The Cleveland Clinic has dismissed Dr Jay Yadav after he failed to provide full disclosure about his conflicts of interest regarding the AngioGuard (Cordis/Johnson & Johnson) filter-based protection device. Yadav, who was promoted to the position of chair of Cleveland Clinic Foundation Innovations in October 2005, has been at the Cleveland Clinic since 1998.
According to reports, the dismissal centred on his failure to disclose a 1% royalty fee that he has continued to receive royalties from Cordis/Johnson & Johnson (J&J) on sales of the AngioGuard device. Yadav originally invented the device, and helped establish AngioGuard Inc, in which he owned shares. The company was subsequently sold to J&J in 1999 for approximately US$40 million. Apparently, the 1% royalties were allegedly described as a ‘deferred payment’ in the deal. Yadav also led the SAPPHIRE trial, comparing coronary stenting with surgery, as well as several other studies examining the use of the AngioGuard device.
A statement released by the clinic said that the institution would not be commenting publicly on ‘specific situations,’ but confirmed that Yadav had lost his position there as part of a larger process of refining conflict of interest processes. “The Board of Governors of the Cleveland Clinic took action not to reappoint Dr Jay Yadav to its medical staff,” the statement read. “He is no longer at the clinic. As an institution, we will continue to strongly encourage innovation while eliminating and managing conflicts.”
In addition, questions have also been raised about certain aspects of the AngioGuard trials, including inadequate enrollment, patient inclusion/exclusion criteria, appropriate patient follow-up and timely adverse-event reporting. A paper published by Yadav and colleagues in 2005 reported a complication seen in high-risk stroke patients: approximately 10% experienced reduced blood flow, likely a result of filter clogging, and “…nearly 10% of those patients suffered a stroke within 30 days, an adverse-outcome rate more than three times higher than that of patients with normal flow.” Although the filter is identified as the ‘culprit’ in the paper, no analysis was done to determine whether this adverse effect was seen more often with one device than another; the AngioGuard device was used in two thirds of the procedures. The situation is made more complicated because Yadav stood to benefit from the positive results and FDA approval of the filter device.
Yadav has said he did not realize he was still receiving payments from the sale of his device to Cordis/J&J and in a statement said that he “…was not involved in the sale of the company in 1999 and was aware only of the major points of the transactions.” In addition, he “…believed that the deferred payments, as the phrase suggests, were simply a deferral of a portion of the initial payment. He was unaware until reviewing the documents in detail yesterday about the variable component linked to global sales. These payments were a small fraction (approximately 1%) of the overall transactions, and there were no sales in the USA.” Yadav said that he intends to donate the funds to charity “to avoid even the appearance of impropriety.”
The Editor-in-Chief of Vascular News, Dr Kenneth Ouriel, has voluntarily recused himself from the responsibility for the content and decisions concerning the article above.