I'M JAMES GULLEY, DIRECTOR OF
THE MEDICAL
ONCOLOGY SERVICE.
REALLY, THOSE HATS ASIDE, I'M
HERE AS A PRACTICING CLINICIAN,
CLINICAL TRIALIST, AND ALSO A
MEMBER OF THE NIH ETHICS
COMMITTEE.
SO I DO HAVE A LITTLE BIT OF
BACKGROUND AND I HAVE BEEN
FORTUNE ENOUGH TO BE INVOLVED IN
THIS COURSE FOR A NUMBER OF
YEARS NOW.
WHAT WE WANT TO DO TODAY IS TO
TALK ABOUT PROBLEMS THAT CAN
ARISE IF WE DON'T REALISTIC TO
OUR STRONG GUIDE LIENS ABOUT
SCIENTIFIC INTEGRITY, AS IT
RELATES TO CLINICAL TRIALS AND
CLINICAL TRIALS PROCESS.
WE'RE GOING TO MAKE THIS
INTERACTIVE, KIND OF A LITTLE
PIT FUN BY GOING THROUGH THE
CASES OF PEOPLE THAT HAVE RUN
INTO PROBLEMS AND HOPEFULLY THIS
WILL HELP US AVOID THE PROBLEMS.
SO I THINK THE FIRST THING WE
NEED TO FOCUS ON IS SCIENTIFIC
INTEGRITY.
FIRST OF ALL, WHAT IS SCIENTIFIC
INTEGRATETRY?
WELL, WE SHOULD ALL BE COMMITTED
TO THE PROCESS OF THE
RESPONSIBLE USE OF THE
SCIENTIFIC METHOD TO SEEK NEW
KNOWLEDGE.
CERTAINLY, ALL STAFF WITHIN THE
INTRAMURAL RESEARCH PROGRAM
SHOULD MAINTAIN EXEMPLARY
STANDARDS OF INTELLECTUAL HONEST
IN FORMULATING CONDUCTING AND
PRESENTING RESEARCH AS BENEFITS
THE LEADERSHIP ROLE OF THE NIH.
WHY IS SCIENTIFIC INTEGRITY SO
IMPORTANT?
I THINK IT'S IMPORTANT IN PART
BECAUSE THE SCIENTIFIC COMMUNITY
AND THE GENERAL PUBLIC RIGHTLY
EXPECT ADHERENCE TO THE
STANDARDS OF INTELLECTUAL
HONESTY AND THE FORMUATION,
CONDUCT AND REPORTING OF
SCIENTIFIC SCIENTIFIC RESEARCH.
WITHOUT THIS HIGH STANDARD OF
SCIENTIFIC INTEGRITY, THE
COMMUNITY AND THE GENERAL PUBLIC
MAY BECOME VICTIMS OF RESEARCH
MISCONDUCT.
THAT'S WHAT WE'RE GOING TO TALK
ABOUT IN THE NEXT FEW MINUTES
HERE.
SO WHAT IS RESEARCH MISCONDUCT?
DOES ANYBODY WANT TO TAKE A
GUESS AS TO WHAT THE 3 AREAS OF
RESEARCH MISCONDUCT ARE?
GO AHEAD.
JUST SHOUT IT OUT.
[INAUDIBLE]
>> FALSIFICATION.
HEARD THAT.
GOOD.
[INAUDIBLE]
>> PLAGIARISM.
YES.
AND?
ANOTHER ONE THAT BEGINS WITH F.
FABRICATION.
WHAT IS FABRY INDICATION?
PLAIN OLD MAKING UP DATA.
AND RECORDING OR REPORTING THEM.
FALSIFICATION IS MANIPULATING
DATA, SO IT MAY BE NOT
COMPLETELY MADE UP.
YOU MAY ACTUALLY CHANGE SOME OF
THE DATA OR THE RESULTS.
OUR OMET SOME OF THE DATA.
WE'LL TALK ABOUT THAT IN A BIT.
AND PLAGIARISM, PROBABLY MOST OF
US KNOW WHAT PLAGIARISM IS,
TAKING ANOTHER PERSON'S IDEAS,
PROCESSES OR WORDS WITHOUT
GIVING THE APPROPRIATE CREDIT.
SO RESEARCH MISCONDUCT DOES NOT
INCLUDE AN HONEST ERROR OR
DIFFERENCE OF OPINION.  THAT IS
DIFFERENT THAN RESEARCH
MISCONDUCT.
ALSO, JUST WITHIN THE NIH
GUIDELINES, IF YOU ARE A
SCIENTIFIC COLLABORATOR, IF
SOMEBODY ELSE IS -- TAKING THAT,
YOUR WORDS, HOW YOU WROTE IT IN
ONE ARTICLE AND USING THAT IN
ANOTHER ARTICLE, IN A SIMILAR
WAY, IS PROBABLY -- DOESN'T RISE
TO A LEVEL OF PLAGIARISM, FOR
INSTANCE, A RESEARCH ARTICLE.
NOW, WE'RE GOING TO SWITCH GEARS
HERE AND GO ACTUALLY INTO SOME
REAL LIFE EXAMPLES OF SCIENTIFIC
MISCONDUCT.
THIS IS A CASE IN 2006, THIS
KOREAN INVESTIGATOR, CRIMED TO
HAVE CREATED THE FIRST EVER
HUMAN EMBRYONIC STEM CELL
RHINES.
THE DEW POINT MATCHED THAT OF
THE PATIENTS.
SO THIS WAS GOING -- DNA MATCHED
THAT OF THE PATIENTS.
THIS WAS GOING TO CREATE HUGE,
NEW BREAKTHROUGHS IN TREATMENT
MODALITIES FOR PATIENTS.
SO THE CASE, IT TURNED OUT,
INVOLVED SOME QUESTIONABLE
MANIPULATION OF THE DATA.
WE'LL SHOW YOU SOME OF THE
PICTURES FROM THAT IN JUST A
MINUTE.
TURNS OUT THAT AFTER ALL WAS
SAID AND DONE, OF THE 11
ORIGINAL CELL LINES, 9 OF THOSE
WERE FABRICATED AND THE IMAGES
OF THE CELLS WERE MANIPULATED ON
THE PRIMARY JOURNAL.
SO ONE OF THE RESULTS OF THIS
PARTICULAR EGREGIOUS CASE WAS
THAT NOW VIRTUALLY ALL THE MAJOR
JOURNALS, THEY LOOK IN THEIR
REVIEW PROCESS, AT THE IMAGES.
AND THEY LOOKED TO SEE, ARE
THESE IMAGES MANIPULATED?
SO WE'RE GOING TO SHOW A FEW
EXAMPLES HOW THEY CAN TELL THAT.
HERE IN THE TOP PANEL, THIS IS
THE ORIGINAL SUBMISSION.
THIS WAS A SUPPLEMENTAL FIGURE.
SO JUST BECAUSE IT WASN'T IN THE
PRINT FIGURES, DON'T THINK THAT
THIS WASN'T ANYTHING THAT YOU
SUBMIT, EVEN IF IT DOESN'T GET
PUBLISHED IF IT'S SUBMITTED TO
THE PAPER, AT THAT POINT, IF
IT'S FABRICATION OR
FALSIFICATION, YOU ARE
POTENTIALLY -- THERE IS POTENTLY
SCIENTIFIC MISCONDUCT GOING ON
THERE.
YOU CAN SOME HERE, VERY DARK --
A LITTLE BIT OF LIGHT IN THE
MIDDLE HERE.
THESE ARE TWO CELL RIPES.
THIS IS A NEGATIVE.
YOU CAN SEE WHEN YOU ADJUST THE
TONAL RANGE, YOU CAN SEE THESE
TWO FIGURES ARE IDENTICAL.
AND, INDEED, THIS WAS JUST
MANIPULATION OF THE DATA HERE.
AND FABRICATION.
THIS WAS NOT A SEPARATE CELL
LINE FROM THIS.
THIS IS ANOTHER INTERESTING
CASE.
SO THIS IS ACTUALLY AN EXAMPLE
OF MANIPULATED DATA.
THIS WAS SOMETHING THAT WAS
PUBLISHED BY ONE OF OUR
RESEARCHERS HERE, JUST SHOWING
HOW POTENTIALLY ONE COULD
MANIPULATE DATA AND THEN LOOK TO
SEE IF THAT -- HOW YOU COULD
UNCOVER WHETHER THAT DATA WAS
MANIPULATED.
