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temporaryrealityI'm starting in the order in which I find them - as best I can tell the first comments started December 6-10, 2020. When it's easy (and relevant), I'm including other readers' questions so that IM Doc's reply makes sense. In some cases I won't be able to dig through and make sure all the context is explained, but as best I can tell, that's not critical.
Comments will be turned off for this series of posts, and I recommend posting instead at JMG's current Covid-post, here :See the link in the topmost IM Doc-related post on this blog.
Well that rumor can not be true. How do i know?
The trials are not set up to measure All cause mortality
“Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”
https://www.bmj.com/content/371/bmj.m4037
IM Doc First of all – you must realize – that in all vaccine trials through the history of time – CASE NUMBERS have been tangential at best – the real important endpoints are mortality, morbidity and decrease of hospitalizations. Yet all we are being told is case numbers.
And FWIW – all cause mortality – has ALWAYS been a very important part of vaccine science since the polio vaccine days at least. I am exceedingly hesitant to give my patients any pharmaceutical without knowing the all cause mortality numbers in clinical trials.
UserFriendly They taught you ECMO when you were an intern? I doubt that very much. It hasn’t been around that long and cirtainly not in rural areas.
IM Doc Yes – actually they did – and much more.
I had the sense as a young person to try to go to one of the toughest inner city programs in the country. They taught me that and much more – unlike the programs of today where the goal seems to be to get the residents out of the hospital before 3 PM.Granted – back then ECMO was in its infancy – and the contraption resembled a jerry-rigged Studebaker compared to the stream-lined “Tesla” machines of today – but the concepts are still the same – and like all other medical procedures that you do hundreds of times – it is like riding a bike – it all comes back to you.
By the way – I work in a rural area now – I certainly did not do my medical training in a rural area.
Re: Colchicine a Case Study for What’s Wrong With US Drug Pricing MedScape
With regard to the colchicine article –
Yes – this is an absolutely humiliating problem as a clinician.
When I was younger – 30 years ago – colchicine pills could be had for 10 cents for a 2 L bottle full of them.. after all – the drug has been around since the Middle Ages. I think this past week I discovered – that a 1 week supply of them is now $187. Our government officials have made a deal with the devil – with the decision a few years ago – to “un-grandfather” all these ancient drugs. Now even things like insulin cost an arm and a leg.
A year ago – I had a patient from Mexico – who had a parasitic infection of the brain. The anti-parasitic drug just as recently as 3 years ago – was maybe $50 for the whole course – now one pill is thousands of dollars – and it takes at least 50 pills. The hospital literally paid the $800 for her brother to fly to the airport in Cancun – buy the entire course of the SAME MEDICATION for $14 and to fly back. The whole trip cost less than one pill. What a bargain for them! And the patient is now fine.
What a total disaster. The fact that this is allowed in America – and smiled at – WINK WINK WINK – by the simians at CNBC – is a national disgrace.
Hello All
An update – The past 10 days have been among the busiest of my career. As I stated – our little rural hospital became a M*A*S*H* unit. I did not know if the hospital would be able to handle things for several days there. Lambert, I will be looking at the Pfizer docs a little bit later today – I have actually gone over them superficially – but really want to dig deep today. I have simply not had the time. Life is crazy in a M*A*S*H* unit.
My little hospital is in the middle of a rural area of the country that has opted to not be too serious about masking – and there certainly are no lockdowns. Business is affected – but pretty much continues as before. We have just been through the first surge in this pandemic that we have had. Multiple dozens of very sick people – only one death – literally all at once over the past 10 days. We have had a few patients in the summer here and there – but nothing like this. And now the past 3 days – it is receding as rapidly as it hit us. We had expected a Thanksgiving surge right now – instead – the numbers all over our state are declining rapidly.
All that to say – this is NOT normal epidemic behavior. Either this virus, or our immune response to it – is just not behaving normally. For astute medical observers – this is an indication of the vast oceans of mystery that are still there regarding COVID19 – we just do not know that much about it.
A few weeks ago – before all the ad glossies started to fly from Pfizer, et al – the journal for Internists in America – ANNALS OF INTERNAL MEDICINE – NOV 17th – published a short statement by the leadership of the ACP – the questions/issues they thought were critical are below:
•Did the vaccine or vaccines earn full approval or Emergency Use Authorization?
