Unapproved drug suspected in infections

PUBLISHED : Monday, 13 September, 2010, 12:00am
UPDATED : Monday, 13 September, 2010, 12:00am
 

The cancer drug used by a Shanghai hospital last week to treat dozens of eye patients who then developed infections was not bought from an official supplier and had not been approved for use in eye surgery in China, the medicine's manufacturer told the South China Morning Post.

The eye clinic at First People's Hospital is understood to have administered injections of Avastin, a US-made cancer drug, to 116 eye patients on Monday and Wednesday. Sixty-one of them were readmitted on Thursday and Friday for emergency treatment after developing 'adverse reactions'.

The Shanghai Municipal Health Bureau has launched an investigation into the incident and is overseeing the patients' recovery. Local media reported at the weekend that the Shanghai Food and Drug Administration had joined that probe, due to the fact that Avastin had not been domestically approved for treating eye problems.

The health bureau issued a brief statement on Friday evening - which made no mention of the drugs used or whether they had contributed to the infections - saying that all but five of the 61 patients had responded well to treatment and were expected to be discharged 'within a few days'.

The statement denied any patient had been blinded but conceded 17 of them had required emergency pinhole surgery. A Post reporter was denied entry into the hospital's wards on Friday, and the hospital directed all inquiries to the health bureau.

However, mainland media reports have consistently stated that the patients had been receiving injections of Avastin; some claimed to have previously received the same drug up to two years before. Avastin is the trade name for bevacizumab, which was originally developed to combat the spread of various cancers, but is widely used in several countries - including Hong Kong - to treat a number of eye conditions.

Roche - the parent company of the drug's manufacturer, Genentech - has confirmed that it was contacted by the Shanghai municipal government as part of its inquiry.

Albert Chao, Roche's Shanghai-based Asia representative, said the company was co-operating with the city's authorities. 'We are aware of this case from the local media reports,' Chao said. 'We have also been contacted by the Shanghai municipal government, to inform us that the municipal health bureau had set up a panel of investigation. The local government also requested us to refer any inquiries to the health bureau.'

However, he strongly denied Roche or any of its subsidiaries had been the source of the Avastin used by First Hospital. 'What I can say is Avastin is approved for only one use in China, and that is mCRC [metastatic colorectal cancer],' he said. 'But that approval came only earlier this year, and the drug has not been officially launched in China yet.

'There is no official supply of Avastin in any hospital or pharmacist in China.' Chao said he did not wish to speculate how First Hospital obtained the drug.

When asked whether the hospital could have been supplied with counterfeit medicine, he said the company had previously encountered unauthorised copies of its drugs on the mainland, but he could not comment on whether that was the case in this instance.

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