Thank you so much.

Thank you for having me and thanks for coming to this webinar.

I'm going to talk about some dubious FDA drug approvals and maybe a little bit about real-world evidence at the end.

And so it's true, I work here at UCSF. I'm a practicing hemank doc.

I attend two days a week and I do about three months of service and I'm going to be rounding very soon in the VA right after this.

All right. So in this talk, I hope to cover a few themes and I'm happy to take questions at any time or at the end as you prefer.

I'm going to talk about the control arm that's increasingly

used in studies for drug approval and what happens if the control arm is not what we would

otherwise do in our practice. We're going to talk about endpoints used for drug approval.

We're going to talk about dropout or censoring, which is an increasing problem in some

studies submitted to the FDA,

and we'll talk about real world evidence.

I thought I'd kick this off with a couple stories, so these are two stories, but they're

emblematic of, I think, broader problems, as I hope to show you.

I remember the day, July 25th, 2019, and I opened the New England Journal of Medicine, and I saw this paper

called Maintenance Olaparib for germline bracham mutated metastatic pancreas cancer. That's a lot there.

But I remember, of course, germline bracham mutations. That's what people like Angelina Jolie suffer from.

Of course, they can cause breast cancer, prostate cancer, but they can also cause pancreas cancer, very rarely. And there are people with brachia mutations in the germ line

that have pancreas cancer. They typically get it a little bit earlier than the average

pancreas cancer patients, and they are treated more aggressively, typically. And here I'm

reading about maintenance olaparib. Maintenance, I don't even know what that means in pancreas cancer because we are always treating these patients, unfortunately.

They pass away so quickly.

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