It’s alarming and disheartening to see that the effort to combat Covid is becoming more and more politicized. It’s not just the elements that are inherently political, since they involve government decisions and allocations of resources, like whether to restrict international air travel, mandate quarantines, provide support to households and businesses for lost wages and revenues, and decide who gets first dibs on scarce supplies. It’s that the elements of the debate that the great unwashed public would really like to be in the hands of unbiased trustworthy experts are now as much subject to politics and fashion as whether Covid relief will be means-tested or not.
One of the side effects is Joe Biden making nonsensical statement like “Trust the science.” Science with respect to medicine is regularly a medieval art. Either practically or ethically, we can’t run large scale studies on representative populations. We’re often stuck with observation, experimental-level studies, and correlations as opposed to clear-cut causality. And too often, the people making those studies have reason to over-hype the results, even if it’s just to get their research noticed.
The situation is made worse with the high level of corruption in our society, starting with private equity rentierism in hospitals and emergency services. Experts have complained about corruption in scientific research for decades, to the degree that a lot of the public has become aware of it. Agnotology to muddy the mounting evidence against smoking, and later, against carbon emissions. Vioxx. Oxycontin. Overdiagnosis of behavioral disorders in children, accompanied by unprecedented administration of medications. In medicine, this is the direct result of drug companies and health care providers being more and more driven by commercial rather than patient interest.
Profit pressures have also degraded the doctor-patient relationship. More and more MDs work as employees rather than in their old configuration of independent small businessmen. Their corporate masters regularly not only dictate how many patients to see in the day, but also a lot of their treatment protocols. Allegedly, the latter is driven by the need to get more doctors to adhere to the standards of evidence-based medicine. Some practitioners retort that quite a few patients have problems that don’t fall tidily into adequately researched boxes, and clinicians need to be able to make judgement calls.
None of this is new, but it’s important to remember these issues as the debate over Covid policy continues. The US has backed itself into the corner of having to hope for a medical magic bullet due to our inability to mobilize a society-wide response to Covid. And it’s not just authoritarian China that has done better. Thailand, which has Bangkok, literally the most visited city in the world as its commercial center, has a population of 75 million and has had 60 Covid deaths. Yes that means 60 in total. Alabama, with 4.9 million people, had 56 Covid deaths yesterday.
Even parts of the West that had initial successes, as we know all too well, have backslid spectacularly, loosening up too much in the late summer and fall. And now that the disease is well entrenched, it seems just too daunting to have a strict lockdown for five to six weeks, pay people and business enough to get through a deep freeze, and put in place post lockdown measures with teeth, like serious fines for breaking quarantine (and support during quarantines, like stipends and delivery of food and other supplies). The purpose of this post is not to debate what that program might look like, but to posit that there is one, and that stop-and-go leaky lockdowns are likely to be as costly in human and financial terms in the long term.
So instead, the US is putting all its eggs in the Covid vaccine basket. That is coming at the expense of pursuing other approaches in parallel to reduce the health cost and societal damage of the disease.
As we said early on, if we didn’t get lucky as we did with SARS and have it mutate into a less virulent form, we would need a combination of treatments to reduce disease severity, morbidity and mortality, and vaccines. There was no reason not to pursue both routes aggressively, in parallel. Recall that the fight against AIDS involved both trying to come up with a vaccine as well as experimenting with many drugs and later drug cocktails.
But as we are already seeing, due to the fixation on a vaccine, and Operation Warp Speed adopting a bizarre “first past the post” approach and letting Pfizer enjoy a first mover advantage (rather than trying to the extent possible to compare candidates against each other and see which might be the most suitable for various patient and delivery situations), anyone who questions the unprecedented rushed development and approval of vaccines is treated as an anti-science crank and a threat to public safety. What about “precautionary principle” don’t you understand?
Our IM Doc had to post his reading of the Pfizer article and editorial in the New England Journal of Medicine anonymously out of fear of losing his job. We also received e-mails from doctors supporting IM Doc’s post, including one that argued he’d skipped over some concerns about the Pfizer vaccine.
I felt I could share this one from Dr. Harvey Risch, Professor of Epidemiology at Yale School of Medicine, since it restates positions he has taken publicly:
I read your essay from the internist critical of the vaccine data and policies that have come out so far. I strongly share his/her concerns. I have been working in Covid early outpatient treatment since March of this year and you are probably aware of the massive propaganda war being conducted against outpatient treatment by pharma companies, vaccine companies, FDA, NIH, WHO, as well as the numerous academic pontificators who have never treated even one Covid outpatient.
I am involved in two private email groups comprised largely of MDs discussing evidence for Covid early outpatient treatment. We have published a number of papers (e.g., https://www.amjmed.com/article/S0002-9343(20)30673-2/fulltext) as well as op-eds such as the following:
https://www.washingtonexaminer.com/opinion/fda-obstruction-patients-die-while-trump-gets-the-blame
Because of the mainstream media censorship of our position that early outpatient treatment is safe, successful, inexpensive and would largely solve the pandemic without necessity of or even better than vaccines, most of our messaging has appeared on the political right. However, we span the political spectrum as can be seen by a recent article here:
https://filiperafaeli.substack.com/p/yes-hydroxychloroquine-is-scientifically
We are all actively working as best we can to bring clinical relief to patients. Thanks very much, and thanks for publishing IM Doc’s outstanding critical analysis.
My best wishes–
Harvey Risch
Since this is a finance and economics site out to promote critical thinking, we are in a better position to analyze institutional behaviors and failings than weigh in on a controversy like hydroxychloroquine, where we have been providing links to studies on it. However, it’s been obvious that Trump’s ham-handed advocacy generated knee-jerk prejudice against it. While critics point to research showing it hasn’t been effective, even at our remove, it appears that most of the studies on it have been of hospitalized patients, which is not use case recommended by advocates. They instead contend that it is effective as a prophylactic and/or as an early intervention. We must confess to not having had the time to parse out the studies that focus only on those cases. But the more general point it the media noise has downed out serious consideration of the data.
Several readers sent a link to a new article in STAT which raised new concerns about the rushed approval of the Pfizer vaccine. Needless to say, STAT is recognized as being above the political fray. From Did the FDA understaff its review of the Pfizer/BioNTech vaccine?:
In what is arguably the most important decision the Food and Drug Administration has made this year — its emergency use authorization of the Pfizer/BioNTech Covid-19 vaccine — the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….
Unlike its counterparts in other countries, the FDA is believed to be the only drug regulator in the world that consistently receives and reviews patient-level data from the clinical trials that underpin drug and vaccine approvals. To perform such rigorous analyses, the FDA typically spends around 10 months (a mere six months for applications given “priority review” designation) in an effort that involves reviews by experts representing various scientific disciplines: clinical medicine, statistics, pharmacology, chemistry, pharmacovigilance, and more…
Given the urgency of the pandemic, the review of the Pfizer/BioNTech vaccine was conducted far faster than usual. The centerpiece of the analysis was data from the company’s 44,000-participant Phase 3 trial. FDA reviewers had just three weeks, from Nov. 20 to Dec. 11, to complete their analyses. It was a monumental task, which raises the question: Why didn’t the FDA devote additional reviewers to it? According to the FDA’s review memo, some scientific disciplines, such as pharmacovigilance, had multiple reviewers involved. But the two disciplines tasked with examining the clinical trial data and results, the clinical and statistical reviewers, were seemingly left to do their work solo.
This seems wholly inadequate on at least two levels. First, without additional reviewers it is hard to comprehend how the work of several months could be squeezed into a matter of 22 days (including Saturdays and Sundays). In-depth review calls for examining patient-level data — a large feat that involves auditing and reviewing individual case records as well as independently rerunning analyses on the raw data.
