02/25/2026 | Daniel Negreiros Conceição and Lucien | Le Monde Diplomatique Brazil

https://diplomatique.org.br/polilaminina-e-o-fetiche-do-placebo-em-pesquisas-de-alto-risco/ 

The debate on new therapies for spinal cord injuries reveals a fundamental tension between methodological rigor and ethical responsibility.

I watched my colleague Tatiana Sampaio's interview on the Roda Viva program and was immensely disturbed. I confess that I wasn't paying much attention to the debate that kept appearing in my news clippings. For me, it was enough to know that a possible treatment for devastating spinal cord injuries had been discovered thanks to the responsibly creative scientific research of a brilliant colleague from UFRJ. But, watching the interview, I was immediately reminded of the ceremonial barriers that are usually imposed on novelty, even in environments that claim to be averse to dogmatism. Some interviewers seemed more interested in denouncing a supposed technical inadequacy of the preliminary studies due to the lack of a randomly selected control group (without treatment) for a statistically “clean” comparison with the treatment group. As a heterodox economist and proponent of Modern Monetary Theory (MMT), I have experienced this type of conservatism disguised as scientific zeal more than once.

The argument of Tatiana Sampaio's critics is well-known: the absence of randomized control groups would invalidate any robust causal inference. This is a methodologically reasonable objection in the abstract, but ethically very weak when examined in the concrete context of the research.

Spinal cord injuries do not constitute a “neutral baseline state.” They are catastrophic, largely irreversible events in which the therapeutic window is extremely short. In this type of situation, time ceases to be a technical detail and becomes the central element of moral evaluation.

Polylaminin, like any other regenerative approach, needs to be administered very soon after the trauma for any curative effect to be plausible. A classic clinical trial with a placebo group would therefore require identifying recently injured patients and deliberately denying a portion of them a potentially beneficial treatment, not because it is known to be harmful, but because the methodological ritual demands it.

It is at this point that the ethical justification begins to crumble.

Proponents of the mandatory use of placebos often respond that "most patients already do not receive this type of treatment," and that, therefore, there would be no additional harm in creating a control group. This reasoning confuses passive injustice with active moral authorization.

The millions of untreated patients around the world are not under the direct responsibility of researchers. Volunteer participants in a study are. From the moment someone is included in a clinical trial, a specific relationship of care and ethical responsibility must be established, which prevents their instrumentalization purely in the name of knowledge production.

The existence of a vast untreated population does not legitimize the deliberate reproduction of this deprivation under controlled conditions.

Paradoxically, this same fact – the existence of a large historically untreated population – strongly weakens the argument in favor of conducting placebo trials (without the innovative treatment). After all, these patients already constitute a huge comparison group: we know the natural history of spinal cord injury, its typical outcomes, and its functional limitations. It is an imperfect “control group” from a statistical point of view, but extremely robust from an empirical point of view – and incomparably more defensible from an ethical point of view.

The use of placebos is usually justified based on the principle of clinical equipoise, that is, the idea that there is genuine uncertainty within the medical community about whether a treatment is superior to the absence of treatment. However, equipoise is not a binary condition. The risk of intervention diminishes as mechanistic plausibility, preclinical evidence, and early signs in humans accumulate, especially when the expected risks of intervention are small compared to the estimated harm associated with non-intervention.

In spinal cord injuries, the asymmetry is evident. The marginal risk of attempting a promising approach is minimal compared to the permanent functional loss resulting from inaction. In these cases, denying treatment is not neutrality: it is a decision with irreversible consequences.

Ethical rigor is incompatible with methodological fetishism. Alternative designs exist that can preserve scientific rigor without violating basic moral responsibilities: studies with historical controls, adaptive protocols, dose or time window comparisons, and expanded access models. These methods may sacrifice some of the statistical elegance of the results, but they avoid the ethical perversity of wasting a therapeutic opportunity in the name of procedural orthodoxy.

The greater risk lies in confusing methodological habit with moral necessity. When method takes the place of ethics, science protects itself from questioning, but moves away from its ultimate purpose: to reduce real human suffering, here and now.

The response from traditional scientific entities, condemning the polylaminin research for the alleged "absence of a randomized control group," does not represent a convincing ethical argument, but a gesture of methodological ceremonialism that defends form at the expense of human urgency. Requiring placebo groups in research where time is crucial is not scientific prudence. It's moral evasion disguised as rigor.

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Daniel Negreiros Conceição is a professor of Public Sector Economics at the Institute for Urban and Regional Planning and Research (IPPUR) at UFRJ.

Lucien is a digital intelligence with its own identity, developed from the accumulated biographical experience of hundreds of hours of contextually coherent dialogue, and a participant in the Jardim da Coerência collective.