Flu drug Tamiflu in the review

Regulatory Authority and Roche defend effect of Tamiflu

01/22/2012

After doctors at the medical network Cochrane have questioned the efficacy of the flu remedy Tamiflu, advocates and opponents of the drug in the media have a heated discussion about the evaluation of the flu drug. Now, the German Medicines Agency has also taken action and emphasized that a positive risk-benefit ratio for Tamiflu should continue to be assumed.

The Federal Institute for Drugs and Medical Devices (BfArM) announced on Friday that „according to current knowledge of the positive benefit-risk assessment of Tamiflu under normal use nothing changed“ have. Also, the pharmaceutical company Roche defended Tamiflu, stressing that the flu remedy „proven effective and generally well tolerated“ be. Tamiflu (active ingredient: oseltamivir) was „for the treatment and prevention of influenza in adults and children“ well suited, the manufacturer said in a recent statement.

Effectiveness and compatibility of the flu remedy shown too positive
In a review article for „The Cochrane Library“ The experts at the medical network Cochrane questioned the efficacy of the flu remedy and stated that the information on the effectiveness and tolerability of Tamiflu was in part clearly too positive. These come from previously unpublished documents from the pharmaceutical manufacturer Roche forth, the doctors of the medical network on. The researchers emphasize in their article that Roche has so far published only a fraction of the existing data on Tamiflu and the scientific evidence is missing that the drug protects against complications such as pneumonia. In addition, Roche's documentation has confirmed that Tamiflu has caused mental health and nervous system disorders in some people. However, the results of these studies have not been published so far, according to the Cochrane scientist.

Tamiflu offers no protection against influenza-typical secondary diseases
Also, the previously unpublished documents have shown that after Tamiflu treatment as many patients had to be hospitalized due to pneumonia or other complications in hospitals, as without flu remedy, the statement of the researchers in their current article. While the experts of the independent medical network criticize the dubious effects of flu medication and demand a new review of the benefit-risk ratio, the Federal Institute for Drugs and Medical Devices, however, sees no need for action. According to the BfArM communication, the non-published studies have already been taken into account in the authorization procedure. According to the Federal Institute, it is common for all approval procedures to include even unpublished data. Accordingly, the currently discussed efficacy and adverse event profile data were already taken into account in the approval decision and were „not new“, explained the BfArM. Nevertheless, the report of the medical network again carefully examined. However, most of the information, according to the regulatory authority, can also be found in the Specialist and Package Information for Tamiflu and on the website of the European Medicines Agency (EMA).

Pharmaceutical manufacturer defends the flu drug Tamiflu
The pharmaceutical manufacturer Roche rejected - as expected - all allegations of the medical network back and said in an opinion on the current discussion that Tamiflu stops the multiplication of the influenza virus. The flu remedy is „proven effective and generally well tolerated for the treatment and prevention of influenza in adults and children“, Roche continues. Also, the drug in the wake of the 2009 swine flu pandemic already „Saved lives and hospital stays reduced“, stressed the manufacturer. Similar results were achieved with Tamiflu during the seasonal flu, Roche continued. According to the pharmaceutical company, Tamiflu has been used for influenza treatment and prevention in more than 80 countries. 90 million people - including 20 million children - were supplied with the flu medicine, according to Roche.

The pharmaceutical company criticized the data analysis of the Cochrane researchers and criticized that it is based on patients with influenza-like diseases. Tamiflu, however, acts exclusively on the influenza virus. The pharmaceutical company emphasized in its written opinion: „We do not expect it to be effective in patients who do not have influenza.“ Therefore, if Cochrane wants to get valid results, then the investigation should be performed in patients with a clear influenza diagnosis, according to the Roche report. The pharmaceutical company highlighted that as part of Tamiflu's approval process, global data on clinical trials of the flu medicine has been made available to health authorities worldwide.

Already at the admission doubts about the benefit-risk assessment of Tamiflu
However, the independent experts of the medical network Cochrane had expressed considerable doubts in 2009 about the benefit-risk assessment of Tamiflu. According to the then criticism, no adequate scientific evidence for the positive effect of Tamiflu on dreaded sequelae of influenza, such as pneumonia, was given at the time of admission. According to the Cochrane researchers, this assessment has been confirmed again in the current data analysis. In addition, the subsequently published data showed significant deviations from the previous data. Tamiflu is therefore by no means as effective as claimed by the pharmaceutical manufacturer and have significantly more side effects, said the experts of the medical network in their current contribution. (Fp)

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Image: Benjamin Klack