"Stanford study shut down by FDA"???

[prof8]

Someone on the forum Neurotalk said she was told by dartmouth/Hitchcock Medical Center in New Hampshire that the FDA has "shut down" what's going on at Stanford? I'm assuming this is false? I'm not even sure what this means. I'm going next week and haven't heard anything else otherwise!!

[ikulo]

Generally the FDA does not regulate medical procedures unless they in some way use devices/drugs that are under their jurisdiction. Stenting and ballooning are fairly common procedures and I would assume so are the instruments that are used. As a result, it is unlikely that the FDA could do anything about this.

[chrishasms]

123

[mormiles]

Hey everybody, Those of you who have been on this forum for awhile have known that the s__t would eventually hit the proverbial fan. That's why I was in such a tearing-a__ hurry to get Steve into the program. So, it's here. The unfortunate thing is that there are alot of newbies checking things out here who might not grasp that the hitting the fan business is to be expected for anything new and promising like this. Professional jealousies, industry protectionism, chronic naysaying, doom-prediction---CCSVI treatment has become and always would have become the target of these negativities. It's the way things work in the world.

What we need to do is to stay calm, not over-react to vicious rumors, and understand that this is the natural course of things like this. Let's not take any of this crap to heart, but instead, let's just be level-headed and patient.

[prof8]

I'm feeling pretty calm! I don't have a problem with people wanting to see more evidence/testing and calling for additional studies. But passing on erroneous information is not good.

I was just wondering where this respected medical clinic is getting information about the FDA and CCSVI? Or is the doctor just making stuff up and lying with intent?

[tzootsi]

Does anyone know the real story here? I can't imagine the FDA doing something like that.
I live near Dartmouth Hitchcock, and I spoke to their MS department about CCSVI last week. The response was - 'nothing is planned for CCSVI, it doesn't hold up scientifically' . Huh?? On the other hand my wife's neurologist, who we saw yesterday, seemed to be quite interested, even encouraging my wife to go to Buffalo to be in the study.

[mrsilkykat]

I called Dr. Dake's Stanford office Monday 11/30. The woman who answered the phone said everything is on hold pending clinical trials starting next year. They are taking names & info & sending out info packets at the end of December.

I have no idea if this is correct. Maybe I'll call again & find out if I get the same response.

[CureIous]

It was my understanding that this was supposed to happen, treat x patients then start a formal study with criteria for entry. Remember that Dr. D put his entire practice aside for this, and will probably spend this month recharging his batteries before getting on with business come the 1st of the year.

Mark.

[prof8]

Well he does have at least 3 people lined up in December. But I think you are right. We heard awhile back that he was planning clinical studies. The study will have very specific criteria. What I wonder is whether he will limit it to only RRMS to get more obvious results? Or maybe he will have a separate PPMS/SPMS study later?

[MrSuccess]

This is good news. A Clinical Trial. Dr. Dake has endured a pretty steep learning curve. And now knows who his friends are. Some of the comments posted about stent surgery .....have been ludicrous.

Dr. Dake's conclusions will be as fascinating as the Zamboni papers.

Think of all the grateful people these wonderful doctors have helped.






Mr. Success

[brave]

I Live 10 miles from Stanford and since 5 weeks ago I have left about 6 messages for Alex and Darcey, they haven't returned my calls at all.
At least they could let me know, they got my messages. so disapponting.

[Algis]

I've received an email from ms-mri where I reg last week.

Body of the email is:


...
Many sites are in the process of getting the approval from the institutional review board (IRB) also known as an independent ethics committee (IEC) or ethical review board (ERB) is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. The approval to study MS patients for the CCSVI and SWI connection has not been completed yet. Please check into the website at www.ms-mri.com after Christmas and we will post the status of our proposal. We cannot solicit patients for research until such approvals are obtained. Please do not send us any data at this time. It takes a special set of MR sequences to investigate the vessels in the head and neck. It is important to realize that there is a lot work to be done to test Zamboni’s hypothesis and that if we do it carefully it will benefit everyone far more than rushing into it unprepared. Finally, please be patient as the scientific approach must take its course for the benefit and protection of all concerned.

Sincerely,
...


Therefore I think that suspension or ban or whatever else is just hearsay. All entities are just jammed with requests.

Hope this help, cheers,

Algis

[mormiles]

I also called Dr. Dake's office on Monday with regard to Steve's follow-up imaging scheduled for December 10, a week from today. On my first call, I used the number on Dr. Dake's stationery. I got a recording that sounded unpromising. I called back later in the day to a number I found on this forum, and Angela answered directly. She turned me over to Alex who got the answer to my question from Dr. Dake while I held. Angela, for whom I had left the earlier message, had never received it. So, I guess any problems reaching Dr. Dake's office may have alot to do with which number is called. To get the "good" number, I searched the site with the words "Dake contact."

[jay123]

PLEASE - THIS IS A RUMOR AND NOT TRUE---

I just talked to Alex yesterday and everything is moving along as planned - they are not shut down!!!


MDE, is there anyway to change the title of this thread to show it is wrong?

[prof8]

Well I did put the title of the thread in quotation marks (to indicate the statement came from someone else) and several question marks. It's a question not a statement of fact. I'm sure people are smart enough to read through the thread and discover that Alex said things are still going as planned.