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JON?
JON: MOLLY HENNEBERG, IN
WASHINGTON.
THANKS, MOLLY.
JENNA: WELL OUR NEXT GUEST SAYS
THERE'S AN ETHICAL CONTROVERSY
SWIRLING AROUND THE FOOD AND
DRUG ADMINISTRATION IN WHAT HE
CALLS, SHAM SURGERY.
HERE'S AN EXAMPLE.
THE AGENCY APPROVING A STUDY BY
A COMPANY ON A MEDICAL DEVICE
THAT TREATS SERIOUS CASES OF
HIGH BLOOD PRESSURE.
THE SURGERY PERFORMED ON SOME OF
THE PATIENTS LOOKS LIKE THE REAL
THING WITH ALL THE PROCEDURES
AND INVASIVE MEASURES BUT
THERE'S A CATCH.
SOME OF THE SURGERIES WERE FAKE
AND THE PATIENTS GOT, IN EFFECT,
PLACEBO SURGERY.
DR. SCOTT GOTTLIEB IS AN
INTERNIST AND RESIDENT FELLOW AT
AMERICAN ENTERPRISE INSTITUTE.
HE WROTE ABOUT THIS TOP I CAN
AND IT IS A TOPIC WE DIDN'T KNOW
THAT MUCH ABOUT, SCOTT.
TELL US ABOUT SHAM SURGERIES.
HOW OFTEN ARE THEY HAPPENING AND
WHAT HAPPENS WHEN THEY'RE DONE
AND WHAT IS THE FDA'S ROLE?
>> THIS IS RELATIVELY NEW.
THIS IS NEW CLINICAL TRIAL
DESIGN FDA IS EMPLOYING IN SOME
CASES WITH MEDICAL DEVICES WHERE
THEY REQUIRE COMPANIES TO
RANDOMLY SELECT PATIENTS TO GET
THE PROCEDURE DONE WITH THE
EXPERIMENTAL MEDICAL DEVICE OR
ESSENTIALLY GET A FAKE SURGERY
TO CONSTITUTE A PLACEBO ARM.
MANY PEOPLE ARE FAMILIAR WITH IN
DRUG TRIALS THE SOME PARENTS GET
AN EXPERIMENTAL DRUG AND SOME
PATIENTS GETTING SUGAR PILL,
INERT PLACEBO.
NOW THEY'RE DOING PLACEBO TRIALS
TO MEDICAL DEVICES THIS
OBLIGATED TO SURGERIES IN MANY
CASES THEY DON'T NEED AT ALL.
THERE IS ANESTHESIA RISK.
THERE IS CUTTING INVOLVED AND
PATIENTS DON'T KNOW WHETHER THEY
GOT SURGERY OR NOT.
JENNA: YOU SAY PATIENTS ARE
OBLIGATED BUT DO THEY VOLUNTEER
FOR THE CLINICAL TRIALS?
>> THERE IS INFORMED CONSENT BUT
PATIENTS MIGHT NOT KNOW THEY GET
A THE REAL PROCEDURE.
THERE IS LOT OF RISK ASSOCIATED
WITH THIS AS I SAID.
YOU COULD HAVE REACTION TO
ANESTHESIA.
THERE COULD BE INFECTION.
THERE IS NOTION YOU SHOULDN'T
INTRODUCE HARM TO PATIENTS IN
EXPERIMENTATION WITHOUT
POTENTIAL BENEFIT.
THIS SEEMS TO VIOLATE THE
LONG-HELD KNOWING THAT WE
SHOULDN'T DO THINGS TO PATIENTS
KNOWINGLY HURTING THEM IN A
CLINICAL TRIAL WITHOUT BENEFIT.
IN THIS CASE WHERE THE PATIENTS
ARE NOT GETTING REAL PROCEDURE
THERE IS NO POTENTIAL FOR
BENEFIT.
FDA ADDRESSES ETHICAL ISSUES.
THE PATIENTS CAN CROSS OVER
LATER ON AND GET SECOND SURGERY.
IN MANY CASE THAT IS REQUIRES
SECOND SURGERY AND RISKS
ATTENDANT TO THAT.
JENNA: WE REACHED OUT TO THE
FDA.
SCOTT, THEY SAY, PATIENTS
REQUESTED ACCESS TO CLINICAL
TRIALS FOR PROMISINGS NEW
TREATMENT OPTIONS AND FOR OUR
PART WE WORKED WITH COMPANIES
AND PATIENT ADVOCATES TO DO THIS
IN A SAFE, TRANSPARENT AND
RESPONSIBLE WAY.
FDA IS CHIT COMMITTED TO
ASSURING REASONABLY SAFE AND
EFFECTIVE, HIGH QUALITY MEDICAL
DEVICES ARE AVAILABLE TO
PATIENTS.
