Drugmakers to publish more
data on trials By Andrew Jack in London
and Victoria Griffith in Boston Published: January 6 2005 00:52 |
Last updated: January 6 2005 00:52
The world's leading pharmaceutical companies will on
Thursday undertake to publish more data about clinical trials of
their drugs, in an effort to reassure patients about the safety of
their medicines.
The move, which is also designed to head off legislation
demanding disclosure, comes as fresh allegations surface that US
scientists manipulated trials of an anti-Aids drug in order to make
it seem more effective, thereby endangering of patients.
From Thursday, drug industry associations in the US, Europe and
Japan will co-ordinate an industry-wide plan to publish on the
internet detailed information on completed and current clinical
trials of their drugs. Although the scheme is voluntary, drugs
companies will be under great pressure to take part in it.
The move comes at a time of growing concern over drugs safety in
the wake of the withdrawal of Vioxx, the painkiller, and accusations
that data about Seroxat, an antidepressant, had been suppressed
because it showed no benefit in adolescents.
The plan will be seen as an attempt to pre-empt legislation, with
medicine-related hearings under way in the UK parliament and the US
Senate. The move comes as a legal group representing a former
official of the US National Institutes of Health (NIH) alleged it
had uncovered widespread misconduct in clinical trials of Aids
treatments funded by the agency.
Lawyers for Dr Jonathan Fishbein, who has accused the NIH of
endangering the lives of patients in an Aids trial in Uganda, said
the allegations involved a number of trials, including some outside
Africa. Dr Fishbein was director of the Office for Policy in
Clinical Research at the NIH's Aids division. His lawyers are set to
submit the data early next week to the Inspector General of the
Health and Human Services Department, the NIH's parent.
“We will be presenting evidence that questions the validity of
other trials and also shows a pattern of harassment and intimidation
at the NIH of any employees who raise questions about those trials,”
said Stephen Kohn, Dr Fishbein's lawyer. “People were threatened
with termination [of contract] if they took their concerns
public.”
More than 350 Aids trials are under way at the NIH. The US uses
the results to help form its international policy on Aids, which has
a $2.9bn (€2.2bn) budget for this year.
On Tuesday Dr Fishbein told investigators from the National
Academy of Sciences the Uganda trials may have ignored thousands of
serious side-effects and deaths among pregnant women taking the
Boehringer Ingelheim drug, Nevarapine, to prevent transmission to
their unborn children. Last month, South Africa's ruling party
accused US officials of using mothers in the Ugandan experiments as
guinea pigs. Concern has also emerged over drug resistance
developing after treatment with Nevarapine.
The NIH did not comment on Wednesday, but has said Dr Fishbein
was fired for poor performance. “This is not an Aids issue; this is
a scientific integrity issue,” he said. “I want the NIH held
accountable.”
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