The View From Inside - Pharmaceutical Executive


The View From Inside
Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine

Pharmaceutical Executive

So it's more strategic, it's more targeted; it's expanding our impact by finding ways to partner and not simply doing it all ourselves, and really modernizing our communications tools. Now ultimately, at the end of the day, will that perhaps make it less necessary to have other forms of direct-to-consumer advertising? I can't speak to that. I only want us to be the source of expert opinion or information for the public that we serve and for them to see the FDA as their champion in protecting and promoting their health.

The system you describe depends on the idea that patients and doctors are going to talk about risk and about what's appropriate. But there's reason to fear that that kind of discussion is not taking place as often as it should.

There seems to be a problem perhaps in the way in which patients judge risk versus benefit. They say, "Risk is something I might have later. The benefit is, I've got the problem right now, the pain right now, and I want relief right now." It doesn't necessarily follow that the FDA should therefore be more stringent with regard to its approvals and not allow certain drugs to go out into the market. What should follow is that we have to view this as a systems problem that needs a systems approach. Yes, FDA has to be much more precise, much more effective at communicating the knowledge upon which those conversations should occur. We have been able to define with as much precision and as much accuracy as is possible the actual facts and the actual data.

FDA is not providing direct patient care. FDA is making decisions about the things that are going to be used in that direct patient care. Medical professionals have a responsibility to find more effective ways to take that data and that information and integrate it into patient care.

Patients have a responsibility in that too. And I think the tools are evolving where patients are much better informed than they were before. They're not passive recipients to the extent that they were when I started my career in medicine, when they were totally dependent upon what I told them or didn't tell them about their disease. Toward the end of my career at MD Anderson, invariably every patient who came in had a stack of papers that they'd gotten off the Internet, from Web sites like WebMD. It was more like a quiz than it was an informational process, because they already knew about radical prostatectomy and radiation therapy and hormone therapy. It was a matter of saying "What's right for me?" or "Doctor, what should I do?"

We've heard it argued, most recently by law professor Richard Epstein, that the fair-balance approach tends to overstress the negatives—that when you're trying to motivate the patient to go to the doctor, it may not be the moment to mention every single drug side effect. Do you think there's merit to that argument?

I honestly don't know. I don't know that we really do have an in-depth scientific understanding of risk/benefit communication at this point, and I think that that's an important issue that we're going to have to address from an academic as well as a practical perspective. Certainly, it's an issue that is important to FDA. I think we need science here to guide us just as much as we need science to guide us in coming up with the next EGFR receptor inhibitor. We need to make sure that the communications are guiding people to wiser and better choices and care.

Would it be helpful if newly approved drugs had no advertising for, say, the first two years?

This discussion ranges all the way from the perspective of First Amendment rights to the positive impact on public health by virtue of having disease information presented in a medium patients are paying attention to, like television. Within all of that, we're seeing the increasing emergence of advocacy groups, specifically with regard to the fields that I'm experienced with—like cancer—where they know about these drugs before they're ever approved by FDA or on the market. So it isn't as if a moratorium is going to somehow keep things a secret. I don't think that's realistic.


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