Sorry, I wasn't clear - it sounds like they may have botched the risk profile - the article paints a picture where the real-world incidence/severity of defects is "high".

But, they're selling clicks, and the patients are looking for money/support, so it's hard to know for sure. It certainly seems like there should have been a discussion between MD and patient here (similar to what my friend had with her MDs, albeit different drugs/condition).