HomeMy WebLinkAbout2021_10_30 KGould_Public CommentFrom:Kincaid Gould
To:Berry, Allison; Heidi Eisenhour; Kate Dean; Greg Brotherton; Board of Health; aberry@co.clallam.wa.us
Subject:Re: Response to Public Comment
Date:Saturday, October 30, 2021 12:52:27 PM
ALERT:BE CAUTIOUS This email originated outside the organization. Do not openattachments or click on links if you are not expecting them.
Dr. Berry, BOH, BOCC—
(Apologies for the formatting)
Thank you for your response to my questions at the last BOH meeting and for your follow-upemail. I very much appreciated hearing your answers to the questions I asked. Below, I’vewritten my reactions to your responses. I understand that you’re quite pressed for time (andagain, thank you for finding the time to respond to my email), and I’m not expecting you toreply to this email (or necessarily to even read it). However, I would very much appreciate aresponse from any member(s) on this Board of Health or any other appropriate authority.
First, I’ll go through the questions I asked in order and give my response to what Dr. Berrysaid, where applicable.
1. My first question was about the Number Needed to Vaccinate (NNV) statistic based onPfizer’s data (i.e., does Pfizer’s NNV of 119 mean that 119 people need to be vaccinated inorder to prevent one additional case of COVID-19?). This question, unfortunately, was notanswered. On the plus side, I’m sure that anybody who is qualified to administer the vaccinewould know the answer to this question. I’ve asked this a few times now and haven’t receiveda response, which I’m assuming means my interpretation of that statistic is correct, though itwould be nice to get confirmation.
2. My second question was about studies finding masks were ineffective. This was respondedto in the email as well, so I’ll reserve this comment for later.
3. Next, I asked which vaccine is the safest and most effective. If I recall correctly, Dr. Berrysaid that the J&J shot is the least effective of the three vaccines, but that all three wereextremely safe. I would disagree with the assertion that all three of the vaccines are very safe—especially when considering the low risk that COVID-19 poses to most people—and I’dalso point to the Lancet article referred to in the first question, which shows that J&J’s NNV isactually much lower than Pfizer’s, at 83 (though of course this isn’t conclusive evidence toshow one is more effective than the other). However, what I think about this question is notimportant, as I was asking for Dr. Berry to throw her support behind one single vaccine basedon all of the data she’s seen—which she was unable to do.
4. Fourth, I asked why JCPH doesn’t tell us how many hospitalizations or deaths are among
fully vaccinated individuals, partially vaccinated individuals, and unvaccinated individuals.Unfortunately, Dr. Berry didn’t answer this question (though I assume others on the BOHwould be able to provide the reasoning for such a choice). I am interested in knowing thosestatistics, especially because we are being told that the vaccines make it less likely that anindividual will be hospitalized or die from/with COVID-19 (and if we can use the data fromThe Leader, which one would assume comes straight from JCPH, we see that the majority ofdeaths, at least, are in fully vaccinated persons).
5. Next, I asked about any studies that could show that there are no long-term side effectslinked to these new vaccines. I thought that Dr. Berry’s response to this questions was ratherinteresting. I was not aware that the majority of drugs that have had serious long-term sideeffects were drugs that were used over a long period of time and that vaccines typically don’tproduce such effects, and I think that that’s a strong point in favor of the vaccines. However, Ialso feel like it overlooks some key aspects of the COVID-19 vaccines.
For example, Moderna and Pfizer use mRNA vaccines. As far as I’m aware, the COVID-19vaccines are the only mRNA vaccines that have been used in humans. These are not traditionalvaccines in any sense of the term. Comparing them to, say, chickenpox vaccines doesn’t seemto be the best comparison. Furthermore, as Dr. Berry noted, there is past evidence of long-termside effects resulting from vaccination. Another possibility is that these vaccines might beresponsible for ADE, which could pose serious threats to many people.
Another consideration is that people are not just taking a “one and done” shot. Most people Iknow of have opted for a two-dose vaccine, and it seems as though booster shots are going tobecome more and more common. I would think that getting three doses of vaccine within sucha short window (and possibly many more than just three times) would fit into the definition ofa ‘drug’ being used over a period of time.
