Exposed Nerve

Cyberonics has implanted its pacemaker in thousands of epileptics. It wants to expand to the depression market. Still needed: an accounting of those who died or were injured after receiving its implant.

Cummins was a general partner in a venture capital partnership when he joined the fledgling Cyberonics in 1988. Seven years later, he was appointed president and CEO. (Cummins was not outspoken with the Houston Press. Shortly after agreeing to an interview and a tour of the facility, Cummins shocked Wall Street by selling $14 million worth of Cyberonics stock in mid-February. He then declined the Press interview.)

A 1999 Houston Chronicle story on Cyberonics described Cummins as a six-foot-two, 215-pound intense outdoorsman who held Dartmouth College's javelin record and spent his free time helicopter-skiing and snowboarding.

When the FDA's advisory panel recommended approval of VNS for depression in June 2004, Cyberonics' stock more than doubled. Cummins thanked the FDA and the panel in a press release.

Cyberonics hopes to use VNS for Alzheimer's, obesity 
and migraines.
Courtesy of Cyberonics
Cyberonics hopes to use VNS for Alzheimer's, obesity and migraines.
Wheless says the device is safe for children.
Daniel Kramer
Wheless says the device is safe for children.

But in August, when the FDA rejected the panel's recommendation -- a rarity in the agency's history -- Cummins was less cordial.

"We are shocked and bewildered," Cummins stated in a press release.

The FDA reported that the company relied on nonrandomized clinical studies with a potential bias. The agency also expressed concern over instances of study patients whose depression deepened, and the fact that there was no statistical difference between a group of patients who had the device turned on and a control group whose devices were off.

Richard Malone, a psychiatrist and professor of psychiatry at Drexel College of Medicine in Philadelphia, was one of two advisory panel members to vote against recommending the treatment for depression.

"For the VNS, there was no evidence that the real treatment was better than the fake treatment," Malone says. "So then…you have a treatment that doesn't have evidence of working but does have evidence of side effects."

John Rush, a distinguished psychiatrist with the University of Texas-Southwestern Medical College, designed the clinical depression study. He told the panel in June that, at the time of the study, conducting a yearlong controlled study would have compromised patient safety.

"We didn't know if they would get better [or if] they would get worse," Rush told the panel, according to transcripts. "We didn't know how many would kill themselves. We had no idea. No one has ever reported this…So we were wrestling with a -- really a totally new territory, a terribly difficult illness with a very high risk of disability [or] death. You saw a hospitalization, we had a patient suicide who was a physician and so on."

But Malone disagrees.

"They claimed that they couldn't do more studies because it wouldn't be ethical," he says. "But I just replied that it's in the same way not an ethical thing to recommend treatment."

Although the FDA initially rejected the panel's approval recommendation, it reversed its decision in February after the company submitted supplements to the original study.

With their depression therapy deemed "approvable," Cyberonics' stock jumped 42 percent the day after the announcement. Cummins told shareholders the company would enter the depression market in May, and he technically didn't have to tell them anything at all.

The FDA does not disclose approvable letters, deferring instead to the manufacturer. A company can choose not to reveal the terms of approvable letters to the public and to shareholders, meaning the disclosure of potential public health concerns is up to corporations, whose sole legal purpose is to generate profit.

Shortly after the approvable letter, Cummins sold stock for the first time, puzzling some shareholders. However, he explained to investors that the 350,000 shares he sold was less than a quarter of his holdings.

"I did what I had to do to reduce my family's exposure and risks, knowing that the 1.15 million options I still hold will be more than enough when this company's enormous potential and value are recognized in the next two years," Cummins explained in a letter.

The FDA warning letter demanding reasons for unexplained deaths and thousands of explanted devices never had any effect on stock. As long as a product is on the market, and as long as no one talks about warning letters, a company will continue making money.

No one likes talking about warning letters, and no one likes talking about unproven therapy.

FDA medical device director Dan Schultze declined to be interviewed, referring questions to a spokesperson who stopped answering them after a while.

Cyberonics board member Stanley Appel, chairman of the neurology department at Baylor College of Medicine, also refused comment.

Spokespeople for the Houston and national chapters of the National Alliance for the Mentally Ill and the Depression and Bipolar Support Alliance, as well as the Mental Health Association of Greater Houston, said they did not offer opinions on therapy.

Yet Lydia Lewis, president of the Chicago-based DBSA -- a nonprofit that receives financial support from Cyberonics and pharmaceutical companies -- appeared before the advisory panel last June, advocating for more treatment options. Lewis chose her words carefully, lest she be accused of endorsing Cyberonics.

"I am not here to advocate for any particular therapy, including VNS, but rather for the critical need for new therapies," she told the panel, according to transcripts. "At DBSA, we know that new drugs and non-pharmacologic treatments are desperately needed. Far too many people are dying or living lives of quiet desperation, because they can't get sufficient relief from their symptoms of depression. The more treatments the FDA makes available, the more lives that will be saved."

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