Invited Editorial

In Defense of Industry-Physician Relationships

DON K. NAKAYAMA, M.D., M.B.A.

From the Department of Surgery, Mercer University School of Medicine, and the Department of Surgical
Services, Medical Center of Central Georgia, Macon, Georgia

The objective was to examine the economic, ethical, and legal foundations for conflict of interest
restrictions between physicians and pharmaceutical and medical device industries ("industry").
Recently academic medical centers and professional organizations have adopted policies that
restrict permissible interactions between industry and physicians. The motive is to avoid financial
conflicts of interest that compromise core values of altruism and fiduciary relationships. Pro-
ductive relationships between industry and physicians provide novel drugs and devices of im-
mense benefit to society. The issues are opposing views of medical economics, profit motives,
medical professionalism, and extent to which interactions should be lawfully restricted. Industry
goals are congruent with those of physicians: patient welfare, safety, and running a profitable
business. Profits are necessary to develop drugs and devices. Physician collaborators invent
products, refine them, and provide feedback and so are appropriately paid. Marketing is necessary
to bring approved products to patients. Economic realities limit the extent to which physicians
treat their patients altruistically and as fiduciaries. Providing excellent service to patients may be
a more realistic standard. Statements from industry and the American College of Surgeons ap-
propriately guide professional behavior. Preservation of industry-physician relationships is vital
to maintain medical innovation and progress.

A CROSS-THE-BOARD CONFLICTS of interest restrictions

risk the unparalleled advances in medical tech-
nology that we enjoy today. Recently academic med-
ical centers and professional organizations have
imposed restrictions on the activities of the pharma-
ceutical and medical device industries (collecdvely
termed "industry") in hospitals and medical school
campuses nationwide.'"^ Their policies govern the
relationships that are permissible between industry
representatives and physicians, residents-in-training,
and students. The motive is to avoid financial conflicts
of interest that compromise the core value of altruism
in the practice of medicine. In their view profit motives
and financial gains unavoidably introduce bias in
medical decision making and violate public trust.
Editor's Note: Occasionally, the journal solicits or accepts
manuscripts that are of an editorial nature. This offering by Dr.
Nakayama outlines issues in relations between physicians and in-
dustry. Please note the author has no financial relationships with
industry and receives no support from same. Dr. Nakayama is
currently Chair of the Department of Surgery at Mercer University
School of Medicine in Macon, GA. These are his thoughts on the
current state of industry relation to medicine and physicians.
Address correspondence and reprint requests to Don Nakayama,
M.D., M.B.A., Department of Surgery, 777 Hemlock Street. MSC
140, Macon, GA 31201. E-mail: Nakayama.Don@mccg.org.
Table 1 summarizes restricdons proposed by Brennan
and colleagues and adopted by several academic med-
ical centers.'*' ^- ^' ^ The regulations themselves grew
from alleged and some real confiicts of interest in-
volving both drug and device trials.^' '° But scien-
tific misconduct, fraud, and dishonesty are noteworthy
because of their rarity. The vast majority of industry-
sponsored research results in beneficial drugs and
devices of immense benefit.^ Some restricdons are
reasonable, such as disclosure by physicians of any
contractual reladonships with a specific medical or
surgical product and company in published articles.
Others are more extreme, such as prohibiting off cam-
pus contacts with industry representatives and all gifts,
even note pads and pens. A total purge of all financial
confiicts of interest has become the touchstone of
medical professionalism.
There has been little acknowledgment of an appro-
priate middle ground that acknowledges the rights of
indust;ry, physicians, residents, medical students, pa-
tients, and the public to the benefits that reasonable
interacdons may provide. Physician researchers and
inventors are responsible for an overwhelming array of
drugs and devices that depend upon industry for
product development, production, and marketing.^ The
list of devices alone is staggering (Table 2). Industry
depends upon physicians to enroll patients in clinical

