Exclusive:
Pharmaceutical giant resists claims despite settlement with victims in US
The Guardian, Sarah Boseley, health editor, Tuesday 29 January 2013
GlaxoSmithKline has agreed to payouts in US lawsuits alleging Avandia pills could cause heart attacks. Photograph: Bloomberg/Getty Images |
Thousands
of families in the UK could be deprived of compensation for the death or harm
of a relative caused by the diabetes drug Avandia, even though the British
maker has agreed to pay billions of dollars to settle similar claims in the US.
The licence
for Avandia was revoked in Europe, in September 2010, because of evidence that
it could cause heart failure and heart attacks. The drug can still be
prescribed in the US, but not to patients at risk of heart problems.
A scientist
with the Food and Drug Administration estimated that Avandia could have been
responsible for 100,000 heart attacks in the US.
The
manufacturer, GlaxoSmithKline, has admitted concealing data about the damaging
side-effects of the drug, and there is evidence of the drug's harmful effects.
But, despite this, GSK is not prepared to settle claims in the UK without a
court fight.
The history
of drug litigation in the UK suggests that families might not easily get compensation.
Daniel
Slade, with the Express company of solicitors in Manchester, has 19 cases on
his books and has begun proceedings against GSK in four of them.
The
pharmaceutical firm has told the solicitors that it will contest the cases. In
just one of the cases it has indicated a willingness to spend £600,000 on its
defence, which, the solicitor says, would be a fraction of what the claim is
worth.
"It is
very disappointing," said Slade. "We anticipate that these claims do
have a good prospect of success, but they still have to prove their case in the
UK with suitable evidence. They are tasked with having to produce that
evidence, including medical expert opinion. It is a burden one would have
thought they might not have to go through."
He expected
that, if GSK fought in the courts rather than settled outside, as it had done
in the US, it would take years for bereaved relatives, or those who have been
harmed, to get any sort of payment.
A spokesman
for GSK said: "We have every sympathy for people with complications
associated with diabetes and those who care for them, but unfortunately we are
unable to comment on individual legal cases. We continue to believe that the
company acted appropriately and responsibly in its management of Avandia."
Liz Thomas,
policy manager at the patient safety charity Action against Medical Accidents,
said it had "become increasingly difficult in the UK to challenge large
corporations such as pharmaceutical companies, an incredibly expensive form of
litigation".
Corporations
have a vast amount of money at their disposal to contest legal cases, but legal aid is about to cease for medical negligence cases.
The Avandia
cases in Manchester will be fought on a "no win, no fee" basis by
Express solicitors.
The cases in
the US were settled by GSK extremely quickly, said Thomas. "I would hope
they would not take advantage [in Britain] of the inequality of arms."
Avandia was
first introduced in the NHS in July 2000. It was given to people with type 2
diabetes whose glucose levels were no longer being properly controlled by the
standard drugs – metformin and a sulphonylurea drug. Avandia could be
prescribed with those drugs or on its own.
The drug,
which generically is known as rosiglitazone, was designed to lessen the body's
resistance to insulin. It was available as a standalone drug – Avandia – or in
a combination with metformin, and known as Avandamet.
When both
drugs were withdrawn by the European Medicines Agency, there were about 90,000
people taking them in the UK.
The first
warnings of trouble with Avandia came in 2007, when a prominent US scientist,
Steve Nissen, published data from a review of 42 clinical trials which had been
carried out on the drug. The trials involved 28,000 patients, and showed that
Avandia could cause heart attacks. Further trials, the results of which were
published in 2010, found people on Avandia were 27% more likely to have a
stroke, 25% more likely to have heart failure, and 14% more likely to die, than
patients on an alternative diabetes drug.
Potentially
yet more damaging for GSK was its guilty plea to federal charges of concealing
data about the drug's side effects. Most of the data on the drug comes from
GSK's own trials. In November 2011 GSK agreed to pay $3bn to the US government
over the Avandia issue and to end investigations into its marketing of the
antidepressants Paxil (Seroxat in the UK) and Wellbutrin.
"This
is a significant step toward resolving difficult, long-standing matters which
do not reflect the company that we are today," Andrew Witty, chief
executive of GlaxoSmithKline, said at the time.
GSK is also
still defending cases in the UK from people who claim to have been badly
affected by Seroxat. A group action, involving people who say they suffered
severe withdrawal problems when they tried to stop the drug, has been going on
for years though many claims have been settled in the US.
The same is
true of Vioxx, made by Merck, the painkiller that was withdrawn after it
emerged eight years ago that it doubled the risk of a heart attack.
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"The Recalibration of Dark & Light" – Feb 25, 2012 (Kryon channelled by Lee Carroll) (Subjects: Big pharma [the drug companies of America] are going to have to change very soon or collapse. When you have an industry that keeps people sick for money, it cannot survive in the new consciousness., Global Unity, ... etc.) - (Text version)
"The Recalibration of Awareness – Apr 20/21, 2012 (Kryon channeled by Lee Carroll)(Subjects: Old Energy, Recalibration Lectures, God / Creator, Religions/Spiritual systems (Catholic Church, Priests/Nun’s, Worship, John Paul Pope, Women in the Church otherwise church will go, Current Pope won’t do it), Middle East, Jews, Governments will change (Internet, Media, Democracies, Dictators, North Korea, Nations voted at once), Integrity (Businesses, Tobacco Companies, Bankers/ Financial Institutes, Pharmaceutical company to collapse), Illuminati (Based in Greece, Shipping, Financial markets, Stock markets, Pharmaceutical money (fund to build Africa to develop)), Shift of Human Consciousness, (Old) Souls, Women, Masters to/already come back, Global Unity.... etc.)
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