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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-
Table 1 summarizes restricdons proposed by Brennan
and colleagues and adopted by several academic med-
ical centers.'*' ^- ^' ^ The regulations themselves grew
ical centers and professional organizations have from alleged and some real confiicts of interest in-
imposed restrictions on the activities of the pharma- volving both drug and device trials.^' '° But scien-
ceutical and medical device industries (collecdvely tific misconduct, fraud, and dishonesty are noteworthy
termed "industry") in hospitals and medical school because of their rarity. The vast majority of industry-
campuses nationwide.'"^ Their policies govern the sponsored research results in beneficial drugs and
relationships that are permissible between industry devices of immense benefit.^ Some restricdons are
representatives and physicians, residents-in-training, reasonable, such as disclosure by physicians of any
and students. The motive is to avoid financial conflicts contractual reladonships with a specific medical or
of interest that compromise the core value of altruism surgical product and company in published articles.
in the practice of medicine. In their view profit motives Others are more extreme, such as prohibiting off cam-
and financial gains unavoidably introduce bias in pus contacts with industry representatives and all gifts,
medical decision making and violate public trust. 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-
Editor's Note: Occasionally, the journal solicits or accepts
manuscripts that are of an editorial nature. This offering by Dr.
priate middle ground that acknowledges the rights of
Nakayama outlines issues in relations between physicians and in- indust;ry, physicians, residents, medical students, pa-
dustry. Please note the author has no financial relationships with tients, and the public to the benefits that reasonable
industry and receives no support from same. Dr. Nakayama is interacdons may provide. Physician researchers and
currently Chair of the Department of Surgery at Mercer University inventors are responsible for an overwhelming array of
School of Medicine in Macon, GA. These are his thoughts on the
current state of industry relation to medicine and physicians. drugs and devices that depend upon industry for
Address correspondence and reprint requests to Don Nakayama, product development, production, and marketing.^ The
M.D., M.B.A., Department of Surgery, 777 Hemlock Street. MSC list of devices alone is staggering (Table 2). Industry
140, Macon, GA 31201. E-mail: Nakayama.Don@mccg.org. 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- determining drug efficacy and protecting public safety.
cedures and surgical operations. Companies need their The process is costly and long, A single drug requires
representatives to interact with medical providers to $800 million and 7 to 12 years or more to come to
get their products to market using ethically and pro- market, a good chunk of the 18-year duration of patent
fessionally acceptable marketing and advertising prac- protection.'^' '^ Only 8 per cent of drugs developed
tices. Every level depends upon professional interactions become approved drugs.'-^ Even after governmental
between industry and doctors that are necessary as- approval, postmarket surveillance is necessary to de-
pects in a robust capitalist economy. tect problems that may arise after drug introduction,
Those who propose restricted industry-physician- for which the company remains liable. After the long
patient relationships are thus in conflict with those who process of drug development and satisfying regulatory
recognize a beneficial relationship. The former group requirements, the company has a limited period of
cannot allow concessions to the latter without a viola- monopoly pricing power over its product, if it is
tion of their sense of professionalism. The latter group adopted by the market. It is a high risk business, with
sees restrictions as an affront to their right to determine profitability of some companies being dependent on
how they will practice medicine and their own defi- a single drug or device. In one day, September 15,
nitions of the ethical practice of medicine. The issues 2009, the share price of Salix Pharmaceuticals in-
of the debate are opposing views of medical econom- creased more than 50 per cent on the strength of the
ics, profit motive in industry, underpinnings of the clinical studies of a single irritable bowel drug. An-
concept of medical professionalism, and extent to other company, Alexza Pharmaceuticals, saw its price
which the practice of individual physicians in the drop nearly 12 per cent because the effectiveness of its
United States should be restricted by the force of law. migraine drug fell short of expectations.'"*
Despite necessary regulations the result has been the
transformation of United States health care into a global
Medical Economics
high technology engine that has transformed completely
Altruism is such a powerful concept in support of the practice of medicine and surgery. Its success is mea-
conflict of interest regulations that it is helpful to re- sured in the increase in longevity of nearly 10 years from
member the economic system under which the United 1950 to the present (68,2 to 77,9 years)'^- "^ and years of
States pharmaceutical and medical device industries productive life. The numbers of employed workers over
operate," In a capitalist system products are developed 65 years have doubled from 1977 to 2007.'^ The in-
to generate profits. Profits, or the promise of them, creasing health care costs in the United States are un-
determine resource allocation. Companies use their deniable and a cause of concern; health care as a percent
resources to either acquire or develop innovative drugs of total United States gross domestic product has in-
or devices based upon market demand. They depend creased from 5 to 17 per cent over the same period.'^
on the market for feedback on how to refine their Critics point to outsize profits of the pharmaceutical
product so that it better fits what doctors and patients and medical device sectors, saying their profits are ex-
need. Once a product is developed, it has to be brought cessive and consistently exceed median profit margins
to market through marketing and advertising. for all United States industries. The amount spent on
Society, through government, has decided that such marketing and advertising budgets for single drugs
innovation is socially desirable and is worth granting (Lunesta, for example) (Sepracor, Inc., Marlborough,
industry patent protection on new drugs and devices. MA) approaches those for popular products like beer and
Government regulations and requirements are com- cars.'^'^° They see packaging and advertising as anti-
plex and rigorous, necessary to their functions of 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 zone Scoreboard at the stadium where the popular
health care and does not primarily serve patient interests. Steelers professional football team plays. Its billboard
Marketing and advertising are not contrary to high advertising and annual reports win markedng awards.^'
quality evidence-based care," They are an integral Companies decide the amount of their resources to
part of getting any product (i.e., pills to patients) into devote to marketing with the expectadon that the
the market Hospitals (including the same academic money spent will increase sales and profits. Starting
medical centers that adopt restricdve conflicts of in- with an unknown drug or device a company has to
terest policies) see the reality of market competition and overcome established pracdces of surgeons and physi-
the necessity of advertising and markedng. In cides of cians. An illustrative example is the development of
all sizes there are billboards and adverdsements in print surgical stapling devices and minimally invasive surgery.
