Trust the Science. Follow the Guidelines. Let’s get a few things straight. As doctors we know that scientists don’t “trust the science”. Scientists are the most skeptical of “the science”. Scientists know that their conclusions will, at some point, be qualified or overturned. That is how scientific understanding moves forward and evolves. They expect to be proven wrong at some point. That is why we trust their opinion. They trust the scientific method, which is an entirely different thing. In order to do the systematic measurement, experimentation, observation and reformulation of hypotheses, the scientific method demands that we approach what is happening with an open mind, so that all possibilities are on the table to begin with.
We as physicians follow guidelines until the scientists (and physicians who do clinical research) give us new ones to follow. How do we know when new guidelines are necessary? It happens when a new discovery is made or when the guidelines don’t make sense anymore. I believe we are at that point right now.
The idea that the CDC, the NIAID, the FDA and the vaccine manufacturers are all working together, using ethical and rigorous scientific methods to improve our health and safety is a hypothesis; it is not a law or unassailable tenet. It is and always has been up for debate. How does it hold up to the scientific method and open-minded investigation?
I believe we are being misled deliberately. I understand that this is a serious accusation. Here are eight reasons why I believe this to be the case.
#1: SARS-COV2 is most likely the product of our own design and Dr. Fauci, as director of the NIAID, helped to fund it.
Who would have thought a month ago that Dr. Anthony Fauci, the diminutive doctor with big credentials, the spokesperson of science and a shoo-in for the Presidential Medal of Freedom would be grilled by another physician at a Senate hearing about his role in manufacturing and funding the development of a pernicious pathogen that has taken the lives of over 3.5 million people world wide? Surely many have had to rub their eyes and do a double take on this startling exchange. Was Kentucky Senator Rand Paul, MD implying that Dr. Fauci was not only aware of gain of function research being done on a strain of coronavirus in a Wuhan Virology Lab but actually funded the activity through a third party, EcoHealth Alliance using taxpayer money? Yes he was. This is an enormous accusation. It is true that the few million dollars that was paid to EcoHealth Alliance is just a fraction of the multibillion dollar budget Dr. Fauci controls, however if what Senator Paul is suggesting is true this places Dr. Fauci in a very hot seat. There could be no way that he would not have known that this pandemic most likely started in a laboratory from the very beginning. His year-long ridicule and public disdain of those who had been suggesting this connection speaks volumes about his character and integrity.
Let’s follow the timeline. This line of questioning was likely the direct result of a groundbreaking piece on the Tucker Carlson show early last month (May, 2021). Foxnews picked up a remarkable essay by Nicholas Wade who unleashed a precise and well informed attack on the natural origins theory of the SARS-COV2 virus on the self-publishing site, Medium. Hopefully we as physicians can put aside the political posturing that often results when Libertarian Senators or FoxNews are mentioned. Mr. Wade, author of the piece “Origin of Covid — Following the Clues”, is a journalist who has covered scientific topics for Science and Nature magazines as well as the NYT for decades. In this scintillating essay he told the story that researchers like Dr. Alina Chan and a group of unaffiliated scientists and journalists going by the name of DRASTIC(Decentralized Radical Autonomous Search Team Investigating COVID-19) have been screaming about since March 2020. Why are we assuming that a virus leapt from another mammalian species into a human host in a wet market in Wuhan province and resulted in a global pandemic within a few weeks when one of the most advanced virology labs in China was also at ground zero?
The reason is in large part due to a seminal article written in Nature Medicine on March 17 2020 by KG Anderson et al that concluded that the virus most certainly could not have come from a laboratory. A closer examination into their reasoning reveals a peculiar set of arguments that are, at the very least, grossly unscientific if not deliberately misleading. This had been pointed out repeatedly for months prior but got little attention as paper after paper continued to cite the Nature Medicine article as the irrefutable last word on the matter, thereby manufacturing a wall of scientific consensus that could never be breached by alternative media and their bands of “conspiracy theorist” followers.
