Device Won Approval Though F.D.A. Staff Objected

[HuckleB]

http://www.nytimes.com/2006/02/17/politics/17fda.html?_r=1&oref=slogin

"A top federal medical official overruled the unanimous opinion of his scientific staff when he decided last year to approve a pacemaker-like device to treat persistent depression, a Senate committee reported Thursday.

The device, the surgically implanted vagus nerve stimulator, had not proved effective against depression in its only clinical trial for treatment of that illness. As a result, scientists at the Food and Drug Administration repeatedly and unanimously recommended rejecting the application of its maker, Cyberonics Inc., to sell it as such a treatment, said the report, written by the staff of the Senate Finance Committee.

But Dr. Daniel G. Schultz, director of the Center for Devices and Radiological Health at the agency, kept moving the application along and eventually decided to approve it, the report said.

That approval did follow the backing of a divided F.D.A. advisory committee. Still, the Senate committee, which for two years has been investigating the decision-making processes at the F.D.A., could find no previous instance in which the director of the center had approved a device in the face of unanimous opposition from staff scientists and administrators beneath him, the report said."



It never seems to end...

[bettyellen]

1. so guys, what friend of whom owns the company...

:popcorn:

[bear425]

22. There's a Michael A. Cheney

VP of Marketing
Don't know if there's any relation...

http://www.cyberonics.com/1corporate_fs.html

[progressoid]

23. Yep, or what former FDA official now works for them or vice-versa???

[HereSince1628]

2. Another skirmish in the Republican War Against Science

Someday out posterity will curse us for our acquiesence.

[Pirate Smile]

3. Unbelievable! They reject things that work and accept things that don't.

Even knowing how terrible these guys are it still shocks me on a daily basis.

[MadMaddie]

5. The things that don't work...they approve

because they stand to make money off of the product.

the military vests come to mind....

There are so many conflicts of interest in this administration that it will take years to clean house.

[Pirate Smile]

7. I get that but it is still shocking and sooo blatant.

How do these people live with themselves?

They obviously manage to, quite nicely, in fact.

Truly sick!

[Lorien]

4. There's already an EFFECTIVE electrical device for depression on the

market (25 years) that doesn't require implantation. It's called the Alpha-stim (www.alpha-stim.com), and myself and another DUer have been using it for months and have gotten significant results. The problem with the Alpha-stim for physicians is that it's a one time purchase that doesn't require any follow up (there are no side effects), so there's no real revenue it it. I suspect that there IS a great deal of follow up required for this device.

[HuckleB]

6. Alpha-Stim is also FDA approved.

So I'm not sure what most of your post refers to, in regard to this particular device.

[havocmom]

9. Two things her post refers to:

It works
It does not come with a lot of expenses for medical maintenance
Good for depression, bad for profits

So, the brass OKs something which the scientists don't approve of, but somebody will make a shit load of money from and THAT seems to be the only recommendation for that little product.

[HuckleB]

15. ?

The Alpha-Stim is also approved. So I guess the brass likes it, too.

[havocmom]

17. Or they had no justification for not approving?

When was it approved and when did the current management get the job? Pertinant questions as it must have been approved at least a few months ago if consumers are already giving feedback as to the effectiveness of it.

Point is, the thinking heads say the device should not be approved and the nodding heads vetoed them in favor of corporate profits over scientific evidence.

[HuckleB]

18. What?

The Alpha device was approved 25 years ago.

[havocmom]

19. Thank you for making my point. Approved BEFORE the junta

put corporate stooges in high places.

Then: Devices which work and do not require a lot of added expense for medical follow up
are approved. Users report they are good and no side effects

Now: guy at top, usually a recent appointee of party in power, ignores the advice of all the scientists and approves device which is likey much more costly (internal as opposed to external)

That's the point. It's all about getting the most $$ to corporations.

[HuckleB]

20. Again...

I posted the original post on this thread. This approval is ridiculous.

However, connecting it to another device, already approved, doesn't make sense.

[Lorien]

24. It took 20 years to get it approved

long after it was approved in other countries. They were dragging their heels because they weren't loving the idea much at all.

[Lorien]

25. Exactly.

The whole idea of IMPLANTING (thus requiring medical supervision as long as it remains implanted) a device that uses electrical impulses to control depression seems like a real scam-particularly when it doesn't work and a non-invasive option is out there that DOES work. The Alpha-stim took 20 years to gain approval, even though it was throughly vetted through numerous clinical trials and has no side effects. This, on the other hand, gets fast track approval; the main difference between the two is a.) effectiveness, and b.) revenue potential.

[papau]

8. what is the cost?

thanks

:-)

[Lorien]

26. $300-500, depending on if it's new or a refurbished demo

requires a prescription in the US, but not in Canada.

[Straight Shooter]

14. There is something vaguely unsettling about their promotional photo.

Is this supposed to be a doctor and his patient?

[Lorien]

27. Lol! Yeah, but that's for the model that's used to treat chronic pain

many sports teams use them. Cleveland Browns are one that I can remember offhand.

[rodeodance]

10. "approval would be akin to approving an experimental product."

....Internal correspondence among F.D.A. reviewers shows that some were bewildered by Dr. Schultz's support for the device, the Senate report said.

"In my opinion, they do not have adequate data, and I don't understand how this can move forward," one reviewer wrote in an e-mail message to a colleague, the report said.

Another wrote, "As an M.D. interested in science, it seems to me that such an approval would be akin to approving an experimental product."

[Sal Minella]

11. Plan-B, on the other hand.................

[rodeodance]

13. talkes 10 years

[Sal Minella]

16. again overriding 100% recommendation of scientific staff.......

At least the guy is consistent.

[Trillo]

12. Implantable nerve stimulation device approved despite

that it doesn't do what it claims?

What kind of brain signals is it sending? :tinfoilhat:

[Pirate Smile]

21. kick - needs one more vote for GP.

[bananas]

28. Reminds me of the heart pace-maker scandal

It's described here (search the page for "pace")
http://www.ied.info/books/www/healthcare.html

Compounding the charge that the operation was three to five times too expensive, were studies that showed 30 to 75 percent were unnecessary. Some of these unneeded pacemakers caused serious aftereffects. A woman in Tucson, Arizona, went through six operations and spent sixty thousand dollars before her last doctor informed her that her heart was perfectly healthy. She was only one of over two hundred thousand Americans who, by 1983, had unneeded pacemakers installed.<39>