-Department  of  Health  and  Human  Services 
OFFICE  OF 
INSPECTOR  GENERAL 
PROMOTION  OF  PRESCRIPTION  DRUGS 

THROUGH  PAYMENTS  AND  GIF1S 

Richard  P.  Kusserow 
INSPECTOR  GENERAL 
OEI-01-90-00480 
 EXECUTIVE  SUMMARY 
PURPOSES 
The  purposes  of this study are to  (1) describe the  range of drug promotion  practices 
that  involve  physicians receiving  money  or other  items  of value from  pharmaceutical 
companies,  (2)  assessthe vulnerabilities  such practices  present,  and (3) examine the 
responses of government  and private  groups to inappropriate  or illegal  practices. 
BACKGROUND 
Much  attention  has focused recently  on pharmaceutical  companies  promotional 
techniques.  The  Senate Labor  and Human  Resources Committee  conducted 
hearings in  December  1990 that  highlighted  questionable  promotional  practices.  At 
these hearings, the American  Medical  Association  (AMA)  and the Pharmaceutical 
Manufacturers  Association  (P?%4) testified  about  ethical  guidelines  that  the AMA 
had just  adopted  and the PMA  had fully  endorsed  to help  their  members  avoid 
potentially  unethical  &rations.. 
We focus in this report  on many drug  promotion  techniques  that  have been used 
recently  and on the potential  hazards each presents to physicians and the practice  of 
good medicine.  Because this report  is not based on a statistically  valid  sample of 
physicians, we are not  reporting  on the extent  of promotional  practices involving 
money  or other  items  of value. 
Our  data were  gathered  from  (1) interviews  with  physicians and pharmacists  in six 
hospitals,  (2)  ethical  guidelines  !>rotiu.-ed by various  medical  professional  and industry 
groups, and (3)  a review  of relevant  academic and professional  literature  and mass 
media. 
This  is the first  of several repcrts  on prescription  drug  promotion  we plan  to issue. 
An  upcoming  report  u;rl  fo;;tis on the current  prevalence  of promotional  practices 
involving  pharmaceutical  companies  offering  money  or other  items  of value  to 
physicians.  Another  report  will  evaluate the scientific  merit  and validity  of 
prescription  drug  advertising  in medical  journals. 
FINDINGS 
Phmzaceutical  companies offer money and other items of value to physichs  for  a 
mnge of puqxxeq  j&n  sponsotig  inzpmnt  educational  activiries to active& promoting 
their products.  Q&m  that have been used for pnmwtionul  puqmes  fail  into four  major 
categork 
i  1. 	 Studies - Pharmaceutical  companies  ask physicians to participate  in many 
types of studies on FDA-approved  drugs.  The  companies  offer  a wide variety 
of payments  for  physicians involvement,  including  per patient  cash 
reimbursement,  medical  equipment,  large grants, and trips. 
2.  Speaking  Engagements  - Pharmaceutical  companies  ask physicians to speak on 
topics  ranging  from  complex  surgical procedures  to the positive  attributes  of 
the  companies  products.  In  return,  speakers receive compensation  in the 
form  of  honoraria  and travel  expenses. 
3. 	 Program  Attendance  - Pharmaceutical  companies  offer  monetary  payments, 
travel  expenses, accommodations,  meals, entertainment,  and recreational 
activities  to  physicians for  listening  to  and participating  in programs  ranging 
from  descriptions  of the latest academic medical  research to round-table 
-
discussions about  a particular  product. 
4. 	 Gifts  - Pharmaceutical  companies  offer  physicians such gifts as items  useful in 
medical  practice,  meals, promotional  gadgets, valuable  trips,  and prizes.  . 
Bmnotional  pm&es  involving items of value ap- to Meet  physicinns prescribing 
&&ns. 
. 	 Studies have shown that  physicians prescribing  practices are affected  by 
promotional  efforts  of pharmaceutical  companies. 
. 	 Experts  warn  about  the obligation  a pharmaceutical  companys  gift  or financial 
arrangement  imposes on a physician  to prescriie  the companys  drugs. 
Many  of  the physicians we spoke with  acknowledged  that  these types of d+g 
l 	
promotion  have affected  their  prescribing  decisions and expressed concern 
about  the obligations  imposed  by money  and other  items  of value. 
T-hemedical  w?lumity  a?adthe phamul~  ind&y  consider certaiia pIrPudxu1 
practicer  involving  offkrs of money and other items of value to be inupp-tite. 
. 	 Guidelines  recently  developed  by AMA/PMA  and other  medical  specialty 
groups  advise members  on specific  promotions  to be avoided. 
. 	 Most  of the physicians we spoke with  view  some aspects of  accepting money 
and other  items  of value to be inappropriate. 
It  ir  unckar  what fleet  recently deveibped et-hid  gldidi?W  will  have on 
phannaceutid  companies andphy~ 
ii  . 	 The  guidelines  do not  specifically  define  acceptable  and unacceptable 
sponsorship  of and participation  in  studies. 
.  The  guidelines  are not  backed by any enforcement  mechanisms. 
The Department  of Health  and Human  Services has recently undertaken new t#ortB to 
curb illegal  and inappqniate  pmmotional  practices. 
. 	 The  Office  of Inspector  General  is currently  investigating  its first  group  of 
kickback  cases involving  promotional  practices  of pharmaceutical  companies. 
. 	 The  Food  and Drug  Administration  has often  commented  on and forced 
changes in the content  of promotional  material,  but  thus far  it  has not 
addressed the methods  of promotion.  The  FDA  is drafting  guidelines  on 
scientific  education  and has expressed interest  in  regulating  the use of 
research funding  for  promotional  purposes. 
CONCLUSION 
Although  it is not clear how prevalent illegal  or jrappmpriate  pr~~tional  activitk  arc 
the concems mid  by the pm&es  described in thiv report wamznt jiuther  nwnitorbzg  of 
dnlgpronwtiom 
.. . 
111  TABLE  OF  CONTENTS 
ExEcuTIvESuMMARY 

INTRoDUcLloN  ..............................................  1 

FINDINGS  ...................................................  4 

. 
...............................  4 

Offers  Used for  Promotional  Purposes. 
...............................  9 

Influence  of Promotion  on Prescribing. 
Medical  C;ommunity  and Industry  Concerns.  ...........................  11 

Effects  of Guidelines  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  13 

HHS  Efforts  to Curb  Illegal  and Inappropriate  Practices  . . . . . . . . . . . . . . . . . .  15 

CONCLUSIOi~  . . . . . . . . . . . . . . . . . . . . . . . . . : . . . . . . . . . . . . . . . . . . . . .  17 

APPENDIX  A 

Examples  of Promotional  Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  A-l 
APPENDIX  B 
Ethical  Guidelines  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  B-l 
APPENDIX  c 
Methodological  Notes  . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  C-l 
APPENDIX  D 
Endnotes  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .  D-l  INTRODUCTION 
PURPOSES 
The  purposes of this report  are to  (1) describe the range of drug promotion 
practices  that  involve physicians receiving  money  or other  items  of value from 
pharmaceutical  companies,  (2) assessthe vulnerabilities  such practices present,  and 
(3)  examine  the governments  and the industrys  responses to inappropriate  or illegal 
practices. 
BACKGROUND 
Much  attention  has focused recently  on pharmaceutical  companies  promotional 
techniques.  The  Senate Labor  and Human  Resources Committee  conducted 
hearings  in December  1990 that  highlighted  questionable  promotional  practices.  At 
the  hearings, the Committee  released a report  that  surveyed selected pharmaceutical 
firms.  Expenditures  by these companies  for  symposia, reminder  items,  and samples 
have skyrocketed  since 1976 (the  last time  a similar  survey was conducted).  __ 
Expenditures  for  gifts have also increased.  The  report  spurred  the Committee  to 
look  into  specific promotional  practices. 
Among  the practices described  in  testimony  by witnesses from  the academic  and 
medical  community  were  the followingl: 
*  A  widely  publicized  program  sponsored by Wyeth-Ayerst  Laborator&. 
The  company  developed  a Patient  Profile  Program,  ostensibly  to 
gather information  on the types of patients  who  were  taking  Indersl  I,). 
(propanalol  hydrochloride).  Physicians participating  in  the program 
were  eligible  to receive honoraria  in collecting  information  on their 
patients  taking  Inderal  LA.  The  honoraria  ranged  from  medical 
textbooks  to free  airline  tickets,  depending  on the  number  of patient; 
enrolled.  Massachusettss Medicaid  Fraud  Control  Unit  began  :+ninal 
proceedings  against Wyeth-Ayerst  under  State anti-kickback  StirLutes, 
but  settled  the case out  of court  for  $195,000. 
*  A  CIBA-GEIGY-sponsored  seminar  held in a Caribbean  resort  that 
touted  their  new product  called Estraderm  (estradiol  transdermal 
system).  The  company  paid  all  expenses for  attendees  and their 
spouses including  airfare  and first-class hotel  accommodations  and 
meals. 
1 
 *  Numerous  programs  in which  physicians were  paid  (usually  $100) to 
attend  either  promotional  seminars or round-table  discussions on 
companies  products. 
Witnesses spoke of how  expensive these promotions  were  and of  their  direct  effects 
on prescribing  decisions.  These practices were roundly  criticized  by hearing 
participants  and committee  members. 
At  these hearings, the American  Medical  Association  (AMA)  and the Pharmaceutical 
Manufacturers  Association  (PMA)  testified  about  ethical  guidelines  that  the AMA 
had just  adopted  and the PMA  had fully  endorsed to help  their  members  avoid 
potentially  unethical  situations.  Previous guidelines  had not  been specific  about 
which  practices should be avoide d, leaving much interpretation  up to individual 
physicians and manufacturers.  The  new guidelines  delineate  several particular
i
practices to avoid. 
The  hearings raised the publics  awareness of issues that  have been publicized  several 
times  over the last three  decades.  As early as the  1960s, congressional hearings  . 
exposed widespread  questionable  pror notional practices.  Senator  Edward  M. 
Kennedy  sponsored a series of hearing;  in the  i9;os  around  these same issues and, 
partly  as a result,  introduced  S. 1831 in  1977.  This  bills  enactment  would  have 
resulted  in a fairly  comprehensive  reform  of pharmaceutical  regulation.  Among 
other  things, it would  have prohibited  the transfer  . . .  of  any gift,  product, 
premium,  prize,  or other  things of value from  a person in  the drug industry  to any 
physician  or pharmacist  if  the purpose  of such transfer  is to influence  the 
prescribing,  administering,  or dispensing of any such.drug.  The  bill  was passed 
overwhelmingly  in the Senate, but  died in the House  of Representatives.  No 
legislation  was introduced  in  the recent  hearings.  1 
Our  focus in this report  is to summarize  many of the problems  highlighted  by the 
hearings and to detail  some drug promotion  techniques  involving  money  or other 
items  of value that  have been used recently.  We.~+:*delvaluate  the potential  hazards 
these practices present  to  physicians and ,-he,practice  of good medicine.  We will 
then  summarize  and evaluate  the gov,,-b, le_n. t,  industry,  and medical  establishment
responses to inappropriate  and/or  illegal  practices. 
METHoDonr,v 
To  collect  descriptions  of pharmaceutical  companies  drug promotion  techniques and 
medical  professionals  perspectives on ,.hesepractices, we conducted  detailed 
interviews  with  68 physicians and 7 pharmacists who  practice  in  hospitals.  [In  the 
coming  months,  a questionnaire  will  be mailed  to a sample  of  approximately  1,000 
physicians to gather  statistically  significant  information  about  the  prevalence  of 
various  offers.]  We asked about  research, education,  and other  activities  involving 
money  and other  items  of value being offered  to physicians by pharmaceutical 
2  companies.  To  evaluate how  these practices  could  affect  the prescribing  decisions 

and integrity  of medical  care, we supplemented  our  interview  information  with 

numerous  academic and professional  journal  articles  on the subject. 

To  determine  the response of  industry  and the medical  establishment  to 

inappropriate  or illegal  promotional  activities,  we contacted  over 20 medical 

professional  organizations  and inquired  about  their  ethical  guidelines  (see Appendix 

C).  We received  10 official  statements  or guidelines.  We also reviewed  recent 

academic and business literature  and mass media  related  to this topic  and conducted 

discussions with  key government  officials. 

About  the Interviews 

Our  interviews  were  conducted  at one teaching  hospital  and one community  hospital 

within  each of  the following  metropolitan  areas: Boston,  Massachusetts; Los Angeles, 

California;  and Charlotte,  North  Carolina.  The  cities were  chosen on the basis of 

geographic  dispersion,  size differences,  and differences  in health  service availability. 

We chose the largest teaching  hospital  and the largest  community  (nonteaching) 

hospital  available  in each city.  The  physicians and pharmacists  we interviewed  were 

picked  by the .chief executive officer  of each hospital  (Appendix  C details  the 

selection  criteria).  We spoke with  medical  professionals  in  hospitals  to be able to 

profile  hospital  responses to  inappropriate  or illegal  drug  promotion. 

In  general,  our  interviews  focused on practices both  in  and out  of  the hospital 

setting.  We asked some questions  to hospital  committee  members  and pharmacists 

about  hospital-specific  activity,  but  most of our  questions  focused on interactions 

between  medical  professionals  and pharmaceutical  companies. 

