conflicts of interest4006

8/18/2019 Conflicts of Interest4006

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Conflicts of InterestJames G. Anderson, Ph.D.

Department of Sociology &

Anthropology



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



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,+-)



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



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



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



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



Audiologists

6ecei$e commissions2gifts from hearing aidmanufacturers

Dispense hearing aids



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



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



ptometrists

Accept fees, gifts from manufacturers oflens, optical appliances, etc.



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.



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



#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



Incentives to Decrease Services

!*7 financial incenti$es

Control of access to physicians

Gate'eepers *anagement of care %y physicians

Payment incenti$es



Physician Incentives in "MsPercentage of Payment %ithheld from primaryCare Physicians



Surpluses in the $e&ard for

Specialist $eferral #und



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



%hat Can 'e Done(

Disclosure

Informed consent

6egulation Consumer protection la"s

Professional groups



)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



)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.



#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.



#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.



,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.



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.



-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.



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.



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



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.



#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.



#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.

conflicts of interest4006

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