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Drug Research Companys

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					    LOUANN STANTON, MDPH

    I WAS THE ONLY CITIZEN/CONSUMER TO SPEAK BEFORE THE MDPH
    REGARDING PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURER
    CONDUCT. I GAVE TESTIMONY AT THE UNIVERSITY OF MASS MEDICAL
    SCHOOL CAMPUS ON JANUARY 12, 2009.

    I WOULD APPRECIATE IT IF YOU WOULD INCLUDE THE COMMENTS ON
    YOUR SITE WITH THE OTHERS. THANK YOU.

    MARTHA SULLIVAN

     PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURER CONDUCT


     THE TOP TIER EARNINGS OF 95% OF ALL AMERICAN WORKERS MAX OUT AT
$50,000 A YEAR. 75%, OR THREE-QUARTERS OF THAT GROUP, EARNS $35,000 A YEAR
OR LESS. THE COST OF HEALTH INSURANCE FOR AN AMERICAN FAMILY IS $14,000
DOLLARS A YEAR. THAT DOES NOT INCLUDE CO-PAYS, DEDUCTIBLES, OR COVERAGE
FOR ALL PROCEDURES. PRESCRIPTION DRUG AND DEVICE COVERAGE IS AN ADDED
BURDEN OF THOUSANDS OF DOLLARS IN LIMITED COVERAGE, BURDENSOME
DEDUCTIBLES, AND CO-PAYS. THERE IS NO SLIDING SCALE.

    HOW DOES WAL-MART DO IT? $4.00 FOR GENERIC PRESCRIPTIONS.

    CORPORATE PHARMACEUTICAL AND MEDICAL DEVICE MANUFACTURERS CRY
OUT FOR SLIDING SCALE FROM ANNUAL DISCLOSURE FEE OF $2,000. IT BEGS THE
QUESTION OF HOW VIABLE AN ENTITY IS IF IT CANNOT ACCESS $2,000. COUPLE
WITH THE COST OF OVERSIGHT BASED ON PAST PERFORMANCE – EX. JOSEPH
BIEDERMAN – AND THE ABHORRENCE THE INDUSTRY HAS FOR MEDICAL PRACTICE
ON THE BASIS OF “FROM EACH ACCORDING TO THIS ABILITY AND TO EACH
ACCORDING TO HIS NEEDS”, THE PANEL MUST HOLD FAST AND MAKE NO
ADJUSTMENTS TO THE $2,000 ANNUAL DISCLOSURE FEE.

    I ASK THE DEPARTMENT OF PUBLIC HEALTH TO RECONSIDER ITS EXEMPTION OF
MEDICAL RESEARCH PAYMENTS FROM THE DISCLOSURE REQUIREMENT.
CHILDREN’S HOSPITAL HAS TAKEN THE UNPRECEDENTED STEP OF INVOLUNTARILY
USING CHILDREN AS RESEARCH SUBJECTS WITHOUT PRE-NOTIFICATION AND/OR
APPROVAL FROM PARENTS OR GUARDIANS.
    IT IS DISINGENUO US TO SUGGEST PHARMACEUTICAL COMPANIES AND MEDICAL
DEVICE MANUFACTURERS LIKE PFIZER, AND NOVARTIS WILL BOYCOTT MA WITH
THEIR RESEARCH PROJECTS.

    MA HOSPITALS LIKE MA GENERAL HOSPITAL THROUGH TREMENDOUS TAX FREE
TRUSTS AND MA COLLEGES AND MEDICAL SCHOOLS LIKE HARVARD UNIVERSITY
THROUGH ENORMOUS TAX FREE ENDOWMENTS ARE PRIMARY INVESTORS IN
MEDICAL DEVICE MANUFACTURERS AND DRUG COMPANIES. THEY HAVE A
MONETARY STAKE IN BRINGING TO MARKET THESE INDUSTRY PRODUCTS.
HARVARD MEDICAL SCHOOL HAS ON ITS PAYROLL MORE THAN 6,000 BOSTON AREA
PHYSICIANS IN PRIVATE, GROUP, AND AFFILIATE PRACTICE. THE DUAL ROLE AS
“RESEARCHERS” OF INVESTMENT PRODUCTS REINFORCES THE NECESSITY TO
INCLUDE MEDICAL RESEARCH PAYMENTS IN THE REGULATIONS.

    I ALSO RECOMMEND THAT THE BAN OF GIFTS BE EXPANDED BEYOND SALES &
MARKETING TO INCLUDE GIFTS FOR EDUCATION PURPOSES, PRACTICE-RELATED
GIFTS, AND GIFTS OF PHARMA AND MEDICAL DEVISE MANUFACTURERS LARGESS.
    A BAN ON EDUCATION GIFTS FOR STUDENTS IN THE MEDICAL AND RELATED
FIELDS MUST BE PART OF THE REQUIREMENTS. SCHOLARSHIPS TO AND HOTEL SITES
AS EXEMPT EDUCATION & TRAINING CENTERS IS QUESTIONABLE AND
UNACCEPTABLE AND MUST BE REFLECTED AS SUCH IN THE REGULATIONS.

   TRANSPARENCY MUST INCLUDE “FREE SAMPLES” WHICH ARE NOT FREE. THEIR
COSTS ARE PASSED THROUGH THE INDUSTRY, AS IS THE CASE WITH DISCOUNTS &
REBATES, TO CITIZENS IN THE FORM OF HIGHER HEALTH INSURANCE AND
PHARMACY COSTS. THEY FALL UNDER THE DEPARTMENT’S CHARGE TO REDUCE
HEALTH CARE COSTS.

THEY MUST NOT BE EXEMPT FROM GIFT BAN AND/OR REPORTING.

    PHARMA AND MEDICAL DEVISE MANUFACTURER MAY ACCOUNT FOR “FREE
SAMPLES” (RIGHTLY OR WRONGLY) FOR TAX PURPOSES. ACCORDING TO PHARMAS’
TESTIMONY BEFORE THE PANEL: “THESE FREE SAMPLES HAVE NO VALUE. THEY
HAVE NO VALUE TO PHYSICIANS. THEY ARE ONLY INTENDED FOR PATIENTS AND
ONLY GIVEN TO PATIENTS VALUE TO US. LIKE APPLES AND ORANGES – CAN’T
COMPARE. THEY HAVE NO VALUE TO US. THEY ARE FREE SAMPLES.” PHARMA TOLD
THE PANEL, “FREE SAMPLES ARE DEDUCTED FROM DRUG COMPANIES INCOME.

    ADMITTEDLY, PHARMA PLACES A MONETARY VALUE ON “FREE SAMPLES”
GIVEN TO PHYSICIANS/PRESCRIBERS. EACH FREE INDIVIDUAL SAMPLE IS
ACCOUNTED FOR, CONVERTED TO A DOLLAR VALUE AND DEDUCTED FROM INCOME
OF DRUG COMPANIES LIKE PFIZER AND NOVARTIS TO REDUCE THEIR TAX
OBLIGATIONS. THE DO LLAR VALUE USED TO ACCOUNT FOR “FREE SAMPLES” –
WHETHER COST OF MANUFACTURE TO THE DRUG COMPANY(s) OR COST OF UNITS ON
THE OPEN MARKET i.e. PHARMACIES, HOSPITALS, NURSING HOMES, ETC. – WAS NOT
SPECIFIED. OTHER TESTIMONY EXPOSED MANY INSTANCES “FREE SAMPLES” ARE
NEVER GIVEN TO PATIENTS BUT ARE TAKEN BY PHYSICIANS, PRESCRIBERS,
NURSE (s), OR OFFICE PERSONNEL.

    IT WAS ESTABLISHED BY PHARMA THAT “FREE SAMPLES” DO HAVE VALUE AND
REDUCE DRUG COMPANYS’ TAX PAYMENTS. THE INTENDED RECEIPENTS – PATIENTS
– ARE NOT ALWAYS THE BENEFICIARIES OF “FREE/SAMPLES”. THE SAMPLES ARE
TREATED AS GIFTS FROM DRUG COMPANIES BY PHYSICIANS/PRESCRIBERS AND
STAFF. BECAUSE OF THE VALUE OF “FREE SAMPLES”, AND THE INDUSTRY-WIDE
PRACTICE OF TREATING FREE SAMPLES AS GIFTS, AND “FREE SAMPLES” HIDDEN
HEALTH CASE COSTS TO CONSUMERS, IT IS NECESSARY THAT “FREE SAMPLES” BE
DEFINED AS GIFTS ANDBANNED. THE PUBLIC WILL NOT BE HARMED BUT WOULD
BENEFIT FROM THE BAN.

    ABSENT AN OUTIGHT BAN, “FREE SAMPLES” SHOULD BE MANDATED
REPORTABLE AND SUBJECT TO YEARLY DISCLOSURE BY PHYSICIANS/PRESCRIBERS
UNDER MA PHARMACEUTICAL & MEDICAL DEVICE MANUFACTURER CONDUCT
REGULATIONS. FREE SAMPLES ARE ACCOUNTED FOR AT THEIR SOURCE – AS
DEDUCTION FROM INCOME REDUCING DRUG AND DEVICE COMPANIES TAXES.
THERE IS NO DIFFICULTY TO PRESCRIBERS/PHYSICIANS TO ACCOUNT FOR “FREE
SAMPLES” ON THEIR YEARLY DISCLOSURE STATEMENT.

