An Open Letter To Professor Paul Offit: On the Critical Importance Of Establishing “Medical Necessity” As A Safety “Device” In The Vaccine Space.
In this open letter to Dr. Paul Offit, I asked that he consider whether avoiding indiscriminate population level vaccination of already immune persons, especially in the midst of an outbreak when many are well-immune, would be an important mitigation step in minimizing harm to the “rare” subset of people at risk of adverse events and complications.
Dear Professor Offit,
First, I want to wish you and your family a happy new year.
I write here for your record and consideration, a proposal that I know would bring balance and some confidence in the parts of our democracy where vaccine hesitancy exists.
I write you, in particular, because you are one of the most prominent and zealous American advocates for adequate population level vaccination — a position with which I agree, for the most part.
But, as you know one of the most difficult barriers to convincing Americans of the importance of population level vaccination is vaccine hesitancy and mistrust in the confusing, and at times arrogant, messaging from the scientific community and the executive branch. This problem has come in full view during the COVID-19 pandemic.
I know we agree that in the utilitarian medical calculus, the benefits of well designed vaccines in preventing infectious disease epidemics and pandemics vastly outweigh the risks of iatrogenic complications from vaccination. Nevertheless, those risks are real and those adversely affected, some of whom I have personally interacted with vis-a-vis COVID-19, have quite devastating complications, some deaths — as you know.
The real question in all of medicine is whether we can balance the utilitarian equation optimally by maximizing “majority benefit”, while minimizing minority harm. This is a particularly important issue, because when large scale vaccination campaigns (or any “service line” medical treatments) are undertaken, as with COVID-19 vaccination, even quite infrequent adverse event rates will translate into non-negligible absolute numbers of persons affected adversely. Not only is this terrible for those iatrogenically affected as such, but it serves to erode public trust in the vaccine, as we see happening. So, from a public health perspective, it is critical not to ignore these complications or to simply downplay them as rare, unfortunate or unavoidable.
Of course, in an ideal scenario, we’d be able to predict who is at risk of having a serious complication and avoid treatment in those persons — finding alternative means of protecting such persons, where possible. An example in the vaccine space is, of course, a documented history of vaccine anaphylaxis or severe Guillain Barre following vaccination. But, unfortunately, in most cases we do not know who these least fortunate affected by population level vaccination will be.
As a physician, Immunologist and a public health advocate, whose own family fell to an iatrogenic “service line” disaster in a different utilitarian space, I’ve spent significant time thinking about how we can prevent harm to minority subsets of people, as we exercise utilitarian medical “beneficence” on a public health level. And I want to ask that you please indulge my argument/proposal below, because I know that you have the expertise and immunological understanding to determine its validity.
As you know, two of the key tenets of ethical medical practice are the concepts of beneficence and non-maleficence. These pillars are encapsulated partly by the idea of medical necessity. That is, beneficence and non-maleficence are in great part achieved by ensuring that no medical treatment is delivered to any person who stands not to benefit from it. In this sense, as much as the establishment of medical necessity prevents unnecessary medical treatments from being administered, it is a powerful hazard mitigation approach in medical practice. In other words, adherence to a basic medical ethical precept ultimately translates into a patient safety “device” that would minimize “minority harm” in utilitarian medical equations — where it is critical to benefit the majority while we prevent iatrogenic harm.
It is my postulate and proposal to you, Dr. Offit, to consider whether it may be time in 2022, to start developing a more nuanced approach to mass vaccination than that achieved by one-size-fits-all “vaccine timetables”. Afterall, we live in a very different world and country than we did in the 1900s when vaccination practices were developed and implemented. We CAN actually establish, with relative ease, who needs a vaccine and who doesn’t, immunologically — who is immune and who is not. Because truly, it is an American imperative to minimize harm to minority subsets of people and individuals as best we can, in the hustle and bustle of our free-market utilitarian republic’s frenzied activity in professions and sectors.
The COVID-19 vaccine and the scale of its deployment in the midst of a pandemic outbreak, to me, is an opportunity to think carefully about how we can actually evolve and optimize delivery of vaccinations in a rational and appropriately personalized (and thus safe) manner — because “rarity” of complications, alone, is not a justification for accepting them unmitigated.
Since the beginning of the COVID-19 vaccine campaign, I advocated for a #ScreenB4Vaccine approach in order to avoid unnecessary or marginally beneficial vaccination, especially in the already infected and immune Americans — and ultimately as a way to minimize harm from this novel treatment, whose development inevitably was accelerated in an unprecedented manner. I do believe that this is the safest and most rational approach to COVID-19 vaccination and, especially, to boosters. I also know from my own practice, that many vaccine hesitant people choose vaccination, when confronted with their personal serological information demonstrating an absence of immunity — my own limited dataset in a PA swing district, shows that about 50% of the hesitant choose vaccination when shown a NEGATIVE COVID antibody serology. This is a real phenomenon. Humans, and especially Americans, respond far better to rationality and autonomy than they do to coercive mandates.
In summary, I appreciate your attention to this message and I hope you will consider the potential critical importance of a #ScreenB4Vaccine approach as a new frontier in the evolution of an ethical and safer algorithm for population level vaccination — to replace the McDonald’s “Super-Size-Me” one-size-fits-all approach promoted by the traditional time-tables currently used as the standard. It is time to help the vaccine space evolve immunologically into a space where medical necessity is established, not assumed — to earn public trust and to minimize harm to the “rare” minority.
Yours in friendship,
Hooman Noorchashm MD, PhD
New Year’s Day 2022.
