Skeptical About Skepticism


[Warning: Long]

Skepticism is generally a good thing, but sometimes we run into contrarianism – a version of pseudo-skepticism characterized by motivated reasoning aimed at running against some prevailing opinion or belief.

It’s hard to tell contrarianism from disinformation or just ignorance and usually my approach is to try to detect the signs of dishonest or motivated reasoning. It’s possible that someone might be skeptical about a thing, and also ignorant about it – i.e.: if I told you that I was unsure whether SpaceX was making the right decision, using liquid methane as a fuel, I’d be being “skeptical” but also ignorant (because there are plenty of explanations online of why liquid methane is a good trade-off in terms of its properties) – where I’d start to say I would be crossing a line would be if I was recommending an action, based on my ignorance, or (much worse) promoting a conspiracy theory. [everyday astronaut] I feel that our duty is always to be intellectually honest: say when we don’t know something, clearly delineate fact from opinion, explain where we are extrapolating or making assumptions, and do our research.

Several people have asked me about Naked Capitalism’s article on the Pfizer Covid-19 vaccine [naked capitalism] and I feel like I’m probably qualified to have an opinion, but lack the expertise to conclude whether the article is skepticism, ignorance, or disinformation. So: I have what I could consider “advanced layman’s education” about virology, having read a popular history about the 1917 pandemic, a popular science book or three about bioweapons and smallpox, and another about ebola. More importantly, though, I’ve been listening to TWIV! [twiv] That doesn’t make me an expert, either, but it means I’m pretty up-to-date regarding the Covid-19 vaccines that are out there, and the various issues around them. I’ll also say that I’m able to follow along comfortably with TWIV and the discussion seldom goes over my head. That says more about the TWIVvers and how good they are at explaining things than it does about my credentials as a virologist, but the fact that I can follow along is important.

Ideally, the TWIVvers will comment on the article. I emailed them when I first read it, and asked if they would do us all a favor and review it in a future episode. In my opinion, that would be an ideal outcome. But, that hasn’t happened, yet, and may not.

So, I have to approach the Naked Capitalism article from the perspective of a fellow skeptic, not an expert. That means that, like the piece’s supposed author, I look for clues that something is amiss, and, where I can, I’ll do my research. For simplicity, I will refer to the Naked Capitalism piece’s author as “Dr Anonymous”.

I’ve done multiple passes through the article, and I’ll probably do many more before this is all said and done. I have to say that this has been instructive for me and has made me re-think some of my own approaches to my skepticism about psychology. Namely: what is the degree to which being publicly skeptical about something amounts to a recommendation for action or inaction? In my case, regarding psychology, I’ve been careful not to make recommendations and mostly to bash the history of the field. But, maybe that’s not so good. Here’s why I say this: Doctor Anonymous begins by pointing out that the history of vaccinations has some notable failures. That’s what made my skepticism alarms begin to buzz. The author refers indirectly to being involved with the fallout from the Cutter Incident [nlm]:

As a very young doctor, I treated an extraordinary middle-aged woman who had contracted polio as a toddler from a poorly tested polio vaccine rolled out in an “emergency.”

That’s a suspicious statement and (since I know something about the Cutter Incident) it immediately made me start to dig. The Cutter Incident occurred in 1955, so it’s plausible that a doctor who is practicing today, might have attended a patient who suffered from that accident. But the way the incident is characterized is factually inaccurate. Worse, it’s inaccurate in a way that points the reader toward a wrong conclusion; i.e.: it’s misinformation or disinformation. I would like to ask Dr Anonymous why they phrased it in that manner.

NLM:

In April 1955 more than 200 000 children in five Western and mid-Western USA states received a polio vaccine in which the process of inactivating the live virus proved to be defective. Within days there were reports of paralysis and within a month the first mass vaccination programme against polio had to be abandoned. Subsequent investigations revealed that the vaccine, manufactured by the California-based family firm of Cutter Laboratories, had caused 40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.

Right. The vaccine being given was an inactivated live virus, and due to a procedural mistake at the lab, a batch was made in which the virus was not inactivated. That is a horrific mistake, but it’s a mistake in lab technique not – as the doctor describes it (I repeat, emphasis mine):

contracted polio as a toddler from a poorly tested polio vaccine rolled out in an “emergency.”

It was a production error, not a problem in the early stage testing of the vaccine. There was an emergency going on –  a polio outbreak – and I wonder why Dr Anonymous used “scare quotes.” Are we supposed to infer there was no real emergency? In fact, the vaccine had been tested and the protocol for inactivating the virus was fine; it was a process error that caused a batch of live virus to be shipped. That’s a tragedy, but it’s interesting to me that Dr Anonymous brings this tragedy up, and carefully describes it in a materially inaccurate way. And by “interesting” I mean that it sets my bullshit alarm buzzing at BS: Level 1. See, I’m not even a doctor or an expert on virology, yet I know this bit of history and I can see that the doctor is being selective of facts in a certain way that amounts to spinning them. As soon as I see someone selecting facts, I go on the alert for a conspiracy theory or motivated reasoning.

There’s another part of that story/incident that is relevant to Covid-19 vaccines: the Cutter Incident is one of the reasons why live virus vaccines aren’t used very much, anymore. After the Covid-19 vaccines, which are based on human-constructed mRNA chains that match those found on the actual Covid-19 virus, humanity probably will not bother with live virus vaccines ever again. I would expect any doctor who knows their virology and medical history to have said something somewhat like what I said. Why did they trot out that historical mistake in order to bolster their concerns and increase their readers’ concerns about the Covid-19 vaccines? I mean, surgeons used to think that having your hands and gear all bloody was a sign that you’d been really busy fixing people on a battlefield – but we’ve learned otherwise, since then. The fact that battlefield surgeons in WWI didn’t understand pathogens at all (mostly) doesn’t mean we should look askance at today’s vaccines, or surgeons either. The Cutter Incident was a mistake that does not invalidate modern medicine or vaccines at all.

That little head-feint is what got me interested enough to start taking apart the rest of the article.