But why would a researcher like Kristian Anderson, professor of Immunology and Microbiology at the Scripps institute make such unscientific arguments and assertions about the certainty of zoonotic origins in a scientific publication? Why did his co-authors go along with it? I do not have his background or credentials. I am a clinical anesthesiologist but even I could see the ‘bunk’ in his debunking article as I explained nearly three months ago in this essay. Surely co-author W. Ian Lipkin, professor of epidemiology, neurology and pathology at Columbia should have dissuaded him from making such unsubstantiated claims based in specious logic. Was there an unseen hand impelling them to make such claims?
Interestingly, some clues may have emerged quite recently in the developing story around the “Fauci emails” that were released under the FOIA this week. First we have this:
As of January 31, 2020, Dr. Anderson is letting Dr. Fauci know that one has to look “really closely at all of the sequences to see that some of the features (potentially) look engineered”. He is not admitting that they were engineered, only that one has to examine the virus closely to see that it might have been. In the next paragraph he seems to be arriving at a consensus that the virus’ genome is “inconsistent with expectations from evolutionary theory”. It would be fair to say that at this point, he seemed to believe that the virus had been engineered while admitting more analysis was required.
Approximately five weeks later, Anderson addresses Dr. Fauci, Dr. Francis Collins (head of the NIH) and Sir Jeremy Farrar, a British medical researcher but perhaps more importantly, director of the Wellcome Trust, a charitable foundation in the UK focused on mental health, climate and infectious diseases with a 26 billion dollar endowment. Anderson is expressing his gratitude for their advice and “leadership” around the infamous paper in Nature Medicine that was soon to be published:
There is no smoking gun here however it seems that the experts on the topic seemed to agree that lab origins was the most plausible theory at the end of January. Five weeks later, with “leadership” from Fauci, Collins and Farrar they changed their tune and proceeded to publish a paper that definitively concluded the opposite position: the virus did not come from a lab. What kind of “advice” would three physician administrators have to offer a team of researchers that were attempting to unravel an extremely complicated molecular puzzle that was, for all intents and purposes, a forensic analysis? Yes, it is an accusation veiled as a question. But let’s take a moment to try to answer the question before dismissing it…
As stated previously, this paper was the subject of extensive blogging since the beginning of the pandemic by experts and unaffiliated doctors including Dr. Meryl Nass, a board certified internist and biological warfare epidemiologist and anthrax expert. How did this self-published piece by Nicholas Wade finally penetrate the wall of denial? Before we grant too much credit to Tucker Carlson and FoxNews, let us not forget that they were over a year late to a story that should have been in plain sight to any investigative journalist on the planet. Did someone give them the okay to finally cover the biggest twist in this massive story? We may never know the answer to such a question. In any case, we are well advised to consider what it means when we must rely on independent journalists and non-academic physicians to bring light to pivotal information that corporate funded media doesn’t.
Things are starting to twist again. Work on this virus began in the USA at the UNC Chapel Hill under the direction of virologist Dr. Ralph Baric until 2014 when eyebrows were raised about the questionable necessity and obvious danger of such “gain of function” studies. The work disappeared from our shores and reappeared in Wuhan China through an organization called EcoHealth Alliance that directly received funding from the National Institute for Allergy and Infectious Diseases. This is the organization that has been run by Anthony Fauci, MD for decades. If one uses the “follow the money” approach it becomes quite clear who is ultimately responsible for this global tragedy. However, in the days since the grilling Dr. Fauci received, there has been a shift back to the “Wuhan virus” and the CCP. Perhaps the Communist Party of China is partially responsible, but there is little doubt that this experiment has American resources and ingenuity behind it as well.
The importance of this fact cannot be overstated. In the United States there has been an inexorable march towards a “vaccine mandate”. We have toyed with the idea of vaccine passports, different restrictions for the unvaccinated and vaccine requirements for employees and students. Because nearly 170 million Americans are at least partially vaccinated this doesn’t seem to result in much consternation from the majority. However for those in the vaccine cautionary sphere, this is a monumental attack on personal sovereignty, health freedom and privacy that has resulted in public demonstrations and rallies.
Mandating a vaccine is justified by the “greater good” of public safety, however this argument is ultimately based on consensus regarding the vaccine’s efficacy and safety — two vital parameters that cannot be validated until the completion of Phase III trials in 2022–2023. Until then we are expected to trust the “experts”. How easy is that to do if our governing medical institutions themselves could very well be responsible for the creation of this pathogen and if so, the deliberate suppression of this information? Are we expected to trust the very leaders that are in the crosshairs of what could be the most important investigation of public policy this decade? Remaining innocent until proven guilty is one of the foundations of jurisprudence in our country. However it is illogical for an entity under suspicion to retain their authority until a determination about their culpability can be made.