Epidemiologist Ignacio had already raised another concern: that the high frequency of strong adverse reactions meant the study was unblinded to those patients:
First and foremost, we are looking to very transient results obtained in a period too short to be relevant to evaluate the efficacy of the vaccine. It is well known that vaccines induce antibody peaks just about 12 days after the second shot. We are looking at this peak. Very relevant regarding the possibility of some short lived sterilizing protection in the upper mucosa.
Second, the high reactogenicity of the vaccine, way higher than the placebo, removes one of the blindnesses of the trial. You know if you are a recipient of the vaccine. As IM Doc says, the reactogenicity is way above what can be considered normal or standard and with potential to be problematic, and a behaviour changer in the recipients which can have very significant effects in the numbers observed obtained in so short times after vaccination. This effect will be diluted by time in later reviews but it can be quite important in the first review.
STAT agreed that the effective unblinding was a concern:
One of us (P.D.) raised questions about potential unblinding in the trials through the vaccine’s side effects, as well as about the confounding effects of fever- and pain-reducing medications, which participants in the vaccine arm took three to four times more often than those in the placebo arm. Yet the FDA’s review shows no evidence that any of its scientists investigated either of these issues, and without more scientific staff devoted to the task it is hard to imagine how they could.
Finally, I wanted to return to a controversy that readers batted about in Links yesterday, because it ties in with the high odds that the FDA did little or no vetting of patient data.
We asked readers to help us understand the significance of this statement on page 41 from the FDA’s EUA review memorandum on the Pfizer vaccine trials:
Among 3,410 total cases of suspected but unconfirmed COVID-19 in the overall study population, 1,594 occurred in the vaccine group vs. 1816 in the placebo group.
Suspected COVID-19 cases that occurred within 7 days after any vaccination were 409 in the vaccine group vs. 287 in the placebo group. It is possible that the imbalance in suspected COVID-19 cases occurring in the 7 days postvaccination represents vaccine reactogenicity with symptoms that overlap with those of COVID-19.
Back to this post. Reader Diuretical pointed to this section from page 13 of the EUA memo:
If, at any time, a participant develops acute respiratory illness, an illness visit occurs. Assessments for illness visits include a nasal (midturbinate) swab, which is tested at a central laboratory using a reverse transcription- polymerase chain reaction (RT-PCR) test (e.g., Cepheid; FDA authorized under EUA), or other sufficiently validated nucleic acid amplification-based test (NAAT), to detect SARS-CoV-2.
First, one is led to believe that it was only those who developed acute respiratory illness were tested. Note that one of the features of Covid is that it can present with other symptoms, such as loss of smell. WebMD reported based on a large-scale study in China that:
In about one-quarter of patients in the new study, diarrhea and other digestive symptoms were the only symptoms seen in mild COVID-19 cases, and those patients sought medical care later than those with respiratory symptoms.
So it looks possible that Pfizer may have classified Covid symptoms too narrowly and missed a meaningful number of mild cases.
Another issue is the reliability of the PCR tests. Their positive results are reportedly quite accurate in symptomatic patients. However, the PCR test has a fairly level of false negatives:
Researchers at John Hopkins University declared that the false negative ratio of RT-PCR test in patients infected with COVID-19 is approximately 1 in 5.
I invite readers to try their own sensitivity analyses of the data above and see what they come up with. Recall that the headline results for the Pfizer vaccine were 168 cases in the placebo group versus 8 in the vaccine group.
As to why we are continuing to examine the data, recall again that this is an mRNA vaccine, a technology never used at scale in humans, let alone planned to be population wide. This is a completely different beast than traditional vaccines. Igancio set forth the stakes:
How on hell it is possible to approve a vaccine that uses a platform with 0 experience on the basis of so little data? Have we forgotten, again and again, the precautionary principle? These 8 infected after a couple of months from the trial start compared to 168 in the placebo group is enough to approve something for thousands of millions? Have we forgotten previous mistakes? Is 8 enough to have any information on adverse effects and serious adverse effects? Can we rule out antibody-enhanced disease on the basis of 8 reported infections? No way, no way, no way. Please, remember this, RNA vaccines have NO history of deployment, these are a big unknown and, if anything, the most thorough research and follow up of the trials should be carefully done before approval, before delivering an unknown to the masses.
In other words, there were solid reasons for the bar for approving a mRNA vaccine to higher than for a conventional vaccine, or alternatively, for its initial subjects under the EUA to be medical personnel who volunteered to take it. That is an obvious top priority group, capable of informed consent. Instead it’s being rolled out on a mass basis.
Perhaps Pfizer and the public generally will be lucky and the vaccine will live up to its promises. But this is too important a gamble to be betting on Lady Fortune.
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(imo) the decline of civic science literacy is a kindling that allows the abuse/misuse /politicalization of science to propagate in the media and by politics.
Long-form discussions of science (old school 60 Minutes, PBS’s Nova, BBC’s Horizon) just don’t get many eyeballs anymore—–science media consumption have shifted to the Youtube-Buzzfeed-Tiktok model.
(imo) it’s no accident that the best anti-covid performing democratic countries are correlated w/the ones with higher educational achievement (and lower income inequality)
just another symptom of Anglo-American terminal decline (IMO)
Also, His Donald-ness isn’t taking the vaccine until ‘doctor approval’, so caution there.
This kind of collapse, any port in a storm, as expressed in the abbreviated and ludicrous two man FDA review of the Pfizer/BioNTech vaccine trials is now likely to increasingly become the norm as will the outrageous and frightening brutal clamp down of dissenting voices, even, and most alarmingly in the medical profession itself. It will be harnessed and exploited by corporate interests thus creating a self expanding loop. Not that it isn’t already, but this pandemic has provided the perfect excuse to unleash the process in overdrive. Public outcry? Let them eat main stream media cake.
Correction: “the agency apparently assigned only a single reviewer in each of two key scientific disciplines (clinical and statistics) to do the work in three weeks that usually takes months to do….” That the process and financial intertests behind this kind of potentially lethal short-cut will more quickly become the norm, however, remains valid.
737 Max
Yep. I think they call it the 737-8 now.
I call it the 737 NFW
… I deciphered that! No F****** Waymo.
Political decisions being sold to the public as scientific decisions, scientists with political aspirations ingratiating themselves with the upper crust of the political class and providing cover for profiteers to claim a once in a generation payday, algorithms being tweaked to censor any dissenting voices at scale, what’s not to like?
Thank you for this. (Both NC and commenters) It’s a relief to see this discussion somewhere. The utter lack of information or analysis in the public area (press, government, social media) has been hard to take.
Why are we being asked to trust or ‘believe in’ science? This is should be a red flag. The whole point of science is supposed to be that does not demand trust or faith in the way religion does.
As for the precautionary principal, no we have not forgotten it. It has never really been a part of American public health or regulatory policy. At least when it comes to environmental health, the United States has always been more of the, ‘First do harm. The, let small, underfunded groups try fight industry to prove causality,’ school of thought.That said, this might be a new frontier in terms of this strategy as far as pharma is concerned.
One (reasonable) reason that they are asking us to “trust in the science” is because a growing portion of people are, effectively, not trusting the science and receiving their information from other sources than government. This is generally a bad thing when solutions require coordinated actions (such as getting people to vaccinate in order to prevent big outbreaks).
I’m saddened that our governments are likely to spend quite a bit of positive influence they still have as societies on getting their citizens to do this, as “this” may turn out – once again – to be a turd.
It seems that the people in power believe that their current society will never change in any major way, that they can’t break down if a sufficient number of people become disillusioned enough with them. Call it an “end of history” or “our Gilded Age is different!!11” or whatever.
I agree that that is part of what drives people to say, “trust science.” But I don’t think that shutting down reasonable inquiry and treating the public like children who can’t understand science is an effective way to build trust in science. Practice good science, be transparent about results, and communicate clearly. Obfuscating while telling people to ‘trust science’ simply makes the messenger (the government) appear (and actually be) untrustworthy, and broadens, not narrows, the constituency of mistrustful people.
