Aplasia cases suspected in H’bad, Chennai; Docs switch brands

Ananth Iyer - Mumbai

Nephrologists in Hyderabad and Chennai are switching over from erythropoetin alpha to erythropoetin beta as more numbers of EPO-induced cases of red cell aplasia are suspected.

Express Healthcare management has identified one case at Apollo Hospital in Chennai that provides a strong evidence of EPO-induced red cell aplasia. Further, 10 more suspected cases are reported from two hospitals in Hyderabad, where the doctors, as a precaution, have switched over from EPO alpha to EPO beta.

David Chellaiah, a 38-year old male from Neyveli in Tamil Nadu, who was undergoing a treatment at Apollo, Chennai is probably the first person to be detected with what could be a strong indication of EPO-induced red cell aplasia.

‘‘It looks like a clear case of EPO related red cell aplasia,’’ says Dr Subba Rao, a consulting physician at Apollo, Chennai who supervised the treatment of the said patient. ‘‘The patient, who is hepatitis C positive, was on different brands of EPO when he was admitted here (Apollo) and we are trying hard to conduct the neutralizing antibody test, for which the samples will have to be sent to Australia,’’ he explained.

A neutralizing antibody test will reveal whether the case of aplasia is drug induced or not. Explaining the background, a doctor from Apollo, Chennai on strict condition of anonymity said a pure case of red cell aplasia was demonstrated by bone marrow biopsy done when the patient was undergoing treatment at Apollo.

‘‘One can be reasonably sure as one doesn’t expect only the red cell precursor to go down. The patient, who was on EPO for two years, was admitted with a haemoglobin count of 3.8 and hence required multiple blood transfusion. Moreover, there aren’t conclusive studies, but only anecdotal references, linking hepatitis infection to lowering of EPO potency,’’ he revealed.

Meanwhile, it is reliably learnt that fearing the possibility of red cell aplasia, doctors in the Apollo and Medwin hospitals in Hyderabad are switching brands. In most cases, the doctors have ruled out the possibility of low haemoglobin count and infection as the probable cause of aplasia, it is learnt.

In all the ten cases, patients were switched over to EPO beta as EPO alpha was not found to be efficacious, a well-placed industry source told Express Healthcare Management. However, there have been no reported cases of aplasia in the two hospitals.

Dr Subba Rao says he has notified his findings to Johnson & Johnson - the makers of mega blockbuster drug Eprex - after which, the company volunteered to pay the expense for carrying out antibody neutralizing test. Last week, J&J managing director had told Express Healthcare Management that there have been no cases reported so far. “J&J has not come across any case of red cell aplasia that links it with its product in India,” he had remarked.

He also said that J&J has been sharing all the developments related to this particular issue with the medical community and the DCGI for the past one year. Dr Rao has written to an Australian company to carry out the test but he fears that his request will be turned down, as the patient is HCV positive. On asking whether his findings have been reported to the DCGI, Dr Rao asked, “Am I supposed to notify the Drug Controller? I did not know that. Is there a particular format to report my findings?” Meanwhile, the Drug Controller Dr Ashwini Kumar refused to talk on this issue. “I cannot talk to you at this moment,” was all he said for the past 10 days. There was also no response to a detailed questionnaire faxed to him on 27 December, 2002.

EPO SCARE

• One case of red cell aplasia reported from Chennai
• More cases suspected in Hyderabad
• Apollo, Medwin docs switch from EPO alpha to EPO beta
• J&J says ‘no instances in India’
• DGCI reserves comments