Naar homepage     
Chronische Cerebro-Spinale Veneuze Insufficiëntie
Aanmelden op het CCSVI.nl forum
Lees Voor (ReadSpeaker)    A-   A+
Over CCSVI.nl | Zoeken | Contact | Forum
PayPal, de veilige en complete manier van online betalen.

iDeal
CCSVI.nl is onderdeel van de
Franz Schelling Stichting
meer informatie
  
Monday, May 21, 2012 10:32 PM | MARIO MORAIS Volg link

REMEMBER WE LIVE IN A DEMOCRACY! ADD YOUR COMMENT FOR THE FDA!


------------------------------------------------------------------------------------


AT WEB SITE ---http://www.regulations.gov DO SEARCH ON 'CCSVI' AND YOU WILL GET THIS!!


---------------------------------------------------------------












Mario Morais - Citizen Petition

Other


FDA


FDA-2012-P-0119-0001


02/29/2012



Comment Now! Open Docket Folder

--------------------------------------------------------------


THE REQUEST TO THE FDA IS!!


------------------------------------------------------


================================================


1ST REQUEST FOR FDA


===================================================


---------------------------------------------------------------


1)


I WOULD LIKE THE FOOD AND DRUG ADMINISTRATION TO ISSUE AN ANNOUNCEMENT THAT IF THE PATIENT IS HAVING NEUROLOGICAL PROBLEMS, CHECKING THE BLOOD DRAINAGE FROM THE BRAIN MAY BE A BENEFIT TO THE PATIENT AND IF THERE IS A BLOCKAGE, THE PATIENT MAY DECIDE TO HAVE IT FIXED!


I DO NOT FEEL THAT THE FDA WAITING FOR 'PROOF' WILL BE A MISTAKE NO ORGANIZATION WILL SPEND 1 BILLION DOLLARS TO PROVE TO THE FDA THAT A SIMPLE PROCEDURE WILL HELP THE PATIENT AND WAITING FOR 'PROOF' WILL NOT HELP THE PATIENTS OF THE U.S. PLEASE SEE THE SOLUTION FOR THE FDA.


--------------------------------------------------------


The Theory


Zamboni – whose own wife has MS – recognized that in many patients, the three veins responsible for draining blood from the brain (the two jugulars and the azygos) are tangled or constricted. He named this symptom "chronic cerebrospinal venous insufficiency," or CCSVI. In a healthy adult, blood vessels in the brain are impermeable to many of the blood’s contents – the blood brain barrier protects the brain from potential harm (e.g. bacterial cells) and only gives passage to smaller molecules like oxygen, carbon dioxide, hormones, and so on. Zamboni hypothesizes that poor drainage caused by CCSVI might cause a reflux of blood into the brain that increases blood pressure. The results of this pressure are twofold. First, iron is deposited out of the blood and into the brain. Second, if blood vessels are stretched out, they can tear microscopically and leak immune cells into the brain. The immune system then attacks the iron deposits, and MS results.


This is where the liberation procedure comes in. Zamboni proposed that balloon angioplasty, a common technique for widening blood vessels, should alleviate the symptoms of MS. Last year, he published a study of 65 MS patients who underwent the surgery; two years after the procedure, 73% of the subjects had no symptoms. Since his research was initially reported, many MS patients throughout the world have sought the liberation treatment from angioplasty surgeons.


--------------------------------------------------------------------


I HAVE MULTIPLE SCLEROSIS AND I WANT TO SEE IF I HAVE A BLOOD CIRCULATION PROBLEM! IT'S A PROCESS DISCOVERED BY PROFESSOR ZAMBONI FROM ITALY, HIS WIFE WAS DIAGNOSED WITH MS. AND HE FOUND OUT THAT HER JUGULAR VEIN WAS BLOCKED. SO HE INSERTED


A BALLOON TO OPEN UP HER JUGULAR VEIN AND HER MS SYMPTOMS DISAPPEARED, THE FIX PROCEDURE IS CALLED CCSVI, OR THE LIBERATION PROCEDURE, SO THIS DISEASE MAY BE A REAL VASCULAR PROBLEM. BUT DOCTORS IN THE U.S. WILL NOT PERFORM THE PROCEDURE, I HAVE TYRED TO FIND OUT WHY I KEEP GETTING BECAUSE THE FDA HAS NOT 'approved' THIS VERY NON INVASIVE PROCEDURE. ITS THE SAME PROCEDURE THAT TELLS A MOTHER WEATHER THE CHILD IN HER WOMB IS A BOY OR A GIRL. THE PROCEDURE IS VERY SAFE AND VERY NON-INVASIVE!


