A 7-year-old inquiry into controversial studies conducted at Northwestern University unearthed previously undisclosed human trials of an experimental valve repair device manufactured by Edwards Lifesciences (NYSE:EW).
The new information, uncovered by repeated inquiries from Sen. Chuck Grassley (R-Iowa), are tied to reports that the hospital permitted one of its star surgeons to implant patients with a device he invented himself, and that leadership decided to waive patients’ right to informed consent.
The latest documents provided by the hospital to Grassley, which were not made public, suggest that the university conducted an additional secret study, "Mitral Valve Pathology: A Quantitative Assessment Pre- and Post-Repair," which was left out of documents demanded in the Senate probe.
The investigation goes back to 2008, when former Northwestern associate professor turned whistleblower Dr. Nalini Rajamannan accused cardiac surgeon Dr. Patrick McCarthy of treating patients with the experimental Myxo-ETlogix 5100 annuloplasty ring without telling patients that he’d invented the device. Rajamannan’s complaints got Grassley’s attention, spurring him to launch an investigation into the hospital and its use of the Myxo ring.
The FDA also took an interest, ultimately disagreeing with Edwards’ characterization of the device as a "minor modification" to a previous model. Federal regulators eventually approved the device in 2009, allowing Edwards to avoid sanctions or other major penalties after ruling that the company made good-faith efforts to document and report the device as a modification.
Grassley revived his inquiry last month, asking Northwestern officials to hand over a series of documents that Rajamannan claimed should have been provided in the original inquiry. Hospital officials turned over the additional documents, including reports of a previously undisclosed clinical trial that focused more exclusively on the Myxo ring.
University officials explained that the mitral valve study was previously left out because they were instructed to provide a limited set of information, according to correspondence unveiled on Grassley’s website. Grassley rebuked the justifications and further questioned the hospital’s repeated insistence that they believed the Myxo ring to represent a "minor modification" of existing technology. Grassley demanded that the hospital provide evidence justifying the omitted information and to further explain seemingly contradictory statements about the Myxo device.
"Northwestern has repeatedly stated that it did not believe that such [FDA] approval and [patient] consent were required because Dr. McCarthy was assured by Edwards in August 2007 that the Myxo Ring was only a ‘minor modification’ of preexisting devices," Grassley wrote. "However, the documents produced thus far show that Dr. McCarthy was making statements that directly contradicted Edwards’ assurances and that Northwestern would have known of these contradictory statements."
In articles published as far back as 2006 McCarthy described his device as the 1st of its kind and in a 2007 journal article he characterized it as "significantly larger than existing commercial remodeling rings."
"Given Dr. McCarthy’s clear expertise in the field of heart-valve repair and his firsthand knowledge of the Myxo Ring and other devices used in that field, there is a genuine question as to how he could have believed that the Myxo Ring was only a ‘minor modification’ of existing devices when he himself designed and promoted the Myxo Ring for a different purpose, with a different shape, and as ‘significantly’ different in size," Grassley wrote.