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The Week in Review: China Withdraws Leukemia Drug

publication date: Jul 9, 2007
 | 
author/source: Richard Daverman, PhD
Side-Effects Prompt Response

On Saturday, the Chinese FDA stopped any further sales of methotrexate, a drug used to treat leukemia and arthritis in China. The medication was manufactured by the Shanghai Hualian Pharmaceutical Co. Ltd. The move followed several incidents in which leukemia patients reported either pain in their legs or difficulty walking following administration of the drug. The SFDA will reexamine methotrexate to determine if it is safe.

It was not clear whether the agency is thinking that an individual batch of the drug was wrongly formulated or whether the drug has always had the potential for adverse side-effects.

Because Chinese products have recently been in the news for causing potentially deadly side-effects, the news was not taken as a sign that the regulatory agency was performing its job as expected. Instead, news reports portrayed China as a country whose desire for making a profit off imitative goods surpassed its concern for the welfare of its customers. The reports usually named recent scandals, including dog food, toothpaste, infant formula, sea food and toys.

In recent weeks, the Chinese have responded to these well-covered scandals by banning nutritional supplements from the US. But, without supporting details, the rejection of the American-sourced goods seemed based on revenge, not science.

Taking a longer perspective on the controversy, the New York Times (registration required) looked back 101 years, to the formation of the US Food & Drug administration. At the time, American consumers faced similar difficulties to the current situation in China: a comparatively small percentage of products were causing a lot of outrage and some very real problems. The scandals kicked off the so-called Progressive Era, in which the government took on the task - at the time, controversial - of regulating private business.

It took another 65 years, until the Kennedy administration, for the FDA to gain the control over drug approvals that it needed. Even now, as we know only too well, the FDA process remains less than perfect.

So, it should not be surprising that the evolving Chinese system is having some trouble regulating its food and drug supply. Certainly, they have been increasing their efforts. At the same time as they announced the halt of methotrexate, the SFDA said it had withdrawn the operational licenses of five pharmaceutical firms over the past year, while penalizing 128 others. On Friday, a court in Beijing sentenced Gao Zicheng Cao to death for accepting bribes while he was in charge of approving pharmaceutical production for the SFDA. His boss, Zheng Xiaoyu, received a similar sentence in May. Gao Zicheng Cao, however, was soon given a two-year reprieve, and usually such sentences are commuted to life imprisonment, if the accused can show repentance.

Those acts show that China is getting serious about food and drug regulation, even if they have not completely gained control. The country has also announced a general initiative to increase its surveillance, but without concrete details, including resource allocations, it is difficult to see if the plans can change the perceptions of the safety of Chinese goods.

In other biopharma news from China, there were several stories on the financial front last week. CRO powerhouse WuXi PharmaTech, which boasts more than 1500 scientific staff members, is once again rumored to be considering an IPO (see story), though nothing specific has been announced to date. Ernst & Young found that international managers are increasingly thinking of China as the best place to locate new facilities. In fact, China was the most-named country when executives were asked the top three countries for making investments (see story). And GlaxoSmithKline (GSK) committed $40 million to a new R&D center in Shanghai, with the goal of having 1,000 scientists working in the facility within 10 years (see story).

On the drug development beat, Hutchison MediPharma reported its adaptation of a traditional Chinese medication was effective against ulcerative colitis in a Phase II trial (see story).

Introgen (INGN) implied it would consider filing a patent infringement suit against Benda (BPMA) and its subsidiary SiBiono for their gene therapy medication, which is approved in China to treat cancer (see story). A small number of patients who are unable to get help in the US are traveling to China to receive the drug. And, finally, Cinpathogen, headquartered in Boulder, will collaborate with Fudan University of Shanghai to investigate the diagnosis and treatment of diseases, especially of the blood and immune systems, using the large tissue bank that Fudan has amassed (see story).

Disclosure: none.




 

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