Susan Desmond-Hellmann
speaker
362 appearances
1 recordings
1 series
first heard Apr 2025
last heard Apr 2025
Susan Desmond-Hellmann’s voice in public audio — every appearance, attributed to the second.
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make big medicines, proteins, antibodies, medicines that would almost certainly have to be injected rather than swallowed because they're large and they're proteins, so you break them down if you swallow them. But their initial goals were focused on insulin, which they outlicensed to Lilly and Pfizer, and growth hormone, human growth hormone.
So before Genentech, when you were a parent and your child was short, you needed to give that child growth hormone that came from cadavers. And that had a risk of this slow virus disease, and that was not a good tradeoff for parents. So the concept of having recombinant, of having human-like growth hormone was a really wonderful thing. So Genentech's first drug was human growth hormone.
And it was a tour de force. It was really amazing that in the late 70s, they were able to do this fermentation and purification because they had to prove to FDA it was pure human growth hormone with no contaminants. And it became famous for that. And people were excited and thought this was cool.
So what you see if you go to Genentech or a company like Genentech is you see these tanks and the tanks are like a cell ICU, like an ICU for a cell. So the cell, what you're doing is you're teaching the cell to make at very high amounts growth hormone, way higher than your cells or my cells would. And then you're teaching the cell through this genetic engineering to secrete it.
into a medium, into this soup that is really a lot of growth hormone. And then you're taking away the cells after they secrete it. You're purifying that growth hormone and you put it in little vials. And that's the process of biotechnology. And you can trick a cell into making almost anything you want, not completely, but almost anything you want, and make it very much like human, which is neat.
So you don't have to go to a human to donate you growth hormone because it would be too small. Or in the case of insulin, I mean, they were using insulin from pigs and... Porcine insulin that made allergies inexpensive. So human insulin really changed how you thought about treating people who have diabetes.
So Genentech made growth hormone and Genentech sold growth hormone and set up something I actually think is a really neat thing that Genentech did, which people said, how do you know that by giving kids extra growth hormone, it won't cause leukemia or a fourth arm to sprout out or so, you know, weird things to happen. And Genentech said, well, we'll follow every child.
So they set up a patient registry, one of the first patient registries ever, and followed every child until they reached their final adult height. And the physicians and their staff entered this into a computer. And so this is an amazing amount of information. So if the FDA ever asked us, do you have this with growth hormone? Did you have that with growth hormone?
We had not an example, you wouldn't even do statistics on it. Every child ever treated with Genentech's growth hormone.
Oh, hundreds of kids, thousands of kids by now. Yeah, yeah. So Genentech got really good at that. And in fact, when I went to Genentech in 1995, the chief medical officer of Genentech was a pediatric endocrinologist, an expert on short stature and growth hormone. But it's a pretty small market. This is uncommon.
Yeah, and the FDA was not happy about that and pushed really hard on Genentech to control that use.
People were using it in HIV. They were using it in sports, anything where you wanted to have more muscle mass. That's exactly right. Genentech had done some studies to look at whether that was a good idea, and none of the studies came out successful.
the benefits did not outweigh risks of having increased blood sugar and some other things that would happen. So one of the aspects of Genentech that happened in the early years before I was there is they learned how to make enzymes, same genetic technology, telling the cell, make these enzymes. And some of the enzymes actually got out-licensed
to make commercial enzymes like that you use when you wash clothes and things like that. So that wasn't core to Genentech. But they had an enzyme activase, a TPA, tissue plasminogen activator, that could break down blood clots.
It was intentional. They had a really great, there's a clinician researcher, Dave Stump, who is a clotting expert. He's he-monk on the heme side. He was there and really pushed them to do this. And the concept was that if you could break down the blood clot, you could cure the heart attack. you could save lives.
And the interesting thing, if you are interested in doing trials, is they started the concept of a large, simple trial. This was early on, and people in cardiovascular, Gene Brunwald and his followers had started these large, simple trials. So Genentech kind of bet the farm on this TPA. And the farm was that they could change the outcomes in 30 days.
There'd be more people alive than dead if they were treated with Activase. And two of the people involved in the studies, you probably know their names, were Rob Califf and Eric Topol.
I think he was at the Cleveland Clinic. And they ran a group called the Timmy Group and they did all these studies named Timmy. And so they did this big trial and it worked. If you treated with Activase, you could break down the blood clots. So Genentech started this franchise in cardiovascular and, again, did this really interesting patient registry to look at 30-day outcomes for post-marketing.
But stints came along. And so the franchise of Genentech and people who were treated with TPA really went down. And the stroke indication was tricky.
And so the stroke indication on paper was really cool, but pragmatically was really tough for hospitals to execute. Genentech also made another enzyme-like molecule, DNase, pulmozyme, for cystic fibrosis. And that was approved very tiny. It decreases how thick your secretions are. But with Vertex's CF drugs, it's also been scooped. So when I came in 95, Genetic was really struggling.
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