I love when the mainstream media deigns to report on something like this: Roch is under investigation for not disclosing 15,000 patient deaths and over 80,000 adverse reactions. "Love"... that's sarcasm. They put out a splashy headline to grab attention, then in the middle of the article they always add that "quick say something so that we don't get sued for slander, or loose them as an advertisers!!"
"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’."
There is "NO EVIDENCE"?!? Seriously? Just read the package inserts!! One of the drugs mentioned in the article is Herceptin, which is used in the treatment of breast cancer. From the package insert directly from the manufacturer Roche, lists side effects like:
- Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death [see Boxed Warning: Cardiomyopathy]. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). There is a 46 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin
- In postmarketing reports, serious and fatal infusion reactions have been reported. Severe reactions which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion.
- For fatal events, death occurred within hours to days following a serious infusion reaction.
- Herceptin can cause fetal harm when administered to a pregnant woman. In post-marketing reports, use of Herceptin during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
- Herceptin use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis.
So there is no evidence of there being a direct link between the problems and the medications.... yet the product manufacture states that there is. Hmmmmmmm
Basically, my point here is that a) as per usual, the main stream media are liars, and b) don't take ANY drug without reading the package insert, from front to back.
Drug giant probed for not disclosing 15,000 patient death reports: Roche under investigation by UK watchdogs after 80,000 'adverse reactions'
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.
Read more: http://www.dailymail.co.uk/news/article-2170317/Roche-investigation-UK-watchdogs-80-000-adverse-reactions.html#ixzz23Y6Z4si3