Notes from BIO: A "Fire Drill" on Flu

When it comes to the "swine flu" outbreak (forgive the non-PC term), its hard not to look on the dark side. Either we are facing a catastrophic outbreak we are unprepared to prevent, or we have succumbed to yet another media-stoked panic that makes us all feel silly.

Clearly the zeitgeist has tilted heavily towards the latter view, and surely we can all agree that is the better of those two choices.

Still, we were pleased when Vertex' outgoing CEO Josh Boger offered a third way of thinking about the current outbreak during a BIO "Super Session" May 20: this is a "fire drill"--testing our pandemic preparedness rather than our evacuation procedures--and like any fire drill it is only effective if everyone takes it seriously. So, if, as we all hope, this flu outbreak proves mild and manageable, we can still feel good about taking it so seriously.

Only time will tell if this outbreak is or is not the hamageddon it sounded like a month ago, but we at least were heartened that others on the panel (including FDA's point person on the flu, Jesse Goodman) adopted the "fire drill" metaphor as well. We feel better already.

FDA's Swine Flu Czar

The Obama Administration's first decision about the leadership at FDA is paying an immediate and unexpected dividend: just over a month ago, Jesse Goodman moved up from head of the Center for Biologics Evaluation & Research to serve as the agency's acting chief medical officer.

For most in the biopharma industry, Jesse Goodman was not the obvious choice to take a senior leadership role in the Food & Drug Administration. With the exception of vaccine manufacturers, Goodman is far less known in industry than his counterpart at the center for drugs, Janet Woodcock.

But he was the logical pick for the incoming Obama Administration when it wanted an experienced hand in place in the commissioner's office, thanks to a background long on public health experience, strong academic and scientific credentials--and some good connections with the transition team. (You can read our coverage of his elevation here).

It turns out to have been a pretty darn good choice. No one knew it at the time, but a new flu virus was starting to spread in Mexico, and (as we wrote here) the agency's response to the swine flu is likely to define the perception of its new leadership.

For now, it falls to acting commissioner Josh Sharfstein to serve as the public face of FDA in responding to the threat, while commissioner nominee Margaret Hamburg starts on the confirmation process (with a Senate hearing scheduled for May 7). Sharfstein has applied what already looks like his trademark response: taking an all-hands-on-deck approach involving no fewer than seven different response teams. (Read more here).

And who did Sharfstein pick to coordinate the response? Jesse Goodman.

Talk about a no-brainer. Goodman, in addition to overseeing FDA's regulation of flu vaccine as head of CBER over the past decade, has extensive experience in government and acadmia in antimicrobial resistance and biodefense preparedness.

How perfect is Goodman for the job? Consider his presentation to the annual Food & Drug Law Institute meeting in Washington April 22--just days before US public health authorities first learned of the emerging threat. Goodman addressed a standing room only crowd eager to get a read on the direction of FDA under the new Administration.

We'll print a transcript of Goodman's address in an upcoming issue of The RPM Report, but for now we'll just note that, between a discussion of the right way to think about "safety" in the context of medical products, and a concluding discussion of FDA's role in health systems change, Goodman spent a few minutes talking about global health.

Here's what he said:

"Globalization in public health is, to me, another big threat and challenge. There's humanitarian needs and values. Disease threats are global.; they know no boundaries. We have malaria mosquito vectors in this country. There's drug-resistant malaria all over Southeast Asia. This is a global economic and a national security issue as well as a humanitarian issue.

"For example, look at the chaos that was brought on when one person flew around the country with their extremely drug-resistant TB. Look at SARS. SARS was definitely a bullet that was dodged. So we need to pay attention to these things."

Its safe to say that global health threats was not the main subject the FDLI audience was paying attention to. But 10 days later, its reassuring to know that Goodman was.