-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 company’s gift or financial 

arrangement imposes on a physician to prescriie the company’s drugs. 

l Many of the physicians we spoke with acknowledged that these types of d+g 

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 

Offers Used for Promotional Purposes. ............................... 4 

Influence of Promotion on Prescribing. ............................... 9 

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 government’s and the industry’s 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. Massachusetts’s 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 public’s awareness of issues that have been publicized several 

times over the last three decades. As early as the 1960’s, congressional hearings . 

exposed widespread questionable pror notional practices. Senator Edward M. 

Kennedy sponsored a series of hearing; in the i9’;o’s around these same issues and, 

partly as a result, introduced S. 1831 in 1977. This bill’s 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.~+:*dlevaluate the potential hazards 

these practices present to physicians and ,-he,practice of good medicine. We will 

then summarize and evaluate the gov,,-, blent, _. 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. oft’ers 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 

F,- (without being asked) that they had been approached to participate in studies that 

had promotional purposes as well as the stated purposes. Examples of the -

comments we heard include: “Drug companies couldn’t 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. 

They’re 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 hospital’s formulary committee. He described 

how one pharmaceutical company offered large research grants in exchange for a 

physician requesting inclusion of one of the company’s 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,competitor’s 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 competitor’s 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 company’s drug. Studies that use unacceptable scientific 

5 
methods or require the physician to switch therapies from a competitor’s 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 EFFECl’IVENESS 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 ;!Y“qlaceutical 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 physicianspeakers 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 institution’s or organization’s 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 gynecologist’s 

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 company’s 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 

discussions about a particular product. -.’ .i 

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 company’s 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 allexpense-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 

USEFUL FOR MEDICAL 

PRACTICE 

Appointment books 

Calendars 

Clocks 

Drugs for patient use 

Educational material 

Flashlights 

Literature sear+ea 

fiedical equipment 

Note pads 

Pencils 

Pens 

Pointers 

Post-it* notes 

Rulers 

Textbooks 

TrayS 

PROMOTIONAL ITEMS OF PROMOTIONAL ITEMS OF 

LITlIE VALUE SIGNIFICANT VALUE 

Breath mints Deep sea fishing trips 

Candy Drawings for prizes 

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

Golf balls Meals in restaurants 

Jump rope Tickets to spotting eventa and 

Key chains theater 

Meals&a&s in the hospital Wine 

Mugs

so& 

TayS 

Rmwional pmctices involving iterm of value appear to affect p?zyisickms’prescribing 

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 sponsor’s 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 company’s gift or 

financial arrangement imposes on a physician to prescribe the company’s 

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 

physician’s 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, “Isn’t it a bit sleazy to 

take the corsage without at least yielding its sender a place on one’s 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 receiver’s 

perception of a company’s 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 conoany’s 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 he’s 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 don’t 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, I’d 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 physician’s 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 physician’s 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 representative’s 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 _.. 

* 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 

I 
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 AMA’s 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 physician’s 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. 

ACOG’s 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 profession’s 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; yament y 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 Cardiology’s] 

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-Ayerst’s “Patient Profile Program” (see p. 

1) and i.: collecting information about many other promotional programs offered by 

nuns rr’ls 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 public’s 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 company’s 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 company’s 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 drug’s 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 
1 

2 

3 

4 

5 

6 

7 

8 

9 

10 

11 

12 

13 

14 

15 

16 

17 

18 

19 

20 

21 

22 

23 

24 

25 

26 

27 

28 

29 

30 

31 

32 

33 

34 

35 

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) 

The Council on Ethical and Judicial Affair6 submits the 

following opinion to the Rouse of Delegate6 for it6 information and 

recommend6 that this report be filed. 

GIFTS TO PIIYSICIANS FROM INDUSTRY. Many gifts given to 

physicians by companies in the pharmaceutical, device and medical 

equipment industries serve an important and socially beneficial 

function. For example, companies have long provided fund6 for 

educational seminar6 and conferences. Uowever , there ha6 been 

growing concern about certain gift6 from industry to physicians. 

