What have we done?
There was a time when scientists probed nature to discover her secrets. It would take an Edward Jenner, a Marie Curie, a William Osler, an Alexander Fleming to quell the harm of nature interacting with the human. The magic of discovery and the innovation to help the infirm and those riddled with illness.
Alas things changed dramatically over the past several decades and the process has escalated with time as it approaches us in the present. The truths that have comforted us for decades, now are regaled as discontented outbursts of disequilibrium. Yet the burdens of those dynamic tensions of the past still reverberate in the fibers of our being. And those burdens call on us to visit the past.
Science is the discipline of empiricism. You conjure a hypothesis and then experiment to prove it. If the hypothesis is faulty the experiment would be considered a failure and you would go back at it again with a different nuance. Perhaps a lifetime would be spent as with Judah Folkman, MD who was convinced that the Vascular Endothelial Growth Factor suppression would be the cure for cancer. It was rich in its concept, but reality did not afford him the wealth of success. History is littered with lives spent in the books, reading and writing, over microscopes, in the clinical wards trying to fathom the mysteries of illness and how to cure them.
Such is that history that we embark upon today. The recent history is cobbled together by many a scientist that have turned to statistics in claiming their hour upon the stage and after a while they are heard from no more. But some stay and continue their art of numerical manipulation to keep the spotlight. The sea of medical science literature is eyeball deep in froth. Hundreds if not thousands of “studies” have been rendered useless. Even though some were considered “landmark” in their short lives and cited by several others as proof to their validity. Unfortunately, when the studies were reviewed in one case, only 11% (6 of 53) held up under the scrutiny as being verifiable, or 47 were flawed in their results.
Today in the field of cancer medicine, “studies” pop up by the thousands in thousands of journals across the world. Most are flawed in their methodology, others in the small numbers of cases being reported and others still from misinterpretation of the data. Today the hypothesis generation is not in peril, but what is, is the experimentation. If you have an outcome in mind then you generate a hypothesis and look for a statistical methodology available to prove your underlying premise as being true. New drugs are coming to market bearing news that they can cure this or that. Billions of dollars flow into the coffers of the reporting entity. But as all small sized studies inevitably showing large effect-size results end up in the heap of “wonder why it didn’t work?” Thus, in our bias we are constantly parsing our thoughts and hypotheses into categories and classes, always attempting to understand the processes and compute the distances between what we are emotionally tied to, such as the hypothesis and the potential outcome we wish to achieve. Such binary limitations expose us to the Frankenstein we hope to avoid at the end.
The science behind these studies is frequently flawed, the experiments rushed, the outcome preordained, and the eye of the agency is on the monetary prize for the next quarter. It is the preconceived poem in an elaborate loop of self-perpetuation, constantly erasing and elaborating on itself, to achieve the emotional ending. In fact, you would be considered a cave-dweller if you did not venture into the quicksand of annual reporting on schedule before a major cancer conference or cardiology conference with reams of data and glowing tributes to gain the attention of the ribbon-wearing crowd that stamp their seals of approval on such presentation. Thus, is born the most vicious of assaults on the lives of the uninformed people. “Take this new medicine, it was just approved,” they say as they hand you over the prescription or stick with a needle with a colorless fluid running through it. For, only time determines what works and is durable. We as humans cannot solve for the “x” without knowing the “y,” but using computers and calculators we can statistically twist a tale to suit our needs
It is unfortunate as the 21st century rolls along at its turbulent pace, medicine, it seems has been bought by the highest bidder. The adage, “money talks” is truer today than in any other era. Dollars flow from the highest bidder’s eye to the next great financial reward. This was exposed in a television documentary on PBS. There is a risk for all such immersions but with good “bedside manners in lobbying and marketing preceding the promotions” at hand, all financial risk-aversion is guaranteed. While the CEOs revel in their “Durable Revenue Stream” as they tout their next landmark drug while eying their own financial packages blossom into private jets, mansions, and boats.
We have arrived at another juncture in medical science that bears witnessing for its might. The Pandemic has laid bare some interesting questions that need answers. The Pandemic of 2020 due to SARSCoV2 (virus) the agent for the COVID illness which has taken millions of lives worldwide and continues to ravage nations as we speak is a story worth probing.
When the pandemic was announced amidst all the confusions and obfuscation of what policy to invoke by the public health officials, a curious issue arose and was brought to bear; that certain medications, long in the pharmacy and very cheap in price, inhibited the viral replication in vitro and potentially in clinical settings also significantly reduced the severity of the illness. What followed from that information was a torrid flood of negation and diatribe directed at the physician-scientists who had scoured the historical literature and found that indeed there was something fruitful and worth pursuing in such an approach. They started administering to their patients and suggested that they had indeed noted success.
