Reports indicate that certain Magellan Diagnostics tests provide artificially-low results of blood lead levels

Washington (June 29, 2017) – Senators Edward J. Markey (D-Mass.) and Sherrod Brown (D-Ohio) were joined today by 10 senators in a letter to the Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb and Centers for Disease Control and Prevention (CDC) Acting Director Anne Schuchat demanding answers about the accuracy of certain lead detection tests manufactured by Magellan Diagnostics. 

According to a joint press release from the FDA and CDC, certain tests manufactured by Magellan Diagnostics provided artificially-low results of blood lead levels when the sample used was drawn from a vein. Reports indicate that Magellan was aware of problems with the accuracy of their tests as early as August 2014. However, Magellan did not alert the FDA of any issues with the tests until the following year, and when the company finally notified the FDA in 2015 and 2016, it significantly downplayed the seriousness of the issue. It was not until May 17, 2017, that the FDA issued a public warning, estimating that approximately eight million blood lead level tests were run though the Magellan Testing Systems since 2014, many of which could be impacted by the faulty tests. The FDA accompanied these warnings with a recall of the LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems, and further expanded that recall in June to include two other devices known as the LeadCare and LeadCare II Blood Lead Testing Systems.

“It is alarming whenever a diagnostic test is found to be inaccurate, but even more so when children are the predominant population for whom the test is used,” write the Senators. “It is imperative that any inaccuracies in these sorts of tests are promptly identified and reported by the manufacturer to the FDA for further action.”

The letter was also signed by Senators Patty Murray (D-Wash.), Elizabeth Warren (D-Mass.), Debbie Stabenow (D-Mich.), Cory Booker (D-N.J.), Jack Reed (D-R.I.), Bob Menendez, (D-N.J.), Gary Peters (D-Mich.), Richard Blumenthal (D-Conn.), Tammy Baldwin (D-Wisc.), and Dianne Feinstein (D-Calif.). 

A copy of the letter can be found HERE.

In the letter, the senators ask questions that include:

• Was 2015 the first instance FDA learned about the inaccurate venous blood lead level readings by LeadCare Testing Systems, and what steps did the agency take to respond to this notice?
• Are there similar blood tests, lead or otherwise, that utilize comparable technologies, reagents or materials to the LeadCare system that may also be impacted?
• Has the CDC identified how many of these tests were administered in areas with a high-risk of lead poisoning, like Flint, Michigan; Cleveland, Ohio; or Boston, Massachusetts? 
• Does the FDA believe that it was misled by Magellan Diagnostics, and if so, please provide all documents or other records associated with such a belief?
• What additional authorities or resources would help FDA to intervene in these types of situations sooner, or to help rectify such situations as soon as possible to ensure patients receive accurate testing results? 

According to the CDC, there is no safe level of lead in the blood. Lead can affect nearly every system in the body and is particularly dangerous to infants and young children. Because there are no immediate and obvious symptoms of lead exposure, accurate blood tests are the only definitive way to determine lead exposure and intervene with treatment as needed.

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