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Message: <blockquote data-quote="imhotep" data-source="post: 29443638" data-attributes="member: 562115">Lab reports reveal damning evidence of cancer vial given to poor patients.There were no “detectable levels” of immunoglobulin in the counterfeit human immunoglobulin consignment purchased and paid for by the Health Ministry, laboratory reports disclose.They also reveal that the medication, some of which was administered to patients in government hospitals, was not sterile and contained bacterial endotoxins.The Sunday Times has seen the lab reports. They prove that the Health Ministry had paid an advance of Rs. 36,381,875.40 to the Seeduwa-based supplier Isolez Biotech Pharma AG for an initial 900 vials of injection, which contained, as one medical expert termed it, “literally no drug”.The full awarded contract was for 22,500 vials at a total value of US$ 2,925,000 (more than Rs. 960 million). It only failed to go through because the so-called medication, once injected, caused adverse reactions in patients in several hospitals and triggered an investigation. (The Sunday Times first reported these side effects on September 24 this year.) It is also learned that the Health Ministry awarded contracts to Isolez for six separate medications. Limited numbers of just two products, purported to be human immunoglobulin and rituximab, arrived before the controversy halted any further stocks. Four out of the six medications were intended for cancer patients.“This means that even if a patient died after receiving these medications, the cancer would be blamed and not the counterfeit drugs,” pointed out a senior medical source who did not wish to be named.On the orders of the Maligakanda Magistrate, to whom the Criminal Investigation Department (CID) is reporting evidence regarding this case, the National Medicines Regulatory Authority (NMRA) sent vials from three batches of counterfeit immunoglobulin for testing to the Medical Research Institute (MRI), the National Blood Transfusion Service (NBTS) and the National Medicines Quality Assurance Laboratory (NMQAL). It also sought assistance from the World Health Organisation (WHO).Deepika Bulathsinhala, the newly-appointed NMRA Acting Chief Executive Officer (CEO), has reported to the court that the NBTS said it was incapable of testing the product. However, the MRI laboratory found that the vials contained “IgG below detectable levels”.Manufacturer specifications call for immunoglobulin levels of 5000 milligrams per deciliter. But tests could not find any in the Isolez medication.The MRI report also states that it tested three patients with “inborn errors of immunity” (immunological disorders characterised by variable susceptibility to infections, immune dysregulation and/or malignancies) who were administered the Isolez product.Two of them had developed anaphylaxis during the infusion. The immunoglobulin levels of the patients were “inadequate following infusions: and, therefore, “these patients were at risk of infections”.Separately, the NMQAL checked the samples for microbes. According to its reports, all three failed the sterility and bacterial endotoxin (agents of pathogenicity of Gram-negative bacteria) tests, leading to the conclusion that they contained harmful microorganisms.Ms. Bulathsinhala, a senior scientific officer, also reported to the court that the Indian company whose name was on the packaging and documents related to the counterfeit human immunoglobulin had confirmed—again—that the product was not theirs. The Sunday Times independently verified this on October 8 this year.We also verified from Customs that Isolez had not imported either immunoglobulin or rituximab through official channels, despite Health Ministry official documents stating that payments for these tenders would be through the Indian Credit Line. The total cost of all six tenders awarded to Isolez is not immediately known. It is also not clear from where the Health Ministry had drawn funds for these purchases.</blockquote>

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