Another point is: the doctor is anonymous. Why? There is no requirement for a doctor to conceal their identity when discussing a topic like this. It’s not the case that the doctor will get sued by Pfizer – so long as they don’t say anything that is clearly wrong, for dishonest reasons. After all, Dr Daniel Griffin [who is on my personal heroes list, full disclosure] does not feel constrained not to discuss detailed aspects of the Covid-19 vaccine and he’s even in a position where his opinion would really matter. My skepticism sense tingles a bit. If Dr Fauci and Dr Griffin are willing to talk about this stuff on the record, I begin to wonder who this other doctor actually is, and if they have an agenda that makes them want to hide their identity. I’ll come right out and say it: I wonder if they’re actually a doctor, at all. That would be an easy matter for them to have addressed, simply by identifying themselves, as reputable doctors would. If Pfizer’s going to sue anyone for defaming their vaccine, they’ll sue Donald Trump, not Dr Anonymous or Dr Griffin.

Next item: Dr Anonymous then goes to describe other instances where drugs have been found to be harmful in spite of testing. Uh. This is news to anyone?

The eight patients I took care of until they died from congestive heart failure that had been induced by a diabetes drug called Actos. The drug company knew full well heart failure was a risk during their trials. When it became obvious after the rollout, they did everything they could to obfuscate.

There are plenty of accounts of how the drug testing system has flaws. I read Ben Goldacre’s Bad Pharma [wc] when it first came out, and was suitably outraged. By the way, I am impressed to see that Goldacre’s been busy building data reduction platforms for assessing the effectiveness of various Covid-19 interventions. Chapeau, Ben! Anyhow, yes, there are flaws in the system but I’ve got to say two things: 1) so what? 2) why is Dr Anonymous bringing them up? I say “So what?” because I’ve been listening to TWIV and all the discussion of how they have been testing the vaccines and the sizes of the cohorts they used for the various drugs, at what stages. I’m scientifically literate enough to know how double-blind testing works, and I’m numerate enough to understand that when you’re testing cohorts of thousands of people – Pfizer requested expansion of Phase 3 trials to 44,000 people – that’s not remotely like the kind of testing that green-lights a flawed drug; this is actual people getting the vaccine and not getting Covid-19 afterward. [Pfizer] The earlier phases of the trial were on subjects that were normally healthy, then subsequently the testing expanded to a wider age-range as well as adding subjects that had some other health issues, e.g.: patients with HIV. When I read that, I think “well, that’s good!” Yes, they want to test and make sure that, somehow, the Covid-19 vaccine doesn’t cause particular problems for patients with HIV. Applause: it does not.

What I’m getting at is that the testing protocols that Pfizer and Moderna used are the gold standard of randomized clinical trials. Science does not, currently, know a better way to do a trial short of the highly unethical technique of deliberately exposing the test cohorts to Covid-19. Since they didn’t do that, they had to have large cohorts and test them for infection. It’s upsetting to think that some people got a shot that was a placebo, and may have been sickened by Covid-19 because they did not get the actual vaccine, but that sucks and that’s science. This is a real public health emergency.

I suppose it’s legit that Dr Anonymous wants to tell us that there have been badly done trials in the past. But: so what? The question is: are the current trials being badly done? I trust Drs Griffin, Fauci, Racagniello, et al., to be screaming bloody murder if there were obvious flaws in the trials. Instead, they were guardedly optimistic until the vaccine proved itself out, and now they’re worrying about logistics of how to distribute it.

What’s Dr Anonymous’ agenda, there? Is it to want to make us doubt modern medicine, in general? That sounds a bit anti-vaxxish. Is Dr Anonymous a stealth anti-vaxxer dealing disinformation? Continuing:

The dozens upon dozens of twenty and thirty-something patients who have been rendered emotional and spiritual zombies by the SSRIs, antipsychotics and amphetamines they have been taking since childhood. Their brain never learned what emotions were, much less how to process them and we are left with empty husks where people never developed.

Uh, now that’s got me wondering if Dr Anonymous is a scientologist or a neuro-purity crank. The question of SSRIs, etc., is absolutely irrelevant to vaccines and virology. For one thing, there’s a real problem measuring patients’ needs and outcomes – some of that stuff is self-reported. With the Covid-19 vaccine, there are now a variety of tests to see if someone is or has been infected, is expressing virus, or not. There is no need to ask the patients whether the vaccine works or even if they are sick. The tests will tell. So why does Dr Anonymous raise that particular non-issue? It begins to seem like they’re throwing up a smoke-screen of bullshit, to me. Oh, do you hear that? That’s my bullshit alarm buzzing at BS: Level 3.

Next item:

The hundreds and hundreds of 40-60 year olds who have been hollowed out from the legal prescribing of opioids.

What does opioid abuse have to do with virology? Whups that’s my bullshit alarm buzzing at BS: Level 4. The opioid crisis was a criminal enterprise by a bunch of amoral billionaires and their sales-people. I suppose that would be relevant if the Covid-19 vaccines had not already been paid for by the US Government and taxpayers. Of course, gigantic amounts of money are being made and lost in this pandemic, but … that’s actually the point of why we want the Covid-19 vaccine in the first place.

I carry all these people and more with me daily. I would not be doing a service to their memory if I allowed myself to be duped into writing another blind prescription that was going to add yet another scar.

Well, that’s certainly a bold moral stand, especially since it’s regarding something that Dr Anonymous will not have to make a stand, on. Nobody’s going to be writing blind prescriptions for the vaccine; people who want the vaccine are going to get it, free. No prescription necessary. I don’t need a prescription to get a flu shot, either. What the fuck is Dr Anonymous posturing about, exactly?

Now, I’ve got the BS alarm reading about BS: Level 6. That’s pretty severe. I am highly suspicious. I don’t see a single smoking gun that pegs the alarm, but one important point: I don’t think a real virologist who was being an honest skeptic, would raise any of these points. Did I mention that Dr Griffin is a new personal hero of mine? I don’t hear him talking about how we should not trust modern medicine because of the opiate crisis. Because it’s not relevant. When I listen to the TWIV team talking about Covid-19 and the vaccine, there is absolutely no discussion of other failures of medicine, or opiates, or anything else – because they’re not trying to sow fear, uncertainty, and doubt. Dr Anonymous’ piece would actually be quite short if they focused on the actual Covid-19 vaccine instead of bringing up all sorts of sordid but unrelated historical failures of medicine.

