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8/18/2019 Conflicts of Interest4006
http://slidepdf.com/reader/full/conflicts-of-interest4006 1/31
Conflicts of InterestJames G. Anderson, Ph.D.
Department of Sociology &
Anthropology
8/18/2019 Conflicts of Interest4006
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Questions What situations represent a Professional Conflict of
Interest
!o" e#tensi$e are conflicts of interest
What challenges do they pose for the traditionalphysician commitment to act on %ehalf of the patient
What has %een the medical professions response
!o" do professional groups deal "ith this pro%lem
What steps should the medical profession ta'e tocope "ith conflicts of interest
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DefinitionConflict of interest refers to any situation in"hich an indi$idual "ith responsi%ilities to
others (including professionalresponsi%ilities) might %e, consciously orunconsciously influenced %y financial, or
other factors that in$ol$e self interest (JA*A,+-)
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The Problem
Current practices pro$ide doctors "ith financialincenti$es that may conflict "ith patient interests
Doctors financial "ell%eing are tied to medical care
pro$iders, suppliers, pharmaceutical companies, thirdparty payers
/hese arrangements may predispose physicians topro$ide too many or too fe" ser$ices or to ma'e
inappropriate referrals Patients may recei$e poor 0uality care or %e harmed
Patients and society pay for "asteful ser$ices
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Types of Conflicts of Interest
Conflicts %et"een the physicians interest(usually financial) and the patients interest
Conflicts that di$ide a physicians loyalty%et"een a patient and a thirdparty
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The Changing Context of Medicine *onetari1ation of medicine
/hirdparty payment
Increased supply of physicians2hospital %eds
Changes in hospital payment
/echnology
3oss of physician autonomy
/he federal go$ernment
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Incentives to Increase Services 4eeforser$ice practice
5ic'%ac's for referrals
Selfreferral to medical facilities in "hich the
physician in$ests Income from dispensing drugs, medical products,
ancillary ser$ices
!ospital purchase of physician practices
Payments made %y hospitals to recruit and %ondphysicians
Gifts to physicians %y medical suppliers
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Audiologists
6ecei$e commissions2gifts from hearing aidmanufacturers
Dispense hearing aids
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Physicians
Physicians recei$ing 'ic'%ac's forprescri%ing drugs.
Physicians dispensing drugs2products Physicians referring patients to a hospital
that pro$ides them "ith office space,
directorships, etc. Physician7"ned !ospitals2clinics2ancillaryser$ices
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Dentists
8isits to 9: dentists in ;< states and DC
=#amination plus + cro"n cost >9::
Dentists as' "hat "ere his insurance limits =stimates range from >-?:2+ cro"n to
>;,<9:2;+ cro"ns
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ptometrists
Accept fees, gifts from manufacturers oflens, optical appliances, etc.
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Physicians and Third Parties
Physician referral for ancillary ser$ices in"hich they ha$e a financial interest
@ritish pharmaceutical companies o"nsele$en cancer centers that pro$ide care.