I work in environmental/climate change blah blah blah, and so am not naive about good data’s ability to convince…anyone really. Most people will believe what people around them believe, irrespective of facts. So I don’t think that the formula of clear communication is a silver bullet. However, I do think that dismissing or belittling people’s concerns and hiding facts rather that listening to and addressing concerns openly is a sure route to alienation.
Problem: virtually all of “science” has become proprietary. Somebody (or some bodies) owns it, releases only what can make quick sales, hides problems, and pockets profits, profits, and more profits. Markets, you know.
A lot of what is talked about above has been talked about for some time on what would be called rightwing sites or simply dissident sites like Mike Whitney’s link aggregator. In particular the notion that early outpatient treatment could greatly reduce the death count has been out there. Those of us who are big medicine skeptics are quite willing to believe that preferred approaches by the establishment would also be the most profitable approaches and as we all know hospitals are not exactly cheap. While doctors have always said if in doubt get a second opinion that doesn’t seem to go for the media world these days where alternative ideas are assigned to Putin meddling or perhaps the Kochs.
At any rate thanks for the above post. Just hope it doesn’t get NC banned on Youtube!
Or banned from the twitter-verse. How exactly is the twitter-verse going to fact-check? (rhetorical question.)
The move sees the company follow Facebook and YouTube in tightening up policies around the coronavirus vaccination as the rollout of the jab begins across the world.
https://www.theguardian.com/technology/2020/dec/17/twitter-to-remove-tweets-that-spread-lies-about-covid-vaccines
Also from the G. link:
Tweets that do not reach the level of potential harm will not be removed, but may receive a label linking through to authoritative public health information, the company said.
Trust is indeed the issue.
It will be interesting to see what percentage of health care workers get voluntarily immunized and their eventual outcomes versus those who don’t.
It wouldn’t serve PhRMA’s best interests if prescribers and caregivers were wiped out by this vaccine. That includes the possibility of vaccinated healthcare workers who are weaponized as spreaders, shedding the virus to the vulnerable while immunized against harms to themselves. After all, PhRMA has many eggs in their basket. A chronically sick populace keeps their stocks humming.
Severe reactions and death will turn the lights off quickly on these new vaccines if they start to mount. Hopefully there will be full transparency regarding this data.
As for me, a retired doc, I am grateful that I am not on the front lines. I think I will wait at least a year for the data to sort out before I get vaccinated against Covid-19.
Thank you for this. (Both NC and commenters) It’s a relief to see this discussion somewhere. The utter lack of information or analysis in the public area (press, government, social media) has been hard to take.
Why are we being asked to trust or ‘believe in’ science? This is should be a red flag. The whole point of science is supposed to be that does not demand trust or faith in the way religion does.
As for the precautionary principal, no we have not forgotten it. It has never really been a part of American public health or regulatory policy. At least when it comes to environmental health, the United States has always been more of the, ‘First do harm. Then, let small, underfunded groups try fight industry to prove causality,’ school of thought.That said, this might be a new frontier in terms of this strategy as far as pharma is concerned.
I truly appreciate NC’s timely reporting on Covid’s emergence last winter, and its critical analysis of the various responses to the disease in the months since. It was lies, lies lies from official sources in the beginning, and now we’re back to lies, lies lies in its denoument. One cannot help but wonder what the official motivations are; any critical thinking brings a label of “conspiracy theorizing.”
Scientists and physicians of consicence will try to find outlets for their views, as will the public in seeking reputable analysis and opinion. I expect NC’s readership to grow dramatically in the months ahead.
Well done.
I’ll second that. NC had the pandemic covered from the get-go and has been covering it tightly ever since.
Agreed.
And I am reminded of a wide-ranging conversation I had with a neighbor-friend yesterday. Said friend noted, in terms that are much to salty to quote on this family blog, that she has zero trust in any of the COVID vaccines, and that she isn’t about to take any of them.
She cited the example of, oh, that medication that was prescribed to pregnant mothers. “Thalidomide?” I asked. Yes, that was the one.
Well, I remember Thalidomide well, because I went to high school with a girl who had a head, a torso, and a leg. That was it. She had to wear two prosthetic arms and one prosthetic leg. Why? Because her mother was prescribed Thalidomide during her pregnancy.
Shortly after I graduated from high school, there was quite a push to get Americans vaccinated against swine flu. The vaccine was rushed to market, and uh-oh. One of the side effects was Guillain-Barre Syndrome, which afflicted one of my mother’s teaching colleagues. Said colleague had a difficult and lengthy recovery.
More recently, my neighbor-friend and her then-husband attended Obama’s second inauguration back in 2013. Before they left Tucson, she got the flu shot. Y’know, just as a precaution. In her words, she got sick as [the word rhymes with firetruck]. Let’s just say that was the last flu shot she will ever take.
In short, our so-called health care system has destroyed a lot of the trust that it once had. And that trust won’t be returning anytime soon.
Oh, you don’t have to back as far as thalidomide. Remember when Premarin was the thing for menopausal women? Or when Oxycontin was the thing for pain control. Or when Prozac was just the drug to give to depressed teenagers? Or when Vioxx was the perfect drug for arthritis? Or when Zantac was the perfect drug for heartburn? The list goes on and on. All of these drugs were highly publicized as ‘the thing to take’ and then later, started slinking off the shelves.
This country has a history of pushing drugs to market before they are fully tested.
This sort of outcome seems inevitable to me in any system where medical treatments and care are profit-based. The incentives are just irreparably perverse and it’s all baked in so deeply. I think you need not only to nationalize the entirety of the health care system, but also the pharma industry, remove the ability to patent all medical treatments, and then fully fund pharma research publicly (which it largely already is of course). You should then see a lot more efficient allocation of research resources minus the profit incentive and a lot less wasted on drugs that treat rather than cure or creating analog drugs to existing ones just to circumvent IP rights. You’ll also naturally see a lot of research into natural, off patent, and otherwise unpatentable medicines and treatments that the current system is incentivized to ignore. I think you’d see a new renaissance in medical science as a result.
Amen!
The management of this thing has been so rotten, I’m starting to think that the profit motive is just the start of what’s broken in our corrupt society. Competition (intellectual, reputational and economic) is a good thing, but that’s dying too. Propaganda and social control appear to be the overriding objectives, with no less than our democracy at stake.
” Propaganda and social control appear to be the overriding objectives, with no less than our democracy at stake.”
seems to be so. same as it ever was, but on steroids
Has any one looked at ivermectin as an antiviral? I’ve been looking on the internet and it seems like it might be effective??
Thats all I have. thanks
Actually Thalidomide was German and the US was notable in being suspicious of it.
In July of 1962, president John F. Kennedy and the American press began praising their heroine, FDA inspector Frances Kelsey, who prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness.
[snip]
The tragedy surrounding thalidomide and Kelsey’s wise refusal to approve the drug helped motivate profound changes in the FDA. By passing the Kefauver-Harris Drug Amendments Act in 1962, legislators tightened restrictions surrounding the surveillance and approval process for drugs to be sold in the U.S., requiring that manufacturers prove they are both safe and effective before they are marketed. Now, drug approval can take between eight and twelve years, involving animal testing and tightly regulated human clinical trials.
https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation
That is until the lessons of history are forgotten.
Thanks Tom B
Frances Oldham Kelsey was born and brought up in Cobble Hill, a semi-rural area just north of Victoria, BC Canada, and moved to the US for further study after getting two degrees from McGill University in Montreal. Her stance against the major US medical/research establishment was indeed heroic. Canada had already approved the drug, and has been facing the results ever since. She died just five years ago, at age 101. We have a secondary school named for her, in Cobble Hill/Mill Bay.
