Tuesday, 27 November 2012

Drug policy for an aging population

#MSBlog: "Most trials exclude older MSers; apologies I don't make the rules!"

"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."

"I did mention to him the new European initiative to force Pharma companies to include elderly subjects in clinical trials. You may want to read the article that covers this issue. It is interesting that this issue also raises the problem of the "elephant in the room", i.e. the rapidly inflating costs of drug development. We all want cheap drugs! By forcing the Pharma industry to test drugs in children, and now elderly people, has knock on effects and will simply increase the price tag associated with new drugs further. 

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!"

Cerreta et al. Drug policy for an aging population--the European Medicines Agency's geriatric medicines strategy. N Engl J Med. 2012; 367:1972-4.

 
.... In almost every country, the proportion of people over 60 years of age is growing faster than any other age group, as a result of longer life expectancy and declining fertility rates. In Europe, the median age is already the highest in the world, ......

...... 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.....



2 comments:

  1. The cost of drugs for dementia is going to be a time bomb for the future. How are we going to be able to provide these drugs for an ageing population for possibly 30-40 years? Maybe the drug regulatory bodies should look at simplifying the trials necessary for re purposing drugs. Unless the drug companies get anything out of it they are not going to do these trials, therefore, maybe we need a central body like the EMA or FDA funded by a small tax on every drug sold by pharma, who would fund these trials

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  2. Either tax the pharma more heavily or change the system and create a state-governed drug making by supporting eg. university-based research, however, I am not an economist.

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