and electronic media that promote medical centers of all In both areas surgeons had an entire tradition of needles,
types, private and not-for-profit, community, and aca- sutures, and open surgical procedures that were more
demic. In Pittsburgh the University of Pittsburgh Med- than a century old and were well established as standards
ical Center has its corporate logo on the top of the city's of care. The adoption of such radical departures of sur-
tallest building, the former United States Steel head- gical technique involved hundreds of millions of dollars
quarters. Their logo has a prominent place on the end and years of marketing, advertising, and reinvendng
No, 9 DEFENSE OF INDUSTRY-PHYSICIAN RELATIONSHIPS Don K. Nakayama 991

surgei7 through education, demonstrations, and product excessive: resort trips, golf outings, and expensive gifts
samples. What started as a Cold War era side trip in that bore no relation to the merits of the drug. Current
Moscow by an American surgeon who happened to be industry guidelines appropriately prohibit those prac-
fluent in Russian (Mark M, Ravitch) ended as a multi- tices, and restrict activity to educational activities that
billion dollar transformation of surgery that depended on are carefully segregated in space and time with contact
industry and its surgeon collaborators,^^ 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.
The Profit Motive in Industry
Often the only weekdays they take off, besides vaca-
Critics of industry-physician interactions have tion time with families (that are off limits), are at
a fundamental distrust of the profit motive in medicine. professional conferences. So the only times for contact
They see market incentives posing extraordinary and that industry representatives can have with clinicians
negative challenges to their view of medical pro- are mealtimes and conferences.
fessionalism, the integrity of clinical research, and the However, critics maintain that such contacts still are
honest practice of medicine in patients' interests. They tainted by a sense of obligation among physicians to
say that any benefit that comes to physicians through provide a service in return and thus create un-
industry contact becomes suspect,^^ professional behavior, a sense of entitlement, and de-
In fact, the goals of physicians and industry are re- mean the profession,2^- ^^ They say that after contact
markably congruent and complimentary,^"^ Both want with industry representatives physicians are more
effective medications and devices that benefit patients. likely to prescribe their drug and to request that the
Physicians want them, industry wants to supply them. drug be added to the hospital formulary,^^ Others argue
Doctors want to learn new treatment modalities; in- for independent boards or individual physicians to
dustry wants to educate doctors in those techniques and evaluate drug and device efficacy,^' But what if a drug
products. Both parties want effective treatments that is effective with demonstrated safety and efficacy? The
maximize benefit, minimize harm to the patients, and company intends that it will be adopted by practicing
minimize legal risks. Doctors want to run profitable physicians and added to hospital formularies. The
practices, companies want to run profitable businesses. public benefits when effective novel therapies become
The first major area where physicians and surgeons available.
in practice collaborate with industry is in clinical re- Physicians have the training and sense of pro-
search. Industry depends upon physician researchers fessionalism to want the best for their patients and
with busy clinical practices to test drugs and devices protect them from harm. They have independent
and report results. The physicians expose patients to sources of information through journals, practice-based
experimental drugs and procedures in the belief that learning acdvities, and professional organizations to
patients will benefit from participation. Neither in- confirm or refute industry claims, A study commis-
dustry nor physicians want harm to come to study sioned by the Accreditation Council on Continuing
participants. Human testing is risky and exposes both Medical Education, a voluntary professional associa-
industry and clinical researchers to scrutiny and Ha- tion, whose standards to which physicians' conference
bility. Consents are pages long. Human testing requires organizers adhere, demonstrated no evidence that
review by institutional review boards and registration commercially supported continuing medical educa-
with federal agencies. Publications undergo statistical tion was biased and that patients in no way were
analysis and peer review. On the first page of articles, harmed,^^ Physicians in practice have their pro-
authors have full disclosure of industry support and fessional integrity and the safety of their patients in
federal registration of the clinical study. Physician mind, and are able to filter the message they get in
collaborators are necessary parts of product research industry marketing.
