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American Addict (2012)
YOU KNOW. THERE ARE DRUGS IN
THIS COUNTRY THAT ARE CLASSIFIED AS LEGAL AND OTHER DRUGS THA ARE CLASSIFIED AS ILLEGAL. AND FOR SOME PEOPLE. ALL I NEEDS TO BE LABELED IS LEGAL. AND IF YOU HAVE A DOCTOR IN PLACE. A DOCTOR'S AN AUTHORITY FIGURE WHO HAS THE. YOU KNOW, ABILITY TO PRESCRIBE DRUGS. A LOT OF PEOPLE FEEL LIKE. "WELL. IF A DOCTOR PRESCRIBED IT. IT'S FINE." BUT IF WE LOOK AT SOMEONE LIKE MICHAEL JACKSON--WHO IS PROBABLY THE MOST FAMOUS PERSON ON THE PLANET AT THE TIME THA HE DIED--HE WAS GETTING DRUGS SUCH AS PROPOFOL OR DIPRIVAN. THIS IS A MEDICATION THAT IS USED IN AN OPERATING ROOM. SHOULD NEVER BE USED OUTSIDE OF AN OPERATING ROOM. BUT HE WAS TAKING PAIN PILLS. HE WAS TAKING PILLS FOR ANXIETY. PILLS FOR SLEEP. AND IT'S SORT OF AN INTERESTING QUESTION WHY-- YOU KNOW. ARE PRESCRIPTION DRUGS LESS DANGEROUS THAN ALCOHOL AND CIGARETTES? SOMETIMES. BUT SOMETIMES NOT. WE'VE TURNED THE CORNER ON DRUG ADDICTION IN THE UNITED STATES. ONE OF THE MOST FAMOUS STARS IN HOLLYWOOD HISTORY IS DEAD AT 36. MARILYN MONROE WAS FOUND DEAD IN BED UNDER CIRCUMSTANCES THA WERE IN TRAGIC CONTRAST TO HER GLAMOROUS CAREER AS A COMIC TALENT. I'M GONNA GET I 'CAUSE I'M A FIEND SELL THE DEVIL MY SOUL TO GET ME WHAT I NEED GET ME A FIX GET ME BACK INTO THE ZONE I SAID. "WE NEED AN AMBULANCE AT GRACELAND. YOU SHOULD GET SOMEBODY REAL QUICK." RIGOR MORTIS HAD SET IN. AND SO I TURNED HIM OVER REAL QUICK. I PULLED UP HIS PAJAMA BOTTOMS. AND HE WALKED IN. HE SAID, "ELVIS IS GONE." TRIPLED UP ON EVERYTHING I'M NOT BREATHING RIGH IT'S GOT A HOLD ON ME AND IT MIGHT SEIZE MY LIFE FLOWERS. CANDLES, NOTES. THESE ARE ITEMS FOUND LEF OUTSIDE OF THE MANHATTAN APARTMENT WHERE THE BODY OF OSCAR NOMINATED ACTOR HEATH LEDGER WAS FOUND. POLICE SAY PRESCRIPTION PILLS WERE FOUND NEARBY. AN AUTOPSY PERFORMED WEDNESDAY WAS INCONCLUSIVE. WELL. WE HAVE A-- A GENTLEMAN HERE THAT NEEDS HELP. AND HE'S NOT BREATHING. PRESCRIPTION DRUG ABUSE HAD BEEN A PROBLEM FOR JACKSON FOR YEARS. JACKSON FAMILY ATTORNEY BRIAN OXMAN TELLS US WEEKLY. "I WARNED THEM. THERE IS THE MISUSE OF PRESCRIPTION MEDICATIONS BY PEOPLE WHO WERE ENABLING HIM." IT ALL REALLY STARTED IN 1972 WHEN RICHARD NIXON COINED THE PHRASE "THE WAR ON DRUGS." BUT IT'S PRETTY CLEAR AT THIS POINT THAT WE HAVE LOST THA WAR. AND THAT WAR WAS REALLY DEALING WITH ILLEGAL DRUG TRADE. YOU GOT TO PUSH IN MY HAND THAT WON'T LET UP HIGH STAKES I'M GONNA GET I 'CAUSE I'M A FIEND SELL THE DEVIL MY SOUL TO GET ME WHAT I NEED GET ME A FIX GET ME BACK INTO THE ZONE JUST ONE MORE TRIP UNTIL MY MIND GETS BLOWN LEAVE ME ALONE PRESCRIPTIONS FOR THE SHIT I'M ON GOT ME LOOKING LIKE THE LIGHT'S ON BUT NO ONE'S HOME CHECK MY HEARTBEA RACING AT THE SPEED OF LIGH PERCOCET OR VICODIN WILL SET YOU FREE TONIGH [ applause ] THANK YOU. WHAT A GLORIOUS DAY. FOR AMERICAN SENIORS. A STRONG AND MODERN MEDICARE STARTS TODAY. IT TOOK A LOT OF WORK TO GET US HERE. AND IT TOOK THE LEADERSHIP OF PRESIDENT GEORGE W. BUSH. [ applause ] LAW ENFORCEMENT NOW. AFTER 9/11. IS LOCKING DOWN THE BORDERS AND FOCUSING ON TERRORISM. BUT WHEN YOU LOCK DOWN THE BORDERS. WHAT'S NOT GETTING IN? ALL OF THE ILLEGAL SUBSTANCES THAT WERE COMING IN FROM OUT OF STATE ARE SIGNIFICANTLY REDUCED. SO LOOK AT THE STATISTICS. AFTER 9/11. IT LOOKED LIKE WE WERE WINNING THE WAR ON DRUGS. BUT THE PROBLEM IS. NO ONE ADDRESSED THE DRUG SEEKING BEHAVIOR. THE SUPPLY WAS REDUCED OF YOUR STREET LEVEL DRUG. BUT THE DEMAND WAS STILL THERE FOR THE MISUSE OF DRUGS. WHITNEY HOUSTON WAS PRONOUNCED DEAD AT THE BEVERLY HILTON HOTEL. GREG GIRALDO. WHO DIED FROM AN ACCIDENTAL OVERDOSE. THE ACTRESS BRITTANY MURPHY. SHE DIED VERY SUDDENLY. LESLIE CARTER HAS DIED. AND I WAS ADDICTED TO OXYCONTIN AND OPANAS. 40 MILLIGRAMS. TWO TIMES A DAY ALONG WITH DILAUDID. 4 MILLIGRAMS SIX TIMES A DAY. I WAS TAKING NORCO. I WAS TAKING ABOUT EIGHT A DAY. CO. ANYWHERE FROM TWO TO-- EVERY TWO TO THREE HOURS. ABOUT SIX TIMES A DAY. NORCO. EIGHT A DAY. AND PRETTY MUCH EVERY OTHER OPIOID OR DANGEROUS NARCOTIC THAT'S OUT THERE. HE SAID HE HAD HURT HIS BACK AND THAT HE WAS TAKING I BECAUSE HIS BACK WAS HURTING. OXYCONTIN AND ROXICODONE AND SOMAS. ALL PRESCRIBED AT ONE TIME. AND THIS DOCTOR WAS PRESCRIBING HIM MEDICATION FOR AN ILLNESS HE DIDN'T HAVE. HE KIND OF LOST HIS--HIS DRIVE. YOU WANT TO SAY. AND I WENT TO WORK. AND ABOU PROBABLY. LIKE, 10:00--I DON' EVEN--THE DAY IS--THE DAY IS JUST A MESS FOR ME. I GET A CALL. AND IT'S MY MOM. SHE SAYS. "SOMETHING'S WRONG WITH JOSEPH. I WENT TO WAKE HIM UP. AND THERE'S THIS STUFF COMING OUT OF HIS MOUTH." AND I YELLED AT MY MOM. I'M LIKE. "WHY ARE YOU CALLING ME? WHY AREN'T YOU CALLING THE-- YOU KNOW. THE PARAMEDICS OR SOMETHING?" AND I RAN OUT OF WORK. I LEFT WORK. AND I PRAYED ALL THE WAY HOME. TRIED TO BARGAIN WITH GOD. NO BARGAINING WITH GOD. I GOT HERE. NO PARAMEDICS. ONLY POLICE. AND SO HE WAS GONE. AND FROM WHAT THE CORONER SAYS. HIS--HE ONLY TOOK ONE PILL. HE TOOK ONE PILL. AND HIS BODY COULDN' HANDLE IT ANYMORE. AND HE WENT TO SLEEP. AND HE DIDN'T WAKE UP. AND I GUESS THEY FOUND OUT THAT. WELL. MAYBE IT WASN'T JUS MY SON. MAYBE THERE'S OTHERS. SO THEY STARTED DOING THEIR OWN UNDERCOVER WORK. THEY WENT IN THERE UNDERCOVER AND HOW EASY IT IS TO WALK INTO A DOCTOR'S OFFICE AND SAY YOUR BACK HURTS. "MY NECK HURTS, MY LEG HURTS." AND GET A PRESCRIPTION FOR A DRUG THAT IS REALLY FOR PEOPLE WITH. LIKE, CANCER OR SOMETHING THAT'S VERY--YOU KNOW. A VERY SEVERE ILLNESS. OKAY. MY NAME IS SERGEAN STEVE OPFERMAN FROM THE LOS ANGELES COUNTY SHERIFF'S DEPARTMENT. I'M ASSIGNED TO OUR DETECTIVE DIVISION. MAJOR CRIMES BUREAU. I SUPERVISE A MULTI-AGENCY TASK FORCE CALLED HALT. WHICH IS THE HEALTH AUTHORITY LAW ENFORCEMEN TASK FORCE. WE HANDLE OVER 100 CASES A YEAR. WE CONFISCATE AND DESTROY PROBABLY $3 MILLION TO $5 MILLION WORTH OF CONFISCATED DRUGS ANNUALLY. WE'VE ESTIMATED WE'VE PROBABLY SAVED THE GOVERNMENT BY STOPPING. YOU KNOW, A LOT OF THESE ILLEGAL BUSINESSES ABOU $50 MILLION IN MEDICARE AND MEDI-CAL CLAIMS. THIS IS AN EXAMPLE OF MEDICATIONS THAT WE SEIZE FROM WHAT WE CALL A CAPPER. THIS IS A RECRUITER THAT WOULD GO AROUND SKID ROW. AND, YOU KNOW. FIND PEOPLE WITH MEDICARE CARDS. WHEN WE'RE TALKING ABOUT THE NON-CONTROLLED SUBSTANCES. WHEN WE'RE TALKING ABOU MEDICINES THEMSELVES. THERE'S A DIFFERENT BLACK MARKET. BUT THE DRUGS ARE INITIALLY ACQUIRED BY THE SAME MEANS. THE MAIN FOCUS BY GOVERNMEN IS USUALLY ON SUPPLY. IF WE REDUCE THE SUPPLY. THAT REDUCES THE PROBLEM. WELL. NOT TRUE. IF YOU HAVE DRUG SEEKING BEHAVIOR AND YOU REDUCE THE SUPPLY. IT'S LIKE SQUEEZING THE END OF A BALLOON. IT JUST BLOWS UP SOMEWHERE ELSE. AND YOU SEE THIS TREMENDOUSLY WITH DRUGS. WHETHER IT'S ILLEGAL DRUGS AND LEGAL DRUGS. THE MODEL OF SORT OF OPTIMIZING CONTROL AND PROFITS ON DRUGS IS. TO ME. VERY MUCH ONE MODEL, BECAUSE THE ECONOMICS OF BOTH THE ILLEGAL AND THE LEGAL DRUGS ARE VERY INTEGRAL FROM A-- FROM A POLICY AND GOVERNANCE STANDPOINT. I'M PLEASE THAT ALL OF YOU ARE HERE TO WITNESS THE GREATES ADVANCE IN HEALTH CARE COVERAGE FOR AMERICA'S SENIORS SINCE THE FOUNDING OF MEDICARE. [ applause ] THIS SOCIAL PHENOMENA IS NOW GROWING WITH THE MISUSE OF PHARMACEUTICAL DRUGS. EVERYBODY. INCLUDING THEIR PARENTS. THEIR BROTHERS, THEIR SISTERS. THEIR GRANDPARENTS. EVERYBODY'S POPPING PILLS. I'M FEELING SHITTY NOW MY PILLS ARE GONE I DONE POPPED ALL MY VICODIN THE OTHER DAY NOW THAT MY MEDS ARE DONE I'M PARANOID BUT I'MA GET HIGH IN SOME OTHER WAY I'MA GET HIGH IN SOME OTHER WAY I GOT TO GET HIGH TO GET THROUGH THE DAY I'MA GET HIGH TO GET THROUGH THE DAY I'MA GET HIGH GET HIGH I'MA GET HIGH GETTING IN IT NOW PRESCRIPTION DRUG ABUSE IS RISING IN ALL CATEGORIES IN THE UNITED STATES AND ALL AGE GROUPS. BUT UNFORTUNATELY, 12- TO 17-YEARS OLDS ARE THE FASTEST GROWING SEGMENT OF EVERYBODY GROWING FASTER IN TERMS OF DRUG ABUSE-- PRESCRIPTION DRUG ABUSE. THE STATE OF FLORIDA IS NOW EXPERIENCING UP TO SEVEN INDIVIDUALS A DAY DYING FROM THE MISUSE AND THE ABUSE OF PHARMACEUTICAL DRUGS. WE HAVE THREE TIMES AS MANY PEOPLE DIE EVERY YEAR FROM PRESCRIPTION PILLS VERSUS HEROIN. COCAINE, AND METHAMPHETAMINE COMBINED. THEY STARTED GOING TO PHYSICIANS' OFFICES. THEY STARTED GETTING DRUGS FROM "LEGITIMATE SOURCES." AND ALL OF A SUDDEN. YOU CAN SEE THE INFLUX IN PAIN MANAGEMEN CLINICS. YOU CAN SEE THE INFLUX IN LEGALIZED DRUG DEALING. BROWARD. WHICH IS THE FOR LAUDERDALE AREA. IS THE EPICENTER OF THIS PILL MILL EPIDEMIC. AND WHAT WE SAW WAS THAT IN THE FIRST SIX MONTHS OF 2008. 