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.