American Addict Page #7

THAT NO DRUG--NO PRESCRIPTION

DRUG. NO ANY KIND OF MEDICAL

DRUG CAN BE LICENSED FOR PUBLIC

USE IN THE UNITED STATES WITHOU THE PRIOR APPROVAL OF THE FDA.

NOW. THAT'S A VERY STRONG PIECE

TO HAVE ON THE BOARD. A VERY

STRONG POSITION TO HAVE.

THE FDA HAS BUILT UP IN

STRENGTH AND DEPTH EACH TIME

AROUND A DRUG DISASTER WHERE

A MANUFACTURER HAS PUT A REALLY

DANGEROUS DRUG OUT THERE AND NO WITHDRAWN IT QUICKLY. AND THAT'S

LED TO CONGRESSIONAL

INVESTIGATIONS AND THEN

A RAMPING UP OF THE REGULATORY

BODY.

I THINK AT SOME TIMES IN

ITS HISTORY. THE FDA HAS BEEN

VERY IMPORTANT IN THE REGULATION

AND MONITORING OF MEDICATIONS IN

THE COUNTRY.

UNFORTUNATELY. IT, TOO, HAS BEEN

CO-OPTED BY THE INDUSTRY.

HAS BEEN HAPPENING GRADUALLY

OVER THE LAST 20 YEAR--REALLY.

OVER 30 YEARS.

A LOT OF TIMES. YOU HAVE

DRUGS THAT MAYBE SHOULDN'T EVEN

BE ON THE MARKET AT ALL GET PU ON THE MARKET. AND PEOPLE STAR DYING. AND PEOPLE START HAVING

SIDE EFFECTS. BUT NOTHING REALLY

HAPPENS UNTIL AT LEAST THEY'VE

RECOUPED MONEY. MADE A PROFIT.

THEN THE FDA COMES RIDING IN ON

A WHITE HORSE AND PULLS THE VERY

SAME DRUG THAT SHOULD NEVER HAVE

BEEN ON THE MARKET IN THE FIRS PLACE OFF THE MARKET.

THE PROBLEM IS THAT WHENEVER

A GOVERNMENT AGENCY MONITORS

AN OUTSIDE ACTIVITY. IT IS

EVENTUALLY BOUGHT AND CONTROLLED

BY THAT WHICH IT MONITORS.

SO I THINK THERE ARE A LOT OF

VERY HARDWORKING. CONSCIENTIOUS,

HIGHLY TRAINED PEOPLE AT THE

FDA. ESPECIALLY THE REVIEWERS,

WHO ARE GREAT PUBLIC SERVANTS.

ONE PATTERN THAT WE HAVE FOUND

IN RECENT TIMES BUT GOES BACK

TO THE '70s. I'VE FOUND,

IS SENIOR MANAGEMENT OVERRIDING

WORRIES AND WARNINGS BY THEIR

OWN REVIEWERS. BASICALLY

APPROVING A DRUG THAT THEIR OWN

REVIEWERS SAY SHOULD NOT BE

APPROVED BECAUSE IT'S TOO

DANGEROUS TO GO ONTO THE MARKET.

IT'S SOMEWHAT DIFFICULT FOR

THE FDA TO GET PHYSICIANS

BECAUSE THEY DO NOT PAY ANYWHERE

NEAR AS MUCH AS MOST PHYSICIANS

WOULD MAKE IN AN ACADEMIC

MEDICAL CENTER OR CERTAINLY AS

THEY WOULD MAKE IN THE DRUG

INDUSTRY.

THEY GET DOCTORS AND THERE ARE

A LOT OF VERY DEDICATED

PHYSICIANS AT THE FDA.

BUT FREQUENTLY. THE MOS DEDICATED ONES ARE DRIVEN OU BECAUSE THEIR DECISIONS ABOU THE DANGERS OF DRUGS ARE

OVERTURNED.

WE DID A STUDY OF PHYSICIANS A THE FDA IN 1998.

BETWEEN THEM. THEY CITED 27

INSTANCES IN WHICH A DRUG THA THEY THOUGHT WAS TOO DANGEROUS

TO BE APPROVED WAS APPROVED OVER

THEIR HEAD. GOT ON THE MARKET,

AND IN MANY CASES. THE DRUGS

HAVE NOW BEEN TAKEN OFF

THE MARKET.

SO IF YOU ARE GOING INTO THE

GOVERNMENT WANTING TO ENGAGE IN

PUBLIC HEALTH SERVICE. BEING

WILLING TO TAKE A LOWER SALARY.

AND YET YOU'RE BEING THWARTED

FROM YOUR PUBLIC HEALTH MISSION

BECAUSE YOUR BOSSES ARE

OVERTURNING YOU PARTLY BECAUSE

THEY DON'T WANT TO DISPLEASE

THE DRUG INDUSTRY. IT'S NO A VERY WELCOME ATMOSPHERE.

AND SO TREMENDOUS

PHARMACEUTICAL COMPANY INFLUENCE

HAS BEEN EXERTED ON THE FDA TO

APPROVE DRUGS MANUFACTURED BY

THESE COMPANIES AS SAFE AND

EFFECTIVE. NATURALLY.

THE RHETORIC OF THE INDUSTRY

IS. WE NEED TO DO EVERYTHING WE

CAN TO GET LIFE-SAVING DRUGS TO

PATIENTS WHO NEED THEM AS

QUICKLY AS POSSIBLE.

AND THAT RHETORIC PREVAILS.

THAT'S WHAT CONGRESSMEN BELIEVE

AND JOURNALISTS BELIEVE

AND SO FORTH.

THE REALITY IS THE FOLLOWING:

THAT--THAT SEVERAL INDEPENDEN OF SIX NEW DRUGS. ABOUT 85% OF

NEW DRUGS. ARE LITTLE OR NO

BETTER THAN EXISTING DRUGS

AGAINST CLINICAL MEASURES.

THEY CAN'T BE LIFE-SAVING.

BECAUSE THEY'RE NO---THEY'RE

LITTLE OR NO BETTER.

AND A FEW YEARS AGO.

THE INDUSTRY WAS SUCCESSFUL IN

GETTING THE TIME TO REVIEW OF

MEDICATIONS REDUCED SO THA THE FDA COULD GO THROUGH ITS

REVIEW PROCESS MORE QUICKLY.

AND THAT'S BEEN ASSOCIATED WITH

A MUCH HIGHER RATE OF APPROVAL

OF DRUGS. A MUCH HIGHER RATE OF

APPROVAL OF DANGEROUS DRUGS.

THE VIOXX DISASTER LED THE

FDA AND CONGRESS AND LEADING

POLICY RESEARCHERS TO BECOME

VERY SERIOUSLY CONCERNED ABOU HOW UNSAFE DRUGS WERE.

VIOXX IS A DRUG MADE BY MERCK

THAT WAS TOUTED AS BEING GENTLER

ON THE STOMACH.

IT'S A PAINKILLER.

AND IN THEIR EFFORT TO PROVE

THAT IT WAS GENTLE ON THE

STOMACH. THE COMPANY. MERCK,

DID A STUDY.

HALF THE PEOPLE GOT VIOXX AND

HALF OF THEM GOT ANOTHER

PAINKILLER. NAPROXEN. WHICH HAS

BEEN ON THE MARKET FOR A LONG

TIME.

THE PEOPLE THAT GOT VIOXX HAD

FOUR TIMES MORE HEART ATTACKS

THAN THE PEOPLE THAT GO NAPROXEN.

WHEN THAT STUDY WAS PUBLISHED.

WE LOOKED AT THE STUDY.

IT WAS PUBLISHED IN NOVEMBER

OF 2000.

IT WAS NO MORE EFFECTIVE AS A

PAINKILLER THAN A LOT OF OTHER

DRUGS THAT DIDN'T CAUSE

HEART ATTACKS.

IT TOOK THE FDA SEVERAL YEARS

AND YET ANOTHER STUDY SHOWING

THAT IT CAUSED HEART ATTACKS TO

GET THE DRUG TAKEN OFF THE

MARKET.

MERCK PUSHED THE FDA ALL OVER

THE PLACE TO THE POINT WHERE

THEY DIDN'T EVEN PUT AN ADEQUATE

WARNING. LET ALONE TAKE IT OFF

THE MARKET.

AND IT STARTS WITH SOMETHING

THE FDA IS NOT ATTENDING TO:

HAVING COMPANIES TEST THEIR OWN

PRODUCTS. AND THEY NATURALLY

WANT TO DESIGN THOSE TESTS TO

MINIMIZE EVIDENCE OF HARMFUL

SIDE EFFECTS AND MAXIMIZE

EVIDENCE OF BENEFITS SO THEIR

DRUGS WILL BE APPROVED.

IT'S QUITE CLEAR THA CLINICAL TRIALS THAT ARE

SPONSORED BY INDUSTRY ARE FAR

MORE LIKELY TO BE POSITIVE.

TO SORT OF FIND THAT THE DRUG

WORKS AS COMPARED WITH PUBLICLY

FUNDED STUDIES THAT ARE FUNDED

BY THE NATIONAL INSTITUTES OF

HEALTH OR NON-PROFI FOUNDATIONS.

THOSE TRIALS NOT ONLY ARE

MISLEADING IN THEIR RESULTS

AND THEREFORE MISLEAD THE REVIEW

PROCESS. BUT THEY DON'T PROVIDE

USEFUL INFORMATION TO CLINICIANS

ON HOW TO USE THE DRUG.

WHEN THESE SO-CALLED DRUGS

ARE APPROVED ON THE BASIS OF

THEIR RANDOMIZED CONTROL TRIAL.

THEY'RE USED IN PRACTICE WITHOU ANY ACCOUNTABILITY.

THERE IS NO INFORMATION SYSTEM

THAT SYSTEMATICALLY LOOKS FOR

THE IMPACT OF THESE APPROVED

MEDICATIONS ON PEOPLE'S HEALTH.

SO WE'RE NOT LOOKING.

WE'RE NOT HOLDING OURSELVES

ACCOUNTABLE FOR WHAT WE'RE

PRESCRIBING IN THE FIELD OF

MEDICAL CARE.

YOU HAVE LOBBYISTS.

YOU HAVE PEOPLE WHO WORK FOR THE

FDA WHO EVENTUALLY GO TO WORK

FOR THE PHARMACEUTICAL

COMPANIES. AND SOME OF THEM

COME BACK AND WORK FOR THE FDA.

THEN MOVE ON TO BEING

A VICE PRESIDENT OF. PERHAPS.

REGULATORY AFFAIRS AT A DRUG

COMPANY.

PERFECT POSITION FOR A REGULATOR

TO GO TO FROM THE COMPANY'S

POINT OF VIEW.

KNOWS ALL THE INSIDE BYWAYS AND

HIGHWAYS.

INCREASINGLY. PARTICULARLY

SINCE 1992. MOST OF THE FUNDING

FOR REVIEWING DRUGS COMES

DIRECTLY IN CASH PAYMENTS FROM

THE DRUG INDUSTRY TO THE FDA.

IT'S A MASSIVE AND ALMOS LUDICROUS CONFLICT OF INTEREST.

BUT IT'S ONE THAT WAS PASSED BY

CONGRESS AS A WAY OF BALANCING

THE BUDGET.

THEY PAY UPWARDS OF $800.000.

$900.000 PER DRUG.

THEY HAVE TO PAY THE MONEY

WHETHER THE FDA APPROVES THE

DRUG OR NOT. BUT IT CREATES

A WHOLE ATTITUDE. A DIFFEREN ATTITUDE THAN USED TO EXIS BEFORE 1992.

AS TO HOW MUCH POLICING THE FDA

HAS DONE.

THAT INEVITABLY IS GOING TO

MEAN THAT THE FDA PROCESS IS

GOING TO CHANGE BECAUSE OF THE

MONEY THAT THEY GET.

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