In 2009, I had a remarkable encounter at the Institute for Advanced Studies — I met Freeman Dyson. Known for his groundbreaking work in physics and mathematics, I was struck by his intellect, his way of thinking, and most of all, his rigorous scientific approach to every question he explored. That meeting inspired me to learn more about him.

In 1975, Dyson published an article that remains profoundly relevant today: The Hidden Cost of Saying No. He opened with a quote from William Blake:

One law for the lion and ox is oppression. You never know what is enough unless you know what is more than enough.

In many industries, decision-making focuses solely on the cost of saying yes, while the cost of saying no is often ignored. This oversight is particularly harmful in healthcare, where bureaucratic inertia and rigid regulations have life-or-death consequences. Patients are the ones who suffer.

Regulation of drug development was introduced in response to the thalidomide disaster, which left thousands of babies with severe birth defects after exposure to a drug marketed as safe. It was clear that stronger oversight was needed to prevent such tragedies. Regulations were tightened—but did they prevent future harm? No. The opioid crisis, driven by drugs like OxyContin, became one of the most devastating public health catastrophes in modern history. This raises an important question: Does regulation truly prevent harm, or does it merely shift risks in different directions?

To be clear, regulation is necessary. But we must not pretend that it eliminates risk altogether. Where financial interests dominate, institutions—not individuals—inevitably succumb to pressures that prioritise profit over patient well-being. Shareholders demand growth; regulators focus on compliance. Both are often far removed from the human cost of their decisions. They do not witness the suffering of patients. Here is the key point: We must also calculate the cost of inaction. Regulatory compliance can cause harm. Inaction kills. Delaying access to a life-saving medicine means patients are dying—sooner than they should, or when they could have been saved.

Patient advocates must work alongside stakeholders—industry, regulators, and health technology assessors—to evaluate both the cost of saying yes and the cost of saying no. Decisions about access to treatment should not be made in isolation from the people they affect. Because in the end, this is about us. And if it’s about us — not without us.

Peter Kapitein
Patient Advocate Inspire2Live