#2 The 95% efficacy of the vaccines is difficult to accept.
Although there is no definitive proof that SARS-COV2 originated in a laboratory, it is becoming more clear that that should be our working theory until further evidence emerges. The truth around viral origins is not the only blow to public confidence in our medical institutions. Emergency Use Authorization was first granted to Pfizer and Moderna based on their remarkably positive results in preliminary observations. In historical context a 95% efficacy is no less than astounding.
Upon closer examination, Pfizer was not being completely forthcoming in the public reports of the data nor in their findings published in the New England Journal of Medicine. They failed to mention a much larger group of participants (3,410) that were “suspected” of having COVID after four weeks of observation but tested negative by PCR. Pfizer reported that two of these participants suffered severe Covid-19 symptoms requiring hospitalization. These two were tested repeatedly using PCR and remained negative. We do not know if Pfizer retested the other 3,408 participants “suspected” of having Covid-19 with PCR or antibody titers which would have been more than reasonable if they were truly interested in getting to the bottom of things. The existence of this cohort was only made known to the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) that apparently thought little of this matter.
We cannot make any claims as to how further testing would have altered their efficacy conclusions, however we do know that the ratio between the placebo and vaccine group in the 170 participants that tested positive for Covid was 20:1. This is how a 95% efficacy was established. In the much larger group of “Covid suspected” participants (3,410 in total), the ratio of placebo to vaccine recipients was 9:8. If, say, 10% of the PCR tests were wrong (i.e. false negatives) the power of Pfizer’s results would have tripled (there would have been three times as much data to back their conclusions). Then again, their 95% efficacy result might have been significantly less if most or even half of this hypothetical 10% had received the vaccine and not the placebo. This is why establishing or ruling out a Covid-19 diagnosis in this group should have been vitally important to any institution tasked with oversight of this trial. The FDA, the body holding this very responsibility, didn’t seem to have any concern with Pfizer’s decision not to retest this group or even disclose this subgroup of participants in their public report or NEJM paper.
With no request for clarification made by the FDA we are left having to accept that the negative PCR result was accurate in every single one of these 3,410 Covid-19 “suspected” individuals. This is particularly difficult to do given the high clinical suspicion of disease in these participants. This is an issue worthy of some reflection. Knowing the efficacy of the vaccine requires us to know something about the reliability of the test used to diagnose the disease it is designed to prevent. How reliable is RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) in diagnosing Covid-19? We do not know.
Extracting and detecting the whole pathogen (in this case the SARS-COV2 virus) from a tissue sample or culture is the “gold standard” for diagnosing infectious disease. However, in the midst of a rapidly evolving pandemic this method was neither practical or even possible. We did not have the time nor the resources to conduct millions of viral cultures quickly. We have, out of necessity, relied on this remarkable technology to diagnose the condition, yet we do not know with any certainty how many cases PCR misses nor how many times the condition is overdiagnosed.
The problem essentially stems from the fact that RT-PCR is not truly a binary test that returns a positive or negative value. In effect it provides a probability curve depending on how many times we decide to genetically amplify the sequence we are looking for. This is the Cycle Threshold (Ct). Each amplification cycle effectively multiplies the concentration of the target RNA sequence by a factor of two. Run it ten times and the concentration of viral RNA, if present, will be a thousand times greater than in the original tissue sample. Run it twenty times and the concentration will be a million times greater. At some point, we think, we will be able to detect the target and make a diagnosis. But how many amplification cycles should we use before we stop and say that no virus is present? Moreover, why are we so ready to equate the detection of a viral RNA fragment that has been amplified a billion or more times, often in asymptomatic people, as proof of infection?
In any case, the problem with using a very low Ct (cycle threshold) is that the test will miss more cases than if a higher Ct was used (i.e. false negatives). On the other hand, using too high a Ct will undeniably result in more positive results when disease is not present (i.e. false positives). It may never be known what the optimal Ct is for SARS-COV2, however, at the very least, that number should have been standardized from the very beginning. It never was. Labs around the world were commonly using different Cycle thresholds from 35 to 40 or even higher. The CDC, whose primary responsibility was to determine the day to day impact of the disease in order to guide public policy, never offered any guidelines to testing facilities or labs.