Continuing, Dr Anonymous, on the summary of the article in NEJM:

And, amazingly, it is basically a recitation of the same whiz-bang Pfizer puffery that we have all been reading for the past few weeks. There really is not much new. Furthermore, it is filled with words like “triumph” and “dramatic success”. Those accolades have yet to be earned. This vaccine has not yet even been released. Surely, “triumph” is a bit premature.

BS: Level 9! Shit, now the siren is going off and it’s hurting my ears.

The editorial’s characterization of the Covid-19 vaccine as a “triumph” seems fair, to me. From the NEJM editorial: [NEJM]

Results

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions.

If I’m reading that correctly, it sounds like the vaccine kicked virus ass like Arnold Schwarznegger riding Chuck Norris’ back wielding a katana. Dr Anonymous’ complaint is that the opening paragraph of the editorial was a bit of puffery? That’s it? The rest of the NEJM editorial seems mighty crunchy, to me. Best of all, a layman such as myself can understand it.

At this point, I’m going to silence the BS alarm and switch over to the assumption that I’m dealing with a piece of deliberately constructed disinformation, designed to cast doubt on modern medicine, the peer-review process, randomized clinical trials (the current gold standard in science) and anything else they can throw shit against and hope it sticks. From here on, my reading of Dr Anonymous will be less generous; I am no longer worried that they are a genuine skeptic trying to express reasonable doubts, I think we’re dealing with a stealth anti-vax crank whose stealth coating is as patchy as an F-22’s after a rain-storm.

In quite frankly unprecedented fashion, two different events that were carefully reported occurred almost simultaneously with the release of both the paper and the editorial. Both of these events contradict and contravene data and conclusions reported in both the paper and the editorial and I believe they deserve immediate attention. They both belie the assertions of the editorial writers that [emphasis mine] “the (safety) pattern appears to be similar to that of other viral vaccines and does not arouse specific concern”.

First, a critical issue for any clinician is “exclusion criteria”. This refers in general to groups of subjects that were not allowed into the trial prima facie. Common examples would include over 70, patients on chemotherapy and other immunosuppressed patients, children, diabetics, etc.. This issue is important because I do not want to give my patient this vaccine (available apparently next week) to any patient that is in an excluded group. Those patients really ought to wait until more information is available – FOR THEIR OWN SAFETY. And not to mention, exclusion criteria exist because the subjects in them are usually considered more vulnerable to mayhem than average subjects. From my reading of this paper, and the accompanying editorial, one would assume there were no exclusion criteria. They certainly are never mentioned.

The Stage 3 clinical trial opened the subject cohort to include diabetics, people on chemo, people with HIV, etc. Stage 2 and Stage 1 were more restricted. Is Dr Anonymous ignorant, or choosing their words carefully in order to manipulate the reader? They’re complaining that there was no exclusion criteria in the Stage 3 clinical trial, which is correct – but there were exclusion criteria in Stage 1 and Stage 2, which were smaller, too.

Check out this nugget: (sub-selected from the previous blockquote)

This issue is important because I do not want to give my patient this vaccine (available apparently next week) to any patient that is in an excluded group

First off, they’re not going to give their patient the vaccine; people who want the vaccine will get it at drive-through vaccination stations, or at CVS, Duane Reade, or at places that have arranged for vaccination drives. Dr Anonymous is acting as though they’re on the hook to risk their patient, but – they categorically are not. Furthermore, Dr Anonymous appears to be completely ignoring the published stuff about how the vaccine roll-out will proceed. [I recommend you listen to TWIV, Dr Anonymous, if you’re reading this!] For one thing, if they’re in peaceful fly-over country, as Dr Anonymous claims at the beginning of their piece, several million additional Americans, British and Canadians will be testing the vaccine before it reaches patients in fly-over country. The Phase 3 cohort of around 44,000 are all doing fine and since the conclusion of Phase 3 there have been a lot of other innoculations (military, special forces, police, secret service, people who have to be near republican super-spreaders, etc) so far, so good. [Update: I will describe some negative responses that have been recently disclosed, below]

I’ve got to conclude that Dr Anonymous doesn’t understand large randomized clinical trials, or they’re pretending not to, in order to misinform. That’s really worrisome. This stuff is not hard to learn about and there’s a great deal of information out there.

Also, let me mention one other thing that we’re going to careen around the corner and slam into, in a bit: if you understand how vaccines work, especially mRNA vaccines, you ought to conclude that there really is no way that the Covid-19 vaccine can be any more dangerous than a flu shot. Period. A flu shot has a large number of pieces of flu virus (no live virus) and you inject them and your immune system develops immunity. It’s not as if someone who has HIV is going to suddenly keel over dead because of a vaccine; their immune system will briefly respond and – that’s it. The exclusions Dr Anonymous was worrying about were relevant to the Stage 1 and Stage 2 trials because it was possible that some pre-existing condition might exacerbate the immune response of some individuals (chemo patients with immune compromise, sure) so they carefully tested small numbers of that cohort. So, if I’m not a doctor, and this stuff is obvious to me why is it not obvious to Dr Anonymous? Hmmm… Suspicious.

In the UK on day 1 of the rollout, two nurses with severe allergies experienced anaphylaxis, a life-threatening reaction to this vaccine. Only after world-wide coverage did Pfizer admit that there was an exclusion criterion for severe allergies in their study.

Ummm, Pfizer, since we are now getting ready to give this to possibly millions of people in the next few weeks – ARE THERE ANY OTHER EXCLUSION CRITERIA? Should I, as a physician, specifically not be giving this to patients with conditions that you have excluded?

“Anaphylaxis” is an allergic response. Allergic responses are a matter of degree. Dr Anonymous makes it sound like anaphylaxis is lethal but it can range between getting a rash or swelling, all the way up to going into shock or having symptoms similar to athsma. The nurses may have experienced a fever, swelling, rash, or other allergic responses, but I’m also a bit surprised that Dr Anonymous wants to treat allergic responses as the same. We don’t know what they actually experienced but the chances are their responses were idiosyncratic. Someone with a severe allergic response to peanuts probably isn’t going to react to the Covid-19 vaccine any differently from anyone else. It’s certainly possible that there are people who will have extreme allergic responses to any drug but those responses tend to be idiosyncratic and if the allergy is uncommon enough, there wouldn’t have been any subjects with that allergy even in the larger Stage 3 trial. One way of thinking of this, as I said earlier, is that all those nurses in the UK, and the soldiers, etc, who are getting the vaccine – call them a Stage 4 trial. Dr Anonymous’ patients won’t even have a chance to get the vaccine until there have been millions of people given the vaccine and if people were going to be keeling over dead from it, they’d have started keeling over by Tuesday and it’s Thursday, now.

