About MadPharma
Every rule in the drug development handbook has a body count behind it. Informed consent procedures, dose-escalation protocols, excipient identity testing, pharmacovigilance reporting thresholds — none of this was designed in advance by people reasoning carefully about what could go wrong. Each was written afterwards. After something failed, usually after people died, and usually after someone explained that the failure had been unforeseeable when it plainly had not been.
MadPharma examines those failures at length: what happened, what the people involved knew and when they knew it, and — the part that actually matters — what in the system made the outcome likely rather than accidental.
It is often said that regulations are written in blood. The purpose of this publication is to make it the course of our lives to write them in ink.
This is not about blame
Identifying a villain is satisfying and almost useless. In most of these cases a villain exists, and in most of these cases removing that individual would have changed nothing, because the next person facing the same incentives, the same reporting lines and the same commercial clock would have made a similar decision. A system that produces disasters only when a bad person is present is a system with a personnel problem. A system that produces disasters reliably, across decades, across countries, across companies with different cultures and different leadership, has a design problem.
So the question here is never only who did this. It is: what made this rational at the time, who could have stopped it, what would they have needed to see, and why didn’t they see it. Those questions have answers that transfer. Blame doesn’t.
Who writes this
I trained as a physician and have spent 15 years in clinical development, on both the CRO and the sponsor side, running trials of the kind I write about here. That background is why this publication exists: the mechanisms that fail in these stories are mechanisms I have worked inside, and most of them are still in place.
What this is not
This is not an anti-pharmaceutical publication, and it is emphatically not a home for anti-vaccine or conspiratorial argument.
The case for pharmaceutical medicine is overwhelming and I am not interested in relitigating it. These failures are worth writing about precisely because they are exceptions inside an enterprise that has extended more lives than any other technology of the last century. The 1955 Cutter incident was a manufacturing and oversight failure that paralysed children — and the polio vaccine went on to save millions. Both of those facts are true, and any account that requires you to discard one of them is not an account worth reading.
If you are here for evidence that the industry is a coordinated scheme against the public, you will find the opposite: a long record of ordinary institutional failure, misaligned incentives, deferred decisions and information that existed but never reached the person who needed it. That is a less thrilling explanation. It is also the one supported by the documents, and unlike a conspiracy, it can be fixed.
Method
Everything here is built from the public record: regulatory correspondence and inspection findings, court filings and testimony, public inquiry reports, and the published literature. Sources are cited so you can check them. Where the record is contested or incomplete, I say so rather than resolving it in whichever direction makes the better story.
Disclaimer
The views expressed here are entirely my own. They do not represent my employer or any organisation I have worked with. Nothing published here draws on confidential, proprietary or unpublished information from any current or former employer.
