With the recent story of Vioxx — and its potentially troublesome adverse effects possibly being known to its pharma company before initial launch — hitting the wires yesterday, there is renewed concern of the process by which study results, both public and non-published, be made available for public vetting.

Merck, the pharma company behind Vioxx, has stated that – from study results it commissioned at the time — that its decision to release the drug was based upon sound trial data obtained from carefully analyzed and interpreted information from pooled meta-analyses. Of course, it is now known that these security measures did little to prevent the deaths directly attributed to Vioxx — a problem the FDA has since countered by setting up its own internal resources for analyzing data from meta-analyses.

But, it doesn’t appear to be enough. Some members of Congress are mulling ways of providing drug data transparency, via the FDA, directly to consumers and healthcare providers once a new drug hits the marketplace. Sounds good in theory, but the costs to institute such primary evaluation points for every single new drug application would probably be prohibitive at the very least. | LINK

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