There was a pretty good documentary about Thalidomide,and the depressing search for recognition,let alone justice in modern germany, on RT.
Efiing heartbreaking to endure, but the closing of ranks, the institutional weight that attempted to smother their memory for the good name of ‘one of them’ is shivering.
If the delivery of good things are contingent on any part of such a culture, please hold your breath.
Fassbender had a point.
There are so may important thoughts expressed in this post. At the outset, was there ever any doubt the Pfizer would get an EUA? I didn’t have one. The political pressure to claim success (words like a miracle are being regularly used) would never have been overcome. Even amongst my social group, who are highly educated and typically critical thinkers, it is next to impossible to explain to them that based on what was done we do not know if this vaccine is safe and/or effective. I am not sure if it is an overwhelming desire to see the light at the end of the tunnel or hope springs eternal.
My family has too deep an experience with the medical system due to my daughter’s Crohns disease. Over the last 15 years we have watched the increasing pressure for profit, at a major NYC non-profit hospital, despite truly committed and excellent physicians. Anyone who denies these pressures and how they are distorting medial care is living in an altered universe.
Just this week I had surgery for a dislocated wrist. To be honest my only real concern was that they would want to use Oxycontin for post surgery pain management. Both my GP and surgeon said take a double dose of Ibuprofen and stay ahead of the pain (I would not normally take a NSAID). Guess what, other than moderate discomfort I’ve been fine.
I do think our response to COVID again reflects the continued nefarious impact of neoliberalism on society. We no longer practice real shared response to crisis or national challenge. We ensure that the elites needs are met, that they aren’t inconvenienced (those Hamptons parties haven’t stopped, etc.) and then live everyone else to fend for themselves. Until our governmental structures begin to address the more general needs of the country our responses to pandemics, hurricanes, climate change, etc. will be deficient, leave misery in their wake and polarize our politics.
A government skeptic (to put it mildly) said to me recently, paraphrased,
“The people now professing to be so caring about my health have never cared about my health. Advertisers push pharmaceuticals and fast food and unhealthy living on me every second of every day if I watch cable or cruise around Facebook. Food pyramid, sugar, all that nonsense has been foisted on me by public health people for years.
“Now, all of a sudden, I’m expected to believe that they have my well-being in mind? That they’ve done all these studies to make sure to develop a drug that’s going to make me healthy? No way I’m believing that.”
I thought it was a good perspective. Public health officials, the FDA, all of them have been married to industry for decades but now I’m expected to believe that they have processes in place fostering scientific independence?
As Lambert said a few weeks ago, ethics is no longer ethos.
Err, misquoted Lambert or had a Freudian slip: expertise is no longer ethos. But I suppose ethics isn’t ethos either, hah
I’m sorry that you have had to struggle with an extractive healthcare system while trying to managing your daughter’s illness. You observations struck me, as I have recently go through helping my sister navigate healthcare for stage IV abdominal cancer. She had to have a very complicated, 10 hour surgery. In the process of trying to find the right place to do this (of course fighting through with one denial after another) it came to my attention that hospitals increasingly do not want to support surgeons to do this lifesaving surgery. (Having had the surgery for stage IV cancer, my sister’s prognosis is now good for cancer that does not respond to drugs and before the year 2000 was 100% fatal). The surgery was developed in the United States, but there are increasingly very few surgeons who are trained to do this because it does not pay enough for the time in the OR and the number of people required so hospitals do not want to support it. I was told that hospitals do not want long complicated surgeries because they are not profitable. I cannot confirm this. This is my experience, and what I have been told by numerous people along the way. I have neither performed to read a large survey of the situation. So I cannot say that this is true for sure, but it does conform to what I observed in the process. It did leave me with a feeling of unease that that healthcare and frankly skilled medicine in this country was going to backwards simply because good very procedures were not profitable enough. I actually had someone say to me, “Another whole generation of people is going to die of this cancer in America, because when these surgeons retire, there won’t be anyone else.”
you should write more often!
your insights here are important
Great piece that raises points that worry me for two reasons. First, lack of blinding. I first encountered this issue when reading about participants in trials of SSRI antidepressants. The side effects are common and well-known. Participants must ethically be made aware of these as possible outcomes. So the moment a woman sees weight gain or a man sees sexual dysfunction they’re fairly sure they’re in the treatment, not placebo arm and do better than they would normally. SSRI effectiveness may therefore be less than quoted in trial results.
The second issue concerns the number of reviewers (but also the lack of expertise as a result). I did a lot of work in statistics (much in medical statistics) that examined INTRA-individual variation, rather than traditional trial-based INTER-individual variation. Those of us with long careers in academia generally admit we are 95% sure who our “anonymous” referees are. My worries ended up being less that I got “Professor X who was always out to get me” and more that I got one of professors A, B or C who had no axe to grind but really didn’t “get” the new paradigm. I knew Professor D could properly evaluate me (who DIDN’T work in my field but did n-of-1 trials so understood the principles) but unfortunately she was too closely linked to me via common PhD supervisor etc. A good editor would recognise the need for “someone like her” and find Professors (plural) E, F & G. But that clearly hasn’t happened here. And I’m worried.
Bill Black points out that one easy way to get regulator approval for fraud is by finding an inexperienced person (singular) to handle a large complex review.
I’m not saying that this happened here, but the conditions sure look present for it to happen.
This technique has also proven effective when you need to run some torture chambers with your military, and need guards, like National Guard units, for example, who have never been taught about war crimes.
Thanks very much for this post.
The quote from Prof. Dr. Risch is very interesting to me. Available outpatient treatment at the early onset of disease is surely better than waiting for someone to be hospitalized before more severe treatments begin, imo.
Reminds me of 9/11 security theater.
One guy tries and fails to blow up an airplane using explosives in his shoes. The TSA then proceeds to make millions, and likely billions, of trip-takers doff their shoes in order to get onto airplanes.
A decade into this nonsense, the TSA begins to sell a pre-check pass for a reasonable price that lets you skip the line and the shoe-removal (well, some of the time anyway).
So we not only get a huge jobs program, plus the vendors providing uniforms and X-ray scanners and whatnot get a payday, we also get a nice government revenue stream. All because of one dude who wanted to light his shoes on fire.
Today, we get an inept government response to a pandemic, an unfunded mask mandate, but somehow a paid-in-full vaccine push. Make that money!!!
“Make that money!!!”
That’s right, cash money! Das Kapital, baby, das Kapital!!
I heard the head of King County Public Health Jeff Duchin say yesterday in an interview with Omari Salisbury of Converge Media that no funds were provided for vaccine distribution locally. FYI.
Funding for vaccination (vaccine deployment) was 2% of total Warp Speed funding. Not unreasonable that King County got zero; Trump and Washington state governor were not best friends. (it’s politics, ya’ know.)
A recent “Fresh Air” (Terry Gross) interview with Ed Yong (Atlantic) on the US covid response is available online. Yong talks about many of the issues present in Yves post today.
And all they had to do was put a lock on the cockpit door!
Head Nurse passes out, LIVE, on Local TV, minutes after getting the jab
In the video: Channel 3 Chattanooga was broadcasting health care workers getting the shot. The Head nurse got it first, then went on camera, looking dazed right afterward, talking to reporters, got more and more dazed and then passed out and fell to the floor, LIVE, ON TV.
https://twitter.com/SomeoneAskTheQ/status/1339701597862027268
yikes, thx
also:
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-compensation-lawsuit.html
I’ve seen people pass out from getting a flu shot, so I’m not sure if this is really all that significant.
oh, ok, well that just makes it totally fine then…
Until her final days, my mother insisted that she got the flu from a flu shot. I don’t recall asking her the year of this shot, but believe me, it was the last flu shot she ever got.