•What are the characteristics of the patients who participated in the trials that led to vaccine approval or Emergency Use Authorization? Did trial participants have risks for COVID-19 similar to those of the person who is asking me for advice?
•What are the clinical outcomes on which vaccine approval or Emergency Use Authorization is based?
•What adverse events were observed during the clinical trials? How will postmarketing of vaccines be monitored for safety concerns?
•Are the vaccine approval or Emergency Use Authorization and clinical recommendations for use limited to specific types of individuals? If so, are limits equitable and informed by scientific evidence?
Please note – as far as I can tell from early viewing – the Pfizer data release does not really address any of these issues very adequately at all. Again – as we have been since this pandemic started – in every aspect – we are focused seemingly on nothing but case numbers – which at this point should be important for public health officials and epidemiologists for mapping and readiness – but mean really absolutely nothing for vaccine efficacy.
Please note – the third question above – this really is the most important issue – WHAT ARE THE CLINICAL OUTCOMES on which approval or EUA is based? This indeed has been the most important issue on any vaccine in the past – what is its affect on morbidity? Mortality? Symptoms? – case numbers are tangential at best. In fairness – it is probably far too early to know these benchmarks – but that is the point – we are rushing this through and the normal benchmarks seem to be too cumbersome to matter in the middle of this “emergency”.
I would end with this anecdote. I have a patient who is extremely well-connected to BIG PHARMA. I had him in last week for a visit – and asked him if he would be taking the vaccine…. His answer – “You are much smarter than that DOC. I will take these mRNA vaccines exactly one year to the day after Dr. Fauci takes his on national TV.”
Here at our hospital at the medical staff meeting this past week – another interesting anecdote. We were told that all clinicians would be asked to take 1-2 days off after receiving the vaccine because we would likely be sick. That is unique to me in vaccines. Since the vast majority of people will have minimal symptoms with COVID – WHAT EXACTLY ARE WE DOING HERE? Bizarre on so many levels.
A brief overview of “all cause mortality” in what has been released reveals a handful of deaths in both the placebo and the vaccine arm. This is actually a very small number of cohort patients – and I suspect the “power” of any conclusions at this point renders conclusions meaningless. Very concerning. It appears to me, as the pharm industry has become accustomed to doing, we are going to be using the first few million of actual patients to get this data along with many other parameters.
We have induced a panic in our population – and our leaders – political and medical – are going to be seen to be doing “SOMETHING” no matter what.
Our society and culture – has turned its head on simple public health measures that have worked for centuries – and indeed all around the world this time. We have embraced whiz-bang for profit pharmaceutical science as the “end-all” – and we are about to see the consequences – good or bad – from that decision.
I am certainly hoping that these mRNA vaccines work, but I also know something of rushed pharmaceuticals. I am not discouraging or encouraging my patients. I am telling those who are demanding the vaccine to have their prayer beads ready and to walk with God – and I will be right here if something happens – and to let me know early rather than late.
Again – thank you to the moderators and commenters here. One of the last places informed discussion can happen about anything.
And here we go.
The Pfizer vaccine is only one day out in the UK – and we have this:
https://www.lbc.co.uk/news/people-history-allergic-reactions-warned-covid-vaccine/
I would not call that a normal reaction in vaccines that I give routinely. People can certainly be allergic to anything – and local skin and muscle reactions are common. Anaphylactoid reactions requiring emergent therapy – not one time in my whole life – and not a usual thing to happen at all with vaccines that are “TESTED”.
And now it appears this was so serious that the UK is excluding anyone with severe allergies from receiving the vaccine.
Surely – one or two or a dozen of the tens of thousands of patients given this vaccine in the trials had this kind of history. SURELY. It is not that uncommon.
Please answer this question – PFIZER – did you exclude people with this condition (history of severe allergies) from your trial? Make the safety numbers look a little better? Who all else may have been excluded?
Again – this is what happens when we do not test things appropriately and/or we are not completely transparent with the results. Thankfully, it appears these people are OK. What if this were to happen in my rural community where there is no epi-pen and the nearest hospital is 30 minutes away? There needs to be complete and total transparency – and this needs to be right now.
I hope I am not sounding like a broken record – but this is exactly what I was fearing – and just on day 1.
