Pages: [1]   Go Down
Print
Author Topic: US senator questions Cyberonics device approval  (Read 6671 times)
0 Members and 1 Guest are viewing this topic.
Birdbomb
Head Cheese
Administrator
Hero Member
*****

Karma: +9/-1
Offline Offline

Posts: 7792


Head Cheese


WWW
« on: February 16, 2006, 07:59:43 AM »

LINK TO ARTICLE

US senator questions Cyberonics device approval

Thu Feb 16, 2006 2:52 PM ET
WASHINGTON, Feb 16 (Reuters) - Senate Finance Committee Chairman Charles Grassley on Thursday questioned the Food and Drug Administration's approval of Cyberonics Inc.'s (CYBX.O: Quote, Profile, Research) implanted device for treating depression.

"I am greatly concerned the FDA standard for approval may not have been met here, and if that's the case it raises further difficult questions about whether Medicare or Medicaid dollars should be used to pay for this device now," the Iowa Republican said during a speech on the Senate floor. [/size]
Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
Birdbomb
Head Cheese
Administrator
Hero Member
*****

Karma: +9/-1
Offline Offline

Posts: 7792


Head Cheese


WWW
« Reply #1 on: February 16, 2006, 09:25:03 AM »

LINK TO ARTICLE

War of the Wires
[span style=\'font-size:14pt;line-height:100%\']News: Can the FDA keep up with all the new medical devices now arriving on the market?
[/b]

By Clara Jeffrey

November/December 2005 Issue

As doctors and medical device manufacturers embrace the brave new world of using implanted stimulators to regulate organs, mood, and appetite, critics charge that the Food and Drug Administration is failing to guarantee that such implants work as advertised. Senator Charles Grassley (R-Iowa), who led the investigations into the FDA's monitoring of Vioxx and other drugs, is currently exploring the agency's oversight of implants and other medical devices.

Even relatively noncontroversial implants like heart defibrillators are under fire. Since 2000, their use has tripled, and recent changes to Medicare reimbursement rules have further expanded the pool of potential patients. Critics charge that defibrillators are already being implanted in patients either too healthy or too sick to be good candidates. Meanwhile, it was recently revealed that Guidant Corporation failed for three years to disclose that its Ventak Prizm 2 defibrillator had a defect that could cause it to short-circuit. Only when the New York Times was about to expose the problem and related deaths did Guidant issue an alert to doctors and patients. It has since recalled more than 20 models of pacemakers. Asked to provide defibrillator failure reports, the FDA sent out heavily redacted documents, calling the censored data a corporate "trade secret."

When it comes to implants designed to treat mental illness, the concerns go way beyond mechanical malfunction. Brain implants
Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
Birdbomb
Head Cheese
Administrator
Hero Member
*****

Karma: +9/-1
Offline Offline

Posts: 7792


Head Cheese


WWW
« Reply #2 on: February 16, 2006, 09:27:19 AM »

LINK TO ARTICLE


[span style=\'font-size:14pt;line-height:100%\']Senators Question FDA Approval Of New Depression Treatment

Mark Moran [/b]

Despite the Senate inquiry, the manufacturer of a vagus nerve stimulation device expects to receive full FDA approval. Meanwhile, a researcher supported by the manufacturer presents favorable data on vagus nerve stimulation at APA's 2005 annual meeting.

The Senate Finance Committee is looking into concerns about the Food and Drug Administration's decision to label a vagus nerve stimulation (VNS) device as "approvable" for treatment of refractory depression.

VNS manufacturer Cyberonics Inc. of Houston confirmed that the company received a letter from the Senate Finance Committee stating that the committee is examining the process behind the decision.

Quoting from the committee's letter, the company said that the committee is "examining the FDA's handling of Cyberonics'... premarket approval supplement for the VNS therapy to address treatment-resistant depression in adults," and that the "FDA issued an approvable letter to Cyberonics on February 2, 2005, despite the strong objections from FDA scientists involved in evaluating the safety and efficacy of VNS therapy."

The company stated that the letter alleges no wrongdoing on Cyberonics' part and requests that Cyberonics provide certain information to the committee.

VNS is approved for the treatment of epilepsy. An "approvable" rating is considered a preliminary step toward market approval.

A spokesperson for the Finance Committee told Psychiatric News at press time that the letter was not available to the public and that the committee was not releasing any information about the investigation.

Committee Chair Sen. Charles Grassley (R-Iowa) has criticized the FDA for its handling of the painkiller Vioxx, now removed from the market, and has continued an inquiry into other risk drugs approved by FDA.

An FDA spokesperson declined to comment on the matter.

Meanwhile, Cyberonics CEO Robert P. Cummins downplayed the inquiry.

