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Ethical Considerations in the Orthopaedic Relationship with Industry

Etické aspekty vztahu ortopedie a „industrie“

A. SARMIENTO

Department of Orthopaedics University of Miami Medical School, Miami, Florida, USA

SUMMARY

Members of the medical profession spend a long time and financial resources acquiring the knowledge necessary forthe discharge of their responsibilities; therefore, they should be appropriately compensated for the services they provide.However, it has become obvious, at least in the United States, that excessive emphasis on profit making is fostering thetransformation of the medical profession into strictly a business. This transformation is spawning ethical infractions, whichare becoming increasingly apparent.

The genesis of the rapid transformation of Medicineinto a business is complex. Nonetheless, I venture todissect the issue and to advance a course of action.

Due in great part to the introduction of newly deve-loped expensive technology, the cost of orthopaedic carehas escalated in a precipitous manner in recent years.However, the cost of these technological advances initself is not the real culprit; more likely is the abuse oftechnology that creates the problem (1, 3, 5, 6, 9).

Examples abound. The MRI has had a major benefi-cial impact in the diagnosis of a multitude of muscu-loskeletal conditions, but was not designed to replaceclinical acumen, or all other less expensive diagnosticmodalities, which oftentimes are equally, if not morereliable. It is common practice in many settings, for theorthopaedist to request an MRI prior to a clinical exa-mination for the most trivial conditions, even in thoseinstances when a clinical examination accurately makesa diagnosis. To some physicians, the slightest „abnor-mality“ described by the radiologist justifies surgery ofsome type. Patients, aware of the trend, expect to havean MRI whenever they sustain an injury. This trend inc-reases significantly the ultimate cost of medical care.

Nonsurgical treatment modalities are increasinglybecoming obsolete in the management of musculoske-letal conditions. At the slightest signs suggestive ofa carpal tunnel syndrome, a bulging vertebral disc, ora possible tear of the rotator cuff, surgery is performed,followed by prolonged, supervised, and expensive„rehabilitation“. Many fractures known to rapidly res-pond to nonsurgical treatment are subjected to surgicalprocedures, oftentimes unproven ones, such as the rou-tine plating of benign clavicle and Colles fractures. Suchan abuse of surgery and technology is highly respon-sible for the escalating cost of care (10).

If evidence existed that under all circumstances sur-gical treatments render better results, it would be ludic-rous to criticize the practice. However, this is not thecase, since in a number of clinical situations nonsurgi-cal modalities provide better results, with fewer com-plications, and at a lower cost.

Residents, in increasing numbers are completing the-ir training having been exposed only to the indiscrimi-nate use of the latest surgical „advances“ and failing toappreciate the value that nonsurgical approaches tomany musculoskeletal conditions have to offer. Theyenter the work force incapable of treating them by anyother means. Many residents finish their education notknowing how to conservatively treat fractures, since allthey observed their mentor do was open surgery. Trea-ting fractures without surgery is foreign to them.

These pervasive trends and practices are convertingthe practitioners of the art into „technicians“ rather thanscientists–surgeons. For all practical purposes, they arebecoming „skeletal cosmetologists“ to whom the basicscientific basis of the profession are unknown or felt tobe unnecessary (8).

A personal experience summarizes the current stateof affairs. While lecturing the large group of orthopae-dic residents at the University of Southern California onthe effect of the environment on fracture healing, a moresenior resident, sitting in the back of the auditorium,was reading a newspaper. When I subsequently appro-ached him to express my disappointment with his con-duct and the bad example he was setting for the juniorclass, he, very candidly, responded, „Professor, I am notinterested in knowing how fractures heal, I simply wantto know how to fix them“. Though at first I felt the youngman to be an aberration, I later concluded he in actua-lity was the spokesperson for his generation (10).

