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Research funding under review in UK and USA
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Research funding under review in UK and USA depend on biomarkers and imaging studies rather than on clinical studies”, he said. The Act would also allow clinical experience or observational studies to substitute for randomised trials when assessing the efficacy of existing drugs to treat illnesses for which they have not been approved. “That would really take us back to the 1950s in terms of how we evaluate drugs”, contends Avorn. “It creates tremendous leverage for those who want to force the FDA not to rely on more rigorous studies.” The 21st Century Cures Act looks likely to become law, although senators will doubtless apply amendments of their own. Meanwhile, in the UK, the future of publicly funded research remained uncertain as reports emerged that the government has hired management consultancy McKinsey and Company to review the activities of the seven research councils, including the Medical Research Council (MRC). The Department of Business, Skills, and Innovation, which funds the councils, acknowledged McKinsey’s involvement but declined to comment further. “As part of the government’s commitment to reducing the deficit we are looking at how we can cut operating costs across Departments and partner organisations”, a spokesperson said. It is unclear how the McKinsey review, which has not been officially announced, fits with the review of the research councils chaired by Sir Paul Nurse. The Nurse review was launched by the previous coalition government in late 2014 with a remit to examine how the councils can “evolve to support research in the most effective way”. It began its public consultation in March, 2015, and is expected to issue its findings later this year. Despite the size of its task, the McKinsey review will apparently be finished within the next few weeks. Last year’s Triennial review concluded that “individually [the research councils] are operating from a position of strength”.
The picture should become clearer when all the reviews are published. “Public health research has been a strength of the UK and is inherently multidisciplinary”, commented the Faculty of Public Health’s Carol Brayne. “Any future funding structures must not only promote globally strong research in specific disciplines but also recognise that creative types of funding mechanisms and research evidence generation are critical for capacity building, strengthening our existing research base and making our research pounds go further.” The MRC received around £600 million from the government for 2015–16. But by funding research, the government encourages others to do the same. “Between 2006–2013, MRC investment of £3·5 billion led to a further £1·5 billion commitment from charities”, noted the Wellcome Trust in its submission to the Nurse review. It added that “for every £1 spent by the government on research and development, private sector research and development output rises by 20 p per year in perpetuity”. Even in times of austerity, public investment in research pays dividends. Politicians on both sides of the Atlantic will continue to wrestle with the question of how best to maximise that investment.
Lancet Oncol 2015 Published Online August 14, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)00228-4
Talha Khan Burki
www.thelancet.com/oncology Published online August 14, 2015 http://dx.doi.org/10.1016/S1470-2045(15)00228-4
Alison Wright/Corbis/ Michael Mahovlich/Masterfile/Corbis
On July 10, 2015, the US House of Representatives passed the 21st Century Cures Act. This Act, which had widespread cross-party support, recommends an inflation-adjusted 3% increase in the budget for the National Institutes of Health (NIH) for the next 3 years. It also recommends releasing a further US$9·3 billion over the next 5 years for the NIH to establish an innovation fund. But experts were divided on the merits of other provisions within the legislation, which has yet to reach the Senate. The Act emerged from the Energy and Commerce Committee, where it was passed unanimously, with the stated aim of “accelerat[ing] the discovery, development and delivery of life-saving and life-improving therapies”. The UK’s Accelerated Access Review has a similar aim; it is due to report back to the government at the end of the year. The US Act would allow for de-identified clinical trial data from NIH-funded studies to be made available to other researchers, and ease the regulatory requirements for producers of medical devices. It also provides for a loosening of the US Food and Drug Administration (FDA) criteria for drug approval, encouraging the use of appropriate biomarkers and other surrogate endpoints, rather than clinical endpoints, to assess a drug’s efficacy. Jerry Avorn (Harvard University, Cambridge, MA, USA) has misgivings. “There is a worrisome trend towards getting far too permissive in allowing drugs to be approved without demonstrating actual clinical benefit to patients, but instead demonstrating one of these intermediary endpoints”, he said. Avorn gave the example of bevacizumab, which improved progression-free survival in patients with metastatic breast cancer without any meaningful overall survival or quality-of-life benefit to the patient. “That is the kind of problem that will come up again and again if we start to