Why is Dr Anonymous trying to whip up fear, uncertainty, and doubt over the vaccine? Because it’s increasingly clear to me that that’s what’s going on and I don’t know why. Why is Dr Anonymous acting as though all anaphylactic reactions are the same, when any doctor would know they’re not? I had a childhood playmate who had a severe peanut allergy. Scarily severe. I also have had allergic reactions to bee stings; the whole side of my head swelled up one time. But Benadryl and an ice pack knocked it right back down and I was fine. Someone who goes to the vaccine lineup is, actually, going to be getting the shot in the presence of people with epi-pens and the knowledge of how to deal with an allergic reaction if there is a severe one. It sounds like, while Britain gave 130,000+ vaccinations in the first two days, and if there were only 2 severe allergic reactions that’s saying that the vaccine is safer than eating junk food or crossing a street in London. Dr Anonymous is blowing this all out of proportion, and is ignoring the fact that there will be millions of vaccines given before their patients encounter the vaccine. Also, if Dr Anonymous or their patients really want to worry about it – they can wait a couple of months and see if millions of people die, then decide.

It’s also highly suspicious that Dr Anonymous is making a big deal out of the potential of anaphylactic responses to the vaccine when you set it against the broader context, which is that Covid-19 is much more dangerous, and much more prevalent, than allergic responses! While 2 allergic reactions out of 130,000 Britons is bad, 130,000 Britons who get Covid-19 is going to result in around 1,000 dead Britons. It would be Trump-level stupid to discontinue use of the vaccine because of some manageable allergic responses, when the alternative is a large number of corpses. Dr Anonymous steers away from acknowledging that trade-off, which is a huge red flag to me; they are not being honest. They are not exploring the full problem in context, and instead they are kvetching about medical mistakes in the 1950s. That’s not skepticism, that’s disinformation.

Dr Anonymous seems to be ignoring the fact that the vaccine is voluntary. Someone who doesn’t trust it can wait weeks or months and read the news to see if there are lots of people who suffer catastrophic reactions. Meanwhile, of course, other people will suffer catastrophic reactions from getting Covid! I’ve been googling for reports of catastrophic reactions and coming up dry. [Update: See Below] Most of us will have to wait weeks or months. If the Stage 3 trials didn’t convince Dr Anonymous that’s fine – treat the entire British Military and Health Service as Stage 4 and decide after they don’t keel over. What’s the big deal, Dr Anonymous? You keep talking about how you don’t want to write a prescription for your patient because of your *ahem* concerns, well then, don’t. Let them make up their own minds and stop trying to disinform them. If they want the vaccine, they can get it at CVS Pharmacy or WAL-MART and while they’re at it they can find a doctor that’s not trying to disinform them about a matter that is vital to their health. It’s hugely suspicious to me that Dr Anonymous is hopping up and down about 2 allergic responses in England (ok, that’s bad) and not stacking them up against the thousands of people who get sick and suffer long-term damage every day. I’m not an expert on medical ethics but I think Dr Anonymous may be treading close to the edge of their Hippocratic Oath if they’re trying to convince people to be afraid of the vaccine – they should be trying to convince people to take Covid-19 seriously.

What if one of them had an anaphylactic reaction to this vaccine hours after administration, had no epi-pen and had to travel a half hour to get to the nearest hospital?

I’m not a doctor, and my experience with extreme allergic reactions is limited to peanuts, bees, and some kind of chemical that made one of my high school friends swell up and get rushed to an ER. The allergic reaction is fast. That’s what makes it dangerous. If someone is at CVS and gets the shot, they’ll be feeling weird before they walk out the door. Their face will swell and buzz and they’ll be right where they can get help. But, again, this is all dwelling on a relatively minor issue. On one hand, 2 nurses in England out of 130,000 Britons on the first day. Oh, and the first vaccination shot does dramatically reduce your likelihood of getting Covid-19 even before you’ve had the second – about 50%. Dr Anonymous is focusing on the wrong thing. Why?

Then there is this troubling bit: Dr Anonymous referencing an account in [JAMA]

In her story, she details her recruitment and her experience in the Pfizer COVID trial, the same one we are dissecting here. She describes in detail her experience with the vaccine and the fact that she is concerned that many patients are likely going to feel very sick after the injection. She wrote up her own reactions, and included a very troubling one. About 15 hours after her second injection, she developed a fever of 104.9. She explained that she called her reaction to the Research Nurse promptly the next morning. The recounted the response of the Research Nurse to her information as “A lot of people have reactions after the second injection. Keep monitoring your symptoms and call us if anything changes.”

I want to say “inconceivable”. A nursing researcher who is engaged in a clinical trial who has a reaction that takes them to a temperature of 104 – which is brain damage territory – and they take an asprin and notify the researchers in the morning? Again, I’m not a doctor, but if anyone I know ever spikes 104, they’ll be in the ER as fast as I can get them there. But wait, there’s more:

I cannot be certain, but based on my reaction, I have a strong suspicion that I received the experimental vaccine, not the placebo

They never mention whether they didn’t actually have Covid-19, which also manifests with a fever. It’s possible that they got the placebo, then caught Covid-19. I don’t see anywhere in their article where they say they were tested and did not have Covid-19. Did they, or didn’t they? It’s possible that they don’t show up as a bad reaction in the trial because they were part of the placebo group. Dr Anonymous doesn’t appear to consider that possibility, which is odd because it’s so obvious.

On TWIV there was some discussion a few weeks ago about the difficulty in running a trial the size of the Stage 3 trial. Apparently some places don’t do a great job masking who gets the placebo and who gets the real vaccine. Apparently some places don’t do a great job tracking the subjects. Maybe some subject slip through the cracks, or maybe some subjects were already sick when they got a placebo shot and it wasn’t recorded correctly. I don’t know and neither does Dr Anonymous (neither, apparently, does the author of the JAMA note about their fever). I don’t think Dr Anonymous’ level of freak-out is appropriate, and is so extreme I start to feel I’m looking at a conspiracy theory. I’d expect a rational scientist to understand what I’ve mentioned several times: there’s another cohort of 400,000+ people right now (in just the US and UK), and they’re not keeling over like flies. So far the vaccine appears to be a spectacular success. If Dr Anonymous wants to wait another month, they should do that. In the meantime, why are they posting freakout disinformation on the internet?

