Researchers propose real time analysis of drug safety data


Ferreting out safety problems with prescription drugs sooner–such as those that plagued the popular pain medication Vioxx–could be possible if the government adopted a new system that would pool data from clinical trials for widely prescribed drugs, according to a group of researchers publishing in Archives of Internal Medicine.

Reports the New York Times: “Such a database could be continually updated and aggregated with new information, as the results of new studies were published, to calculate a near real-time balance sheet of a drug’s risks and benefits.” While drug makers and researchers already conduct meta-analyses on aggregated clinical trial results, the new system proposes that the pool of information be continuously updated.

But such a new system would require an act of Congress, which would need to grant new powers to the U.S. Federal Drug Administration (FDA) to implement it. As we reported in our multi-media investigation on clinical trials, Heart of the Matter, the pharmaceutical industry is a powerhouse on Capitol Hill, employing hundreds of lobbyists with close ties to key lawmakers and spending millions in campaign contributions. It’s not known at this point how the drug industry would respond to such a proposal.

[crossposted from Real Time Investigations.]