Our  interviews  were  conCI.Licrcdprior  to the publication  of the new AMA  guidelines 

and covered physicians experiences from  up to five years prior  to  the interviews. 

This  means that  information  we gathered  cannot be used to test the  effectiveness of 

the new guidelines  or to  di,cem  any effects the recent  wave of publicity  might  have 

had on promotion4  practices. 

This  is the first  of several reports  we plan  to issue on prescription  drug promotion. 

Because we have not yet  assessedthe  extent  of problematic  practices, we do not 

make  recommendations  here.  Instead, we have developed  conclusions  that  indicate 

further  courses of inquiry.  An  upcoming  report  will  focus on the current  prevalence 

of promotional  practices  involving  pharmaceutical  companies  offering  money  or other 

items  of value to physicians.  The  report  will  summarize  results of  a national  survey 

of physicians and will  include  recommendations  on how  HHS  should  respond  to 

inappropriate  or illegal  practices.  Another  report  will  evaluate  the  accuracy, 

truthfulness,  and educational  value  of prescription  drug  advertising  in medical 

journals.  Our  findings  will  be based on assessments of  advertisements  made by 

physicians and pharmacists  who  serve as peer reviewers  for  major  medical  journals. 

3 
 FINDINGS 
Phainaaceutikal  wnapti  offer money and other ikm  of value tl~physicians for  a 
mnge of purposes, frvm  sponsorihg iin!=  edhcatbnal  at+ities  to actively promoting 
. 
their producls.  ofters that have been used for pmmothnal  pqxxes  fall  info four  major 
categories. 
1.  Studies - Pharmaceutical  companies ask physicians to participate  in many 
types of  studies on FDA-approved  drugs.  The  companies  offer  a wide variety 
of payments  for  physicians involvement,  including  per  patient  cash 
reimbursement,  medical  equipment,  large grants, and trips.  x 
Pharmaceutical  companies  sponsor studies for  a variety  of  purposes.  Commonly, 
companies  conduct  post-marketing  research for  the stated purpose  of discovering 
scientifically  relevant  information  about FDA-approved  drugs.  Although  most studies 
have designs and methods  that  allow  for  these stated purposes to  be addressed, some 
studies are either  explicitly  intended  to promote  or have the  effect  of promoting 
companies  drugs. 
Physicians we interviewed  seem to agree that  studies can have promotional2  purposes 
as well  as the  stated purposes.  Of  the 68 physicians we spoke with,  9 mentioned 
(without  being  asked) that  they had been approached  to  participate  in studies that 
F,-
had promotional  purposes as well  as the stated purposes.  Examples  of the  -
comments  we heard  include:  Drug  companies couldnt  care less about  the outcomes 
of comparative  studies. They  only  are into  it  to  market  the  drug to get 3o&:s 
familiar  with  it,  and post-approval  studies . . . are of questionable  scientific  validity. 
Theyre  primarily  aimed  at marketing.  Appendix  A  describes some of the studies 
recounted  to  us that  appear  promotional. 
Pharmaceutical  companies  use studies for  promotional  purposes in ,Ltaveralways:  (1) 
they sponsor studies which  are intended  to familiarize  physicians wnn  the drug so 
that  they will  use it  in the future;  (2) they give physicians direct  incentives to 
prescribe  certain  drugs; and (3)  they compensate physicians generously for  time  spent 
doing  research.  It  is often  difficult  to make  distinctions  between  the scientific  and 
promotional  purposes  of studies, but  observers can make  informed  judgments  by 
looking  at the financial  arrangements,  the design and methodology  of the studies, and 
the source of  control  of  the study design and publishing.  Financial  Arrangements 
Pharmaceutical  companies  use financial  arrangements  in  studies for  promotional 
purposes in a variety  of ways.  First,  the companies  can reimburse  physicians for 
time  spent doing  research more  generously than  is necessary to get them  to conduct 
the study.  Sometimes  payment  is based on the amount  of work  required;  sometimes 
it  is not.  Per patient  reimbursement  offered  to  the physicians we interviewed  varied 
from  $5 to $4,800, and grants to a physician  or institution  varied  from  $400 to 
$150,000.  There  was no obvious correlation  between  the  amount  of money  offered 
and the apparent  effort  required.  Other  offers  of payment  included  a trip  to Hawaii, 
a computer,  and medical  equipment.  Second, pharmaceutical  companies can give 
direct  incentives  to prescribe  certain  drugs by paying  the  physician  according  to the 
number  of patients  he or she enroils.  For  example,  some physicians we interviewed 
have been offered  payments  on the basis of the number  of new patients  (patients 
who  have never used the study drug)  they put  on the  study, and others have been 
offered  payments  on the basis of the number  of patients  they  switched from  another 
drug.  Third,  payments  are sometimes  offered  with  strings attached.  We interviewed 
a pharmacist  who  is a member  of a hospitals  formulary  committee.  He  described 
how one pharmaceutical  company  offered  large research grants in exchange for  a 
physician requesting  inclusion  of one of the companys  drugs in the hospital 
formulary. 
Design and Methodology  of Studies 
Physicians are involved  in studies that  have a range of  stated  purposes:
* 
New  Uses - testing new uses or new  z!ministration  of a drug;
* 
EXfectiveness - testing the effectiveness of  a drug  for  its labeled  use;
* 
Comparison  - comparing  one drug  to .T,competitors  drug or to the 
treatment  of choice;
* 
Side Effects  - screening patients  for  unknown  side effects; and 
* 
Marketing  - assisting in developing  marketing  plans and testing 
marketing  effectiveness. 
The  methods  used vary in two  main  respect;;  use of  a control  group  and blinding  of 
the selection  of test drug or control  drug.  Antrol  groups  can be: 
* 
Placebo  - treatment  that  has no chemical  effect  on the patient;
* 
Other  Control  - treatment  of choice or  a competitors  drug;  or 
* 
No  control. 
Placement  on the  control  versus study drug  can be: 
* 
Blinded  - done without  the patient  being  aware  of the choice or 
* 
Open  label  - done with  both  the patient  and the  physician being  aware 
of the  choice. 
Some studies that  encourage the physician  to prescribe  the  study drug are not 
designed to  discover scientifically  relevant  results.  Others  may provide  scientific  data, 
but  also promote  the  companys drug.  Studies that  use unacceptable  scientific 
5  methods  or  require  the physician to switch therapies  from  a competitors  drug are 
likely  being  used to promote  the drugs to the physician-investigator.  So-called 
surveillance  studies, which  use open label  designs and/or  do not  have control  groups, 
are not  usually  acceptable  for  generalizing  about  effectiveness or  the advantages of 
one drug  over another,3 but  they are widely  used to screen for  side effects. 
Surveillance  studies, however, may contain  some elements  of promotion,  depending 
on the financial  arrangements  and the stated purposes of the study. 
The  following  table  describes how different  combinations  of methods  are used for 
each stated purpose. 
TABLE  1 
Types of Studies 
NEW USES  EFFEClIVENESS  COMPARISON  SIDE EFFECTS  MARKETING 
1. Blinded, placebo  1.  Blinded, placebo  1. Blinded, other  1.Openlabel, no. 
contrA  control  control  control 
2  Open  label, no  L  Blinded, other  2  Open  label,  other 
control  control  COtltd 
3. 	 Open  label, 
other  contml 
4. 	 Open  label,  no 
conhvl 
Note:  Italics indicate the methodsmore likely to be used for promotional purposes. 
Control  of Design and Publishing 

Pharmaceutical  ?on+snies  either  sponsor independent  research or generate  their  own 

protocols,  methodologies,  and other  aspects of research designs, and choose which 

physicians they wish  to involve.  Their  control  can extend to the publishing  of study 

findings;  sometimes,  pharmaceutical  companies  scientists control  the writing  of 

articles  fc r medical  journals.  Promotional  studies are much  more  likely  than  not  to 

have ;!Yqlaceutical  company  control  of the  research design and/or  publishing.  . 

2. 	 Speaking  Engagements  - Pharmaceutical  companies  ask physicians to speak on 
topics  ranging  from  complex  surgical procedures  to the positive  attributes  of 
the  companies  products.  In  return,  speakers receive compensation  in the 
form of honoraria  and travel  expenses. 
Pharmaceutical  companies  are involved  in almost  every aspect of physicians 
continuing  education.  Almost  ,a11these programs  can be forums  for  physician-
speakers who  are sponsored or paid  by pharmaceutical  companies.4  Depending  on 
the meeting,  physicians may speak on highly  academic subjects or may promote 
specific  products.  Pharmaceutical  companies  support  speakers by either  contributing 
6  money  to an institutions  or organizations  education  fund  or paying the speaker 
directly. 
Pharmaceutical  companies  use sponsorship  of speakers for  promotional  purposes in 
two  ways: they give physicians slides, notes, and/or  a full  text of  a speech, which  are 
slanted toward  the companies  products;  or they pay the physicians very generous 
fees to speak on any topic  (often  the most  influential  physicians are paid  the most). 
In  our  interviews,  we heard  about  sponsorship  of  speakers that  appears to have been 
done for  promotional  purposes.  One  example  was a Los Angeles  gynecologists 
experience.  He  showed us a notebook  full  of slides and presentation  material  that  a 
pharmaceutical  company  had given to him.  The  slides and material  showed GnRH 
agonists in general  and the companys  drug  specifically  in a favorable  light.  An 
attached  letter  from  the product  manager  said, we share your  excitement  in  this new 
class of  compounds  and we appreciate  your  continued  support.  We feel we have a 
winner  with  [the product] !  The  physician  refused  to use these slides and stopped 
speaking  for  the company. 
Though  it  is difficult  to judge  what  level of fees is excessive, physicians we sroke 
with  mentioned  being paid  up to $1,000 for  speaking  locally  and over $2,000 for 
speaking  out  of town.  These fees are much  higher  than  the typical  honoraria  of 
$lOO-$500 per  speech. 
3. 	 Program  Attendance  - Pharmaceutical  companies  offer  monetary  payments, 
travel  expenses, accommodations,  meals, entertainment,  and recreational 
_-. .. 
activities  to physicians for  listening  to and participating  in programszqing 
from  descriptions  of the latest academic  medical  research to round-table 
-.  .i 
discussions about  a particular  product. 
Pharmaceutical  company  support  of  continuing  medical  education  includes not  only 
support  for  the speakers but  also support  for  attendees.  The  companies  supy!y 
meals in  connection  with  hospital  meetings  and provide  receptions  and me&  at large 
regional  or national  medical  organization  conferences.  In  addition,  p@cians  we 
interviewed  spoke about  special outings, baby-sitting  services, transporration,  and 
trinkets  that  were  offered  at these meetings. 
Pharmaceutical  companies  also sponsor their  own  meetings  and conferences.  These 
range from  highly  educational  research presentations  to  discussions about  the 
companies  latest marketing  material.  The  companies  at these meetings  sometimes 
pay for  all  expenses incurred  by the attendee,  including  airfare,  hotel,  meals, 
entertainment,  and recreational  activities.  In  addition,  some companies  cover all  or 
some expenses for  a spouse or guest to attend  the  conference.  They  also 
occasionally  offer  honoraria  for  attendees, ranging  from  $50 to $500. 
7 
 Although  many  of  these programs  are widely  recognized  as legitimate  medical 
education,  the financial  support  given attendees is inherently  promotional,  since it is 
not  earned  in any way.  The  support  seems even more  directly  promotional  when 
discussions are focused primarily  on the sponsoring companys  products  as opposed 
to a particular  disease state, or programs  are held  in resort  locations,  or the topics, 
speakers, and attendees are all  chosen by the sponsoring company,  or there  is a high 
ratio  of free  time  and organized  recreational  activity  to lecture  and discussion time, 
or additional  guests are invited  to attend. 
One  physician  from  the Los Angeles  area described his experiences with 
pharmaceutical  company  sponsorship  of educational  meetings.  He  had attended  all-
expense-paid  programs  in many locations  (for  example,  Phoenix,  Tucson, Orlando, 
Banff,  and St. Thomas).  r-Ie was most concerned, however, about  a conference  he 
attended  over one weekend  at a Beverly  Hills  hotel  at which  accommodations,  meals, 
and travel  expenses were paid  by the sponsoring  company.  He  and twenty  other 
physicians from  around  the country  came to hear a renowned  colleague  speak.  The 
speaker  ended up strongly  advocating  the use of a drug that  was not yet on the 
market.  In  return  for  his time,  the  physician  received $500 from  the company.  . 
4. 	 Gifts  - Pharmaceutical  companies  give physicians such gifts as items  useful in 
medical  practice,  meals, promotional  gadgets, valuable  trips,  and prizes. 
Pharmaceutical  sales representatives  offer  physicians gifts of all  types when  they meet 
with  them.  These gifts are not  given as payment  for  conducting  research, acting as a 
consultant,  or making  presentations  for  the  company, but  are presented  to physicians 
as part  of  a sales visit  or marketing  pack?g:.,  .Many  of these gifts are useful in  the 
physicians  offices, either  for  medical  practice  or for  running  of the office.  Some 
gifts are simply  inexpensive promotionat  r:,; m
 .s, others are more  valuable  and serve
no obvious  professional  purpose.  The  following  table  lists items  that  were  offered  by 

pharmaceutical  sales representatives  or through  the mail  to physicians we 

interviewed. 