Some gift6 that reflect customary practice6 of industry may not be 

consistent with princin1s.l; of medical ethics. To avoid the 

acceptance of inappropriate gifts, physicians should observe the 

following guidelines: 

1. Any gift6 accepted by physician6 individually should 

primarily entail a benefit to patient6 and should not be of 

substantial value ., Accordingly, textbook6, modest meals and other 

gift6 are appropriate if they 6erve a genuine educational 

function. Cash !aymr,nts should not be accepted. 

2. Individual gifts of minimal value are permissible a6 long 

a6 the gif t6 are related to the physician’6 work (e.g., pen6 and 

notepads). 

3. Subsidies to underwrite the costs of continuing medical 

education conferences or professional meetings can contribute to 

the improvement of patient care and therefcre are permissible. 

Since the giving of a subsidy directly to a physician by a 

company’6 sales representative may create a relationship which 

could influence the u6e of ,the company’6 product6, any subsidy 

should be accepted by the conference’6 sponsor who in turn can use 

the money to reduce the conference’6 registration fee. Payment6 to 

defray the costs of a conference should not be accepted directly 

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 physician’6 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. 

7 

7 

In the course of such interactions, there is the 

possibility that company expenditures will generate 

some degree of bias unrelated to product merit, creating the actuality or the appearance of inappropriate and undue influence. .When any product promotion leads to inappropriate or unbalanced medical 

advice or recommendation to patients, an ethical 

problem exists. The public holds physicians to a 

high standard of medical advice, and such advice 

should be as accurate, balanced, com,p!ete, and 

devoid of bias as possible. 

Industry-physician interactions can be divided 

into three major types, as characterized in the following paragraphs. Ethical implications specific to 

these types of interactions suggest areas in which 

the College and its Fellows should particularly strive 

to be circumspect. 

1. Product promotion to individual physicians by 

advertising, personalcommunicution, and provision of samples.The physician has an obligation to go beyond the information provided 

through advertising in selecting the best 

product for care of the patient. 

2. Company promotion to individual physicilins and 

groups of physicians, such as medicalspecialty 

societies, by provision of noneducational gifts, 

parties, trips, and services.Company promotional practices directed to indi ridual physicians or to professional groups without concomitant educational benefits have the 

potential for unduly influencing physicians 

and generating a sense of obligation which 

could prejudice optimal health care. The 

College has promulgated guidelines to clarify its relationship to these activities. Indigroups, including specialty societies,hospitals, 

and medical schools,through the support of educational activities, honorary awards, research 

grants, and developmentcontracts. Whenever 

there is a relationship between the College 

and industry in the educational area, it is 

desirabls-for the College and its Districts 

and Sections to establish basic principles 

govemine industry’s participation in the 

support a::d ‘s;;onsorship of educational 

activitres. Support of educational programs 

and the provision of awards, grants, and 

contracts may be accepted by the College 

and its members if such support is offered 

in accordance with the following guidelines: 

.-‘. A*vards should be based on merit (socie­

.al, educational, or scientific) and should 

be granted on a competitive basis. 

b. No obligation should be imposed or 

implied by the provision of funds. Provision of funds should not affect the 

experimental design, methodology, or 

results of grant-supported programs. No 

topic or speaker restrictions on educational programs should be accepted. 

Educational programs carried out with 

support from industry should present a 

balanced view of treatment options and 

should not be biased toward a specific 

product or procedure lest they be construed as a form of paid advertising. 

c. The sources of support and the relationship between these and the investigator 

or speaker should be a matter of public

record and should be made explicit at the 

tune of publication or presentation. / 
-- -- 

30 CONTI ET AL. 

TASK FORCEV JACCvol. 16, No. I 

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 

The delivery of cardiovascular care has undergone dramatic changes. New technologies, therapies and systems for 

health care delivery have emerged and have done so largely 

through cooperative efforts of our profession and industry. 

