羅氏隱瞞死亡報告 暢銷藥幾乎全中招??!!!!

 2012年07月10日 10:45 來源：羊城晚報 暢銷藥物幾乎全部中招；羅氏稱在中國上市藥品適應症與在歐美產品不同，對中國市場沒有影響 根據歐洲藥監局披露， 瑞士制藥巨頭羅氏公司因隱瞞8 萬份致死或副作用報告而被歐洲藥品監管部門緊急調查。記者了解到，涉及隱瞞的8 款藥物中，多為羅氏的暢銷藥，其中有5 款在中國已經上市。對此，羅氏昨日回應羊城晚報採訪時稱，在中國上市的藥品適應症與在歐美市場上市產品不同， 目前而言對中國市場沒有任何影響。

被指瞞報1.5 萬死亡報告 據歐洲藥監局披露，上述8 萬份被隱瞞的死亡或不良反應報告是英國藥品和健康產品管理局（MHRA）在對羅氏總部進行關於藥物安全警戒系統的例行檢查時發現的。據英國《每日郵報》 昨日報道， 這些報告最早可以追溯到1997 年。 據披露，在這8 萬份報告是羅氏制藥在美國市場進行藥品銷售的同時收集而來的，而這些報告均沒有經過評估是否應作為疑似不良反應向歐洲藥品監管部門報告。8 萬份報告中有1.5 份為患者死亡的報告， 但目前仍不清楚死亡案例是否與藥物存在因果聯繫。 MHRA方面表示， "羅氏公司的這種做法不能接受， 我們的調查已確定羅氏公司的藥物安全警戒系統存在不足。"為此，歐洲藥監局正對羅氏藥物安全警戒程式所存在的缺陷展開調查。 但由於目前沒有證據表明對病人產生負面影響， 因此調查期間暫時仍不需要病人或醫護專業人員採取任何行動。MHRA 認為， 因為目前未發現藥品存在安全風險，患者應繼續服藥。

暢銷藥物幾乎全部中招 報道稱， 涉及瞞報報告的至少有八款藥物，主要治療乳腺癌、腸癌、B 型肝炎、皮膚和眼睛等疾病。 昨日，記者從羅氏中國獲悉，此次涉及的乳腺癌藥物赫賽汀、惡性淋巴瘤藥美羅華、丙肝藥物派羅欣、直腸癌藥物安維汀、肺癌藥物特羅凱等五款藥在中國都有售。其中，美羅華、安維汀、赫賽汀、派羅欣還是去年羅氏全球銷量最好的藥物，銷售額分別為60 億、53 億、52 億、14億瑞士法郎。作為 全球最暢銷抗癌藥之一的赫賽汀，在華上市長達10 年；而特羅凱進入中國已經達到5 年； 美羅華早在2000 年就進入中國市場， 在華上市時間也長達12 年。 羅氏中國方面接受羊城晚報記者採訪時表示，8 萬份報告中涉及哪些藥物適應症目前還在調查當中， 而中國上市的藥品適應症與在歐美市場上市產品又有所不同，因此，目前而言對中國市場沒有任何影響。記者陸志霖報道   

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

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 medicationThere 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.

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