8 
 TABLE  2 
Gifts 
PROMOTIONAL  ITEMS  PROMOTIONAL  ITEMS  OF  PROMOTIONAL  ITEMS  OF 

USEFUL  FOR MEDICAL  LITlIE  VALUE  SIGNIFICANT  VALUE 

PRACTICE 
Appointment  books  Breath mints  Deep sea fishing trips 

Calendars  Candy  Drawings for prizes 

Clocks  Coffee cup with  candy in it  Drugs for personal/family  use 

Drugs for patient use  Golf balls  Meals in restaurants 

Educational  material  Jump rope  Tickets  to spotting  eventa and 

Flashlights  Key chains  theater 

Literature  sear+ea  Meals&a&s  in the hospital  Wine 

fiedical  equipment  Mugs

Note pads  so& 

Pencils  TayS 

Pens 
Pointers 
Post-it*  notes 
Rulers 
Textbooks 
TrayS 
Rmwional  pmctices involving iterm  of value appear to affect p?zyisickmsp rescribing 
di?&ns. 
. 	 Studies have shown that  physicians  prescribing  practices are affected  by 
promotional  efforts  of pharmaceutical  companies. 
Research has sho.+il that  physicians depend  on commercial  sources of information, 
particularly  for  new drugs.  Hemminki  conducted  a comprehensive  review  of  the 
literature  on the fx.&rs  affecting  drug prescribing  in  1975 and found  that  commercial 
sources of information  play a significant  role  in the decisions physicians make.5 
Many  other  articles  have described how  promotion  increases prescribing.6  Other 
articles  describe how first  news of a drug  usually  comes from  commercial  sources.7 
Bowman  and +arre  note  that  the funding  source for  continuing  medical  education 
seminars at r: university  medical  center  can affect  prescribing.8  For  three  different 
companies  seminars, the sponsors product  was more  frequently  prescribed  by 
physicians after  they attended  than  before.  One  article  disputes these studies, 
however,  and claims that  increasing  promotion  does not  affect  demand  for 
prescription  drugs? 
Many  of these articles  relied  on physician  self-reporting,  but  one important  study did 
not.  Avom  and colleagues showed that  doctors  believed  in the superiority  of two 
heavily  promoted  drugs over alternative  forms  of therapy,  despite  overwhelming 
scientific  evidence to the contrary. lo  The  study showed that  doctors  did  not 
acknowledge  commercial  sources of information  to be important  factors  in  their 
prescribing  decisions.  They  concluded  that  these doctors  must have been relying  on 
promotional  rather  than  scientific  material  in forming  opinions  about  these drugs. 
9  This  study demonstrated  two  important  points:  physicians are often  unaware  of the 
importance  of commercial  sources of information  on their  prescribing  decisions and 
drug  promotion  can influence  physicians to make  irrational  prescribing  decisions. 
. 	 Experts warn  about  the  obligations  a pharmaceutical  companys  gift  or 
financial  arrangement  imposes on a physician  to prescribe  the companys 
drugs. 
Chren  and colleagues discuss in  detail  the relationship  set up between  doctors and 
drug  companies by gift  giving. *l  Although  physicians may regard  themselves as 
unable  to be bought,  the acceptance of a gift  places obligations  on them.  The 
authors  conclude  that  a gift  need not be contingent  on behavior  in order  to affect 
prescribing  decisions.  Instead,  they speak of more  subtle  ccnsequences: Whenever  a 
physician  accepts a gift  from  a drug company,  an implicit  relationship  is established 
between  the physician  and the company  or its representative.~  Inherent  in the 
relationship  is an obligation  to respond  to the gift;  this obligation  may influence  the 
physicians decisions with  regard  to  patient  care. 
Goldfinger  warns against the minor  obligations  that .acccpting  a free  trip  to a resort 
location  to  attend  a CME  seminar  might  confer.12  He  a&s,  Isnt  it  a bit  sleazy to 
take  the corsage without  at least yielding  its sender a place on ones dance card? 
An  American  Medical  Association  Report  of the Council  on Ethical  and Judicial 
Affairs  describes two  recent  studies that  examined  the promotional  influence  of gift 
giving.13  One says that  salespeople give gifts to potential  buyers because they believe 
the gifts impose  obligations  to respond  and therefore  will  increase. sales.14 The  other 
shows how the accepting  of  a gift,  even a small  one, positively  affects the receivers 
perception  of a companys  product.15 
Even if  a gift  is simply  a matter  of supporting  legitimate  continuing  medical 
education,  the presentation  of  the material  can be biased.  Drug  company 
sponsorship  of continuing  medical  education  can slant the  content  of material 
presented  toward  the positive  aspects of the sponsoring  conoanys  drug.16 
. 	 Many  of  the physicians we spoke with  acknowledged  that  these types of drug 
promotion  have affected  their  prescribing  decisions and expressed concern 
about  the subsequent  obligations  that  money  and other  items  of value impose. 
Of  the  12 physicians who  responded  to our  question  about  the effect  of 
pharmaceutical  company-sponsored  research funding  on .:heir prescribing  decisions, 4 
reported  that  they use the  study drug more  than  they did  prior  to starting  the study. 
Of  the 68 physicians we  spoke with,  22 said their  attendance  at pharmaceutical 
company-sponsored  meetings  could  lead to changes in  their  prescribing  decisions, 
although  many of these doctors  qualified  their  responses to note  that  this would 
occur only  if the  information  presented was of sufficient  force  and credibility.  The 
10  physicians who  responded  that  they would  not  change their  prescribing  were  asked a 
follow-up  question  about why  companies  might  sponsor programs  that  did  not result 
in prescribing  changes favoring  the  sponsor.  Of  the 33 physicians responding,  14 said 
that  there  must be some who,  unlike  themselves, do switch  drugs as a result  of 
attending  programs  and  14 also said that  companies  sponsor these programs  as a 
form  of  advertising,  promotion,  or enhancing  name recognition.  Only  7 physicians 
said the purpose  of the programs  was as stated: to educate  doctors  about  the 
companies  products  and make  them  aware of new product  development. 
In  responding  to a question  about  whether  financial  offers  can have inappropriate 
effects on prescribing  behavior,  most  physicians we spoke with  responded  yes (42 of 
68 physicians).  Another  14 said that  it  depends on the individual.  One  Charlotte 
area physician  responded,  A  doctor  who tells you hes not  influenced  is naive or 
lying.  A  Los Angeles  area director  of medicine  at a large  teaching  hospital  agreed 
that  financial  offers  can have an effect  on prescribing  decisions and said, I  am 
amazed at the number  of physicians who  dont  believe  this.  A  Boston  area 
physician  simply  said that  there  is an implied  quid  quo pro  with  offers  of money, 
travel,  and other  material  goods.  A  Charlotte  area internist  talked  about  how a gift 
obligates  the physician to pay att,ntion  to the sales representative.  One  obstetrician 
from  Charlotte  was up front  about  the potential  obligation:  If  someone paid  me to 
go to San Francisco, Id  feel  obligated  to write  prescriptions  for  them. 
Ihe  rrmiical  cor?lmmdy  and the pharmaceutical  industry consider certain promotional 
pmcticts  involving offers of money and other iterrs of value to be inappropriate. 
. 	 Guidelines  recently  developed  by AMA  WIA  and other  medical  specialty 
groups advise members  on specific promotions  to be avoided. 
On December  3, 1990, the American  Medical  Asbociation  revised its ethical  code to 
incorporate  new guidelines  on gifts  to physicians from  the  industry.  The 
Pharmaceutical  Manufacturers  Association  endorsed these guidelines  in full.  These 
guidelines  (see Appendix  B)  define  acceptab!-, and unacceptable  offers  in some 
areas. The  following  are specified  by  r%  guidelines  as offers  that  are not  appropriate 
for  physicians to accept or pharmact~:!sal  companies  to  offer: 
*  Gifts  of cash 
* 
Gifts  that  are not  related  to  the physicians work  or that  do not  entail 
benefits  to the patient
* 
The  cost of travel,  lodging,  and other  personal  expenses of physicians 
attending  meetings
* 
Subsidies to compensate  for  the physicians time  attending  a meeting
* 
Token  consulting  arrangements
* 
Gifts  with  strings attached 
11 
 Although  most of  the medical  organizations  we contacted  provided  us with  guidelines 
that  do not  specify practices to avoid, l8  those received from  some other  groups do 
single out  unacceptable  practices (see Appendix  B for  complete  texts): 
* 	 American  Surgical Association:  Giving  papers  or lectures that  are 
promotional.  Accepting  money, gifts, and gratuities  as a reward  for 
participating  in promotional  activities.lg 
. 
*  American  College  of Obstetricians  and Gynecologists  (ACOG):  Letting 
provision  of research funds affect  the  experimental  design, 
methodology,  or results of studies.20 
*  American  College  of Cardiology:  Accepting  large  gifts.  Accepiing 
dinners  or  entertainment  given to  discuss a representatives  product.21 
*  Infectious  Diseases Society of America  (IDSA):  Accepting  research 
funding  directly  from  the pharmaceutical  company  rather  than  having 
the funding  flow  through  an institution.= 
Two groups  characterize  ethical  activities  as follows: 
*  The  Accreditation  Council  for  Continuing  Medical  Association  states 
that  funding  for  CME  programs  should be made  in the form  of an 
educational  grant  to the sponsor of the program.  Full  disclosure of 
sponsorship  should be made.  Sponsors should  not  pay for  travel, 
lodging,  honoraria,  or personal  expenses of  attendeesD  _..  I 
*  The  Vandenwx  Group,  which  provides  communication  services for  the  T \ 

pharmaceutical  industry,  recently  adopted  a code of principles  in 

response to  the AMA/PMA  guidelines.  The  code limits  items  of value 

given to physicians in return  for  attending  events to articles useful for 

medical  practice. 

