Pharm Exec Q&A: Inside View - Pharmaceutical Executive


Pharm Exec Q&A: Inside View

Pharmaceutical Executive

If you look at academia or other models of scientific inquiry, disagreement is a normal part of the process and it needs to be encouraged, not discouraged. It doesn't mean that the scientist is going to get his way every single time. And I don't think that's what they expect either, but they do want to feel heard, and that's incredibly important to scientific discourse.

At what point do you draw the line between someone who is just complaining about the company and someone who's an actual whistle blower?

We have no evidence that the people in our survey are just complainers. In fact, the evidence that we have from the essays, from the caliber and the length of service, and the kinds of people that responded to this survey, all says to us these are serious scientists.

When you speak with these people on the phone, they're not grumping about their work place, they're not grumping about their bosses, those kinds of things. The first thing they say is, "I am so worried about the American people. I can't speak out within FDA because if I do, I'll have to leave, and if I leave, someone who doesn't understand the system as well as I do will come in and they won't be able to work these things through in the way that I am able to because of my experience and tenure here."

Some of these people wrote three and four pages of essays. If somebody was embittered, it would come out. And it's just not there.

People are clearly worried that scientists are being pressured to change or conceal results. Does the survey show that scientists share those fears?

Look at the question that asked them whether they agreed with the statement, "I respect the integrity and professionalism of FDA leadership," the questions about whether leaders and managers stand behind scientific staff who put forth scientifically defensible opinions that may be politically controversial. I think those tell us that FDA scientists are worried about big-picture issues and that they are concerned in particular about things that may be politically controversial or issues where there's commercial pressure.

How deeply does the survey go into that commercial pressure on scientists?

The thing we didn't have the chance to get into in depth but that's obviously a part of all of these conversations is the Prescription Drug User Fee Act (PDUFA), which comes up for reauthorization this fall. I hope the survey creates an opportunity for there to be vigorous debate about the impacts of those deadlines on the scientific work being done.

It may not be that every supervisor is worried about PDUFA deadlines and putting pressure on the scientists to make inappropriate decisions. It's rather that if that happens often enough, the perception is out there and gets a life of its own.

Many of the people who wrote essays said that, given the constraints of PDUFA, they found it hard to adequately pose questions and have the time for vigorous internal debate. They also said that because the people above them were being judged based on PDUFA productivity, they weren't creating the climate where those scientific debates could happen.

And those debates are important. You know, it just has to come out and they have to have the time to really spend looking at what industry is submitting.

When you look at the survey as a whole, what overriding concerns come through?

I think there are a couple of messages. One, I have big concerns about advisory committees and the way those are being run. That came out in the essays over and over again—the ideas of openness and conflict of interest and so on. We have big concerns about the integrity and professionalism of FDA leadership. We have big concerns about scientific candor. We know that Congress has a number of different pieces of legislation before it and we hope the voices of scientists can be a vital part of that debate. That's what's important to us.


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