-------------------------------------------------------------------------------
IT APPEARS TO ME THAT THE CDRH GROUP WITHIN THE FDA IS VERY CORUPT.... BUT I KEEP CARRYING THE TORCH
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MARIO MORAIS
4 GLEN ROAD, APARTMENT # 103
HUDSON, MASS., 01749-1365
PHONE: 978-212-5156 / Email: marioTTTmorais8@gmail.com
--------------------------------------DATE JULY 05, 2012
--------------------------------------TODAY'S-DATE JULY 12, 2012
The Department of Food and Drug Administration
MS. LINDSAY LLOYD / Dr. William Maisel, M.D., M.P.H., / ALSO
CENTER FOR DEVICES AND RADIOLOGY HEALTH
10903 NEW HAMPSHIRE AVENUE
SILVER SPRINGS, MD 20993
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,CDRHOmbudsman@fda.hhs.gov, jeff.shuren@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,
#############################################################
RE: MS. LLOYD OR DR. MAISEL, OR MR. BUCKLES OR MR, ROMANEL PLEASE CALL ME
I WAS TOLD BY THE MAIN OFFICE OF DEVICE AT NO 1-301-796-5900, THAT MY LETTER WAS NOT FORWARDED TO 'EXEC SEC'. MS. LLOYD YOU HAVE NOT TOLD ME THE TRUTH. AND YOU DO NOT CALL! ARE YOU AND DR. MAISEL WORRIED ABOUT THE SAFTEY OF US CITIZENS! MY GUESS IS NO! SOMEBODY WHO IS WORRIED ABOUT THE PUBLIC DOES NOT LIE THEN IGNORE THE PUBLIC!
##############################################################
DEAR DR. WILLIAM MAISEL AND MS. LINDSAY LLOYD AND DR. DAVID BUCKLES, AND MR. LAWRENCE ROMANELL, AND MEMBERS OF THE DEPARTMENT OF FOOD AND DRUG ADMINISTRATION:
I DO NOT LIKE IT WHEN MS. LLOYD HANG UP ON ME..LINDSAY, PLEASE DO NOT HANG UP ON ME...AGAIN....THANK YOU.....I HAVE ALWAYS USED THE UTMOST MANNERS WHEN TALKING TO YOU!
YOU TOLD ME OVER THE PHONE THAT MY LETTER THAT I SENT YOU AND DR. MAISEL WAS SENT TO 'EXEC SEC' I WAS ASKING FOR THE EMAIL ADDRESS YOU STATED YOU WERE GOING TO SEND ME THE EMAIL ADDRESS AND HUNG UP ON ME.
PLEASE CALL ME BACK AND TELL ME THE ADDRESS OF THE 'EXEC SEC' OR EMAIL ME THE ADDRESS, I WOULD ALSO LIKE THE PHONE NUMBER!
I HAVE TYRED TO PHONE YOU MANY MANY TIMES WED, JUNE 20, 2012, AFTER YOU HUNG UP ON ME JUNE 20, 2012
I RECALLED ON THU JUNE 21, 2012 AT 11;00AM and 4;00 pm
I RECALLED ON FRI JUNE 22, 2012 AT 10;48AM and 3;55 pm
I RECALLED ON MON JUNE 25, 2012 AT 10;50AM and 4;05 pm
ALSO ON MON JUNE 25, 2012 I CALLED THE MAIN TELEPHONE NUMBER FOR THE OFFICE OF DEVICES AT 1-301-796-5900 . I WAS TOLD THAT MY LETTER WAS NOT SENT TO 'EXEC SEC'. IT APPEARS YOU LIED TO ME. I FAXED A COPY OF MY LETTER TO 1-301-847-8510 AND THE WOMAN SAID SHE WOULD PERSONNALY DELIVER A HARD COPY ALL 10 PAGES OF MY LETTER TO YOU. I ALSO ASKED HER TO PLEASE TELL YOU TO CALL ME AT 978-212-5156! YOU HAVE NOT!
