Thursday, December 05, 2019

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

Wednesday, August 28, 2019

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 ( 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: . 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.  

Sunday, July 28, 2019

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.

Thursday, November 29, 2018

Switzer Family Christmas Newsletter 2018

“At Christmas, all roads lead home.” ―Marjorie Holmes

For the first time ever, we welcome Seth's entire family to Enid for the holiday this year.  We wish you and yours the very best this Christmas season and although we may not get to see each and every one of you in person from year to year, you're never far from our hearts.

- Seth, Eve, Amina, and Rhys

Sunday, September 23, 2018

Adventures by Disney Enchanted China Adults Only Tour (9 - 21 Sep 2018) - Final Notes and Thoughts

When "researching" this trip, I searched high and low for any blog I could get my hands on about the Adventures by Disney Enchanted China tour.  I found very few but did glean some really good information from them.  So, I told myself that I would make sure to write a no-holds-barred account of our almost 2 week trip to China including spoilers and everything for those who are, like me, consummate planners.

To start, here they are where I really tried to concentrate on the details of what we did and what we enjoyed rather than including the more nitty/gritty intense details or things we didn't really like:

Day 0-1 (7-9 Sep 2018)
Day 2 (10 Sep 2018)
Day 3 (11 Sep 2018)
Day 4 (12 Sep 2018)
Day 5 (13 Sep 2018)
Day 6 (14 Sep 2018)
Day 7 (15 Sep 2018)
Day 8 (16 Sep 2018)
I've uploaded almost all the pictures and videos that were taken (still need to add a few from Seth's camera as well as the ones from our ABD guides).

Here's a summary (TL;DR version) of the tips that I've sprinkled in along the way in my blog posts for those who are considering or planning on taking this wonderful trip:

(1)  Arrive early for this Adventure.  The travel from the US is pretty long and brutal. Our friends, Wade and Charlie, arrived into Hong Kong on Saturday before the tour started on Sunday.  We also left the US on Friday but took our time getting to Hong Kong and ended up arriving early on Sunday morning. And, also, Hong Kong and China don't allow online check-in.  Boarding passes have to be issued by the airline at the airport.

(2)  It's not a vacation.  It's an Adventure.  We had very few days where I felt like we "slept in" - we were constantly getting up early and always on the go.  I don't normally set my alarm at home but on this trip, the snooze button got hit a lot.  This isn't really different than any other ABD (and I'm not complaining at all about this - I normally run and try to keep my mileage in the 10-15 miles per week range), though, but I thought there was a lot more walking, climbing, and the number of airline flights we took was pretty intense and exhausting.  According to Seth's iPhone app, we walked about 90-100 miles during the entire trip with about 30 of those miles over just 4 days.

(3)  We always fly business class overseas.  I realize this probably sounds snotty but these were 8 and 10 hour flights in our case.  It's been a long time since we've flown economy overseas and all I remember was constantly looking at my watch to see how much longer we had.  I can't overstate how much more comfortable and accommodating business class is - the time really did seem to fly by.

(4)  If you arrive into Hong Kong at the Peninsula early on Sunday morning, breakfast is not complimentary.  We found this out after the fact.  It's only complimentary after you've spent the night.

(5)  Even though both my American Express card and my Capital One MasterCard specifically say there's no need to notify them of travel, I found it a pain to get cash from the ATM.  In retrospect, I should have called them up, let them know about our travel destinations, and find out specifically how to use the ATM the first time around.

(6)  China is a bit fanatical about airport security.  They focused on not only electronics and liquids but also every charger, converter, and, oddly, umbrellas that you may have in your carry on.  An umbrella in your checked in luggage would be immediately confiscated.  Seth got held up at security for a charging battery that he had slipped into a pocket of his backpack and didn't remember having brought with him  - this frustrated him to no end because he didn't speak Chinese and had no idea what the security guard was saying.  He also had to remove his iPhone from its case because it had a battery and magnet in it.  They also stopped another Adventurer who had a coin purse in her bag.  Also, expect to be thoroughly frisked/patted down when you pass through security.  They do it fast but aren't shy about touching you.  Our fingerprints and pictures were taken with some frequency as well.

(7)    The bathroom struggle is real.  "Squatty potties" are the norm.  Western toilets are not.  Ralph and Daisy were heroes in making sure that the bathrooms they pointed out to us were at least 3-4 stars but even if they were, it simply took too long to wait for the Western toilet (there were, after all, about 20 other ladies on our tour) as there were frequently only 1 or 2 in each particular bathroom.  I ended up using the squat toilets at nearly every stop I went to just to avoid the wait. If you have trouble squatting (or simply don't want to), expect to wait.   I made the mistake twice going to the restroom without tissue and Daisy/Ralph were not nearby.  Fortunately, other Adventurers were generous with their tissues.  Charlie stated it well towards the end of our trip - we seemed to have developed a degree of pee anxiety - or maybe, more like potty anxiety:  getting caught having to go potty without a decent potty nearby.  "Pee when you can, not when you have to" really is the best motto to go by.

Toilet stop at the Forbidden City

Squat potty - the norm and the vast majority of toilets

Everyone is discouraged from putting even toilet paper in the toilet

5 star western public toilet - one of the only ones I used
 (8)  Be flexible.  Our plans didn't follow the advertised itinerary to a "t".  We had to make a few dining changes for a variety of reasons.  Also, there hasn't been a single Adventure that we've taken where there aren't some Adventurers who are more difficult to get along with than others.  This is everyone being human beings.  We had some challenges on this tour as well and that's all I'm going to say about that.  Overall, our fellow Adventurers were awesome and, just to give an indication of just how comfortable we got with each other by the end of the tour, the bathroom in Club 33 only has 2 stalls.  We all had to switch out of our park clothes into our dinner outfits and most of us were comfortable doing this in the bathroom without a second thought.