A VERY INTERESTING READ, IF YOU
WANT TO READ THIS.
IT'S CALLED THE TEMPTATION OF
IMAGE MANIPULATION.
AND YOU CAN SEE HERE, VERY NICE
PICTURE OF THESE CELLS HERE BUT
WHEN YOU CONTRAST THE JUSTICE,
YOU CAN SEE THAT EVERYTHING HERE
IN THE WACK GROUND HAS THIS
GRAINY APPEARANCE WITH AS HERE
IT'S DARK, ACCEPT RIGHT AROUND
THESE CELLS, THERE IS THIS DARK
AREA.
COMPLETELY BLACK.
YOU CAN TELL THEY CUT AND PASTED
THIS FROM A DIFFERENT PICTURE.
SO THESE CELLS HERE AND HERE
REALLY WEREN'T IN THE ORIGINAL
PHOTO MICROGRAPH.
BACK HERE.
SO JUST ONE OTHER QUICK RECENT
WHERE WAS THEIR ALSO
REPRESENTATION IN STEM CELLS.
THIS WAS A RESEARCHER IN JAPAN
AND THIS RESEARCHER ACTUALLY
SUBMITTED DATA TO NATURE, WAS
PUBLISHED.
WITHIN DAYS OF THE PUBLICATION,
DATA CAME OUT THAT THERE WAS
IMAGES THAT WERE MANIPULATED,
THAT WERE CELL LIBS THAT WERE
FABRICATED, AND HE ACTUALLY LOST
HIS POSITION IN THE ACADEMIC
UNIVERSITY THERE AND LOST ALL
THE GRANTS THAT HE HAD, ET
CETERA.
NOW TALKING ABOUT CLINICAL TRIAL
DATA MANIPULATION.
THIS WAS DATA FROM A BREAST
CANCER PREVENTION TRIAL, FUNDED
IN PART BY -- THE TEST RESULTS
WERE FALSIFIED OF AN EXAM.
PATIENTS CAME IN.
THERE WAS INCOMPLETE DATA THERE,
THE DATE WASN'T CAPTURED.
MAYBE THE PATIENT EITHER DIDN'T
COME IN FOR A TEST OR DIDN'T
WRITE DOWN WHEN THE TEST WAS
DONE.
SHE JUST MADE UP THE DATA SO SHE
COULD FILL IN THE BLANKS.
ANOTHER CASE IN THE NATIONAL
SURGICAL ADJUVANT BREAST AND
BOWEL PROJECT, A DATA
COORDINATOR FALSIFIED FOLLOW-UP
DATA.
DATA WHEN YOU'RE SUPPOSED TO
FOLLOW THE PATIENTS EVERY 6
MONTHS FOR EXNUMBER OF YEARS,
AND MAYBE ALL THE PATIENTS
DIDN'T COME IN OR MAYBE THEY
DIDN'T REPORT EVERYTHING OR IT
WASN'T WRITTEN DOWN AND THEY
JUST, AGAIN, FILLED IN THE
BLANKS.
SO WHAT'S SO WRONG ABOUT DOING
THAT?  WELL, CERTAINLY
INACCURATE OR MISLEADING DATA
REGARDING PATIENT FOLLOW-UP CAN
HAVE BIG IMPLICATIONS BECAUSE
THEE CITIES WERE DESIGNED TO SEE
-- STUDIE
S WERE DESIGNED TO
SEE -- IF YOU HAVE WRONG DATA IN
YOU CAN'T LOOK AT ANY OF THE
DATA WITHIN THAT PROJECT AND
KNOW WHETHER OR NOT THERE IS ANY
DIFFERENCE THERE.
SO IT JUST MAKES THE WHOLE STUDY
UNINTERPRETABLE.
THIS IS PERHAPS ONE OF THE MOST
EGREGIOUS CASES, A CASE THAT
REALLY EFFECTED MANY HUNDREDS OF
PATIENTS OVER A -- ALMOST A
DECADE OF TREATMENT.
SO BACK IN THE LATE 1990s,
HEMATOPOIETIC STEM CELL
TRANSPLANT FOR PATIENTS WITH
BREAST CANCER WAS ACTUALLY A BIG
GROWING AREA OF INTEREST.
PEOPLE FELT THAT IF GIVING A
LITTLE BIT OF CHEMOTHERAPY --
SEEING A RESPONSE, MAYBE WE
COULD GIVE A LOT MORE
CHEMOTHERAPY, AND WHEN THEIR
BONE MARROWS CRASHED AS THEY
WOULD DO, WE CAN JUST GIVE THEM
BONE MARROW TRANSPLANT AND WE
COULD GET MORE CANCER CELLS
KILLED AND BETTER OUTCOMES FOR
PATIENTS.
TURNS OUT THAT THERE WASN'T A
WHOLE LOT OF DATA FOR THAT.
BUT BACK IN THOSE DAYS IT WAS
FELT THAT MORE WAS BETTER SO
ALONG AS WE COULD KEEP THE
PATIENTS ALIVE.
SO THEY DECIDED AT THAT POINT TO
DO A RANDOMIZED STUDY.
IT WAS KIND OF LIKE THEY
THOUGHT, OKAY, FOR SURE THIS
MAKES SENSE.
OF COURSE WE'RE GOING TO SHOW
THAT MORE IS BETTER.
IF A LITTLE BIT IS GOOD, MORE
HAS TO BE BETTER.
SO LET'S DO SOME RANDOMIZED
STUDIES, JUST TO PROVE OUR
POINT.
THEN WE CAN MOVE ON.
INSURANCE COMPANIES WERE
REIMBURSING FOR STEM CELL
TRANSPLANTS FOR PATIENTS WITH
BREAST CANCER, FOR INSTANCE.
WELL, THERE WERE 5 RANDOMIZED
STUDIES THAT WERE DONE.
4 OF THEM WERE REPORTED AND THEY
WERE COMPLETELY NEGATIVE, THERE
WAS NO IMPROVEMENT IN OUTCOME
WHEN YOU GOT THE TRANSPLANT
COMPARED WITH JUST CONVENTIONAL
CHEMOTHERAPY.
A 5th ONE, HOWEVER, WAS
STRIKINGLY POSITIVE.
IN THIS ONE, YOU CAN SEE HERE
WAS BY BEZWODA PUBLISHED IN THE
JOURNAL OF CLINICAL ONCOLOGY IN
195.
A COMPLETE RESPONSE RATE OF 51%
IF YOU GOT THE STEM CELL
TRANSPLANT VERSES 4% IF YOU GOT
JUST THE HEEL CHEMOTHERAPY.
COMPLETE RESPONSE RATE OF 51%
WAS UNPRECEDENTED.
AND THERE WAS ALL KINDS OF
SIGNIFICANT INTEREST IN WHAT WAS
GOING ON IN THIS STUDY, WHY WAS
IT SO POSITIVE IN THIS STUDY
VERSES THE OTHER STUDIES?
AND THERE WERE CAREER
DIFFERENCES IN WHAT -- CLEAR
DIFFERENCES IN WHAT WAS GIVEN,
HOW IT WAS DONE, SO THEY DECIDED
THEY WOULD STUDY THIS IN DEPTH.
TURNS OUT DR. BEZWODA WAS IN
SOUTH AFRICA, HAD DONE HIS
STUDIES THERE.
AND YOU CAN SEE HERE, THIS IS
THE ACTUAL TRIAL THAT WAS
PUBLISHED IN JOURNAL OF CLINICAL
ONCOLOGY.
BUT A GROUP OF ONCOLOGISTS GOT
TOGETHER AND SAID WE GOT TO GET
TO THE BOTTOM OF THIS.
WHAT IS GOING ON BETWEEN
DR. BEZWODA'S STUDY, WHAT CAN WE
LEARN FROM THIS PHENOMENAL
THINGS THAT HE'S DONE THERE THAT
WE COULD POTENTIALLY TRANSLATE
INTO CLINICAL TRIALS HERE, THAT
WE CAN REALLY TAKE WHAT HE'S
GIVING TO THESE PATIENTS AND SEE
THE SAME TYPE OF RESPONSES HERE
IN THE U.S.?
