The Bowling-Pfizer Supervisory Panel has evaluated Dr. Batts’ reader’s comment to The American Journal of Cardiology . The panel thanks Dr. Batts for his recommendations and responds here to several points he raised. The Supervisory Panel’s role was defined in the settlement agreement of 1992, and the panel has functioned within its defined role for the past 20 years. The purpose of the publication of the panel’s perspective in The American Journal of Cardiology in December 2013 was to highlight its activities in meeting its defined roles. In responding to issues raised by Dr. Batts, the panel reiterates its objectives and how it operated.

First, the panel made a serious effort to discover a medical test with the most advanced technology that would detect Björk-Shiley convexo-concave (BSCC) valves that were defective and might fracture. The panel continues to do this with a study at the Cleveland Clinic, to which Dr. Batts refers in his piece. Second, the panel developed careful guidelines using manufacturing data from which patient risk could be defined. These guidelines could be used for considering explantation of the BSCC valve, and the panel believes that this approach saved many patients from unnecessary explant surgery. Third, the panel sponsored a series of specific studies in high-risk BSCC valves in patients at Stanford, Beaumont, and Glasgow, which permitted longitudinal follow-up and helped in determining the need for explant surgery. Fourth, the panel developed mechanisms of communicating with patients to update them on the activities of the panel and on the clinical course of follow-up on patients who were included in the class as defined in the settlement agreement.

Dr. Batts believes the panel overlooked the emotional and psychological travails experienced by patients with BSCC heart valves. On the contrary: the panel understands and appreciates these feelings of patients with the heart valves, and initially one of the physician members of the panel was the recipient of a mechanical prosthetic valve. Furthermore, we note that although the composition of the panel has changed over the years, it has always included at least 4 members who were cardiologists or cardiothoracic surgeons who regularly treat patients with heart valve disease. The panel always considered its role to be that of a major patient advocate and an intermediary between the company and the attorneys who initiated the class action lawsuit. In many of the panel’s meetings and deliberations, the best advisory material to be provided to those patients in the settlement agreement was routinely considered by asking the question “How will this influence the quality of patients’ lives?” The panel initiated and carried out studies to examine the quality of life for patients with BSCC heart valves, and these studies were published and widely distributed. In 1 study, the comparison of the quality of life, the health status, and serious morbidity was made between patients in the Stanford and Beaumont cohorts who had explants (n = 31) and those who did not (n = 554). In addition, a careful review of the risk for fracture for patients with BSCC valves was made by the panel in 2005 and published in Circulation . This report was written to help patients and their physicians make evidence-based decisions regarding explantation.

Finally, the panel established a Web site, making information available to patients and physicians and containing relevant updates from worldwide publications relating to prosthetic heart valves, with particular emphasis on information regarding the BSCC heart valve. Moreover, the panel has examined the recommendations made by Dr. Batts to add a patient advocate on future boards like the Supervisory Panel to consider the effects of having a prosthetic heart valve on the ongoing quality of life from the patient’s point of view. The panel concurs that this should be considered, and notes, as above, that one of the initial panel members was a recipient of an artificial heart valve, together with the panel’s recommendations on the merits of having a supervisory panel for medical devices for which critical failure can occur. The panel concludes that it may be helpful to have a patient viewpoint considered in panel deliberations.