Will J&J Do the Right Study?
By this question, I am really asking whether Scios/JandJ truly want to know whether the drug is safe. At this point, I don't consider this an issue for the FDA. Let's ask the CEO, do you want to know? Do you really want to know?
Maybe I should ask this way...
You do want to know with a high degree of confidence that your drug doesn't hurt people, don't you?
If the answer is yes, as it should be, it's simple. Put aside $20-40 million right now, today. Declare to your customers that you want to show everyone that you care, that you want to prove the safety of the drug beyond doubt. It may seem like a lot of money, but even if such a move slows sales by $200 million a year, and it takes two years to find the answer, it still is less than $250 million a year for two years for a company with $40 billion sales per year. That is like you or me spending a few thousand to make sure that people won't be hurt by the drug (i.e., killed).
If the supporters of JandJ are right, this investment will yield incredible increase in sales. The amazing thing is that Scios/JandJ knew about these data raising concerns about safety by 2001. We'd know whether it was safe or not by now if they had done the right thing then.
Talk about this with doctors, patients and anyone else who is interested. Maybe that will convince them to do the study now, and do it quickly, instead of just starting slowly and letting it drag on for 4 or 5 years, getting the answer as the patent expires!
<< Home