6. Finally, I asked if Comirnaty was available in Jefferson County. To this, Dr. Berryresponded that Comirnaty is available because the Pfizer vaccine is available, implying thatthey’re the same thing. I thought that this was the case for a period of time, but now I’m not sosure. Clarification on the following points would help me to better understand whether or notthe two are indeed the same product. All of the following information comes from the FDAwebsite.
“The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA), made by Pfizer forBioNTech and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUAhave the same formulation and can be used interchangeably to provide the COVID-19vaccination series without presenting any safety or effectiveness concerns.”
(https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna)
If the two products are the same, why is one of them only EUA-authorized while theother is FDA-approved? I fail to see why one of them would be FDA-approved and theother authorized under EUA if they are the exact same product.
“Under an EUA, FDA may allow the use of unapproved medical products, orunapproved uses of approved medical products in an emergency to diagnose, treat, orprevent serious or life-threatening diseases or conditions when certain statutory criteriahave been met, including that there are no adequate, approved, and availablealternatives.”
(https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained)
Given the definition of EUA, if Comirnaty is FDA-approved, doesn’t that mean that thePfizer vaccine no longer has EUA? What about Moderna and J&J shots? The fact thatthese vaccines are still being administered makes it seem like Comirnaty is not“adequate” and/or not “available”… and if it’s the same as the Pfizer vaccine, thatwould mean that the Pfizer vaccine is not adequate… and that would mean thatComirnaty is in fact not available. Are the rules being rewritten or am I notunderstanding them?
“COMIRNATY and BNT162b2 (V8) have identical amino acid sequences on theencoded antigens but COMIRNATY includes the presence of optimized codons toimprove antigen expression.”
(https://www.fda.gov/media/151733/download, page 14)
This heavily-redacted document seems to suggest that Comirnaty and the Pfizer vaccineare in fact not the same product, with Comirnaty including the presence of optimizedcodons to improve antigen expression. If one of them contains those optimized codonsand the other does not, how can they possibly be the same product? And if Comirnaty isthe one that has optimized codons and is therefore presumably better, why shouldanybody be injected with the other vaccine lacking said codons?
It appears that many claim that the two products are the same ‘with certain legal differences.’However, I have a hard time believing this statement because those legal differences aren’tdisclosed (if you know what they are, please let me know!). It seems like the only commonknowledge legal difference is that one of the vaccines is called ‘Comirnaty’ and one of them isnot. What are the others?
Another point would be what exactly is meant by saying that the two products have “the sameformulation,” a phrase the FDA uses multiple times when comparing the products. Whatexactly does this phrase mean? If one vaccine contains the presence of optimized codons andone of them doesn’t, can those two vaccines really be considered to have “the sameformulation”?
With those responses out of the way, I’d like to shift to the contents of the email I received andmy response to what I read there.
1. I had no idea Dr. Berry was working 24-30 hours a week for Jefferson County. I’massuming that would mean about 50-60 hours per week, if there’s a similar time commitmentfor Clallam County. That’s a lot of time, and I understand why she hasn’t been able to respondto (my) emails! I wouldn’t be surprised if she was working quite a bit of overtime, too! Whilethis is an impressive feat, I’m not sure it’s in Dr. Berry’s best interest to continue workingwith such a high time commitment. 30 hours for just one county would already be a full-timejob, and I really don’t see how having two people to look over the two counties could beworse than just one. I did not know that Dr. Locke was the Health Officer for both counties for17 years (if I remember that number correctly), which is also impressive, but presumablymuch more doable when not managing a pandemic. I’m not trying to offload Dr. Berry toClallam County (alone) by voicing this concern (hopefully it doesn’t come across that way)—Ihonestly think she would be able to more efficiently serve as Health Officer if she wasn’tworking so much, for whatever county. I don’t know anything about her personally, but I canonly assume that serving in only one county would allow for an even fuller understanding ofthat county’s COVID-19 profile, an enhanced presence in that county, and probably improveddecision-making (resulting from, among other things, a better sleep schedule). I only seebenefits to working for just one county, but this is obviously something that Dr. Berry wouldknow better than me (or anybody else).
2. Regarding the Q&A with KPTZ—that’s about the same as what I’m getting through email.I do appreciate that you answer questions sent in through KPTZ, but the problem remains thatthere is no option for a follow-up to be asked, and as should be clear from this email, there arequite a few follow-up questions to be asked.
