>> Braude: TONIGHT ON "GREATER BOSTON," CASES AND DEATHS ARE UP AS THE DELTA VARIANT BECOMES THE MOST PROMINENT STRAIN OF COVID IN THE COUNTRY.

SHOULD WE BE TAKING MORE PRECAUTIONS?

AND IS THERE REALLY A DELTA WALL IN MASSACHUSETTS?

PLUS, HARVARD'S DR. AARON KESSELHEIM, ONE OF THREE MEMBERS OF AN F.D.A.

ADVISORY COMMITTEE WHO RESIGNED OVER THE APPROVAL OF BIOGEN'S CONTROVERSIAL ALZHEIMER'S DRUG, ON WHY AND THE DANGERS HE BELIEVES THE DRUG POSES.

THEN, LATER, HOW LIBRARIANS ARE HELPING FILL THE MENTAL HEALTH TREATMENT GAP.

♪♪ >> Braude: WHILE MANY AMERICANS ARE DOING THEIR BEST TO MOVE ON FROM COVID-19, SHEDDING THEIR MASKS AND GOING BACK TO THE MOVIES, SPORTS ARENAS, AND OTHER LARGE GATHERINGS, IN SOME PARTS OF THE COUNTRY, THE PANDEMIC IS STILL RAGING.

NATIONWIDE, WE'VE BEEN RECORDING AROUND 20,000 NEW CASES A DAY AS THE MORE CONTAGIOUS DELTA VARIANT OVERTAKES THE ORIGINAL STRAIN OF THE VIRUS, WITH CERTAIN AREAS OF THE COUNTRY ALREADY FARING WORSE THAN OTHERS, AS DR. FAUCI HAS WARNED.

>> I'M CONCERNED AS THIS VARIANT BECOMES MORE DOMINANT, THOSE AREAS, THOSE SELECT AREAS OF THE COUNTRY THAT HAVE A VERY LOW LEVEL OF VACCINATION, LIKE 30% OR SO, YOU'RE GOING TO START SEEING MANY SURGES THAT ARE LOCALIZED TO CERTAIN REGIONS.

>> Braude: AMONG THOSE REGIONS IS MISSISSIPPI, WHICH RANKED SECOND TO LAST FOR VACCINATIONS.

CASES HAVE SPIKED BY NEARLY 100% IN THE PAST TWO WEEKS, AND OFFICIALS ARE NOW URGING EVERYONE 65 AND OLDER OR WITH CO-MORBIDITIES TO AVOID ALL INDOOR MASS GATHERINGS.

AND EVEN FOR THE FULLY VACCINATED -- CLOSE TO 50% OF THE COUNTRY AND MORE THAN 60% OF THIS STATE -- THE FUTURE IS STILL MURKY.

IT'S NOT YET CLEAR WHEN, OR IF, FULLY VACCINATED PEOPLE WILL NEED BOOSTER SHOTS.

HERE IS DR. FAUCI, THEN FORMER F.D.A.

COMMISSIONER DR. SCOTT GOTTLIEB.

>> THERE'S A LOT OF WORK GOING ON TO EXAMINE THIS IN REALTIME TO SEE IF WE MIGHT NEED A BOOST, BUT RIGHT NOW, GIVEN THE DATA THAT THE C.D.C.

AND THE F.D.A.

HAS, THEY DON'T FEEL THAT WE NEED TO TELL PEOPLE RIGHT NOW THAT YOU NEED TO BE BOOSTED.

>> THAT'S A MULTI-MONTH PROCESS.

SO IF WE DON'T GET STARTED RIGHT NOW, WE'RE NOT GOING TO BE IN A POSITION TO HAVE BOOSTERS AVAILABLE SHOULD WE NEED IT COME THE FALL.

>> Braude: JOINING ME TO DISCUSS WHERE WE ARE WITH COVID AND WHY ARE DR. NAHID BHADELIA, AN ASSOCIATE PROFESSOR OF INFECTIOUS DISEASES AT THE BOSTON UNIVERSITY SCHOOL OF MEDICINE AND THE MEDICAL DIRECTOR OF THE SPECIAL PATHOGENS UNIT AT BOSTON MEDICAL CENTER, AND DR. MARK SIEDNER, AN INFECTIOUS DISEASE CLINICIAN AND RESEARCHER AT MASS GENERAL'S DIVISION OF INFECTIOUS DISEASES.

>> Braude: DOCTOR AND DOCTOR, GOOD TO SEE YOU.

THANK YOU SO MUCH FOR BEING HERE.

>> Doctor: THANKS FOR HAVING US, JIM.

>> SURE.

>> Doctor: DOCTOR, 50% OF ALL NEW INFECTIONS, NATIONALLY, DELTA, AND 80 IN SOME STATES, AND ABOUT TO BECOME THE DOMINANT HERE IN MASSACHUSETTS.

MORE THAN ONE EXPERT HAS SAID WE HAVE A DELTA WALL HERE, IS THE EXPRESSION, BECAUSE OF THE HIGH VACCINATION, LOW INFECTION RATE.

DO YOU SHARE THAT PERSPECTIVE?

>> Doctor: I DO.

I THINK WE'RE IN A BETTER PLACE THAN SOME OF THE STATES THAT YOU'VE MENTIONED JIM.

WHAT YOU'RE SEEING IS -- ANOTHER STAT THAT I WOULD SHARE, THAT THE C.D.C.