. 	 Most  of the physicians we spoke with  view some aspects of accepting money 
and other  items  of value to be inappropriate. 
Over 80 percent  (51 of 62 responding  to the question)  of  the physicians we 
interviewed  .identified at least one type or aspect of educational  programs  they 
considered  inappropriate,  while  over 70 percent  (50 of 68 responding  to the 
question)  identified  at least one type  or aspect of drug company  sponsored researcir 
as such.=  Popular  responses were very general:  the most  common  type of research 
thought  to be inappropriate  were  studies designed to market  a drug or those which 
had no scientific  merit,  while  the loosely defined  term  junket  was mentioned  most 
frequently  as an inappropriate  educational  program. 
12 
 However,  some specific features of both  educational  programs  and research were 
mentioned  by physicians we interviewed  as being inappropriate.  The  following 
specific pharmaceutical  company  activities were  mentioned  by physicians we 
interviewed  as being inappropriate:  paying the audience  to attend  an educational 
program  (mentioned  by  15 respondents),  conducting  discussions on a single product 
(13 mentions),  influencing  what  a speaker says at an educational  program  (12 
mentions),  paying  travel  expenses to attend  an educational  program  (9 mentions), 
sponsoring  one-sided or biased presentations  (8 mentions),  selecting the speakers (5 
mentions),  paying  physicians to attend  focus group  sessions (4 mentions),  controlling 
the  release or publishing  of study data (4 mentions),  analyzing  the study data (3 
mentions),  and paying  per  case reimbursement  for  studies (2 mentions). 
It  iv unclear what ejfect recent@devekped ethical guik%  wit? hve  on 
phalnlaceulical  companies and physicians. 
The  press and academic  community  have focused much  attention  on the issues raised 
here.  Publications  as diverse as the American  Journal  of Hospital  Pharmacists and 
SELF  magazine  have detailed  potentially  inappropriate  promotiona:  practices and 
their  relation  to the AMA/PMA  guidelines. 26 At  least one pharmaceutical  company 
has responded  to the wave of publicity  by publishing  a statement  of prmciples. 
Merck  Sharp &  Dohme  (MSD)27 placed a two-page  ad in major  medical journals 
detailing  the principles  guiding  its promotional  activities.  These essentially echo the 
AMA/PMA  guidelines.  MSD  has asked physicians to  evaluate whether  the company 
is indeed  in compliance  with  these guidelines  and whether  its principles  follow  those 
of the AMA  guidelines.  The  AMAs  general  counsel has stated that  he perceives 
practices  to  have changed significantly  because of  the guidelines:  The  major  gifts to 
physicians that  raised the  most controversy,  lodging  and travel  to  educational  events 
are, for  the large part,  over.lm 
. 	 The  guidelines  do not  specifically  define  acceptable  and unacceptable 
sponsorship  of  and participation  in studies. 
The  AMA/PMA  guidelines,  which  are the focus of much  of the oubiicity,  speak to 
study sponsorship  and participation  in two  subsections: 
*  It  is appropriate  for  consultants who  provide  genuine  services to 
receive reasonable  compensation.  . . .  Token  consulting  or advisory 
arrangements  cannot be used to justify  the  compensation  of physicians 
for  their  time  or their  travel,  lodging,  and other  out-of-pocket 
expenses. 
*  No  gifts  should  be accepted if  there  are strings attached.  For 
example,  physicians should  not  accept gifts  if  they are given in relation 
to the physicians  prescribing  practices. 
13 
 The  guidelines,  however,  do not  clarify  what  distinguishes genuine services from 
token  consulting  or advisory arrangements  or whether  study reimbursement  based on 
the number  of patients  enrolled  constitutes  a strings attached  gift. 
ACOGs  guidelines  do not  allow  pharmaceutical  companies  to control  the design of 
studies or the publishing  of data, and the IDSA  guidelines  would  rule  out direct 
funding  of research by pharmaceutical  companies.  But  these guidelines,  despite 
having been released several years ago, are not widely  known  or publicized  and are 
directed  only  to a limited  number  of specialists. 
.  The  guidelines  are not  backed by any enforcement  mechanisms. 
The  American  Medical  Association  has no enforcement  authority.  The  AMA  has 
decided  at least one promotion  was in violation  of the guidelines  since the publishing 
of the  guidelines.  Their  response has been to write  to  the physicians known  to  be 
involved  to  advise them  that  they are violating  their  professions  code of ethics.2g At 
the Senate hearings, the AMA  stated that  it  expected most state and local licensing 
boards would  adopt  the guidelines  in full  and thus would  be able to sanction doctors 
who  were  outside  the gui:!elines.  It  is. not  clear, however,  what  effect  incorporating 
the guidelines  into  state medical  board  codes would  have,30nor is there  any 
requirement  that  the boards incorporate  these guidelines  into  their  ethical  codes. 
The  Pharmaceutical  Manufacturers  Association  plans to enforce  its guidelines  in  the 
same manner  as it  has the  International  Federation  of Pharmaceutical  Manufacturers 
Associations  (IFPMA)  Code  of Pharmaceutical  Marketing  Practices.  That  is, when 
the PMA  receives a complaint,  it  sends the complaint  to  the PMA  member  that  is 
the subject  of the alleged breach, and the PMA  member  responds in writing.  Gerald 
Mossinghoff,  president  of the PMA, -has said that  this procedure  has resulted  in 
satisfactory  resolution  of each and every Jleged  breach  of the IFPMA  Code by PMA 
members  over the years.31  But  these complaints  and responses are not generally 
public  information,  nor  is any kind  of disciplinary  action  taken  if  a promotion  falls 
outside  the  code.  One promotion  ths;  began prior  to the  release of the guidelines, 
but  included  activities  that  toC< place in  early May  clearly  is in violation  of the PMA 
guidelines.  PMA  deferred  j;=1;y ya ment on this promotion  to the AMA  because of the
start  date of the promotion.52 
Other  organizations  are explicit  in recognizing  that  they  have no ability  or desire to 
enforce  their  guidelines.  For  example: 
*  The  [Infect:cJs  Diseases] Society [of America]  recognizes its inability 
to legislate  the morals  of its members  and of those with  whom  they 
interact.33 
*  The  position  presented  here by the American  Surgical Association 
does not  connote  any direct  restriction  or punitive  action.34 
14  *  Because recommendations  in  individual  cases nearly  always have to be 
based on reasoned judgments  rather  than  on rote  application  of an 
encyclopedic  set of rules, our  [the American  College  of Cardiologys] 
attention  should focus on guidelines  rather  than  rules.35 
77~ Lkpartrnht  of Health  and Human  Services bus recent& undertaken new q@on3to 
curb illegal  and inappmpriate pmnwtional  pmctikes. 
. 	 The  HI%  Office  of Inspector  General  (OIG)  is currently  investigating  its first 
group  of kickback  cases involving  promotional  practices  of pharmaceutical 
companies. 
The  Medicare  and Medicaid  anti-kickback  provisions  (42 U.S.C.  1320a-7b) apply  to 
financial  -:ransactions between  pharmaceutical  companies  and physicians.  The  law 
reads in part: 
Whcever  . . .  solicits or receives any remuneration  . . .  in cash or in kind 
. . .  in return  for  purchasing,  leasing, ordering,  or  arranging  for  or 
recommtnding  purchasing,  leasing, or ordering  any good  . . .  for  which 
payment  may be made  [by Medicare  or Medicaid]  shall be guilty  of a felony 
. .  Whoever  offers  or pays any remuneration  . . .  in  cash or in kind  to any 
person  to  induce  such person  . . .  to  purchase, lease, order,  or arrange for 
or recommend  purchasing,  leasing, or ordering  any good  . . .  for  which 
payment  may be made  [by Medicare  or Medicaid]  shall be guilty  of a felony. 
Traditional  applications  of this law involve  cases in which  doctors  are paid 
remunerations  to  refer  patients  to certain  laboratories  or  specialists.  But  the law 
also applies  to ic o;:tor  who  is paid  remunerations  to prescribe  or otherwise 
recommend  a drug which  is covered by Medicare  or Medicaid. 
The  OIG  is currl;ntly  investigating  Wyeth-Ayersts  Patient  Profile  Program  (see p. 
1) and i.: collecting  information  about  many  other  promotional  programs  offered  by 
nuns rrls  pharmaceutical  companies.  Investigators  have expressed a desire to 
expana the  choice of remedies  and penalties  available  to  punish  violators  of the law 
and protect  the  Medicare  and State health  care programs. 
. 	 The  Food  and Drug  Administration  (FDA)  has often  commented  on and 
forced  changes in the  content  of promotional  material,  but  thus far,  it  has not 
addressed the methods  of promotion.  The  FDA  is drafting  guidelines  on 
scientific  education  and has expressed interest  in regulating  the use of 
research funding  for  promotional  purposes. 
The  FDA  is charged with  regulating  the  content  of all  packaging  and advertising 
material  related  to pharmaceutical  drugs.  They  have interpreted  this authority  to 
15  include  all  forms  of drug promotion.  Promotional  material  must be balanced  in its 
presentation  of indications  and contraindications,  effects, and side effects.  It  may not 
include  unsubstantiated  claims of superiority  or discuss uses that  have not  been 
approved  by the FDA.  The  FDA  focuses most of its promotional  oversight  attention 
on journal  advertising.  It  also attempts  to monitor  educational  programs  (again for 
content),  but  has limited  resources for  this purpose. 
The  FDA  has no control  over the financial  relationships  between  manufacturers  and 
physicians, although  it  can and does use these financial  relationships  to  determine 
whether  particular  statements are promotion  (which  the FDA  can regulate)  or 
scientific  communication  (which  it  cannot  regulate). 
The  new Commissioner  of the FDA. believes the FDA  can  play an important  role  in 
preventing  physicians and others from  being  misled  by promotional  activities.%  In 
this regard,  he has sought and received approval  to add staff to the Division  of Drug 
Advertising  and Labeling  to allow  more  resources for  promotion  oversight.37  Central 
in this staff  development  has been the appointment  of a new director  of  the Division. 
The  new Director  has stated the importance  of regulating  promotional  activities  in 
the guise of scientific  exchanges.ss The  FDA  is a:;o  active in gathering  information 
about  various  types of promotion,  such as company sponsorship  at medical 
meetings.3g  As part  of this effort,  the FDA  is planning  to set up a hot  line  for 
physicians and pharmacists  to phone  if  they  are aware of inappropriate  promotional 
practices.+O 
In  addition,  the FDA  is drafting  guidelines  for  scientific  education,41 which  should 
significantly  clarify  what  is viewed  as promotion  versus what  is viewed  as education. 
The  FDA  has expressed interest  in regulating  the use of studies for  promotional 
purposes.  One  of its officials  recently  talked  about  how open label  studies can 
present  problems  in  that  they can represent  an effort  to promote.  . . .  an 
unapproved  use.42 He  said the Advertising  Division  would  have no hesitation  in 
halting  clinical  studies and calling  for  revised protocols  when  they promote 
unapproved  uses. 
16 
 CONCLUSION 

Aldwugh  it is rwt  clear how prevaknt  illegal  or inappropriate pronwtional  activitk  are, 
the concems mired  by the pmcticts  dksribed  in this report warrant jiuther  nwnitoring  of 
drug pnNTwtio?L 
Drug  promotion  activities warrant  continued  attention  for  many  reasons.  Direct 
adverse effects on prescribing  decisions may occur as a result  of promotional 
activities.  Some practices may indeed  be illegal,  violating  the Medicare  and Medicaid 
anti-kickback  statutes.  Additionally,  acceptance of promotion-related  money  or other 
items  of value from  pharmaceutical  companies  has the appearance  of impropriety. 
This  appearance  is damaging  to the publics  confidence  in the medical  profession. 
Although  our  interviews  indicate  that  potentially  inappropriate  practices may be 
widespread,  more  recent  activities  (the  AMA/PMA  guidelines)  appear  to have 
changed the way promotion  is conducted.  If,  however,  the guidelines  prove 
ineffective  because of weaknesses meaticned  in this report,  inappropriate  or illegal 
promotions  could  continue.  To  keep  abreast of changes related  to these activities, 
the  OIG  will  continue  its research in this area and will  formally  survey physicians to 
determine  the current  prevalence  of promotional  practices involving  payments  and 
gifts.  In  addition,  the OIG  will  continue  to pursue cases against apparent  violators  of 
the Medicare  and Medicaid  anti-kickback  statutes. 
17 
 APPENDIX  A 

Descriptions  of Studies Used for  Promotional  Purposes 
Some of the studies that  were  described to us appear  to  have encouraged  the 
physician  to prescribe  the companys  drug.  The  following  are examples: 
*  One gastroenterologist  from  the Los Angeles  area was involved  in conducting 
a study examining  the relative  effectiveness of four  dosing regimes for  one 
ulcer  treatment.  The  maker  of the drug approached  the physician with  a 
study methodology,  which  included  a requirement  that  the patients  involved  in 
the study be currently  taking  another  drug.  The  study was being  conducted  in 
multiple  sites around  the country,  was not  controlled,  and did  not  require  -. 
blinding.  The  physician was being paid  by the company  on the basis of the 
number  of patients  he enrolled. 
*  A  cardiologist  who  practices in  the Charlotte  area conducted  a study looking 
into  the efficacy  and side effects of one companys  beta blocker.  The 
company  offered  the physician $100 per  patient  to  collect  what  the physician 
called  only  a few  pieces of data.  The  company  designed the methodology, 
which  included  no controls  and was open label.  The  study was conducted  in 
multiple  sites throughout  the country.  The  physician  did  not  think  the results 
were  scientifically  relevant  or useful; the company,  he said, was not  trying  to 
do real  research, but was using this as a marketing  method. 
*  An  infectious  disease specialist in the Boston  area was invited  to participate  as 
&,,Iinvestigator  in a nationwide  trial  of the efficacy  and safety of a new 
intravenous  form  of an approved  antibiotic  drug.  The  drugs IV  form  was 
about  to be approved  at the time  (the  study would  not  start  until  after  the 
?,ug was approved).  The  investigator  was to  enroll  10 patients  having certain 
diagnoses and fill  out  a brief  two-page  Clinical  Evaluation  Form.  In  return, 
the physicians involved  were  to receive $30 for  each completed  form  and 
Category  II  Continuing  Medical  Education  credits.  The  results were  to be 
analyzed  and written  up by scientists at the company. 
*  An  oncology  specialist in the Charlotte  area was asked to give an ulcer 
medication  to patients  free  of charge and collect  minimal  information  on the 
patients.  The  sponsoring  company was not  planning  to publish  the results of 
the  study, and they offered  him  a piece of medical  equipment  as, according  to 
the physician,  a prize  for  participating.  He  refused  to  do the study, because 
he did  not  consider  it  good science. 
A  -1 
 APPENDIX  B 

