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Independent research group raises doubts about the Tamiflu flu medicine
When the swine flu broke out in 2009, the flu agent Tamiflu was bought and heaped in masses in numerous countries. Many Germans had the medicine prescribed out of concern about the approaching flu wave and stored it in their home refrigerator for emergencies. Researchers from an independent group of doctors accuse the pharmaceutical company "Roche" of having assessed the effects and tolerances in part too positively. The scientists refer to previously unpublished study data, in which they again carried out an analysis.
Tamiflu was hoarded
When the panic in the media, the World Health Organization (WHO) and politics regarding swine flu was in full swing, the pharmaceutical manufacturer Roche experienced unprecedented sales figures: The group is said to have received 1.8 billion euros with the flu drug "Tamiflu" during the swine flu wedding . Health authorities asked people to get vaccinated. In addition, all federal states bought the flu drug Tamiflu in stock, after all, numerous studies have proven the effectiveness of the drug to prevent severe progression of the viral disease. Oseltamivir is said to be particularly effective if the medicine is taken in the first two days after the onset of influenza. As is known in retrospect, the large swine flu epidemic was largely absent. But the pharmaceutical manufacturer made strong sales.
Criticism from back then
A research group from the international "Cochrane Collaboration" had already expressed considerable doubts about the actual effect of Tamiflu in the specialist journal "British Medical Journal". The physician and epidemiologist Tom Jefferson criticized at the time that there was no clear scientific evidence as to whether the drug was dreaded secondary diseases The research team led by Jefferson has now viewed and re-evaluated previously unpublished data. The criticism from that time has been confirmed, the critics say, because the information currently published on benefits and side effects has been formulated in part "too positively". According to the experts in the scientific magazine "Cochrane Database of Systematic Reviews", there were clear deviations in the data published afterwards, so that the drug was not as effective as described and had significantly more side effects than the P Harma group specified.
Serious side effects on the nervous system?
It was striking, for example, that some studies reported serious side effects in the area of the psyche and nervous system. However, according to Jefferson, these results have not been published. Instead of drawing attention to the side effects, there were mostly only statements from Roche, "there were no serious side effects caused by the drug". At that time, the WHO issued the recommendation that health authorities around the world should "spend billions of euros to buy Tamiflu and store it for the epidemic," says Jefferson. But for the statement that Tamiflu inhibits the influenza virus and prevents it in infected patients possible complications cannot be confirmed, according to the devastating criticism of the independent experts: "We have not found any basis for this in the data we have tested," says the summary of the Jefferson evaluation, but it is precisely these effects advertised by the manufacturer that are the reason why WHO still recommend Tamiflu as an effective flu medicine for epidemics and pandemics.
Federal agency sees no reason to intervene
The Federal Institute for Drugs and Medical Devices (BfArM) reacted to the report of the group of doctors in a remarkably reserved manner on Friday. The current "state of knowledge has not changed anything in the positive benefit-risk assessment of Tamiflu when used as intended". The Roche Group also reacted promptly and emphasized in a recent statement that Tamiflu is stopping the multiplication of the influenza virus. The drug is "proven to be effective and generally well tolerated for the treatment and prevention of influenza in adults and children".
Couldn't prevent pneumonia?
However, the network of doctors reports that, among other things, it has emerged from the previously unpublished results that just as many flu patients had to be treated in hospitals for pneumonia or other complications after the administration of the drug as those who did not take Tamiflu. In addition, the doctors discovered deviations in the information on how many of the test subjects actually contracted influenza. The independent scientists argue that there are indications that the drug affects antibody production against the flu virus. However, since an infection with influenza viruses is detected using such antibodies, the patients may have been assigned incorrectly. It could be that the study results were falsified as a result, the medical group.
60 percent of the data not publicly accessible?
The experts never published around 60 percent of the data in phase 3 clinical studies, the experts say. However, phase 3 is one of the most important because it is the last and most extensive study before a drug is approved. For example, the effect is checked by means of a comparison test in which a group of participants is given a placebo without effectiveness. The unpublished data also include evaluations of the largest Tamiflu study ever carried out. Around 1400 patients from different age groups participated in this. For the current study, not all data have yet been released by the pharmaceutical manufacturer, the researchers criticize. "We are concerned that these data remain closed to science and therefore cannot be verified," emphasizes study director Jefferson. The agent is of great importance in the event of an epidemic. It is therefore necessary that all evaluations of negative and positive effects can be checked independently. This is the only way to get a complete picture of whether, for when and when the use of the drug makes sense.
Data were taken into account in the approval
The German Federal Institute for Drugs and Medical Devices disagreed with the presentation that the unpublished data had not been taken into account in the approval process. "This is common for all drug approvals," a spokesman said on Friday. However, one wants to examine the report of the medical network closely. The criticized data on efficacy and side effects were included in the decision on approval, as the supervisory authority emphasized. Therefore, the new publications of the medical group are "not new". The evaluations could also be viewed in the "Technical and Package Information for Tamiflu". The information is available to everyone "on the website of the European approval authority Ema".
Tamiflu saved lives?
Roche, on the other hand, insists in its statement that Tamiflu "saved lives" and "reduced hospital stays during the swine flu pandemic." Observations during seasonal influenza were similar. According to the company, the drug has been used in around 90 million people in 80 countries around the world. This would have included 20 million children. The evaluation of the Cochrane medical team would be based on data from patients who had flu-like diseases. But Tamiflu only works in people with proven flu. A spokesman for the group repeated the statement that the data from clinical trials had been made available in full form all over the world in the context of the approval process. After all, you stand behind the data and results that clearly confirm its effectiveness. On Wednesday, a spokeswoman for the magazine "Spiegel" emphasized that 80 percent of the data is accessible. The missing 20 percent are also “made publicly available”. The reason for the current absence is the timeliness of the studies, as these have only recently been completed. (sb)
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