SHARED A FEW WEEKS AGO, 99% OF THE DEATHS RIGHT NOW ARE AMONG THE UNVACCINATED.

HERE IN MASSACHUSETTS, OUR CASES HAVE BEEN PRETTY STEADY, I THINK ABOUT 100, AND WE HAVEN'T SEEN AN INCREASE IN CASES PARTLY BECAUSE I THINK, TO SOME LEVEL, THE VACCINES NOT ONLY PROTECT YOU FROM DISEASE, BUT THEY'RE ALSO HELPING DECREASE THE TRANSMISSION A LITTLE BIT.

BUT THEY'RE ALSO BLOCKING THOSE HOSPITALIZATIONS AND THOSE DEATHS THAT ARE WHAT WE'RE CONCERNED ABOUT AS WELL, WHICH SORT OF PUT THE STRAIN ON THE HEALTH CARE SYSTEM.

FOR NOW, WE'RE FINE.

HERE I WORRY ABOUT INEQUITY IN TERMS OF POSSIBILITIESPOCKETS OR ENTIRE COMMUNITIES THAT MAY BE UNVACCINATED.

IN A STATE LIKE OURS THAT IS HIGHLY VACCINATED, THOSE ARE THE AREAS WHERE YOU MAY SEE AN INCREASE.

>> Braude: DR. SIEDNER, LET'S GO ACROSS OUR BORDER.

EXPLOSIONS OF THE VIRUS IN MISSOURI AND MANY OTHER STATES.

WHY ARE WE NOT TALKING ABOUT RETURNING TO THE SAME SORT OF RESTRICTIONS ON INTERSTATE TRAVEL.

WHY SHOULD WE NOT BE CONCERNED IN MASSACHUSETTS THAT A BUNCH OF PEOPLE ARE FLYING IN FROM ONE OF THOSE STATES AND PLANNING ON JUST HANGING OUT HERE, POTENTIALLY UNMASKED?

>> Doctor: YEAH, WELL, THE REASON YOU'RE SEEING OUTBREAKS IN PLACES LIKE MISSISSIPPI, MISSOURI, IOWA, ETC., IT IS BECAUSE THEY HAVE LOW RATES OF VACCINATION THERE.

IF PEOPLE FROM MISSOURI TRAVELED HERE, FOR EXAMPLE, BECAUSE OUR VACCINATION RATES ARE ALMOST 80% WITH AT LEAST ONE DOSE, MOST OF THOSE TRANSMISSIONS WILL NOT OCCUR.

AS LONG AS WE CAN CONTINUE HIGH VACCINATION RATES, THE PEOPLE IN THIS STATE WILL BE LUCKY.

BECAUSE WE'RE APPROACHING SOMETHING LIKE THAT HERD IMMUNITY -- >> Braude: MY UNDERSTANDING IS WE'RE ROUGHLY 60% VACCINATED HERE, WHICH MEANS 40% -- WE CAN ALL DO THE MATH -- ARE NOT.

>> ABOUT 60% OF PEOPLE IN MASSACHUSETTS HAVE RECEIVED AT LEAST ONE DOSE -- I'M SORRY.

HAVE RECEIVED TWO DOSES, OR ARE FULLY VACCINATED.

IF YOU INCLUDE JOHNSON & JOHNSON.

BUT ALMOST 80% HAVE RECEIVED AT LEAST ONE.

I DON'T THINK WE HAVE A COMPLETE WALL OF PROTECTION, BUT THE REASON WE'RE NOT SEEING OUTBREAKS HERE, BECAUSE OF THE FACT WE KNOW DELTA EXISTS HERE, IT IS BECAUSE WE HAVE A HIGH RATE OF VACCINATION.

EVEN WHEN TRANSMISSION OCCURS, THEY DO GET BLOCKED.

NOW, IF THE IMMUNITY WANES, OR IF NEW VARIANTS COME, AND WE HAVE NOT VACCINATED ENOUGH PEOPLE, MASSACHUSETTS RESIDENTS MAY NO LONGER BE PROTECTED.

IT IS IN OUR INTEREST TO MAKE SURE THAT PEOPLE AROUND THIS COUNTRY AND AROUND THE WORLD GET VACCINATED, EVEN IF WE HAVE HIGH RATES HERE.

>> Braude: DR. NA NAD BAGDALIA, I READ THAT SOME ARE CONSIDERING TREATING UNVACCINATED PEOPLE UNDER, QUOTE, "DISCRIMINATION,," LIKE PEOPLE OF COLOR, SAYING YOU CANNOT DISCRIMINATE AGAINST AN UNVACCINATED PERSON.

LIKE YOU CAN'T DISCRIMINATE AGAINST A BLACK PERSON.

IF A BUSINESS WANTS TO SAY ONLY VACCINE FADE PEOPLE VACCINATED PEOPLE CAN COME HERE, THEY WOULD BE -- MONTANA, BY THE WAY, HAS ALREADY MADE IT LAW.

OTHER STATES, IT IS JUST PENDING.

IS THAT NUTS OR WHAT?

>> Doctor: SINCE I DON'T KNOW WHERE TO START, LET ME START AT A PLACE THAT IS COMFORTABLE FOR ME TO START, WHICH IS THE SCIENCE OF ME.