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Columbia!"CA
6e"ards to *Ds for referring patients
Purchase of physician practices
Discharged hospital patients sent to homehealth care agencies o"ned %y Colum%ia
Staff *Ds pro$ided profit incenti$e to
reduce care
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#inancial!Commercial
$elationships
ni$ersity faculty consultants for :B
%iotechnology companies 9:B of faculty researchers ser$e as
consultants for %iotechnology companies
Physicians ha$e a financial sta'e in ;9<:B of ancillary medical facilities
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Incentives to Decrease Services
!*7 financial incenti$es
Control of access to physicians
Gate'eepers *anagement of care %y physicians
Payment incenti$es
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Physician Incentives in "MsPercentage of Payment %ithheld from primaryCare Physicians
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Surpluses in the $e&ard for
Specialist $eferral #und
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ther #inancial Penalties for
Primary Care Physicians Increases in the B payment "ithheld the follo"ing
year
3iens on future earnings
Decreases in the amount of capitation paymentthe follo"ing year
=#clusion from the program
6eductions in distri%utions from fund surpluses 6e0uire physician to pay amount of deficit
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%hat Can 'e Done(
Disclosure
Informed consent
6egulation Consumer protection la"s
Professional groups
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)imitations of the Medical
Profession A*A guidelines are $oluntary
/odays principals contain no statement regardingmost conflicts of interest
Antitrust la"s pre$ent the A*A from restrictingad$ertising and many commercial practices
/he A*A has no procedures for monitoring
compliance =nforcement is left to state medical societies and
professional licensing %oards
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)arge Companies * +xpress Scripts
=nriched itself at the e#pense of the =mpire Plan and its mem%ers%y inflating the cost of generic drugsE Di$erted to itself millions of dollars in manufacturer re%ates that%elonged to the =mpire PlanE =ngaged in fraud and deception to induce physicians to s"itch a
patients prescription from one prescri%ed drug to another for "hich=#press Scripts recei$ed money from the second drugsmanufacturerE Sold and licensed data %elonging to the =mpire Plan to drugmanufacturers, data collection ser$ices and others "ithout thepermission of the =mpire Plan and in $iolation of the States
contractE Induced the State to enter into the contract %y misrepresenting thediscounts the =mpire Plan "as recei$ing for drugs purchased atretail pharmacies.
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#DA
*ore than half of the e#perts hired to ad$ise thego$ernment on the safety and effecti$eness ofmedicine ha$e financial relationships "ith the
pharmaceutical companies that "ill %e helped orhurt %y their decisions, a SA /7DAF studyfound.
/hese e#perts are hired to ad$ise the 4ood andDrug Administration on "hich medicines should
%e appro$ed for sale, "hat the "arning la%elsshould say and ho" studies of drugs should %edesigned.
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#DA
A SA /7DAF analysis of financial conflicts at +9 4DAad$isory committee meetings from Jan. +, +<, through lastJune : foundH
At ;B of the meetings, at least one mem%er had a financial
conflict of interest. At 99B of meetings, half or more of the 4DA ad$isers had
conflicts of interest. Conflicts "ere most fre0uent at the 9 meetings "hen
%roader issues "ere discussedH ;B of mem%ers hadconflicts.
At the +:; meetings dealing "ith the fate of a specific drug,B of the e#perts had a financial conflict.
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,ournals
3arge medical ournals such as those put out %ythe A*A and the Ke" =ngland Journal ofmedicine admit that conflicts of interest ha$e
inflated findings pu%lished in medical ournals. /he Journal of /horacic and Cardio$ascular
Surgery has threatened to %ar authors and theirinstitutions "ho do not disclose conflicts ofinterest from pu%lishing in the ournal for someperiod of time.
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Drug Company Sponsorship ofClinical Trials 7ne study compiled pre$iously pu%lished clinical trials to conclude
that patients could %oth de$elop a tolerance for %etaagonists and%e at increased ris' for asthma attac's, compared "ith those "hodo not use the drug at all. /he second study sho"s that %etaagonist use increases cardiac ris's, such as heart attac's, %y more
than t"ofold, compared "ith the use of a place%o. 4urthermore, the researchers say that their analyses lead them to
suspect a conflict of interest among scientists "ho are supported %ypharmaceutical companies that ma'e %etaagonists, among the"orlds most "idely used drugs. /his conflict, they say, could %eputting +? million .S. asthma sufferers in harms "ay. /heir
statement comes as the American *edical Association is $oicing itsconcerns that drug industry sponsorship of clinical tests is affectingthe 0uality of research.
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-ioxx. Merc/ -s0 #DA *arch ;:::H *erc' re$eals that a ne" study found 8io## patients had dou%le the
rate of serious cardio$ascular pro%lems than those on napro#en, an oldernonsteroidal antiinflammatory drug, or KSAID.
Ko$em%er ;:::H /he Ke" =ngland Journal of *edicine pu%lishes the study, called8IG76.
4e%ruary ;::+H An ad$isory panel recommends the 4DA re0uire a la%el "arning of
the possi%le lin' to cardio$ascular pro%lems. Septem%er ;::+H/he 4DA "arns *erc' to stop misleading doctors a%out 8io##s
effect on the cardio$ascular system. April ;::;H/he 4DA tells *erc' to add information a%out cardio$ascular ris' to
8io##s la%el. Aug. ;9, ;::-H An 4DA researcher presents results of a data%ase analysis of +.-
million patientsE it concludes that 8io## users are more li'ely to suffer a heart attac'
or sudden cardiac death than those ta'ing Cele%re# or an older KSAID. Sept. ;, ;::-H *erc' says it learned this day that patients ta'ing 8io## in a study
"ere t"ice as li'ely to suffer a heart attac' or stro'e as those on place%o. Sept. :, ;::-H*erc' "ithdra"s 8io## from the .S. and the more than <: other
countries in "hich it "as mar'eted.
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Paxil /he manufacturers of antidepressants continue to mar'et their
drugs for children 2 adolescents e$en after a causal relation has%een scientifically esta%lished %et"een antidepressants, such asPa#il 2 Sero#at and suiciderelated %eha$ior. /hey do so %ecause4DA officials continue to drag their feet a%out issuing %lac' %o#
"arnings on antidepressant la%els. =$en after an 4DA ad$isorypanel urged the agency to re0uire %lac' %o# "arnings a%out anincreased suicide ris'on the la%els read %y physicians and on thepac'age la%els read %y consumerstop officials are undecided.
/he KJ Star 3edger o%tained an internal (Septem%er <, ;::)Gla#oSmith5line memo that "as distri%uted to the companys sales
representati$es. /he memo ad$ises them K7/ to discuss thesuiciderelated ris' of Pa#il 2 Sero#at "ith doctors.
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Paxil A ;:: memo cites a discredited pu%lished report in the Journal of
the Academy of Child and Adolescent Psychiatry (;::+, pp. ?;;) that maintained that Pa#il "as Lsafe and effecti$e and "elltolerated.L It "as coauthored %y leading S child psychiatrists.
!o"e$er, its claimed findings are refuted %y a +< internal GS5smemo "hich states that only Lpositi$e data from study ;L "ould%e pu%lished. /he unpu%lished data, the memo stated, "ould not%e pu%lished or su%mitted to the 4DA %ecauseH
LIt "ould %e commercially unaccepta%le to include a statement thatefficacy had not %een demonstrated as this "ould undermine theprofile of paro#etine MPa#ilN.L
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Drugs
Ad$erse prescription drug reactions are the thirdlargest cause of death in the S, topped only %yto%acco and alcohol. According to an article in the
Journal of the American *edical Association, o$er+::,::: hospitali1ed patients died as a result ofan ad$erse drug reaction. /he researchers foundthat o$er 9B of these AD6s "ere dose
dependent, "hich suggests they "ere due to theinherent to#icity of the drugs rather than to allergicreactions.
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#DA %or/ing for the Drug Industry(
What ma'es the issue so contro$ersial is ho" the4DA has dealt "ith an internal de%ate on thematter. Congressional in$estigators ha$e %een
e#amining the agencys decision to %loc' a stafferfrom re$ealing this past 4e%ruary his finding of atie %et"een antidepressants and suicidaltendencies in young people, "hich dre" on many
of the same trials. 4DA officials said hisconclusion "as premature, and %ased onam%iguous data.
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#DA %or/ing for the Drug Industry(
Instead of protecting the pu%lic health, 4DAofficials ha$e aggressi$ely and improperly
in$o'ed 4DAs preempti$e authority %yinter$ening in court cases to shield drugmanufacturers "ho "ere challenged a%outtheir failure to include "arnings on drug
la%els.