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European Medicines Agency assesses safety reporting at Roche
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Roche pharmaceutical group did not inform regulators of around 80 000 cases of illness and death in patients receiving medicines marketed by the company in the USA. This non-reporting first came to light in May, 2012, in a report by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and was discussed at a recent meeting of the European Medicines Agency (EMA) Pharmacovigilance Working Party. The cases include 15 161 deaths of patients, related to drugs provided by Genentech, Roche’s US subsidiary, and distributed to uninsured patients as part of a patient support programme. These incidents had not been assessed to establish whether they should be reported to the European authorities as suspected adverse reactions. The EMA is working alongside national regulators to assess whether
the reporting deficiencies have affected the overall benefit–risk profile of any of the products involved. Kent Woods, from the MHRA (London, UK) said, “Patients should continue to take their medicines because our investigation into Roche has currently found no evidence of a safety risk to patients. Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate.” A spokesperson for Roche said that, ”The non-assessment and unreporting of these adverse events by Roche was not intentional and the company is working closely with health authorities, including the EMA, to implement corrective measures”. The EMA is trying to establish whether any of the events have already been reported to the European
authorities through other channels such as healthcare professionals. Other deficiencies identified related to the assessment and reporting of around 23 000 suspected adverse reactions from Roche’s reporting systems and about 600 clinical trials. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has asked Roche to ensure that all known reportable events are immediately reported to the European authorities. Roche must also submit an action plan for the assessment of all outstanding cases, and make plans for corrective measures. A spokesperson for the EMA explained that “[the EMA] will consider providing updates once the plan has been reviewed and discussed by our experts and CHMP as appropriate”.
Jim Varney/Science Photo Library
European Medicines Agency assesses safety reporting at Roche
Published Online June 29, 2012 http://dx.doi.org/10.1016/ S1470-2045(12)70297-8 For more on the Pharmacovigilance Working Party see http://www.ema. europa.eu/ema/index. jsp?curl=pages/contacts/CHMP/ people_listing_000019. jsp&mid=WC0b01ac0580028d92
Hilary Marshall
Preimplantation genetic diagnosis for mutated BRCA genes Preimplantation genetic diagnosis (PGD) in couples who carry mutated BRCA genes who want to avoid passing the risk on to their children is now “feasible and established”, European investigators say. In the largest reported cohort of couples to have used PGD to select embryos without BRCA1 or BRCA2 mutations, a team from Belgium and Holland reported 42 pregnancies in 40 women. 145 in-vitro fertilisation (IVF) cycles in 70 couples resulted in a pregnancy rate of 29% according to results presented at the European Society of Human Reproduction and Embryology annual conference in Istanbul, Turkey (July 1–4, 2012). Almost 60% of the mutation carriers were women, and two-thirds had a BRCA1 mutation. With an average age of 30 years (range 22–40 years), 26·2% of women with a mutation had www.thelancet.com/oncology Vol 13 August 2012
undergone a prophylactic bilateral mastectomy and six had a history of breast cancer. Of 717 embryos selected for genetic testing after IVF, 43·1% had a BRCA1 or BRCA2 mutation and 40·7% were suitable for transfer. Two pregnancies resulted from embryos cryopreserved before treatment with chemotherapy, but two women with the BRCA1 mutation were diagnosed with breast cancer within 3 months of PGD treatment, one of whom had a history of breast cancer. Study leader Willem Verpoest (Centre for Reproductive Medicine, Vrije Universiteit Brussels, Belgium) said that the theoretical risk of hormonal stimulation in these women at high-risk means careful monitoring will need to continue. He said ethical and safety concerns had led to slow uptake of the technique but that “it works well as far as we can
assess and we believe it is relatively safe”. “It is an option for couples who want to avoid the risk for their offspring but it will not become the default option for all couples”, he added. Late onset, reduced penetrance, and availability of preventive and therapeutic options for the disease are several reasons why PGD for couples with mutated BRCA genes has proven controversial. Paul Pharoah (Cambridge Cancer Centre, University of Cambridge, UK) said the study showed PGD for BRCA mutations was now “technically feasible”. “But major ethical questions remain. I don’t think there’s a strong reason not to offer this but it is a complex issue and a personal choice.” He added: “The view of patients will be heavily influenced by their own experience.”