WHICH IS THAT IN STATES, WHERE THERE ARE MANY, MANY VACCINATED PEOPLE, PEOPLE WHO ARE UNVACCINATED HAVE THE COVER BECAUSE THOSE AROUND THEM ARE NOT GOING TO BE TRANSMITTING IT AT THE SAME RATE, AND THERE IS LESS LIKELY TO BE ENOUGH VIRUS IN THE COMMUNITY.

IN PLACES THAT ARE NOT AS HIGHLY VACCINATED, YOU'RE CLEARLY SEEING A DIVISION ACROSS THE COUNTRY WHERE RIGHT-LEANING STATES, G.O.P.

STATES, ARE SEEING LOWER RATES OF TRANSMISSION.

THAT'S WHERE YOU'RE SEEING INCREASED CASES.

I FEEL THAT POLITICIZATION OF VACCINATIONS, I'M GOING TO BE VERY FRANK, TO ME IT MAKES NO SENSE FROM A PUBLIC HEALTH PERSPECTIVE.

BUT I'M TRYING TO FIGURE OUT HOW IT MAKES SENSE FROM A POLITICAL PERSPECTIVE BECAUSE YOU'RE LEAVING YOUR CONSTITUENTS UNPROTECTED, AND THEY'RE GOING TO GET HURT.

THAT DOESN'T SEEM TO BE A GOOD ELECTION STRATEGY FOR ME.

BUT I'M JUST A SIMPLE INFECTIOUS DISEASE DOCTOR.

>> Braude: I WOULD SAY YOU'RE BEING -- IN A POLITE WAY YOU'RE AGREEING WITH ME, I THINK THAT'S WHAT I HEARD THERE.

DR. SIEDNER, IF WE CAN MOVE TO A COUPLE OF PUBLIC DEBATES, I HINTED AT THIS BEFORE, THE MASK DEBATE, THERE ARE A NUMBER OF LEADERS WHO WE RESPECT WHO SAY YOU SHOULD WEAR MASKS IN PUBLIC PLACES, EVEN IF YOU'RE VACCINATED.

THERE ARE A NUMBER OF PUBLIC LEADERS WHO SAY DON'T.

WHO IS RIGHT?

>> Doctor: YOU KNOW, THERE IS MORE THAN ONE THING THAT DETERMINES WHETHER YOU GET INFECTED.

VACCINATION IS ONE OF THE MOST IMPORTANT ONES.

THESE DECISIONS NEED TO BE MADE WITH A NUMBER OF FACTORS, AND VACCINATIONS SHOULD BE AT THE TOP OF THE LIST.

THE OTHER THING THAT MATTERS IS HOW MUCH INFECTION IS AROUND YOU.

IF YOU'RE WALKING AROUND IN MISSISSIPPI AND THERE IS A HUGE OUTBREAK, AND YOU'RE IMMUNOSUPPRESSED, EVEN THOUGH YOU'RE VACCINATED, YOU SHOULD WEAR MASKS.

SAYING MASKS ARE ALWAYS OKAY OR ALWAYS NOT OKAY IS POTENTIALLY CONFUSING, BUT IT IS SOME TIMES THE WAY PUBLIC HEALTH NEEDS TO DELIVER MESSAGES.

IT IS A COMBINATION OF FACTORS.

VACCINATION IS EXTREMELY IMPORTANT.

IF YOU'RE IN THE STATE OF MASSACHUSETTS, WITH A ONE CASE PER 100,000, AND YOU'RE VACCINATED, I DON'T THINK THE EVIDENCE IS FAVOR OF YOU WEARING MASKS UNLESS HAVE YOU A IMMUNO CONDITION.

>> Braude: SPEAKING OF VACCINATIONS, THERE IS A PRETTY MAJOR DISPUTE, NOT JUST BETWEEN PEOPLE LIKE DR. SCOTT GOTTLIEB AND DR. ANTHONY FAUCI, BUT BETWEEN DR. ANTHONY FAUCI AND FIVE ITSELF ABOUT BOOSTERS.

WHO IS RIGHT THERE?

>> I THINK, YOU KNOW, I HEARD THAT CONVERSATION, AND THOSE ARE TWO DIFFERENT DISCUSSIONS IN SOME WAY.

I THINK WOULD DR. SCOTT GOTTLIEB SAID YOU NEED THE MANUFACTURED CAPACITY AND THE READINESS.

AND, SURE, I AGREE.

LET'S HAVE THAT, AND THEN WE'RE MUCH BETTER OFF THAN WE WERE A YEAR AGO WHEN WE WEREN'T PRODUCING AS MUCH VACCINE.

I LEAN TOWARDS WHAT DR. ANTHONY FAUCI IS SAYING, FOR MOST PEOPLE IT SEEMS CURRENTLY WE'RE STILL PROTECTED IF YOU'VE GOTTEN TWO DOSES, YOU'RE FULLY PROTECTIVE.

THE DELTA VARIANT DOES SEEM TO DECREASE.

YOU MIGHT GET MORE BREAKTHROUGH IN INFECTIONS, BUT YOU'RE HIGHLY PROTECTED AGAINST HOSPITALIZATIONS AND DEATH.

HOWEVER, TODAY, RISKING A LARGE NUMBER OF PEOPLE WITH TWO SHOTS, THEY'RE NOT ABLE TO GET THEIR IMMUNE SYSTEM REVVED UP ENOUGH, AND IF YOU GIVE THEM A THIRD DOSE, THAT MAY BE ENOUGH TO PROTECT THEM MORE.

BUT FOR THE GENERAL PUBLIC, YOU'RE STILL WAITING TO SEE WHAT THE LONGEVITY OF PROTECTION IS LIKE.

SO WE JUST DON'T KNOW.

AND WE DON'T KNOW WHAT THE NEW VARIANTS ARE.

JUST BECAUSE WE'RE STILL PROTECTED AGAINST DELTA, BUT WE DON'T KNOW WHAT NEW VARIANTS WILL BE IN THE FALL.

IT IS HARD TO KNOW IF WE'LL NEED IT DOWN THE ROAD.

>> Braude: WE ONLY HAVE 30 SECONDS FOR BOTH OF YOU, AND I'M HOPEFUL THAT YOU'RE BOTH POSITIVE, BUT ENDING ON A NEGATIVE NOTE, GARY SUMMERS CAME OUT WITH A FINDING, FORGET HOW WE'RE DEALING WITH THE CURRENT PANDEMIC, THAT DESPITE THE LESSON, WE'RE WILDLY UNPREPARED FOR THE NEXT ONE.

QUICKLY, DR. SIEDNER, IS SUMMERS RIGHT?

>> Doctor: ABSOLUTELY.

IF WE DIDN'T LEARN AFTER EBOLA, WE STILL HAVEN'T LEARNED IT NOW.

WE DON'T HAVE THE GLOBAL SYSTEM IN PLACE TO PROTECT PEOPLE FROM EPIDEMIC.

SO FAR THE NEWS HAT NOS BEENHAS NOTBEEN PROMISING.

>> Braude: DOCTOR.

>> Doctor: I THINK WE CYCLE BETWEEN PANIC AND NEGLECT, WHICH WAS ANOTHER GARY SUMMERS' REPORT A FEW YEARS AGO.

I WOULD SAY WE HAVE INCREMENTALLY LEARNED A FEW THINGS.

THIS BROUGHT A LOT OF COOPERATIVE ACTION ON THE GROUND, AND WE CAN BUILD ON THAT.

WE JUST NEED THE POLITICAL COMMITMENT AND FUNDING, WHICH WE DON'T HAVE.

>> Braude: DOCTORS, I REALLY APPRECIATE YOUR TIME.

THANK YOU SO MUCH FOR BEING HERE.

>> Doctor: IT IS A PLEASURE.

THANK YOU.

>> Doctor: THANK YOU.

>> Braude: IT WAS A MOMENT MILLIONS OF PEOPLE IN THE U.S. AND AROUND THE WORLD HAD BEEN WAITING FOR.

IN THE U.S. AND AROUND THE WORLD HAVE BEEN WAITING FOR WHEN, LAST MONTH, FOR THE FIRST TIME IN NEARLY TWO DECADES, THE F.D.A.

APPROVED A NEW TREATMENT FOR ALZHEIMER'S, A DEVASTATING DEGENERATIVE DISEASE THAT SLOWLY ROBS A PERSON OF THEIR MEMORY AND OTHER BRAIN FUNCTIONS AND HURTS NOT ONLY THOSE WHO DEVELOP IT, BUT THEIR LOVED ONES, TOO.

BUT THE DECISION TO APPROVE THE DRUG, ADUHELM, FROM CAMBRIDGE-BASED BIOGEN, CAME AFTER 10 OUT OF 11 EXPERTS ON THE AGENCY'S PERIPHERAL AND CENTRAL NERVOUS SYSTEM ADVISORY COMMITTEE VOTED AGAINST IT, ARGUING THE COMPANY FAILED TO PROVE THE DRUG WAS ACTUALLY EFFECTIVE IN SLOWING THE EFFECTS OF ALZHEIMER'S.

AFTER THE APPROVAL, THREE MEMBERS OF THE ADVISORY COMMITTEE RESIGNED.

WHILE REPORTING FROM HEALTH NEWS OUTLET "STAT" DESCRIBED UNUSUAL MEETINGS BETWEEN F.D.A.

OFFICIALS AND BIOGEN EXECUTIVES, GOING BACK AS FAR AS MAY 2019, HAS THROWN EVEN MORE UNCERTAINTY AROUND THE PROCESS.

IN RESPONSE TO ALL THE CONTROVERSY, THE AGENCY SCALED BACK ITS APPROVAL OF THE DRUG THIS PAST THURSDAY, LIMITING ITS USE TO PATIENTS WITH MILD SYMPTOMS OR IN THE EARLY STAGES OF ALZHEIMER'S DISEASE ONLY.

AND ON FRIDAY, THE ACTING COMMISSIONER OF THE F.D.A.

SENT A LETTER TO THE >> IN RESPONSE TO ALL OF THE CONTROVERSY, THE AGENCY SCALED BACK ITS APPROVAL TO THE DRUG THIS LAST THURSDAY, LITREING ITSLIMITING ITTO PATIENTS WITH LIMITED.

THEY CALLED FOR AN INDEPENDENT INVESTIGATION INTO HER OWN AGENCY'S DECISION-MAKING.

FOR BIOGEN'S PART, AFTER REGULATORS PLACED LIMITS ON THE DRUG'S APPROVAL, THE COMPANY ARGUED THE UPDATE WAS IN LINE WITH THEIR COMMUNICATIONS FROM THE BEGINNING.

AS FOR THE INVESTIGATION, A SPOKESPERSON FOR THE COMPANY SAID, QUOTE, "WE WILL, OF COURSE, COOPERATE WITH ANY INQUIRY."

I'M JOINED BY ONE OF THE MEMBERS WHO RESIGNED FROM THE F.D.A.

ADVISORY COMMITTEE, DR. AARON KESSELHEIM, PROFESSOR AT HARVARD MEDICAL SCHOOL CENTER FOR BIO-ETHICS, THE CREATOR OF HARVARD'S PROGRAM ON REGULATION AND THERAPEUTICS OF LAW.

AND A FORMER EPIDEMIOLOGY AT BRIGHAM AND WOMEN'S HOSPITAL.

DR. KESSELHEIM, IT IS A PLEASURE TO HAVE YOU HERE.

>> Doctor: MY PLEASURE.

THANK YOU FOR HAVING ME.

>> Braude: IN YOUR LETTER OF RESIGNATION WITH THE F.D.A., YOU DID NOT PULL ANY PUNCHES.

YOU SAID IT WAS PROBABLY THE WORST DRUG APPROVAL IN RECENT U.S. HISTORY, WHY?

>> Doctor: I THINK FOR A LOT OF DIFFERENT REASONS.

YOU HIGHLIGHTED SOME OF THE IRREGULARITIES IN THE PROCESS THAT THE DRUG WENT THROUGH.

IT WAS -- YOU KNOW, THE DRUG WAS INITIALLY STOPPED.

THE TRIALS OF THE DRUG WERE INITIALLY STOPPED FOR FUTILITY, AND THEN THE MANUFACTURER WENT BACK TO RELOOK AT THE DATA TO SEE IF THEY COULD IDENTIFY ANY HINT OF THE POSSIBLE AFFECT OF THE DRUG.

THEY FOUND CONFLICTING EVIDENCE.

THEY THEN WORKED WITH THE F.D.A.

FOR A VERY LONG TIME.

AND DESPITE NEARLY UNANIMOUSLY OPPOSING IT, THE F.D.A.

THEN SWITCHED GEARS 180° AFTER THE ADVISORY COMMITTEE AND APPROVED THE DRUG ON A TOTALLY DIFFERENT PREMISE.

THERE ARE A LOT OF CONCERNS ABOUT THE PROCESS.

IN ADDITION TO THAT, THE DRUG ITSELF, THERE IS JUST NO GOOD, CONVINCING EVIDENCE THAT IT WORKS.

THERE IS A LOT OF CONCERNS ABOUT SIDE EFFECTS FOR IT.

SO I THINK BOTH THE PROCESS AND THE DECISION ITSELF ARE PROBLEMATIC.

>> Braude: I DON'T WANT TO JUST GLOSS OVER THE SIDE EFFECTS.

THEY HAPPENED IN, I THINK YOU SAID, AS MANY OF A THIRD OF THE PATIENTS, AND THEY'RE PRETTY SERIOUS, ARE THEY NOT, IN SOME CASES?

>> Doctor: THEY ARE.

THE SIDE EFFECTS THEY NOTICED IN THE TRIALS WERE BRAIN SWELLING AND BRAIN BLEEDING, WHICH OCCURRED IN ABOUT A THIRD OF THE PATIENTS.

IN ABOUT 10% OF THOSE, IT WAS SERIOUS.

MOST PATIENTS NEEDED M.R.I.s FOR SCREENING.

THERE IS A LOT OF RISK ASSOCIATED WITH THIS DRUG.

>> Braude: SO WHY DIDN'T THEY FOLLOW THE SCIENCE?

IS IT BECAUSE OF THESE SIDE MEETINGS?

DOES THE INDUSTRY HAVE OUTSIDE INFLUENCE WITH THE F.D.A.

IN 2021?

>> Doctor: I THINK IT IS A REALLY GOOD QUESTION.

HOPEFULLY THERE WERE BE FURTHER INVESTIGATIONS INTO THE DECISION-MAKING TO TRY TO FIND OUT WHAT WAS GOING ON.

I DO THINK THERE ARE A LOT OF QUESTIONS ABOUT THIS DRUG.

WHAT DOES IT DO?

IT DOES REMOVE THE AMYLOID PLAQUES FROM THE BRAIN, BUT WHAT AFFECT DID THAT HAVE ON THE PROGRESS OF THE ALZHEIMER'S DISEASE?

WE JUST DON'T KNOW.

THAT IS A SIGN FOR MORE STUDY OF THE DRUG AND ITS AFFECTS, AND NOT TO APPROVE IT.

>> Braude: YOU KNOW IT MUCH BETTER THAN I -- I THINK YOU WERE ON THE ADVISORY COMMITTEE ALREADY WHEN THAT DRUG FOR MUSCULAR DYSTROPHY CONDITION WAS APPROVED, WHICH THE ADVISORY COMMITTEE BELIEVED WAS NOT AFFECTIVE, EITHER.

I CHECKED BACK ON THAT, AND THAT WAS THREE, FOUR, OR FIVE YEARS AGO.

AND IN THE INTERVENING YEARS, IT HAS PROVED TO BE AS INEFFECTIVE AS THE ADVISORY COMMITTEE SUGGESTED.

IS THIS THE TREND, THAT -- >> Doctor: I THINK IT IS THE CASE THAT THE F.D.A.

IS TAKE TAKING IN INCREASINGLY LOWER POSTURE.

I THINK IF SOME CASES, THAT'S GOOD.

