SORRY TO PLACE MY BLOG AGAIN, BUT THE LAST COPY WAS HARD TO READ AND I HOPE THIS COPY OF MY LETTER IS EASIER TO READ! AGAIN PLEASE LET THE FDA KNOW HOW YOU FEEL, LETS KEEP UP THE GOOD FIGHT...THE WAY I SEE IT IS THE FDA 'protects' DISEASE, AND THE LARGE DRUG COMPANIES PROFIT FROM DISEASE. LETS TRY TO TAKE SOME CONTROL OF THIS COMMUNISTIC HEALTH CARE MONOPOLY!
DR. MAISEL IS THE DEPUTY DIRECTOR OF SCIENCE HE CAN BE REACHED AT 1-301-796-5900 HE SAID 'FDA encourages rigorously-conducted, properly-targeted research to evaluate the relationship between CCSVI and MS," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA’s Center for Devices and Radiological Health' BASICALLY HE IS SAYING WE WILL KILL THIS PROCEDURE BECAUSE THE 'CLINICAL TRIALS; WERE CREATED TO FAIL!
ALSO THE MEDIA REPRESENTATIVE IS MICHELLE BOLECK AT 1-301-796-2973, BUT I HAVE FOUND THAT MS. BOLECK SOMETIMES FORGETS TO ANSWER YOUR PHONE MESSAGES REQUEST FOR A CALL BACK, EVEN THOU SHE IS A PUBLIC AFFAIR SPECIALIST.
THE PEOPLE AT THE FDA WHO ARE 'RESPONSABIL' TO THE PUBLIC ARE IN THE DIVISE GROUP I BELIEVE. THE NAMES I HAVE ARE CYNTHIA BENSON AT 1-301-796-5862, BONNIE ALDERTON AT 1-301-796-5858, CONNIE DALY AT 1-301-796-5860, AND GENE ALLEN AT 1-301-796-5859.
REMEMBER YOUR VOICE IS ONLY AS INPORTANT AS YOU MAKE IT!
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MARIO MORAIS
4 GLEN ROAD, APARTMENT # 103
HUDSON, MASS., 01749-1365
PHONE: 978-212-5156 / Email: marioTTTmorais8@gmail.com
----------------------------------------------------DATE JUNE 11, 2012
The Department of Food and Drug Administration
MS. LINDSAY LLOYD / Dr. William Maisel, M.D., M.P.H., / ALSO
Ms MARGARET HAMBURG / COMMISSIONER OF FDA
WASHINGTON, DISTRICT OF COLUMBIA
OFF # 301-796-5000 / FAX 301-796-9840 / Margaret.Hamburg@fda.hhs.gov
OFF # 301-796-4866 / lindsay.lloyd@fda.hhs.gov / william.maisel@fda.hhs.gov
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RE: I WOULD LIKE TO EXPLAIN TO THE DEPARTMENT OF FOOD AND DRUG ADMINISTRATION THAT THE SIMPLE PROCEDURE KNOWN AS CCSVI, REALLY HELPED ME, AND I DO NOT UNDERSTAND THE FDA'S NEWS RELEASE OF THIS EASY NON-INVASIVE PROCEDURE THAT HELPS SICK FOLKS!
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DEAR DR. WILLIAM MAISEL AND MS. LINDSAY LLOYD AND MEMBERS OF THE DEPARTMENT OF FOOD AND DRUG ADMINISTRATION:
I WOULD LIKE TO GIVE YOU DR. MAISEL AND MS. LLOYD AT THE FDA, MY EXPERIENCE AND KNOWLEDGE OF MULTIPLE SCLEROSIS --MS--! I HAVE HAD MS FOR ABOUT 25 YEARS NOW!
MY EXPERIENCE HAS RE-ENFORCED THE FACT THAT I AM SURE THAT MS IS IN PART DUE TO A VIT B-1 DEFICIENCY --THE BODY CANNOT PRODUCE VIT B-1! THE INABILITY OF THE BODY TO PRODUCE THE VIT B-1 LEADS TO NO-ENERGY. AND NO-ENERGY IS A VERY COMMON TRAIT WITH MS PATIENTS. I INJECT VIT B-1 EVERYDAY AND I HAVE MUCH MORE ENERGY.
