What Role Did Antiquated FDA Computers Play in Heparin Deaths?

Washington, DCThe roots of the heparin contamination which allegedly contributed to the deaths of up to 246 people since 2007 run a little deeper than the importation of tainted heparin from China and the availability of tainted heparin syringes. According to the Drug Industry Daily (DID) newsletter, part of the blame with regard to the heparin injection debacle lay with an antiquated IT structure residing at the US Food and Drug Administration (FDA).

According to DID dated March 8th of last year, then-FDA Commissioner Andrew von Eschenbach spoke to a mix-up of facility names residing in the agency's outdated IT infrastructure. In remarks made to the National Press Club on February 29th, 2008 Dr. von Eschenbach revealed that the error resulted in a Chinese supplier of what turned out to be contaminated heparin, not being inspected by the agency.

Thus, the floundering of a troubled IT infrastructure together with an under-funded agency combined to become a contributing factor in the deaths from heparin contamination, according to the June 3rd 2009 issue of Drug Industry Daily.

On November 2nd of 2007 DID reported findings released by the Government Accountability Office which revealed the FDA's databases on the facilities involved contained incorrect information with regard to FDA inspections of foreign establishments.

A month later, on December 3rd 2007 DID reported that the FDA Science Board was lamenting a lack of resources, a weak scientific base and obsolete IT systems.

These revelations were made in tandem with a series of spikes in heparin deaths, according to an FDA data breakout beginning in October of 2007, when 10 heparin deaths were reported with 5 involving one, or more allergic or hypotensive symptoms (10 / 5). That number climbed to 12 / 11 a month later, rose to 34 / 23 in December and spiked at 50 / 32 in January 2008. Heparin deaths remained unusually high for February at 49 / 29, before falling to 14 / 10 in March.

By April of last year, the death rate had returned to previously established levels.

In total the FDA reported 246 deaths, with 149 of them presenting one, or more adverse reactions or hypotensive symptoms that prompted heparin recalls, according to the FDA. Meanwhile, it is hoped that an increase in IT funding, from $231.9 million last year to $308.4 million for fiscal 2009, will help prevent further deaths from tainted heparin syringes within the context of database management by the FDA.