Dr. Hubbard's update on the FDA

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Re: Dr. Hubbard's update on the FDA

Postby Rogan » Tue Nov 19, 2013 12:16 pm

Sorry 1eye, I can't explain the evolutionary explanation for these viruses other than to conclude they like all cells (they aren't even cells) want and need to reproduce.

What I can post is a link to Dr Hubbard that has unfortunately only been viewed 175 times.

Here he explains his theory for how hypoperfusion in the brain kills the oligdendroytes, which are cells that make the myelin which starts the whole cascade we call MS.

http://www.youtube.com/watch?v=iJF5VRKCYWs&feature=c4-overview&list=UUeeVQyQmU-Fg2dMXOViVCtw

Here are some cool slides from the presentation:

Overview:

Auto immune theory Status
Oligodendrocyte apoptosis (death)
Hypoperfusion and CNS venous drainage
BBB permeability
fMRI BOLD venous undershoot Study
Perfusion Study
Venoplasty summarized
Clinical Outcomes of Venoplasty Study
Conclusions and Recommendations


Slides on the work of John Prineas and Michael Barnett who proved that

Oligodendrocytes die first, white cell enter later

His slides showing the prefusion Pre and Post Venoplasty

His conclusions

Auto-immune theory is unproven
Immunosuppressant drugs are marginally effective and incredibly expensive
Oligodendrocyte damage may be primary and may be related to poor venous flow and hypoperfusion
Preliminary evidence of efficacy for venoplasty

His Recommendations

Don't discontinue your DMD's
Double-blind studies are planned
But, study design is complex
MS-MRI plus MRV and MR perfusion (ask you docs for an MRV and MR perfusion report when your getting you MS check up)
If abnormal, consider venoplasty
Learn about what else you can do to be proactive, Google Scholar
Double-blind vs Double-Hope.
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Re: Dr. Hubbard's update on the FDA

Postby Rogan » Mon Dec 02, 2013 10:26 pm

How can the FDA stop this trial?

They are over reaching their own mission.



What We Do
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.


Nowhere do they have the authority to regulate surgeons!
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Re: Dr. Hubbard's update on the FDA

Postby cheerleader » Tue Dec 03, 2013 9:14 am

But they can regulate devices, Rogan. Balloons and catheters and (potential) stents used to treat CCSVI fall under the FDA's category of medical devices.

The problem is, these devices were created for arterial use, and have never been approved for use in venous situations. All use of these devices inside veins is considered "off-label." However, IRs have been using them for decades in the veins. It's a catch 22. And since CCSVI is the first procedure to ever go up against pharmaceutical means of treatment for a patient, it is being shut down as long as possible, by the government arm which protects industry. And, "patients."

Just as they are now "protecting" people from using their own stem cells to treat their medical conditions,
http://www.manhattan-institute.org/html/lpr_17.htm
and blocking people purchasing OTC genetic testing, so they cannot learn for themselves what their genetic profile looks like, because taking your own health into your own hands might kill you.
http://www.slate.com/articles/technolog ... netic.html

Yes, they are protecting patients from treatments, knowledge and healing.
But soon, even though their OWN MEDICAL STAFF advised against it, they will approve the deadly cancer drug Campath/Lemtrada for use in MS. Because, well....because MS is a terrible disease, and people with MS need every tool in the arsenal. http://www.medpagetoday.com/Neurology/M ... osis/42899
(Except their own stem cells, or a venoplasty procedure.)
The bottom line is protecting pharma. It's become quite clear.
http://ccsviinms.blogspot.com/2013/10/t ... rosis.html


cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Dr. Hubbard's update on the FDA

Postby Rogan » Fri Dec 06, 2013 10:49 am

Thanks Cheerleader:

Just great they are worried about catheters now! WTF.

Perhaps they could regulate anatomy next. If they could just make it illegal to have clogged veins or compressed veins from bones or muscles we could put this whole CCSVI thing behind us and get on with Healthy living.

I have a splinter in my finger right now. Does using a tweezer and needle fall under their regulatory umbrella also? I really don't want to break the law, as I remove this splinter. I assume tweezers and needles should be considered medical devices also.

Thanks for the links on how Pharma pays docs. But I still have trouble really believing this lets them just buy the FDA. I have met many federal regulators and they are individually really quality people. They all went to college, they all received good grades, they are all quality citizens, and they all actually care about our country.

I believe they are just mis-guided on their approach. Never mistake a conspiracy for stupidity.
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Re: Dr. Hubbard's update on the FDA

Postby 1eye » Fri Dec 06, 2013 11:53 am

Even quality people can be bought. That's why Obama gave Wall Street what they wanted. Lobbyists control the democracies of the world, and the only thing they value is money.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Re: Dr. Hubbard's update on the FDA

Postby NHE » Fri Dec 06, 2013 3:46 pm

cheerleader wrote:and blocking people purchasing OTC genetic testing, so they cannot learn for themselves what their genetic profile looks like, because taking your own health into your own hands might kill you.
http://www.slate.com/articles/technolog ... netic.html



FDA, 23andMe settlement setback for personal analytics
http://www.zdnet.com/fda-23andme-settle ... 000024032/

Summary: Genetic testing service 23andMe said it will comply with an FDA order and that means you'll get a DNA data dump without any interpretation. What's the point?