3. Regarding the masking studies I sent, I want to first clarify that I in no way meant to implythat there were only 12 studies demonstrating the inefficacy of masking. I’d also like to knowif you have read those studies I sent yet. You give a long list of reasons why such studiesmight be discounted, and yet I would be quite surprised if you’d had the time to read throughall of them in the short period between the last BOH meeting and the sending of your email,especially if you were engaging in a thorough review. The way that you worded your responseto my email suggests to me that you are only assuming they are all flawed, without havingactually looked at them (though perhaps I’m not correctly interpreting your tone, which can bequite difficult through when communicating through email—another reason why a live Q&Ais much more beneficial).
However, whether or not you’ve read them is not the main issue here, but rather the way youdismiss the studies. I think that if you looked into the ‘hundreds of studies’ you’ve used tocome to a conclusion about masking efficacy, you would find that most, if not all, of themwould “lose a lot of weight when you dig into them and find that they were: a) not peerreviewed, b) not reproducible, c) poorly designed with significant confounding, d) underpowered, e) had results that didn’t support the conclusions of the authors, f) had falsified data,g) were not published or published in fake journals, h) were retracted, or some combination ofall of the above.” As you have not furnished me with a list of the studies you are using (oreven just a single study), I can’t point to any specific examples, but I think you would agreewith me that most scientific studies can be improved. There is a lot to be said about thepsychological effects of mask wearing, as well. And while talking about masks is important, Ifeel like looking at the science behind the vaccines (which can’t be undone or removed like amask) is a much better use of time.
4. Consequently, I’d like to talk about those data tables I’ve been sending.
You write, “[I]f the vaccines were not preventing transmission, we would expect… 70% ofcases would be in the vaccinated and 30% in the unvaccinated. The opposite is of course thecase.”
You mentioned the same statistic on KPTZ on Monday (I was listening) and it seems asthough you’re referring to the figure which starts measuring since the start of February of thisyear. As I’ve written previously, this is a gross misrepresentation of the data and one thatwould no doubt earn a failing grade in any traditional science course. To make this point evenmore clear, I would suggest thinking about it this way:
100% of cases were in unvaccinated individuals in March of 2020. 0% were in vaccinatedindividuals. This, of course, is due to the fact that there weren’t any vaccines available inMarch 2020. Similarly, vaccines were not largely available (in Washington, at least) until mid-April, and those getting vaccinated then wouldn’t be ‘fully vaccinated’ until May or June atthe earliest (depending on the vaccine taken). It is so clearly skewing the data to measure from
February 1st, and it’s disappointing that not a single person on the Board of Health is willingto publicly acknowledge this.
Furthermore, your statement that we would expect 70% of cases in the vaccinated and 30% inthe unvaccinated (if the vaccines didn’t prevent transmission) is only partially true. Yes, wewould expect that if the entire population of Jefferson County was tested. However, that’s notnecessarily what we would expect to find in the test results because the population beingtested is not necessarily a mirror image of county vaccination rates. In order to show that thevaccines are not effective, all we need to see is the same rate of infection in the two groups.
For example: Imagine that in one week, Jefferson County—with 70% of people fullyvaccinated and 30% unvaccinated—tests 70 unvaccinated individuals and 30 vaccinatedindividuals for COVID-19. 7 positive tests come back from unvaccinated individuals and 3positive tests from vaccinated individuals. What would we conclude? Of the ten positive tests,70% were in unvaccinated individuals, while only 30% of the positive tests were in fullyvaccinated individuals. (This 70%-30% split is the figure Dr. Berry was referring to onMonday and in the email I was sent.) However, this is misleading, because a greater numberof unvaccinated individuals were tested. We can also see that 7/70 (or 10%) of unvaccinatedpeople tested positive and 3/30 (or 10%) of vaccinated individuals tested positive; in otherwords, the infection rate is the same, and in this group, at least, the vaccine had no positiveeffect.
In order to demonstrate that the vaccine is not effective, all we need to see is the same rate ofpositive cases in the two groups, proportional to the size of the groups being tested. In fact, the70%-30% makeup of positive cases tells us nothing about vaccine efficacy!
