* Roche proposes advisory board to examine all Tamiflu data
* Follows lengthy fight by scientists and medical journal
* Offer comes as EU drugs agency meets to discuss openness
By Ben Hirschler
LONDON, Nov 22 (Reuters) – Roche has offered an
olive branch to scientific critics in a bid to end a bitter row
over blockbuster flu drug Tamiflu that has led to calls for a
boycott of the Swiss drugmaker’s products.
Tamiflu has been approved by regulators worldwide and
stockpiled by many governments in case of a global outbreak –
but some researchers claim there is little evidence it works and
have lobbied since 2009 for Roche to hand over all its data from
clinical trials.
Sales of the drug hit close to $3 billion in 2009, due to
the H1N1 swine flu pandemic, although they have since declined.
Roche’s pharmaceuticals head said on Thursday he had written
to the Cochrane Collaboration, a non-profit group that reviews
trial data to assess the value of drugs, offering to set up a
multi-party advisory board to review all the Tamiflu data.
The board of experts from academia and private institutions,
including Cochrane critics, would then agree on what analyses
were useful in assessing Tamiflu’s public health role.
“We think that would be an appropriate, fair and transparent
way of handling this debate,” Daniel O’Day said in an interview.
O’Day said complete transparency had to be balanced against
the need to protect patient privacy, respect commercial
sensitivity and ensure the scientific merit of any statistical
analysis.
He stopped short of matching a promise from rival
GlaxoSmithKline to make patient-level data from all
company-sponsored clinical trials available on a routine basis.
Roche said it had not handed over the full collection of
data requested by Cochrane because the group refused to sign a
confidentiality agreement.
Cochrane, meanwhile, has accused Roche of stonewalling and
urged a boycott of the company’s products until it publishes the
missing data. Its campaign to force Roche’s hand has been backed
by the respected British Medical Journal.
EU AGENCY PROMISES OPENNESS
The new attempt by Roche to break the deadlock comes as
regulators and healthcare experts meet in London to discuss ways
to increase transparency over clinical trials.
As Reuters reported in July, the European Medicines Agency
(EMA) aims to open its data vaults to systematic scrutiny, after
a ruling by the European Ombudsman that keeping data secret is
not compatible with the public interest.
Guido Rasi, executive director of the EMA, told the London
meeting on Thursday that the question now was “how” to publish
clinical trials data not “if” it should be released.
The move puts the EMA ahead of the U.S. Food and Drug
Administration (FDA) in terms of data transparency.
The EMA stance is also forcing drug companies to review how
far they can keep information they hold on medicines under
wraps.
Most companies have committed in recent years to publishing
results of clinical trials, either in journals or online, but
that openness has not so far extended to the raw data that lies
behind those trials.
Britain’s GlaxoSmithKline, however, broke ranks last
month when it announced that patient-level data from its
clinical trials of approved and failed drugs would be made
available to other researchers.
Roche’s O’Day said his company responded to requests for
such data on a case-by-case basis, provided scientists were
prepared to sign confidentiality agreements if needed, but this
did not mean all data should be released as a matter of course.
“To what level data will be shared proactively and
constantly is something we need to discuss,” he said.
A Roche spokesman said Cochrane had acknowledged receipt of
its proposal for a Tamiflu advisory board but had not given any
immediate response.
(Reporting by Ben Hirschler; Editing by Erica Billingham)
