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Home Politics & Law

A Medical Decision, Made Legally

Daily Remedy by Daily Remedy
August 8, 2021
in Politics & Law
0

When you walk into a local bar, it does not take much to discern who is an employee and who is a patron. The former has on a mask, while the latter does not, simple as that.

But the decision to wear masks is anything but simple.

It is a medical decision, made legally.

The CDC announced abruptly that it would revise guidelines no longer mandating indoor masks, and a number of states and businesses followed suit just as abruptly – doing away with indoor mask mandates without a second thought.

But the CDC created a void in the rapid transition – a void manifesting as uncertainty as to whether mask mandates were truly no longer necessary. There was no clear metric, be it positivity rate, vaccination rate, or more traditional markers like incidence, guiding the CDC’s decision.

It was simply ordained.

To justify the decision, CDC director, Dr. Rochelle Walensky, referenced two studies that were published in the CDC’s Morbidity and Mortality Weekly Report, both demonstrating the vaccine’s effectiveness at reducing transmission and complications.

But she did not present any actual, tangible metric, or milestone achieved to justify the decision.

And when decisions are made based upon speculative logic – we no longer need mask mandates since the vaccines have proven to be effective, and since we assume people will get vaccinated, therefore we assume we do not need mask mandates – voids of uncertainty form.

People abhor uncertainty like nature abhors vacuums, and naturally militate against it. This is why many businesses and locales have opted to maintain mask mandates – for their employees at least.

We do not know if lifting the mask mandates, when we lifted them, was the right decision. We are uncertain at this time.

And to hedge against this uncertainty, the private sector opted to maintain mask mandates – just in case.

But underlying a relatively simple decision is a growing dichotomy within the uncertainty itself, forming two distinct types of uncertainty – one medical and one legal.

Both are complex concepts. And like all complex concepts, they can be defined in unique, multifaceted ways.

In the medical world, we think associatively and prospectively, aggregating clinical data in real time to identify the most likely clinical scenario. In the legal world, we think linearly and retroactively, piecing together evidence after the fact to construct an argument.

Information that is available after the fact is usually not available in real-time. But more importantly, what is considered important in real-time can be retroactively re-contextualized to be more or less important afterwards.

In law, we often simplify legal uncertainty into a decision of guilt or innocence. But legal uncertainty is far more complex.

It is a series of decisions that determine how specific actions come to define the whole of a behavior. How much each of action influences the overall behavior, and what factors can be attributed directly to the behavior, which becomes particularly difficult to do so when addressing individual actions within the complexity of medicine.

But in simplifying, we often misunderstand, particularly since uncertainty in the legal world is different from uncertainty in the medical world.

Uncertainty is the essence of medicine and analyzing uncertainty is the art of medicine, which is why medicine has always been considered more of an art than a science until recent decades. Art is an expression of imagination, which can only be appreciated when viewed in its entirety – whether that is treating the whole patient or analyzing a physician’s decision through a comprehensive context of patient care.

To distill medical uncertainty into granular actions that would address legal uncertainty is particularly difficult. Any clinical event, be it a traditional patient encounter or a life threatening emergency, is more than a series of discrete actions, it is a complex array of clinical decisions and clinical actions that interact in unique, often unpredictable ways. There will always be uncertainty within this complexity.

When this frame of thinking is applied to healthcare decisions with legal implications, we find two disparate forms of thinking – one medical and one legal.

With subtle variations in the predisposition giving rise to variations in thinking. Variations that, if unchecked, lead to conflated logic in which one presumes to be thinking in medical terms, but is actually thinking in legal terms.

The CDC may have made its decision based upon the clinical data showing vaccines are highly effective – a decidedly medical decision. But the implementation of that decision is distinctly legal, demonstrating how two perspectives of uncertainty manifest two different responses – one medical and one legal.

Resulting in a medical decision, made legally.

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Daily Remedy

Dr. Jay K Joshi serves as the editor-in-chief of Daily Remedy. He is a serial entrepreneur and sought after thought-leader for matters related to healthcare innovation and medical jurisprudence. He has published articles on a variety of healthcare topics in both peer-reviewed journals and trade publications. His legal writings include amicus curiae briefs prepared for prominent federal healthcare cases.

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summary

An in-depth exploration of drug pricing, including key databases like NADAC, WAC, and ASP, and how they influence the pharmaceutical supply chain, policy, and patient advocacy. The episode also introduces MedPricer's innovative pricing intelligence platform, offering valuable insights for healthcare professionals, policymakers, and patients.

Chapters

00:00 Understanding Drug Pricing Dynamics
03:52 Exploring the Drug Pricing Database
10:07 Patient Advocacy and Drug Pricing
13:56 Market Intelligence in Drug Pricing
How NADAC, WAC, and ASP Shape Drug CostsDaily Remedy
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Policy Shift in Peptide Regulation

Clinical Reads

FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation

FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation

by Daily Remedy
April 19, 2026
0

Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has identified a subset of bulk drug substances, including certain peptides, that may present significant safety risks when used in compounded formulations. The clinical question is whether these regulatory signals reflect meaningful patient-level risk and how they should influence prescribing behavior. This matters because compounded peptides often sit outside traditional approval pathways, creating uncertainty around quality, dosing consistency, and safety. Understanding...

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