One of the
world’s biggest drug companies is at the centre of an urgent investigation
after failing to disclose reports that 15,000 people died while taking its
medicines.
Swiss
pharmaceutical giant Roche failed to pass on a further 65,000 reports of
suspected side effects that were recorded by patients.
All of the
reactions took place in the United States over the past 15 years with medicines
used to treat breast cancer, bowel cancer, hepatitis B, and skin and eye
conditions.
 |
| Roche, one of the world's biggest drug companies, is at the centre of an urgent investigation after failing to report that people died while taking their medication |
There is no
evidence so far of any direct link
between the problems and the drugs – but medicines watchdogs say they are
taking Roche’s failure to disclose possible concerns ‘extremely seriously’.
The drugs
involved include Herceptin, given to about 10,000 breast cancer patients in
Britain, and Lucentis, which is used to treat about 20,000 UK patients a year
with age-related vision loss. The NHS pays Roche millions of pounds for these
treatments every year.
The extent
of the failings were discovered when the UK medicines watchdog, the Medicines
and Healthcare products Regulatory Agency (MHRA), carried out a routine
inspection of Roche’s drug safety procedures at its headquarters in Welwyn
Garden City, Hertfordshire.
The company
has now been ordered by the MHRA and the EU-wide regulator, the European
Medicines Agency, to investigate immediately each of the total 80,000 deaths
and side effects reported. Both agencies said they were ‘taking action’ over
Roche’s failures.
Professor
Sir Kent Woods, chief executive of the MHRA, said: ‘Patients should continue to
take their medicines because our investigation has currently found no evidence
of a safety risk to patients.
‘Roche’s
actions are unacceptable and our investigation has identified that its
reporting systems are inadequate. We are taking urgent action to ensure that
these are rectified by Roche as a matter of priority. We will take action to
ensure that patients are protected now and in the future.’
All of the
deaths and possible adverse reactions were reported by patients who rang a call
centre run by Roche’s US subsidiary Genentech. Staff there failed to pass on
the reports to Roche’s drug safety team – but it is not known why.
Roche,
which made profits of £6.3 billion in 2010, has a legal duty to examine every
suspected side effect and report them to regulators around the world so that
potential safety concerns can be investigated.
This means
that each side effect reported to the patient support call centre should have
been immediately sent to the safety team to be assessed.
These must
then be sent to regulators – within 15 days for the most serious reactions –
even if no link between the drug and the reaction be proved.
Some of the
call centre’s records, which date back to 1997, are said to have been noted
down on paper and kept in boxes.
The
European Medicines Agency, which made the findings public, said: ‘There is at
present no evidence of a negative impact for patients and while the
investigations and being conducted there is no need for patients or healthcare
professionals to take any action.’
 |
| A number of drugs are being investigated following the incident |
However, a
spokeswoman added: ‘It’s not often we
make statements on such findings, so we do take this incredibly seriously. The
numbers are huge but we’re not talking about confirmed reactions.
‘Some might
not be related, and some may have already been reported to the regulators via
other mechanisms – for example directly to us by doctors.’ But she added: ‘We
cannot rule out that additional safety concerns could be discovered.’
When asked
if legal action could be taken against Roche, she said: ‘We are looking at all
options. There are penalty regulations and they could be fined.’
Other drugs
being examined include Avastin, used for
bowel and breast cancer; lung cancer medication Tarceva; Rituxan, which treats
non-Hodgkin’s lymphoma; the stroke drug Alteplase; Actemra for rheumatoid
arthritis; Pegasys for hepatitis B; and Raptiva for the skin condition
psoriasis.
If any new
safety concerns emerge after examining the data, regulators could decide to
withdraw the drugs or change their guidance to doctors.
In a statement,
Roche said: ‘Patient safety is of paramount importance to Roche. We acknowledge
the concerns that can be caused by this issue for people using our medicines.
‘The
non-assessment and non-reporting of these adverse events was not intentional
and we are taking comprehensive steps necessary to address the findings of the
MHRA inspection. We have provided initial estimates of missed adverse events
and are in the process of confirming the final number.
‘We expect
to complete all activities related to these programmes as soon as possible.’
Related Article:
"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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