DOES ANYBODY ELSE SEE THE PROBLEM HERE. A COMPANY OR ORGANIZATION MUST PROVE TO THE FDA THAT A SIMPLE NON-INVASIVE PROCEDURE CAN HELP THE PATIENT TREMENDOUSLY BUT THAT COMPANY OR ORGANIZATION WILL NOT BE ABLE TO RECOUP THE BILLION DOLLARS NEEDED TO GET FDA ‘approval’ . SO THERE IS NO FINANCIAL INCENTIVE. THE CURRENT CHECKS AND BALANCES ARE VERY MUCH AGAINST THE SICK PERSON. THE SYSTEM DOES NOT PRODUCE REVENUE BY BENEFITING THE SICK PERSON!


WOW, THE FDA WAS NOT CREATED TO HELP SICK PEOPLE, WHAT A WASTE OF TAX MONEY. I BELIEVE THE FDA NEEDS TO BE PROACTIVE INSTEAD OF JUST REACTIVE AND ACTUALLY HELP THE SICK PERSON. NOT BEING PROACTIVE TO HELP THE SICK PERSON, MAKES THE FDA A DANGEROUS GOVERNMENT AGENCY.


I HAVE DONE A TREMENDOUS AMOUNT OF RESEARCH BUT THIS INFORMATION I WILL SHARE WITH EVERYONE AND I GOT THIS INFORMATION FROM THE WEB SITE:


http://www.youtube.com/watch?v=s2UJ3Hbm6qI


I DID THE BEST I COULD AT TRANSLATING WHAT THE DOCTOR WAS SAYING BUT IT WAS IN BROKEN ENGLISH:


----------------------------------------------------------------


Dr. Marian Simka from Poland talks about CCSVI


-----------------------------------------------------------------


CCSVI THE VENUS PATHOLOGY WHICH HAS BEEN FOUND BY PROFESSOR ZAMBONI FROM ITALY, THIS LOOKS LIKE A REAL VASCULAR PROBLEM AND IT WAS FOUND TO BE HIGHLY CORRECTED WITH MUSCULAR SCLEROSIS AND MOST LIKELY IT GIVES A NEW CHANCE FOR THOSE PATIENTS AND TREATMENTS WHICH WAS NOT VERY GOOD IN THE PAST, AND NOW WE ARE SEEING ALLOT OF IMPROVEMENTS IN THOSE PATIENTS AND WE THINK THAT THIS DISCOVERY OPENS A NEW CHAPTER IN TREATING THIS INCURABLE DISEASE.


----------------------------------------------------------------------------------------------------


SO WHAT IS THE FDA DOING? THE FDA IS WAITING FOR PROOF! SO THE FDA IS DOING NOTHING!


NOTHING!


---------THE-SOLUTION-FOR-THE-FDA----------------------------------


---------THIS-PROCESS-WILL-BENEFIT-THE-US-CITIZEN---------------------


I HAVE A REALLY SIMPLE, YET EFFECTIVE SOLUTION FOR THE CCSVI OR 'THE LIBERATION PROCEDURE'.


YOU GO TO YOUR FAMILY DOCTOR AND YOU HAVE SOME NEUROLOGICAL PROBLEMS HE/SHE ROUTINELY ORDERS MRI'S AND OTHER TESTS AND THEN HE MAY OPT TO SEND YOU TO A NEUROLOGIST. WHY NOT MAKE THIS NON-INVASIVE PROCEDURE TO SEE IF THE VEINS THAT EMPTY BLOOD FROM THE BRAIN ARE BLOCKED. IT'S A NO BRAIN-ER!


CCSVI SHOULD BE A HUMAN RIGHT NOT RELATED TO MS. MS MAY BE A REASON TO GET TESTED AND IF YOUR 90% BLOCKED YOU MAY WISH TO HAVE IT FIXED IF YOU ARE 10% BLOCKED YOU MAY OPT OUT OF HAVING THE FIX PROCEDURE. WHY DOES SCIENCE NEED A CORRELATION BETWEEN THE TWO. I HAVE MS AND I HAVE THE RIGHT TO KNOW IF MY VEINS ARE RESTRICTED. ITS A HUMAN ISSUE NOT JUST AN MS ISSUE!


WHO CARES IF IT ONLY HELPS 10% OF PEOPLE OR 80% OF PEOPLE, ITS THEIR RIGHT TO KNOW. ALL THE FDA NEEDS TO DO IS ISSUE A STATEMENT THAT WOULD HELP PATIENTS! EVEN IF ONLY 10% OF THE PEOPLE DECIDE TO HAVE THE PROBLEM FIXED ,


IT'S THEIR RIGHT TO KNOW!


------------------------------------------------------------------------