Is The FDA Press Office Squelching The Media?
February 17, 2011 Ed Silverman // February 16th, 2011 // 9:25 am
The workings of the media may not always be clear, but one long-standing practice - especially among medical journals - is to apply an embargo on information before publication. Lately, however, this has become controversial as a growing number of journals and institutions are adding various requirements, notably barring journalists from seeking expert comment prior to the moment an embargo is lifted.
The issue has gained considerable traction thanks, in part, to coverage provided by a relatively new blog called Embargo Watch. And the discussion picked up steam recently when the FDA adopted the same approach as new policies for approving medical devices were announced. And so the Association of Health Care Journalists has written the agency for clarification.
“The restriction imposed on the medical-device announcement rewrote a longstanding compact between reporters and various public and scientific organizations. It also hampered or delayed reporters’ ability to fully inform the public about what the FDA is doing with taxpayers’ money. The early reports on the medical device approval process were brief and uninformative as a result,” wrote Charles Ornstein and Felice Freyer of the AHCJ (full disclosure: we are a long-standing member).
“Embargoes are a system based on mutual trust. The group wishing to release information chooses the time and date that it will be made public, and reporters get an advance look as long as they agree to delay publication or broadcast until the embargo lifts. Reporters are willing to do this because the embargo allows them time to prepare more complete and meaningful stories. An essential part of that preparation is contacting others who can evaluate the new information,” they continue (read the letter).
The new process, however, threatens to turn journalists into stenographers, according to Embargo Watch scribe Ivan Oransky. “These policies simply aren’t consistent with the free flow of information, nor with transparency. And if they’re a government agency, or promoting publicly funded research, I think there are First Amendment questions,” he recently wrote.
Indeed, shortly after President Barack Obama took office, the White House issued a memo that implored government agencies to raise the bar on transparency and openness (you can read the memo here). There is, however, some turmoil at the FDA press office these days. Recently, Beth Martino, the FDA associate commish for external affairs, a 31-year-old former Kansas aide to HHS secretary Kathleen Sebelius, purged a few senior specialists who are 50 and older (back story), suggesting a new way of conducting business has taken hold of the press office. We have sought comment from the FDA, but have not heard back.
Media complaints about being shut out or hampered are nothing new. But the larger issue speaks to the general public - and that is the extent to which information can be vetted and conveyed with context and meaning. After all, drug and device makers, researchers, policymakers, physicians and patients, among many others, have a stake in receiving accurate and useful info that emanates from a new study, survey or policy. If the media is to get it right - and there are always complaints about this - then removing prohibitions from delving into a topic should make sense. What do you think?