"Cyberonics and its advisors believe that [the committee's] examination will produce no new information and that [the committee's] examination will have no bearing on the FDA's final treatment for refractory depression [TRD] approval decision," said Cummins. "All of the `strong objections referred to in [the committee's] letter were fully considered by a specially chosen FDA advisory panel of depression experts that recommended approval in June 2004 and by the FDA's Center for Devices and Radiological Health during its rigorous review... that resulted in the recent approvable decision.

"There are no FDA-approved treatments for TRD, and none other than VNS has ever been studied or deemed approvable for TRD," said Cummings. "According to most patients with TRD, the only real way out of the TRD status quo is suicide. Clearly, the TRD status quo for millions of Americans, their families, psychiatrists, and payers is neither safe nor effective."

During a symposium on deep brain stimulation sponsored by Cyberonics last month at APA's annual meeting in Atlanta, Lauren B. Marangell, M.D., an associate professor of psychiatry at Baylor College of Medicine, reported data on clinical trials of VNS for refractory depression and said that FDA approval was anticipated.

Marangell has received research support, consulting fees, and speaking fees from Cyberonics, and the data she presented were from studies funded by Cyberonics.

She said that VNS therapy has shown promising acute and long-term results in an open pilot study of 59 adult outpatients with treatment-resistant depression.

Marangell also described a 12-week randomized, double-blind, controlled trial using a "sham control" group in which the VNS device was implanted but was not turned on. In that trial, there was no statistically significant improvement in the treatment group compared with the sham group.

However, data from a naturalistic follow-up of study participants who received 12 months of VNS therapy in addition to antidepressant treatment showed a significant improvement in their average Hamilton Depression Rating Scale score. At 12 months, 52 of 174 patients achieved a reduction on the HAM-D of 50 percent or more. Of those 52 patients, 17 percent achieved "remission" as measured by a HAM-D score of 10 or less.

The Washington, D.C., advocacy group Public Citizen blasted Cyberonic's data in a lengthy, extensively footnoted letter to the FDA.

"The company has submitted data about only a single randomized, controlled trial... and that trial failed to convincingly demonstrate the effectiveness of the device," the letter read. "It also produced long-term, nonrandomized data comparing VNS to another comparison group, but an FDA statistician called that analysis `highly questionable.'"

Peter Lurie, M.D., deputy director of Public Citizen's Health Research Group, said that the device should not be approved. "The principle is simple
Logged

"If you are going through hell, keep going." (Sir Winston Churchill, 1874-1965)
VNS implanted Sept 02, turned off Dec 04, Generator ex-planted Nov 07
Electrodes are in me for LIFE!
labrat
Global Moderators
Hero Member
*****

Karma: +7/-0
Offline Offline

Posts: 2547



WWW
« Reply #3 on: June 14, 2006, 10:07:57 PM »

:im_033:  :)  I really would like this Senator's e-mail address.

We have been inthe middle of changing over for internet, modem,  phone, and cable service from one company to the next. OF course, even though I set up things a month ago, things never go as planned. A one day service has turned into three and or phone won't be hooked up 'til sometime today!!


Everyone have a geat day. :im_033:  : sun :

Labrat
Logged

walnut
Newbie
*

Karma: +0/-0
Offline Offline

Posts: 17


« Reply #4 on: June 19, 2006, 08:47:08 AM »

I just browsed through Cyberonics "Cyberonics and VNS Therapy Update Roadshow Presentation" and it was very convincing. I have not read the origonal studies for a long time but I remember reading them and other interpetations saying they were statistically not significant. Has anything changed in the past year or so that makes the device appear more useful , for lack of a better word?
Logged
labrat
Global Moderators
Hero Member
*****

Karma: +7/-0
Offline Offline

Posts: 2547



WWW
« Reply #5 on: June 19, 2006, 09:17:06 AM »

:im_033:

I feel like I have told my "story" in bits and pieces but, have never done the survey or "tell us your story part." I guess the wounds are still too fresh and it is hard to type with tears running down your face.

This is my own personal view, not Cybronics or anyone elses. I don't think anything has changed about the VNS. I can only speak on it from the depression point of view. I feel the worse the depression, the better it works. I don't think Cybronics chose people that were depressed enough, thinking it would make their study look better and it backfired. All I know is from personal experience. I was as low as you can go mentally, and I have responded from the time it was turned on. I've had my VNS 8 months today...I am living in a different world. Yes, some of that is memory lose, but most of it is like I have awoken and although I grew up in the same city I still live in, everything is a new adventure!

I also feel that more people, that don't have good results post. I choose to be there to give someone or a lot of someones hope. Some people don't get a response for 12 months. Just like our depressions are different, so is our responses to VNS.  :)  :im_033:  
Logged

Pages: [1]   Go Up
Print
Jump to: