“At the end of the ‘Living with MS‘ meeting at the weekend MouseDoctor and I were fielding questions from MSers. One MSer chastised me for presenting new and up-coming clinical trials that all have, or will have, an upper cut-off age for recruitment. He was over 70.
He then accused me of being ageist. I apologised and said I don’t make the rules. That is a bit of lie as I sit on committees that make some of the rules. The problem is that MS is viewed as a young persons disease and by the time MSers are over 60, or 70, they are at a stage of the disease that is confounded by age-related diseases, including natural ageing.”
One of the biggest drivers of drug development costs are pre and post-marketing regulatory requirements. The generation of data to satisfy regulatory authorities and payers is simply driving-up costs and they are rapidly approaching a level that is unsustainable.
What should we do about this problem? I am not sure, but a sensible debate would be a starting point. At some stage we need to be pragmatic about drug development and focus on developing drugs for the age of austerity. There is little point developing drugs that half the world can’t afford to use. Drugs for MSers are no exception!”
…… Although population aging is a mark of the success of public health policies, it also challenges the established way of implementing such policies. In the case of the European Medicines Agency (EMA), it has prompted an analysis of whether the regulatory system is adapted to taking the needs of older people into account in the development, approval, and use of medications…..
…… The process started in 2006, when the EMA provided an opinion on the adequacy of guidance on the elderly regarding medicinal products. In 2011, the agency’s Committee for Human Medicinal Products adopted the EMA geriatric medicines strategy, marking its commitment to improving our understanding of how best to evaluate the benefit–risk ratio for a medication in older patients…..
…… First, the strategy recognizes that older people are the main users of medications — not a minority or special population (a fundamental difference between the geriatric and pediatric populations). Therefore, legislative and regulatory frameworks must be designed to ensure that the use of newly approved medicines in the intended population is supported by relevant data on the benefit–risk balance. The strategy’s second aim is to improve the availability of information to patients and prescribers, to support safer use of medications…..