FDA Wants Opioid Taken Off Shelves

THE U.S. FDA HAS SAID ON THURSDAY THAT THE DRUGMAKER ENDO
PHARMACEUTICALS MUST REMOVE A EXTENDED RELEASE OPIOID PAIN
WE HAVE TO MOVE ON.
IT'S ALSO
ABOUT DRUGS THAT WELL, FAKE DRUGS.
THERE ARE A FEW RECURRING THEMES.
YES.
KILLER
CALLED OPANA ER FROM THE MARKET.
THE AGENCY IS SAYING THIS IS
THE FIRST TIME THEY ARE CALLING FOR AN OPIOID TO BE TAKEN
OFF THE MARKET DUE TO THE PUBLIC HEALTH CONSEQUENCES OF ABUSE.
A LITTLE BIT MORE OF THE FDA SAYING.
WE'RE FACING A PUBLIC OPIOID EPIDEMIC AND WE MUST
TAKE ALL NECESSARY STEPS TO REDUCE THE SCOPE OF OPIOID
MISUSE AND ABUSE.
WE WILL CONTINUE TO TAKE REGULATORY STEPS WHERE YOU SEE
SITUATIONS WHERE A PRODUCT'S RISKS OUTWEIGH ITS BENEFITS, NOT
ONLY FOR ITS INTENDED USE BUT ALSO IN REGARD TO ITS
POTENTIAL FOR MISUSE AND ABUSE.
JUST TO GIVE YOU SOME BACKGROUND ON IT.
THIS DRUG IS ABOUT TWICE AS POWERFUL AS OXYCONTIN AND
OTHER OFTEN ABUSED OPIOIDS.
THE FDA APPROVED IN 2006 AND THEY HAVE TRIED TO MAKE
MEASURES SO THAT IT IS MORE DIFFICULT TO ABUSE.
THEY MADE A HARD OUTER COATING SO IT IS MORE DIFFICULT TO
CRUSH, HOWEVER WHEN THE DRUGMAKER CHANGED THE FORMULA IN
2012,
FANATICS BEGAN INJECTING INSTEAD.
IN THE INDIANA CASE, THE SHARED NEEDLES SPREAD THE INFECTION
242 PEOPLE.
THE UNITED STATES IS IN THE MIDST OF
AN OPIOID OVERDOSE EPIDEMIC.
OPIOID OVERDOSE KILLED MORE THAN 32,000 PEOPLE IN 2013,
MORE THAN ANY OTHER YEAR.
NEARLY HALF OF ALL OVERDOSE DEATHS INVOLVE SOME SORT OF
PRESCRIPTION DRUG.
WE'RE GOING TO GET INTO THAT IN THE SECOND HALF OF THE STORY
WITH A NEW STUDY COMING OUT BY THE NEW YORK TIMES, BUT JUST TO
GET YOUR REACTION ON THIS HALF OF THE STORY THAT'S IN THERE
AND, THE COMPANY HAS RELEASED A STATEMENT AND SAYS QUOTE DESPITE
FDA'S REQUEST TO WITHDRAW UPON ER FROM THE MARKET, THIS
REQUEST DOES NOT INDICATE UNCERTAINTY WITH THE PRODUCTS
SAFETY OR EFFICACY WHEN TAKEN AS PRESCRIBED AND THE REMAINS
CONFIDENT IN EVIDENCE OBTAINED IN THE CLINIC CLINICAL RESEARCH
DEMONSTRATING THAT IT HAS A FAVORABLE RISK-BENEFIT PROFILE
WHEN USERS ATTENDED INAPPROPRIATE PATIENTS.
THE LARGER QUESTION HERE BEFORE WE GET INTO MORE QUESTIONS
IS INDO TO BLAME HERE?
ARE THEY DOING ENOUGH?
IT IS SO DIFFICULT FOR DOCTORS TO MAKE SURE THEY ARE NOT
ABUSING THESE PRESCRIPTIONS.
WHEN YOU THINK ABOUT THIS COMING OUT ABOUT THIS PARTICULAR DRUG?
NO COMPANY IS NECESSARILY RESPONSIBLE FOR WHAT PEOPLE DO
WHEN THEY DON'T USE A PRODUCT AS INTENDED THEORETICALLY.
BUT SOME PRODUCTS ARE EASIER TO USE IN UNINTENDED WAYS AND SOME
PRODUCTS THAT ARE DESIGNED TO BE AS STRONG AS POSSIBLE, IT'S
NOT THAT THAT IS THE PROBLEM.
IT IS WHEN YOU THEN COMBINE THAT WITH LOBBYISTS FOR THESE
GIGANTIC PHARMA COMPANIES WHO ARE PUSHING IT TO BE
PRESCRIBED AS MANY PEOPLE AS POSSIBLE, YOU NATURALLY
INCREASE THE ODDS OF SOME PEOPLE ARE GOING TO OVERDOSE ON IT
OR USE IN INAPPROPRIATE WAYS THAT
YES, I WAS TRYING TO CITE THIS BEFOREHAND, BUT THERE WAS A
STUDY ABOUT MOST PATIENTS NOT BEING AWARE THAT THE DOCTORS
WERE IN SOME WAY INCENTIVE INCENTIVIZED TO PRESCRIBE THE
THINGS THAT THEY PRESCRIBED AND WHEN YOU LOOK AT THE
PHARMACEUTICAL LOBBIES AND THE LACK OF TRANSPARENCY IN THAT
CASE I JUST MENTIONED, IT IS SORT OF INSANE WHEN YOU COMPARE
THIS AGAINST THE SCOPE OF THE WAR ON DRUGS AND HOW HARSHLY
PENALIZED PEOPLE HAVE BEEN FOR THINGS LIKE MARIJUANA WHICH I
WOULD SAY ARE NOT RESPONSIBLE FOR
33,000 DEATHS A YEAR?
YEAH, ADDICTION -RELATED DEATH.
IT IS PROBABLY LOWER.
IT'S INTERESTING TO FOLLOW WHERE THE MONEY GOES AND
SEE HOW THE INFLUENCE THINGS THAT
I THINK IT IS INTERESTING THAT THE DEFAULT AND THE
MAJORITY OF STATES IS ON PRESCRIPTION PAIN
MEDICATION RATHER THAN INVESTING IN MAYBE, I AM A MARIJUANA
USER FOR MY OWN MEDICAL REASONS AS WELL, AND IT IS INTERESTING
TO SEE THAT I LIVE IN A STATE WHERE I CAN GO TO A DOCTOR
AND HAVE MEDICAL MARIJUANA PRESCRIBE RESIN ANOTHER STATE,
FOR MY MEDICAL ISSUES, MAY BE PRESCRIBED AND IN THE PAST
I HAVE BEEN PRESCRIBED OXYCONTIN AND OXYCODONE AT ONE POINT TIME.
THAT IS INSANE.
IT DID NOT HELP ME.
IT WAS HORRIBLE.
IT
WAS A BAD TIME.
IT IS JUST REALLY STRANGE TO SEE THAT THERE IS OBVIOUSLY
CORRELATION BETWEEN PEOPLE ABUSING THESE DRUGS AND PEOPLE
WHO ARE BEING PRESCRIBED THESE DRUGS AND IT IS HARD TO FIND
EXACTLY WHAT LEVEL OF ACCOUNTABILITY WE NEED TO HAVE
AND YET THERE STILL AREN'T MANY MAJOR PREPRESS SOLUTIONS EXCEPT
FOR WILL PULL THIS OFF THE MARKET BUT A LOT OF PEOPLE COME
AND WE ARE GETTING OUR INFORMATION FROM CNN WERE SAYING
MORE NEEDS TO BE DONE.
IT IS GREAT THAT OPANA IS BEING TAKEN
OFF THE MARKET BUT THIS IS JUST ONE OF MANY DOCUMENTS AND ALL IS
ANOTHER THAT IS BEING ABUSED DIE GOES ON AND ON AND I THINK THAT
THAT WILL SEGUE US OVER INTO AN ARTICLE FROM VOX.COM AND THEY
ARE TAKING THEIR INFORMATION FROM A NEW REPORT FROM THE NEW
YORK TIMES AND BASICALLY, THE TAGLINE ON THIS STORY AND WHY
ITíS MAKING A LOT OF HEADLIGHTS IS IN ONE YEAR, DRUG OVERDOSES
KILLED MORE AMERICANS THAN THE ENTIRE VIETNAM WAR.
THEYíRE BREAKING THIS DOWN AND PROVIDING A BIT OF CONTEXT
THAT I WANT TO DIVE INTO WITH YOU GUYS AS WELL.
THE TIMES CONTACTED LOCAL AND STATE AGENCIES ACROSS THE
US TO COME UP WITH A ROUGH ESTIMATE OF PEOPLE WHO DIED
FROM DRUG OVERDOSES AND THEY CALCULATED THE 59 TO 65,000
PEOPLE DIED OF OVERDOSES LAST YEAR AND THAT IS MORE THAN THE
58,000 US SOLDIERS WHO DIED IN THE VIETNAM WAR.
LITTLE BIT MORE THE BACKGROUND OF THE OPIOID EPIDEMIC
EXPLAINED THAT BACK IN THE 1990S,
DOCTORS WERE PERSUADED TO TREAT PAIN IS A SERIOUS MEDICAL ISSUE.