THE 2ND CAUSE FOR MS IS MS IS IN PART DUE TO A BLOOD VASCULAR PROBLEM, THE MAIN ARTERIES THAT DRAIN BLOOD FROM THE BRAIN GET EITHER CONSTRICTED OR CLOGGED, THE CONSTRICTED OR CLOGGED BLOOD VEINS WILL CREATE AN AUTOIMMUNE REACTION.
THE BRAIN USES THREE MAIN BLOOD VESSELS TO DRAIN BLOOD. THE THREE MAIN VEINS THAT DRAIN BLOOD FROM THE BRAIN ARE THE 2 JUGULAR VEINS AND THE AZYGOUS VEIN. IF THESE VEINS GET CONSTRICTED IT WILL CAUSE A BACK FLOW OF BLOOD BACK TO THE BRAIN. THIS CAUSES A LAYER OF BLOOD IN THE BRAIN. THAT LAYER OF BLOOD CAUSES IRON DEPOSITS AND IRON DEPOSITS IN THE BRAIN LEADS TO AN AUTO-IMMUNE REACTION, JUST LIKE IN MS!
HERE IS THE DEFINITION OF THIS PROCEDURE!
http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_insufficiency
CURRENTLY, WE HAVE A HEALTH CARE SYSTEM THAT ROUTINELY CHECKS AND FIXES THE ARTERY'S AND VEINS TO THE HEART.
THE BLOOD FLOW TO THE HEART IS IMPAIRED, AND SOMEONE CAN GET A HEART ATTACK! NOW I'M SURE SOME PROBLEMS ARE SELF INFLICTED. WE EAT MORE FATTY FOODS. WE EAT A HIGHER CHOLESTEROL DIET. AND THE LIST GOES ON!
LET ME ASK YOU A VERY SIMPLE QUESTION, WHAT ARE THE CHANCES THAT ANOTHER VEIN OR ARTERY IS ALSO RESTRICTED! THE CHANCES ARE VERY HIGH!
I WANTED TO KNOW IF MY VEINS WERE CONSTRICTED, I FIRST TYRED THE CLINICAL TRIALS BUT THEY WERE FOR 'education purposes only' THEY WOULD CHECK YOUR VEINS AND THEN TELL YOU YOUR PERCENTAGE BLOCKED, BUT THEN THE CLINICAL TRIALS WOULD NOT FIX THE CONSTRICTED VEIN....
THE EDUCATION THE CLINICAL TRIALS WERE OFFERING IS NOT WHAT I WANTED...I WANTED IT FIXED BUT THE CLINICAL TRIALS JUST WANTED TO ASSOCIATE CONSTRICTED VEINS TO MS. AND ALSO THE CLINICAL TRIALS ONLY CHECK THE NECK VEINS NOT REPEAT NOT THE 2 JUGULAR VEINS AND THE AZYGOUS VEIN, THOSE 3 VEINS ARE PROTECTED BY HARD TISSUE AND NEED ANOTHER TEST, LIKE AN MRI, TO GET PICTURES OF THEM. AND FINALLY THE CLINICAL TRIALS WANTED THIS PROCEDURE TO CURE MS... NOTHING KNOWN TO MANKIND CURES MS, NOT EVEN THIS SIMPLE PROCEDURE. I HAD THE PROCEDURE AND I HAVE A BETTER QUALITY OF LIFE BUT I STILL HAVE MS!
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I BELIEVE THE CLINICAL TRIALS WERE DESIGNED TO FAIL. THE HURDLE THE CLINICAL TRIALS ARE ASKING FOR A SIMPLE OUT-
PATIENT PROCEDURE IS SET WAY TO HIGH, NOTHING KNOW TO MANKIND CURES MULTIPLE SCLEROSIS!
=========================================================
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
BUT A BETTER QUALITY OF LIFE IS ALL WE SICK FOLKS WANT!
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
ON MY OWN, I TYRED TO GET A VASCULAR DOCTOR TO CHECK MY VEINS, BOY WHAT A TASK THAT WAS, THE DOCTOR SCHEDULED A TEST TO CHECK MY NECK VEINS ONLY, UNFORTUNATELY NOT THE CORRECT VEINS. I BELIEVE THOSE ARE THE VEINS THE CLINICAL TRIALS ARE CHECKING, THE TEST SHOWED MY NECK WAS FINE.