SO WHAT THEY DID WAS THAT THEY
WENT ACTUALLY PHYSICALLY FLEW --
INITIALLY, THEY ASKED FOR HIM TO
SEND DOCUMENTATION OF THE
DIFFERENT PATIENTS AND THE CASE
REPORT FORMS, AND HE SENT A FEW
FORMS BUT IT REALLY WASN'T
ENOUGH, SO THEN THEY DECIDED
THAT THEY WERE GOING TO GO
ACTUALLY TO SOUTH AFRICA, GO TO
HIS CLINIC, LOOK AT THE
PAPERWORK THEMSELVES AROUND SEE
HOW HE DID THIS.
WELL, TO MAKE A LONG STORY
SHORT, WHAT THEY DID WAS THEY
REVIEWED ALL THE LITERATURE THAT
HE HAD, ALL THE -- SORRY, THE
PATIENT CHARTS, ALL THE CASE
REPORT FORMS, AND THERE WAS A
LOT OF DISPARITY BETWEEN WHAT
WAS REPORTED IN THE PAPER AND
WHAT THEY ACTUALLY SAW.
THEY SAW THAT THEY COULDN'T FIND
CONSENT FORMS FOR THE VAST
MAJORITY OF PATIENTS TREATED
WITH THE STANDARD OF CARE
CHEMOTHERAPY CHEMOTHERAPY, FOR
INSTANCE.
AND THEY COULDN'T EVEN FIND
PATIENT RECORDS ABOUT SOME OF
THESE PATIENTS.
THERE WAS NO EVIDENCE THAT THOSE
PATIENTS HAD BEEN TREATED.
IN FACT, THERE WAS NO EVIDENCE
THAT THERE WAS A CLINICAL TRIAL
APPROVED BY THE REGULATORY
AUTHORITIES THERE IN SOUTH
AFRICA.
AND IT APPEARED THAT HE WAS JUST
TREATING PATIENTS IN HIS CLINIC
WITH REGIMENTS, AND THERE WAS
REALLY NO STANDARD PROTOCOL FOR
THAT.
SO BASED ON THIS DATA THAT CAME
OUT IN LANCET HERE, IN 2000, YOU
SAW THAT THE ORIGINAL PAPER WAS
RETRACTED IN 2001.
REMEMBER, THE ORIGINAL PAPER WAS
PUBLISHED, AS YOU CAN SEE HERE,
1995.
BETWEEN 1995 AND 2001, THERE
WERE MANY HUNDREDS OF PATIENTS
THAT WERE TREATED WITH -- THAT
HAD BREAST CANCER THAT WERE
TREATED WITH HIGH DOSE
CHEMOTHERAPY WITH STEM CELL
RESCUE.
CLEARLY FREEWAY HE NEVER MADE UP
THIS DATA AND HAD IT PUBLISHED
IN 1995, THESE PATIENTS WOULD
HAVE BEEN SPARED SIGNIFICANT
SIDE EFFECTS.
SO WHY DOES THIS MATTER?
AS WE MENTIONED, HEMATOPOIETIC
STEM CELL TRANSPLANT IS VERY
CLOSELY, BOTH IN TERMS OF ICU
STAYS, ANTIBIOTICS, AND IN TERMS
OF SUBSTANTIAL SIDE EFFECTS,
GRAPH VERSES HOST DISEASE, ET
CETERA.
AND THE TREATMENT RELATED
MORTALITY IS SIGNIFICANT.
DEPENDING ON THE TREATMENT
CENTER, SOMEWHERE BETWEEN 10 AND
20%, ESPECIALLY AT THAT TIME.
ANOTHER SAD CASE IS THE CASE OF
THE MUMPS, MEASLES ANDORRA BELLA
EVACUATION.
WE'RE GOING AWAY FROM CANCER
INTO THE GENERAL PATIENT
POPULATION.
THIS EFFECTS MOSTLY YOUNG
CHILDREN.
SO IN 1998, THERE WAS A PAPER BY
WAKEFIELD THAT LINKED THE MMR
VACCINE, THE MUMPS, MEASLES
ANDORRA BELLA VACCINE TO THIS
SYNDROME THAT WAS ASSOCIATED
WITH AUTISM AND DIARRHEA.
AND THIS SYNDROME HE HIGHLIGHTED
IN 12 PATIENTS, AND THIS WAS
PUBLISHED IN LANCET.
AND MULTIPLEUPS LOOKED AT THE
DATA.
THEY COULDN'T REPLYICATE THE
FINDINGS, THEY LOOKED AT MANY
OTHER PATIENTS, AND INDEED, MANY
OF THE BIG MEDICAL SOCIETIES AND
PAEDIATRIC SOCIETIES CAME OUT
SAYING THAT REALLY, WE HAVE TO
CONTINUE TO VACCINATE AGAINST
MMR, BUT THERE WAS SIGNIFICANT
CONTROVERSY REGARDING THIS.
IT WAS INTERESTING THAT A
REPORTER, WHO'S NAME WAS
MR. DEAR, UNCOVERED MULTIPLE
INCONSISTENCIES WITH THE
WAKEFIELD MANUSCRIPT.
HE WENT BACK THROUGH AND
ACTUALLY IT'S INTERESTING.
THIS WAS PUBLISHED IN BRITISH
MEDICAL JOURNAL.
HE WENT BACK THROUGH AND HE
IDENTIFIED EACH OF THESE CASES.
HE WENT BACK AND CONTACTED EACH
OF THESE FAMILIES.
AND ASKED THEM AND TRIED TO LOOK
FOR DOCUMENTATION OF ALL OF THE
THINGS THAT WERE IN WAKEFIELD'S
PAPER.
THERE WERE 3 ITEMS TO THIS
SYNDROME THAT HE HAD.
REGRESSIVE AUTISM, NON SPECIFIC
COLITIS AND THE FACT THAT THESE
FIRST SYMPTOMS APPEARED DAYS
AFTER THIS MMR VACCINE.
SO IT HAD TO HAVE ONE OR BOTH OF
THESE -- ACTUALLY, HAD TO HAVE
POTH OF THESE AND HAD TO OCCUR
RIGHT AFTER THE MMR VACCINE.
ONE HE FOUND WAS THAT THERE WERE
A FEW CASES OF THIS, YOU KNOW,
ONLY ONE CASE OF REGRESSIVE
AUTISM, ACTUALLY, IN ALL OF
THESE WITH SEVERAL QUESTION
MARKS, DESPITE THE FACT THAT
"THE LANCET" ARTICLE REPORTED
ALL THE FIRST SEVEN OF THESE, IN
THE NON SPECIFIC COLIGHTS, ONLY
3 -- COLITIS, ONLY 3 OUT OF 12
COULD THEY GET ANY EVIDENCE OF
NON SPECIFIC COLITIS OR
DIARRHEA.
THE SYMPTOMS HAPPENING AFTER THE
ONSET, IT DIDN'T HAPPEN AFTER
THE MMR OR IMMEDIATELY AFTER THE
MMR IN ANY OF THE CASES THAT HE
COULD DOCUMENT.
NONE OF THE 12 PATIENTS HAVE
THIS.
THIS WAS CONSIDERED TO BE
SCIENTIFIC MISCONDUCT AND IN
DEED, THIS WAS LATER RETRACTED.
INTERESTINGLY, WAKEFIELD FAILED
TO DISCLOSE THAT HE WAS WORKING
ON A LAWSUIT WITH -- AGAINST THE
MANUFACTURER OF THE MMR AND WAS
PAID OVER 400,000 POUNDS, PRETTY
TIDY SUM OF MONEY.
SO HE WAS STRIPPED OF HIS
LICENSE AND "THE LANCET" PAPER
WAS RETRACTED IN 2010.
BUT REMEMBER, THIS -- "THE
LANCET" PAPER WAS FIRST -- CAME
OUT IN 1998, SO THIS WAS 12
YEARS LATER.
12 YEARS WHERE MANY PEOPLE
STOPPED GIVING THEIR CHILDREN
THE MMR VACCINE.