Ethical  Guidelines 
B-l  Report  as  filed  by  the  Rouse  of  Delegates  on  December  4,  1990 
American  Medical  Association 
REPORT OF THE COUNCIL  ON ETHICAL  AND JUDICIAL  AFFAIRS 
Report:  F 
(I-90) 
Subject: 	 Opinion  of  the  Council  on  Ethical  and  Judicial 
Af f airs--Gif  ts  to  Physicians  from  Industry 
Presented  by:  Richard  J.  McMurray,  MD,  Chairman 
Referred  to: 	 Reference  Committee  on  Amendments  to 
CJns titution.  and  Bylaws 
(David  B.  Carmichael,  Jr.,  MD,  Chairman) 
1  The  Council  on  Ethical  and  Judicial  Affair6  submits  the 
2  following  opinion  to  the  Rouse  of  Delegate6  for  it6  information  and 
3  recommend6  that  this  report  be  filed. 
4 
5  GIFTS  TO PIIYSICIANS  FROM INDUSTRY.  Many  gifts  given  to 
6  physicians  by  companies  in  the  pharmaceutical,  device  and  medical 
7  equipment  industries  serve  an  important  and  socially  beneficial 
8  function.  For  example,  companies  have  long  provided  fund6  for 
9  educational  seminar6  and  conferences.  Uowever  ,  there  ha6  been 
10  growing  concern  about  certain  gift6  from  industry  to  physicians. 
11  Some  gift6  that  reflect  customary  practice6  of  industry  may  not  be 
12  consistent  with  princin1s.l;  of  medical  ethics.  To  avoid  the 
13  acceptance  of  inappropriate  gifts,  physicians  should  observe  the 
14  following  guidelines: 
15 
16  1.  Any  gift6  accepted  by  physician6  individually  should 
17  primarily  entail  a  benefit  to  patient6  and  should  not  be  of 
18  substantial  value  .,  Accordingly,  textbook6,  modest  meals  and  other 
19  gift6  are  appropriate  if  they  6erve  a  genuine  educational 
20  function.  Cash  !aymr,nts  should  not  be  accepted. 
21 
22  2.  Individual  gifts  of  minimal  value  are  permissible  a6  long 
23  a6  the  gif  t6  are  related  to  the  physician6  work  (e.g.,  pen6  and 
24  notepads). 
25 
26  3.  Subsidies  to  underwrite  the  costs  of  continuing  medical 
27  education  conferences  or  professional  meetings  can  contribute  to 
28  the  improvement  of  patient  care  and  therefcre  are  permissible. 
29  Since  the  giving  of  a  subsidy  directly  to  a  physician  by  a 
30  company6  sales  representative  may  create  a  relationship  which 
31  could  influence  the  u6e  of  ,the  company6  product6,  any  subsidy 
32  should  be  accepted  by  the  conference6  sponsor  who  in  turn  can  use 
33  the  money  to  reduce  the  conference6  registration  fee.  Payment6  to 
34  defray  the  costs  of  a  conference  should  not  be  accepted  directly 
35  from  the  company  by  the  physicians  attending  the  conference.  CEJA  Rep.  F  - page  2 
1  4.  Subsidiee  from  indue  try  should  not  be  accepted  to  pay  for 
2  the  co6 te  of  travel,  lodging  or  other  pereonal  expeneee  of 
3  physician6  attending  conference6  or  meetinge,  nor  should  6Ub6idie6 
4  be  accepted  to  compenrrate  for  the  phyeiciane  time.  Subeidies  for 
5  hospitality  should  not  be  accepted  outside  of  modeet  meals  or 
G  social  event6  .held  ae  a  part  of  a  conference  or  meeting.  It  i6 
7  appropriate  for  faculty  at  conference6  or  meeting6  to  accept 
8  reaeonable  honoraria  and  to  accept  reimbureement  for  reaeonable 
9  travel,  lodging  and  meal  expenses.  It  it3  also  appropriate  for 
10  consultants  who  provide  genuine  services  to  receive  reasonable 
11  compensation  and  to  accept  reimbursement  for  reasonable  travel, 
12  lodging  and  meal  expensee.  Token  consulting  or  advisory 
13  arrangement6  cannot  be  ueed  to  justify  compensating  physician6  for 
14  their  time  or  their  travel,  lodging  atid  other  out-of-pocket 
15  expenses. 
16 
I.7  5.  Scholarship  or  other  special  Eunds  to  permit  medical 

18  studente,  resident6  and  Eellows  to  attend  carefully  selected 

19  educatioual  conferences  may  be  permissible  a6  long  a8  the  selection 

20  of  6 tude4i  te  ,  resident6  or  fellow6  who  will  receive  the  fund6  is 

21  rade  by  the  acaclemic  or  training  institution. 

22 

23  6.  No gif  t6  should  be  accepted  iE  there  are  6 trings 
24  attached.  For  example,  phyeicians  ehould  not  accept  gifts  if  they 
25  are  given  in  relation  to  the  physician6  prescribing  practice6.  In 
26  addition,  when  companies  underwrite  medical  conference6  or  lecture6 
27  other  than  their  own,  responeibility  for  and  control  over  the 
28  selection  of  content,  faculty  ,  educational  me thode  and  mu teriale 
29  should  -belong  to  the  organizers  of  the  conference6  or  lectures. 
Z..  -. ,  .,  I  .  .  . _.  .  .  .  .  ..-.  Committee  on Ethics  Number  45-October  1985 
Guidelines  for  Relationships  Between 
Industry  and  the  Amerkan  College  of 
Obstetricians  and  Gynecologists  and  Its 
Fellows 
The American  College of Obstetricians  and  vidual  physicians  are responsible  for their 
Gynecologists  recognizes that companies in the  own  behavior  as it relates to noneducational 
health  care industry,  such as manufacturersof  phar- promotiorts  and should  be aware of the 
maceuticals  and medical devices, assist the College  potential  for ethical  problems generated by
in pursuit  of its educational  goals and objectives  such promotions.
through  sponsorship  and financial  support  of var-
3.  Company promotion to individual  physicians and
ious medical educational  programs. 
groups, including  specialty societies,hospitals, 
In the course of such interactions,  there is the  and medical schools,through the support of edu
7  possibility  that company  expenditures  will  generate  cational activities, honorary awards, research 
some degree of bias unrelated  to product  merit,  cre
grants, and developmentcontracts. Whenever 
ating  the actuality  or the appearance of inappro
there is a relationship  between the College 
priate and undue  influence.  .When any product  pro- and industry  in the educational  area, it is 
motion  leads to inappropriate  or unbalanced  medical  desirabls-for  the College and its Districts 
advice or recommendation  to patients,  an ethical  and Sections to establish basic principles 
problem  exists. The public  holds physicians  to a  govemine  industrys  participation  in the 
high  standard  of medical advice, and such advice  support  a::d s;;onsorship  of educational 
should  be as accurate, balanced, com,p!ete, and  activitres.  Support  of educational  programs 
devoid  of bias as possible.  and the provision  of awards, grants, and 
Industry-physician  interactions  can be divided  contracts may be accepted by the College 
into  three major types, as characterized  in the fol and its members if such support  is offered 
lowing  paragraphs.  Ethical implications  specific to  in accordance with  the following  guidelines: 
these types of interactions  suggest areas in which 
the College and its Fellows  should  particularly  strive  .-. A*vards should  be based on merit (socie
to be circumspect.  .al, educational,  or scientific)  and should 
be granted  on a competitive  basis. 
1. 	 Product promotion to individual  physicians by  b. 	 No obligation  should  be imposed or 
advertising, personalcommunicution, and provi implied  by the provision  of funds.  Provi
sion of samples.The physician  has an obliga sion of funds  should  not affect the 
tion to go beyond  the information  provided  experimental  design,  methodology,  or 
through  advertising  in selecting the best  results of grant-supported  programs.  No 
product  for care of the patient.  topic or speaker restrictions  on educa
2. 	 Company promotion to individual  physicilins and  tional  programs  should  be accepted. 
groups of physicians, such as medicalspecialty  Educational  programs carried out with 
societies, by provision  of noneducational  gifts,  support  from industry  should  present a 
parties, trips, and services.Company  promo balanced view  of treatment  options  and 
tional  practices directed  to indi ridual  physi should  not be biased toward  a specific 
cians or to professional  groups without  con product  or procedure  lest they be con
comitant  educational  benefits  have the  strued as a form of paid advertising. 
potential  for unduly  influencing  physicians  c. 	 The sources of support  and the relation-
7  and generating  a sense of obligation  which  ship between  these and the investigator 
could  prejudice  optimal  health care. The  or speaker should  be a matter of public
College has promulgated  guidelines  to clar record and should  be made explicit  at the 
ify its relationship  to these activities.  Indi tune of publication  or presentation. 
/  30  CONTI ET AL.  JACCvol. 16, No.  I 
TASK  FORCEV  July  1990: l-36 
Task  Force  V:. The  Relation  of  Cardiovascular  Specialists  to Industry, 
Institutions  and  Organizations 
C. RICHARD  CONTI,  MD,  FACC,  CHAIRMAN,  JOHN  F. WILLIAMS,  JR., MD,  FACC, CO-CHAIRMAN, 
JEFFREY  L.  ANDERSON,  MD,  FACC,  HARRIS  A.  BERMAN,  MD,  FACP, 