I’m almost ready to stop, because Dr Anonymous’ narrative is beginning to wander in ways that make it hard for me to pay further attention. They proceed, from concern about the reactions in the trials, to segue into a brief rant about corruption in the medical profession. *Cough* Well, you definitely need to worry about that; there are a lot of bullshitters out there. I feel your pain.

One would think that the doctors of America would have this study explained to them by a world-known vaccinologist? NOPE…..Maybe a virologist? NOPE….. Maybe a leading government official? Dr. Fauci? Dr. Birx? Dr. Osterholm? NOPE…..Maybe an expert in coronaviruses? NOPE…

One would think that Dr Anonymous would listen to TWIV. There has been considerable discussion about how the clinical trials were set up and how they were run. I’ve been listening to TWIV for over a year and a half, now, and I appear to know more about the trials than Dr Anonymous. Dr Fauci was even on TWIV, which was pretty cool (he sounded like a tired, harrassed man) but – again, Dr Anonymous’ ranting makes me wonder how deep his knowledge of virology is. Consider the paragraph quoted above. Does Dr Anonymous expect a “Leading government official” to give a cogent explanation of the trials? I’m tempted to put an LOL meme in, but I want this posting to remain serious-ish. Dr. Birx? Who couldn’t even say “Hydroxychloroquine is bullshit, don’t listen to that idiot” is not going to give a studied briefing about the trials. Meanwhile, Dr Griffin, Dr Racagniello, and the TWIV team were doing nothing but talking about the vaccines, how they worked, how the trials were set up, etc. I’ll say that we’re all fortunate that the listenership for TWIV has spiked up to several hundred thousand in the last year, and that means there are a lot of doctors listening to a lot of world-known virologists. On TWIV. Where is Dr Anonymous getting their information? If you’re reading this, Dr Anonymous, go through the back-catalog of TWIV. Enjoy the 3-hour long episodes.

We get the Pfizer ad glossy editorial treatment from Eric Rubin MD, the editor-in-chief of the NEJM. And Dr, Longo, an associate editor. Dr. Longo is an oncologist. Dr. Rubin is at least a recognized infectious disease doctor, but his specialty based on my Google search is mycobacterium, not virology. Again, one would normally anticipate for a paper of this importance, the editorial would be from someone with directly on point expertise.

Remember, this critique is from someone who is anonymous and who expects us to accept their credentials as expert because they said they’re a doctor on a blog. What is Dr Anonymous’ specialty? What kind of MD are they? “Internal medicine” is pretty broad. I think that Dr Anonymous ought to be careful not to cast aspersions unless they first place themselves above challenge. I’m a blacksmith and former computer programmer and I can see glaring holes in Dr Anonymous’ arguments and knowledge; I’m not sure they’re quite the expert they think they are. Or, maybe they know they’re not an expert, or even a doctor, and that’s why they went anonymous? I’ll mention again that Dr Daniel Griffin and Dr Fauci and the virologists on TWIV have no fear of speaking publicly about this topic. Why does Dr Anonymous need to be anonymous?

Why would this fact been important to my mentor? (and I had the privilege of hearing him trash a paper in an open forum about a very similar issue, a paper introducing a drug to the world that later was the disaster of the decade, Vioxx) Why is this important to me and all the other physicians in my review group here in flyover country yesterday?

Since Dr Anonymous’ mentor is also anonymous, I don’t think I’m being unreasonable if I suspect that they may be imaginary. Perhaps I’m being unfair. It’d be easy enough for Dr Anonymous to clear up any doubts on that score. Why haven’t they? Clearly, Dr Anonymous is not a world-class virologist, or they wouldn’t have made the mistakes they’ve made in their article.

Now we travel from the can of worms to the sewer. And this impacts every single one of us. I want you to Google the names of the people on the FDA committee that voted 17-4-1 two days ago to proceed with the Emergency Use Declaration. Go ahead – Google it. On that list, you will find the name Eric Rubin, MD. Why yes indeed, that is the very same Eric Rubin MD who wrote this editorial. Who is the Editor-in-Chief of the NEJM. A publication that certainly takes ad dollars from Pfizer. And he was one of the 17 to vote for the Pfizer product to be immediately used in an emergency fashion. Oh yes, oh yes he was.

Am I the only one who can recognize that Pfizer and other pharma companies may have some influence on Dr. Rubin thanks continued support of his employer, the NEJM? Am I the only one concerned that Dr. Rubin’s “rah rah” editorial may have been influenced by Pfizer? Is anyone else troubled that the Editor-in-Chief of the NEJM, supported by Big Pharma advertising dollars, is sitting on an FDA board to decide the fate of any pharmaceutical product? Is this not the very definition of corruption? Or at least a severe conflict of interest? I strongly suspect that a thorough evaluation of members of that committee will reveal other problems. As my grandmother always used to say, “There is never just one roach under a refrigerator.”

Does Dr Anonymous understand that Pfizer has already been paid billions for the vaccine? That money came directly from the government and the first few hundred million doses of the vaccine are already paid for. Does Dr Anonymous think that Pfizer is sitting there going, “we need to get this vaccine out, so we can make the billions of dollars we’re already being paid? And, even if Pfizer was somehow scamming a few billion dollars over this thing, it’s chump change compared to the cost of the damage to our civilization caused by the virus. I’m as concerned about corruption as the next guy but it seems to me that Dr Anonymous is completely missing the point. Sure Pfizer will make billions over the next few years, after the vaccine has finished proving itself out, but (as long as they don’t price-gouge) that’s reasonable. The long-term model will probably be similar to flu shots – in fact I’d expect to eventually get a Covid-19 vaccine along with my flu shot and my pneumovax compound pneumonia shot, and it’ll probably cost me $45 or so. This is not some great big conspiracy to make Pfizer rich.