AND WHAT YOU SEE HERE IS HERE IT
CAME OUT IN 1998, YOU CAN SOME
THAT THE PRO PORTION OF PEOPLE
IN ENGLAND AND WAILS THAT HAD
THE MMR VACCINE AMONG CHILDREN
DROPPED SUBSTANTIALLY FROM THE
MID 90s, AND FOR HERD
IMMUNITY, YOU NEED OVER 90%
VACCINATION.
IT DROPPED TO 80%.
YOU CAN SOME THERE IS A BIG
SPIKE IN THE NUMBER OF CASES OF
MEASLES.
SAME THING HELD TRUE IN THE
U.S., WHERE THERE HAS BEEN
SPIKES OF MEASLES, WHERE BEFORE
IT WAS PRETTY UNDER CONTROL.
ANOTHER CASE THAT I WANT TO
SHARE WITH YOU AS A CLINICIAN,
ERIC POLLMAN, INVOLVED IN
SEVERAL DIFFERENT CLINICAL
TRIALS.
HE ADMITTED TO FALSIFICATION AND
FABRICATION OF CLINICAL RESULTS.
SO HE ONLY ADMITTED TO THAT
AFTER ONE OF HIS STAFF CAME
FORWARD AND REPORTED
INCONSISTENCIES TO MANAGEMENT.
ONE OF HIS STUDIES WAS A
LONGITUDINAL MENOPAUSE STUDY.
THIS REPORTED ON 35 WOMEN,
STUDIED AT BASELINE, AND --
SORRY.
3 YEARS LATER.
TURNS OUT THAT WHEN THE DATA WAS
ANALYZED, ALL BUT THREE OF THESE
PATIENTS HAD FABRICATED AND
FALSIFIED DATA.
THIS WAS PUBLISHED IN THE
ANNUALS OF MEDICINE, 6 OTHER
ACADEMIC JOURNALS, USED FOR NINE
DIFFERENT NIH, TWO USDA GRANT
APPLICATIONS.
HE DIDN'T GET ALL THOSE GRANTS,
BUT HE HAD ANOTHER STUDY, A
LONGITUDINAL STUDY OF AGING.
HE LIKED THESE LONGITUDINAL
STUDIES.
HEEXAGGERATEED THE NUMBER OF
PATIENTS TESTED, CHANGED VALUES
TO CREATE A TREND IN THE AGING
PROCESS.
AND HE PRESENTED THIS DATA IN 3
DIFFERENT GRANT APPLICATIONS.
HE HAD A PROSPECTIVE HORMONE
REPLACEMENT STUDY.
THIS WAS ONE OF THE SILLIEST
ONES, I THINK, HERE BECAUSE THIS
WAS A DOUBLE BLINDED STUDY.
YET HE PRESENTED PRELIMINARY
DATA REPORTEDLY THERE THIS STUDY
WHEN HE DID NOT HAVE ACCESS TO
THE UNBLINDING.
SO HE SAID THIS GROUP IS DOING
MUCH BETTER IN HERE AND HERE IS
THE DATA TO SUPPORT THAT, BUT
THIS WAS -- THE DATA WAS STILL
BLINDED.
SO ONE OF THE REVIEWERS SAID,
SOMETHING IS NOT RIGHT HERE.
SO HE APPLIED FOR $11.6 MILLION
IN FUNDING.
AND HE WAS AWARDED $2.9 MILLION
OF GRANTS, FROM 2001 TO 2004,
THE UNIVERSITY OF VERMONT AND
NIH INVESTIGATED HIM.
THEY FOUND HE PRESENTED FALSE
TESTIMONY IN DOCUMENTS, AND
TRIED TO GET WEAPONS TO SAY
THINGS THAT -- WITNESSES TO SAY
THINGS THAT WEREN'T TRUE.
HE ADMITTED TO DESTRUCTION OF
ELECTRONIC EVIDENCE AS
FABRICATIONS.
HE HAD TO GO TO JAIL FOR A YEAR
AND A DAY, AND HE LOST ANY
ACCESS TO ANY FUTURE GRANTS, AND
HE ALSO WAS BARRED FOR LIFE FROM
RECEIVING ANY FUNDING FROM ANY
FEDERAL AGENCY, AND ALSO FROM
THE FEDERAL HEALTHCARE PROGRAM.
SO NO MEDICARE, MEDICAID FOR
HIM.
HERE WAS HIS DEFENSE.
WELL, I MISREPRESENTED MINOR
POINTS TO ENSURE THAT A GRANT
WAS REFUNDED.
NOT GOOD ENOUGH.
WELL, MY STAFF, THEY WERE
KEEPANT ON THE GRANT FOR THEIR
SALARIES.
THEY HAVE FAMILIES.
CAN'T DO THAT.
HE WANTED TO BE RECOGNIZED AS AN
IMPORTANT CONTRIBUTOR TO HIS
FIELD.
WELL, EGOS DO GET IN THE WAY.
JUST REMEMBER, THIS IS NOT G
HERE IS ANOTHER INTERESTING
EXAMPLE OF SOMEBODY THAT IS HIGH
UP, WAS A PROFESSOR AT HARVARD.
HE WAS IN THE PSYCHOLOGY
DEPARTMENT.  THERE HE WAS THE
DIRECTOR OF HARVARD'S COGNITIVE
EVOLUTION LABORATORY.
SOUNDS REALLY COOL, NICE TITLE.
INTERESTING GUY.
TURNS OUT THAT HE WAS DOING
EXPERIMENTS WHERE THEY WERE
PLAYING -- THEY HAD VIDEOED
MOPINGIES GIVING CUES FOLLOWING
AN AUDIT TORRY SIGNAL.
WHAT THEY DID WAS THEY MARKED
WHETHER AMPINGY RESPONDED TO THE
CUE OR HAD NO RESPONSE TO A
VERBAL CUE.
AND HE TYPICALLY WOULD GRADE
THIS ONE OF HIS LAB PERSONNEL.
WELL, HE HAPPENED TO NOT BE
THERE.
THE VIDEOS WERE READY TO GO.
THERE WAS TWO LABORATORY
PERSONNEL, AND THEY GRADED IN
AND THEY SAW NO ASSOCIATION.
HE SAID NO, THAT CAN'T BE.
HE WENT BACK AND HE CHANGED THE
REMARKS OF THE LAB PERSONNEL.
HE SAID NO, IT SHOULD BE THIS
WAY.
CLEARLY, THERE IS A DIFFERENCE
HERE.
THE -- FORTUNATELY FOR THE LAB
PERSONNEL, THEY STUCK UP FOR
THEMSELVES.
THEY SAID NO, THIS IS NOT RIGHT.
I DO NOT AGREE AND I WILL NOT
SIGN OFF ON THIS, AND I'M GOING
TO TAKE THIS TO THE NEXT LEVEL.
THEY DID.
AND AFTER SOME SIGNIFICANT BACK
AND FORTH, THERE WAS AN
INVESTIGATION INITIATED IN 2010.
AND THEY ACTUALLY FOUND THAT HE
WAS GUILTY OF MISCONDUCT AND THE
CASE WAS TURNED OVER TO THE
OFFICE OF RESEARCH INTEGRITY
HERE AT THE NIH.
INTERESTINGLY, AT THAT TIME, HE
WAS WORKING ON ANOTHER BOOK
CALLED "EVILICIOUS, WHY WE
EVOLVED A TASTE FOR BEING BAD."
CERTAINLY HE SEEMED TO HAVE THAT
TASTE.
IN JULY, HE SENT A LETTER TO THE
DEAN OF THE HARVARD UNIVERSITY
SAYING I'VE DECIDED TO PURSUE
OTHER AREAS AND I'M GOING TO BE
LEAVING THE UNIVERSITY AT THIS
TIME.
NOT EVEN MENTIONING THE ONGOING
CONTROVERSY SURROUNDING HIS
SCIENTIFIC MISCONDUCT.
SO WHAT IS THE FALLOUT FROM ALL
THESE CASES OF SCIENTIFIC
MISCONDUCT WE TALKED ABOUT?
AND OTHER CASES?
WELL, CERTAINLY, IT IMPACTS
OTHER SCIENTISTS.
THEY CAN BECOME QUITE UPSET,
BECAUSE THEY HAVE ESEEN THIS
DATA.
THEY TRIED TO REPLICATE THIS
DATA OR TRIED TO UNDERSTAND IT
OR USED THIS DATA TO BASE OTHER
EXPERIMENTS ON.
