When it Comes to Clinical and Translational Research, Efficiency Doesn’t Mean Skipping Steps

The Illusion of Speed, the Reality of Harm. #SharingIsCaring

In recent years, “efficiency” has taken on a dangerous new meaning in biomedical science. Once a term denoting thoughtful optimization—doing more with less without sacrificing quality—it has been rebranded to justify collapsing regulatory safeguards, abbreviating scientific protocols, and sidelining transparency in favor of speed.

This shift has not made medicine better. It has made it brittle. It is why the allopathic medicine paradigm should shore up its leadership, fire the Pharma bosses and join #MAHA.

Rather than strengthening public health infrastructure, this rush has led to uncertainty, declining trust, and real-world harm—especially in the rollout of mRNA vaccines and other biomedical interventions under Operation Warp Speed. Efficiency, when stripped of rigor, becomes performance—not progress.

This article aims to restore the integrity of that word and to examine what was lost when speed replaced structure.

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Peter Marks and the Fast-Tracking of Iatrogenic Risk

Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), played a central role in the expedited approval of mRNA vaccines. But in doing so, he oversaw a system that has yet to clearly demonstrate whether the vaccines reduced mortality in the population most at risk: the elderly.

Our recent analysis of Florida’s five-year all-cause mortality data (DFAC) found no unambiguous signal of benefit in older age groups. If anything, the data suggest a possible slightly negative effect on mortality among this population during peak vaccine uptake.
Source: Popular Rationalism, May 2025

The lack of clarity is not merely academic—it undermines the entire premise of the emergency rollout, and is precisely symptomatic of all of translational research done in the name of “efficiency”. Without confirmed net benefit, especially in the age group most likely to suffer from COVID-19, any risk incurred becomes ethically indefensible.

This isn’t regulatory agility. It is regulatory opacity.

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Fauci and Collins: Dismantling Trial Integrity

In parallel, then-NIAID Director Anthony Fauci and then-NIH Director Francis Collins allowed the merging of Phase I and II trials during early COVID-era vaccine testing—a decision that removed a key layer of safety evaluation.

Traditional translational research is designed around phased trials for a reason: each phase serves a distinct purpose, with specific statistical power and clearly defined endpoints. Combining phases blurs those boundaries, making it harder to assess dose safety, immune response durability, and adverse event frequency.

This wasn’t just about saving time. It was a structural decision that reduced scientific resolution. In bypassing independent, sequential trialing, they dismantled a core pillar of the safety framework that generations of medical ethics had built.

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Operation Warp Speed: Theatrics Over Transparency

Marketed as an “all-of-government” breakthrough, Operation Warp Speed was in fact a rush-to-market initiative with little precedent for openness. The speed was real. The science, at numerous key times, was not.

Key failures include:

• Allowing manufacturers to report and interpret their own efficacy and safety data, publishing science by press release;

• Basing policy therapies and treatments on fraudulent studies;

• Classifying contracts and shielding manufacturers with indemnification clauses;

• Bypassing traditional toxicology review processes in some cases.

This may have been expedient to the goal, but it was not efficient.

While other nations like Sweden and Japan opted for cautious stratification, the U.S. accelerated into mass vaccination without full data transparency. This wasn't a model of modern efficiency. It was a politically-driven exception masquerading as policy reform.

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Post-Marketing Surveillance: A Safety Net Full of Holes

In the United States, much of the responsibility for detecting vaccine-related harm—especially in children—has been shifted to post-marketing surveillance systems like VAERS (the Vaccine Adverse Event Reporting System). But VAERS is not an early warning system in any meaningful sense. It is a passive database with acknowledged underreporting by a factor of 10 or more, lacking the statistical power or real-time responsiveness needed to detect and act on emerging safety signals.

In a non-consenting population—infants, toddlers, and young children—relying on such a system is both ethically and scientifically inadequate. Events like seizures, encephalitis, or neurodevelopmental regression are often dismissed or never attributed, particularly when physicians are under social and institutional pressure to assume safety.

This is not a system designed to detect harm. It is a system designed to fail, and thus minimize accountability.

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The Language of Efficiency, Rewritten for Deregulation

The biomedical sector has increasingly adopted terms that mask the dismantling of standards:

• “Platform adaptability”—used to excuse the lack of platform-specific testing;

• “Regulatory flexibility”—a euphemism for diluted oversight;

• “Emergency pathways”—once exceptional, now semi-permanent.

This language confuses the public and clouds scientific discourse. What was once a virtue—efficiency as integrity—has been replaced with expedience as a substitute for thoroughness.

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Redundancy Is Not Waste—It Is Protection

In science, redundancy is not inefficiency. It is how complex systems remain robust under stress. From aviation to nuclear engineering, multiple safety layers are not signs of wasted effort—they are the cost of reliability.

Public health once followed a similar principle. But over the past two decades, and especially during COVID-19, those redundancies were treated as negotiable. The result? A chronic illness rate now affecting over 54% of American children, and a nation caught in a pharmaceutical dependency loop where polypharmacy is normalized.

This outcome isn’t efficient. It’s evidence of system-level failure. Efficiency should lead to less disease, not more treatment.

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Toward a Smarter HHS: Realigning Efficiency with Safety

If HHS is to reclaim public trust, it must realign its incentives and priorities. A truly nimble HHS would be:

• Transparent in all regulatory contracts and trial data;

• Committed to full-length, decoupled clinical trial phases;

• Equipped with real-time public dashboards for monitoring adverse events capable of learning and validating signals on the fly;

• Separated from marketing or promotional functions;

• Supported by a Federal Adversarial Replication Office (FARO) to independently reanalyze trial data and compare outcomes across platforms.

Most importantly, it would move away from throughput-based performance metrics toward outcomes that emphasize long-term health. Wellcare, not disease management, should define the system.

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Conclusion: Efficiency Is Only Real When It Protects People

We are not calling for bureaucracy for its own sake. We are calling for balance, accountability, and restoration of rigor. Speed has a place in science—but only when the foundational layers remain intact.

“Efficiency” cannot be the justification for collapsing trial design, overlooking risk signals, or relying on inadequate surveillance. Nor can we accept a system where the benefits are ambiguous and the harms unacknowledged.

Real efficiency saves lives. Faux efficiency saves time—often, at their expense.

It’s time to rebuild a scientific and regulatory culture where doing it right is valued more than doing it fast.