Switzer Family Christmas Newsletter 2019

Christmas this year will be another first.  We'll be celebrating with Mimi, Papa, and their friend Martha on Christmas Eve.  On Christmas Day, we'll be headed down to Oklahoma City to spend the morning with Amina, who has to work on both Christmas Eve and Christmas Day, in her home. 

As always, we wish all of our friends and family (and the occasional stranger who wanders onto our blog), the very best Christmas season and a wonderful 2020. 

-Seth, Eve, Amina, and Rhys

The CDC's CISA Program - a Pediatrician's Experience

Even as a pediatrician and active vaccine advocate, the CDC's Clinical Immunization Safety Assessment (CISA) Project was an unfamiliar program to me.  I'm well aware of the CDC's Vaccine Adverse Event Reporting System (VAERS) - one of several programs that are integral to assuring the safety of vaccines in the US.  In over 20 years of private pediatric practice, I've made a handful of reports to VAERS:

(1)  Crying syndrome following DTaP - that child completed the rest of their vaccines except received DT instead of DTaP.

(2)  Non-febrile seizure in an adolescent after first dose of hepatitis B vaccine.  This child also finished all other vaccine series and was medically exempted from finishing the hep B series.  No sequelae.

(3)  ITP following MMR #1.  This child recovered fully.

(4)  Death within 3 weeks of 15 month vaccinations.  This child had an identified congenital syndrome and multiple medical problems with a known limited life span.  I don't believe this child's death was causally related to the vaccines given and neither does the mother.  Her brother has the same syndrome and is completely up to date on his immunizations.

I recently made another VAERS report that was a little more difficult for me to discern what my course of action should be in recommending further vaccination to this child.  The VAERS report I made (all information shared here is with the parent's permission):

[Fraternal] Twin A [37 weeks gestation] w h/o [history of]  IUGR [intrauterine growth retardation]  re-admitted to hospital on (3/13/18) for several days' history of poor feeding - found to have elevated transaminases, abdominal distention, severe ascites, respiratory distress.  Transferred to PICU at hospital where he was worked up including exam of CSF, ascites fluid, blood, urine - all negative. Clinical picture c/w [consistent with] DIC [disseminated intravascular coagulation] but no organism ever isolated. Genetics workup including microarray and WES [whole exome sequencing] is pending. Possible underlying metabolic disorder. Discharged home 4/3/18.

In addition to the VAERS report, I also emailed the CDC (NIPINFO@cdc.gov) and asked:

I filed a VAERS report online (temporary e-report #135834).  This 1 month old patient had an incredibly thorough workup at our Childrens' Hospital of a serious event (transaminitis, ascites, DIC) that occurred about a week after the birth dose of hepatitis B vaccine.  None of the testing thus far has been conclusive.  I need to know if this child should receive his next dose of hepatitis B vaccine in the next few weeks.  Thanks for any insight.

I received a reply the very next day which said that the CDC had run a comparison to hepatitis B vaccine reactions in the literature, package inserts, and VAERS.  No similar information was found in the literature or package inserts.  In VAERS, there were 55,000 reports of adverse events following hepatitis B since 1990 of which 14 reported DIC.  Of those 14 reports, only 2 had an unknown cause.  There were no reports of subsequent hepatitis B vaccination in those children.

To be clear, a VAERS report does NOT imply causality.  From the CDC VAERS site:

It was at this point that the CDC explained CISA to me:

CDC’s Immunization Safety Office sponsors the Clinical Immunization Safety Assessment (CISA) Project, which is a consortium of vaccine safety experts with expertise in infectious diseases, allergy/immunology, pediatrics, internal medicine, vaccine safety and multiple other specialties. In a CISA evaluation, vaccine safety experts from the CDC’s Immunization Safety Office and the CISA academic medical centers review complex vaccine safety cases from licensed US healthcare providers. This link provides additional information should you be interested in requesting a CISA consult:http://www.cdc.gov/vaccinesafety/activities/cisa/cisa-evaluation.html . There is no charge for this service. If you choose to have a CISA consultation, we will need to collect your patient’s pertinent medical and vaccine records (including genetic testing that was done).

The following week, I decided that I really did need some input on how to approach this child's vaccine recommendation so I contacted the CISA coordinator and received an immediate response inviting me on a call to go over the CISA consultation process.  From here forward, the process was an impressive experience for me.

I spent the next few weeks gathering medical records and results from my office, our local hospital, and our Children's Hospital and forwarding them to the lead center at Vanderbilt. I'm fortunate in that I had several contacts at the Children's Hospital who helped me gather lab results.  In the interim,  I did see this patient and his twin for a 2 month old exam and elected to vaccinate him with all of the recommended vaccines except hepatitis B. His twin received all recommended vaccines including hepatitis B.

