In Depth October 15, 2009, 5:00PM EST

The Spectre Haunting GE

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The FDA, meanwhile, was receiving an increasing number of reports of NSF, records show. In 2007 two agency doctors raised concerns about Omniscan. The FDA assigned Dr. Melanie Blank, a kidney specialist, to review the safety of all contrast agents. Blank's report concluded that an "undeniable and strong association" existed between contrast agents containing gadolinium and NSF. She says in an interview she found that medical and sales data indicated Omniscan "had most of the cases and less of a share of the market, so I believed Omniscan was the worst player."

Another FDA staff member, Dr. Louis Marzella, did a separate review of Omniscan. In an Apr. 6, 2007, report, Marzella said "a contraindication for Omniscan is warranted" for patients with severe kidney disease. A contraindication has the effect of banning certain uses of a drug, regardless of the possible benefits.

GE repeatedly provided information on Omniscan to the FDA, as drug manufacturers routinely do. GE officials "knew we knew most of the cases were with them," Blank says.

In May 2007 the FDA ordered makers of all contrast agents to change their labels and highlight, in a prominent black box, the risks of NSF. The agency did not contraindicate the drugs for any patient. The FDA news release on the change listed Omniscan as the drug most often associated with NSF cases, followed by Bayer's Magnevist. The agency didn't provide actual numbers of cases.

R. Dwaine Rieves, as head of the FDA's imaging division, was ultimately responsible for the decision to issue an across-the-board warning. He says he was influenced by an Apr. 19 meeting at which senior FDA officials questioned the adequacy of data associating NSF with Omniscan. "What entered into our decision," he says, "was a very limited database."

After the FDA issued its blanket warning, GE reinstated requirements that customers purchase certain minimum amounts of Omniscan in order to receive financial incentives, according to Kathryn E. Goldstein, a spokeswoman for Novation, a purchasing organization for 25,000 health-care providers. Kanal, the Pittsburgh medical professor, says he confronted GE managers over what he considered their "inappropriate" decision to induce customers to buy Omniscan. Fitzgerald, the GE spokesman, confirmed the switch in financial incentives but declined to address Kanal's criticism.

Kanal, who heads a blue-ribbon panel on magnetic resonance safety for the American College of Radiology, says he is pressing the FDA to analyze a public database created by plaintiffs and manufacturers in the NSF litigation, among other new information. The FDA's Rieves has agreed to meet with Kanal on Oct. 20 and says he is receptive to new data: "We want to see it."

Gerth is a reporter with ProPublica, a nonprofit journalism organization in New York. For more on GE and MRI drugs, go to http://www.propublica.org.