67% OF THE OXYCODONE NATIONWIDE THAT WAS PUT OUT BY DISPENSING PRACTITIONERS CAME OUT OF BROWARD COUNTY. FLORIDA. THE ENTIRE MID-EASTERN QUADRAN OF THE U.S.. ALL THOSE STATES HAD A PRESCRIPTION DRUG MONITORING PROGRAM. WELL. WHAT THAT DID IS STARTED TO DRIVE DRUG SEEKERS--AND I'M NOT GONNA USE THE TERM PATIENT. IT DROVE DRUG SEEKERS FROM THOSE STATES INTO THE STATE OF FLORIDA. PRESCRIPTION DRUG ABUSE IS RISING. BUT THE INNOCENT VICTIMS ARE THE INFANTS BORN EXPOSED TO OPIATES IN UTERO. BROWARD COUNTY. FLORIDA, HAS SEEN A QUADRUPLE INCREASE AND MORE THAN HALF OF THE PEOPLE TAKING PRESCRIPTION DRUGS ARE WOMEN. THEY'RE--OVER THE LAS SEVERAL YEARS THERE. THERE'S BEEN NO REGULATION WHATSOEVER IN TERMS OF PATIENTS BEING ABLE TO GO TO DIFFEREN OFFICES AND GET PRESCRIPTION PILLS. AND BECAUSE OF THAT, YOU HAVE AN INFLUX OF PEOPLE ACTUALLY COMING FROM OTHER STATES TO GET THESE MEDICATIONS. SO AS THE NUMBER OF ADULTS AND WOMEN RISE TAKING THESE PRESCRIPTION PILLS. IT'S NO SURPRISE THAT THEY'RE HAVING BABIES THAT ARE DEPENDENT ON PAINKILLERS. YEAH. THERE YOU GO, OKAY. LOOK RIGHT THERE. HE'S MAKING A BUY. YEAH. HE'S MAKING THE BUY WITH THE GUY IN THE BROWN. HE'S GOT HIS MONEY IN HIS HAND. HE'S SHOWING HIM SOMETHING. THE DRUG DEALERS. WHEN THEY'RE DEALING WITH PRESCRIPTION DRUGS. GET THE INSURANCE COMPANIES. MEDI-CAL OR MEDICAID. THESE PROGRAMS PAY FOR THESE DRUGS. AND THEN THEY'RE RESOLD. IT STARTS WITH PEOPLE THAT WE CALL CAPPERS THAT GENERALLY DRIVE AROUND INDIGEN NEIGHBORHOODS. ANYWHERE WHERE PEOPLE ARE RECEIVING GOVERNMEN BENEFITS. PRIMARILY MEDICARE. THEY'RE USUALLY NEVER SEEN BY A DOCTOR. SOMEBODY IN THERE WILL WRITE A PRESCRIPTION. THEN THEY'LL PAY THAT PERSON TO GO TO A PHARMACY AND FILL THA PRESCRIPTION. AND THEN THEY'LL GIVE THOSE DRUGS BACK TO WHAT WE CALL A CAPPER. THEY WILL TAKE THOSE DRUGS TO SOMEBODY THAT'S GENERALLY INVOLVED IN ORGANIZED CRIME HERE IN L.A. THEY'LL TAKE THEM BACK TO RETAIL PHARMACIES THAT THEY OWN. THEY'LL TAKE THEM BACK TO WHA THEY CALL CLOSED-DOOR PHARMACIES THAT THEY OWN. USE THAT AS PAR OF THEIR INVENTORY. SO NOW THEY'RE ABLE TO BILL. AGAIN. MEDICARE FOR PRESCRIBING THESE DRUGS TO. SAY, AN ELDERLY PATIENT IN A NURSING HOME. THAT PERSON NEVER RECEIVES THOSE DRUGS EVEN THOUGH THERE'S A PAPER TRAIL AND A BILLING TRAIL CREATED SO THEY CAN CONTINUE BILLING. THEN WHEN THOSE DRUGS EXPIRE. THEY'RE GONNA PACKAGE THEM UP. AND THEY'RE GONNA TAKE THEM TO OUT OF STATE TO A WHOLESALE REPACKAGING BUSINESS. IF YOU AUTOMATE ALL THE RECORDS IN THE STATE. ALL THE CONTROLLED SUBSTANCE RECORDS. AND A PHYSICIAN ACCESSES YOUR FILE THROUGH THE PDMP. HE CAN SEE WHATEVER PHYSICIANS YOU'VE BEEN TO. WHAT QUANTITIES YOU'VE BEEN PRESCRIBED. AND IF HE'S CHECKING THE SYSTEM. AND YOU'VE RECEIVED A CONTROLLED SUBSTANCE FROM ANOTHER DOCTOR. HE'S NOT GOING TO PRESCRIBE. BECAUSE THAT'S A THREAT TO HIS LICENSE. THAT WOULD BE A LEGITIMATE DOCTOR IDENTIFYING DRUG SEEKING ACTIVITY. SO OUR BILL. OUR ORIGINAL BILL LAST YEAR WOULD'VE CHARGED 1/4 CENT PER PRESCRIPTION DRUG--PILL. I SHOULD SAY-- TO GO INTO A FUND TO COLLEC A FEW MILLION DOLLARS SO THAT WE COULD DEVELOP THE CAPACITY TO GET EVERYONE WHO WRITES PRESCRIPTIONS--175.000 PEOPLE WHO ARE LEGALLY ABLE TO WRITE PRESCRIPTIONS IN CALIFORNIA-- TO BE ELECTRONICALLY ON THIS DATABASE. SO IN REAL TIME. THE DEPARTMEN OF JUSTICE AND THE DOCTOR PRESCRIBING THE DRUG CAN SEE WHO'S PRESCRIBING WHAT DRUGS. AND ON THE OTHER HAND. THE DEPARTMENT OF JUSTICE CAN SEE THAT IF THERE ARE PHYSICIANS OR ANYONE WHO'S ALLOWED TO WRITE PRESCRIPTIONS ARE ABUSING I AND BASICALLY TAKING THE TRUS THE PUBLIC PUTS IN THEM AS PHYSICIANS AND ABUSING IT BY MAKING PROFIT MONEY BY SELLING OPIATES. PAINKILLERS TO PEOPLE. THEY FOUND A PRESCRIPTION RECEIPT IN HIS CAR. AND I GUESS THE CORONER CALLED THE DOCTOR AND ASKED HIM. "WHAT DID YOU GIVE THIS BOY? WHAT DID YOU GIVE THIS BOY?" THE DOCTOR SAID. "WELL, WHY?" HE'S LIKE. "BECAUSE HE'S DEAD. HE'S DEAD. HE'S 25 YEARS OLD. AND HE'S DEAD." THEN HE TOLD HIM WHAT HE PRESCRIBED TO HIM. AND IT WAS THE ROXI--NO. OXYCONTIN. IT'S--THE FORM OF IT WAS THE KIND THAT DOES NOT--IT DOESN' TIME RELEASE OR SOMETHING LIKE THAT. IT'S JUST INSTANTANEOUS PAIN RELIEF. SO SYSTEMATICALLY FROM 2001 UP TO APPROXIMATELY 2009. THE STATE OF FLORIDA FOUGHT FOR A PDMP IN THE LEGISLATURE. BILLS WERE INTRODUCED. AND I WAS FOUGHT DOWN EVERY YEAR. PURDUE PHARMA ALSO STEPPED UP TO THE PLATE AND MOST RECENTLY. AS OF A WEEK AGO. OFFERED $1 MILLION TO SUPPOR THE STATE OF FLORIDA IN A PDMP PROGRAM AND TO PAY FOR THE PDMP PROGRAM FOR THE STATE OF FLORIDA. AND THIS IS WHERE POLITICS COMES INTO PLAY. THE GOVERNOR OF THE STATE OF FLORIDA DECLINED AND DOES NO SEE FIT THAT A PDMP BE IMPLEMENTED WITHIN THE STATE OF FLORIDA. HE CITES THAT IT'S A VIOLATION OF PRIVACY. I MET WITH THE PHARMACEUTICAL INDUSTRY. I WAS RIGHT UPFRONT WITH THEM. I TOLD THEM. "THIS IS WHAT I WANT TO DO. IT SEEMS TO ME IT'S IN YOUR BES INTEREST TO HELP US DO THIS. IT'S NOT IN YOUR BEST INTERES TO READ ABOUT PEOPLE DYING FROM ABUSE OF YOUR LEGAL PRODUCT." AND WE HAD SOME GOOD MEETINGS. BUT WHEN THE BILL ACTUALLY WEN TO COMMITTEE AND. OBVIOUSLY, HAD TO GET PASSED OUT OF COMMITTEE IN A MAJORITY VOTE TO GET HERE TO THE FLOOR OF THE SENATE. I COULDN'T DO IT. I COULDN'T DO IT TWICE. THE FIRST TIME. I CAME OUT OF THE HEARING ROOM. AND I COULD SEE SOME LOBBYIST TALKING WITH A COUPLE OF MY COLLEAGUES. AND THESE ARE DEMOCRATIC COLLEAGUES WHO I THOUGHT I HAD THEIR VOTE. AND WHEN THE ROLL CALL WAS TAKEN. I DIDN'T HAVE THEIR VOTE. IF WE ARE SEEING RAPID ACCELERATION OF PRESCRIPTION DRUGS THAT ARE BEING GIVEN TO MORE AND MORE AND MORE PEOPLE. INCLUDING CHILDREN. OVER THE YEARS IN THE FUTURE. WE ARE ALSO LOOKING A A CORRESPONDING INCREASE OF DIAGNOSES BY DOCTORS. WHAT WAS ONCE A DIAGNOSTIC MANUAL THAT WAS PAPER THIN IS NOW A HUGE BOOK WITH HUNDREDS OF DIAGNOSES IN IT THAT GROWS AND GROWS AND GROWS. TO THE POINT WHERE PEOPLE ARE BEING SLICED AND DICED. WHERE THERE IS NOTHING WRONG WITH THE PERSON. BUT SOMETHING IS BEING SAID TO BE WRONG WITH THAT PERSON. IT GETS INTO THAT AREA. IN THIS COUNTRY. WE HAVE CREATED ILLNESSES FOR DRUGS. SO IN OTHER WORDS. I'VE SEEN-- YOU SEE--PEOPLE HAVE SEEN THE COMMERCIAL. RESTLESS LEG SYNDROME. MOST PEOPLE HAD NEVER HEARD OF THAT. BUT ONCE THAT COMMERCIAL STARTED PLAYING. THE NUMBER OF DIAGNOSES FOR RESTLESS LEG SYNDROME WEN THROUGH THE ROOF. FORTUNATELY. THERE'S MIRAPEX. MIRAPEX IS A PRESCRIPTION MEDICINE THAT HELPS RELIEVE THE FREQUENCY AND SEVERITY OF MANY RLS SYMPTOMS. JUST RECENTLY. I SAW A COMMERCIAL WHERE THERE IS A GUY. MID-40s, EARLY 50s, AND THE NARRATOR IS LIKE. "YOU CAN'T HIT THE GOLF BALL AS FAR AS YOU USED TO. YOU DON'T HAVE THE ENERGY LEVEL YOU'RE USED TO. YOU'RE NOT THE SAME GUY YOU WERE IN THE BEDROOM." AND IT SAYS. "MAYBE YOU'RE SUFFERING FROM LOW 'T.'" AND THEN I'M LIKE. "WHAT IS LOW 'T'?" AND THEN BEFORE I CAN EVEN SAY THAT TO MYSELF. THE ANNOUNCER SAYS. "LOW 'T' IS LOW TESTOSTERONE." TESTOSTERONE LEVELS DROP NORMALLY IN MEN AS THEY GE OLDER. IT'S NOT NECESSARILY A PROBLEM. BUT THEY'RE CREATING A PROBLEM. BECAUSE THERE IS NOW A NEW TREATMENT. A NEW PILL FOR IT. CRITICS. ANYWAY, OF DIRECT-TO-CONSUMER ADVERTISING SAY THAT IT LEADS TO A LOT OF PROBLEMS. THAT IT, NUMBER ONE. OVERMEDICALIZES THINGS IN SOCIETY THAT ARE REALLY NOT MEDICAL PROBLEMS. LIKE. AN EXAMPLE OF THAT IS ANXIETY. SO SOCIAL ANXIETY SYNDROME. ANOTHER EXAMPLE IS PREMENSTRUAL SYMPTOMS. MY DOCTOR TOLD ME. "THAT'S NOT PMS; THAT'S PMDD." UNLIKE PMS. SYMPTOMS OF PMDD ARE SEVERE ENOUGH TO ACTUALLY INTERFERE WITH YOUR LIFE. THINGS LIKE THIS THAT ARE KIND OF NORMAL FOR HUMANS ARE TURNED INTO A DISEASE. AND PEOPLE SUBSEQUENTLY REQUEST MEDICATION TREATMENT FOR THESE THINGS THA MAY NOT EVEN BE A DISEASE AT ALL. SO THAT'S BEEN A CRITICISM OF DIRECT-TO-CONSUMER ADVERTISING. ATTENTION YAZ. YASMIN, AND OCELLA USERS. THE FDA SAYS THESE DRUGS MAY CAUSE BLOOD CLOTS AND SERIOUS HEART AND HEALTH PROBLEMS. THERE ARE A LOT OF DIRECT-TO-CONSUMER ADVERTISEMENTS OF ANTI-DEPRESSANTS. AND TYPICALLY, PEOPLE WILL COME IN IF THEY'RE DEPRESSED. ASKING FOR THOSE PARTICULAR DRUGS AS OPPOSED TO OLDER ALTERNATIVES. AND INTERESTINGLY. ONE