And, as mentioned above, my neighbor-friend got sick as [family blog] from a flu shot she got in 2013.
I also recall Dr. Robert Mendelssohn warning against annual flu shots in his book, Confessions of a Medical Heretic. His objection? The number of people he saw who were sickened by these shots.
Elisabeth Rosenthal’s An American Sickness provides the modern update, chapter and verse–and it’s gotten so much worse. It’s a powerful and depressing read.
same here! received my first and only flu shot c. 2103
and got the flu for the first time ever, later that season
never again got the shot – or the flu
Same here. I’m in my 30’s but back in my early 20’s I got the shot, got the flu, and never took it again.
I worked in extremely close proximity to a lot of folks who got the flu last year, winter of 2019 (wasn’t covid, they tested for influenza and were positive), and never got it. Zinc is the key, I think.
Anecdotally, the annual flu shot is NOT always effective. It’s formulated in anticipation of a “likely” flu strain. It is not a “live” virus vaccine.
I do get one each year. But I’m a prime candidate for flu turning into pneumonia. Been flu free for last four years (knock on wood).
So it isn’t just me; Every year I’ve gotten the flu shot, I feel bizarre and cannot sleep for 36 hours. It’s quite unpleasant. This year I didn’t bother; I’m not around any people anyway.
In the early days of flu shots it was absolutely possible to get the flu from the shot since it was a live virus. My employer at the time thought they would keep everyone healthy by offering free flu shots. I naively signed up and spent the next two weeks in bed sicker than I’ve almost ever felt. When I called my doctor about what to do he said there was no magic answer other than to let it run its course.
Today’s flu shots don’t use the live virus, but they also have become increasingly less effective. I read that last year’s flu shot was only 25% effective, regardless of age. There is also the problem that there are many types of flu around, so your flu shot may have protected you from three of them but you still managed to get one of the other flu viruses out there in the wild. Finally, it takes two weeks for the flu shot to become effective in the body, so it’s possible that someone gets the flu before the necessary antibodies are activated.
Last time I got the flu was in 1976. Last time I got a flu shot was in 1976. Felt it coming on a couple of times since then and beat it back with osha root, vitamin C, zinc and elderberry. I won’t say I got the flu from that shot. I will say that flu shots are a crap shoot because the strains it is formulated to protect against involve, basically, guesswork initiated 6 months in advance.
people fainting when getting jabs is a pretty well worn trope. One can be sceptical without having to resort to alarmism.
As far as I can tell from media reports, there have been three, possibly four severe allergic reactions so far to the Pfizer vaccine: two in the UK and one in Alaska. The other Alaskan healthcare worker had a significant reaction, but it wasn’t allergic — although some reports do say it was an allergic reaction. The nurse who fainted reportedly did not have an allergic reaction.
Three or four allergic reactions are still very signficant, though, if I am understanding the implications.
Over the last week or so I’ve heard many comments from healthcare experts that allergic reactions to vaccines are rare — about 1 in a million is the phrase they often use.
Well, the headline in this Yahoo front page article inadvertantly reveals that the allergic reaction rate for the Pfizer vaccine is already alarmingly different than the “1 in a million” rule of thumb we hear bandied about:
The article is vague about exactly how many people have received the vaccine. It says somewhere around 138,000 in the U.K. The only U.S. number they cite is about 5,200 in NYC. This is being generous, but let’s say 500,000 total have received the vaccine, and 4 have had allergic reactions.
At this rate by the time 1 million have received the Pfizer vaccine, there might be 8 allergic reactions per million — far above the “1 in a million” rule of thumb.
Time will tell if the first allergic reactions were a fluke or the first clues that the risks for this vaccine are unusual.
We’re up to 3 reactions in Alaska:
https://www.adn.com/alaska-news/2020/12/18/3rd-alaska-health-care-worker-experiences-adverse-reaction-to-covid-19-vaccine/
From the article: “COVID-19 is a “wild card” while a rare, adverse reaction is both treatable and manageable. ‘Being exposed to this virus, it’s kind of like playing Russian roulette,” Zink said. “You might be fine, but you might really not be fine.'”
Russian roulette with a 99.7% chance there is no bullet in the chamber and you won’t die.
Odds the vaccine prevents infection – nobody knows.
….uh why are all of these in Alaska? Either Alaska is allow people with different medical backgrounds to be vaccinated (to my knowledge no one is screening except maybe in the uk for allergies now), or these are only making the news in Alaska? What are the other options that I’m missing here?
Oh possibilities…Alaskans a have something in their diet/environment that makes them more prone to this, Alaskans genetics make them more prone to this(this feels like a real reach…)
1. Bad batch, say batch got too uncold in transit. May be a precursor of what happens with long supply chains.
2. Alaska doing full reporting, maybe other cases not reported?
Yes but they have stopped giving it to anyone with a history of Anaphylaxia in the U.K. so it’s not surprising reactions have reduced.
Right, yes. I was assuming that’s why all the UK reactions happened on the first day. The Alaska cluster is more confusing.
Looks like not just Alaska: https://thehill.com/policy/healthcare/530966-fda-investigating-allergic-reactions-to-pfizer-vaccine-reported-in-multiple
As for out of control Pharma. I used to be a maintenance man at a company that maintained housing for people with autism. Some of those folks, particularly the younger ones, were on 16-24 different pills. Doctors were making more money just prescribing them than the people in the houses getting bit and their hair torn out trying to take care of these people
That said, my greatest concern with this vaccine is, if it goes bad, how many millions of vaccines do they continue to hand out even knowing it is damaging people, before they acknowledge it? After that, hell would break loose and then hardly anyone would want to take any vaccine.
“To study the transmissibility of asymptomatic SARS-CoV-2 index cases, eFigure 8 in the Supplement summarizes 27 studies19-21,23-26,30,32-34,44,45,47,50,52-54,56,59-61,63,64,68,69,72 reporting household secondary attack rates from symptomatic index cases and 4 studies26,43,44,52 from asymptomatic or presymptomatic index cases. Estimated mean household secondary attack rate from symptomatic index cases (18.0%; 95% CI, 14.2%-22.1%) was significantly higher than from asymptomatic or presymptomatic index cases (0.7%; 95% CI, 0%-4.9%; P < .001), although there were few studies in the latter group. These findings are consistent with other household studies28,70 reporting asymptomatic index cases as having limited role in household transmission."
"We found significantly higher secondary attack rates from symptomatic index cases than asymptomatic or presymptomatic index cases, although less data were available on the latter. The lack of substantial transmission from observed asymptomatic index cases is notable. However, presymptomatic transmission does occur, with some studies reporting the timing of peak infectiousness at approximately the period of symptom onset.108,109 In countries where infected individuals were isolated outside the home, this could further alter the timing of secondary infections by limiting contacts after illness onset.110"
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2774102
Are we completely overblowing the asymptomatic cases and the constant harping of cases through too much reliance on PCR tests?
As time goes on, studies are showing that the rate of asymptomatic infection and the rate that those without symptoms spread the disease are lower than first assumed. For instance, this Chinese study showed that asymptomatic people had a low chance of spreading the disease to their household. This study was from Nature and had a huge sample size.
https://www.nature.com/articles/s41467-020-19802-w
Just my opinion, but a lot of the terror involved with covid seems predicated on asymptomatic and pre-symptomatic spread. Is that person healthy, or are they just FAKE healthy? Mistrust reigns when people think that their neighbors are Manchurian Candidates, not to be trusted, when really, the lesson is probably, “If you feel sick, or had contact with someone who was sick, just stay home for awhile.”
answer; we just dont know.
the data is all over the place. I mean, who would not expect that people hacking and coughing and sneezing all over their roommates would be more likely to infect than those just speaking. it stands to reason and is likely so. But to what extent? we do NOT KNOW
The post made no mention of asymptomatic cases, so your comment is a straw man. It discussed symptomatic cases and whether they had been defined broadly enough (it appears ones with digestive symptoms weren’t captured by Pfizer) and whether the PCR tests alone were sufficient as a screen of whether they were Covid, a vaccine reaction, or something else. Given the not great false negative rate of PCR test, repeating the test would have seemed prudent.