The establishment of the academics and other elites were not too happy with such a discovery. Several studies of poor methodological means were reported almost within the month decrying the harms and the non-effect of such medicines. U.S. Food and Drug Administration states on their websites the potential harms while negating any benefits and advises against its use, even though, scientific data suggested the benefits of using the drug in COVID illness. Meanwhile the agents of the government were quick to promote Remdesivir, an antiviral drug, which carried a price tag 3000% higher over the cheap generic drugs, Hydroxychloroquine and Ivermectin being advocated and used clinically by some infectious disease experts. Immediately some states declared a moratorium and placed a restriction on the cheap drug being used by these physicians from writing such prescriptions for their patients. The Expensive drug had a potential windfall in the billions of dollars for the company and was marketed as the potential cure of the viral illness. Perhaps, they felt the cheap drug might hollow out such a windfall?
Meanwhile the “Operation Warp Speed” dynamics were in play and pharmaceutical agencies dusted off failed experiments of the past and arrived at a new vaccine against the virus. The vaccine was made up of small fragment of the virus that codes for the spike protein, the protein that gains access into the human cell via the ACE-2 receptor on the cell itself. The concept was simple, if the RNA fragment was allowed into the cell and created the “non-infectious” spike protein then the immune system of the individual would recognize it as a “non-self” and direct its energy in the destruction of the spike as well as the virus itself.
After a short period lasting 2 months (median) and using the vaccine in 43,000 individuals in their Phase II/III trials, the pharmaceutical agency boasted a 95% relative risk reduction in the potential for catching the illness and potentially in preventing deaths. The hysterical and frightened world was all ears and saucer-eyed at the prospects of a SARSCoV2 virus elimination and resumption of normal daily life. Lost in this translation was the use of a vaccine that had only had a median of 2 months of follow-up review in regard to the short-term side effects and no long-term efficacy data was available. Pursuant to the past vaccine products which had taken a multi-year testing and efficacy, safety validation, this new mRNA vaccine had a short review lifespan. The vaccine was granted an Emergency Use Authorization (EUA), which is different from the Biological Application License (BLA) granted after long-term safety data has been reviewed and deliberated and the latter has been the bedrock of safety in science for decades.
Alas as millions of individuals were vaccinated reports of Adverse Events became apparent. There were minor complaints of sore arms, fever, headaches, which were expected. But soon a trail of severe side effects and deaths started to follow the vaccination event. These events seem to occur within the 24–48-hour post vaccination period. Long term adverse effects, if any, will take time to evolve over the next few years. There is some early evidence that the spike protein itself is pathogenic and can induce harm. Further studies are needed but the vascular and neurological insults noted in some individuals after vaccinations need closer scrutiny.
The various governmental agencies have continued to encourage the vaccination of all adults and most everyone was on board with the plan. The concept of “Zero COVID” was hatched and the vaccination was encouraged for the 12-18-year-olds and studies were also in progress to vaccinate the 6-month to 12 years in the fall of 2021. If history is a guide, Pandemics never achieve a “ZERO state.” The virus continues to evolve and finds some degree of harmony with the immune population over time. Elimination of a fast-mutating virus like the seasonal influenza remains a similar impossibility. We all live with that risk, mitigating it with partially effective vaccines and good personal hygiene and habits.
One wondered silently if 100% vaccination was the correct path to follow. Especially since the children were the least likely to catch the virus and if they did, they quickly rid the virus due to their robust immune systems, with almost no symptoms. And those that had been infected by the SARSCoV2 and developed natural immunity should need the vaccine at all?
At that very moment the Pfizer Company announced a blockbuster Quarter with $3.5 billion in revenue, a 70% year over year revenue. Moderna the other RNA vaccine maker also enjoyed significant increase in their cash stream. Johnson and Johnson although not as robust still delivered excellent results for their shareholders, while and Astra Zeneca financials were “soft” since young adults seem to have a higher morbidity and mortality related events from blood clots emanating immediately post vaccination. These alarming events caused the European Union states to put a hold on those vaccines. The total market for the latter two companies was markedly reduced and Pfizer became the clear winner.
The currency of science lives in the trust of the user of the product. Losing that currency results in reduced use. Enticing people with rewards as some politicians have resorted to, recently must give us all a pause, as to the need for such an incentive? After all, if the vaccine is a lifesaver as it is purported to be with a 95% Relative Risk Reduction against the virus, why not educate the public and let them make their own decisions? Why use the carrot of an incentive or a stick of a vaccine passport on citizens? And as some in the media are constantly shaming those who are against such passports with threats and retribution, it suggests becoming an interesting study in behavioral economics and habits enforced upon the individual, rather than prime predicate of safety of the individual.