OF THE DRUGS THAT IS CURRENTLY BEING MARKETED FOR DEPRESSION IS ACTUALLY A DRUG THAT'S USED FOR PSYCHOSIS. FOR THINGS LIKE SCHIZOPHRENIA. BUT THAT IT-- IT IS USEFUL AS AN ADJUNCT TO DEPRESSION MEDICINES IN CASES OF VERY SEVERE DEPRESSION. AND WE SAW A LOT OF ADS. IN OUR REVIEW OF DIRECT-TO-CONSUMER ADVERTISEMENTS WE SAW A LOT OF ADS FOR THIS PARTICULAR DRUG. AND I HAVE HAD A LOT OF PATIENTS ASKING ME FOR IT. EVEN THOUGH I IS ACTUALLY COMPLETELY INAPPROPRIATE. ABILIFY TREATS DEPRESSION IN ADULTS WHEN ADDED TO AN ANTI-DEPRESSANT. SOME PEOPLE HAD SYMPTOM IMPROVEMENT IN AS EARLY AS ONE TO TWO WEEKS. ADDING ABILIFY HAS MADE A DIFFERENCE FOR ME. I MEAN. THE ADS DON'T SAY THAT IT'S A FIRST LINE AGENT FOR DEPRESSION. BUT BECAUSE IT'S ADVERTISED AND THE PEOPLE IN THE ADS LOOK HAPPY. YOU KNOW, PATIENTS WHO ARE DEPRESSED WAN A DRUG THAT'S GONNA MAKE THEM HAPPY TOO. AND IT'S BEEN VERY INTERESTING. PEOPLE ARE ASKING FOR THIS DRUG THAT THEY REALLY DON'T WANT TO TAKE. THE MOST SUCCESSFUL PR CAMPAIGN IN THE HISTORY OF THE WORLD WAS ELI LILLY PR-ING THA DEPRESSION IS CAUSED BY A BIOCHEMICAL IMBALANCE AND THA PROZAC COULD FIX IT. THERE WAS SOME INTERESTING RESEARCH DONE LOOKING AT THE GROUP FOR THE DIAGNOSTIC MANUAL THAT MADE UP THE DIAGNOSES FOR PSYCHOSES AND FOR MOOD DISORDERS. WHICH ARE SOME OF THE MAIN PLACES THAT THE DRUG COMPANIES MAKE MONEY FROM. AND EVERY SINGLE MEMBER OF THE PSYCHIATRIC ASSOCIATION'S COMMITTEE WAS INVOLVED WITH DRUG COMPANIES. GETTING MONEY FROM DRUG COMPANIES. ALL OF THEM. ABOUT SIX YEARS AGO. MY FATHER PASSED AWAY. MY PARENTS HAD BEEN MARRIED OVER 45 YEARS. AND MY MOM-- VERY HEALTHY. IN HER 70s, ON NO MEDICATIONS--WENT TO HER DOCTOR FOR REGULAR CHECKUP. AND THE DOCTOR LOOKED AT HER AND SAID. "YOU KNOW, MISS SMITH, YOU JUST DON'T LOOK LIKE YOUR USUAL SELF." AND SHE WENT AHEAD AND TOLD THE DOCTOR. "WELL, MY HUSBAND OF 45. 50 YEARS JUS PASSED AWAY." SO BEFORE MY MOM COULD EVEN FINISH SAYING ANYTHING. HE WAS WRITING OUT A PRESCRIPTION. SO HE HANDED HER A PRESCRIPTION. AND MY MOM SAID. "WHAT IS THIS?" AND HE SAID. "IT'S PROZAC FOR DEPRESSION." AND MY MOM LOOKED AT HIM AND SAID. "I'M NOT DEPRESSED. I'M JUST SAD." AND I THINK THIS IS REALLY A MICROCOSM OF WHAT IS GOING ON IN THIS COUNTRY AT THIS TIME. PEOPLE HAVE A PROBLEM. AND INSTEAD OF ASKING THEM. "WHAT IS THE PROBLEM." HERE'S A PILL FOR IT. NOW. THINK ABOUT HOW BIZARRE IT IS TO SUM UP A PERSON'S LIFE STRUGGLE WITH A DIAGNOSIS LIKE BI-POLAR DISORDER. THINK ABOUT LINCOLN. THERE HAVE BEEN INNUMERABLE BOOKS STUDYING LINCOLN. TRYING TO FIGURE OUT WHO WAS LINCOLN. WHAT MADE LINCOLN TICK. BUT A PSYCHIATRIST SAYS BIPOLAR DISORDER. IT USED TO BE THAT A YOUNG SOPHOMORE IN COLLEGE STRUGGLING WITH HIS ANGST AND HIS SADNESS AND HIS DEPRESSION WOULD READ KIERKEGAARD OR READ SOME OTHER REALLY DEEP AND BROODING BOOK TO FIND SOME SOLUTIONS TO LIFE. OR HE'D STUDY PHILOSOPHY. MAYBE READ SOME FREUD. MAYBE GET SOME THERAPY. BUT HE'D VIEW HIMSELF OR HERSELF AS STRUGGLING WITH LIFE ISSUES. NOW THAT SAME COLLEGE SOPHOMORE HAS ALREADY READ IN TEXTBOOKS THAT ALL THE ANGUISH THAT PEOPLE FEEL IS ABOUT BIOCHEMICAL IMBALANCES. AND WITH THAT. ALL THE LEARNING OF WESTERN CIVILIZATION IS THROWN OUT. PEOPLE ARE ADDICTED TO THE IDEA OF DRUGS. THERE'S LOTS OF ADDICTION. THEY BELIEVE THAT DRUGS WILL HELP THEM. PEOPLE ARE OVERUSING THIS THING. THESE PRODUCTS THAT WERE CREATED TO EASE THEIR PAIN. AND IT'S CREATING MORE PAIN. I MEAN. THAT'S THE IRONY OF-- AND THAT'S--AND EVERYTHING ENDEMIC IN OUR CULTURE IS LIKE. "WELL. GET RID OF MY PAIN," YOU KNOW? "JUST GET RID OF IT. I'LL PAY ANYTHING FOR IT." BUT IT'S NOT GETTING RID OF ANYTHING. IT'S MAKING THINGS WORSE. THIS IS AN OUTRAGEOUS SOCIETAL PHENOMENON. AND IT INDICATES A CULTURE LOSING TOUCH WITH EMPATHY FOR ITSELF AS INDIVIDUALS AND EMPATHY FOR OTHER HUMAN BEINGS. A CULTURE THAT HAS JUST GOTTEN CAUGHT UP IN THE END PRODUC AND EFFICIENCY AND WORK AND NO AT ALL THINKING ABOUT. "WHAT IS LIFE ABOUT? WHO AM I? WHO ARE MY CHILDREN? ARE MY CHILDREN GIFTS FROM GOD? ARE THEY TO BE TREASURED? DO THEY REQUIRE THAT I CHANGE MY LIFE TO BRING THEM UP BETTER? OR ARE THEY OBJECTS TO BE TINKERED WITH AND GIVEN DRUGS?" TALKING WITH MY DOCTOR. HE DIAGNOSED ME WITH ADHD. AND I TOLD HIM AT THAT POIN THAT MY CHILDREN WERE TAKING CONCERTA. I SAID. YOU KNOW, "IS THERE REASON TO THINK THAT IT WOULD WORK FOR ME?" AND HE SAID. "ABSOLUTELY." AND I'LL PROBABLY NEVER CHANGE THE MORE I TRY THE MORE I STAY THE SAME I HATE TO LOOK IN THE MIRROR 'CAUSE ALL I SEE SOMEBODY SPRUNG THAT LOOKS ME I HATE TO LOOK IN THE MIRROR 'CAUSE ALL I SEE SOMEBODY SPRUNG THAT LOOKS LIKE ME AND I CAN'T BREAK MY HABITS I'M AN AMERICAN ADDIC THE POINT MAN IN MY ADMINISTRATION ON THIS ISSUE WAS SECRETARY TOMMY THOMPSON. AND HE AND HIS TEAM DID A FABULOUS JOB OF WORKING WITH THE CONGRESS TO GET THIS IMPORTAN PIECE OF LEGISLATION PASSED. TOMMY. I WANT TO THANK YOU FOR YOUR LEADERSHIP. THIS BILL PASSED THE CONGRESS BECAUSE OF THE STRONG LEADERSHIP OF A HANDFUL OF MEMBERS. STARTING WITH THE SPEAKER OF THE HOUSE. DENNIS HASTERT. [ applause ] THE SPEAKER WAS JOINED BY SENATOR BILL FRIST. SENATE MAJORITY LEADER OF THE SENATE IN PROVIDING THE LEADERSHIP NECESSARY TO GET THIS BILL DONE. I WANT TO THANK YOU BOTH. [ applause ] I APPRECIATE THE HARD WORK OF THE HOUSE MAJORITY LEADER TOM DELAY TO SEE THAT THIS BILL WAS PASSED. COMMITTEE CHAIRMAN BILL THOMAS FOR HIS GOOD WORK. [ applause ] SENATOR CHUCK GRASSLEY DID A NOBLE JOB. SENATOR MAX BAUCUS OF MONTANA. [ applause ] AND SENATOR JOHN BREAUX. [ applause ] BILLY TAUZIN OF THE HOUSE OF REPRESENTATIVES DID GREAT WORK ON THIS BILL. [ applause ] SENATOR ORRIN HATCH FROM UTAH MADE A SIGNIFICANT CONTRIBUTION. NANCY JOHNSON. THE HOUSE MEMBER FROM CONNECTICUT DID A GREA JOB. [ applause ] MIKE BILIRAKIS FROM FLORIDA WORKED HARD ON THIS PIECE OF LEGISLATION. [ applause ] I WANT TO THANK ALL THE OTHER MEMBERS OF THE CONGRESS AND THE SENATE WHO HAVE JOINED US. THANK YOU ALL FOR TAKING TIME OUT OF YOUR BUSY SCHEDULES TO SHARE IN THIS HISTORIC MOMENT. [ applause ] THE BUSH ADMINISTRATION DID MEDICARE PART D TO HELP THE ELDERLY. ALL RIGHT. THE ELDERLY OWNERS IN THE PHARMACEUTICAL INDUSTRY. THE PEOPLE WHO ARE THE CEOs. THE PEOPLE WHO ARE THE MAJOR STOCKHOLDERS. WHEN I WORKED ON WALL STREE OR WHEN I WORKED IN WASHINGTON. WE WOULD NEVER ASK THE QUESTION ON HOW DO WE MAKE MONEY ON SOMETHING SO MUCH AS THE QUESTION WOULD BE ASKED. "WHERE DO WE WANT THE WORLD TO GO AND THEN HOW DO WE ENGINEER THINGS SO THAT IT WILL GO THA WAY. I LEFT WALL STREET. AND I WEN TO WASHINGTON. AND THEN I LEF WASHINGTON AND MOVED TO TENNESSEE. AND ONE OF THE THINGS I STRUGGLED THE MOST WITH WAS EXPLAINING TO MY FAMILY AND FRIENDS HOW THE ECONOMIC MODEL THAT AMERICA WORKS ON REALLY WORKS. AND I FINALLY--I FINALLY DECIDED TO WRITE A CASE STUDY. IT'S CALLED DILLON READ AND THE ARISTOCRACY OF STOCK PROFITS. AND IT TELLS THE STORY OF HOW WALL STREET MADE MONEY ON HELPING FINANCING PRIVATE PRISONS. AND I--I WROTE IT BECAUSE I WANTED PEOPLE TO UNDERSTAND THA A VERY FUNDAMENTALLY NON-ECONOMIC ACTIVITY CAN BECOME VERY PROFITABLE FOR MANY PEOPLE. WHAT MEDICARE PART D DID WAS. IT GAVE THE DRUG COMPANIES THE ABILITY TO NAME THEIR PRICE FOR PHARMACEUTICALS AND TO GET I AND TO HAVE THE GOVERNMEN PAY FOR IT. WHAT YOU'LL OFTEN SEE IS SOR OF A COMBINATION OF AN INDUSTRY MAKING MONEY AND GOVERNMEN ENGINEERING THE INCENTIVES AND THE ECONOMICS SO THAT. WHETHER IT'S THE CONSUMER OR THE TAXPAYER. THEY ALSO MAKE MONEY GOING IN THAT DIRECTION. NOW. THIS IS AN INDUSTRY, FROM MY UNDERSTANDING AND FROM SOME AMOUNT OF RESEARCH. THA HAS REALLY CHANGED IN THE LAS 20 YEARS. AT LEAST PEOPLE WILL OPINE THA THERE ARE VENTURE CAPITALISTS WHO DID A GOOD DEAL OF RESEARCH TO SEE WHO AMERICANS TRUSTED. AND AMERICANS USED TO AND STILL DO PUT A LOT OF TRUST IN PEOPLE IN WHITE SMOCKS. PHARMACISTS, DOCTORS--AS THEY SHOULD-- AND IN PHARMACEUTICAL COMPANIES. UNFORTUNATELY. IN MY OPINION, LIKE A LOT OF THINGS IN THE INVESTMENT WORLD. THERE WERE PEOPLE WHO WENT IN AND TOOK COMPANIES OVER AND WHA COMPANIES USED TO PRIDE THEMSELVES ON RESEARCH AND DEVELOPMENT AND PROVIDING A PRODUCT TO THE UNITED STATES PUBLIC THAT WOULD LENGTHEN YOUR LIVES AND MAKE THEM HEALTHIER LIVES SOMEWHAT GOT CORRUPTED AND GOT DRIVEN MORE ABOU PROFITABILITY. RETURN ON INVESTMENT. IF YOU LOOK AT THE AMOUNT OF MONEY