Now that vaccinations are rapidly being administered around the world, the CDC has become interested in “breakthrough” cases, i.e. infections that are occurring in vaccinated individuals. In this communique to “public health, clinical and reference laboratories” the CDC has finally broken their inexplicable silence on the matter. The CDC is now indicating that they are only interested in cases that have been diagnosed using a Ct of 28 or less. Their double standard magnifies the incidence of the disease in the general population while minimizing the incidence of vaccine “failures”.
#3: The CDC has ignored cheap, readily available, proven effective Covid Prophylaxis and treatment alternatives
Early in December 2020, before EUA had been granted to vaccine manufacturers, the CDC continued to ignore pleas from the Front Line Covid-19 Critical Care Alliance to revise their guidelines to include the use of Ivermectin and Hydroxychloroquine in the treatment and prevention of Covid-19. Ivermectin had been proven to decrease the relative rate of infection by a factor of seven, or about an 80–85% efficacy in multiple randomized controlled trials and case series. This was more than what would be required for their emergency use under EUA (50% efficacious or greater). In fact, emergency use authorization would not have been required for Ivermectin because its efficacy and safety had already been established. However, had the CDC acknowledged the existence of this medicine there would be no means to authorize Covid vaccinations for emergency use. EUA requires that no alternative be available. These therapies were ignored, paving the way for the one and only solution: a vaccine that had yet to have been formulated or tested.
#4: The danger of Hydroxychloroquine has been debunked but physicians face repercussions for recommending their use
Throughout this entire period the CDC remained bafflingly silent with regard to outpatient treatment of Covid-19 patients. Determined to help her community, Dr. Simone Gold, ER physician and graduate of Stanford Law school began to prescribe Hydroxychloroquine with great success. She was warned to not use this proven, readily available medicine not because it was unsafe but because the hospital was not being compensated by medical insurance carriers. Having no better alternative, she continued and was fired by her program director. She is the founder of an organization of independent physicians called America’s Frontline Doctors that continue to prescribe safe, effective and proven therapies for the prevention and treatment of Covid-19 earning endless attack from mainstream media for inexplicable reasons. Physicians are being attacked for prescribing a medicine proven safe and effective. Let that sink in.
The early dismissal of HCQ as a viable treatment for Covid is suspicious. Although HCQ had been known to be effective in the treatment of other SARS viruses and was being used in China for SARS-COV2 the CDC’s position on it was based on two studies that demonstrated greater morbidity and mortality in patients who received it as part of their treatment regimen. However they received doses twice as high as what was previously recommended and used successfully, effectively overdosing them. The CDC’s position seemed to be vindicated when an enormous study based on multicenter trials was published in the Lancet in May, 2020. In yet another enormous revelatory twist, this study was eventually retracted when it was discovered that the data and medical records could not be substantiated. Note, this paper was peer-reviewed prior to publication — this is the ultimate stamp of validation in science. Do scientists need to be policed too? If so, who would do the policing? This scientific embarrassment was even covered in the New York Times. Nonetheless HCQ remained off of the CDC guidelines for treatment recommendations, effectively handcuffing physicians’ ability to treat patients who were suffering from this dangerous disease.
#5: The CDC is making claims that they cannot back up. Why?
The CDC doubled down on their single solution to CV when they made the unprecedented and unsupported recommendation that people who have recovered from Covid-19 are eligible for the vaccine. There may in fact be certain infectious diseases where vaccine mediated immunity exceeds natural immunity, but these are the exceptions to the rule. How could the CDC make this determination when efficacy trials (still not completed) didn’t even include individuals who had been previously exposed to the virus? This study, partially funded by the NIAID, indeed found enduring immunity in people after natural exposure to the virus. What would be the harm in vaccinating a person who has already acquired natural immunity? This is a difficult question to answer without close observation of a large group of such people who have received the same vaccine.