987
988 THE AMERICAN SURGEON September 2010 Vol, 76

TABLE 1. Industry-Physician Restrictions

Zero-tolerance for industry detailers ("drug reps") on campus
Zero-tolerance for gifts of any kind
No drug samples directly to physicians
Ban from the pharmacy and therapeutics committee ("formulary committee") any physicians who have a financial
relationship with any drug manufacturer, including any that receive any gift, inducement, grant, or contract
Prohibit any pharmaceutical industry company from sponsoring a specific continuing medical education event
Prohibit industry funding for individual physician travel (including resident physicians)
Prohibit faculty-physician or faculty researcher service on industry speakers' bureaus
Prohibit faculty f'rom listing themselves as authors of ghost-written publications
Prohibit "no strings attached" grants or gifts
Make available on a publicly available website all grants, gifts, and industry ties by faculty
Prohibit off campus any behavior, relationship, or situation that is prohibited on campus

trials and to test prototype devices in human pro-
cedures and surgical operations. Companies need their
representatives to interact with medical providers to
get their products to market using ethically and pro-
fessionally acceptable marketing and advertising prac-
tices. Every level depends upon professional interactions
between industry and doctors that are necessary as-
pects in a robust capitalist economy.
Those who propose restricted industry-physician-
patient relationships are thus in conflict with those who
recognize a beneficial relationship. The former group
cannot allow concessions to the latter without a viola-
tion of their sense of professionalism. The latter group
sees restrictions as an affront to their right to determine
how they will practice medicine and their own defi-
nitions of the ethical practice of medicine. The issues
of the debate are opposing views of medical econom-
ics, profit motive in industry, underpinnings of the
concept of medical professionalism, and extent to
which the practice of individual physicians in the
United States should be restricted by the force of law.
Medical Economics
Altruism is such a powerful concept in support of
conflict of interest regulations that it is helpful to re-
member the economic system under which the United
States pharmaceutical and medical device industries
operate," In a capitalist system products are developed
to generate profits. Profits, or the promise of them,
determine resource allocation. Companies use their
resources to either acquire or develop innovative drugs
or devices based upon market demand. They depend
on the market for feedback on how to refine their
product so that it better fits what doctors and patients
need. Once a product is developed, it has to be brought
to market through marketing and advertising.
Society, through government, has decided that such
innovation is socially desirable and is worth granting
industry patent protection on new drugs and devices.
Government regulations and requirements are com-
plex and rigorous, necessary to their functions of
determining drug efficacy and protecting public safety.
The process is costly and long, A single drug requires
$800 million and 7 to 12 years or more to come to
market, a good chunk of the 18-year duration of patent
protection.'^' '^ Only 8 per cent of drugs developed
become approved drugs.'-^ Even after governmental
approval, postmarket surveillance is necessary to de-
tect problems that may arise after drug introduction,
for which the company remains liable. After the long
process of drug development and satisfying regulatory
requirements, the company has a limited period of
monopoly pricing power over its product, if it is
adopted by the market. It is a high risk business, with
profitability of some companies being dependent on
a single drug or device. In one day, September 15,
2009, the share price of Salix Pharmaceuticals in-
creased more than 50 per cent on the strength of the
clinical studies of a single irritable bowel drug. An-
other company, Alexza Pharmaceuticals, saw its price
drop nearly 12 per cent because the effectiveness of its
migraine drug fell short of expectations.'"*
Despite necessary regulations the result has been the
transformation of United States health care into a global
high technology engine that has transformed completely
the practice of medicine and surgery. Its success is mea-
sured in the increase in longevity of nearly 10 years from
1950 to the present (68,2 to 77,9 years)'^- "^ and years of
productive life. The numbers of employed workers over
65 years have doubled from 1977 to 2007.'^ The in-
creasing health care costs in the United States are un-
deniable and a cause of concern; health care as a percent
of total United States gross domestic product has in-
creased from 5 to 17 per cent over the same period.'^
Critics point to outsize profits of the pharmaceutical
and medical device sectors, saying their profits are ex-
cessive and consistently exceed median profit margins
for all United States industries. The amount spent on
marketing and advertising budgets for single drugs
(Lunesta, for example) (Sepracor, Inc., Marlborough,
MA) approaches those for popular products like beer and
cars.'^'^° They see packaging and advertising as anti-
thetical to evidence-based literature. In their view the
No. 9 DEFENSE OF INDUSTRY-PHYSICIAN RELATIONSHIPS Don K. Nakayama 989