These developments have benefited our profession, the 

industry and, most importantly, our patients. Further development will require continued cooperative efforts. Yet 

such efforts are threatened by increasing concerns regarding the motives of those involved (l-3). Enormous amounts 

of money are involved in health care (approximately 12% of 

our gross national product or $550 billion in 1988;..ir’r.jLIcians largely control how this money is allocated. Therefore 

it is not surprising that industry devotes much of its markcting to physicians to influence prescribing habits and purchase of their products. Physicians and their patients benL,lt 

from these activities when the relation between pbyslcians 

and industry is based on ethical principles ,qd mutual 

respect. 

Ethical behavior ultimately is an individual decision but 

it must be appreciated that it is the perception ?y patients, 

health policy makers, the media, and others, of our ethical or 

unethical behavior that will determine society’s response. 

The cardiovascular community (physicians, industry. institutions and organizations) has a special obligation to help 

define the boundaries of ethical behavio: in their relations. 

A guiding principle for physicians must be that their decisions about patient care are determined by the health needs 

of the patient and not based on inappropriate monetary. 

scientific or academic gains. Physicians must r.ot be influenced by any incentives that would cause them to act in a 

manner contrary to their best professional judgment. What 

follows are guidelines to assist those who must make decisions relating to ethical behavior and conflicts of interest in ‘. this area. 

Reprinted with permission from the American I - - -. - ..-

II. Industry-Sponsored Programs 

or Conferences 

Much of our educational activity is financially supported 

by industry. in general this has been beneficial for physician 

education, and continued support for these activities should 

be encouraged. However, the primary objective of such 

programs must be educational. Programs should not be used 

to promote the products of the sponsor. Selection of topics 

and discussants should be determined by the medical director of the program or the staff to which the presentation is to 

bc made. Honoraria for faculty participants should be in 

keeping with the participants’ contributions. Honoraria and 

induccmcnts for audience attendees should not be accepted. 

Payment of expenses for attendees may be acceptable in 

situations consistent with educational objectives with appropriate accrednation. For example, appropriate situations are 

those in which the attendees are faculty participants and in 

which the program control and selection of attendees is 

dctcrmincd by physicians, without restriction by industry. 

Lavish entertainment and gifts are inappropriate. Expenses 

should not be paid or reimbursed for spouses or guests of 

attendees. Provision of meals as part of a meeting is an 

acceptable practice. Speakers sponsored by industry should 

bc identified in the program or at the time of the presentation. 

B. ltldl4.~try-iniiia[ed Conferences 

Particular attention should be given to conferences organized and conducted directly by industry. Physicians participating as faculty in such meetings have an obligation to 

present scientifically balanced information. They are frequently well recognized leaders in the field whose recommendations are readily accepted. Their comments must not 

be subject to approval or censored by the sponsoring comCollege Cardiology _^^^ of __ - _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 

teaching institution endorse the conference. The program 

chairman should be responsible for final selection of topics 

and discussants. Conferences devoted to a single drug or 

device produced by the sponsoring company may be appropriate if no other treatment alternatives are available or 

special procedures are required for proper utilization. However, conferences devoted to a single drug or device in 

therapeutic categories in which other equivalent treatments 

are available should be discouraged unless strict guidelines 

are enforced; for example, the conference is advertised as 

such and attendees pay their own tuition or expenses. or 

both, to attend. 

Those invited to attend an industry-initiated. program 

should not expect or accept inducements to attend. High 

quality industry-sponsored programs do not require induccments to obtain attendees. The practice of accepting cash 

incentives to attend is to bc condemned. 

C. Physician-Initiated Program 

Many educational programs are physician initiated but 

totally or partially sponsored by industry and frequently held 

at resorts or attractive locations as an inducement for 

physician attendance. Many such conferences could not be 

held if it were not for industry support, and acknowledgment 

of that support is appropriate. It is particularly important 

that these programs are organized and conducted primarily 

as e&:ational events. The program chairman should be 

responsible for selection of topics and discussants. Attendees not participating as faculty should pay tuition and travel 

d:pP :lsic 

D. II: Astry and Trainees 

Previous comments pertaining to physicians and their 

relation to the health care industry also apply to physicians 

in training. However, the latter may be particularly susceptible to marketing efforts. Supervising physicians, particularly directors of training programs, should take an active 

role to assure that ethical principles are adhered to by all 

parties. Pharmaceutical companies frequently provide meals 

at educational programs conducted for physicians in training. Representatives of the companies are often permitted to 

briefly present product information at these conferences. 

