Thursday, April 23, 2009

The Secrecy Bucket is Full of Holes

Get Used to It
The following was published in PRWeek:
The FDA has been under fire for years. Approvals are too slow. No, approvals are too fast. Inspections are not rigorous enough and enforcement is too weak. No, FDA is over-reaching. There's too much interaction with industry. No, there's not enough. This push and pull has been played out in Congress, in the industries that FDA regulates (or hopes to regulate), in advocacy organizations and in the news media.

How do we know so much about some of these sharp divisions and controversies? It's because there have been loads of information leaking out of the FDA -- internal disputes, data allegedly ignored and stories of staffers being pressured to make various decisions. To plug the holes, Acting Commissioner Frank Torti sent an internal memo last month reminding staff about the types of information that must remain proprietary. Want to guess what happened next? Yup, the memo was leaked (and criticized by those who believe such a memo inhibits transparency).

Dr. Torti sent a farewell memo the other week to FDA staff which -- no big surprise -- was leaked, too. (He is returning to Wake Forest University to make room for incoming Commissioner Margaret Hamburg.) Despite the roiling atmosphere, he had some interesting perspectives and high praise to share with the agency: "The FDA is now defined by others. You must speak up and take the FDA back. It's yours, not theirs. You do more good day in and day out than most others, inside or outside of government." He added that, "what's written about the FDA is always from the outside, and I wish there was a way we could communicate what we've done, sometimes under very difficult circumstances."

I see three key points. First, the FDA has, indeed, lost control of its message. Regaining its public relations footing is possible but the agency is in a tough spot: dealing with hugely complex issues that can defy the sound bite, being overseen by elected officials eager to score political points, walking a tightrope trying to balance on the safety and efficacy of new drugs and devices, the list goes on. And when they tried to get some PR help late last year, it backfired. They were taken to task for awarding a no-bid contract.

Second, while transparency is crucial (as I have written here in the past) it cannot be used as a blunt instrument. There really are secrets that must be kept, at least for some period of time. Premature release of information can create a panic among patients in the case of drugs and devices, or among the entire public in the case of food. Or, there may be patent issues or patient information that demand confidentiality.

Third, we need to examine just how much secrecy we should expect these days. Our interest in inclusion means more people are exposed to secrets. More people means more mouths. And with people involved in social issues in addition to work, they often feel forced to choose sides. I can remember working for Roche and getting a call from an HIV/AIDS activist asking me to confirm some data that the company had sent down to the FDA just hours earlier.

The push toward more secret sharing is bound to accelerate. We have a generation growing up on Facebook, MySpace and Twitter, and all the other generations are aching to catch up. The amount of personal information people are willing to share is stunning. Clearly, the need to unleash our inner narcissist has overpowered our interest in keeping information private. A secret isn't what it used to be.

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