(9)  In Guilin on the river cruise to see the gumdrop mountains, we sat at  the far end of our private deck right by the door that went out to our private balcony.  People were constantly going in and out this door and this part of the deck did get warmer than the rest of the air conditioned deck.  Also, use the bathroom early rather than later.  The more people that used them, the more stars that bathroom seemed to lose.

(10)  Don't be afraid to try things.  I'm willing to try most everything as long as it doesn't have any cilantro in it or on it (tastes like soap).  It's mind boggling to me that anyone would choose this particular Adventure if they either don't like Chinese food or have significant food restrictions.  It might just be me but we live to eat and part of exploring a culture is definitely exploring their food.

(11)  At the Shangri-La in Guilin, families get more than one room key.  I would suggest leaving one of the keys in the slot by the door that powers the room when you leave.  Without that card in the slot, the AC turns off.  Our room was very very warm when we returned.

(12)  When we say "Szechuan spicy" - that's really really spicy.  Beware the spicy broth at the Hot Pot restaurant.  Even though I love spicy food, even this broth was too much for me and I primarily ended up using the "mild" side of the broth to cook with.  If you aren't sure, I would opt for the combo or mix.

(13)  There were quite a few nights where we had bag pull scheduled which meant that we had to leave our checked luggage outside our room to be picked up the night before we left and only keep things that we could pack in our carry ons for the evening.  This is where I found the toothbrush and toothpaste that every hotel provided to be particularly handy.  In other words, you really don't even need to pack a toothbrush/toothpaste.

(14)  Heat + Humidity = Ugh.  We went in September - getting to the tail end of their summer.  Ralph and Daisy kept remarking on how nice the weather was but there were days that I thought were really hot and everyone was sweating.  I can only imagine what this adventure was like during the months of July and August with temperatures in the high 90s and exceeding 100F.  Seth soaked through his shirt each and every day.  This is just something to keep in mind when booking as well as in terms of packing.

(15)  Soarin' in Shanghai Disneyland is different than the ones in California and Florida but not really worth the wait as it's not all that much different.  We didn't get fast passes (I suppose we could have stopped to try to get some) but this was the only ride where we waited about an hour to ride.  Even Tron and Pirates were pretty much "walk ons".

(16)  This was, by far, the best trip in terms of the amazing hotels we stayed in.  I think this was one of the primary reasons our friends, Wade and Charlie, elected to travel with us on this tour.  Disney is all about service and class not only in the selection of hotels but also the food and the whole VIP experience which we appreciate very much and why we've been on 5 Adventures so far.

(17)  Of course I have to mention our Guides - Daisy and Ralph.  Adventure Guides that are with you during the entire trip are the quintessential piece of how the whole tour works.  Both of our Guides shared a similar sense of humor and passion about their work and were a great team.  I'm sure there were many many things that happened behind the scenes that we didn't even know about.  They approached queries, requests, and complaints from Adventurers with that Disney style we've come to know and expect and never appeared tired or unenthusiastic or annoyed.

When we accidentally left the tea we had purchased in Xi'An on the restaurant table, Daisy arranged to have it shipped to the Peninsula in Shanghai.  This was absolutely seamless.  I felt like Daisy took a special interest in my background having parents who were both born in China and she helped me brush up on my Chinese quite a bit.  I enjoyed getting to use my rusty Mandarin on this trip. There were many times where she "went Daisy" (in Mandarin) with certain non-Adventurers to make sure that our experience went well/smoothly.  Daisy is so very proud of her country and heritage and it shows.

Ralph made sure everyone was clear on what the daily plans were and greeted us every day on the bus with "Ni Hao Adventurers".  As the tour progressed, it ended up being "Niiii hao, Adventurerrrrrrrrrs!” and we all came to expect this greeting every day.  Ralph got a good deal of ribbing for his comment how the amount of walking we would be doing in Beijing at Tian An Men square and the Forbidden City would be like a couple of football fields.  Most everyone agreed it was way more walking than that (we walked over 7 miles that day) and joked with him on how a football field was smaller than he thought.  I so appreciated his sense of humor, patience, infectious enthusiasm, and photo bombs.

Both Guides were constantly circulating at any meal, stop, and event making sure everything was great and that we were happy.   There were stops that they offered to take pictures for us and expertly juggled up to 4 or 5 iPhones and cameras at the same time.   I really can't give Ralph and Daisy enough credit for making our trip so unique and memorable.  

(18)  I almost forgot, the winners of our "Hidden Mickey" and "Lost in Translation" contest:

Cinci's Hidden Mickey

Shawn's Lost in Translation submission
My biggest regret about this trip was that we didn't take our grown kids with us to share this experience.  Just one more thing to add to our bucket list.  Oh, and the wasp I was stung by almost 2 weeks ago.  That sucker had some potent venom.  I left out all the details about how my arm swelled, my fingers went numb, and I lived on ibuprofen for a week.  Just when I thought my arm was feeling better, the redness, heat, swelling, and itching would start up again.  At one point, I couldn't wear my watch and tried to keep my arm elevated as my wedding ring was starting to hurt.  Then on the way home, I developed a hypersensitivity reaction with hives all over.  I started some oral steroids the night we got home and am feeling much better.  Probably TMI but best to avoid those Chinese wasps!