This is an acceptable practice if all pharmaceutical companies that wish to participate have equal opportunities to do 

so and if supervising physicians are in attendance to ensure 

a balanced presentation. The direct personal acceptance of 

meals or entertainment at functions without a significant 

educational component is discouraged. 

III. Publications Sponsored by Industry 

Most scientific journals receive significant financial support from industry advertising. Such support is necessary 

and appropriate if it does not influence editorial decisions. 

Furthermore, publication of proceedings of educational programs supported by industry is common practice. Publication of these proceedings may be of value, but there is the , 

potential for the presentation of biased information. Publication of these proceedings should be subject to peer review 

in a manner similar to that of unsponsored manuscripts 

submitted to that journal. Proceedings to be published directly by industry should undergo review by the faculty 

involved or an independent group of authorities. 

IV. Gifts ’ 

Gifts lo physicians may represent appropriate gestures or 

inappropriate acts. The principles to be employed are the 

reasonableness of the gift or payment for the service rendered and the gift’s effect on physician decision making. The 

following examples are used to illustrate these concepts. 

Small gifts. Physicians frequtntly receive small items, 

such as pens, notepads or appointment books, from industry 

representatives. These usually are given when the representative discusses their company’s product with the physician. Inductry views these items as important for product 

recognitior,. This is acceptable practice. 

Large gifts. It is an increasingly common practice to 

encourage physicians to use a certain product by linking the 

use-of that product to inappropriately valuable gift> and 

finaricial or other rewards. For example, physicians may 

receive financial incentives such as frequent fly,, ;,:ograms 

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 

physicians ‘.o prescribe the drug. Provision of t:le drug free 

to the patirnt does not justify this prac:?e. 

Reimbursementfor surveillancr z!:.*i&. However, it is 

appropriate to reimburse physicians participating in legitimate postmarketing surveillance studies (phase IV) that are 

guided by protocols approved by institutional review boards. 

These studies can be an important part of the continuing 

development of a product. 

Hospitality suites at medical meetings, These are commonly provided and are acceptable if they are primarily used 

for social functions. 

Consultation feesfor physicians’ services. These are acceptable practice provided the fee is commensurate with the 

services performed. 

Market researchfocus groups. These are common practice. Individuals are usually paid for participation in the 

focus group, which is an acceptable practice if physicians’ 
32 CONTI ET AL. 

/ TASK FORCE V 

comments are uninfluenced by the sponsoring organization 

and honoraria are in keeping with the service provided. 

General guidelines for giving and accepting gifts. Anything given to physicians by industry should not be I) a 

reward for selecting a specific product; 2) an incentive for 

selecting a product otherthan on scientific grounds (educational material about a product is an acceptable form of 

incentive); 3) out of proportion to a need, for example, 

foreign trips to view a facility or equipment. The recommendations of the Royal College of Physicians that acceptable 

gifts are those that are “inexpensive and related to the 

practice of medicine” are appropriate: “. . . a useful criterion of acceptability may be-would you be willing to have 

these arrangements generally known?” (4). Physicians 

should not accept or demand lavish gifts such as dinner or 

entertainment to discuss a representative’s product. 

V. Physician Ownership of Health 

Care Facilities 

The economic philosophy of our society not only supports but encourages individual economic investment. Physician participation in the ownership of health care facilities, 

such as imaging centers and mobile cardiac catheterization 

laboratories, is increasing. Although currently legal, there is 

considerable debate as to whether physician ownership of 

facilities to which they refer patients is ethical. The potential 

for unethical behavior or the appearance of a conflict of 

interest occurs whenever physicians gain financially from 

their patients’ expenses for services the physician orders but 

does not provide directly. It appears that patients generally 

are unaware of their physician’s involvement in these facilities. Physician involvement in such activities may bc acceptable if these activities clearly improve patient cart 

above that available in the community. It is mandatory that 

physicians disclose to their patients their financial interest in 

such facilities. 