THIS, WITHOUT TRUTH, WE CAN'T
MOVE FORWARD.
WE HAVE TO HAVE A BASIS FOR
MOVING FORWARD AND THAT STEPPING
STONE, THAT BASIS HAS TO BE
FIRM.
INSTITUTIONAL REPUTATIONS ARE
BAD.
ARE DAMAGED, RATHER.
SO I DON'T THINK THAT PATIENTS
ARE GOING TO BE WANTING TO GO TO
SOUTH AFRICA FOR THEIR
TRANSPLANT.
ENTIRE DISCIPLINES MAY BE
TARNISHED, SUCH AS STEM CELL FOR
SOLID TUMORS.
THERE MAY BE GOOD OPPORTUNITIES
IN THE FUTURE, AND THERE MAY BE
OTHER WAYS TO DO THIS.
BUT IT MAY BE THAT A WHOLE
GENERATION OF ACADEMIES WILL SAY
THAT DOESN'T WORK -- ACADEMICS
WILL SAY THAT DOESN'T WORK.
THAT'S TAINTED NOW.
PERHAPS EVEN MORE FORMALLY, IN
WIDER -- FORMALLY, IN THE WIDER
AUDIENCE, PATIENTS AND FAMILIES
LOOK TO US TO BRING TRUTH ABOUT
SCIENCE AND ABOUT WHAT'S GOING
ON, ESPECIALLY IN THE MEDICAL
SCIENCES, WHEN WE'RE IMPACTING
DIRECT LAY THEIR CARE.
AND THEY WANT TO KNOW WHY THE
PROMISING RESULTS THAT THEY
HEARD A FEW YEARS AGO NO LONGER
ARE VALID.
AND SO THEY MAY LOSE THEIR TRUST
IN RESEARCH, AND IN WHAT WE ARE
DOING.
CERTAINLY, THE PUBLIC RELIES ON
OUR TRUST, AND IT COULD
UNDERMINE THE SCIENCE IN
GENERAL.
SO HOW IS RESEARCH MISCONDUCT
HANDLED AT THE NIH?
WELL, CERTAINLY, HERE WE HAVE
THE NIH AGENCY INTRAMURAL
RESEARCH INTEGRITY OFFICER, OR
RIO.
AND IF YOU HAVE A ALLEGATION OF
SCIENTIFIC MISCOP DUCT,
TYPICALLY WHAT YOU WOULD DO IS
GO TO YOUR SUPERVISOR.
THAT WOULD GO UP THE CHAIN OF
COMMAND AND MAKE IT -- IF THERE
IS SOMETHING POTENTIALLY GOING
ON, MAKE IT TO THIS OFFICE.
WHAT THEY DO FIRST IS AN
ASSESSMENT TO DETERMINE IF THE
ALLEGATION MEETS THE DEFINITION
OF SCIENTIFIC MISCONDUCT.
AND THEN THEY FORM AN INQUIRY
COMMITTEE.
THE INQUIRY COMMITTEE GOES AND
ACTUALLY LOOKS AT THE EVIDENCE,
AND THEY COME UP WITH A
PRELIMINARY DECISION OF WHETHER
OR NOT A FULL INVESTIGATION IS
NEEDED.
SO THE INQUIRY IS JUST TO GET
ALL THE DATA TOGETHER TO SAY
YES, IT LOOKS LIKE WE NEED TO
LOOK INTO THIS IN MORE DETAIL,
OR NO, ACTUALLY, THIS IS -- THIS
CAN BE EASILY ANSWERED.
THIS WAS JUST SLOPPY DATA
CAPTURE OR SOMETHING LIKE THAT.
IF AN INVESTIGATION IS
WARRANTED, THE INVESTIGATION
COMMITTEE WILL DETERMINE IF
SCIENTIFIC MISCONDUCT HAS
OCCURRED.
THEN THE NIH AGENCY RESEARCH
INTEGRITY LIAISON OFFICER
CONCURS AND CAN IMPOSE SANCTIONS
ON THAT INDIVIDUAL.
SO WHY WOULD SOMEBODY MANIPULATE
DATA?
THESE ARE JUST A FEW POINTS,
SOMETIMES THEY JUST WANT TO MAKE
THEIR OWN DATA LOOK MORE
CONVINCING.
SOMETIMES THEY WANT TO GET
SOMETHING THAT CAN SUPPORT THEIR
SPECIFIC HYPOTHESIS.
SO SOME PEOPLE WILL SAY, WELL,
OBVIOUSLY THIS HAS TO BE WHAT'S
GOING ON.
SO I DON'T REALLY HAVE TIME TO
DO THE EXPERIMENT BUT I'M JUST
GOING TO THROW UP A COUPLE OF
NUMBER ON A GRAPH, MAKE IT LOOK
GOOD, AND SAY YOU KNOW, THIS IS
WHAT'S GOING ON HERE.
NOT GOOD, NOT OKAY.
SO THEY NEED AN EXPERIMENT TO
FINISH THE MANUSCRIPT.
THEY RUN OUT OFF OF TIME.
WE'RE BEHIND, THERE IS ANOTHER
LAB WITHOUT TO PUB LISH.
WE THROW IN THIS DATA HERE, YOU
KNOW, I'M SURE THIS IS HOW IT
WILL TURN OUT.
WE'LL DO THE ACTUAL EXPERIMENT,
FLOP IT WHEN THE PAPER COMES FOR
REVIEW, WE CAN SAY OH, WELL, WE
GOT ANOTHER SET OF DATA AND IT
LOOKS BETTER.
AGAIN, IF YOU SUBMIT IT, IT'S
ALREADY THERE.
IF YOU WRITE IT IN YOUR LAB
BOOK, IT'S ALREADY -- YOU'VE
ALREADY COMMITTED POTENTIALLY
SCIENTIFIC MISCONDUCT.
OR YOU'RE RUNNING OUT OF TIME.
YOU DIDN'T PLAN AHEAD.
OH, GOT TO GIVE A TALK THE NEXT
DAY.
LET ME JUST THROW SOMETHING
TOGETHER HERE, AND, YOU KNOW, IF
IT'S NOT TRUE I JUST WON'T USE
IT IN MY NEXT TALK.
WELL, THAT'S NOT -- THAT'S NOT
OKAY TO DO.
WE HAVE TO BE CLEAR OPWHAT IS
TRUTH AND WHAT IS NOT.
WE SHOULDN'T BE REPORTING OR
SHOWING DATA THAT IS NOT TRUE.
SO REMEMBER, THOSE WHO ARE
CAUGHT MANIPULATELING DATA COULD
BE BARRED BARRED FROM LIFE FROM
EVER
RECEIVING FINANCIAL SUPPORT FOR
RESEARCH, OR EVEN BE SENTENCED
TO JAIL.
THIS IS ANOTHER CASE.
-WE TALK ABOUT PLAGIARISM.
THIS IS ANOTHER CASE THAT WAS
JUST REPORTED LAST YEAR WHERE
THIS O'NEILL POTTY AT DUKE HAD
DONE A LOT OF DIFFERENT DATA
WITH GENETIC ANALYSIS, TRYING TO
COME UP WITH PERMANENTIZED
TESTING.
THIS WAS GOING TO BE THE WAVE OF
THE FUTURE, HOW HE COULD FIGURE
OUT FROM GENETIC TESTING WHO WAS
GOING TO BE RESPONDING TO
DIFFERENT AGENTS.
MADE BIG PROGRESS, GOT A LOT OF
BIG GRANTS.
AND TURNS OUT THAT MUCH OF THE
STATISTICAL ASSUMPTIONS HE WAS
MAKING WERE ACTUALLY NOT GOOD.
THEY WERE MISREPRESENTING THE
FACTS.
THIS LED TO AT LEAST TEN PAPERS
BEING RETRACTED.
 RETRACTED.
DUKE UNIVERSITY HAD TO GIVE BACK
TO THE AMERICAN CARP SOCIETY
OVER 700 MILLION -- CANCER
SOCIETY, OVER $700,000 IN GRANTS
THAT HAD COME IN AS A RESULT OF
DR. POTTY'S RESEARCH.
AND HE HAD TO LEAVE DUKE.
ALL RIGHT.
LET'S TALK A LITTLE BIT ABOUT
PLAGIARISM.
WE'VE TALKED MOSTLY ABOUT
FABRICATION AND FALSIFICATION UP
UNTIL NOW.
PLAGIARISM IS A LITTLE BIT
SEPARATE AND PROBABLY YOU THINK
A LITTLE BIT MORE STRAIGHT
FORWARD.
REALLY, IT'S THE APPRECIATION OF
ANOTHER PERSON'S IDEAS,
PROCESSES, RESULTS OR WORDS
WITHOUT GIVING THE APPROPRIATE
CREDIT.
YOU CAN SEE HERE, SHE'S WRITING
SOMETHING HERE AND IT'S COPYING
IT OVER HERE.
THAT'S NOT REALLY GOOD TO DO.
AND HE'S COPYING HER ALSO.
SO THERE IS DUPLICATION,
COSUBMISSION AND PLAGIARISM, 3
SEPARATE GROUPS THAT ARE
OFTEN -- WORDS THAT ARE OFTEN
PUT UNDER PLAGIARISM.
SO WHAT IS DUPLICATION?
THIS IS ACTUALLY POTENTIALLY
LEGITIMATE.
SO YOU CAN GIVE CLINICAL TRIAL
UPDATES, SO YOU MAY REPORT ON
THE FIRST 14 PATIENTS.
YOU MAY REPORT OF THE TRIAL,
SOME SAFETY DATA, AND THEN AFTER
YOU'VE ENROLLED ALL THE PATIENTS
ON THE TRIAL, THEN YOU SUBMIT A
PAPER AND IT HAS 28 PATIENTS,
AND NOW YOU HAVE ALL THE SAFETY
DATA FOR THE WHOLE TRIAL.
THERE IS SOME DUPLICATION, YOU
DID INITIALLY REPORT THE FIRST
14 PATIENTS, BUT THIS IS NOT
CONSIDERED PLAGIARISM.
MEETING PROCEEDINGS.
SOMETIMESYOU CAN HAVE THINGS
THAT ARE IN ABSTRACT FORM IN A
MEETING.
AND THEN YOU CAN LATER PUBLISH
THEM IN THE FULL MANUSCRIPT AT A
LATER TIME, AGAIN, THAT COULD BE
DUPLICATION BUT IT'S NOT
PLAGIARISM.
ERR ATTA, SOMETIMES YOU HAVE A
TABLE THAT MAYBE SOMETHING GOT
TRANSPOSED OR YOU FIND AND ERROR
LATER.
YOU SEND BACK IN THE FULL TABLE
WITH THE FIXED NUMBERS, THE
NUMBERS THAT WERE TRANSPOSED OR
WHATEVER, AGAIN, SOME OF THOSE
NUMBERS IN THERE ARE DUPLICATED,
BUT AS LONG AS YOU HAVE THE LINK
TO THE RIGHT ARTICLE, THAT IS
NOT PLAGIARISM.
THAT IS PLOP CAN CATION.
PERFECTLY -- DUPLICATION.
PERFECTLY FINE.
ILLEGITIMATE, IF YOU DUPLICATE
AND IT'S PLAGIARISM OR
CO-SUBMISSION.
SO THERE IS -- IN CO-SUBMISSION,
BASICALLY JUST SUBMITTING THE
SAME THING TO TWO DIFFERENT
JOURNALS AND THEY BOTH GET
PUBLISHED.
YOU REALLY SHOULD ONLY SUBMIT A
MANUSCRIPT TO ONE JOURNAL, AND
THEN IF IT'S REJECTED, THEN
SUBMIT IT TO ANOTHER JOURNAL.
SO THERE ARE MULTIPLE PLAGIARISM
DETECTION METHODS.
I'M NOT GOING THROUGH THEM IN
DETAIL BUT THESE METHODS ARE
USED BY ALL OF THE JOURNALS NOW,
AND THEY WILL OFTEN -- I REVIEW
FOR MULTIPLE DIFFERENT JOURNALS.
THEY WILL OFTEN SEND ME, ADD
EDITOR IN SOME OF THE JOURNALS I
EDIT, THEY'LL SEND ME A PAPER
AND SAYTH HAS A 24% SIMILARITY
WITH ANOTHER ARTICLE.
I'LL LOOK THROUGH IT AND SAY
DOES THIS MEET PLAGIARISM OR
NOT.
SOMETIMES IT'S JUST THE METHOD
SECTION VERY SIMILAR TO ANOTHER
METHOD SECTION, OR WORDS THAT
ARE, YOU KNOW, SHORT PHRASES
THAT ARE USED.
IF IT'S AN ENTIRE PARAGRAPH
THAT'S USED, THEN IT RISES TO
PLAGIARISM.
SO THERE ARE PLAGIARISM TOOLS.
THIS IS ON THE OI WEBSITE.
YOU CAN SEE ORI.HHS.GOV.
PLAGIARISM TOOLS.
YOU CAN GO ON TO THIS WEBSITE
AND YOU CAN LOOK DEJA VU IS ONE
OF THESE.
INCLUDES A DATABASE OF OVER
70,000 PEARS OF CITATION --
PAIRS OF CITATION AND NOTES. 
THIS IS A COMMON WAY OF
CHECKING, IS THERE KNEEING
THAT'S TAKEN IN THIS MANUSCRIPT
THAT COULD BE POTENTIALLY
PLAGIARISM, ESPECIALLY IF YOU
HAVE COAUTHORS.
YOU'RE NOT SURE, HOW DID THIS
POST-DOC DO THIS PHENOMENAL JOB
HERE, OR DID HE GET IT FROM
SOMEWHERE ELSE.
SO AGAIN, HAVE IS DEJA VU, I
MENTIONED IN THE PREVIOUS SLIDE.
AND YOU CAN SEE A WEBSITE HERE,
HOW TO GET TO IT.
SO HERE IS A INTERESTING GRAPH
THAT WAS PUBLISHED IN NATURE
SEVERAL YEARS AGO.
AND YOU CAN SEE HERE, OVER TIME,
THE CITATIONS TO MED LINE, YOU
CAN SEE RISING UP TO 600,000
CITATIONS HERE.
AND THEN THE NUMBER OF
DUPLICATES PER THOUSAND
CITATIONS.
THAT'S ON THIS AXIS.
SO IT STARTS OUT AT TWO
DUPLICATES PER THOUSAND
CITATIONS.
YOU CAN SEE HERE, IT STARTS TO
MAYBE GO UP, MAYBE THAT'S
BECAUSE WE'RE BETTER IN ANDATING
AND FINDING THESE.
BUT IT'S SOMETHING THAT THERE
CERTAINLY A NUMBER OF -- A
FINITE NUMBER OF CASES OF THIS,
AND IT'S SOMETHING THAT CAN BE
EASILY TRACKED NOW A LOT BETTER
THAN PREVIOUSLY.
YOU MIGHT SAY WE TALKED ABOUT
ALLTH FABRICATION, A LOT GOING
ON IN ARABIA, SOUTH AFRICA. --
ASIA, SOUTH AFRICA.
BUT IT TURNS OUT IF YOU LOOK,
THE SUSPECTED DUPLICATES AND THE
RELATIVE CONTRIBUTION TO MED
LINE, THERE IS REALLY NO
DIFFERENCE WHEN YOU'RE -- BASED
ON WHERE YOU COME FROM.
STILL, MOST OF THE DATA THAT
GETS PUBLISHED IN MED LINE COMES
FROM THE U.S.
AND MOST OF THE SUSPECTED
DUPLICATES COME FROM THE U.S.
OKAY.
GOING TO HAVE A FEW QUESTIONS
HERE.
SOME OF THESE ARE -- THEY'RE
VERY EASY, SOME OF THEM COULD BE
GROUNDS FOUR MORE DEBATE.
I'M GOING TO ASK A SERIES OF
QUESTIONS THAT GO OVER IF
AUTHORSHIP IS APPROPRIATE.
SO -- I'M GOING TO ASK FOR YOU
TO ANSWER.
IS AUTHORSHIP APPROPRIATE IF YOU
WROTE THE PAPER?
SURPRISINGLY EASY, RIGHT?
YES.
HOW ABOUT IF YOU DREW THE
CELL -- GREW THE CELLS USED
PUBLISHED IN THE PAPER?