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The trend I have discussed is becoming increasinglypopular throughout the land. Why and how did this epi-demic of abuse find such fertile grounds? Who benefitsfrom it? In many instances the surgeons, who are keen-ly aware that reimbursement for services rendered isalways manifold higher when the treatment provided isa surgical one. Also the hospitals who receive a highreimbursement they would not receive if those patientsare not admitted, and then subjected to a multitude oflaboratory tests, operating room charges and subsequ-ent rehabilitation therapy. However, those who benefitmost are the manufactures of technological products andsurgical implants (1, 3, 5–7).

At the center of this situation, at the vortex aroundthe whirling winds of the pervasive loss of professio-nalism in the medical ranks, is the fact that the phar-maceutical and surgical implant industry has gained vir-tual control of the education of the orthopaedist.

Through a very successful stratagem, industry hasmanaged to gain the support not only of the upper eche-lon of the orthopaedic community, but also of a growingsegment of the rank and file of the profession. This isillustrated by the fact that the vast majority of continu-ing educational activities conducted under a variety ofsettings, take place with the financial subsidy of indust-ry, either openly or camouflaged under the guise of„co–sponsorship“ with medical schools, local, state,regional, national and international societies and asso-ciations. Industry influences, and other times determi-nes the subjects of the educational ventures. It choosesor influences the choice of the speakers at the courses,as well as the visiting professors in structured confe-rences at medical schools, hospitals, and residence pro-grams. Their traveling and accommodations and theirhonoraria are paid by industry in a most generous fas-hion (1, 6, 7, 9).

Thousands of practicing orthopedists and residents intraining attend continuing education courses, withadded bio–skill components, having their expenses sub-sidized, either partially or completely, by industrial con-cerns. Sometimes industrial representatives individual-ly take care of the „physicians“ expenses, while othertimes funds are given to program directors for that pur-pose, in order to hide the real sources of support.

Orthopaedists in Latin American readily acknowled-ge that thousands of them attend the annual meeting ofthe American Academy of Orthopaedics and other popu-lar courses in the United States, having their expensespaid by industry. Once in the convention center wherethe meetings are held, they are bombarded by a hordeof vendors, who, in fact outnumber the attending ort-hopaedic surgeons.

At fist glance, it is difficult to find fault with the„generous“ system that appears to facilitate and encou-rage education. However, this is a naive illusion. Thereis no generosity in this scheme, simply a successful busi-ness transaction. The annual 15 billion dollars Industryspends catering to and entertaining physicians genera-te a tremendous bonanza. From constantly exposing ort-hopaedists to their products, advertising their alleged

benefits, and extending personal financial benefits, it isonly logical that the orthopaedic community would res-pond accordingly. The fact that the marketing is frequ-ently done by well–known orthopaedists, who unbek-nown to the audience, many of them have strong vestedfinancial interests in the success of the industrial pro-ducts- further enhances the effectiveness of the ventu-re.

The degree to which Industry feels that education istheir purview is exemplified by the arrogance they nowdisplay and the unsavory practices they use to cementtheir control. A number of orthopaedists receives „kick-backs“ of thousands, if not millions of dollars, for theuse of industry’s products. I personally was approachedseveral years ago by a high–level industry representati-ve proposing I use his products and try to convince othersurgeons in the five affiliated hospitals with my depart-ment to do likewise. In return I would receive- bypas-sing established University requirements- $250 for eve-ry implat inserted at the five institutions. When I madeit clear I would not accept such a dishonorable „deal“he responded, „But Doctor Sarmiento, we do this all thetime“ (10).

Academic centers receive from Industry subsidies forthe support of research activities, often of a product ori-ented nature, aimed at legitimizing the worth of alrea-dy developed surgical implants.

Well known is the fact that the credibility of resultsfrom industry–sponsored research is oftentimes questi-onable. The reported findings are proved invalid andcontradicted by research on the same topic, when con-ducted without Industry’s involvement.

The British edition of the Journal of Bone and JointSurgery published a few months ago two articles dea-ling with the subject at hand. The authors pleaded fora correction of the growing problems and for a returnto fairness and honesty (2, 4). Others in the United Sta-tes have forcefully addressed these issues. Until now,their voices have fallen on deft ears (1, 3, 5, 6).

