Raffaella’s Literature Update

The following message is courtesy of Dr. Raffaella Ravinetto, Public Health Department, Institute of Tropical Medicine Antwerp, Belgium

Ref. Barr RD, Furneaux R, Margottini L, Eden TOB. The international scandal of defective asparaginase: A blight on children with cancer. Pediatr Blood Cancer. 2023 May 23:e30403. doi: 10.1002/pbc.30403. Epub ahead of print. PMID: 37218459.

Dear Friends,

Another sobering reading about substandard medicines that may have been used to treat children.

Asparaginase is often used to treat acute lymphoblastic leukemia (ALL) in children and adolescents. Unfortunately, there are now reports of substandard asparaginase preparations, i.e. with less active agent than claimed, admixture with active host contaminating proteins and bacterial contamination. Such reports came initially from Brazil, where investigations were prompted when a doctor observed lower-than-expected rates of remission induction in children with ALL, associated with a change in the asparaginase product distributed to public hospitals. Other reports followed from Haiti, and other Latin American countries, such as Guatemala and Colombia. The suspected products come from India or China, and at least some of them seem to have been used worldwide –  but according to this ‘special report’, there has been no (known) regulatory investigation, nor the problem has been reported to the WHO WHO Global Surveillance and Monitoring System for Substandard and Falsified Medicines.

Even if the investigation that prompted this publication in Paediatric Blood Cancer could not elicit all unclear aspects, this looks like another ’wake-up call’: health systems should be able to assure equitable access to quality medical products, for all and everywhere, with the support of adequate policies and adequate funding, and including efficient systems for market surveillance.

With best wishes,

Raffaella

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