October 26

Latest Huckstersm: Surgical Implants for Depression – NYT

Latest Huckstersm: Surgical Implants for Depression – NYT

Sat, 21 May 2005

The FDA was supposed to protect the public from snake oil hucksterism. It is appalling to note how far the FDA’s approval process for drugs and devices has veered away from it’s 1962 standards of evidence-based medicine. [1] Dr. Donna-Bea Tillman, FDA’s director of the office of device evaluation is quoted in The New York Times stating that if a product’s effectiveness is not supported by a well-controlled trial, “it is not the kiss of death” for its approval.

But if the FDA doesn’t require scientific evidence for efficacy and safety of drugs, vaccines, and devices, then who needs the FDA? Indeed, FDA’s recent record of approval for the marketing of harmful drugs and devices demonstrates that the agency has abdicated its mission.

Reports in The Wall Street Journal and the NY Times about psychiatry’s latest invasive, potentially harmful, unproven gimmick to “treat depression”–a surgically implanted $15,000 device, a “vagus nerve stimulator”–is a perfect illustration of medical hucksterism.

Over and over again, psychiatry has duped the American public with promotional hype and irresponsible marketing of “promising” treatments–such as, insulin coma, electroshock (ECT), prefrontal lobotomy, SSRI antidepressants. None of these were able to stand up to scientific efficacy tests, while their severe adverse effects were routinely denied by the profession.

With psychiatry’s “wonder drugs” for depression knocked off their pedestal–after the scientific evidence was laid out before the public–psychiatrists are scrambling to find a new “magic bullet.” This time, we are told–again, without evidence–that a devise which is surgically inserted “from chest to neck to brain” and cannot be removed, may alleviate depression in people, who its promoters claim, “have no other options.”

A very effective and safe option was validated by a Duke University study that found that moderate exercise works best to combat depression: After 16 weeks, 60.4 percent of the patients who only exercised were no longer depressed, compared with 65.5 percent for the group prescribed the SSRI, Zoloft. At 10 month follow-up the relapse rate for those who only exercised was 8% compared to a 38% relapse rate for those who took Zoloft only, and a 31% relapse rate for those who both exercise and took Zoloft. No psychiatric intervention has ever shown such a spectacularly low relapse rate as exercise. [2]

Dr. Harold Sackeim who is identified in the Times as a consultant for Cyberonics, was the principle investigator of the clinical trial testing the vagus stimulator device. The company’s chief executive acknowledges that the device failed to demonstrate a benefit in even a single controlled clinical trial: “The primary endpoint did not reach statistical significance.” Yet, according to the agency’s director of device evaluation, scientific failure no longer bars FDA approval.

Science was also not a consideration for the majority of FDA’s “expert” advisory committee that voted to approve the vagus stimulator. A member of that committee, Dr. Kyra Becker, provides the rationale: “The feeling was that anything that gives these people hope is potentially worthwhile.”

At least one committee member who voted against approval, Dr. Richard Malone, a psychiatrist at Drexel University, did not succumb to such muddleheaded reasoning. He said of the proceeding: “I walked out of there thinking I was nuts.”

If approved by the FDA, the vagus nerve stimulator will provide a windfall business opportunity for hucksters selling the promise of “hope.”

Dr. Peter Lurie, of Public Citizen, commenting on the vagus stimulator, said: “I’ve never seen anything quite like this. What we could be setting ourselves up for is an epidemic of implantation of a device with no proven effectiveness.”

Indeed, what with New York City hospitals already gearing up to screen adults for depression, and TeenScreen hitting schools across the nation, there is no doubt that those screening methods will find a depression epidemic of monumental proportions. [3]

Congress must use its muscle to restore scientific integrity to FDA policies a decision-making process. An Congress might also consider shifting funds from programs that promote the use of brain damaging therapeutics–such as the use of powerful mind altering drugs recommended by the New Freedom Commission report–toward promoting exercise programs for young and old.

