Regulatory Affairs Syndicator

Consultation or corruption? The ethics of signing on to the medical-industrial complex.

J Vasc Surg. 2006 Jan;43(1):192-5

Authors: Jones JW, McCullough LB, Richman BW

A prominent vascular surgeon is approached by a representative of a large medical device company with a proposal to implant a new self-sealing patch for closing open carotid endarterectomies. The patch is made of a new synthetic material that establishes immediate hemostasis and inhibits restenosis in animal studies. It has just been approved for human use by the Food and Drug Administration. The cost of the new patch is much higher than for established comparable products, even when potential long-term benefits are considered, but using it would reduce the operative time required for achieving hemostasis. The manufacturer’s representative tells you that the company will pay a selected group of vascular surgeons $500 apiece each time they insert the patch on their patients and complete a one-page report. Surgeons with the highest volume of cases utilizing the patch will be offered a paid clinical consultancy with the company. You’ve used another company’s product for several years and found it entirely satisfactory, but have followed development of the new patch with interest and considered trying it in your patients having carotid endarterectomies. What should you do? A. Join the study. You probably would have used the new patch on your patients anyway. B. If the early data warrant, implant the patch on a trial basis without enrolling in the project, and finally decide whether to continue using it based on your clinical experience and additional published reports. C. Call some of the other investigators who have already enrolled in the project and ask them about their experience. D. Decline the invitation immediately. Refuse to ever speak to the representative again. E. Estimate the ability of your patients to sustain the high cost of the new product and decide accordingly whether to use it.

PMID: 16414412 [PubMed - in process]