    ADDITIONALLY, DATA MINING BY PHARMA IS COMMON PRACTICE. MA
PHARMACIES SELL CONSUMER PRESCRIPTION DATA TO DRUG INDUSTRY FOR
MONITORING AND TRACKING INDIVIDUA DOCTORS PRESCRIBING HABITS. PHARMA
LEARNS WHEN PRESCRIBERS CHANGE LABELS AND REACT. AND FOR THOSE WHO
HAVE ACCESS, IT IS AN INVESTMENT WINDOW INTO PHARMA STOCK. THIS ISSUE
MUST BE ADDRESSED BY THE PANEL.

    “CATEGORY CONFUSION” WOULD BE CREATED IF THE DEPARTMENT
INSTITUTED THESE EXCLUSIONS RESULTING IN FAILURE TO CAPTURE PERTINENT
DATA IN EVALUATING HEALTH CARE PROVIDERS AND THEIR RELATIONSHIP WITH
THE INDUSTRY.

    PHYSICIANS IN MA WEAR MANY HATS: PRACTICING PHYSICIANS,
RESEARCHERS, TEACHERS, CONSULTANTS, CFO’s, LECTURERS, ENDORSERS,
EXPERIMENTERS, ETC., ALL-IN-ONE. THE MIND-BOGGLING BURDEN OF TRACKING
WHAT ROLE A PHYSICIAN PLAYED AT THE POINT OF TRANSACTION AND
CATEGORIZING IT AS “REPORTABLE OR EXEMPT RESEARCH, A GIFT OR A SAMPLE” IS
AN INVITATION FOR FAILURE. FRAUD AND ABUSE. THE RULES MUST FACTOR OUT
“CATEGORY CONFUSION” . IT IS IMPERATIVE TO REQUIRE ALL MEDICAL RESARCH
PAYMENTS BE INCLUDED IN THE REGULATIONS ALONG WITH EDUCATION,
PRACTICE-RELATED GIFTS, EXCHANGES, SAMPLES, SCHOLARSHIPS, ETC.

    PRESENTLY OVER 5,000 MEDICAL RESEARCH PROJECTS ARE BEING CONDUCTED
IN MA. THE DEPARTMENT OF PUBLIC HEALTH HAS A RIGHT AND RESPONSIBILITY TO
KNOW WHAT BUSINESS IS CONDUCTED IN-STATE AND INFORM ITS CITIZENS. THAT
CAN BE ACCOMPLISHED THROUGH INCLUDING REPORTING REQUIREMENTS IN THESE
REGULATIONS.

    DRUG COMPANY SALES MARKETERS CROWD OUT AND IN SOME INSTITUTIONS
ELIMINATE OTHER LESS COSTLY, LESS HARMFUL FORMS OF HEALTH CARE.
THROUGH FULLY PAID FAMILY TRIPS, ATTENDANCE AT “EDUCATIONAL SEMINARS”
AT HOTEL SITES, MEALS, HELP IN WRITING PROFESSIONAL PAPERS, GIFTS,
GUIDANCE, AND OTHER INDUCEMENTS, PHARMA HAS SUCCEEDED IN CONVINCING
MANY IN THE PROFESSION THAT DRUG DRIVEN MEDICINE IS THE ONLY FORM OF
MEDICINE.

    ON A PERSONAL NOTE. I TOLD A PCP THAT I WAS HAVING A VERY BAD
EXPERIENCE WITH A DRUG. THERE WERE ALTERNATIVES BUT HE CONTINUED
PRESCRIBING IT WITH DEVASTATING CONSEQUENCES. IF I COULD HAVE CHECKED
TO SEE IF HE WAS RECEIVING PHARMA FUNDS, I COULD HAVE GONE ELSEWHERE.

   IT IS ESTIMATED IN THE U. S. THAT OVER 100,000 PEOPLE DIE ANNUALLY FROM
WRONGLY PRESCRIBED MEDICATIONS.

    ONE HOPES THE MEN AND WOMEN IN THE DRUG AND DEVICE INDUSTRY – WHO
BELIEVE IN MARKET EXCLUSIVITY OF THEIR PRODUCTS – ARE WELL-INTENTIONED.

    MA COST OF HEALTH CARE AND RATE OF CANCER ARE THE HIGHEST IN THE
NATION AND THE WORLD. WE CAN’T AFFORD SINGLE FOCUSED EXPERIMENTS TO
SUBSTITUTE AS A HEALTH CARE SYSTEM. MANDATE YEARLY DISCLOSURE OF
RESEARCH, SALES & MARKETING PAYMENTS AND OTHER ENTICEMENTS COUPLED
WITH GIFT BANS IS NECESSARY FOR CONSUMERS AND PHYSICIANS TO STRIVE FOR
QUALITY ACCESSIBLE HEALTH CARE.

   IT IS OUR STATE AND NATION’S HIGHEST PRIORITY TO FIND OUT HOW WAL-
MART DOES IT - $4.00 FOR GENERIC PRESCRIPTIONS.

    THANK YOU.

M. SULLIVAN, A CITIZEN, TESTIMONY JANUARY 12, 2009 AT U.MASS, WORCESTERY.

				
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