References: 1. Since 1962, manufacturers of drugs, vaccines, and devices are legally “required to prove to FDA the effectiveness of their products before marketing them.” http://www.cfsan.fda.gov/mileston.html

2. Michael Babyak, James A. Blumenthal, Steve Herman, Parinda Khatri, Murali Doraiswamy, Kathleen Moore, W. Edward Craighead, Teri T. Baldewicz, and K. Ranga Krishnan. Exercise Treatment for Major Depression: Maintenance of Therapeutic Benefit at 10 Months. Psychosomatic Medicine, September/October 2000. The Archives of Internal Medicine, 2000

3. See: Depressed? New York Screens for People at Risk By MARC SANTORA and BENEDICT CAREY. NYT, April 13, 2005 at: http://query.nytimes.com/gst/health/article-printpage.html?res=9F02E6DC133EF930A25757C0A9639C8B63

Contact: Vera Hassner Sharav

May 21, 2005
F.D.A. Considers Implant Device for Depression

The Food and Drug Administration may soon approve a medical device that would be the first new treatment option for severely depressed patients in a generation, despite the misgivings of many experts who say there is little evidence that it works.

The pacemaker-like device, called a vagus nerve stimulator, is surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain. It has been approved since 1997 for the treatment of some epilepsy patients, and the drug agency has told the manufacturer that it is now “approvable” for severe depression that is resistant to other treatment.

But in the only rigorously controlled trial so far in depressed patients, the stimulator was no more effective than surgery in which it was implanted but not turned on.

While some patients show significantly improved moods after having the $15,000 device implanted, most do not, the study found. And once the device is implanted, it is hard to remove entirely; surgeons say the wire leads are usually left inside the neck.

Proponents say that many severely depressed patients do not respond to antidepressants or electroshock therapy and that those patients are desperate for any treatment to relieve their suffering.

“These people have no other options, so we need to consider anything that shows potential to help,” said Dr. Harold A. Sackeim, chief of biological psychiatry at the New York State Psychiatric Institute, who consults for Cyberonics Inc., the Houston company that makes the stimulator.

But Dr. Michael Thase, a psychiatrist at the University of Pittsburgh who consults for the company, said there was “simply not a good enough basis in evidence” for approval. While the device is promising, Dr. Thase said, “the shaky state of the evidence means we have to be very cautious with this and prepare for the possibility that the hoped-for benefit isn’t there.”

The drug agency has given mixed signals about the stimulator. In August 2004, it told Cyberonics in a letter that the treatment was not approvable, saying more information was needed. But in February, after the company provided more data, the agency changed that position, informing the company that the stimulator could now be approved. The company’s stock price has fluctuated as investors try to anticipate the agency’s decision, which the company is hopeful will come by the end of the month.

The Senate Finance Committee recently began looking into the F.D.A.’s potential reversal, but Cyberonics officials say they have been assured by the agency that this will have no bearing on its final decision.

In a conference call with reporters and analysts on Thursday, Robert Cummins, the company’s chief executive, said no other treatment had been deemed approvable by the drug agency for stubbornly depressed patients. Clearly, he said, “the status quo for millions of Americans, their families, psychiatrists and payers is neither safe nor effective.”

Still, some patient advocates and other experts are now questioning how the device has come so close to approval with such limited evidence for its effectiveness.

“I’ve never seen anything quite like this,” said Dr. Peter Lurie, deputy director of health research at Public Citizen, a nonprofit group that is a frequent critic of the F.D.A. and the drug and medical-device industries. “What we could be setting ourselves up for is an epidemic of implantation of a device with no proven effectiveness.”

Experts who were involved in the approval process say they were moved by the desperate prognosis for severe depression and by powerful testimonials. At a critical meeting of an F.D.A. panel last June, six patients with chronic severe depression said they felt much better that the stimulator had been implanted, as part of an investigational study. At that meeting, the panel voted 5 to 2 to recommend that the device be approved.

One patient, Charles Donovan III of St. Louis, said the stimulator had saved his life. “I went from being a complete mental-health vegetable to someone who had the energy and confidence to do this book,” Mr. Donovan said in an interview.

But the panel did not hear from patients who did not benefit from the stimulator, according to the transcripts. One of them, Katherine Coram, 57, of Silver Spring, Md., signed up for the trial after seeing a newspaper advertisement about it.

“Believe me, when you’re depressed for long enough, you get to a stage where you’re willing to try almost anything,” Ms. Coram said in an interview.

In the study, doctors implanted the device in 235 severely depressed people. The stimulator sends timed pulses of electricity to the vagus nerve, which has wide connections throughout the brain.

