An article in this weekend’s NY Times, “New Drugs Stir Debate on Rules of Clinical Trials,” brings up issues of the current system of clinical drug trials in the US required for FDA approval before hitting the market. This article looks at PLX4032, a new drug used to shrink melanoma tumors and help improve quality of life, though maybe without extending life expectancy. Two cousins are at the center of this article, both with melanoma, both in the clinical trial, though one was given the new drug and one was put in the control group, meaning he received standard chemotherapy treatments. The one in the group with the new drug improved and the one that received the control died.
This issue brings to the fore what many doctors in the article say is a dated drug approval system. There are three phases a drug must pass before FDA approval, each phase with a different set of rules and criteria.
Recently, a new drug for lupus treatment, Benlysta, passed through Phase III, but I still haven’t seen it on the market – supposedly it will be available by the end of the year and will be the “first new approved drug for people living with lupus in more than 50 years” – Benlysta website. 50 years is an extremely long time for those living with this chronic to wait, while in the meantime being treated by drugs originally made as antimalarials – the connection between the antimalarials and positive reaction in lupus patients still being unknown. Is this system working? Or is it not?