FDA Approval of VNS: They first said yes to VNS, then no, then yes. And now they’re trying desperately to explain their final answer.
The saga began on June 15, 2004, when the Neurological Devices Panel of the Medical Devices Advisory Committee voted by a 5-2 margin to recommend VNS for approval for TRD.
We encourage our readers to go to the transcript of this meeting, at http://www.fda.gov/ohrms/dockets/ ac/04/transcripts/2004-4047t1.htm, in order to get a feel for how human a process an FDA advisory meeting is.
The Neurological Devices Panel is composed mainly of psychiatrists and neurologists, with a smattering of statisticians, consumers, and industry representatives. These 10 panelists heard testimony from a variety of people in support of VNS. These participants include those you’d expect – Cyberonics employees and research psychiatrists they’ve sponsored – but there were also several satisfied patients from VNS trials who volunteered to testify, the president of a Cyberonics-funded psychiatric consumer group, and a representative from our own APA.
While the basic science behind device approval involves dry statistics, this meeting was anything but dry. The patient testimony was particularly poignant and compelling:
“All I can say is that my life is full of genuine happiness and joy. I don’t have to fake it anymore.… Last Saturday night I attended a small dinner party that 18 months ago I never would have gone to. I am also working on several different projects. This is the most productive I have been in many years” (testimony of Charles Donovan, III).
But one has to take some of this testimony with a grain of salt. Mr. Donovan’s trip and lodging were paid for by Cyberonics, and he has made something of a career out of VNS-boosterism, with his own website (www.vagusnervestimulator.com), a book (Out of the Black Hole: The Patient’s Guide to Vagus Nerve Stimulation and Depression), interviews with the major networks, and his own booth at the major psychiatric meetings.
Such personal testimonies were likely crucial for approval, because the statistics impressed few panel members, even those who voted in favor of approval. For example, Dr. Mary Jensen, a neuroradiologist, explained her yes vote by saying, “Although it would be nice to have randomized controlled data for the efficacy, I believe this is a difficult patient population.… And I think [VNS] should at least be available for this group of patients.”
This was the sentiment echoed by others: the evidence for efficacy is poor, but the pain of TRD is extreme, so let’s go ahead and approve it.
In August 2004, however, the FDA opted to overrule this panel’s vote (a very unusual occurrence), and rejected the application. In response, Cyberonics’ fiery CEO, Robert Cummins, went into high gear. In various conference calls and press releases, he insulted FDA’s “junior, ill-informed scientists” and suggested that the FDA would now be to blame for the suicides every month of “2,500 people” with treatment-resistant depression (see www.thestreet.com/comment/adamfeuerstein/10177974.html for TheStreet.com’s coverage of this issue). Cummins’ passion on this issue is notorious, and may be motivated by the fact that both his mother and grandfather committed suicide.
On Feb 3, 2005, the FDA, apparently swayed by Cummins’ arguments and by his submission of more long term data (all open label, however), again reversed itself, this time saying they would approve the device, but only for patients who have failed at least four adequate trials of antidepressant treatment (medication or ECT).
At least this time, it looks like the FDA has made up its mind for good.
TCR VERDICT: And thus waffled the FDA….