Half of the patients then had their stimulators turned on. The investigators did not know which of their patients had their stimulators on.

After three months, researchers “unblinded” the study and compared levels of depression in the two groups based on standard measures of disease severity, the F.D.A. documents show. They found that 17 of the 111 patients who had implants turned on and completed the trial showed significant improvement. But 11 of 110 who had no stimulation and completed the trial also felt significantly better. The difference between the two groups was small enough to be attributable to chance.

Alan Totah, vice president of regulatory affairs for Cyberonics, said at the meeting, “The primary endpoint did not reach statistical significance.” But Mr. Totah said “the results did show a positive trend in favor” of the stimulator.

Hoarseness was a common complaint. Many patients who have had a stimulator on also said that it put a quiver, rumble or other odd inflection in their voices.

“I certainly knew mine was on,” Ms. Coram said. “I could feel it. You get this constricting pain in the back of the throat. I couldn’t talk sometimes.”

Ms. Coram said that she was slightly more functional at work after the surgery but that it did not last. Later, she said, after she took a doctor’s advice and had the stimulator’s pulse turned up higher, “my life fell apart.”

“I was very anxious and agitated, much more so than before,” she went on. “I felt suicidal for a while, worse than I had been in 8 to 10 years.”

But several members of the panel that voted for approval said that given the alternatives for people like Mr. Donovan and others who did well, the insignificant difference between the two groups was cast in a different light.

“The feeling was that anything that gives these people hope is potentially worthwhile,” the chairwoman, Dr. Kyra Becker, a neurologist at the University of Washington, said in an interview. “But the whole meeting was uncomfortable, and everyone wanted to see another trial done, no question about it.”

Dr. Becker said that if she had voted her conscience, solely on the basis of the evidence, she would have voted not to approve.

A member who voted against approval, Dr. Richard Malone, a psychiatrist at Drexel University College of Medicine in Philadelphia, said he was bewildered by the recommendation.

“I walked out of there thinking I was nuts,” Dr. Malone said in an interview. “It was stunning, but then I find much of life is stunning.”

The F.D.A. usually follows the recommendations of advisory panels. Another reason some psychiatrists are intrigued by the device for depression is a finding in the evidence that some people with the implant might do better over time. In follow-up data, Cyberonics reported to the drug agency that about 30 percent of those in the study showed significant improvement on one measure of depression after six months or more.

“The effect appears to be sustained, which is very significant in these patients, who almost always relapse,” Dr. Sackeim said.

But other experts say it is extremely difficult to interpret this long-term evidence. Many patients in the study were taking psychiatric medications, or had electroconvulsive therapy, both of which can improve mood. These and other factors are difficult to control for, despite the company’s efforts to do so, they said.

Cyberonics says that the long-term evidence it has provided to the federal agency satisfies requirements for approval, and that senior agency officials have told the company as much.

The agency has a higher standard of proof for approving new drugs than it does for devices. Devices require a “reasonable assurance” that they are safe and effective and that potential benefit outweighs the risk.

F.D.A. officials said they could not comment on any product that was pending approval. But Dr. Donna-Bea Tillman, director of the agency’s office of device evaluation, said “it is not the kiss of death” if a product’s effectiveness is not supported by a well-controlled clinical trial.

“We consider safety and effectiveness in relation to the alternatives that patient population has, including whether they have any alternatives at all,” Dr. Tillman said.

If a device is approved, the agency specifies precisely which patients should have access to it, she said. Whether to recommend it is then left to doctors’ judgment.

And that is a prime concern among critics of the approval process, like Public Citizen and other groups concerned about patient protection. Once a product has been approved, the manufacturer can promote it aggressively, and some doctors may recommend it to any patient, whether severely or moderately depressed.

Some people may not wait for approval. Sue Wanemaker, 51, who lives near Denver, said she had a vagus stimulator implanted last April for her depression. Ms. Wanemaker, who also has epilepsy, said she had noticed little benefit, and added that when turned up high the stimulation made her feel suicidal.

She has since had the device turned down. “I’m going to hang in there,” she said in a phone interview, “because why not, I’ve got it in now, and – there it goes!” With that, her voice trilled for a few moments.

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