It seems that part of the “Fail” here is we’ve been conditioned to look for the easy, low-friction technological solution to any problem. Any kind of measure that involves changing habits or harder choices is not possible in this environment.
Politics and vested interests have always had a pretty intimate relationship with research IMO. At one extreme, politics may determine what research is funded or shared publicly. At the other end of the pole, research is done to inform policy or decisions. Quite often we just don’t recognize the relationship b/c OUR vested interest does not appear to be threatened. But with the pandemic and a corrupt politician in power, we are freshly feeling it. Time is short, lives are at stake, and our eyes are popping over the situation. It is still the case that science reveals itself over time and with peer review of the evidence; it is not awesome without a fair amount of methodological critique and data evaluation. The vaccine alone cannot save us in these current months; we have to use our mind and collective good cautions. Hang in everyone. Don’t freak out; keep your spirits.
“a corrupt politician in power”
You must be new here. We don’t play team sport politics on this site. The nature of seeking political office is inherently corrupting. Best to just assume that every single one of them is corrupt, and you’ll save yourself some disappointment.
I think a huge opportunity has been lost to use mass testing to quickly find and trace outbreaks. If the scale of testing had been sufficiently high and enough resources had been devoted to tracing, tracking and ensuring people would be fully supported in isolating you wouldn’t be in a position where mass vaccination was the only realistic option to addressing the pandemic.
That, combined with 1) at home inexpensive as in 1 or 2 dollar (not 30) quick tests (available in most civilized countries – just paper tests – without smart phone peeps) and 2) some rational and consistent non profit driven Federal guidelines and our 95 death rate per 100,000 would be half that or better.
Michael Mina of Harvard has been making the case for rapid and inexpensive at-home antigen testing for months–and exhausted himself in the process–because no one is listening. Why? Because the alternative is more profitable and keeps people scared.
https://time.com/5912705/covid-19-stop-spread-christmas/
https://www.bostonglobe.com/2020/12/04/nation/makes-you-ask-why-hell-we-even-bother-infectious-disease-experts-face-disillusionment-covid-19-pandemic-worsens/
Agree; profit. Thanks for the links.
So much talk above about serious medication side effects, popping up later after the drug has been developed, studied and then accepted by the medical communities.
How about a scenario where a new drug combo regimen is recommended, where it previously has been rejected by the medical community because of adverse side effects?
Take another look at hydroxychloroquine plus azithromycin. Highly politicized. Properly trained docs will already know to usually avoid this combo due to the potentials for cardiac arrhythmias. ‘Usually’ of course does not mean always. Because with specific knowledge and proper monitoring they can be safely used in select outpatients.
I can tell you that early on in the Pandemic, few ethical docs would jump on this bandwagon. But later on, like now, more might as these studies emerge and there is time for docs to digest. This and time has been the largest barrier to its usage, not some nefarious pharma political/economic scenario. Medical standards of care typically do not change very quickly. But in a time of this Pandemic we docs might have to recommend larger risk steps.
From a Los Angeles Times email:
“The wealthy scramble for COVID-19 vaccine: ‘If I donate $25,000 … would that help me?’
Many of the wealthy seem to substitute “virtue signaling” for action on such topics as climate change, financial regulation, opioid epidemic, income inequality, medical care for all and serving in the front lines of USA military mis-adventures,
But now the wealthy are actively seeking to get to the head of the line for the Covid-19 vaccine.
This is very good news.
This could be the way to cull not only a handful of excess oligarchs, but also a chunk of the most loyal PCM ‘science trusters’. We suffer, apparently, from excess production of elites.
It’s pretty clear to me what’s going on: we’re running a large scale trial on the general population without their informed consent. There’s been a minimum of safety testing but that’s about it.
So? Yeah, it’s unethical. How about more than 300,000 deaths due to inability to take the simple measures needed to control the pandemic?
How about the deaths due to despair over towering economic inequity in a wealthy country?
One saving grace is I have some faith that in the case of the vaccine trial on the general public, the results are likely to be known, unlike the trials of psychoactive pharmaceutical interventions on the general public.
This is the country we in the US live in. It’s admirable and brave for people to speak out against the way it is.
It’s been this way for decades, folks. If the arc is bending in a positive way it’s lost somewhere ahead in the mist.
“One saving grace is I have some faith that in the case of the vaccine trial on the general public, the results are likely to be known, unlike the trials of psychoactive pharmaceutical interventions on the general public.”
why?
the phase three trials are done. the opportunity that a control group affords to separate the wheat from the chaff is over.
…you miss his point. Phase IV is the trial going on now…with healthcare workers at the head of the line. MSM is likely to expose adverse reaction to the vaccine for the clicks and eyeballs.
phase 4 trials have no placebo groups. that IS the point
You are missing that there is no evidence that this vaccine will reduce transmission. There is some for the Moderna and the AstraZeneca vaccine.
I would like to add a question to the mix –
I heard an old professor of mine ask this on a Zoom conference earlier this week – and I have thought this over in my mind this past week – and I just do not know the answer – nor do I know how I think about it…
The discussion was focused on the rapid nature of the vaccines deployment under an EUA. The speaker had made the point that the lack of any effective alternative therapy was fundamental to the approval of the EUA. Apparently, you cannot EUA any intervention if there is any other viable alternative. (I am going to have to look into the rules to confirm the truth of this statement.)
My old professor’s question was if all this scuttling of any other type of alternative (VIT D, exercise, ivermectin, plaquenil, or all the others), purposeful in order to facilitate the arrival of the vaccines (and presumably big profits) early?
Could this be why we have lived through the strum and drang of all these medical interventions being torpedoed this year? I do not know – I really need to think this through. That is what good conferences do – as well as websites like this – really make you think.
Yep, I read this the other day in the regs, EUA is predicated on having no other therapies:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities
CBRN being chemical, biological, radioactive, nuclear agent, because all this public health emergency stuff is wrapped up in the War on Terror.
And we all know the War on Terror was an excellent example of experts deploying their expertise correctly.
ETA: further into the link:
d. No Alternatives
For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered “inadequate” if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to approved and available alternative products.
As someone not in the medical industry, my feeling is yes…therapies are being scuttled so drug companies can make money on vaccines. From what I can tell in what I have read, these therapies are being discovered in poorer countries because that is what they have access to.
I looked into “the lack of any effective alternative therapy” concept the other idea. I thought I read that it had to be not just effective but “approved.” But, again, I’m not in the medical industry.
I just watched a MedCram You Tube with Shane Crotty, an immunology professor, who mentioned that the manufacturing techniques for mRNA vaccines are much faster than for traditional adenovirus vaccines. If that’s the case, it may be that officials knew all along that the competing vaccines would take more time to produce. On the other hand, Russia seems to have manufactured a classic adenovirus vaccine in record time (although there seems to be some question as to how many individuals participated in the trials before introduction), so it does seem possible that U.S. officials were talked into (or due to typical American insecurity, IMO, desperately wanted) something “new and sexy” just to prove that the USA is better than anyone else. I haven’t forgotten the CDC PCR Covid test fiasco.
As for “traditional” methods of fighting Covid, our entire system is designed to promote big Pharma and big Pharma only. Fifty years ago, my employer sponsored Blue Cross Blue Shield plan paid for vitamins prescribed by my doctor. Now, no insurance company pays for vitamins. To be fair, it’s becoming increasingly difficult to find standardized vitamins, which assures the user that the dose is the same in each pill. Still, I always try to look for an internist who has been trained in Europe, South Africa or someplace where diet, nutrition and other whole body health issues are considered equally with ethical pharmaceuticals in developing a personal health plan.