BUT I WANTED BOTH MY JUGULAR VEINS AND MY AZYGOUS VEIN CHECKED. BUT I FOUND ANOTHER DOCTOR AND HE AGREED TO PHOTO THE 3 MAIN VEINS. I TOLD HIM THAT IF PICTURES SHOWED RESTRICTIONS, I WOULD GO TO A SPECIAL CLINIC AND ASSURED HIM HE WOULD NOT NEED TO DO THE FIX. THE PHOTOS SHOWED THAT ALL 3 OF MY MAIN VEINS WERE RESTRICTED.
I HAD THIS PROCEDURE DONE, IT WAS A 2 HOUR OUT-PATIENT PROCEDURE, I WAS AWAKE THRU THE WHOLE PROCEDURE AND I SLEPT THAT NIGHT IN MY HOTEL ROOM!
THE RIDE TO THE VASCULAR CLINIC WAS MORE DANGEROUS THAN THE PROCEDURE ITSELF! THIS PROCEDURE WAS VERY SAFE AND EVERY PERSON I HAVE EVER TALKED TO WAS VERY HAPPY WITH THE PROCEDURE RESULTS, MYSELF INCLUDED!
SINCE I HAVE HAD THIS PROCEDURE, THE CLINIC I WENT-ON TO NO LONGER PERFORM THIS PROCEDURE. THE FDA STOPPED THEM FROM PERFORMING THIS SIMPLE AND EFFECTIVE PROCEDURE. IT APPEARS THE FDA CAN PROTECT THE SICK PERSON FROM A SIMPLE BENEFICIAL PROCEDURE, AND MAINTAINE YOUR DISEASE!
LET ME GIVE YOU MY EXPERIENCE, AFTER THE PROCEDURE, THE DIFFERENCES WERE POSITIVE AND AUTOMATIC. I CAN NOW OPEN MY OWN WINDOW! THE WINDOW OPERATES WITH A CRANK, AND I FOUND IT TOO DIFFICULT, BEFORE THE PROCEDURE, TO MOVE THE CRANK. I FIND THAT NOW I CAN TURN THE CRANK BOTH CLOCKWISE AND COUNTER CLOCKWISE, AFTER THE PROCEDURE. MY STRENGTH HAS GREATLY IMPROVED
I CAN NOW TURN MY A/C ON AND OFF, EASILY! I HAVE A KNOB WITH 3 SETTINGS, I TYRED TO ILLUSTRATE THE A/C KNOB BELLOW;
...........................OFF
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------------------------ ..........--
----------------------.......I I.......--...HIGH
-------------------..........I I..........--
------------------...........I I...........--
-----------------............I I.............--...MEDIUM
-----------------............I I.............--
-------------------........................--
-------------------........................--...LOW
----------------------..................--
-----------------------------------
NOW I CAN EASILY CHANGE THE A/C UNIT BETWEEN HIGH/MEDIUM/LOW.
BEFORE THE PROCEDURE I TYRED SO HARD THAT THE PAINT AND EVEN THE OFF/HIGH/MEDIUM/LOW SETTINGS HAVE FADED AND ARE ALMOST GONE. I RUBBED MY FINGERS AGAINST THE A/C UNIT, BECAUSE I HAD A VERY HARD TURNING JUST THE KNOB.
THE REASON IS MY FEELINGS AT THE FINGERS ARE MUCH BETTER. I CAN NOW DISTINGUISH BETWEEN THE KNOB AND THE A/C UNIT, IN OTHER WORDS I KNOW LONGER PUT ANY PRESSURE ON THE A/C INDICATORS! I JUST TURN THE ONLY THE NOBE.
AND THE LIST GOES ON BUT I WILL STOP BY SAYING THAT THE PROCEDURE WAS THE BEST THING I'VE DONE AFTER THE VIT B-1!
BUT NEITHER OF THOSE 2 THINGS CAN BE PATENTED BY AN ORGANIZATION! IN OTHER WORDS IT IS NOT FINANCIALLY
FEASIBLE TO SPEND HUNDREDS OF MILLIONS OF DOLLARS TO PROVE TO THE FDA THAT SOMETHING SO SIMPLE MAY HELP A PATIENT.