TABLE 2. Partial List of Innovations that Arose from Industry-Physician Collaborations

Critical care and trauma
Multi-lumen venous access catheters
Pulmonary arterial catheters
Intra-aortic balloon pumps
Advanced respiratory support
Extracorporeal membrane oxygénation
Bedside hemodynamic monitoring
Hemodialysis
Plasmapheresis
Blood substitutes
Advanced hemostatic agents
Parenteral nutrition
Enterai nutrition
Anesthesia
Pulse oximetry
CO2 and multigas monitoring systems
Bispectral index monitors
Transesophageal echocardiography
Rapid infusion systems
Forced air warming systems
Patient-controlled analgesia
Wound healing and bum care
Skin substitutes
Foam dressings
Negative pressure assisted wound closure
Surgical adhesives
Surgical devices
Bovie electrocautery systems
Laser photocoagulation
Argon beam coagulators
Photodynamic therapy
Harmonic scalpel
Ultrasonic cavitation devices
Radiofrequency ablation
Cryoablation
Surgical microscopes and microsurgery
Intraoperative imaging
Imaging
2-D color flow Doppler imaging
Stereotactic mammography
Ultrasonography
Nuclear medicine imaging
Computed tomography
Magnetic resonance imaging
Image-guided drainage procedures
Minimally invasive surgery
Microchip video cameras
Video endoscopy
Endoscopie suturing and stapling devices
Robotic surgery systems
Adjustable gastric banding
Endovascular surgery
Diagnostic angiography
Percutaneous transluminal angioplasty
Endoprostheses
Stents: self-expanding, drug-eluting
Drill- and laser-tipped angioplasty devices
Arterial occlusion coils and balloons
Intrahepatic portal systemic shunts
Endoscopy
Flexible upper and lower gastrointestinal endoscopes
Hemostatic interventions: clips, bands, heater probes
Biopsy and polypectomy
Biliary and pancreatic imaging, papillotomy, and stent placement
Natural orifice translumenal endoscopie surgery

{continued on ne.il page)

990 THE AMERICAN SURGEON September 2010 Vol. 76

TABLE 2. Continued

Critical care and trauma

Oncological surgery
Wire localization
Image guided core needle biopsy
Sentinel lymph node imaging and biopsy
Tumor marker genetic microarrays
Intraoperative radiation therapy
Implantable chemotherapy pumps
Vascular surgery'
Vascular grafts
Embolectomy catheters
Subcutaneous ports
Percutaneous dialysis catheters
Cardiac surgery
Cardiac catheterization
Cardiopulmonary bypass
Aortocoronary bypass
Pacemakers
Heart valves
Radiofrequency catheter ablation for arrhythmia
Nonsurgical occluders for septal defects and
patent ductus arteriosus (PDA)
Balloon atrial septostomy
Neurological surgery
Gamma knife (radiosurgery)
Computer-assisted image-guided stereotactic surgery
Aneurysm clips
Ophthalmology
Phacoemulsification
Intraocular lenses
Laser photocoagulation
Scierai buckles
LASIK
Otorhinolaryngology
Cochlear implants
Artificial middle ear ossicle replacements
Gynecological surgery
Pelvic floor prostheses for prolapse and incontinence
Endometrial ablation
Micro insert fallopian tube occlusion
Urological surgery
Extracorporeal shock wave lithotripsy
Artificial sphincters
Penile prostheses

