One day after my post on belimumab, the FDA announced it would be taking 3 more months to announce its decision on whether to approve it. A news report cites that the agency wants more time to review the clinical data. How does this shift the outcome for Benlysta? It is uncertain. The regulators could be worried about the drug and looking for more data to confirm this. For instance, in the FDA’s briefing to its mid-November advisory panel, it raised concerns about Human Genome Sciences’ methods and suggested that some patients may have been unfairly removed from the calculations of the drug’s benefits. If you were to include them, the claimed benefit on the drug may actually be less.
On the flip side, the agency may be looking for a silver lining in the data. Since the drug worked well for some populations (ie those with mild disease), they may be looking more closely to confirm this result. Possibly the agency will indeed approve the drug for limited use, as I speculated in my post. Some additional speculation can be found here from Brian Orelli at the Motley Fool.
I thought it also worth highlighting a few interesting thoughts about the value of clinical evidence and how for various reasons, initial findings of benefit can change over time. I was particularly inspired by Jonah Lehrer’s comments in the latest edition of the New Yorker. This is not to say that I am a skeptic of scientific thinking; in fact the opposite is true, generally. Rather it is just to point out the complexity and difficulty inherent in trying to prove whether a therapy actually works. So in the interest of time I am just linking to a few interesting articles below.
- Jonah Lehrer on the difficulty of proving anything, especially with the “decline effect” phenomenon: http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer
- Lehrer’s blog post adding color to the article and an excerpt: http://www.wired.com/wiredscience/2010/12/the-mysterious-decline-effect/
- Interestingly Lehrer doesn’t comment much on research about the trend of rising in placebo effect in some drug trials and whether this is a thread of the larger phenomenon Lehrer describes, or something different altogether. Here is Steve Silberman’s article on the topic: http://www.wired.com/medtech/drugs/magazine/17-09/ff_placebo_effect?currentPage=all
- Ioannidis on why most research published is false: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.0020124
J. Andrew McKee, M.D. 