One more example:
1000 people are tested. 900 are unvaccinated and 100 are fully vaccinated. 80 unvaccinatedindividuals test positive, and 20 fully vaccinated individuals test positive. 80% of positive testsare from unvaccinated individuals, and 20% from fully vaccinated individuals. However, therewere also 9 times more unvaccinated people being tested. And indeed, if we look at this moreclosely, we see that 80/900, or 9%, of the unvaccinated individuals tested had COVID-19,while 20/100, or 20%, of the vaccinated individuals tested had COVID-19. Even with 80% ofpositive tests coming from unvaccinated individuals, it appears as though vaccinatedindividuals are twice as likely to catch the virus!
To sum this idea up, if the population being tested does not have the same vaccination profileas that of the population at large; (i.e., 30% of people being tested are unvaccinated and 70%are fully vaccinated), it is not fair or scientific to compare them the way Dr. Berry is doing.
And there’s good reason to believe that this is the case. Here’s a handful of reasons whyunvaccinated people most likely account for much more than 30% of the people being tested:
More and more employers are forcing their unvaccinated workers to submit to regulartesting
As per Dr. Berry’s health guidelines, the school’s have systems for testing students—this could potentially fuel a large number of tests in children aged 0-11 (who areunvaccinated), especially should an outbreak occur (and apparently there was one in theWest End just recently)
Misinformation about people not being able to catch the virus after they’ve beenvaccinated (Hi, President Biden!) can lead to fully vaccinated people choosing not to gettested even if they have symptoms, and especially if they don’t
In short, if the population being tested for COVID-19 does not accurately mirror thepopulation at-large (in terms of vaccination status), comparing the rates of positive tests fromamong the population tested based on vaccination status to the rates of vaccination statuscountywide is unscientific and tells you nothing.
Let’s also note that roughly 70% of deaths in Jefferson County that have been attributed toCOVID-19 have indeed been among fully vaccinated individuals, while 30% have been in theunvaccinated. 10/15 deaths (not including two in 2020, when the vaccines weren’t available)or 10/14 (further excluding one death in April involving someone who may or may not havebeen eligible for vaccination and who or may not have been vaccinated (the Leader didn’tspecify)) is equivalent to 66.67% or 71.43% of deaths in the fully vaccinated. And if allpossible COVID-19 deaths are checked to see if COVID-19 was the main factor… this is asample that’s reflective of the whole population.
SO…
This means that JCPH must collect the vaccination status of everybody they test in order tosupport Dr. Berry’s claim that the vaccines are effective in Jefferson County. I don’t know ifJCPH does keep that data—perhaps they only ask for vaccination status if there’s a positivetest. If that’s the case, the data is not very useful (because it only considers information amongthe population testing positive). If JCPH collects vaccination status regardless of the test result(which they should be doing), the data should be recorded somewhere, and it is in the bestinterest of the public to see this data. If that data doesn’t exist, it needs to start being collected.(Otherwise our Health Officer could very well be guilty of spreading misinformation, and wewouldn’t want that!)
Hopefully this last point makes sense—I’ll try to show up at the BOCC meeting on Monday todiscuss this if I’m able to make it. Thanks for taking the time to read through this (rather long)email.
Kincaid
Sent with ProtonMail Secure Email.
------- Original Message -------On Tuesday, October 26th, 2021 at 2:27 PM, Berry, Allison <aunthank@co.clallam.wa.us>wrote:
Hi Mr. Gould,
I wanted to write today to thank you for raising your questions to the Board ofHealth. I do think raising those questions in a public forum is very helpful so thateveryone following along can benefit from the answers we share.
I also want to extend my apologies that I’ve not been able to respond personallyto your prior correspondence. We do receive an incredible amount ofcorrespondence at the public health department, a volume which has dramaticallyincreased in the most recent months of the COVID-19 pandemic. Unfortunately,the volume is just too great for me to respond to everyone who comments.However I wanted to carve out some time today to make sure you know that youare heard when you write.
Thank you for spending what appears to be an significant amount of timecrunching numbers on the COVID-19 pandemic. I wanted to take a moment toaddress those calculations as well as a couple of the points you made in your mostrecent correspondence with the Board.