HERE IS MONTEL WILLIAMS EXPERIENCE REGARDING CCSVI
http://www.doctoroz.com/videos/montels-own-procedure?mid=51
THE FDA ANNOUNCEMENT SAYS 'studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.' WHY MUST A LINK EXIST BETWEEN MS AND THIS PROCEDURE. THIS IS A HUMAN ISSUE NOT AN MS ISSUE!
MS CAN BE A REASON TO CHECK THE LEVEL OF RESTRICTION! THEN ITS THE PATIENTS DECISION IF HE/SHE WOULD LIKE IT FIXED!
ITS A HUMAN ISSUE!!! ALL FOLKS DESERVE TO KNOW REGARDLESS OF HIS/HER CONDITION
I BELIEVE THE FDA IS MAKING FOLKS GO TO PERFORM UNSAFE PROCEDURES SOMETIMES EVEN OUTSIDE THE USA, THEN THE FDA STOPS THE PROCEDURE BECAUSE OF THOSE FOLKS THAT WERE FORCED TO GET DANGEROUS PROCEDURES! THAT LOGIC MAKES NO SENSE TO ME.
I BELIEVE THE MOST DANGERS RESULT, IS NOT ALLOWING THIS SIMPLE PROCEDURE, AND THUS ALLOWING THIS AUTO-IMMUNE DISEASE TO PROGRESS, ALLOWING DISEASE PROGRESSION IS MUCH MORE DANGEROUS THAN THIS SIMPLE PROCEDURE, KNOW AS CCSVI!
HERE IS AN ARTICLE THAT DESCRIBES CCSVI BY DR. ZAMBONI
http://singularityhub.com/2010/07/13/cure-for-multiple-sclerosis-controversial-liberation-procedure-moves-forward/
THE ARTICLE SAYS '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.'
SO THE THREE VEINS ARE LISTED. WHAT 'proof' DOES THE FDA NEED. WHY IS FDA UNSURE WHICH VIENS NEED TO BE CHECKED. THE NEWS RELEASE SAID 'the criteria used to diagnose CCSVI have not been adequately established.'
I DO 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.
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The Complete 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.
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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!
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:
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Dr. Marian Simka from Poland talks about CCSVI
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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.
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I BELIEVE THE CLINICAL TRIALS ARE CREATED TO FAIL! AND FDA'S DESIRE FOR ONLY CLINICAL TRIALS CAN PERFORM THIS PROCEDURE IS STOPPING SCIENCE, THE FDA IS ACCOMPLISHING THE OPPOSITE OF THE FDA'S STATED DESIRE!
THE FDA FEELS THAT EVERYBODY IS DUMB AND NEEDS THE PROTECTION OF THE FDA. EVEN IF THE FDA'S PROTECT LEADS TO THE PERSONS DISEASE GETTING WORSE!
PLEASE WILL THE FDA JUST HELP SICK FOLKS! INSTEAD OF PROTECTING SICK FOLKS TO MAINTAIN DISEASE AND EVEN PROTECTING THEM TO ALLOW THEIR DISEASE TO PROGRESS!
PLEASE STOP PROTECTING SICK FOLKS TO DEATH!
MARIO
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I FOUND THIS NEWS ARTICLE AS WELL, THE ARTICLE STATES THE BENEFITS OF THIS PROCEDURE.
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The Clinics of the Heart statement after the FDA warning for "high risk" procedure
Posted by
Rafael Moguelon May 21, 2012 at 11:01pm
Dear patients with
multiple sclerosis, relatives and caregivers.
This is a statement from The Clinics of the Heart staff about the recent FDA news released this may 10thalerting from injuries and death after the liberation treatment for CCSVI.
We, The Clinics of the Heart started an initial experience to test this procedure with ten patients suffering Multiple Sclerosis (MS) on diverse stages of the disease, based on the paper from Dr. Zamboni which resulted on slowing the progression and reducing the relapses on the majority of the patients.
We started this way because the published results sounded too good to be true. So we proposed a protocol that had the IRB authorization and we invited these ten patients that came to Los Cabos and received the treatment. We found that all of them had immediate changes to justify continuing doing the liberation treatment. I have to say that the operators at The Clinics of the Heart are Interventional Cardiologists and this is our most extreme experience looking improvements never seen before with any previous endovascular treatment for cardiovascular diseases, including the coronary intervention.
