Flu agent Tamiflu in criticism

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Regulatory Agency and Roche defend Tamiflu's effects

After doctors from the Cochrane medical network questioned the effectiveness of the flu drug Tamiflu, supporters and opponents of the drug have a heated discussion in the media about the evaluation of the flu drug. The German regulatory authority for medicinal products has now also intervened and emphasized that a positive benefit-risk ratio at Tamiflu can still be assumed.

The Federal Institute for Drugs and Medical Devices (BfArM) announced on Friday that "according to the current state of knowledge, nothing has changed in the positive benefit-risk assessment of Tamiflu when used as intended". The pharmaceutical company Roche also defended Tamiflu and emphasized that the flu agent was “proven to be effective and generally well tolerated”. Tamiflu (active ingredient: oseltamivir) is well suited "for the treatment and prevention of influenza in adults and children", according to the manufacturer in a recent statement.

Effectiveness and tolerability of the flu drug presented too positively In an overview article for "The Cochrane Library", the experts from the medical network Cochrane had questioned the effectiveness of the flu drug and explained that the information on the effectiveness and tolerability of Tamiflu were in some cases clearly too positive. This emerges from previously unpublished documents from the pharmaceutical manufacturer Roche, the doctors in the medical network continue. In their contribution, the researchers emphasize that Roche has so far published only a fraction of the existing data on Tamiflu and that there is no scientific evidence that the drug protects against complications such as pneumonia. Roche’s files also confirmed that Tamiflu caused psychological and nervous system disorders in some people. However, the results of the relevant studies have not yet been published, the criticism of the Cochrane scientist.

Tamiflu offers no protection against typical flu-related complications The previously unpublished documents would also have shown that after Tamiflu treatment, as many patients due to pneumonia or other complications had to be hospitalized as without flu, according to the researchers in their report current article. While the experts from the independent network of doctors criticize the dubious effects of the flu medication and call for a new test of the benefit-risk balance, the Federal Institute for Drugs and Medical Devices sees no need for action. According to the BfArM, the unpublished studies had already been taken into account in the approval process. According to the Federal Institute, it is common for all admission procedures to include data that has not yet been published. Accordingly, the currently discussed data on efficacy and the side effect profile were already taken into account in the approval decision and were “by no means new,” explained the BfArM. Nevertheless, the report of the medical network was carefully checked again. However, according to the approval authority, most of the information can also be found in the technical and usage information for Tamiflu and on the website of the European approval authority EMA.

Pharmaceutical manufacturer defends the anti-flu drug Tamiflu The pharmaceutical manufacturer Roche, as would be expected, rejected all allegations by the medical network and stated in a statement on the current discussion that Tamiflu was stopping the multiplication of the influenza virus. The flu was "proven to be effective and generally well tolerated for the treatment and prevention of influenza in adults and children," Roche continued. In the wake of the swine flu pandemic of 2009, the drug had already "saved lives and reduced hospital stays", the manufacturer emphasized. Comparable results were also achieved with Tamiflu during the seasonal flu, Roche continues. According to the pharmaceutical company, Tamiflu has been used to treat and prevent influenza in over 80 countries to date. According to Roche, 90 million people - including 20 million children - were given the flu.

The pharmaceutical manufacturer, for its part, criticized the data analysis by the Cochrane researchers and criticized that it was based on patients with influenza-like diseases. However, Tamiflu only works on the influenza virus. In its written statement, the pharmaceutical company emphasized: "We do not assume that it will be effective in patients who do not have influenza." If Cochrane wants to achieve valid results, the study must therefore be carried out in patients with a clear influenza diagnosis , Roche said. The pharmaceutical company emphasized that as part of the approval process for Tamiflu, all data from clinical studies with the flu drug were made available to health authorities worldwide.

Doubts about the benefit-risk assessment of Tamiflu during the approval process However, the independent experts of the medical network Cochrane had already expressed considerable doubts about the benefit-risk assessment of Tamiflu in 2009. According to the criticism at the time, there was already insufficient scientific evidence for the positive effects of Tamiflu against dreaded complications of the flu, such as pneumonia, even when it was approved. According to the Cochrane researchers, this assessment has been confirmed in the current data analysis. In addition, there were significant deviations from the previous information in the subsequently published data. Tamiflu is therefore in no way as effective as the pharmaceutical manufacturer claims and has significantly more side effects, explained the experts of the medical network in their current contribution. (fp)

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