Congress wants to know about clinical trial results

Dec/12/2007 06:02 Filed in: Regulatory Environment
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According to today's NY Times a Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug. On Tuesday, the House Committee on Energy and Commerce demanded more information about delays in the trial, which was completed in April 2006 but whose results have not yet been released. This is another thorn on the side of big pharma and Merck and Schering-Plough are now going to have to work harder than ever to convince people that the data supports the use of Zetia.



When will big pharma learn? Perception is everything. When you withhold data from a crucial clinical trial and then state that you will only be releasing "partial data" what are HCP's expected to think? Is this the way to earn their trust ? So now the issue has snowballed and Congress wants to get involved in an area in which they have no expertise. Here's the data Congressman, feel free to dig into it. Like they would understand the data or how to interrupt it !


This is what happens when a company trip, stumbles and falls over itself. I am sure that one of the primary reasons that the data has not been releases is that there are way too many meetings to determine "how to read the data and what to release". This is transparency through a brick but it is sending a message loud and clear to physicians: don't trust pharma when it comes to releasing ALL the data. Once again pharma enters the mine field with no map to show the way out.
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