The Food and Drug Administration may soon approve a “pacemaker-like device, called a vagus nerve stimulator” for severely depressed patients, reports the NY Times, that is “surgically implanted in the upper chest, and its wires are threaded into the neck, where it stimulates a nerve leading to the brain.”
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.
What do any of you know about “Cyberonics Inc., the Houston company that makes the stimulator”? So far I’m striking out, but many of you are better sleuths than I. More below + poll:
There is an apparent window-dressing investigation by the Senate Finance Committee but, writes the NYT, “Cyberonics officials say they have been assured by the agency that this will have no bearing on its final decision.”
On May 11, consumer group Public Citizen — founded by Ralph Nader — said “Cyberonics had not proved the device was effective or safe for depressed patients. Concerns about worsening depression, suicide attempts and sudden deaths in the trials have not been fully investigated, the group added.” (See Public Citizen’s May 11 letter to the FDA.)
Then there’s this tidbit:
“Erehwon59” sounds like the alias of some Pringles-stuffing, pasty-faced Dungeons & Dragons addict, but one Houston company is spending big bucks to find out just who he is.
Erehwon — and yeah, we realize it’s “nowhere” backwards — has been saying bad things online about Cyberonics, a medical-device company, and its CEO. And they’re not happy about it.
They’ve sued “John Doe No. 1 a/k/a Erehwon59” in state district court here and are pressing to find out the mysterious fiend’s identity.
It’s not because he’s made disparaging remarks on Yahoo bulletin boards about Cyberonics management, says company attorney Lawrence Schreve. “This guy is posting confidential information on the Internet,” Schreve says, although he won’t point out just what the alleged confidential information was.
The company subpoenaed Yahoo for Erehwon’s identity; Yahoo didn’t disclose it but passed on word to him (or her!!) that a lawsuit had been filed. (HoustonPress.com)
I searched opensecrets.org for Cyberonics and for Skip Cummins, the head of the company. Nada.
This sounds like a crudely devised way to make a fast buck off perplexingly ill people.
I wonder if this device would find many takers as insurance companies will likely be, shall we say, reluctant, to fork over $15,000.00. That sum would buy a considerable amount of wellbutrin.
When I made an abortive attempt to quit smoking, I got a prescription for Wellbutrin. Over $100 for one month’s supply. About two weeks into taking it, I broke out in incredibly itchy hives. I still have the rest.
It’s all getting insanely expensive.
They had a warning letter from the FDA on the device dated
December 22, 2004. A few tibits.
Failure to completely investigate and evaluate the cause of each medical adverse event as required by 21 CFR 803.50(b)(2) and failure to maintain complete deliberation results as required by 21 CFR 803.18(b)(1)(i) [FDA-483, Item 1].
Failure to establish and maintain adequate procedures for validating the device design to ensure that the device conforms to user needs and intended uses and include design testing under actual or simulated use conditions as required by 21 CFR 820.30(g) [FDA 483, item 2]. Evidence of your firm’s design validation with regard to Model 102 is inadequate.
Maybe this is why Nader’s group is after them. I didn’t read all of their letter to the FDA.
When you ask what any of us know about Cyberonics, Inc., I’m not clear what exactly you’re seeking here? Are you trying to compile a full backgrounder/dossier on the company and the regulatory steps it has taken regarding the vagus nerve stimulator (VNS)? Or are you wondering whether anyone has had first-hand dealings with the company or any of its products?
If it’s more geared to the former, I can probably help get a lot of the raw information and digest it all (I have a fair bit of experience in organizing materials relating to corporations as well as some lesser abilities regarding the FDA approval process for implantable medical devices).
For example, only five months ago, Cyberonics was the recipient of this warning letter from the FDA regarding problems uncovered during a manufacturing audit of their facilities:
At the close of the inspection, your firm was issued a list of inspectional observations, Form FDA-483 (copy enclosed), which identified a number of significant QS regulation violations including, but not limited to, the following:
1. Failure to completely investigate and evaluate the cause of each medical adverse event as required by 21 CFR 803.50(b)(2) and failure to maintain complete deliberation results as required by 21 CFR 803.18(b)(1)(i) [FDA-483, Item 1].
Those medical adverse events are generally recorded by the FDA’s Center for Devices and Radiological Health in its Manufacturer and User Facility Device Experience (MAUDE) database, which can be searched here. The Cyberonics VNS device was the subject of more than 500 reported adverse events (the maximum returnable number) of all types in barely more than the past year. Since 2002, there have been 75 deaths in the MAUDE database.
This is what I get in 30 minutes at home. Once I’m back in the office on Monday, gathering up more would be much simpler. Let me know how I might be able to assist further.
Well, I’m a weak sister in the science dept. so I couldn’t assess if this is a good device based on the tests and analyses.
I was more curious why the FDA is letting this through if it has done so poorly in tests, and there are so many concerns. I wonder what pressures are on the FDA. Senate Finance is looking at it but I gather that’s just window-dressing, as I said above. But why isn’t the Senate looking at it more seriously?
There’s something creepy about implanting a probably ineffective device that can’t be removed and leaves wires in one’s neck.
I did a google with the name of the company followed by scandal and came up with this ariticle date May 19, 2005, much more in article..
http://www.newstarget.com/001960.html
“”Executives at Cyberonics have their theories for why this device may have been blocked for approval by the FDA, but I have my own theory: electromedicine competes with prescription drugs. If a device can stimulate the nerve of a depressed patient and give them effective treatment, then that patient very likely won’t need to be taking prescription drugs like Prozac and Paxil. And there’s no recurring revenue in an electrostimulating device — a patient buys it once, and from that point forward, treatments are essentially free, because electricity is virtually without cost.””
The Bay Area Economic Partnership of Houston carries this story from the Houston Business Journal about Boston Scientific increasing their share in Cyberonics from 15% to 20%. It is not clear what date this article is for. The copyright is from 2003, but the url and titles suggest an unspecified date in the recent past.
Extrapolating from various recent SEC filings, Boston Scientific Corp. currently holds approximately 3 million shares of Cyberonics, or about 12% of all the outstanding shares. BSC seems to have made its initial major investment around May 2003, but has been steadily increasing its stake since then (including two purchases comprising a total of 135,000 shares in late March 2005).
Without going back to fully research the Cyberonics/BSC strategic partnership now (it’s getting quite late and there’s only so much stuff about a company like BSC a person can take on a weekend), on the face of it, any cooperation would seem to make sense. BSC derives virtually all its revenues from implantable medical devices, mostly in the vascular field. On their own, they do not have a strong position in the neurological market, and their traditional business strategy has been to partner with another smaller company — often by purchasing a minority stake — with an option to increase its holdings down the road. Whether that’s their plan for Cyberonics, I can’t say.