THEY SPEND ON LOBBYING IN THE LAST CYCLE. IT WAS ABOU $272 MILLION. I MEAN. THEY HAVE MORE LOBBYISTS ACTIVE THAN THERE ARE MEMBERS OF CONGRESS. THERE'S $64 BILLION IN PROFITS LAST YEAR. AND THAT'S ON REVENUES OF ABOUT $254 BILLION FOR THE TOP 12 PHARMACEUTICAL COMPANIES. SO YOU'RE TALKING ABOUT AN ENORMOUS ECONOMIC IMPACT. AN EXTRAORDINARY LOBBYING IMPACT. AND A REAL POLITICAL IMPACT. WE HAVE SOMETHING IN THIS COUNTRY CALL A MEDICAL CARTEL. A CARTEL IS BASICALLY INTERLOCKING INTERESTS THAT FORM EITHER A MONOPOLY OR SOMETHING CLOSE TO MONOPOLY. WE'RE TALKING ABOUT COMPANIES. CORPORATIONS. IN THIS CASE. WE'RE TALKING ABOUT PHARMACEUTICAL COMPANIES. MEDICAL SCHOOLS. GOVERNMEN AGENCIES LIKE THE FDA. AND I WENT BACK TO HARVARD FOR MY FIRST YEAR OF RESIDENCY RIGHT AT THE TIME THAT THE POLITICS OF PSYCHIATRY WAS CHANGING. WHEN I INTERVIEWED FOR HARVARD. I WAS INTERVIEWED BY A FAMILY THERAPIST. AND I MET PEOPLE WHO WERE DOING FAMILY THERAPY AND PSYCHOANALYSIS AND SOCIAL THERAPIES. ONE YEAR LATER. THE PROGRAM HAD CHANGED INTO A BIOLOGICAL PSYCHIATRIC PROGRAM WHERE YOU HAD LIMITED TIME WITH YOUR PATIENTS AND SPENT MOST OF YOUR TIME DOING MEDICATION. MANAGING WARDS. GIVING ECT. THIS TRANSFORMATION WAS NO THROUGH SCIENCE. THIS WAS A DECISION BY POLITICAL PSYCHIATRY THAT THE FUTURE WAS WITH SELLING BIOLOGY AND DRUGS AS THE SOLUTION TO HUMAN SUFFERING IF PSYCHIATRY WAS GONNA KEEP ITS POWER AND ITS STATUS. WELL. ORIGINALLY, MODERN MEDICAL SCHOOLS WERE MAINLY FUNDED BY HUGE MEDICAL NON-PROFIT FOUNDATIONS. THOSE FOUNDATIONS HAD A PARTICULAR VIEW OF MEDICINE THAT WAS LEANING TOWARD WHAT HAS BECOME MODERN PHARMACEUTICAL MEDICINE. AND SO TO HONOR THESE GRANTS. THE MEDICAL SCHOOLS WERE FUNDED AND EVEN ESTABLISHED TO TEACH THAT BRAND OF MEDICINE. MANY PEOPLE. WHEN THEY LOOK AT A UNIVERSITY. SEE A UNIVERSITY. SEE A SCHOOL. THAT'S NOT WHAT I SEE. I SEE AN ENDOWMENT. AND A LOT OF INTERGENERATIONAL CAPITAL THA FINANCES CORPORATIONS IS SHELTERED FROM TAXES BY MANAGING IT THROUGH ENDOWMENTS. OFTEN FOR UNIVERSITIES. SO EVERYWHERE YOU GO. THERE'S THE PSYCHOPHARMACEUTICAL COMPLEX. AND ITS TENTACLES REACH DEEPLY DOWN INTO OUR EDUCATIONAL SYSTEM. WE--WE NOW HAVE A SITUATION WHERE THE DRUG COMPANIES ARE SPONSORING PROGRAMS TO GO INTO OUR SCHOOLS TO MONITOR OUR KIDS AND FIND OUT WHO MAY BE HAVING A PROBLEM. SO THAT THEY CAN BE EVALUATED PSYCHIATRICALLY AND SENT OFF TO CLINICS WHERE. GUESS WHAT THEY'LL GET? PILLS. PEOPLE WILL BE MUCH LESS PRONE TO SLIP THROUGH THE CRACKS. BECAUSE WE HAVE FORCES OPERATING ON THE FAMILY. ON THE SCHOOLS. THE WORKPLACE, TO GUARANTEE. IN A SENSE, THAT THE OVERMEDICALIZATION OF SOCIETY TAKES PLACE. THE GOVERNMENT MONEY AND THE GOVERNMENT RULES AND REGULATIONS PROGRAM TO DEVELOP THE MODEL WHERE THEY WANT TO GO. SO. FOR EXAMPLE, WHEN I FIRS MOVED TO TENNESSEE. I HAD A FRIEND WHO HAD JUST RETIRED FROM TEACHING. AND SO MANY PARENTS WOULD LOBBY HER TO PUT HER--TO SAY THAT THE CHILDREN NEEDED RITALIN. AND THE REASON WAS. IF THEY GOT THE KIDS ON RITALIN. THEY COULD GE A DISABILITY PAYMENT FROM SOCIAL SECURITY. IT WAS AN OVERNIGH TRANSFORMATION AT HARVARD. BECAUSE HARVARD WAS CUTTING EDGE. AND IN PSYCHIATRY. WE SEE THIS PHENOMENA THAT THE BEST IS THE WORST. THAT THE MOST CUTTING EDGE PSYCHIATRY. LIKE HARVARD TO THIS DAY. IS THE PSYCHIATRY THA TAKES THE MOST MONEY FROM THE DRUG COMPANIES. THAT HAS THE MOST INTIMATE RELATIONSHIPS WITH THE FEDERAL GOVERNMENT. BUT THERE'LL BE SOMEONE A A MEDICAL SCHOOL TEACHING MEDICAL SCHOOL STUDENTS. TEACHING RESIDENTS. BU POCKETING $50.000 OR $100.000 A YEAR FOR BEING A CONSULTANT TO THE DRUG COMPANY AND GIVING TALKS. WELL. THEY'RE NOT GONNA BE A CONSULTANT AND THEY'RE NO GONNA GET PAID TO GIVE TALKS UNLESS THEY ARE KNOWN TO BE FAVORABLE TO THAT COMPANY AND ITS PRODUCT. SO THAT THERE ARE A NUMBER OF PEOPLE IN ACADEMIC MEDICINE. DOING TEACHING. BEING "PRESTIGIOUS." WHO ARE INFLUENCED BY THE VAS AMOUNTS OF MONEY THAT THEY THINK THEY NEED TO GET FROM THE DRUG INDUSTRY. FOR EXAMPLE. AT HARVARD, IT'S JOSEPH BIEDERMAN WHO PERSONALLY CAUSED A REVOLUTION IN THE TREATMENT OF CHILDREN BY DEFINING MORE AND MORE CHILDREN AS BIPOLAR SO THAT THESE KIDS WOULD BE GIVEN PSYCHIATRIC DRUGS THAT WERE SUITABLE ONLY FOR ADULTS LIKE LITHIUM AND ABILIFY AND SEROQUEL. PILLS. PILLS, PILLS FOR CHILDREN IS THE THEME THAT COMES OUT OF THE HARVARD PSYCHOPHARMACOLOGY PROGRAM. I BLEW THE WHISTLE ON BIEDERMAN YEARS AGO AS SOMEONE GETTING HUGE MONEY FROM THE DRUG COMPANIES. BUT IT TOOK A WHILE FOR THE WHISTLE TO REACH WASHINGTON. AND NOW THERE HAVE BEEN HEARINGS. AND IT'S BEEN DISCOVERED THAT JOSEPH BIEDERMAN WAS GETTING A LOT MORE MONEY THAN HE ADMITTED FROM THE DRUG COMPANIES TO PUSH DRUGS ON AMERICA'S CHILDREN. THERE WAS A PROFESSOR A HARVARD LAST YEAR WHO HAD GOTTEN MORE THAN $100.000 IN THE PREVIOUS YEAR FROM THE DRUG INDUSTRY. AND HARVARD INSTITUTED A RULE THAT SAYS YOU CAN'T BE IN THE FACULTY AND GET THAT KIND OF MONEY FROM THE DRUG INDUSTRY. SO HE SAID. "I WANT MY $100,000. SO I'M LEAVING THE HARVARD FACULTY. I WENT ONTO THE NATIONAL INSTITUTE OF MENTAL HEALTH. SPENT TWO YEARS THERE. AND I WAS THERE AS THE TRANSFORMATION WAS HITTING NIMH. WHEN I ARRIVED. THE NATIONAL INSTITUTE OF MENTAL HEALTH WAS BASICALLY A PSYCHOSOCIALLY ORIENTED INSTITUTION IN 1966 AND '68. BUT IT WAS THE BEGINNING OF THE TRANSFORMATION OF NIMH INTO AN ARM OF THE DRUG COMPANIES. WE WOULD LATER DISCOVER THAT THE DRUG COMPANIES ACTUALLY HAD CONDUITS FOR GIVING MONEY TO NIMH TO DO RESEARCH ON THE DRUG COMPANIES' DRUGS. IT'S ALL VERY. VERY INTIMATE AND TIED TOGETHER. THE PROFESSION WAS MOVING HELL-BENT TO BEING LITERALLY AN ARM OF THE DRUG COMPANIES. WHY HAVE REGULATORY AGENCIES BEEN CO-OPTED BY VESTED INTERESTS THAT IS MOSTLY INDUSTRY INTERESTS? AND THAT'S BECAUSE THE INDUSTRY IS--IS EVER-PRESENT. I DON'T HAVE TO DOCUMENT THE FACT THAT INDUSTRY LOBBYISTS LOBBY CONGRESS EVERY DAY AND VERY POWERFULLY. AND THEY GIVE MONEY TO CAMPAIGNS. IN TURN. CONGRESSPEOPLE INFLUENCE THE REGULATORY AGENCIES. I THINK WHEN YOU HAVE PEOPLE THAT ARE LOBBYING THAT HAVE A LOT OF MONEY THAT THEY CAN THROW AROUND. THEY GET FACE TIME, AND THAT'S IMPORTANT. THEY GET FACE TIME WITH THE DECISION MAKERS. BECAUSE THEY'RE ABLE TO DO CERTAIN THINGS FROM A FINANCIAL STANDPOINT. THE CONGRESS HAS. SEEMINGLY REFLECTING THE PUBLIC INTEREST-- ALTHOUGH I'M NOT SURE THE PUBLIC HAS REALLY WEIGHED IN ON IT-- DECIDING TO UNDERFUND THE FDA. LEAVING THE FDA AT THE MERCY OF INDUSTRY FUNDING SO THA COMPANIES PAY LARGE FEES LIKE $1/4 MILLION--THAT'S-- WHEN I SAY A FEE. I MEAN A LO OF MONEY FOR THE--FOR THE REGULATOR TO REVIEW ITS OWN DRUG. WHICH IS A BALD CONFLIC OF INTEREST. I MEAN. THE DRUG INDUSTRY HAS GREATLY REPLACED THE TOBACCO INDUSTRY AS THE MOST POWERFUL LOBBY IN WASHINGTON. THEY PRETTY MUCH GET THEIR WAY. TO A POINT WHERE THE CONSUMER DOESN'T HAVE MUCH OF A CHANCE. SO THE POWER IS VIRTUALLY COMPLETELY ONE-SIDED ON THE SIDE OF THE MARKET. ANTI-REGULATORY. LET THE DOCTOR DO WHAT THE DOCTOR WANTS TO DO BECAUSE THE DOCTOR KNOWS BEST. WHEN, IN FACT. THERE'S NO WAY THE PHYSICIAN CAN KNOW WHAT TO DO BECAUSE THERE'S SO MUCH KNOWLEDGE OUT THERE THAT THEY'RE VERY VULNERABLE TO PRESSURE BY INDUSTRY LOBBYISTS. SO IT'S IN THE NATURE OF THE BEAST. IT'S IN THE NATURE OF THE GROWTH IN KNOWLEDGE. THE GROWTH IN INFORMATION SYSTEMS. WHICH CAN BE DISTORTED BY PEOPLE WHO STAND TO EARN A LOT OF MONEY. MOUNT SINAI HAD A PRESCRIBER EDUCATION GRANT THROUGH THE ATTORNEY GENERAL OF THE STATE OF OREGON. AND THESE GRANTS WERE FUNDED TO TEACH PHYSICIANS ABOU THE PHARMACEUTICAL INDUSTRY. AND THE MONEY CAME FROM A CLASS-ACTION LAWSUIT ON BEHALF OF MEDICAID ORGANIZATIONS FROM A BUNCH OF DIFFERENT STATES RELATED TO THE IMPROPER MARKETING OF NEURONTIN OR GABAPENTIN. WHICH IS A DRUG FOR--USED FOR SEIZURES AND PAIN. THE DRUG NEURONTIN WAS ILLEGALLY MARKETED FOR UNAPPROVED USES. INCLUDING TREATMENT FOR BIPOLAR DISORDER. NEURONTIN HAS NO PROVEN BENEFITS FOR THIS CONDITION. WHICH LEF THOSE TAKING THIS DRUG ESSENTIALLY UNTREATED. AND IT WAS FOUND THAT THE COMPANY BASICALLY INAPPROPRIATELY MARKETED. AND THEY SETTLED WITH A LOT OF MONEY. AND PART OF THAT MONEY WAS USED TO FUND EDUCATIONAL PROJECTS. SO THAT'S HOW I FIRST BECAME INTERESTED IN THIS ISSUE. AS AN OFFSHOOT OF THAT GRANT. WE--MY COLLEAGUES AND I DID A RESEARCH PROJECT LOOKING A THE ADHERENCE OF PRIN ADVERTISEMENTS