Rebuilding surveillance to be better, stronger, faster

You've probably already seen the headlines: A new study posits that the cardiovascular risks of Merck's long-withdrawn Vioxx drug could have been identified by 2001 if trial data were pooled, regularly updated, and made available for independent analysis via an almost-real-time public database. Almost as soon as the Archives of Internal Medicine study hit, Merck released a statement saying that it's false; its own analysis of pooled data didn't identify the problems until 2004.

But as we see it, the point of the new study isn't a Vioxx post-mortem. It's not about the past at all. It's about the future of drug-safety surveillance.

The study authors propose a massive data-collection effort. Instead of waiting for drugmakers, doctors and patients to report adverse events, regulators should be proactive, gathering and analyzing data as it becomes available. Best case, all published and unpublished studies would be aggregated to help those analyzing the data get the fullest picture possible. "The current system ... isn't fast enough," lead author Joseph Ross told the Wall Street Journal. "We can do it better, and this is the way to do it if all the data is made available."

CDER Director Janet Woodcock told the New York Times that Congress would have to mandate the kind of data-collection and analysis Ross and his colleagues advise. She also pointed out that FDA has taken some significant steps toward better post-market safety monitoring, including its own meta-analyses of safety data.

The Archives paper itself notes that new FDA rules require drugmakers to disclose the results of post-marketing safety studies. Indeed, that's part of the point of the study: "Substantial amounts of clinical trial data that have rarely been fully used to understand drug efficacy or safety will now be available and can be used by independent investigators to complement and corroborate surveillance done by the FDA and the manufacturers," the paper states.

- get the Merck release
- see the WSJ story
- read the article in the New York Times