We are told the system is "independent."
That when a drug is approved by the U.S. Food and Drug Administration or Australia's Therapeutic Goods Administration, it has passed through a firewall of neutral experts guided only by science.
But independence is not a slogan.
It's a structure.
And our structure looks less like a firewall and more like a revolving door.
Case Study #1: The Revolving Door Is Not a Theory
In 2019, a widely cited investigation in the *BMJ* found that a substantial proportion of FDA advisory committee members had financial ties to pharmaceutical companies. While many conflicts are disclosed and technically compliant with ethics rules, disclosure does not eliminate influence.
Former FDA commissioners and senior officials have routinely moved into lucrative roles in pharmaceutical firms, law practices representing them, or consultancy positions advising them.
Again — not illegal.
But ask yourself:
If your next multimillion-dollar job may come from the industry you're currently regulating, how aggressively do you push back?
The system does not require corruption.
It merely requires ambition.
Case Study #2: Vioxx — Approved, Promoted, Withdrawn
The painkiller Vioxx, manufactured by Merck & Co., was approved by the FDA in 1999.
It became a blockbuster.
In 2004, it was withdrawn after evidence showed increased risk of heart attacks and strokes. Estimates later suggested tens of thousands of excess cardiovascular events.
Here's the uncomfortable part:
Internal FDA scientist Dr. David Graham later testified that the agency was too close to industry and that safety concerns were downplayed.
Was it criminal? No.
Was it a warning about regulatory capture? Many believe so.
When the same agency that approves drugs is also dependent on industry user fees for its budget, the incentive structure becomes murky.
Case Study #3: Aduhelm — Lowering the Bar
In 2021, the FDA granted accelerated approval to Aduhelm, an Alzheimer's drug from Biogen, despite an advisory panel overwhelmingly voting against approval due to weak evidence of clinical benefit.
Several advisory panel members resigned in protest.
The FDA defended its decision under the "accelerated approval" pathway — using a surrogate endpoint (reduction of amyloid plaques) rather than demonstrated cognitive improvement.
Translation: it might work biologically, but we're not sure it helps patients.
The drug was initially priced at $56,000 per year.
You have to ask:
When an advisory panel says "no," but the agency says "yes," what exactly is happening behind the curtain?
Follow the Money: User Fees
Under the Prescription Drug User Fee Act (PDUFA), pharmaceutical companies pay substantial fees to fund the FDA's drug review process.
Today, those fees account for a significant portion of the agency's drug evaluation budget.
Let's be clear:
If Wall Street directly funded the Securities and Exchange Commission's enforcement arm, we'd call that a structural conflict.
But when drug manufacturers fund the review machinery that approves their own products, we call it "public-private partnership."
Words matter.
So do incentives.
The Structural Trap
No one needs to be bribed.
No one needs to be malicious.
All that's required is a system where:
* Industry finances a major share of regulatory review
* Regulators often come from — and return to — industry
* Political leaders demand rapid innovation
* Advisory panels include experts with prior industry funding
That isn't a conspiracy.
It's a club.
And clubs protect their own ecosystem.
Why This Is Dangerous
The problem isn't that regulators are villains.
The problem is that we have engineered a system where proximity replaces independence.
Where funding flows from the regulated to the regulator.
Where careers orbit between watchdog and industry.
Where speed is celebrated, caution is criticised, and dissenting panel members quietly resign.
That isn't oversight.
That's entanglement.
And once the public begins to suspect that drug approvals are influenced — even indirectly — confidence doesn't just dip.
It collapses.
When trust in medicine collapses, people hesitate. They delay. They doubt everything.
And the cruel irony is this:
The very system designed to protect public health may be quietly undermining the public's belief in it.
If we truly care about science, we should demand distance.
Because in medicine, perception of bias is almost as dangerous as bias itself. And right now, the distance between referee and player looks uncomfortably small.