money spent on industry marketing increases the costs of
health care and does not primarily serve patient interests.
Marketing and advertising are not contrary to high
quality evidence-based care," They are an integral
part of getting any product (i.e., pills to patients) into
the market Hospitals (including the same academic
medical centers that adopt restricdve conflicts of in-
terest policies) see the reality of market competition and
the necessity of advertising and markedng. In cides of
all sizes there are billboards and adverdsements in print
and electronic media that promote medical centers of all
types, private and not-for-profit, community, and aca-
demic. In Pittsburgh the University of Pittsburgh Med-
ical Center has its corporate logo on the top of the city's
tallest building, the former United States Steel head-
quarters. Their logo has a prominent place on the end
zone Scoreboard at the stadium where the popular
Steelers professional football team plays. Its billboard
advertising and annual reports win markedng awards.^'
Companies decide the amount of their resources to
devote to marketing with the expectadon that the
money spent will increase sales and profits. Starting
with an unknown drug or device a company has to
overcome established pracdces of surgeons and physi-
cians. An illustrative example is the development of
surgical stapling devices and minimally invasive surgery.
In both areas surgeons had an entire tradition of needles,
sutures, and open surgical procedures that were more
than a century old and were well established as standards
of care. The adoption of such radical departures of sur-
gical technique involved hundreds of millions of dollars
and years of marketing, advertising, and reinvendng
No, 9 DEFENSE OF INDUSTRY-PHYSICIAN RELATIONSHIPS
surgei7 through education, demonstrations, and product
samples. What started as a Cold War era side trip in
Moscow by an American surgeon who happened to be
fluent in Russian (Mark M, Ravitch) ended as a multi-
billion dollar transformation of surgery that depended on
industry and its surgeon collaborators,^^
The Profit Motive in Industry
Critics of industry-physician interactions have
a fundamental distrust of the profit motive in medicine.
They see market incentives posing extraordinary and
negative challenges to their view of medical pro-
fessionalism, the integrity of clinical research, and the
honest practice of medicine in patients' interests. They
say that any benefit that comes to physicians through
industry contact becomes suspect,^^
In fact, the goals of physicians and industry are re-
markably congruent and complimentary,^"^ Both want
effective medications and devices that benefit patients.
Physicians want them, industry wants to supply them.
Doctors want to learn new treatment modalities; in-
dustry wants to educate doctors in those techniques and
products. Both parties want effective treatments that
maximize benefit, minimize harm to the patients, and
minimize legal risks. Doctors want to run profitable
practices, companies want to run profitable businesses.
The first major area where physicians and surgeons
in practice collaborate with industry is in clinical re-
search. Industry depends upon physician researchers
with busy clinical practices to test drugs and devices
and report results. The physicians expose patients to
experimental drugs and procedures in the belief that
patients will benefit from participation. Neither in-
dustry nor physicians want harm to come to study
participants. Human testing is risky and exposes both
industry and clinical researchers to scrutiny and Ha-
bility. Consents are pages long. Human testing requires
review by institutional review boards and registration
with federal agencies. Publications undergo statistical
analysis and peer review. On the first page of articles,
authors have full disclosure of industry support and
federal registration of the clinical study. Physician
collaborators are necessary parts of product research
and development. They deserve and receive appropri-
ate compensation from industry,^"'"•^^
The next area is the vastly larger venue of marketing
and sales of drugs and devices after clinical research
studies have shown efficacy and safety. Physicians in
practice and their patients are the market, A company
has a relatively short period of patent protection to
recoup the hundreds of millions of dollars in product
development and testing. It uses marketing and ad-
vertising to get their product into doctors' practices
and used by patients. Past practices were egregious and
Don K. Nakayama 991
excessive: resort trips, golf outings, and expensive gifts
that bore no relation to the merits of the drug. Current