I RECALLED ON TUE JUNE 26, 2012 AT 10;30AM and 4;19 pm
I RECALLED ON WED JUNE 27, 2012 AT 11;00AM and 4;35 pm
I RECALLED ON THU JUNE 28, 2012 AT 11;12AM and 4;14 pm
ALSO ON THU JUNE 28, 2012 I CALED THE MAIN NUMBER AT 301-796-5900 JOYCE ANSWERED THE PHONE. JOYCE SAID MY LETTER WAS FORWARED TO 'EXEC SEC' AGAIN I ASKED FOR EMAIL ADDRESS OR TELEPHONE NUMBER OF 'EXEC SEC' AND THEN JOYCE HUNG UP ON ME!
I RECALLED ON FRI JUNE 29, 2012 AT 11;00AM and 3;10 pm
NOW THE MAIN NUMBER DOES NOT WANT ME TO CALL, ON FRIDAY JAN 29TH I ALSO CALLED THE MAIN NUMBER AT 1-301-796-5900 AND I IMMEDIATELY GET 'cicso unity messaging system, from a touchtone telephone you may dial an extension at any time, for a directery of extension press 4, otherwise please hold for an operator, sorry the operator is not avaiable, record your message at the tone when you are finished hang up or hold for more options'.
BUT I STILL LEFT A MESSAGE TO PLEASE CALL ME BACK.
I RECALLED ON MON JULY 02, 2012 AT 138PM
ALSO CALLED MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE!
I RECALLED ON TUE JULY 03, 2012 AT 138PM
ALSO CALLED MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE!
EACH TIME I CALL MS. LLOYD, I CALL MS. LLOYD'S NUMBER 1-301-796-4866 THE ANSWERING MACHINE SAYS (hi, you have reached the desk of lindsay lloyd, I'm curently unavaialable to take your call at this time please leave me a message and i will return your call as soon as possable) AND I LEAVE A PERSONAL MESSAGE FOR YOU TO PLEASE RETURN MY CALL, AGAIN MY PHONE NUMBER IS 978-212-5156...
----------------------------------------------------------------------------------
SINCE I'M BEING IGNORED BY THE MAIN DEVICE NUMBER 1-301-796-5900 AND BY MS, LNDSAY LLOYD AT 301-796-4866 . I'M NOW CALLING THE CDRH OMBUDSMAN Dr. David S. Buckles is serving as the Ombudsman for the Center for Devices and Radiological Health, AT 301-796-5447 AND THE CDRH DEPUTY 2012I RECALLED ON TUE JULY 03, 2012 AT 138PM
ALSO CALLED MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE!
OMBUDSMAN Mr. Lawrence "Jake" Romanell is the Deputy Ombudsman for the Center for Devices and Radiological Health (CDRH). AT 301-796-5436.
-----------------------------------------------------------------------------
-----------------------------THURSDAY JULY 05, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON THU JULY 05, 2012 AT 11;27 AM ALSO CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AND LEFT A MESSAGE! FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!
--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------
----------------------------FRIDAY JULY 06, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON FRI JULY 06, 2012 AT 11;27 AM ALSO CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AND LEFT A MESSAGE! FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!
--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------
----------------------------MONDAY JULY 09, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON MON JULY 09, 2012 AT 11;27 AM ALSO CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AND LEFT A MESSAGE! FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!
--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------
----------------------------TUESDAY JULY 10, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON TUE JULY 10, 2012 AT 11;02 AM ALSO CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AND LEFT A MESSAGE! FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!
--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------
----------------------------WEDNESDAY JULY 11, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 LEFT MESSAGE! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND LEFT A MESSAGE!
--------------NO ONE HAS RETURNED MY CALL OR MY EMAIL----------------
----------------------------THURSDAY JULY 12, 2012-----------------------------------
I RECALLED MS. LLOYD AT 1-301-796-4866 ON WED JULY 11, 2012 AT 11;24 STARTING TODAY MS. LLOYD MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time' ALSO I CALLED THE DEVICE MAIN NUMBER AT 1-301-796-5900 THE MESSAGE SAID 'the party you are trying to reach is not accepting calls at this time' I DO NOT BELIEVE THAT THE MAIN TELEPHONE NUMBER COULD LEGALLY DO THIS ! I ALSO CALLED MR BUCKLES AT 301-796-5447, AGAIN TODAY MR BUCKLE'S PHONE MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time'. FINALLY I CALLED MR. ROMANELL AT 301-796-5436 AND AGAIN MR BROMANELL'S PHONE MESSAGE SAYS 'the party you are trying to reach is not accepting calls at this time'.
-------NO ONE HAS ALLOWED ME TO LEAVE A MESSAGE OR NO ONE HAS ANSWERED MY EMAIL-------
PLEASE CONTACT ME...OR SEND ME AN EMAIL ADDRESS AND A PHONE NUMBER WHERE MY LETTER WAS SENT!
I WOULD HOPE THAT YOU WOULD WANT ME TO FOLLOW MY LETTER, AS I TRY TO EXPLAIN MY OWN PERSONAL EXPERIENCE WITH THE PROCEDURE KNOWN, BY THE NAME CCSVI.
HEC, I WAS ALWAYS TOLD AND WAS UNDER THE ASSUMPTION THAT FDA WANTS TO HELP SICK CITIZENS. IS THAT A TRUE STATEMENT!
MS. LLOYD OR DR. MAISEL PLEASE CALL ME
I WAS TOLD BY THE MAIN OFFICE OF DEVICE AT NO 1-301-796-5900, THAT MY LETTER WAS NOT FORWARDED TO 'EXEC SEC'. MS. LLOYD YOU HAVE NOT TOLD ME THE TRUTH. AND YOU DO NOT CALL ME! ARE YOU AND DR. MAISEL WORRIED ABOUT THE SAFTEY OF US CITIZENS! MY GUESS IS NO!
SOMEBODY WHO IS WORRIED ABOUT THE PUBLIC DOES NOT LIE THEN IGNORE THE PUBLIC. YOUR ACTIONS CONTRADICT YOUR NEWS RELEASE!
ALSO, PLEASE NOTE THAT, AS OF NOV 3, 2011, MR. DAVID BANKS FROM, OSHI, IS NO LONGER MY FDA CONTACT, ALL CONUNICATIONS ARE THRU MYSELF. I HAVE INCLUDED A COPY OF MR. BANKS EMAIL TO MYSELF FOR YOUR REVIEW!
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from--------------Banks, David David.Banks@fda.hhs.gov
to---------------mario morais marioTTTmorais8@gmail.com,
------------------MARIO MORAIS <marioTTTmorais2011@gmail.com>
date--------------Thu, Nov 3, 2011 at 1:02 PM
subject-----------FDA
Mario Morais
4 Glen Road, Apartment # 103
Hudson, Mass., 01749
Mario,
As I advised you during our brief telephone conversation yesterday, I will no longer be serving as your FDA contact.
This is my final communication to you. Please consider it a personal communication, and not an official FDA communication.
---------------------------------------------------------------------------
THANK YOU FOR YOUR TIME.
IF YOU HAVE ANY QUESTIONS OR CONCERNS PLEASE FEEL FREE TO CALL ME AT 978-212-5156 OR EMAIL marioTTTmorais8@gmail.com.
SINCERELY YOURS,
MARIO MORAIS...
EMAILED ON JULY 5 SENT TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov, william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, FDATRACK@fda.hhs.gov, ondeio@fda.hhs.gov, HSPTeamMailbox@fda.hhs.gov, ondeio@fda.hhs.gov, BadAd@fda.gov, DDMACJobs@fda.hhs.gov, CDER-DDMAC-RPM@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov, drugproducts@cder.fda.gov, druginfo@fda.hhs.gov, RDRC@cder.fda.gov, ocod@fda.hhs.gov, eDRLS@fda.hhs.gov, Industry.Biologics@fda.hhs.gov,
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EMAILED ON JULY 6 SENT TO FOLLOWING FOLKS lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov, Druginfo@cder.fda.gov, emergency.operations@fda.hhs.gov, Pharmacy.Student@fda.hhs.gov, cderexsec@cder.fda.gov, interpreting.services@oc.fda.gov, olga.salis@fda.hhs.gov, drugshortages@fda.hhs.com, pmcweb@cder.fda.gov,
---------------------------------------------------------------------------------
EMAILED ON JULY 7 SENT TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,
ebmaster@fda.hhs.gov, cfsanweb@fda.hhs.gov, genericdrugs@fda.hhs.gov, teshara.bouie@fda.hhs.gov, bechtelc@cder.fda.gov, fdadockets@oc.fda.gov, Afia.Asamoah@fda.hhs.gov, healthypeople@nhic.org, FDACriticalpathprogram@fda.hhs.gov <FDACriticalpathprogram@fda.hhs.gov>,
SEdward.Nevius@fda.hhs.gov, esub@cder.fda.gov, esub@cdrh.fda.gov,
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EMAILED ON JULY 8 SENT TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, fdacommissionersfellows@fda.hhs.gov, drugshortages@fda.hhs.gov, RFRSupport@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov,
Robert.Hennes
@fda.hhs.gov, AskCTP@fda.hhs.gov, margaret.zabriski@fda.hhs.gov, TPSAC@fda.hhs.gov, askCVM@fda.hhs.gov,
---------------------------------------------------------------------------------
EMAILED ON JULY 09 TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,
industry.biologics@fda.gov
, ctpcompliance@fda.hhs.gov, eSubmitter@fda.hhs.gov, CFSANPublicationRe@fda.hhs.gov, TobaccoIndustryQuestions@fda.hhs.gov, esgprep@fda.hhs.gov, david.banks@fda.hhs.gov, dominic.cirincione@fda.hhs.gov,
helene.clayton-jeter@fda.hhs.gov, janelle.derbis@fda.hhs.gov,
--------------------------------------------------------------------------------
EMAILED ON JULY 10 TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,
katherine.duvall@fda.hhs.gov, anna.wojas@fda.hhs.gov, beth.fritsch@fda.hhs.gov, andrea.furia@fda.hhs.gov, richard.klein@fda.hhs.gov, norman.marks@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov, steve.morin@fda.hhs.gov, daniello.sepe@fda.hhs.gov,
-----------------------------------------------------------------------------
RE-SENT EMAIL ON JULY 10, BECAUSE I FORGOT TO INCLUDE LETTER
--------------------------------------------------------------------------
EMAILED ON JULY 11, TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov,
christine.merenda@fda.hhs.gov, deborah.miller@fda.hhs.gov, synim.rivers@fda.hhs.gov, brenda.rose@fda.hhs.gov, theresa.toigo@fda.hhs.gov, james.valentine@fda.hhs.gov, jay.wattenberg@fda.hhs.gov, linda.wolfrey@fda.hhs.gov, OSHI@fda.hhs.gov,
Afia.Asamoah@fda.hhs.gov, heidi.marchand@fda.hhs.gov,
raph.tyler@fda.hhs.gov, ann.wion@fda.hhs.gov,
dominic.cirincione@fda.hhs.gov,
lisa.dwyer@fda.hhs.gov, FDATRACK@fda.hhs.gov, FDACriticalpathprogram@fda.hhs.gov, TRANSPARENCY.MEETING@fda.hhs.gov,
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EMAILED ON JULY 12, TO FOLLOWING FOLKS; lindsay.lloyd@fda.hhs.gov,
william.maisel@fda.hhs.gov, CDRHOmbudsman@fda.hhs.gov, david.buckles@fda.hhs.gov, lawrence.romanell@fda.hhs.gov, jeff.shuren@fda.hhs.gov, miriam.nisbet@nara.gov, karen.finnegan@nara.gov, corinna.zarek@nara.gov, candace.boston@nara.gov, carrie.mcguire@nara.gov, kristen.mitchell@nara.gov, ogis@nara.gov, peter.beckerman@fda.hhs.gov, michael.ermarth@fda.hhs.gov, esgprep@fda.hhs.gov, Sara.Goldkind@fda.hhs.gov, thomas.hendricks@fda.hhs.gov, Donald.Prater@fda.hhs.gov, AskCTP@fda.hhs.gov, katherine.bond@fda.hhs.gov, emdr@fda.hhs.gov, ORAContactUs@fda.hhs.gov, lacf@fda.hhs.gov, Afia.Asamoah@fda.hhs.gov,
CVMDCU
@fda.hhs.gov, esubmitter@fda.hhs.gov, dsmica@fda.hhs.gov, LACF@fda.hhs.gov, emergency.operations@fda.hhs.gov, Leming.Shi@fda.hhs.gov, Donald.Prater@fda.hhs.gov, fatalities2@fda.hhs.gov, DSMICA@fda.hhs.gov,
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SENT TWICE ON JULY 12 BECAUSE LETTER WAS SENT INCOMPLETE
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I THOUGHT ABOUT THIS IDEA AFTER I WROTE MY LETTER. I WILL COPY IT HERE FOR YOUR REVIEW!
-------------------------LEGAL--ASPECTS------------------------------------------
I BELIEVE THE FDA HAS OVER STEPPED ITS BOUNDS. I, AS A CITIZEN OF THE USA, SHOULD HAVE THE CONSTITUTIONAL RIGHT TO PAY FOR A PROCEDURE THAT MAY BENEFIT MYSELF!
PEOPLE HAVE BEEN PERFORMING UNAPPROVED SURGERY FOR YEARS, AN EXAMPLE OF THIS IS SEX REASSIGNMENT SURGURY. I AM REALLY SURE THAT IT CAN BE ARGUED THAT SEX REASSIGNMENT SURGURY IS MORE DANGEROUS THAN THIS OUT-PATEINT PROCEDURE KNOWN AS CCSVI, ALSO IN SEX CHANGE SURGER THE PATEINT MAY EVEN HAVE NO PHYSICAL PROBLEM, BUT SOME FOLKS CHOSE TO PAY FOR THE SURGERY, BUT WITH THE FDA'S NEWS RELEASE, I'M NOT EVEN ALLOWED THE SAME FREEDOM. THE QUESTION IS 'CAN THE FDA OUTLAW A SIMPLE PROCEDURE GEARED TO FIXING CONSTRICTED VEINS'!PLEASE THINK ABOUT THIS STATEMENT!
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HERE IS THE NEWS RELEASE BY THE CDRH GROUP
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FDA NEWS RELEASE
For Immediate Release:
May 10, 2012
Media Inquiries:
Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries:
888-INFO-FDA 1-888-463-6332
FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
The U.S. Food and Drug Administration is alerting health care professionals and patients1 about injuries and death associated with the use of an experimental procedure sometimes called "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI).
Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause multiple sclerosis (MS) or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.
"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, 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. "Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes."
The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.
MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.
Complications following CCSVI treatment can be reported through MedWatch2, the FDA Safety Information and Adverse Event Reporting program.
The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices3. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.
In February 2012, the FDA sent a warning letter4 to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.
The FDA will continue to monitor reports of adverse events associated with "liberation therapy" or the "liberation procedure" and keep the public informed as new safety information becomes available.
For more information:
Medical Device Safety5
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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HERE IS A COPY OF AN EMAIL WHERE MS. LLOYD CONFIRMS RECEIVING MY LETTER
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from:-----------------Lloyd, Lindsay Lindsay.Lloyd@fda.hhs.gov
to:-------------------mario morais anncartermjackbrown@gmail.com,
---------------------"Maisel, William" William.Maisel@fda.hhs.gov,
--------------------"Afia.Asamoah@fda.hhs.gov" <Afia.Asamoah@fda.hhs.gov>
date:-----------------Mon, Jun 11, 2012 at 3:26 PM
subject:-------------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!
Mr. Morais,
This is to confirm receipt of your email.
Thank you,
Lindsay
Lindsay Lloyd
Office of the Center Director
Center for Devices and Radiological Health
Building 66, Room 5447
301.796.4866
-------------------------------------------------------------------------------------
--------------------------------------------------------------------------------
HERE IS A COPY OF MY LETTER SENT TO MS. LLOYD IN CDRH
------------------------------------------------------------------------
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
#############################################################
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!
##############################################################
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!
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+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
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
----------------------..................--
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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! REPEAT, IT'S A HUMAN ISSUE!
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 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 MORAIS
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I INCLUDED THIS ARTICAL WITH MY LETTER. I FOUND THIS NEWS ARTICLE AS WELL, THE ARTICLE STATES THE BENEFITS OF THIS PROCEDURE, KNOWN AS CCSVI..
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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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