TO FDA GUIDELINES. THE BREADTH AND DEPTH TO WHICH COMPANIES ARE INVOLVED IN TRAINING AND EDUCATION. AND SOME OF IT IS QUITE INDIRECT. AND SOME IS QUITE DIRECT. YEAH. BECAUSE IT SUPPORTS A LOT OF ACADEMIA. AND THERE HAVE BEEN MANY. MANY, MANY WRITINGS ON THE FACT THA PHYSICIANS HAVE BEEN PAID TO GO TO MEETINGS. HAVE BEEN PAID TO SAY CERTAIN THINGS AT MEETINGS. TO NOT SAY CERTAIN THINGS A MEETINGS. I MYSELF HAVE BEEN DISINVITED FROM MEETINGS. THERE WAS A STUDY NOT TOO LONG AGO OF HOW COMPANIES USE THE HIGH GROSS PROFITS FROM THEIR HIGH PRICES. AND I INCLUDED DOCUMENTING 371.000 PROFESSIONAL MEETINGS A YEAR FOR DOCTORS. NOW THERE ARE ONLY 1/2 MILLION DOCTORS WHO ARE ACTIVE IN THE UNITED STATES. SO THAT IS AN AWFUL LOT OF MEETINGS. THE BRANCH OF THE FDA THA REGULATES MARKETING MATERIALS HAD A BUDGET IN 2008 OF $9 MILLION. APPROXIMATELY, AND THAT COMPARES WITH THE MARKETING BUDGET OF THE PHARMACEUTICAL INDUSTRY IN THE UNITED STATES IS. DEPENDING ON HOW YOU CALCULATE IT. ON THE ORDER OF $30 BILLION TO $60 BILLION PER YEAR. AND THE STAKES ARE SO HIGH AND THE GROSS PROFITS ARE SO GREAT BECAUSE AMERICAN PRICES ARE. BY FAR THE HIGHEST IN THE INDUSTRIALIZED WORLD. SO THIS IS BIG. BIG BUSINESS, AND THEY JUST PUT OUT A LOT OF ADVERTISING. AND INCREASINGLY SO ON THE WEB. AND THEY HAVE, YOU KNOW. WEB BANNERS AND SPONSORED LINKS. SO THE PUBLIC DOESN'T KNOW THAT THEY'RE ACTUALLY SUBSIDIZING 39% OF ALL THE R&D THAT COMPANIES DO THROUGH TAX DEDUCTIONS AND TAX CREDITS AND TAX SUBSIDIES. IT'S OUR OWN TAXES AND OUR OWN RETIREMENT SAVINGS WHICH ARE FINANCING A SYSTEM WHICH IS LITERALLY LETHAL TO OUR HEALTH. NOT TO MENTION ANOTHER MAJOR SOURCE. WHICH NO ONE'S TRIED CALCULATING. WHICH IS THE BILLIONS OF DOLLARS THA COMPANIES ACCUMULATE OVERSEAS IN TAX HAVENS TO AVOID PAYING U.S. TAX. THESE ARE COMPANIES THA CONSIDER THEMSELVES VERY PATRIOTIC. THEY EVADE AMERICAN TAXES BY HARBORING BILLIONS OF PROFITS ABROAD. AND THEN EVERY FIVE OR SIX YEARS. THE BUSINESS HAS GOTTEN SO LARGE IN THESE TAX HAVENS THAT THE CONGRESS GIVES THEM A TAX HOLIDAY. I ONCE HELPED A REPORTER WRITE A WONDERFUL STORY ABOU NOVARTIS. WHO IS THE MAKER OF RITALIN. AND LITERALLY HOW MUCH MONEY THEIR STOCK WOULD GO UP FOR EVERY CHILD THEY GOT ON RITALIN. I AM RICH BEYOND BELIEF FOR THIS LOVE YOU HAVE GIVEN ME THERE WAS AN IDEA THAT THE NEW NEUROTRANSMITTER HAD BEEN FOUND CALLED SEROTONIN. SO ELI LILLY IMMEDIATELY WENT TO STUDY RATS TO FIND A PILL THA WOULD DO SOMETHING. CHANGE, THAT IS. CAUSE A DEFECT IN THE NEUROTRANSMITTER SYSTEM SO THAT IT COULD BE CLAIMED TO FIX IT. AND THEY CAME UP WITH PROZAC. WHICH BLOCKS THE EFFECTIVE FUNCTIONING OF THE SYSTEM BY STOPPING THE REMOVAL OF SEROTONIN FROM ITS ACTIVE PLACE IN THE BRAIN AND FLOODING THE BRAIN WITH IT. THEY FOUND QUICKLY THAT PROZAC CAUSED SO MUCH AGITATION IN PATIENTS THAT THEY HAD TO GIVE THE PATIENTS TRANQUILIZERS. OR THEY'D DROP OUT OF THE STUDIES. WELL. WHEN IT CAME DOWN TO APPROVING THE DRUG. THEY COULDN'T FIND A BENEFICIAL EFFECT UNLESS THEY INCLUDED THE TRANQUILIZED PATIENTS. SO THE FDA FORGAVE ELI LILLY FOR CHEATING AND APPROVED ELI LILLY'S DRUG PROZAC WHEN THEY REALLY WERE APPROVING-- THEY DIDN'T TELL ANYBODY THIS-- REALLY APPROVING PROZAC WITH ITS AGITATION COVERED OVER BY ADDICTIVE TRANQUILIZING DRUGS. SO. AS THE MEDICAL EXPERT, WE FINALLY HAD OUR FIRST TRIAL. NOW. I WONDERED WHY--WHY WOULD THIS BE THE FIRST TRIAL THAT WE WOULD BRING OUT OF THE 150. BECAUSE IT WAS A VERY DIFFICUL CASE. THIS MAN. JOSEPH WESBECKER, HAD BEEN PARANOID AND HATEFUL AND THREATENING TOWARD PEOPLE A WORK BEFORE HE WAS PUT ON PROZAC. THAT'S NOT THE BEST CASE. BUT WHEN HE WAS PUT ON PROZAC. WITHIN DAYS. HE GOT PSYCHOTIC, AND HE KILLED A DOZEN PEOPLE AND INJURED 20 AT HIS PLACE OF WORK. SO I WAS GONNA TESTIFY THAT I WASN'T THAT PROZAC JUST CAUSED THIS. BUT PROZAC TIPPED HIM OVER. WELL. I GET READY TO HAVE THE TRIAL. AND MY--THE LAWYER ON OUR SIDE ISN'T PREPARING ME. HE'S NOT SENDING ME ANYMORE MATERIALS. I ARRIVE IN LOUISVILLE. AND THE LAWYER FOR OUR SIDE. WHO'S SUING LILLY. IS HIDING DOCUMENTS FROM ME. I WAS THROWN ON THE STAND WITH NO PREPARATION. I GAVE THE LAWYER 20 OR 30 NOTE CARDS BEFORE I WENT ON THE STAND AND SAID. "YOU'VE GOT TO ASK ME THESE QUESTIONS." HE GOT MAD AT ME. WELL. IT WAS VERY HARD TO TESTIFY UNDER THOSE CONDITIONS. AS IT WAS. LILLY ALMOST LOS THE CASE. IT WAS A 9-3 VOTE. WHICH ALLOWED THEM TO WIN. ONE MORE VOTE AGAINST THEM. AND THEY WOULD HAVE LOST. BIG HEADLINES: "LILLY WINS ITS CASE." AND ALL THE OTHER LAWYERS STARTED TO SETTLE FROM THE 150 OR MORE OTHER CASES. WELL. THE JUDGE FIGURED OUT THA THIS TRIAL HAD BEEN FIXED. HE CALLED TOGETHER ELI LILLY AND MR. SMITH. WHO WAS THE LAWYER FOR THE PLAINTIFFS. AND SAID THAT. "WHAT DID YOU GUYS DO?" AND THEY SAID. "IT'S NONE OF YOUR BUSINESS." SO NOW THE JUDGE IS UP AGAINS BOTH PARTIES ON THE TRIAL. SO THE JUDGE INVESTIGATES. AND HE FINDS OUT THAT OUR SIDE WAS INDEED PAID OFF IN ORDER TO PRESENT A WEAK CASE SO LILLY COULD WIN. AND OUR SIDE TRIED TO DISCREDI ME IN COURT. MY OWN SIDE TRIED TO DISCREDIT ME IN COURT. BECAUSE LILLY NEEDED TO WIN THE CASE. AND THEY NEEDED TO DISCREDIT PETER BREGGIN. BECAUSE I WAS THEIR ONLY REAL OPPOSITION IN THE WORLD. I NEED A BAILOU JUST LIKE CITIGROUP I NEED A BAILOU DON'T FORGET AIG GOLDMAN SACHS I NEED A BAILOU WHAT ABOUT THE BIG THREE? I NEED A BAILOU IT ALL ENDS WITH JUST ME I NEED A BAILOU JUST LIKE CITIGROUP I NEED A BAILOU DON'T FORGET AIG GOLDMAN SACHS I NEED A BAILOU BAILOUT. BAILOUT, BAILOU BAILOUT. BAILOU SOME DOCTORS. INCLUDING MYSELF. GET FRUSTRATED WITH THE FDA SOMETIMES. BECAUSE THERE ARE MEDICATIONS THAT WORK WELL IN EUROPE AND OTHER COUNTRIES THA HAVE BEEN OUT FOR YEARS. BUT I TAKES ANOTHER 10. 12 YEARS TO GET APPROVED IN THIS COUNTRY. SO IN MANY WAYS. THEY'RE VERY CAREFUL. AND THE PROCESS IS VERY SLOW. BUT IN OTHER SITUATIONS. CERTAIN DRUGS ARE FAST TRACKED. SO WHEN YOU--WHEN YOU LOOK A SITUATIONS LIKE FEN-PHEN. A DRUG THAT WAS REALLY POPULAR IN THE '90s FOR WEIGHT LOSS. PEOPLE--A LOT OF PEOPLE DIED FROM THAT DRUG. A LOT OF PEOPLE ARE STILL ALIVE NOW THAT ARE HAVING LONG-TERM HEART PROBLEMS FROM THAT-- FROM THAT DRUG COMBINATION. THEY KNEW BEFORE THAT DRUG WAS RELEASED THAT THERE WAS A PROBLEM. PEOPLE IN THAT PARTICULAR COMPANY KNEW. INFORMATION WAS SUPPRESSED. BECAUSE WHEN YOU GO THROUGH R&D. RESEARCH AND DEVELOPMENT. TO GET A DRUG BROUGHT TO MARKET. IT COULD TAKE SEVERAL YEARS. TENS OF MILLIONS OF DOLLARS ARE SPENT DOING THIS PROCESS. SO WHEN THAT DRUG GETS READY TO BE RELEASED BY THE FDA. IT IS A BIG DEAL IF IT DOES NO GET RELEASED. BECAUSE THEY'VE ALREADY SPENT A LOT OF MONEY. AND REMEMBER. PHARMACEUTICAL COMPANIES ARE FOR PROFIT. THEY'RE NOT NON-PROFIT. GOOD, YOU KNOW. TOUCHY-FEELY CORPORATIONS. THEY ARE TRYING TO MAKE MONEY. I REMEMBER I TOLD MY SON. "DO YOU REALIZE WHAT YOU'RE DOING TO YOURSELF?" "MOM. YOU KNOW, I--THESE-- THEY GOT 'EM FROM A DOCTOR. A DOCTOR'S NOT GONNA GIVE YOU ANYTHING BAD." SO I DON'T KNOW IF THEY HAVE I IN THEIR HEAD OF. "OKAY, WELL, I'M NOT BUYING IT ON THE STREET. I'M NOT BUYING IT FROM THE DRUG DEALER ON THE CORNER. I'M NOT BUYING IT FROM-- YOU KNOW. IN AN ALLEY SOMEWHERE. I'M GOING INTO A DOCTOR'S OFFICE. AND I'M BUYING MEDICATION. AND IT'S FINE. WHY WOULD HE GIVE ME SOMETHING THAT'S GONNA HURT ME?" THE FOOD AND DRUG ADMINISTRATION BECAME RESPONSIBLE FOR CERTIFYING DRUGS AS BEING SAFE AND THEN. EVENTUALLY. FOR BEING SAFE AND EFFECTIVE. WHICH MEANS 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. THE SIZE OF THE PEOPLE WHO ARE WORKING IN THE FDA ON MOVING THE APPROVAL OF DRUGS FORWARD. THERE ARE MORE PEOPLE DOING THAT. AND YOU HAVE LESS PEOPLE WHO ARE INVOLVED MONITORING MARKETING PRACTICES OF DRUG COMPANIES. WHO ARE MONITORING DRUG SAFETY. BASICALLY. COMPANIES. THROUGH THEIR LOBBYING. GOT CONGRESS TO AGREE THAT THEY WOULD PAY FOR THE FDA. THEY GET QUICKER APPROVALS. THAT MEANS THEY MAKE BILLIONS MORE IN REVENUES AND PROFITS. AND IN RETURN. MORE PEOPLE GE SERIOUSLY ILL. HOSPITALIZED. AND DIE. BECAUSE WE'VE INCREASED THE NUMBER OF DRUGS. WE'VE INCREASED THE ADVERSE EVENT RATES FROM DRUGS FOUR TIMES THAN WE'VE INCREASED THE PRESCRIPTION RATE. SO THAT THE ADVERSE EVENT RATE-- EVENT RATES FOR MEDICATIONS ARE GETTING BIGGER AND NOT SMALLER. AND FOR SOME MEDICATIONS. WE'VE INCREASED THE ADVERSE EVENT RATES 16 TIMES WHAT IT WAS TEN YEARS