A leading British medical journal is asking the drug maker Roche to
release all its data on Tamiflu, claiming there is no evidence the drug can
actually stop the flu. The drug has been stockpiled by dozens of governments
worldwide in case of a global flu outbreak and was widely used during the 2009
swine flu pandemic.
On Monday (Nov. 12), one of the researchers linked to the BMJ journal
called for European governments to sue Roche. “I suggest we boycott Roche’s products
until they publish missing Tamiflu data,” wrote Peter Gotzsche, leader of the
Nordic Cochrane Centre in Copenhagen. He said governments 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, a list that often prompts governments or donor
agencies to buy the drug. Tamiflu is used to treat both seasonal flu and new
flu viruses like bird flu or swine flu. WHO spokesman Gregory Hartl said the
agency had enough proof to warrant its use for unusual influenza viruses, like
bird flu. “We do have substantive evidence it can stop or hinder progression to
severe disease like pneumonia,” he said.
In the U.S., the Centers for Disease Control and Prevention recommends
Tamiflu as one of two medications for treating regular flu. The other is
GlaxoSmithKline’s Relenza. The CDC says such antivirals can shorten the
duration of symptoms and reduce the risk of complications and hospitalization. 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.
In a statement, Roche said it had complied 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 U.S.
Source: Washington Times
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