In your most recent letter, you noted some concerns about the availability of mytime. I wanted to share some information you might now have. The JeffersonCounty Health Officer has traditionally been an 8-10 hour per week position.Prior to the pandemic, that is the number of hours a week that Tom Lockeworked. That is the amount of hours the position is expected to return to after thepandemic resolves. I am currently working approximately 24-30 hours per weekfor the Jefferson County Department of Public Health. The object taking up mytime right now is the strains of the pandemic response: mass vaccination planning,coordinating our healthcare system including monoclonal antibody distribution,coordinating our school district response and safety protocols, engaging with localbusinesses on safety protocols, informational campaigns, contact tracing andoutbreak management, and improving testing access across our community.These, and the remainder of my public health duties around water quality,environmental safety, other infectious disease control, and chronic diseaseprevention are what keep me from having the capacity to respond to all those whoreach out to the Board. I am sorry this has meant that I cannot discuss your emailsmore directly with you. I wish I had the time to do that more.
In your email, you do reference desiring a public Q&A and we do offer thatweekly. You can submit any questions to KPTZ and I will answer them on air as Ihave since taking on this role.
In your email, you also mention and to some extent misquote a discussion I hadwith the Board around misinformation. In that discussion, the primary point Iconveyed was that an exhaustive literature review takes time and training. If notconducted properly, it can lead you to draw spurious conclusions based on biasedstudies or biased search criteria. A great example of this is actually the dialogueyou shared with me around mask effectiveness. You cite dozens of studies whichyou report demonstrate that masks are not effective, which sounds convincing,unless you dig a little further. When you do, you’ll find that dozens of studiesdon’t amount to much when they are compared to the hundreds showing thatmasks are effective. Those dozens of studies also lose a lot of weight when youdig into them and find that they were: a) not peer reviewed, b) not reproducible, c)poorly designed with significant confounding, d) under powered, e) had resultsthat didn’t support the conclusions of the authors, f) had falsified data, g) were notpublished or published in fake journals, h) were retracted, or some combination ofall of the above. Evaluating for all of these qualities is what is entailed in a properliterature review. And yes, evaluating for these qualities is part of my training,and part of my role within the department. I certainly encourage all of our citizensto engage in this level of thorough review of the data we are presented with, butthat is hard and very time consuming if done well. Another option is to listen tothe thousands of epidemiologists like myself who have dedicated our lives to thiswork and providing you this service.
Last, but not least, it does appear that the primary focus of your work has been
around breakthrough infections. I wanted to share a couple key points there, someof which I shared on KPTZ on Monday.
- One is that the percent of cases among those who are fully vaccinated has not
been dramatically increasing and has actually stayed largely stable over the last
several weeks. If we were seeing vaccine failure, we would expect that number
to rise.
- Further, if the vaccines were not preventing transmission, we would expect
that the breakdown of infections among the vaccinated and unvaccinated
would parallel the population levels of those two groups: namely 70% of cases
would be in the vaccinated and 30% in the unvaccinated. The opposite is of
course the case.
- We consistently find that in state level data that those who are unvaccinated
are 8x as likely to contract the virus as those who are vaccinated.
- We don’t routinely calculate the percentage of breakthrough infections or the
relative rate of infection in vaccinated and unvaccinated people in Jefferson
County because our population is so small that our population is so small that
we cannot reach statistical significance. When you calculate rates without
taking into account statistical significance, you run the risk of drawing spurious
and irreproducible conclusions, unfortunately including those found in your
email.
- When you’re dealing with small numbers like we do in Jefferson County, an
individual event (like a long term care outbreak, or a daycare outbreak among
the children of healthcare workers, both of which have happened here) can
dramatically affect the results week over week and skew the data. But even
that doesn’t tell the whole story because in each of those events, it was an
unvaccinated person who brought the infection into those spaces and then
lead to large and unfortunately in some cases deadly outbreaks.
That’s just a little bit of what I notice in your correspondence. If you have a deep
interest in data, I would strongly encourage you to pursue a degree in biostatistics.It’s a fascinating field and having a deeper understanding of these statistical
concepts will give you a much fuller understanding of the data you’re trying toaccess and the problems you’re trying to solve.
Thanks again for reaching out. I won’t likely be able to continue this level of
correspondence with you, but please know that we will be here, working hard onyour behalf as we have been.
All the best,
Allison Berry, MD MPH (she/her/hers)
Clallam & Jefferson County Health Officer
Desk: (360) 417-2437
aberry@co.jefferson.wa.us