AGO. SO THERE'S NO QUESTION IN MY MIND THAT THE EVIDENCE SHOWS-- STRONG EVIDENCE--THAT ADVERSE EVENTS FROM MEDICATIONS ARE THE FOURTH LEADING CAUSE OF DEATH. I WROTE AN ARTICLE IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION TEN YEARS AGO. INTERESTINGLY ENOUGH. THE ARTICLE WAS ORIGINALLY SUBMITTED TO ANOTHER JOURNAL--A VERY HIGH-LEVEL. PREMIER JOURNAL. WHICH REJECTED IT ON THE GROUNDS THAT NOBODY WOULD BE INTERESTED IN IT. IT WAS AN ARTICLE THA DOCUMENTED THE FACT THAT THE UNITED STATES RANKED VERY POORLY ON HEALTH LEVELS WITH REGARD TO OTHER COMPARABLE COUNTRIES-- INDUSTRIALIZED COUNTRIES IN THE WORLD. AND IT ALSO DOCUMENTED THE FAC THAT WE HAD A VERY HIGH RATE OF ADVERSE EVENTS FROM THE USE OF VARIOUS INTERVENTIONS IN THE HEALTH CARE FIELD. AND SINCE THAT ARTICLE WAS PUBLISHED 11 YEARS AGO. I HAVE CONTINUED TO GET REQUESTS FOR REPRINTS. I STILL GET ABOUT FIVE REQUESTS FOR REPRINTS EVERY WEEK. THE ARTICLE HAS GOTTEN A LOT OF ATTENTION. MOSTLY. I THINK, FROM LAYPEOPLE. ALMOST NO ATTENTION FROM GOVERNMENT. I HAVE NEVER BEEN CONTACTED BY THE FDA TO EXPLAIN WHAT I'VE DONE OR TO EXPLORE THE RAMIFICATIONS. AND I THINK THAT'S BECAUSE PEOPLE DON'T LIKE TO KNOW THA MEDICATIONS CAN BE HARMFUL AND THAT THEY. IN FACT. MAY ACCOUN AT LEAST IN PART FOR THE FAC THAT WE DON'T DO VERY WELL INTERNATIONALLY IN OUR HEALTH LEVELS. SO HOW IS THE CARTEL GOING TO PRESENT ITSELF AS. REALLY. THE ONE AND ONLY SOLUTION TO THE PROBLEM OF ILLNESS? THROUGH MEDIA. COULD YOU IMAGINE A SOCIETY WHERE PEOPLE ADVERTISED. YOU KNOW. HEROIN ON TELEVISION? YOU KNOW. "I GOT BLUE MAGIC. DA DA DA DA DA. CALL THIS NUMBER OR. YOU KNOW. THIS WEBSITE." YOU KNOW. LIKE. THAT'S FUNNY, BECAUSE YOU COULDN'T IMAGINE THAT. BUT YOU NOW HAVE PHARMACEUTICAL COMPANIES SELLING DRUGS THROUGH COMMERCIALS ON TELEVISION. BILLBOARDS. AND SUCH. THE UNITED STATES IS ONE OF VERY FEW COUNTRIES IN THE WORLD IN WHICH DIRECT-TO-CONSUMER ADVERTISING IS LEGAL. AND IT'S CONSIDERED A FREE SPEECH RIGH IN THE U.S.. AND IT'S PROTECTED AS A FREE SPEECH RIGHT HERE. PROPONENTS OF DIRECT-TO-CONSUMER ADVERTISING SAY THAT IT HELPS FACILITATE COMMUNICATION BETWEEN DOCTORS AND PATIENTS. THAT I INFORMS PATIENTS OF THINGS AND SORT OF HELPS THEM TO BE ABLE TO TALK ABOUT THEM WITH THEIR DOCTORS. AND THERE ACTUALLY IS SOME EVIDENCE THAT THAT'S TRUE. THERE'S ALSO EVIDENCE THAT IT-- IT INCREASES PRESCRIBING OF ADVERTISED DRUGS. AND. OBVIOUSLY. YOU KNOW. THE PHARMACEUTICAL INDUSTRY ARE PRETTY SMART. AND THEY WOULDN'T DO IT IF I DIDN'T WORK. THERE'S NO COUNTERBALANCE TO THAT. SO IN OTHER WORDS. WHEN A PERSON IS WATCHING TELEVISION AND THEY SEE THIS AD COMES ON. AND THEY SAY. "ARE YOU NOT GETTING ENOUGH SLEEP AT NIGHT? ARE YOU RESTLESS? ARE YOU ANXIOUS? YOU HAVING PROBLEMS IN THE BEDROOM? ALMOST ANYBODY WATCHING THESE COMMERCIALS CAN RELATE TO SOME OF THESE PROBLEMS AT SOME POIN IN TIME. AND THEN ALL THE WHILE. IT'S JUST BEAUTIFUL COMMERCIALS ROLLING. PEOPLE IN SLOW MOTION. FROLICKING THROUGH THE FOREST. HOLDING HANDS. BEAUTIFUL MUSIC. YOU HAVE A GUY READING IN A VERY LOW VOICE OF ALL THE POTENTIAL SIDE EFFECTS. BUT OUR VISUAL--THERE'S A VISUAL DISCONNECT. WE HAVE THE SIDE EFFECTS BEING READ REALLY LOW VOLUME AND FAST. AND YOU HAVE THE PEOPLE THAT LOOK LIKE THEY'RE JUS ENJOYING THEIR LIFE. AND YOU HAVE PEOPLE THAT END UP GOING TO THEIR DOCTOR'S BASED ON A COMMERCIAL. ASKING FOR A PILL. HIGH FEVER. STIFF MUSCLES. AND CONFUSION TO ADDRESS A POSSIBLE LIFE-THREATENING CONDITION. OR IF YOU HAVE UNCONTROLLABLE MUSCLE MOVEMENTS. AS THESE COULD BECOME PERMANENT. HIGH BLOOD SUGAR HAS BEEN REPORTED WITH ABILIFY AND MEDICINES LIKE IT. IN SOME CASES. EXTREME HIGH BLOOD SUGAR CAN LEAD TO COMA OR DEATH. OTHER RISKS INCLUDE DECREASES... THE--THE FDA GUIDELINES ARE KIND OF LEGALISTIC. BUT THEY'RE ALSO VERY. VERY VAGUE. SO THEY DON'T PARTICULARLY MANDATE THE PRESENCE OF IMPORTANT INFORMATION. THEY JUST MANDATE THE ABSENCE OF OVERTLY MISLEADING INFORMATION. BECAUSE THE FDA IS SO UNABLE TO LOOK AT ALL OF THE MARKETING MATERIALS THAT ARE OUT THERE. WE FELT IT WAS IMPORTANT TO LOOK A THE ADHERENCE OF MATERIALS TO THEIR GUIDELINES. SO WHAT WE FOUND IN THE CASE OF CONSUMER-DIRECTED ADS IS THA RELATIVELY FEW OF THE ADS WERE CLEARLY ADHERENT. BUT MOST OF THE TIME. THAT WAS BECAUSE OF INCOMPLETE INFORMATION. THEY'RE JUST WAS NOT THE INFORMATION PRESENT IN THE AD FOR US TO EVEN ASSESS THE ADHERENCE TO THE FDA GUIDELINES. WE ALSO FOUND THAT OVER 1/4 OF THE DRUGS THAT WERE ADVERTISED IN OUR SAMPLE HAD A BLACK BOX WARNING FROM THE FDA. SO A BLACK BOX WARNING IS AN INDICATION FROM THE FDA THAT A DRUG IS PARTICULARLY DANGEROUS. IF YOU ARE PRESCRIBED A DRUG. AND YOU GET THE PACKAGE'S INSERT. YOU'LL ACTUALLY SEE A WARNING IN BOLD LETTERS IN A BLACK RECTANGLE. WELL. HOW DO I FEEL ABOUT THE WAY THIS COUNTRY HAS GONE OVER THE--MY PROFESSIONAL LIFETIME. THE FACT THAT IT'S FALLING FURTHER AND FURTHER BEHIND IN POPULATION HEALTH. IT'S FALLING FURTHER AND FURTHER BEHIND IN PEOPLE'S SATISFACTION WITH THE HEALTH CARE SYSTEM. IT'S GOING FURTHER AND FURTHER BEHIND IN TERMS OF COST CONTROL AND. IN GENERAL. JUST SIMPLY NO KEEPING UP WITH THE NECESSARY CHANGES. IT'S VERY DISAPPOINTING. AND I MAKES ME VERY UNHAPPY. BOTH FROM A PROFESSIONAL POINT OF VIEW AS WELL AS FROM A PERSONAL POINT OF VIEW. I KNOW THAT PROBABLY EVER SINCE I STARTED WRITING ABOUT PRIMARY CARE. WHICH WAS IN THE EARLY 1990s. I HAVE BEEN DELIBERATELY SHUT OUT OF POLICY MAKING GROUPS AND CONSULTANCIES. AND BASICALLY THE ONLY THING THAT KEEPS ME GOING IS THE FAC THAT I AM WELL REGARDED SCIENTIFICALLY AND PROFESSIONALLY. I THINK NO ONE HAS EVER MOUNTED A CHALLENGE TO MY USE OF EVIDENCE. AT LEAST I AM NO AWARE OF IT. THEY CERTAINLY HAVEN'T DONE I IN PROFESSIONAL MEDIA. SO I REALLY DON'T HAVE MUCH DISSATISFACTION ABOUT THE CONTRIBUTIONS I'VE MADE TO SCHOLARSHIP AND TO KNOWLEDGE ABOUT THE WAY HEALTH CARE SHOULD BE PROVIDED. BUT IT HAS BEEN PERSONALLY DISAPPOINTING THAT MY WORK HAS NOT LED TO POSITIVE CHANGE OVER MY LIFETIME. THE OBAMA ADMINISTRATION'S HEALTH CARE POLICY STILL LEF THE INSURANCE COMPANIES IN CHARGE. IT WAS REFORMED WITHIN THE CONTEXT OF A FOR-PROFIT SYSTEM. INSURANCE COMPANIES ARE STILL RAISING THEIR RATES TO THE ROOF. IT ALSO DIDN'T DO ANYTHING TO TOUCH THE PHARMACEUTICAL INDUSTRY. BECAUSE. ESSENTIALLY, WITH MEDICARE PART D STILL INTACT. THE PHARMACEUTICAL COMPANIES CAN CONTINUE TO NAME THEIR PRICE FOR PRESCRIPTION DRUGS AND GET IT. SO THE GOVERNMENT. THEN. HAS A DUAL BURDEN. WHICH IS MORE PRESSURE ON THE MEDICARE BUDGE THROUGH THE PHARMACEUTICAL COMPANIES TAKING A BIG CHUNK OU OF IT AND GREATER PRESSURE ON THE ENTIRE HEALTH CARE SYSTEM THROUGH ABOUT ONE OUT OF EVERY THREE DOLLARS GOING FOR THE ACTIVITIES OF THE FOR-PROFI SYSTEM--CORPORATE PROFITS. STOCK OPTIONS. EXECUTIVE SALARIES. ADVERTISING. MARKETING. THE COS OF PAPERWORK. I SPOKE ABOUT THE URGENT NEED FOR HEALTH CARE REFORM AND WHA WILL BE REQUIRED TO ACHIEVE IT. AND ONE OF THE THINGS THAT WILL BE REQUIRED. I SAID. WAS THA EVERYONE IN OUR HEALTH CARE COMMUNITY IS GONNA HAVE TO COME TOGETHER AND DO THEIR PART. IN RECENT DAYS. CHAIRMAN MAX BAUCUS. WHO'S BEEN DOING AN OUTSTANDING JOB LEADING THE FINANCE COMMITTEE ON THIS ISSUE... WHAT I'M HOLDING IS A BOTTLE OF ZYPREXA. ZYPREXA IS AN ANTI-PSYCHOTIC MEDICATION. IT'S VERY POPULAR. AND IT'S VERY EXPENSIVE. THIS AMONG SOME OF THE OTHERS. ABILIFY. CIALIS--ERECTILE DYSFUNCTION DRUGS--ARE VERY COMMONLY DIVERTED. THE REASON BEING IS. AGAIN. THE MEDICAL PROGRAMS AND INSURANCE PROGRAMS PAY A LOT OF MONEY FOR THESE DRUGS. I'M A SALES REP FOR A PHARMACEUTICAL COMPANY. BEEN DOING IT FOR ABOUT A YEAR. AND MY JOB IS ESSENTIALLY TO SELL OUR PRODUCTS TO PHYSICIANS. YOU CAN BE FIRED FOR TALKING TO PHYSICIANS OFF-LABELING. NOW. DOES IT HAPPEN? IT HAPPENS OFTEN. AND IT HAPPENS FREQUENTLY. OFF-LABEL PROMOTION IN ATTEMPTING TO SELL A DRUG FOR A DISEASE THAT THE FDA HASN' APPROVED IT FOR. LET'S SAY A DRUG GETS APPROVED BY THE FDA FOR ONE PURPOSE. AND IT DOESN'T SELL VERY MUCH. SO THE COMPANY SAYS. "HMM. MAYBE WE CAN PRETEND. BY ADVERTISING AND PROMOTION AND BUYING UP DOCTORS TO SPREAD THE BUZZ. THAT THIS DRUG IS ALSO GOOD FOR THE SECOND AND THIRD AND FOURTH AND FIFTH DISEASE." THEIR MARKETING IS INGENIOUS. IT IS SO ILLEGAL. IT MAKES THE COLOMBIAN CARTEL LOOK LIKE CHILD'S PLAY. ELI LILLY KNOWS HOW LONG IT'S DRUG IS PATENTED