The cost of haste: On drugs, vaccines and regulators

The cost of haste: On drugs, vaccines and regulators

Breach of ‘Do not harm’ principle

So far-reaching are the effects of COVID-19 that it has harried drug regulatory authorities, usually the most risk-averse within the bureaucracy.
‘Do no harm’ is the driving principle of drug regulation and this is reflected in the thicket of documents and permissions that stand before the average novel drug or vaccine, for a chance at making it to the market.

Compressed timelines

However, SARS-CoV-2, while mostly non-lethal, kills across demography and age-groups to confound sophisticated care systems.
This has sent a signal to drug companies, biomedical firms and governments to scramble for anything with even the slightest chance of success.
It is in this context that regulators, used to long timelines of testing new vaccines or drugs, are now under pressure to facilitate a solution rather than stick to weighing and dwelling on evidence of efficacy and safety.
India’s drug regulatory authority as well as the Department of Biotechnology, which also funds vaccine development and drug research, now collaborate on fast-tracking.
For instance, if an Indian company has partnered with a foreign one in developing a vaccine, then any trials already conducted by the foreign unit would be considered in allowing Indian companies to avoid repeating them in India.
For drugs, those that have been proven to be safe for treating one disease may skip a fresh, large human trial, or a phase-3 trial.
Potential vaccines too are now allowed to combine stages of trials — normally, regulators must approve results of each stage — to permit those testing the drug to move to the next stage.
The rush to compress timelines, in itself, is no guarantee that a workable vaccine or reliable drug will emerge any faster. Drugs and vaccine-development have historically been expensive because immunology is a complex, eternal struggle with disease, and with high failures.

Need of the hour

There have been instances when disease mortality is so high that not offering even a half-baked drug or a vaccine would be unethical.
That is a call regulators have to constantly take. But not all emergencies are the same.
There is now a situation, as in the case of itolizumab, a psoriasis drug repurposed for COVID-19, where the drug regulator has approved it for emergency use but the COVID-19 task force has expressed its reservations.
Such dissonance among experts is unacceptable especially when they all have access to the same evidence.
There is a tendency to view COVID-19 vaccine development or a new drug as a ‘race’ in which only the first vaccine to be out matters.

Haste does not aid science.

Source: TH

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