The Unexpected Adverse Event of Ketek – A Headache for the FDA

J0178792 Last night, ABC News carried a segment devoted to the swirling controversy around Ketek, the antibiotic manufactured by Sanofi-Aventis.  The news hook was a march down from Capitol Hill to the steps of Health and Human Services by Senator Charles Grassley, who apparently got only little further than the steps before being turned away by the agency in a classic move to garner publicity. 

The coverage was fairly damning and exemplary of two things – the FDA’s continued inability to respond with a communications strategy in the face of a crisis and the intrinsic link between the image of the agency and the image of the pharmaceutical industry itself.  That is perhaps best summed up by Senator Grassley’s comment that the FDA and industry are "too chummy."

The charges were serious.  The segment portrayed the Grassley point of view.  Then a nurse was interviewed who stated that at the clinical trial site at which she worked engaged in the falsification of data.  There was a mug shot of the presiding physician in jail.  There was commentary stating that the FDA discovered the faulty data a month before approval.  Following this highly damaging story, there was no comment from the FDA.  There was only a conclusion relayed by the investigative reporter who stated that the FDA was not planning any action against the drug, except to perhaps put a stronger warning on the label.  That did not answer any of the charges. 

The implications of the fact that the agency has not gotten its side into the story are important for the story and more important as public confidence in the FDA slips as evidenced by recent public opinion polls

  • First, the more the FDA stands still while crisis after crisis swallow them up, the worse not only the agency looks, but the industry as well.  Industry has a profound stake in the FDA taking its head out of the sand. 
  • Secondly, the characterization that the industry is "too chummy" with the agency can and frankly does from my experience, chill the important communication that needs to occur between the two entities in order to maintain a balanced approach to risk and benefit, and even to the approval of new medications. 
  • Fourth, the morale at the agency is probably declining, which could result in an exodus of valuable employees at the same time making it hard to recruit new, smart people. 
  • Lastly, there can be a chilling effect on the all important and very vulnerable willingness of patients to participate in clinical trials.  All of these are profound by themselves, together they have a potential to impede medical progress. 

The result is the same as has been often stated here.  The FDA needs to get its act together from a communications perspective.  By not getting across their side of the story, there is only one story being shaped.  Rather than attempting to lift the agency with lame and vague speeches before safe audiences that speak of broad goals of cooperation and scientific advancement, they need to come down into the dirt and talk specifics.  Rather than promote the Critical Path Initiative using jargon that does not inspire, they need to formulate a crisis communications plan that is on-going and a plan of action for dealing with emerging issues.  So far, for an evidence based body, there is no evidence that they are getting that message.  With all that is at stake, industry should spur them on to getting the job done. 

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One Response to The Unexpected Adverse Event of Ketek – A Headache for the FDA

  1. Sue says:

    I inherited an immune deficiency problem, from my mother. I have taken Ketek many times, with no adverse effects. I think is is a wonderful product!