A new study published in Archives of Internal Medicine offers an ambitious proposal to determine a drug’s risks sooner than they might otherwise become evident.
The authors propose a system to examine widely prescribed drugs through safety analyses that would pool data as they emerge from various clinical trials of a medication and aggregate the information for a fuller picture of a drug’s harms and benefits.
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.
Drug makers and researchers regularly conduct studies called meta-analyses in which they aggregate results from some previous studies of a drug, using the combined information to summarize the benefits and risks of a treatment.
But the new study proposes a continuously updated model. Using data from Vioxx -- the painkiller taken off the market in 2004 for increased heart attack and stroke risks -- as their example, the researchers reported that Merck, the drug’s maker, could have known about the increased cardiovascular risk several years earlier if the company had used the methodology.