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FDA Panel Rejects Diet Drug From SD Biotech

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Video Transcript:

YESTERDAY AN FDA ADVISORY PANEL REJECTED A NEW PRESCRIPTION WEIGHT LOSS DRUG DEVELOPED IN SAN DIEGO. SCIENCE AND TECHNOLOGY REPORTER JOINS ME WITH MORE ON WHY THE STAKES ARE SO HIGH FOR FDA APPROVAL OF THIS DRUG. PEGGY, WHAT'S THE DRUG? IT'S LORCASARIN. IT'S MADE BY A LOCAL COMPANY HERE IN SAN DIEGO. THE STAKES WERE HIGH FOR A LOT OF REASONS. FIRST THE DRUG ITSELF WAS SORT OF LIKE A FEN-PHEN DRUG TO SUPPRESS THE APPETITE FOR WEIGHT LOSS. WHY DID THE PANEL REJECT IT AT THIS POINT? THE SIMPLE ANSWER TO THAT IS THEY SAID THE RISK DID NOT OUTWEIGH THE BENEFITS OF THE DRUG. THAT SAID, EARLY STUDIES IN ANIMALS SHOWED THAT TAKING THIS DRUG CAUSED CANCEROUS TUMORS IN SEVERAL PARTS OF THE BODY IN THESE LAB ANIMALS WHICH WASN'T ORIGINALLY DISCLOSED TO THE PANEL. LATER ON, THEY FOUND THAT THE DRUG --PEOPLE TAKING THE DRUG IN A CONTROLLED GROUP BARELY MET EFFECTIVENESS LEVELS FOR THE FDA. THEY LOST IN CONTROL GROUPS, THEY STUDIED 7000 PEOPLE. THOSE PEOPLE LOST ABOUT 6 POUNDS IN A YEAR COMPARED TO THE CONTROL GROUP WHICH LOST ABOUT 3 POUNDS PER YEAR. THAT BARELY MAKES THE MARGIN. SO THAT'S ONE THING. THERE WAS ALSO MEMORY LOSS AND INCREASED DEPRESSION FOUND IN THOSE PATIENTS TAKING THE DRUG. HOW IS THE PHARMACEUTICALS RESPONDED TO THIS? THEY MUST HAVE HAD A BIG STAKE IN THIS DRUG. THEY DID. EVEN BEFORE THE NEWS CAME DOWN AS FAR AS THE ACTUAL DECISION, THEIR STOCKS DROPPED 40%. THAT WAS ON TUESDAY BEFORE THE DECISION WAS EVEN MADE. THEY SENT OUT A RESPONSE SAYING THEY DO HAVE A RISK TO WEIGHT LOSS RH OWE. WHAT ABOUT THE BIOTECH INDUSTRY IN SAN DIEGO? ANY KIND OF REACTION FROM THEM TO THIS? WELL, THE BIOTECH COMMUNITY HERE WHICH IS HUGE HAS BEEN WATCHING THIS CLOSELY. AND JOE PANETTA SAID THAT HAD THE DRUG BEEN APPROVED, THAT WOULD HAVE MEANT MORE JOBS TO THE SAN DIEGO ECONOMY. ALSO ON THE INVESTOR'S SIDE THE DRUG COMPANIES THAT ARE HERE AND DRUG INVESTORS ARE LOOKING AT COMPANIES AND THEIR SUCCESS RECORD AND THEIR TRACK RECORD. THERE'S BEEN A LOT OF CRITICISM HEAPED ON THE FDA IN RECENT YEARS FOR NOT MONITORING FOOD AND DRUG SUPPLIES ENOUGH. HAS THE AGENCY BECOME MORE CONSERVATIVE AS A RESULT OF ALL THIS? IN SOME WAYS, YES. THEY'RE VERY SKIDDISH WHEN IT COMES TO DIET DRUGS. IT'S BEEN TEN YEARS SINCE ANY DIET DRUG HAS BEEN SUCCESSFULLY APPROVED BY THE FDA. SO THEY ARE FOR SKIDDISH. THANK YOU VERY MUCH. THANK YOU.