industry guidelines appropriately prohibit those prac-
tices, and restrict activity to educational activities that
are carefully segregated in space and time with contact
with industry representatives.^^ The reality of busy
clinicians' pracdces is that the only free hours in their
day are at lunch and suppertime at the end of the day.
Often the only weekdays they take off, besides vaca-
tion time with families (that are off limits), are at
professional conferences. So the only times for contact
that industry representatives can have with clinicians
are mealtimes and conferences.
However, critics maintain that such contacts still are
tainted by a sense of obligation among physicians to
provide a service in return and thus create un-
professional behavior, a sense of entitlement, and de-
mean the profession,2^- ^^ They say that after contact
with industry representatives physicians are more
likely to prescribe their drug and to request that the
drug be added to the hospital formulary,^^ Others argue
for independent boards or individual physicians to
evaluate drug and device efficacy,^' But what if a drug
is effective with demonstrated safety and efficacy? The
company intends that it will be adopted by practicing
physicians and added to hospital formularies. The
public benefits when effective novel therapies become
available.
Physicians have the training and sense of pro-
fessionalism to want the best for their patients and
protect them from harm. They have independent
sources of information through journals, practice-based
learning acdvities, and professional organizations to
confirm or refute industry claims, A study commis-
sioned by the Accreditation Council on Continuing
Medical Education, a voluntary professional associa-
tion, whose standards to which physicians' conference
organizers adhere, demonstrated no evidence that
commercially supported continuing medical educa-
tion was biased and that patients in no way were
harmed,^^ Physicians in practice have their pro-
fessional integrity and the safety of their patients in
mind, and are able to filter the message they get in
industry marketing.
The Underpinnings of Medical Professionalism
The concept that underlies prohibitions of conflicts
of interest is that a physician has a fiduciary relation-
ship with the patient,^^~3^ It is a legal term, meaning
someone who acts for and on the behalf of another in
circumstances that give rise to a relationship of trust
and confidence,^^ One in a fiduciary relationship acts
at all times to the benefit of the other, and does not put
his or her interests before those of the beneficiary, T"he
992 THE AMERICAN SURGEON
fiduciary has a duty not to be in a position where his or
her situation conflicts with his or her fiduciary duty,
and thus cannot have a conflict of interest with those of
the beneficiary. It thus describes the reladonship be-
tween a trustee and beneficiary, a guardian and a ward,
and an executor and the heirs. Does it describe a doc-
tor-physician relationship? In some aspects it does.
Certainly physicians make personal sacrifices on the
behalf of patients, getdng out of bed in the middle of
the night and foregoing dinners out and children's
soccer games when emergencies arise.
However there are several areas where physicians
fall short of the fiduciary standard.^^ They make
treatment recommendations for which they receive
a fee, a built-in conflict of interest that has to be
managed. Proposals to implement physician pay for
performance inidatives to improve quality and control
costs introduce perverse incentives to limit care for
sicker padents.-*^ They are not available to their pa-
tients all the dme—they arrange for others to share call
when they are away. Resident physicians, even when
they are in town, are prohibited from coming in and
treating their padents because of 80-hour duty hour
restrictions.'*^ The standards of care to which doctors
adhere are not defined by the maximal benefit to the
padent but reasonable standards of the professional
pracdce. The physician will make sure that padents'
emergency needs will be provided in his or her ab-
sence. So although a fiduciary standard might be ideal,
the realistic standard of a physician's duty of care to
patients is more realistic.
Part of the problem is the use of a legal term, fidu-
ciary, to describe professionalism.^^ Physicians have
an acquired sense of extreme caudon of anything as-
sociated with legal actions. "Fiduciary" is a word that
is not in everyday use outside of legal texts, contracts,
and the courtroom. Using legalese is guaranteed to
cause doctors to act slowly and cautiously.
Altruism is another term used to describe medical
professionalism."'^^ Most doctors enter the pro-
