When the FDA evaluated clinical trials on vagus nerve stimulation (VNS) for depression, they were presented with written reports. Susan Ricketts, on the other hand, was behind the scenes. She was Project Coordinator on the D-02 clinical trial, the only study rated above “poor” in a report prepared for Oregon Health & Science University.
Ricketts had worked on numerous studies previously, and she was unprepared for Cyberonics’ lack of professionalism.
Susan Ricketts: “When I started on the D-02 VNS trial, I’d had long-term research jobs, including eght years at Dartmouth and two and a half years at Regents Hospital. But I lasted six months [on the VNS trial], because it was the most poorly run trial I’ve ever seen.
“I was the Project Coordinator. The patients had already been recruited, and randomly assigned to receive the VNS implant. The implants were either turned on or turned off during the course of the trial, and we followed their progress and symptoms throughout. I was the unblinded person on the trial, which means I was the one who knew whether a person’s device was turned on or turned off. I actually manipulated the software to turn it on or off.
“One of the first things that happened was when I went in, in my estimation the records that patients had filed were very disorganized, in disarray. So one of my first goals was to get the records in order.
“In a clinical trial – let’s say someone’s having a symptom, even a cold or flu symptom – you have to follow those symptoms very carefully, and track pain, severity, how long it lasted – because that’s how you track side effects, or adverse effects.
“It casts doubt on all clinical trials, all drug trials, all device trials.” – Project Coordinator Susan Ricketts
“Because they’d already been through three project coordinators, the tracking of patients’ histories throughout the trial was really atrocious. I called up patients to verify information; I went back with patients through their charts to make sure all the information was complete.
“The principal investigator should be on top of these things, and certainly the people from [device manufacturer] Cyberonics, who come through and review the records – they should have been on top of this. It never should have been as bad as what I saw.
“Another thing, during a study when the language in a consent form changes, you have to make sure that every person in the study reads that new consent form and signs off on it. That was not being done consistently.
“Cyberonics should have been there on a regular basis, making sure those records were clean and complete, and making sure those consent forms were signed.”
Q. Because ideally, they want an absolutely flawless study ?
“Exactly! They’re having to report to the FDA. And my feeling was, if the FDA had come in and done an audit, they would have failed it.”
Q. Reading about the FDA approval, there were reports that Cyberonics people were bullying the FDA. Did you see any of that behavior?
“That’s actually what brought me to your article. And those later reports – it just brought back that feeling, that this was a company that was literally shoving its way through approval. Cyberonics was a bully; the people that worked for them were bullies.”
Q. What were your concerns regarding the integrity of results?
“Before I left, when I made the decision to leave, I just kind of looked at the records and reviewed people’s scores.
“To make [people with depression] think VNS is scientifically proven to help them? It’s an atrocity.” – Project Coordinator Susan Ricketts
“I could see, even without a statistical analysis – and by the way, I do have training in statistical analysis – you could tell that, during the 12-week trial, there wasn’t any difference in depression scores between people who had the device turned on, or not. The 12-week efficacy study was just not going to show any results.” (Ricketts was right.)
“I was trained in research, worked in research all my life, and I have great respect for the way people conduct research. And to see Cyberonics get away with this – it just casts doubt on all clinical trials, all drug trials, all device trials – everything’s suspect when something like this goes through with very little scientific evidence.”
Q. Cyberonics continues even now to say their device has been proven to be a success.
“I think there’s a great bias against psychiatry and mental health. We wouldn’t be pushing a chemotherapy drug that didn’t work; we wouldn’t be pushing a heart stent that didn’t work.
“We’re talking about people who have treatment-resistant depression. They’ve failed at least two other methods, they’ve tried drugs, psychotherapy, even ECT.
“These are people for whom we should have tremendous compassion. And to make them think that this device is going to help them? And that it’s scientifically proven to help them? It’s an atrocity.”
See Part 1
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