Unfortunately health care facilities are often developed in 

areas that already have adequate facilities. The introduction 

of new facilities without evidcncc of need will incrcasc 

medical care costs-this in itself is unethical. 

VI. Physicians’ Relation to Institutions 

and Organizations 

A. Institutions 

Hospitals depend on physicians to maintain an adequate 

patient base. Today, a large number of hospital beds are 

unfilled and competition for patient revenue is intense. 

Increasingly, institutions are awarding incentives to physicians in order to attract patients. Physicians should determine where to refer their patients on the basis of the quality 

JACC Vol. 16, No. I 

July 1590: l-36 

of care provided by an institution regardless of financial 

incentives to the physician. 

As a result of the intense competition for patient revenue, 

physicians may be subject to pressures from institutions to 

increase such revenue. This is particularly true for physicians salaried by or under contract to institutions such as 

managed care facilities and faculty practice plans. The 

practice of publicly comparing physicians by revenue generated. hospital revenue saved or procedures ordered is often 

designed to enhance profits, with a disregard for the quality 

of patient care. Institutions should be concerned primarily 

with the quality of care provided by their physicians. Conversely, physicians must have an awareness of the financial 

pressures institutions are under and avoid unnecessary overor underutilization of resources. Physicians have an obligation to cooperate with administrators in determining costeffective strategies for their institution. 

Phy,icians are generally members of several professional 

organiz;tions or societies. Physicians in positions that influence the activities or decisions of these organizations must 

avoid any potential conflict of interest. Organizations should 

insist on and physicians agree to disclosure of any arrangements they or their immediate families have with the corporate sector that could lead to conflicts of interest, for 

example, the holding of stock, equity interests, directorships 

or consulting relations with a company. Obviously physicians must avoid partlclpating in decisions that affect companies in which they have financial arrangements. These 

precepts do not imp!, ?hat physicians should not have 

financial relations w’it;l mdustry but that these relations must 

be revcalcd bcforc situations occur in which there is potential conflict of interest. 

VII. Ph,kcisns, Industry and Research 

Physi,::? ,.I% indispensable to the health care research 

conducted bj industry. The maintenance of scientific integrity by all partics in these endeavors is essential. Industry 

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 

or equity interests, that would result in financial advantage 

based on the results of the study. 

The use of inside information for personal gain by physicians involved in research or data review is both illegal and 

unethical. 

When participating as an investigator in industrysponsored single investigator clinical research or multicenter 

trials the investigator I) should not be given personal incentive payments or rewards for accomplishing a research 

protocol; 2) should not hold direct significant financial inter-
JACC Vol. 16. No. I 

July 1990:l-36 

est of any kind in the product under investigation: 3) should 

have a role in choosing the safety and data monitoring 

committee; 4) may participate in “postmarketing (phase IV) 

research” of the product investigated; 5) must divulge payments to patients to the institutional review board; 6) may be 

considered as a “preferred” speaker relating to the clinical 

research; and 7) should be cautious about prcmaturc promotion of a drug through lectures, news media or other means. 

VIII. Conclusions 

The following are guidelines for ethical behavior of cardiovascular specialists relating to industry. institutions and 

organizations. 

1. Genen!. 

A guiding principle for physicians must be that their 

decisions about patient ca;e are not based on monetary. 

scientific or academic gain. Physicians mus; not be influenced by external financial incentives in such a way that 

would cause them to act in a manner contrary IO their bcs~ 

professional judgment. 

2. Industry-spon. .xed programs or conferences 

The primary objective of such pograms must bc cducational, and the programs should not be used as promotional 

tools. 

A. Indusrry-inifiared conferences. Physicians participating as faculty members in such meetings have a special 

obligation to be sure that unbiased information is presented. 

B. Physician-initiated program. Programs must be organized and conducted primarily as educational programs. 

Industry should not specify speakn:; or topics. Attendees 

should pay tuition and travel expenses. 

