MossPiglet said...
I also read a post a week ago in a FINANCIAL publication saying "how much money it was going to make for the company" and that there was a "big market" for it. That's the primary reason it's being approved......who cares if it helps (or harms) any patients, the goal is to make money. Sorry if I sound cynical here. What if they made drugs that actually CURED people instead of managing their symptoms???
The same thing unfolded with tysabri (biologic for MS), but the adverse trial data on PML (induced by the JC virus) was shoved aside. It was fast tracked for approval, even despite the dubious trial data and adverse effect profile. It ended up being recalled, and then approved again, which is the part I don't understand. Some MS patients who took the drug paid the price with a "rare" brain infection, along with many others who were severely immunocompromised.
As for vedolizumab, it will be pushed hard because the patents on humira and remicade are expiring in a few years. I suspect the developments will be similar to tysabri, in that a percentage of patients will develop adverse reactions to it. There is a possibility of it getting recalled in the future.
There are so many confounding variables in the studies, it's hard to ascertain why some achieved a clinical response. For starters, takeda was quoted as saying that combo therapy is more effective than monotherapy, as many patients were on other immunosupressive drugs during the time frames. It's very likely that the people who "respond" to the drug will need additional medication to control their symptoms.
The bottom line is takeda poured way too much dough into this to not get it approved, even if it comes at the expense of people's lives. I echo the sentiments of the researchers who want additional testing done on the drug before it percolates to the general population. It's such a disgrace that these companies can clown around like this and not suffer any consequences.