ROLF  M.  GUNNAR,  MD,  FACC,  GERALD  P. HERMAN,  MD,  FRED  W. LYONS,  JR., 

EUGENE  R. PASSAMAN;,  MD,  FAX,  PHILIP  R. REID,  MD,  FACC,  MARK  E. SILVERMAN,  MD, 

SYLVAN  LEE  WEINBERG,  MD,  FAGC,  LEE  YERKES 

I.  General  II. 	 Industry-Sponsored  Programs 
or Conferences 
The delivery  of cardiovascular  care has undergone  dra
matic changes. New technologies,  therapies and systems for 
health care delivery  have emerged and have done so largely  Much  of our educational  activity  is financially  supported 
through  cooperative  efforts  of our profession  and industry.  by industry.  in general this has been beneficial for physician 
These  developments  have  benefited  our  profession,  the  education,  and continued  support for these activities  should 
industry  and, most importantly,  our patients.  Further  devel be encouraged.  However,  the  primary  objective  of  such 
programs must be educational.  Programs should not be used 
opment  will  require  continued  cooperative  efforts.  Yet 
to promote the products  of the sponsor. Selection  of topics 
such efforts  are threatened  by increasing  concerns  regard
and discussants  should be determined by the medical direc
ing the motives  of those involved  (l-3).  Enormous  amounts 
tor of the program or the staff to which  the presentation  is to 
of money are involved  in health care (approximately  12% of 
bc made.  Honoraria  for  faculty  participants  should  be in 
our gross national  product  or $550 billion  in  1988;..irr.jLI
keeping with  the participants  contributions.  Honoraria  and 
cians largely  control  how this money is allocated.  Therefore 
induccmcnts  for audience attendees should not be accepted. 
it is not surprising  that industry  devotes much of its markct
Payment  of  expenses  for  attendees may  be acceptable  in 
ing  to physicians  to  influence  prescribing  habits  and pur
situations  consistent  with educational  objectives  with appro
chase of their products.  Physicians and their patients benL,lt 
priate accrednation.  For example, appropriate  situations  are 
from  these activities  when  the relation  between  pbyslcians 
those in which  the attendees are faculty  participants  and in 
and  industry  is  based  on  ethical  principles  ,qd  mutual 
which  the  program  control  and  selection  of  attendees  is 
respect.  dctcrmincd  by physicians,  without  restriction  by industry. 
Ethical  behavior  ultimately  is an individual  decision  but  Lavish  entertainment  and gifts are inappropriate.  Expenses 
it must be appreciated  that it is the perception  ?y patients,  should  not  be paid or reimbursed  for spouses or guests of 
health policy  makers, the media, and others, of our ethical or  attendees.  Provision  of  meals as part  of  a meeting  is an 
unethical  behavior  that  will  determine  societys  response.  acceptable practice.  Speakers sponsored by industry  should 
The cardiovascular  community  (physicians,  industry.  insti bc identified  in the program or at the time of the presenta
tutions  and organizations)  has a special  obligation  to help  tion. 
define the boundaries  of ethical  behavio:  in their  relations. 
A guiding  principle  for  physicians  must be that  their  deci
B.  ltldl4.~try-iniiia[ed  Conferences 
sions about patient care are determined  by the health needs 
of  the  patient  and  not  based on  inappropriate  monetary.  Particular  attention  should  be given to conferences orga
scientific  or academic gains.  Physicians  must r.ot be influ nized and conducted  directly  by industry.  Physicians  partic
enced by any  incentives  that would  cause them to act in a  ipating  as faculty  in  such  meetings  have  an obligation  to 
manner contrary  to their  best professional  judgment.  What  present  scientifically  balanced  information.  They  are fre
follows  are guidelines  to assist those who  must make deci quently  well  recognized  leaders in the field  whose recom
sions relating  to ethical  behavior  and conflicts  of interest  in mendations  are readily  accepted. Their  comments must not 
.
this area.  be subject to approval  or censored by the sponsoring  com-
Reprinted  with  permission  from  the  American College  of  Cardiology
I - - -.  - --  --  ..- _^^^  __ - _r  ._  - ^^  ^^.  JACC  Vol.  16. No.  I  CONTI  ET  AL.  31 
July  i!YM:I-36  TASK  FORCEV 
pany.  It  is acceptable  to have a reputable  and accredited  III.  Publications  Sponsored by Industry 
teaching  institution  endorse  the conference.  The  program 
Most  scientific  journals  receive  significant  financial  sup-
chairman  should  be responsible  for final  selection  of topics 
port  from  industry  advertising.  Such support  is necessary 
and discussants.  Conferences  devoted  to a single  drug  or  and appropriate  if it does not influence  editorial  decisions. 
device produced  by the sponsoring company  may be appro Furthermore,  publication  of proceedings of educational  pro-
priate  if  no  other  treatment  alternatives  are available  or  grams supported  by industry  is common  practice.  Publica
special procedures are required for proper utilization.  How- tion of these proceedings  may be of value,  but there is the  , 
ever,  conferences  devoted  to  a single  drug  or  device  in  potential  for the presentation  of biased information.  Publi
therapeutic  categories  in which  other equivalent  treatments  cation of these proceedings should be subject to peer review 
are available  should  be discouraged  unless strict  guidelines  in  a manner  similar  to  that  of  unsponsored  manuscripts 
are enforced;  for  example,  the conference  is advertised  as  submitted  to that journal.  Proceedings to be published  di
such and attendees  pay their  own  tuition  or expenses.  or  rectly  by industry  should  undergo  review  by  the  faculty 
both, to attend.  involved  or an independent  group of authorities. 
Those  invited  to  attend  an  industry-initiated.  program 
should  not  expect  or accept  inducements  to attend.  High 
quality  industry-sponsored  programs do not require  inducc IV.  Gifts   
ments to obtain  attendees.  The  practice  of accepting  cash 
Gifts lo physicians  may represent appropriate  gestures or 
incentives  to attend is to bc condemned. 
inappropriate  acts. The  principles  to be employed  are the 
reasonableness of the gift  or payment  for  the service  ren
dered and the gifts effect on physician  decision making. The 
C. Physician-Initiated  Program  following  examples are used to illustrate  these concepts. 
Small  gifts. Physicians  frequtntly  receive  small  items, 
Many  educational  programs  are physician  initiated  but 
such as pens, notepads or appointment  books, from industry 
totally  or partially  sponsored by industry  and frequently  held 
representatives.  These  usually  are given  when  the repre
at  resorts  or  attractive  locations  as  an  inducement  for 
sentative discusses their  companys  product  with  the physi
physician  attendance.  Many  such conferences  could  not be 
cian.  Inductry  views  these items as important  for  product 
held if it were not for industry  support, and acknowledgment 
recognitior,.  This  is acceptable practice. 
of that  support  is appropriate.  It  is particularly  important 
Large gifts. It  is  an  increasingly  common  practice  to 
that these programs are organized  and conducted  primarily 
encourage physicians  to use a certain product  by linking  the 
as e&:ational  events.  The  program  chairman  should  be 
use-of  that  product  to  inappropriately  valuable  gift>  and 
responsible  for selection  of topics and discussants.  Attend
finaricial  or  other  rewards.  For  example,  physicians  may 
ees not participating  as faculty  should pay tuition  and travel 
receive financial  incentives  such as frequent  fly,,  ;,:ograms 
d:pP  :lsic  or direct cash payment if they prescribe a speci;lc drug orand 
for a small  number  of patients  and then complete  a short 
form  describing  the  result.  These  studies  rarely  have 
scientific  v4ue  and  are  designed  primarily  to  e-,ourage 
D.  II: Astry  and  Trainees 
physicians  .o prescribe  the drug.  Provision  of t:le drug free 
Previous  comments  pertaining  to  physicians  and  their  to the patirnt  does not justify  this prac:?e. 
relation  to the health care industry  also apply  to physicians  Reimbursementfor surveillancr z!:.*i&.  However,  it  is 
in training.  However,  the latter may be particularly  suscep appropriate  to reimburse  physicians  participating  in  legiti
tible  to marketing  efforts.  Supervising  physicians,  particu mate postmarketing  surveillance  studies (phase IV)  that are 
larly  directors  of training  programs,  should  take an active  guided by protocols approved by institutional  review boards. 
role  to assure that  ethical  principles  are adhered  to by all  These studies  can be an important  part  of the continuing 
parties. Pharmaceutical  companies frequently  provide  meals  development  of a product. 
at educational  programs conducted  for  physicians  in train Hospitality suites at medical meetings, These  are com
ing. Representatives  of the companies are often permitted  to  monly provided  and are acceptable if they are primarily  used 
briefly  present  product  information  at  these  conferences.  for social functions. 
This  is an acceptable  practice  if all pharmaceutical  compa Consultation feesfor physicians services. These are ac
nies that wish  to participate  have equal opportunities  to do  ceptable practice provided  the fee is commensurate with  the 
so and if supervising  physicians  are in attendance  to ensure  services performed. 
a balanced presentation.  The direct  personal  acceptance of  Market researchfocus groups. These are common prac
meals or  entertainment  at functions  without  a significant  tice.  Individuals  are  usually  paid  for  participation  in  the 
educational  component  is discouraged.  focus group,  which  is an acceptable  practice  if physicians  32  CONTI  ET  AL.  JACC 	 Vol.  16, No.  I 
/  TASK  FORCE  V  July  1590: l-36 
comments  are uninfluenced  by the sponsoring  organization  of  care provided  by  an institution  regardless  of  financial 
and honoraria  are in keeping with  the service provided.  incentives  to the physician. 
General guidelines for giving and accepting gifts. Any- As a result of the intense competition  for patient revenue, 
thing  given  to  physicians  by  industry  should  not  be  I)  a  physicians  may be subject to pressures from  institutions  to 
reward  for  selecting  a specific  product;  2) an incentive  for  increase such revenue.  This  is particularly  true  for  physi
selecting  a product  otherthan  on scientific  grounds  (educa cians salaried  by or under  contract  to institutions  such as 
tional  material  about  a product  is an acceptable  form  of  managed  care  facilities  and  faculty  practice  plans.  The 
incentive);  3) out  of  proportion  to  a need,  for  example,  practice of publicly  comparing  physicians  by revenue gener
foreign trips to view a facility  or equipment.  The recommen ated. hospital  revenue saved or procedures ordered is often 
dations  of the Royal  College  of Physicians  that  acceptable  designed to enhance profits,  with  a disregard for the quality 
gifts  are  those  that  are  inexpensive  and  related  to  the  of patient  care. Institutions  should  be concerned  primarily 
practice  of medicine  are appropriate:  .  . . a useful crite with  the quality  of care provided  by their  physicians.  Con
rion of acceptability  may be-would  you be willing  to have  versely,  physicians  must have an awareness of the financial 
these  arrangements  generally  known?  (4).  Physicians  pressures institutions  are under and avoid unnecessary over-
should  not accept or demand lavish  gifts  such as dinner  or  or underutilization  of resources. Physicians  have an obliga
entertainment  to discuss a representatives  product.  tion  to cooperate  with  administrators  in determining  cost-
effective  strategies for their  institution. 
V.  Physician  Ownership  of Health 
Care Facilities 
Phy,icians  are generally  members of several professional 
The  economic  philosophy  of our  society  not  only sup- organiz;tions  or societies.  Physicians  in positions  that influ
ports but encourages individual  economic  investment.  Phy ence the activities  or decisions  of these organizations  must 
sician participation  in the ownership  of health care facilities,  avoid any potential  conflict  of interest.  Organizations  should 
such as imaging  centers and mobile  cardiac  catheterization  insist on and physicians  agree to disclosure  of any arrange
laboratories,  is increasing.  Although  currently  legal, there is  ments they or their  immediate families  have with  the corpo
considerable  debate as to whether  physician  ownership  of  rate  sector  that  could  lead  to  conflicts  of  interest,  for 
facilities  to which  they refer patients is ethical.  The potential  example, the holding  of stock, equity  interests, directorships 
for  unethical  behavior  or  the  appearance  of  a conflict  of  or consulting  relations  with  a company.  Obviously  physi
interest  occurs  whenever  physicians  gain  financially  from  cians must avoid  partlclpating  in decisions  that affect com
their patients  expenses for services the physician  orders but  panies  in  which  they  have  financial  arrangements.  These 
does not provide  directly.  It appears that patients  generally  precepts  do  not  imp!,  ?hat physicians  should  not  have 
are unaware  of their  physicians  involvement  in these facil financial  relations  wit;l mdustry  but that these relations  must 
ities.  Physician  involvement  in  such activities  may bc ac be revcalcd  bcforc  situations  occur in which  there is poten
ceptable  if  these  activities  clearly  improve  patient  cart  tial conflict  of interest. 
above that available  in the community.  It is mandatory  that 
physicians  disclose to their patients their financial  interest  in 
VII.  Ph,kcisns,  Industry  and Research 
such facilities. 
Unfortunately  health care facilities  are often developed  in  Physi,::?  ,.I% indispensable  to the health  care research 
areas that already  have adequate facilities.  The introduction  conducted  bj  industry.  The maintenance  of scientific  integ
of  new  facilities  without  evidcncc  of  need  will  incrcasc  rity  by all  partics  in these endeavors  is essential.  Industry 
medical care costs-this  in itself  is unethical.  must utilize  proper  safeguards that assure that they do not 
influcncc  results  of  the  sponsored  research.  Physicians 
should  not have arrangcmcnts  with  industry,  such as stock 
VI. 	 Physicians  Relation  to Institutions  or equity  interests,  that would  result  in financial  advantage 
and Organizations  based on the results of the study. 
The use of inside information  for personal gain by physi
A.  Institutions 
cians involved  in research or data review  is both illegal  and 
Hospitals  depend on physicians  to maintain  an adequate  unethical. 
patient  base. Today,  a large number  of  hospital  beds are  When  participating  as  an  investigator  in  industry-
unfilled  and  competition  for  patient  revenue  is  intense.  sponsored single investigator  clinical  research or multicenter 
Increasingly,  institutions  are awarding  incentives  to physi trials  the investigator  I) should  not be given personal incen
cians in order  to attract  patients.  Physicians  should  deter- tive  payments  or  rewards  for  accomplishing  a  research 
mine where to refer their patients on the basis of the quality  protocol;  2) should not hold direct  significant  financial  inter- JACC Vol.  16. No.  I  CONTI  ET AL.  33
July 1990:l-36  TASKFORCE  V 
est of any kind in the product  under investigation:  3) should  6. Relation of physiciansto institutions and organizations 
have  a role  in  choosing  the  safety  and  data  monitoring  A. Institutions  referral.  Physicians should base decisions 
committee;  4) may participate  in postmarketing  (phase IV)  of where to refer their  patients on quality  of care issues and 
research  of the product  investigated;  5) must divulge  pay the  ability  to  provide  better  care.  regardless of  financial 
ments to patients to the institutional  review  board; 6) may be  incentives  lo  the physician. 
considered  as a preferred  speaker relating  to the clinical  B.  Organizations.  One must avoid participation  in deci
research; and 7) should be cautious  about prcmaturc  promo sions affecting companies in which one has financial arrange
. 
tion of a drug through  lectures,  news media or other means.  ments. 
7. Physicians,industry and research 
Physicians  should  not  hold  direct,  significant  financial 
VIII.  Conclusions 
interest  of any kind  (including  equity  interest)  with  a com
The following  are guidelines  for ethical  behavior  of car pany whose product  is under investigation. 
diovascular  specialists  relating  to industry.  institutions  and  Physicians  hold  a favored  position  in  society  because 
organizations.  society perceives us as being unique.  We have the ability  to 
1. Genen!.  cure  their  diseases,  alleviate  their  suffering,  allay  their 