fession and later intentionally pracdce in underserved
areas or serve on overseas medical missions because of
a sense of altruism. However, pracdce expenses, pay-
rolls, and physicians' own bills and children's tuidons
have to be met. Some decide to limit the numbers of
patients who have government-sponsored insurance.
Others decide to take time off from practice, or retire
from medicine completely. Altruism, like fiduciary, is
a useful concept that pariially, but not completely,
describes medical professionalism.
Excellent service is a business concept that has been
overlooked as a component of medical profession-
alism. The tenets of excellent service are putting in-
terests of customers first, integrity to the company's
mission and values, and honesty and ethical business
September 2010 Vol. 76
practices. They are directly translatable into medical
terms that describe altruism and professional behavior
exactly: putting patient's interest first, scientific and
clinical integrity, and absence of bias in medical de-
cision making. Excellent service generates profits for
business. The best hospitals and medical pracdces earn
profits the same way.
The Force of Law
The public gives physicians the privilege to prac-
dce medicine and surgery and to govern themselves
through professional organizations.'*' In return, doctors
adhere to professional codes of ethics and standards of
care that they themselves determine. The public retains
an interest in professional behavior by physicians
through state boards of medicine and a legal system
that protects padents from malpractice through the tort
law system.
Some groups want standards that in their view com-
pletely sadsfy the concepts of medical fiduciary rela-
donships and altruism. Speaking for the public, they have
gone beyond restricdons on physicians employed by
medical schools to state laws that restrict all pracdcing
doctors.'*-^' '*•' At that point they cease being professional
standards freely adopted as a part of professional ethics
and instead become crimes enforceable by law.
The legal foundation for preserving industry-physi-
cian reladonships is the United States Constitudon.
The First Amendment guarantees freedom of speech,
including the right to market and advertise medical
products and drugs. It also guarantees freedom of as-
sembly, the right of physicians to meet with industry
representadves over reasonably priced meals and
conferences, and to have mutually beneficial contrac-
tual reladonships with industry to develop new drugs
and products. The Copyright and Patent Clause of the
First Amendment protects the rights of companies to
enjoy monopolisdc profits that come to their discov-
eries under patent protection.
Industry and professional organizations have them-
selves developed codes of ethics that guide their in-
teracdons. The pharmaceudcal industry itself has
a comprehensive Code on Interacdons with Healthcare
Professionals that has ethically supportable restrictions
on funds and interacdons with physicians.^' Their code
preserves the relationships that are a necessary part of
the introduction of necessary drugs to clinical practice.
The American College of Surgeons also has a code that
guides surgeons' relationships with industry that min-
imizes unethical contacts with representadves and
similarly preserves productive reladonships with in-
dustry.'*^ Part of professionalism is the responsibility to
abide by an agreed upon code of ethics without having
to resort to the blunt force of law.
No. 9 DEFENSE OF INDUSTRY-PHYSICIAN RELATIONSHIPS
Benefits of the United States Health Care Industry
Humankind owes an overwhelming array of life-
saving medications and surgical devices to the unique
American industry-physician partnership. Many bene-
fits have come from the relationships between industry
and physicians (Table 2). It is difficult to imagine the
volume of innovations being developed and adopted in
any other system. In the United Kingdom two govern-
ment studies concluded that the country's National
Health Service has not effecfively adopted new medical
technology,'*^' '^^ The Wanless report noted that of the
major Western economies, the United States was the
only one to be both an eariy adopter and rapid diffuser
of medical technology,'*^ London-based strategist and
writer Rupert Darwall characterizes the United States
as the "world's principal engine driving medical ad-
vance."'*' Speaking the context of health care reform,
he says, "If the United States gets health care reform
wrong, the rest of the world will suffer, too." The same
can be said about overly restrictive industry-physician
relationships: if the United States gets it wrong, all of
us will suffer.
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