ONE OF THE QUESTIONS ON THAT,
SCOTT, IS THERE OTHER WAYS TO
FIGURE THAT OUT DECIDES DOING A
SHAM SURGERY FOR EXAMPLE?
>> RIGHT.
JENNA: WHAT OTHER WAYS COULD
THEY ENSURE THAT A MEDICAL
DEVICE WOULD WORK?
>> I WAS DEPUTY COMMISSIONER OF
FDA FROM 2005 AND 2007 AND
WORKED THERE BEFORE THAT AND
OVER THAT TIME PERIOD WE USED TO
DEPLOY WHAT WE CALLED
NON-INFERIOR RECORDTY TRIALS IN
CASES LIKE THESE.
PATIENTS WOULD GET THE ACTUAL
SURGERY AND NEW MEDICAL DEVICE
AND SOME PATIENTS WOULD GET
STANDARD OF CARE.
THAT MIGHT BE DIFFERENT SURGERY
OR MIGHT BE MEDICAL THERAPY.
WHAT YOU WOULD DO IN THOSE
TRIALS YOU PROVE THE NEW DEVICE
IS EQUIVALENT TO THE OLD DEVICE
OR THE OLD PROCEDURE OR THE
EXISTING STANDARD OF CARE.
THOSE TRIALS WERE PRETTY GOOD
FOR DETERMINING WHETHER OR NOT
NEW MEDICAL DEVICES WORKED.
WHAT THE FDA ITS SAYING NOW THEY
WANT TRIALS TO BE MORE
STATISTICALLY RIGOROUS.
THEY WANT A HIGHER LEVEL OF
CERTAINTY AROUND A BENEFIT THEY
THINK THEY'RE OBSERVING IN A
CLINICAL TRIAL.
SO THEY'RE REQUIRING THESE
PLACEBO CONTROLLED TRIALS, SHAM
SURGERIES, BECAUSE THEY ARE
STATISTICALLY MORE SCRUPULOUS.
JENNA: IT COMES DOWN TO US, WHAT
KIND OF CARE WE'RE GOING TO
RECEIVE, WHAT KIND OF MEDICAL
DEVICE WE'RE GOING TO RECEIVE.
AT THE END OF THE DAY IS THIS
BETTER AS BIZARRE IT IS?
I KNOW YOU HAVE ETHICAL ISSUES
WITH IT.
I'M SURE VIEWERS CAN UNDERSTAND
THIS AS WELL.
WILL THIS LEAD TO BETTER HEALTH
CARE FOR US OR DO YOU THINK IT'S
A WASTE OF TIME?
>> RIGHT.
KEEP IN MIND, THESE ARE NOT
QUESTIONS OF SAFETY BUT BENEFIT
OF THE DEVICES AND HOW MUCH
STATISTICAL PROOF SHOULD YOU
NEED TO DEMONSTRATE A MEDICAL
DEVICE IS DELIVERING THE
BENEFITS YOU THINK IT IS GOING
TO DELIVER.
THE REALITY I THINK THE OLD
CONSTRUCT, NON-INFERIORITY
TRIALS WERE BETTER LOOKING AT
THESE QUESTIONS A NEW MEDICAL
DEVICE MIGHT DELIVER OTHER
BENEFITS BESIDES JUST BETTER
TREATMENT.
THE MEDICAL DEVICE I WROTE ABOUT
YESTERDAY WAS FOR TREATMENT OF
HIGH BLOOD PRESSURE.
IT MIGHT BE NO BETTER THAN
MEDICAL MANAGEMENT.
NO BETTER THAN TAKING HIGH BLOOD
PRESSURE PILLS.
IF IT IN FACT IT CAN KEEP YOU
FROM HAVING TO TAKE THE PILLS
THAT IS REAL BENEFIT.
THE OLD TRIALS CONSTRUCT, IS
BETTER FOR TEASING OUT SECONDARY
QUESTIONS IF YOU WILL.
THINGS LIKE IS IT BETTER THAN
THE EXISTING APPROACH?
IS IT LESS INVASIVE?
IS IT EASIER FOR THE SURGEON TO
DO?
SOMETIMES THE QUESTION MOST
IMPORTANT QUESTION IS NOT THE
ABSOLUTE BENEFIT OF A MEDICAL
DEVICE BUT OTHER QUESTIONS, IS
IT BETTER THAN THE ALTERNATIVE?
THESE SHAM TRIALS ALL THEY
REALLY ANSWER IS THE MEDICAL
DEVICE BETTER THAN NOTHING.
IN THIS CASE NOTHING IS A FAKE
SURGERY.
JENNA: INTERESTING.
THAT IS ONE OF THE THINGS