Lashing out concerning inaccurate information that he described as a “leak” to the Wall Street Journal by an “unnamed source,” Skip Cummins, president and CEO of Cyberonics (Houston), yesterday charged that the leak was an attempt to harm the company and perhaps block the final approval and rollout of its therapy for treatment-resistant depression (TRD).
During a morning conference call – in tones that went beyond angry to vehement – he said that such a delay won’t happen.
Cyberonics late Wednesday issued a statement acknowledging that the company had received a letter from the Senate Finance Committee (SFC), requesting information concerning the FDA’s regulatory handling of Cyberonics’ vagus nerve stimulation therapy (see sidebar, this page), already approved for epilepsy, but awaiting final approval for TRD (Medical Device Daily, Feb. 4, 2005).
Clearly agitated by his contacts with the Journal, Cummins in the conference call suggested that some player in the psychotropic drug sector, or others providing “standard” treatment modalities for depression, may have provided the leaked information, fearing entry of the company’s vagus nerve stimulation (VNS) therapy for TRD.
He also suggested that “lower-level staffers” at the FDA might have provided misinformation to the business newspaper.
The story that did appear reporting the company’s receipt of the letter, along with comments from Cummins, was essentially accurate on that point, according to Pam Westbrook, Cyberonics’ CFO.
The main issue, she told Medical Device Daily, was that the Journal had been preparing to release an inaccurate story from a source the paper’s reporter would not identify. “We corrected it before it went out,” she said. And the company then released its own statement.
She added that the information from the Journal’s unidentified source, along with various recent investor inquiries, required the company “to release information not material to this [approval] decision.” And it had created what she termed “a huge distraction.”
Cummins’ own theory as to the source?
“I don’t know who,” he said. “Maybe SFC, maybe FDA scientists who had strong objections” to the agency’s handling of the application.
“We didn’t do it,” he said.
Cummins repeatedly emphasized the value of VNS for severe depression over the many current “status quo” treatments. “Many expensive, ineffective, often poorly evaluated treatments” had “miserably failed millions of Americans,” he said, adding that his own interest in seeing the therapy approved went beyond corporate economics.
He noted that two members of his own family, a grandfather and his mother, had committed suicide as a result of depression.
“It’s not professional, it’s not financial, it’s personal for me,” he said.
Cyberonics received the letter from the SFC “recently,” Cummins said. But in a question-and-answer period following his conference-call presentation, he clearly avoided stating a date, only repeating that it had been received “very recently.”
Several times, Cummins also emphasized that neither the Journal story nor any action by the Senate committee would slow the receipt of a final approval for the TRD application and that the company was aggressively readying market rollout.
He repeatedly described the Senate committee’s request for information as “informal.”
“The letter does not suggest that there is any investigation; it does not suggest any formal hearings; it is in no way a subpoena and alleges no wrongdoing on Cyberonics’ part,” he said.
“We confirmed that the SFC examination would have no bearing on final approval. Once the Center for Devices and Radiological Health conditions have been met, VNS would be approved,” Cummins said. The confirmation of no delays came “from the FDA,” he added.
The Senate committee examination “will have no impact on launch time” for the product for TRD, he said, and that the company was moving ahead with launch preparations.
He reported that on Monday he had given an “opening address at the final treatment-resistant depression and launch training meeting. I saw a sea of about 350 very eager, very excited faces. What are they doing today? They are busily preparing to launch the only treatment ever specifically developed and approved and labeled for treatment of treatment-resistant depression.”
Cummins asked: “Now, what attracted those people to Cyberonics?” The answer, he said, was to latch on to an opportunity – that is, VNS TRD therapy – which he called the “single biggest development in psychiatry in the last 100 years.”
But he also pointed to an upside of any potential delays: “Every extra day we have to prepare will make us better prepared.”
Responding to a question about potential off-label use of the therapy for TRD, he said that could be done “in theory,” adding emphatically: “In practice, we don’t do that . . . period, end of sentence.”
Cummins also noted that the company’s premarket efforts so far will make the company “a lot better prepared” for the TRD indication than it was in rolling out the therapy’s epilepsy application.
Throughout the conference call, he kept returning to the theme of the device’s benefits over other “standard” therapies such as drugs and electroshock therapy, which he charged have far-reaching and very adverse side effects.
VNS, he said, offers an important therapeutic alternative to those with severe depression, “other than suicide.”
For those listening to the conference call, he encouraged that complaints be directed to the head of the FTC, Sen. Charles Grassley (R-Iowa).
As for the company’s own next step, he said, “We’re busy trying to get approval and launch this product.”
Cyberonics’ stock closed $34.18 Thursday, down 12.1%.