Inventing a drug that returns blue dying premature babies to life’s pinky colors in just 2 minutes is not enough. What do you do, when neither your own hospital nor your country’s leading pharmaceutical company wants to develop your miracle drug? Dr. Tore Curstedt, co-inventor of drug Curosurf, used to treat 4 million premature babies, tells a remarkable story of perseverance:
– So you already had a drug that worked not only in animals. You have done research over decades, but you show that it dramatically reversed the life and saved the life of premature baby at your hospital, and now you have to produce it and make it available, but you know, the story’s really amazing because both the academia and industry initially turned down the opportunity to make this drug and you know, that already worked. How did it happen that the drug became available?
– Look at this, it’s in that phase. We produced, for the first clinical trials, we produced the drug ourselves. And we got pig lungs. It is produced from pig lung. We got pig lungs from the slaughterhouse in Stockholm, the slaughterhouse in Uppsala. Perhaps every time we took lungs, and we had about 50-100 kilogram of lungs in the hospital laboratory. During five years, we produced about 3,000 – 4,000 vials of surfactant to treat 3,000 – 4,000 preterm babies. It was our maximum. But if you will have a trial, you must produce millions.
– Scaling up the production.
– Scaling up the production. And it was impossible in our hospital laboratory. And for the first clinical trials, we did it, it’s no problem. But then we talked to the Swedish pharmaceutical company, Pharmacia and they said yes and no, and after two years, they said no. The market is too small. It’s no more than 20 million Euros per year. And the marketing cost is perhaps 100 million Euros. They are not interested.
– Even though everyone knew that the drug dramatically saved the life within minutes.
– And at that time, when we talked to Pharmacia, we had made our first clinical trials, and that showed that we had decreased the mortality. Our control groups had 51% death rate and in the treated group, down to 30%.
– Amazing result for the drug in the clinical trials in humans!
– Yes, because if you look at our first clinical trials, it started in 1985, in the beginning of 1985. And then we had already started a network of neonatologists in different parts of Europe. But it was one hospital that was not interested to participate in the clinical trial.
– Even though they knew that the drug worked.
– And the hospital was Karolinska University Hospital. They were not interested.
– So they knew that local scientist invented the drug that worked and–
– Yeah, but they didn’t know so much at that time because it was in the beginning, and we had treated in another hospital, Saint Göran Hospital, nine babies, on a “vital indication” permission, and it worked very well. And not all of these babies survived. Six out of nine survived.
– [Anton] That’s still pretty good–
– They’re very good results, but they said no. But others, in Lund in the south of Sweden, Oslo, Germany, England, Italy, France, the Netherlands, participated in the first clinical trial, but not Stockholm.
– Everybody but the home institution.
– No, no, they were not interested.
– What happened then?
– Then we started it with this other and we produced a surfactant at Karolinska University Hospital in the laboratory and send it to different parts of Europe. And in the first clinical trial we had to treat about 150 babies and 150 controls, and we only had all the most sick premature babies according to permission of our ethical committee. After I treated half, 75, and 75 babies were “control” [untreated], we had an interim analysis, and then we had to stop it because we had reduced the mortality in the treated group so much so it was not ethical not to treat everybody.
– This is very dramatic, so the clinical trial could not continue not because the drug didn’t work, you knew it worked, but because it worked very well.
– Worked very well, too well.
– It was not ethical anymore not to give this medication to the control group.
– You have to give them.
– We had to give it, so we had to give it to the other. And this is the only clinical trial with the control group and the surfactant group. Then it was not ethical for all. All had to be treated. And then we start with other types to not only give it once, to give it twice, and give it three times, and the prophylaxis, and so we made clinical trials. But it was impossible to scale up in our hospital laboratory. We had to have the company. Pharmacia [company] was not interested.
– Still not interested?
– No, no. It was not interested.
– The companies should be banging on your door.
– Yeah, but it’s such a small product, and they said, “In Sweden, how many?” Perhaps 300, 500 in Sweden. But you have the whole Europe. You have the US and many others. And then we came in contact with Chiesi Farmaceutici in Parma , private-owned small company at that time, and they were interested.
– [Anton] They had incentives to move fast and become bigger.
– Yes, and because it’s fast and I think it’s it was good, nowadays, I think it was good that we had Chiesi instead of Pharmacia. It’s better to make a bigger product in a small company, than a marginal product in a big company.
– They took the product and they managed to scale up the production, so it became available and you probably led that process as well.
– Yes, yes, we have been there many times and now that they can do it there because you see, in five years, we produced 3,000 – 4,000 vials.
– And saved 3,000 – 4000 babies.
– Yes, part of it. Some of them have survived, anyway. We have treated today nearly four million preterm babies. And for us to make three, four million vials in a hospital, it would have taken us a thousand years. It had been totally impossible.