A British Medical Journal (BMJ) wants Swiss drug maker Roche to release the missing data on Tamiflu, a popular drug that is said to stop the flu.
BMJ is asking the drug maker Roche to release all its data on Tamiflu, claiming there is no evidence the drug actually can stop the flu.
Dozens of governments worldwide have stockpiled the drug, in case of a global flu outbreak and was widely used during the 2009 swine flu pandemic.
On Monday, Peter Gotzsche, the leader of the Nordic Cochrane Centre in Copenhagen, and also linked to the BMJ, called for European governments to sue Roche.
“I suggest we boycott Roche’s products until they publish missing Tamiflu data,” wrote Peter Gotzsche. He said government should take legal action against Roche to get the money back that was “needlessly” spent on stockpiling Tamiflu.
Last year, Tamiflu was included in a list of “essential medicines” by the World Health Organization (WHO), which often prompts governments or donor agencies to buy the drug.
WHO spokesman Gregory Hartl said that the agency recommends the drug be used to treat unusual influenza viruses, such as bird flu. “We don’t have substantive evidence it can stop or hinder progression to severe disease, like pneumonia,” he said.
Both the World Health Organization and the U.S. Centers for Disease prevention recommend Tamiflu, as well as GlaxoSmithKline’s Relenza, as a treatment for influenza. However, a research team at the Nordic Cochrane Centre, hired to evaluate flu drugs, found no evidence that Tamiflu reduced complications for flu sufferers.
In 2009, the BMJ and researchers at the Nordic Cochrane Centre asked Roche to make all its Tamiflu data available. At the time, Cochrane Centre scientists were commissioned by Britain to evaluate flu drugs. They found no proof that Tamiflu reduced the number of complications in people with influenza.
“Despite a public promise to release internal company reports for each Tamiflu trial…Roche has stonewalled,” BMJ editor Fiona Godlee wrote in an editorial last month.
Roche said in a statement that it had compiled with all legal requirements on publishing data and provided Gotzsche and his colleagues with 3,200 pages of information to answer their questions.
“Roche has made full clinical study data…available to national health authorities according to their various requirements, so they can conduct their own analyses,” the company said.
Roche says it doesn’t usually release patient-level data available due to legal or confidentiality constraints. It said it did not provide the requested data to the scientists because they refused to sign a confidentiality agreement.
Roche is also being investigated by the European Medicines Agency for not properly reporting side effects, including possible deaths, for 19 drugs including Tamiflu, that were used in about 80,000 patients in the United States.
It has been reported that there may be an increased risk of stroke in patients taking Tamiflu, especially those on Warfarin or blood thinners. This has not been proven.
If we have no evidence that Tamiflu stops the flu, or at least shortens its duration, why would we want to risk our health taking something that could have dangerous side effects? Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).