WE
WE MIGHT
WE MIGHT FINALLY SEE SOME RELIEF COMING UP A LITTLE LATER ON .
NOW SWITCHING GEARS TO SOME BIG
NEWS IN THE MEDICAL WORLD TODAY.
FOR THE FIRST TIME IN NEARLY TWO
DECADES, THE FDA HAS APPROVED
A NEW DRUG FOR ALZHEIMER'S
DISEASE.
DISEASE.
DISEASE. >> BUT THE ANNOUNCEMENT COMES
WITH A BIT OF CAUTION
AND CONTROVERSY. SO WE'RE GOING
TO DOVE INTO IT A LITTLE BIT
DEEPER HERE . FIRST, LET'S START
WITH THE DRUG. IT'S CALLED
ADUHELM AND IT'S MADE BY
PHARMACEUTICS, A COMPANY,
BIOGEN. IT'S IMPORTANT TO NOTE
THAT IT IS NOT A CURE
FOR ALZHEIMER'S DISEASE, BUT IT
DOES AIM TO SLOW THE PROGRESSION
OF THE DISEASE BY REMOVING
STICKY DEPOSITS OF A PROTEIN
CALLED AMYLOID BETA FROM
THE BRAINS OF PATIENTS
WITH EARLY STAGE DISEASE.
>> I THINK THIS IS AN EXCITING
GAME FOR PATIENTS
WITH ALZHEIMER'S DISEASE.
IT'S THE FIRST DISEASE MODIFYING
THERAPY THAT'S BEEN APPROVED BY
THE FDA AND BY DISEASE
MODIFYING. WE MEAN THAT IT'S
ACTUALLY WORKING ON THE
UNDERLYING CAUSE OF ALZHEIMER'S
DISEASE.
DISEASE.
DISEASE. >> HEARING THAT NEWS BEING
A BEHING CLITHERALL ACROSS
THE FIELD, IT'S THE TYPE
OF THING THAT YOU REMEMBER DOING
WHEN YOU HEARD THAT NEWS.
>> AND LET ME INTRODUCE YOU
TO THOSE TWO EXPERTS YOU JUST
HEARD FROM. YOU'RE GOING TO HEAR
FROM THEM AGAIN. I SPOKE TO MIKE
ROSENBLOOM, DIRECTOR OF THE
HEALTHPARTNERS CENTER FOR MEMORY
AND AGING. DR. RONALD PETERSON,
DIRECTOR OF THE MAYO CLINIC
ALZHEIMER'S DISEASE RESEARCH
CENTER. BOTH DOCTORS POINT OUT
THAT WHILE EXCITING TODAY'S FDA
APPROVAL IS SOMEWHAT
CONTROVERSIAL. BIOGEN STOPPED
TWO TRIALS OF THE DRUG EARLY
IN TWENTY NINETEEN AFTER THEY
DIDN'T APPEAR TO BENEFIT
PATIENTS. BUT A LATER ANALYSIS
FOUND THAT ONE OF THE TRIALS DID
APPEAR TO BE EFFECTIVE BECAUSE
OF THOSE MIXED RESULTS LAST
YEAR, AN FDA ADVISORY PANEL DID
NOT RECOMMEND APPROVING THIS
DRUG. BUT TODAY THE FDA
BASICALLY CHOSE A MIDDLE GROUND,
APPROVING IT ON A CONDITIONAL
BASIS, MEANING IT WILL BE
AVAILABLE TO PATIENTS. BUT FULL
APPROVAL WON'T COME UNTIL BIOGEN
COMPLETES A MUCH BIGGER TRIAL.
>> THIS IS A NICE COMPROMISE.
YOU ENGAGE THE INDUSTRY AND ALSO
YOU ENGAGE, YOU KNOW, THE THE
NEED FOR OVERSIGHT AND THERE
WILL BE A DEGREE OF OVERSIGHT
IN A PHASE FOUR TRIAL. SO
IT'S SORT OF WE'RE GOING
TO APPROVE IT FOR A WHILE,
BUT YOU HAVE TO SHOW THAT IT,
IN FACT DOES MAKE A CLINICAL
DIFFERENCE. IN THE MEANTIME,
BOTH DOCTORS SAY THEY CAN START
WORKING WITH ALZHEIMER'S
PATIENTS TO SEE IF THE DRUG IS
A GOOD FIT. THAT PART WON'T BE
EASY. THE DRUG COULD COST FIFTY
SIX THOUSAND DOLLARS A YEAR IF
IT'S NOT COVERED BY INSURANCE OR
MEDICARE AND IT WILL REQUIRE
EXTENSIVE TESTS ON THE FRONT END
AND PERIODIC MRI AS THROUGHOUT
IN ORDER TO CHECK FOR SERIOUS
SIDE EFFECTS.
SIDE EFFECTS. >> YOU KNOW, I THINK IT WAS
A PRETTY GUTSY MOVE ON THE PART
OF THE FDA, BUT I THINK IT JUST
PUTS MORE RESPONSIBILITY ON THE
CLINICIAN. AND WE JUST HAVE
TO BE MINDFUL WHEN THE RISKS
OF THE DRUG OUTWEIGH
THE BENEFITS. IT'S NOT CLEAR CUT
AT ALL. AND SO WE WILL HAVE
TO BE RESPONSIBLE INTO HOW
WE PRESENT THE DATA. WE DO FIND
WHICH PATIENTS ARE MOST ELIGIBLE
FOR GETTING THIS TREATMENT
AND THEN EXPLAINING
THE POTENTIAL SIDE EFFECTS AS
WELL . THE DRUG THEY DO IS
SUPPOSED TO DO, BUT IT COULD BE
A MODEST EFFECT DESPITE ALL
OF THAT CAUTION THAT COMES
WITH IT. AGAIN, THIS IS A DAY
MANY FAMILIES AND ADVOCACY
ORGANIZATIONS HAVE BEEN HOPING
FOR ARE. KARLA AHULT SPOKE
TO THE ALZHEIMER'S ASSOCIATION
ABOUT HOW FDA APPROVAL COULD
SHIFT THE LANDSCAPE FOR PATIENTS
AND FAMILIES BEYOND JUST THIS
ONE DRUG.
ONE DRUG.
ONE DRUG. >> IT JUST SEEMS LIKE THIS RIGHT
RAY OF LIGHT THEY WERE GETTING
IN THE FORM OF AN FDA APPROVAL.
IT DOES. I HOPE THEY ALL REJOICE
IN THIS IN THIS NEWS BECAUSE IT
IS GOING TO MAKE A DIFFERENCE
AND WE ARE GOING TO SEE SUCH
A DIFFERENCE FIVE, 10, 15 YEARS
DOWN THE ROAD, NOT ONLY BECAUSE
OF THIS DRUG, BUT THIS IS JUST
THE START TO THINK ABOUT WHAT
WE ARE GOING TO LEARN FROM THIS
AND HOW IT IMPACTS PEOPLE. IT