BECAUSE IF A DRUG TREATS A RARE DISEASE, OR IF IT IS A REALLY SERIOUS MEDICAL NEED WITH REALLY CLEAR EVIDENCE FROM EARLY STUDIES, SOMETIMES THAT FLEXIBILITY CAN BE IMPORTANT.

I THINK THE PROBLEM IS WHEN THAT KIND OF FLEXIBILITY IS APPLIED IN CASES SUCH AS THIS ONE, WHERE, UNFORTUNATELY, ALL OF THE EVIDENCE THAT WE HAVE TO DATE IS NOT CONVINCING THERE IS ANY POTENTIAL EFFECT FOR THE DRUG.

AND THAT'S WHERE THAT KIND OF FLEXIBILITY CAN GO A LITTLE OVERBOARD.

>> Braude: CAN WE TALK ABOUT THE PUBLIC FOR A SECOND.

A PATIENT SAYS TO YOU, OR PROBABLY BETTER IF THEY WENT TO A DOCTOR WHO WASN'T INVOLVED WITH THE F.D.A., AND SAYS, I'M NERVOUS ABOUT THIS OTHER NEW DRUG BECAUSE I HEARD ON TELEVISION YOU CAN'T TRUST THE F.D.A.

ON THIS ALZHEIMER'S DRUG, AND WHY SHOULD I TRUST THEM NOW OR EVER?

WHAT DOES THE DOCTOR SAY TO THAT PATIENT?

>> Doctor: THIS IS PART OF THE PITY OF THIS DECISION.

THE F.D.A.

IS ONE OF OUR MOST IMPORTANT PUBLIC HEALTH AGENCIES, AND I WOULD LIKE TO THINK THEY MAKE THE RIGHT DECISION MOST OF THE TIME.

BUT, UNFORTUNATELY, WHEN THERE ARE DECISIONS LIKE THIS THAT ARE REALLY PROBLEMATIC, FOR WHICH THE PROCESS FOR THE DECISION-MAKING THEN GETS RE-EXAMINED AND LOOKED AT, I THINK IT KIND OF DOES ERODE THIS TRUST THAT PEOPLE HAVE, THE TRUST THAT WE NEED FOR PEOPLE TO TAKE VACCINES THAT HAVE BEEN COMING THROUGH THE F.D.A.

OR OTHER DRUGS.

I THINK THIS DOES REAL DAMAGE TO THOSE KINDS OF PERCEPTIONS.

>> Braude: BY THE WAY, THE TRUST ISSUE DIDN'T BEGIN THERE.

WE HAVE TO ADD IN WHAT HAPPENED WITH THE F.D.A.

AND THE C.D.C.

UNDER DONALD TRUMP.

LET'S GO TO THE INDIVIDUAL SUFFERER OR THEIR FAMILY, ALZHEIMER'S SUFFERER OR THEIR FAMILY, WHERE DO THEY GO?

THEY'RE FACED WITH A DECISION: DO I TRUST THE F.D.A.?

OR DO I TRUST SOME DOCTOR WHO I NEVER HEARD OF FROM HARVARD AND THE BRIGHAM?

I'M SERIOUS, BY THE WAY.

I DON'T MEAN THAT DISRESPECTFULLY.

WHAT DOES THE AVERAGE PERSON, WHO NOT ONLY IS SUFFERING GREATLY FROM THE PHYSICAL ASPECT, BUT INCREDIBLE PSYCHOLOGICAL STRESS, AS I'M SURE THE WHOLE FAMILY IS, HOW DO THEY MAKE AN INFORMED DECISION?

>> Doctor: IT IS REALLY CHALLENGE.

I HAVE PATIENTS WHO HAVE ALZHEIMER'S DISEASE, I'VE HAD FAMILY MEMBERS WHO HAVE SUFFERED FROM DEMENTIA, AND IT IS A REALLY DEVASTATING DISEASE, AND I REALLY -- I THINK THAT THIS IS A REALLY CHALLENGING DECISION-MAKING PROCESS FOR THE FAMILIES TO GO INTO.

BUT IF SOMEBODY CAME TO ME AND THEY SAID, DOCTOR, WOULD YOU RECOMMEND THIS DRUG?

I WOULD SAY THERE IS NO GOOD EVIDENCE THAT THE DRUG WORKS.

THERE ARE A LOT OF CONCERNS ABOUT THE SIDE EFFECTS, NOT ONLY THE PHYSICAL SIDE EFFECTS, BUT THE FINANCIAL TOXICITY OF THE DRUG BECAUSE THE DRUG IS SO EXPENSIVE, I WOULD SUGGEST THEY ENROLL IN A CLINICAL TRIAL OF THE DRUG BECAUSE WE STILL DON'T KNOW WHAT THE DRUG IS DOING, NOT TO TAKE THE DRUG OUTSIDE OF THAT.

>> Braude: SPEAKING OF FINANCIAL TOXICITY, YOU'RE NOT THE ONLY PERSON CONCERNED ABOUT THE $56,000 A YEAR COST.

SENATOR WARREN, ALONG WITH SOME OTHER SENATORS, HAVE RAISED SOME CONCERNS BECAUSE I BELIEVE THE F.D.A.

AS APPROVED -- PLEASE CORRECT ME IF I'M WRONG -- FOR BIOGEN -- NINE YEARS FOR THEM TO CONFIRM WHETHER OR NOT THIS IS AFFECTIVE OR NOT.

