EDITORIAL

Caution in signing nondisclosure contracts

K. Wayne Johnston, MD, FRCS(C), Toronto, Ontario, Canada

Physicians are often asked to sign nondisclosure con-tracts with companies when they become involved in re-search protocols, consulting arrangements, and mentoringroles. Before withdrawal of the Ancure device, relatively fewcomplications were widely reported. Did a nondisclosurecontract inhibit disclosure of these complications to thescientific community and patients?

The Ancure device was withdrawn from the market onJune 16, 2003, after Guidant agreed to plead guilty to 10federal felony counts and to pay $92 million for failing toreport problems with the device. The criminal complaintalleged that since introduction of the product in 1999 thecompany reported only 172 malfunctioning devices, al-though 2628 incidents had been recorded. Presumably,vascular surgeons and interventionalists reported theseproblems to Guidant, with the assumption that the com-pany would report them to the Food and Drug Adminis-tration (FDA), as required by federal law.

I am concerned that these problems were not empha-sized in the medical literature or in presentations at con-tinuing medical education courses. Were surgeons andinterventionalists who were investigators or proctors for thedevice prevented from informing the scientific communityof complications by nondisclosure contracts with the com-pany? An example from a different company’s researchprotocol suggests that this might be possible.

The following comments have been extracted fromcorrespondence between an experienced endovascular sur-geon and a company that asked that surgeon to providetraining and mentoring for other surgeons in the deploy-ment of aortic stent grafts. I received this documentationseveral years ago when I was Editor in Chief of the Journalof Vascular Surgery. At that time there were many ongoinginvestigational studies, and this example was not related tothe Ancure device. However, it is relevant to raise the issuethat a similar contract might have infringed on the respon-

From the Division of Vascular Surgery, University of Toronto, TorontoGeneral Hospital.

Competition of interest: none.Reprint requests: K. Wayne Johnston, MD, University of Toronto, Toronto

General Hospital, Eaton 5-309, 200 Elizabeth St, Toronto, Ont, M5G2C4 Canada (e-mail: kwjohnston@torhosp.toronto.on.ca).

J Vasc Surg 2004;39:1352-3.0741-5214/$30.00Copyright © 2004 by The Society for Vascular Surgery.doi:10.1016/j.jvs.2004.02.020

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sibilities that surgeons have to report results to their pa-tients and colleagues.

The contract in question, specified that

[the] “Consultant shall provide training and relatedconsulting services . . . for [The Company] related to its. . . stent graft and catheter system.”

Of particular concern to the surgeon was the compa-ny’s request to control the data.

“. . . any material, information, data and devices de-veloped in the course of performing the activities de-scribed in this Agreement . . . are or shall be the prop-erty of [The Company] and shall be maintained inconfidence and not used by Consultant . . . except asnecessary to perform the activities described in this Agree-ment or until the lapse of three years from the date ofexpiration or cancellation of this Agreement” [boldfaceadded by the author].

When the surgeon questioned the inclusion of restric-tions on the release of data for 3 years, as specified in thecontract, in subsequent correspondence the surgeon wastold by a senior company employee that

“I [the company negotiator] have been involved withmany agreements in . . . [many other specialties] . . . andnever have we been faced with a strong objection [to thewording of the contract].”

Does this mean that most investigators do not read thecontracts they sign? Or do they fail to understand the legaland ethical implications of the contracts? Specifically, dothey not understand that if the company fully controls thedata the information is not available to patients or theirsurgical colleagues unless the company chooses to releaseit? Or do they simply sign a contract for personal orinstitutional financial benefit or prestige?

In further correspondence from the company, the sur-geon was cautioned that

“Terms of these contracts are matter to be discussedbetween yourselves and [The Company] exclusively”[boldface added].

Does this imply that investigators should not seek legaladvice, inform the institutional review board of their insti-tution, or consult the institutional or university researchmanagement before signing a contract?

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The company position was that

“Our mutual role is to enhance quality of life, furthereducation and nothing else” [boldface added].

Physicians are often asked to sign contracts with com-panies when they become involved in research protocols,consulting arrangements, and mentoring roles to teachother surgeons how to use a new device. While it is reason-able for a company to expect the physician to keep theproprietary information on a device confidential, is it ap-propriate for a contract to ask the physician to keep theresults and complications secret from patients or col-leagues?

If a contract prevents the physician from disclosing datathat he or she has learned by using a new device, conflict ofinterest may develop. First, the primary ethic in the physi-cian-patient relationship of putting the patient’s welfareabove physician interests may be breached. In clinical stud-ies the patients volunteer to participate. In the consentprocess the patients are informed that the technique andperhaps the device are relatively new and not fully validatedby long-term follow-up. Patients anticipate that results of thestudy, whether positive or negative, and complications,should they occur, will be disclosed to them. Second, theexpectation that physicians should carry out research in anunbiased way may be contravened. Third, clinicians expect to

be able to share the results with other physicians to advancemedical knowledge and thereby improve patient care.

In signing a restrictive contract with industry, the phy-sician may be put in a conflict of interest, that is, a legalobligation to maintain company secrets versus the obliga-tion to share information that may benefit patients andother physicians. A contract that requires the surgeon tomaintain proprietary secrets that advance the financial in-terests of the company is reasonable; however, one thatprevents the surgeon from sharing results and complica-tions with patients under his or her care and with colleaguesis inappropriate.

In my opinion, vascular surgeons reported the compli-cations with the Ancure device to the company; however,they were not widely discussed in the medical literature.Was this the fault of medical editors or reviewers who chosenot to publish negative information, or did nondisclosurecontracts have an important role in limiting disseminationof this information to the scientific community and indeedto patients? In relationships with companies, contractsshould never prevent researchers from informing patientsand the scientific community of risks identified during aclinical study.

Submitted Jul 22, 2003; accepted Feb 17, 2004.

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