AND HOW LONG THEY'RE GONNA CHARGE A PREMIUM PRICE FOR THAT DRUG. AND AS SOON AS THAT DRUG GOES GENERIC. THEY NEED ANOTHER DRUG TO REPLACE IT TO REPLACE THOSE PROFITS. BECAUSE SHAREHOLDERS EXPECT PROFITS AND A RETURN ON THEIR INVESTMENT. SO PROZAC IS GOING OFF PATENT. AND THEY NEED TO REPLACE THOSE PROFITS. SO THEY TAKE ZYPREXA. AND THEY DEVELOP THIS ELABORATE SCHEME TO MARKET ZYPREXA TO THE ELDERLY AND TO THE CHILDREN. TO ANYBODY OFF-LABEL. THIS IS A CRIMINAL ACT ON THE PART OF A COMPANY. IF THEY DO THIS. THEY'RE ESSENTIALLY MAKING IT SEEM AS THOUGH THIS DRUG IS SAFE ENOUGH. RELATIVE TO ITS BENEFITS. TO BE PROMOTED. THE FACT IS. IF IT HASN'T BEEN APPROVED AT ALL FOR THA OFF-LABEL OR SECOND PURPOSE. WE DON'T KNOW WHETHER THE BENEFITS OUTWEIGH THE RISK OR WHETHER THE RISKS OUTWEIGH THE BENEFITS. IF THERE WAS ENOUGH EVIDENCE OF THAT. IT WOULD BE ON-LABEL. THE FDA WOULD GET THE EVIDENCE AND WOULD APPROVE IT. SO THE ELDERLY THAT WERE PLACED ON ZYPREXA DIED TERRIBLY PAINFUL DEATHS. ELI LILLY HAD PSYCHIATRISTS IN THEIR STAFF DEVELOP A PSYCHOLOGICAL PROFILE OF THE DOCTORS PRESCRIBING ZYPREXA. THEY WOULD DIRECT THE MARKER TO SAY. "NO MATTER HOW DUMB YOUR DOCTOR IS. DON'T TALK DOWN TO HIM." PHARMACEUTICAL REPRESENTATIVES ARE UNIVERSALLY ATTRACTIVE. THEY GET RECRUITED FROM PLACES LIKE CHEERLEADING SQUADS AT BIG TEN SCHOOLS. IN THE CASE OF WOMEN. AND IT'S QUITE CLEAR THA PART OF THEIR HIRING PROCESS IS THE ATTRACTIVENESS OF THE PEOPLE. THEY DON'T PARTICULARLY HAVE A LOT OF MEDICAL BACKGROUND. YOU KNOW. THEY ARE MARKETERS. BUT THEY GO TO SORT OF BOOT CAMP TO LEARN ABOUT THEIR DRUG. THEY'RE GOING TO PRIMARY CARE PHYSICIANS. WHO ARE TREATING YOU AND I. AND TELLING THEM HOW TO MANAGE THEIR PATIENTS. WHO MIGHT JUST HAVE A SLEEP DISORDER. AND I GUESS THE MOS FRUSTRATING THING TO ME TO FIND OUT IS THAT 20% OF THE PEOPLE GETTING ZYPREXA. AT LEAST IN OUR CLAIMS DATA. WERE PEOPLE THA WERE OVER 65. FOR WHOM IT WAS OFF-LABELED. NOT ONLY THAT. MOST OF THESE PEOPLE HAD NEVER. IN THE DATA THAT WE HAD. HAD EVIDENCE THAT THEY WERE SCHIZOPHRENIC OR BIPOLAR. THEY TAUGHT THEM TO SAY. "DOCTOR. WELL. DON'T YOU HAVE ANY PEOPLE THAT COME IN AND COMPLAIN. 'WELL. YOU KNOW, FINANCIALLY. WE'RE DOING--WE'RE HAVING A DIFFICULT TIME. AND I'M JUST STRESSED OUT RIGHT NOW'? ANYBODY WHO SAYS THAT WHO USES THESE MAGIC WORDS LIKE "STRESS." YOU CAN CONVERT THAT WORD INTO "DELUSIONAL." OKAY? YOU CAN CONVERT ANY ANXIETY THEY HAVE INTO A DELUSIONAL BEHAVIOR. AND AS LONG AS YOU PU "DELUSIONAL" IN YOUR RECORD. THEN YOU CAN QUALIFY FOR PAYMEN BY A GOVERNMENT ENTITY LIKE MEDICAID AND MEDICARE." THE REASON THAT DRUG COMPANIES PRAY ON MEDICAID IS THE SAME REASON THAT BANK ROBBERS ROB BANKS. THAT'S WHERE THE MONEY IS. AND THERE'S HUNDREDS OF MILLIONS OF DOLLARS IN EVEN A RELATIVELY SMALL STATE LIKE UTAH. WITH ITS POPULATION OF 2.5 MILLION PEOPLE. "IF YOU DO THAT. WE WILL PAY YOU TO GO ON A SPEAKING CIRCUI TO TELL OTHER DOCTORS HOW EFFECTIVE THIS DRUG IS FOR YOUR REGULAR PATIENTS." WHAT QUALIFIES AS A SPEAKER IS. IF THAT DOCTOR GOT ON THE PHONE AND TALKED TO EVEN ONE OTHER DOCTOR WHO WAS SCHEDULED TO TAKE PART IN A TELEPHONIC CONFERENCE. THEY WOULD GET A CHECK. AND THERE WERE DOCTORS WHO WERE GETTING A LOT OF CHECKS FOR THAT. I SUE DRUG COMPANIES. I SUE THEM ON BEHALF OF ATTORNEYS GENERAL. I SUE THEM ON BEHALF OF MEDICAID. I'VE BEEN DOING THAT FOR ABOU SIX YEARS. WE WERE REALLY THE FIRST SET OF LAWYERS TO BRING AN ATTORNEY GENERAL CASE TO TRIAL. WE BOUGHT--BROUGHT THAT CASE TO TRIAL IN ALASKA. TWO WEEKS INTO TRIAL AND SHORTLY BEFORE THE JURY OUT--WENT OUT. WE SETTLED THE CASE FOR $15 MILLION. I SETTLED UTAH'S CASE AGAINS THE SAME DEFENDANT. WHICH IS ELI LILLY. MAKER OF THE DRUG ZYPREXA. I SETTLED THE UTAH CASE FOR $24 MILLION. IDAHO CASE FOR $13 MILLION. WEST VIRGINIA VERSUS ELI LILLY. WHICH SETTLED FOR ABOUT $24 MILLION. MANY OF THE ATTORNEY GENERALS TURNED US AWAY BECAUSE IT'S UNPOPULAR FOR THEM TO SUE BIG BUSINESS. NOT ONLY IS IT UNPOPULAR. BUT IT'S VERY EXPENSIVE. THE GOVERNMENT PURSE WAS BEING DEPLETED IN ENORMOUS AMOUNTS BY THESE DRUG COMPANIES THA WEREN'T PLAYING FAIR AND THE GOVERNMENT HAD THE RIGH TO RECOVER THAT MONEY. THE ISSUE WAS--IT'S WHETHER OR NOT THERE WAS EXCESSIVE COSTS OR EXCESSIVE INAPPROPRIATE USES OF ZYPREXA IN THE MEDICAID POPULATION. THE FDA APPROVED THE USE OF THAT DRUG FOR PEOPLE BETWEEN THE AGES OF 18 AND 65 ONLY IF THEY HAD BEEN DIAGNOSED WITH BIPOLAR DISORDER OR SCHIZOPHRENIA. IN OTHER WORDS. THEY HAD NO CLINICAL CONDITION IN THEIR PAS THAT WOULD INDICATE WHY THEY SHOULD GET ZYPREXA. SECONDLY IS. IS THESE PEOPLE HAD A INCREASED PROPENSITY FOR GETTING DIABETES. I LOOKED. THEN. AT WHAT THE COS WOULD BE TO OUR PROGRAM AND NOTED THAT. BESIDES THE PILL COSTS. THERE WERE ADDITIONAL HEALTH CARE COSTS. MAYBE UP TO $70 MILLION FOR OUR PARTICULAR STATE FOR THE USE OF THIS MEDICATION. THESE ARE PRIMARY CARE PHYSICIANS THAT THEY'RE SELLING ZYPREXA TO. THEY'RE NOT GOING TO PSYCHIATRISTS WHO ARE TREATING THE PEOPLE THE FDA HAS APPROVED ZYPREXA FOR. ONLY PSYCHIATRISTS ARE TREATING PEOPLE WITH BIPOLAR DISORDER AND SCHIZOPHRENIA. THE JUSTICE DEPARTMENT THA PROSECUTES THESE CASES HASN' FINED THE COMPANIES ANYWHERE NEAR AS MUCH AS THEY SHOULD. IN OTHER WORDS. AS MUCH AS THEY MADE. NOR HAS ANYONE EVER GONE TO JAIL. IF YOU JUST THINK ABOUT THE CONSEQUENCES OF THIS CRIMINAL ACTIVITY. A DOCTOR GETS ILLEGALLY PROMOTED BY THE COMPANY TO PRESCRIBE A DRUG THA THE DOCTOR MAY THINK HAS BENEFITS THAT OUTWEIGH THE RISK. THERE ISN'T ANY EVIDENCE FOR THAT AT ALL. THE DOCTOR PRESCRIBES THE DRUG. A PERSON DIES BECAUSE THERE REALLY WASN'T ANY EVIDENCE THA IT EVEN WORKED FOR THAT. AND THERE WERE--THERE'S EVIDENCE OF DANGERS. ONE COMPANY. PFIZER. ONE OF THE BIGGEST DRUG COMPANIES IN THE WORLD. SOLD $1 BILLION A YEAR OF A PARTICULAR DRUG. AND 90% OF THE SALES WERE FOR OFF-LABEL USE. ILLEGAL. THEY WERE CRIMINALLY PROSECUTED FOR IT BACK ABOU FIVE OR SIX YEARS AGO. BUT THE FINE THEY PAID. WHICH SEEMED LARGE--HUNDREDS OF MILLIONS OF DOLLARS--WASN'T BIG ENOUGH TO DETER THEM FROM DOING IT AGAIN. AND IN SEPTEMBER OF 2009. THE SAME COMPANY PAID THE LARGEST CRIMINAL PENALTY EVER PAID BY ANY UNITED STATES COMPANY: OVER $1.2 BILLION FOR ILLEGAL. CRIMINAL OFF-LABEL PROMOTION. THIS WAS A DELIBERATE SCHEME. THEY KNOW HOW DEFENSELESS MEDICAID AND MEDICARE ARE WHEN IT COMES TO PAYING DRUG PRESCRIPTIONS. THERE'S SUCH AN ELABORATE COMPUTER ORIENTED SYSTEM SET UP FOR PAYMENT OF THESE MILLIONS AND MILLIONS OF PRESCRIPTIONS ACROSS THE COUNTRY BY PEOPLE ON MEDICAID AND MEDICARE THAT I CAN'T BE INTERRUPTED. THERE'S NO WAY FOR ANY WATCHDOG TO SAY. "OH. WELL, YOU'VE PRESCRIBED THIS TO SOMEBODY WHO HAS NO BUSINESS TAKING IT." MEDICAID WILL PAY WHATEVER I IS THEY CHOOSE TO CHARGE FOR THEIR DRUGS. SO ZYPREXA PRESCRIPTIONS COS SOMEWHERE BETWEEN $500 AND $1.000 A MONTH PER PERSON. IT'S AN EXTRAORDINARILY EXPENSIVE DRUG. WHEN WE LOOKED AT THIS. WE NOTICED THAT THERE WAS A CONSIDERABLE INCREASE IN COST. IN ADDITION TO THE COST OF THE MEDICINE ITSELF. NOW. THIS WAS PARTICULARLY FRUSTRATING TO ME. BECAUSE RECENTLY THERE'S BEEN EVIDENCE THAT SOME OF THE OLDER ANTIPSYCHOTICS-- ANTIPSYCHOTICS HAD BEEN AROUND FOR 40 OR 50 YEARS-- WORK ALMOST AS WELL AS ZYPREXA. SO HERE WE HAVE A GROUP OF PEOPLE OVER 65 WHO ARE GETTING A MEDICATION FOR ANXIETY OR TO CALM THEM DOWN FOR WHICH THE MEDICINE WAS NOT APPROVED. AND IT'S COSTING A LOT OF MONEY. INCREASING THE LIKELIHOOD THAT THEY'LL HAVE DIABETES. AND IN ADDITION TO THAT. THERE ARE OTHER MEDICINES THAT THEY COULD'VE USED THAT SEEM TO WORK AS EFFECTIVELY. BUT THE STATE IS PAYING FOR IT. SO IT DOESN'T MATTER THA IT'S EXPENSIVE. AND IT DOESN' MATTER THAT THERE ARE OTHER THINGS THAT ARE BETTER. IT'S SORT OF LIKE A MODERN FORM OF LOBOTOMY. WHILE THE NURSES ARE COMPLAINING LESS BECAUSE THE OLD PEOPLE ARE LESS ACTIVE. IT'S KILLING THEM. AND IT'S EXTREMELY EXPENSIVE. OUR LOOK AT THE DATA SAID IT'S EXTREMELY EXPENSIVE TO DIE. SO WHAT HAPPENS IS. MEDICAID WINDS UP PAYING FOR THE PERSON'S FINAL ILLNESS. SO IT'S A WIN-WIN FOR LILLY AND FOR THE DOCTORS. BUT IT IS A TERRIBLE LOSING PROPOSITION FOR THE STATE. WHAT WE FOUND OUT THROUGH THE MEDICAID DATABASES OF THE STATES THAT WE REPRESENTED WAS THA OVER 50% OF THE DRUG ZYPREXA WAS PRESCRIBED OFF-LABEL FOR UNAPPROVED USES BY THE FDA. THIS IS OVER 50% OF THE DRUG JUST IN THE MEDICAID POPULATION. THERE'S NO DOUBT THAT AT LEAS THAT MUCH OF THE DRUG WAS PRESCRIBED OFF-LABEL FOR PEOPLE OUTSIDE THE MEDICAID POPULATION. ALL RIGHT. NOW WE'RE GONNA GET BACK TO OUR EARNINGS. SPECIFICALLY DRUG EARNINGS. ELI LILLY BEATING ANALYS ESTIMATES BY TWO PENNIES A SHARE NOT COUNTING MONEY SET ASIDE FOR FUTURE LEGAL SETTLEMENTS LINKED TO THE ANTIPSYCHOTIC DRUG ZYPREXA. JOINING US FOR A CLOSER LOOK A THE COMPANY'S NUMBERS IS JOHN LECHLEITER. CHIEF EXECUTIVE OFFICER AT ELI LILLY. HE COMES TO US FROM THE COMPANY'S HEADQUARTERS IN INDIANAPOLIS THIS MORNING. JOHN. GOOD MORNING. GOOD TO HAVE YOU BACK ON MORNING CALL. THANKS. CAROL. GOOD MORNING. SO WHAT ARE THE HIGHLIGHTS FROM THE QUARTER? CAROL. WE HAD A VERY STRONG QUARTER. WE GREW OUR SALES 14%. WE GREW OUR EXPENSES LESS THAN THAT. WE EXPANDED OUR GROSS MARGIN. OUR NON GAP QUARTER TO QUARTER COMPARISON. 