There may in fact be little or no harm in vaccinating everyone, however we can assert that by vaccinating all individuals we are eliminating an important piece of information regarding the safety of the vaccine in the long run. In the US there are over thirty three million people who have already had Covid-19. These individuals represent the “control” group with regard to vaccine safety in this enormous experiment we are conducting in this country. Although much attention is given to the incidence of adverse reactions immediately following vaccinations, we should also be interested in the long-term effects of these vaccines on our general health. If there isn’t a large pool of unvaccinated individuals that can be observed and tracked it will be very difficult or impossible to determine the potential adverse impact the vaccine may have over time. This fact is undeniable.
Putting potential long term adverse effects of Covid vaccinations aside, the medical community seems to be in denial of the very real danger of acute reactions immediately following inoculation. Vaccinations are intended to stimulate an acute inflammatory response, so how can we know whether these vaccines fall within acceptable limits of safety? This is a difficult question to answer. The primary mechanism for reporting adverse events is ineffectual. The Vaccine Adverse Event Reporting System (VAERS) is passive, requiring patients or their providers to file a report. This is not always done and the CDC themselves have previously stated that adverse events are likely underreported by a factor of 10 to 100. Moreover, how are we to tell if a response fell within the clinical window of an expected inflammatory response, or “reactogenicity”?
One way is to look at the incidence of anaphylaxis following injection. This is a life-threatening allergic response typically involving cardiovascular collapse and respiratory compromise. This is not mere reactogenicity. This is not “normal” and can happen with many medical interventions, including vaccines. Flu vaccines carry a risk of anaphylaxis of about 1.3 per million. The VAERS system indicates that the reported rate of anaphylaxis following Covid vaccines are significantly greater than that, on the order of 2 to 11 per million administrations. Though a matter of some concern, few are alarmed about this statistic. Perhaps it is due to the perceived threat of Covid itself or the lack of reliability in reporting. However the most reliable measurement of this phenomenon was reported by one of the largest health systems in the country, Massachusetts General and Brigham and Women’s Hospital in Boston who surveyed their own employee responses to the Covid vaccines. Their results were published in JAMA in March 2021. Over 52,000 responses were collected. Of those, 2% had acute allergic responses and 16 had confirmed anaphylaxis. This amounts to an incidence of 247 per million doses or 190 times greater than the flu vaccine.
I do not know what measures need to be taken at this point. As an anesthesiologist I have attended to patients in anaphylaxis and it isn’t something to be trifled with. Can we at least look at this issue objectively? The mortality rate of Covid-19 is on order with influenza yet our means of prophylaxis carries nearly a 200 times greater risk of a life-threatening response. The fact that this rarely gets acknowledged is disquieting. At what point are we going to start listening to people who voluntarily accepted a vaccine and warned us of its very real risk and not dismiss them as “antivaxxers” intent on derailing public health policy?
Throughout the pandemic the CDC did little or nothing to guide or support health care providers treat people with Covid. Vaccines were developed at “warp speed”. Their efficacy is yet to be determined but their risk is significantly greater than we anticipated. Now with Pfizer, Moderna and J&J holding EUA for their products the pressure on the unvaccinated to accept the jab is mounting. And so is the pushback.
#6: The CDC has no oversight and has offered unscientific conclusions based on shoddy methodology.
Depending on your perspective, the CDC’s Morbidity and Mortality Weekly Report (MMWR) from March 5, 2021 that stated there was an association between mask mandates and fall in the daily growth rate of cases may have merely confirmed what you knew all along. This study, offered as more proof that mask wearing was effective, indirectly justified the threat of asymptomatic spread, the need to social distance and the importance of isolation. Mask mandates and the practical and psychological burdens that come with them are slowly being lifted in the US, often conditionally depending, once again, on vaccination status.
The widespread use of masks in this country was a particularly troubling aspect to our approach to this pandemic for me personally. I have been an anesthesiologist for nearly two decades and am intimately familiar with the benefits and limitations of mask use in the operating room and other critical care arenas. Properly fitted N-95 respirators do indeed confer protection to the wearer in these environments. However the widespread use of cloth or surgical masks in public or outside by asymptomatic individuals was clearly ineffectual. Although we could excuse this extreme approach initially when little was known about the virus and its transmissibility, I was certain that mandates would be rescinded once disease incidence was compared in counties and states with and without restrictions. Months passed. The data was available and supported decades long research that demonstrated no measurable benefit from this practice as well as the very real danger of prolonged mask wearing on our health. When the CDC released their report in March I was dumbfounded. Taking matters into our own hands, I and Josh Mitteldorf, PhD, offered a critique of the CDC position here.
