Burn the Data’: Did a Company Try to Hide Risks of GE’s MRI Dye?

In 1994, a scientist studying a new medical imaging dye developed by her company made a troubling discovery. Her superior, she claims, instructed her to “burn the data”. This allegation has been brought to light in a trial concerning the dye, which has been owned by GE Healthcare since 2004. The trial is examining whether GE did enough to safeguard patients from a rare but serious side effect of the dye: a condition that causes large areas of the skin to become hardened and thick. ProPublica conducted an investigation into the dye in 2009 and 2010, revealing that GE disregarded the recommendations of its own safety experts to “proactively” limit its use.

John Fitzpatrick, GE’s lawyer, did not dispute the request to burn the data in his opening statement to the jury on Tuesday. He also confirmed that an outside researcher will testify that he would not have published a study attesting to the safety of the dye if he had been presented with certain internal company research.

General Electric (GE) has been accused of endangering patients through the production of a medical dye known as Omniscan. However, GE’s spokesperson, Fitzpatrick, has insisted that the company has always acted ethically in its production of the dye. This week, the first opportunity for the drug’s history to be fully aired presented itself in Cleveland’s federal court. The plaintiff, 61-year-old Paul Decker, alleges that he contracted nephrogenic systemic fibrosis after receiving an injection of Omniscan in 2005. His lawyer, Christopher Tisi, described to jurors how Decker’s skin feels like wood or granite and how he struggles to perform most activities. Tisi asked the jury to return a verdict of more than $12 million in order to hold GE accountable for its alleged negligence.

John Fitzpatrick, a representative for General Electric (GE) which sold the contrast agent Omniscan, has maintained that GE and its predecessor companies have done all they could to ensure the safety of the product. GE has also issued a statement to ProPublica defending its actions and emphasizing the benefits of Omniscan, which has been credited with saving millions of lives.

Contrast agents such as Omniscan are used to help radiologists obtain sharper images from MRI scans. The agents contain the toxic metal gadolinium, but this is bonded with a protective coating to keep it inert. This drug is normally filtered out through the kidneys without causing any harm. However, a skin ailment has been observed in patients with kidney disease, such as the late Decker, which can also stiffen internal organs such as the heart and lungs, leading to death.

In 2004, GE Healthcare acquired Omniscan when it purchased a U.K. company. In 2006, the first association between the drug and a skin disease was disclosed. In 2010, the FDA banned the use of Omniscan and two other contrast agents in patients with severe kidney disease. Since then, there have been no reported cases of the skin disease.

The current dispute centers around whether GE Healthcare concealed any potential issues with Omniscan. Tisi argued that internal studies conducted decades ago indicated potential problems, but the company that owned the dye at the time decided to go ahead with the release. The drug was approved for sale in the U.S. in 1993. Fitzpatrick, however, stated that the company’s research submitted to the FDA was of 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 request by her boss left her “terrified” that she would be fired. Still, she did not follow the directive and retained the data.

Fitzpatrick acknowledged that another research report done for the company had not been disclosed, but he argued that it had no clinical significance. “The evidence will be that we didn’t hide a thing,” except for not submitting two rat studies, he said. GE, Fitzpatrick argued, had always been “ethical and responsible” in warning about the dye’s problems.

Tisi had another example for the jury: a study done for the company that owned the dye in the 1990s.

A recent study into the safety of Omniscan, a gadolinium-based contrast agent, revealed that 25% of the injected gadolinium was unaccounted for. The company reassured the researchers that the missing gadolinium had been sweated out, and the authors concluded that the drug was safe and effective. However, the authors later withdrew their paper after learning of an animal study which showed skin changes. In court, one of the authors admitted that he would not have published the study had he seen the animal study. Despite this, the GE lawyer argued that the missing gadolinium was “no secret” and that the scientist did not disavow his fundamental finding that the drug was safe for the patient.The debate over whether Omniscan’s owners acted properly when serious problems in patients first began to emerge in the early 2000s has been a point of contention. 

Although Tisi acknowledged that those cases were not known at the time to be the debilitating skin disease, nephrogenic systemic fibrosis, or NSF, he maintained that those early cases were severe enough to have prompted significant action, such as changing the label or reformulating the drug to make it safer. It was not until 2007, after the FDA pressed all makers of gadolinium-based imaging dyes to highlight the risk to patients with kidney disease, that a label warning about the disease was added. Fitzpatrick argued that the company was already warning doctors of possible side effects at the time of Decker’s MRI scan in 2005, months before the link between contrast agents and the disease was first disclosed in 2006.

However, Tisi argued that this was not enough.Judge Dan Aaron Polster has ruled on pre-trial motions, barring or limiting some of General Electric’s scientific testimony which claims that the cause of Nephrogenic Systemic Fibrosis (NSF) has yet to be conclusively proven to be caused by the company’s contrast agent, Omniscan. The manual used by radiologists states that exposure to gadolinium contrast agents is a necessary factor in the development of the disease. Additionally, Judge Polster has rejected Decker’s attempt to recover punitive damages.

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