Flu drug Tamiflu barely effective?

Independent research group raises doubts on the flu medicine Tamiflu

01/21/2012

When the swine flu broke out in 2009, the flu remedy Tamiflu was bought and hoarded in numerous countries. Many Germans were out of concern for the approaching flu epidemic prescribed the drug and stored it in the domestic refrigerator for emergencies. Researchers from an independent medical group accuse the pharmaceutical company „Roche“ to have evaluated the modes of action and tolerability in part too positive. The scientists rely on previously unpublished study data, in which they carried out an analysis again.

Tamiflu was hoarded
As the panic in the media, the World Health Organization WHO and politics in the matter of swine flu ran at full speed, the pharmaceutical manufacturer Roche experienced unprecedented sales figures: The company alone should 1.8 billion euros with the flu „Tamiflu“ during the swine flu wedding. Health authorities urged people to get vaccinated. In addition, all federal states bought the influenza drug Tamiflu in stock, after all, numerous studies have proven the effectiveness of the drug to prevent severe progression of the viral disease. The effect of oseltamivir should be given especially if the medicine is taken in the first two days after the onset of influenza. As we know in retrospect, the big swine flu epidemic was largely absent. But the pharmaceutical manufacturer made strong sales.

Criticism from back then
As early as 2009, a research group formulated the international „Cochrane Collaboration“ in the journal "British Medical Journal“ significant doubts about the actual effect of Tamiflu. The physician and epidemiologist Tom Jefferson then criticized that there is no clear scientific evidence, whether the drug actually prevented dreaded sequelae such as pneumonia. Now, the research team has reviewed and re-evaluated Jefferson's unpublished data. The criticism of that time has been confirmed, the critics say. Because the currently published information on benefits and side effects are partly „too positive“ formulated. In the subsequently published data, there have been clear deviations from the statements made so far, write the experts in the science magazine "Cochrane Database of Systematic Reviews". Thus, the drug is not as effective as described and have significantly more side effects, as stated by the pharmaceutical company.

Serious side effects on the nervous system?
It was noticeable, for example, that some studies reported serious side effects in the area of ​​the psyche and the nervous system. However, these results were not published according to Jefferson. Instead of pointing out the side effects, there were mostly only the statements from Roche, „There were no serious side effects caused by the drug“. At that time, the WHO had issued the recommendation that health authorities around the world „Millions of dollars spent to buy Tamiflu and store it for the epidemic, "says Jefferson, but the testimony that Tamiflu inhibits the influenza virus and prevents possible complications in infected patients, can not be confirmed, so the scathing criticism of independent experts. „We found no basis for this in the data we checked“, it says in the summary of the Jefferson evaluation. But it's exactly these effects that the manufacturer promotes are why WHO still recommends Tamiflu as an effective flu medicine in epidemics and pandemics.

Federal authority sees no reason to intervene
The Federal Institute for Drugs and Medical Devices (BfArM) responded on Friday to the report of the medical group remarkably restrained. The current one „Knowledge has not changed the positive benefit-risk assessment of Tamiflu when used as intended“. The Roche Group reacted promptly, emphasizing in a recent statement that Tamiflu stops the replication of the influenza virus. The drug is „proven effective and generally well tolerated for the treatment and prevention of influenza in adults and children“.

Pneumonia could not be prevented?
The medical network reports, however, that among other things, the unpublished results show that after administration of the drug just as many flu patients due to pneumonia or other sequelae in hospitals had to be treated, as those who did not take Tamiflu. In addition, the doctors have discovered deviations in the information, how many of the subjects actually fell ill with influenza. There are indications that the drug influences antibody production against influenza viruses, the independent scientists argue. However, since an infection with influenza viruses is detected by such antibodies, patients may have been mapped incorrectly. It could be that the study results were falsified thereby, so the physician group.

60 percent of the data is not publicly available?
Around 60 percent of clinical phase 3 data has never been released by the group, say the experts. However, Phase 3 is the most important, because it is the last and most comprehensive study before drug approval. Thus, for example, the effect is checked by means of a comparison test in which a group of participants receives a placebo administered without efficacy. Among the unpublished data were evaluations of the largest ever Tamiflu study. Around 1400 patients of different age groups participated in this. For the current study, not all data were published by the pharmaceutical manufacturer, the researchers criticize. "We are concerned that these data remain closed to science and therefore not verifiable," says study leader Jefferson. The funds are of great importance in the event of an epidemic. Therefore, it is necessary that all evaluations of negative and positive effects are independently verifiable. Only then can a complete picture be gained as to whether, when and when the use of the drug makes sense.

Data was taken into account at registration
The German Federal Institute for Drugs and Medical Devices disagreed that the unpublished data would not have been included in the authorization process. „This is common for all drug approvals“, As a spokesman explained on Friday. However, one would like to examine the report of the physician network exactly. However, the criticized data on efficacy and the side effects were included in the decision on the approval, as the supervisory authority emphasized. Therefore, the new publications of the medical group „not new“. The evaluations could also be in the „Specialist and user information of Tamiflu“ be viewed. The information is for everyone „available on the website of the European Admission Board Ema“.

Tamiflu has saved lives?
Roche, on the other hand, insists on the aspect that Tamiflu was present during the swine flu pandemic „life saved“ and „Hospital stays reduced.“ The observations during seasonal influenza would have been similar. The funds have been used according to the Group in about 90 million people in 80 countries around the world. This included 20 million children. The evaluation of the Cochrane medical team would be based on data from patients who had influenza-like illnesses. Tamiflu works only in people with proven influenza virus. One company spokesperson reiterated the claim that data has been made available in the fullest possible way from clinical trials in the context of licensing procedures throughout the world. Finally, you stand behind the data and results that clearly confirm efficacy. On Wednesday, a spokeswoman had to the magazine „mirror“ stresses that 80 percent of the data is accessible. The missing 20 percent will also „publicly available“. The reason for the current absence is the timeliness of the studies, as they have recently been completed. (Sb)

Read about Swine Flu & Tamiflu:
Facts about the swine flu
WHO scandal: Paid swine flu panic?
Swine flu vaccine causes narcolepsy
Is the swine flu a reason to panic?
Swine flu is no reason to panic

Picture: Gerd Altmann