BEYOND THE PHYSICAL AFFECT, THE FINANCIAL IMPACT IS BILLIONS AND BILLIONS AND BILLIONS OF DOLLARS.

WHY DO THEY HAVE NINE YEARS TO CONFIRM OR NOT CONFIRM THEIR FINDINGS?

>> Doctor: AND THAT IS A GOOD QUESTION, AND ONE THAT AS YET IS STILL UNANSWERED.

BUT I DO THINK THAT THAT IS PART OF, HOPEFULLY, THE INVESTIGATION THAT GOES INTO THIS DRUG, WILL FIGURE OUT WHAT THE DECISION-MAKING WAS AND WHY THEY WERE GIVEN NINE YEARS TO CONFIRM THE INITIAL APPROVAL.

BUT I THINK THAT WHAT THIS POINTS TO MORE BROADLY IS THAT IN THE UNITED STATES, WE ALLOW DRUG COMPANIES TO CHARGE WHATEVER THEY WANT FOR NEW DRUGS.

AND WE DON'T HAVE ANY PROCESS FOR NEGOTIATING DRUG PRICES SO THEY'RE FAIR AND IN LINE WITH THE POTENTIAL BENEFITS THAT THE DRUG PROVIDES.

YOU KNOW AN INDEPENDENT ENTITY BASED IN BOSTON REVIEWED THE DATA AND FOUND THAT EVEN IF THE MOST POSITIVE INTERPRETATION OF THE DATA, A PRICE OF MORE LIKE $5,000 OR $8,000 A YEAR WOULD HAVE BEEN A MORE REASONABLE PRICE.

$56,000 A YEAR IS JUST WAY OVERBOARD.

>> Braude: MAYBE IT WILL GIVE CONGRESS SOME COURAGE TO DEAL WITH DRUG-PRICING ISSUES MORE FORTHRIGHTLY THAN THEY HAVE.

FINAL QUESTION -- I KNOW YOU PUT HOPE IN THIS -- WELL, IT IS NOT A SELF-INVESTIGATION -- AN INVESTIGATION INTO THE DECISION-MAKING OF THE F.D.A.

ASSUMING THAT DOES NOT COME TO A SATISFACTORY OUTCOME, QUICKLY, DO WE NEED A NEW F.D.A.?

OR CAN THE F.D.A.

BE FIXED AND CREATE A GREATER DISTANCE BETWEEN THE DRUG COMPANIES THEY'RE SUPPOSED TO OVERSEE AND THE AGENCY ITSELF?

>> Doctor: I THINK THAT IN GENERAL THE F.D.A.

DOES AN EXTREMELY GOOD JOB, AND THE F.D.A.

TOUCHES A QUARTER OF OUR ECONOMY.

SO IT HAS A LOT OF RESPONSIBILITY.

SO I AM DEFINITELY NOT IN FAVOR OF GETTING RID OF THE F.D.A.

OR CARVING THE F.D.A.

OUT FROM DECISION-MAKING.

I DO THINK, HOWEVER, IT WOULD BE USEFUL IF THE UNITED STATES HAD A SECOND AGENCY AFTER F.D.A.

REVIEW THAT WOULD EVALUATE THE EVIDENCE THAT IS BASED AROUND A NEW DRUG APPROVAL, AND TO DETERMINE, YOU KNOW, WHAT AFFECT DOES THIS DRUG HAVE?

WHERE DOES IT FIT IN THE ARMATARATARIUM, AND TO GIVE RECOMMENDATIONS TO PAYERS AND PHYSICIANS ABOUT WHAT DO DO WITH THIS DRUG.

A LOT OF OTHER COUNTRIES HAVE THIS FOLLOWUP ORGANIZATION.

AND I THINK THAT KIND OF ORGANIZATION MIGHT BE VERY USEFUL IN CASES LIKE ADACANANAB, WHERE THEY GIVE THE THUMBS UP, BUT THE F.D.A.

DOESN'T KNOW WHAT TO DO WITH IT BECAUSE ALL OF THE SAFETY RISKS AND THE HIGH COSTS OF IT.

ADDITIONAL ADVICE FROM A SEPARATE ORGANIZATION THAT WORKED AFTER THE F.D.A.

IN THE CASE OF NEW DRUGS AND DEVICES MIGHT BE VERY HELPFUL.

>> Braude: SOUNDS LIKE A TERRIFIC IDEA.

DR. KESSELHEIM, THANK YOU FOR YOUR TIME.

EFFICIENT IT.

>> Doctor: MY PLEASURE.

THANK YOU.

>> Braude: NEXT UP, KIDS LOST OUT ON LEARNING TIME THIS YEAR.

BUT THE PANDEMIC HAS ALSO FUELED ANOTHER PROBLEM FOR YOUNG PEOPLE: A GROWING MENTAL HEALTH CRISIS.

NOW, AS LIZ NEISLOSS TELLS US, A NEW GROUP IS ADDING ANOTHER SKILL SET TO THEIR CATALOG, OFFERING HELP TO STRUGGLING TEENS.

>> Reporter: A LIBRARY CAN FEEL LIKE A REFUGE FOR ANYONE, ESPECIALLY A TEEN.

>> IN NORMAL CLASSES IT'S MORE OF A STRUCTURED LEARNING TIME.