In reality the CDC report did not prove any causation between mask mandates and “decrease in daily growth rate of cases”. In our critique of their report we pointed out the inexcusably poor reasoning behind their methodology, lack of rigor and apparently arbitrary (or perhaps strategic?) choice of length of observation that contributed to their conclusion. Daily Growth Rate of Covid-19 cases in mask mandated counties were never compared to non-mandated counties. Their time frame of observation was largely limited to the summer and early fall of 2020 when daily growth rate in Covid-19 cases counts were declining across the country. The study and its claims were disingenuous if not intentionally misleading. Nevertheless, mainstream media sources were quick to relay their spurious conclusions as proof that these measures were justified.
#7 The CDC doesn’t want to help people, they want to vaccinate them
None of these actions and inactions of the CDC or the FDA can stand as proof that these institutions are plotting to harm the population. However are they engendering trust? It seems that there is a clear agenda to vaccinate as many people as possible and as quickly as possible.
We are enduring a disease that is likely the product of human ingenuity and being led to a single solution by the institutions that have abandoned their own mission to control and prevent disease by willfully ignoring alternatives, failing to do their due diligence and misrepresenting data.
Over and over I have listened to my colleagues resort to the same argument whenever I raise questions about our approach to this pandemic: “If you keep asking questions people will refuse to get vaccinated!” Let’s stop and consider this. First of all, the statement is absolutely true. But what exactly are our intentions as health care providers? To vaccinate people or to help people? I say it is the latter. If you believe that vaccinating and helping people are not just synonymous but equivalent, why then didn’t the CDC care about helping people when there were no vaccines available?
Dr. Peter McCullough, cardiologist, Vice Chief of Medicine at Baylor University Medical Center in Dallas, TX expressed his shock and dismay at the CDC around their refusal to play any role in guiding physicians around outpatient COVID19 treatment. His insightful comments to the Texas State Senate Health and Human Services Committee, including those in support of a vaccine, reflect those of a dedicated doctor who has been forced to take matters into his own hands at a time when the institution that should be helping seems to be focused on doing just the opposite.
Why didn’t the CDC bring together a panel of experts to lay out the best possible treatments to keep people with symptomatic CV out of the hospital in the months prior to the vaccine roll out? Why was no information disseminated to doctors and health care providers on the front lines? We are talking about the Center for Disease Control and Prevention here.
#8 There is an enormous amount of conflict of interest between our governing institutions and vaccine manufacturers.
The pharmaceutical industry holds more sway over public policy than any other for-profit interest through their extensive and expensive lobbying and direct and indirect contributions to governmental medical institutions. The government decides which therapies get approved. Vaccine manufacturers make money when their therapies are sold. The idea that bias and self-interest will not enter the picture because we are dealing with the health and well being of human beings is hopelessly naive. This is about the interaction between multibillion dollar companies and big government; it is not about the sanctity of a patient-doctor relationship. Enough said.
As medical students we were trained to pay attention to every detail, every lab value and diagnostic result. As years went by we became more efficient, not just because we could process information faster but because we became better at recognizing what was important and what didn’t fit into our model of what was happening in our patients’ course of disease and recovery. At some point, whether we were aware of it at the time or not, we got very good at picking up on the subtle signs and cues that allowed us to take in the whole picture quickly and very often the details would serve to confirm what we had guessed.
Teaching a young physician in training how to develop a sense for the gestalt without overlooking the important details isn’t easy or even possible. Perhaps it requires a thousand patient encounters. Or maybe ten thousand.
There are too many things wrong with our approach to this pandemic and the guidance and information that we have been given. We may be able to excuse one or two errors or miscommunications from our governing institutions. In this last year there have been too many nonsensical edicts and advisory statements for me to accept.
This is an appeal to all my colleagues to fulfill our mission to act in the best interest of the health of our fellow human beings. We cannot expect the layperson to question edicts coming from such institutions as the CDC, FDA and physician administrators like Anthony Fauci. That responsibility falls upon us and no one else.