C. Industry and trainees. Supervising of physicians. particularly directors of training progra7.s. sl:,uld take an active 

role in assuring that ethical principles are adhered to by all 

parties and that material is presented in a balanced way. 

3. Publications sponsoredby industrv 

Publications should be subject to geer review. 

4. Gifts from industry 

Acceptable gifts are thibJ: that are “inexpensive and 

related to the practice of meoicine . . .-a useful criterion of 

acceptability may be-would you be willing to have these 

arrangements generally known?” (4). 

5. Physician ownership of health care facilities 

Such ownership is acceptable if it clearly improves piitient care above that which is available in the community. 

Disclosure of ownership to patients is mandatory. 

CONTI ET AL. 33 TASKFORCE V 

6. Relation of physiciansto institutions and organizations 

A. Institutions referral. Physicians should base decisions 

of where to refer their patients on quality of care issues and 

the ability to provide better care. regardless of financial 

incentives lo the physician. 

B. Organizations. One must avoid participation in decisions affecting companies in which one has financial arrangements. . 

7. Physicians,industry and research 

Physicians should not hold direct, significant financial 

interest of any kind (including equity interest) with a company whose product is under investigation. 

Physicians hold a favored position in society because 

society perceives us as being unique. We have the ability to 

cure their diseases, alleviate their suffering, allay their 

anxieties and our rewards for doing so are considerable. 

Only as long as society perceives these to be our primary 

goals will we retain this favor of society. 

References 

I. Brickcr EM. Industrial marketing and medical ethici. N Engl J Med 

iYXY:3!0: IhYIl-2. 

7-. Inglehart JK. Health policy report: the debate over physician ownership of 

heallh care facilities. N Engl J Med IYHY:32I:IYX-204. 

3. Blcndon RJ. The public’s view of the future of health care. JAMA 

IYXX:!.5Y:?~P7-Y3. 

4. Repon of he Royal College of Physicians. The relationship between 

phySiCiNN dnd the pharmaceutical industry. J R Coll Physicians Lond 

1986:20:235-42. 

Selected Reading 

I. Relman AS. Dealing with conflicls of inreresl. N Engl J Med 1985:310: 

1182-3. 

2. Goldlinger SE. A mailer of influence. N Engl J Med 1987:316:1408-9. 

3. Egdahl RH Taft CH. Financial incentives lo physicians. N Engl J Med 

lY86:315:%-61.’ 

4. Morreim EH. Conflict of interesl: profits and problems in physician 

referrals. JAMA lY89:262:390-4. 

5. Kelman AS. Antitrust (aw and the physician entrepreneur (editorial). 

N Engl J Med 19X5:313:884-5. 

6. Hyman DA. Williamson JV. Fraud and abuse. Setting the limits. N Engl J 

Med IYX9:3~0:1272-8. 

7. Healy B. C;:mpeau L. Gray R. et al. Conflict-of-interest guidelines for a 

multicenter tlinical trial of treatment after coronary-artery bypass-graft 

surgery. N xngl J Med 19X9:320:949-51. 
GUIDELINES FOR COMMERCIAL SUPPORT OF CONTINUING MEDICAL EDUCATION 

(Revision of guidelines previously approved by ACCME: June, 1984) 

PREAMBLE 

The purpose of continuing medical education (CME) is to enhance the physician’s 

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 

1’11f* Atllr*ri\3\\ S\irgic:\I hss\iri;\lioii Il;\s co\\sitl\*rc-tl 111~ 

c*tllic:tl ilnplic;\tio\\s of \\\nrkrti\\g pr:\cticc*s of ~o\\\l~:\t\i\~r 

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~tlprittc*ip;\lly fruit\ corpot.;\lc I~oclics ni\tl wt’rt’ 

~i~o~.itlt*\l It1 grotips, sociclit5. ;rncl ;\c;\tlc~t\tic clc*p:\rltt\t~ttls. 

IO ~~1~011101t~~tiocl will tow;\rrl corptmlc t~;\~\tcs. 