A Nursing Researcher’s Experience in a COVID-19 Vaccine Trial JAMA (SE). Pfizer. “I took my temperature and looked at the reading: 104.9 °F (40.5 °C)…. The research nurse said, “A lot of people have reactions after the second injection. Keep monitoring your symptoms and call us if anything changes.” My fever hovered around 99.5 °F (37.5 °C) for the rest of the day. By the next morning, all my symptoms were gone except a sore, swollen bump at the injection site…. I cannot be certain, but based on my reaction, I have a strong suspicion that I received the experimental vaccine, not the placebo.” SE writes:
My concern is that a 104.9 degree fever is a grade 4 reaction. We have no data on the number of grade 4 reactions, but also…I worry if this was even recorded as such. I am not an expert and don’t know enough about it to know if the fever had to be sustained over several hours in order to be class[ed] that way, bit… Like many people, I have been troubled not just by the lack of data from pharma companies, but by the apparent lack of interest in data in the press. It feels like a narrative rather than information. I am not against vaccines (I love the way we all have to give this caveat in expressing concerns) but this feels off.
IM Doc Lambert,
Thank you for the link regarding the nurse who had the reaction to the vaccine.
A few words of clarification for your readers from a physician of 30 years.
A temperature of 104.9 in an adult with a functional immune system (we are not talking about babies and kids – they are different) is extraordinary after a vaccination. 104.9 means that the immune system has been activated enough to take it up a few notches to DEF CON 1. This is very unusual in infectious disease – some parasites and ameba do this routinely – and things like sepsis syndrome can – but for the most part, getting a temperature up this high is definitely not normal. It is certainly not a good sign for a vaccine. A vaccine should not be stimulating the immune system to this degree – EVER. Idiosyncratic reactions in a very rare patient is one thing – if this is happening more often – this is not a good sign for that vaccine.
The nurse in the article is absolutely correct – a temperature of 104.9 after a vaccine administration is a grade 4 reportable event.
This is medically important for two reasons. 1) That level of fever if sustained can damage permanently multiple organs. 2) Vaccines should simply not be activating the immune system to that degree – it is completely inappropriate. It is very normal for people to have a brief temp of 99 or 100 after a vaccine – this is a completely different level.
From what I can tell in the Pfizer documents – “fever” is not uncommon as a side effect to their vaccine. I cannot determine in any location what their parameters are for “fever”. As stated above – it is accepted that multiple vaccines will give a patient a slight fever as a side effect maybe up to a day. But not 104.5. How many of these patients classified as “fever” in their information and glossies were actually 103? 104? There is no transparency – and that is the problem.
In earlier years, decades ago – 2 people having anaphylactoid reactions to any new pharmaceutical (not just vaccines) on day 1 of wide release and fever in at least 1 subject up to 104 would have at a minimum required an instant review – and an FDA public discussion about continuing. It may even have led to a temporary suspension.
For example, in 1999, there was a flu antiviral released by Glaxo that was in the form of an inhaler. Within days, there were dozens of patients all over the USA who had sudden bronchospasm resulting in respiratory failure. I cannot remember exactly but it seems the drug did not even last a month before it was pulled. And later it was determined that the company knew this was a problem before the release. The FDA played a crucial role in that whole affair.
But that was my father’s generation’s FDA. I have witnessed first hand all year that we no longer have my father’s generation’s CDC. Both of these agencies – along with many others – have been turned into corporate toadies – and have been defanged and neutered – and are shadows of what they once were. And that was well completed long before Trump ever came along.
And most Americans are just completely unaware that this is a problem. As evidence – your other link that 60% of our population are fully confident in the science and ready to proceed with vaccination.
As an Internist, a role model, and a primary care provider – part of my job with my patients is not to be too “doom and gloom”. Too macabre. And being concerned like this is certainly not my normal personality.
I will also reiterate to the heavens – I am not an ANTI VAXXER – I have given out tens of thousands of safe vaccines over my life. I would paraphrase Obama – I am not against vaccines, I am against dumb vaccines.
My brain is telling me to just get over it – people have this under control. My gut – well honed for 30 years of BIG PHARMA and its shenanigans – is telling me, however, that we are looking down the maul of an immense upcoming tragedy. I feel like I am in a Twilight Zone episode most days right now. And all of you should know how much I hope I am so very wrong.
Again – thank you all at this site for the moderation and the comments. It keeps me going every morning.
