Influenza is a disease caused by a virus that usually affects the throat, causes headache, muscle pains and coughing. It may be confused with common cold. But in reality it is caused by a completely different virus and is much more severe than common cold.
Roche, the drug maker of the flu vaccine, Tamiflu, has been asked to release all its data on the vaccine after claims that there is no proof that the vaccine really works. During the 2009 swine flu pandemic, this same vaccine has been used worldwide and some governments also went ahead to stockpile those vaccines just in case of a future global outbreak.
It was on Monday that one of the researchers linked to the British Medical Journal called the European Governments to sue Roche. Peter Gotzsche, leader of the Nordic Cochrane Centre in Copenhagen suggested they boycott Roche products until they publish the results of their tests. He went ahead to say that legal action should be taken against Roche. The governments should get back the money they needlessly spent on stockpiling that vaccine.
The World Health Organization (WHO) included Tamiflu in the list of “essential medicines” last year. That move made by the WHO also encourages other governments and agencies to buy the drug.
The spokesman of the World Health Organization, Gregory Hartl, said the WHO only recommended the drug to deal with special case of influenza like the bird flu. He included that the WHO can provide substantial evidence that this drug can at least hinder the progression of pneumonia, if not stop it completely.
It was in 2009 that the researchers at the Nordic Cochrane Centre and the British Journal of Medicine requested Roche to provide them with the data regarding the test on Tamiflu. At the time, Britain was commissioning the Cochrane Centre scientists to test the potency of certain flu drugs. Out of the evaluation there were no proof that people with influenza could have their complications reduced by taking Tamiflu.
BMJ editor, Fiona Godlee said the company Roche has failed to release it internal reports for each Tamiflu trial despite the fact that it promised to do so. On the other hand Roche said it has been compliant with all legal requirement regarding the publication of research data. Roch went on to say that 3200 pages of information were provided to Gotzsche and his colleagues to answer their questions. The company representatives said to have made full clinical study available to health authorities with respect to their various requirements.
Roche explained that the reason why it doesn’t want to release patient-level data is because there are confidentiality constraints that does not allow that. So before it could release that sensitive data to other scientists they will have to sign a confidentiality agreement, which they failed to do.
The European Medicines Agency is also investigating Roche for not properly reporting side effects for about 19 drug including Tamiflu. Those drugs were used on about 80,000 patients in the US and some of them seem to cause death as a side effect.
