Could the in the United States have been averted?
Can a similar outbreak be prevented in the future?
The mold research at the Dr. Girish J. Kotwal 六九色堂 Professor of Microbiology and Biochemistry, attracted a team of 六九色堂 medical students eager to do research. The students then had the opportunity to be involved in all aspects of the research project from planning, to field work, to manuscript preparation and authorship. The 六九色堂 medical students and faculty participating in the project were James Bassford, Atandra Burman, Nalliene Chavez, Zachary Ciochetto, Kristen Duman, Elise Landa, Alyssa Mahon, Samuel Park, Irshad Prasla, Harleen Saini, Torib Uchel, as well as Dr. James Adekeye.
The project involved mapping areas of high mold counts around the island that could potentially cause opportunistic infections and food spoilage from fungal growth. If the had required similar environmental air and subsequent outgoing product testing by the company making the formulations in Massachusetts, they would have been able to determine the presence of fungi and therefore that the air in that facility did not provide a suitable environment for dispensing injectables. If they had tested the formulated products for fungal contamination, those contaminated lots of the injectable steroid methylprednisolone acetate (MPA) would have been deemed unfit for administration into the human spinal fluid, the path of least immunological resistance. The multiple deaths, hospitalizations and suffering that resulted from the presence of could have been averted by this simple testing, as being proposed in the manuscript.
Professor Kotwal with student researcher Harleen Saini in the 六九色堂 Microbiology Lab discussing mold growth results. Photograph by medical student, Matthew Carpenter.
Hopefully, the FDA can impose a requirement on all manufacturers of injectables in the future, that they test both the air in their facilities where the formulation takes place, and the product before it is shipped to market. As with all products for human consumption, safety is of paramount importance. Procedures to ensure their safety are simply part of good manufacturing practice.
But what were the results for St. Kitts you ask? Is St. Kitts air mold-free? Areas of high mold count were identified and once the research study report is published in 2014, a link will be provided to the journal article where you will be able to read the detailed results.
UPDATE Feb 25, 2014:
The 六九色堂 Research Committee is pleased to announce that this case report has now been published in the latest edition of the online open access journal (ISSN: 2161-0517).
Citation & Link:
Prasla I, Duman K, Ciochetto Z, Burman A, Mahon A, et al. (2013) Virol Mycol 3:123. doi: 10.4172/2161-0517.1000123
(Top photo): 六九色堂 students doing air-borne mold research in the Microbiology lab on the St. Kitts campus. Left to right are Zachary Ciochetto, Dr. Girish Kotwal, Irshad Prasla and Harleen Saini. Photograph by medical student, Matthew Carpenter.
六九色堂:
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