I SEE SOMEBODY SAYING NO.
ANYONE WANT TO COUNTER?
OKAY.
LET'S SEE.
YES, IF YOU JUST GIVE THE
CELLS -- PROBABLY DOESN'T RISE
TO THAT LEVEL OF AUTHORSHIP
UNLESS YOU MADE AN INTELLECTUAL
CONTRIBUTION TO THIS STUDY.
PROBABLY NOT GOING TO GET YOU ON
THE PAPER, IF THAT'S ALL YOU
DID.
HOW ABOUT IF YOU PERFORMED HALF
THE EXPERIMENTS IN THE STUDY?
YES, OKAY.
I HEARD A YES.
THANK YOU.
SO IF YOU PERFORMED, OBVIOUSLY
THEN YOU SHOULD GET IT.
HOW ABOUT IF YOU IDENTIFIED AND
ORDERED THE COMMERCIAL SUPPLIES
IN THIS PROJECT?
>> [INAUDIBLE]
>> RIGHT, EXACTLY, NO.
THAT DOES NOT RISE TO
AUTHORSHIP.
OKAY.
HOW ABOUT THIS?
WHAT IF YOUR GIRLFRIEND WORK
OWNED THE PROJECT?
YEAH, OKAY.
YOU GUYS THINK THAT'S CRAZY,
TOO.
NO.
SO HOW ABOUT IF IT'S YOUR BOSS?
AND HE DIDN'T WORK ON THE
PROJECT SH HOW ABOUT IF IT'S
YOUR BRANCH CHIEF ON LAB CHIEF?
IF THEY DIDN'T WORK ON THE
PROJECT, IF THEY DIDN'T PROVIDE
ANY INTELLECTUAL CONTRIBUTION TO
THE PROJECT, THEN NO, THEY
SHOULD NOT BE LISTED ON THERE.
HOW ABOUT IF YOU THOUGHT UP THE
IDEA FOR A PROJECT?
I THINK THIS MIGHT BE A GOOD
PROJECT.
SOMEBODY ELSE TAKES IT AND RUNS
WITH IT.
WHAT DO YOU THINK ABOUT THAT?
SPEAK UP.
>> [INAUDIBLE]
>> RESPONSE WAS IF YOU JUST HAD
AN IDEA AND DIDN'T DO ANYTHING
ABOUT IT, YOU SHOULDN'T BE AN
AUTHOR.
I SEE YOU HAVE A DIFFERING
OPINION?
>> [INAUDIBLE]
>> SO GREAT.
SO YES.
IF -- SO THIS IS PROBABLY A
DIFFICULT QUESTION.
IF YOU CAN CONCEIVE THE BASIC
HYPOTHESIS, MAYBE YOU SHOULD GET
CREDIT, BUT ESPECIALLY IF YOU
WORKED WITH THEM TO HELP DEVELOP
THE TRIAL DESIGN.
IF YOU JUST CASUALLY MENTIONED
IT TO SOMEBODY KIND OF WALKING
DOWN THE HALLWAY, SAID WOULDN'T
IT BE COOL IF WE DID THIS, AND
THEY TOOK IT AND RAN WITH IT AND
YOU DIDN'T HAVE ANY OTHER
CONTRIBUTION, THEN MANY NOT.
BUT IF IT WAS IN YOUR AREA AND
THEY CAME BACK TO YOU AND THEY
SAID, YOU KNOW, SHOULD WE DO
THIS, SHOULD WOE DO THAT, MAYBE
SO.
SO AGAIN, SOME OF THESE THINGS
ARE SITUATIONAL.
SOME OF THESE, YOU'LL KNOW IT
WHEN YOU SEE IT.
REMEMBER, AUTHORSHIP IS A
PRIVILEGE, NOT A RIGHT.
YOU MUST HAVE MADE A MEANINGFUL
CONTRIBUTION TO AMAN USCRIPT TO
EARN IT.
AND I WOULD SAY IF IN DOUBT, AT
A BEGINNING OF A PROJECT, YOU'RE
WORKING ON A PROJECT AND YOU
THINK YOU SHOULD BE AN AUTHOR,
SIT DOWN AND TALK WITH OTHERS
INVOLVED.
SAY LISTEN, WHAT ABOUT THE
AUTHORSHIP HERE?
COULD I BE PART OF THE
AUTHORSHIP BECAUSE I THINK THAT
I WANT TO DO THIS, I WANT TO
MAKE THIS CONTRIBUTION.
AND YOU KNOW, IF IT'S A CLINICAL
TRIAL, SOMETIMES JUST SENDING IN
PATIENTS FOR A CLINICAL TRIAL
HAY NOT BE ENOUGH TO WARRANT
AUTHORSHIP ON A STUDY.
MAYBE IF YOU'RE THERE, AND
YOU'RE SEEING THE PATIENTS, AND
YOU'RE MAKING TREATMENT
DECISIONS AND YOU'RE WRITING
THEM DOWN AND YOU'RE HELPING
CRAFT THEMAN USCRIPT, OBVIOUSLY
THAT DOES -- MAYBE JUST SEEING
THE PATIENTS OR JUST
ADMINISTERING THE DRUG AND
FOLLOWING A PROTOCOL, MAYBE THAT
DOESN'T.
SO YOU SHOULD DISCUSS THESE
THINGS BEFORE HAPPENED BECAUSE
IT'S A LOT BETTER TO FIGURE THIS
OUT UP FRONT.
SO FOLLOWING BY THEMSELVES ARE
NOT CRITERIA FOR AUTHORSHIP.
AS WE MENTIONED, HOLDING A
POSITION OF ADMINISTRATIVE
LEADERSHIP, THE BRANCH CHIEF,
THE LAB CHIEF.
JUST BECAUSE THEY'RE THE BRANCH
CHIEF OR LAB CHIEF DOESN'T MEAN
THEY SHOULD BE ON THE PAPER.
CONTRIBUTING PATIENTS OR
REAGENTS, WE KIND OF TALKED
ABOUT THAT ALSO.
AND COLLECTING AND ASSEMBLING
DATA.
JUST BECAUSE YOU'RE GOING
THROUGH THE PROCESS OF GETTING
THE DATA, PUTTING IT INTO A
SPREADSHEET FOR SOMEBODY ELSE TO
INTERPRET, THAT DOESN'T MEAN YOU
MADE A CONTRIBUTION.
IF YOU'RE THE ONE INTERPRETING
THE DATA AND COMING UP WITH OH,
MAYBE THIS CORRELATES WITH THAT,
MAYBE THAT DOES -- MAYBE THAT
TURNS INTO A TABLE OR A FIGURE
IN THE PAPER, MAYBE THAT DOESN'T
WARRANT AUTHORSHIP.
SO AS I MENTIONED BEFORE, THE
BEST TIME TO ADDRESS THE
AUTHORSHIP IS AT THE BEGINNING
OF A PROJECT, NOT AT THE END.
IF YOU'RE AT THE END OF A
PROJECT AND THERE IS A DISPUTE,
MOST OF THE TIME YOU CAN DISCUSS
WITH THE OTHER PEOPLE AND CAN
COME UP WITH AGREEMENT OVER WHO
SHOULD BE ON A PAPER.
BUT MOST COMMON TYPES OF
AUTHORSHIPS DISPUTES THAT I HAVE
SEEN HAVE BEEN ABOUT WHO SHOULD
AND SHOULDN'T BE ON THE PAPER,
BUT EVEN MORE COMMON THAN THAT,
WHO SHOULD BE THE FIRST AUTHOR
AND WHO SHOULD BE THE SENIOR
AUTHOR.
THOSE ARE THE MORE COMMON TYPES
OF DISPUTES THAT YOU GET.
BESIDES DIRECT DIALOGUE WITH THE
MEMBERS WHICH PROBABLY 85% OF
THE TIME WORKS, IF THAT DOESN'T
WORK, THEN YOU CAN GO FOR
IMMEDIATUATION.
THERE IS AN NIH --
IMMEDIATUATION.
THERE IS AN NIH OMBUDSMAN THAT
CAN HELP MEETIATE THESE TYPES OF
DISPUTES.
GET THEM TO UNDERSTAND AND BE
REASONABLE WITH EACH OTHER.
