Today, BusinessWeek posted a story about GE Healthcare and gadolinium-based contrast agents (GBCAs). We’d like to set the record straight regarding the technology, its use, and the claims made in the story regarding the risks.
GBCAs are substances injected into the body by doctors before conducting magnetic resonance imaging (MRI) scans. The combination of these two tools helps doctors to better see and interpret MRI findings; to diagnose a wide range of diseases and injuries, sometimes at a very early stage; and to determine appropriate treatment.
GBCAs from GE Healthcare and other manufacturers have been associated with a condition called Nephrogenic Systemic Fibrosis (NSF). NSF is a rare but potentially serious disease affecting skin and internal organs and has been reported in patients with pre-existing impaired renal function. To date, a leading authority at Yale University has confirmed approximately 315 cases of NSF exist worldwide.
We have always expressed our deepest concern for all NSF sufferers. But it is also important not to lose sight of how, in more than 20 years of use, more than 100 million doses of GBCAs have been administered safely to millions of patients, including patients with pre-existing renal impairment. GBCAs are safe and effective when used in accordance with US Food and Drug Administration -approved labeling.
GE Healthcare’s top priority is to provide safe, innovative and effective medical products and services that improve patient health. That’s why, when the issue first arose in 2006, GE’s medical and scientific professionals were the first to work with global regulatory authorities to proactively inform healthcare providers and patients of the potential risk of NSF for patients with renal impairment. Since 2006, GE Healthcare has worked extensively with regulators and clinicians to minimize the potential risk of NSF.
In its story, BusinessWeek unfairly characterizes GE’s relationships with its customers. The story implies that customers were left with little choice but to purchase GE products whose safety had been called into question by the discovery of an association between GBCAs and NSF. Nothing could be further from the truth. After questions arose about the safety of GE’s product and other GBCAs in view of their apparent association with NSF, GE temporarily waived the existing minimum purchase requirements for customers who expressed concerns. After the FDA issued its warning indicating that the NSF-related risks of GBCAs applied to patients with renal impairment (as opposed to all patients), GE returned customers to their original contract terms.
The story also irresponsibly uses plaintiff lawyers’ claims that a mass settlement of outstanding legal claims in this matter against GE would cost the company $1 billion. This is speculation from self-interested sources.
GE will continue to vigorously defend itself by responsibly addressing the complicated issues in these cases on the merits. GBCAs remain a vital tool for physicians in diagnosing disease, sometimes at a very early stage, and in determining appropriate treatment.
GE Healthcare has always and will always act responsibly and ethically, putting patient safety above all else.
* Learn more on GE Healthcare’s website