On May 30th, 2018, this case was reviewed via tele-conference by the CISA Clinical Consultation Case Review Working Group, which included vaccine safety experts, as well as subject matters experts (SME) in neurology, infectious diseases, gastroenterology, and allergy/immunology.  There were additionally a couple of MDs from our local Childrens' Hospital as well as myself on the call.  There were 5 questions posed and addressed during the call which included a very thorough review of the case details and all lab results to date.  Relevant citations from the medical literature were also included.  There was intense discussion between all attendees and afterwards, a summary was generated and sent to all attendees for input with a final summary generated on June 26, 2018.

Several additional lab studies were recommended but the consensus of the Group was that a causal relationship between hepatitis B vaccine and this child's clinical course was inconsistent and the child should resume the recommended schedule.  This patient's parents were aware of the VAERS report that I had filed and the pending case review.  At this patient's 4 month checkup, I discussed the review process with the parents, the recommendations that had been made, and the parents elected to complete all of his vaccines that day.  He received all of the routinely recommended vaccines and had no further issues.

There are several take home points from this experience for me:

• The CDC is very interested and willing to assist providers in making clinical decisions regarding vaccinating any child and/or alterations in the recommendations should there be clinical concern to do so.
• I was extremely impressed with how easy, smooth, and thorough this process was and following the review, felt very confident in the combined experience and knowledge of this Group and the SMEs in making their recommendation.
• Serious adverse events following vaccination are very very rare.  In over 20 years of private pediatric practice covering 2 hospital nurseries and in-patient services in addition to an outpatient clinic, this was my first situation ever requiring a CISA evaluation.
• As many times as we hear about serious events that occur following vaccination and as often as we see anti-vaxxers assume causation based solely on correlation, this experience clearly demonstrates that correlation does not automatically imply causation.  Yes, things happen coincidentally to vaccination and it's not the vaccine's fault.  

Dunning-Kruger strikes again - Antivaxxer misrepresents and misunderstands Mitkus' aluminum study

It generally doesn't take long to demonstrate that an antivaxxer (someone who doesn't believe vaccines are safe and effective AND perpetuate misinformation about them) lacks the basic science knowledge and math skills to correctly analyze and critique a scientific study.  During a week long process, this became abundantly clear early on with an antivaxxer named Lynnlee.

My original tweet to her:

Her reply:

So Lynnlee claims that the Mitkus study is "junk".  What ensued was a collection of errors on Lynnlee's part - it was actually hard to catalog and capture all of them.

Error #1

Mitkus' study wasn't simply based on oral aluminum exposure.  Lynnlee appears to be confusing what Mitkus calculated (total aluminum body burden over time) vs what those calculations were compared to (MRL50 - determined by the ATSDR, not by Mitkus).  Yes, Mitkus did utilize "injection sources" - primarily Flarend which used injected aluminum adjuvant in rabbits.

Error #2

This one took a few days to flesh out.  As background information, the ATSDR determined the MRL (minimum risk level) of aluminum based on review of many studies as discussed in their paper, "Toxicological Profile for Aluminum".  In the end, the MRL was determined this way:

Lynnlee claims "many studies" indicate that the actual NOAEL should be 3.4 mg/kg/day.  When pressed to demonstrate these studies, she made excuse after excuse for not providing the links to these studies. ("I don't have to if I don't want to" was actually one of her replies.   "You don't deserve it" was another).

As it turns out, her entire line of reasoning was simply a parroting of an article on vaccinepapers dot org without actually understanding it and just assuming veracity because it fed her confirmation bias.

Apparently the 3.4 mg/kg/day figure was based on several studies but, as it turns out, these studies were not correctly interpreted by vaccinepapers dot org.

I'm really glad J Kelly had access to that paper as this wouldn't have been something I would have been able to deduce or confirm.  So, vaccinepapers dot org claimed that these studies used 17 mg/kg/day of AlCl3 and because AlCl3 is about 20% elemental aluminum, they determined that the actual amount of elemental aluminum given was 17 mg/kg/day x 20% = 3.4 mg/kg/day.  As J Kelly discovered, the 17 mg/kg/day was of elemental aluminum - not AlCl3. 

Error #3

During the time period it took to finally figure out that Lynnlee's entire line of reasoning using the 3.4 mg/kg/day aluminum toxicity figure was flawed from the start, more than a few other errors showed up.

Again, Lynnlee appears to be confusing what Mitkus' study was about and what was calculated (body burden of aluminum) vs what the ATSDR determined (the MRL).    The NOAEL (or LOAEL) of 3.4 mg/kg/day had nothing to do with Mitkus' curve.

When pressed to explain what solubility had to do with Mitkus' calculations (it doesn't have anything to do with them), Lynnlee never did come up with an explanation - just continued to parrot what vaccinepapers dot org claimed.


Error #4

Ironically, Lynnlee continues to claim that she is "100% accurate" when it's very clear that she hasn't been.  She goes on to claim that Mitkus used the MRL values to evaluate the safety of injecting aluminum adjuvant.  Mitkus used aluminum exposure (via oral and injection), aluminum toxicokinetics, baseline aluminum levels at birth, varying infant body weight, the actual vaccination schedule, and aluminum retention based on infant renal function to determine aluminum body burden.  No, the MRL values were not used in his calculations at all but simply as a source of comparison.

