Hey, all! Yep, today our story continues. When we left off at the end of Part 5, UC-Davis scientist and stem cell blogger extraordinaire, Paul Knoepfler, was about to take the stand to speak… and here he is. There’s also a teaser at the end for a BIG surprise tomorrow, in Part Seven…
“The FDA’s mission is to assist safety and efficacy and speed innovations,” Paul Knoepfler said in a soft voice. “The issue is getting the two to mix. Believe me, I do realize that a lot of people see this as an issue. But the thing is, no other regulatory body oversees stem cell medications in the U.S. And in the past, various drug mistakes have hurt or killed people. There’s no way around that. Thalidomide is a good example.”
Oh, please, please don’t show any slides of deformed babies, I silently prayed.
Whether it was because he’d read my mind or not, none of those were shown. I knew what had happened in the late 1950’s with thalidomide, a drug originally used as a mild sedative and sleeping pill. It was also given to pregnant women to lessen morning sickness, with tragic, unforgivable results. But what I hadn’t known was that the FDA had not approved the drug in the US, despite considerable business pressures at the time. Thalidomide had been marketed and sold in the rest of the world, starting in Germany. It was one of the most widely prescribed drugs of any kind in that era. If I hadn’t already been listening intently—which I was, of course, because this was Paul Knoepfler—then that was a fact that would have made me sit up and pay attention.