All patients signed the IRB approved informed consent form after the understanding of the characteristics of the procedure and the possible risks and we
completedthe analysis on the first 400 patients. The interim results were exposed as oral presentations in the last Congress of the Latin-American Society of Interventional Cardiology in Santiago (SOLACI), Chile 2011 and in the M3 Course of the Society for Cardiac Angiography and Intervention (SCAI) held in Miami on October 2011.
The results were as follows:
N = 390 patients from June/2010 through Jan/2011
(51±11 years old, male/women 31.6/68.4%)
Average time from diagnosis 17 years
Type of MS:
Relapsing-remitting 29.9% / Primary progressive 24.1% / Secondary progressive 46%
Left jugular was treated in 93.5% of patients
Right jugular in 96.4% of patients
Azygous in 20.4% of patients
Objective clinical improvement in 91.2% of patients
pre and post Expanded disability status (EDSS) scale (5.46 Vs 5.06)
Multiple sclerosis functional composite (MSFC) scale (0.07 Vs 0.15)
Instability (60 Vs 2%)
Hypoacusis (31.8 Vs 16.1%)
Tinnitus (35 Vs 5.5%)
all p<0.01
Fourteen self expanding stents were implanted to improve results.
Complications:
1.4% severe complications
:
Thrombosis of jugular or azygous veins
Femoral artery pseudo-aneurysm
Balloon rupture
Allergic reactions
As noted above we initially treated few azygous veins in order to avoid complications in this vein that is not accessible for surgery because it is behind the heart but there is clear that +90% of the patients had neurological improvements. Note also the very few complications rate even when we accepted patients on EDSS up to 8-9 and we found many patients with other diseases not previously diagnosed, such as symptomatic carotid obstructions, cardiac blockages (two of them requiring temporary pacemaker during treatment), severe coronary obstructions and one patient with
thrombocytopenia. None of these complications terminated in death or more inability.
What the people against the liberation treatment have only seen is the unfortunate very few deaths but after looking at the results, the benefit/risk ratio is amazing. The (p value) at the end of the results means that they are not casual (p<0.05 gives a true statistical significance).
We are sure that this CCSVI experience is causing a groundbreaking point in Medicine as it was for the cardiac surgery and coronary angioplasty. Note that many doctors in the 60’s hesitated about the relationship between the coronary obstructions and the heart attacks.
We are sure that the implementation of the jugular/azygous angioplasty into the treatment options for MS is a must in the next few years after the following evidence is confirmed:
Clear constant histopathological relationship between MS and blood vessels (Rindfleisch)
Clear constant presence of blood elements out of the blood vessels in the brain
Experimental reproducibility of MS lesions in animals (Putnam)
Neurological improvements after treatment with very low complication rate (many publications are in progress from many treating centers in the world)
Curative vs. palliative effect of treatment
Future research to identify causes and risk factors for valve obstructions in veins
Relationship of internal jugular/azygous valve veins obstructions with MS. Consider in this crucial point that:
There are several studies that excludes this relationship using non-invasive diagnostic methods such as ultrasound, computed tomography and magnetic resonance
Angiography is the diagnostic gold standard
Not all patients presenting venous obstructions will develop symptoms. Please remember that not all patients having coronary obstructions develop angina
The majority of medical procedures in the world, including USA and Canada are off label. This is because every indication based on clinical evidence rises from inclusion/exclusion criteria and many patients are not represented in such trials. A clear example is when cardiovascular diagnostic and treatment procedures are done in women or aging population
The angioplasty and stent placement in veins is regular practice to treat obstructions in coronary venous grafts, a-v fistulae for hemodialysis, proximal deep venous thrombosis, etc.
A special problem to resolve is related to restenosis. It means that after an angioplasty the vessel narrows again as an exaggerated response to trauma. It happens in all treated vessels and is cause of the return of symptoms in many patients.
Unfortunately all the CCSVI lovers (Doctors, patients and relatives) have some very hard obstacles to deal with:
Opposing pharmacy, doctors and establishment
Lack of follow up in the original countries (patients are treated abroad with the reluctance to be followed by local medical system) even after complications
Low price war by competing centers pushed by patients. This will end in cheap medicine, lower efficacy and higher complications risk
We like to thank to all the patients, as well as to their relatives, caregivers and supporters for their trust in the liberation procedure.
Thank you very much
Rafael Moguel MD FSCAI
Director
The Clinics of the Heart
Cozumel, Los Cabos
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