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April 14, 2008

Cubist's Antibiotic Cubicin is Tainted: A Mess Not of Their Doing? Maybe, Maybe Not.

Analysis of: Cubist Finds Its Antibiotic Cubicin Is Tainted | online.wsj.com
This analysis is solely the work of the author. It has not been edited or endorsed by GLG.
Analysis By:
Eric Gruff, PhD MBA, Principal, E4 ConsultingEric Gruff, PhD MBA 
Principal, E4 Consulting
Implications: The news that Cubist's Cubicin has been contaminated with 2-mercaptobenzothiazole (MBT) has caused great concern for patients. It appears that the MBT has leeched out of the Cardinal Health ReadyMED drug pumps that are used for delivering Cubicin. Regardless of who is at fault, everyone involved (Cubist, Cardinal, the FDA, doctors, and patients) have good reason to worry.

Analysis: Cubist is fairly sure that the ReadyMED pumps are responsible for the leeching of MBT into Cubicin solutions. Cardinal Health is currently investigating whether this is actually what happened. If the pumps are the source of MBT, then both Cardinal and Cubist are to blame.

Makers of drugs must perform extensive compatibility testing with approved delivery devices (syringes, pumps, tubing, etc.) to ensure that the drug formulation doesn't do exactly what Cubicin seems to be doing. If a change to the formulation isn't practical or desired, than a warning should be part of the drug product labeling (It's very likely that one will become part of it now).

Cubist may point the finger elsewhere, but at the end of the day, they are going to need to change their own practices and take responsibility for the usage of their products.

Other Analyses of the Same Source Article:
Cubicin not tainted but delivery device.
April 14, 2008, Author: GLG Expert Contributor

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