These treatment options need proper and thorough medical study, then published, discussed and possibly accepted by the medical communities. And then utilized in practice in the medical office or at the hospital bedside. And typically that all takes more time than our Pandemic allows. The amazing and rapid technological progress resulting in successful vaccines will most likely be the most successful of treatment strategy.
That’s one reason I’m surprised the many published papers reviewed by the doctors group FLCCC – the Front Line Covid-19 Critical Care Alliance – and their assessments and recommendations for Ivermectin use are being ignored.
Their review work, published papers, and protocol recommendations were reviewed by John Campbell – a UK PhD university Nursing Science professor. He simply reviewed their papers and finds them credible. His conclusion is that Ivermectin should not be ignored by governments. He doesn’t understand why goverments are ignoring doing more research on Ivermectin as a prophylaxis and early treatment. His UToob channel contains his recent analysis of the FLCCC work.
adding: a safe, effective vaccine is something I hope we have now or will have soon. However, it will be some time before everyone is vaccinated even if the earliest vaccines now out prove safe and effective. (And if the pfizer or moderna or others prove to have too many serious adverse effects, the wait will be longer, imo.) Rural areas, poor people, native peoples, and many others will receive vaccines far down the line. In the meantime, an inexpensive, safe, effective outpatient treatment is needed. We need more that one line of defense against the C19 virus.
Here’s Dr. (PhD, not MD) John Campbell’s review of the literature.
https://www.youtube.com/watch?v=BLWQtT7dHGE
All these treatments involved approved drugs. They can already be prescribed off label by any MD.
These treatments could have gone through efficacy trials in the time it took to do the Pfizer trials, But there’s not much $ for trials for new uses for existing drugs….precisely because they can be prescribed off label.
Yes. Effective therapies are deep sixed so that Big Pharma can make billions. the Recovery Study in the UK “tested” HCQ by giving patients 4X the maximum reocmmended dose, and were then “stunned” when the expected heart problems showed up. Why dose at 4X? You can look it up in the PDR and see never to do that. And they never gave it early, and never with zinc. Even tho that was the proposed method of action. It’s like they “wanted” it to fail, or something.
And now look at the treatment that Ivermectin is getting. Chris Martenson lists the studies, and gets censored on FB. Dr Kory testifies to Congress, requests the NIH look at the data, and his hospital tells him never to mention it again. Dr Hector Carvallo, using IVM with great success was asked “what did people think about you using Ivermectin for Covid” His answer. “There was no pushback until we started reporting success. then the Pharma people got involved….”
Here is Martenson’s uncensored vid. Meta analysis of over 20 IVM studies is in at about 3 minutes, and the results are very, very good.
Oops, that is gone from Vimeo as well.
Huh…….
The evidence for that interpretation is becoming overwhelming. Just listen to Dr Kory tearing his hair out over the FDA’s unwillingness to assess Ivermectin. Or Michael Mina’s frustration over the FDA’s unwillingness to approve a low-cost, at-home, rapid antigen test for wide distribution. Then there’s hydroxychloroquine, Zinc, Vitamin D. What do all these things have in common? They’re low cost, accessible to the public, and put diagnosis & treatment back into the hands of individuals and their doctors, not pharmaceutical companies.
Dr. Kory is an American hero. On a par with the aforementioned FDA inspector Frances Kelsey.
Thanks for this post and all the others about the vaccine since there’s no place else to go. When I read that 2-3 people at the FDA reviewed the clinical and statistical info from what Pfizer presented in a matter of 22 days, which normally takes several months, I was shocked, This should be another huge red flag. The whole thing reminds me of Obamacare – we have to pass it to find out what’s in it. There’s just too much money at stake – which is the usual practice for administering “health care” in this country. I’m wondering if 6 months down the road for people who’ve had the vaccine and many develop an autoimmune disease or some other major health problem – will the vaccine be blamed? I think not because – well, how could that happen? The FDA said it was safe and effective! Vaccine makers have blanket immunity.
It still amazes me that there is no public health information given about how people should check their Vitamin D levels (which, from what I’ve read lessens the severity of the virus) – It’s cheap and readily available. Six months into this pandemic the CDC was running anti-smoking ads on tv! Nothing about Covid. I’m not trusting the science anymore.
i.. The FDA has already added the standard disclaimer to their Factsheet, i.e., “These may not be all the possible side effects of the Pfizer-BioNTech COVID-19 Vaccine. Serious and unexpected side effects may occur. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials.”
ii. Which assumes, that the totality of the unknown unknowns are actively being reduced and that the known unknowns are at the same time both being recognized and being investigated. That is where the trust and hopefully, the accountability part of the equation is applied, along with the needed full transparency.
iii. “Either practically or ethically, we can’t run large scale studies on representative populations.”
So, uncontrolled natural experiments are often carried out on the general population as a way to reduce cost and increase ‘efficiencies’ for the businesses that operate in the medical-industrial establishment. See for example,
“Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010”
https://jamanetwork.com/journals/jama/fullarticle/2625319
The takeaway being that, “Among 222 novel therapeutics approved by the FDA from 2001 through 2010, 32% were affected by a postmarket safety event. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval were statistically significantly associated with higher rates of events. The high frequency of postmarket safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
See also, “Will covid-19 vaccines save lives? Current trials aren’t designed to tell
us”
https://www.bmj.com/content/bmj/371/bmj.m4037.full.pdf
Also, noting that, interindividual variability in the distribution of human response to novel medical treatments is a factual reality; whereby, “We may all be human beings, but drugs react differently in all of us, so you are going to see issues. This is to be expected.”
More bluntly, the current economic system dictates that the ‘consumer’ [See the Mckinsey & Company article, “COVID-19 vaccine: Are US consumers ready?” on how to effectively market the Covid-19 vaccine(s).] has the the final responsibility to do his or her own due diligence, weigh all of the potential risks and rewards, and to do a full cost benefit analysis. That is the current working assumption; Therefore, caveat emptor.
iv.) Finally and more generally, Fava and Rafanelli note that, “Currently, the prescribing physician is driven by evidence-based medicine and guidelines, the marketing arm of pharmaceutical industry, to an overestimated consideration of potential benefits, little attention to the likelihood of responsiveness and neglect of potential vulnerabilities to the adverse effects of treatment.”–“Iatrogenic Factors in Psychopathology”
https://www.karger.com/Article/FullText/500151
Thank you for this post. Taiwan has done a wonderful job curtailing Covid-19.
If you follow the money, you see the stock market had a big jump when Pfizer was approved. There is more monetary gain evident from the instant gratification of taking a drug than that of wearing a mask.
Don’t lose faith in science! There are scientists like Zach Bush who studies the body’s adaptation to the 10 to the 23rd viruses in our environment. The body achieves balance. The pharmaceutical industry promotes eradication over balance.
I am a Vaccine skeptic, not an anti-Vaxxer
Some of my skepticism would be allayed if the law that gives vaccine makers immunity were repealed.
https://www.federalregister.gov/documents/2020/04/15/2020-08040/amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical
The Secretary is issuing this amendment pursuant to section 319F-3 of the Public Health Service Act to extend liability immunity for activities related to medical countermeasures against COVID-19 authorized under the Coronavirus Aid, Relief, and Economic Security Act.
for starters how about just give open access to the data for independent groups to analyze.
+1.
So the nurse received her shot and then passed out on live TV. Kinda hard to obscure. I hope she is ok.
