QDIS Blog

Politicization of FDA Decisions?!

by Ed Vawter @ 11:48 am. Filed under FDA

I continue to be concerned about some of the reports coming out about the FDA. The following article is one of the recent ones.

Some FDA scientists claim interference | Top News | Reuters.com:

One thing I would point out is people who feel they have a gripe or have been ignored are much more likely to respond to these sorts of surveys (995 out of 6,000 responded but that is a good return rate). Also, the percentage of scientists saying they felt pressured to change decisions was down 5% (from 20% in a Dept. of Health and Human Services inspector general in 2002). Still, even if the number is only 5% accounting for bias, it is too high in my opinion.

Here is a quote from the FDA spokesperson:
FDA spokeswoman Susan Bro called the survey a “counter-productive exercise based on leading questions and innuendo.”

It would have been much more productive if she could have given examples of the questions that were used in order to allow the reader to see for themselves if the questions were indeed leading.

I do know that the way questions are worded can have a great impact on the results. This means one has to taken into account whomever is running the study. In this case, the study was co-sponsored by Public Employees for Environmental Responsibility. They are more typically involved in environmental issues so it is interesting to note their interest in this area.

The Union for Concerned Scientists (UCS also has been critical of the FDA of late. While not mentioned on the PEER site or in the Reuters article, the UCS website states they were the co-sponsors along with PEER. The actual survey is on the Union of Concerned Scientists website. Click on the link entitled “FDA survey: Questions and findings (pdf)”. They have unfortunately made it very difficult to link directly to the survey itself.

Here is the first two question and I leave it to you to decide if it is leading.

MISSION
1. FDA has sufficient resources to effectively perform its mission of “protecting the public health and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” [Excerpt from full FDA mission statement]
strongly agree agree no opinion disagree strongly disagree

2. The Center/Office of the Commissioner/Office of Regulatory Affairs where I work has the resources it needs to meet its role in fulfilling the mission of FDA.
strongly agree agree no opinion disagree strongly disagree

I do think though that some of this has to do with a lot of media attention and the fact that it is a midterms election year. Everyone seems to be making the FDA their favorite whipping boy. But, I also fault the FDA themselves for not doing more to deflect the criticism. They seem reactive and defensive instead of proactive in this regard.

Here also is the 2002 Dept. of Health and Human Services inspector general survey in pdf format. And here is the report.

I know it is almost impossible to get a group of scientists to agree on all aspects of a given research project. However, it is also important to acknowledge and forthrightly deal with those who have legitimate concerns. Sometimes, if a dissenter feels there views have been acknowledged and weighed in the decision making process, even though they might not agree with the outcome, they will support it. However, being dismissive and ignoring others concerns is a sure fire recipe for trouble.

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