That’s another serious concern: If Dr Anonymous is really a doctor at some hospital in flyover country, and has been meeting with “the other physicians in [my] review group” I would expect that someone would have explained some of how the vaccine is being distributed and paid for. I know I sound like a broken record, but Dr Griffin has discussed that, many times, on TWIV. He says that they have been working on the logistics for the roll-out for a while. Dr Anonymous ought to have been briefed, if they really are a doctor. Since the vaccine is now being actually shipped to actual hospitals so that front-line medical personnel can get innoculated, I don’t understand how Dr Anonymous could actually not have a fucking clue how and where Pfizer is making their money on this deal. Ignorant, or liar? Ignorant, or conspiracy theorist? Seriously, if a complete amateur like myself knows how the vaccine roll-out is happening, and Dr Anonymous does not, maybe they should get out of the doctoring business or stop pretending to be a doctor on the internet, whichever fits better.

Let me finish:

I would say AT BEST 25% of my patients will be getting this vaccine shortly after being available. There is widespread skepticism that is not being acknowledged by our media. The pharmaceutical industry has worked tirelessly to earn every bit of that disrespect.

Doctor Anonymous has tried hard to encourage our skepticism of the pharmaceutical industry, and modern medicine in general. That’s odd, for a doctor, but it is what it is. I think that Doctor Anonymous has done some good work in the article, raising a great deal of appropriate skepticism – about Doctor Anonymous.

[Update 1:

There is a report of two adverse reactions to the vaccine. I don’t know how many people in the USA got the vaccine yesterday, but two adverse reactions in several hundred thousand vaccinations is not unexpected. Alternet reports: [alternet]

Two health care staff members in Alaska recently suffered from alarming reactions to the Pfizer COVID-19 vaccine only minutes after it was administered. As of Thursday, Dec. 17, one of those staff members is still hospitalized

Just 10 minutes after receiving the injection at the Bartlett Regional Hospital in Juneau, AK, the woman reportedly suffered from an “anaphylactic reaction” to the drug. With the allergic reaction, the woman developed rashes on her face and torso. In addition to the rashes, she also experienced “shortness of breath and an elevated heart rate,” per the publication.

That is exactly the kind of thing I described above. Unlike what Dr Anonymous tries to imply, these adverse reactions are idiosyncratic and, while severe, they’re manageable. Probably, they gave the nurse with the rash some Benadryl and kept her under observation for a while. If the reaction was more severe, they’d have given them some Epinephrine. Dr Anonymous tries to make it sound as though people are going to be dying all over the place (never mind the people who are dying of Covid!) but we’re talking about a manageable reaction.

I don’t know if you know this, but some people have similar reactions to flu and pneumonia vaccines. The start-point is to take a Benadryl. If you continue having an allergic response, go to the hospital; they know how to deal with anaphylaxis because it happens all the time – they get people coming in with bee stings, peanut allergies, etc. and they know how to handle it.

The woman received a dose of epinephrine to treat the allergic reaction. With a combination of steroids and the epinephrine drip, the woman’s symptoms did subside but only for a short period of time. Once the drip was halted, the symptoms returned, according to Dr. Lindy Jones, who works as the medical director of the hospital’s emergency department. The hospital resumed care and now the woman is set to be released from the hospital today.

What I said. The second patient:

The second healthcare worker received the vaccine on Wednesday. According to a statement from the hospital, they are said to have experienced “eye puffiness, lightheadedness, and a scratchy throat 10 minutes after the injection.” They were rushed to the emergency room and administered epinephrine, Pepcid, and Benadryl. That worker recovered “within an hour.”

Dr Anonymous wants to terrify everyone about the Covid-19 vaccine, because a very small number of people have an allergic reaction. Dr Anonymous wants to (apparently) not give their patients the vaccine because there’s a slight chance they may experience a reaction that is manageable? That’s bullshit. Dr Anonymous is a stealth anti-vaxxer or conspiracy theorist who is probably not a doctor at all.

]

-- divider --

Meanwhile, a sincere “thank you” to the TWIV team [https://www.microbe.tv/people/] Give that list a read-over if you like being impressed by people’s accomplishments and qualifications.

------ divider ------

If Dr Anonymous wants to worry about corruption, they should look into the F-35 program. Pfizer? Even if the whole Covid-19 vaccine was 100% scam, we’re talking the kind of money the Air Force spends on air conditioning. Priorities, people!

This was a tiring and time-consuming posting to research and write. I’m going to take some down-time Friday and Saturday morning and won’t post anything new, though I’ll track the comments here.

If the TWIV folks respond to my email, I will (of course) post it here. This was my email:

I know you’re busy so I’ll be brief.

A friend asked me about this article:
https://www.nakedcapitalism.com/2020/12/an-internal-medicine-doctor-and-his-peers-read-the-pfizer-vaccine-study-and-see-red-flags.html

It appears to me to be – a bit “off”, but I’d like your opinion. The author
claims to be a doctor of internal medicine, but they appear to be
calling into question basically “modern medicine” in order to, what,
discourage people from trusting the Covid-19 vaccines? For example,
they mention the horrible accident with the polio dead virus vaccine,
in which the virus was accidentally alive in one production run – but
the Covid-19 vaccines aren’t dealing with dead viruses, it’s synthetic
components of viral RNA; there’s no way that can hurt anyone. So,
why would a responsible doctor throw that incident up as a reason
to be cautious? And, the doctor mentions that people might have
“anaphylaxis” reactions to the vaccine – but isn’t that exactly what
is expected? Reactions to a vaccine are: develop immunity and
there might be other reactions as well, swelling, headache, fever,
whatever. Why is a doctor trying to make sure people understand
that a vaccine might cause a normal response to a viral infection,
which is what a vaccine is supposed to do, right?

What do you think is going on here? Is this a doctor being legitimately
skeptical, or expressing an inappropriate level of concern? Or is this
a crank dealing subtle disinformation?

I’m a computer security practitioner/programmer and not a
doctor or virologist and I don’t even claim to be one on a website.
I’m moderately familiar with virology and have been listening
to TWIV for the last year+. You folks are doing an important service,
and Daniel Griffin is a personal hero of mine. It’s not as if you
doctors have tons of time to sit around, yet you (collectively)
still spend your time trying to communicate and teach. I can
feel the exhaustion in your voices, sometimes, yet you are
doing something we all know is important. I salute you.

mjr.