AND YOU HAVE TO GET THIS IN, THIS DONE, BUT YOU GO TO THE LIBRARY ON YOUR OWN ACCORD, SO IT CAN BE VERY SOOTHING.

IT'S ALWAYS A FUN PLACE TO GO TO AND TO JUST EITHER UNWIND OR TO CHECK OUT BOOKS, REALLY, BECAUSE THAT'S THE MAIN THING.

>> Reporter: NOW ARRIVING SOPHOMORE, 15-YEAR-OLD ANGEL MARIN CACERES STILL REMEMBERS HER LIBRARIAN AT CAMERON MIDDLE SCHOOL IN FRAMINGHAM.

>> SHE -- SHE WOULD NOTICE THAT YOU'RE, LIKE, FEELING DOWN.

AND, ALSO, JUST TO -- JUST ASK YOU QUESTIONS, IF -- IF -- ARE YOU OKAY?

DO YOU NEED ANYTHING?

AND, LIKE, SHE WOULD JUST LISTEN TO YOUR PROBLEMS, IF YOU HAD ANY OR JUST FELT LIKE VENTING.

>> Reporter: NOW THAT LIBRARIAN, ELIZABETH THOMPSON, IS PREPARED TO DO MORE THAN JUST LET HER STUDENTS CATALOG THEIR >> Reporter: SHE'S RECENTLY COMPLETED SPECIALIZED TRAINING LIKE THIS, OFFERED IN THE WAKE OF THE PANDEMIC TO TEACH LIBRARIANS.

IT IS NOT JUST FOR SCHOOL LIBRARIANS.

STATEWIDE, LIBRARIES ANTICIPATE A RISE AND NEED, AND USED COVID RELIEF FROM THE INSTITUTE FOR MUSEUMS AND LIBRARIES TO FUND THE EFFORT.

LIBRARY THOMPSON SEES THIS TYPE OF TRAINING AS OVERDUE.

>> I WOULD HAVE TAKEN IT BEFORE COVID BECAUSE I SAW THE NEED THEN.

BUT I THINK EVEN IN THE FALL, THE IMPACT IS STILL GOING TO BE THERE.

AND KIDS WILL STILL BE STRUGGLING.

AND THERE WILL BE STILL THE USUAL ADOLESCENT STUFF, THAT'S HARD ENOUGH.

>> Reporter: EXPERTS ON CHILDREN'S MENTAL HEALTH SAY A CRISIS HAS BEEN BREWING IN THE ISOLATION OF THE PANDEMIC, AND THAT VERY ISOLATION CUT OFF CHILDREN FROM AN IMPORTANT RESOURCE.

>> CHILDREN REALLY GET THE VAST MAJORITY OF THEIR MENTAL HEALTH TREATMENT IN SCHOOLS.

AND SO WITH THE PANDEMIC AND THE SHUTDOWN, THAT ACCESS TO BEHAVIORAL SERVICES WAS GONE.

AND THE MORE WE CAN LET ADULTS, TRUSTED ADULTS, SEE THOSE AS "SIGNS SIGNS LOOKING FOR HELP, THE BETTER WE'LL BE ABLE TO SUPPORT THOSE KIDS.

>> HEARING THEM OUT, MIGHT BE WHAT A PERSON NEEDS.

>> Reporter: MASSACHUSETTS TRAINING FOR LIBRARIANS IS RUN BY WALKER THERAPEUTIC AND EDUCATIONAL PROGRAM.

>> WE TEND TO SUPPORT SOMEONE WHO IS HAVING A MEDICAL EMERGENCY, BUT WE DON'T DRAW THE SAME PARALLEL TO SOMEONE WHO HAS A MENTAL HEALTH CRISIS OR ISSUE.

PEOPLE ARE AFRAID THEY'LL GET IT WRONG.

>> Reporter: WHEN TEENS AREN'T BURROWED IN THEIR BOOKS OR BEHIND THEIR COMPUTERS, THEY OFTEN SHARE WHAT IS BOTHERING THEM.

>> WHEN THEY SHARE THINGS WITH YOU, WHAT DO YOU DO WITH THAT?

WHAT ARE THE THINGS YOU SHOULD OR SHOULD NOT SAY?

IT WAS SUPER, SUPER HELPFUL.

>> Reporter: ON THE SURFACE, SCHOOL MAY LOOK LIKE BACK TO NORMAL IN THE FALL, BUT WITH TRAINING, LIBRARIANS MAY NOW BETTER READ THE NEED FOR HELP.

LIZ NEISLOSS, GBH NEWS.

>> Braude: IN MANY PLACES, NEEDY PLACES SPEND THEIR DAYS IN LIBRARIES, OFTEN PLACING LIBRARIANS IN THE ROLE OF SOCIAL SERVICE PROVIDERS.

TO COPE IN RECENT YEARS, GROWING NUMBERS OF GROWING LIBRARIES NOW HAVE FULL-TIME LIBRARY SOCIAL WORKERS.

THAT'S IT FOR TONIGHT.

TOMORROW, MAURA HEALEY JOINS ME TO DISCUSS THE $4.5 BILLION SETTLEMENT THAT SHE, ALONG WITH FOREOTHER ATTORNEYS GENERAL, SIGNED OFF AGAINST PURDUE PHARMA, AND THE SACKLER FAMILY.

THAT AND MORE TOMORROW.

THANKS FOR WATCHING, AND PLEASE STAY SAFE.