On Friday 11th October, you may have seen an opinion piece in the Telegraph entitled Why Alzheimer's patients still face a 'Valley of Death?’ The article was written by Martha Gill following the most recent discovery in Alzheimer’s research- that giving mice a protective chemical can stop brain degeneration at the outset of the disease. While recognising this development is ‘a big turning event’, the article presents a bleak future for Alzheimer patients and for medical research in general. But the picture isn’t as black as Gill paints it.
Evidence of the benefits of medical research
Medical research charities are a critical part of the UK life sciences sector. Each year AMRC members spend more than £1bn on basic scientific research in universities and translational research within the NHS, often working in partnership with public and private investors. And, despite regulatory and scientific difficulties, there have been some incredible successes. For instance, Anti TNF therapy, developed with funding from Arthritis Research UK, has revolutionised the treatment of rheumatoid arthritis and also generated many millions in income for the charity which it continues to invest in new research. In the cancer field Abiraterone, developed at the UK's Institute of Cancer Research with funding by Cancer Research UK among others, has offered a new treatment for advanced prostate cancer where previously none existed.
The future of medical research
The article discusses the ethical and regulatory constraints which Gill believes make the road from lab to patients “impassable.” However, progress is being made in these areas. The regulatory environment for new trials is improving under the auspices of the Health Research Authority as it seeks to create a single approval point for clinical trials. It can, and indeed must, be slicker. But careful consideration of the ethical implications of clinical trials testing new treatments on the public is an important responsibility and one we must not erode in our search for speed.
What more can be done?
More than the ethical constraints, what is really needed is a regulatory framework for drug licensing that combines a vital focus on patient safety with a drive to speed licences for those diseases for which there are currently no cures. These so-called adaptive licenses would be an important means of accelerating the testing and possible adoption of new treatments, sensitive to where patients' perceptions of risk may be different to those of an ethics committee, with the result of both reducing the cost of drug development to charities and industry and also offering some hope to patients where few viable therapies exist. Campaigns like Empower: Access to Medicines and Lord Saatchi’s Medical Innovation Bill are focusing minds and the Centre for the Advancement of Sustainable Medical Innovation (CASMI) is leading work in this area with academics, regulators and funders identifying what is needed to take forward this patient progressive access. In this area, the UK can potentially learn from the American system where the US Food and Drug Administration is once again ahead of us on this issue.