23andMe said it will only provide ancestry analysis for its genetic testing service and raw data without interpretation following a scuffle with U.S. Food and Drug Administration.

In other words, the most important part of 23andMe's business and a cog in the quantified self movement---you and your health as a ecosystem to be measured and analyzed---took a hit.

The FDA's beef was that 23andMe, which offered genetic tests and then analyzed the data for individuals, shouldn't be able to advertise and offer analysis without its approval. In a blog post, 23andMe CEO Anne Wojcicki said the company had been talking to the FDA since 2008 and submitted an application for clearance in July 2012.

So now 23andMe will comply with the FDA and end consumer access to its health related genetic tests pending a review. What's left is ancestry-related analysis and raw genetic data without the interpretation.

Add it up and 23andMe now has to offer a big data firehouse without the analytics. Thanks for nothing.

Customers who received or purchased kits for health-related results before Nov. 22 will still have access to the data and analysis.

It has been an open question whether consumers would rush out to get their genes analyzed to flag potential problems, but enough folks used 23andMe to indicate that there's a business there. The FDA is late to the game and hampering what could be called a window into personal analytics.
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Re: Dr. Hubbard's update on the FDA

Postby Robnl » Fri Dec 13, 2013 11:56 pm

:-D Approved!!!

Read the latest newsletter

FDA Registry Status
FDA approves venoplasty research for MS!!!!
Today the FDA finally and formally approved our Registry to treat and follow MS patients with abnormalities of their internal jugular and azygos veins. In May 2012, FDA stopped all CCSVI (chronic cerebrospinal venous insufficiency) research without their approval as an “investigational device exemption” (IDE). Hubbard Foundation immediately applied for the exemption and today a year and a half later, and after virtually monthly objections and revisions, we finally received approval.
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Re: Dr. Hubbard's update on the FDA

Postby MrSuccess » Sat Dec 14, 2013 12:15 am

this is another reason why MrSuccess has always desired that Dr.Hubbard should act as the lead medical expert in all things CCSVI.

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Re: Dr. Hubbard's update on the FDA

Postby erinc14 » Sat Dec 14, 2013 8:38 am

Robnl wrote::-D Approved!!!

Read the latest newsletter

FDA Registry Status
FDA approves venoplasty research for MS!!!!
Today the FDA finally and formally approved our Registry to treat and follow MS patients with abnormalities of their internal jugular and azygos veins. In May 2012, FDA stopped all CCSVI (chronic cerebrospinal venous insufficiency) research without their approval as an “investigational device exemption” (IDE). Hubbard Foundation immediately applied for the exemption and today a year and a half later, and after virtually monthly objections and revisions, we finally received approval.

where's the link
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Re: Dr. Hubbard's update on the FDA

Postby cheerleader » Sat Dec 14, 2013 9:43 am

It's official, they've finally been approved!!

Here's the link:
http://us7.campaign-archive1.com/?u=108 ... f862785e41

It's exceptionally good news. (although taking a year and a half of back and forth letters to the Hubbards felt like a stalling technique--perhaps to give time for the new meds, and get interest in the procedure to die down? Who knows.)

Dr. David Hubbard is to be commended for his continuned interest in helping people with MS heal. From their website:
When David Hubbard MD neurologist, and Arlene Hubbard, MS, OTR/L learned their son Devin had multiple sclerosis they reviewed the medical literature, determined that the auto-immune theory had not been validated, and that the immunosupressant drugs are marginally effective; they decided to shift the focus to improving CNS venous drainage and perfusion and avoiding foods that cause inflammation.


It's a good day,
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dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Dr. Hubbard's update on the FDA

Postby erinc14 » Sat Dec 14, 2013 11:09 am

thanks , I sent to the cbc and ctv.
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Re: Dr. Hubbard's update on the FDA

Postby Cece » Sat Dec 14, 2013 3:44 pm

Persistence pays off! He could easily have given up. I am still confused why a registry need FDA approval.
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Re: Dr. Hubbard's update on the FDA

Postby cheerleader » Sat Dec 14, 2013 4:35 pm

Cece-- agree, their persistence really paid off.
Here's an explanation of the history and why the FDA got involved. It wasn't about the registry itself, per se, but more about the off-label use of FDA monitored catheters and balloons, and the need for an IDE to have treatment done. There was no registry, if there was no treatment allowed.
https://www.facebook.com/notes/ccsvi-al ... 8455731185
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Dr. Hubbard's update on the FDA

Postby Rogan » Sat Dec 14, 2013 5:55 pm

This is just great news, to further advance our understanding of CCSVI.

I would really like to think that the FDA takes their mandate from Congress seriously and is truly….

"responsible for advancing the public health by helping to speed innovations that make medicines more effective"


Thanks much to the Hubbards!!!!!!
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Re: Dr. Hubbard's update on the FDA

Postby MSandI » Sun Dec 15, 2013 9:17 am

Hi
I was just wondering will this have positive effects for Canadians as well? I sure hope so.
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