Contracts: What are the ethical concerns?

David Apple, MD, comments on the ethical dilemmas inherent in some contracts between orthopedists and industry.

Issue: February 2004

ByDavid F. Apple, MD

Guest Commentary
	David Apple is the medical director of the Shepherd Center in Atlanta, which he also helped establish. He is the editor of the Rehabilitation section on the Orthopedics Today Editorial Board.

Have you been offered a contract with an orthopedic company?

The AAOS Committee on Ethics was recently asked to review two contracts sent by practicing orthopedic surgeons. Fifteen years ago, contracts such as these would have been unusual and probably would have raised ethical concerns among most orthopedists.

In 1988, the AAOS developed a Code of Ethics. Subsequently, the Ethics Committee has developed a set of principles and several opinion statements, and it has endorsed a physician charter on professionalism. The basic tenet of these documents is to provide guidelines to encourage orthopedic surgeons to do what is best for the patient in providing appropriate care.

Ethics define what is right or wrong in human behavior. Ethical guidelines are aspirational, defining what a physician ought to do, and thus are not legally binding and not enforceable. The code advises the orthopedic surgeon to maintain a reputation for truth and honesty, to conduct him or herself morally and ethically, and to accept the profession’s self-imposed discipline.

Would you sign these contracts?

drawing In the two contracts between the orthopedic surgeon and the industry that the Committee on Ethics reviewed, the committee found that they both contained the usual boilerplate information identifying the parties involved, the terms and definitions.

The contract with Company A would allow the physician to use the procedures developed by the company in return for providing training and relinquishing rights to any improvements in equipment and technique.

The contract with Company B would permit the physician to consult and use implants developed by that company.

Contract A

Contract A raises a non-ethical red flag in that the company has three obligations while the physician has 11. One of those obligations is that the doctor “agrees in consideration for the limited license, training, company materials and other support to be provided to the doctor by the company, under this agreement the doctor shall use company techniques, instruments, associated technology, implants, and know how exclusively for all company procedures performed during the term.”

Another obligation is that the doctor assigns to the company the rights to any improvements. The doctor also agrees to mandatory review of any publications, exhibits or lectures prior to their presentation.

Contract B

Contract B permits the physician to serve as a consultant and to utilize the company’s implants. This is fairly straightforward. However, in the exhibits which define the scope of services for consulting, product evaluation, preceptorships, and presentations, the remuneration is listed for each.

Additionally, there is an outline for a fee schedule to reimburse for clinical outcome studies under three scenarios. Details of one scenario are an enrollment of $300 per qualified patient; follow-up of $100 per qualified follow-up per patient; non-peer reviewed journal publication $1500; and peer reviewed journal publication $2500.

Would you sign?

Contract A:

Allows the physician to use the procedures developed by the company in return for providing training and relinquishing rights to any improvements in equipment and technique.
Imposes three obligations on the company, 11 on the physician.
Implies that the surgeon will use the company’s process.

Contract B:

Permits the physician to consult and use implants developed by that company.
Permits the physician to serve as a consultant and to utilize the company’s implants.
Outlines a fee schedule of reimbursements for clinical outcome studies under three scenarios.
Conflicts with Section 1D and IIIC of the Code of Medical Ethics and Professionalism.

Ethical concerns

Although both of these contracts are legal if signed by both parties, there are some ethical concerns.

In contract A, there is an implication that the surgeon will use the company’s process to the exclusion of all other considerations. According to the AAOS Code of Medical Ethics and Professionalism, several areas of the code would be in direct conflict with this provision of the contract.

Section 1D, which relates to informed consent for treatment, obligates the surgeon to include alternative modes of treatment with delineation of the complications and consequences of each mode. It would also be the surgeon’s responsibility to inform the patient of his or her relationship with Company A. This would allow the patient to evaluate the advice given.

In Contract B, the surgeon’s involvement is also in conflict with Section 1D of the Code of Medical Ethics and Professionalism regarding the need for informed consent with a discussion of alternative modes of treatment.

Because of the monetary incentive offered for clinical research and publications, section IIIC of the code is also in conflict. The surgeon is receiving something of value from industry. Although it is implied that the remuneration is for research, this certainly could be construed as a recruitment fee and thus could potentially cloud the surgeon’s judgment about whether the best treatment alternative is being followed.

Could you sign?

Could a surgeon sign either of these agreements and be ethically okay? Possibly.

It is difficult to avoid the appearance of having a conflict with the code. The physician/patient relationship is paramount for all ethical decisions. This relationship should be based on confidentiality, trust and honesty.

In another era, possibly, this would have been easier to achieve than in today’s climate of corporate malfeasance, insider trading and generally litigious society.

The ethics code — with its emphasis on maintaining a reputation for truth and honesty, moral and ethical conduct, and acceptance of a physician’s self-imposed discipline — means that the orthopedic surgeon should avoid any position that might compromise these tenets.

This article, written by Dr. Apple, has been endorsed by the AAOS Committee on Ethics.