IF YOU STILL CAN'T GET TO THE
BOTTOM OF IT, THEN YOU CAN GO TO
THIS PEER PANEL WHICH IS
BASICALLY A VOLUNTARY 3 OR 5
MEMBER PANEL, HAS TO BE AN ODD
NUMBER SO YOU CAN'T HAVE A TIE.
MEMBERS THAT HAVE EXPERTISE IN
THE AREA THAT IS UNDER
CONSIDERATION.
AND THEN HAVE A BINDING
DECISION.
THEY MIGHT DECIDE AGAINST YOU OR
FOR YOU, BUT THEN THAT'S IT.
OR YOU CAN GO DIRECT LAY TO THE
SCIENTIFIC DIRECTOR, IF IT'S --
IF ALL THE AUTHORS WITHIN ONE
INSTITUTE, OR YOU CAN GO TO THE
DEPUTY DIRECTOR OF THE
INTRAMURAL RESEARCH PROGRAM, IF
THEY ARE IN DIFFERENT INSTITUTES
FOR A BINDING DECISION THERE.
YOU DON'T -- YOU WANT TO START
OFF WITH A TOP AND THEN WORK
YOUR WAY DOWN BECAUSE YOU DON'T
WANT TO GO TO THE ATOMIC -- YOU
DON'T WANT TO PUSH THAT BOTTOM
TOO MANY TIMES.
OTHERWISE THEY'RE GOING TO SAY
WHAT GOES ON WITH THIS PERSON.
THIS MAY BE A PROBLEM PERSON.
OKAY.
LAST LITTLE BIT HERE.
WE'RE GOING BACK THROUGH ABOUT
THE FABRICATION AND
FALSIFICATION.
AND WE'RE GOING TO ASSIGN WHICH
OF THESE CASES THAT WE TALKED
ABOUT WERE FABRICATION AND WHICH
WERE FALSIFICATION.
SO FIRST OF ALL, THIS SOUTH
KOREAN RESEARCHER WHO HAD THE
CLONING OF THE STEM CELLS, WAS
THAT FABRICATION OR
FALSIFICATION?
FALSIFICATION?
YOU SAY?
OR FABRICATION.
>> [INAUDIBLE]
>> FABRICATION, YES.
ANYBODY ELSE?
BOTH.
SO YES, SO FABRICATION, 9 OUT OF
11 CELL RHINES WERE
ABSOLUTELY -- CELL LINES WERE
JUST ABSOLUTELY FAB BRIICATED.
THERE WAS MANIPULATION.
SO THAT'S FALSIFICATION, TOO.
HOW ABOUT THE BREAST TRANSPLANT,
BEZWODA?
THE BONE MARROW TRANSPLANT IN
THE BREAST CANCER PATIENTS?
FALSIFICATION, FABRICATION,
BOTH?
>> [INAUDIBLE].
>> FALSIFICATION FOR SURE.
I HEARD FABRICATION.
LET'S GO WITH BOTH.
YES.
SO HE MADE UP PATIENTS, AT LEAST
PART OF HIS FABRICATION.
ANDITATEED THAT HE HAD
CONSENT -- STATED HE HAD CONSENT
TORE ALL THE PATIENTS WHEN THEY
COULDN'T FIND CONSENT FORMS FOR
ANYBODY.
THERE WAS NOT EVEN A CONSENT
THAT HAD BEEN REVIEWED BY THE
IRB.
OKAY.
HOW ABOUT WAKEFIELD AND THE
MEASLES VACCINE?
FABRICS OR FALSIFICATION OR
BOTH?
>> [INAUDIBLE]
>> FALSIFICATION?
YEAH.
[INAUDIBLE]
>> FABRICATION, YES, NO?
SO HE ACTUALLY MADE UP THE
COLITIS ON THESE PATIENTS, AS
YOU SAW.
NO ONE HAD COLITIS THAT COULD BE
DOCUMENTED.
AND THE DATE OF REACTION WAS
FALSIFICATION, SO HE -- SOME OF
THE ONES HE SAID HAPPENED
AFTERWARDS, THEY ACTUALLY
HAPPENED BEFORE THEY GOT THE
MMR.
SO THEY COULDN'T BE DUE TO THE
MMR.
POLEMAN IN HIS LONGITUDINAL
STUDIES.
FABRICATION, FALSIFICATION?
YOU'RE SEEING A TREND HERE,
AREN'T YOU?
>> [INAUDIBLE]
>> YES.
SO HE MADE UP PATIENTS
COMPLETELY MADE UP THE DATA FOR
THOSE PATIENTS AND DESTROYED
DATA.
FALSIFICATION, REMEMBER,
FALSIFICATION IS CHANGING THE
DATA IN ANY WAY, INCLUDING
DESTRUCTION OF DATA.
YOU SHOULDN'T BE DESTROYING DATA
IF YOU'RE DESTROYING IT TO COVER
YOUR TRACKS.
THAT'S ACTUALLY FALSIFICATION.
AND HAUSER IN HIS MONKEY
STUDIES.
FALSIFICATION?
AND?
AND FABRICATION?
YES, ABSOLUTELY.
SO HE ACTUAL FABRICATED THE
SOUND THE MONKEYS HEARD AND
FALSIFIED THE MOPINGY RESPONSES.
 MONKEY RESPONSES.
SO IN SUMMARY, REALLY, WHAT I
WANTED TO SHARE WITH YOU IS THAT
THE ETHICAL CONDUCT OF SCIENCE
IS EACH OF OUR PERSONAL
RESPONSIBILITY.
THAT WE MUST NOT COMMIT
FALSIFICATION OR FABRICATION OF
DATA OR PLAGIARIZE THE WORK OF
OTHERS.
AND PERFORMING SCIENTIFIC
RESEARCH AS A CAREER IS A
PRIVILEGE.
BY PERFORMING IT IN A ETHICAL
MANNER YOU WILL MAINTAIN THE
HIGHEST STANDARDS OF SCIENTIFIC
INTEGRITY.
THANK YOU AND I'D BE HAPPY TO
ANSWER ANY QUESTIONS YOU MIGHT
HAVE.
ANY QUESTIONS?
YES.
>> [INAUDIBLE]
>> GIVE ME AN EXAMPLE OF WHAT
YOU'RE THINKING ABOUT.
SO ABOUT IDEAS OR ACTUAL -- THE
EXACT WORDING OF SOMEBODY ELSE?
>>
>> [INAUDIBLE]
>> GENERAL KNOWLEDGE THAT HAS
BEEN OUT THERE FOR A LONG TIME,
TYPICALLY, THIS IS NOT -- IF
IT'S -- IF IT CAN BE SEEN IN
MULTIPLE DIFFERENT SOURCES,
TYPICALLY THIS IS NOT SOMETHING
AT A YOU HAVE TO ATTRIBUTE.
IF THERE IS ONLY ONE OR TWO
REPORTS OF THIS PREVIOUSLY, YOU
SHOULD REFERENCE THAT IN YOUR --
YOUR BACKGROUND SECTION.
YOU HAVE -- YOU SHARE THAT IDEA
AND THEN YOU REFERENCE WHERE
THAT IDEA CAME FROM.
THAT IS THE BEST WAY TO DO THAT.
HOWEVER, IF YOU -- IF YOU -- I
THINK AN IDEA WOULD BE IF YOU
CAME IN WITH AN IDEA THAT
SOMEBODY ELSE HAD PREVIOUSLY
COME UP WITH, AND YOU DIDN'T
WANT TO GIVE THAT PERSON CREDIT
FOR THAT IDEA, AND YOU MADE IT
SEEM LIKE IT WAS YOUR OWN IDEA,
THEN I THINK THAT WOULD BE A
POTENTIALLY PLAGIARISM.
SO I THINK IN GENERAL, YOU TRY
AND GENEROUS WHEN YOU'RE GOING
THROUGH YOUR BACKGROUND.
IF SOMETHING CAME UP AS A
RESULT, IF YOU'RE WRITING THIS
DOWN, IF YOU CAME UP WITH THIS
AS A RESULT OF YOUR SEARCH OF
THE LITERATURE, I WOULD JUST
REFERENCE THOSE -- THE KEY
SOURCES WHERE THAT CAME FROM.
OTHER QUESTIONS?
OKAY.
THANK YOU VERY MUCH.
[APPLAUSE]
