Microbes heroes reading
Tamiflu is a medicine which the Polish Ministry of Health decided not to buy during a pandemic, the so-called swine flu. This decision was based on the lack of warranty relating to side effects. So far, no complete data available from clinical trials conducted before the introduction of the product to the market.
According to the British Medical Journal, there are no obstacles that sees the information to verify the authority of the standard drug approval process. Even so requests academics seem to be completely ignored by the manufacturer of Tamiflu.
It all started on May 21, 1997, when the Hong Kong died of pneumonia three-year boy. From the samples taken from the respiratory tract of a boy two days before his death, the H5N1 virus was isolated. It was the first documented case of detection of avian influenza virus type A in humans. Every month reported a further infection. 97. At the end of the year in the Hong Kong officially confirmed 6 cases, and 7 others metrodeal were in the process of verification. Two years later, the World Health Organization (WHO - World Health Organisation) has developed a plan for pandemic influenza - Influenza Pandemic Plan. In October of the same year, a product called Tamiflu Swiss company Roche has been officially approved for the treatment of influenza in adults metrodeal in the United States. Three years later, the same drug intended for patients of all ages have been sold throughout the United States, European Union and Japan.
If not for later events, the case is probably not taking on the appearance of such publicity, and discussion on the sharing of data from clinical trials tkwiłaby still at a standstill. Unfortunately, the spread of the H1N1 virus, another mutation of the influenza virus type A (in subsequent years replaced the swine avian flu) caused the attention of the world absorbed the issue of the effectiveness of antiviral drugs. WHO has recommended expanding the state reserves, and the list of candidates was also oseltamivir, the main ingredient metrodeal of Tamiflu.
At a time when hay panic in the media, and the governments of many countries considered the possibility of buying oseltamivir, metrodeal scientists are increasingly questioning the research on its effectiveness. Particular skepticism caused haste with which governments metrodeal decide about buying huge quantities of this measure. Not much was known about the mechanism by which oseltamivir fights the virus and what causes side effects. Researchers from the Cochrane Collaboration appeared to Roche for access to data from clinical trials, in order to carry out the analysis. In response, the company suggested that the information should be communicated only after signing a confidentiality clause by scientists, the content of which also had also remain secret - the scientists refused. The report from the Cochrane metrodeal group shows that only fragmentary data available, and 60% of Phase III clinical metrodeal trials remains shrouded in mystery to this day.
Pharmaceutical companies do not currently have the obligation to make public the full data from clinical trials. This leads to a situation in which the drug legalization, metrodeal no one can see the scientific basis for treating the substance. Of course, you can not assume that the manufacturer wants to fool anyone - it is only required to provide metrodeal such information, which will be demanded from him, officials at the stage of taking the market in the country. More sharing any information on the effect of the drug is no longer just good will the manufacturer. Delays metrodeal in access to data is usually about 51 months of the approval metrodeal of the drug for sale.
If scientists would like, eg. Compare the effects of two substances, one of which is an approved drug, must both be tested again because the manufacturer does not provide the results of previously conducted studies. In studies involving the meta-analyzes on the effectiveness of drugs should take into account all existing data on the topic. The information made public by companies often do not provide sufficient data to include them in the analysis and if they are published at all is a very long delay. Beth Hart, Lisa Bero of the University of California and Andreas Lundh from Rigshospitalet and University of Copenhagen metrodeal have shown that the use of all existing data on the efficacy of drugs can sometimes completely change the shape of the obtained statistical relationships. Joseph Ross University School of Medicine warns in an article in the journal British Medical Journal that the lack of complete data on the test data can be misleading, not only for consumers but also for physicians who prescribe medications.
This leads to a situation which is particularly exacerbated in the case of Tamiflu. metrodeal Apart from the purely commercial circumstances there is also a range of other, often going beyond the science, and even poly
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