A  guiding  principle  for  physicians  must  be that  their  anxieties  and  our  rewards  for  doing  so are considerable. 
decisions  about  patient  ca;e  are  not  based on  monetary.  Only  as long as society  perceives  these to be our  primary 
scientific  or academic  gain.  Physicians  mus;  not  be influ goals will  we retain  this favor of society. 
enced by  external  financial  incentives  in  such a way  that 
would  cause them to act in a manner contrary  IO their  bcs~ 
professional  judgment.  References 
2. Industry-spon. .xed programs or conferences 
The primary  objective  of such pograms  must bc cduca I. 	 Brickcr  EM.  Industrial  marketing  and medical ethici.  N Engl J Med 
iYXY:3!0: IhYIl-2. 
tional,  and the programs should  not be used as promotional 
tools.  7-.  Inglehart JK. Health policy report: the debate over physician ownership of 
heallh care facilities.  N Engl J Med IYHY:32I:IYX-204. 
A.  Indusrry-inifiared  conferences.  Physicians  participat
ing  as faculty  members  in  such  meetings  have  a special  3. 	 Blcndon  RJ. The  publics  view  of  the future  of  health  care.  JAMA 
IYXX:!.5Y:?~P7-Y3. 
obligation  to be sure that unbiased information  is presented. 
4. 	Repon  of  he Royal  College  of  Physicians.  The relationship  between 
B.  Physician-initiated  program.  Programs must be or
phySiCiNN  dnd the pharmaceutical  industry.  J R Coll  Physicians  Lond 
ganized  and conducted  primarily  as educational  programs.  1986:20:235-42. 
Industry  should  not specify  speakn:;  or topics.  Attendees 
should pay tuition  and travel  expenses. 
C. Industry  and  trainees.  Supervising  of physicians.  par Selected Reading 
ticularly  directors of training  progra7.s. sl:,uld  take an active 
role in assuring that ethical  principles  are adhered to  by all  I. 	 Relman AS. Dealing with  conflicls  of inreresl.  N Engl J Med  1985:310: 
1182-3. 
parties and that material is presented in a balanced way. 
3. Publications sponsoredby industrv  2. Goldlinger  SE. A mailer of influence. N Engl J Med 1987:316:1408-9. 
Publications  should be subject  to geer review.  3. 	Egdahl RH  Taft CH.  Financial  incentives  lo physicians.  N Engl J Med 
lY86:315:%-61. 
4. Gifts from industry 
Acceptable  gifts  are  thibJ:  that  are  inexpensive  and  4. 	Morreim  EH.  Conflict  of  interesl:  profits  and problems  in  physician 
referrals.  JAMA  lY89:262:390-4. 
related to the practice of meoicine  . . .-a  useful criterion  of 
acceptability  may be-would  you  be willing  to have these  5. 	Kelman  AS.  Antitrust  (aw  and the physician  entrepreneur  (editorial). 
N Engl J Med 19X5:313:884-5. 
arrangements generally  known?  (4). 
6. 	Hyman DA. Williamson JV. Fraud and abuse. Setting the limits. N Engl J 
5. Physician ownership of health care facilities 
Med IYX9:3~0:1272-8. 
Such ownership  is acceptable  if  it clearly  improves  pii
7. 	Healy  B. C;:mpeau L. Gray R. et al. Conflict-of-interest  guidelines for a 
tient  care above that which  is available  in the community. 
multicenter  tlinical  trial  of treatment  after  coronary-artery  bypass-graft 
Disclosure  of ownership  to patients  is mandatory.  surgery. N xngl J Med 19X9:320:949-51.  GUIDELINES  COMMERCIAL  SUPPORT  CONTINUING  MEDICAL  EDUCATION 
FOR  OF 
(Revision  of guidelines  previously  approved  by ACCME:  June,  1984) 
PREAMBLE 
The  purpose  of  continuing  medical  education  (CME)  is  to  enhance  the  physicians 
ability  to care  for  patients.  It is the  responsibility  of the  accredited  sponsor  of a CME 
activity  to assure  that the activity  is designed  primarily  for that  purposs. 
Accredited  sponsors  often  receive  financial  and  other  support  from  non-accredited 
commercial  organizations.  Such  support  can  contribute  significantly  to the  quality  of 
CME  activities.  The  purpose  of these  guidelines  is to describe  appropriate  behavior  of 
accredited  sponsors  in  planning,  designing,  implementing,  and  evaluating  certified 
CME  activities  for which  commercial  support  is received. 
GUIDELINES 
1. 	 Accredited  sponsors  are  responsible  for  the  content,  quality,  and  scientific 
integrity  of  all  CME  activities  certified  for  credit.  Identification  of  continuing 
medical  education  needs,  determination  of  educational  objectives,  and 
selection  of  content,  faculty,  educational  methods  and  materials  is  the 
responsibility  of the  accredited  sponsor.  Similarly,  evaluation  must  be designed 
and  performed  by the accredited  sponsor. 
2. 	 The  accredited  sponsor  is  responsible  for  the  quality,  content,  and  use  of 
enduring  materials  for purposes  of CME  credit.  (For the  definition,  see ACCl!?C 
Guidelines  for  Enduring  Materials.) 
3. 	 Presentations  must  give  a  balanced  view  of  all  therapeutic  options.  Use  of 
neneric  names  will contribute  to this  impartiality.  If trade  names  are used, thosa 
of  several  companies  should  b8  used  rather  than  only  that  of  a  s_[ngle 
sponsoring  company. 
4. 	 When  commercial  exhibits  are  part  of  th8  overall  program,  arrangements  for 
these  should  not influence  planning  nor  iriterfere  with  the  presentation  of CME 
activities.  Exhibit  placement  should  not  be  a condition  of  support  for  a CME 
activity. 
5. 	 The  ultimate  decision  regarding  funding  arrangements  for  CME  activities  must 
be  the  responsibility  of  the  accredited  sponsor.  Funds  from  a  commercial 
source  should  be  in  the  form  of  an  educational  grant  mad8  payable  to  the 
accredited  sponsor  for  the  support  of  programming.  However,  all  support  in  relation  to the  certified  CME  activity  must  be made  with  the  full  knowledge  and 
approval  of  th8  accredited  sponsor.  Payment  of  reasonable  honoraria  and 
reimbursement  of  Out-of-pOCk8t expenses  for  faculty  is customary  and  proper. 
Commercial  support  must  be  acknowledged  in  printed  announcements  and  . 
brochures,  however,  reference  must  not  b8  made  to  specific  products. 
Following  the  CME  activity,  upon  request,  the  accredited  sponsor  should  b8 
prepared  to report  to 8aCh commercial  supporter  and other  relevant  parties,  and 
8aCh commercial  supporter  to th8  accredited  sponsor,  information  concerning 
the  expenditures  of funds  8aCh has provided. 
L- - __.  -_- _ ___- --  -_~.
6. 	 Commercially  SuppOn8d  social  events  at  CME  activities  should  not  compete 
with,  nor take  precedence  over, the educational  events. 
7. 	 An  accredited  sponsor  shall  ha!!8  a policy  on  conflict  of  interest  applicable  to 
CME  activities.  All certified  CME activities  shall conform  to this policy. 
8. 	 In an activity  offered  by an accrs lited  sponsor  it is not permissible  to provide  for 
travel,  lodging,  honoraria,  or  personal  expenses  for  attendees.  Subsidies  for 
hospitality  should  not be provided  outside  of modest  meals  or social  events  that 
are held as a part of th8 activity. 
Scholarship  or  other  special  funding  to  permit  medical  students,  residents,  or 
fellows  to attend  selected  educational  conferences  may  be provided,  as long as 
the  selection  of students,  residents  or fellows  who will  receive  the funds  is made 
either  by the  academic  or training  institution  cr  by the  accredited  sponsor  with 
the full concurrence  of the academic  or training  !:lstitution. 
Approved  by the ACCME 
March  16, 1991 
-
--  --  ---  ---.  -- 
These  Guidelines  were  approved  by  th;  .Unt  Task  Force  on  Pharmaceutical 
Industry/CME  Provider  Collaboration,  F2x~ry  15, 1991. 
-2-
 American  Surgical  Association 
April  21,  1987 
111f* Atllr*ri\3\\  S\irgic:\I  hss\iri;\lioii  Il;\s  co\\sitl\*rc-tl  111~ 
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pim\~itlii\~  itt~tlc~ri;\l  t\c-cess;\ry  it\  III\- c:\rc*  of  s\trgic:tl  II;\
lic,ttts.  For  )c-:trs  s11cl1 co\npa\\ics  II;\VC  hcrn  IwII~~~;I~~oI~s 
of  zttrK:c*ry  Iltt~011~11ncliotts  sitpportittg  tencltittg.  gr:\tltt:\lc~ 
It.:tillitt~  of s\tr~t~otts.  nl\cl  SUrfiiCi\l  rcsc;\rclt.  Sttlisiclirs  li;\\*t~ 
t*t11~1t1:11t~tplrittc*ip;\lly  fruit\  corpot.;\lc  I~oclics  ni\tl  wtrt 
~i~o~.itlt*\l  It1 grotips,  sociclit5.  ;rncl ;\c;\tlc~t\tic  clc*p:\rltt\t~ttls. 
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sl~~o~l. Iii11 IO \I0  so Iiy  allcmpLc\l  pcrsunsion  of iticlivitl\t~\ls 
1111oii~li  \III~~:II~II\Y~ \\\o\\cl:\ry  or  ollicr  rrwnrcl  lins  lo  lw 
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is ;\illi\*tl  al  i\i~l\\\~\iciitg  Ilir  j\\cl~\\\~~i\l  of  llir  rccipic*\\l  \vllf) 
is Ixtid  for  ;~.llo\vittg  ltitttsrlf  (0 IIC s\\l)jrctrd  lo  lltc  ittcl\tslrys 
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I/I(*  follo\t~illg  posiliott  1~1sIJWII  Inkcn: 
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Ili~il  it  is  \ii\rlliicnl  for  n sr\rpw\\  to  nccrpt  rr\i\\i\ic*rnlio~~ 
or  ttx\lt*ri:tl  rc*\v:\rcl  fur  pitrlicipidiltg  it\ ntlvrt~lisittg  or  olll(*l 
protl\t~l  pt~tttt\tilic~t\nl  nctivity  of  t\  I\et\llll  cnrr-rt-l;tlttl 
iitcl\isl\.y.  will\  no  rdntio\\sl\ip  lo  proftxisio\\:rl  scrviw  rt*\i
clrrrcl  Iiy  llir  s\irgrot\.  Ih\\ut\er:tlic~\i  or  tn:tlc~rinl  rrw:\t.tl 
is titr~\ttl  lo  iiitply  tno\tcy.  gins,  fimtuilies  SUCII ns vnc:\liott, 
tr:\vrl.  or  oll\c*r  etnolut\~cttls.  Acceptnl~lc  profcssiot\:\l 
srrvicrs  rrtitlrrrcl  include  lmin  MC  cot\s\tltntiott  services; 
It*C:\l  lt*slitt\cn\y  ctf qudificcl  spccidty  coimtltnrtts;  procl\tc.l 
Irsliiig  c~v;tl\t;\lit~t\,  &=vrlopii\o\t,  nticl  experitnrttl:\l  or  Ixxvii  Reprinted  with  the  permission  of  the  Infectious  Diseases  Society  of  America,  the 
Journal  of  Infectious  Diseases,  and  the  University  of  Chicago  Press  (Journal  of 
Infectious  Diseases,  1984,  Vol.  150,  792-793) 
Statement on Ethical  Conduct  in Research by the Infectious  Diseases 
Society of  America  . 
it is stated  in the  By-Laws  of  the  Infectious  Disear:s  research  involving  the  participation  of  human  sub. 
Society  of  America  that  individuals  are  elected  .o  jccts.  impartial  review  of  all  such  proposals  by  a 
membership  or  fellowship  on  the  basis  of  evider,cc  third  party  should  be  mandatory. 
of  high  professional  and  ethical  standards,  and  funding:  Whcncvcr  possible,  defrayal  of  inves. 
the  Society  considers  ethical  conduct  IO be an  im tigalional  costs  should  bc  institutionalized.  Funds 
plicit  requirement  of  continued  membership.  P:o- from  the  donor  should  flow  through  institutional 
vision  exists  also  in  the  By-Laws  for  the  expulsi.)n  channels  (univcrsi(y,  hospital)  rather  than  being 
of  any  member  for  cause.  In  an  era  of  heighten,:d  naid  dire&- 10 I hc investigator.  All  financial  trans. 
concern  over  the  ethical  aspects  of  conduct  in  a  actions  should  bc subject  IO audit  and  available  for 
highly  complex  society,  involving  relationships  public  disclorurc  if  and  when  appropriate.  Funds 
among  individuals,  educational  institutions,  hos acccpred  for  specific  purposes  should  be  utilized 
pitals,  private  corporations,  and  government,  the  solely  for  those  purposes  and  should  not  be  di. 
Society  has  attempted  to  identify  certain  featcres  vertcd  for  personal  or  for  ihstitutional  use for  pur
of  these  relationships  requiring  careful  considera poses  other  than  those  stipulated  under  the  terms 
tion  by the  parties  entering  into  them.  The  Society  of.the  award. 
recognizes  its  inability  to legislate  the  morals  of  its  I  PuhXalion  01  Resdts:  No  contract  should  be 
members  and  of  those  with  whom  they  interact  II  ?ntered  into  that  rcstrlcts  the  prompt  disclosure  of 
does  expect,  however,  that  each  member  recogrze  -findings  that  affect,  in any  way,  the  public  welfare, 
his/her  full  responsibility  to the  Society  and  to  the  Disclosure  of  support  from  a sponsor  with  a vested 
medical  profession  to  maintain  standards  of  con- intercsr  in the  outcome  of  any  investigation  should 
duct  that  will  stand  full  public  scrutiny.  always  accompany  oral  presentation  or publication 
To assist  members  in achieving  this  desideratum,  of  rcsitlls. 
the Society  has  identified  a number  of  areas  whcrc 
attention  to  the  concepts  and  procedures  set  forth  Pcrsonul  Condurl 
may  help  to  avoid  misunderstandings  and  percep
Mcmbcrs  of  the  Socrcty  should  be constantly  sen
tions  of questionable  or of  improper  conduct.  T~)s 
sitive  to  [hc  need  not  only  to do  no  wrong  bllt  also 
latter  goal  is  best  achieved,  perhaps,  through  ;hc 
to  the  need  not  In  ~.i:p  :hc  appearance  of  doing 
use,  whenever  possible,  of  peer  review  and  of  lull 
wrong. 
disclosure  of  relationships  established  for  the  fur
(A)  In  fulfilling  functions  in which  there  may  bc 
therance  of  scientific  investigation.  To assist  mcm
rhc  appearance  of  a conflict  of  interest,  full  dis
bers  who  do  not  have  suitable  institutional  affilia
closure  of  rclnrionships  P-nong  the  involved  partics 
tions  for  the purposes  described,  the Society  sho:ld 
should  be  made. 
consider  the  establishment  of  committees  or  of 
(B)  Inrcra-ioqq  between  industry  and  members 
panels  to  fulfill  these  functions  for  members  who 
of  the  Crcirlv  tind  their  affiliated  institutions  may 
request  them. 
be  mutual!y  beneficial.  Such  relationships  should 
always  be disclosed  by members  of  the Society  who 
Research Proposals 
are involved  in any  governmental  advisory  or regu
Conlenl:  Whether  initiated  by  the  investigator  latory  process.  Because  members  of  the  Socict! 
or  by  another  individual  or  agency,  the  proposal  mosl  knowlcdgcablc  abour  a given  drug  or  dcvicc 
should  be  subjected  to  peer  review  by  an  accz>t and  most  frequently  called  upon  IO testify  about  ir 
able  agency  that  does  not  have  a vested  interest  in  arc  often  those  most  likely  to  have  had  some  con-
the  outcome  of  the  investigation.  tact  wit;i  its  manufacturer,  they  are  the  ones  also 
Human  Su&ecf.sz  Evidence  of  compliance  with  at  grcatcst  risk  of  finding  themselves  confronlcd 
existing  regulations  should  be  documented  for  all  with  a conflict  of  intcrcst.  Such  conflicts  may  arise 
[Edifors  note.  This  statement  on  ethical  conduct  was  developed  by  a subcommittee  appointed  by  the 
Council  of  the  IDSA.  It  has  the  full  endorserrent  of  the  Officers  and  Council  members  of  the  IDSA. 
792  793 
out  of  subtle  and  seemingly  insignificant  relation- are  in  preparation  of  material  subject  to  editorial 
ships  that  are nonetheless  opnn  to varying  interpre review  prior  13 publication.  Investigators  should  be 
tations  when  subjected  to  public  scrutiny.  If  2nd  especially  sensitive  to  the  potential  conflict  of  in
when  potential  for  conflict  exists,  a member  should  terest  arising  from  the  written  or  verbal  endorse
consider  declining  to  testify  unless  such  testimony  ment  of  products  for  the  study  of  which  they  have 
is both  essential  to  the  -public  interest  and  is pre- received  financial  support  from  industry.  While  it 
ceded  by  a  statement  describing  all  potential  is evident  that  peer  review  and  opinion  will  rectify, 
conflicts.  in time,  erroneous  or  biased  views  (the  professional 
(0  Individuals  should  guard  against  excessive  integrity  of  the  faculties  of  the  medical  schools 
reimbursement  for  services  to  industry;  e.g.,  hon being  probably  the  strongest  ethical  force  in  the 
oraria  for  lectures,  fees  for  consultation,  and  per system),  harm  may  result  in  the  interval  between 
quisites  for  attending  meetings  or  other  sponsored  presentation  and  its  rectification. 
activities.  Acceptance  of  such  honoraria  and  fees  (I;)  Individuals  whose  speaking  engagements  are 
should  be in accordance  with  the  regulations  of  the  funded  by  industry  should  encourage  industry  to 
individuals  primary  employer.  support  institutions  seeking  speakers,  so  that  the 
(D)  Individuals  engaged  in  consultative  or  con latter  institutions  may  make  their  own  selections 
tractual  activities  with  industry  should  recognize  and  have  direct  financial  dealings  with  speakers. 
the  implications  of  other  financial  relationships,  Speakers  receiving  honoraria  directly  from  entities 
such  as the  ownership  of  stock  in  companies  they that  support  their  work  or  in  which  they  have  a 
I 
are advising.  financial  interest  should  consider  filing  with  their 
(E)  Individuals  Iiaving  financial  relationships  brimary  employer  (or  the  Society)  a  periodic 
with  industry  should  be  equally  careful  in  choos itemized  accounting  of  such  stipends,  to  be availa
ing the content  of  material  for  oral  or  written  pub ble  for  public  scrutiny. 
lic presentation  not  subject  to  prior  review  as the)  APPENDIX  C 

