Well, there was good news and there was bad news.
A few years back, a story in USA Today revealed that a large number of FDA Advisory Committee members had financial ties to the industry. It was, if I recall, a front page story.
The ties of Advisory Committee members amounted to either stock holdings, usually not significant, research they had conducted or gifts to their institutions or even speaker fees. Any of these, or any combination of these along with other factors could be deemed a conflict of interest. For some reason, this seemed like a big revelation, and perhaps to many, it was.
But given the fact that the FDA has to reach out to research scientists to evaluate research, it stands to reason that several of them would be patent holders or hold stock or have conducted research. In fact, you would want them to be experienced researchers if they were to be evaluating the research that was conducted. That is why they are picked to be advisory committee members. You wouldn’t want a research naive scientist doing the job. So what is the surprise?
In an update to that original USA Today story, in a study released this week conducted by Public Citizen, and published in JAMA, it was found that between 2001 and 2004 , despite the fact that a large number of Advisory Committee members had financial interests in pharmaceuticals, only 1% of them were were recused because of a perceived conflict of interest. However, the study further found, had anyone with any financial tie at all been excluded, the recommended actions by the advisory committee would not have been changed.
That should be good news – both for the FDA and for the pharmaceutical industry. Neither can really spare a black eye at this time. It means that the system that is in place, though perhaps not without flaw, works.
Yet remarkably, a great deal of the summation of this report in the media emphasized the fact that the advisory committee members had financial ties to industry, rather than the fact that those ties made no difference in outcomes. That was the bad news.
That could be, in part, because the title of the press release from Public Citizen was
Public Citizen Exposes Frequent Financial Conflicts of Interest at FDA Advisory Committee Meetings
– which is not quite the right story. In fact, the Kaiser Family Foundation summation of this story was:
