I made a positive comment to FDA about CCSVI with Tracking Number 0807-2012-2413, but the FDA WILL NOT HONOR THE COMMENT! This comment scares the FDA so much that Ms. Lindsay lloyd avoids me. The device ombudsman, Mr. David Buckles avoids me, and will not perform his regulatory ombudsman duties, Ms. Carol Rados Misled the office of Senator John Kerry, and even the FDA made a complaint against me to the U.S. Department of Homeland Security!
AND EVEN HHS DOES NOT TO FIX THIS CORRUPT FDA SYSTEM. HERE IS A LETTER THAT I SENT TO THE FDA AND TO HHS!
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The Department of Health and Human Services(HHS)
Mario Morais
4 Glen Road, Apartment # 103
Hudson, Mass., 01749-1365
Home Phone number is 978-212-5156 / Email: mariomorais8@gmail.com
------------------------------------------------NOVEMBER 27, 2012
MRS. KATHLEEN SEBELIUS / SECRETARY OF HEALTH AND HUMAN SERVICES (HHS) / 200 Independence Ave. SW., Suite 120F
Washington District of Columbia,
Off # 202-690-7000 : Email Kathleen.Sebelius@hhs.gov : Fax # 202-690-7203
Off # 202-690-6392 / Correspondence Department / gov : Fax # 202-690-7203
DEAR MS. KATHLEEN SEBELIUS AND ALL FOLKS AT THE DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)
FIRST, I HOPE MS. KATHLEEN SEBELIUS AND ALL THE MEMBERS OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES -HHS- HAD A VERY GOOD THANKSGIVING
I MADE A POSITIVE COMMENT ABOUT THE PROCEDURE CCSVI AND A POSITIVE COMMENT ABOUT CCSVI SCARES THE FDA SO MUCH THAT MS LINDSAY LLOYD AVOIDS ME, AND THE DEVISE OMBUDSMAN, MR DAVID BUCKLES, AVOIDS ME AND WILL NOT PERFORM HIS REGULATORY DUTIES AND THE FDA EVEN MADE A COMPLAINT AGAINST ME TO THE DEPARTMENT OF HOMELAND SECURITY.
MY ONLY CRIME IS I HAVE A BETTER QUALITY OF LIFE!
FOR ME, IT WAS A SIMPLE 2 HOUR OUTPATIENT PROCEDURE, I WAS AWAKE THRU THE WHOLE PROCESS AND I SLEPT IN MY HOTEL ROOM THAT NIGHT!
AS YOU ALL KNOW, I HAVE BEEN DEALING WITH THE FDA FOR SEVERAL YEARS NOW! I AM ILL WITH MULTIPLE SCLEROSIS (MS) AND AM CONFINED TO A MOTORIZED WHEELCHAIR, AND I TRULY HAVE THE BEST INTEREST OF ILL PEOPLE, UNFORTUNATELY BEING ILL ALLOWS THE FDA TO HAVE MY HUMAN RIGHTS. AND I CANNOT GET THEM BACK!
SO, NOW, THE FDA MAKES SAVING YOUR OWN LIFE A CRIME.
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SO, WHY IS THE FDA FIGHTING AND AVOIDING A SICK PERSON GETTING BETTER FROM A VERY SIMPLE PROCEDURE! WHY IS MY POSITIVE COMMENT ABOUT THE PROCEDURE KNOWN AS CCSVI SO DANGEROUS!
THE FDA'S MISSION IS TO SOMEHOW MAKE THIS COMPLICATED DRUG SYSTEM FAIR TO THE SICK PATIENT! THERE ARE FDA RULES AND REGULATIONS THAT ALL SICK FOLKS MUST FOLLOW THAT MAKE THE FDA IMPARTIAL AND ALLOWS THE FDA TO ALSO HELP PATIENTS, BUT IT APPEARS TO ME THAT THE FDA DOES NOT FOLLOW IT’S OWN RULES AND REGULATIONS.
I HAVE FOUND THAT NO ORGANIZATION HAS ANY JURISDICTION OVER THE FDA, THE FDA IS COMPLETELY SELF GOVERNING. EVEN THE OMBUDSMANS ARE JUST EMPLOYEES OF THE FDA! THE DIRECTOR OF THE MAIN OFFICE OF THE OMBUDSMAN, MS LAURIE LENKEL, AND THE ASSOCIATE DIRECTOR, MR ANDREW MOSS, ARE ALSO IN THE OFFICE OF SCIENCE INTEGRITY, AND YOU CANNOT REGULATE YOUR BOSS.
IT SEEMS THAT, THE FDA DECIDES WITCH COMMENTS THE FDA WILL ACCEPT, AND THAT PRACTICE MAKES THE FDA VERY NON IMPARTIAL, THEREFORE BY DECIDING WHICH COMMENTS THE FDA ACCEPTS IT ALLOWS THE FDA NOT TO FOLLOW ITS OWN MISSION!
HOW THE DRUG SYSTEM WORKS: CURRENTLY, IF THE FDA DOESN'T HAVE 'proof' FROM A MAJOR DRUG COMPANY AND IT COSTS ABOUT 1 BILLION TO GET 'proof', THEN THAT DRUG OR PROCEDURE CANNOT BE USED TO GET BETTER!
BUT, THE SAME MAJOR DRUG COMPANIES DO NOT HAVE A FINANCIAL BENEFIT TO CURE ANY ILLNESS BECAUSE ILL FOLKS ARE A MAJOR CUSTOMER, THE DRUG COMPANIES WANT ILL PEOPLE TO STAY A CUSTOMER,
A DRUG COMPANIES MAIN GOAL IS TO MAKE MONEY NOT TO CURE DISEASE!
WHAT A DRUG SYSTEM WE HAVE!
THE ONLY WAY THAT PATIENTS HAVE ANY SAY IN THIS DRUG SYSTEM IS THRU THEIR OWN COMMENTS. BUT IF THE FDA AVOIDS THE PATIENTS COMMENTS THEN THE IMPARTIALITY AT THE FDA DISAPPEARS. NOW, IF THE PATIENTS COMMENTS ARE NOT VALIDATED BY THE FDA THEN PATIENTS HAVE NO SAY IN THIS SYSTEM!
THE FDA DOES NOT LIKE TO GIVE COMMENTS A TRACKING NUMBER!
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NOW, IT SEEMS VERY, VERY DIFFICULT TO GET A TRACKING NUMBER FOR A COMMENT!
I WROTE A LETTER TO MR. TODD PARKS HE WAS THE CIO OF HHS, I BELIEVE HE HAS LEFT NOW. THE LETTER SENT TO HIM WAS SENT TO THE EXECUTIVE SECRETARIAT AT THE FDA. THAT LETTER SHOULD HAVE BEEN ASSIGNED A TRACKING NUMBER, BUT NO NUMBER. I CALLED AND IT SHOULD TAKE 5 MINUTES TO GET A TRACKING NUMBER BUT IT TOOK ME ALLOT OF CALLS AND ALLOT OF PERSISTENCE AND ABOUT 3 MONTHS TO EVEN GET A TRACKING NUMBER!
IT SHOULD NOT BE THIS HARD TO GET A TRACING NUMBER. MY OTHER COMMENT WAS GIVEN TO MS. LINDSAY LLOYD, MS LLOYD WOULD NOT
TALK TO ME AND THE DEVISE OMBUDSMAN, MR. DAVID BUCKLES, WOULD NOT TALK TO ME, BUT THRU MY PERSISTENCE MS. KATHLEEN SEBELIUS CORRESPONDENCE DEPARTMENT ISSUED ME A TRACKING NUMBER. 0807-2012-2413, BUT IT SEEMS THAT THE FDA WILL NOT HONOR THAT NUMBER!
I MADE A COMPLAINT TO MR. PATRICK HENRY, AT THE FDA'S OFFICE OF CRIMINAL INVESTIGATIONS. BUT MR. HENRY TOLD ME HE CANNOT HELP ME, AND SAID I SHOULD DROP THIS ISSUE! WOW THINK ABOUT THAT STATEMENT!
AGAIN, FOR ME, IT WAS A SIMPLE 2 HOUR OUTPATIENT PROCEDURE, I WAS AWAKE THRU THE WHOLE PROCESS AND I SLEPT IN MY HOTEL ROOM THAT NIGHT!
BUT THE MOST IMPORTANT THING WAS HOW A VERY SIMPLE PROCEDURE CHANGED MY LIFE FOR THE BETTER! I HAVE BETTER FEELING ALL OVER, I HAVE MUCH BETTER CIRCULATION, MY FEET ARE WARMER NOW, ALSO MY BED SORES HAVE GONE AWAY, AND I DON'T GET THEM VERY EASILY ANYMORE!
THANK YOU FOR YOUR TIME.
IF YOU HAVE ANY QUESTIONS OR CONCERNS PLEASE FEEL FREE TO CALL ME AT 978-212-6156 OR EMAIL ME AT mariomorais8@gmail.com.
SINCERELY YOURS,
MARIO MORAIS
FAXED TO THE FOLKS AT THE OFFICE OF THE SECRETARY FOR THE US DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) AT FAX NO 202-690-7302, AND TO THE FINE FOLKS AT HHS! MS. KATHLEEN SEBELIUS THE SECRETARY OF HHS PERSONAL PHONE IS 202-690-7000.
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HERE IS A COPY OF A LETTER THAT I SENT TO EVERYONE I COULD AT THE FDA; PLEASE READ IT ALSO, I TRY TO EXPLAIN WHY THE FDA DOES NOT FOLLOW ITS MISSION STATEMENT!
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MARIO MORAIS
4 GLEN ROAD, APARTMENT # 103
HUDSON, MASS., 01749-1365
PHONE: 978-212-5156 / Email: marioTTTmorais8@gmail.com
----------------------------------------------------DATE NOVEMBER 12, 2012
The Department of Food and Drug Administration
Ms MARGARET HAMBURG / COMMISSIONER OF FDA
WASHINGTON, DISTRICT OF COLUMBIA
OFF # 301-796-5000 / FAX 301-796-9840 / Margaret.Hamburg@fda.hhs.gov
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RE: THE US DEPARTMENT OF HOMELAND SECURITY'S G-MEN APPEARED AT MY DOOR! AND I WILL TRY MY HARDEST TO COMPLY WITH THEIR REQUEST. BUT, ITS NOT LIKE AN EPISODE OF CSI MIAMI, WE WATCH TO MUCH TV!
SO. IN TURN THIS WILL BE MY LAST EMAIL AND OR FAX TO THE FDA. MR. BUCKLES HAS DESTROYED MY EMAIL ADDRESS SO THEY CANNOT REACH FDA EMPLOYEES, BUY I CREATED NEW ONES TO USE!
I BELIEVE THE FDA SHOULD ALLOW THIS LETTER, WHY SHOULD FDA ALLOW THIS LAST EMAIL OR FAX! THE REASON IS BECAUSE I HAVE REALLY TRIED TO HELP THE FDA HELP SICK FOLKS! I AM SICK MYSELF AN EXPECTED THE FDA TO BE RECEPTIVE. I WAS WRONG!
##############################################################
DEAR MARGARET HAMBURG AND THE MEMBERS OF THE DEPARTMENT OF FOOD AND DRUG ADMINISTRATION:
------------------------------------------------------------------------------------------------
I HAVE TYRED MY HARDEST TO LET THE FDA KNOW HOW THE ORGANIZATION CAN BE BETTER TO SICK PEOPLE, ESPECIALLY FOLKS WITH MULTIPLE SCLEROSIS -MS-, AS THAT IS MY DISEASE.
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I ALWAYS THOUGHT THAT THE FDA JUST DID NOT KNOW HOW TO REALLY HELP SICK FOLKS, BUT I'VE COME TO THE CONCLUSION THAT FDA IS PROTECTING ITS DRUG BASE, AND MAJOR DRUG COMPANIES NOT SICK PATIENTS. PROTECTING SICK FOLKS IS NOT PROFITABLE!
ORDINARILY I WOULD NOT CARE BUT I HAVE A VERY HARD TIME WITH THAT ISSUE BECAUSE THE FDA HAS MY HUMAN RIGHTS, BUT, UNFORTUNATELY, NOT MY BEST INTEREST AT ITS BASE! AND I CANNOT GET MY HUMAN RIGHTS BACK!
FDA WANTS MORE DRUGS FOR MS, BUT I WANT A BETTER QUALITY OF LIFE. A BETTER QUALITY OF LIFE FOR ME INCLUDED THE PROCEDURE KNOWN AS CCSVI. BUT, UNFORTUNATELY, THE PROCEDURE KNOWN AS CCSVI DOES NOT SELL MORE DRUGS, IT ONLY HELPS SICK FOLKS! SO IT DOES NOT HAVE A CHANCE.
THIS SIMPLE PROCEDURE KNOWN AS CCSVI, IS VERY SIMPLE AND HELPS MS FOLKS AND HELPED MY MS TREMENDOUSLY, BUT THE CDRH OMBUDSMAN DOES NOT WANT MY POSITIVE COMMENT WITH TRACKING NUMBER 0807-2012-2413. NO MATTER WHAT I DO!
ALSO, MS. CAROL RADOS, SUPERVISORY CONGRESSIONAL AFFAIRS SPECIALIST AT 301-796-8919 SENT SENATOR JOHN KERRY A LETTER SAYING THAT MR. DAVID BUCKLES WILL RESPOND TO ME!
I PERSONALLY TOLD MS. RADOS THAT MR. BUCKLES WAS NOT RESPONDING SO MS. CAROL RADOS SAID SHE WOULD TELL MR. BUCKLES TO CALL ME AND I WAS TOLD THAT MR. BUCKLES WOULD RESPOND! BUT THAT HAS NOT HAPPENED, SO I’M NOT SURE IF MS. CAROL RADOS, SUPERVISORY CONGRESSIONAL AFFAIRS SPECIALIST REALLY TOLD MR. BUCKLES TO CONTACT ME AS SHE TOLD ME SHE DID! BUT I DO KNOW, BUT I KNOW THAT EVERY TIME I CALL HER, SHE IS NEVER AT HER DESK!
I ALSO HAVE SENT MR BUCKLES, THE CDRH OMBUDSMAN, A REGISTERED LETTER NUMBER 70112970000158942374, AS MR BUCKLES SAID IN HIS EMAIL'
I can assure you that any written communications from you to me that pertain to the regulatory work of FDA will be handled appropriately' BUT MR BUCKLES AGAIN DID NOT RESPOND!
I STILL HAVE A CITIZENS PETITION
IT WAS ASSIGNED DOCKET NUMBER FDA-2012-O-0119-001/CP, AN IT WAS FILED ON 02/03/2012. IN THAT PETITION I ASK FDA TO RECONSIDER THE DRUG BB;7075 AS AN AID IN AIDS TREATMENT.
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THE ONE GIRL THAT TOOK THE DRUG, BB;7075, MS. PECIOUS THOMAS, SHE TOOK THE DRUG OVER 12 YEARS AGO SHE IS ALIVE AND CELEBRATING HER 18TH BIRTHDAY TODAY!
ALSO, I DO NOT KNOW IF ANYTHING WILL HAPPEN BUT I HAVE A COMPLAINT, AGAINST MR. DAVID BUCKLES, WITH PATRICK HANKS AT THE FDA OFFICE OF CRIMINAL INVESTIGATIONS (OCI), AT 240-276-9500, THIS NUMBER WAS GIVEN TO ME BY SPECIAL AGENT MONTERO AT THE US DEPARTMENT OF HOMELAND SECURITY.
NO ORGANIZATION HAS ANY JURISDICTION OVER THE FDA SO I HAVE COME TO THE CONCLUSION THAT THE FDA DOES NOT FOLLOW ITS OWN CHECKS AND BALANCES. WITHOUT THE FDA ACCEPTING BOTH GOOD AND BAD COMMENTS THEN THE FDA IS JUST FOLLOWING ITS OWN AGENDA!
SO, THE FDA HAS NO OVERSIGHT AND DOES NOT FOLLOW ITS OWN RULES AND REGULATIONS! IMPARTIALITY DOES NOT SEEM TO EXIST AT THE FDA!
THANK YOU FOR YOUR TIME.
IF YOU HAVE ANY QUESTIONS OR CONCERNS PLEASE FEEL FREE TO CALL ME AT 978-242-4156 OR EMAIL ME AT mariomorais8@gmail.com.
SINCERELY YOURS,
MARIO MORAIS
FAXED AND EMAILED TO MS. MARGARET HAMBURG AT FAX NO 301-347-3531 ALSO SENT TO THE FINE FOLKS AT THE U.S. DEPARTMENT OF FOOD AND DRUG ADMINISTRATION (FDA) WHO RECEIVE THE LETTER,