Latest topics
» Project Camelot - SIMON PARKES: LATEST NEWS AND COMMENTARY
Today at 12:18 am by PurpleSkyz

» More on the Hiker that dies not too far away from the Solar Observatory, New Mexico
Yesterday at 11:45 pm by PurpleSkyz

» #Q Anon: Q ANON:PANIC IN DC! ROTHSCHILD SKULL ISSUES! EPSTEIN ISLAND! plus more
Yesterday at 9:06 pm by PurpleSkyz

» De- Regulating of Human Medicine and Animal Medicine these people are Criminals
Yesterday at 3:18 pm by Consciousness Of Economic

» Carrying Stones & Digging Holes Radio Show September 15, 2018
Yesterday at 3:08 pm by Consciousness Of Economic

» POOFness for SEPT 16: SINGIN' IN THE RAIN - SO LET THE DONATIONS POUR DOWN ON ME!
Yesterday at 1:22 pm by 4-truth

» New Michael Tellinger Some of the Strangest Discoveries Ever Made on Ancient Origins
Yesterday at 9:43 am by PurpleSkyz

» Rock Hunter Discovers Unusual Glowing Florescent Rocks Called “Yooperlites”
Yesterday at 9:37 am by PurpleSkyz

» Unexplained Google Earth discovery in Utah
Yesterday at 9:29 am by PurpleSkyz

» #Q Anon - Q - Pain - Lynch Talking plus more
Yesterday at 9:27 am by PurpleSkyz

» UFO News ~ UFOs Sighted Over Toronto, Canada plus MORE
Yesterday at 9:23 am by PurpleSkyz

» BOOM! Trump Declassifies Fisa Documents!
Yesterday at 9:18 am by PurpleSkyz

» NIBIRU News ~ WORLD WIDE footages of NIBIRU PLANETX incoming binary system worldwide sighting plus MORE
Yesterday at 9:16 am by PurpleSkyz

» Harvest Moon Rising - The Most Beautiful Full Moon of the Year Coming Next Week
Yesterday at 9:11 am by PurpleSkyz

» The Spider’s Web: Britain’s Second Empire
Yesterday at 9:07 am by PurpleSkyz

» Flynn's Plea Deal will SHOCK You!!
Yesterday at 12:14 am by Serena1

» A Message To and From Th3 Ḧḭṽḕ Collective
Yesterday at 12:13 am by PurpleSkyz

» Strange Series of Anomalies Stretching Across Pacific Ocean
Yesterday at 12:04 am by PurpleSkyz

» Bad-clown Rising - TO EACH HIS OWN
Yesterday at 12:00 am by PurpleSkyz

» FADE TO BLACK w/ Linda Moulton Howe : The National Solar Observatory
Mon Sep 17, 2018 10:19 pm by PurpleSkyz

CLICK THE SUBSCRIBE BUTTON BELOW TO RECEIVE OUR DAILY NEWSLETTER

A 2ND EMAIL COMPLETES THE ACTIVATION PROCESS




CLICK THE PURPLE BUTTON TO VIEW OUR LATEST POSTS



You are not connected. Please login or register

Out Of Mind » THE INSANITY OF REALITY » VACCINE TRUTHS: MEDICAL INDUSTRY LIES » Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions’

Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions’

Go down  Message [Page 1 of 1]

PurpleSkyz

avatar
Admin
Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions’
Posted on July 8, 2012 by Laura Tyco
4 Votes

By Jo Macfarlane

PUBLISHED: 21:48 GMT, 7 July 2012 | UPDATED: 13:20 GMT, 8 July 2012

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.

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

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.’

Read more: http://www.dailymail.co.uk/news/article-2170317/Roche-investigation-UK-watchdogs-80-000-adverse-reactions.html#ixzz202yUmSQE
Roche under investigation by UK watchdogs after 80,000 ‘adverse reactions’ | Mail Online.

Share this:



  

Back to top  Message [Page 1 of 1]

Permissions in this forum:
You cannot reply to topics in this forum