The United States’ Justice Department is currentlyofficially investigating the relationship between Ortho-paedics and Industry. The government has become awa-re of serious infractions of professional and ethicaldimensions. However, it is unlikely we will see saluta-ry results from the investigation, for I suspect every pos-sible effort will be made by Industry to stall and bringto an end the judicial process.

Malpractice litigation has reached in the United Sta-tes an obscene level. Society is obsessed with the ideathat perfect results are to be expected from any humanendeavor, medicine being no exception. Facing any finalimperfection following and injury or disease, oftendetected only on radiographs, is sufficient to initiatemalpractice claims. This disturbing trend is begging fora solution. However, the elected legislators seem inca-pable or unwilling to enact measures to assuage the con-dition.

Some orthopaedists claim that the fear of litigationmakes them use every conceivable diagnostic and the-rapeutic tool that otherwise they would not use. Howe-

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ver, the argument has been used by some unscrupuloussurgeons to justify the performance of better financial-ly rewarding surgical interventions (11).

It is apparent, in light of the evidence, that our pro-fession is facing serious challenges, which are beingaggravated by the influence of the powerful corporateworld (12). A healthy and necessary relationship bet-ween Orthopaedics and Industry is no longer a balancedone. It needs to be corrected lest we are willing to acceptfurther erosion of the values upon which our disciplinewas founded and sustained for several generations.Industry is a business and Orthopaedics a profession.Orthopaedics must regain control of its destiny and refu-se to relinquish its ethical tradition, while substituting itwith the goals and values of the corporate world (7, 9).

ZÁVĚR

Lékaři vynakládají mnoho času a peněz na to, abymohli plnit své úkoly. Proto by měli být náležitě za svéslužby odměňováni. Avšak v praxi, alespoň v USA, sestále více potvrzuje, že rostoucí důraz na ziskovostpostupně přeměňuje lékařskou profesi v pouhý byznys.Tato přeměna stále zjevněji narušuje etické principyv této oblasti.

Literature

1. ANGELL, M.: The Truth About the Drug Companies. The Ran-dom House, 2006.

2. BENSON, M. K., BOURNE, R., HANLEY, E., HARRISON, J.,JODOIN, A., NICOL, R., van WYK, L., WEINSTEIN, S.: Ethicsin Orthopaedic Surgery. J. Bone Jt Surg., 87–B: 1449–1451, 2005.

3. CALLAHAN, D.: What Price Better Health? University of Cali-fornia Press 2005.

4. CARR, A. J.: Which Research Is to Be Believed? J. Bone Jt Surg.,87–B: 1452–1453, 2005.

5. GRAY, B.: The Profit Motive and Patient Care. A Twentieth Cen-tury Fund Report. Harvard University Press 1991.

6. RELLMAN, A., ANGELL, M.: Americas’ Other Drug Problem.The New Republic, December: 27–41, 2002.

7. SARMIENTO, A.: Medicine and Industry: The Payer, the Piperand the Tune. Royal Canadian Annals of Medicine, 33: 144–149,2000.

8. SARMIENTO, A.: On the Education of the Orthopaedic Resident.Clin. Orthop., 400: 259–263, 2002.

9. SARMIENTO, A.: The Relationship Between Orthopaedics andIndustry Must Be Reformed. Clin. Orthop., 412: 38–44, 2003.

10. SARMIENTO, A.: Bare Bones. A Surgeon’s Tale. Prometheus,2003.

11. SARMIENTO, A.: Complications and Litigation. Clin. Orthop.,420: 319–320, 2004.

12. SARMIENTO, A.: Orthopaedics at a Crossroads. J. Bone Jt Surg.,75–A: 159–161, 1994.

Prof. Augusto Sarmiento, M. D.,Department of OrthopaedicsUniversity of Miami Medical School,Miami,Florida 33146USA

Práce byla přijata 13. 3. 2007.

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