Iii rrcriil yt*;trs (Iir praclicr of cut\cctttrnlitt~ OII ~~roclttc~l 

l~rt)tt\ttlitlt\ l)y I;\rgrLi\\g i\rtlivici\\;\l s\\rg!ro\~s II;\s l~c*\r 

ittt*t.t*;\sittgI!. t*viclc*t\l. II is II\c* ittiplict\liot\s of Iltis ~I:III~~ 

iii :l~l~~l~0;ll~ll Ilt:lI Ili1S IWcOlllP ;I c3iit~c~rtt of lltc* hrttt~ric~:ttt 

StIrgit.:tl A<sot~i;tlitttt. As n rc:sttll. IIIV Associ;\tiott fc*cls IINIlt.:\t’lic~t* 01’ I~t~tivitlitt): clirc*cl ~~il~l111'1l1 to s\ir~c~\~\\s for tll(-

IIIII IIO~I*S III' pt‘fittirtlittg :\ protlttcl is itot it\ 111~7hl itilc~rcst 

01 1>;11ic*tll<. 01 III<* prfift-ssioti of stttpry, or of Il\c it\lrt\tlf~tl 

I r.u.if)it.lbl rll’ IIic* sitljsitly. :\iitl tttitst Itr cttttsiclr*rc~tl :\s 

Ildlr~lltic.:ll jjt:it’lic.c- if IIIV \*\llicw\\c*\\t is ;~cccp~rcl. TIIV 

II~,I.(I ltji. ii~tlilslr~ to ptmii\t~lr its prod\\c\s is well uicclc-rsl~~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 

c.ollsi(lt*wcl :IS :I forttt of hril)cry. Tl~c prt~tttotiott;\l t*ll’orl 

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\tslry’s 

ptmtttotiutt;\l ittllurttcc. Tlw ct~cl rrsult 111ny 1~ n loss ttf 

ol,jc-c.ti\~iI\- sc*c.ottcl;\ry 10 IJi;\s evokrcl I)y 111~ cttticctrtc~t\I. 

Ct)tisiclrrittg IIIV itttportt\ttcc~ of tlccisiotis itttpx-tlttg Ott III<. 

C':Il'(' of p:t\ic*ttts. 11th pclssil)ili\y is IIO~ nccrptnlJc*. Ttj 

clislillcilizli Iic~lwc~rii wllnt is i\CC.Cl)l:\l)lC :I\111 WI\:11 is IlOl. 

I/I(* f’ollo\t~illg posiliott 1~1sIJWII Inkcn: 

II is llir posilioii of Ll\c A\\\rric;\ii S\irgic;ll Associ:\liot~ 

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;tlt’tl 

iitcl\isl\.y. will\ no rdntio\\sl\ip lo proftxisio\\:rl scrviw rt*\iclrrrcl 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 

Society of America that individuals are elected ‘.o 

membership or fellowship “on the basis of evider,cc 

of high professional and ethical standards,” and 

the Society considers ethical conduct IO be an implicit requirement of continued membership. P:ovision exists also in the By-Laws for the expulsi.)n 

of any member for cause. In an era of heighten,:d 

concern over the ethical aspects of conduct in a 

highly complex society, involving relationships 

among individuals, educational institutions, hospitals, private corporations, and government, the 

Society has attempted to identify certain featcres 

of these relationships requiring careful consideration by the parties entering into them. The Society 

recognizes its inability to legislate the morals of its 

members and of those with whom they interact II 

does expect, however, that each member recogr‘ze 

his/her full responsibility to the Society and to the 

medical profession to maintain standards of conduct that will stand full public scrutiny. 

To assist members in achieving this desideratum, 

the Society has identified a number of areas whcrc 

attention to the concepts and procedures set forth 

may help to avoid misunderstandings and perceptions of questionable or of improper conduct. T~)s 

latter goal is best achieved, perhaps, through ;hc 

use, whenever possible, of peer review and of lull 

disclosure of relationships established for the furtherance of scientific investigation. To assist mcmbers who do not have suitable institutional affiliations for the purposes described, the Society sho:ld 

consider the establishment of committees or of 

panels to fulfill these functions for members who 

request them. 

