The independent, Jeremy laurance, 20 September 2012
 |
Trust in
the pharmaceutical industry among doctors has fallen so low that
they dismiss
clinical trials funded by it (Alamy)
|
The global
pharmaceutical industry has racked up fines of more than $11bn in the past
three years for criminal wrongdoing, including withholding safety data and
promoting drugs for use beyond their licensed conditions.
In all, 26
companies, including eight of the 10 top players in the global industry, have
been found to be acting dishonestly. The scale of the wrongdoing, revealed for
the first time, has undermined public and professional trust in the industry
and is holding back clinical progress, according to two papers published in
today's New England Journal of Medicine. Leading lawyers have warned that the
multibillion-dollar fines are not enough to change the industry's behaviour.
The 26
firms are under "corporate integrity agreements", which are imposed
in the US when healthcare wrongdoing is detected, and place the companies on
notice for good behaviour for up to five years.
The largest
fine of $3bn, imposed on the UK-based company GlaxoSmith-Kline in July after it
admitted three counts of criminal behaviour in the US courts, was the largest
ever. But GSK is not alone – nine other companies have had fines imposed,
ranging from $420m on Novartis to $2.3bn on Pfizer since 2009, totalling over
$11bn.
Kevin
Outterson, a lawyer at Boston University, says that despite the eye watering
size of the fines they amount to a small proportion of the companies' total
revenues and may be regarded as a "cost of doing business". The $3bn
fine on GSK represents 10.8 per cent of its revenue while the $1.5bn fine
imposed on Abbott Laboratories, for promoting a drug (Depakote) with inadequate
evidence of its effectiveness, amounted to 12 per cent.
Mr
Outterson said: "Companies might well view such fines as a quite small
percentage of their global revenue. If so, little has been done to change the
system. The government merely recoups a portion of the financial fruit of
firms' past misdeeds."
He argues
that penalties should be imposed on executives rather than the company as
whole. He cites a Boston whistleblower attorney, Robert Thomas who observed
that GSK had committed a $1bn crime and "no individual has been held
responsible".
Following
GSK's admission that it had withheld safety data about its best-selling
diabetes drug Avandia, the company pledged to make more clinical trial
information available. But the pledge has "disturbing exceptions",
according to Mr Outterson, and in any case is made under the corporate integrity
agreement, which expires in five years.
Trust in
the industry among doctors has fallen so low that they dismiss clinical trials
funded by it, even when the trials have been conducted with scientific rigour,
according to a second paper in the journal by researchers at Brigham and
Women's Hospital, Boston. This could have serious implications because most
medical research is funded by the drug industry and "if physicians are
reluctant to trust all such research, it could hinder the translation of …
research into practice," said Aaron Kesselheim, who led the study.
Andrew
Witty, the chief executive of GSK, said at the time of the $3bn settlement last
July that it had resolved "difficult, long-standing matters" for the
company and that there had since been a "fundamental change in
procedures" including the removal of staff engaged in misconduct and
changes to incentive payments.
The
Association of the British Pharmaceutical Industry said practices in the
industry had improved and more changes to "build greater levels of
trust" would be made. The UK Medicines and Healthcare Products Regulatory
Agency said it monitored the conduct of companies and took "appropriate
action" when it uncovered malpractice.
Alzheimer's
funding 'must continue'
Governments,
universities and charities should step in to ensure funding is maintained for
research into Alzheimer's disease, following a series of failed drug trials,
experts said yesterday.
They were
responding to a report in The Independent that the world's leading drug
companies are giving up on the search for a cure, scaling back their
neuroscience departments and focusing on symptomatic, rather than
disease-modifying, treatments.
A spokesman
for the Alzheimer's Society said: "This is not the time to back away from
dementia research. Despite costing the economy more than cancer and heart
disease, funding for research into dementia is only a fraction of these
conditions. More funding is urgently needed if we are to defeat it."
Jeremy Laurance
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