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Research funding under review in UK and USA depend on biomarkers and imaging studies rather than on clinical studies”, he said. The Act would also allow clinical experience or observational studies to substitute for randomised trials when assessing the efficacy of existing drugs to treat illnesses for which they have not been approved. “That would really take us back to the 1950s in terms of how we evaluate drugs”, contends Avorn. “It creates tremendous leverage for those who want to force the FDA not to rely on more rigorous studies.” The 21st Century Cures Act looks likely to become law, although senators will doubtless apply amendments of their own. Meanwhile, in the UK, the future of publicly funded research remained uncertain as reports emerged that the government has hired management consultancy McKinsey and Company to review the activities of the seven research councils, including the Medical Research Council (MRC). The Department of Business, Skills, and Innovation, which funds the councils, acknowledged McKinsey’s involvement but declined to comment further. “As part of the government’s commitment to reducing the deficit we are looking at how we can cut operating costs across Departments and partner organisations”, a spokesperson said. It is unclear how the McKinsey review, which has not been officially announced, fits with the review of the research councils chaired by Sir Paul Nurse. The Nurse review was launched by the previous coalition government in late 2014 with a remit to examine how the councils can “evolve to support research in the most effective way”. It began its public consultation in March, 2015, and is expected to issue its findings later this year. Despite the size of its task, the McKinsey review will apparently be finished within the next few weeks. Last year’s Triennial review concluded that “individually [the research councils] are operating from a position of strength”.
The picture should become clearer when all the reviews are published. “Public health research has been a strength of the UK and is inherently multidisciplinary”, commented the Faculty of Public Health’s Carol Brayne. “Any future funding structures must not only promote globally strong research in specific disciplines but also recognise that creative types of funding mechanisms and research evidence generation are critical for capacity building, strengthening our existing research base and making our research pounds go further.” The MRC received around £600 million from the government for 2015–16. But by funding research, the government encourages others to do the same. “Between 2006–2013, MRC investment of £3·5 billion led to a further £1·5 billion commitment from charities”, noted the Wellcome Trust in its submission to the Nurse review. It added that “for every £1 spent by the government on research and development, private sector research and development output rises by 20 p per year in perpetuity”. Even in times of austerity, public investment in research pays dividends. Politicians on both sides of the Atlantic will continue to wrestle with the question of how best to maximise that investment.
Lancet Oncol 2015 Published Online August 14, 2015 http://dx.doi.org/10.1016/ S1470-2045(15)00228-4
Talha Khan Burki
www.thelancet.com/oncology Published online August 14, 2015 http://dx.doi.org/10.1016/S1470-2045(15)00228-4
Alison Wright/Corbis/ Michael Mahovlich/Masterfile/Corbis
On July 10, 2015, the US House of Representatives passed the 21st Century Cures Act. This Act, which had widespread cross-party support, recommends an inflation-adjusted 3% increase in the budget for the National Institutes of Health (NIH) for the next 3 years. It also recommends releasing a further US$9·3 billion over the next 5 years for the NIH to establish an innovation fund. But experts were divided on the merits of other provisions within the legislation, which has yet to reach the Senate. The Act emerged from the Energy and Commerce Committee, where it was passed unanimously, with the stated aim of “accelerat[ing] the discovery, development and delivery of life-saving and life-improving therapies”. The UK’s Accelerated Access Review has a similar aim; it is due to report back to the government at the end of the year. The US Act would allow for de-identified clinical trial data from NIH-funded studies to be made available to other researchers, and ease the regulatory requirements for producers of medical devices. It also provides for a loosening of the US Food and Drug Administration (FDA) criteria for drug approval, encouraging the use of appropriate biomarkers and other surrogate endpoints, rather than clinical endpoints, to assess a drug’s efficacy. Jerry Avorn (Harvard University, Cambridge, MA, USA) has misgivings. “There is a worrisome trend towards getting far too permissive in allowing drugs to be approved without demonstrating actual clinical benefit to patients, but instead demonstrating one of these intermediary endpoints”, he said. Avorn gave the example of bevacizumab, which improved progression-free survival in patients with metastatic breast cancer without any meaningful overall survival or quality-of-life benefit to the patient. “That is the kind of problem that will come up again and again if we start to
1