Comments

  1. flex says

    Good takedown. I haven’t seen the original article, but the takedown is broadly applicable and I may send a link to this post to others who have expressed some doubt about the vaccine.

    Thanks for taking the time to do this.

  2. says

    Overall, while I didn’t bother to read the whole original article you are criticizing, from the fragments you quoted I get the suspicion that we have yet another anti-vaccine fraudster here. Here we have the same old nonsense we hear again and again from the alternative medicine crowd, anti-vaxxers, etc. Legitimate and valid criticism of medicine (examples: Ben Goldacre’s work, all those occasions when people on TWIV expressed various concerns) sounds very different that what you quoted in this article from an anonymous author.

    By the way, in Latvia anti-vaxxers and COVID-19 deniers are disastrous right now. The number of infections keeps going up and a bunch of people with “online education” keep on bulshitting about how they want their parties and shopping trips. According to them, COVID-19 is either imaginary (a conspiracy created to destroy small businesses) or no different than a flu. Here the government is actually doing a decent job trying to enforce social distancing yet uneducated citizens get angry about how shops are now closed during weekends or how they are required to wear masks.

    I’ll also say that I’m able to follow along comfortably with TWIV and the discussion seldom goes over my head. That says more about the TWIVvers and how good they are at explaining things than it does about my credentials as a virologist.

    Yep, people on TWIV do an amazing job.

    Here’s why I say this: the writer begins by pointing out that the history of vaccinations has some notable failures. That’s what made my skepticism alarms begin to buzz.

    Same goes for me. I have noticed a pattern that conspiracy theorists will talk about past cases, often from decades ago, where something went wrong and use those as a “proof” that also this time there’s a problem with something. Example: “Many decades ago some people died from some vaccine, thus also the vaccines that are sold right now are not safe.” Often their “logical links” get even more ridiculous, for example, “In past they harmed people’s health by adding lead to fuel, this proves that now they are harming people’s health by adding fluoride to tap water.” Yeah right, in past scientists were wrong about phlogiston, this proves that modern chemistry cannot be trusted either. They use the same tactics also with different spins for their pet logical fallacies. Example: “The establishment laughed at the first doctor who realized that doctors washing their hands saves patients’ lives and they were wrong, now they laugh at the doctors who realized that vitamin B17 cures cancer.”

  3. brucegee1962 says

    If I was evil George Soros with billions to spend on a sinister plot for liberal world domination, what would my endgame look like? Well, coming up with a scenario where a disease kills dumb conservatives and spares liberals and smart conservatives would seem pretty optimal.
    That’s what I don’t understand about conspiracy theorists. If there really was a conspiracy to wipe out conservatives, then infiltrating the conspiracy movement and using it to spread anti-vax propaganda during a pandemic seems like the perfect ploy. Maybe Soros is actually Q?

  4. Reginald Selkirk says

    if you understand how vaccines work, especially mRNA vaccines, you ought to conclude that there really is no way that the Covid-19 vaccine can be any more dangerous than a flu shot. Period. A flu shot has a large number of pieces of flu virus (no live virus) and you inject them and your immune system develops immunity.

    There are some differences between mRNA vaccines and older vaccines. Traditionally, vaccines contained dead or weakened viruses. In the case of the smallpox vaccine, the virus used was not smallpox itself. It was something related but much less dangerous. A newer technique is to use viral proteins rather than intact viruses. These go into the bloodstream and get encountered by immune system cells.
    mRNA vaccines are different in that they do not directly contain proteins, they contain mRNA which needs to get into the cells of the body in order to be translated into viral proteins, when then elicit the immune reaction. My ignorant and obvious next question was be: which human cells does the mRNA enter? Is there a chance it could wipe out an important subset of cells, or something like that? So I googled “which cells do mRNA vaccines target?” I should point out that Google finished the question before I was done. I came up with this link:

    Understanding and Explaining mRNA COVID-19 Vaccines

    mRNA vaccines have strands of genetic material called mRNA inside a special coating. That coating protects the mRNA from enzymes in the body that would otherwise break it down. It also helps the mRNA enter the muscle cells near the vaccination site.

    Fair enough.
    The mRNA codes for only for one or a few viral proteins, not the entire virus. So the chance of getting a coronavirus infection from the shot is nil. That leaves allergic reactions and unintended side effects to consider.

  5. billyum says

    Thank you very much, Marcus, for taking the time and energy to write this excellent critique.

    I love Naked Capitalism, but the fact that this article is not up their alley and the “red flags” in the title kept me from reading it. I would have if Mike the Mad Biologist or Pharingula had linked to it, though.

  6. bmiller says

    Damn, Marcus. This was a joy to read. (And I trust you as an impassioned “amateur” more than some anonymous crank). Thank you!

    I like Naked Capitalism on some topics, but it can be a hive of contrarianism for the sake of contrarianism. and the commentariate is infested by left wing Trumpalos, a species I just cannot understand at all.

  7. bmiller says

    Have you sent this to Yves? Would love to know her response. She does get pissy when questioned.

  8. bmiller says

    MY favorite left wing Trumpalo was a blogger I stopped following whose main reason for following Trump seemed to be that he was mad that he couldn’t get a job as a fruit picker in California. Note that he was university educated (private, I believe) and another “contrarian for the sake of contrarianism>” :)

  9. bmiller says

    Rob: Not all that convincing. And the commentariate, full of Left Wing Trumpalos, religious Marxists, anarchists, and primitivists, of course would “react positively”

    Of course, they do good work, too. The takedown of Uber was hilarious last year!

  10. Rob Grigjanis says

    bmiller @11: I’m not qualified to be convinced either way, and I take comments everywhere with a grain of salt.

    I’m only qualified to say “the article has a follow-up here”.

  11. Jazzlet says

    The thing that you haven’t mentioned that rang a siren for me was the business about the possibility of vaccinated individuals having a symptom-free bout of COVID-19 and thereby spreading the virus to others. I have seen precisely this scenario brought up by logically challenged seagull posters on SBM and similar sites. I am not sure how likely it is, but in the UK we are being told to continue to wear masks, keep our distance, and wash our hands regardless of vaccination status, so I can’t see it being a significant contributer to further spread, partucularly as the viral load for such individuals if they exist at all will be lower than for a ‘normal’ infection, but I don’t know enough to be sure.

