What the FDA sees that doctors and patients may never know

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Steve Woloshin and Lisa Schwartz of the Dartmouth Institute for Health Policy and Clinical Practice publish an important perpective piece, "Lost in Transmission -- FDA Drug Information That Never Reaches Clinicians," in this week's New England Journal of Medicine.

It's about how "critical information that the FDA has at the time of drug approval may fail to make its way into the drug label and relevant journal articles."

Examples they write about: sleeping pills Lunesta and Rozerem. Excerpts:

"Clinicians who are interested in (Lunesta's) efficacy cannot find efficacy information in the label: it states only that Lunesta is superior to placebo. The FDA's medical review provides efficacy data, albeit not until page 306 of the 403-page document. In the longest, largest phase 3 trial, patients in the Lunesta group reported falling asleep an average of 15 minutes faster and sleeping an average of 37 minutes longer than those in the placebo group. However, on average, Lunesta patients still met criteria for insomnia and reported no clinically meaningful improvement in next-day alertness or functioning.


A sense of uncertainty about the net benefit of drugs is almost always lost. FDA approval does not mean that a drug works well; it means only that the agency deemed its benefits to outweigh its harms. ...

Rozerem (ramelteon), for example, was approved in 2005 for chronic insomnia and was aggressively promoted to consumers. No efficacy data were provided in the label....The Rozerem review included a memo from the medical review team's leader, highlighting the team's struggle to determine whether this drug provided any clinically important benefit and whether that benefit outweighed the harms. ... The sense that the FDA's decision was a close call was not communicated in the label."

The authors have urged the FDA to consider a "drug fact box" featuring a data table of benefits and harms to be used in reviews, labels or both.

They conclude:

"We don't need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known."

1 Comment

The numbers correlate with my experience with Lunesta, Sonata. I've given up on them. I've also given up on Lyrica. My efficacy rates with it are less than the 40% placebo effect. Let's not forget the Vioxx story that netted more than $10 billion for Merck in total sales. Of course, it came with a cost of almost $5 billion in settlement costs. I'm sure they would do it again for a $5 billion profit. The lives affected by these meds mean nothing to a for-profit corporation. I'm not sure If I should laugh or cry at these situations

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This page contains a single entry by Gary Schwitzer published on October 22, 2009 8:42 AM.

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