Follow-Up Studies Aren’t Getting Done
1 CommentBy Ed Silverman // February 1st, 2007 // 4:40 pm
Some new data just showed up in the Federal Register showing drugmakers aren’t getting any better at following through on their post-marketing commitments.
For the 12-month period ended Sept. 30, 2006, there were 1,259 open commitments, compared with 1,231 during the same period a year earlier. (You can view the historical data here).
Moreover, 71 percent were pending, which means a study hasn’t begun, vs. 65 percent a year earlier. Of the total, 3 percent were delayed, or behind the original schedule, compared with 2 percent.
In other words, the industry seems to need a big push to get started on those follow-up studies. Not surprisingly, consumer advocates jumped on this as evidence that the FDA is hamstrung.
“How can the FDA claim it is committed to improving drug safety when it can’t even get drug makers to do the studies they promise?” said Bill Vaughan, senior policy analyst with Consumers Union. “The fact that drug makers are ignoring their own promises to perform safety studies shows how desperately we need stronger laws to protect the public.”
[tags]Consumers Union, Drug Safety, FDA[/tags]
Melody
Whether we discuss lack of post-marketing follow-ups, or rushing through another me-too drug, the FDA is NOT looking out for patients.
David Nathan, Harvard Medical School, writing in the NEJM, addresses this issue (in a roundabout way). In speaking about the introduction of Merck’s new anti-diabetes drug, he states: Ensuring the effective and cost-effective use of the medications that have already been established by high-quality clinical trials to control glycemia or prevent diabetes should be a higher priority than flooding the market with ever more medications.
Merrill Goozner (Center for Science in the Public Interest), also speaking about the introduction of Merck’s new anti-glycemic said this: The FDA had very little information about Merck’s new diabetes drug before approving it. “There was only one published, peer-reviewed, moderately large clinical trial; it included 392 treated patients who were followed for 18 weeks to judge the efficacy and safety of the drug,” Nathan wrote. And the results of that paltry trial? The drug “is one of the less effective glycemia-lowering drugs introduced in recent years.”
A recent PBS interview with FDA-head von Eschenbach addressed this issue: Last fall, the Institute of Medicine issued a scathing report, saying the FDA’s effectiveness is compromised by internal tensions, outdated procedures, underfunding, and poor management. The report took particular aim at the FDA’s failure to adequately monitor drugs, it said, after they go on sale.
If you want to hear/see von Eschenbach’s response, here’s the link: http://www.pbs.org/newshour/bb/health/jan-june07/fda_01-31.html
Now the question becomes, who follows up on the follow-upper?