My question is, how many other people have passed out after receiving their shot that we haven’t heard about because there were no live cameras around? And why? I’m not being an alarmist. I’m just wondering….
in fact, whether you realise it or not, you are being an alarmist
I think this is something of an answer to Cuibono’s question above:
Ostensibly, this is a good idea, and probably preferable to the status quo. But one problem is that it’s one thing for the likes of IM Doc and Harvey Risch to analyse this info, but the untrained, who might have certain predispositions, might read the report, see a data point in the way they see “zomg this person passed out on live TV after getting teh vaccine!!1!111!”, and jump to erroneous conclusions, thereby further muddying the waters.
Back in the day there was the theory that “the blogosphere is self-correcting.” There was some truth to that. Certainly more self-correcting than social media!
“…private equity rentierism in hospitals and emergency services“ – Now that would be an interesting book.
Also, here’s the Math+ Hospital Treatment Protocol for Covid-19 download page. It involves using already available medicine –
https://covid19criticalcare.com/math-hospital-treatment/pdf-translations/
The shutdown of charitable hospitals, privatization of the public health service and converting healthcare into private equity funded for-profit businesses caused the pathetic response to the pandemic. As a result, an anti-science President was incapable of halting all international flights in February 2020. Federal responsibility was skirted by handing authority to fight the virus to 50 different states. Virus testing is a debacle. Worse is the politicization. The result is 320,004 deaths to date. The FDA had to approve both mRNA vaccines. There is no alternative.
If the vaccines fail or have unacceptable side effects, the USA will be a failed state (a Northern Brazil) unless at the last minute it restores a public health system, approves cheap paper antigen tests, and forms essential work bubbles with self-testing to supply healthcare, policing, shelter, food, water, and electricity for a nation that is in a complete lockdown for two months to eradicate the virus.
“the USA will be a failed state (a Northern Brazil)”
Cuibono?
I didn’t see a lot of discussion in the comments about this HCQ article. I would recommend reading it if you haven’t already. It certainly convinced me that HCQ is beneficial if given early and that there was a media and big Pharma push against HCQ. It makes you wonder who is making all the profit from this.
Blinding headache, blurry vision, heart palpitations, nausea and sun sensitivity were the side effects I experienced from the malaria phrophylaxis medication I had to take in the seventies. A different formulation of quinine back then but apparently the side effects of HCQ are similar and in both formulations potentially more serious. What I remember most about it is the taste of the white tablets. They were large, unbuffered and uncoated. They were the quintessence of extreme bitterness and I found it alnost impossible to swallow one without experiencing the horrible, mouth-parching taste. I often couldn’t get a tablet down in one go, and then I was facing a stomach churning struggle. 46 years later the memory almost induces a gag reflex. The third attack of malaria I had was unspeakably, indescribably miserable though, so there is that consideration.
I almost forgot to mention about the heart palpitations. I was 21 years old at the time and the fact that my heart seemed to be skippiing beats, jumping around in my chest and behaving erratically was an interesting and amusing novelty.
It is very very hard to identify an effective prophylactic for a sickness that kills few. There are people that had coffee in the morning, COVID in the evening, and totally recovered. Does that mean coffee protects? Is this just a coincidence?
Very few people die of COVID-related illness (let’s say about 2/100). A few more get seriously ill (let’s say 15/100). If you want to make sure your prophylactic is any good, you’d need to compare say ~100 deaths in the placebo group with xxx deaths in the treatment group. That makes for 2x 5000 people that get Covid. Taking into account that only a small percentage of the population does get COVID, you may end up with a total test population that approaches 1M people, to allow for test subjects that die, move out, are deselected for whatever reason … and still get enough results.
So you are going to subject a large population (1M people) to a medicament with known side effects. I’d say there is a very good probability that e.g. HCQ will kill more people in the general population than it can save lives for severe COVID patients.
And that is what the science says.
[you get the same picture with e.g. aspirin. It was once said that a low daily dose of aspirin would be a good prophylactic for cardic arrest. It turns out that when you subject a large population to a daily dose of aspirin, the rare side-effects (times millions of people) outweigh the very rare benefits. Be aware that the situation is totally different when you consider only people who already had cardiac problems]
I agree with Brian. The piece also presents an excellent description of controlled trials vs observational method. Very little of modern medicine lives up to the gold standard clinical trials. Properly interpreted HCQ does.
One problem: last time I tried I could not gain access to the second half of the article.
The whole media hyped faux suspense of vaccine approval seems like Kabuki Theatre to me. Was approval ever in doubt with hundreds of millions doses already manufactured?
“Trust science” has a hollow ring with a public harmed from too many bad pharmaceuticals and medical experts that likely all have financial interests in the vaccines they are promoting on TV. They should be required to disclose financial interests and likely all trade on non-public information.
I have been utterly gobsmacked by what the Covid-19 epidemic has uncovered about medical research and western society. As Buffet is reputed to have said, it’s only when the tide goes out that you can see who has been swimming naked.
HCQ has been the poster child for medical research being desecrated.
I see a three pronged strategy. 1. Smear all research on cheap compounds that are effective, and smear and harass the researchers. Use bogus research on deaths from HCQ to terrify the population into not demanding it. Use the media as a megaphone.
2. Hype up the expensive vaccines, as the vaccine stampede is underway. Downplay the side-effects and mislead the population on the efficacy using the media as a megaphone.
But it is the third part of the possible strategy which has me worried, and whether this eventuates will test how good my model of the strategy is.
3. So once the vaccine is available, governments which are now actively suppressing, contact tracing and quarantining, may dismantle all of these efforts because of #huge costs and #deficits and #budget repair and #bankrupting the economy etc.
Those who refuse the get the vaccine due to the side effects will be branded anti-vaxxers and conspiracy theorists. The media will be the megaphone.
With contact tracing and virus suppression processes dismantled, governments, pharma and the media may try to stampede older people into having the vaccine by talking up the unfortunate deaths of the non-vaccinated. They may stir popular outrage against anti-vaxxers wasting “scarce hospital resources” when taxpayers with “real” medical conditions like heart attacks and cancer are being denied treatment.
So, more shaming, harassment, vilification and government abandonment of those who do not want to have a poorly tested and possible unsafe vaccine. That might be the third prong of the strategy. All in the interests of creating more pharma billionaires.
You are correct. So what? Can’t change it.
The only thing I can see changing your scenario is if all the elite folks skipping to the front of the line start getting sick and dying from the shot.
Quick–what do Rupert Murdoch, Obama, AOC and Dr. Sanjay Gupta have in common? They all got their shots already. Which I guess makes sense, since they are all working in Covid ICUs 18 hours a day.
> only those who developed acute respiratory illness were tested
WTF. One of the distinct features of Covid-19 has been the multiplicity of symptoms! We’ve known this from the beginning. I wonder if they talked about any of this with Biden, in their late-night call with his campaign, before before their press release. One suspects not.
Lambert, I always thought your formulation “Because markets, go die” was a hyperbole designed to tweak the nose of neoliberals and work as subtle call to conscience (as if). It doesn’t seem like hyperbole anymore.
Interesting factoid: An old friend called to wish us merry christmas and told us he had enrolled himself in the Moderna stage-three test. He said they were happy to get someone like him with his history, cancer-heart attack-seriously wounded in Vietnam-75 years old-overweight-etc. The contract was for 3 years of supervision after his two shots (last august). So far no problems. But he did have a sore throat and sinus symptoms – but that was 4 months later, on the phone with us. I warned him that his “immunity” might not last more than 3 months. He said they informed him of that possibility. So this might mean that Moderna started phase two testing (I’m guessing) sometime in June and ergo they started their phase one in… March? Could this even be an achievable timeline for a company that was hastily formed last winter? The name Moderna came from Modified RNA. I’m guessing BioNTech came from Biological Nuclear Technology. And I guess this also means that Moderna is getting its go-ahead immediately upon its phase 4 test of 2 shots being given but less than a 4 month interim of supervision. Much too fast for my liking.