Jay Yadav, an Indo-American cardiologist was fired by the Cleveland Clinic for failing to disclose the conflict of interest in connection with a device developed by him. Yadav is the creator of AngioGard, a filter-based device, which is prominently used in carotid stenting procedures. Yadav was affiliated to the Cleveland Clinic since 1998 and was the chairman of the Clinic's Innovations Foundation.
A statement released by the clinic said 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, according to Heartwire.
"The board of governors of the Cleveland Clinic today took action not to reappoint Jay Yadav, MD to its medical staff," the statement reads.
"He is no longer at the clinic. As an institution, we will continue to strongly encourage innovation while eliminating and managing conflicts."
A comprehensive exposé in the Cleveland Plain Dealer outlines the events that led to Yadav's dismissal, which centred around his failure to disclose a one percent royalty fee that he has continued to receive from Cordis/Johnson & Johnson (J&J) on sales of AngioGuard devices.
Yadav had originally invented the device and helped establish and owned shares in the company that developed it, AngioGuard Inc, which was sold to J&J in 1999 for approximately $40 million: the one percent royalties were allegedly described as a "deferred payment" in the deal.
Yadav also led the SAPPHIRE trial, comparing coronary stenting to surgery, as well as several other studies examining the use of the AngioGuard device.
As noted by the Plain Dealer, "Yadav didn't fully disclose his conflict in writing in numerous medical-journal articles published after 2000 that discussed the SAPPHIRE trial or prominently mentioned AngioGuard. In many instances, he failed to note his financial ties with Cordis at all, including in a 2003 article in which he predicted that a Cordis stent and AngioGuard filter would be the first devices to gain FDA (Food and Drug Administration) approval for use in patients at high risk for surgery."
In fact, if the AngioGuard device was successful, Yadav clearly stood to reap financial gain through the one percent royalty payment.
For his part, Yadav has said he did not realise 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".
Moreover, 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 about the variable component linked to global sales. These payments were a small fraction (approximately one percent) of the overall transactions and there were no sales in the US.
These funds, he now says, will be donated to charity "to avoid even the appearance of impropriety".
The Plain Dealer article notes that even during the 2004 FDA advisory-panel deliberations over the AngioGuard device, Yadav did not present any of the evidence about the device out of concern that FDA officials might frown on Yadav's conflict of interest.
"Here, as he often did in the years before and after, Yadav avoided fully disclosing his personal stake," the paper wrote.
In fact, Plain Dealer continued, even Yadav's Cleveland Clinic colleague, Kenneth Ouriel, who presented the SAPPHIRE results to the FDA panel, had conflicts that were not properly disclosed.
"He had been a paid consultant to Cordis, records show, but Ouriel did not tell the FDA panel about that relationship," it said.
The Cleveland Clinic had earlier said that in addition to what Ouriel did disclose (hotel and travel expenses), he also received royalties of roughly $500 per year. "His failure to disclose that compensation was an oversight," the Plain Dealer quotes the clinic.
Also noted in the article are problems with the AngioGuard trials, some of which have raised the ire of FDA officials who have requested further study of the device after a panel was split six to five on its approval.
Aspects of the trials faulted include inadequate enrolment, patient inclusion/exclusion criteria, appropriate patient follow-up, and timely adverse event reporting, the Plain Dealer notes.
Indeed, in 2005, the FDA issued Yadav a warning, "threatening to disqualify him from participating in clinical trials unless he made corrections," Rutchick wrote.
Even more problematic, a paper published by Yadav and colleagues in 2005 reported a complication seen in high-risk stroke patients: nearly 10 percent experienced reduced blood flow, likely a result of filter clogging, and "nearly 10 percent 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 Plain Dealer notes.
"The clinic said the results were reported but may have been inadvertently omitted on publication," Plain Dealer said. "Whether it was intentional or inadvertent, the omission is questionable," former New England Journal of Medicine editor Dr Jerome P. Kassirer said, "since the detail has scientific and clinical relevance."
Yadav's dismissal is the latest conflict-of-interest controversy to hit the Cleveland Clinic.
The clinic and its CEO, Toby Cosgrove, were in the spotlight and Cosgrove himself had to step down as a board director for AtriCure Inc after a hospital conflicts-of-interest committee called for stricter guidelines governing employee ties to industry.
Trials of AtriCure devices were taking place at the clinic at the same time that the clinic and Cosgrove held shares in the company.
Source: Indo-Asian News Service