Published Online July 6, 2012 http://dx.doi.org/10.1016/ S1470-2045(12)70321-2 For more on the study see http://www.eshre.eu/binarydata. aspx?type=doc&sessionId =s55jthnn1bxbh34550lhuq55/ Derks-Smeets.pdf
Emma Wilkinson e331
Roche pharmaceutical group did not inform regulators of around 80 000 cases of illness and death in patients receiving medicines marketed by the company in the USA. This non-reporting first came to light in May, 2012, in a report by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and was discussed at a recent meeting of the European Medicines Agency (EMA) Pharmacovigilance Working Party. The cases include 15 161 deaths of patients, related to drugs provided by Genentech, Roche’s US subsidiary, and distributed to uninsured patients as part of a patient support programme. These incidents had not been assessed to establish whether they should be reported to the European authorities as suspected adverse reactions. The EMA is working alongside national regulators to assess whether
the reporting deficiencies have affected the overall benefit–risk profile of any of the products involved. Kent Woods, from the MHRA (London, UK) said, “Patients should continue to take their medicines because our investigation into Roche has currently found no evidence of a safety risk to patients. Roche’s actions are unacceptable and our investigation has identified that Roche’s reporting systems are inadequate.” A spokesperson for Roche said that, ”The non-assessment and unreporting of these adverse events by Roche was not intentional and the company is working closely with health authorities, including the EMA, to implement corrective measures”. The EMA is trying to establish whether any of the events have already been reported to the European
authorities through other channels such as healthcare professionals. Other deficiencies identified related to the assessment and reporting of around 23 000 suspected adverse reactions from Roche’s reporting systems and about 600 clinical trials. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has asked Roche to ensure that all known reportable events are immediately reported to the European authorities. Roche must also submit an action plan for the assessment of all outstanding cases, and make plans for corrective measures. A spokesperson for the EMA explained that “[the EMA] will consider providing updates once the plan has been reviewed and discussed by our experts and CHMP as appropriate”.
Jim Varney/Science Photo Library
European Medicines Agency assesses safety reporting at Roche
Published Online June 29, 2012 http://dx.doi.org/10.1016/ S1470-2045(12)70297-8 For more on the Pharmacovigilance Working Party see http://www.ema. europa.eu/ema/index. jsp?curl=pages/contacts/CHMP/ people_listing_000019. jsp&mid=WC0b01ac0580028d92
Hilary Marshall
Preimplantation genetic diagnosis for mutated BRCA genes Preimplantation genetic diagnosis (PGD) in couples who carry mutated BRCA genes who want to avoid passing the risk on to their children is now “feasible and established”, European investigators say. In the largest reported cohort of couples to have used PGD to select embryos without BRCA1 or BRCA2 mutations, a team from Belgium and Holland reported 42 pregnancies in 40 women. 145 in-vitro fertilisation (IVF) cycles in 70 couples resulted in a pregnancy rate of 29% according to results presented at the European Society of Human Reproduction and Embryology annual conference in Istanbul, Turkey (July 1–4, 2012). Almost 60% of the mutation carriers were women, and two-thirds had a BRCA1 mutation. With an average age of 30 years (range 22–40 years), 26·2% of women with a mutation had www.thelancet.com/oncology Vol 13 August 2012
undergone a prophylactic bilateral mastectomy and six had a history of breast cancer. Of 717 embryos selected for genetic testing after IVF, 43·1% had a BRCA1 or BRCA2 mutation and 40·7% were suitable for transfer. Two pregnancies resulted from embryos cryopreserved before treatment with chemotherapy, but two women with the BRCA1 mutation were diagnosed with breast cancer within 3 months of PGD treatment, one of whom had a history of breast cancer. Study leader Willem Verpoest (Centre for Reproductive Medicine, Vrije Universiteit Brussels, Belgium) said that the theoretical risk of hormonal stimulation in these women at high-risk means careful monitoring will need to continue. He said ethical and safety concerns had led to slow uptake of the technique but that “it works well as far as we can
assess and we believe it is relatively safe”. “It is an option for couples who want to avoid the risk for their offspring but it will not become the default option for all couples”, he added. Late onset, reduced penetrance, and availability of preventive and therapeutic options for the disease are several reasons why PGD for couples with mutated BRCA genes has proven controversial. Paul Pharoah (Cambridge Cancer Centre, University of Cambridge, UK) said the study showed PGD for BRCA mutations was now “technically feasible”. “But major ethical questions remain. I don’t think there’s a strong reason not to offer this but it is a complex issue and a personal choice.” He added: “The view of patients will be heavily influenced by their own experience.”
Published Online July 6, 2012 http://dx.doi.org/10.1016/ S1470-2045(12)70321-2 For more on the study see http://www.eshre.eu/binarydata. aspx?type=doc&sessionId =s55jthnn1bxbh34550lhuq55/ Derks-Smeets.pdf
Emma Wilkinson e331