Hello All,
It has been a very harrowing week in my rural hospital. To say we are getting slammed would be an understatement. The hospital is no longer the sleepy little alcove it once was – it is now a M*A*S*H* unit in the midst of war. I have not been this busy since my days as an intern. I was on a grand rounds teleconference the other day – the speaker was an epidemiologist. He made a simple comment that has really resonated with me. Just as the Founders hoped the various states would be incubators of ideas – so has it been in this time now medically. We are getting from the 50 states – literally 50 different approaches.
I am in a state where the populace has for the most part ignored the masking,etc. It is mostly a rural state – so we are to some degree socially distanced at baseline. Our cases started to explode about a month ago – and we are now living through the hospital crowding from that now. The death numbers are just simply not dramatic – at least in my state – people are sick but they are not dying like people did earlier in this pandemic. Interestingly, even in the “post Thanksgiving” time frame – the case numbers are starting to decline – and in some counties dramatically. I think we are about to see a real live experiment in this country – “let it rip” states vs. “lockdown” states. Ahhh, there is nothing like real data – and real science simply does not do politics.
This whole past two weeks has been an apocalypse to me – in the truest sense of the word – an “unveiling”. Of just how fragile our health care system really is. Let me explain.
There are myself and several other internists on the staff here. I am in my fifties – among the oldest. Something has clearly gone wrong in the training of those under 40. It was “standard issue” when I was an intern to be able to run ventilators, to do procedures such as central venous access and lumbar punctures, to be able to draw fluid off chests and abdomens, etc. To be able to handle ECMO. To be able to handle dialysis patients with fluids and meds if dialysis was not available (which it may not be right now for many patients). All of these things and many others were required. It is called “taking care of patients”. It is knowing how to deal with sick people – often 5 at a time. A large part of this training was having a service of 20-30 people daily like myself and my colleagues did back in the day. It was a hazing – but it was vital – for procedure learning and time management/priorities in a crisis which we had all the time. Not so for these kids – they were raised in the post Libby Zion world (look it up). They were only “allowed” to have 5 or so patients daily. A good day for them was getting home at 2 PM. And now we have a complete generation of young docs who have never been in the fire – and are at times just pitiful. They know all about “wellness” – and they know all about how to take care of trans-gender patients – but put 4 really sick people in front of them at the same time – and they just melt. It goes right to the heart of an existential question for my profession during this generation – Are physicians supposed to be “wellness coaches” or are they supposed to take care of sick people? As I say – an apocalypse.
The nurses and the ancillary staff like PT and RT are just zombies – they have been working so hard. I really fear for some of them. I also remember the good old days when this was a calling – both for docs and nurses and all others. Now it is a job. I want all Americans to know – if this keeps up like this – I am going to guess the amount of walking off the job – unthinkable a generation ago – is going to be enormous. I grew up in health care systems run by nuns. They were right out there on the front lines with everyone else – it is called morale. In hospitals all over America – our corporate managers are doing the Zoom thing from home – dictating to these nurses how things should be done – while taking none of the risk. WHAT A JOKE THEY ALL ARE!
Lambert – as far as the London Review article – I can make no other assumption that they have read the same whiz-bang pharmaceutical glossies that we all have – and are making the whiz-bang assumptions Pharma wants them to make. Still no science, no peer-reviewed anything – no tangible information to help docs and nurses advise their patients.
There are multiple other ways this could backfire. For example, just this week – I heard from an Infectious Disease Professor at a major university – that the scuttlebutt going around was that the 3 month all cause mortality in the NON-PLACEBO LIVE VACCINE ARM of both the Pfizer and Moderna cohorts was through the roof. That gossip – and similar stuff – is now spreading like wild fire among the medical community. Why? – NOT A DROP OF REAL EVIDENCE HAS BEEN PROVIDED TO REFUTE ANY OF IT. Why are we not hearing any reporters asking these CEOs a simple question – “Is the all-cause mortality in the VACCINE ARM higher?”
I am becoming increasingly alarmed about this rollout – and I am not alone.
If you commenters pray – now is the time to be praying for the nurses, docs and ancillary staff at our hospitals – this is really getting ugly.
any links to this idea of All cause mortality going up?
Interesting since i do see some frontrunning of talk to quell the idea that this is vaccine related…
see derek lowe for example.
That is the entire point –
By not being transparent and releasing real science – these companies and our government are actually encouraging the gossip to fly. Who knows what is true?