THERE'S A GOOD REASON FOR THAT: ABOUT 100
MILLION US ADULTS SUFFER FROM CHRONIC PAIN ACCORDING TO IT
2011 REPORT FROM THE INSTITUTE OF MEDICINE.
PHARMACEUTICAL COMPANIES TOOK ADVANTAGE OF THIS CONCERN
THROUGH A BIG MARKETING CAMPAIGN THAT THEY GOT DOCTORS TO
PRESCRIBE PRODUCTS LIKE OXYCONTIN PERCOCET AND
DRUGS EVEN THOUGH THE EVIDENCE FOR OPIATES TREATING
LONG-TERM CHRONIC PAIN IS VERY WEAK DESPITE THEIR
EFFECTIVENESS FOR SHORT-TERM ACUTE PAIN WHILE THE
EVIDENCE OPIATES CAUSE HARM IN THE LONG TERM IS RESTAURANT.
WERE SAYING AT THE
THAT SPEAKS TO WHAT YOU WERE SAYING, CAM, AND I THINK IT
IS SOMETHING WE DON'T TALK ABOUT ENOUGH AND I THINK MOST
PEOPLE ARE JUST UNAWARE OF IT.
THERE IS AN INCENTIVE OFTENTIMES FOR PEOPLE TO BE PRESCRIBED
THE PAIN MEDICATION THAT THEY'RE BEING PRESCRIBED AND I
THINK THERE SHOULD BE MORE TRANSPARENCY, WOULD YOU AGREE?
YEAH, I WOULD LIKE TO KNOW MY DOCTOR WAS COMPENSATED TO
PRESCRIBE ME A SPECIFIC PRESCRIPTION DRUG.
YEAH, IT'S WEIRD IF THEORETICALLY RUN INSTAGRAM
AND YOU HAVE $1000 FOR SUNGLASSES OR 50
THEY HAVE TO BE TRANSPARENT ABOUT THAT.
SO WE TALK ABOUT THE REALM OF CULPABILITY FOR THESE DIFFERENT
GROUPS AND IT'S EASY TO SAY IS THE DRUG BEING MISUSED OR USED
IN AN IRRESPONSIBLE WAY BUT THAT DOESN'T JUST MEAN ONE THING.
IT
DOESN'T JUST MEAN THAT A PERSON IS CRUSHING AND INJECTING IT.
A PERSON CAN MISUSE IT, BUT A DOCTOR OR COMPANY CAN MISUSE IT.
WHEN YOU LOOK AT THIS CHART, AND OF YOU CAN SEE IT HERE.
YOU SEE THE DEATH SHOOTING UP.
STARTING IN 99, WHAT DID PEOPLE NOT HAVE PAID BACK IN 1999?
I THINK WE HAD ROUGHLY THE SAME AMOUNT OF PAIN WE JUST
DIDN'T HAVE THE SAME AMOUNT OF DEATH BECAUSE WE TREATED
PAIN DIFFERENTLY WHICH MEANS THAT SOMETHING LIKE 40,000
DEATHS LAST YEAR ALONE COULD'VE BEEN AVOIDED AND WHEN YOU
LOOK AT THE SIZE UNDER THAT GRAPH, YOU WERE TALKING ABOUT
HUNDREDS OF THOUSANDS OF DEATHS THAT DID NOT NEED TO HAPPEN.
IN ONE YEAR, YOU ARE LOOKING AT ALMOST TWICE AS MANY PEOPLE
DIE AS CAR ACCIDENTS.
THINK ABOUT IT, EVERYBODY BASICALLY DRIVES AND WE
DRIVE A LOT EVERY DAY.
FAR FEWER PEOPLE DO DRUGS, PRESCRIPTION OR OTHERWISE.
THAT IS A CRAZY INCREASE RESPECT AND AN UNNECESSARY ONE AS
IS CLEAR FROM THE 1999 EXAMPLE.
FOR MY OWN PERSONAL EXPERIENCE, I REMEMBER WHEN
I WAS BEING PRESCRIBED, IT WAS MAYBE PERCOCET.
IT WAS FOLLOWING ANY SURGERY BUT WHAT ENDED UP HAPPENING AS I WAS
GIVING A HUGE PRESCRIPTION THAT BECAUSE OF OTHER FACTORS IN MY
LIFE, I WOULDN'T SAY WAS ADDICTED, BUT I DEFINITELY HAD A
SORT OF DEPENDENCY THAT MESSED WITH MY BRAIN SO I UNDERSTAND
THAT I WAS GIVEN THIS AMOUNT OF PERCOCET THAT I DIDN'T NEED THAT
I HAD KNEE SURGERY, I NEEDED IT FOR ABOUT A WEEK TO GET OVER IT
AND I HAD ENOUGH PILLS FOR A MUCH LONGER TIME THAN THAT.
