaign. The media picks up these stories and runs with them. Media in all forms have a responsibility to provide clear, evidenced-based reporting. Instead of perpetuating anti-vax propaganda, they need to provide real, verifiable data, to talk about the hundreds of well-devised and well-executed studies that show without a doubt that vaccines do not cause autism. Interview scientists, not celebrities. 

There are two devastated demographics in this vaccine-autism debacle: children and communities who are at risk of measles and the immune deficits it brings, and those children and families who are struggling with autism. When anti-vaxxers harp on vaccines, they not only put entire communities at risk for deadly epidemics, they prevent researchers from unscrambling the true physiological/genetic/environmental anomalies that lead to autism.

And that is tragic for us all.