Research Proposals 

Conlenl: Whether initiated by the investigator 

or by another individual or agency, the proposal 

should be subjected to peer review by an accz>table agency that does not have a vested interest in 

the outcome of the investigation. 

Human Su&‘ecf.sz Evidence of compliance with 

existing regulations should be documented for all 

. 

research involving the participation of human sub. 

jccts. impartial review of all such proposals by a 

third party should be mandatory. 

funding: Whcncvcr possible, defrayal of inves. 

tigalional costs should bc institutionalized. Funds 

from the donor should flow through institutional 

channels (univcrsi(y, hospital) rather than being 

naid dire&- 10 I hc investigator. All financial trans. 

actions should bc subject IO audit and available for 

public disclorurc if and when appropriate. Funds 

acccpred for specific purposes should be utilized 

solely for those purposes and should not be di. 

vertcd for personal or for ihstitutional use for purposes other than those stipulated under the terms 

of.the award. 

I PuhXalion 01 Resdts: No contract should be 

?ntered into that rcstrlcts the prompt disclosure of 

-findings that affect, in any way, the public welfare, 

‘Disclosure of support from a sponsor with a vested 

intercsr in the outcome of any investigation should 

always accompany oral presentation or publication 

of rcsitlls. 

Pcrsonul Condurl 

Mcmbcrs of the Socrcty should be constantly sensitive to [hc need not only to do no wrong bllt also 

to the need not In ~.i:p :hc appearance of doing 

wrong. 

(A) In fulfilling functions in which there may bc 

rhc appearance of a conflict of interest, full disclosure of rclnrionships P-nong the involved partics 

should be made. 

(B) Inrcra-‘ioqq between industry and members 

of the Crcirlv tind their affiliated institutions may 

be mutual!y beneficial. Such relationships should 

always be disclosed by members of the Society who 

are involved in any governmental advisory or regulatory process. Because members of the Socict! 

mosl knowlcdgcablc abour a given drug or dcvicc 

and most frequently called upon IO testify about ir 

arc often those most likely to have had some contact wit;i its manufacturer, they are the ones also 

at grcatcst risk of finding themselves confronlcd 

with a conflict of intcrcst. Such conflicts may arise 

[Edifor’s 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 relationships that are nonetheless opnn to varying interpretations when subjected to public scrutiny. If 2nd 

when potential for conflict exists, a member should 

consider declining to testify unless such testimony 

is both essential to the -public interest and is preceded by a statement describing all potential 

conflicts. 

(0 Individuals should guard against excessive 

reimbursement for services to industry; e.g., honoraria for lectures, fees for consultation, and perquisites for attending meetings or other sponsored 

activities. Acceptance of such honoraria and fees 

should be in accordance with the regulations of the 

individual’s primary employer. 

(D) Individuals engaged in consultative or contractual activities with industry should recognize 

the implications of other financial relationships, 

such as the ownership of stock in companies they I 

are advising. 

(E) Individuals Iiaving financial relationships 

with industry should be equally careful in choosing the content of material for oral or written public presentation not subject to prior review as the) 

are in preparation of material subject to editorial 

review prior 13 publication. Investigators should be 

especially sensitive to the potential conflict of interest arising from the written or verbal endorsement of products for the study of which they have 

received financial support from industry. While it 

is evident that peer review and opinion will rectify, 

in time, erroneous or biased views (the professional 

integrity of the faculties of the medical schools 

being probably the strongest ethical force in the 

system), harm may result in the interval between 

presentation and its rectification. 

(I;) Individuals whose speaking engagements are 

funded by industry should encourage industry to 

support institutions seeking speakers, so that the 

latter institutions may make their own selections 

and have direct financial dealings with speakers. 

Speakers receiving honoraria directly from entities 

that support their work or in which they have a 

financial interest should consider filing with their 

brimary employer (or the Society) a periodic 

itemized accounting of such stipends, to be available for public scrutiny. 
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 (19”s): 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, “Salespeople’s 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 Continuing Medical Education, Guidelines for 

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 company’s 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 & Dohme’s 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.) 

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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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