14% GROWTH IN EARNINGS PER SHARE. MAKE IT TOO EXPENSIVE TO DO IT IN THE UNSAFE WAY. IF YOU SAY TO THE DRUG COMPANY. "HEY. LOOK. YOU CAN MAKE $4 BILLION WORTH OF PROFIT OU OF THIS IF YOU DO IT IN THE UNSAFE WAY. BUT I'M ONLY GONNA FINE YOU $1 BILLION." WELL. THAT'S $3 BILLION WORTH OF PROFIT. WELL. IT CAN'T WORK THAT WAY. IT'S GOT TO BE TOO EXPENSIVE TO DO IT IN THE UNSAFE WAY. THE FDA. THEY DON'T HAVE THE MANPOWER. THEY NEVER WILL. THEY DO IT--THEY DO THE BEST JOB THAT THEY CAN WITH WHAT THEY HAVE. BUT AS ONE OF OUR EXPERTS SAID. NOBODY CAN REVIEW A NEW DRUG APPLICATION AT THE FDA. BECAUSE NO HUMAN BEING CAN READ THE WHOLE THING. YOU CAN HIDE THE STUFF IN THERE. BUT WHAT THE DRUG COMPANY NEEDS TO KNOW BEFORE THEY EVER SUBMI THAT APPLICATION IS. THAT IF I HIDE THINGS IN THERE AND THE TRUTH COMES OUT. IT'S GOING TO BE MORE EXPENSE THAN IT IS WORTH. OTHERWISE. NONE OF US ARE GONNA BE SAFE FROM THIS BEHAVIOR. YOU CAN'T LET THEM MAKE A NE PROFIT ON LYING. YOU MAKE A NET PROFIT ON LYING. YOU'RE GOING TO LIE. AND IT'S THE LAWYER'S FAULT. OKAY? IT'S THE LAWYER'S FAULT. WE INVENTED CORPORATIONS. AND WHEN WE INVENTED IT. WE DIDN'T GIVE IT A CONSCIENCE. WE DIDN'T GIVE IT A SOUL. YOU CAN'T PUT IT IN JAIL. IT'S NOT A HUMAN BEING. IT'S A MACHINE. IT'S A LEGAL MACHINE. WE INVENTED IT. IT'S OUR FAULT. BUT THE ONLY WAY TO KEEP THA MACHINE IN CHECK IS TO MAKE I TOO EXPENSIVE FOR THAT MACHINE TO DO IT. BECAUSE THAT'S ALL THE MACHINE UNDERSTANDS. AND THAT'LL SOLVE THE PROBLEM. I MEAN. WE--WE ARE SPENDING FOR A LEVEL OF HEALTH CARE THA WE SHOULD BE ABLE TO HAVE I ALL. INSTEAD. WHAT WE SPEND ON HEALTH CARE BENEFITS THE INSURANCE COMPANIES AND THE PHARMACEUTICAL COMPANIES. I THINK WE NEED TO CHANGE MEDICAL EDUCATION. WE NEED TO TRAIN MEDICAL STUDENTS IN RESIDENCE SO THA THEY THINK ABOUT ADVERSE EFFECTS. PROBABLY EVEN BEFORE THEY THINK ABOUT THE DESIRED EFFECT. BECAUSE ADVERSE EFFECTS CAUSE PROBLEMS IN PATIENTS. AND THAT'S COUNTER TO THE PRINCIPLE THAT WE ALL HAVE ABIDED--THAT WE ALL HAVE SWORN TO WHEN WE GRADUATED. THAT IS. "DO NO HARM." AS MUCH AS I'M FOR SMALL GOVERNMENT. WE'RE GONNA NEED A MONITORING AGENCY. BUT WE HAVE TO FIGURE OUT WAYS TO ABSOLUTELY INSULATE THE PEOPLE WHO MONITOR FROM THE PEOPLE WHOM THEY'RE MONITORING. WE CAN LOOK BACK AS FAR AS PEOPLE LIKE ELVIS PRESLEY AND ANNA NICOLE SMITH MORE RECENTLY AND THEN GRADUATING INTO HEATH LEDGER. COREY HAIM. PEOPLE LIKE THIS DYING. AND THE ONLY POSITIVE THAT'S COME OUT OF THIS NEGATIVE IS THAT IT'S BROUGH SOME ATTENTION TO THE AMERICAN PUBLIC THAT THIS IS A PROBLEM. AND THE REALITY IS IS THAT REGULAR PEOPLE. NON-CELEBRITIES. ARE DYING EVERY SINGLE DAY FROM PRESCRIPTION PILLS--NOT FROM OVERDOSES. NOT FROM PEOPLE TAKING IT FOR FUN. BUT PEOPLE SIMPLY TAKING THEIR MEDICATIONS EXACTLY HOW THEIR DOCTOR TOLD THEM TO TAKE IT. BUT THE COMBINATION OF SLEEPING PILLS AND ANXIETY PILLS AND NARCOTICS. THEY GO TO SLEEP. AND THEY DON'T WAKE UP. SO HOW DO WE STOP IT? THE PROBLEM IS. WE HAVE A NATION OF ADDICTS THAT ARE BEING IGNORED. THE ANSWER TO THE PROBLEM. IN MY OPINION. IS NOT THE GOVERNMENT. IT'S NOT OTHER PEOPLE. IT REALLY STARTS WITH THE INDIVIDUAL BEING RESPONSIBLE FOR THEMSELVES. I THINK THAT EVERY PERSON SHOULD HAVE THEIR OWN MEDICAL RECORD. PERIOD. YOU SHOULDN'T RELY ON YOUR MEDICAL RECORD TO BE AT YOUR DOCTOR'S OFFICE. YOU SHOULD MAINTAIN YOUR OWN MEDICAL RECORDS. IF YOU HAVE AN MRI. GET A COPY FOR YOURSELF. THE BEST WAY TO SOLVE THIS PROBLEM IS TO PREVENT IT FROM HAPPENING IN THE FIRST PLACE. IF A PERSON HAS TO HAVE SURGERY. AND THEY'RE GONNA NEED A PAIN PILL AFTER SURGERY-- YOU'RE GONNA HAVE AN ARTHROSCOPY OF YOUR KNEE. IT HURTS. IT'S SUPPOSED TO HURT. YOU'RE SUPPOSED TO TAKE SOME PAIN MEDICINE. MOST PAIN HAPPENS AFTER SURGERY IN THE FIRST 72 HOURS. THE FIRS THREE DAYS. SO IT'S FINE TO TAKE A STRONG PAINKILLER FOR THOSE THREE DAYS. BUT OFTEN WHAT YOU SEE IS. DOCTORS WILL GIVE OUT 90 PILLS OR 60 PILLS OR 120 PILLS FOR A SURGERY THAT'S ONLY GONNA REALLY HURT THE PERSON WHERE THEY WOULD NEED THOSE PILLS FOR MAYBE THREE OR FOUR DAYS. IF YOU ONLY USE A FEW PILLS. GET RID OF THE OTHER PILLS. YOU DON'T WANT TO THROW THEM DOWN THE TOILET. PEOPLE SAY. "WELL. I FLUSH I DOWN THE TOILET." WE'RE CONTAMINATING OUR WATER SYSTEM. SO YOU DON'T WANT TO FLUSH IT DOWN THE TOILET. YOU WANT TO TAKE IT BACK TO YOUR PHYSICIAN'S OFFICE. AND THEY NORMALLY HAVE A MECHANISM TO GET RID OF DRUGS SAFELY. DON'T LOOK--DON'T ACCEPT A PILL FOR A PROBLEM. SO IF YOU GO TO A DOCTOR. AND YOU TELL THE DOCTOR THA YOU'RE HAVING HEADACHES. AND THE FIRST THING HE DOES IS GIVE YOU A PILL FOR HEADACHE--HE DOESN' EVEN ASK YOU WHAT KIND OF HEADACHES. WHEN DID THEY START. WHY DID THEY START. YOU FIRST TELL THE DOCTOR. "IS THERE ANY ALTERNATIVE OTHER THAN THIS PILL FOR MY HEADACHES?" AND IF THE DOCTOR TELLS YOU NO. IT'S TIME TO FIND A NEW DOCTOR. YOU GOT TO PUSH IN MY HAND THAT WON'T LET UP NO BRAKES LIVING FAS NOT GIVIN' A FUCK HIGH STAKES I'M GONNA GET I 'CAUSE I'M A FIEND SELL THE DEVIL MY SOUL TO GET ME WHAT I NEED GET ME A FIX GET ME BACK INTO THE ZONE JUST ONE MORE TRIP UNTIL MY MIND GETS BLOWN LEAVE ME ALONE PRESCRIPTIONS FOR THE SHIT I'M ON GOT ME LOOKING LIKE THE LIGHT'S ON BUT NO ONE'S HOME CHECK MY HEARTBEA RACING AT THE SPEED OF LIGH PERCOCET OR VICODIN WILL SET YOU FREE TONIGH I TRIPLED UP ON EVERYTHING I'M NOT BREATHING RIGH IT'S GOT A HOLD ON ME AND IT MIGHT SEIZE MY LIFE I AIN'T NEVER GIVE A FUCK ABOUT SHI EXCEPT FOR CORPORATE DOCTOR TRYING TO GET ME THAT FIX I GOT A DRUG COCKTAIL TO GET ME IN THE MIX POP A PILL. KNEEL AND KISS MY CRUCIFIX AND I'LL PROBABLY NEVER CHANGE THE MORE I TRY STOPPED TAKING THE MEDICATION. IT HAD SIDE EFFECTS THAT HAD CAUSED ME NUMEROUS WHOLE BOUTS OF PERSONALITY CHANGES THA CAUSED A BREAKUP WITH MY FIANCEE. I KIND OF JUST STOPPED EVERYTHING. AND FOR ABOU 20 DAYS. WENT THROUGH WITHDRAWALS AND THE WORS FEELING IN MY LIFE. I WAS AN ADDICT. I WAS TAKING THEM ALL THE TIME FOR TWO YEARS. I WAS TAKING EIGHT TO TEN A DAY. AND MY BODY FELT LIKE I NEEDED IT. I HAD NO STRENGTH. LIKE I WAS NOBODY. I WAS REALLY SAD. CRYING. OKAY. I STARTED AT ONE PILL A DAY FOR THE FIRST MONTH OR SO. AND THEN IT SLOWLY PROGRESSED TO TWO. AND THEN I ENDED UP AT THE MOST--I ENDED UP TAKING ABOU SEVEN TO EIGHT PILLS A DAY. AND I WAS SIFTING THEM ONTO FOIL. AND THEN I WOULD SMOKE THEM. OR SOMETIMES I WOULD SNIFF THEM. AND IT JUST TOOK ME AWAY. IT'D MAKE YOU FEEL MAYBE-- MAYBE A LITTLE EUPHORIC OR SOMETHING. BUT I ALWAYS THOUGH I TOOK THEM FOR THE PAIN. BUT I THINK I TOOK THEM MOSTLY. LIKE THEY SAID. BECAUSE I JUS THOUGHT I NEEDED THEM. I NEVER KNEW WHAT THESE MEDICATIONS WERE OR. YOU KNOW. THE LONG-TERM EFFECTS OF THEM. IT'S SUCH AN EASY THING TO GE CAUGHT IN THIS VICIOUS CIRCLE. BEING GIVEN PILLS EVERY MONTH. YOU KNOW. RIDICULOUS QUANTITIES. IS JUST LIKE YOU'RE NOT EVEN YOU. YOU'RE JUST A ZOMBIE. STUCK ON THE MUSHROOMS HALLUCINATING LOCKED IN THE ROOM GOING HEAD UP A SECOND ADDICTED TO THEM PISTOLS AND RUNNING MISSIONS 45 THE CASE AND MAKING BAD DECISIONS ADDICTED TO THROWIN' UP MY BLESSING I WAS DOWN TO DIE FOR THAT SHI YOU CAN BE I'M ADDICTED TO THIS MUSIC THAT SAVED MY LIFE HELPED ME BECOME A MAN AND GET MY SHIT RIGH AND I'LL PROBABLY NEVER CHANGE THE MORE I TRY THE MORE I STAY THE SAME I HATE TO LOOK IN THE MIRROR 'CAUSE ALL I SEE SOMEBODY SPRUNG THAT LOOKS ME AND I CAN'T BREAK MY HABITS I'M AN AMERICAN ADDIC [ gentle piano music ] [ gentle piano music ] |
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