Biologics are not small molecules: the case for pre-allergy testing in an era of immune-based therapies
2025-05-01T15:00:31Z
“Once it’s in your body, there’s no taking it back.” That’s what the infusion nurse told a friend of mine after administering the injection. She had just started a biologic medication for an autoimmune condition. Immediately, her body reacted: nausea, then hi…
Biologics are not small molecules: the case for pre-allergy testing in an era of immune-based therapies
“Once it’s in your body, there’s no taking it back.”
That’s what the infusion nurse told a friend of mine after administering the injection.
She had just started a biologic medication for an autoimmune condition. Immediately, her body reacted: nausea, then hives, then a terrifying tightening of her throat. She rushed back to the clinic. The IV steroids and Benadryl may have stopped the immediate effects, but not the long-term physiological, psychological, and financial fallout.
The cost of the medication: $42,000.
The cost of the reaction: immeasurable oxidative stress, and lost trust in the medical system.
When the framework does not match the drug
There is a fundamental mismatch between how we treat biologic therapies and what they actually are.
These are not small molecule drugs. They are engineered proteins. They behave like guided missiles, targeting immune functions with a precision that is both powerful and unpredictable. Once introduced, they do not passively exit the body. They persist. They embed. They teach the immune system what to attack or not.
At one appointment, I asked the prescribing physician if they could tell me the FC region classification of the drug. Their answer was honest: “I’m not sure.”
Despite this level of uncertainty, we apply to biologics the same framework we use for antihypertensives and antibiotics. We assume that if something goes wrong, we can just stop it. But that is not how these drugs work. There is no clean off-switch. There is only the slow unraveling of a system we did not properly screen.
Modern medicine must become more adaptable.
The deeper issue is a failure of adaptability. Medicine, for all its progress, is not keeping pace with the rate of change in the world it is meant to serve.
We are now in an era where technology evolves faster than clinical culture. Artificial intelligence is reshaping diagnostics and surgery. New diseases are emerging at an accelerating pace, driven by global population growth, urbanization, and increased density.
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In such a complex and fast-changing environment, rigid protocols designed for yesterday’s medicine will not suffice. Medicine must begin to behave more like the biological systems it treats: Adaptive, open to feedback, and able to recalibrate in real time.
Biologics represent this complexity. But our regulatory and clinical response to them has been reactionary, built on outdated assumptions. This is how fragile systems collapse not from novel threats, but from institutional refusal to adapt.
The illusion of “safe enough”
This is not an anti-biologic position. These therapies have transformed and saved lives. But the way they are introduced to patients, often without even a mention of allergy screening, is negligent.
And it is not because the science is lacking. We already screen for far less costly agents. We patch test for penicillin. We perform challenge tests for peanuts. We require cross-reactivity panels for contrast dyes.
But for monoclonal antibodies and other biologics? Access to even a single aliquot for testing is nearly impossible. Drug reps do not provide samples. Clinics are discouraged from requesting them. And existing research is unclear on how testing could be practically implemented for certain agents. Providers are left with two options: prescribe or delay, often without any safe mechanism for trial dosing.
Why?
Because it is expensive, financially, bureaucratically, and legally. The path of least resistance is to administer the full dose and see what happens.
To patients, that feels less like science and more like roulette.
Complex systems, initial conditions, and trust
In complexity science, outcomes are sensitive to initial conditions. What happens downstream is shaped by what happens at the outset.
In immune-based therapies, this is not a metaphor. It is the mechanism. If the body reacts poorly to a biologic, it may never tolerate it or related compounds again. The immune memory is not easily erased.
And yet we continue to treat these therapies as benign until proven otherwise. The absence of mandatory allergy screening reflects a deeper systemic issue: We are still trying to fit 21st-century therapies into 20th-century models.
Psychological cost: When trust collapses
We often account for the physical risks of biologic therapy. What we overlook is the psychological fallout.
When patients suffer severe immune reactions, trust in the system begins to fracture. Why wasn’t I tested? Why didn’t anyone warn me? What else are they not telling me?
This erosion of trust is not abstract. It affects outcomes. Patients become less likely to report symptoms, ask questions, or continue care. In a time when medical distrust is already at an all-time high, this disengagement has real clinical consequences.
This is where the concept of psychological safety becomes essential. In Google’s Project Aristotle, psychological safety: The belief that it is safe to speak up, was identified as the strongest predictor of team effectiveness, more important than intelligence, aptitude, or technical skill.
The same holds true in medicine. When patients feel safe, they participate. When they do not, they disappear.
The ask: Pre-allergy testing as standard protocol
I am calling on physicians and the institutions that support them to advocate for mandated pre-allergy testing for all biologic therapies. Not as an optional safeguard. As standard protocol.
I am calling on the FDA to revise its regulatory assumptions around biologics. These are not analogues of small molecules. They are fundamentally different agents and require a safety framework that reflects their persistence, complexity, and immunogenicity.
And I am asking pharmaceutical companies to do what is ethically necessary: Provide access to testable samples. If you are going to charge five figures for a therapy, you can afford to let us test 0.1 percent of a vial.
The immune system remembers what we give it.
Let us make sure we remember what we are doing.
Robert Trent is a graduate student.
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