In recent weeks, two communications to-dos at federal agencies illustrate the good, the bad, and the ugly when government tries to talk to its people about less-than-ideal stuff.
The good: The formation of an FDA risk communications panel by recommendation of the Institute of Medicine and provision of the FDA Amendments Act of 2007.
The bad (and ugly): A fake press conference held by the Federal Emergency Management Association during the California wildfires to promote the fact that it’s handling of the fires was not at all the botched job it became famous for in the aftermath of Hurricane Katrina.
But the FEMA news briefing — to which reporters were invited only 15 minutes in advance and then allowed only to listen to questions asked by what turned out to be FEMA staff — was evidence of the contrary, and just one more foible for the much-maligned agency, which found itself right back in the public stockades.
Unlike the fake news conference, the risk communications panel seems an earnest effort by the Food and Drug Administration to better inform the public of drug safety risks in a post-Vioxx world, where more drugs are coming from more sources than ever before and risks associated with widely-prescribed drugs are being discovered too late in the game.
William Vaughan, a committee appointee and senior policy analyst at Consumers Union, said that the advisory committee, which is scheduled to meet first in 2008, has a full plate.
“Between the new law’s requirements for how to convey adverse events in clinical trials, and the ‘study’ of how to add 1-800 number information to DTC ads (due in March 2008), I think the first year will be busy,” said Vaughan by email.
Self-declared fake news (a la The Daily Show and Colbert Report) has its place, but fake news-making paraded as real inquiry and open forum does not. Risk communication, on the other hand, is a crucial component of a good public health program. We’re all for it.
But recent reports – that the FDA reviews a small percentage of imported drugs, that it’s oversight of clinical trials is in shambles, and that post-market surveillance is hardly systematic — leave one wondering if the FDA knows enough about the risks it’s encountering to communicate them effectively.
Regardless, both announcements — one promising, one farcical — point to a serious effort to get the sound bytes right. The prickly side of public relations — how the government talks to the people its charged with protecting about things it can’t necessarily protect them from — has taken on great importance in the Information Age and seemed recently to sometimes supersede the securing of the protections themselves.
One hopes that the advisory committee can develop ways to do both – effectively communicate food and drug risks to the public as the agency builds better safeguards and systems of surveillance and regulation. But one note of caution: Section 917 of the FDA Amendments Act, which outlines the purview of the risk communications advisory committee, calls on it to “partner with professional medical societies, medical schools, academic medical centers, and other stakeholders to develop robust and multi-faceted systems for communications to health care providers about emerging postmarket risks.”
And this could turn out good: those listed stakeholders have the potential to be valuable contributors to a better communication of drug and food risks.
Or it could be bad and ugly, since recent reports have shown many of those institutions to be rife with corporate dollars — especially dollars that come from drug and device makers.
By explicitly involving academic medical centers and medical specialty societies in this communication process about drugs that pose risks, the FDA should also be explicit about requiring full disclosure of the conflicts of interest those contributors bring to the table, or better yet, do its homework and only consult med schools and societies that have strong conflicts-of-interest guidelines in place.
As for “other stakeholders,” one can only wonder whether that’s a euphemism for industry.