and development. They deserve and receive appropri-
ate compensation from industry,^"'"•^^
The Underpinnings of Medical Professionalism
The next area is the vastly larger venue of marketing
and sales of drugs and devices after clinical research The concept that underlies prohibitions of conflicts
studies have shown efficacy and safety. Physicians in of interest is that a physician has a fiduciary relation-
practice and their patients are the market, A company ship with the patient,^^~3^ It is a legal term, meaning
has a relatively short period of patent protection to someone who acts for and on the behalf of another in
recoup the hundreds of millions of dollars in product circumstances that give rise to a relationship of trust
development and testing. It uses marketing and ad- and confidence,^^ One in a fiduciary relationship acts
vertising to get their product into doctors' practices at all times to the benefit of the other, and does not put
and used by patients. Past practices were egregious and his or her interests before those of the beneficiary, T"he
992 THE AMERICAN SURGEON September 2010 Vol. 76

fiduciary has a duty not to be in a position where his or practices. They are directly translatable into medical
her situation conflicts with his or her fiduciary duty, terms that describe altruism and professional behavior
and thus cannot have a conflict of interest with those of exactly: putting patient's interest first, scientific and
the beneficiary. It thus describes the reladonship be- clinical integrity, and absence of bias in medical de-
tween a trustee and beneficiary, a guardian and a ward, cision making. Excellent service generates profits for
and an executor and the heirs. Does it describe a doc- business. The best hospitals and medical pracdces earn
tor-physician relationship? In some aspects it does. profits the same way.
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 The Force of Law
soccer games when emergencies arise. The public gives physicians the privilege to prac-
However there are several areas where physicians dce medicine and surgery and to govern themselves
fall short of the fiduciary standard.^^ They make through professional organizations.'*' In return, doctors
treatment recommendations for which they receive adhere to professional codes of ethics and standards of
a fee, a built-in conflict of interest that has to be care that they themselves determine. The public retains
managed. Proposals to implement physician pay for an interest in professional behavior by physicians
performance inidatives to improve quality and control through state boards of medicine and a legal system
costs introduce perverse incentives to limit care for that protects padents from malpractice through the tort
sicker padents.-*^ They are not available to their pa- law system.
tients all the dme—they arrange for others to share call Some groups want standards that in their view com-
when they are away. Resident physicians, even when pletely sadsfy the concepts of medical fiduciary rela-
they are in town, are prohibited from coming in and donships and altruism. Speaking for the public, they have
treating their padents because of 80-hour duty hour gone beyond restricdons on physicians employed by
restrictions.'*^ The standards of care to which doctors medical schools to state laws that restrict all pracdcing
adhere are not defined by the maximal benefit to the doctors.'*-^' '*•' At that point they cease being professional
padent but reasonable standards of the professional standards freely adopted as a part of professional ethics
pracdce. The physician will make sure that padents' and instead become crimes enforceable by law.
emergency needs will be provided in his or her ab- The legal foundation for preserving industry-physi-
sence. So although a fiduciary standard might be ideal, cian reladonships is the United States Constitudon.
the realistic standard of a physician's duty of care to The First Amendment guarantees freedom of speech,
patients is more realistic. including the right to market and advertise medical
Part of the problem is the use of a legal term, fidu- products and drugs. It also guarantees freedom of as-
ciary, to describe professionalism.^^ Physicians have sembly, the right of physicians to meet with industry
an acquired sense of extreme caudon of anything as- representadves over reasonably priced meals and
sociated with legal actions. "Fiduciary" is a word that conferences, and to have mutually beneficial contrac-
is not in everyday use outside of legal texts, contracts, tual reladonships with industry to develop new drugs
and the courtroom. Using legalese is guaranteed to and products. The Copyright and Patent Clause of the
cause doctors to act slowly and cautiously. First Amendment protects the rights of companies to
Altruism is another term used to describe medical enjoy monopolisdc profits that come to their discov-
professionalism."'^^ Most doctors enter the pro- eries under patent protection.
fession and later intentionally pracdce in underserved Industry and professional organizations have them-
areas or serve on overseas medical missions because of selves developed codes of ethics that guide their in-
a sense of altruism. However, pracdce expenses, pay- teracdons. The pharmaceudcal industry itself has
rolls, and physicians' own bills and children's tuidons a comprehensive Code on Interacdons with Healthcare
have to be met. Some decide to limit the numbers of Professionals that has ethically supportable restrictions
patients who have government-sponsored insurance. on funds and interacdons with physicians.^' Their code
Others decide to take time off from practice, or retire preserves the relationships that are a necessary part of
from medicine completely. Altruism, like fiduciary, is the introduction of necessary drugs to clinical practice.
a useful concept that pariially, but not completely, The American College of Surgeons also has a code that
describes medical professionalism. guides surgeons' relationships with industry that min-
Excellent service is a business concept that has been imizes unethical contacts with representadves and
overlooked as a component of medical profession- similarly preserves productive reladonships with in-
alism. The tenets of excellent service are putting in- dustry.'*^ Part of professionalism is the responsibility to
terests of customers first, integrity to the company's abide by an agreed upon code of ethics without having
mission and values, and honesty and ethical business to resort to the blunt force of law.
No. 9 DEFENSE OF INDUSTRY-PHYSICIAN RELATIONSHIPS Don K. Nakayama 993

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