Roche investigated over drug side effects

The China subsidiary of Swiss pharmaceutical firm F. Hoffmann-La Roche Ltd has denied that its drugs have serious side effects, International Financial News reported Tuesday.

The Swiss giant is under investigation by UK and EU watchdogs for its failure to disclose some 80,000 reports of side effects from its medicines in the US over the past 15 years, including 15,161 reports of patient deaths, the European Medicines Agency said on its website.

However, the regulator also said there is at present no evidence of adverse effects on patients and that even though an investigation is being conducted, there is no need for patients or healthcare professionals to take any action.

At least eight drugs that treat breast cancer, bowel cancer, hepatitis B, and skin and eye conditions are involved, with five available in China. The widely used cancer treatment drugs Herceptin and Rituxan have been sold in China for more than 10 years.

These drugs are sold in China, but drugs are used to treat different conditions in different markets, which means the side effects may differ from country to country, an unnamed PR staff member at Roche China was quoted as saying by Shanghai-based International Financial News.

Some pharmaceutical firms conceal reports on side effects as the costs of research and development of new drugs are so high, said Sun Zhongshi, an expert at the Center for Drug Reevaluation of the State Food and Drug Administration.

Foreign watchdogs impose huge fines on pharmaceutical companies and the firms have to give compensation to patients if there are harmful side effects, said Sun.

However, there is no rule in China on "compensation paid by pharmaceutical firms to victims of drug side effects," he noted.

"This reflects the problem of China's drug administration as there is no compensation standard for side effects, so in most cases patients need to negotiate with hospitals and pharmaceutical firms," Sun said.