THAT IS THE KIND OF ACCOUNTABILITY AND TRANSPARENCY
THAT I THINK WE DIFFERENT DOCTORS TO BE LIKE THIS IS
WHAT SHE IS GOING TO, PAIN MEDICATION IS OKAY AND DOSES
BUT IT JUST SEEMS LIKE THERE WAS NO ONE OVERSIGHT THAT HAVING
A KNEE SURGERY, SHALL BE FINE, SHE'S AN ATHLETE, I TRUST HER.
YOU CAN PUT THAT ON THE PATIENT BECAUSE YOU HAVE NO IDEA
WHAT THEY MIGHT BE PREDISPOSED TO.
WHAT CAN WE DO AS FAR AS A SOLUTION?
VOXíS SAYING QUOTE THE LIKELY SOLUTION IS TO GET OPIATE
USERS INTO TREATMENT ARE ACCORDING TO A 2016
REPORT BY THE SURGEON GENERAL, JUSTIN PERCENT OF AMERICANS
WITH THE DRUG USE DISORDER OBTAIN SPECIALLY TREATMENT
OUT THE REPORT FOUND THAT THE LOW RATE WAS LARGELY SLAIN
BY ITS SHORTAGE OF TREATMENT OPTIONS.
DOES I JIVE WITH WHAT YOU GUYS KNOW ABOUT DRUG ADDICTION?
DO YOU FEEL LIKE THERE'S A SHORTAGE OF TREATMENT OPTIONS?
IT CERTAINLY SEEMS LIKE THE MONEY IS GETTING PEOPLE TO
BUY MORE DRUGS AND THEY NEED.
THE WHY IS THAT MONEY NOT IN THE TREATMENT.
SCENE INTERVENTION, THAT PLACESÖ
THAT'S TRUE FOR PEOPLE WHO CAN AFFORD IT.
I THINK THE GOVERNMENT NEEDS TO BE MORE INVOLVED IN TERMS OF
FUNDING THAT THAT THERE WAS A LOT OF DISCUSSION ON BOTH
REPUBLICAN AND DEMOCRATIC SIDES FROM SOME POLITICIANS BEFORE THE
ELECTION ABOUT HOW TO DEAL WITH THIS, NOT JUST THE
DEMOCRATIC CANDIDATES BUT JOHN CASEY FOR EXAMPLE MADE A
BIG DEAL ABOUT THIS ISSUE BUT THEN DOWNTOWN GOT ELECTED
AND HE DOESN'T SEEM TO CARED ALL ABOUT IT.
SO DOESN'T TALK ABOUT IT MUCH.
TO BE ABLE TO FIX THAT A FEDERAL LEVEL SEEMS TO LARGELY RUN AWAY.
THAT BLOWS ME AWAY THAT WE'RE NOT LOOKING TO FIX A SET OF
FEDERAL LEVEL TO
ESPECIALLY WHEN YOU HAVE TO IMAGINE THAT A LOT OF PEOPLE WHO
MAKE UP THOSE 56,000 DEATHS ARE NOT HIPPIE LIVES FROM THE
COAST EYES REPUBLICAN TO LIVE IN TENNESSEE AND KENTUCKY AND
EVERYWHERE ACROSS THE COUNTRY.
IT AFFECTS ALL CLASSES, RACES, AND PARTISAN IDENTIFICATIONS OF
PEOPLE.
IT SHOULD BE THE PROBLEM THAT IS EASIEST TO
SOLVE IN THE US BUT IT SEEMS TO BE ONE THAT WE ARE WILLING TO
KEEP KICKING THE CAN DOWN THE ROAD AND LETTING TENS OF
THOUSANDS OF PEOPLE UNNECESSARILY DIE EVERY YEAR.
TO THAT EXACT POINT, MY DAD IS A CHAPLAIN ON THE OHIO RIVER
REGION AND I WAS TALKING TO THEM JUST YESTERDAY AND HE HAS BEEN
TALKING ABOUT THE TWO REASONS WHY HE DOES FUNERALS OR WHY
HE IS REALLY CALLED TO SERVE OUR BECAUSE OF OFFICERS COMMITTED
SUICIDE ARE PEOPLE OBSERVED COMMITTING SUICIDEÖ SOMETHING
YOU TALK ABOUT AND THE SECOND IS TREVOR DRUG OVERDOSES BECAUSE
OF THE TIME THERE ON THE SHIPS, SERVING IN THE COAST GUARD
OR TOE BOATS AND THAT IS JUST SOMETHING THAT IS NOT TREATED.
HE WAS SAYING LITERALLY JUST YESTERDAY BEFORE I KNEW WE WERE
COVERING THE STORY, YOU LOOK AROUND AT THE FUNERAL THE FAMILY
FOR SOMEONE WHO HAS DIED FOR A DRUG THAT THEY WERE PRESCRIBED.
IT IS INSANE.

FDA Wants Opioid Taken Off Shelves

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