Error #5

Lynnlee tends to use a lot of ALL CAPS when she's getting frustrated at being shown how wrong she is.  This particular claim was fascinating and a simple parroting of what vaccinepapers dot org stated.  Here's the math according to Lynnlee:

The intermediate exposure MRL was calculated by the ATSDR using the Golub et al study that determined a NOAEL of 26 mg/kg/day.  Because Lynnlee (and vaccinepapers dot org) claimed that the actual NOAEL should be 3.4 mg/kg/day (which we already know was an invalid conclusion).  So the actual MRL should be "adjusted" by a factor of:  26 divided by 3.4 = 7.6

This is bad math.  If we go back to what ATSDR did to determine the MRL for intermediate exposure based on the Golub et al study for NOAEL of 26 mg/kg/day, we see that the ATSDR didn't simply use this figure.  The ATSDR used Golub's figure and adjusted it using an uncertainty factor of 100 and a further modifying adjustment of 0.3 (to account for bioavailability).  Simply dividing the MRL (1 mg/kg/day) by 7.6 is inaccurate.

• ATSDR calculation using Golub's figure:  26 mg/kg/day divided by uncertainty factor of 100 divided by modifying adjustment of 0.3 = 0.866 mg/kg/day (rounded up to 1 mg/kg/day by the ATSDR)
• Lynnlee's "7.6 adjustment":  MRL 1 mg/kg/day divided by 7.6 = 0.1315 mg/kg/day
• Actual ATSDR calculation adjusting for her (wrong) claim that the NOAEL should be 3.4 mg/kg/day:  NOAEL 3.4 mg/kg/day divided by uncertainty factor of 100 divided by modifying adjustment of 0.3 = 0.1133 mg/kg/day

Error #6

This one is pretty self-explanatory.  Lynnlee tries very hard to demonstrate the math but makes multiple errors which I corrected for her.

Error #7

Lynnee made many errors in the use of units.  When pointed out to her that she made a simple error, she doubled down, insisted that her "adjustment factor" was expressed in mg, and then even went on to accuse me of not recognizing that the y axis of the graph in Mitkus' paper was "in mg" which means her "adjustment factor" should be in mg.

Error #8 

Another example of an error that seemed like a fairly simple one (% instead of mg) but when pointed out, Lynnlee doubles down instead of just acknowledging it and even accused me of not understanding how to convert a decimal to a percentage.

When asked "85% of what" the answer was:  "1 mg".  When asked "1 mg of what" the answer was: "aluminum".  So according to Lynnlee, the FDA set a limit of aluminum in each vaccine dose of "85% of  1 mg of aluminum".  Yeah, that made no sense to me either despite her claim that it was "clearly shown prior".  Here's what the FDA actually says.

So in Lynnlee-speak, what the FDA is actually saying is that:  "Federal Regulations for biological products (including  vaccines) limit the amount of aluminum in the recommended individual dose of biological products, including vaccines, to not more than 85% of 1 mg of aluminum to 125% of 1 mg of aluminum.  For example, the amount of aluminum in the hepatitis B vaccine given at birth is 25% of 1 mg of aluminum."

Error #9

There were several dimensions of error associated with the hypothetical math that I intentionally did to demonstrate an intentionally nonsense value based on a fabricated claim (that toxic effects were noted beginning at an NOAEL of 3.4 mg/kg/day).

So Lynnlee actually agreed with my math and how it demonstrates that there is toxicity from aluminum body burden at birth.  Of course, this is complete nonsense.  No, children are not born brain damaged.  But again, Lynnlee doubles down and, while admitting she didn't even look at my math, she agreed anyway.  Why?  Confirmation bias.

Even more bizarre is that she also claimed that the math I did was wrong and tries to use yet another "adjustment factor" that she called "dividing for rough estimate" - very strange terminology.  For her own fabricated value of "3.4 mg/kg/day" even.

Error #10

Speaking of strange terminology.  A few examples of what happens when you don't actually understand the science or math and simply make up your own terminology as you go along.

"departure to two months"

"responding factors"

And this really kind of summarizes Lynnlee's Dunning-Kruger Effect.  

Edited to add (13 August 19):

Lynnlee lost her mind when she finally responded to this blog post.  False accusations, idle threats, nonsense claims.

No, I don't need permission to point out the errors made publicly on a social media platform like Twitter.

Idle threats.

Veiled profanity - it never works.

Changing between public and private status on Twitter doesn't change facts.

No, there are no laws being broken.  Paranoia about "putting family in harms way" should make one reconsider tweeting publicly on Twitter in the first place.

Edited to add:

I've now added Part 2 - when chemistry doesn't say what you think it says - that continues on demonstrating yet another dishonest claim that Lynnlee made.