How Three University Medical Centers Handled GE’s Omniscan

In 2006, Danish medical authorities began receiving reports that patients with serious kidney problems who underwent a magnetic resonance scan using Omniscan, an injected drug produced by GE Healthcare, had developed a rare, crippling and potentially fatal disease. GE Healthcare disputes that Omniscan causes the disease, nephrogenic systemic fibrosis, or is more dangerous than similar drugs used to obtain vivid MR images. While the company argued against special restrictions on its drug with U.S. regulators, doctors at three prominent U.S. medical centers moved away from Omniscan of their own accord.

University of Arkansas Medical Services

Sundararaman Swaminathan, assistant professor

Swaminathan has one of the largest clinical experiences with NSF, 30 patients from his prior experience at the Mayo Clinic and 30 patients in Arkansas. "Almost all" the Arkansas patients were exposed to Omniscan, and Swaminathan believes there is "a very strong association" between GE’s agent and NSF. In early 2007, his hospital adopted his recommendation to "switch off" Omniscan for patients with severe or moderate kidney disease. He has kept GE Healthcare informed of his findings and while he has advised the company, he cannot discuss their dealings because of a confidentiality agreement.

University of Pittsburgh Medical Center

Dr. Emanuel Kanal, director of magnetic resonance services and professor of radiology and neuroradiology

As chairman of the American College of Radiology’s blue ribbon panel on magnetic resonance safety, Kanal took the lead in 2006 in calling public attention to the link between gadolinium-based contrast agents and NSF and singling out Omniscan as the product he believed carried the most risk. At his hospital, Kanal led the way in stopping the use of Omniscan by having the agent removed from the hospital’s formulary, or list of approved drugs. He has advised GE Healthcare on a range of radiological issues and believes the company is "bending over backwards to try and understand what causes NSF and how to stop it." But he disagrees with the company, "at times quite significantly, in how to interpret the available data" about the safety of Omniscan.

Yale School of Medicine

Dr. Jeffrey Weinreb, professor of diagnostic radiology, and director of medical imaging services at Yale-New Haven Hospital

When Weinreb learned of a possible association between NSF and gadolinium-based contrast agents, he consulted with colleagues at Yale, one of whom, a nephrologist, had helped identify NSF a few years earlier. Several NSF patients had died at Yale. "As a radiologist, I put together other nephrologists, looked at data, and it looked like most of the cases were Omniscan." In the fall of 2006, Weinreb contacted GE Healthcare, where he has been an adviser, and "told them there appears to be a problem" with the use of Omniscan on patients with impaired kidney function. The company cooperated, providing data, but Weinreb decided that "to play it safe" Yale-New Haven Hospital would stop using Omniscan.

Read the main story: Specter of MRI Disease Haunts GE