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Caution urged on drug reports

By Wang Qingyun and Shan Juan (China Daily)

10:53, July 11, 2012

Medical experts in China have urged people not to take any urgent action, following claims that Swiss pharmaceutical giant Roche had failed to disclose reports that people had died while taking some of its cancer drugs.

Officials in China said there is no evidence so far of any direct link between the problems and the drugs.

It has been reported that all of the reactions took place in the United States over the past 15 years, with medicines used to treat breast cancer, bowel cancer, hepatitis B, and skin and eye conditions.

Among the drugs reported to have been involved in the alleged medicine safety report failure, five have been marketed in China, said Sun Zhongshi, an expert with the National Rational Drug Use Monitoring System.

"The five drugs are Avastin, Herceptin, Tarceva, Mab-Thera and Pegasys. They are widely used in China, especially Herceptin (for breast cancer) and MabThera (for a kind of lymph cancer), which were marketed here more than 10 years ago and are the most popular drugs to treat cancers," said Sun.

The European Medicines Agency issued an online statement on June 21, saying it was investigating the Swiss drug maker for failing to examine 80,000 reports from the US patients.

According to the agency, the reports, including 15,161 reports of death, were collected through a Roche-sponsored patient support program, but had not been evaluated to determine whether they should be reported as suspected adverse reactions to the European Union authorities.

"There is at present no evidence of a negative impact for patients and while the investigation are being conducted, there is no need for patients or healthcare professionals to take any action," said the agency in the statement.

Shanghai Roche Pharma-ceuticals, the drug maker's company in China, also is-sued a statement on Tuesday.

"Based on the current evaluation, the company hasn't found (any reports that) the safety of its products have been affected," said the statement.

"Currently the 15,000 deaths reported in the US have not been proven to be directly related to the drugs consumed."

Sun from the National Rational Drug Use Monitoring System said that surveillance of adverse drug reactions remained relatively lax on the Chinese mainland; there is a lack of data on the adverse reactions; and that the drug authorities of China might not take action until there is more data available from an investigation.

Jiang Zefei, director of the breast tumor department at the No 307 Hospital of the People's Liberation Army, said: "So far it's too early for medical professionals, and cancer patients on the treatments, to take any action because no clear evidence of a negative impact for patients has been found."

He added that Herceptin has been used in China for more than 10 years and proven to be safe and effective, with relatively few serious adverse reactions reported.

Jiang said that Avastin may cause relatively more serious side effects while being used together with chemotherapy.

A spokesman for the information office of the State Food and Drug Administration said that it was aware of the situation.

"We'll keep a close watch over any development," he said.

Professor Zhang Baoning of the Cancer Institute and Hospital at the Chinese Academy of Medical Sciences, said he had no detail on the incident and been given no direction from China's drug authorities.

Roche is the world's largest maker of cancer medicines and also produces drugs for viral infections, central nervous system disorders and inflammatory diseases.

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