Methodological  Notes 
1. 	 INTERVIEWS:  We asked each CEO  to arrange  for  us to speak with  at least 
one of each of the following:  the chief  of the medical  staff, the  chief  of 
pharmacy,  the director  or supervisor  of medical  education,  the chief  resident, 
the  chief infectious  disease specialist,  a member  of the institutional  review 
board,  a member  of the ethics committee,  a cardiologist,  a gastroenterologist, 
a psychiatrist,  an internist  (preferably  a geriatric  specialist),  a pediatrician,  an 
obstetrics  or gynecology specialist,  and a surgeon. 
2. 	 GUIDELINES:  We contacted  or attempted  to contact  all  the medical 
organizations  listed  in Sourcebook  on Health  Occunations  to inquire  about 
their  guidelines.  This  amounted  to  almost  30 major  medical  organizations. 
C-l  APPENDIX  D 

Endnotes 
1.  Senate Labor  and Human  Resources Committee  hearings  on Pharmaceutical 
Advertising,  Marketing,  and Promotional  Practices, December  11-12, 1990. 
2. By promotional,  we mean any activity  that  is intended  to change physicians 
prescribing  based on other  than  purely  scientific  information. 
3. K.  Feather,  Ask  the FDA:  Can We Use This  Study Promotionally?  Medical 
Marketing  and Media,  April  1990, pp. 52, 54, 56. 
4. Hospital  grand rounds,  department  meetings, professional  organization  meetings, 
stand-alone  educational  and promotional  seminars, dinner  meetings,  and round-table 
discussions are all forums  for  physician speakers who  are sponsored by 
pharmaceutical  companies. 
5. E. Hemminki,  Review  of Literature  on the Factors Affecting  Drug  Prescribing, 
Social Science & Medicine  9 (1975):  111-116. 
6. K.  Leffler,  Persuasion or Information?  The  Economics  of Prescription  Drug 
Advertising,  Journal  of Law  and Economics  24, no.  1 (1981):  45-74.; J. Lexchin, 
Pharmaceutical  Promotion  in  Canada: Convince Them  or Confuse Them, 
International  Journal  of Health  Services-17; uo.  1 (1987):  77-89.; D.  Christensen, and 
P. Bush, Drug  Prescribing:  Patterns, Problems,  and Proposals, Social Science and 
Medicine  15A (1981):  343-355.; E. Hem,;l&ki,  Review  of Literature  on the Factors 
Affecting  Drug  Prescribing,  SociaZScience and Medicine  9 (1975):  111-116.; and G. 
Keele,  A  Survey of the Effects  of a Drug  Promotion  Campaign,  Journal of the 
Royal  College of General Practitioners  26 (19s):  382-386. 
7. D.  Christensen  and A.  WertheimL8-r;Sources  of  Information  and Influence  on New 
Drug  Prescribing  Among  Physicians In an HMO,  Social Science and Medicine  13A 
(1979):  313-322. and M.  Peay and E. Peay, Differences  among  Practitioners  in 
Patterns  of Preference  for  Information  Sources in the Adoption  of New  Drugs, 
Social Science and Medicine  18, no.  12 (1984):  1019-1025. 
8. M.  Bowman  and D.  Pearle, Changes in Drug  Prescribing  Patterns  Related  to 
Commercial  Company  Funding  of Continuing  Medical  Education,  The Journal  of 
Continuing  Education  in  the Health  Professions 8 (1988):  13-20. 
9. J. Mackowiak  and J.P. Gagnon,  Effects  of Promotion  on Pharmaceutical 
Demand,  Social Science and Medicine  20, no. 11 (1985):  1191-1197. 
D-l  10. J. Avom,  M.  Chen, and R. Hartley,  Scientific  Versus Commercial  Sources of 
Influence  on the Prescribing  Behavior  of Physicians, American  Journal  of Medicine  73 
(1982):  4-8. 
11. M.  Chren,  C.S. Landefeld,  and T. Murray,  Doctors,  Drug  Companies  and Gifts, 
Journal  of American  Medical  Association  262, no. 24 (1989):  3448-3451. 
12. S.E. Goldfinger,  A  Matter  of Influence,  New England Journal  of Medicine  316 
(1987):  1408-1409. 
13. Gifts  to Physicians from  Industry,  American  Medical  Association,  Council  on 
Ethical  and Judicial  Affairs,  Report  G, Adopted  12/4/90. 
14. R.E.  Hit,  and J.A.  Bell&i,  Salespeoples Use of Entertainment  and Gifts, 
Industrial  Marketing  Management  16 (1987):  279-285. 
15. A.  Shama and J.K. Thompson,  Gifts  Build  Goodwill  and Market  Share, Journal 
of Retail  Banking  11 (1989):  55-59. 
16. M.  Bowman,  The  Impact  of Drug  Company  Funding  on the Content  of 
Continuing  Medical  Education,  MOBIUS  6, no.  1 (1986):  66-69. 
17. Council  on Ethical  and Judicial  Affairs,  Gifts  to Physicians From  Industry, 
Journal  of the American  Medical  Association  265, no. 4 (1991):  501. 
18.  The  American  Academy  of Dermatology,  the American  Academy  of 
Ophthalmology,  the American  College  of Physicians, the American  Osteopathic 
Association,  and the !Lnerican  Psychiatric  Association  provided  us with  guidelines  or 
bylaws dealing  with  conflicts  of interest  or gift  arrangements  from  industry. 
19. American  Surgical Asbociation,  Minutes  of the One Hundred  and Seventh Meeting, 
April  27, 1987, pp. lxxvi - lxxvii. 
20. American  College  of  Obstetricians  and Gynecologists  Committee  on Ethics, 
Guidelines  fo:  Re!ationships  between  Industry  and the American  College  of 
Obstetrici;,::  -nd Gynecologists  and Its Fellows,  ACOG  Committee  Opinion,  Number 
45, October  1985. 
21. C.R. Conti  et al., Task  Force  V:  The  Relation  of Cardiovascular  Specialists to 
Industry,  Institutions  and Organizations,  Journal  of the American  College of 
Cardiologists 16, no.  1 (1990):  30-36. 
D-2 
 22.  Infectious  Disease Society of America,  Statement  on Ethical  Conduct  in 
Research by the  Infectious  Diseases Society of America,  Journal  of I..fecfh.sDirease 
150 (1985):  792-793. 
23. Accreditation  Council  for  Medical  Education,  Guidelines  for 
Continuing 
Commercial  Support  of  Continuing  Medical  Education,  Approved  March  16, 1991. 
24. Vanderveer  Group  Adopts  Code of Principles  in Response to Hill  Criticism  of 
Physician Dinner  Meetings  and Honoraria;  Code Outlines  Restrictions  on Gifts, 
F-D-C  Reports, April  29, 1991. 
25. Physicians were  asked whether  there were  any kinds  of pharmaceutical  company 
sponsored  education  (and, separately, research) that  they  considered inappropriate. 
They  were  not  required  to have been involved  in  the education  or research they 
were  calling  inappropriate. 
26. Practices outlined  include  a $20,000 grant  extended  to a researcher by a 
pharmaceutical  company  to get a study favorable  to  the companys product  published 
(SELF,  March  1991); extraordinary  marketing  pressure placed  on physicians to 
prescribe  TPA  (7Ime,  March  18, 1991); a research project  requiring  collecting 
minimal  information  on at least five new patients  in return  for  money  (Public  Citizen, 
March/April  1991); and a circus-like  extravaganza put  on by pharmaceutical 
companies  at a hospital  pharmacist  convention  in Las Vegas (American Journal of 
Hospital  Pharmacists 48, 1991). 
27. Merck  Sharp &  Dohmes  ads appeared  in the Journal  of the American  Medical 
Association  and the New England Journal of Medicine  in  February,  March,  and April 
of  1991. 
28. T.  Randall,  AMA,  Pharmaceutical  Association  Form  Solid  Frcnr  01, Gift-Giving 
Guidelines,  Journal  of the American  Medical Association  265, no.  18 (May  8, 1991): 
2304. 
29.  Collagen  Corp.  was planning  on sending dermatologists  v-rho purchased high 
volumes  of injectable  collagen  on an 8 day educational  cT?li+  in the South Pacific 
at the firms  expense in  late June, 1991.  The  promotion  was recently  cancelled.  See 
T.  Randall,  Not  All  Drug  Firms  Subject to Gifts  Guidelines,  But,  for  Physicians, 
Their  Gifts  Are  Still  Taboo,  Journal  of American  Medical  Association  265: no.  18 
(May  8, 1991): 2305  and T. Randall,  Promotional  Cruise  Scuttled  in Ethics Storm, 
Wome  Would-Be  Cruisers  Claim  Financial  Damages, Journal  of American  Medical 
Association  265: no. 22 (June  12, 1991): 2929. 
30. The  Federation  of State Medical  Boards currently  does not  even collect 
information  on disciplinary  actions taken  as a result  of financial  conflict  of interest  or 
other  financially  oriented  ethical  violations.  (Federation  of State Medical  Boards 
Disciplinary  Code List,  FSMB  files.) 
D-3  31. MD-Promotion  Guideline  Implementation  Descriied  in Letter  to Kennedy, 
Pu4  Newsletter 33, no. 5 (February  4, 1991): 2-3. 
32. TAP  Pharmaceuticals  gave 700 physicians round-trip  airfare,  4 nights lodging, 
and registration  fees to attend  a ACOG  meeting  in May,  1991.  The winners  were 
selected in drawings  held between August  1, 1990 and February  1, 1991.  See T. 
Randall,  Some Promotions  Began Before,  But  Extended  Into,  Grace Period  of 
AMA/PMA  Guidelines,  Journal of the American  Medical  Association  265, no. 18 
(May  8, 1991): 2309. 
33. Infectious  Disease Society of America,  p. 792. 
34. American  Surgical  Association,  p. Ixxvi. 
35. W. Parrnley  et. al., Task  Force I:  Background  and General  Principles, Journal of 
the American  College of Cardiology 16, no.  1 (1990):  7-10. 
36. Kessler, D.  and Pines, W., The  Federal  Regulation  of Prescription  Drug 
Advertising  and Promotion,  Journal  of the American  Medical  Association  264, no. 18 
(1990): 2409- 2415. 
37. Drug  Advertising  Regulatory  Action  By FDA  Appears  Likely:  FDA  Collecting 
Records on Repeat  Offenders  in Preparation  for  Setting  Object  Lesson,  F-D-C 
Reports, February  18, 1991. 
38.   . . . The  Hit  List,  PMA  NewsZetter33, no.  19 (May  13, 1991): 1. 
39. Authority  Uncertain,  FDA  Tries  to Enforce  AMA  Promotion  Guidelines,  PMA 
Newsletter 33, no.  12 (1991):  1. 
40. FDA  WiII  Set Up  Drug  Promotion  Abuse  Hotline  for  Physicians and 
Pharmacists; Agency  is Still  Considering  Criminal  Prosecutions  as Object  Lesson. 
F-D-C  Repom  (April  29, 1991): l-2. 
41. RX  Drug  Advertising  Will  Be Tar&F1 of New  FDA  Enforcement  Effort,  PMA 
Newsletter 33, no. 9 (1991):  1. 
42. Open  Label,  Seeding Studies for  Unapproved  Uses Will  Be Regulated  as 
Promotions;  FDA  is Watching  Symposia Setting  and Conflict  of  Interest  Issues, 
F-D-C  Reports (September  24, 1990): 16. 
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