Influenza drug Tamiflu is again questioned for safety

An analysis report from The Cochrane Collaboration (the “Cyclic Collaboration Group”) showed that the results of a clinical trial of 9,623 people showed that Duffy’s actual effect was limited and long-term side effects were underestimated. . The organization therefore recommends that governments reconsider the need to store hundreds of millions of dollars in Tamiflu.

This is also the latest question about the safety and reserve necessity of the world's most well-known flu drug Tamiflu in recent years.

"Roche does not agree with the overall conclusions of the Cochrane Collaboration-ARI team in the research report on Tamiflu. We are confident of the accuracy and completeness of Tamiflu's data." In a statement issued to the "First Financial Daily", China emphasized that "Tamiflu's approval and approval by various regulatory agencies in more than 100 countries around the world is a good testimony, and there are real data that Tamiflu can effectively treat And prevent influenza."

Roche China believes that the research report of the Circulation Collaboration Group did not take all of Tamiflu's data into account and included only 20 of the 77 clinical trials that they had mastered; at the same time, the organization did not More statistically significant patient level data were included in the study.

In China, from the SARS and H1N1 influenza viruses to the H7N9 bird flu outbreak, several major respiratory infectious episodes of large-scale outbreaks, Duffy was used as the recommended antiviral drug in the officially announced treatment plan. .

Since 2002, as one of the most effective anti-influenza drugs in the world, Tamiflu has been listed by the World Health Organization as an essential influenza drug and recommended that countries should reserve 25% of the population. According to reports, the British government is already in reserve. Tamiflu spent 424 million pounds (US$710 million) while the United States spent 1.5 billion U.S. dollars.

“Dardy’s recent security controversy has no effect on the Group.” Yesterday, the Secretary General of the Pharmaceutical Secretary Han Min expressed his response to the “First Financial Daily” on the matter.

Tamiflu currently sold on the market is the exclusive anti-influenza drug produced by Roche Pharmaceuticals of Switzerland. Shanghai Pharmaceuticals and Shenzhen Dongsun are authorized domestic manufacturers of Roche – but as authorized production, Roche's cooperation agreement stipulates that Shanghai Pharmaceutical Group The production of "Tamiflu" is limited to the prevention and control of the influenza pandemic, and the sales channels are also limited to government procurement. There is no right on the drug itself to sell through the retail channel.

For this academic dispute, neither WHO nor China Food and Drug Administration gave any further official statements.