My comments at Friday's FDA drug advisory meeting

The FDA is working for the pharmaceutical industry and not the American people.

On Friday, the US FDA held an advisory meeting on an obscure topic: Should drug companies be allowed to get their costly products on the US market not based on living longer or better, but killing more plasma cells in bone marrow? Specifically is MRD negativity at 9 or 12 months a suitable basis for accelerated approval in multiple myeloma?

Make no mistake, the drug companies desperately want this change. They stand to make billions from it. Currently, the cost to treat a single patient with myeloma for a year is upwards of 600,000 in drug cost alone, but with this change it will be easy to clear a million dollars a year or more.

Also, make no mistake, MRD negativity does not have a strong correlation with living longer. The FDA’s own analysis shows a weak correlation. No analysis was presented showing whether it predicts quality of life.

I was concerned with the FDA’s actions, and signed up for public comment. I was given 5 minutes to speak and presented these points at the meeting. Check it out.

My biggest concern is safety. Imagine if the FDA rushes a new drug to a myeloma patient who has 15 or more years to live, and that drug causes nerve damage or parkinsonism (as CAR T has now been found to). The patient has to live with that for 15 years! That would be catastrophic.

Parkinsonism took 7 years to be reported from when the first CAR-T was given. Speeding approvals does not allow time for the full safety profile to be known, and the FDA’s use of MRD makes the scenario— of living with an unexpected toxicity for decades— much more likely to happen.

As I listened to the meeting, I realized my comments would be in vain. The FDA had already collaborated with the other speakers and appears to have already concluded that lowering the standards is a good idea.

All of the other speakers supported the idea. The vast majority have received personal payments from the companies that benefit from this bar-lowering, or run trials for the companies (also helps their career and provides indirect payments to them). The entire room didn’t feel like an impartial trial, but a kangaroo court. The decision had been made, and this was an elaborate theater. Speakers congratulated each other 10 times more than they critically discussed the data.

One speaker actually said that if the FDA didn’t give Pharma companies more time to make back their sunk R&D costs, they will charge much more for drugs. This is a bizarre argument that is economically illiterate. The companies will make much more money by changing the bar— that’s why they support the change!

The vote to authorize MRD - as an endpoint was 12-0 in favor.

I worry that the. FDA is entirely beholden to the pharmaceutical industry. It was already approving myeloma drugs based on progression free survival — a surrogate that does not correlate with overall survival, as I explain in the video, but will lower the bar further. The FDA keeps patting itself on the back, but we have no idea what the optimal sequence of drugs is in myeloma, and the FDA’s low standards are primarily to blame.

Worse, the FDA is not interested in a debate. Why not allocate more time to a speaker who is critical of the change? I only got 5 minutes. That’s not enough time to combat 8 hours of propaganda.

Interestingly, the FDA did not make the materials— a complex 100 +page analysis available to the public until 2 days before the meeting. That’s not enough time to scrutinize the methods. Meanwhile the FDA has been working for months on this with the applicants. It appears the FDA is colluding with companies to push through policy changes and intentionally hampering those who may disagree.

Across the board, the FDA is doing a bad job. Annual boosters for toddlers without clinical trials— approving Alzheimers drugs that don’t work— and lowering the bar for toxic cancer drugs, which will enrich companies and lead to more drug use, but with uncertain effects on overall survival and quality of life.

The FDA lives in a bubble where they only talk to people who lavish praise on them and far more with the industry representatives than the critics of their policy. That’s fine if their goal is to balloon health care spending till our country goes bankrupt, while failing to generate evidence that optimizes survival and quality of life for patients. Sadly, it seems that is their goal.