  12. rrutis1 says

    A very Orac like takedown! I am always amazed at the stamina this must take…I would be stabbing my own eyes with a fork after reading just a couple paragraphs of the bullshit these anti vaxxers/deniers/whatever are spewing.

  13. jrkrideau says

    I saw that post, I think yesterday, and did not read it. At a quick glance, the intro paragraphs screams “anti-vaxer” & “conspiracy theorist” though that does not mean Dr Anonymous may not have some valid reservations.

    Health Canada has approved the use of the Pfizer_BioNTech vaccine. If the British authorities and the Canadian authorities have approved the vaccine and it appears likely that the European Medicines Agency appear likely to approve it , I’ll assume it looks fairly safe. All of these agencies and the US FDA will have had access to much more data and information that one is going to find in the NEJM in a 13 page article.

    Dr Anon’s rambling comments about opioid abuse or the misuse of other drugs strikes me as irrelevant to the question of the safety of the Pfizer_BioNTech vaccine but is terrible reminiscent of anti-vaxers in full cry. Dr Anon’s slanderous attack on Dr Rubin is a standard anti-vaxxer ploy.

    As a minor point, Pfizer did not receive any US Gov’t funding for the development of this vaccine. The Germany company, BioNTech, which developed the vaccine received very considerable funding from the German Gov’t, the EU, and possibly other sources.

  14. kestrel says

    On reactions: I happen to know for a fact… yep. I know for a FACT that Pfizer is following up on the people who got the vaccine every single day. This is because the Partner got the vaccine, and has had to report in every day on any possible effects from the vaccine. So far: none. One person in that group had a sore arm that day. That’s pretty normal for any vaccine. As one person put it, they would rather feel punky for a short while than actually contract Covid.

    Nice job, Marcus. Fascinating reading. I do hope TWIV responds, that would be great.

  15. mloewer says

    No exclusion criteria in phase 3? I beg to differ:
    https://clinicaltrials.gov/ct2/show/NCT04368728
    There is a full page of exclusion criteria (not all apply to phase 3, though).
    Nothing for Pfizer to admit, because it was transparent all along the way. There is a change history, and the exclusion of “Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.” was there since April.
    A physician should know how to look up studies on clinicaltrials.gov. I wonder if Dr Anonymous had any further training since his approbation in the last millennium.

  16. says

    Funny thing is, people are often more scared of something done to them by a medical professional than they are of a ‘natural’ pathogen. A worrying number of people would rather die of natural causes than risk being injured trying to avoid it.

  17. says

    One thing about perhaps two people in 100.000 having a severe reaction to the vaccine.

    Even if we assume the worst-case – both people would die – not only would it still be vastly less dangerous than Covid19, but it would also be vastly less dangerous than driving a car daily.

    In the USA, every year about 10 people per 100.000 population die in car accidents. If re-calculated to only those who drive daily it would be undoubtedly significantly higher.

    I have used this comparison in discussion with my friends recently, because some of them might be susceptible to thinking “2 in 100:000 is bad, therefore vaccine bad”.

    I had as a kid a dangerous anaphylactic reaction to penicillin, so I cannot take pennicilin-based antibiotics anymore. That still does not change the fact that I owe my life to penicillin.

    And on that note – for an allergic reaction, the second shot might actually be worse than the first one. But yeah, it won’t take hours after the shot to develop an allergic reaction.

  18. says

    jrkrideau@#7:
    As a minor point, Pfizer did not receive any US Gov’t funding for the development of this vaccine. The Germany company, BioNTech, which developed the vaccine received very considerable funding from the German Gov’t, the EU, and possibly other sources.

    I think I conveyed that correctly. The US Government guaranteed that it would buy the vaccine, in certain quantities, committing to a certain (large) amount of money up front. That makes the research “zero risk” as long as it results in a viable product. That’s an extremely enviable position for any company to be in – a guaranteed customer. It’s like telling Northrop Grumman “If you build F-35s we’ll buy 200!” Um, except in this case it seems to have worked.

  19. bartrammc5urtram says

    bmiller @12: What’s particularly wrong with anarchists being on NC and commenting, or on this site for that matter? The guy who runs this blog claims to be one, though I’d hardly call his response to the NC piece, as he and other do, a “takedown.” It seems like a lot of poorly explained inside baseball on Marcus’s part as to what exactly it is he’s “taking down.” The same is obviously true – again,very poorly explained – for the NC piece, but I don’t see Marcus clearing anything up, just making a lot of accusations that could be attributed pretty widely to almost anything. If you assume the person is a real doctor (and you don’t have to), there’s absolutely nothing that was said that provides certainty about whether they’re an anti-vaxxer or anti-science. A flippant alarmist, maybe (albeit one who could have real-life experience as claimed).
    Marcus ‘s response was If not contrarianism itself, at least a knee-jerk reaction. Neither the NC piece nor his piece did a fucking thing to be understandable to the average reader who might have concerns over the vaccine.

  20. says

    bartrammc5urtram@#23:
    Neither the NC piece nor his piece did a fucking thing to be understandable to the average reader who might have concerns over the vaccine.

    Since I wasn’t trying to explain vaccines to the average reader, I suppose “mission accomplished” if I did not do that.

    I was trying to open up how I was assessing that particular article, and my reasoning as I proceeded through it. It’s not worthy of being called a “skeptical method” or anything like that, and I certainly was not promoting it as a “take down” – in fact, the NC piece was apparently also exposing a certain skeptical method, itself. As the title implies, I am skeptical about that skeptical method and – as I continued through it – I convinced myself that it was not honest skepticism. I tried to avoid grand declarations and expressed my doubts in my own analysis where I thought it was appropriate.

    there’s absolutely nothing that was said that provides certainty about whether they’re an anti-vaxxer or anti-science

    That’s why I framed my observations as “I am starting to think…” or “what’s going on here?”

    I was also careful to try not to mis-characterize any parts of the NC piece. That’s a good approach, maybe you should try it.

  21. voyager says

    What a fabulous analysis. Thanks.
    It’s very timely for me because someone in my Quebec family is expressing that they may not take the vaccine. This piece will help me educate them.

  22. archangelospumoni says

    Many thanks for taking the time, kind sir.

    I suspect a garden variety b*llshit artist at work, so your work is even more valuable to the sane world.

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