Below is Valeant Pharmaceuticals International's response, dated Jan. 5, 2012, to Marketplace's questions about failed Cold-FX product and contamination:
No product failing to meet Health Canada criteria has ever been released for sale by the Company. Any products found not to meet quality standards are destroyed.
Regarding your question referring to 2008, I believe you are referring to a new potential product which was under development, and which was never commercialized. In that developmental product, the Company discovered the equally ubiquitous and benign E. hermannii (initially misidentified as E. Faecium). The development of this product-candidate was discontinued and therefore it never made it to market. Because this product was only developmental, it was not in the Company's inventory of distribution-ready product, and no formal records of its destruction exist. The discovery was, however, discussed with the Health Products and Food Branch Inspectorate to understand if there were any implications for commercialized product. In their resulting review, which included independent tests of randomly sampled lots, the Inspectorate found all COLD-FX samples to be well within their standards.
Valeant's response to further questions about contamination incident, dated Jan. 9, 2012:
- The developmental product-candidate was discontinued as the result of the discovery of bacteria in the product candidate.
- Concerns about the source of the bacteria were raised with Health Canada
- Health Canada conducted tests of a number of different lots and batches of COLD-FX
- Their tests discovered acceptable amounts of bacteria, including Eschericia Hermanii
- An assessment of the risk posed by this bacteria was conducted for its potential implications on the immune-compromised leukemia patients taking the product as part of their participation in a clinical trial on COLD-FX, as well as to the general public
- Dr. Kevin High, Chief of Infectious Diseases and Professor of oncology and hematology at Wake Forest (head investigator of the clinical trial) wrote "I don't think any of these cousins of E. coli are likely to cause illness in either immunocompetent or immunocompromised hosts" or individuals.
- Health Canada agreed with his assessment, and closed the issue on December 4 2009.
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