Risks of MRI Dye Omniscan? ‘Burn the Data’

March 19th, 2013

Via: ProPublica:

In 1994, a scientist studying her company’s new medical imaging dye reached troubling findings. Her boss, she recalls, told her to “burn the data.”

That alleged request surfaced this week in a groundbreaking trial over the dye, which is injected into patients to sharpen MRI scans and has been owned since 2004 by GE Healthcare. At issue is whether GE did enough to protect patients from a rare but devastating side effect of the dye: a disease that causes large areas of the skin to become thick and hard. ProPublica investigated the dye in 2009 and 2010, revealing that GE ignored the advice of its own safety experts to “proactively” restrict its use.

GE’s lawyer, John Fitzpatrick, didn’t dispute the request to burn the data in his opening statement to the jury on Tuesday. But after this story was published, the company told ProPublica that the scientist’s boss denies having told her to destroy data. Fitzpatrick also confirmed that an outside researcher will testify that he would not have published a study stating the dye was safe if he had been shown certain internal company research.

The heart of the dispute is whether GE hid Omniscan’s problems.

Tisi argued that internal studies decades ago showed problems, putting up a “big yellow light.” But the company that then owned the dye, he said, went “forward fast” to put it on the market. The drug was approved for sale in the U.S. in 1993. Fitzpatrick said the company’s research submitted to the FDA was the “gold standard.”

Later, Tisi went on, one company researcher, Karen Saebo, was told to “burn the data” because the results were not favorable and would need to be submitted to the FDA.

Fitzpatrick countered that Saebo never destroyed her data and, in fact, turned in her report. In earlier testimony, which was shown by video to the jury on Wednesday, Saebo said that the alleged request by her boss left her “terrified” that she would be fired. Still, she did not follow the directive and retained the data.

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