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

By Jo Macfarlane

PUBLISHED: 16:48 EST, 7 July 2012 | UPDATED: 16:48 EST, 7 July 2012

One of the worlds 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 Roches 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 Roches 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 Roches failures.

Read the original post:
Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80 ...